Tag Archives: glaxosmithkline

APA ghostwriting/COI scandal simmers quietly

For folks who have had trouble keeping up, MIWatch.org’s Phyllis Vine has pieced together a particularly readable roundup of where the American Psychiatric Association’s Nemeroff/Schatzberg/Glaxo ghostwriting controversy now stands.nemeroff

Alan Schatzberg (a former APA president) and Charles Nemeroff are, of course, prominent psychiatrists who, in 1999, put their names on the APA-published Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. Recent discoveries seem to show that the book, intended to teach primary care physicians about certain new pharmaceuticals, was actually penned by the ghostwriters over at Scientific Therapeutics Inc. Not only that, but the book was bankrolled by an unrestricted grant from the company that’s now GlaxoSmithKline. In other words, it’s double-decker scandal including both ghostwriting and conflicts of interest.

Though the news really hit the mainstream with Duff Wilson’s November 2010 piece in The New York Times, Vine also points out the dogged work of folks like Paul Thacker over at the Project on Government Oversight and others. Work which, Vine writes, has been met by a concerted APA stonewalling effort which appears to continue straight through to the present, despite many unanswered questions.

A MIWatch request to speak to someone about accusations of stonewalling was returned with an email signed by Ron McMillen and rehashing previous statements. His title, “CEO of the APA Office of Publishing Operations” was amended with the word “retired.”

In other words, while the scandal hasn’t gone away, the APA has thus far managed to keep it in a sort of holding pattern, presumably with the hope that it will soon complete its journey to the back burner.

Barlett & Steele uncover chaos, peril of global drug industry

In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.

globePhoto by amyvdh via Flickr

It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.

They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.

After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.

The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.


WikiLeaks cables: Pfizer used dirty tricks to avoid clinical trial payout in Nigeria

Ghostwritten textbook just ‘tip of the iceberg’

The New York Times‘ Duff Wilson has uncovered what he calls the first ghostwritten book. Published in 1999 under the names of two prominent psychiatrists, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care” coyly mentioned that it was funded by an unrestricted educational grant from the company that is now GlaxoSmithKline.

What it doesn’t mention is that GSK apparently also paid ghostwriters to create the outline and text of the book, then signed off on the final version. Up to this point, ghostwriting had been restricted to journal articles.

A Washington advocacy group called the Project for Government Oversight released documents detailing the relationship on Monday, but Wilson also  explains how the Times found their copies:

The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.

Wilson writes that the book was co-published by American Psychiatric Publishing and the American Medical Association. He does not, however, delve deeply into its content or address how it discusses Glaxo’s products.

Everyone reacts to Avandia roller coaster

First, the background: Avandia, also known as rosiglitazone, is an anti-diabetes drug that helps patients control their blood sugar. It made billions of dollars for GlaxoSmithKline until it became associated with higher risks for cardiovascular issues. On Sept. 23, the FDA and European regulators issued their verdicts on the drug. In America, it will still be available, though with much stronger restrictions than before. In the European Union, regulators are looking to stop sales entirely and steer patients toward alternatives.

If you’re looking for the official lines and basic news, start with CardioBrief, where Larry Husten recapped a few of the highlights and then provided each agency’s press release, as well as the official take of Avandia maker GlaxoSmithKline.

Then, it’s time for the reactions. On the NPR health blog, Richard Knox examined the dueling story lines that have emerged since yesterday’s announcements. This larger framework makes all subsequent reactions a little easier to contextualize.

Speaking of other reactions, The Hill‘s health blogger, Julian Pecquet, rounded up the thoughts of some Washington heavy hitters involved in the Avandia debate, from the omnipresent Sen. Max Baucus to the consumer group Public Citizen. Another key player, cardiologist and Avandia critic Steven Nissen, spoke to The Wall Street Journal‘s Alicia Mundy.

In terms of the big regulatory picture, Avandia is the 30th drug which has been restricted under the FDA’s risk evaluation and mitigation strategy provisions since they began in 2007. Merril Goozner says that the FDA has created a new class of drugs. “They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them,” he wrote. Five years ago, he said, Avandia would have been pulled from the market. Now, it just gets restricted. It remains to be see how effective those restrictions really are.

Finally, Pharmalot’s Ed Silverman brings us the thoughts of cardiologist and Yale professor Harlan Krumholz, who you might remember from his recent star turn in Forbes. His take emphasized a principle well-known to health journalists: Marketing matters, and often it matters even more than regulation does.

“The company has announced it will no longer promote the drug,” Krumholz wrote, “and the practical result in Europe and the US may be a lot more similar than the decisions at first appear. Usage will stop in Europe and new use should virtually stop here.”

That said, Krumholz raises some interesting questions, any one of which could form the basis of a follow-up story or two. I’ll paraphrase:

  • A long series of fortunate coincidences lined up to produce the evidence that led to Avandia’s delayed near-demise, which begs the question: Why are we relying on luck when it comes to spotting danger in major pharmaceutical products?
  • “Why does the FDA believe that the barriers to prescription in new users should be stronger than those for current users? There are no studies that indicate that the excess risk dissipates over time.”
  • Will the FDA really be able to effectively implement the regulations and guide physician/patient behavior, especially when it comes to a blockbuster such as Avandia?
  • Have we done anything to prevent the next Avandia? How do we even go about doing that?

Update: The European Association for the Study of Diabetes weighs in

Journalist recounts the pressure of GSK clinical trial

In the wake of questions about GlaxoSmithKline’s Avandia clinic trials, the Austin American-Statesman‘s Ana Cantú talks about her own experience in a different GSK clinical trial five years ago. Her column isn’t long, but she manages to capture the pharmaceutical giant’s desperation and the pressure put on participants. It helps that Cantú was, in some ways, a fulcrum for the study’s success.

I don’t want to spoil the story, but it all revolves around the requirement that seven of the 20 participants complete the study to garner sufficient data for submission to the FDA. After 13 participants dropped by the wayside, a sick and unhappy Cantú found herself on the bubble. She needed a medical authorization to drop out and still receive the $4,800 she was due for her participation, but the physicians in charge of the study were under immense pressure to keep her around and maintain that all-important quorum.

In the end, there’s a reason she refers to it as the “most miserable month of my life,” but at the time Cantú had only scratched the surface of the significance of her participation. Now, her reflections are revealing.