Drug Maker Puts Words in Mouth of Top Doctors

It is no secret that drug companies have long arranged to have ghost authors write journal articles touting their products and then paid doctors to sign off on these articles. Now comes a story of an even more ambitious scheme: ghost authoring a whole textbook. As Duff Wilson reported recently in the New York Times:

Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”

The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

The doctors named in this episode are not low level figures, either. One co-author is Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that. The other is Dr. Alan F. Schatzberg, chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.

The money involved was not huge. According to the Times story, the authors received just $18,000 in royalties.

Dr. Nemeroff has been in trouble before about his ties with drug companies. As the Times reports, "In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline."



Drug Company Hyperbolizes Benefits of Alcohol-Dependency Drug

Selling a product in the 21st century is rarely about the product itself; what matters is making the most noise and rising above the cacaphony of numerous competitors in order to capture the buyer's attention. And when that jungle of sounds rises as more and more companies enter the market, the individual seller must in turn raise his own voice, creating the self-perpetuating cycle that is today's ever-louder marketing world.

In tandem with this loud talk is the idea that companies must whisper when addressing the risks associated with their products so that they go in one ear and out of the other of their potential customers. Take, for example, a recent DVD produced by Alkermes touting the benefits of its alcohol-dependency drug, Vivitrol. As Ed Silverman from Pharmalot recently noted,

Alkermes stuck the risk info for the injectable after testimonials and toward the end of the videos where, as the FDA notes in a warning letter, it is “unlikely to draw the viewer’s attention.” Moreover, the risk info appears in the form of fast-moving, movie-style credits displayed in small type. Still more curious, there is no accompanying narration, but music is playing, which can be distracting.

Why is Alkermes doing this? To improve the image of their drug without any concrete discussion of actual scientific research:

In fact, the videos and brochures are replete with hyperbole designed to create the impression that Vivitrol is a wonder drug that can help you sleep better (even though sleep disorder is a common side effect); improve tattered relationships with family and friends; reduce problems on the job and experience spiritual growth...As far as the FDA is concerned, Alkermes went too far by implying the usual outcome of Vivitrol treatment is “a positive effect on a patient’s interpersonal relationships, emotional functioning, work productivity, productivity in general, and overall quality of life.”

Maybe John Adams was right - facts are certainly stubborn things.

GSK Still Employs Executives Who Allegedly Ignored Fraud

Five of the six senior GlaxoSmithKline (GSK) executives (uncovered by a whistleblower) involved in the cover-up of contamination problems at the group's Puerto Rico factory are understood to be still employed by the pharmaceuticals company.

Cheryl Eckard (who has a whistleblower recently received $96 million of the $750 million in fines) was fired from her position as quality control manager in 2003 after repeatedly raising her concerns with a series of GSK executives, stated that company executives had refused to acknowledge the gravity of the production violations through the belief that it would delay the approval of two new drugs by the FDA. The five executives still at the company and cited by Eckard to have been informed of the quality violations at the plant in Puerto Rico are as follows:

• David Pulman: President of global manufacturing and supply.
• Janice Whitaker: Senior vice president of global quality.
• Peter Savin: Vice president of global quality assurance.
• Diane Sevigny: Director of global quality assurance, risk management and compliance. 
• Jonathan Box: Vice president of manufacturing and supply for North America.

More interestingly, Eckard also alleged that she told Diane Sevigny "that she would not participate in a cover-up … and would not take part in any further meetings with the FDA about the Cidra plant.” And the conflict continued thereafter with both disagreeing more frequently about GSK’s management of the quality and compliance problems at Cidra.

Of course, GSK denies all other wrongdoing, except for the five specific breaches associated with the fine.

Read the Eckard article here.

Glaxo Forced To Accept Massive Settlement

What do Paxil, Avandia and Tagamet all have in common? They were all sold by GlaxoSmithKline even after the drug company learned that they had been contaminated in the same plant in Puerto Rico. Now, it is time to foot the bill, to the tune of a massive $750 million settlement.

The case is just one in a long line of recent, multi-million dollar settlements agreed to by Big Pharma (in Pfizer's case, over a billion). The Department of Justice has been cracking down as hard as ever on drug companies and the fines, they claim, will only begin to rise as more unethical behavior is discovered. In an industry that has been rife with fraud and unsafe practices for decades, it is about time that the government raised the stakes and sent a clear message that messing with the lives of patients will be punished with the harshest measures possible.

Read the story here.

Even Big Pharma Has Corporate Integrity Agreements

In this day and age when corporate fraud runs rampant, especially in the Pharma world, where is the reprieve? Well it seems most of the major drug companies have at one point or another have held themselves to higher integrity standards. They have signed Corporate Integrity Agreements with the Department of Health and Humans Services. It almost seems humorous at this point but here are some of the more well know names who have signed such agreements and the salient points associated with them. For the full PDF's see this link. 

Companies Who have Signed:

• Allergan, Inc. - 8/30/2010
• AstraZenaca LP - 4/27/2010
• Bayer Healthcare LLC - 11/25/2008
• Bristol-Myers Squibb - 9/26/2007
• Eli Lilly - 1/14/2009
• Forest Laboratories - 9/15/2010
• Intermune, Inc. - 10/25/2006
• Sanofi-Aventis - 8/30/2007

The Code of Conduct sets forth and shall continue to set forth, at a minimum, the following:

A. XXXX’s commitment to full compliance with all Federal health care program and FDA requirements, including its commitment to market, sell, promote, research, develop, provide information about, and advertise its products in accordance with Federal health program requirements and FDA requirements;

B. XXXX’s requirement that all of its Covered Persons shall be expected to comply with all Federal health care program and FDA requirements and with XXXX’s own Policies and Procedures as implemented pursuant to Section III.B (including the requirements of this CIA);

C. XXXX’s requirement that all of XXXX’s Covered Persons shall be expected to report to the Chief Compliance Officer, or other appropriate individual designated by XXXX, suspected violations by XXXX or persons acting on behalf of XXXX of any Federal health care program and FDA requirements or of XXXX’s own Policies and Procedures; and The Code of Conduct sets forth and shall continue to set forth, at a minimum, the following: a. XXXX’s commitment to full compliance with all Federal health care program and FDA requirements, including its commitment to market, sell, promote, research, develop, provide information about, and advertise its products in accordance with Federal health program requirements and FDA requirements; b. XXXX’s requirement that all of its Covered Persons shall be expected to comply with all Federal health care program and FDA requirements and with XXXX’s own Policies and Procedures as implemented pursuant to Section III.B (including the requirements of this CIA); c. XXXX’s requirement that all of XXXX’s Covered Persons shall be expected to report to the Chief Compliance Officer, or other appropriate individual designated by XXXX, suspected violations by XXXX or persons acting on behalf of XXXX of any Federal health care program and FDA requirements or of XXXX’s own Policies and Procedures; and

D. the right of individuals to use the Disclosure Program described in Section III.E, and XXXX’s commitment to nonretaliation and to maintain, as appropriate, confidentiality and anonymity with respect to such disclosures.