"Henry I. Miller, a physician and fellow at the Hoover Institution, was an F.D.A. official from 1979 to 1994. Barron's selected his most recent book, "The Frankenfood Myth," one of the 25 Best Books of 2004" [in whose opinion?]
"Crazy Lawyering, Crazy Journalism
By Dr. Henry I. Miller 22 Jan 2007
Would you try to review a 700-page book after reading a single paragraph? Of course not - but major newspapers have done the equivalent, by publishing sensational and censorious articles about defendants in civil litigation that are based on selective leaks from lawyers. Unethical lawyering combined with shoddy journalism threatens many sectors of the economy, especially those that commonly face costly lawsuits alleging torts -- the drug, chemical, automobile and financial sectors, among others.
An egregious example occurred recently when a lawyer who represents mentally ill patients violated a gag order by leaking to various news outlets documents related to litigation over damages allegedly caused by Eli Lilly Company's anti-psychotic drug, Zyprexa. Based on information that was obviously incomplete and out of context, the New York Times made outrageous - and often misleading - allegations in news articles and editorials.
Lawyers owe their clients zealous representation, to be sure, but that is not the same as conducting an ideological vendetta in the media or attempting to poison the jury pool by trying a case in the newspapers and on National Public Radio. James B. Gottstein, the lawyer who leaked selected documents concerning the Zyprexa litigation to the New York Times and other media outlets, certainly appears to fall into the former category. He admits to conducting a "campaign against forced (court ordered) psychiatric drugging and electroshock around the country," because "the massive amounts of forced drugging in this country, amounting to probably at least a million cases a year, is resulting in decreased, rather than increased, public safety; causing an almost unimaginable amount of physical harm, including death; [sic] turning many patients into drooling zombies." The culprits? "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs . . ."
Mr. Gottstein appears to think he qualifies as a mental health expert because he has experienced psychotic episodes intermittently for a quarter-century. (See his autobiographical information at http://akmhcweb.org/recovery/jgrec.htm.) I think he needs to have his medications adjusted.
Within the past month, two federal judges independently have harshly condemned both the underhanded manner of Mr. Gottstein's obtaining of the documents and his dissemination of them, which violated a court-issued gag order. Another jurist, Judge Jack B. Weinstein, who is presiding over the consolidated federal cases in the Zyprexa litigation, wrote this about the need to prevent unauthorized leaks: "First, the cost and time to explain a single document taken out of context by a plaintiff's lawyer creates an incentive not to prepare memoranda. Second, what appears damning may, in context after difficult proof, be shown to be neutral or even favorable to the defendant." My own experience as an expert witness (in other litigation) corroborates Judge Weinstein's observations.
Access only to documents that argue one side of the case has not deterred the Times from repeated, vicious attacks on Lilly and Zyprexa, a drug widely prescribed and highly regarded by psychiatrists. In spite of relatively frequent side effects - the most common of which are sleepiness, weight gain and dry mouth - the drug has been administered to almost 20 million seriously ill patients in 84 countries. Many psychiatrists consider it a wonder drug for two of the most debilitating mental illnesses: schizophrenia and bipolar disorder.
The Times (and other papers that subscribe to its news service) accuses Lilly of promoting Zyprexa for not yet approved, or "off-label," uses, but the F.D.A. - which carefully monitors and takes a dim view of such violations of federal regulations - has never issued a warning to the company about this.
Without access to the complete database related to the litigation, I cannot judge the merits of the other accusations against Lilly and Zyprexa. However, the Times' call for Lilly's protestations of innocence regarding promotion of off-label uses "to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry's marketing materials" is clearly disingenuous. The Times knows that House Speaker Nancy Pelosi (D-Calif.) and influential committee chairmen such as Senator Ted Kennedy (D-Mass.), Henry Waxman (D-Calif.) and John Dingell (D-Mich.) have long been antagonistic to the pharmaceutical industry, and that such hearings would be no more than a witch hunt.
Henry I. Miller, a physician and fellow at the Hoover Institution, was an F.D.A. official from 1979 to 1994. Barron's selected his most recent book, "The Frankenfood Myth," one of the 25 Best Books of 2004."