Sunday, August 02, 2015

Sarbanes-Oxley for vaccines

We need a Sarbanes-Oxley type law for vaccines and other pharmaceuticals. 

Sarbanes-Oxley (SOX) was passed by Congress in 2002 following a series of corporate financial scandals (chiefly involving Enron, but there were others as well) in order to hold corporate boards and company officers accountable for how their business was conducted, in order to reduce the risk that they would engage in unethical practices. 

Merck is currently embroiled in a whistleblower lawsuit with two of their scientists alleging that the mumps portion of the MMR is not as efficacious as it has been represented. Merck has a monopoly on the MMR vaccine because of tests presumably demonstrating it has greater efficacy than other vaccines. The scientists are alleging that the tests were spiked to get the desired results. If the fraud is proved in court this may threaten Merck's monopoly of this portion of the vaccine market. 

An HIV vaccine researcher has been sentenced with jail for his fraudulent research. 

Why do we not have a similar requirement (ie: SOX) for the corporate heads and boards of pharmaceutical companies (as well as FDA/CDC/ACIP officials)? Would Vioxx have hurt and/or killed so many if they had been required to sign off on the nature and manner (ie: the quality and soundness) of the research done to justify its development and approval? 

If we had this sort of requirement would we have editorials (Marcia Angell, former editor of the New England Journal of Medicine) by major researchers decrying (John Ioannidis) the poor quality (Richard Smith, former editor of The British Medical Journal) of studies healthcare providers are using as a basis for care? 

What good are IRBs (Institutional Review Boards) doing given all of the above? If they are doing their job why is it that we cannot trust the research that is being published? In theory the IRBs are the first line of defense against bad research and peer-review prior to publication is the second. Apparently these safeguards are not working or are themselves seriously compromised.  

Even if our Congress were to pass such a law (an event I consider unlikely given the influence of the pharma lobby upon them), and even if research were strengthened so the results were more trustworthy it would still be my position that we deserve freedom in medical decision-making, including receipt or declination of vaccination.