Outsourcing Pharma Research to "Rescue Countries"

One of the closest things we've seen recently to a "must read" article for followers of this blog is in Vanity Fair by Donald Bartlett and James Steele:
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

Please check out the link if for no other reason than to view the highly effective and chilling illustration.

The basic gist of the article is to say that US drugs are becoming less safe as companies increasingly resort to nations in Eastern Europe, Africa and Asia to get their clinical trials done, for reasons that have nothing to do with good science and everything to do with profits. Some highlights:

• The concept that is new to me, but reportedly well known to Pharma insiders, of "rescue countries." These are supposedly the counties that if you are having trouble finding evidence to persuade FDA to approve your company's drug, outsource your clinical trial to that country, and you can count on getting positive results that you can submit and gain approval. Examples: When the FDA approved the antibiotic Ketek, later shown to have huge safety problems, the decision was based heavily on trial results from Hungary, Morocco, Tunisia, and Turkey. This was shortly after a US trial physician from Alabama was sentenced to prison for falsifying 90 percent of her data.
• Some of the worst examples of outsourcing causing harm to local populations occurs due to the pediatric exclusivity law, which had the good intention of creating incentives for drug companies to do more research on children to identify the best dose, etc. rather than simply trying to extrapolate adult data to kiddies. The problem has been that the reward for doing these pediatric trials--6 months' extra patent life--can be so lucrative that the companies do pediatric trials on drugs that never conceivably could have a pediatric use, just to get the extra 6 months of brand-name sales. At the All India Institute of Medical Sciences in New Delhi, 49 babies died over a 30-month period while being administered drugs in clinical trials for conditions like hypertension, which virtually never occurs in infants. The head of pediatrics at the Institute insisted that none of the deaths was due to a study medication--but if the practice there was similar to other trial sites, that guy was pocketing about $350 for every child enrolled in the trials.
• Studies in foreign countries often take place with inadequate or absent consent and purely pro forma ethics committee review. Patients often believe that they are getting routine medical care, not participating in experiments. These ethical laxities (as well as the much lower personnel costs of running experiments in resource-poor nations) are partly what attract the for-profit contract research organizations overseas.

A while back I reported the statistic from Donald Light's book on the risks of prescription drugs (http://brodyhooked.blogspot.com/2010/08/how-many-new-drugs-are-lemons-ask.html) that approximately 111,000 deaths annually in the US are caused by prescription drugs taken properly and as directed. Bartlett and Steele propose that the number of deaths due to unsafe prescription drugs is as high as 200,000 annually--their figures may differ due to Light's concern to restrict his statistic to drugs that are actually taken as prescribed rather than to medication errors, etc. Regardless of which figure you use, more people die of prescription drug use in the US than of many major diseases. It is high time that we frankly recognize that the financial incentives that currently control the drug industry research/marketing machine are making drugs less safe and less effective in a seriously widespread fashion. (That's the topic of a paper that Don Light and I have forthcoming in the American Journal of Public Health, which I hope to be able to blog about soon.)