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.
Reading the media, many doctors are fascinated as to the plethora of new drugs claiming to provide a ‘cure’ against diseases which hitherto were considered incurable. Why, new drugs have even pervaded the social media – pharma companies have started posting widgets on Facebook in a bid to attract readers. Last month, FDA cautioned the drug company Novartis for overstating the benefits of a drug without pointing out the ill-effects (see here).
This rampant form of advertising naturally may confuse the public about the efficacy of new medications. In fact, its sometimes difficult to know the validity of claims made in the media.
Here are some tips on how to evaluate the validity of medical news items that you may come across..
- It is a fact that competition is intense among medical journals, research bodies and medical journals to attract media attention. Media themselves compete with each other to come out with the latest. Try to read the same news from several sources. Obviously, if the item is reported in just one obscure source, it should carry less weight.
- Look for key-words like suggestive or may (as opposed to will) as this does not always indicate a cause and effect meaning. Many people make hard-core assumptions based on such words.
- It is the nature of scientific studies that, for a given topic, several would say one thing and a few would say the complete opposite. It is for the trained professional and their peer-groups to make an informed decision to advise consumers. Bear in mind that space is a premium with the mass media and such reports usually omit vital details which will affect accuracy.
- Separate the wheat from the chaff..make sure the website you’re looking at is a reliable one!
- Personally, I feel reports originating from researchers and pharma companies should not appear in the mass media without vetting by an appropriate professional body so as to convey the proper perspective to the audience at large. So if a news report originates from a known professional body, this should carry a lot of weight; as opposed to a solitary item in a nondescript health magazine.