FDA Spanks Pfizer For Schizo Drug Ad
6 CommentsBy Ed Silverman // August 13th, 2007 // 4:45 pm
The drugmaker omitted important risk info and made unsubstantiated claims that Geodon is better than another drug, according to a July 16 warning letter posted on the FDA web site. And the agency asked Pfizer to stop running the ad, which appeared in an unnamed medical journal.
The FDA wrote that the ad, which you can see by clicking on this link, included some info about potential side effects from the injectable version of Geodon, but didn’t mention “other serious warnings and precautions,” such as the possibility of neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes.
The ad also suggested Geodon was more effective than a generic drug, haloperidol, “when this has not been demonstrated by substantial evidence or substantial clinical experience,” the FDA wrote. “This piece is false or misleading because it omits important risk information and contains unsubstantiated superiority claims.”
Lisa Van Syckel
Ed,
Do you know what medical Journal this ad appeared in and when?
We have a Doctor here in NJ who tied up an 18 year old and injected her with this drug against her will,because she had refused
the oral med.A Family member has a history of Congenital prolong QT and has a pace maker.
The patient had been hospitalized due to Prozac Toxicity.
Lisa Van Syckel
Ed,
I forgot to mention that Taxpayers got stuck with paying the “Bill”………
Tony Miller
These very unethical if not criminal pharmaceutical companies should at least have their noses rubbed in the truth and perhaps swatted with a newspaper or two. The dirty dogs!
The combination big pharma and Madison ave may well prove to be more dangerous than the diseases. The wholesale bribing of our elected representatives called campaign contributions is shameful.
Whatever happened to ‘do no harm’? Big money talks …silly slogans walk..I suppose.
Atlex
Ed,
Despite the paranoid remarks by other responders, this is a typical example of a pharma company operating in the huge gray area created by drug laws and FDA regulations. The only way to get a somewhat solid answer regarding what can and cannot be communicated to physicians is by testing it in this way. Notice that the FDA reviewer even stated that if these corrections were made, the ad still may have violations, but he doesn’t name them. Of course, this is a serious game that is played regularly. If the ad is submitted in advance, the process is slow and there is a consistent bias toward rejection, with limited information as to why. If the ad is used first, there is a better chance that the FDA, if it rejects the ad, will provide better guidance. In this instance, while the FDA rejected this ad, the ultimate request was simple withdrawal, not significant corrective action. Thus, it doesn’t seem as though the FDA viewed this as a serious offense. It is worth noting that this drug has been on the market for years and its ill effects, both serious and minor, are well know by prescribers.
Bottom line…like it or not, this is the way the regulatory game is played. All pharma get warning letters. The key is to keep them to a minimum and ensure that they are minor.
Atlex
pamela
Pharmaceuticals know exactly what they are doing when they make false claims in their advertisements or just simply forget to mention side effects. After all their overpriced drugs help pay for these advertising strategies. It is interesting to see how the experts who work at these established medical journals do not seem to notice that such unscientific and misleading adverts conflict with the high scientific standards they put forth. In some cases these ads probably negate some of the research that is published in these journals, amusing.
It is also interesting how the pharmaceuticals ignore FDA advertising regulations, which can be serious if the FDA decides to enforce the law. But hey, what does the FDA do…send these guys a warning letter, i.e. the government is on your side. This is just fun and games for big pharma, exercising their control over the FDA.
Simon Passanante - FDA sends Pfizer a warning letter
[...] or misleading advertising in connection with an anti-schizophrenia drug, Geodon for Injection, Pharmalot [...]