System under constant review
The pharmaceutical industry make sure that drugs that end up in the market are safe and perform as intended
WITH reference to Syed Nadzri’s commentary on the “The Manipulation of medical research” (NST, July 7), it is prudent to point out several issues concerning his and Dr Horton’s conclusions.
The pharmaceutical industry in both Europe and the United States are some of the most highly regulated and scrutinised industries in the world. The industry is acutely concerned that the drugs that end up in the market are safe and perform as intended. Many countries take their cue from the US Food and Drug Administration and the European Medicines Agency.
The idea that “much of the scientific literature, perhaps half, may be untrue” has no basis in fact. Yes, there have been isolated cases of falsified research attributed to rogue scientists.
However, the vast majority is highly scrutinised and reviewed by independent scientific advisory panels and regulators.
The contention that drugs are approved using sample sizes too small to be statistically significant is also not factual.
Pharmaceutical companies submit to regulatory agencies their clinical research plans, inclusive of the statistical model used to determine the necessary patient size to prove safety and effectiveness. It is then independently reviewed and approved before any clinical trials are initiated.
If there is concern, as mentioned in Syed’s column, relative to diabetes as the example provided, that even drug intervention patients are poorly managed, perhaps we need to look at the clinical care provided and the fact that physicians are prescribing from their own clinics and profiting from dispensing the drugs.
The information provided by the pharmaceutical companies to physicians is once again reviewed and approved by regulators before it is disseminated.
Before we indict the industry wholesale, let us keep in mind the overwhelming benefits pharmaceutical products provide in terms of reducing or preventing hospital stays, providing enhanced quality of life for patients with chronic conditions, and for prolonging life for many.
The system is under constant review, and the idea that “the system needs to be cleaned up” is inflammatory and irresponsible.
Jeffrey Scott Yablon,Vice-president business development, general manager, Asia, Independent Pharmaceutical Research
