Avandia is rosiglitazone, a popular diabetes 2 drug. Doubts have been raised about the safety of this drug and there are arguments for and against it. The arguments and concerns will not be resolved quickly. Avandia is marketed by Glaxo, which, like all drug companies, vigorously defends its big money drugs. Sales of Avandia  reached $3.2 billion per year.

Our perspective is that the drug treatment of diabetes is lacking in convincing long-term efficacy and there are an number of important concerns about side effects and long-term adverse effects. Oral medications should not be considered as primary treatment. MDs tend to be drug prescribers and do not teach self-management skills. 

Dr. Steven Nissen and colleagues from the Cleveland Clinic reviewed more than 40 studies and concluded that Avandia increased the risk of heart attacks by 43 percent. Psaty and Furberg recalculated Nissen’s analysis using interim results of the Record study in addition to the studies that Nissen used. They found that Avandia increased a patient’s risk of having a heart attack 33 percent. Nissen is an experienced but independent FDA advisor who has become an ombudsman for the american people.

In the US where Avandia was developed and concerns were announced, questions about the safety of Avandia and how regulators have dealt with its risks were asked at Congressional hearing in June 2007. Glaxo had an ongoing study, REPORT,  and rushed to submit favorable interim results for publication in advance of the government hearing.

In his New England Journal editorial, Dr. David M. Nathan, a  Harvard diabetes expert, doubted the value of the REPORT study because of the high number of patients who dropped out and the study design which compared Avandia to a combination of metformin and sulfonylurea. While this combination is popular, doubts about its safety were raised and never resolved in another study that showed  a 96 percent increase in diabetes-related mortality. Metformin alone appears to be relatively free of cardiovascular risk. Nathan concluded that the interim results of the Record trial do not provide any assurance of the safety of treatment with rosiglitazone and suggested that doctors should use medications other than Avandia.

A series of drug adverse effect withdrawals in recently years have generated criticism, that the US Food and Drug Administration fails to protect the public. In the Avandia case, critics say that the US FDA should have warned about the potential heart risks years ago. A supervisor in the drug safety office at the agency said in an interview that she was rebuked after calling for a stronger warning label on Avandia and a competing drug, Actos.

November 20, 2007: A US Senate Committee on Finance released a report describing what it terms the "intimidation" of Dr John Buse by GlaxoSmithKline (GSK) over his concerns about the cardiovascular risks associated with the company's antidiabetes drug rosiglitazone (Avandia). The committee stated: "According to documents provided to the committee by, among others, GSK and the University of North Carolina, it is apparent that the original allegations regarding Dr Buse and GSK’s attempts at silencing him are true. According to relevant emails, GSK executives labeled Dr Buse a 'renegade' and silenced his concerns about Avandia by complaining to his superiors and threatening a lawsuit." 

Update February 2010  In the US, a senate committe report condemned GlaxoSmithKline’s conduct regarding the serious health risks associated with Avandia.  The report reviewed more than 250 000 pages of documents provided by GSK, the FDA, and several research institutes. Its investigators also interviewed numerous people at GSK and the FDA, as well as anonymous whistleblowers.  It alleges that GSK knew about a risk of myocardial infarction with rosiglitazone for several years prior to the 2007 review that first raised the concerns;  the company failed to  warn patients and the FDA of the dangers; that it actively attempted to discredit any research showing rosiglitazone in a poor light, including the intimidation of independent physicians; and that it tried to downplay findings that competing agent pioglitazone might reduce cardiovascular risk.  The senators recommended that a separate, independent safety unit to be established in the FDA to avoid any inherent conflicts of interest.

False Belief

The main problem for a growing number of patients is the false belief that a drug or combination of drugs can rescue an individual from a disease-causing lifestyle. While there may be benefits to be had with medications, a person with diabetes 2 should  learn expert self-management skills and exercise all the therapeutic and preventative options available before considering medications. 

See further discussions of medical biases and limitations

Also See Diabetes Drugs

Managing Diabetes 2

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