On 27th April, Michael Rosenblatt, the Chief Medical Officer of the drug company Merck and Co, said universities should return industry funds if they produce non-reproducible research results. The statement was released as part of an editorial proposal which was published in the journal Science Translational Medicine.
The hard-hitting proposal allegedly aims to reduce the number of unprofitable researches being carried out by universities which do not provide the same results when carried out by other researchers in industry laboratories. Such experimental data costs the pharmaceutical companies million in wasted funds and “threatens the entire biomedical research enterprise”.
An analysis of the editorial reveals the drug company wants to place in money back guarantees before giving out any more funds to researchers. So if the academic discoveries turn out to be wrong in an industrial research facility, Merck can ask the university to give back its money. The proposal by Merck’s CMO is basically an alleged bid to address the current “reproducibility crisis”; however, it should be noted Merck is also one of the 10 largest drug companies in the world and generates annual revenue of over $40 billion globally.
While discussing the current issue we can assume the drug companies are neither saints nor sinners, especially in the case of Merck, which already contributes substantially to its R&D department and therefore has reservations when the research results prove to be false. Merck is known to produce pharmaceutical products which range from vaccines and oncology drugs to animal health and they have one of the highest numbers of approved drugs in the United States. In 2009 it was found Merck has been spending approximately $5.8 billion on its research and development department.
“Recent studies have shown that the key findings in 50% or more of published reports in certain fields cannot be reproduced,” wrote Michael Rosenblatt who is also the executive vice president at Merck and Co, in Kenilworth, New Jersey.
In the editorial Rosenblatt suggested that the public expects the industry to interpret research results derived from academics collaborations, and such translations to improve public health as soon as possible. However, since data cannot be reproduced it poses a problem for the industry. Rosenblatt said, “This irreproducible data problem has a major impact on… translational research, which sits poised at the interface of academic science, and industry research and development.”
According to Rosenblatt, more focus is needed on work which produces potentially successful projects; otherwise, wasting time can delay the delivery of health welfare in the form of guidelines for the masses. In his statement Rosenblatt also estimated it takes a group of two to six scientist’s, a total duration of one or two years to work in an industry lab, in order to replicate outcomes from the original investigations. Additionally, the industry has to bear a huge cost for the reproduction of the research, usually ranging from $500,000 to $2 million, equal to about £340,000 to €440,000.
As a solution Rosenblatt proposed the universities carrying out the original researches should be given the grants with some form of financial accountability in place. If a research data does not prove to be useful or duplicable then institutions should offer “some form of full or partial money-back guarantee”. Rosenblatt stressed if such conditions are placed upon researchers then even the companies would feel assured and rapidly proceed on valuable projects with more ease and frequency. ,Additionally, companies could add more payment or ‘premium’ for authentic data backed up with proof rather than pay for ‘non-guaranteed’ data.
In his statement Rosenblatt acknowledged his proposal is assured to raise ‘objections’; however, his suggestions can lead to the betterment of the entire university and industry research collaboration system. Furthermore, the establishment of ‘pilot trial’ between partnering university and a biopharmaceutical company would be a ‘first step’ or an innovative approach for emerging research projects, with increased chances of success.
Although many companies have been known to falsify their results for the sake for profits in the past, mistakes in initial research can also cost the pharmaceutical in the form of financial fines. For instance, in 2004, Merck had to recall their pain drug ‘Vioxx’ (Rofecoxib) on the orders of the US Food and Drug Administration (FDA) when it was implicated in more than 38,000 deaths. Merck had to pay millions in damages after Vioxx was found to pose deadly side effect risks such as heart attack and stroke, which the company already knew about.
Although the proposal by Rosenblatt highlights some major points when it comes to research replication, but if it is adopted then all the pressure would be focused on the scientists. The scientific community even with its faults has a code of responsibility when it comes to carrying out researches. Discrepancies in academic research results is a given, but steps can be taken to avoid mistakes as much as possible. Therefore, a review of the situation is necessary but the imposition of a money back guarantee would be premature and may even prove to be damaging to the research community.
The problems in academic and industry research collaborations have not gone unnoticed. Even the International Alliance of Patients’ Organizations (IAPO) has acknowledged many problems and the organization’s Chief Executive Jo Groves said, “We aspire to be as transparent as possible. Different people have a different understanding of what that means.”