Life Science Compliance Update

May 08, 2015

Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation

Stossel

Long a champion of physician and industry collaboration, Thomas Stossel, M.D., has published a new book entitled Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation. In it, Stossel, a distinguished Harvard hematologist and researcher, decries the conflict of interest movement as detrimental to medical progress and ultimately the patients who would benefit from new, innovative therapies.

Writing about conflicts of interest has been an increasingly surefire way to get published—the Journal of the American Medical Association even has its own conflict of interest category. What’s often missing from both sides of the mostly academic “COI” debate, however, is a relation back of nebulous concepts to what is important: tangible medical innovations and patient well-being.

One of the reasons Dr. Stossel’s writing is so engaging is that he bucks this trend by illustrating in plain language what is at stake. “Physician-industry interactions have been critical to the development of a large percentage of the medical products that allow physicians to prevent heart attacks, cure cancers, and restore mobility to the elderly,” he writes.

Over the course of my career, medicine and industry have together made spectacular progress against diseases. Cardiovascular deaths are down 60 percent, HIV has been converted from a death sentence to a chronic disease, and cancer mortality is at a historic low. Despite such progress and the role of physician-industry interactions in fomenting it, physicians are reducing or severing their relationships with biopharmaceutical and medical device companies out of fear that their patients will mistakenly view such interactions as a sign of corruption, rather than expertise.

In addition to the large amount of ink being spilled in academic journals on COI, Stossel characterizes a number of recent legislative measures as being similarly “pharmophobic.” He points specifically to the medical device excise tax and the Physician Payments Sunshine Act, which requires pharmaceutical and device companies to report any payments to physicians and teaching hospitals of more than $10. These payments are reported on a publicly accessible website, “with minimal explanations,” he notes, which “stigmatiz[es] relationships that are critical to the development and dissemination of new medical products.”

“[O]ne of the highest-paid physicians in the Sunshine database is a world-famous vascular surgeon who received royalties for his invention of multiple aneurism repair devices,” Stossel illustrates. Similarly, "Paul Offit, who invented the rotavirus vaccine that is believed to have reduced the incidence of hospitalizations for rotavirus-induced diarrhea by more than 85 percent among U.S. toddlers since its addition to the childhood-vaccine schedule in 2006, is often maligned for his industry ties." Stossel concludes: “Such cases, along with research grants for clinical trials, dominate the largest payments documented under the Sunshine Act. They are unequivocally beneficial and should not be stigmatized in this manner.”

Dr. Stossel’s book also aims to illustrate just how important private industry has been to these amazing breakthroughs. Again, he is the perfect spokesman for this. “I’ve done medical research for most of my career, and people say that I’ve been successful at it," he notes. “I hope that this research will save lives someday, but only drug and device companies can make that happen.”

He writes:

Publicly supported academic research certainly advances medical knowledge. But converting that knowledge to clinical benefits isn’t straightforward. Helping patients justifies public research funding, but obtaining such funding depends far more on impressing grant review committees with the novelty and virtuosity of research than with its practical medical applications. I know, because following these precepts has certainly contributed to my success. I have had continuous government research funding for over 45 years, have published research papers in prestigious scientific journals, won prizes, and been elected to elite scientific societies. Yet no one has lived one second longer or better as a direct result of my research.

But regulations, largely stemming from the conflict of interest movement has only served to impede medical innovation. “Regulations always slow things down, and compliance and enforcement divert precious funds from research and development,” states Dr. Stossel. “It takes on average 16 years and costs over $2 billion to get a new drug approval by the FDA.” This delay matters:

For patients desperate for new treatments and cures, such delays can be lethal. Marketing restrictions mean doctors don’t learn about drug and device advances. Delays or prevention of potentially innovation-promoting relationships between researchers and industry have been documented. The myth that device and drug development isn’t difficult and expensive encourages enactment of taxes on companies and calls for price controls. Both inhibit innovation.

--

Dr. Stossel stands as a rare counter to the COI movement, and provides years of experience and patient-centered arguments to back it up.  Pharmaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation is out now and available here. Also, read  a Q&A with Stossel about his book.

In full disclosure, Thomas Sullivan, Editor of Policy and Medicine is listed in the preface to Pharmaphobia, he receives no remuneration from the sales of this book or his work with Dr. Stossel.  

December 12, 2014

NIH Launches "ClinRegs" Website Aggregating Country-By-Country Clinical Research Regulation

 

ClinRegs


The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online database of country-specific clinical research regulatory information “designed to save time and effort in planning and implementing clinical research.” The website, ClinRegs, provides users with useful comparison capabilities between thirteen countries. 

“By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons involved in planning and implementing international clinical research,” the website states.

ClinRegs provides an overview of country-specific regulations in the following topic areas.

  • Competent Authority Oversight
  • Ethics Committee Oversight
  • Clinical Trial Lifecycle
  • Sponsorship
  • Informed Consent
  • Investigational Products
  • Specimens

The website currently asks for feedback from users, and NIAID notes that additional topics may be added based on that feedback. 

As an example, the Clinical Authority Oversight section for India states, in part:

In India, the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), is the competent authority responsible for clinical trial oversight, approval and inspections. The DCGI grants permission for clinical trials to be conducted in India in accordance with the provisions of the DCA, 1940/DCR, 1945 and Schedule Y. The DCGI is also commonly referred to as the Licensing Authority in the Indian regulations.

CDSCO is India’s central regulatory body for pharmaceuticals and medical devices. The DCGI, who directs CDSCO, handles the drug and device regulatory process; he/she is also responsible for registering all imported drugs and new drugs and for overseeing clinical trials. CDSCO functions under the Directorate of General Health Services (DGHS) which is part of the Ministry of Health and Family Welfare (MOHFW).

NIAID has aggregated information from Brazil, China, India, Kenya, Liberia, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, the United Kingdom, and the United States. Mali, Mexico, Haiti, and Vietnam will be possible additions to the programs, according to NIAID.  

The comparator tool provides side-by-side comparisons with countries on your chosen topic. For example, this shows a look at the "informed consent" requirements of both the United Kingdom and the United States. 

ClinRegs


Given the fact that large pharmaceutical companies operate internationally and must navigate a wide variety of complex clinical regulation, this website is very helpful. Having one master resource such as this can serve to both clarify a company's obligations, and expedite their understanding of responsibility in one country verses another. 

 

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