Life Science Compliance Update

August 31, 2011

ACRE Releases Statement on Enhancing FDA Advisory Committee Recruitment

FDA Advisory Committee 
The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug Administration’s (FDA) conflict of interest standards.  ACRE strongly recommends that FDA adopt new policies that ensure experts with the highest scientific and clinical qualifications are actively recruited to serve as advisory committee members.

The FDA regulates more than 150,000 marketed drugs and medical devices, with nearly 3,000 investigational new drugs being developed at any given time.  These advances offer hope for patients and the opportunity to improve public health, which must be balanced against the potential risks.

Although FDA employees have extensive scientific and medical training and experience, they cannot alone encompass the full range of expertise necessary to evaluate the increasingly complex minutiae associated with medical innovation.  The agency therefore looks to outside experts to serve on technical and scientific advisory committees that evaluate the safety and efficacy of experimental products. Advisory committees provide crucial independent advice to assist with regulatory decision-making processes and support sound decision-making by the FDA.

In 2007, new conflict of interest standards were adopted that set an arbitrary financial threshold for committee participation.  Experts with personal or family financial interests above $50,000 are excluded from serving as committee members, and even if conflicts are resolved, they must wait at least one year before being permitted to serve.  Those with interests below the threshold are allowed to serve, but are stripped of their voting rights.

Since adoption of these new policies, committee vacancy rates have steadily increased.  The most recently released data for overall FDA committee membership from the third quarter of 2010 show vacancy rates ranging from 25% to 27%.  The Center for Biologics Evaluation and Research (CBER) vacancy rates are markedly worse, reaching 32% for the last three months of 2010.

“These rising vacancies clearly demonstrate the unintended consequences of overly restrictive conflict of interest policies,” stated Michael Weber, MD, a Director of ACRE, “Both government and industry rightfully seek out accomplished leaders in many fields for their expertise.  Excluding a portion of these leaders because they have collaborated with industry to promote advancements in science and health is hindering the FDA’s ability to meet its responsibilities to patients.  Product reviews are unnecessarily delayed along with patients’ access to new therapies and medical devices.”

Data obtained by both critics and supporters of industry collaboration consistently reveal that industry consultants are often the most qualified and prominent physicians and productive researchers.  Moreover, detailed analysis of FDA panels’ recommendations reveals no effect of industry relationships on panel members’ voting behavior.

“Advisory committee members should be chosen based on their direct experience with, and expert knowledge of, the specific technology under review,” stated Weber.  “ACRE supports a transparent evaluation process under which remuneration from for-profit and non-profit entities is examined and made available to the public. Relationships that indicate direct financial interests with an entity whose product is the subject matter of a particular Advisory Board meeting would reasonably lead to recusal of a potential advisor..  Other interests, including so-called perceived conflicts, should not be used as exclusion criteria.”

“We urge the FDA to further scrutinize the impact its current conflict of interest policy is having on product reviews and approvals and make the appropriate adjustments.”

About ACRE

The Association of Clinical Researchers and Educators (ACRE) is a non-profit professional organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts. ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration. In addition, ACRE will identify and train next generation of researchers and educators.

July 26, 2011

Association of Clinical Researchers and Educators: Claiming Lost Ground -- Advancing Patient Care

Montel Closeup 
Late last week, the Association of Clinical Researchers and Educators (ACRE) held a conference to discuss the importance of physician-industry collaboration.

ACRE is an organization of physicians and colleagues engaged in promoting excellence in medical service, education, and innovation. ACRE members have records of achievement in these endeavors.

The second ACRE meeting took place at the Weill Cornell Medical Center in New York City, New York.  This year’s ACRE 2011 meeting covered a number of areas and topics and included speakers and representatives from across the health care industry.  Slides and presentation materials are posted on the meeting site. Topics included:

  • The History of the Conflict of Interest “Mania”
  • Issues in the field of continuing medical education (CME)
  • Why Academia/Industry Collaboration is under attack
  • Academic Medical Centers
  • The Importance of Academic-Industry Collaboration for Patients; and
  • Washington and Innovation

The meeting was covered by the New York Times, which noted how the conference started by addressing the term “conflicts of interest.” Several presenters noted that, “conflict of interest” is a “pejorative term” and that a better term is “overlap of interests,” because the drug and device companies want to market products to help people, and the researchers and professors want to help them find new cures and spread the word.

Another panel during the meeting looked at why academic-industry collaboration is under attack by not only “politicians, deans and the media” but also medical journal editors, the Association of American Medical Colleges, the Institute of Medicine of the National Academy of Sciences, the National Institutes of Health, the American Medical Association, the United States Department of Justice, and of course the media.

Dr. Thomas P. Stossel, a Harvard medical professor and co-founder of the group, said that drug companies, years ago, reported their financial support for professors and researchers to honor them.

“Now, it’s a confession of guilt,” he said of the lengthy financial disclosures that many speakers flashed on the screen. Most of them said the industry support proved their value.

He noted that several academic organizations that received media in their announcements of strict policies have since backed off these policies due to push back from faculty, the implacability of the proponents of the rules and difficulty of implementation of these strict policies.

Dr. J. Michael Gonzalez-Campoy, chief executive of a Minnesota obesity center and past president of that state’s medical association, said the growing pressure to disclose financial ties with drug and device makers is leading further, too far, to outright bans of such ties in the leadership of some medical societies.

The collaborative research and marketing, he said, help to bring drugs to patients that prolong and save lives.

Dr. Michael A. Weber, another cofounder of the group and professor of medicine at the SUNY Downstate Medical Center in Brooklyn, said ACRE plans to push back by drafting its own guidelines for what is proper in industry-academic collaborations.

A panel of grateful patients was led by Montel Williams, a former talk show host who is battling multiple sclerosis, raising funds for medical causes, and recently received experimental treatment with what he described as great success.   It was encouraging that Montel pushed the audience to be proud of the work they do with the medical products industry and not cower back because of criticisms.

Mr. Williams urged the beleaguered professors and researchers to stand up to critics and make it clear they are life-savers.

“Do your job!” he said to applause.

ACRE

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry.

Another of ACRE’s main tasks is to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. ACRE also represents a voice that is heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

Additionally, ACRE provides education for health care professionals and patient advocates to empower them to fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

It is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research.

The slides for many of the presentations are available on the ACRE website:

ACRE 2011 Slides (Underline and Green)

In the near future the full program will be available in streaming video and MP3 audio files.

June 02, 2011

Association of Clinical Researchers and Educators 2011 Meeting – July 22 in NYC

DSC01740 
The Association of Clinical Researchers and Educators (ACRE) is an organization of physicians and colleagues engaged in promoting excellence in medical service, education, and innovation. ACRE members have records of achievement in these endeavors.

Consequently, ACRE recently announced that it will be holding its annual meeting.  The meeting will take place on July 22, 2011 at the Cornell Medical Center in New York.  For more information about the meeting and registration, click here.  ACRE previously held its charter meeting in 2009.

This year’s ACRE meeting will cover a number of areas and topics and will include speakers and representatives from across the health care industry.  Topics include:

-          Issues in the field of continuing medical education (CME)

-          Why Academia/Industry Collaboration is under attack

-          Academic Medical Centers; and

-          Washington and Innovation

The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry.

Another of ACRE’s main tasks is to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. ACRE also represents a voice that is heard and quoted when these industry-academia relationships are attacked, as they have been in the past.

Additionally, ACRE provides education for health care professionals and patient advocates to empower them to fight those policies that undermine productive collaboration.” The organization is also charged with training our current and next generation physicians so they can promote true excellence in medical education and innovation.

It is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research.

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