Merck and the Mumps Vaccine

A blog post under the HuffPost Canada aegis brings publicity to whistleblower law suits that are currently in the courts: researchers are claiming that Merck concealed the inadequate efficacy of its mumps vaccine in order to further their monopoly interest in the the vaccine.

The blogger, or HuffPost columnist, is Lawrence Solomon, and he seems to be a real muckracker.   Nonetheless, the facts of this set of whistleblower suits seem to speak for themselves.  Two former Merck scientists and a researcher for the Centers for Disease Control have filed suit.  A federal civil suit charging fraud in obtaining a US monopoly on the mumps vaccine is also wending its way through the courts.  In a fascinating coincidence with my last two posts, Merck’s address is given as Hunterdon County, New Jersey.  I noted that the Sheriff of Hunterdon County has been accused of gross corruption in his management of his office, and apparently Celgene is also headquartered in this county.

To return to Merck and mumps: a private practice in Alabama, Chatom Primary Care PC, filed suit in June 2012, alleging financial damages because Merck fraudulently obtained monopoly status for its mumps vaccine, raising the price, even though it knew that the vaccine was less than 95% effective, a standard needed for induction of “herd immunity.”

A second federal case, United States vs. Merck, “stems from claims by two former Merck scientists that Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].””(from the HuffPost blog post.)

The third case is a little more murky, and is being flogged by a Republican Congressman, Bill Posey of Florida, who still wants to blame vaccines for autism.  As the blog post states, “The third whistleblower — a senior CDC scientist named William Thompson — only indirectly blew the whistle on Merck. He more blew it on himself and colleagues at the CDC who participated in a 2004 study involving the MMR vaccine. Here, the allegations involve a cover-up of data pointing to high rates of autism in African-American boys after they were vaccinated with MMR. ”

A reanalysis of the original study from 2004, which found no link between autism and the MMR vaccine in whites or blacks, was published in August 2014 in Translational Neurodegeneration, but was retracted within a month.   The original study was published in Pediatrics and still stands.  The author of the new study was Brian Hooker, a biochemical engineer, who reanalyzed the original data from the old study.  He reinstated data from patients who had been excluded because they had no birth certificates, after being contacted by William Thompson, a senior scientist at CDC who has worked there since 1998.  However, the blog post states that Thompson complained about Hooker having recorded his telephone conversations without his knowledge and then posting them online without his permission.  The CDC claims that it presented data for both sets of patients: those with Georgia birth certificates and those without; no relation between vaccine and autism was found in either set.  The new Hooker study was roundly condemned as an example of data-trolling (making multiple comparisons between dependent and independent variables without making proper statistical compensation for the extra comparisons.)

Hooker, it turns out, is associated with an anti-vaccine group (Focus Autism Foundation) that claims vaccines cause autism, and Hooker himself has a sixteen year old child who is developmentally delayed (whom he claims is “vaccine injured.”)  The lead author of the original 2004 study, Dr. Frank De Stefano, and the rest of the authors still stand by their work and say that it is clear that autism does not result from vaccinations; in fact, it probably begins in the womb.

The additional information about the new study was gleaned from a FOX13 article by Ashton Edwards and CNN Wire, posted online on August 24, 2014.  This article goes on to detail the vaccine-autism controversy and explains that the original scare was started by an article written by Andrew Wakefield and published in the Lancet in 1998.  This study, which had only 12 subjects, was retracted and resulted in Wakefield losing his medical license for fraud.  The entire scare, brought on by this absurdly bad article alone, has still not died down, and some parents and even people who should know better still think that autism (and mental retardation, among other things) is somehow related to vaccines.

The vaccine-autism bridge notwithstanding, it appears that Merck has been playing fast and loose with its research on the efficacy of its mumps vaccine.  This would not be hard to do, as the mumps virus is attenuated by multiple passages through cell cultures and there is a fine balance between the virus’ potency and its benignity.   Internal research performed by pharmaceutical companies is shrouded in secrecy as it is considered proprietary information.  That is, the company can refuse to reveal anything about its research as it can claim that this information could give its competitors an unfair advantage.  They say it’s a trade secret, like the formula for Kentucky Fried Chicken spices.

Vaccines are not fast food, unlike KFC chicken.  But the capitalist, competition-oriented system under which pharmaceutical companies flourish (or barely keep their heads above water, in the case of vaccines) makes it possible for them to violate a basic tenet of scientific research: transparency, and the ability to replicate another researcher’s work.

This violation of transparency works against advancement in scientific knowledge about pharmaceuticals and vaccines, and slows the progress of medicine in its continuing fight to conquer disease and alleviate human suffering.

The only way to resolve this roadblock to the progress of medicine is to transform pharmaceutical companies (and medical and surgical equipment companies) into public trusts so that knowledge about advances in medicine can be freely shared.  How this can be done without upsetting the profits of pharmaceutical companies is problematic, but surely a solution can be found that opens up the flow of knowledge without beggaring the stockholders.

Until transparency in pharmaceutical research can be obtained, drug companies will continue to encourage corruption in government and commit fraud in their efforts to get a competitive advantage.