The New York Times reports (below) that a federal court overseeing Zyprexa litigation has ordered Jim Gottstein to return confidential Lilly documents that reveal Lilly knew the lethal risks of Zyprexa but withheld that information from prescribing doctors and the public, and that Lilly illegally promoted the drug to primary care physicians.
The question is: will Eli Lilly succeed, once again, to divert public attention from the revelations contained in its internal documents about the company's illegal marketing practices and its failure to warn about lethal risks posed by its product?
The focus currently–as reported by the Times this week, is how Lilly turned Zyprexa, a toxic drug approved only for schizophrenia and bipolar disorder into a blockbuster $4.2 billion seller–even as the evidence shows the drug induces acute, dangerous weight gain, accompanied by metabolic dysfunction, abnormal blood sugar levels, hyperglycemia and diabetes.
In 2005, Lilly snookered the NY Times twice:
In January, the Times excoriated Jeanne Lenzer who reported in the BMJ (2005) that Lilly's secret Prozac documents that had been unearthed during legal court proceedings (Wesbecker v. Lilly, 1994) but remained inaccessible for public examination, revealed that the company knew since 1984, but failed to disclose to physicians and the public that Prozac increases the risk of violent and suicidal behavior.
See also, the time-line presented to the jury in the Forsyth v. Eli Lilly trial during closing arguments by the plaintiffs. The time-line, reproduced by Baum Hedlund, emerges from Lilly's internal documents: www.ahrp.org/cms/content/view/275/29
In June 2005, the Times praised Lilly for its "quite scrupulous" disclosure of clinical trial results. http://select.nytimes.com/search/restricted/article?res=F00710F9345D0C728CDDAF0894DD404482
Below are five published letters to the editor about the revelations in Eli Lilly's secret Zyprexa documents.
Of note: the letter by Marshal Mandelkern, M.D., a Yale psychiatrist, is a classic demonstration of the pivotal service rendered by academic psychiatrists who rally to the defense of pharmaceutical companies' morally and legally indefensible marketing / promotional practices.
My (unpublished) letter and the Times June 1, 2005 editorial follow.
Contact: Vera Hassner Sharav
<strong>THE NEW YORK TIMES </strong>
<strong>December 20, 2006</strong>
<strong>Court Orders Lawyer to Return Documents About an Eli Lilly Drug </strong>
<strong>By JULIE CRESWELL</strong>
A federal court in Brooklyn overseeing product liability lawsuits against Eli Lilly's best-selling drug Zyprexa has ordered the lawyer who provided company documents to The New York Times and other organizations and individuals to return the documents.
The internal Eli Lilly documents and e-mail messages detailed efforts by the drug maker to play down the health risks of Zyprexa, a medication to treat schizophrenia and bipolar disorder, as well as to encourage primary care physicians to use it in patients who did not have the disorder.
The documents, the basis for front-page articles on Sunday and Monday, were provided to a Times reporter and to organizations and individuals interested in mental health issues by James B. Gottstein. Mr. Gottstein, who is not involved in the Lilly lawsuits, is a lawyer representing mentally ill patients. He has sued the State of Alaska, accusing it of forcing patients to take psychiatric medicines against their will.
Lilly originally provided the documents, under court seal, to lawyers for plaintiffs who sued the company, contending that they developed diabetes from taking Zyprexa. Lilly agreed last year to pay $700 million to settle about 8,000 of the claims, but thousands more are pending.
Mr. Gottstein, who was not a party to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from another person involved in the suits, Dr. David Egilman, an expert witness for the plaintiffs, who was also named in the federal court's order.
The order, issued yesterday by the United States District Court for the Eastern District of New York, requires Mr. Gottstein to return all of the documents provided to him by Dr. Egilman or any other source.
Mr. Gottstein was ordered to provide the court a list of people or organizations to which he gave the documents and to preserve all related voice mails and e-mail messages.
Mr. Gottstein said he was cooperating with the order and that he had asked the Times reporter, Alex Berenson, by e-mail and telephone, to return the documents.
George Freeman, a Times lawyer, declined to comment on the court order, other than to say, "Our customary practice is to retain documents which we legitimately required during our news gathering process and which are likely to be relevant to future reporting."
The order did not name The Times or any other organizations or individuals who may have received the documents nor did it require them to turn over the documents.
Mr. Gottstein said he believed that he had followed the orders established by the court in the Zyprexa lawsuit when he subpoenaed Dr. Egilman for the Lilly documents. Dr. Egilman declined to comment.
In a statement, Michael J. Harrington, Lilly's deputy general counsel, said:
"Lilly is concerned that this deliberate violation of a court order and the selective disclosure of incomplete information may cause unwarranted concern among patients that could cause them to stop taking their medication without consulting their physician. We are pleased with the seriousness with which the court addressed this matter and look forward to Mr. Gottstein's swift compliance with the order."
Copyright 2006 The New York Times Company
THE NEW YORK TIMES
December 20, 2006
Eli Lilly and the Dangers of a Drug (5 Letters)
To the Editor:
"Eli Lilly Said to Play Down Risk of Top Pill <http://www.nytimes.com/2006/12/17/business/17drug.html> " (front page, Dec. 17), about the company's decision to cover up health effects of its top-selling schizophrenia medication, Zyprexa, is a good example of the strong link between product safety and product liability.
Lawsuits are often the only means for the public to learn about dangerous drugs. This is especially true today, as the Food and Drug Administration has proved unable to keep some unsafe drugs off the market.
The article also illustrates the problems caused when companies settle cases and force the injured to sign confidentiality agreements, as was apparently done in this case. In such cases, wrongdoers can prolong misconduct and suppress information for years.
If lawsuits had not been brought in this case and a lawyer who was not bound by a confidentiality agreement had not come forward, the dangers of this drug would never be known to the wider public.
Joanne Doroshow, Executive Director, Center for Justice and Democracy
New York, Dec. 17, 2006
To the Editor:
It seems from your article about Eli Lilly's marketing of Zyprexa, and from what I know from my experience as a psychiatrist, that the company has behaved as any for-profit corporation would.
While it may not have suppressed important information, it has certainly tried to present the situation in a way that maximizes sales of its product.
For it to do anything else would be a dereliction of duty, which is to shareholders, not patients. The main hope for patients, then, lies in an objective physician, whose only duty is the good of his patient.
The physician must remain as free as possible from financial incentives and concerns, whether from drug companies or insurance companies, and exert his efforts to obtain objective information about drugs from as many sources as possible, and use this knowledge solely for his patient's benefit.
It is in the public's interest for physicians to remain objective, and devoted solely to their patients' well-being, free from financial entanglements with drug or insurance companies.
Marshal Mandelkern, M.D., New Haven, Dec. 17, 2006
The writer is an assistant clinical professor of psychiatry at Yale School of Medicine.
.To the Editor:
Zyprexa is a miracle drug for some of us. That should not be forgotten in light of all that is coming out about Eli Lilly's marketing practices. It opened up the world, allowed me to read and feel a crackling enthusiasm for life for the first time in years, and it cut down drastically on the voices and strange thoughts.
Zyprexa was also the worst drug I have ever taken, making me gain 65 pounds, adding 100 points to my cholesterol and raising my triglycerides sky-high. I was both ecstatic to be involved in the world and miserable, obese and unhealthy.
The problem is to solve the difficulties with Zyprexa, not simply take it off the market. It is too helpful a drug, especially for those who can tolerate it. I could not. I now take three different antipsychotics that are effective but not as miraculous. I miss Zyprexa.
Pamela Spiro Wagner Wethersfield, Conn., Dec. 18, 2006
.To the Editor:
Zyprexa is also prescribed in an "off label" manner to some children with autism whose behaviors may be self-injurious, dangerous to others or sometimes merely annoying to the "typical" population.
It is administered by desperate parents who, in the midst of an autism epidemic, are faced with no cure, no other answers and often inadequate educational and support systems.
Children with autism often gain weight on Zyprexa, too, and the specter of their also developing diabetes is horrifying in light of the injections and other additional medication they may need and the inability of some of those afflicted with autism to regulate such a disease without a great deal of assistance.
Barbara Fischkin, Long Beach, N.Y., Dec. 17, 2006
.To the Editor:
Re "Playing Down the Risks of a Drug <http://www.nytimes.com/2006/12/19/opinion/19tue2.html> " (editorial, Dec. 19):
Congressional hearings into Eli Lilly's playing down Zyprexa's side effects, which you call for, will dabble only with the surface of the problem. The rules make the game, and with "nearly every major drug company … under civil or criminal investigation for alleged efforts" to promote drugs for unapproved uses, it's time to consider that there's something fundamentally wrong with our privatized pharmaceutical industry.
Conservative dogma is that market forces lead to innovation and quality, but our experience in the drug business is that the profit motive leads to price-gouging, cover-ups and expensive litigation.
Meanwhile, even when Big Pharma is obeying the law, vital medicines for poor children and rare diseases are neglected, while research and development budgets are spent on advertising to a market that is flooded with erection enhancers.
We need to get the money-changers out of medicine, and make drugs for people, not for profit.
David Berman New York, Dec. 19, 2006
To the Editor:
Re: "Eli Lilly Said to Play Down Risk of Top Pill" [front page news, December 17] and "Drug Files Show Maker Promoted Unapproved Use" [ front page news, December 18]
In June, 2005, a New York Times editorial ["Hiding the Data on Drug Trials"] was simultaneously right and dead wrong.
The editorial was right when it stated: "Any Americans gullible enough to believe that the drug industry can be trusted to report fully on what clinical trials it is sponsoring or what results were found must be sorely disappointed by recent developments."
But it was surely wrong when it singled out Eli Lilly as a trustworthy company whose conduct (the Times was gullible enough to believe) contrasted with that of the other giants of the pharmaceutical industry.
The Times called Lilly "quite scrupulous" believing the company's public relations ploy. Lilly claimed that it had posted "the results of hundreds of completed clinical trials" on its website. The editorial chided other companies: "Surely if one big company can make its trials transparent, other drug makers can do the same."
The Times declined to publish my letter which contained sobering facts to correct that unearned praise:
I wrote at the time: "Unfortunately an examination of Lilly's website reveals that Lilly is hardly forthcoming or transparent. In particular, Lilly has not disclosed the incidence of suicides during completed antidepressant trials. For example, the antidepressant duloxetine (Cymbalta) was tested in more than 45 placebo controlled trials. Lilly has posted only five duloxetine trials without mentioning the occurrence of any completed suicides.
Traci Johnson, a 19-year old healthy volunteer who tested duloxetine at Lilly's laboratory in Indianapolis was among at least five test subjects who committed suicide while on the drug. Similarly Lilly has never disclosed how many attempted suicides occurred in the Zyprexa clinical trials. Lilly's disclosure of data is highly selective and uninformative about precisely those safety issues that concern the public. Only ederal legislation mandating full disclosure will change the culture of duplicity in the pharmaceutical industry."
I do believe my opinion about the veracity of Eli Lilly's false claims has been strengthened by the Times report about Lilly's Zyprexa documents.
Vera Hassner Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
New York City December, 18, 2006
New York Times Editorial
Hiding the Data on Drug Trials
Published: June 1, 2005
Any Americans gullible enough to believe that the drug industry can be
trusted to report fully on what clinical trials it is sponsoring or what
results were found must be sorely disappointed by recent developments. A
government survey determined that three of the largest drug companies have
effectively reneged on their pledges to list trials in a federal database. A
report in yesterday's Times by Alex Berenson reveals that this intransigence
also extends to a voluntary industry database. It looks as if demands from
researchers and the medical profession for full access to clinical trial
data will continue to be frustrated.
Companies already provide the data to the Food and Drug Administration,
which is required to keep much of it confidential. A public listing of
trials is important to prevent drug makers from hiding results that reflect
badly on their drugs while publishing only results that make their drugs
look good. By law, the companies are supposed to register important trials
with a government Web site. Most manufacturers are complying, but the three
big obfuscators – Merck, GlaxoSmithKline and Pfizer – are often getting
around the requirement by not naming the drugs they are testing, instead
using phrases like "an investigational drug." Merck was the worst offender,
failing to provide a drug's name some 90 percent of the time. Glaxo withheld
a name 53 percent of the time, and Pfizer 36 percent of the time.
Merck and Pfizer are also the most prominent withholders of trial results
from the industry's voluntary database. As Mr. Berenson reported, Pfizer has
posted only a few results of clinical trials, and Merck has posted none.
That meager contribution appears to satisfy the weak guidelines set by the
industry, but it offers a sorry contrast with the record of Eli Lilly. Lilly
appears to have been quite scrupulous in listing its current trials with the
government site and has posted the results of hundreds of completed clinical
trials on the industry site. Surely if one big company can make its trials
transparent, other drug makers can do the same.
A coalition of medical editors has just stiffened its announcement that
leading journals will soon refuse to publish the results of any clinical
trial that has not complied with tough international standards for
transparency. That should apply useful pressure to recalcitrant companies.
But the best hammer would be federal legislation to compel all companies to
provide critical information when a trial is begun and full results when a
trial is completed, with stiff penalties for noncompliance.