Articles Posted in GlaxoSmithKline

Published on:

Eager to underscore the point I made last week, GlaxoSmithKline has agreed to plead guilty to misdemeanor criminal charges – read that again, criminal charges – and pay $3 billion – read that again, $3 billion – to settle the largest case of healthcare fraud in American history.

Among other things, Glaxo was pushing the drug Wellbutrin for uses for which it was not approved, such as weight loss and treatment of sexual dysfunction.

Published on:

Speaking of GlaxoSmithKline, the pharmaceutical giant was told by the Hong Kong government to recall its antibiotic Augmentin because it contained detectable levels of plasticizers. The level of plasticizers is unlikely to be harmful in the usual dosages of Augmentin, which is easy to say unless you are the one taking the Augmentin.

Plasticizers are beating down Glaxo in Hong Kong a bit of late. Last month, Glaxo issued a recall for a pediatric antibiotic because of plasticizers in the product.

Published on:

James Murdock was elected to the GlaxoSmithKline board of directors in 2009. He was re-elected to the Glaxo board in May, making Stalin proud by winning 97 percent of the votes cast. Glaxo’s love for Murdock is understandable. Anytime you can get a billionaire’s son whose only business accomplishment is working for his dad, you have to jump on that opportunity. “Should we recall Actos? Let’s get Murdock in here to figure it out.” Inside sources tell me Glaxo turned to Murdock when their first choice, Ivanka Trump, wasn’t available. I think they actually meant to get Matlock.

I’m taking a shot at James Murdock because it’s funny. Is James Murdock an idiot? Corrupt? I don’t know, of course. But I doubt it. He’s probably a very smart guy. Maybe he was born on third base, but what does that ultimately have to do with anything?

But still. Why is he on the board at Glaxo? I’m a smart guy, too. But I’m not qualified to be on the board at Glaxo either. I think shareholders of Glaxo should look at exactly how the sausage is being made at Glaxo and whether they really want some.

Published on:

Some folks I’d rather not mess with – the Chinese government – has ordered Glaxo to a recall of an antibiotic medication that contained trace levels of a plasticizer. China’s version of the FDA found small amounts of Di-isodecyl phthalate, an additive used in plastics that may cause liver problems. The medication, a combination of amoxicillin and clavulanate potassium, is used to numerous infections.

Published on:

Health Canada, the Canadian version of the FDA, said it is taking a long look at the association between the diabetes drug Actos (pioglitazone) and bladder cancer. France and Germany have already ceased Actos sales after more information is coming to light about the connection between Actos and bladder cancer.

The Health Canada press release said:

Health Canada has been closely monitoring this potential risk, and has been reviewing all relevant studies on an ongoing basis. We are taking these studies, including their strengths and limitations, into account as we continue to monitor pioglitazone safety.

Published on:

Is there an Actos recall in the future? No one knows. But the opinion that patients on Actos face a higher risk of developing bladder cancer is gaining currency.

Actos treats diabetes, an indisputably serious condition. So it is certainly acceptable that diabetes drugs – from a cost-benefit perspective – come with risk. But the question is whether there are unnecessary risks.

That might be where we are with Actos. Studies are piling up to suggest that Actos patients have a disproportionate risk of bladder cancer when compared to patients on other diabetes medications.

Published on:

Lots going on in GlaxoSmithKline’s Avandia world. They’ve been wounded but avoided summary execution yesterday when twelve of 33 members voted to allow it to stay on the market, albeit with significant restrictions and black box warnings. See CNN’s article.

One expert cited in the article noted that:

“I don’t have any patients currently taking Avandia,” said Nathan. He stopped prescribing the drug because “it just didn’t make sense,” considering there are alternatives that didn’t carry the potential risk, he said.

Published on:

May 6, 2001.

We’ve reported a lot on Avandia this year. It is a drug, manufactured by GlaxoSmithKline (GSK), used to treat type 2 diabetes mellitus. It is being associated with heart attacks and liver failure. There are 13,000 filed lawsuits over the drug, and GSK just settled about half of them, including the case first up for trial this month in Philadelphia.

In May, GSK settled 700 lawsuits to the tune of $60 million. We don’t know how it was divided, but if it were divided equally (no reason to think it was), each plaintiff would have received $85,714.00 in the Avandia settlement. Now, GSK settled approximately 5,000 more Avandia claims. We don’t know the amount, but this represents about 44% of the Avandia cases. Assuming that the amount was consistent with the first settlement, GSK has now paid about $488,569,800, nearly half a billion. As all the analysts say, this puts their expected total exposure at much less than the predicted $6 billion (just as we predicted way back when).

Published on:

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

  • At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
Published on:

The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.