New Thoughts on Drug Safety Prompted by Court Ruling

When a drug is tested and approved for use by the FDA, we often take for granted its safety. Obviously this is not the case, as we have seen with many approved drugs causing harm, COX-2 Inhibitors like Vioxx being an example. Although we often turn to medicines to fix our problems (and it’s great when they do!), we need to keep in mind that these are foreign substances that make significant changes to our bodies. Sometimes these are good, sometimes not so good. Usually it’s a combination of the two.

An interesting ruling was made on a case in San Francisco last week, involving the safety of medications. What made this case so unique is that the court ruled that drug makers could be held liable for harm when a generic version of their name-brand product is used. Obviously, the drug companies are not happy about this and it’s easy to see why. They are not manufacturing the product; they have no control of the product that is produced by other companies.

However, I see where the court is coming from on this one. Let’s say you’re taking a drug for the long term and, barring any manufacturing mistakes, the drug harms you in some way. What’s most likely is that your doctor prescribed you the name brand and, due to dispensing laws, the pharmacist filled a generic version of that drug for you. Your doctor prescribes that drug, name-brand or generic, with certain results in mind. Pharmacists fill the prescription with the generic because it’s the same product, possibly with different inactive ingredients. The effects of the generic should exactly mimic that of the name-brand.

So, in a sense, I can see why the ruling was what it was. The drug company had to prove safety and effectiveness in order to get the drug approved. The manufacturer of the generic drug did not. They are producing the drug in accordance with the name-brand standards. So when the drug harms somebody, the scrutiny goes back to the clinical trials and safety that was proven or missed in the research.

I don’t think that the manufacturers of generics should be completely dismissed in these cases. They are producing products to make themselves money. Whether they are manufacturing the drugs based on faith of their effectiveness and safety or not, they should still be held liable for the effects of the product on people.

My question is this. Did Wyeth warn of the safety concerns of taking the mentioned drug for long periods of time, even just for the name-brand? It seems like if this were the case, they shouldn’t be held liable. The generic manufacturers should know of the side-effects and use warnings as well. In this case, I could not fault the drug company for the mistake of the generic manufacturer. In cases where it is not publicized, that is less clear and needs further scrutinizing.

Must be something in the water....

Apparently we are being drugged through our drinking water. Trace amounts of pharmaceuticals have been found nationally and in New York's reseviors. Time for my sarcastic side to come out. Does this mean that pharma is going to start trying to claim intellectual property rights on drinking water? Pfizer gets a certain region, Merck another, etc. Or better yet, bottle the water and sell it as a "healing tonic". We already pay multiple dollars for bottled water, why not pay $50/month for medicated water?
Alright, enough with the sarcasm, down to the real issue. What are the implications of these findings? Many people are saying that the amounts are so trace, there is not a sustantial impact from them. But, as the article about the situation in NY states, it appears to be affecting marine life. What other ecological effects do these trace amounts have over time? Not too mention, trace or not, there are just some substances I do not want to have in my body.
So, now that the AP has released this information, what do we do with it? The arcticles do point out that water testing procedures do not include testing for pharmaceuticals. It appears that this could be a point for environmental and health advocacy. As we continue to take increasing amounts of presciption drugs over the years, how will this affect our water? Our environment? My solution - we should tell people in upstate New York to quit dumping out their drugs in the toilet. That will solve everything!
As always, the Onion puts it into perspective.