Posted by Alan on September 7, 2002, at 0:52:21
In reply to Am I bleeding?, posted by pharmrep on September 7, 2002, at 0:35:53
This is what's becoming an old trick to keep revenues up. Lexapro doesn't give you anything you weren't already getting in Celexa, it's just sort of "purified". By doing that, they can get a new patent for what is essentially the same medication. And by investing many times as much money in marketing as they do in development, the drug companies can convince an amazing number of naive doctors that Lexapro actually IS newer, better, and amazingly free of all the side effects and withdrawal phenomena that have emerged with all previous miracle drugs for the mind.
And speaking of side effects, get a load of the statistics cited on for instance sexual dysfunction. You wonder how a doctor can cite numbers like that without smirking all the way to the bank. He HAS to know they're fictitious. He can't be that blind to his own patients. Can he?
The whole thing is pretty close to putting new paint on an old pill and selling it again. The makers of Prozac tried to do the same thing but had to abandon it before getting to market because the "purified" Prozac turned out to cause dangerous heart arrhythmias.
The patent on Prozac was close to expiring and its manufacturer was scrambling to hold on to revenues and came out with a "new" prozac to treat PMS.
It makes you think. If they can get a patent on Prozac Weekly, the same active ingredient as normal Prozac in a different delivery matrix, they're not patenting medications -- they're patenting the physical pills!!!
So why don't they just patent something like a 2 mg (or whatever size) pill of every med to begin with? Then when that patent is about to expire, they can "invent" a 1 mg pill and patent that as a new medication that needs only half the dosage of the old one. Hell, with enough money spent on marketing, they can probably persuade tens of thousands of doctors that the 1 mg pill has less than half the side effects of the old, obsolete, addictive 2 mg pill.
It's a good thing for the drug companies that the FDA exists to keep a short leash on the patent office and other arms of government. Otherwise all kinds of rational thinking might break loose.
To make a profit these days, the co's have to differentiate. The best way to do that within a single class of drugs is to claim to have fewer side effects. Because of a serious loophole in our laws about drug research, they just keep doing trial after trial until they figure out how to get some of them to come out as desired. Then they negotiate with the FDA about what trials to include and how to summarize them in the prescribing info.We need to change our laws so that as part of the price for approval of a drug, ALL studies on its use in humans (at the least) get placed into the public domain. That way it won't be as easy to make distorted claims. For instance, the public and the FDA have seen only a small fraction of SKB/GSK's studies on Paxil. In the majority of them it worked worse than placebo to a statistically significant degree*. At least that's what plaintiffs in one of the class-actions suits alleged, promising to provide supporting evidence. It just shouldn't be legal to hide things like that. And now that scandals like the HRT and cox-2 inhibitor surprises are emerging (i.e. it affects more than just us "head cases") I think there's some chance the regulatory environment may change.
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* Still, that's an average response. It doesn't negate the fact that some people respond and some of those respond extremely well. Statistical truth and statistical inference, important as they are, have considerable limits. The closer you narrow it down to an individual case, the fuzzier the picture gets until there is no statistical picture at all when dealing with a sample of one. Just because the number of people doing well on a drug is less than the number doing well on placebo does not prove that all those people are experiencing a placebo effect or spontaneous remission. Some of them may very well be experiencing a bona fide pharmacologically therapeutic effect. It's just that one can't prove it statistically. With the right tools, one could hypothetically prove it chemically or by doing repeated double-blind crossover trials on one or more individuals.
poster:Alan
thread:109458
URL: http://www.dr-bob.org/babble/20020906/msgs/119144.html