Accidental Blogger

How many times have you opened up the newspaper or a magazine to see large colorful spreads advertising the latest prescription drug, followed by precisely formatted fonts cooing at you to 'Talk to your doctor to see if this is right for you', and pages of print so microscopic that you need an jeweller's loupe to read it?

The problem is that yesterday's silver bullet, having been the goose that laid golden eggs for the big pharmaceutical companies,  now ends up causing more problems than it solved.

Case in point #547 (or thereabouts): Rosiglitazone maleate (sold under brand name 'Avandia' and also in combination with other drugs).

That Avandia presented an increased risk of fatal heart-related events isn't unknown. Concerns were raised as early as 1999, and more recently,  as this 2007 article shows.

The diabetes drugs Actos and Avandia raise the risk of heart failure but do not increase the risk of heart-related death, U.S. researchers said on Thursday, confirming earlier findings.

The popular drugs for treating type 2 diabetes have been the subject of numerous analyses — with more to come — as doctors attempt to weigh their risks following the May report that Avandia increased the risk of death by 64 percent and the risk of heart attack by 43 percent.

Both Actos, made by Takeda Pharmaceutical Co Ltd (4502.T), and Avandia, made by GlaxoSmithKline (GSK.L) (GSK.N), already carry U.S. Food and Drug Administration "black box" warnings that they may cause or worsen congestive heart failure, a chronic condition in which the heart fails to pump blood efficiently.

Note that the point of comparison was another similar drug pioglitazone, marketed as Actos. Both Avandia and Actos come from a class of drugs called thioazolidinediones. Their main function is act to reduce the insulin resistance in diabetics, operating at a cellular level to help improve the ability to absorb and use insulin to maintain the appropriate blood sugar values. Both come with a panoply of risks, all in 'black box warnings' of heart failure and other serious side effects.

You can read about the whole sorry saga of how a blockbuster seller has
degenerated into the next bête noire in a pretty good nutshell here.

Now, several studies and years later, the jury is in, with a split verdict.

After two days of contentious discussion, a federal advisory committee voted on Wednesday to keep the troubled diabetes drug Avandia (rosiglitazone) on the market, but with added restrictions for its use.

Experts had expected the 33-member panel to recommend removing the drug altogether, based on evidence that Avandia, prescribed to control blood sugar in patients with Type 2 diabetes, increases risk of heart attack. That is a particularly worrisome side effect in this population, considering that diabetes itself raises the risk of heart disease.

The panel's divided vote – with 12 members moving to ban the drug and 17 recommending that it continue to be sold with stricter warnings and limitations on use – could still be a devastating blow to the controversial 11-year-old medication. (Three members voted for no change, and one abstained.) The committee's recommendation will now go to the commissioner and deputy commissioner of the Food and Drug Administration (FDA), who will make a final decision on the drug's fate.

Meanwhile, the makers of Actos lost no time in trumpeting their advantage over Avandia. They have taken out full page ads, black box warnings and all, in major newspapers across the country. 

Takeda, in its response after the meeting and in an ad breaking today, is underscoring Actos' safety profile and stressing that Avandia's CV issues are not a class effect. The full-page promotion in today's New York Times notes, “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke.”

So, the goose laying the golden eggs is on its deathbed for one company, while it has taken a fresh lease of life for another. At least, till that silver bullet is proved to induce some other malady.