Marketus Interruptus: No OTC Viagra In Europe
6 CommentsBy Ed Silverman // November 20th, 2008 // 8:51 am
Pfizer has withdrawn its application for the little blue impotence bill to be available without a prescription after concerns were raised by European regulators. A European Medicines Agency committee says there would be too little medical oversight - worries that related problems, such as heart disease, could be missed.
The drugmaker wanted to make 50mg tablets available over-the-counter, because such availability would help men who are too embarrassed to seek help from their doctor and reduce counterfeit sales that take place over the Internet. “A lot of men don’t go to the doctor or talk about their condition,” tells the BBC. “”By offering it via a pharmacy, it would offer them another option.” (Pfizer statement)
But the EMEA’s Committee for Medicinal Products for Human Use (CHMP), had major concerns. “If the drug is available without prescription, there is no medical supervision which could delay diagnosis of underlying disease,” a spokeswoman tells the BBC. “The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which ED can be an early marker.”
She said there had also been concerns over complicated product information, which could lead men to “unintentional misuse…In addition, a switch to being an over-the-counter medicine could lead to an increase in people who are not intended users taking Viagra recreationally.” (EMEA statement)
PBurns
Best. Clip Art. Ever.
You rock!
P.
Insider
http://pharmagossip.blogspot.com/2008/11/status-quo.html
Salmon
So OTC Viagra may cover up cardiovascular problems.
Sildenafil (Viagra - Pfizer) is also marketed as REVATIO to treat Pulmonary Arterial Hypertension. Which is a known complication of Phen-Fen and even Zyprexa has an FDA warning letter for PAH.
Besides Viagra, there’s Cialis (Lilly) marketers of Zyprexa, and Levitra (Bayer/Schering Plough/GSK). SP has a Zyprexa like drug under FDA review whose review is unexplicitably delayed by several months, and GSK markets Paxil and Avandia.
What could possibly precipitated the EU’s concern about OTC Viagra? Especially on the heels of the recent FDA announcements about long term antipsychotic drug AEs and the concern about evaluating CV of new drugs (using more POSTMARKETING Studies).
Inquiring minds want to know.
Salmon
atlex
Salmon,
I think you misunderstood the various reports. Viagra doesn’t cover up CV disease. For a high percentage of men who present at a physicians requesting Viagra, the cause is underlying CV disease that requires treatment (hypertension, etc). The concern was that OTC Viagra would not require these patients to be seen by a physician. As a result the underlying CVD would not be discovered.
Not everything is a conspiracy.
Atlex
ExPFE
Anything to make a buck, I guess. At Pfizer, we used to be proud of the fact that Viagra had saved lives — it forced middle-aged men (the worst ones for regular doctor visits)to go see their docs and get their cv health evaluated. PFE even had events and trailers at NASCAR events…
Salmon
“The CHMP was particularly worried about the diagnosis of overt and silent cardiovascular disease, of which ED can be an early marker.”
Although HTN is a silent CV disease, the EMEA also mentioned OVERT CV disease which could mean numerous things. OTC use of Viagra could alleviate symptoms and people may even wind up self medicating. Either being evaluated and determination of the underlying pathophysiology and appropriate treatment may be delayed with potentially lethal consequences.
As for conspiracy I never said any such thing. People can act independently in their own self interest in a manner that is exactly the same as if they had conspired. Plus these companies can all look at the science and come to their own conclusions as as well as I can.
The EMEA gave there response in regulatory speak. Thus it’s difficult to know exactly what they were thinking, did they have the same things in mind as I did or were they just concerned in general and used broad terminology. I don’t know if I’ll ever know.
Salmon