Life Science Compliance Update

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25 posts from November 2009

November 29, 2009

Medical Education Companies, Commercial Support and Transparency

Continuing Medical Education (CME) Companies have recently been targeted as being opposed to transparency in continuing medical education funding.   Let me set the record straight: This is simply not true.  


We ardently support the guidelines established by the Accreditation Council for Continuing Medical Education (Standards of Commercial Support) and the Food and Drug Administration (Guidance on Industry Supported Scientific and Educational Activities) and other organizations to ensure the integrity of continuing medical education and to insulate it from undue influence by pharmaceutical and medical device companies.   


For the companies I am involved all our programs include disclosure of funding source, disclosure of faculty and staff relationships with industry.

The 2004 ACCME standards for commercial support tightened the rules about commercial support and made them clearer and more specific about how to resolve, and disclose potential conflicts of interest, and deliver high quality commercially supported continuing medical education.


I also support disclosure of CME payments made by pharmaceutical and device companies to educational providers included in the Physicians Payments Sunshine Act, but since the medical industry is rapidly adopting greater transparency and voluntarily disclosing its payments to CME providers and individual doctors, It may not be necessary for those payments to be included in health care reform legislation now being considered by congress.


A Phony War?


What I do object to is the suggestion that commercial enterprises, be they pharmaceutical companies or medical device firms, ought to have no role in medical education.  


I call this controversy a “phony war” since the vast majority of those directly affected by medical education—the health care community—readily accepts industry participation. 

In fact, a recent study by Manhattan Research revealed that only nine percent of American physicians object to commercial support for continuing medical education (“CME”).  A recent study of over 1 million CME participants in the American Journal of Medicine showed that bias was found by less than 1% of physicians regardless of the funding source.


A proposal to purge CME of industry funding was defeated for the third time by the American Medical Association’s House of Delegates less than three weeks ago, with groups such as the American Academy of Pediatrics and American Academy of Family Physicians affirmed that existing guidelines sufficiently guard the integrity of medical education.


Yes, health care companies fund medical education related to disorders for which they have treatments.  Isn’t that logical?  But critics imply that funding programs equates with controlling content; that implication makes for riveting headlines, but it simply does not happen in practice.  


One thing to ponder is that today, it is considered by our critics as honorable for physicians and CME providers to work with trial lawyers and insurance companies which add little value to the medical system, but dishonorable to work with industry which provides significant advances in patient care.  Those fighting the “phony war”, need to be reminded of all the progress and advances in patient care that those working with industry have helped to make happen.  In fifty years, I want my children to remember that I helped to educate physicians and healthcare professionals on the latest treatments and which potentially helped saved millions of lives.


Financial Support


Private CME providers help fill an educational gap since the need for updated medical education is extremely high working alongside academic institutions and medical associations to deliver high quality medical education.  This is how the free enterprise system works.  


Critics attempt to make a case that private companies with resources dedicated to produce educational programs are somehow “corrupt” because they accept commercial financial support for their programs.  It is foolish to think however that any group–whether it be an institution, association, or private company — would not seek out all funders or sponsors that are available to them to conduct their business and to educate physicians.  The critical factor is not the funding source, but the independence and integrity of the programs offered.


Companies like ours receive grant support from industry and others to help underwrite our educational programs.  Our revenues also have expenses which include venue costs, honoraria, travel and other operational expenses including salaries, health insurance and overhead (all of which are appropriately reported) and translate into modest profit margins. 


We provide excellent medical education programs, spending significant amounts of staff time ensuring that the content is relevant to patient care, understandable to the participant and useful to medical practice. 


Physicians and other healthcare professionals willingly participate in our programs often spending large amounts of time to learn and advance their knowledge of medicine.   They have many choices so the quality must remain high, and credible for any group to be able to continue to produce CME programs.  Commercial companies that fail to meet high standards of education are forced out of business.


Continuing Medical Education: A Business Challenged


Doctors are required to continue their education and pursue CME credits because medicine is one of the most dynamic of all professions.  Perhaps no other field equals the pace of new information and in the field of CME, patients lives can depend on timely delivery of new information.


New medication strategies, new devices and new discoveries about human biology mean that health professionals must refresh their knowledge constantly.   With the avalanche of scientific developments, the requisite to improve the health of the under-served and the fierce urgency to improve health outcomes, the need for medical education has never been greater.


Medical colleges, not-for-profit organizations and government agencies are important sources of information about these new developments and provide slightly more than half of continuing medical education courses.  But they are underfunded and unprepared to assume a greater role.  In short, they are definitely not prepared to assume sole responsibility for medical education.  


The private sector health care industry is the logical source for this educational programming.   It should be monitored—and it is.  It should be transparent in its dealings—and it is.  And it should be encouraged to invest more—not less—in unbiased continuing education programming without the hectoring and suspicion that has defined recent reports.  Let’s hope that this comes to pass.


November 26, 2009

Memorial: Richard (Buzz) Goodstein, MD -- Founder of the Good Guys

Buzz Goodstien Cropped

On this thanksgiving we have a lot to be thankful about and one thing that I am personally thankful for is that I was able to know Richard (Buzz) Goodstein, MD.

Buzz passed away this weekend from a long battle with advanced prostate cancer.

Buzz was an innovator and educator who career covered academia, media and industry.

He was one of those people you meet and say to yourself he has lived a full life.  He served as a mentor and friend to numerous people, and was the founder of the “Good Guys” a virtual organization that has worked to disseminate information on early detection of prostate cancer.  The goal of the “Good Guys” was to change the test for prostate cancer from a straight PSA number to changes in PSA velocity which is has greater specificity than straight PSA.

I first met Buzz at a Global Alliance for CME meeting in 1999, at that time he was playing his Clarinet and speaking on the music of medicine.   Later we became friends when he would regularly drop by my office when he was visiting Washington DC.  He always had kind things to say and was always interested in how you were doing as a friend.

Through the good guys, Buzz has served as an inspiration to many cancer patients and those of us involved in medical education.  He fought an admirable fight against prostate cancer which he eventually lost.

He was an honorable man, and a first class gentleman.  Since his deaths I have received dozens of emails all extolling how important he was in so many people’s lives.   We all want to leave a legacy, and it is clear that Buzz is leaving more than just a legacy but a long list of “good guys”.

A little about his life:

Dr. Goodstein graduated summa cum laude and magnum cum laude respectively from Valley Forge Military Academy, Wayne, PA and from the Honors College of Michigan State University where he had joint majors in biological sciences and telecommunications while attending both schools on full music scholarship.

Buzz received his medical training at George Washington University in Washington DC, he then joined the Navy and worked on space flight medicine doing clinical research for NASA while assigned from the US Naval Aerospace Medicine School, on the effects of weightlessness and magnetic fields upon the Mercury/Gemini Program astronauts and new astronaut selection. After graduation from GWU, he completed his medical internship at E. Sparrow Hospital, Michigan State University (where he did his undergraduate), and then earned his wings as a graduate of the US Naval Flight Surgeon School in Pensacola, FL.  He served on active duty in the “Regular” US Navy as Lieutenant Commander for four years in the positions of senior flight surgeon and senior medical officer for various aviation combat squadrons.

After leaving the Navy he completed three years post-doctoral psychiatry residency training at Dartmouth Medical School, Hanover, NH.  He was then invited to join the Dartmouth College Medical School faculty where he remained for seven more years.

He was then recruited to the Carrier Clinic Foundation, the neuropsychiatry teaching hospital of The University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School, where he was Deputy Medical Director and Senior Vice President for Education.  For ten years he was in charge of all training/education for employees, and graduate students from 25 affiliated colleges.

While at UMDNJ, Dr. Goodstein was the originator, executive producer, and on-camera moderator of the popular live, weekly CME satellite TV series titled, MIND and BODY, which was broadcast on HIN/HSN and later PBS from 1984-1990 to over 1,000 hospitals and 100 universities in the US and Canada.  As a by-product he also introduced computerized medical education and clinical data tracking to the Carrier Clinic.

He was then recruited by Merck and Company to develop the Professional Information, Communications, and Education areas headquartered within the Medical and Scientific Affairs Division. 

At Merck one of the things he was most proud of was helped develop and lead The Urban Health Alliance Initiative (a minority health 501(c) 3 Foundation), the Men’s Health Initiative, and The Healthy Aging Initiative.  Dr. Goodstein became a member of the AMA-Industry National Task Force on CME in 1990.

Dr. Goodstien was an innovator and saw the value of the internet very early on.  After the sale of Medco, in 1995 Dr. Goodstien became one of the founding Senior Vice Presidents for Physicians’ Online in Tarrytown, NY.  In that role he created new medical internet products and personal computer initiatives for all clinical disciplines as well as built alliances with professional organizations and customers as platforms for the use of Physicians’ Online products.  Physicians’ Online was later purchased by WebMD.

In 1997 Dr. Goodstein was recruited as Vice President of Scientific Relations at Bayer Corporation, Pharmaceutical Division, USA.  He was asked to conceive, develop, and lead a clinical science division which eventually totaled ten departments (including the Bayer Institute for Healthcare Communications – a 501(c)3 foundation with CE/CME accreditation) encompassing 230 professional staff representing the information scientists, clinical medicine educators, health economists, innovation teams, and all 130 medical science liaisons at Bayer.

He retired in 2006 and shortly after that was diagnosed with advanced prostate cancer.    Buzz continued to work for two more years, finishing in January 2007.  During that time he created a small internet working group called the good guys which was dedicated to advancing information around prostate cancer. 

Buzz set up small group luncheons around the country with no strings attached, to teach executives and others about prostate cancer.  In the coming days we will include links to copies of the emails and articles he passed around.  If you are a man over 45 and have not had your PSA checked, please do every year, and at the same time track what that number is, if you see it moving up by more than 1 point, you may have a problem, and should get checked out.

Buzz had a statement he would make that in many ways defines his life.

"Think, understand, feel, respond, pay forward" - Buzz Goodstein


Buzz Goodstien Child
Buzz as a child playing his clarinet

November 23, 2009

HHS OIG: How Grantees Manage Financial Conflicts of Interest in Research Funded By NIH

The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) recently published a follow up report from January 2008 on How Grantees Manage Financial Conflicts of Interest in Research Funded by NIH.”

The report focused on the fact that  90% of the institutions that get NIH money--$29.5 billion in FY 2008—“rely solely on researchers’ discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported.” As a result of this practice, OIG listed its findings and policy recommendations, which are very similar to the 2008 report.

OIG first noted that institutions receiving grants must already have a written policy for identifying financial conflicts of interest, and ensuring that such conflicts are managed, reduced, or eliminated by enforcing administrative processes. Grantees must also certify:

-    That existing conflicts (but not the nature of the interest or other details) will be reported to NIH prior to the expenditure of any funds under that award;

-    That these conflicts have been managed, reduced, or eliminated; and

-    That any subsequently identified conflicts will be reported and will be managed, reduced, or eliminated, at least on an interim basis, within 60 days of identification.

The November 2009 report collected information from each of the 41 grantee institutions that reported conflicts to NIH in FY 2006. The report found that “the most common type of financial conflict of interest among NIH-funded researchers is equity ownership, (including stock and stock options) in companies in which the researchers’ financial interests could significantly affect the grant research.”

The average equity value for researchers was $232,464 and the median was $22,500. The average dollar amount of the compensation for all researchers was $79,248 and the median was $23,000. To date, only nine cases that involved NIH-funded researchers have been made public by the Senate Finance Committee staff.

In managing these conflicts, “Grantee institutions frequently disclosed the conflict in publications and/or presentations in which research results are presented.” As a result of this practice, “NIH found no instances of intentional noncompliance by grantee institutions” in disclosure.

Still, the report indicated that “vulnerabilities exist in grantee institutions’ identification, management, and oversight of financial conflicts of interest.” OIG stated that “specific financial interests of NIH-funded researchers are often unknown; grantee institutions do not routinely verify information submitted by researchers; conflicts were not uniformly reported by grantee institutions; the majority of grantee institutions do not have policies and procedures to address subgrantee compliance with Federal regulations regarding conflicts; grantee institutions lack documentation to support their oversight of conflicts; and grantee institutions are not required to report to NIH any financial interests that they have with outside companies.


To address these vulnerabilities, OIG recommended to NIH that increased oversight is needed to ensure that (1) these conflicts are managed appropriately, (2) the research conducted using Federal funds is not biased by any conflicting financial interests of researchers, and (3) human subjects are not subjected to unnecessary risks. Other recommendations that NIH will consider are:

-    Require grantee institutions to collect information on all significant financial interests held by researchers and not just those deemed by researchers to be reasonably affected by the research.

-    Require grantee institutions to collect information on specific amounts of equity and compensation from researchers.

-    Overall, the NIH did not state whether it concurs or does not concur with OIG’other recommendations. “NIH also stated that many of the report findings were not made within the context of the current financial conflict-of-interest regulation and therefore, many of the recommendations are difficult to assess and/or cannot be implemented.”

OIG also made the same recommendation from its January 2008 report that NIH “request grantee institutions to provide details to NIH regarding the nature of all reported financial conflicts of interest and how they are managed, reduced, or eliminated.” NIH, as in January 2008, did not concur with this recommendation.

“NIH stated that the responsibility for identifying and managing conflicts must remain with grantee institutions and that collecting such information would effectively transfer the responsibility to the Federal Government.”


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