The thing was why did they attempt to take it to market before the overall study was complete? To me that is like driving a car off the lot with a mechanic sitting on the engine tighting down bolts... I know for the most part that all the chemists in the company are wanting to develop things that help people not hurt them but it seems that the "money-side" has managed to turn into the all righteous side. How much money is enough? Whatever happened to the thought that people had a responsiblity to each other?
Merck had completed all of their studies before they marketed the drug. The FDA decides which studies the companies must conduct, how they conduct them ,etc. Then, as part of their continued surveillance, companies are required to futher monitor for adverse events. In view of adverse events that come up in post-surveillance monitoring, the FDA or the company (or both) can decide to conduct further clinical trials. This is the case for vioxx. Merck decided to do additional post-marketing studies specifically powered to look for cardiovascular effects (along with some other things) in a post-marketing studies. The study showed an effect only after 18 months. As soon as it reached the point where an effect could be determined, Merck pulled the drug. The crazy thing is, the FDA never asked them to pull the drug. Later, when the FDA looked at all of the data, they still felt the drug was safe enough to be marketed!!! All drugs have side effects! Merck acted very ethically, going beyond even what the super strict FDA required. If every drug had to undergo the type of scrutiny that the trial lawyers would insist on, we would have no drugs on the market, because, believe me, no drug that works is always safe....get that, no drug. Doesn't McDonalds have a responsibility to not sell its McBurgers? Gun companies should not be able to sell guns, liquor store liquor, supplement manufacturers supplements, etc. Trust me, if you can get enough cases into the courts of Texas (or wherever), you can eventually bankrupt the manufacturers of anything. How many clinical studies have been done on Superdrol? How many double-blind, placebo controlled studies of any supplemnt have been done with the kind of studies the FDA companies requires of drug companies (three phases, proof of safety effiacacy and post marketing surveillance)? The FDA has one of the strictest set of guidelines of any drug approval agencies in the world, but what people need to remember is that, no drug is safe. Get it, no drug is safe. Sure, drug companies like to make money, does that make them bad? Which company in America does not try to make money, are they all bad? Quite simply, drug companies are more regulated then any other business that I know of. Every drug must be extensively scrutinized in many animal in human studies for both safety and efficacy before they can come on market. The process is already prohibitively expensive. If we decide we want to include additional studies, we will eventually end up with less drugs, at greater cost, and at the end of the day will still be faced with the fact that no drug is safe.
All drugs have side effects. It is, and always has been a cost benefit analysis. If you want to drive a "safe" car, force all manufacturers to put 600 lb titanium bumbers on them and force them all to have roll cages. It will cost 10,000 dollars more per car, but hey, we all must be safe right? As for me, I don't want to buy that car, I'd rather have more choice than less but hey, we increasingly live in a nanny state where we want everything to be "safe": and decided for us....won't people be surprised that even after all their choices are removed, all their freedom (along with their responsibility) is gone, they will still not be safe, and will have sacrificed all their choice and freedom for nothing.
Then I showed him that thread by Ageless and he walked away dumbfounded.
