Despite FDA vote, the word’s caution on Avandia

Away from the bustle of corporate deals, the pharmaceutical industry’s attention was diverted to one place this week — the USFDA’s joint advisory committee meeting, which was called to decide if anti-diabetes drug Avandia (generic rosiglitazone) can stay on the market.

After 2007, this was the second time GlaxoSmithKline’s Avandia came close to being declared highly risky for cardiovascular patients, thereby requiring its withdrawal from the shelves. The product has been on the market for close to a decade but it was only after years of long-term clinical investigations across patient groups that medical experts could conclude that it may harm certain patients. Rosiglitazone’s benefits in maintaining insulin levels in the body have been outlined in hundreds of publications, but that it may also lead to complications over a period of time has not been so well documented.

The product has been studied against its closest rival Actos or Pioglitazone and though Glaxo has stood firm that the benefit of Avandia outweighs its risks, some medical experts have a difference of opinion.

As was evident from the outcome of the FDA advisory meeting, while a few felt the product should be withdrawn from the market owing to its risky indications, a few others held the view that Avandia can stay on but should have clear warnings plastered prominently on its label. Avandia already carries a black box warning in the US, but that has not been a mandatory requirement from regulators in other countries.  However, the whole process seems to have taken a very confusing turn since Avandia has been voted to stay in the market. The final verdict will be with the FDA, but going by the pressures the product is witnessing, it may be a tough call for the FDA to justify its continuation in the market. What’s more, soon after the FDA review gets over, European authorities are also slated to study Avandia’s profile. In the light of the developments faced by Avandia, one cannot help but remember the events in 2004 that laid to the withdrawal of Merck’s pain management product Rofecoxib, branded Vioxx.

Brands become famous mainly at the back of marketing strategies and though science does come in as a big driver, there are good chances that over longer term a product may see some unexpected obstructions.

Looking at it from GSK’s angle, the company may have tried to bring out an effective drug to combat diabetes. It may have generated several studies to establish the effectiveness of the product. How a drug’s effects pan out over a longer period of time may not always be so predictable.  It will be prudent to stay clear of allegations that GSK did not disclose adverse data on Avandia to push its approval process forward. That will be unfair till the time the charges are proved by the right legal authorities. If those allegations come true, it will most likely send all the wrong signals about the transparency of large organisations in developing objective data for drugs put into market.

In the Indian context, the situation remains rather fluid on ensuring safety of marketed drugs. Leaving aside the patented or newly introduced medicines, the Indian regulator has not done enough in checking the effectiveness of the presently marketed scores of combination drugs.

For years together, government agencies have been making noises about pulling the plug on irrational combinations, but every time the noises remain, well just that.

However, in a move that is indeed commendable, the Indian regulator has asked GlaxoSmithKline to hold its Phase IV trials on Avandia. Some doctors have played advocacy in telling the media that Avandia is a safe product but many still feel the need for caution. More so, because there are better compounds available in the Indian market.

It will therefore be very important to put the safety of the patients before any opinion is shared arbitrarily. On the part of the regulators, it is desired that a thorough fool-proof mechanism is evolved to ensure adequate safeguards to a patient. Avandia has already burnt a big hole in GSK’s pocket as it is in the process of settling law suits in the US.

Has anyone in India ever thought of raising similar issues against generic companies that market Rosiglitazone or even against the brand innovator? Well, there is no data to support the Indian patients’ claims as in the US

Pillman is an executive closely linked to the global pharma industry.