Thursday, April 10, 2014

More on Flu Drugs and the Broken Drug Research System


We’ve discussed the debate over oseltamivir (Tamiflu) and the problems in determining whether it offers advantages to flu patients, given how hard reviewers had to search to get all the data:
http://brodyhooked.blogspot.com/2009/12/bmj-medical-research-is-broken.html
http://brodyhooked.blogspot.com/2012/09/more-on-tamiflu-challenges-of-getting.html

The story led the editor of BMJ back in 2009 to proclaim about the scientific evaluation of drugs, The current system isn’t working. Worse than that, it gives a false sense of security.”

The latest BMJ readdresses the oseltamivir story, and if the system was broken in 2009, it has not gotten fixed since. The summaries of what they have to say can be found in two editorials:
http://www.bmj.com/content/348/bmj.g2630
http://www.bmj.com/content/348/bmj.g2548?ijkey=ded5662cf46f75236fb45a9cda0bb2a671ec0e98&keytype2=tf_ipsecsha&linkType=FULL&journalCode=bmj&resid=348/apr09_2/g2548&atom=/bmj/348/bmj.g2630.atom

In the previous blog posts, I reviewed how difficult it was for the authors of a Cochrane review of neuroaminidase inhibitors for influenza (the class of drugs to which oseltamivir belongs) to get their hands on all the relevant data from unpublished studies conducted by the manufacturer. Once they did get a reasonable amount of data, they found the data so voluminous that it took several person-years of labor to sort through it all. But they persevered, and what we now know is that drugs like oseltamivir may shorten your bout of flu, if you start taking the drug within the first two days of symptoms, by half a day. It may cause a number of worrisome side effects. And we have no reason to believe that the drug will prevent the bad complications of influenza requiring hospitalization and admission to an ICU (which is the anticipated benefit that led the WHO to champion the drug and many nations to spend billions of dollars stockpiling the drug as a public health precaution).

We also know that the published studies on these drugs, virtually all of which were conducted by the manufacturers, overstated the benefits and understated the adverse reactions. In short, if you went to legitimate, prestigious medical journals for information, as all us docs were taught to do in med school, you’d be mostly clueless.

The editors of BMJ gamely propose a list of reforms. But I believe that two conclusions are inescapable. First, if it took this much time and effort to get the goods on oseltamivir—and we still don’t know what the drug is really good for, if anything, since the really important studies of its potential value have not yet been conducted—then what about the hundreds of other drugs that have been introduced with great fanfare in the last few decades, and none of which have been subjected to anything like this degree of inquiry and investigation? Second, on what basis can we claim any longer that we should have any faith at all in drug research sponsored by manufacturers?

2 comments:

John H Noble Jr said...

Howard,
Thank you for your unswerving commitment to getting to the truth of the matter. I'm particularly intrigued by your statement that "the editors of BMJ gamely propose a list of reforms." But did the list include referral to the US Department of Justice for prosecution under the False Claim Act? Surely, similar laws exist in the other countries where Roche bamboozled the drug regulatory agencies. Part of Roche's $22 billion sales of worthless Tamiflu was paid from public funds that the False Claims Act is meant to protect from fraud. See:http://en.wikipedia.org/wiki/False_Claims_Act

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