Feb 14, 2007 03:00 AM

Original content.

On February 13, 2007, Judge Jack Weinstein issued a permanent injunction, prohibiting attorney, Jim Gottstein, and Dr David Egilman, an expert witness in litigation involving Zyprexa, from further disseminating certain Eli Lilly documents that were sealed with a court order until Mr Gottstein released them to the media in December 2006.

After reviewing the documents as a plaintiff’s expert in the underlying Zyprexa litigation, Dr Egilman became so alarmed over what he found that as a doctor, he believed he had an obligation to find a way to make the information public.

In an effort to get the documents out from under the court order, Attorney Gottstein subpoenaed Dr Egilman for a deposition in a lawsuit unrelated to the Zyprexa case and asked him to send the documents for review ahead of the actual deposition date.

As soon as Mr Gottstein received the documents he provided copies to reporter, Alex Berenson, at the New York Times, along with a number of other journalists and patient rights activists and groups.

Mr Gottstein argues that the public has a right to know the truth about the risks associated with the drug. “The files show that the manufacturer hid vital information about the drug’s safety,” he states, “not only from patients, but also from doctors.”

“Zyprexa has killed and permanently sickened thousands of people who have taken it,” he says.

Mr Gottstein openly admits that he wanted to get the information out to save lives. “The bottom line is patient safety,” he said.

The documents quoted by Mr Berenson in articles for the Times, showed that Lilly had concealed Zyprexa’s links to weight gain, high blood sugar, and diabetes for a decade.

The documents also reveal that Lilly trained its sales representatives to increase prescriptions for Zyprexa by influencing doctors to prescribe it for off-label conditions, and with patient populations such as children for uses that have never been tested or approved by FDA.

Zyprexa is an antipsychotic approved for the limited use of treating adults diagnosed with schizophrenia or bipolar disorder, and yet it is currently Lilly’s number one selling product with sales over $4 billion last year and 20 million people have taken the drug.

To date, Lilly has paid about $1.2 billion to settle roughly 28,000 lawsuits out of court filed on behalf of persons who were injured or died after taking Zyprexa. However, another batch of plaintiffs is already lined for the next round of litigation.

A secret document not cited in the Times, shows exactly what was going on behind the scenes to prevent a freefall in Zyprexa sales when Lilly knew for sure that the FDA was going to order a black box warning on Zyprexa about diabetes and the American Diabetes was also ready to release a statement on the issue.

A July 7, 2003, Lilly memo titled, “Diabetes Update,” said that a way to get doctors to keep prescribing Zyprexa when news of the diabetes risk did come out was to legally indemnify doctors who prescribed it. “Indemnification represents the most meaningful demonstration of confidence in Zyprexa–both with our customers and with our employees,” the Update stated.

“We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase),” the memo said,
“solely on the basis of personal fear (of being sued).”

In translation, that comment means doctors might curtain the use of Zyprexa with patients who may not need it because they are no longer psychotic, whereas Lilly tries to convince doctors to keep patients on Zyprexa for life as a maintenance program.

Lilly apparently pulled this indemnifying stunt with doctors when the truth about the risks of Prozac leaked out from documents also sealed with a court order. “Our experience with Prozac,” the memo states, “confirms the impact and goodwill of such an initiative.”

It’s not clear from the Update whether Lilly did in fact indemnify doctors, because the memo states: “We are investigating the viability of this action,” it explains, “and are preparing a business case analysis for senior management’s consideration–ASAP.”

However, the memo does make one thing clear; that Lilly knew the plan was improper evidenced by comment that the American Medical Association considered indemnification an “inappropriate incentive” to doctors.

The Update also spoke of a plan to pay the National Alliance on Mental Illness, the most notorious Big Pharma backed front group in the US, millions of dollars to help downplay the news about diabetes and Zyprexa.

The memo said the plan was to “mobilize our allies” and provide “NAMI a multimillion dollar grant to stage a national screening” to “help educate physicians and patients on the inherent risks of diabetes–regardless of the antipsychotic.”

It’s also unclear here, whether NAMI did “stage” a national screening or how much money the group was paid if it did.

It should be pointed out that there was not one peep in the memo about lets hurry up and warn patients and doctors about the risk of diabetes before more people are harmed, it was all about damage control because Lilly knew that information about diabetes was about to become public, but certainly through no fault of its own.

In announcing his ruling in favor of allowing Lilly to keep the documents sealed, Judge Weinstein issued a 78 page opinion which states in part:

Publication of the protected documents has already created irreparable harm to Lilly by revealing its trade secrets, confidential preliminary research, and merchandising techniques.

This may be true, in fact hopefully it is true. If the disclosure of these documents prevents even one person from taking Zyprexa without knowing about the health risks involved, the ends will justify the means, and Mr Gottstein and Dr Egilman should be declared saints.

But the truth is that they probably will have saved many lives, because on February 13, 2007, FDA scientist Dr David Graham, the guy brave enough to blow the whistle on Merck and Vioxx, testified at a US House of Representatives Energy and Commerce subcommittee hearing and said the off-label use of antipsychotics like Zyprexa to sedate nursing home residents kills roughly 15,000 people a year.

Dr Graham also told members of the committee that Lilly and the FDA had known “for a long time” that Zyprexa caused weight gain that can lead to diabetes.

In addition, for the umteenth time, Lilly’s conduct of concealing side effects identified in its own research from doctors and millions of consumers is not entitled to protection under the umbrella of “confidential preliminary research” or “trade secret” or “merchandising techniques.”

Furthermore, engaging in illegal marketing schemes to promote the sale of Zyprexa off-label to the elderly and children, does not qualify for protection under “trade secret,” or “merchandising techniques.”

Judge Weinstein also said releasing the documents “has made settlement of the remaining MDL and state cases and trials more difficult by creating probable prejudice largely irrelevant to the issues posed by the pending cases and by making impartial juror selection more difficult.”

This would be a wonderful outcome as well. The minds of potential Zyprexa jurors will hardly be poisoned by the truth.

Besides, there is a reason why trials are public in this country. Americans have a right and a need to know when giant corporations are knowingly causing harm.

The judge also states that the release of the documents “may have adversely affected prospective plaintiffs who may be less willing to sue if their intimate medical problems can be revealed through violation of the court’s protective orders.”

That statement at best is speculation and at worst plain BS.

In response to the many articles that I have written on this topic, the only uniform complaint that I have received from past Zyprexa plaintiffs is that they signed agreements without knowing that Lilly documents produced in litigation proved that Lilly definitely knew about the risks of weight gain, high blood sugar, and diabetes long before the FDA ordered the black box warning.

And they each agreed on one other point. Each said they did not know that by signing the agreement, they might be helping Lilly to keep this kind of information hidden from doctors and future Zyprexa patients.

Granted, concealing information with court orders that will have a negative impact on sales has become a marketing technique for Lilly, but it’s high time for the courts in this country to quit helping companies hide evidence that shows people are being killed and injured while they con injured victims into settling their cases for peanuts while the executives of the companies doling out the poison go sleep at night counting their millions instead of sheep.

Evelyn Pringle
evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)