This is hardly surprising, but worth noting, nonetheless. Now that a majority of FDA advisory panel members voted in favor of allowing GlaxoSmithKline's Avandia diabetes pill to remain on the market - but with restrictions - Takeda Pharmaceuticals is taking advantage by running a national media blitz over the next two weeks in newspapers and magazines.
The ads, which brag that "Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke,” are appearing in 154 publications spanning 85 different markets. The national publications include The New York Times, USA Today and The Wall Street Journal, as well as such magazines as Parade, Newsweek, Time and BusinessWeek.
Of course, the Avandia story is not over - 12 FDA panelists voted to withdraw the drug, although the agency usually takes the advice of its panels when making such decisions. Avandia, however, is a much trickier issue, given the internal bickering at the FDA over the Glaxo pill and the need for agency officials to use this decision as a defining moment for their public health mission. "Our number one concern right now is making sure patients and physicians have the information they need about Actos and any concerns about their health," Takeda spokeswoman Elissa Johnsen tells us. She reminds us Takeda ran a similar ad campaign the last time Avandia was beaten up publicly - in 2007, when the FDA added warnings to both drugs and Takeda tried to differentiate Actos from Avandia. The latest ad campaign, by the way, was designed by AbelsonTaylor.
3 Comments
Don Henley said it best:
"Kick 'em when they're up, kick 'em when they're down Kick 'em when they're up, kick 'em when they're down Kick 'em when they're up, kick 'em when they're down Kick 'em when they're up, kick 'em all around".
Ironically the song is entitled "Dirty Laundry".
Aggressive marketing, comfortable regulatory dept. BUT they are missing the boat without a social media component to this. Traditional advertising wont yield the same immediate net-impact on awareness through social sharing (earned media) and certainly will not produce the same return on reach vs. spend ratio.
Takeda is in business to make a profit; therefore, it should surprise no one that Takeda is attempting to capitalize on GSK's problems. When the entire matter shakes down, I suspect that the problems with Avandia will prove to be a class effect with all Thiazolidinediones displaying similar adverse characteristics. Then it will be Takeda's turn to go before the FDA and say its mea culpas.
No drug exists without adverse side effects. Therefore, studies upon which the FDA makes its decisions should report both positive and negative findings. I consider any pharmaceutical company that refuses to provide true informed consent to be an unethical renegade, and when patient suffer, the company should be subject to the full force of the law.
It infuriates me on behalf of my patients most of all; also it exposes me to malpractice risk. No physician truly wants to practice defensive medicine, but given the lack of integrity by pharmaceutical companies and the feckless behavior of the FDA, we have little choice.
Mark Gary Blumenthal, MD, MPH Knoxville, TN