Studies show that...

Pharmaceutical companies are constantly pushing the envelope on drug development and testing, because each new product proven safe and effective means more cash flow. So is it really surprising to anyone that industry-funded, published studies are 55% more likely to provide positive results than non-industry funded ones?

There are two things at work here. First, the pharmaceutical companies are less likely to want to publish unfavorable results. They're scientists with an agenda and that agenda is selling more product. Publishing studies that showed deleterious side effects or no therapeutic effect at all aren't worth the time to put the study to print.

Second, pharmaceutical-funded studies are also half as likely to use a control group to test their drugs. This is a major science no-no. A control group is necessary to ensure that your intervention - drug or otherwise - is not simply inducing the placebo effect. This still-not-understood effect often shows healing results in people who merely think they are receiving therapy, even if they just ingest sugar pills. Two-thirds of the drug companies' studies eschew the control group - and any change of ruling out the placebo effect.

What does this mean? Next time you see a commercial for Havidol touting how "studies show miraculous effects," just remember who paid the scientist.


Note: I also recall a fascinating tidbit about statistical significance in scientific studies. There are a disproportionate number of studies published with findings that are just over the threshold of statistical significance (here's a link to an analysis of political science studies). The study of peer-reviewed journals revealed a slight bias in scientific publications toward publishing findings that could "prove" something, although a little bit of mathematical tinkering is often the only barrier between "just significant" and "insignificant." This may be why 54% of all pharmaceutical studies found positive results instead of just half.

Drug companies and patent law, part 2

Thanks to G$ and Rick for their comments on my drug patent law post. Their thoughts were provoking enough to get me to write on the subject again, no doubt to the dismay of my two other readers...

I think the point of patent law revision is that the public good is served by developing drugs that treat the most prevalent illnesses or diseases that post the greatest threat. Repackaging an antacid drug to treat a stomachache by varying the dosage, on the other hand, doesn't really represent the innovation that patent law exists to protect. Nor does developing drugs for "restless legs" or erectile dysfunction serve the public in the same way that an AIDS vaccine, a malaria vaccine, or a staph antibiotic could.

In other words, the public policy should reflect (as Rick noted), the desired public outcome.

The problem presented by the GAO study is that drug companies are a) making money hand over fist b) pouring money into R&D, but c) not developing these new molecular entities (NMEs) that can provide the substantial human benefit.

One solution is to amend patent law so that there's less of an incentive to focus on modified or marginal drug improvements. I'm not suggesting that patent terms on new drugs be reduced, but that companies be sent the message that we value (legally) developments of new drugs, not repackaging of old ones.

Another solution is to (as G$ recommends) increase federal R&D budgets. This is undeniably a good thing, because the results of federal research are public, adding to the body of general scientific knowledge. Additionally, the kind of general research done with federal dollars often serves several scientific disciplines and not just the goals of a particular industry.

My final thought is this: drug companies are constantly researching new or modified therapies and are still making profits, so their research costs are part of their bottom line. Yet they are still making record profits. To me, this makes the argument about recouping research costs inane. They're doing research and making millions!

Maybe they're paying down debt from 20 years ago when they started developing the drugs that are paying off today. But that's all the more reason to make sure patent law offers advantages for companies seeking the most promising and novel drugs, to keep the health benefits (and profits) flowing.

Non-surprise of the week: patent law lines drug company pockets

Most Americans have a sneaking suspicion that pharmaceutical companies are making pretty good money (pdf), but many probably don't understand exactly why. Well, the Government Accountability Office (formerly General Accounting Office - GAO in either case) just released a report (pdf) that explains why.

Because minor changes in existing drugs allow for new patents, giving extended monopolies, drug companies have used very little of their increased R&D budgets (147% from 1993-2004) to develop new drugs. Applications for new molecular entities - the FDA term for significantly new therapeutic drugs - increased only 7% in the same period.

In other words, instead of sparking innovation, drug patent law is doing the reverse - allowing companies to make big money off marginal modifications instead of expanding the realm of medicine. This might be good for Eli Lilly's shareholders, but it doesn't do much for the treatment of antibiotic resistant diseases or some of the world's more prevalent diseases. Time for an amendment to patent law.