Dr Gigi Chow

Another Big Pharma Blunder Goes NOTICED???

In Big Pharma on November 30, 2012 at 10:05 pm

Two days after Thanksgiving, The Washington Post published a huge exposé article on the dangerous anti-diabetic drug Avandia and the willingness of the drug maker GlaxoSmithKline (GSK) to knowingly allow thousands of innocent lives to suffer and perish. The drug was associated with 83,000 heart attacks in the US alone along with other adverse cardiovascular conditions such as elevated cholesterol and strokes.The article also exposed some of the tactics used by the pharmaceutical giant to suppress negative data and publicity.

Here are some of the highlights:

Avandia was an anti-diabetic drug that was approved by the FDA May 1999. About a year after approval, GSK received research data from a small internal study suggested that Avandia might raise “bad” cholesterol levels more than a competitor and therefore the drug could cause adverse cardiac outcome. This was just the beginning of myriad indications for years to come that suggested negative associations between Avandia and increased cardiovascular risks such as elevated cholesterol levels, heart attacks, and strokes.

Interviews, FDA documents and e-mails released by a Senate investigation indicate that GlaxoSmithKline withheld key information from the academic researchers it had selected to do the work; decided against conducting a proposed trial, because it might have shown unflattering side effects; and published the results of an unfinished trial even though they were inconclusive and served to do little but obscure the signs of danger that had arisen.

  • When an analysis showed a sign of danger-Avandia raised bad cholesterol levels more than the competitor the company decided to drop the subject. “The study results support a ‘no-go’ decision,” the internal report concluded, meaning that a full trial would not be conducted.
  • The researchers even warned one another against sharing the results of the preliminary study.
  • “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” said an internal e-mail that was widely reported after it turned up in the Senate investigation.

But as more people went on the drug, the picture on cardiovascular risk began to get clearer.

In 2003, the World Health Organization had issued the company a warning that drugs of this type might be associated with heart trouble. Then, in 2005 and 2006, GSK conducted an examination of records from more than 14,000 patients and concluded that Avandia raised the risk of coronary blood flow problems by about 30 percent, the Senate investigators said.

When the company was ordered by the FDA to study potential dangers, it arranged a trial in which danger signs were muffled, or missed completely.

In their article for New England Journal of Medicine, one of the most if not the most prestigious medical journals in the world, the authors focused mainly on the fact that Avandia had performed the best: it was able to control blood sugar for the longest period compared to other generic anti-diabetic drugs. It was later found that the trial was funded by GSK and each of the 11 authors received money from the company.

Avandia is not the only drug that was approved and promoted at the expense of patient safety, other blockbuster drug such as Vioxx and Celebrex involved a similar dangerous quid pro quo.Vioxx, a drug manufactured by Merck was featured positively in the NEJM and was approved by the FDA. Yet 5 years later, it was discovered that the authors of the research had omitted key incidences of heart troubles, creating misleading conclusions about the drug’s safety. When the drug was finally pulled off the market, it had already caused 27,000 heart attacks and cardiac-related deaths.

I thought this article was great in that it highlighted how deep the connection is between what is considered “good” science (let’s face it when research is published in the NEJM, it is considered excellent and rigorous in the medical community) and the huge pockets of big pharma. What was also great was that the article was on the front page of The Washington Post when articles like this seldom deserve this kind of attention. What I thought a bit lacking in the exposé was the comfy and cozy relationship between big pharma and the FDA. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, as the story of Avandia illustrates, is a gamble. Nevertheless, the article veraciously emphasized the ability of big pharma such as GSK to influence science, medicine, decisions, and lives.

To read the Washington Post article, go to:


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