Life Science Compliance Update

July 06, 2015

NIH approves strategic vision to transform National Library of Medicine


The National Institutes of Health (NIH) Director Francis S. Collins, M.D., Ph.D., recently approved a federal report that describes the scientific vision for the NIH’s National Library of Medicine (NLM), the world’s largest biomedical library. Early in 2015, Dr. Collins tasked a working group of his Advisory Committee to the NIH Director (ACD), to create a strategic vision for the NLM. The ACD is comprised of experts in the fields of biomedical research, bioinformatics, library sciences, publishing, and patient care. The working group assessed the current mission, organization, and programmatic priorities of the NLM.

The report’s executive summary lists six recommendations from the ACD to guide the future of the NLM and notably it does not recommend that anything be cut:

(1)  Continually evolve to remain a leader in assimilating and disseminating accessible and authoritative biomedical research findings and trusted health information to the public, healthcare professionals, and researchers worldwide.

(2)  Lead efforts to support and catalyze open science, data sharing, and research reproducibility, striving to promote the concept that biomedical information and its transparent analysis are public goods.

(3)  Be the intellectual and programmatic epicenter for data science at NIH, including becoming the center of intellectual and programmatic activities in biomedical data science, and stimulate its advancement throughout biomedical research and application.

(4)  Strengthen its role in fostering the future generation of professionals in biomedical informatics, data science, library sciences, and related disciplines through sustained and focused training efforts.

(5)  Maintain, preserve, and make accessible the nation’s historical efforts in advancing biomedical research and medicine, thereby ensuring that this legacy is both safe and accessible for long-term use.

(6)  Have new NLM leadership evaluate what talent, resources, and organizational structures are required to ensure NLM can fully achieve its mission and best allocate its resources.

The report also acknowledges the challenges faced by the NLM. The ACD notes that future of biomedical research will require an expanded role for data science and the expertise of the NLM. This is happening in conjunction with ongoing budget constraints. Short of directly calling for additional funding, the ACD instead believes the NLM will need to maximize efficiency of existing resources, citing “care consideration and strategic planning” as essential for NLM to maintain and likely expand its role.

The ACD concluded its recommendations, writing that it believes the “NLM must evolve to seize this critical moment in biomedical history and be a trustworthy source of biomedical data and information, an advocate for open science, a promoter of the next generation of data scientists, a protector of the legacy of the past, and a vital partner for those who are generating biomedical knowledge for the future.”

Dr. Collins accepted the ACD recommendations in full, but acknowledged that NIH will need to consider the requirements and infrastructure implications for centering NIH’s biomedical data science activities within the NLM. In addition, NIH has launched a nationwide search for the director of the NLM to replace Donald Lindberg, M.D., who served as the NLM director for more than 30 years and retired in March 2015. The next director will need to conduct a thorough review and decide which programs “should be expanded or stopped,” according to the ACD report.


June 05, 2015

NIH Halts Drug Making Operations after FDA Inspection

Today, the National Institutes of Health (NIH) was ordered to halt drug making operations after a fungal contamination potentially affected 46 clinical studies. In April, two vials of albumin, which is used for administration of the drug interleukin in experimental studies, were found to be contaminated with fungus. As it has been reported, vials from the same batch had been administered to six patients. The patients have been notified and are being monitored for the development of infection.

The FDA's inspection report can be found here. It reads as a heavy indictment of the NIH facility. 17 specific observations are listed, describing the NIH's lack of compliance with the government's own standards. For example, FDA writes "an operator was observed processing sterile drug products with an exposed wrist from a gap between their gloves and their gown. The same operator had exposed facial hair."

The Washington Post lists a number of other FDA concerns, including no filter or screen covering a vent into a laboratory "clean room." Insufficient documentation about the cleaning of the facility. Insects found in a pair of ceiling light bays in clean rooms. Employees not wearing protective apparel. A water system that could harbor "microbial proliferation." Inspectors found that the facilities themselves were "not designed and controlled to prevent contamination risks to sterile drugs."

According to the NIH release, the following steps are being taken immediately to protect patients:

Operations of The Pharmaceutical Development Section have been suspended and no products will be made or distributed until all problems are fully understood and corrected. Materials produced by the Section are being systematically tested for contamination.

Of the participants in the 46 studies that are potentially affected, approximately 250 are currently scheduled to receive products manufactured by the PDS. NIH has notified the individual principal scientists responsible for each of those protocols, and is in the process of notifying the participants in these protocols. The vast majority of these patients are not immediately due for treatment and NIH is working to secure alternative sources for the products.


An external group of experts in microbiology and sterile manufacturing practices will be appointed to conduct a thorough review, including an assessment of all standard operating procedures, policies, staffing, and training, and make recommendations to the NIH director on the corrective actions required.

 In addition to the immediate steps NIH is taking, it will provide an interim corrective action plan to the FDA by Friday, June 19, 2015.

“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, M.D., Ph.D. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”


This event is reminiscent of the FDA's New England Compounding Center inspection controversy. FDA's inspectors observed problems with NECC's ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. In that case The U.S. Centers for Disease Control and Prevention (CDC) reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections from the NECC. Of those 751 patients, the CDC reported that 64 patients in nine states died.

The closure is a good example just how difficult and costly it is to produce pharmaceutical grade products.  Pharmaceutical and biologic manufacturing requires skill sets and often overtime commitments that don't match government's skills and experience.  This serves as an example to academics and Pharmascolds that the government is not capable of doing everything and needs the pharmaceutical industry to do what they do best.

Francis Collins has to take responsibility for the mess.  He announced he is personally overseeing this.   But the best use of his time may be in finding alternative manufacturing then quickly returning to focus on developing cures.  In the future NIH should consider contracting the manufacturing to facilities near NIH.  Maryland has a robust Biotech Corridor which has extensive manufacturing experience and familiarity with FDA inspections and procedures.

May 08, 2015

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


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.  


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