Avandia Sales Suspended in Saudi Arabia

Saudi Arabia Suspends Sales of Diabetes Drug Avandia Due to Heart Damage Concerns

 

According to a story in Reuters, the Saudi Food and Drug Authority have decided to suspend the sale and use of Avandia within its borders for six months due to concerns that it might cause “adverse cardiovascular effects” in its users. The SFDA is giving Avandia manufacturers GlaxoSmithKline six months to provide them with evidence that their concerns are unwarranted.

Although Saudi Arabia is the first country to actively suspend the sale of Avandia over health concerns, they are certainly not the first to examine whether the benefits outweigh the purported dangers of the drug. The U.S. Senate Finance Committee, after studying the anti-diabetes drug for two years, came to the conclusion that not only can an estimated 83,000 heart attacks over eight years be attributed to flaws in the drug, but also that GlaxoSmithKline were aware of the added risks.

The name of the actual functioning medicine in Avandia goes under the name of Rosiglitazone. It belongs to a class of drugs that work as insulin sensitizers. What this means is that it makes people who have Type 2 diabetes more receptive to the insulin that they already have in their blood, which makes constant blood sugar monitoring unnecessary.

 

There have been quite a few studies claiming that Avandia can cause heart problems. One of the first was a study published in 2007 by the New England Journal of Medicine, entitled “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The study itself was done by The Cleveland Clinic, who concluded that the main ingredient in Avandia “was associated with a significantincrease in the risk of myocardial infarction and with an increasein the risk of death from cardiovascular causes.”

A few months after the Cleveland Clinic study was published in the New England Journal of Medicine, the medical journal Lancet published a study by the Lahey Clinic Medical Center in Burlington, Massachusetts, which claimed that the relative risk for people who take Avandia or Actos (which is a similar pill marketed by Takeda Pharmaceutical) have an “increased relative risk (for heart failure or myocardial infractions) of 72%.”

There have been an onslaught of studies that either spoke positively of Avandia or discounted any studies which called the safety of Avandia into question, but a recent article in Business Week referenced a study which found that 94% of the authors of these positive reports were receiving money from pharmaceutical companies, either through research grants, consulting fees, or simply being on the payroll in one capacity or another. This certainly calls into question the neutrality of their research.

GSK has every reason to want to keep the sale of Avandia unfettered and unobstructed. This medication has earned them $521 million in this quarter alone, and that’s even after all of the studies and hearings by the Senate Finance Committee and the FDA. Granted, it’s a drop off compared to what they were earning before the controversy began, but $521 million in a fiscal quarter is still nothing to sneeze at.

This is probably why they are being so proactive about countering every single study, claim and editorial that portrays Avandia in a negative light. The idea that authors of positive Avandia reports were being paid by pharmaceutical companies was dismissed as an “unjust challenging of the motives of physician scientists seeking to inform diabetes treatment and patient safety.” Similarly, GSK took the Senate Finance Committee to task by claiming that they “didnot present an accurate, balanced, or complete view of the currently available information on Avandia (rosiglitazonemaleate). Further, the Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline LLC (“GSK”) took to continue to monitor the safety and efficacy of its diabetes medication.”

The general position of GSK is that Avandia has been unfairly victimizes, as if the NEJM, the FDA, the Senate Finance Committee and the Lancet just pulled a random drug out of a hat and decided to focus a smear campaign against it. This does a disservice to these publications and Committees. They are not businesses. They don’t have market shares or profits to worry about. They exist to serve the public interest. And Avandia was not chosen randomly. Diabetes patients who were taking Avandia were suffering from heart attacks at a greater number than what could be considered random occurrences. We have a hard time understanding what further motives GSK thinks the US Senate and these publications have.

 

Greenberg and Bederman is a personal injury law firm based in Silver Spring, Maryland. We are currently offering legal help to type 2 diabetes patients who have suffered heart complications due to the use of Avandia. We are an injury law firm with decades of legal experience, and we have helped thousands of injury victims in Maryland, Virginia, and Washington, D.C. If you or a loved one has suffered from an adverse cardiac event from taking Avandia, contact Greenberg and Bederman for a free avandia legal consultation today.

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