Going down the wrong path

Pharma and scientists in the COVID era

In recent decades, scientific investigations in the medical and public health fields faces a new challenge from Big Pharma. In the SMON era, Big Pharma did not significantly influence mainstream academic researchers. To our misfortune, this is no longer true!

Tamiflu, Big Pharma, and a BMJ investigation

Just as the FCA (False Claims Act) was violated by delivering dying donkeys, faulty muskets, and bullets filled with sawdust to the government during the Civil War, Roche violated the FCA by selling the government a drug for pandemic use that could not achieve the pandemic purposes for which the government bargained and paid. The FCA is intended to protect the treasury against the hungry and unscrupulous hosts that encompass it on every side. The facts here show an incredibly hungry and unscrupulous pharmaceutical company that deceitfully caused the U.S. and various state governments to spend over $1.4 billion to acquire Tamiflu for pandemic use.

These are the opening lines of a law suit filed on September 2019 by the Lanier Law Firm on behalf of Dr. Thomas Jefferson of the Cochrane Collaboration against Hoffman-La Roche Inc, and Genentech Inc.

The allegations involve the claim that Roche masterfully marketed an ineffective product for profit by preparing scientific studies that sought to show benefits that Roche knew that the drug did not possess.

These so-called scientific studies were first questioned by a Japanese paediatrician, Dr. Keiji Hayashi. He had written to the Cochrane Collaboration that its previous evaluation showing that Tamiflu had high efficacy in reducing flu-related complications was supported mostly by industry funded research data.

Subsequently, the Cochrane Collaboration sought research data (that supported Tamiflu's benefits) from the scientists who had published the most favourable and influential reports, in The Lancet, the Archives of Internal Medicine, in Journal of the American Medical Association (JAMA) . The major challenges that arose before the Cochrane team in this endeavour are reported in a BMJ investigation. The main findings from the investigation are shocking:

1. Roche influenced these scientific publications in multiple ways
• by including Roche employees as co-authors and/or
• paying the main scientists involved in the publications in different ways and/or
• hiring professional publishing services to draft manuscripts that got messages out in favour of Tamiflu, in spite of the lack of scientific support
2. Further, the scientists who wrote the influential articles supporting Roche's claims about Tamiflu did not analyze the data from the clinical trials themselves, but had allowed Roche to compile, process, and analyze this data for their papers without questions.

It is worth noting that just three days after the publication of one of the scientific articles, Tamiflu was added to the list of approved drugs for the Strategic National Stockpile (of the USA).

From SMON to Diovan^®

The recent Diovan scandal in Japan, is a stark reminder of the fact that the scientific integrity of no nation is immune to the pernicious influence of Big Pharma.

The data manipulation in investigator-initiated trials on Novartis Pharma K.K.'s (NPKK) antihypertensive drug valsartan (Diovan^® ) has damaged the integrity of the Japanese science community. An NPKK employee was involved in the papers including the Jikei Heart Study published in The Lancet. Moreover, research teams have received more than 1.1 billion yen as unrestricted grants from the company. It was also revealed that Elsevier Japan K.K., the global publishing group which publishes The Lancet, participated in the promotion strategy for Diovan® . NPKK carried out marketing and promotional activities by using these favorable trials, so that Diovan® became one of its flagship products. Annual sales of Diovan® exceed 100 billion yen in Japan. We have to develop a critical eye on the dependency circle among researchers, the pharmaceutical industry and the medical journals.