Its all very well for big pharmaceutical companies (pharmas) to release a new medication with a big bang , what with the enormous money invested in its research, development and production . However, not often enough, such new launches become unstuck when unexpected side-effects appear after a few months on the market, despite the most strenuous prelaunch testing and extensive marketing as a blockbuster-to-be.
Unexpected side-effects aside, what’s potentially more serious is when clinical trials (designed to prove a drug’s efficacy before its official launch) are falsified, thereby giving end-users erroneous data proclaiming (falsely) the drug’s efficacy. Such appears to be the case with regards to the Kyoto Heart Study.
What was the significance of this study? This study by Japanese scientists was greeted with great fanfare in 2009 and centres around the ability of a medication ,already extensively used for the treatment of high blood pressure, to reduce the possibility of getting stroke by 50% when used in high-risk patients. This was a milestone in drug treatment for hypertension and enabled the maker, Novartis , to make it one of the best-selling drugs in the world.
The drug itself, valsartan, which is marketed as Diovan has been on the market since around 2001 for the treatment of hypertension and belongs to the new group of ARBs (angiotensin-receptor blockers). In fact, its patent expired in 2012, thereby enabling any pharma to produce its own version, so-called generic drug.
And now the bombshell: Last Friday, Japan’s minister of health, Norihisa Tamura, as well as university officials at Kyoto Prefectural University announced that the Kyoto Heart Study data were “very likely” fabricated, Apparently, incomplete data was used and some of the scientific investigators were in fact employees of Novartis.
The reaction to this has been deafening. the respected European Heart Journal retracted the study from its 2009 issue. There has been widespread condemnation among medical circles, resulting in the resignation of the principal Japanese investigator from the Kyoto University, Dr Matsubara.
This episode puts into perspective the over-reliance of the efficacy of new medications on so-called landmark scientific studies, whose integrity may be subject to the temptations of big bucks and commercialism. Often, the losers are the consumers themselves.