Life Science Compliance Update

23 posts categorized "Collaborations"

February 27, 2015

New Poll Shows Majority of Americans Are Concerned About Pace of Medical Progress


According to America Speaks, a compilation of public opinion polls commissioned by Research!America, the majority of Americans agree with the central tenets of the 21st Century Cures Bill

"Majorities across the political spectrum say it is important that the new 114th Congress takes action on assuring the discovery, development and delivery of treatments and cures for diseases in the first 100 days of the legislative session (75% Democrats, 64% Republicans and 60% Independents)," states Research!America. "As Congress considers numerous proposals in support of research, including the 21st Century Cures draft legislation aimed at speeding the delivery of lifesaving treatments to patients, it is notable to see public support in favor of accelerating medical progress."

Speed Drug Approval Pic

The report found that an increasing percentage of Americans say the U.S. Food and Drug Administration (FDA) should move more quickly in order to get new treatments to patients, even if it means there may be risks. In 2015, 38% favor faster regulatory review, compared to 30% in 2013 (see the graphic to the left). Meanwhile, 25% say the FDA should act more slowly in order to reduce risk, even if it means patients may wait longer for treatments.  Another 19% are undecided on this question and 18% do not agree with either position.  

When it comes to rising health care costs, 46% say research to improve health is part of the solution, while 28% are not sure and 26% say research is part of the problem. Meanwhile, 41% say that the roughly 1.5% of government spending allocated for biomedical and health research is not enough. Nearly one-third (29%) say it is about right, 21% are not sure and 9% say it is too much.

Furthermore, 44% say they are willing to pay $1 per week more in taxes if they were certain that all of the money would be spent on additional medical research, while 32% say no and 24% are not sure.

Currently, only 27% of Americans believe the U.S. has the best health care system in the world, but more than half say it is important that the U.S. is a leader in medical and health research. Furthermore, confidence in the current system in the U.S. for evaluating the safety of vaccines and recommendation for when they should be given dropped to nearly half, compared to 85% in 2008.


Among the polling results:

  • 70% of Americans agree basic scientific research that advances the frontiers of knowledge, even if it brings no immediate benefits, is necessary and should be supported by the federal government.
  • 80% of Americans say it’s important that elected officials at all levels listen to advice from scientists.
  • 78% of Americans say it’s important that our nation supports research that focuses on improving how our health care system is functioning.
  • A plurality (44%) say they’re willing to pay more in taxes if they were certain that all of the money would be spent on additional medical research, and
  • More than half (53%) say it’s important to make the R&D tax credit permanent
  • 56% of Americans favor expanding federal funding for research using embryonic stem cells.
  • More than half (55%) of Americans are willing to share their personal health information to advance medical research. An even higher percentage (60%) say they will share personal health information so that health care providers can improve patient care, and 46% percent are willing to share information so public health officials can better track disease and disability and their causes.
  • 73% of Americans say the federal government should assign a higher priority to improving education focused on science, technology, engineering and mathematics (STEM) and careers in those fields.
  • Studies show that certain health problems such as diabetes, heart disease and infant mortality happen more often among minorities or citizens with lower incomes. More than two-thirds of Americans (69%) say it is important to conduct medical or health research to understand and eliminate these differences.

 View the full report:  Download AmericaSpeaks Volume 15

Research!America notes that their online polls are conducted with a sample size of approximately 1,000 U.S. adults, age 18+, with a maximum theoretical sampling error of +/- 3.2%. Data are demographically representative of adult U.S. residents. Polling in this publication was conducted by Zogby Analytics.


January 19, 2015

Industry Involvement in Medical Education: Debunking the Myth



A recent article by Harry Pellman, M.D. entitled The importance of bias in education dispels some of the myths about pharmaceutical company involvement in physician education. With 22 years of chairing the CME Committee of an active American Academy of Pediatrics (AAP) Chapter and co-chairing the CME Committee of an AAP District, Pellman notes that he's had "intimate interactions with hundreds of nationally recognized speakers, some with and some without industry affiliation." He writes: "Myths, frequently perpetuated by those with little or no real-world contact with these programs or by people with anti-industry bias and peppered with words like 'perceived' and 'potential conflict,' need to be corrected."

Pellman's article looks at a few in particular that individuals who work in industry or are involved in continuing medical educational have come across. He writes:

Myth: Faculty with a pharmaceutical relationship are inferior to faculty without this relationship. They are privy to much more data, have frequently been involved in the product research, often freely duel with industry scientists and others about the data generated and how the information needs to be disseminated, interact with others researching the topic, and present newer, not-yet-published information (and disclose this) to attendees.

Myth: Education is better off without the pharmaceutical industry. At a time when medical knowledge is rapidly expanding, and it is becoming increasingly more complicated, and greater dissemination of the latest, best information is desperately needed, pharmaceutical financial support can help. Pharmaceutical support allows us to invite – free of charge – all University of California, Irvine-Children’s Hospital of Orange County pediatric residents and U.C. Irvine medical students to every CME program. Industry restrictions already in place are sufficient to promote more educational opportunities and less-expensive attendee costs. No new restrictions are needed.

Myth: Only faculty without industry relationships are unbiased and should be allowed to influence policy regarding education. This nasty, modern-day expression of “McCarthyism” attacks those with industry relationships, dismissing their contributions, intelligence, and sincerity with the “of course they support so-and-so; they are being paid by industry.” A 5-year evaluation of CME programs sponsored by California Chapter 4 AAP from 2009 to 2013 reveals the following data: 23 CME programs, 24 of 55 speakers listed a potential conflict of interest (44%). There were 1,995 attendees and 1,370 returned a response on whether or not a commercial bias was in the presentation; 1,342 responded “No” (98%) and 28 responded “Yes” (2%). Although almost half of the faculty had a potential conflict, only 2% of attendees felt their presentation suggested a commercial conflict. Interestingly, some of the “yes” responses were for faculty with no conflict to disclose.

How are these myths started and in many cases perpetuated? Pellman looks to a comprehensive journal review regarding industry-academic relationships in four influential journals published over the last few decades.  

Of the 108 published articles the study looked at, only 12 were either neutral or emphasized some benefit. Of these 12, all addressed the opposing points of view, and 50% critically emphasized and attempted to refute the alternative points of view. On the other hand, however, 16 research articles (15%) emphasized the risks of a relationship with industry, and none critically analyzed and attempted to refute the alternative points of view. The majority, 80 (74%) were commentary articles that emphasized the risks of a relationship with industry, and only 7 articles critically analyzed and attempted to refute the opposing points of view.

"The authors conclude that a major anti-industry publication bias exists and that a conformity cascade – where policy does not emerge from objective weighing of evidence but from social pressure – may be a factor for this major bias from medical journals that are influential in affecting policy," Pellman writes.

He also worries that the Sunshine Act may be particularly detrimental. "Many of the few remaining academics that still have a relationship with industry will sever this relationship for fear of being a 'target,'" he fears. Furthermore, academic institutions have restricted faculty members' interactions with pharmaceutical scientists and other faculty. "Past speaker and advisory sessions were attended by an eclectic group of specialists and generalists, and were filled with fertile discussions and debates regarding disease and treatment perspectives," Pellman writes. "There are no winners when these bright educators are kept away from potential learning and teaching situations."

"Those of us interested in education need to keep an eye on the prize – educating providers so that health care is optimized," Pellman notes. "This is best done by broadening the dialogue about how to improve and better disseminate both the quality and quantity of health care information being generated."

"Besides, the industry that has given us medications and vaccines that have improved the quality of life for so many needs to be treated with less contempt and more respect," Pellman concludes. "It is time to build bridges, not walls, and broaden the collaboration needed to better disseminate the vast amount of new information being generated. Improving practitioner education will need fresh ideas, an open mind, validating studies, a gentler dialogue, and the respect, inclusion, and collaboration of all stakeholders."

View the full article on pm360 here


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