WASHINGTON, D.C. [February 4, 2013] Pharmaceutical Research and Manufacturers of America (PhRMA) Executive Vice President Josie Martin issued the following statement today:
Dr. Ben Goldacre’s book Bad Pharma provides a one-sided and factually questionable view of the clinical trial process led by the innovative biopharmaceutical sector. The book ignores that the current clinical trial system, which is essential to the development of new medicines that save and improve lives, is scientifically rigorous, tightly regulated and working well. “The book’s unfounded and sensational claims may attract attention, but they do not advance biomedical science or patient health. Based on cherry-picked examples and incomplete stories, the accusations leave countless unanswered questions that could threaten public health and the development of future medicines. Criticizing the research process without acknowledging the vigorous oversight and broad commitment to safe and ethical conduct is a disservice to the tens of thousands of scientists exploring new medicines and the millions of patients hoping for cures…The demands by Dr. Goldacre and the British Medical Journal (BMJ) to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials. It would also encourage second-guessing of the regulatory approval process, which would be disastrous for patients. The FDA has the most advanced and rigorous review process for potential new medicines and it is continuously improving its regulatory and scientific capabilities.
Why so snappy? Here’s a paragraph from the introduction to Bad Pharma:
Ben Goldacre has been writing about these matters for quite a while, but it appears that his widely viewed TED Talks have skyrocketed him into a position of leadership. He has that combination of qualities that are tailor-made for the job: he’s intelligent and knowledgeable; he’s iconoclastic; and he’s something of a court jester. Throughout the history of drama, role of truthsayer often falls to the royal fool, or an innocent child [the emperor's new clothes], or the Greek Chorus – some unlikely character perceived as an "outsider" – someone free from the constraints and protocols of convention. The 1960s were ushered in by the Merry Pranksters and sustained by Abbie Hoffman and the Yippies.
There are currently over 5,000 new medicines in the pipeline, 70 percent of which are potential first-in-class medicines that could provide exciting new approaches to treating diseases for patients. Personalized medicines and drugs for rare diseases account for a growing share of the research being conducted by the biopharmaceutical sector. Clinical trials are critical to fulfilling the promise of this robust pipeline. Our sector and other stakeholders in the trials process welcome a constructive dialogue and are focused on protecting the privacy and safety of study participants, overcoming barriers to greater participation and discovery. Debating the self-serving claims of Dr. Goldacre does nothing to advance patient health.