The New York Times reports that in 1999 GSK began studying Avandia against Takeda's competing drug, Actos, and found that the Avandia patients faced greater risks for heart trouble. The company decided to cover up the results, the NYT reports:
"This was done for the U.S. business, way under the radar," Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK," the corporate successor to SmithKline.
... When Rhona A. Berry, a company official, asked about publishing two of the trials, Dr. Freed responded in an e-mail message dated July 20, 2001, that referred to Avandia by the abbreviation of its generic name, rosiglitazone: "Rhona -- Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm," the message said. "It is a difficult story to tell and we would hope that these do not see the light of day."Memo to managers: If you ever find yourself typing an email that asks colleagues to make sure something does "not see the light of day," you're probably doing something wrong. Rosemary Johann-Liang, a former manager in the FDA's drug-safety unit, told a deposition that a 2001 GSK study found Avandia posed a greater heart-attack risk than rival medicines:
Glaxo also didn't turn over an e-mail from researchers who concluded Avandia "strengthens the signals" of heart ailments, she testified in a pre-trial deposition last month ...It all casts GSK in a very poor light. But then, GSK has worked diligently to make itself look as shadowy as possible. The company's own history makes the case against it:
- An FDA reviewer accused GSK a few days ago of removing from Avandia data "a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study's tally of adverse events."
- President Deirdre Connelly banned GSK employees from looking at CafePharma, the online drug industry gossip website. (The ban is futile, but it speaks to GSK's paranoia.)
- Chief medical officer Ronald Krall improperly obtained an advance draft of an Avandia study by Dr. Steve Nissen of the Cleveland Clinic, a critic of the drug, and didn't tell Nissen he'd read it even though the pair had a meeting on the topic to discuss Avandia's risks.
- GSK employs an academic hit man, Dr. Tachi Yamada, who calls up scientists and their bosses if they appear to be doing research that might show Avandia in a bad light, and persuades them that it's "not anyone's best interest" that they continue.
- GSK has installed software on its pharmaceutical sales reps' laptops to monitor their usage.
- GSK uses its blog, "More Than Medicine," to bash reporters it believes are getting the story wrong. (The company has every right to do this, but it's unusual in the drug business to be so vocal.)
- When the FDA looked into reports of liver damage associated with the diet drug Alli, the company put out a feisty press release denying there was anything wrong with the product. (GSK turned out to be correct, but again it is unusual for a company to call out the FDA publicly before the data is in.)
- While many drug companies have employed ghostwriters to author questionable medical journal articles, it was GSK that had the chutzpah to name its ghostwriting program "CASSPER."
- Even though the company is based in London and the U.S., it angered American authorities by pretending to be Swiss for tax purposes.
- It angered British authorities for pretending that its drugs were Irish and Puerto Rican, also for tax reasons.
- When GSK needed to find a new chief lawyer, it employed Daniel Troy, most anti-FDA, ultra-conservative attorney in the Washington circles, even though it later emerged that Troy delayed GSK from getting a new safety warning added to the cancer drug Tykerb for irreversible lung disease.
- GSK once sued Nelson Mandela to keep the price of HIV drugs high in South Africa.
- The company has even had the bad luck to get itself linked to the Catholic Church child abuse scandal via its antidepressant, Paxil. (Not GSK's fault, unless you believe in karma.)
Coming up: The FDA will almost certainly withdraw Avandia or hobble it with so many warnings that its commercial life will be ended. Litigation from patients who took the drug and had heart attacks will move forward. About 8,000 of some 11,000 suits are consolidated under seal in federal court in Philadelphia.
GSK agreed in May to pay about $60 million, to resolve 700 Avandia suits, per Bloomberg. The company's potential liability may go as high as $1.1 billion, according to Gbola Amusa, a UBS AG analyst in London.
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