29.8 Million dollar settlement?!
08-21-2005 01:10 PM
I think the industry standard is 5 yrs in remission for a 'cured' status. Dying in the first month of the 6th from cancer doesn't change cured statistics.
Gleevac doesn't cure but seems to keep patients alive like insulin for diabetics. Its more profitable business model for patients to keep paying for drugs for the rest of their lives than to cure the disease.
You neglect to mention that the Bush administration castrated FDA's oversight capability by increasing the amount of red tape before the FDA can issue warning letters. The red tape has delayed the warning time by months thus letters are issued only after the broadcast cycle of an offending advertisement.
Originally Posted by Nullifidian
The data from Vioxx studies were manipulated by big pharma to show only the favourable outcomes. The CLASS study published in JAMA only showed data from the first 6 months out of the 12-16month study. The next 6 months showed that subjects had more gastro bleeding on Vioxx but that was hidden. So big pharma knew about it all the while from day 1. The VIGOR study was manipulated as well.
08-21-2005 03:38 PM
Actually I'd supporting simply getting rid of the FDA, because I don't think it serves any useful purpose that couldn't be gotten through other, less destructive means.
Originally Posted by FOCUS
08-21-2005 04:35 PM
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.
Originally Posted by Matthew D
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.
08-21-2005 04:42 PM
Running with the Big Boys
I quit.. there is no use trying to argue with you on this.. I know that there risks with any medications but at the same time I do know that FDA has also stated that they do not have the time nor the personel to keep up with the studies that are being conducted. I also know that MOST of the adverse reaction studies have been suppressed by major drug companies and if you think that they are all operating for the public good then great for you..
08-21-2005 07:29 PM
Damn CDB, are you a libertarian? You're beating me to the punch on these things.
Our world is quite imperfect, and mistakes will happen. The FDA can/will **** up, and the same goes for drug companies. However, the existence of an FDA kills the market for competing, independent QA comissions, and provides a false sense of security to consumers. In this particular circumstance, it makes it hard to tell who, if anybody, is at fault.
In an unregulated market, MERCK would only be responsible for living up to their claims. If they release a product they claim to be totally safe and **** up, that's their ****. If, on the other hand, they release with incomplete clinical trial data and somebody buys the goods and croaks, that's the fault of the corpse. This would mean there would be a very strong impetus for drug companies to not lie, and a very strong impetus for consumers to play it safe. Right now, food and drugs are little more than a lawyer's playground.
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