Shortly after launching its blockbuster diabetic drug Avandia in the market in 1999, SmithKline Beecham's research labs began a study to find out whether the drug was safer for the heart than a competing pill, Actos, made by Japanese drug company Takeda.

The findings were something that SmithKline Beecham could not digest says a report by The New Yorlk Times, based on documents recently obtained by it that showed that Avandia posed significant heart risks.

Within a year of its internal research finding, US drug giant SmithKline Beecham merged with British drug giants Glaxo Wellcome in 2000 to form GlaxoSmithKline (GSK). (See: Glaxo Wellcome, SmithKline Beecham agree to merge) <http://www.domain-b.com/companies/companies_g/glaxo_sk/20000117glaxoskb_merger.html>

Although GSK is required in most cases by US and other country's law to post the research results on its website or submit them to drug regulators, the merged entity chose to ignore the law.

GSK then spent the next 10 years trying to cover up the findings as putting a ''safety risk'' tag to the drug would have resulted in $600 million in lost sales from 2002 to 2004 alone.

In May 2007, Steven Nissen, chair of cardiovascular medicine and medical director at Cleveland Clinic, published his findings on Avavdia in The New England Journal of Medicine that suggested that the drug increased the risk of heart attacks in diabetic patients, the NYT report says.

In a presentation before the US Senate Finance Committee in November 2007, FDA scientists had said that according to their estimates Avandia was responsible for having caused approximately 83,000 heart attacks since coming into the market.

In February 2010, the Senate Finance Committee, which completed its investigation into the possible heart risk posed by Avandia, expressed its outrage at the discovery that GSK knew that the drug was a risk for many years before Nissen published his findings.

A key clinical trial relied on by GSK and put up as defence of Avandia was treated with scepticism last week by the US Food and Drug Administration (FDA) advisory panel.

The advisory panel has been asked to advise the FDA whether the drug should be removed from the market because it increases the risk of heart attacks.

The FDA advisory panel will meet next week to vote whether Avandia should be removed from the market and whether it was ethical on the part of GSK to test Avandia directly against Actos.

According to the NYT, an FDA reviewer, who closely examined a landmark Avandia clinical trial called ''Record,'' found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial's tally of adverse events, mistakes that further obscured Avandia's heart risks.

Late last week European drug regulator, The European Medicines Agency (EMA), said that it would launch a new probe into the safety of Avandia following Nissen's publication that the drug posed risks of a heart attack as well as the FDA decision to vote on pulling the drug from the market.

GSK does not seem to have learnt from its past blunder with its antidepressant drug, Paxil - in 2004, regulators said that the company had hidden crucial data showing that Praxil had an adverse effect on children and teenagers by heightening suicidal behaviour who took the drug.

As part of the court settlement over Praxil, GSK had agreed to post drug trials data on its website, which most pharmaceutical companies often do with technical and cryptic references that are not understood by a lay person.

Another US drug giant Merck & Co had hidden internal findings for two years that its Vioxx, used in the treatment of patients with arthritis and other conditions causing chronic or acute pain, is five times more likely to cause heart attacks than among those taking a similar drug.
 
After having to face more than 10,000 lawsuits, Merck settled most of the cases at a cost of $4.85 billion in 2007.