Death by Black Box
GlaxoSmithKline convinced an FDA panel on August 1st to keep its best selling diabetes drug, Avandia, on the market. If you weren’t aware, the drug was removed from the market recently because it was linked to cardiovascular disease in a small percentage of patients.Three cheers for Glaxo, right? Well, not quite. The advisory panel agreed that the drug could be allowed back on the market, but with the dreaded “black box” warning on its packaging. The black box is a special kind of warning label the FDA reserves for drugs that are indicated to cause serious side effects, even death, when taken as prescribed by a doctor. Unfortunately, I believe this is the kind of restriction that will signal the death knell for the blockbuster potential of this product.
In recent memory, the black box warning is preceded by a flurry of bad press for a particular product due to increasing deaths or serious side effects for patients taking the drug over long periods of time. The warning in and of itself probably has no immediate effect on the sales of the drug, since the bad press takes care of that. However, being that the black box is a permanent fixture on the product’s packaging, if it doesn’t make doctors think twice about prescribing the medication, the patients will probably think twice about blindly accepting a doctor’s prescription.
For Glaxo, this means an aggressive marketing campaign to convince doctors that Avandia is worth prescribing, even though analysts don’t believe that the drug will reach its original target of $6 billion a year in sales by the year 2011. Any percentage of that, however, still impacts the bottom line and there is no denying that the pill was beneficial to a number of patients using it to treat diabetes. Now it will be a question of whether it is too late to get those patients back — it’s likely that the pill was not prescribed by doctors while it was under review by the FDA, and competing drugs like Takeda Pharmaceutical Co.’s Actos or products being developed by Merk & Co. and Eli Lilly & Co. will be preferred to the now blacklisted Avandia.
It actually reminds me of a situation I had with Pfizer’s Celebrex and a family member who was taking the drug when it came under scrutiny by the FDA. She was taking the drug for arthritis, and had said that the drug was doing wonders for pain relief. When the drug was given the black label by the FDA, she was profoundly disappointed because she had found that it was the only medicine that had helped relieve her symptoms. I was performing some contract work for Pfizer at the time, and though I knew a little more about the study than most because of internal email that was circulating around the company, yet there was no way I would do anything to convince her to take the medication. Granted, the possibility of a side effect, especially one that would lead to immediate death, was slim, but it was there. I ultimately decided to leave it up to her to discuss with her doctor.
How do you feel about the “black box”? Is it really the death of a medication? Would you continue taking something even if you knew it had received the FDA’s most severe warning label? What would you say to a family member taking the drug? Would you ask that they not, no matter how low the risk of an adverse event?
I’d love to hear your thoughts. Meanwhile, I’ll be back from vacation Monday, so I hope you’ve enjoyed the two little gems I’ve left you with while I’m away. Have a great weekend!
