(Assisting Public Citizen in helping GSK to not forget to uphold the court's decision)

FOR CLAIM FORMS WHERE STATED, GO TO THIS URL WHERE THEY CAN BE DOWNLOADED in PDF format: 

http://www.paxilpayback.org/

"...If you qualify, you MUST fill out a claim form and mail it to the Paxil Pediatric Settlement Administrator in order to receive compensation. The claims must be received by August 31, 2007..."

For details and downloadable claim forms go to: 

http://www.paxilpayback.org

http://blog.wired.com/sterling/2007/07/head-of-the-fda.html

"Head of the FDA Executed For Taking Corporate Bribes

By Bruce Sterling July 10, 2007 | 9:45:45 AM

(((I meant the *Chinese* FDA; although the USA executes prisoners at a brisk clip, high-ranking federal officials are never among them.)))

Link: BBC NEWS | Asia-Pacific | China food safety head executed.

The former head of China's State Food and Drug Administration, Zheng Xiaoyu, has been executed for corruption, the state-run Xinhua news agency reports.

He was convicted of taking 6.5m yuan ($850,000; £425,400) in bribes and of dereliction of duty at a trial in May.

The bribes were linked to sub-standard medicines, blamed for several deaths.

China has been criticised over a number of recent cases involving tainted goods, and correspondents say Zheng had become a symbol of the crisis.

Zheng had appealed against his sentence, arguing that it was "too severe" and saying he had confessed his crimes and co-operated with police.

But his appeal, heard in mid-June, was rejected shortly afterwards.

Toxic chemicals

Zheng, who headed the administration from 1998 to 2005, was found guilty of accepting bribes from firms to register their products without making them undergo the necessary checks...."

http://www.counterpunch.org/rhames07122007.html

"July 12, 2007

A Bullet for Zheng

Requiem for the Paxilated

By RICHARD RHAMES

"Prozac was introduced by Eli Lilly to the US market in January 1988. Zoloft and Paxil followed in 1991 and 1992, respectively. Some 45,000 reports of adverse reactions to Prozac have been filed with the FDA. These include reports of about 2500 deaths, with the large majority linked to suicide or violence."

-- Class Action America

On Tuesday, July 10th, Zheng Xiaoyu was executed in China. The former head of the State Food and Drug Administration was sentenced to death because of his agency's approval of unsafe medicines and food products and his role in those approvals. According to the New York Times he "became the first ministerial-level official put to death since 2000 and the fourth ...[in] 30 years..." The Times continued, "The official Xinhua news agency announced the execution, but did not say how Mr. Zheng was killed. In most cases, the court police execute prisoners by shooting them in the back of the head, though recently the police have also used lethal injections."

Reports indicate that the death toll from Zheng's bureaucratic streamlining numbered "dozens" in Panama who fell to a cough syrup tainted with diethylene glycol (imported from China) and mis-labeled as glycerin (NYT). The AP recalled "at least 10 people" who died from a suspect antibiotic. Most famously, many US pets fell to Big Box retailed food and treats containing melamine-laced Chinese wheat gluten.

It all just goes to show what a backward nation China really is. Killing a perfectly useful official is such a waste. We in the civilized world don't do such things. Hell, such folks don't even go to country-club prison over here. We believe in the rule of Law----the Law that says jails and executioners are for working people with drowsy lawyers, or for famous young women who drive poorly, or famous older women who cook judiciously but invest rashly. Karla Faye Tucker (1959-98), Paris Hilton, Martha Stewart---these dangers to national probity and the public order must be dealt with sternly. Meanwhile, Irving "Scooter" Libby walks in the sun, along with Colin Powell, Henry Kissenger, Bill Clinton, Bush 41, and Bush 43.

But leaving genocidal war criminals aside for the moment, let's ponder the state of drug administration in the USA, where FDA chiefs are safe from the policeman's round or even a wrist-slapping, and drug company execs never even have to say they're sorry for killing tens of thousands. Since the advent of a class of so-called "anti-depressant" drugs about 20 years ago, the courts and independent scientists have had lots of work. These "selective serotonin reuptake inhibitors" (SSRIs in the trade) work by boosting the amount of serotonin in the patient's brains. Problem is that in some people, this chemical's increase leads to "akathisia"---a profound agitation often leading to violence and suicide.

The drug companies apparently knew about this effect. Prozac's developer, Eli Lilly noticed early that something was seemingly going on. Class Action America reports that, "Lilly's own figures indicate that one in every 100 previously non-suicidal patients who took the drug in early clinical trials developed akathisia, causing them to attempt or commit suicide." Dr. David Healy, a serotonin wonk and director of the North Wales department of Psychological Medicine at the University of Wales has estimated that, "probably 50,000 people have committed suicide on Prozac since its launch, over and above the number of those who would have done so if left untreated."

Britain's Guardian newspaper reported in 2003 on the testimony of coroner Geraint Williams. It seems that Colin Whitfield, a 56 year-old retired headteacher committed suicide soon after ingesting the SSRI, paroxetine or "Paxil". Williams told the court of inquiry, " I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken...I am profoundly disturbed by the effect this drug had on Colin Whitfield." The Guardian also reported the verdict of a Cheyenne, Wyoming federal jury two years earlier. In that case, GlaxoKlineBeecham (now GlaxoSmithKline) "was ordered... to pay ...[$6.4 million ] to the family of Donald Schell who killed his wife, daughter, baby granddaughter and then himself after two days on [Paxil]."

The report continued, "...evidence was given by British psychopharmacologist , David Healy...(see above) who was granted access to GlaxoSmithKline's archives. He found that a small number of volunteers in perfect health, who took part in early trials of the drug, had become very agitated or suicidal." Glaxo et al were the subject of a class action suit over past damage from Paxil. They settled the case for a cool $63.8 million. You probably didn't hear much about that one. Though the papers and distractionist electronic media are full of personal violence stories, they don't go near the tale of profit-based murder or the union of corporate greed and revolving door regulators who sponsor it.

You won't hear about Matthew Miller, a boy of 13 who committed suicide after less than a week of Zoloft swallowing; or the sad 1993 case of William Forsyth who, in a fit of akathisia, stabbed his wife 15 times as she lay in bed and then laid on the knife himself; or British teacher Reginald Payne, 63, who after 11 days of Prozac suffocated his wife and then threw himself off a cliff. You won't read the details of Colin Whitfield's death----a man who only days before had been talking about the future---locking himself in a garden shed and opening his wrists while his daughter slept only feet away.

Those stories aren't good for business, so they can't be told. And the people responsible for those thousands of deaths won't, like that backward Chinese bureaucrat, have their brains spattered or their hearts chemically arrested. No, this is a civilized country, a beacon to the world, where the little people pay and bleed and the powerful .... Prevail.

Richard Rhames is a dirt-farmer in Biddeford, Maine whose place is just north of the Kennebunkport town line. When the swaggering cod-piece king is in town one dreams of Paris. He can be reached at..."

http://www.newsinferno.com/archives/1615

Repeating message with different heading to ensure no parent in the US misses the point, and good-day to "SmithKline Beecham" from "King of Prussia, Pennsylvania", I hope you enjoyed today's visit to this site.

Message repeated:

"(Assisting Public Citizen in helping GSK to not forget to uphold the court's decision)

FOR CLAIM FORMS WHERE STATED, GO TO THIS URL WHERE THEY CAN BE DOWNLOADED in PDF format: 

http://www.paxilpayback.org/

Extract of correspondence from Professor David Healy to the UK  regulatory body,
the MHRA

http://www.socialaudit.org.uk/58096-DH%20to%20WARK.htm

"...Reports on these trials list patients who have committed suicide, and list those patients as being of a certain age and as having committed suicide at a certain point during the trial, when the patient in question has a very different age and the event in question happened at a completely different point during the trial".

"Miscoding of suicidal act as emotional lability."

" Lilly have resorted to treatment non-response and a range of other headings to code what happened."

"...records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance."

"Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;"

"But it is also worth adding specifically that this has been a feature of all trials of Zoloft / Lustral, Seroxat / Paxil and Prozac throughout, as far as I can make out... "

Leaked internal confidential documents:

Memo re withdrawal issue: 

http://www.ssri-uksupport.com/files/GSKprFirmMemo.pdf

Memo with cartoon of agitated withdrawal patient: 

http://www.ssri-uksupport.com/files/GSKwheresmypaxil.pdf

Memo with moneybag cartoon pointing out why it was important to not disclose withdrawal severity:

http://www.ssri-uksupport.com/files/GSKmoneybagmemo.pdf

Memo on how to make money by promoting paxil for SAD:

http://www.ssri-uksupport.com/files/GSKbusinessplanguide.pdf

Memo to Reps, the contents of which NOT to be disclosed to physicians:

http://www.ssri-uksupport.com/files/GSKtoReps.pdf

Ensure GlaxoSmithKline / SmithKline Beecham pay for the risk they put your child and every other child in, and for those children who never survived.  Children like Kara:

http://www.ssri-uksupport.com/kara.html

"...There are several processes which the government needs to go through especially when you have foreign defendants," said government lawyer Babatunde Irukera.

Under Nigerian law, defendants must be present at their criminal trials. A source at the Justice Ministry said two of the nine defendants were already under arrest, without specifying the names..."

http://africa.reuters.com/wire/news/usnBAN547217.html

"Nigeria files criminal charges against Pfizer

 ABUJA (Reuters) - The Nigerian federal government has filed criminal charges against U.S. drugmaker Pfizer over a 1996 drug trial in the northern state of Kano in which 11 children died, a government lawyer said on Wednesday.

The federal government was already seeking $6.5 billion in a separate civil case. The government of Kano state is also seeking $2 billion in damages from Pfizer and has filed separate criminal charges too.

The charges were filed in May but this was not made public at the time. The case was due to come up in court on Wednesday, but in the absence of any representatives of the defendants, the case was adjourned until October 29.

"There are several processes which the government needs to go through especially when you have foreign defendants," said government lawyer Babatunde Irukera.

Under Nigerian law, defendants must be present at their criminal trials. A source at the Justice Ministry said two of the nine defendants were already under arrest, without specifying the names.

The case centers on 200 children who were given drugs during a meningitis outbreak in 1996, including Pfizer's antibiotic Trovan. In the civil case, the Nigerian government says Pfizer deceived authorities about the details of the tests and caused the deaths of 11 children.

Pfizer has steadfastly denied the allegations."

 

The Drug and its side effects:

http://www.medicinenet.com/alatrofloxacin-injection/article.htm

"GENERIC NAME: ALATROFLOXACIN - INJECTION (uh-lay-troh-FLOX-uh-sin)

BRAND NAME(S): Trovan

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

WARNING: This medication may cause serious, even life- threatening, liver problems. Therefore, first doses must be given in a hospital setting. Use should be reserved for serious infections and only when other safer drugs cannot be used. This drug has been restricted in its use in the U.S. market due to safety problems. Notify your doctor immediately if you develop yellowing eyes or skin, dark urine, or unusual fatigue.

USES: This medication is used to treat serious and life-or-limb- threatening infection.

HOW TO USE: After proper dilution, this drug is given slowly by vein (IV) exactly as directed by your doctor, usually once daily. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Do this by using the medication at the same time each day. Continue to use this medication until the full prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow resulting in a relapse of the infection. Use of this drug for more than 14 days is not recommended. Consult your doctor. This medication should not be given together with any solution containing multivalent cations (e.g., magnesium or calcium) in the same IV. Check visually for any particles or change in color of the solution (it should be colorless or pale yellow).

SIDE EFFECTS: Dizziness, nausea, change in taste sensation, headache or pain at the injection site may occur. If these effects persist or worsen, notify your doctor promptly. Unlikely but report promptly: vomiting, diarrhea, stomach pain, dark urine, yellowing eyes or skin. Very unlikely but report promptly: chest pain, unusually fast or slow heart beats, seizure, persistent sore throat or fever, muscle weakness or cramps, pain or swelling of tendons (e.g., tendons of the shoulder, hand and ankle), bleeding or bruising, increased sensitivity to the sun (sunburns), mental/mood changes, vision problems, increased thirst or hunger, change in the amount of urine. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, fainting, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this drug, tell your doctor your entire medical history, including: any allergies (especially drug allergies), liver disease, brain/spinal disorders (e.g., seizures or severe blood vessel disease), heart disease (including irregular heart beats), lung disease. Use of this medication for prolonged or repeated periods may result in a secondary infection (e.g., oral, bladder or vaginal yeast infection). This medication increases sensitivity to the sun. Avoid prolonged sun exposure. Wear protective clothing and use a sunscreen when outdoors. Limit alcohol intake, as it may worsen certain side effects of this medication. Since this drug may cause dizziness, use caution if operating machinery or performing hazardous tasks (e.g., driving). To avoid dizziness or lightheadedness when rising from a seated or lying position, get up slowly. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast- feeding. Elderly patients may be more sensitive to the effects of this drug therefore caution is advised.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially: blood pressure medications (e.g., prazosin), other antibiotics (especially quinolone-type). Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. This drug may increase and/or prolong the effects of caffeine. Also, certain cough/cold products (with "adrenaline-like" medicine such as decongestants), isoniazid and cholinesterase blockers such as tacrine and donepezil might increase the chance of seizures. Other medicines or IV additives should not be combined with this drug, or given through the same IV. Certain IV fluids (e.g., normal saline or lactated ringers) should not be used with this drug. Consult your pharmacist. Do not start or stop any medicine without doctor or pharmacist approval.

 

http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601201.html

"...Alatrofloxacin may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away:

• dizziness
• lightheadedness
• headache
• drowsiness
• upset stomach
• vomiting
• diarrhea

If you experience any of the following symptoms, or those listed in the IMPORTANT WARNINGS section, call your doctor immediately:

• skin rashes
• hives
• itching
• sunburn
• swelling of the face or throat
• difficulty breathing or swallowing
• depression
• hallucinations
• seizures or convulsions
• change in vision
• vaginal infection
• pain, inflammation, or rupture of a tendon

 

IMPORTANT WARNING:  

Alatrofloxacin injection is no longer available in the U.S. If you are currently taking alatrofloxacin injection you should call your doctor to discuss switching to another treatment. Alatrofloxacin has been associated with serious liver injury leading to liver transplantation or death. Alatrofloxacin-associated liver injury has been reported with both short- and long-term drug exposure. Alatrofloxacin use exceeding 2 weeks in duration is associated with a significantly increased risk of serious liver injury. Liver injury has also been reported following alatrofloxacin re-exposure. Alatrofloxacin should be reserved for use in patients with serious, life- or limb-threatening infections who receive their initial therapy in an in-patient health care facility (i.e., hospital or long-term nursing care facility). Alatrofloxacin should not be used when safer, alternative antimicrobial therapy will be effective. If you experience any of the following symptoms, call your doctor immediately: increased fatigue, loss of appetite, yellowing of the skin and eyes, severe stomach pain with nausea and vomiting, or dark urine. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to alatrofloxacin.

http://www.tribune.com.ng/26072007/news/news7.html

We’ve not withdrawn suit against Pfizer - FG

Lanre Adewole, Abuja - 26.07.2007

The Federal Government has not withdrawn its suit against Pfizer and has charged the company and eight others with deliberate application of a killer drug known as “Trovafloxacin” on 200 Nigerian children, leading to the death of many of them.

Those listed for prosecution include Pfizer Incorporated, Pfizer Nigeria, Isa Dutse, Scott Hopkins, Debra Williams, Mike Dunne, Samuel Ohuabunwa, Robert Buhl and William Steere.

Security agents have also been directed to get the accused persons for arraignment on October 29.

The charge was filed in the registry of the Federal High Court, Abuja, where their trial was mentioned on Wednesday before Justice Anwuri Chikere.

In the criminal case no FHC/ABJ/CR/ 47/07 brought against them, the accused persons were also said to have engaged in bribing and forging of documents to cover up the crime, as well as engaging in illegal importation of the said killer drug.

In a 23-count charge dated May 3, 2007 and signed by Mahammad Saidu Diri on behalf of the Attorney-General of the Federation and Minister of Justice, the prosecution said the crimes were committed on April 3, 1996, when some personnel of the company used an outbreak of meningitis in Kano to conduct an unlawful clinical trial of the drug on infected children, leading to adverse reactions.

Specifically, Pfizer Incorporated, Scott Hopkins and Isa Dutse were accused of offering on June 30, 1996, one Dr. Isa Dutse of the Aminu Kano Teaching Hospital, Kano, $20,000, to procure a forged and back-dated letter of approval for the clinical trial conducted in April 1996.

The importation of the drug, its possession and application, are also said to have been in disregard of extant laws governing such activities in Nigeria, offences which are contrary to certain provisions of the National Drug Formulary and Essential Drugs List Act Cap N29 Laws of the Federation of Nigeria 2004."

Ritalin, the drug commonly used to treat attention deficit/hyperactivity disorder (ADHD) in children, may have the potential to cause changes in their brains, according to a new study at Weill Cornell Medical College in New York.

The study, recently mentioned in the Journal of Neuroscience, was conducted by injecting baby male rats twice a day with Ritalin (methylphenidate) from a week after their birth until they were 35 days old. At the conclusion of the study, researchers found changes in four parts of the rats' brains.

"First, we noticed alterations in brain chemicals such as catecholamines and norepinephrine in the rats' prefrontal cortex -- a part of the mammalian brain responsible for higher executive thinking and decision-making," said Teresa Milner, senior author of the study and a professor of neuroscience at Weill Cornell, in a press release.

Changes were also detected in the hippocampus, which controls memory, as well as the striatum, which affects motor function. Finally, scientists saw alterations in the hypothalamus, the area of the brain involved in appetite, emotions and arousal.

Milner and Jason Gray, a graduate student who was a lead author on the study, noted that the doses of Ritalin used on the rats corresponded to a fairly high dose in human children. The rats were also treated with the drug at an earlier age than most human children begin treatment, though Gray noted that Ritalin studies are currently being conducted on 2- and 3-year-old children.

In addition to the changes in the rats' brains, researchers also noted that the rats lost weight, much like human patients do once starting on the drug. Also, three months after receiving their last Ritalin injections, the treated rats seemed to display fewer signs of anxiety than subjects that received no drugs.

Despite the results of the study, Milner said that Ritalin use isn't necessarily harmful to children. In fact, children who have ADHD may have an out-of-balance brain chemistry, and Ritalin may help restore the proper balance of chemicals. "On the other hand, in brains without ADHD, Ritalin might have a more negative effect," Milner said. "We just don't know yet."

It's also important to note that three months after they stopped receiving the drug, the rats' brains had mostly returned to normal - an encouraging find, Milner said, which may support the assertion that Ritalin should only be used in children over a short period of time. "We're concerned about longer-term use," she said.

Weill Cornell Medical College Press Release - "Pediatric Ritalin Use May Affect Developing Brain, New Study Suggests." Available at: http://news.med.cornell.edu/wcmc/wcmc_2007/07_17d_07.shtml

"ADHD Drug Does Stunt Growth

July 20, 2007 – After three years on the ADHD drug Ritalin, kids are about an inch shorter and 4.4 pounds lighter than their peers, a major U.S. study shows.

The symptoms of childhood ADHD -- attention deficit hyperactivity disorder -- usually get dramatically better soon after kids start taking stimulant drugs. But this benefit may come with a cost, says James Swanson, PhD, director of the Child Development Center at the University of California, Irvine.

"Yes, there is a growth suppression effect with stimulant ADHD medications," Swanson tells WebMD. "It is going to occur at the age of treatment, and over three years it will accumulate."

Whether these kids eventually grow to normal size remains a question. Kids entered the study in 1999 at ages 7 to 9. The current report is a snapshot taken three years later. The 10-year results -- when the kids are at their adult height -- won't be in for two more years.

"The big question now is whether there is any effect on these kids' ultimate height," Swanson says. "We don't know if by the time they are 18 they will regain the height."

The finding appears to end decades of debate over whether stimulant medications affect children's growth. Less than 10 years ago, a National Institutes of Health panel concluded that the drugs carried no long-term growth risk.

That opinion was so widely accepted that the study authors -- who include most of the leading ADHD researchers in the U.S. -- did not warn parents that the study medication might carry this risk.

At the time, researchers thought that any short-term stunting of growth would be made up by a hypothesized "growth spurt" that would occur with continued treatment. But Swanson and colleagues saw no evidence of such a growth spurt.

Another widely accepted theory was that ADHD itself stunted kids' growth. But in a surprise finding, the study found that ADHD kids who do not take stimulant drugs are much larger than kids without ADHD. And these untreated kids continued to grow much faster than kids taking stimulant drugs.

Swanson says that children who had been taking ADHD drugs before the study began were smaller than kids who had not yet started treatment. Those who first began treatment at the start of the study were normal in size, but grew more slowly than normal kids as the study went on.

After three years, the growth suppression seemed to reach its maximum effect. That's also when the effect of the ADHD drug used in the study -- immediate-release Ritalin three times a day, every day of the year -- seemed to wear off.

"We compared the effect of medication relative to just pure behavioral treatment," Swanson says. "That effect was substantial at 14 months and reduced a bit at 24 months. But at 36 months the relative advantage of ADHD drugs over behavioral treatment is gone."

Swanson and colleagues note that the study did not test the sustained-release stimulant medications that are now the standard treatment for ADHD.

Omar Khwaja, MD, PhD, a neurologist at Children's Hospital in Boston, last year analyzed studies of different ADHD drugs and found strong evidence that ADHD drugs do, indeed, stunt children's growth. In fact, Khwaja and colleagues calculated a growth effect that almost exactly matches the effect seen in the Swanson study.

But Khwaja agrees with Swanson that nobody yet knows what the long-term results of this side effect will be.

"Whether there will be rebound growth at end of puberty, the jury is still out," Khwaja tells WebMD.

"Parents have to be aware that stimulants are an enormous benefit to a lot of children with ADHD, but there is reason to be cautious with all medicines that affect the brain," he says. "Growth monitoring should be standard practice for kids taking these medications."

Swanson and colleagues report their findings in the August issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

Other findings from this large study show that both ADHD drugs and behavioral therapy work in children"

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Isn't it absolutely extraordinary that studies in 2007 show that Ritalin STILL increases delinquency just as it did in a study of 1971?  I wonder how it works that a drug causes the same effects consistently for almost 4 decades.

http://www.audiblox2000.com/learning_disabilities/ritalin-effects.htm

"Learning Disabilities Online
Ritalin Effects 
 

In a study entitled “Hyperactive Children as Teenagers: A Follow-up Study” (1971), eighty-three children were followed from two to five years after being diagnosed as hyperactive or as having attention deficit disorder. Ninety-two percent of the children were treated with Ritalin. Results were as follows:

60% of the children were still overactive and had poor schoolwork (the original reasons for being put on Ritalin), but in addition were now viewed as rebellious;

59% had had some contact with the police;
23% had been taken to the police station one or more times;
58% had failed one or more grades;
57% had reading difficulties;
44% had arithmetic difficulties;
78% found it hard to sit still and study;
59% were viewed as a discipline problem at school;
83% had trouble with frequent lying;
52% were destructive;
34% had threatened to kill their parents;
15% had talked of or attempted suicide.

Another research study, the Satterfield study (1987), states,

We found juvenile delinquency rates to be 20-25 times greater in our hyperactive drug-treated only group than in the normal control group. In the “Delinquency outcome for the drug-treated group,” the results were: of 61 boys, 46% were arrested for one or more felony offenses before age 18; 30% were arrested for two or more felony offenses; 25% were institutionalized.… Studies of the long-term effectiveness of drugs have been consistently discouraging.

There is also scant evidence of improved academic performance with stimulant treatment. According to Rooney, research has still not shown the use of medication to be significantly effective in the treatment of processing deficits or academic achievement. In The Learning Mystique, Gerald Coles confirms the findings of a 1978 review of both short- and long-term studies on the use of stimulants with children who were hyperactive and learning disabled. Of a total of seventeen studies included in this review, short- or long-term, whether they met basic scientific criteria or not, all the conclusions agreed: “stimulant drugs have little, if any, impact on…long-term academic improvement.” Their major effect seemed to be an “improvement in classroom manageability.”

In the Journal of Behavioral Optometry (1991), a study evaluated twenty-two previous studies/articles since 1976 concerning Ritalin use for hyperactive children. It states:

The fact that the above studies do not show the efficacy of Ritalin for helping hyperactive children should be apparent to the skeptic and make a skeptic out of the believer. But the argument should not stop at this point. The weak evidence for the value of Ritalin must now be viewed in the light of its reported side effects."

But never give up hope: 

36 years later and still a deep scientific mystery worthy of continuous, expensive and arduous attention... valiant 'expert' researchers and concerned manufacturers work hard running regular clinical studies in the desperate hope that one day they will discover that Ritalin is filled with remorse, has learned to change the way it acts within the human body and has at last started working towards the well-being of children.

http://www.boston.com/business/globe/articles/2007/07/25/menopause_pill_by_wyeth_fails_to_get_fda_nod/

Menopause pill by Wyeth fails to get FDA nod

Agency to examine heart, liver effects

By Bloomberg News  |  July 25, 2007

http://www.boston.com/business/globe/articles/2007/07/25/menopause_pill_by_wyeth_fails_to_get_fda_nod/

"...Wyeth chief medical officer Gary Stiles said the company hasn't been asked to give the FDA more data on Pristiq for depression, and that the delay for menopause symptoms shouldn't influence an FDA action on the other use..."

So if there are INDICATIONS OF SERIOUS RISKS in a drug where the manufacturer applies for approval for the menopause -  it warrants the FDA seeking more data and more tests ......

BUT when approval for the VERY SAME DRUG with the same INDICATIONS OF SERIOUS RISK  is sought for use as in the PSYCHIATRIC FIELD, - the FDA just let it pass?

Why is that?

Do the FDA consider that the life of people with depression is not worth protecting?

Didn't Hitler's Nazi Germany have a similar view on mental health?  

Its not a huge leap between allowing a drug to go through for mental health which is not deemed safe for any other use in medicine without further studies, and that of exterminating people with mental health problems outright.

http://allafrica.com/stories/200707310024.html

"Nigeria: Pfizer Moves to Quash Committee Report on Controversial Drug Test

31 July 2007
Posted to the web 31 July 2007

Ise-Oluwa Ige
Abuja

Pharmaceutical giant, Pfizer, yesterday began a legal move before the Abuja division of the Federal high court to quash a report by the Investigating Committee on the Clinical Trial of Trovan conducted in Kano in 1996 which indicted it (Pfizer).

The fresh suit seeking for an order of certiorari reviewing the report with a view to quashing it has been assigned to Justice Anwuri Chikere for trial.

The application for certiorari, if successful, is capable of collapsing the multiple criminal and civil actions pending against the pharmaceutical giants. The case briefly came up yesterday before the high court judge who granted Pfizer an extension of time to apply for leave to challenge the report.

The Federal Government, had, last week, charged Pfizer Incorporated and eight others before the Federal high court sitting in Abuja with alleged criminal application of a killer-drug known as "Trovafloxacin," more than a decade ago, on 200 Nigerian children, terminating lives of many of them, with others suffering various permanent disabilities.

The eight others are Pfizer Nigeria, Isa Dutse, Scott Hopkins, Debra Williams, Mike Dunne, Samuel Ohuabunwa, Robert Buhl and William Steere. They are facing a total 23-count charge.

The case though had come up for mention in court but the accused persons could not be arraigned because they were not in court at the last adjourned date."

A little on the Report in question, from a May 2006 article:

http://hcrenewal.blogspot.com/2006/05/nigerian-committee-criticizes-pfizers.html

"...The Washington Post recently obtained a copy of the confidential report, which is attracting congressional interest. It was provided by a source who asked to remain anonymous because of personal safety concerns.
Aspects of the affair remain mysterious, such as why the report remains confidential. The head of the investigative panel, Abdulsalami Nasidi, said in a brief telephone conversation from Nigeria, 'I don't really know myself' why the report was never released.
Dora Akunyili, director of the Nigerian drug control agency, said she did not know why the report remained confidential but added that her agency had independently concluded that 'these people did not have authority to conduct the trial.'

It sounds like Pfizer CEO Hank McKinnell (see related post here) has another big issue to deal with, albeit retrospectively. This story sounds another warning that physicians and patients need to be skeptical about how clinical research sponsored by commercial firms was actually implemented.   The Post further reported,

Last week, Rep. Tom Lantos of California, the senior Democrat on the International Relations Committee, described the report's findings as absolutely appalling' and called on Pfizer to open its records.   Lantos said he expected to introduce a bill requiring U.S. researchers to give regulators details of tests they plan in developing countries..."