12/04/2004

Sex Patch Decision could Slow Research

Proctor and Gamble sought allowance of post-marketing trials of the hormone patch Intrinsa, in order to bring the testosterone hormone to market where 3 million women who have had their ovaries removed would be P&G's primary buyers. However a FDA advisory panel, made up primarily of physicians, denied P&G's request citing concerns that in clinical trials cardiovascular safety issues weren't sufficiently tested. This is in part due to a not-for-profit organization's findings that postmenopausal women who take hormones are more likely to develop heart disease -- the number one killer of women in the U.S..

P&G apparently hasn't learned enough from Merck's recent Vioxx woes, if a medicine that turns out to be unsafe goes to market every personal injury lawyer in the nation will soon be filing lawsuits in every state of the nation. Although the potential profits of a drug that can cure sexual dysfunction are great, the potential losses from punitive damage awards could easily be more devastating than the benefits.

P&G needs to be patient and get a safe drug to market and enjoy the fruits with less risk of law suits and health problems for customers.

The article was found at: http://www.cnn.com/2004/HEALTH/conditions/12/03/sexual.disfunction.ap/index.html




9 comments:

Max said...

The FDA, which evaluates the safety and effectiveness of all drugs, has recommended that the sex patch be tested on at least 5,000 women for several years to evaluate the long-term effects. Is the more stringent testing in consideration of the vioxx recall? Will it effect all new drugs? How will it affect the cost of medication?

pramahaphil said...

I'm not sure if the FDA's decision was influened in part by Vioxx or not. The article sounded as if the deciding factor had more to do with heart risks that other hormone related treatments posed for women than anything else.

Biancca said...

I think new medications are released much too early. Diet pills are an obvious example that comes to mind. It seems like every year there is another "miracle" diet pill that turns out to be harmful if not fatal. I think a lot more testing should be done before medications are released to the public.

Rufio said...

I also believe that drug companies need to be a little more cautious in the introduction of new drugs. Being patient can cost drug companies a lot of money though, and that is why I think they are always jumping the gun.

Another interesting idea stated in your blog was that, "although the potential profits of a drug that can cure sexual dysfunction are great, the potential losses from punitive damage awards could easily be more devastating than the benefits." My question is, if a drug company found that the benefits of putting an unsafe drug on the market were more than the cost of potential lawsuits, should they put the drug on the market?

In my opinion if you look at the situation economically they would be stupid if they did go after the profits, but morally I don't think it would be a very good idea. What does everyone else think?

Rufio said...

I also believe that drug companies need to be a little more cautious in the introduction of new drugs. Being patient can cost drug companies a lot of money though, and that is why I think they are always jumping the gun.

Another interesting idea stated in your blog was that, "although the potential profits of a drug that can cure sexual dysfunction are great, the potential losses from punitive damage awards could easily be more devastating than the benefits." My question is, if a drug company found that the benefits of putting an unsafe drug on the market were more than the cost of potential lawsuits, should they put the drug on the market?

In my opinion if you look at the situation economically they would be stupid if they did go after the profits, but morally I don't think it would be a very good idea. What does everyone else think?

Bruce Banner said...

Every chemically created drug has some type of side effect. Some are not as severe as others. Where is the fine line for drugs in the long run be more harmful than helpful? I think it is important for R&D to continue with the help of the FDA. I would rather have the research be more effective if it takes longer than something quick and find out later they have to pull it and have the never ending law suites.

Dr. Tufte said...

One note: things like diet pills are not covered by the FDA. We have much more oversight of stuff that has to be handed to you through a pharmacy window than other things people put in their bodies.

This is a really tough issue to sort through. Here's what I wonder: if a pharmaceutical company can only incur costs prior to FDA approval, and reap benefits after FDA approval, why doesn't FDA approval give them a "get out of jail free card" if there are problems? I know that might not be the best solution, but absent that, what is the purpose of what the FDA actually does?

Further, any drug, once approved by the FDA, can be prescribed by doctors for any ailment that they see fit (whether the manufacturer approves or not). Now, let's see if I have this right: doctors can prescribe approved drugs for things they're not approved for, but they can't prescribe unapproved drugs for anything (even the conditions they were designed to alleviate)!

To me, it seems that the entire drug approval process is working at cross-purposes with the ultimate social good. Here's an example: do you know why most over-the-counter medication say "see your doctor" if you want to give them to a small child? It isn't necessarily because that is inherently risky. It's actually because no one will fund research on what the appropriate dose of (say) ibuprofen is for a 2 year old because they might get sued. But, it would seem to me that the most important thing to figure out is what that dosage should be in the first place.

Both personally and professionally, I'm just completely perplexed by the entire pharmaceutical/regulatory/medical/legal nexus. The only thing that I am absolutely certain of is that people are willing to pay a lot for pharmaceuticals because they really do work. How many other products can you say that about?

Jake said...

You can still see the legal ramifications of Vioxx and the risk that comes with entering this market. In response to the questions possed by Max, hopefully the negative consequences that came about from Vioxx will have an affect on the new drugs, to prevent future problems for both the consumer and the producer. I don't think that this will affect the cost of medications that are of necessity, but it may affect the other drugs that are for increased pleasure.

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