Whitney Palmer

Healthcare. Politics. Family.

Academic Medicine, Industry Collaborate on Better Partnerships

Published in the October 2011 AAMC Reporter

By Whitney L.J. Howell

Partnerships between academic medicine and pharmaceutical and device makers are increasingly seen as beneficial for progressive bench-to-bedside research. Medical schools and teaching hospitals have ramped up initiatives to release information on faculty relationships and help faculty navigate these murky waters.

Over the past several years, corporate support of medical research conducted by academic institutions, including medical schools and teaching hospitals, has attracted increased public and congressional scrutiny for potential financial conflicts of interest. As a result, new guidelines are emerging on how to manage these alliances.

The National Institutes of Health (NIH) last August released its final rule on conflicts of interest in federally funded research that provides a framework for identifying and managing an investigator’s potential conflicts. AAMC President and CEO Darrell G. Kirch, M.D., called the final rule, “an important step forward on the path to strengthening the integrity of biomedical research through enhanced requirements for disclosure and transparency.”

On the industry side, companies are changing their practices, including how they invest in academic research. For example, in June, Pfizer announced a $100-million investment for drug discovery at several Boston-area facilities, including Partners Healthcare, Tufts University School of Medicine, and the University of Massachusetts Medical School.

Pfizer has formed similar partnerships with the University of California, San Francisco, and with seven medical centers in New York City.

The ultimate goal of these kinds of partnerships according to Michael Rosenblatt, M.D., executive vice president and chief medical officer at Merck, is to create genuine, mutually beneficial partnerships, as well as an environment in which the investigations that industries need are conducted in an ethical and scientifically sound manner.

“The most important thing for both sides to understand is that they both bring essential pieces to the collaboration,” Rosenblatt said. “Without that realization, they will not succeed.”

The interest in bolstering these relationships springs from two changes affecting the medical world, said Lans Taylor, M.D., director of the University of Pittsburgh Drug Discovery Institute.

“In the face of spiraling research and development costs, the historically large revenue producers for pharmaceutical companies will be coming off patent in the next few years, and the pipeline for new drugs is relatively dry,” Taylor said. “And academic medicine has its own financial worries, as federal funding is becoming harder to secure.”

The discovery institute employs a milestone approach to funding. External companies now issue funding after yearly reviews, instead of providing lump-sum grant payments, Taylor said. If investigators have not made sufficient progress during the year, the company can fund new projects.

A major concern for academic medicine and industry is intellectual property, said Lawrence Botticelli, Ph.D., chief business officer for Tufts University Institute for Biopharmaceutical Partnerships, which currently has partnerships with several companies and offers a searchable Web clearinghouse that matches industry interests with appropriate faculty.

In the past, Botticelli said, individual investigators usually negotiated agreements alone, which sometimes allowed industry to claim sole ownership of all data and analyses associated with the research. To eliminate this possibility, Tufts handles negotiations on investigators’ behalf. The strategy helps faculty identify opportunities and safeguard the medical school.

“It’s important to have a clear description of which responsibilities lie with industry and which lie with the university,” he said. “What happens to the intellectual property must be written out, and each party must know what the agreed-upon rights are.”

Even with these changes in place, there is no guarantee these relationships will be bona fide partnerships, said Howard Brody, M.D., Ph.D., director of the Institute for Medical Humanities at the University of Texas Medical Branch-Galveston. Brody, who wrote the book, Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, warned that the public does not have a clear understanding of the issue, and until it does, medicine and industry will continue to battle against a lack of public trust.

“Industry cannot simply say, ‘Trust us,’” Brody said. “They must demonstrate how these relationships are balanced and how they are based in the advancement of science. At the same time, the U.S. taxpayer must understand they can’t get their science on the cheap. They can’t have tax cuts and state and federal budget cuts that slash research funding.”

Succeeding in this new playing field requires much from both academia and industry, said Barbara Barnes, M.D., the University of Pittsburgh Medical Center’s vice president of contracts, grants, intellectual property, and continuing medical education. All researchers must receive research integrity training and participate in educational discussions about fair relationships.

“Both parties must set objective timelines for projects and set realistic milestones,” she said. “It’s also extremely important to establish good communication. To be successful, you must really understand each other.”

According to Heather Pierce, J.D., M.P.H., AAMC’s senior director of science policy and regulatory counsel, the association is helping medical schools and teaching hospitals identify ethically sound practices for these interactions.

“The AAMC is creating tools to help institutions find their way,” she said. “There’s no one-size-fits-all guideline, but we’re providing assistance to ensure they’re working together toward effective, safe treatments that will improve patient care and the health of patients and populations.”

To read the story on its original site: https://www.aamc.org/newsroom/reporter/october2011/262392/partnerships.html

October 19, 2011 Posted by | Healthcare | , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

MRI Safety Concerns Prompt FDA Meeting

Published on the Oct. 13, 2011 DiagnosticImaging.com website

By Whitney L.J. Howell

In recent years, speculations about imaging safety have swirled around the long-term effects of CT scans. But, industry leaders are hoping to now turn the water cooler conversation toward making MRI safer for both you and your patients.

Even though MRI scans themselves are widely considered to be extremely safe, data from the FDA Manufacturer and User Facility Device Experience database reveal patients and providers are sustaining injuries during the MRI process. In fact, from 2004 to 2009, the number of injuries spiked four-fold to 193 accidents.

Whether more accidents are really occurring or injury reporting is on the rise is up for debate among radiologists. But the trend is concerning enough to prompt the FDA to hold a conference later this month to examine the biggest MRI safety concerns and discuss best practices to truncate the number of incidents.

“There are increasing numbers of MR scans and an increasing demand to scan patients with implants or accessory medical devices and other equipment. With the increased use, we are also seeing a number of preventable incidents,” said Sunder Rajan, PhD, of the FDA’s Center for Devices and Radiological Health Division of Physics Biophysics Laboratory. “Given the new experience base, this is a good time for FDA to learn what MR practices are being used and what changes practitioners feel would improve safety to the MR environment.”

The Main Concerns

MRI accidents and injuries fall into three main categories: thermal burns, projectiles, and hearing loss in poorly protected patients.

According to Tobias Gilk, president and MRI safety director at Mednovus and senior vice president at the design and architecture firm Rad-Planning, thermal burns pose the greatest risk to patients because they are associated with a relatively recent technology advancement – gradient improvements that allow for better image quality and scan efficiency.

“Burns are a newer safety issue that have grown out of the advancement of stronger, faster gradients,” Gilk said. “Moving to a stronger magnetic field from 1.5T to 3T makes it necessary to use more radiofrequency, increasing the chance that a patient will be burned.”

In addition, ferromagnetic objects in the MRI suite also pose a real danger to patients and providers. The 2001 Colombini case in which a 6-year-old boy died when an oxygen tank flew across the room and struck him during his imaging procedure brought this risk possibility industry-wide attention.

Although these incidents are rare, they are expensive. A U.S. Department of Veterans Affairs’ Center for Patient Safety study found that each occurrence costs more than $43,000, accounting for MRI machine repair, injury treatment, and legal costs. It doesn’t, however, take into account lost revenue due to an inoperable MRI machine.

Regardless of the reason, Emanuel Kanal, MD, director of magnetic resonance services at the University of Pittsburgh Medical Center and chair of the American College of Radiology (ACR) MR Safety Committee, said you must still take precautions to prevent projectile accidents.

“The most serious incidents, albeit quite rare, involve projectile effects,” he said. “These need to be addressed if we are to significantly lower the incidence of MR-safety relative adverse events.”

Unfortunately, there are no regulations that require proper identification of materials unsuitable for being in a MRI suite, Gilk said. And, sometimes it’s the MRI suite itself that creates the risk. When it comes designing a new suite, he said, many office architects look at a prototype design and implement it without taking the unique factors of the hospital or physician office into account.

To read the remainder of the article: http://www.diagnosticimaging.com/mri/content/article/113619/1970950

October 19, 2011 Posted by | Healthcare, Politics | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment


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