March 2012: Adding a link here to RxISK ORG from Data Based Medicine 'the first free website (not sponsored by big pharma or advertising) for patients and their doctors to research, and more importantly, easily report drug side effects'.
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Paula
This message has been edited by peagee on Jun 15, 2002 11:40 AM
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Mothershara
Article from Idaho Observer stating Bush Administration in bed with GSK
The British newspaper, "The Guardian" has provided several clues that indicate how pharmaceutical companies are able buy government complicity in efforts to market dangerous prescription drugs without having first demonstrated their safety or efficacy with independent scientific studies. Information published by The Guardian shows that the powerful Pharmaceutical Research and Manufacturers Association (PhRMA) contributes heavily to the political campaigns of certain politicians and has managed to place pro-PhRMA persons in positions of policy-making authority.
".[T]he distinction between the interests of the pharmaceutical industry and the Bush presidency have blurred. There is a fast-spinning revolving door between government and the pharmaceutical industry," wrote Julian Borger of The Guardian.
"Mitch Daniels, the new director of the office of management and budget in the White House, was formerly the vice-president for strategy and policy at the pharmaceutical giant, Eli Lilly. Two members of the Bush transition team, Anne Marie Lynch and Bill Walters, are PhRMA members. Three others were selected from big pharmaceutical firms," The Guardian reported.
"The PhRMA doesn't need to lobby," Democratic congressman Sherrod Brown said in a memo to staff last month. "The industry is in the White House already."
Historically the pharma industry covered its political bases by making campaign contributions to both Republicans and Democrats. This last election cycle, however, the industry reportedly placed most of its campaign contribution chips on Republicans. The pharma cartel apparently had reason to believe that Republicans were going to gain control of Capitol Hill and $billions were at stake amid the hotly debated campaign issue of who was going to pay the rising costs of drugging the elderly.
"The [pharmaceutical] industry spent nearly 70 percent of its unprecedented $24.4 million campaign war chest on the Republicans," reported The Guardian February 11, 2001.
GW reportedly received the greatest amount of pharmaceutical company campaign contribution largesse and Senator Orrin Hatch (R-Utah) came in second after having received $340,000 from the industry.
Under the Bush administration, The Guardian predicts that, "The U.S. government is expected to return to its customary role as a battering ram for the interests of the pharmaceutical industry."
"[Understanding] the political ties of the drug companies is key to understanding why we have [dangerous] drugs remaining on the market." commented Dr. Ann Blake Tracy, Executive Director of the International Coalition for Drug Awareness (www.drugawareness.org)
Dr. Tracy is also the author of “Prozac: Panacea or Pandora's Box?” Dr. Tracy's well documented attempts to make the pharma industry realize the dangers of its "therapeutic" psychotropic drugs has repeatedly fallen on deaf ears.
In recent years we have seen how the pharma cartel has been able to force dozens of products into the marketplace. As a result, millions of people are being damaged by vaccines, psychotropics, birth control pills, diet pills and other drugs that have side effects that range from nausea and neurological complications to death.
The problem is destined to get worse as mega mergers in the pharmaceutical industry are creating multinational corporate behemoths with assets greater than entire continents. "The combined worth of the world's top five drug companies is twice the combined GDP of all sub-Saharan Africa and their influence on the rules of world trade is many times stronger because they can bring their wealth to bear directly on the levers of western power," reported The Guardian.
In the second part of a series entitled, "George Bush's America,” Borger observed what he refers to as a "pantheon of corporate muscle," Washington, D.C., "teems with a thousand industrial lobbyists. They cluster around the band of luxury offices and expensive restaurants which stretches from the White House to the Capitol building - a two-mile axis along which money and power are constantly traded." He added that "no industry wields as much power as PhRMA," which he described as, "a pressure group breathtaking for its deep pockets and aggression, even by the standards of U.S. politics."
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Corrections and Clarifications
"Footnotes for The Buying of the Congress" Article
March 31 2002, 11:40 AM
Footnotes for The Buying of the Congress
Chapter 8 — Prescription for Disasters
Page 143
Where was my government?" Testimony of Dorothy C. Wilson before the House Energy and Commerce Subcommittee on Health and the Environment, July 29, 1993.
many more accidents waiting to happen." Ibid.
Page 144
two decades with virtually no regulation. "Hearing Examines L-Tryptophan Regulation," Nutrition Forum, November 1992, p. 481.
thousands of birth defects here. Morton Mintz, "The Cure That Could Kill You: FDA Reforms Are Bad Medicine," The Washington Post, July 14, 1996, p. C1.
meet even that basic standard. Michele Robinson, "Senate Panel Searches for Compromise on Regulation of Drug Promotional Materials," BioWorld Today, February 23, 1996.
to pure food and drugs. Mintz, "The Cure That Could Kill You: FDA Reforms Are Bad Medicine."
Page 145
for those "off-label" purposes. Michael Conlan, "Unapproved Uses Prove Worrisome," Drug Topics, October 21, 1996, p. 60.
are safe for young users. Testimony of Sanford N. Cohen, for the American Academy of Pediatrics, before the House Commerce Subcommittee on Health and the Environment, April 23, 1997.
to them differently than adults. Ibid.
routinely fail to do so. Mintz, "The Cure That Could Kill You: FDA Reforms Are Bad Medicine."
to prescribe certain medications. Kasper Zeuthen, "FDA Loosens Restrictions on Drug Ads on TV, Radio: Commercial Can Now Reveal Purpose of Product Without Listing Side Effects and Warnings," Los Angeles Times, August 9, 1997, p. A12.
side effects and other important concerns. Ibid.
in the billions of dollars. Jeff Gelles, "Drug-Ad Boom: A Prescription for Problems? Critics Say the Marketing Is Distorted. Proponents Say Consumers Will Be Better Informed." The Philadelphia Inquirer, August 17, 1997, p. A1.
Page 146
products are safe and effective. "Bid to Weaken the FDA Masquerades as Reform," Los Angeles Times, August 4, 1997, p. B4.
tune of nearly $28 million. The Center for Public Integrity, analysis of 1987-96 campaign finance records.
in the 1996 elections. Ibid.
giving $746,835 in 1995-96. Ibid.
Glaxo Wellcome’s PAC in 1996. Ibid.
$57,000 to the thirteen Democrats. Robert Dreyfuss, "Popping Contributions: The New Battle for the FDA," The American Prospect, July/August 1997, p. 53.
Page 147
an Eli Lilly corporate jet. Larry Margasak, "Lawmakers Fly High on Corporate Planes," Associated Press, May 29, 1997.
on a Glaxo Wellcome airplane. Ibid.
his 1996 Senate reelection campaign. Ibid.
at his party’s 1996 convention. Sharon Schmickle and Tom Hamburger, "Campaign Loopholes Let Cash Flow at Lavish Parties for the Powerful," Star Tribune, August 13, 1996, p. A1.
fees to Capitol Hill lawmakers. The Center for Public Integrity, analysis of 1987-96 financial disclosure forms.
according to public filings. The Center for Public Integrity, analysis of 1996 lobbying disclosure forms.
the Generic Pharmaceutical Industry Association. Ibid.
giant to export its products. Ibid.
several former Capitol Hill lawmakers. Chris O’Brien, "How Glaxo Sells Itself to Congress: The Drug Giant’s Prescription for Power: PACs, Lobbying, and Official Encouragement of Employees’ Grass-Roots Efforts," The News and Observer (Raleigh, N.C.), February 23, 1997, p. A1.
Page 148
out of the public’s pockets. John Maggs, "Drug Firms Fight to Preserve Windfall," Journal of Commerce, September 28, 1995, p. A1.
break to the drug companies?" National Public Radio, Morning Edition, October 26, 1995, transcript #1724-15.
political contributions from 1990 to 1995. O’Brien, "How Glaxo Sells Itself to Congress: The Drug Giant’s Prescription for Power: PACs, Lobbying, and Official Encouragement of Employees’ Grass-Roots Efforts."
also received $15,000 in political contributions from 1990 to 1995. Ibid.
will be the prime beneficiary. Ibid.
that got the patent extension. Interview with Rick Sluder, October 15, 1997.
Page 149
from drug and biotechnology companies. Robert Pear, "Lawyers and Lobbyists Help Guide Effort by Republicans to Speed Drug Approvals," The New York Times, March 4, 1996, p. A15.
invested $623,000 in such efforts. Michael Tarsala, "Lilly, Others Fund Drive to Reform FDA: Firms Gave Millions to Think Tanks Backing Watchdog’s Reduced Role, Public Citizen Reports," The Indianapolis Star, July 24, 1996, p. A5.
ties to House Speaker Newt Gingrich. Peter Stone, "The Demolition Prescription: Industry Leaders and Lawmakers Want to Overhaul the Food and Drug Administration," The Orlando Sentinel, March 26, 1995, p. G1.
and introduced tariff-lifting legislation. Ibid.
"a thug and a bully." Ibid.
precautions on new drugs "excessive." Progress and Freedom Foundation, "Advancing Medical Innovation: Health, Safety, and the Role of Government in the 21st Century," downloaded from www.pff.org.
it’s an independent study." Interview with Tom Lenard, October 15, 1997.
Page 150
"fast track" toward early passage. Thomas Bliley, "FDA Still Needs Reform Despite Improvements," Roll Call, September 16, 1996.
clients include drug companies. Robert Pear, "Lawyers and Lobbyists Help Guide Effort by Republicans to Speed Drug Approvals."
a pinkie finger into it." Ibid.
the FDA had not approved. Ibid.
fifty years of public protection." John Schwartz and Ruth Marcus, "FDA Reformers Race the Calendar: Sponsors of New Plan Expect Legislation to Reach House Floor Before August Recess," The Washington Post, July 13, 1996, p. A4.
Page 151
at our peril," he warned. Testimony of Thomas J. Moore, before the Senate Labor and Human Relations Committee, February 22, 1996.
drug is safe and effective." Michele Robinson, "Senate Panel Searches for Compromise on Regulation of Drug Promotional Materials," BioWorld Today, February 23, 1996.
Hawkins told the Center. Interview with James Hawkins, November 16, 1997.
Page 152
quickly before the recess. "Bid to Weaken the FDA Masquerades as Reform: Drug Companies Fail to Sneak Past the Senate . . . Barely." Los Angeles Times, August 4, 1997, p. B4.
knowing what’s in the bill." Ibid.
the way into the future." Lawrence Knutson, "Clinton Signs FDA Overhaul for Speedier Drug Approvals," Associated Press, November 21, 1997.
Page 153
these drugs for off-label use. Statement of Lewis J. Rubin, September 23, 1997, downloaded from www.publiccitizen.org
medical journals and other sources. General Accounting Office, "Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies," September 1991.
to aid in weight loss. Christine Gorman, "Double-Duty Drugs: Approved Medications Are Being Widely Prescribed for Unapproved Uses," Time, September 18, 1995, p. 96.
market it for that purpose. Francesca L. Kritz, "Some Drugs Perform More Than One Thing," Good Housekeeping, September 17, 1995, p. 22.
off-label use was relatively rare, Testimony of Sarah Jagger, director of Health Services Quality and Public Health Issues, General Accounting Office, before the House Government Reform and Oversight Subcommittee on Human Resources and Intergovernmental Relations, September 12, 1996.
upward of 5,000 off-label uses. Kritz, "Some Drugs Perform More Than One Thing."
Page 154
patients with milder heart problems. "Flawed Studies Helped Cardiac Drugs Take Off," USA Today, September 12, 1995, p. A2.
cardiac arrests in some patients. Thomas J. Moore, "Sugar-Coating a Bitter Pill: Sweet Talk Aside, the GOP and the Pharmaceutical Industry Want to Cripple Safety Testing," The Washington Post, March 10, 1996, p. C1.
died after taking the drugs. Ibid.
rule violated the First Amendment. John Schwartz, "FDA Is Told Not to Block Drug Data," The Washington Post, July 31, 1998, p. A23.
of drugs for untested purposes. S. 1477, bill summary and status, 104th Congress, downloaded from thomas.loc.gov.
incentive to avoid FDA review. Testimony of Michael Friedman before the House Government Reform and Oversight Subcommittee on Human Resources and Intergovernmental Relations, September 12, 1996.
Page 155
several hundred children had died. Elizabeth Stone, "Move On to Approve Kid Drugs," The Star-Ledger (Newark, N.J.), December 31, 1995.
and loss of their teeth. Ibid.
have received approval for children. Testimony of Sanford N. Cohen, for the American Academy of Pediatrics, before the House Commerce Subcommittee on Health and the Environment, April 23, 1997.
doses appropriate for their age." Ibid.
written for children each year. Food and Drug Administration, "Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients," Federal Register, August 15, 1997, downloaded from wais.access.gpo.gov.
annually to patients under twelve, Ibid.
elevated blood pressure, and nausea. United States Pharmacopeia, downloaded from www.usp.org.
to patients under sixteen. Food and Drug Administration, "Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients."
47 percent from 1995 to 1996. Barbara Strauch, "Use of Antidepression Medicine for Young Patients Has Soared," The New York Times, August 10, 1997, p. A1.
Page 156
what risks it might pose. Stone, "Move On to Approve Kid Drugs."
induce violent or suicidal behavior. United States Pharmacopeia, downloaded from www.usp.org.
one-third who took the placebo. Cherry Norton, "Child Depression Rates Reach 10%," The Sunday Times (London), December 7, 1997.
much as $30,000 per participant. Stone, "Move On to Approve Kid Drugs."
100,000 young patients a year. Statement of President Bill Clinton, White House press release, August 13, 1997.
to treat their young patients." Ibid.
Page 157
to $21 million a year. Laurie McGinley, "Clinton to Call for Drug Testing on Children for New Medicines," The Wall Street Journal, August 12, 1997.
an unfounded sense of security." Peter Breggin, Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock, and Biochemical Theories of the "New Psychiatry," New York: St. Martin’s Press, 1995, p. 168.
stimulant used to treat ADHD. "Agency Survey Reports Overuse of Ritalin Among U.S. Children," The Brown University Child and Adolescent Behavior Letter, March 1996, p. 3.
don’t improve while taking it. Alfie Kohn, "Suffer the Restless Children: Though Nearly a Million Children Are Regularly Given Drugs to Control Hyperactivity, We Know Little About What the Disorder Is, or Whether It Is Really a Disorder at All." The Atlantic, November 1989, p. 90.
disturbances; and elevate blood pressure. Ibid.
which may not be reversible. "Stimulant Medication May Cause Motor Tics in Children," United Press International, March 26, 1982.
long-term effects are no known. Michelle Gammaitoni, "Attention-Deficit/Hyperactivity Disorder: Treatments of Children and Adults," American Druggist, May 1997, p. 58.
(CHADD), a parents’ lobby. Karen Thomas, "Ritalin Maker’s Ties to Advocates Probed: Financial Link Called Understated," USA Today, November 16, 1995, p. D14.
commonly used to treat it. Interview with Todd Forte, March 25, 1998.
Page 158
rose from 22,000 to 150,000. Rebecca Perl, "Ritalin: Controversial Stimulant: Overdoses Raise Questions About Alternative Drug," The Atlanta Journal-Constitution, November 8, 1992, p. D6.
thirty-one children died from overdoses. Ibid.
appropriate safety and efficacy studies." Testimony of Richard Wurtman before the House Government Operations Subcommittee on Human Resources and Intergovernmental Relations, July 18, 1991.
an accident waiting to happen." Ibid.
Page 159
Congress was not on its side. Testimony of Mary Pendergast, Food and Drug Administration attorney, before the House Government Operations Subcommittee on Human Resources and Intergovernmental Relations, July 18, 1991.
health foods, took no action. Ibid.
worth of L-tryptophan a year. Leslie Berkman, "Group Hopes to Get FDA to Lift Ban on Tryptophan," Los Angeles Times, July 10, 1990, p. D5.
worst cases, EMS was fatal. Christina LeBeau, "Attorney Presses Suits Against Japanese Maker of Amino Acid," Rochester Business Journal, July 10, 1992, p. 1.
all three patients had taken L-tryptophan. Lawrence Altman, "The Doctor’s World: How Medical Detectives Identified the Culprit Behind a Rare Disorder," The New York Times, November 28, 1989, p. C3.
a recall of the supplement. LeBeau, "Attorney Presses Suits Against Japanese Maker of Amino Acid."
more than 1,500, including twenty-one deaths. Sandra Boodman, "Prednisone Effective in L-Tryptophan Cases," The Washington Post, June 6, 1995, p. 5 (Health section).
genetically engineered microorganism fermented L-tryptophan. "Illness Is Tied to Way Diet Additive Was Made," Associated Press, August 9, 1990.
Page 160
victims in the United States. "Showa Denko to Clear Cumulative Loss Over Damage in U.S.," Japan Economic Newswire, February 17, 1997.
a purified form, was safe. Carolyn Lockhead, "Discrepancies in FDA Regulations," The San Francisco Chronicle, November 11, 1993, p. A14.
occurred in 1978 in Montreal. Victor Herbert, "L-Tryptophan: A Methodological Case Against Over-the-Counter Marketing of Supplements of Amino Acids," Nutrition Today, March 1992, p. 27.
reduced its filtering in 1988. David Wilson, "Tracking Down a Killer," National Journal, October 13, 1990, p. 2491.
posed by L-tryptophan, including osteoporosis. Herbert, "L-Tryptophan: A Methodological Case Against Over-the-Counter Marketing of Supplements of Amino Acids."
liver cancer in laboratory animals. Benedict Carey, "Bitter Pill: Side Effects of L-Tryptophan," In Health, January 1991, p. 74; Sandy Rovner, "Natural but Not Always Safe," The Washington Post, November 28, 1989, p. 11 (Health section).
1,500 in the United States. Ken Sugar, "Tighter Regulation May Have Averted L-Tryptophan Problem," Associated Press, May 17, 1990.
can prove that it is dangerous. Marie McCullough, "Herbs, Oils, and Your Health: A Debate on Supplements," The Philadelphia Inquirer, August 24, 1997.
Page 161
treat, cure, or prevent any disease. Ibid.
access to "low-cost medicine." Statement of Representative Frank Pallone, The Congressional Record, October 24, 1995.
FDA approval was withdrawn. Kathleen McCleary, "Are We Safe from the FDA?" Health, April 1991, p. 34.
manufacturer learns of the problem. Paula Kurtzweil, "German Firm Fined Under FD&C Act," FDA Consumer, September 1991, p. 42.
illnesses in the United States. Tim Weiner, "Drug’s Deadly Side Effects Spark Whodunit," The Chicago Tribune, January 6, 1985, p. C1.
Page 162
nonfatal liver and kidney failure. Morton Mintz, "Eli Lilly Pleads Guilty in Arthritis-Drug Case: Fined $25,000 for Failing to Report Side Effects to FDA," The Washington Post, August 22, 1985, p. A1; letter from Eli Lilly and Company to the Center for Public Integrity, March 31, 1998.
including the popular antidepressant Zoloft. "FDA Warns Pfizer to Report Rx Problems Promptly," Drug Topics, May 20, 1996, p. 7.
and analyses" of the drug. "Drug-Firm Employees Testify About Halcion," Bloomberg News, May 2, 1997.
enforcement proceedings were not warranted." Interview with Kaye Bennett, Pharmacia & Upjohn spokesperson, March 31, 1998.
statute enacted by Congress allowed. Weiner, "Drug’s Deadly Side Effects Spark Whodunit."
to about $1,538 per death. Mintz, "Eli Lilly Pleads Guilty in Arthritis-Drug Case: Fined $25,000 for Failing to Report Side Effects to FDA."
for taking on drug companies. Michael Day, "U.S. Drug Safety Regime ‘Flawed,’" New Scientist, November 9, 1996, p. 10.
Page 163
make sixty dollars an hour." Katie Rodgers, "Counseling for Bed-Wetting: New Business Opportunity. Pharmacists Can Offer Advice," Drug Topics, April 8, 1996, p. 61.
his youthful bed-wetting experience. "Campaign Focuses on Educating the Public, Not Selling a Brand," Healthcare PR and Marketing News, January 23, 1997.
for that person, it gets prescribed." Interview with Doug Arbesfeld, October 15, 1997.
of the nine-year-old prescription drug. "Campaign Focuses on Educating the Public, Not Selling a Brand."
which Desmopressin treatment is based). Sally Squires, "Bed-Wetting a Common Inconvenience: Though It May Worry Young Campers and Their Parents, Doctors Say Most Cases Resolve Themselves," The Washington Post, April 8, 1997, p. 17 (Health section).
far more effective than drugs. "Alarm Called Best for Treating Bed-Wetting," Urology Times, January 1995, p. 19.
Page 164
Jeff Gelles, "Drug-Ad Boom: A Prescription for Problems? Critics Say the Marketing Is Distorted. Proponents Say Consumers Will Be Better Informed," The Philadelphia Inquirer, August 17, 1997, p. A1.
loosened restrictions on television advertising. Ibid.
more information can be obtained. Ibid.
Page 165
drug companies more than the FDA. Testimony of Jeff Bloom, executive director, Patients’ Coalition, before the House Commerce Subcommittee on Health and the Environment, April 23, 1997.
This message has been edited by peagee on Jun 15, 2002 11:50 AM
As drug gets remade, concerns about suicides surface
By Leah R. Garnett, Globe Staff, 5/7/2000
Just as the 14-year patent on Prozac is about to expire and the drug's maker, Eli Lilly and Co., is preparing to launch a new and improved Prozac, a body of evidence has come to light revealing the antidepressant's dark side.
The company's internal documents, some dating to the mid-1980s, as well as government applications and patents, indicate that the pharmaceutical giant has known for years that its best-selling drug could cause suicidal reactions in a small but significant number of patients. The reports could become critical as Lilly seeks government approval for its new Prozac.
Among the findings:
Internal documents show that in 1990, Lilly scientists were pressured by corporate executives to alter records on physician experiences with Prozac, changing mentions of suicide attempt to ''overdose'' and suicidal thoughts to ''depression.''
Three years before Prozac received approval by the US Food and Drug Administration in late 1987, the German BGA, that country's FDA equivalent, had such serious reservations about Prozac's safety that it refused to approve the antidepressant based on Lilly's studies showing that previously nonsuicidal patients who took the drug had a fivefold higher rate of suicides and suicide attempts than those on older antidepressants, and a threefold higher rate than those taking placebos.
Lilly's own figures, in reports made available to the Globe, indicate that 1 in 100 previously nonsuicidal patients who took the drug in early clinical trials developed a severe form of anxiety and agitation called akathisia, causing them to attempt or commit suicide during the studies.
Though Lilly has steadfastly defended the drug's safety and downplayed studies linking Prozac to suicide, the patent for the new Prozac, R-fluoxetine, expected to be marketed by Lilly beginning in 2002, notes that the new version will not produce several existing side effects including ''akathisia, suicidal thoughts, and self-mutilation,'' which the patent calls ''one of its more significant side effects.''
A McLean Hospital researcher and associate professor at Harvard Medical School, Dr. Martin Teicher, whose early 1990s studies linked Prozac to akathisia and suicide, is a co-inventor of the new Prozac, which Lilly plans to market, along with Timothy J. Barberich, the CEO of Sepracor Inc., a Marlborough drug company, and James W. Young.
A just-published book, ''Prozac Backlash,'' by a Cambridge psychiatrist, Dr. Joseph Glenmullen, has drawn Lilly's ire for discussing Prozac's link to suicide, tics, withdrawal symptoms, and other side effects of Prozac and similar antidepressants.
Lilly officials continue to defend the drug's effectiveness, saying its track record is borne out by the fact it is still the most widely prescribed drug of its kind. In a written statement, Jeff Newton, a Lilly spokesman, said: ''There is no credible evidence that establishes a causal link between Prozac and violent or suicidal behavior. There is, to the contrary, scientific evidence showing that Prozac and medicines like it actually protect against such behaviors.''
Using figures on Prozac both from Lilly and independent research, however, Dr. David Healy, an expert on the brain's serotonin system and director of the North Wales Department of Psychological Medicine at the University of Wales, estimated that ''probably 50,000 people have committed suicide on Prozac since its launch, over and above the number who would have done so if left untreated.''
Healy, meanwhile, is conducting a new study that he says is the first of its kind, giving antidepressants to healthy people to study possible links to suicide. The results are expected to be published in June.
Prozac's success is certainly unquestioned. The introduction of the drug to the US market in the late 1980s changed the way Americans viewed their most intimate emotions and limitations. Billed as a wonder drug to combat depression by boosting levels of the brain chemical serotonin, Prozac and others like it were also said to remedy a host of human frailties from poor self-esteem and concentration to fear of rejection.
By the end of last year, more than 35 million people worldwide were using the drug, which provided Lilly with more than 25 percent of its $10 billion in 1999 revenue.
Yet the problems with Prozac were known even before it was introduced to the US market. Figures in a 1984 Lilly document indicated that akathisia, the severe agitation that can lead to suicide, occurs in at least 1 percent of patients, a level considered a ''frequent'' event, and as such must be disclosed in a company's product literature and package inserts. But there is no such disclosure in Prozac's US literature, and it is not clear whether the FDA panel charged with approving Prozac simply overlooked or did not have access to certain critical data of Lilly's.
As a result, researchers say that most US doctors do not know to warn patients of the potentially dangerous effect which, according to published literature on the topic, can be alleviated with sedatives or by going off the drug.
German regulators, who eventually approved Prozac for use in that country, require a warning label about the risk of suicide and suggest the concurrent use of sedatives when necessary.
Akathisia is listed in Lilly's US product literature, but as an infrequent event in Prozac users. No mention is made of its potential relationship to suicide.
A relationship, however, was found in a Globe search of US patents. The patent for the new Prozac or R-fluoxetine (US Patent no. 5,708,035), which Lilly will market after the existing patent expires in 2001, contains a wealth of information about the original Prozac. According to the patent, the new Prozac will decrease side effects of the existing Prozac such as headaches, nervousness, anxiety, and insomnia, as well as ''inner restlessness (akathisia), suicidal thoughts and self-mutilation'' - the same effect Lilly has contended has not occurred in any substantial way in some 200 lawsuits against it over the past decade. Most of the suits were settled out of court and the terms kept confidential.
A 1990 communique
In an electronic communique obtained by author Glenmullen dated Nov. 13, 1990, from Claude Bouchy, a Lilly employee in Germany, to three Lilly corporate executives at the company's Indianapolis headquarters, Bouchy says he and a colleague ''have problems with the directions our safety people are getting from the corporate group (Drug Epidemiology Unit) and requesting that we change the identification of events as they are reported by the physicians. ... Our safety staff is requested to change the event term `suicide attempt' [as reported by the physician] to `overdose.'''
Bouchy continued that ''... it is requested that we change ... `suicidal ideation' to `depression.'''
And then Bouchy makes an appeal to his US Lilly colleagues: ''I do not think I could explain to the BGA, to a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicide ideation. At least not with the explanations that have been given to our staff so far.''
Lilly has also aggressively sought to discredit researchers who published data linking its product to suicide. One of its early targets was Dr. Martin Teicher, an associate professor of psychiatry at Harvard Medical School and a McLean Hospital researcher, who wrote a crucial paper on the link between suicide and Prozac in 1990; he found that 3.5 percent of patients put on Prozac either attempt or commit suicide due to severe agitation from akathisia. As a result of Lilly's campaign, many in the psychiatric community say they believe Teicher has distanced himself from his original work. But in a rare interview with the Globe, Teicher said that he stood by his work, and that the ability of Prozac to induce suicide in a minority of patients ''is a real phenomenon.''
Teicher, Barberich, and Young filed their patent for the new Prozac in August 1993, the same year Teicher published another report, this one in the journal Drug Safety titled ''Antidepressant Drugs and the Emergence of Suicidal Tendencies.''
The paper was a direct challenge to data reported in the March 1991 issue of the Journal of Clinical Psychiatry by Drs. Maurizio Fava and Jerrold Rosenbaum of Massachusetts General Hospital. Their study found no significant difference in ''suicidal ideation'' in patients treated with fluoxetine compared to those receiving other antidepressants.
Teicher wrote in his 1993 paper that Fava and Rosenbaum's statistics were flawed. Using Fava and Rosenbaum's data, Teicher came to the opposite conclusion: namely, that patients on Prozac were at least three times more likely to become suicidal than those on older antidepressants.
The FDA came up with similar results even before Teicher published his 1993 data. Dr. David Graham, chief of the FDA's Epidemiology Branch, wrote on Sept. 11, 1990, that Lilly's data on suicide and Prozac, as well as the Fava and Rosenbaum study, were insufficient to prove that Prozac was safe. In an internal FDA memo, Graham wrote: ''Because of apparent large-scale underreporting, the firm's analysis cannot be considered as proving that fluoxetine and violent behavior are unrelated.''
''Prozac Backlash''
Now a decade later, Lilly has targeted Dr. Joseph Glenmullen, whose book ''Prozac Backlash'' has apparently incensed Lilly executives.
Glenmullen, a clinical instructor in psychiatry at Harvard Medical School and a clinician at the Harvard University Health Services, says he wrote the book because he was alarmed by the number of patients who were reporting severe side effects from the serotonin-boosting antidepressants including Prozac, Paxil, Zoloft, and Luvox. ''The two most upsetting side effects were patients becoming suicidal on the drugs, and the development of disfiguring facial tics,'' he said in an interview.
After obtaining hundreds of pages of FDA documents through the Freedom of Information Act, as well as internal Lilly memos that are part of the public record in lawsuits filed against the drug company, Glenmullen says he believes he sees a pattern: that since the mid-1980s, Lilly had tried to squelch its own findings on the link between Prozac and suicide.
Lilly alerted newspapers and TV stations to the book and began a campaign to discredit the author, saying Glenmullen, a graduate of Harvard Medical School, had inflated his resume, and that top officials of the school were unfamiliar with his work and did not recognize his name. Glenmullen is one of more than 420 clinical instructors in medicine at Harvard.
Blast from a critic
Chief among Glenmullen's critics is Mass. General's Rosenbaum, a professor of psychiatry at Harvard Medical School, who, in a written statement sent to the Globe calls ''Prozac Backlash'' a ''dishonest book'' that is '' manipulative'' and ''mischievous.''
But Rosenbaum's objectivity has also been questioned. Not only was his 1991 study on Prozac and suicide criticized by at least two sets of researchers as well as the FDA, documents obtained by the Globe show that Rosenbaum's relationship to Lilly is a cozy one: he served as a Prozac researcher and sat on a marketing advisory panel for Lilly before Prozac was launched.
When asked in an interview why he was speaking out against Glenmullen's book, Rosenbaum said that the suicide controversy was ''old news'' and that the book presents the information as new research. He noted that akathisia is ''pretty rare'' and that ''it doesn't occur more than in people given a placebo.''
But because there is no official reporting system for drug side effects, no one knows how common drug side effects are, said Larry Sasich, a research analyst at Public Citizen in Washington, D.C.
''There is no active surveillance system to look at adverse events,'' he said. ''Unless something very unfortunate happens and a large number of people are harmed in a unique way, no one is going to look at it; nobody ever puts two and two together.''
Sepracor's patent
On April 12, the Federal Trade Commission opened the way for Lilly to market Teicher's, Barberich's, and Young's new Prozac, for which Sepracor holds the patent. The new Prozac, R-fluoxetine, is a modified form of an active ingredient found in Prozac, which, according to Sepracor, not only has fewer side effects but more potential uses and benefits than the original Prozac.
In making the decision, the FTC rejected arguments from its lawyers and the generic drug industry that the agreement unfairly limits generic Prozac competition.
According to a Sepracor press release dated April 13, the company will receive an upfront payment and license fee of $20 million from Lilly and an additional $70 million based on the progression of the drug. Sepracor will receive royalties, and in exchange, Lilly will get the exclusive world rights to R-fluoxetine for all indications and uses. Lilly will be responsible for the development of the drug, regulatory submissions, product manufacturing, marketing and sales, according to the release.
Glenmullen wonders whether the new, improved Prozac will, in fact, be little more than an effort to prolong the life of a product with a soon-to-expire patent. Although it is touted as having fewer side effects, no one knows what effects may surface once large numbers of people begin taking it for months or years. In the epilogue to his book, he simply says: ''Like any new drug, it too will be an ongoing experiment.''
This story ran on page A01 of the Boston Globe on 5/7/2000."
Paula
Psychiatrist settles out of Court after job withdrawn.
"Psychiatrist settles out of court after job withdrawn
EducationGuardian.co.uk
Polly Curtis
Guardian Unlimited
Tuesday May 7, 2002
Dr David Healy, the British psychiatrist who sued the University of Toronto for withdrawing a job offer after he gave a lecture criticising a product made by one of its sponsors, has settled his case for an undisclosed sum.
Dr Healy and the university announced the settlement late last week in a joint statement. It followed mediation out of court.
According to the statement, Dr Healy "accepts assurances that pharmaceutical companies played no role in either CAMH's [Centre for Addiction and Mental Health] decision to rescind his clinical appointment, or the University of Toronto's decision to rescind his academic appointment following upon the rescission of his clinical appointment."
The university also announced it would appoint Dr Healy as a visiting professor to the faculty of medicine for a three-year term to show its support for the "free expression of critical views."
Dr Healy, director of the University of North Wales' department of psychological medicine and author of the definitive history of anti-depressant drugs, brought the £4.14m action against the centre after it withdrew the offer of a clinical appointment a week after he gave a talk in which he said there was a link between the use of a group of anti-depressant drugs, including Prozac, and suicide.
Dr Healy, who the university had pursued for the post for a year, claimed the withdrawal of the offer was linked to the fact that Prozac manufacturers Eli Lilly had funded CAMH.
The action had three components - breach of contract, libel and academic freedom.
Today, Dr Healey told EducationGuardian.co.uk that he had settled the case in order to get on with his work, which included highlighting the issues surrounding the use of anti-depressant drugs and issues regarding academic freedom.
He said: "I was clear that I wouldn't settle for anything that left me gagged, so I'm free to talk about the case, and glad to move on."
The case was the first to question the notion of academic freedom in Canada. Two Nobel laureates and 25 other internationally respected scientists came out in support of Dr Healy.
Dr Healy said he is still concerned about the use of anti-depressant drugs known as Selective Serotonin Re-uptake Inhibitors.
"I think they can be the right drug for some people; I still use them, but I give warnings of the hazards," he said.
"The critical issue is that there are hazards - I don't think anyone will find that surprising. What is surprising is that the companies deny that anything can go wrong. The evidence is increasingly clear that it is a hazard, and less rare than even I once thought."
Peas
This message has been edited by peagee on May 25, 2002 11:27 AM
Last night David Healy presented "Drug Story" on Channel 4 TV (UK) but I'm still searching for a link that I can post here which will give a synopsis of the program. The link above seems to only show a picture from that program without linking specifically to any information on it. If anyone can find one - please post on this board as I don't have much time left. Thanks.
paula
DR HEALY's CASE HIGHLIGHTS PHARMA/ACADEMIA RELATIONSHIP
"Bitter pill
David Healy's open criticism of Prozac took him to a US court - and brought the relationship between academic institutions and the pharmaceutical companies centre stage
Sarah Boseley
Guardian
Tuesday May 21, 2002
It took nearly 17 months, and the intervention of a batch of Nobel prizewinners, but at last a major international bust-up over academic freedom and the deep pockets of the pharmaceutical companies, fought out between psychiatrist David Healy and the University of Toronto, has been settled, out of court. The dust, however, will take longer to disperse.
Dr Healy is director of the North Wales department of psychological medicine, Bangor, which is part of the University of Wales College of Medicine. He is well known both as one of the foremost historians of psychopharmacology and as an outspoken critic of the Prozac class of antidepressants. Toronto may have sought him on the first count, but it was certainly well aware of the second when it offered him a psychiatry professorship in August 2000. By the end of the year, however, with only the immigration paperwork to complete, the job offer had been withdrawn abruptly. Quite why, and how, is a story with Le Carré reverberations.
The accusation at the heart of the affair was that the drug companies, and certain influential figures in psychiatry who receive large consultancy fees from them, scuppered Dr Healy's prospects in Toronto. The Centre for Addiction and Mental Health (CAMH) - where Dr Healy would have held a clinical role as director of the mood and anxiety programme, in addition to his academic post - has received more than $1.5m in recent years from Eli Lilly, the manufacturers of Prozac.
Lilly and other manufacturers of SSRIs (selective serotonin reuptake inhibitors) - as the Prozac class of drugs is known - have crossed swords with Dr Healy in the US courts. Dr Healy has been an expert witness against them, backing the claims of families who say the drugs have caused people to kill and commit suicide. In June 2001, just six months after his Toronto job was rescinded, a US jury agreed with him that Paxil (Seroxat in the UK), an SSRI manufactured by the British giant GlaxoSmithKline, caused Donald Schell to kill his wife, daughter, granddaughter and himself and awarded the remaining family members £4.2m compensation.
The Canadian Association of University Teachers (CAUT) backed Dr Healy with a passion when his job loss became public. For them, there was a troubling resonance with the case of Nancy Olivieri, the Toronto-based researcher who incurred the wrath of a pharmaceutical company when she told the world of the results of a clinical trial which showed, she believed, that a drug for thalassaemia would harm, rather than help, sick children. The Hospital for Sick Children, where she worked, part of the University of Toronto, tried to fire her when she refused to cooperate with an investigating committee whose members, she said, had too many links to drug companies.
With the backing of CAUT, Dr Healy began a legal action against the university. The case became high profile and a long list of respected scientists from all over the world, including Nobel prizewinners, signed a petition in defence of academic freedom. On April 29 a settlement was announced which was described as "a complete vindication for Dr Healy" by Vic Catano, president of CAUT. The University stated that "it underscores its support for free expression of critical views and acknowledges Dr Healy's scholarship by confirming it will be appointing him as a visiting professor in the faculty of medicine."
For his part, Dr Healy accepted that there had been no direct contact between the university and any of the drug companies before his job was rescinded. He never thought there had been, he says. The problem is deeper-rooted. The influence of the pharmaceutical industry within psychiatry is all-pervasive, he says, and in the case of some senior academics it is hard to see where their interests and those of the companies diverge.
It all went wrong for Dr Healy on November 30 2000, when he gave a lecture at CAMH. It was very well received by much of the audience both there and then a few days later at Cornell in New York. But David Goldbloom, physician-in-chief at CAMH, who was to be Dr Healy's new boss, was upset. People would take two things from the lecture, he told Dr Healy: first that Prozac caused people to commit suicide and second that antidepressants were too widely used. Within days he had emailed Dr Healy saying he had something urgent to discuss, and on December 7 he told him the job offer was rescinded on the grounds that there was "not a good fit" between him and CAMH.
The lecture was clearly key. Dr Goldbloom claimed many of those who would have been colleagues of Dr Healy's at CAMH were unhappy with it. But Dr Healy finds that surprising. "Almost any lecture I gave could have caused the problem," he said. More to the point, he believes, was the presence of Charles Nemeroff, a professor of psychopharmacology at Emory University in Atlanta at CAMH for the two-day meeting, has strong links to, and at the time held shares in, Eli Lilly, GlaxoSmithKline and Pfizer.
Professor Nemeroff, headlined "Boss of bosses" in the psychiatric journal Ten, which asked "Is the brash and controversial Charles Nemeroff the most powerful man in psychiatry?" and described him as "among the most coveted advisers to the pharmaceutical industry", was asked by the university for his opinion of Dr Healy's science, said his lawyer, Nina Gussack. The professor, said Ms Gussack,"finds himself to be at the very opposite end of the spectrum" from Healy on the issue of Prozac and suicide.
Discussion and debate is the very stuff academia. But Dr Healy found that his views were not being challenged in the lecture theatre or the seminar room - they were being undermined in private conversations. Somebody rang senior figures at Cornell, where he was due to speak just after Toronto, suggesting that he was manic depressive and even violent. But the lecture went ahead.
After the job offer was rescinded, another academic suddenly entered the fray against Dr Healy, but this time publicly. James Coyne, professor of psychology in the department of psychiatry at the University of Pennsylvania, says he first became involved because the Toronto Globe and Mail asked him for an opinion of a study of healthy volunteers that Dr Healy carried out in North Wales in which two out of 20 became suicidal on SSRIs. He expressed his firm opinion to the newspaper, and later to the British Medical Journal, that it was unethical because the volunteers were from Dr Healy's own hospital. The result, he told the Guardian, anyway "strains credibility" and had been blown up out of proportion. He told the BMJ that "as a paid expert witness, Dr Healy had a financial interest in the outcome of this 'study'" that should have been declared.
Professor Coyne told the Globe and Mail that he did not have drug company funding for his research. His name, however, is on the Eli Lilly website as a member of a committee handing out awards "to recognise excellence and courage in the mental health community". He is also a member of the Depression Knowledge Center Advisory Board, which describes itself as an independent institution, but is funded by Solvay Pharmaceuticals, which manufactures an SSRI.
The professor says he was paid $1,000 by Chamberlain Communications to judge an Eli Lilly-funded award. It was Chamberlain that organised prominent scientists to write reviews of the book Prozac Backlash, lambasting it for its criticisms of Lilly's best-selling drug, which were then sent to newspapers. Professor Coyne says he was also paid $400 indirectly by Solvay for an article criticising over-reliance on antidepressants at the end of life. "I leave for you to decide for yourself if these interests motivate my critiques of Healy. If these payments are the source for my critiques, I obviously come cheap," he told the Guardian.
Dr Healy says that, to his anger, Professor Coyne's criticisms of him in the BMJ were later passed to a journalist from Health Which in the UK by the Royal College of Psychiatrists, without an opportunity for him to refute them. He claims that the findings from his study have since been supported by a great deal more evidence that he has obtained through the court hearings and in company archives. He has passed much of his evidence to the Medicines Control Agency, which regulates the drugs.
The Healy case has shown up the blurring of the boundaries between academic institutions, which are short of money, and an industry that has a bottomless wallet - certainly in an area like psychiatry, where drugs have become hugely important. There is an urgent need for more openness, but the stakes have become very high."
SCIENTIST [Dr HEALY] STANDS BY VIEWS OF DRUGS AFTER SETTLING OUT OF COURT
"May 23, 2002
Scientist stands by views of drugs after settling lawsuit with U of T
TORONTO (CP) --
A prominent British psychiatrist who found his offer of a post at a University of Toronto teaching hospital rescinded after he criticized a popular form of antidepressants says he stands by his controversial view of the drugs.
Dr. David Healy said he continues to believe that Prozac and other drugs of its class -- known as selective serotonin reuptake inhibitors -- can be addictive and cause suicidal tendencies in some people.
"My views haven't changed at all," said Healy, who recently reached an out-of-court settlement with the university and the hospital, the Centre for Mental Health and Addiction.
"I think the SSRIs can make people suicidal. I think you can get physically dependent on them and can have a withdrawal problem. . . . You may not be able to stop. Full stop."
Healy, who teaches at the University of Wales, made the comments at a news conference Thursday, his first since he settled his $9.4-million lawsuit against the university and hospital.
The settlement, many of the terms of which remain undisclosed, has resulted in the university offering Healy a visiting professorship which will see him spend a week a year at the University of Toronto for several years, beginning next spring.
Healy launched the lawsuit after the university withdrew in November 2000 a five-year job offer to run the centre's mood and anxiety program.
"I bore no ill will towards them," he insisted Thursday. "And clearly the process going on too violently or too long wouldn't do them any good, wouldn't do me any good."
That's because Healy has other issues he wants to bring to the public's attention, such as the way drug companies selectively release safety and efficacy data on drugs and use ghost writers to author articles on their drugs for submission to scientific journals.
"And there's a real hazard that I go on about these things and the legal action was still there, people would say: 'Well, we don't need to pay any heed to that. He's just saying this because he's trying to sue the University of Toronto.'
"If I want people to listen to some of the other things, it seemed to be a good idea, (especially) when people on the other side (the university) were being reasonable and weren't awful people."
Peas
Paula
BBC1 Wales TV: Week In, Week Out, on SSRIS
May 29 2002, 1:37 AM
WOW! 2nd program. Was on Tuesday 28th May 2002 at 10.35 pm and had David Healy, brought up lawsuits, people were interviewed, etc. We need more and hopefully at an earlier hour soon so that more people view it.
EXTRACT (small part, read the full story at above website):
....."The data sheet supplied to doctors by manufacturers GlaxoSmithKline (GSK) does inform them that withdrawal should be gradual, but Harvey believes that the language employed deliberately downplays the potential problems. 'However you dress it up,' he says, 'they're trying to suggest that it's not a major issue. But I've got people who have been trying to get off it for four or five years and say, "My life is a misery." I've heard this argument about [it not being addictive], but I think it's mischievous. What they're saying is that the body doesn't become so absorbent to the drug that you have to keep prescribing larger and larger amounts. That may well be right. But I have to say that if you're a patient and you read your information sheet that says "These tablets are not addictive," then they understand that as meaning: "If I want to come off this drug then I should be able to do so without any problems, like coming off penicillin." But to say that there's a technical definition to "addiction" is wrong. It's bad enough doing it to a doctor, but you certainly shouldn't do it to a member of the public.' ......"
END OF EXTRACT. Mark Harvey is the lawyer dealing with the UK litigation matter re Seroxat (Paxil) - details of how to contact him can be found under the LEGAL ACTION LINKS thread.
Paula
Paula
BBC (UK) ARTICLE: SEROXAT WARNING (11th June 2002)
EXTRACT:
"Thousands of people in the UK could be hooked on the anti-depressant drug Seroxat, without knowing it.
Dr David Healy, a UK expert in antidepressants, has said he has seen records of trials carried out by the manufacturers which showed healthy volunteers were suffering withdrawal symptoms after taking the drug for just a couple of weeks.
He said more than half of people on Seroxat may have "significant" withdrawal problems.
He said: "For most people who take the drug, one of the key points that will concern people is that Seroxat (paroxetine) could make you physically dependent."
One of the key points that will concern people is that Seroxat could make you physically dependent
Dr David Healy
Dr Healy, director of the North Wales department of psychological medicine was given access to the results of early trials of the drugs while a witness in a US case.
The case dealt with a seperate concern about the drug, which is that some people who take it could become violent towards themselves or others.
The family of David Snell won a $6.4m payout from manufacturers GlaxoSmithKline (GSK) after Mr Snell was found to have murdered three members of his family, and himself, after taking the drug for just two days.
The company denies the link and is appealing against the decision.
Two weeks earlier, in Australia, a judge ruled Sertraline, a drug in the same family, had caused David Hawkins to murder his wife and attempt to kill himself.
Dr Healy told BBC News Online, of the 100m people world-wide who were on Seroxat, one in 1,000 could have a suicidal reaction.
There have been concerns expressed in the past about antidepressants such as Prozac making healthy people with no history of mental illness feel violent.
New generation
Seroxat is part of a family of antidepressants called SSRIs (selective serotonin re-uptake inhibitor) which were introduced to the market in the early 1990s.
They were a replacement for benzodiazepines such as Valium and Librium - and their selling point was that people would not become physically dependent on them, unlike the older drugs.
Dr Healy was given access to GSK's archives because he was an expert witness in the Snell case.
And he said a trial a study of 34 healthy company workers by GSK, carried out before Seroxat was licensed, showed 25% became agitated.
Dr Healy believes a small number could be so disturbed by the effects of SSRIs that they could kill.
He said some of those involved in the pre-licensing trial had gone on to "suicidal acts".
He wrote to the Medicines Control Agency, which grants drug licenses in the UK, and said: "The relationship between their intake of paroxetine (Paxil/Seroxat) and later suicidal acts is a matter about which neither you, nor SmithKline Beecham should be sanguine."
Dr Healy said the company has failed to pass on information to patients or doctors.
'Warning' call
He says a study which looked at the effect of stopping the drug for people who had successfully been treated for the depression showed many got worse.
The company argued this meant the drug should be licensed for long term treatment of depression.
Dr Healy says this is potentially more evidence that the participants in the trial were suffering withdrawal symptoms
He said the drug should carry warnings that some people who take it may experience violent or unusual thoughts, which were linked to the drug and not their condition.
And he said doctors who were treating people who suffered symptoms after coming off the drug "should be aware that maybe the underlying problem has cleared up and maybe the symptoms are due to withdrawal."
'Withdrawal problems
A World Health Organization report which ranked antidepressants in order of withdrawal problems found Seroxat was the hardest to come off.
Prozac (fluoxetine) was seventh.
Alan Chandler, a spokesman for GSK denied Seroxat was caused dependency, withdrawal symptoms or violent tendencies.
He said independent analysis last year by the MCA and others had concluded SSRIs did not cause dependency.
He said: "Withdrawal symptoms may occur with all SSRIs if treatment is abruptly stopped. This is not a sign of addiction or depression."
END OF EXTRACT
Paula
BBC COVERAGE 13 JUNE 2002 - SEROXAT
June 13 2002, 6:00 PM
Patients may sue over anti-depressant
Millions of patients have used Seroxat
More than 100 people who say they have suffered serious side effects after taking a pill for mental illness are deciding whether to take legal action.
Seroxat was meant to be the wonder drug of the last decade - giving relief to patients with a range of mental health problems.
The manufacturers, British pharmaceutical company GlaxoSmithKline say the drug has transformed the lives of thousands of people.
Seroxat is an effective and generally well tolerated treatment for the management of depression
Dr Alistair Benbow, GlaxoSmithkline
Three million prescriptions for the drug are given out in the UK alone each year.
However, legal action against the makers of the drug has already begun in the US, and could now spread across the Atlantic.
'Nightmare'
John Simmons started taking Seroxat to treat his depression 12 years ago.
He hoped the drug would help him, but he claims that instead he has suffered side effects from a drug that he is now unable to give up.
"You have got things buzzing through your mind, splitting headaches, you just cannot sit still - it is a nightmare."
John's wife Janice has carried out extensive research into the drug.
Mr Simmons says he has suffered side-effects
"I have got piles and piles of paperwork and reports from different places that are recognising this as a problem."
Mark Harvey, solicitor for the action group representing Seroxat patients, said more and more people are coming forward, claiming they cannot come off the drug.
He told the BBC: "A lot of the people accepted this drug because they were assured that it was not addictive.
"And yet quite clearly the stories that are coming through to us on a daily basis show that not only themselves, but also their doctors have clearly been fooled - that it is addictive, they cannot get off this drug."
The action group wants GlaxoSmithKline to put clearer warnings about the side effects of the drug on its information leaflet.
A new version of the leaflet, printed a few months ago, warns that withdrawal from Seroxat should be gradual.
However, they say that withdrawal symptoms are not caused by dependence.
The leaflet also mentions for the first time the word "suicide".
The group are concerned that this puts the blame on the patient's condition, rather than the drug.
Effective treatment
But GlaxoSmithKline say depression gives risk to an increased risk of suicide.
Dr Benbow said the drug is safe
Dr Alistair Benbow, of GlaxoSmithkline, said: "Seroxat is an effective and generally well tolerated treatment for the management of depression.
"It has been used effectively in tens of millions of patients in many countries world-wide, and I think patients have nothing to fear from taking Seroxat."
Dr Benbow said the regulators had scrutinised all the available data on Seroxat.
"I have personally reviewed all the data, and from my personal studies I say there is no credible evidence that Seroxat causes suicide."
END OF EXTRACT
Maybe Dr Benbow would like to review some of the articles on this and other sites? What constitutes "CREDIBLE" in his mind? Do GSK have a different dictionary than the rest of the world?
Peas
A group of patients who claim their lives have been ruined by a popular anti-depressant drug, have launched a campaign for compensation. Millions of people are prescribed Seroxat for a range of mental health problems, and its makers, GlaxoSmithKline, say it's safe and effective. But the patients claim agonizing withdrawal symptoms show it's not. "
Then it codes describes video shots with various people, and the only other bit thats understandable is:
"Seroxat patients meeting with lawyers to discuss compensation claim (3 SHOTS)
Mark Harvey (Patients' lawyer) interview
- Ultimately people may feel they have to go to litigation over this
Dr Alastair Benbow (GlaxoSmithKline) along and interview
- Take patients safety extremely seriously
London"
LOL, not a lot to go on when you haven't actually SEEN the thing, but at least we can get the drift of it from this. Paula
Derek
EDINBURGH EVENING NEWS COVERAGE OF SEROXAT USER GROUP
THE Government has been called on to investigate the "soaring number" of reported side-effects from the UK’s most widely prescribed antidepressant.
Around 100 people have gathered in London for the first meeting of the Seroxat Users Group.
Seroxat is an anti-depressant licensed to treat episodes of mild to moderate depression, as well as anxiety disorders.
But the Seroxat Users Group said thousands of people around the world had reported side-effects including physical problems and suicidal feelings.
In America, GlaxoSmithKline, the manufacturer of Seroxat, made a confidential out-of-court settlement with the family of 61-year-old Donald Schell.
Mr Schell killed his wife, daughter and granddaughter, then committed suicide, the day after taking Paxil - the US name for Seroxat.
The Seroxat Users Group today called on the Department of Health to look into "the soaring number of reported serious side effects" .
Mark Harvey, of Hugh James Solicitors, representing the group, also called on GSK "to carry out in-depth research into exactly who should be prescribed this drug".
The group says some of the worst problems occur when trying to come off the drug, even though GSK maintains that Seroxat is non-addictive.
A spokeswoman for GlaxoSmithKline said today: "Extensive clinical trials and more than 100 million patient treatments worldwide since 1991 have continued to show Seroxat to be an effective and generally well-tolerated treatment for depression and anxiety disorders."
She said Seroxat was not addictive and there was no scientific or clinical evidence to suggest it caused dependence.
A spokesman for the Medicines Control Agency said: "We have reviewed the safety of this family of antidepressants on numerous occasions and their safety profile remains favourable."
END OF ARTICLE
Derek (Scotland)
VARIOUS GUARDIAN ONLINE (UK NEWSPAPER) ARTICLES
June 15 2002, 11:47 AM
Have moved these links from the original thread heading, in keeping with lower down where the heading is merely indicative of the contents. These articles were first posted on the board in or around March 2002.
1. The Guardian: Article regarding danger of prescription drugs being sold over the internet:
Paula: Luckily I copied the information from ITN to my Seroxat group lol. ITN remove the story after 24 hours, and replace it with an archive with html characters :P Derek
ARTICLE
"Seroxat users want compensation
19.16PM BST, 13 Jun 2002
A group of people who take a controversial drug to combat depression
are demanding compensation from the manufacturers for the side-
effects they say they've suffered.
The group also called on the Government to investigate the "soaring
number" of reported side effects from the UK's most widely prescribed
antidepressant, Seroxat.
Around 100 people from across the country gathered in London for the
first meeting of the Seroxat Users Group.
Seroxat is an antidepressant licensed to treat episodes of mild to
moderate depression and anxiety disorders.
But the Seroxat Users Group says thousands of people around the world
have reported side effects, including physical problems and suicidal
feelings.
In America, GlaxoSmithKline (GSK), the manufacturers of Seroxat, made
a confidential out-of-court settlement with the family of 61-year-old
Donald Schell.
Mr Schell killed his wife, daughter and granddaughter, then committed
suicide, the day after taking Paxil - the US name for Seroxat.
Mark Harvey, of Hugh James Solicitors, representing the group, called
on GSK "to carry out in-depth research into exactly who should be
prescribed this drug".
The group says some of the worst problems occur when trying to come
off the drug, even though GSK maintain that Seroxat is non-addictive.
A spokeswoman for GlaxoSmithKline said today: "Extensive clinical
trials and more than 100 million patient treatments world-wide since
1991 have continued to show Seroxat to be an effective and generally
well-tolerated treatment for depression and anxiety disorders."
She said Seroxat was not addictive and there was no scientific or
clinical evidence to suggest it caused dependence.
The company states that stopping any antidepressant can result in
some patients experiencing symptoms such as dizziness, agitation,
anxiety and nausea, but the chances of this occurring are reduced by
gradually tapering the daily dose.
The spokeswoman added: "In the 10 years that it has been available,
Seroxat has become well established with physicians around the world
who have prescribed it for millions of patients.
"Seroxat has helped many of these patients overcome depression and
other anxiety disorders to lead healthier, happier lives."
A spokesman for the Medicines Control Agency said Seroxat was kept
under continuous review by the MCA, as were all medicines.
"We have reviewed the safety of this family of antidepressants on
numerous occasions and, looking at the current evidence, their safety
profile remains favourable," he said."
END OF ARTICLE.
Derek: OK, OK! No need to stick your tongue out at me, its sooooooo rude LOL. ~(<:oP) Paula
JUNE 2002.The inaugural meeting of the Seroxat Users Group is to be held in London. Pam Armstrong and Professor David Meakes, Professor of Psychological Medicine at the University of Wales, Wrexham and a colleague of Dr.David Healy are both guest speakers.
JUNE 2002. A 'Guide to SSRI and Withdrawal' becomes available, complied by Pam Armstrong and available from CITA or 'Back to Life'
SPRING/SUMMER 2002. Media interest in SSRI problems increases, including the BBC Panorama set for July 14th 2002 and a cable documentary set for the Autumn 2002, which features Pam Armstrong. Other media interest has included 'Case Notes' on Radio 4, BBC Wales, 'Company' magazine June 2002, 'The Observer' , 'The Guardian', The Daily Express'. "
End of Extract
PLEASE NOTE THAT THE HOME PAGE OF THE ABOVE URL OFFERS HELP TO PEOPLE WITH ADDICTION PROBLEMS re SSRIS and BENZO MEDICATION. You will need to go to the above link and then click on Home and follow leads.
Peas
Paula
SSRI - MURDER AND SUICIDE IDEATION (UK NEWSPAPER ARTICLE)
Plagued by "evil thoughts" telling him to kill his fianc??e and child, David Allison decided to take his own life. After just five months on Seroxat, David, 31, of Highnam, claims he had become obsessed by thoughts telling him to drive his 26-year-old fianc??e and his three-year-old son into a wall.
In June, 2001, a jury in the United States ordered GlaxoSmithKline (GSK) to pay 6.4m (£4.6m) to the family of Donald Schell, 60, who killed his wife, daughter and granddaughter then himself after two days on Seroxat.
"I am convinced that, had I had access to a gun, we would all be dead now," said David.
Seroxat had been prescribed to David - then just 29 - on April 1, 2000, after he suffered a nervous breakdown brought on by the intense stress of his high-powered sales job.
The first six weeks saw an improvement, as he began to feel better and started to socialise with his friends and family again.
A little over three months later, David was huddled in a derelict shed in Highnam, slashing his wrists.
It is a day he says he will never forget.
He said: "I stayed in bed literally every day, unable to speak to anyone or do anything.
"As time went on, the evil thoughts would come into my head more regularly, and became more impulsive.
"It was like someone had come into my body, put these thoughts in and then left again."
David's fiance knew something was seriously wrong, and asked him to see a counsellor.
"I had planned to take the kitchen carving knife with me, so I could threaten the bloke to make me better," said David.
"It sounds awful now but at the time it was almost a natural thing for me to think.
"I wanted to drive with my fiancee and son as fast as I could on the motorway into another car, or maybe into a brick wall."
On August 9, David's plan to take the kitchen knife and slice open his wrists was foiled as his fianc??e didn't go to work. Instead, he bought some razor blades and headed off to an old shed he used to play in when he was a boy to end his life.
After lying, cut and bleeding heavily, for an hour, David came to his senses and hurried to a house nearby.
He was admitted to Wotton Lawn Mental Hospital for treatment, and after a few weeks, was taken off Seroxat as a doctor thought his suicidal thoughts could be a side effect of the drug.
Just five days later, David says he was almost back to his old self.
Seroxat manufacturers, GlaxoSmithKline, said they were unable to comment on David's experiences, but said: "Seroxat is a safe and effective treatment with experience in more than 100 million patient treatments worldwide since its launch more than 10 years ago."
Two weeks earlier, an Australian judge ruled that another drug in the same class of anti-depressants as Seroxat, Sertraline, caused David Hawkins to murder his wife and attempt to kill himself.
David finds these cases deeply disturbing, and eerily similar to his own terrible experience.
He said: "At first I was relieved to discover I was not the only one, but then I was angry that I was allowed to take this drug without knowing what it could do to me and my family.
"I shudder to think what could have happened," he said.
A lawsuit, launched in the LA Superior Court in September last year, contended that the U.S. version of Seroxat - Paxil - is addictive.
The suit, filed on behalf of 35 people from around the country, alleges that GSK concealed evidence that the drug could be addictive.
The plaintiffs claim to have suffered from symptoms ranging from electric-like shocks to suicidal thoughts when they came off the drug.
The lawsuit, which is still under way, claims GSK concealed the possibility of physical and pyschological withdrawal symptoms from the drug."
'WHICH' Magazine: "MISLEADING ADVICE ON ANTIDEPRESSANTS"..
12 - 02 - 2002
Misleading advice on antidepressants
Health Which? today said that people are not being given full information on the efficacy and safety of antidepressants, including the risk of withdrawal problems and a possible risk of increased suicidal behaviour.
Over 22 million prescriptions were written for antidepressant medication in England in 2000, up from 9 million in 1991. Over the same period, the cost of these prescriptions to the NHS jumped from just over £54 million to £310 million. In the US in 2000, more than $2.5 billion was spent on Prozac (fluoxetine) alone - one SSRI-type (selective serotonin reuptake inhibitor) antidepressant. While antidepressants have become the treatment of choice for depression, some clinicians interviewed by Health Which? have broken rank, and are questioning this view.
Evidence examined by Health Which? strongly suggests that the effectiveness of antidepressants has been exaggerated and their unwanted effects underplayed. Antidepressants do work in some cases. But advice to patients produced by the Royal College of Psychiatrists (RCP) and the Depression Alliance claims that 60-70% of patients will get better within a few weeks of taking antidepressants. Yet results from clinical trials are far from convincing, and many have found that antidepressants perform no better than placebo (dummy) treatment. There is also strong evidence that clinical studies which find antidepressants to be ineffective are less likely to be published. And recent studies looking at the combined results of both published and unpublished trials suggest that antidepressants are only marginally more succesful than placebos.
And patients aren't being given all the facts about the likelihood of experiencing withdrawal reactions when they try to come off SSRI antidepressants. If patients do experience such problems, it's possible they may be told they're experiencing a return of their condition. The RCP advice to patients states 'there is no evidence that antidepressant drugs cause dependence', and GlaxoSmithKline says in the patient information leaflet for top-selling drug Seroxat (paroxetine) 'these tablets are not addictive'. However, the UK Medicines Control Agency (MCA) says that SSRIs are recognised to cause withdrawal reactions. And evidence has come to light during US court cases showing that paroxetine causes withdrawal reactions in healthy volunteers - symptoms which could not therefore be attributed to depression. Patients in the US are taking class action against GlaxoSmithKline claiming they have suffered extreme reactions including vomiting, anorexia, aggression, nightmares and fatigue as a reaction to stopping taking the drug.
The conventional view is that those who kill themselves while taking antidepressants do so because of their condition. As the debate rages about links between taking antidepressants and increased tendency towards suicidal feelings, new material shown exclusively to Health Which?, shows that there is evidence to suggest that some people are more likely to attempt suicide when using SSRI antidepressants. This evidence has been sent to the MCA by the researcher concerned.
On all these issues - effectiveness, withdrawal symptoms, and possible increased risk of suicide - leading clinicians and Health Which? believe that advice and warnings to patients are inadequate, and that people may consider alternatives to antidepressants if they had more information.
Sue Freeman, Managing Editor of Health Which?, said:
"Antidepressants do help in some cases. People should not suddenly reduce their dose or stop taking their medication. If they're concerned they should talk to their doctor or call the Mind Infoline (0845 766 0163). But current advice from the Royal College of Psychiatrists and other sources is potentially misleading patients."
"Much more accurate information is needed about the efficacy of antidepressants, about the risk of withdrawal reactions and the possible increased risk of suicide for some people taking SSRIs. People might choose alternatives if they were given all the facts."
"Doctors, drug companies and regulators have argued for some time about how to describe the problems patients may have when they stop taking SSRI type antidepressants. Terms such as "discontinuation problems", or "withdrawal syndrome" are used instead of "dependency" or "addiction". The fact remains that some patients will experience very unpleasant symptoms when they stop taking SSRI antidepressants which are not related to a recurrence of their illness."
"The Medicines Control Agency should review the warnings it requires SSRI manufacturers to give both in patient information leaflets and information provided for prescribers about withdrawal and increased risk of suicidal behaviour. The Royal College of Psychiatrists and others should reconsider their advice about antidepressants."
ends
A full copy of the article is available. Call David Whitely on 020 7770 7062. Health Which? spokespeople are available for interview.
The mental health charity Mind has an information line - 0845 766 0163 - open Monday to Friday, 9.15am to 5.15pm.
Health Which? investigates healthcare, food, fitness and medical issues. The magazine is an independent voice, free from advertising and funded entirely by subscriptions. Consumers' Association publishes Health Which? six times a year, at a cost of £7.75 a quarter (£31 annually) to new subscribers. Telephone 0845 924 5000 for more details."
Peas
UK GOV QUIETLY PLANS GIVING CONTROL OF NHS TO FOREIGN COMPANIES??
September 21 2002, 10:59 PM
OH please, NO!.. Americans are currently planning to put nose picking as a mental disorder(WITH A SYMPTOM NAME), happiness ditto (INABILITY TO SEE THE WORLD AS IT SHOULD BE SEEN !!) etc. Thanks to Derek for this one.
30 June, 2002
More Milburn duplicity?
THE GOVERNMENT'S SECRET AGENDA FOR PRIMARY CARE REVEALED ! (IGPA Press release)
The government's secret agenda for primary care has been revealed. The Times newspaper (26 June 2002) reports that that Alan Milburn has been holding secret talks with American healthcare providers, including Kaiser Permanente and United Healthcare.
The Department of Health has confirmed that discussions have included taking over the responsibilities of several Primary Care Trusts (PCTs).
The intention to hand control of NHS General Practice over to foreign
companies has never been announced to Parliament, nor has it appeared in any Department of Health publication. On the contrary, the public position of the government has been that PCTs will be led by clinicians and local people, although doctors have long realised that real power will be wielded by managers.
This revelation comes a very sensitive time, as GPs vote on a new
contractual framework.
Strategy Group member, Dr Mark Pasola said "GPC endorsement of the contract has depended upon trust in the government to act honourably over issues such as pricing and unilateral contractual changes. It is now clear that the Secretary of State who promised us the lead role in PCTs has been playing a dirty game. We would be crazy to trust our livelihoods to his good faith."
IGPA co-ordinator, Dr Jonathan Reggler added "The government sees the new contract as a tool to take ever greater control of our professional lives. It is surely no coincidence that Mr. Milburn has turned to American HMOs, where rigid compliance with protocols is the norm. American doctors complain that they have lost their clinical freedom and with it their job satisfaction."
The IGPA calls upon those colleagues who have not yet returned their ballot paper to vote "No". In doing so they may yet save British General Practice."
This message has been edited by peagee on Sep 21, 2002 11:02 PM
Anonymous
****SUNDAY 13 OCTOBER 2002 - BBC PANORAMA "SECRETS OF SEROXAT" PROGRAM ****
October 8 2002, 1:10 AM
This is the one we've been waiting for. Its official, had confirmation today and there's been an advert tonight on TV publicising the programme, is as sure as it can be
Programme details:
'Secrets of Seroxat'
Panorama
Sunday 13th October 2002 (THIS COMING SUNDAY)
10.15pm
BBC1. '
So for anyone in the UK - turn on the TV on Sunday night
Paula
Paula
**** BBC DOC. HAS DRUG MAKERS REACHING FOR THE ANTIDPRESSANTS - STOCKS DROPPING ****
October 8 2002, 10:36 AM
"BBC documentary has drug makers reaching for the antidepressants
From Daily Telegraph - 08/10/2002 (778 words)
By Yvette Essen
DRUG giant Glaxo Smithkline and pharmaceutical company SkyePharma had something to be depressed about yesterday as jittery traders drove down the prices of the stocks in advance of a Panorama programme due to be aired on Sunday.
The BBC documentary will examine claims that Seroxat, one of the world's best-selling antidepressants, can have unpleasant side-effects and may provoke violence and suicide.
Glaxo Smithkline, which manufactures the drug, fell 28 to pounds 12.76. A spokesman emphasised the safety of Seroxat, pointing out that it has been used by tens of millions of patients worldwide since its launch a decade ago.
SkyePharma, which has a royalty share in the controlled-release version of the drug, known as Paxil, was the second-largest faller in the FTSE 250, down 5 3/4 at 42p. The company would not comment yesterday....."
Seroxat is one of the world's biggest selling and most successful anti-depressants.
But this Panorama investigation discovers the drug may have a darker side - the programme claims that people can get hooked on it, suffering serious withdrawal symptoms when they try to come off it.
For some it can lead to self harm and even suicide. But little warning of these possible side effects accompanies the drug.
These are accusations that the drug's maker Glaxo SmithKline denies.
The programme follows one Seroxat user and charts her nine month struggle to wean herself off it.
Panorama also spoke to Dr David Healy, an expert on the drug who has had access to confidential Seroxat studies in the Glaxo SmithKline archives.
Panorama: The Secrets of Seroxat will be shown on BBC One on Sunday 13 October at 2215BST
Production team:
Reporter: Shelley Jofre
Producer: Ed Harriman
Assistant Producer: Sarah O'Connell
Assistant Producer: Calum Walker
Editor: Mike Robinson"
TO THE PANORAMA TEAM AND ALL THOSE WHO ARE TAKING PART IN IT - THANK YOU ALL SooOOOOOooo MUCH ON BEHALF OF ALL THE SURVIVORS
Paula
PANORAMA ONLINE VIDEO IS IN PLACE.. (SECRETS OF SEROXAT)
October 14 2002, 11:23 AM
Panorama SEROXAT online video is NOW IN PLACE Its Monday, 14th October 2002. Go to:
Go the list on the right hand side of the page.
Click on 'Latest Programme' and your realplayer will come up
will come up. It takes a few minutes. (If you haven't got realplayer, when you double click on the link it should bring up something like "do you want to download realplayer?" etc. So you can get it from there, but that takes a couple of hours - on my puter anyway LOL).
The recording for the video clearly started at 10.15 pm, but Panorama started about 5/10 mins late (the news was late) and so what you first hear is about Ireland, then a bit about Sports, then the weather and the main news points. ITS OK, JUST WAIT cos THEN panorama, SECRETS OF SEROXAT comes on.
Am now watching it first time today - I hope it doesn't cut off the last 5/10 mins at the other end, if the recording was set to cut off ON TIME, don't yet know.
The Seroxat programme will be on the video there for one week, then will be replaced by the next progamme and then only the transcript of this one will be available.
BRILLIANT WORK FROM THE PANORAMA TEAM, DAVID HEALY and THE SURVIVORS and RELATIVES. ALL OF WHOM CARRIED THEMSELVES WITH DIGNITY AS THEY HAVE A RIGHT TO DO AS DECENT CARING PEOPLE. A WELL REASONED, WELL DOCUMENTED INVESTIGATION.
GREAT WORK TOO FROM GSK's ***ALASTAIR BENBOW*** WHO DID A WONDERFUL EXPOSE ON HIMSELF AS UNCARING, ARROGANT AND WITHOUT COMPASSION. UNWAVERING EVASIVENESS WITHOUT ONE TINY FACIAL OR BODILY SIGN OF UNEASE OR DISCOMFORT THAT WOULD BE EXPECTED FROM NORMAL HUMAN BEINGS PROTECTING THEIR INTERESTS AT THE COST OF LIVES. EVEN WHEN THE SCHELL JURY FINDINGS WERE PRESENTED TO HIM THERE WAS THE SAME ROBOTIC EVASIVENESS AND DENIAL OF ANY RESPONSIBILITY WITHOUT EVEN THE BATTING OF AN EYELID.
WHATEVER HAPPENED TO THE PERSON YOU WERE BEFORE YOU QUALIFIED MR BENBOW?? SURELY AT SOME TIME YOU HAD ETHICS AND IDEALS? DID YOU AS A MEDICAL STUDENT NEVER DREAM OF HOW YOU WOULD HELP OTHERS, HOW YOU WOULD BE A GOOD AND CARING DOCTOR, HOW YOU WOULD FOLLOW THE SALIENT POINTS IN THE HIPPOCRATIC OATH? HOW YOU WOULD TO "DO NO HARM" TO OTHERS??
LOOK AT WHAT YOU HAVE BECOME NOW. COUNT YOUR GLOBAL VICTIMS. THE MANY VICTIMS WHO NEVER MADE IT. THE STRUGGLING SURVIVORS WHO ARE MAKING IT.
BENBOW, I'M GLAD TO SEE THAT YOU, IN THOSE MINUTES YOU TOOK PART, PERSONALLY DID MORE DAMAGE TO GSK THAN THE REST OF THE PROGRAMME PUT TOGETHER. AND I'M AFRAID YOUR ARGUMENT WAS WITHOUT REASON OR LOGIC. AND YOU CANNOT DENY ONE VERY OBVIOUS AND UNARGUABLE LIE, THAT WHEN YOU SAID THAT THRE WAS FREEDOM FOR CLINICIANS TO ACCESS CLINICAL TRIALS THAT ARE SO WELL PROTECTED THEY HAVE ONLY BEEN SHOWN UNDER COURT ACCESS. AND AS THAT WAS SO OBVIOUSLY A LIE, THEN I THINK ITS QUITE SAFE TO SAY THAT YOU ARE A LIAR? THANK YOU SO MUCH FOR SHOWING THE WHOLE WORLD THE COLD CALCULATING DUPLICITOUS FACE BEHIND GSK, EXCELLENT JOB. WELL DONE.
WELL DONE ALSO TO THE BAYOU 'STEPFORD WIVES', WHO SO CHILLINGLY, WITH THAT TYPICALLY FANATICAL 'I'M SO HAPPY - THE WHOLE WORLD IS JUST SUCH A PARADISE' SMILE, SHOWED HOW LITTLE CHILDREN UNDER THEIR CARE HAD SUCH AN ENJOYABLE TIME, HOW THEY COULD HELP THEMSELVES TO SHELVES UPON SHELVES OF TREATS AND CANDY - WHILE YOU EXPOSE THEIR FRAGILE DEVELOPING BRAINS AND CENTRAL NERVOUS SYSTEMS TO MIND-ALTERING DRUGS, PROVEN IN HIDDEN GSK CLINICAL TRIALS TO HAVE ADVERSLEY AFFECTED 85% OF HEALTHY ADULT VOLUNTEERS.
EVERY READ HANSEL AND GRETEL??? THE HOUSE MADE OF CANDY?? ADD SOME STEPFORD WIVES AND YOU HAVE A CHILLING FAIRY TALE TURN INTO A TERRIFYING REALITY.
AND THE MCA... YOU PASSED THOSE DRUGS AFTER SEEING THOSE CLINICAL TRIALS FOR YOURSELVES?? YOU GET PAID TO PROTECT THE PUBLIC AND YET YOU SAW THE HIDDEN TRIALS, THE GSK TRIALS SHOWING 85% of HEALTHY VOLUNTEERS SUFFERED ADVERSE EFFECTS AFTER ONLY A SHORT TIME ON SEROXAT/PAXIL?? WHAT CAN I SAY. YOU HAVE DISCREDITED YOURSELVES AND YOU HAVE BETRAYED THE PEOPLE YOU ARE PAID TO PROTECT. YOU ARE AS MORALLY CULPABLE AS GSK IN DOING SO. AND EQUALLY MORALLY DERELICT.
I JUST HAVEN'T ENOUGH WORDS TO EXPRESS THE UTTER DISDAIN AND DISGUST I HAVE FOR 'MR' BENBOW (YOU HAVE LOST THE RIGHT IN MY VIEW TO BE ADDRESSED AS A PHYSICIAN', GSK, BAYOU, AND THE MCA. ITS SOMETHING SIMILAR TO THE FEELINGS I HAVE FOR ADOLF HITLER, THE GESTAPO AND ALL THOSE OTHERS WHO HAD SUCH LITTLE RESPECT FOR THE LIVES OF OTHERS.
Paula
IRELAND TAKING SEROXAT/PAXIL OFF THE MARKET :)) 16.10.02
"Top Stories Europe
10/16 15:06
GlaxoSmithKline Told to Recall Antidepressant Drug in Ireland
By Thomas Molloy
Dublin, Oct. 16 (Bloomberg) -- Ireland told GlaxoSmithKline Plc to recall one of its most prescribed drugs because a patient leaflet for the Irish market fails to warn about possible suicidal behavior, the Irish Medicines Board said.
The U.K. pharmaceuticals company has been ordered to recall all stocks of the antidepressant drug Seroxat stored by wholesalers, the board said.
The Irish Medicines Board, which controls the sale of medicines in Ireland, asked GlaxoSmithKline to change the leaflets at the end of 2001. Glaxo responded by adding new wording warning patients that suicidal thoughts may increase in the first few weeks of treatment, the board said.
The Brentford, England-based company has now been told to ``revise the wording on the license and patient information leaflets to include a reference to suicidal behavior and depression,'' the board said in the statement.
Shares in GlaxoSmithKline fell 19 pence, or 1.4 percent, to 1,357p at 3:04 p.m. local time in London.
Seroxat, also known as Paxil, is one of GlaxoSmithKline's most prescribed drugs, with sales of $2.7 billion last year. It's part of a class of treatments known as selective serotonin re- uptake inhibitors, which the U.S. Food and Drug Administration doesn't consider habit-forming.
Last year, a jury in federal court in Wyoming said Glaxo should pay $6.4 million to the relatives of a man who went on a shooting rampage, killing his family and then himself after taking Seroxat. At the time, Glaxo said it would appeal.
Martin Sutton, a spokesman for GlaxoSmithKline in London, declined to comment, saying the company would issue a statement later today. "
NB: THIS TRANSCRIPT WAS TYPED FROM A TRANSCRIPTION UNIT RECORDING AND
NOT COPIED FROM AN ORIGINAL SCRIPT: BECAUSE OF THE POSSIBILITY OF MIS-
HEARING AND THE DIFFICULTY, IN SOME CASES OF IDENTIFYING INDIVIDUAL
SPEAKERS, THE BBC CANNOT VOUCH FOR ITS ACCURACY.
........................................................................
PANORAMA
THE SECRETS OF
SEROXAT
RECORDED FROM TRANSMISSION: BBC-1 DATE: 13:10:02
........................................................................
SHELLEY JOFRE: The chances are you, or someone you know, is taking Seroxat. It's almost
overtaken Prozac as Britain's most popular antidepressant. Prescribed for everything from
anxiety to stress, Seroxat has transformed the lives of millions. But for some, the 'happy pills'
have a darker side.
HELEN KELSALL: If I'd known what I wd have had to go through, there is no way that I would
have started taking the drug.
JOFRE: Internet chat rooms are packed with complaints from people who claim they are
addicted to Seroxat. Others say it can be a prescription for violence, suicide and self-harm.
ED CASEY: I was burning myself with cigarettes. I was taking the blades out of disposable
razors and sort of cutting my arms and my chest.
DR HEALY: If they aren't the right drug for you, they can cause a range of problems. They can
make you suicidal, they can throw you into a state of mental turmoil, and even if they are the right
drugs for you, in some instances they can leave you hooked.
JOFRE: After just two days on Seroxat one man slaughtered his family.
ANDY VICKERY: He shot and killed the three women that he loved most in the world, his wife,
his daughter and his 9 month old granddaughter.
JOFRE: The company that makes Seroxat has long known about safety concerns. Tonight the
evidence that's remained under lock and key here in Essex for 15 years.
Video diary, May 2002
HELEN: I'm 22, I live in London. I've been taking Seroxat for four and a half years. It was
originally prescribed to me to stop me having panic attacks. These are them. I've wanted to
come off it for quite a few years now but when I stopped taking it, I was so ill that I had to start
taking it again and doctors kept telling me that it was impossible to be addicted to them.
JOFRE: Helen Kelsall's problems began as a teenager. Beneath her vivacious shell her
confidence was crumbling. Seroxat was supposed to be her cure.
HELEN KELSALL
I've been having panic attacks and I was also doing my A-levels at the time, and I probably was a
bit depressed as well, but mainly the panic attacks because I've had some quite serious ones and
I had ended up in hospital a couple of times, and I didn't really know what they were, and at that
time I didn't really know how to do research into your own medical things and I trusted what the
doctor said, so I started taking them and that's how it's been from there.
I'm feeling really crap. Shocks.. head shocks really throwing me off. Headaches, muscle pains,
sweating, trembling. As I take each step there's this shock in my head that's completely throwing
me off balance.
JOFRE: Using a video camera, Helen has been keeping a unique record of her long running
struggle with Seroxat. She's been trying to wean herself off the drug since the start of the year,
but it's not easy. The tablets are so potent she can't just stop taking them. That makes her feel
too ill. The only way she can make small enough reductions in dose is to chop the tablets up.
The withdrawal symptoms have forced Helen to miss much of her university course this year.
She's in danger of failing her degree.
HELEN: I'm going into my final year of my masters degree. I can't afford to take time off because
I'm ill and because I'm getting these shocks and this nausea. I've already had enough problems
with university that's come about from this withdrawal, and I can't carry on like that.
JOFRE: Seroxat is second only to Prozac as the nation's favourite antidepressant. It's one of the
drugs that has revolutionised the treatment of mental illness. Taking Seroxat can transform
people's lives, but stopping it can be a nightmare.
TELEPHONE: Hello, Medication helpline....
JOFRE: The Maudsley Hospital in London runs a national information service for people taking
psychiatric medicines. Trouble coming off Seroxat is the number one complaint from callers.
Doctors too report far more withdrawal problems from patients on Seroxat than on any other drug.
DAVID TAYLOR
Chief Pharmiacist, Maudsley Hospital
If a patient is to stop taking Seroxat suddenly, then usually they would quite soon become quite
anxious. They may feel very dizzy and unsteady on their feet. Often people experience electric
shock sensations. They may also have a fever and feel generally unwell and they also may
experience mood changes or very vivid nightmares for example.
JOFRE: The information leaflet that accompanies Seroxat says these symptoms are not
common and will generally disappear within a few days of stopping the drug. It says:
"Remember, you cannot become addicted to Seroxat." Not unreasonably perhaps, many think
that means they can stop taking Seroxat whenever they want.
TAYLOR: Although people might suspect that the effects that they're getting are caused by
stopping the medication, very few are aware that that might be the case. Very few have been
forewarned that they might experience these kind of symptoms.
June 2002
HELEN: When the doctor said this is going to help and it's not got any downside which is
effectively what they said, I just thought.. oh, brilliant, absolutely brilliant. Now I realise that they
couldn't really have been more wrong.
JOFRE: Helen isn't the only one. On the Internet she's found hundreds of others who had no
idea what to expect when coming off Seroxat. And like Helen, many have had withdrawal
symptoms that are worse than their original illness.
HELEN: Visual distortions, almost like hallucinations. Small tingle rapidly blasting up my torso.
This guy is saying: "I find the worst side-effects is the feeling of sickness and giddiness, like
you're roaring drunk and the world is spinning." Somebody else saying: "Don't try to come off it
cold turkey, it's not recommended." That must be so disturbing.
JOFRE: Seroxat is one of a family of five antidepressants known as SSRIs. They're the wonder
drugs of the last decade offering a cure for everything from anxiety to depression to phobias.
Millions of people have been helped by them and they're extremely popular with doctors.
Dr ANDY CLAYTON
Medical Director, Derby Mental Health Trust
They're so simple, you don't kneed to be a genius to prescribe antidepressants and they get
seven out of ten people better in a couple of months and they're not even very expensive.
JOFRE: Cheap, effective and apparently even Seroxat withdrawal symptoms can be beneficial.
CLAYTON: Interestingly I've actually found the withdrawal effect to be quite handy for a few
people. I've had several patients who've come to see me in clinic and said: "I actually sort of
stopped taking my antidepressant doc because I thought I didn't need it. But after a day or so I
felt a little twitchy, a little uncomfortable and it made me realise I did need it."
JOFRE: But wouldn't that just be the withdrawal effect?
CLAYTON: Well exactly, that's the withdrawal effect that they had noticed for a day or so and it
had prompted them to go back on the pills which is very helpful.
JOFRE: Helpful or not the drug's maker, Glaxo SmithKline, is satisfied patients know exactly
what to expect before they start taking Seroxat.
Dr ALASTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
Seroxat is a generally well tolerated medicine that's been used extensively around the world over
the last ten years. As with all serious medicines.. all prescriptions medicines, Seroxat does have
side effects, but these are clearly stated in the information that's made available to doctors and to
patients.
JOFRE: Many patients, though, complain the information isn't clear. They say they've been
misled by the company's reassurance that Seroxat is not addictive. Because of this, thousands of
people both here and in America are now taking legal advice.
Your leaflet says: "Remember, you cannot become addicted to Seroxat" but that's not true, is it.
BENBOW: Yes it is true. There is no reliable evidence that Seroxat can cause addiction or
dependence, and this has been borne out by a number of independent clinical experts, by
regulatory authorities around the world, by the Royal College of Psychiatrists and a number of
other groups.
JOFRE: If people can't stop taking a drug when they want to stop taking it, they're addicted,
aren't they.
BENBOW: No, that's not correct. The definition of addiction is not as you describe it. Addiction
is characterised by a number of different criteria which includes craving, which includes
increasing the dose of drug to get the same effect and a number of other features, and these are
not exhibited by Seroxat.
JOFRE: That's not, with respect, what the Oxford English dictionary says. It says Addiction is
having a compulsion to take a drug the stopping of which produces withdrawal symptoms. Now
we've spoken to plenty of people who say they're compelled to take Seroxat because stopping it
produces withdrawal symptoms - they're addicted.
BENBOW: If you use that limited description of addictive, then most prescription medicines could
be defined as addictive. Beta blockers which are used for the treatment...
JOFRE: This is the common usage of the word, this is what people are understanding addicted
to mean, and you're misleading them in the patient leaflet by saying they can't become addicted.
BENBOW: No, we are not misleading them. The information in the patient leaflet and in the
information we supply to doctors, is based on fact. It's based on data which is generated during
clinical trials and during the marketing of the product over the last ten years.
Dr DAVID HEALY
Director, NorthWales Dept of Psychological Medicine
They should be framing these things in language that patients will understand. Now what most
patients will understand that Seroxat is not addictive means is that if I take this drug I can halt it
and I wont have a problem halting it. Well that's not true.
July 2002
HELEN: This is my final week of having one day where I get a whole tablet. So next week I'll be
on half a tablet every day. And to be honest I'm really dreading it.
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Family and friends may not understand chronic anxiety - PAXIL
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JOFRE: If Seroxat is big here, it's massive in the States. There it's called Paxil and, unlike in
Britain, it can be advertised direct to the public.
NICK ALCOCK
Pharmaceutical Company Analyst
Datamonitor
Well in 1999 Glaxo SmithKline were estimated to spend around 30 million advertising Paxil in the
US. In 2000 this figure had probably risen to just around 90 million.
JOFRE: And it was money well spent. Sales of the drug earned Glaxo SmithKline nearly 2 billion
pounds last year. Another reason for its phenomenal success is that it's licensed to treat more
illnesses than any other antidepressant, illnesses you may not yet have heard of, like generalised
anxiety disorder.
ALCOCK: Glaxo SmithKline sought out indications in anxiety disorders to essentially increase
the number of patients who can actually take the drugs.
JOFRE: So the more patients they get, the more money they get.
ALCOCK: Precisely.
[Advertisement]
With the help of Paxil you can see someone you haven't seen in a while - yourself.
Hey, I remember you.
JOFRE: On both sides of the Atlantic, criticism of Seroxat is growing. There's evidence that in
the first few weeks of taking the drug it can make people more anxious. Some research suggests
this can happen in up to a quarter of patients, throwing them into a temporary state of mental
turmoil.
HEALY: What you've got to realise is by mental turmoil here, we mean a state where people are
having thoughts and impulses that they've never had before, thoughts of harming themselves or
harming others. They haven't been having these thoughts at all, but within a few days of being on
the drug they begin to have thoughts like this.
JOFRE: Ed Casey's ambition was to make it as a musician. With some friends in his home town
of Newport he formed a band six years ago. They recorded a couple of singles and for a while
things were looking good.
ED CASEY
I was in a band, yeah, that was good fun. When we started to do that, that was really good. It
started off really, really well, so that side of my life was excellent. The other side, I was sort of
feeling not very nice about myself. My confidence started to go. I started not to like myself, and
then I started to suffer from anxiety and that was really, really scary.
JOFRE: Scary for Ed and for his parents. His mother took him to see the doctor. The doctor
prescribed Seroxat. But shortly after going on the drug the son she knew began to change.
GLYNIS CASEY
The one thing he said was he didn't feel real sometimes, it was very strange but just in his
manner really, he just became very much more introverted I suppose and liable to just go off into
a mood for nothing at all really.
JOFRE: And things were to get worse, much worse. Within a fortnight of starting on Seroxat Ed
started mutilating himself.
Would you mind showing me what you did?
ED: No, not at all. I'll have to strip off. There across the top of my shoulder and on my chest.
These cigarette burns and there's sort of razor marks there as well.
JOFRE: Had you ever done anything like that before?
ED: Never. Never, no.
JOFRE: When you found out what Ed was doing can you remember how you felt?
GLYNIS: I just couldn't understand it to be honest, but obviously was very concerned about him,
just wanted him to get some help so we could get to the bottom of it really so he could get better.
ED: I went back to the doctor just a month after I first started to take Seroxat and that's sort of
little while after the burning and what have you had started. They said continue taking Seroxat
and see how it goes.
JOFRE: So there was no suggestion it was the drug causing it?
ED: No, not at all.
JOFRE: Side effects usually occur in the early stages of taking the drug. In Ed's case the self
harm stopped after a few months. It never occurred to him at the time that the drug might have
been the cause. But why should it? There was no warning. Glaxo SmithKline denies that
Seroxat is linked to self-harm, just as they deny it's addictive.
HELEN: This is what I've woken up to this morning, an enormous leak in my roof, just what I
could really do without right now. I've got really awful head shocks and I'm just.. I've woken up
and I'm.. I can't get through to anyone to sort this problem out. I'm going to have to miss another
day of uni and I'm feeling terrible. I'm not really in the mood to do this. I'm so fed up.
JOFRE: It's taken a legal battle on the other side of the world to finally lay bear the secrets of the
Seroxat, secrets that have been locked away for 15 years. The case began four years ago in
Gillette, Wyoming, home to retired oil man Donald Shell and his wife Rita. They'd just become
grandparents and were enjoying a visit from their daughter and the baby. Tim Tobin, their son-in-
law was on his way to join them all at the weekend. But when he got to the house he realised
something was wrong.
TIM TOBIN
I started noticing things like the paper was still in the front door. I went to the neighbour's house
and he said he hadn't seen them, and I, at that point, became frantic.
MIKE WENZ
Gillette Police Department
I met Mr Tobin outside standing in front of the residence. He told me that he was concerned
about his family and that he thought that they were inside and something may have happened to
them.
TOBIN: He wouldn't open the door so I broke the window out of the rear door and I ran upstairs
and the policeman was behind me, and that's when I found everybody.
WENZ: We found three adults and about a ten month old infant that had been shot to death that
were all laying on the floor in the bedroom.
13TH February 1998
The Wyoming State Crime Lab Team is in Gillette tonight reconstructing the scene that left four
people dead. Neighbours can't believe Donald Shell, his wife Rita, their daughter Debbie Tobin
and her 9 month old daughter are dead. They were all found in this house Friday night in an
upstairs bedroom with gunshot wounds all to the head.
JOFRE: By all accounts Donald Shell was a doting grandfather. For ten years on and off,
though, he'd been depressed, depressed but never suicidal according to his medical records, and
he had no history of violence or aggression.
TOBIN: I felt like something had almost turned him into a monster and.. because there's no way
that anybody in their right mind would do something like that, it was just horrible. The Don that I
knew wasn't that type of person. The only thing that had changed was the medicine that he was
taking, the Paxil.
JOFRE: Paxil is the American brand name for Seroxat. Donald Shell had been on Paxil for just
two days and taken just two tablets before the carnage. His family could see only one
explanation. The drug must have turned Don into a killer. They decided to take Glaxo
SmithKline, the world's second largest drug company to court. But the company was not about to
let its best selling drug take the blame. That much was obvious when the family's lawyer took a
sworn statement from the company's then head of world-wide safety, Doctor Ian Hudson. This is
his interview recorded on video and later played to the jurors in court. He was asked a number of
times if Paxil was linked to violence or suicide.
Reconstruction
Voice of Andy Vickery
Tim Tobin's lawer
How many instances are there in which Paxil has been reported to SmithKline Beecham to be
temporarily associated with acts of aggression or suicidality?
Actual video evidence
Dr IAN HUDSON
Worldwide Director of Safety
SmithKline Beecham 1999-2001
Could you clarify what you mean by that, the temporarily associated? I'm not sure what you
mean.
VICKERY: I mean that a patient becomes homicidal or suicidal within a relatively short period of
time from either taking Paxil or getting an increase in dose of Paxil.
HUDSON: You haven't defined what you mean by a relatively short period of time, but I would
also have to go back and.. I don't know the answer to that question. I would need to go back and
discuss that with people within my department.
JOFRE: Tim Tobin's lawyer struggled to get a clear answer from him on the question of Paxil and
suicide.
VICKERY: If a doctor reported to your company 'Hey, I think Paxil caused this man to be
aggressive or suicidal' explain to me why you would not make your own determination of whether
he was right or wrong.
HUDSON: We would review the reported event, we would decide whether there are confounded
factors, but the sorts of events that we're talking about here, or perhaps I should ask you to clarify
which events we are talking about here actually.
ANDY VICKERY
Tim Tobin's lawyer
I do not believe that was an adequate response. I think that a company that sells mind altering
drugs to the public, particularly in the volume that this entire class of drugs sells, has an obligation
to thoroughly investigate any instance where their drug may be the cause of violence or suicide or
death.
JOFRE: Glaxo SmithKline maintained it was depression, not the drug that made Donald Shell
kill, but here at Harlow in Essex, the company keeps a vast archive of clinical trial results
including trials in which Seroxat was tested on healthy people with no hint of depression. For 15
years these results remained confidential until the Wyoming case. The judge granted the family
an order to allow an expert into the archive to examine these files. The man they chose was
Doctor David Healy, an expert on SSRIs who'd just got some disturbing results from trials of a
drug similar to Seroxat.
Dr DAVID HEALY
Director, North Wales Department of Psychological Medicine
We'd run a trial where we're given a group of healthy volunteers working in this unit and SSRI.
These included GPs, consultant psychiatrists, senior nurses, all of whom were both healthy and
senior and responsible. And what we'd seen was when people went on the wrong drug for them,
that they went through a state of mental turmoil on to becoming frankly suicidal.
JOFRE: Doctor Healy's task was to find out if Seroxat had produced similar side effects when it
was tested on healthy people. If so, it could be crucial evidence in the case.
VICKERY: The drug companies in a suicide case for example will say well, the person committed
suicide because they were depressed. Well, if you have a healthy volunteer who is not
depressed, that takes that out of the equation, and so the effects that those people have on the
drugs are very important as giving us some indication of what this drug can do to people.
HEALY: In the Tobin -v- SmithKline trial I had to file a report, and expert report for this trial, and
as part of that.. some months beforehand I'd asked to get access to the archives. It was only in
the last week before I had to file the final report that I got access to the archives.
JOFRE: Doctor Healy's task bordered on the impossible. He had just two days to find and read
all Glaxo SmithKline's confidential studies on healthy people. He knew it was going to be difficult.
He didn't realise quite how difficult until he got there.
Reconstruction
HEALY: What I was faced with when I got there was a long room with a series of files. I'm told
there are over 250 thousand sheets of paper there, a quarter of a million sheets of paper. When I
saw what I was actually faced with my heart literally sank. I had no real idea about how to go
about trying to work out what I could learn from all this.
Reconstruction
JOFRE: A few files were missing from the archive but in just two days Doctor Healy read all the
available studies the company had done on healthy people. The secrets of Seroxat were finally
beginning to unfold.
HEALY: It seemed clear that some people that went on the drugs had no major problems, but
equally clear that others who went on the drug ended up more restless, in a state of mental
turmoil, complaining about dreams, nightmares and a range of things like this. These don't seem
to have been explored further in any great detail.
Reconstruction
JOFRE: He discovered around one in four suffered these sorts of side-effects on Seroxat, even
when they were on normal doses and even when they'd only been taking it for a few days. And
remember, these were people with no previous sign of mental illness.
In his evidence to the court in Wyoming, Doctor Healy's conclusion was clear. It wasn't
depression that made Donald Shell kill three generations of his own family, it was Seroxat, a
conclusion Doctor Hudson was reluctant to accept.
Reconstruction
Voice of AndyVickery
Tim Tobin's lawyer
You're telling me under oath it's simply impossible for SmithKline Beecham to decide whether
Paxil did or did not cause Mr Shell to murder his wife, his daughter, his granddaughter and then
to commit suicide. Is that right sir?
Actual video evidence
Dr IAN HUDSON
Worldwide Director of Safety
SmithKline Beecham
HUDSON: It is impossible on an individual case basis for individual courts to assign causality,
especially in a very complicated area such as this, that is why, when we have issues, we review
all the available data and make a determination on the basis of all the available data whether
there is an issue or not.
HEALY: Listening to Ian Hudson in court, I have to say that I didn't get any feel that he was
actually concerned about the welfare of people going on this drug. But I have to say that it
seemed to me that he was much more concerned about the welfare of the company.
JOFRE: The Wyoming jurors were unanimous in their verdict. They decided Seroxat was the
main factor in the four deaths. Glaxo SmithKline was found guilty of failing to warn patients and
doctors of the drug's dangers and ordered to pay over $6 million in damages.
VICKERY: We feel elated. Justice has been done.
TOBIN: It felt like people had looked independently from my pain and looked at the facts as
everybody had brought them together, and everybody had their chance and time to put in their
facts and their witnesses and in the end those people actually felt that what we were saying was
right.
Dr ALASTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
There is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This
tragic, tragic case is something that does occur from time to time in patients who are depressed.
JOFRE: This man had no history of suicide or thoughts or tendencies. The jurors sat and
listened to all the evidence and decided that there were four deaths that were mainly caused by
Seroxat. Your company was found guilty of negligence. You can't ignore that.
BENBOW: No, nor would we want to ignore it. This was a tragic case but we remain firmly
convinced that Seroxat did not cause the tragic events in this case.
JOFRE: A fortnight after the verdict the company added a warning to patient leaflets in Britain,
but the wording still avoids any suggestion that Seroxat itself may cause suicidal thoughts.
"Occasionally the symptoms of depression may include thoughts of harming yourself or
committing suicide. Until the full antidepressant effect of your medicine becomes apparent, these
symptoms may increase in the first few weeks of treatment."
It sounds to me here like you're trying to have it both ways. You're trying to say the risk increases
when you start taking the drug but it's nothing to do with the drug. It's a meaningless warning.
BENBOW: No, the warning is there and has been agreed with the regulatory authorities which
basically is to tell doctors, look, you have a patient who is depressed, they are at risk of suicide.
Don't just think, just because you've started them on antidepressants, that they are not going to
remain at risk of suicide immediately. The fact is that antidepressants take a while to work.
JOFRE: Even after the historic Wyoming verdict, it's business as usual for the company. They
still maintain their best selling drug does not cause self-harm, suicide or addiction.
It's now 8 months since Helen Kelsall started her Seroxat withdrawal programme. She's had
trouble making small enough reductions in dose with the tablets.
August 2002
HELEN: It looks like... well... we'll see.
JOFRE: So she's switching to a liquid version because it's easier to measure out. Helen hopes
to kick it completely in a month or so.
HELEN: Oh God!
JOFRE: The company's claim that Seroxat is not addictive was also undermined by the evidence
brought to light in Wyoming. Glaxo SmithKline's own research showed even some healthy
people suffered withdrawal effects when they stopped the drug.
Dr DAVID HEALY
Director, North Wales Department of
Psychological Medicine.
Yes, it was clear from early on that the company had recognised that people who had been on
this drug even for a relatively brief periods of time could go through withdrawal when they halt it.
And they ran healthy volunteer trials to look at this further and found that in some instances up to
85% of the volunteers who had been on this drug for only two or three weeks had withdrawal
problems when they halted.
JOFRE: 85%! That's most of the people who took it.
HEALY: Yes.
Reconstruction
JOFRE: The company says that in that study the frequency of problems was generally
comparable to those suffered by people who were just given sugar pills. But Doctor Healey
maintains withdrawal symptoms from Seroxat were more frequent and much more serious. Of
course if the data was publicly available this sort of dispute could be easily resolved.
Why should this information be secret?
BENBOW: It's not secret, it's been made...
JOFRE: Well I can't see it so it's secret.
BENBOW: No, but you are not a clinician or a health care professional. The consent forms for
the healthy volunteers clearly say who we can and who we can't...
JOFRE: So if my GP wants to see it, can he see it?
BENBOW: The data effect... he is not... Your GP is a clinician, if he asked to see some of the
data then of course he could see the data... if it was appropriate.
JOFRE: But Doctor Healey is a clinician and he needed an American court order to see the data.
HEALEY: Not only can you not see what I've seen, but I've made notes on those as well and you
can't even see my notes, and it seems extraordinary to me that really that the only way anyone
can get to see things like this is through a legal case, and not even a legal case happening here
in the UK but one that happens over in the US. It's difficult to call it scientific and it's hard to see
how it can be good for patients.
JOFRE: Drugs that are considered safe for patients are given a license by the medicines control
agency. They saw the healthy volunteer data before they licensed Seroxat and remained
satisfied there's insufficient evidence to link the drug to suicide. But no one was willing to be
interviewed for this programme. Now there's a new market that Glaxo SmithKline is hoping to tap
into, and it raises new concerns about the drug's possible side effect. This Texas office block is
home to one of the many private clinics in America where Seroxat and drugs like it are being
tested on a whole new group of patients - children.
KATHY HARPST
Vice President: Bayou City Research
Hi, welcome to Bayou City Research. Here's where we do pharmaceutical research in trials on
children and adolescents from any psychiatric disorder that we have. They come in here and
they help themselves to crackers, cookies - free candy, free crackers, free sodas.
JOFRE: So they like coming here.
KATHY: Yes, we let them.. everybody here just helps themselves, as soon as they come in they..
it's like home here. That's how we wanted to make them feel comfortable.
JOFRE: The clinic advertises for children in local newspapers and it's not just free cookies they
get for taking part.
PATTI BLACKWELL
Study Co-ordinator, Bayou City Research
They get a travel reimbursement and for several studies, some studies it has to be approved by
the regulatory board. We did a study where the children got reimbursed $25 each time they
came in. The other incentive is that they get their medication free. So these are drugs that
maybe would cost several hundred dollars a month in the pharmacy they're actually getting free in
the research.
JOFRE: Sounds generous until you realise just how much Glaxo SmithKline stands to gain if
trials like these are successful. The patent which gives the company its lucrative monopoly on
producing Seroxat runs out soon. A new license offers a way of extending it.
NICK ALCOCK
Pharmaceutical Company Analyst
Datamonitor
In the United States, if a company such as Glaxo SmithKline can gain an additional licence for the
treatment of children, it means that they get a six month extension to their overall patent.
JOFRE: And is that worth a lot of money?
ALCOCK: For Paxil it's worth.. six month's worth of sales is around a billion dollars, so yes.
JOFRE: That billion dollar windfall now looks tantalisingly close, thanks to a recent study co-
written by American child psychiatrist Neal Ryan. It was the biggest ever trial of Seroxat in
children funded by Glaxo SmithKline. The depressed children who took Seroxat did better than
those who took an older drug, or were just given sugar pills. That's the good news. The bad
news is that ten of the ninety-three children on Seroxat suffered serious psychiatric problems
within weeks of going on the drug. Most of them had to be hospitalised.
There were five children out of ninety-three children on Seroxat who had suicidal thoughts and
gestures. Another five out of that ninety-three had serious psychiatric side effects. Don't you
think parents would be worried about that if their child was to be given this drug?
Dr ALASTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
I think what parents would be more worried about is the risk that their children have of committing
suicide and other symptoms of severe depression if no treatment was available. I think parents
would want treatments to be properly evaluated during clinical trials before their children are
given any medicine.
JOFRE: But the evidence here suggest that their children might be at more risk of suicide if they
go on Seroxat.
BENBOW: No, the evidence is not there, there is no statistical difference between the groups.
The reality of the situation is that in this trial, Seroxat was generally well tolerated by this difficult
to treat population.
JOFRE: Seroxat has yet to be formally approved as safe for children, but some doctors who
found it useful in adults are already prescribing the drug to their younger patients. They're
allowed to do this, but they're unlikely to be aware of the recent trial results.
Dr DAVID HEALY
Director, North Wales Department of Psychological Medicine
Thoughts of self-harm and actual self-harm episodes are happening much more frequently on this
drug than on the older drug it was being compared with are than on sugar pills, and I'm pretty
sure that very few GPs or consultant psychiatrists treating children up and down the UK with this
drug will have a clue of results like this.
JOFRE: Seroxat was prescribed nearly five million times last year. It's hugely popular and even
the drug's critics acknowledge a great many people have been helped by it, butt here is concern
that patients aren't being given the full picture before they start taking Seroxat.
For Helen Kelsall life is just starting to get back to normal. She took her final dose of Seroxat last
month. But she's angry that it's taken the best part of a year to withdraw from a drug she was
assured was non-addictive.
September 2002
HELEN: If I knew five years ago what I know now about the drug, I never would have taken it,
and that's what it boils down to. I didn't know what it would do to me, and I would have never
made the choice to take it had I known, and that's pretty much the strength of it, so there you go.
JOFRE: If you're concerned about issues raised in this programme you can call the BBC help
line on 0800 88 88 09. You should not stop taking any medication without consulting your doctor.
On Thursday Glaxo SmithKline won a court case in America allowing them to market Seroxat as
non-habit forming. But on the same day in Britain they were found in breach of the drug
industry's code of practice for playing down the drug's withdrawal problems. There's other
information on our website where you can join us for an online discussion at 3pm tomorrow.
_________
www.bbc.co.uk/panorama
A reminder of the number to call if you've been affected by the issues in tonight's programme and
would like details of organisations that can provide information and support.
The BBC Action Line : 0800 888809
All calls are free and confidential
CREDITS
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Shelley Jofre
Camera
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Sound
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VT Editor
Boyd Nagle
Dubbing Mixer
Andrew Sears
Original Music
Neil Brand
Production Assistant
Susan Marimo
Production Co-ordinator
Rosa Rudnicka
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Kate Redman
Research
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Web Producer
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Assistant Producers
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Editor
Mike Robinson"
Anonymous
VIDEO LINK TO THE POST-PANORAMA PROGRAMME FORUM WITH DAVID HEALY
DECEMBER 6. EXCLUSIVE STRATIA WIRE REPORT. THE LID IS OFF, FINALLY. THE TRUTH IS OUT.
For over a year, I have been pursuing a story about Prozac. I have received much opinion and estimate, but until now I have been chasing elusive facts. Now the facts are in.
I am perfectly willing to have these facts challenged, but only with better facts, not with feelings or presumptions or agendas.
Here is what I’ve been chasing down: the assertion that Prozac actually contains fluorides.
As many of us know, the subject of fluorides (in toothpaste, mouthwash, water supplies of cities) has been a very hot topic. As in, are these chemicals toxic to the human body?
I’ve written on this before, and you can find the stories in my archive. Particularly, there has been terrific conflict at the EPA, where scientists have gone on the record with claims that fluorides in water supplies ARE toxic.
See other data on overgrowth of bones, crippling skeletal malformations, arthritic symptoms of varying severity, et al. From Fluorides.
There is much data in the counter-literature suggesting that fluorides can cause cancer.
I believe no one with an open mind can read the vast counter-literature on fluorides without concluding that these ubiquitous compounds do cause very serious problems.
Okay. Let’s start with this: The RxList site is an authoritative venue for information about medical drugs. After looking up Prozac and its composition, I emailed RxList and asked for a statement about the possible fluoride content of Prozac.
I received a timely answer from one of their pros, Neil Sandow, Pharm. D. “Each molecule of fluoxetime HCL (Prozac) contains three fluoride atoms.”
I queried back to find out whether “fluoride atoms” meant “FLUORINE atoms,” since it was my understanding that fluoride is a term that applies to molecules (combinations of atoms), whereas fluorine is the element and therefore any atoms would be called fluorine. I was told that I was correct.
With that little personal confusion straightened out, I asked RxList another question: Could they tell me the weight, in milligrams, of the fluorine in a standard daily dose of Prozac? After all, you always want to know about dose level.
Here was the reply from Sandow. I am giving you the details, in case anyone wants to challenge these facts or the arithmetic. F stands for fluorine in the message I received: “F molecular weight=18.9984032. There are 3 F’s in each Prozac molecule, so 3 x 18.9984032 = 57.
“The molecular weight of the Prozac molecule is 345.79.
“The proportion of Fluorine to Prozac is 57 / 345.79 = .165 or 16.5%.
“So, for a typical daily dose of 20mg of Prozac the amount of fluorine would be .165 x 20 = 3.3mg (or 6.6mg for a 40mg/day dose).”
Every day that a person takes a standard dose of Prozac, he gets 3.3 milligrams of fluorine. At the higher dose, he gets 6.6 milligrams of fluorine.
As you might imagine, over the years there has been much debate about the level at which fluorine becomes toxic for humans. I found a writer, Darlene Sherrell, who has done much work in this area. With a search engine, you can find her highly recommended piece which goes over this issue with a fine tooth comb. (“The Dose is the Poison”)
I wrote her and relayed the fluorine content of Prozac. She replied, “It is certainly clear…for the typical individual, 6.6mg/day [of fluorine] is more than enough to cause crippling skeletal fluorosis…and 3.3mg [of fluorine per day] is darn close. For the sensitive individual one Prozac a day would be excessive and likely to cause gastrointestinal problems almost immediately.”
So there it is.
Of course, I am commenting here on a narrow aspect of what Prozac does to the human brain and body. My archived articles go into all the other forms of damage this drug can deliver.
I’d say it’s time to get this information out to people.
In a related matter, Dartmouth researcher, Roger Masters, has discovered in a survey of Massachusetts communities, that there is a correlation between areas where silicofluorides are placed in the water and the presence of LEAD. I have queried him as to why he thinks this correlation is present. But his detailed research shows that (highly toxic) lead seems to “follow” these fluoride compounds around. One can only imagine how many cases of the bogus disorder called ADHD have been diagnosed---when lead and fluorides are the real culprits.
Masters writes, “Silicofluorides are largely untested. Virtually all research on fluoridation safety has focused on sodium fluoride, even though the studies in the 1930s showed important biological differences between these chemicals. The correlation with blood levels is especially serious because lead poisoning is associated with higher rates of learning disabilities, hyperactivity, substance abuse and crime.”
Masters, according to a Dartmouth press release, points out that “over 90 percent of America’s fluoridated drinking water supplies are treated with silicofluorides.”
(I want to thank RxList for timely help. They had no idea where I was going with this fluorine information, and it should not be inferred that they were trying to help me make a case against Prozac.)
Footnote: I'm well aware that varying degrees of evidence have been put forward to show that fluorides create a marked sedative effect in humans. I'm still followiong that one down. If true, this would put yet more light on the impact of Prozac on the population."
Anonymous
"WONDER DRUG" Article in IRISH TATLER re SSRIs (December 2002)
December 9 2002, 11:40 PM
Following article copy/pasted from email, and many thanks to that person
"IRISH TATLER, ISSUE DATED DECEMBER 2002
WONDER DRUG?
Some alarming stories about side effects from wonder drug Prozac and related anti-depressant drugs are now emerging
REPORT BY TOM FARRELL
Drug dependency nearly ended Ramo Kabbani's life. But the drug she battled was handed out by a qualified GP, is being taken by 40 million other people and is still lauded as a 'wonder drug.'
On 16 February, she will celebrate her fifth 'clean' year and a full decade has passed since her descent into an anti-depressant-poisoned hell. Not that she has yet fully escaped.
"It's taken me a long time to put back on the weight that I lost, my weight plummeted to five stone," she says.
PROZAC NATION
"I also still have the seizures. I'd say it averages out at about nine in a day although I have the odd day where I've not had any."
Ramo is chair of the K Prozac Survivors Support Group (PSSG), founded in March 198 to advise and help people prescribed antidepressants in the Selective Serotonin Reuptake Inhibitor (SSRI) class. This is the class that has seen some atrocious side effects.
For the majority of people taking Prozac and similar medications, the impact of these drugs on their lives has been positive. But Ramo's experience serves as a grim medical parable. Where the use of medicine hinges upon theories of 'chemical imbalances', and where drug companies are not fully open about their possible side effects, a minority of patients are at great risk.
"I'm no longer battling with anxiety-depression, that's the ironic thing," she says. "I've developed seizures through being prescribed these drugs. I've no longer got the problem for which these drugs were prescribed but I'm still battling with the problems that the drugs caused."
In August 1991, Ramo's fiancé died suddenly, one month before their wedding. "I was never offered any bereavement counselling or any alternative…I was just put on tablets and it was downhill from there."
Some months later, while working at Manchester's Fountain Street Employment Service, she broke down. A visit to the GP led to the instant prescription of fluoxetine (Prozac). Initially, she was transfused by an unnatural 'high', a manic sense of exaltation. Six weeks later, Ramo crashed, becoming actively suicidal and haunted by insomnia, anxiety and dread.
Over the next few years each worsening side effect was met with one response: another prescribed drug. She made several suicide attempts.
"There was one particular one which to be honest, I can't believe how close I'd come," she says. "Looking back, I can see that I was in a trance-like state. What actually brought me back to reality was I had Spot my dog who was a little puppy at the time and he literally jumped up at me as I stood in front of the bathroom mirror with a knife against my throat, ready to slit my throat. My first thought was not 'Oh my God! What am I doing?' It was 'Oh my God! I can't do this in front of Spot."
Ramo recalls the various cocktails of alcohol and pills she would take in overdose: Sometimes, I'd be unconscious for about a week. The only way I'd know I'd been out of it was that I'd go into the newsagent, look at a newspaper date and I'd go 'Oh my God…'
"I'd even started looking into my own funeral arrangements. And this is somebody who used to live life to the full. I'd never felt down. I thought 'depression' was a case of the Monday morning blues…"
A CHEMICAL IMBALANCE?
It was an angry encounter at the Royal Oldham Hospital in Manchester, with a psychiatrist who was referred to as a neurologist (Ramo had previously suffered 23 seizures in a day) that compelled her to research her own drug therapy. Reading up on Prozac and other case studies set her towards setting up the PSSG and weaning herself off drugs.
For millions of people, Prozac and its sister anti-depressants are very helpful, releasing them from much psychic pain. But they are now being handed out across GPs' desks, for everything from post-natal depression to menopausal problems. Moreover, they are being marketed with a not fully proven theory of 'chemical imbalance' that is based on the theory that topping up the brain's supply of a chemical called serotonin will alleviate depression.
Just as happened with the earlier so-called 'minor tranquillisers' of the 1960s, the benzodiazepines, including Atavan, Xanax and Miltown, a backlash may now be imminent. In its own way, this could prove as unhelpful as the current vaunting of SSRIs as 'miracle drugs', causing them to acquire an unnecessarily sinister ring.
"It's going to be a replay of the benzodiazepine story." This is the prediction of UCD -educated psychiatrist Dr David Healy, now based at the University of Wales, Bangor. "Part of the problem with this will have been caused by the pharmaceutical industry. The way they handle these things, trying to deny there are problems means that when people get disenchanted, they really do get very disenchanted and it's very hard for someone like me who thinks that SSRIs can be useful to actually prescribe them. So they move from a situation where they're being overused, to one where they're being underused…"
BLOWING IN THE WIND
Certainly, the drug companies, previously hailed as the saviours of millions of depressed people, are now feeling an increasingly chill wind blowing. The high point so far came in June 2001, when the Glaxo Smith Kline company had to give $6.4 million to the family of a man who had shot to death his daughter and grandchildren before turning the gun on himself, while put on Seroxat (paroxetine) for sleeping problems.
Cases like this, involving aggression or suicide are extremely rare. However, Seroxat, whose sales match those of Prozac, now looks as though it could emerge as potentially highly addictive for some people. Last year, America's Food and Drug Administration (FDA) ordered Glaxo Smith Kline to warn GPs that for some people, Seroxat packaged as 'Paxil' in the US) could be as addictive as Valium.
Mark Harvey, a solicitor with the Cardiff firm Hugh James Ford Simey, has something to say on the subject: "My feeling is GSK knew, and they certainly know damn well now, their drug had the capacity to cause a lot of harm to a small number of people. In particular in relation to coming off it and they're not being honest to either prescribing doctors or patients."
Hugh James Ford Simey has already been contacted by over 120 people, complaining of problems with Seroxat. They're coming in, says Mark Harvey, at a rate of nearly three a week. In order to facilitate these people, the firm is setting up a 'User Group' to form the focus for future litigation against the drug companies. Many of these people have experienced 'cold turkey-like symptoms while coming off the drug.
"I've seen an advert in the States. It actually says "Talk to your doctor about non-habit forming Paxil," says Harvey. "That's outrageous, that's clearly designed to catch patients and it deals with what they want to know, which is if it's non-addictive…"
Far from being a zealot against the use of drugs to treat psychological distress, Dr Healy researched serotonin effects at Addenbrooke's Hospital in Cambridge, after leaving Ireland.
But as the author of The Antidepressant Era (Harvard Press), he is candid about the pitfalls of SSRIs, such as Prozac, Seroxat, Lustral and Cipramil.
"The estimates are that one in 20 of us gets so agitated on a SSRI that we have to stop treatment," he says. "One in 100 of us going on a SSRI will make a suicide attempt. One in 1,000 might commit suicide. There are other hazards: probably 30-50% of us going on a SSRI will have problems trying to withdraw. The withdrawal symptoms will be severe; for some people they may continue for a year."
MOTHER'S LITTLE HELPER
"It's hard to know how many. It may be only five percent who really have a severe problem. But if 40 million have gone on Prozac and 100 million have gone on a SSRI, five percent is five million people so it is a major problem…"
The relentless marketing has apparently repackaged not just the medicines, but the condition they are used to treat. Depressed people lose serotonin through 're-uptake' between the brain cells: take an SSRI and you get more serotonin. But the biology of the brain is barely understood: serotonin might not be the key to mood and the drugs may not even work by stimulating it.
Anti-depressants were invented in the mid 1950s and the majority of people who these days get Prozac or Seroxat would have once been given minor tranquillisers. Thus when SSRIs were launched, the companies' emphasis was on 'depression' as a chemical deficiency to avoid association with the minor tranquillisers, by then known to be addictive.
BEYOND PROZAC
Limerick-based psychiatrist Dr Terry Lynch, author of the book Beyond Prozac, is highly critical of the way a theory about depression has become accepted wisdom. This he believes, reflects the doctors' relationship with the drug companies.
"Certainly, I think psychiatrists and GPs to a certain degree need to feel that they're the ones driving the whole thing. They're the ones with the knowledge and the patient's job is to follow the doctor's advice," he says. "I also think that the pharmaceutical companies are involved here because over the past 50-60 years, medicine in general but maybe particularly psychiatry has become very closely aligned to the pharmaceutical industry.
"Psychiatry has allowed itself to become very dependent on the industry for funding of its meetings, of its research, of its ongoing education. I'm guessing, but my sense is that the majority of psychiatric post-graduate meetings are funded by drug companies and I think that that's unhealthy."
Among those people who have approached Hugh James Ford Simey regarding legal action is Glenys (not her real name), a grandmother with no previous history of depression. When she suffered her first panic attack, she was showing symptoms that may well have been hormonal and associated with the menopause. She did not meet the traditional diagnostic criteria for depression when given Seroxat.
Previously, she had been given HRT, then Valium and Prozac; the Valium had caused withdrawal problems, something that is a recognized risk. But Glenys was not warned about problems coming off Seroxat. It seems she belongs in the five percent Dr Healy warned would have severe withdrawal. Now off Seroxat for 18 months, she has been told she may have to wait up to five years for the physical and mental effects to clear.
"I have never had headaches really, until I started the menopause," she says. "All I can say it's like it's crushing my head like an eggshell. After the head, the face will burn, my body will shake and I'll get pins and needles in my arms. It's just horrendous and the agitation is terrible…"
She plans to contribute to the 'Seroxat Users' Group' soon to be set up. In the meantime, she waits for her problem to clear.
"I just feel it's taken part of my life away. I want to be normal…I just hope it hasn't done any permanent damage".
Contact the Prozac Survivors Group by e-mail at Pssguk@aol.com. Alternatively, their helpline number is 0044 161 682 3296"
Anonymous
INTERNET CONFERENCE Feb 3-24 2003 SOCIAL WORK & PSYCHOPHARMACOLOGY
January 18 2003, 2:23 PM
The First National Internet Conference on
Social Work & Psychopharmacology
February 3-24, 2003 (discussions on the Internet)
Sponsored by the Ittleson Foundation
and Virginia Commonwealth University School of Social work
in association with Psy Broadcasting Company (go register at
www.psyBC.com)
You are invited to the first-ever conference exclusively focused on
social
work practice and psychopharmacology. The mission of this conference is
simple: to serve as an innovative forum for social work scholars,
researchers and interested practitioners to learn, share knowledge and
experiences, and to discuss and debate information about psychiatric
medication's relevance to social work practice. The entire conference
will
take place on the Internet over the course of three weeks. Invitational
papers and book reviews by the leading scholars in social work (and
beyond)
can be downloaded from the conference site bulletin boards at PsyBC.com,
then post comments or see what others have said about the ideas
presented.
You will be exposed to a variety of perspectives on the value placed on
medication in practice, as well as creative ideas on how to be more
responsive to both adults and children who take medication. You will
hear
ideas on how to better manage the complex collaborative relationships
with
clients and physicians. You will consider the safety of herbal
preparations, read the latest qualitative and quantitative research that
explores practitioner dilemmas in helping to manage and monitor
psychiatric medication, and be challenged by new ways of conceptualizing
medication use from a public health perspective. A key cross-cutting
topic
is ethics. CEUs will be offered by Virginia Commonwealth and are
included
in your registration fee of $20 (before January 24th).
Invitational Papers:
Joseph Walsh, Rosemary Farmer & Kia J. Bentley
School of Social Work Virginia Commonwealth University
" Ethical dilemmas of practicing social workers: Results of a national
survey"
David Cohen
School of Social Work Florida International University
"The psychiatric medication history: Meaning, purpose and method"
Jerry Floersch
Mandel School of Applied Social Sciences, Case Western Reserve
"Child and adolescent psychopharmacology: Developmental issues affecting
medication management in the community"
Sophia F. Dziegielewski
School of Social Work, University of Central Florida
"Complementary medications and herbal preparations: A new frontier for
social work practice"
Jeffrey Longhofer & Janis Jenkins
Department of Anthropology Case Western Reserve University
"Medication effect interpretation and the social grid of community
management"
Vikki L. Vandiver
Graduate School of Social Work, Portland State University
"Health promotion and psychopharmacotherapy: Strategies for an
integrated approach"
Jill Littrell
Department of Social Work, Georgia State University
"Obtaining informed consent when a profession labels itself as providing
treatment for mental illness"
Sarah S. Bradley
Graduate School of Social Work, Portland State University
"The psychology of the psychopharmacology triangle: The client,
the clinicians and the medication"
Invitational Book Reviews:
Joel Kanter, M.S.W. reviews Jerry Floersch's Meds, money and manners:
The
case management of severe mental illness (2002, Columbia University
Press).
Melissa Floyd Taylor, Ph.D. reviews Lauren Slater's Love works like
this:
Moving from one kind of life to another (2002, Random House).
Patricia Higgins, M.S.W. reviews Peter Breggin & David Cohen's Your
drug
may be your problem: How and why to stop taking psychiatric medications
(1999; Perseus Publishing).
Patrick Miederhoff, Pharm.D. compares and contrasts Joseph Glenmuller's
Prozac backlash: Overcoming the dangers of Prozac, Zoloft, Paxil, and
other
antidepressants with safe effective alternatives (2000, Simon &
Schuster)
and Robert Heydaya's The antidepressant survival guide: The clinically
proven program to enhance the benefits and beat the side effects of your
medication (2001, Three Rivers Press).
ASHINGTON, Jan. 20 (AP) — The government announced plans today to begin clinical tests this year on 12 drugs commonly prescribed for children even though their safety and effectiveness has been tested only in adults.
"Children often react differently to drugs than adults do," Tommy G. Thompson, the health and human services secretary, said. "We need to conduct testing now to fully understand the effects of these medications in children."
The drugs include azithromycin, an antibiotic used to treat bacterial infections, and lithium, used to treat bipolar mood disorders. The others are baclofen, bumetanide, dobutamine, dopamine, furosemide, heparin, lorazepam, rifampin, sodium nitroprusside and spironolactone.
Dr. Jane M. Orient, executive director of the Association of Physicians and Surgeons, questioned whether most of the drugs on the list should be tested in children because of potential risks.
"Safety testing needs to be done, but adults should bear the risks," Dr. Orient said.
The National Institute of Child Health and Human Development developed the list of drugs to be tested in consultation with the Food and Drug Administration and experts in pediatric research.
Congress passed legislation last year giving drug makers financial incentives for conducting the tests. Congress also set up grants to finance pediatric studies. Mr. Thompson said tests would be the first sponsored by the government under the new law. The National Institutes of Health, which will oversee the tests, has set aside $25 million from its budget, and the drug administration, which will review the test results, has set aside $6.6 million.
Mr. Thompson said President Bush's budget request for the fiscal year that begins in October would include another $61.5 million for the testing program.
The 12 drugs are no longer under patent."
********2nd PANORAMA PROGRAMME re SEROXAT/PAXIL SUNDAY 11th MAY 2003 10.15 pm ******
Panorama: Seroxat: E-mails from the edge, will be broadcast on Sunday, 11 May 2003 at 22:15 BST on BBC One.
Last October Panorama revealed the dark and shocking side of Seroxat, one of the world's favourite anti-depressants.
The feedback to that film was unprecedented with thousands of people contacting the programme.
For many who take the drug it is a tremendous help but in e-mails and phone calls many Panorama viewers linked Seroxat to violence, addiction, self-harm and suicide.
This second investigation into Seroxat, "Emails from the Edge" has been driven by the viewers' response.
Production team:
Presenter: Shelley Jofre
Producer: Andrew Bell
Assistant Producers: Calum Walker, Sarah Mole
Deputy Editors: Andy Bell, Sam Collyns
Editor: Mike Robinson"
***SHORTLY AFTER THE PROGRAMME HAS BEEN AIRED, IT WILL BE ON THE INTERNET, AND CAN BE VIEWED WITH REALPLAYER AND THE LINK TO IT WILL BE PLACED IN A MESSAGE BELOW THIS ONE, OR CAN BE TRACKED THROUGH THE ABOVE BBC SITE***
Many thanks to the Production Team for all their efforts )
As they seem to say in the USA 'YOU GUYS ROCK' ))
Special thanks to Calum for keeping us all in touch too )
Peas
Paula
REALPLAYER VIDEO of PANORAMA webcast of 11/5/03
May 27 2003, 2:27 PM
of a discussion which took place immediately after the
Panorama programme of 11th May 2003, between Charles Medawar of Social Audit, Benbow of GSK, and Dr White, psychiatrist.
If you have RealPlayer, then watch the video by clicking on the link:
"NB: THIS TRANSCRIPT WAS TYPED FROM A TRANSCRIPTION UNIT RECORDING AND
NOT COPIED FROM AN ORIGINAL SCRIPT: BECAUSE OF THE POSSIBILITY OF MIS-
HEARING AND THE DIFFICULTY, IN SOME CASES OF IDENTIFYING INDIVIDUAL
SPEAKERS, THE BBC CANNOT VOUCH FOR ITS ACCURACY.
........................................................................
PANORAMA
Seroxat:
e-mails from the edge
RECORDED FROM TRANSMISSION: BBC-1 DATE: 11:05:03
........................................................................
Seroxat is an anti-depressant which helps millions of people around the world
but what about those it doesn't help?
GIRL: Two years ago I tried to take my own life by slashing my wrists with a rusty knife, and last October
I finally understood why.
SHELLEY JOFREY: In October last year Panorama raised concerns about one of the world's best selling
antidepressants. We examined claims that Seroxat is addictive.
MAN: This – cigarette burns, and there's sort of razor marks there as well.
JOFREY: And that it can even provoke suicide and violence in some people who take it.
MAN: He shot and killed the three women that he loved most in the world.
JOFREY: Your response to last October's programme was unprecedented. There were 67,000 phone calls
to the BBC helpline. Panorama received nearly 1,400 e-mails. We read all of them. The same theme
cropped up time and time again – until you saw that programme, many of you had thought you were alone.
MAN: Watching Panorama was the first time that I'd ever made a link between my condition and Seroxat.
WOMAN: It was strange to learn from a TV programme rather than your GP what these side effects were.
MAN: I thought yes, brilliant, somebody is actually taking notice.
JOFREY: In that programme Glaxo SmithKline denied their advice to patients was misleading.
GLAXO: The information clearly says that Seroxat is not addictive and it is not.
JOFREY: But tonight they're backtracking on that advice.
GLAXO: It's quite clear that the phrase "Seroxat is not addictive" was poorly understood.
JOFREY: There is a government regulator, the Medicine's Control Agency, whose job it is to monitor drug
safety. But your e-mails reveal how it's failing in its duty to protect patients. So many e-mails and within
them so many stories. It was clear that they merited further investigation, so we called in the experts.
Charles Medawar has been researching drug safety for over three decades. And Doctor Andrew
Herxheimer is a pharmacologist whose world renowned for his work on medicine side effects. Actually
reading every one of the e-mails was a daunting task, and not one they initially relished.
Dr ANDREW HERXHEIMER
Pharmacologist
I thought it was a huge chore really but when I got down to actually reading them, it wasn't. Time sort of
disappeared because I could get.. they were so interesting, so riveting.
CHARLES MEDAWAR
Social Audit
If you looked at any one of the 1400 e-mails it might not tell you very much and it might be mainly
distinguished by not telling you nearly enough. But then you put them altogether and you get immersed in
these data and you look at the key points that some of them are making, and they come across as so vivid.
JOFREY: Vivid e-mails about violence.
WOMAN: The worst, I personally feel, was when I attacked my daughter. I held her head in my hands and
I was hitting her head on the floor over and over again.
JOFREY: Vivid e-mails about addiction.
WOMAN: I was driving around pharmacies begging them to give me a packet of Seroxat.
JOFREY: Vivid e-mails about suicide.
MAN: There was my son with a leather belt around his neck and he was dead.
JOFREY: Yet so many of your stories have been ignored.
MAN: So I said to him: "Doctor I'm dreaming about murdering children." And he just started to laugh.
JOFREY: Seroxat has been a lifesaver for many people suffering from severe depression, but according to
your e-mails and phone calls, for some it can have a very different effect.
What did you actually find?
MEDAWAR: The raw figures? There were 16 accomplished suicides, there were 47 cases of attempted
suicide and I mean serious, and I think there were 92 cases of people who had thoughts of harming
themselves or others, but I mean quite marked thoughts, emotional turmoil would be putting it mildly.
If you are concerned about any issues raised in this programme, a helpline number will follow. You
should not stop any medical treatment without first consulting your doctor.
BBC Helpline Number: 0800 88 88 09
JOFREY: These cases underline the failure of the drugs regulator, the Medicines Control Agency. The
MCA has an early warning system that's supposed to ring alarm bells if a prescription drug produces
harmful side effects. A system, it boasts, is one of the best in the world, yet it's a system that doesn't take
complaints direct from patients, which might explain why the MCA maintained after the last programme
that there's no need for new concerns about Seroxat. They declined to be interviewed for this programme.
But the company that makes Seroxat, GlaxoSmithKline, agreed to read all your e-mails. Nearly half of
them contained complaints about Seroxat.
Dr ALISTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
Anybody who suffers side effects of any sort I feel every sympathy for, but that does have to be balanced by
the enormous benefit that is seen by many millions of patients around the world. In those e-mails there
were a considerable number of people who talked about the positive benefit that Seroxat had given them.
JOFREY: Seroxat earns GlaxoSmithKline almost two billion pounds a year. Only Prozac is a more
popular antidepressant, both are in a class of drugs known as SSRIs. GPs use Seroxat to treat not just
depression but anxiety, phobias, even shyness. It's a drug that's improved the lives of many people, and one
in five of your e-mails said we should have emphasised that more in last October's Panorama.
GIRL: It was almost as if the people on that program weren't actually taking the same drug as I was. It did
not relate at all to my experiences with Seroxat.
MAN: Seroxat has allowed me to continue with my life basically. It's taken away the anxiety and the
depression down to a point where I now feel more relaxed than I ever have done.
GIRL: I was just mortified that they hadn't looked at the good side of it.
MAN: I would say to the makers of Seroxat that they have made a drug that's seriously helped a very large
number of people and they should be quite proud.
Panorama, October 2002
JOFREY: But what most troubled critics of our last programme was a case we featured from America. A
triple murder and suicide in Wyoming that had been blamed on Seroxat.
[News Bulletin]
The Wyoming State Crime Lab Team is in Gillette tonight reconstructing the scene that left four people
dead. Neighbours can't believe Donald Shell, his wife Rita, their daughter Debbie Tobin and her 9 month
old daughter area dead.
JOFREY: And some of you couldn't believe that Seroxat was responsible. Mr Shell had been on the drug
for just two days and taken just two tablets when he killed his wife, daughter, granddaughter and then
himself.
TIM TOBIN
I felt like something had almost turned him into a monster and because there's no way that anybody in their
right mind would do something like that. The Don that I knew wasn't that time of person. The only thing
that had changed was the medicine that he was taking.
Reconstruction
JOFREY: GlaxoSmithKline blamed Mr Shell's depression. But when it came to court and the jurors heard
all the evidence, they agreed with the family, Seroxat had provoked Donald Shell to murder and then
commit suicide. Some of your e-mails were sceptical to say the least.
MAN: Total rubbish. Unworthy of Panorama.
WOMAN: It is ridiculous to suggest a man killed his entire family after taking just two tablets.
MAN: Malicious, unresearched docu-soap. Any further episodes I watch will be taken with a pinch of salt.
MAN: Quite a number of people, including a number of health professionals were very critical of that
aspect of the programme. They simply didn't believe that two tablets could have such an effect.
JOFREY: This was despite evidence in that programme from Doctor David Healy. As an expert in the
Wyoming court case he was given unique access to GlaxoSmithKline archive of clinical trial results. There
he found results from the 1980s when Seroxat was tested on volunteers, people with no trace of mental
illness. He discovered that up to a quarter of these healthy people became disturbed after just a few days on
Seroxat.
DAVID HEALY: It seemed clear that some people who went on the drugs had no major problems, but
equally clear that others who went on the drugs ended up more restless, in a state of mental turmoil,
complaining about dreams, nightmares and a range of things like this.
JOFREY: Doctor Healy said it was this mental turmoil that turned Donald Shell into a killer. That clearly
struck a chord with some of you. Mental turmoil after just a few tablets was something that was vividly
described in your e-mails.
MAN: There were certainly ten reports in the sample of Panorama e-mails which described very, very
convincingly that yes, a dose or two could have exactly that kind of effect.
MAN: On the day of taking Seroxat I woke up, and my temperature inside my head felt really hot. As the
day progressed it got worse and worse until in the evening it felt like the inside of my skull was boiling. I
went to bed and I started thinking that everybody was out to get me. I started to feel angry, murderous, I
wanted to kill my partner and my family. I've never felt like that before. I sat on the edge of the bed
holding my knees up against me because I knew that if I moved I would kill everybody.
WOMAN: My husband took Seroxat for four days and tried to kill me. Dawn Owen, Helswick, Cheshire.
JOFREY: This is the house Dawn Owen once shared with her husband. It was their dream home. Two
years ago they were doing it up together.
DAWN OWEN
We had everything. We were really happy. We had all our plans for the future, waiting for our first
granddaughter to come along, you know.. it was just… life was great really.
JOFREY: But Dawn says the pressures of work and doing up the house finally took their toll on her
husband. He became stressed and anxious. Dawn took him to the GP who prescribed Seroxat. Soon after
starting the tablets he became agitated and had terrible nightmares. On the fourth morning, after the fourth
tablet, he lay in bed talking to his wife.
DAWN: Next thing I know, my husband had punched me, put the pillow over my face. At the time I didn't
know that he was stabbing me. So I ended up with three puncture wounds through… that had come through
the pillow. When I managed to pull the pillow down, I saw the knife coming. At the same time my
daughter appeared here. She was 7 months pregnant and she got the next knife in her back. But she pushed
him off me. If my daughter hadn't come in at that time, I'm 100% sure I wouldn't be here now.
JOFREY: Thankfully both women survived. Afterwards, Dawn's husband went upstairs and tried to hang
himself. He's still too upset to talk publicly about it all. But Dawn is adamant it was completely out of
character.
DAWN: I know it's not his fault. I know he wasn't that type of person. I worry about him, how he is now,
but I feel guilty I can't help him. But I can't deal with what happened to me.
JOFREY: Now Dawn Owen and her husband are getting divorced. The dream home is up for sale.
You have seen a number of viewers who reported this fairly rapid, intense reaction to Seroxat being thrown
into a state of mental chaos. Are you taking these reports seriously?
Dr ALASTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
We take every single safety report seriously. Absolutely every single one. And anybody… my heart goes
out to anybody who experiences any of the symptoms of depression or the side effects related to the
treatment of course.
JOFREY: So do you accept that this could be a side effect from Seroxat?
BENBOW: No. Based on all the data available to us I don’t believe it is. I thin…
JOFREY: So you'll look for anything else to blame apart from your best selling drug.
BENBOW: No. No, no, quite clearly there are side effects which appear as a result of this serious
medicine.
Panorama, October 2002
JOFREY: The patient information leaflet that comes with Seroxat doesn't warn that the drug can throw
some people rapidly into mental turmoil. But there's one thing it states unequivocally, Seroxat is not
addictive. Yet Seroxat attracts more complaints by far about withdrawal problem than any other
prescription medicine. For last October's Panorama, Helen Kelsell kept a video diary. It showed how she
suffered while trying to wean herself off the drug.
HELEN KELSELL: As I take each step there's this shock in my head that's completely throwing me off
balance.
GIRL: When I saw Helen, holding her camcorder and explaining how she found it difficult to walk along
because electric shocks were knocking her off balance, that really struck a chord with me.
MEDAWAR: Over and over again you find users trying to come off this drug in the Panorama e-mails are
describing these weird electric shock sensations in the head, "zaps" they sometimes call them or "electric
head" or.. and they make them intensely dizzy and there's obviously a lot of visual distortion that goes on,
and it's a very distinctive and very marked side effect.
JOFREY: A very marked side effect that patients have been complaining about for years. Yet there's no
clear warning about it on the Seroxat information leaflet. It's only since reading all your e-mails to
Panorama that Glaxo SmithKline has conceded it needs to spell out much more clearly the sorts of
withdrawal symptoms people may suffer.
BENBOW: We are strengthening the information on side effects, particularly on stopping, so that there is
greater clarity in terms of the exact wording. So for instance we have in the information leaflet that you
may get sensory disturbances. But it was clear to talking to patients that some of them sensory disturbance
is a bit of a medical term – what does that mean? So we are going to specifically strengthen it and talk
about some of the thing which those patients in the e-mails, in phone calls, ringing us, writing to us have
said, and one of those for instance would be the electric shocks.
JOFREY: This isn't the only climb down following your e-mails. Last October Doctor Benbow was
adamant that withdrawal problems were not a sign of addiction. But it turned out he was using a strictly
medical definition of addiction.
Panorama, October 2002
BENBOW: Addiction is characterised by a number of different criteria which includes craving, which
includes increasing the dose of drugs to get the same effect, and a number of other features and these are not
exhibited by Seroxat.
JOFREY: That's not, with respect, what the Oxford English Dictionary says. It says addiction is having a
compulsion to take a drug, the stopping of which produces withdrawal symptoms.
BENBOW: If you use that limited description of addictive then most prescription medicines could be
defined as addictive.
WOMAN: They were playing on words. We shouldn't need to get dictionaries out when there are so many
of us out here who are actually suffering.
WOMAN 2: I'd like to tell the makers of this drug to try it themselves, and to come back to me in five
years time and tell me that it's not addictive.
JOFREY: Using that medical definition of addiction, GlaxoSmithKline's leaflet says you cannot become
addicted to the Seroxat. Those words were approved by the Medicines Control Agency. Yet the MCA's
own rules say leaflets must be written in terms that patients can understand.
WOMAN: From reading the information that GSK gave with the medicine, there's no way I could have
known that I was going to suffer as I have.
Dr JIM KENNEDY
Royal College of General Practitioners
It is very important to tell patients up front on Seroxat and other drugs like it, that there may be difficulties
in coming off the drug, and that there maybe at the very least a habit forming potential with that drug in
some patients.
JOFREY: When we interviewed Doctor Benbow last year he steadfastly denied that Seroxat could be
habit-forming or addictive, and he refused to accept that the leaflet was misleading.
Your patient leaflet is meant to help and inform patients, isn't it.
BENBOW: Yes it is, and it does I believe.
JOFREY: Well not according to the people we've spoken to who feel they were not warned that that is
could happen to them. They read you can't become addicted to Seroxat and thought they could stop the
drug any time they wanted.
BENBOW: No, the reality is they can stop the drug. It is true that….
JOFREY: But they can't stop any time they want.
BENBOW: Yes they can and the information clearly says that Seroxat is not addictive and it is not. It is
true that they….
JOFREY: What a difference six months and 1400 e-mails can make.
BENBOW: Additionally it was quite clear from talking to patients, and as a doctor that's very, very
important to me, it's quite clear that the phrase "Seroxat is not addictive" was poorly understood by them.
JOFREY: That was very obvious from the e-mails.
BENBOW: Yes. Now we therefore had a decision to make. Whilst acknowledging that patients will get
symp… or may get symptoms on stopping Seroxat, although we still don’t think – and I'm absolutely
certain that Seroxat is not addictive – that language was clearly misunderstood and therefore we have
proposed that we will take out that specific wording.
If you are concerned about any issues raised in this programme, a helpline number will follow.
You should not stop any medical treatment without first consulting your doctor.
BBC Helpline Number: 0800 88 88 09
JOFREY: This is a major turnaround for GlaxoSmithKline. Since reading your e-mails they're now
proposing to abandon the advice they so recently defended. But any change to the wording can only go
ahead with the regulator's say so and that hasn't happened yet. We wanted to interview someone from the
Medicines Control Agency to ask why they approved the previous wording when it was misleading to
patients. But no one was willing to come on this programme.
MEDAWAR: To be honest I sometimes wonder if the world wouldn't be a better place if the regulators just
packed up and went away. They are the last to find out what is actually happening because they don’t think
that patient reports are scientific.
JOFREY: Among the most disturbing patient reports were 23 about children who'd had a terrible time on
the drug. Seroxat has not been approved as safe for use in under 18s but doctors are allowed to prescribe it
to them if they think it may help them.
GIRL: It was actually my 14th birthday. School noticed that I was really depressed and so my mum made a
doctor's appointment for me and the doctor just told me to take these tablets.
GIRL2: When I was first prescribed Seroxat I was around 16 years old. I was prescribed them because I'd
suffered quite a lot of depression and my parents wanted to help me solve my problems.
MOTHER: My teenage daughter was on Seroxat in 2001. Whilst on it she was having hallucinations,
nightmares, was suicidal and self-harming. Julie Workman, Witney, Oxfordshire.
JOFREY: Holly Workman was just 14 years old when she was diagnosed with depression. Throughout the
previous year she'd had a pretty rough time both at home and at school.
HOLLY WORKMAN
My parents split up and stuff like that. That sort of made me a bit unhappy and I got bullied for quite a long
time which just made me a bit worse really.
MOTHER: She was diagnosed as being severely depressed and the psychiatrist said she ought to go onto
antidepressants. I wasn't happy about that and questioned a lot about side effects, about withdrawal
symptoms, how long she'd need to be on them, that sort of thing because it seems a pretty massive thing for
a young teenager not only to be diagnosed with severe depression but to be told they need to be on
antidepressants. The response I got was well if she had a broken leg, would we refuse to have the leg put in
plaster.
JOFREY: But when she took Seroxat Holly quickly became anxious and agitated and she began to have
horrific nightmares.
HOLLY: There was this person that looked like the devil and he was just covered in blood. He was telling
me to kill people and he was saying if I didn't kill people, then I'd have to kill myself and stuff like this.
JOFREY: And the nightmares soon took on a grim reality.
MOTHER: There was one particular day, school rang, could I come to school straightaway, that Holly had
injured herself.
HOLLY: I just walked out my lesson and I went into the science block because there's nobody normally
around the old science block. So I sat down there and I just kind of cut my arm.
JOFREY: For Holly and her family it was the start of a nightmare few months. On bad days she would cut
herself six or seven times, and she even started to list all the ways she could kill herself.
HOLLY: Cutting myself until I bleed, slitting my throat, walking in front of a bus, all sorts of things going
from one extreme to the other really. Stealing a car and driving it off a cliff, jumping off a bridge, all sorts
of things.
MOTHER: I spent most of 2001 convinced she was going to be dead by Christmas.
HOLLY: The one I actually wanted to do the most was I wanted to sit in front of a mirror and watch myself
bleed to death.
JOFREY: Holly's depression had led to disturbed thoughts before she took Seroxat. But it was only on the
drug that she self-harmed or actually attempted suicide. Some of the other children who e-mailed us said
the same thing.
GIRL1: When I was taking Seroxat within the first week I did self-harm. I started off by cutting my arms
with scissors or razors.
GIRL2: And I just put the point to my arms and just scrape until it bled.
GIRL1: I did attempt suicide a couple of times by taking overdoses and slitting my wrist.
GIRL2: There was points where I did just want to die.
HOLLY: I knew that this wasn't what I was like.
JOFREY: Did you ever associate it with Seroxat at the time?
HOLLY: Well I guess I thought it was something to do with them, but then a part of me thought no, they
wouldn't have given me them if they were going to hurt me.
JOFREY: Doctors who prescribe Seroxat to children may not be aware of the results of a recent clinical
trial in America costing millions of dollars it was funded by GlaxoSmithKline. We revealed last October
that more than 5% of the depressed children given Seroxat in that study became suicidal within weeks of
going on the drug.
Dr ALASTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
Whilst self-harm and suicidal thoughts are clearly a feature of depression, they have not been shown in
carefully done studies to be a feature of treatment with these medicines.
JOFREY: Well in the carefully done study, it was the biggest study of its kind in America, more children
became suicidal on Seroxat than on placebo – sugar pills.
BENBOW: Yes, that may be true in that particular study, but if you look at…
JOFREY: Well that's pretty worrying, isn't it?
BENBOW: No, that's part of the pieces of evidence that we have to gather together to decide together with
the regulatory authorities and obviously they are the appropriate people to assess this. They will look at all
the data that's been generated in children.
JOFREY: The Medicines Control Agency relies on clinical trial data to work out whether a drug is safe to
be prescribed. In the 1960s it was thalidomide, a very different drug to Seroxat, that highlighted the need
for medicines to be monitored for side effects long after they've been approved as safe. It was only when
thousands of pregnant women had taken thalidomide that doctors discovered the devastating effect the drug
could have on their babies. So the government launched an early warning system that's called the "Yellow
Card" reporting scheme. It's nearly 40 years old now and relies heavily on doctors to make it work. If they
suspect someone has been harmed by a drug they're expected to fill out a yellow card and send it to the
MCA but few doctors ever do, and the Medicines Control Agency doesn't accept reports from patients.
CHARLES MEDAWAR
Social Audit
It's desperately inadequate and it's inadequate because only a tiny fraction of the numbers of reportable
adverse effects are actually reported. It really wouldn't be unfair to characterise this as a system which is..
which predominantly doctors ignore.
JOFREY: To test this claim we asked Holly Workman to ring her previous GP, the one who prescribed her
Seroxat. Holly is convinced the drug prompted her to self-harm and attempt suicide when she was just 14.
She asks him to fill out a Yellow Card.
HOLLY: [on telephone] There's been things in the papers about the safety of Seroxat and there was that
programme that Panorama did.
JOFREY: The doctor tells her: "Panorama is going down the pan" and he's not prepared to fill out a yellow
card for her.
Dr JIM KENNEDY
Royal College of General Practitioners
I certainly think that any patient reports are of great value. The patient is the person actually taking the
drug. They have the best idea of what's happening to them. It's very important that they report these things
to the prescribing doctor, and it's important that the prescribing doctor reports them to the monitoring
authorities because it's only by collecting that kind of data that we can make a real assessment of the effects
– positive and negative – of a medication.
JOFREY: So if in doubt, a GP really ought to fill one of these cards out.
KENNEDY: Absolutely.
MAN1: When I spoke to my GP about the problems I was having with the medication he wasn't convinced
that I wasn't making it all up.
MAN2: I told him explicitly about the dreams I was having and he just started to laugh. So I said to him:
"Doctor I don’t find this very funny because I'm dreaming about murdering children."
JOFREY: The problem is, if doctors don’t believe you, they wont report your suspicions to the regulator on
a yellow card. So, with the help of the leading mental health charity "Mind" we drew up a Panorama
yellow card, then we asked hundreds of you who e-mailed us to answer detailed questions about your
experience with Seroxat – 239 people filled them out. Then we asked the Royal College of Psychiatrists to
recommend one of its members, someone independent, to read the completed yellow cards. They chose
Doctor Alfred White.
Dr ALFRED WHITE
Royal College of Psychiatrists
The first impression was the vast majority of the people shouldn't have been on the drug in the first place.
There were hardly any, if any, that I saw where I felt convinced that they had an illness which would be
appropriate. It's an extremely good antidepressant, extremely useful drug for the right illness, can be
lifesaving. And if you give it to anybody with life problems then you're going to over prescribe it and
you're going to cause problems as well as solving them.
JOFREY: Is it any wonder if it's over prescribed though? More than a third of our respondents said they
were put on Seroxat after just five or ten minutes with their often hard-pressed doctors.
That surely isn't long enough to diagnose depression and prescribe a drug like Seroxat?
KENNEDY: Certainly it is good practice to spend an appropriate amount of time on diagnosing and
monitoring depression. It is probably not appropriate to spend such a short time as five or so minutes on
this kind of problem.
JOFREY: And it gets worse. More than two thirds said their doctors gave them no warning that stopping
Seroxat could be difficult. Even more worrying, almost 30% of respondents said they began to have
thoughts of self-harm or suicide on Seroxat when they'd never had them before.
RICHARD BROOK
Chief Executive, Mind
I mean how can we in all consciousness just sit here and say it's not a problem when you hear those stories.
The very least they should be investigated, looked at and listened to, and the very least we should have
answers that actually are compatible with our knowledge, and if we don’t have that, to continue down this
road seems to me totally irresponsible.
JOFREY: Most damning of all, Panorama has discovered that the number of suicides that may be linked to
Seroxat has been significantly underreported to the regulator. The MCA has been notified of seven suicides
in the last two years. But Panorama has been told of eleven, none of which, as far as the families are aware,
has been reported to the MCA.
BROOK: You could take one view of this which is the regulators playing Russia roulette with people's
lives. It's not listening to people, it's listening to selective evidence, it's not taking the real evidence which
is people's experiences.
WOMAN: The suicidal thoughts only happened while I was taking the drug. They've never happened
before or after.
MAN: My father was on Seroxat for four days. On the fourth day of taking them he was in possession of a
hunting gun and he went to a local wood and shot himself.
MAN2: He put a loop in the belt and put his head through the loop and let himself hang. His own weight
killed him. That's what I believe Seroxat did to my son.
GRAHAM ALDRED: My interest in this is the tragic death by suicide of my wife Rhona. She was on day
11 of Seroxat. Graham Aldred, Cheshire, England. Rhona was somebody who had, I think, remarkable
strength and she was a very determined person. She would fight for issues that she believed in. What
happened was totally out of her character. It was completely uncharacteristic.
JOFREY: Graham Aldred's wife, Rhona, was diagnosed with depression by her GP in October 2001. She
was prescribed Seroxat. Over the next 11 days Rhona kept a record in her diary of how she was feeling.
ALDRED: Friday 26th October, 2001: "Black day, pouring with rain. Went to the doctor's, saw a locum, a
new young doctor, prescribed me antidepressants."
Now I didn't know much about antidepressants and so all I did was read the patient information leaflet and
found that it was fairly innocuous. It didn't advise about any harmful effects that could arise from this drug.
How wrong we were.
JOFREY: Day 3 on Seroxat Rhona's diary suggests she's becoming increasingly disturbed.
ALDRED: Tuesday 30th October: "Graham was out when I got in and I was a bit worried as I have said
some terrible things to him in the morning about our relationship."
The worst thing that happened quite soon was that Rhona's emotions were switched off. She became
switched off emotionally, and she couldn't.. didn't laugh anymore. Now this was coupled with extremely
violent, horrible nightmares.
Thursday, 1st November: "Woke up 6am with apprehension running over me, then felt sick and dry
mouthed and restless when I got up, walking up and down. Graham wants me to carry on with the Seroxat.
I blame the above symptoms on it."
JOFREY: After 11 days of mental turmoil Rhona Aldred sat down and wrote her final diary entry.
ALDRED: "Trace of sleet on Kinder, dreadful night. Messed up the morning by playing half an hour
tennis and then leaving tennis to go to see the optician. But it didn't work either. Bought some fish and
some dish draining racks. Don’t feel like eating though. Graham offered to take me to the park. When can
I start living again. Feel like I've burnt my boats."
What happened was that Rhona left the house some time after I left the house, and drove with the vacuum
cleaner hose in the car to a little lane that has a rather nice name called Oakham Bank Lane that I didn't
know then. She drove about 8 miles and backed the car under a holly bush so that it would partially hidden,
and taped the hose to the exhaust pipe, and then got in the car, started the engine and just sat there and
waited. I think she died in the sunset. It was a most beautiful sunset.
JOFREY: Graham is convinced that Seroxat was the trigger for his wife's suicide, and hers is not the only
case. After the last programme another 15 people contacted Panorama with similar suspicions.
FATHER: I find it very difficult to believe that Adrian would have done this on his own. Adrian was not
depressed. Adrian was not suicidal. Adrian didn't like pain. Adrian wanted to live, he was full of life.
WIFE: The month before he had said to me that he must be the luckiest man alive, he'd got a lovely wife, a
lovely family, a lovely home and no money worries. There was absolutely no reason at all for him to
commit suicide.
Dr ALISTAIR BENBOW
Head of European Clinical Psychiatry
GlaxoSmithKline
Now not everybody who tragically takes their own life will say to people: "I'm feeling suicidal, I'm going to
kill myself." In fact many people who have decided that they're going to do that, deliberately withhold that
information from their friends and family.
JOFREY: So in spite of the stories that our viewers have told us, your views remain unchanged on this, you
don’t believe that Seroxat can, even in a small number of cases, provoke self-harm or suicide?
BENBOW: Tragic though these cases are, we do not believe that… I do not believe that Seroxat causes
people to take their own lives or self-harm.
JOFREY: Both the manufacturer and the regulator have long maintained that Seroxat reduces the risk of
suicide. But Doctor David Healy has recently uncovered evidence that suggests the opposite is true.
Through lawyers in America Doctor Healy got hold of some confidential GlaxoSmithKline trial results. He
says they show the risk of suicide in depressed patients increases when they take Seroxat. This is data that
both the drug company and the regulator have had for 13 years.
Dr DAVID HEALY
Director, North Wales Department of
Psychological Medicine
The evidence is that roughly one person in sixty that goes on this drug makes a suicide attempt. Now you
have to contrast that with the people going on placebo or sugar pill, and the rate there is one person in five
hundred and fifty. That's nine or ten times less. The risk on the drug is nine or ten times greater than the
risk on sugar pill.
BENBOW: We have been asked by the regulatory authorities to provide all our information related to
suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an
increased risk of suicide – no link.
JOFREY: So does the research suggest a link or doesn't it? Doctor Healy has been pressing the MCA for
an answer for over a year. Last November he and Doctor Herxheimer were finally invited to meet them to
present their concerns.
HEALY: I really don’t want to be on a programme like this saying that there are figures pointing to a
hazard from the drug if someone can actually explain to me why these figures don’t mean that there's a
hazard. Now the answer from the MCA has been nothing. They didn't offer me any reasons back there and
then or since as to why there isn't a hazard on the drug, and they haven't taken any action either.
JOFREY: Doctor Healy has so far waited six months, yet the MCA seems in no hurry to answer. When we
point out to them, they confirm they haven't even begun to reanalyse the clinical trial data on Seroxat and
suicide.
GRAHAM ALDRED
It's just staggering. It's just incompetence… it's worse. If it was another industry, if we were talking about
aeroplanes and aeroplane engines then the words 'corporate manslaughter' would be mentioned.
If you are concerned about any issues raised in this programme, a helpline number will follow.
You should not stop any medical treatment without first consulting your doctor.
BBC Helpline Number: 0800 88 88 09
JOFREY: Graham Aldred is in no doubt that Seroxat caused the death of his wife Rhona. She had never
expressed any suicidal thoughts. The change in her behaviour on the drug was rapid and marked. Graham
has sent Rhona's diary and her medical records to North Wales to be examined by Doctor Healy. Today we
come with him to hear Doctor Healy's assessment of the case.
HEALY: The things that leap out at me from what you say are things like the nightmares, this is very, very
common. Strange nightmares, violent nightmares, and this can happen when you go on the drug, or when
you halt it. A certain restlessness that people get, it's not just a physical restlessness, it's a mental
restlessness.
ALDRED: Yes, yes.
HEALY: And you said Rhona's mind seemed to be in chaos.
ALDRED: Yes.
HEALY: That's very like what… well they're the kinds of things I look for from what people say.
JOFREY: Did Seroxat kill Rhona Aldred?
HEALY: Yes, I think you can be pretty confident that it did. Her death happened within the classic
timeframe of deaths that happen on this group of drugs. She had nightmares, restlessness, mood swings, all
of which occurred very quickly after she went on the drug, and I think can make all of us fairly confident
that yes, if she hadn't had this drug, she wouldn't have killed herself and she would be here now today.
JOFREY: Doctor Healy may be convinced about Rhona Aldred, but neither the regulator nor
GlaxoSmithKline regards individual case reports like hers as compelling evidence.
Will you be proposing any change to the leaflet on this issue?
BENBOW: No we wont because the information available does not support that conclusion and we must
be driven, as always, by facts and data. Anecdotes of course important but they're not the same as carefully
controlled work to look at these things.
CHARLES MEDAWAR
Social Audit
I defy any scientist, any good scientist to look at the data that you accumulated and not conclude there is a
problem. You'd have to be from another planet not to see that there is a serious problem and moreover that
this is a problem that the regulators have so far missed.
WOMAN1: My message to the MCA would be you're obviously not doing your job properly otherwise we
wouldn't be where we are now, on this programme that Panorama is doing, investigating all these suicides
and people are addicted to the drug and can't get off.
WOMAN2: There are side effects, there are things happening to too many of us out here to be ignored.
JOFREY: The e-mails you sent us haven't been ignored. Doctor Herxheimer and Charles Medawar have
analysed them all and written the results up into a medical paper. That paper has been peer reviewed. It's
on the Panorama website now and has just been published in an international medical journal.
MEDAWAR: It was an absolutely conscious decision simply to let the e-mails speak for themselves. All
we did really was to string together these powerful and impressive and deeply credible reports. If it doesn't
make a huge difference and a… a seismic difference to evaluation of drug effects in future I would be very,
very surprised. Don’t ask me how long it will take.
JOFREY: The regulator has reviewed the safety of Seroxat and the other SSRI antidepressants four times.
Each time it has decided none of the causes suicide and none of them is addictive. But just six weeks after
our last programme and six weeks after the regulators said there was no need for new concerns, Health
Minister Hazel Blears announced another intensive review of the drugs. But that has since descended into
farce. In March the review committee had to be disbanded when it was revealed that half the members had
shareholdings in GlaxoSmithKline. The Regulator is now trying to put together a new committee.
Drug inquiry thrown into doubt over members' links with manufacturers
Dr ANDREW HERXHEIMER
Pharmacologist
If they do not reach a different conclusion from previous reviews, that will reflect very badly on them, and I
think that restructuring of the regulatory body and replacement of some of the staff would be an inescapable
consequence.
JOFREY: The MCA says that this time they will be listening to patients, but how seriously will they take
them? Back in February we offered to give them the yellow cards we'd collected as evidence of what some
patients say they've experienced on Seroxat. They said: "Thanks but no thanks". However, since the
embarrassment over the committee members financial links, they've had a change of heart and a change of
name. The MHRA, as they're now known, say they'd be happy to consider the yellow cards as part of their
review.
Dr DAVID HEALY
Director, North Wales Department of
Psychological Medicine
They seem to review these things from the point of view of the company. They seem to be waiting for the
public out there to prove there is a problem with the drug, rather than acting to make sure that people aren't
at risk.
JOFREY: The mental health charity 'Mind' is now demanding a truly independent review, a review that
takes into account the experiences, good and bad, of Seroxat users.
RICHARD BROOK
Chief Executive, Mind
If the regulator does nothing now and further people die, and ultimately it was proved to be something in
relation to Seroxat, then the Regulator would be guilty. The Regulator must resolve this issue.
WOMAN: If I were to have a message for the regulators it would be test it and test it again. Do not allow
these drugs to come onto the market without being absolutely certain of the potential side effects.
MAN: This drug devastated my life, my wife's and my life, and I would not like this to happen to anyone
else. But certainly I wouldn't like it to happen to young people. I think that Seroxat should be banned until
such times as it's improved.
MAN2: Your drug does help a lot of people but it also destroys a lot of lives, like it's destroyed my son.
My son Adrian was 19 years of age – 19.
Seroxat is an anti-depressant which helps
millions of people around the world.
You should not stop any medical treatment without
first consulting your doctor.
JOFREY: Next week Panorama investigates America's neo-conservatives. The small and unelected group
of right-wingers who critics claim have hijacked the White House and are making the world a more
dangerous place. If you're concerned about issues raised in tonight's programme, you can call the BBC
helpline. Seroxat has helped many people and you should not stop taking any medication without
consulting your doctor. Glaxo and some other contributors to this programme are taking part in a live
discussion now on the web. Join us on the Panorama website.
Panorama: What happened next? will be broadcast on BBC One on Sunday, 13 July, 2003 at 2215 BST.
In the last programme in the summer run, Panorama returns to some of the stories covered in the last year and asks: what happened next?
Over the last year Panorama's journalists have broken new ground with investigations from around the world, including subjects as diverse as the food scandal involving doctored chicken.
The secrets of Seroxat - one of the UK's favourite anti depressants - and the award-winning investigation into collusion between the British security services and Loyalist killers in Northern Ireland.
In What Happened Next?, Panorama examines how these programmes have prompted change in many of the areas investigated.
Production team:
Producer: Eleanor Plowden
Assistant Producers: Rebecca Woodward, Howard Bradburn
Deputy Editors: Andy Bell, Sam Collyns
Editor: Mike Robinson"
Current Topic - MEDIA ARTICLES ON SSRIs (TV AND JOURNALISM)
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