Policy and Medicine

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.

 

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

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 as a child playing his clarinet

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.

Recommendations

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.”

Senate Opens Debate on Health Reform Bill

The Senate on Saturday voted 60 – 40 to open debate on their version of Health Reform.  We expect debate to begin December 2^nd and the vote prior to the Christmas recess. 

Medical Journals Conversion to New Disclosure Forms

When the International Committee of Medical Journal Editors came out with a new conflict of interest disclosure form last month there were mixed reviews.  An article in American Medical News outlined the issue.

Much of the problem of reporting disclosures to begin with is a problem of the journals themselves. As JAMA Editor-in-Chief Catherine D. DeAngelis, noted herself, there are “over 1,500 biomedical journals and everyone has their own author form with different requirements, and it's extremely confusing for authors." She even indicated that the authors have a lot of “legitimate confusion."

 

Merrill Goozner, a member of the Center for Science in the Public Interest, an advocacy group, helped convene a group of journal editors to come up with the uniform disclosure form. The results of their work are slated for publication in a forthcoming issue of Addiction, the journal of the Society for the Study of Addiction.

 

Some parts of the new form seem reasonable: authors submitting for publication must disclose any payment for the research that generated the article as well as other kinds of industry relationships such as consultancies, honoraria or stock options from the last three years.

 

Other parts of the form could be considered an invasion of privacy. For example, the form also asks authors to disclose whether spouses or children have financial relationships with "entities that have an interest in the content of the submitted work." The form even goes as far as asking authors to provide "any relevant nonfinancial associations or interests" of a personal, political or religious nature "that a reasonable reader would want to know about." For example, authors who write about the clinical consequences of abortion who are ardently anti-abortion.

 

Jerome P. Kassirer, MD, former editor of NEJM noted that "asking people to declare nonfinancial conflicts of interest is likely not to be fruitful." As a result, he acknowledged that a form that includes this irrelevant information dilutes the importance of these financial conflicts."

 

J. Michael Gonzalez-Campoy, MD, PhD, a medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology, a private practice near Saint Paul, and an ACRE leader also had objections. He particularly felt that "It is an unwarranted extreme to require spouse, partner or children information."

 

Do we know who the spouses of our favorite politicians work for? How about their staffers? What about the spouses of lobbyists who work on the Hill or in industry? While Dr. Gonzalez-Campoy certainly believes "in disclosure of working relationships that may have bearing on a publication or presentation," he said the ICMJE form goes too far.

 

Revealing financial relationships

 

Among other things, the form asks authors to disclose whether, in the previous three years, they or their institutions had financial relationships "with any entities that have an interest related to the submitted work, including:

Board membership

Consultancy

Employment

Expert testimony

Gifts

Grants/grants pending

Honoraria

Payment for manuscript preparation

Patents (planned, pending, or issued)

Royalties

Payment for development of education presentations, including service on speakers' bureaus

Stock/stock options

Travel/accommodations expenses covered or reimbursed

Source: International Committee of Medical Journal Editors Uniform Disclosure Form for

Potential Conflicts of Interest (www.icmje.org/coi_disclosure.pdf)

 

While the ICMJE form is undergoing beta-testing and will be finalized at the committee's April 2010 meeting, journal editors should begin discussing what relevant information they could use from these questions that people have objected to. If the main goal of having a uniform disclosure form is to reduce conflicts of interest, then financial disclosures should be the main priority for those directly involved, plain and simple, at least until evidence suggests otherwise.

Harvard Medical School Dean Gives Health Care Reform Proposals Failing Grade

In a recent evaluation of current health care reform proposals, Harvard Medical School dean Jeffrey FIier, MD Dean of Harvard Medical School gave “a failing grade” to recent policy efforts because the discussion has left out the people who actually care about health.

As a result, Dr. Flier asserted that “the speeches and news reports that have lead Americans to believe congressional legislation will solve the problems of cost, access and quality, are not true.”

He explained that our current health care system suffers from a “tax policy that drives employment-based insurance, which results in overinsurance and drives costs upward while creating inequities for the unemployed and self-employed.” He also noted the limitations to healthcare that are created by “a regulatory morass that limits innovation, and the deep flaws in Medicare and Medicaid that drive spending without optimizing care.”

The reason these speeches and reports are not true, according to Dr. Flier, is because “while the various bills give more access to health care by expanding Medicaid and mandating subsidized insurance at substantial cost ... there are no provisions to substantively control the growth of costs or raise the quality of care.” Since no provisions address these critical issues, “the overall effort will fail to qualify as reform.”

He also noted that “dozens of health-care leaders and economists he has spoken with find near unanimity that whatever reform is passed will markedly accelerate national health-care spending rather than restrain it, and it will do little or nothing to improve quality or change health-care's dysfunctional delivery system.”

Instead, Dr. Flier asserted that “currently proposed federal legislation would undermine any potential for real innovation in insurance and the provision of care by overregulating the health-care system in the service of special interests such as insurance companies, hospitals, professional organizations and pharmaceutical companies, rather than the patients who should be our primary concern.” Current reform also threatens physicians and health care entities’ “capacity to innovate and develop new therapies.”

From his own firsthand experience, Dr. Flier has seen these results in Massachusetts, where although “insurance mandates similar to those proposed in the federal legislation succeeded in expanding coverage, they also increased total spending.” Accordingly, a new Commission in Massachusetts will have to be created in the future to reduce payments, which will “limit the dollars spent per patient for all of their care.”

With such “unclear and unspecified changes that would impact physician practices and compensation,” Dr. Flier concluded that “we should not be making public policy in such a crucial area by keeping the electorate ignorant of the actual road ahead.”

University of Minnesota to Adopt University Wide Interest Policies

According to the Minneapolis Star Ledger a draft policy requiring faculty, researchers and staff to file annual reports disclosing any financial interests that overlap with their work was passed by a committee at the University of Minnesota last week.  The university has already proposed a wide-ranging conflict of interest policy that bans controversial practices such as ghostwriting in research publications, promotional talks including non medical faculty and gifts from industry including text books.

According to the press release, a committee within the university will review the reports to determine if a conflict exists. If the policy is adopted, any faculty and staff who do not comply could face termination. The university wide policy was proposed after a medical school task force crafted a similar policy in 2008. Some version of the policy is expected to be adopted within 90 days.

University of Minnesota’s general counsel, Mark Rotenberg, said “the university needs to balance the need to collaborate on new products and technologies with industry in a way that does not create a conflict of interest and an erosion of the public's trust.”

According to sources at the University this has several departments outside of medicine fuming.   Engineering, computer science and others include world renowned faculty that draw large honorarium for industry consulting and talks.   The departments are concerned these bans will be unnecessary restrictions and limit new faculty recruitment.

Rotenberg however also noted that while many medical schools across the country have tightened regulations governing these relationships, university-wide policies are fairly rare.

Health Care Reform: CMS Report House Bill Costs Seniors

On Thursday the US Senate will begin debate on the Health Care Reform bill that has yet to be released.  In the mean time a report released this past week from the Centers of Medicare and Medicaid (CMS) noted that the House health care reform bill will slash more than $500 billion from future Medicare spending -- one of the biggest sources of funding for President Obama's proposed overhaul of the nation's health-care system -- would sharply reduce benefits for some senior citizens and could jeopardize access to care for millions of others.

For example, the bill reduces Medicare payments to hospitals and nursing homes over time based on productivity targets. If such hospitals cannot meet the productivity targets, many of the hospitals would withdraw from Medicare.

According to the Washington Post, the report found that “Medicare cuts contained in the health package approved by the House on Nov. 7 are likely to prove so costly to hospitals and nursing homes that they could stop taking Medicare altogether.”

The report specifically indicated that “Congress could intervene to avoid such an outcome, but "so doing would likely result in significantly smaller actual savings" than is currently projected.

Additionally, “the report questions whether the country's network of doctors and hospitals would be able to cope with the effects of a reform package expected to add more than 30 million people to the ranks of the insured, many of them through Medicaid, the public health program for the poor.” For example, with a greater increased demand for services, “providers are likely to charge higher fees or take patients with better-paying private insurance over Medicaid recipients, "exacerbating existing access problems" in that program, according to the report from Richard S. Foster.

If the $500 billion cut stays, then the Medicare program could live another five years without cash infusions until 2022 but, Republicans still argue that the report forecasts an increase in total health-care spending of more than $289 billion.

An analysis of the report done by Politico found that by 2019, health costs would rise to 21.1 percent of GDP compared to 20.8 under current law, according to an actuarial report prepared by the Centers for Medicare and Medicaid Services.

A public plan would cost 4 percent more than private plans because its utilization rules would not be as strict as the private sector (pg. 6).

About 3 million more people would get coverage through their employers. The report figures that about 15 million more people would gain employer coverage but 12 million would lose it because it would be cheaper for their employers to let them buy coverage through the public insurance exchange; 18 million people will remain uninsured and choose to pay the fines for not carrying insurance rather than buy coverage (pg. 7).

By 2014, Medicare Advantage enrollment would drop 64 percent from 13.2 million to 4.7 million because of less generous benefit packages (pg. 9).

The report also notes how preventive measures such as more screenings and preventive care combined with a longer lifespan generally will increase costs.

From the sound of this report, it looks like Americans, especially seniors, will not get to keep the health insurance coverage they have today, at least not all of it.

Three Felonies a Day: How the Feds Target the Innocent

Sensationalist headlines discussing large settlements from cases involving medical device and pharmaceutical companies usually leave the meaningful details out. As a result, the majority of the public is left confused about the legal process and the impact these cases have on physicians, the health care industry, and most importantly, patients.

Fortunately, a recently published book titled, Three Felonies A Day: How the Feds Target the Innocent, written by defense attorney Harvey A. Silvergate, and forwarded by civil liberties attorney Alan M. Dershowitz explains how the government has participated in these “Unhealthy Pursuits of Medical Device and Drug Companies.” In discussing the problems with today’s system, Mr. Silvergate highlights a few cases where the “dictates of the Food, Drug, and Cosmetics Act (FDCA),” unnecessarily harmed doctors, and the patients they served.

United States Catheter and Instrument, Inc.

The first case discussed involved Lee Leichter, who worked for United States Catheter and Instrument, Inc. (USCI). Mr. Leichter was charged with 392 separate federal felony counts “based on a chain of events involving the testing and sale of medical devices for clearing clogged arteries.”

The heart catheter devices manufactured by USCI, were “Class III” medical devices, meaning that they were the most inherently risky and hence the most heavily regulated. Before marketing Class III medical devices such as USCI’s catheters, a device manufacturer has to submit to the FDA a “pre-market approval” (PMA) application.

If there are any substantial changes, during or after marketing, that affect the safety and effectiveness of the device, the manufacturer is required to obtain approval for such modifications by filing a PMA Supplement. In this way, the FDA can follow a product’s progress through development, and decide whether such changes affect the products approval enough to be pulled off the market for public safety.

The information in the PMA application must assure the FDA that the device is both “safe” and “effective.” By law however, the FDA must recognize that no drug or medical device can be 100 percent safe or always effective. Rather, the agency authorizes a manufacturer to sell a regulated device after weighing several factors:

1)    An assessment of the category of patients for whom the device is intended

2)    The conditions under which the device will be used and the instructions for use recommended by the manufacturer in the label contained in the packaging; and

3)    A weighing of the probable benefits to health from use of the device, against any probable risk of injury or illness from such use.

When weighing such factors in Mr. Leichter’s case, the FDA (in conjunction with the Department of Justice) charged that the company had failed to seek PMA Supplement approval for modifications to the design and manufacture of certain catheters, in response to problems experienced by doctors, before distributing the modified catheters to the market. Such problems, the government argued, needed to be reported even if the problems occurred only when the device was misused.

USCI believed that the company did not need to report such information to the FDA because the problems were caused by the doctors’ misuse of the products, rather than by design or manufacturing flaws in the products. For example, doctors failed to follow instructions of use properly and they failed to properly prepare the device before procedures as required by the instructions.

When the issue of failing to report such problems was brought before the court at trial, the judge used his own unique instructions. He told the jury to decide whether (1) the defendants were guilty of “concealing or failing to report material facts” that should have been reported to the FDA, and (2) whether the company had “knowingly and willfully, with an intent to defraud, failed to submit” required information to the FDA.

Under FDA’s own regulatory language, the jurors “should have judged the statute governing the marketing of medical devices in the context of the risk-reward calculus for all medical devices, rather than absolute terms.” The fact that there were some mishaps and some injuries from use of the product was part of this calculation.

It was the smoke and mirrors produced by prosecutors in the Leichter case that tried to confuse the judge and jury that “safety” meant “freedom from danger or risks,” and “effective” meant “having a definite or desired effect.”

When the case was reviewed by the Federal Court of Appeals for the First Circuit, the court noted this confusion, and asserted that the trial judge failed to explain all of the highly technical regulations adequately. As a result, the Court reversed all of the convictions for Mr. Leichter and the company because “no one could say with any reasonable degree of certainty what their crimes were.”  Between 1990, when the jury investigation started, it took eleven years, in 2001, for Mr. Leichter to clear his name.

TAP Pharmaceuticals

The TAP case began when a person inside the company, a “whistleblower,” claimed to have knowledge that the company was “ripping of the government.”

Improper payments—secret or disguised—from pharmaceutical companies to induce a physician, group practice, or hospital to use that manufacturer’s product in lieu of a competitor’s is the most common form of illegal promotion. This practice is particularly harmful when a particular product that is neither more nor less effective than a competing drug, but is significantly more expensive, is illegally promoted.

In charging TAP, prosecutors believed that the companies salesmen were giving free samples to “induce prescribing physicians to order free samples of the prostate cancer drug Lupon instead of its “essentially identical,” cheaper competitor, Zoladex.” In doing so, prosecutors claimed the company hoped to “receive money from Medicare and others for the prescription of that free product.” The government essentially called such free samples bribes, and a form of fraud.

The case also attacked the educational grants given by the drug company and the salesmen “to pay for attendance at seminars and conferences of professional organizations, to purchase medical equipment, to pay for education for the physician’s office staff.”

In the end, federal prosecutors lost on all their claims that TAP’s discounting sales and promotional practices constituted illegal kickbacks and bribes to induce physicians and hospitals to use TAP products.

Swiss drug maker Serono SA

Another concern of federal prosecutors is the prescription of drugs for “off-label” uses, something that a doctor is legally allowed to do, even when a regulatory agency has not approved the drug for that off-label condition. What is illegal however, is when a drug manufacturer or its sales representatives seek to induce physicians to prescribe a pharmaceutical for off-label uses (e.g. bribe).

Prosecutors in the Serono case claimed that company sales reps promoted off-label uses of the drug by “launching a campaign to ‘redefine AIDS wasting’ in order to create a market for Serostim by expanding the disease state for which Serostim could be prescribed as a treatment.”

The claim was problematic because Serostim had already been approved by the FDA for the AIDS wasting syndrome. So the government essentially tried to change the FDA regulation by prosecuting the company, instead of changing the label through FDA administrative procedures.

While the company agreed to pay $740 million fine to settle the charge that it paid kickbacks to physicians to induce them to prescribe Serostim, charges against two former vice presidents of the company were dismissed.

Conclusion

As summarized above, these three cases are just a glimpse into the bystanders whose lives were altered from investigations that “had no evidence that the administration of the company’s drug for off-label uses had in fact harmed anyone,” according to U.S. attorney Michael J. Sullivan.

Instead, these stories give us a look into the billions of dollars health care fraud settlements have obtained. American must ask however, whether such financial gains are worth the impact these cases have on preventing companies from developing and disseminating new therapies.

Many of the devices and drugs created by these companies were on the cutting edge of technology. Although such products and the procedures or treatments associated with them came with some risks to the patient, doctors believe in most cases that using these products—that have been tested and approved—have less severe risks than more invasive options, or doing nothing at all.

Moreover, the investment these companies make into such products are significant, and when patents expire, competitors quickly produce generics that take away much of the rewards such companies took risks for in the first place.

As a result, there should be no question—legal or ethical—if physicians might want to stick with a known formulation by a known and trusted manufacturer, rather than take a chance with an unknown generic manufacture.  Such decisions are supposed to be made by medical professionals who have evaluated the comparative merits of the products and who know their patients.

Additionally, there should be no issue with the use of free samples when such a practice is widespread in the pharmaceutical industry and medical profession because it helps doctors become familiar with the drug’s efficacy in their own medical practices, which ultimately leads to better treatment for patients. Equally as important and widespread are educational functions, which keep physicians up to date on new breakthroughs and treatments.

Ultimately, the DOJ’s nonchalant attitude toward “creative” prosecutions based on extensions and interpretations of vague statues and regulations needs to be changed. Physicians rely on their and their colleagues’ judgments and experiences as to the uses, including off-label uses, of pharmaceuticals all the time. “Virtually any physician would admit, perhaps even boast that he relies to a great extent on his own judgment and experience, as well as that of others expressed in medical journals, in deciding what to prescribe for various conditions. The manufacturer’s FDA-approved label is just one source of guidance; experience is another.”

If you have some time this weekend or the coming holidays, you should add this book to your holiday wish list.  Also there is a webcast of the author discussing the book on his website www.harveysilverglate.com

 

 

FDA Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media – Webcast and Testimony

During the next two days we will be hearing from experts around the country at the FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media, a number of good ideas will be presented.

There are a number of websites with links to testimony covering the event and the live webcast. 

One twitter site has live tweets (thanks to the reader who set me straight on this)

http://www.fdasm.com/

For a live video and audio feed of the hearing:

http://www.capitolconnection.net/capcon/fda/111209/FDAlive.htm#

FDA Agenda, Speakers, and Other Documents.

We have highlighted several testimonies.  As more testimonies come in we will provide links to them.

Arnold Friede

Speaking from over 35 years of food and drug law experience, Arnold I. Friede, a former Associate Chief Counsel in the FDA’s Office of Chief Counsel, offered a refreshing look at a regulatory pathway to advance public health by enabling robust marketing by regulated companies, and at the same time coordinating effective enforcement against health fraud on the Internet.

In his written testimony before the panel, Mr. Friede noted three primary interpretive impediments to FDA policy on the use of Social Media and the Internet. First, where and how risk information must be disclosed in advertising and promotion. Second, whether and when statements should be attributed to a medical product “sponsor” for purposes of the prohibition on “off-label” promotion. Finally, mandatory reporting requirements whenever a sponsor becomes “aware of” information suggesting that an adverse event may have been caused (or “contributed to”) by one of the sponsor’s products.

During his first day of testimony Mr. Friede offered a framework of how to approach these hurdles. He noted that FDA’s position to requrie instantaneous and contemporaneous disclosure of all risk information whenever a product name and any mention of any product attribute appear together in a sponsored medium, is problematic.  Mr. Friede explained that such a requirement is not “always possible or even desireable.”

Instead, he offered a an alternative: FDA should focus on context in determining the adequacy of risk disclosur. Such a notion Mr. Friede reminded the panel, is consistent with the approach FDA has taken to “bookending” of help seeking and reminder advertisements, where FDA has said that it will look to overall context, including perceptual similarity, in deciding if the two in proximity to each other should be considered a single “advertisement” subject to risk disclosure requirements. 

The focus on context would also be consistent with the statutory definition of “labeling”, which looks at overall “context” in determining when an item “accompanies” a product so that it is deemed, by law, to be “labeling”.

Another argument for the use of context are existing regulations that apply to direct-to-consumer (DTC) television advertising, where FDA acknowledges that contemporaneously available complete risk information, even if not physically or technologically connected in any way to the advertising in question, can nevertheless satisfy statutory risk disclosure requirements. This so called “adquate provision” should be used for Social Media, Mr. Friede asserts.  

Moving onto the topic of off-label promotion, Mr Friede acknowledged that not all “off-label” statements by anyone on an Internet web site or Social Media site operated or sponsored by a pharmaceutical or medical device manufacturer are inappropriate. In fact, to suggest so would seriously hurt the “information marketplace” where many consumers and patients have learned to depend on social media.

The liability of having such statements on sponsored sites could hurt companies, “such as Sidewiki, where information can be posted to, and effectively become part of,  a web site without any involvement whatsoever by the manufacturer and can thereafter be viewed by anyone with the appropriate Internet tools.”

When a manufacturer has done nothing more than provide a a facility whereby someone posts an unsolicited off-label comment, there should be no liability. Sponsored sites should however, have the ability to direct or control the content of the posting, or delete it or disclaim it. In fact, the “FDA, has acknowledged in a variety of circumstances that a manufacturer is not automatically liable for third party behavior that it does not dictate or have the ability to control.” 

Likewise in the context of its Guidance on Continuing Medical Education (CME), FDA has implicitly acknowledged that agency law principles of “direction and control” are relevant in determining if “off-label” CME will be imputed to a manufacturer who provides funding for a CME program. With regards to social media, Mr. Friede believes FDA should also direct and control “the content of a communication, for when a company that maintains or sponsors a Social Media or other Internet web site is legally responsible for "off-label" communications posted there.” 

Consequently, Mr. Frieder also recommends the FDA adopt the Federal Trade Commission (FTC) policy where “by third party bloggers are imputed to a product “sponsor” only if there are indicia of direction and control by the sponsor over the content of the communication.  Otherwise, the product sponsor will not be liable for the endorsement.” 

On his second day of testimony, Mr. Frieder spoke about the Adverse Event Reporting System (AERS or AE). He explained how “the concern about AE reporting stems from FDA rules that mandate reporting whenever a sponsor becomes “aware of” information of sufficient specificity showing that the sponsor’s product may have caused, or contributed to, an AE.”

In addressing this concern, he asserted that there is no need to worry about such requirements for two reasons. First, because “some of this information is likely duplicative of what has already been reported.” Second, “because some is undoubtedly cumulative in the sense that the incidence and severity of the AE is already fully and completely addressed in the product’s labeling and the additional information does not add meaningfully to what we know about the product’s risks and how to manage them.” 

He also appeased such a concern by noting that “companies probably spend 99% of the time in safety monitoring in finding and reporting the very last AE.” In addition, the FDA also spent $2.7 million on study these reports. As a result, Mr. Frieder simply asked that the agency to wait until the system has been “empirically validated as a meaningful basis for regulatory decision making,” before worrying about how social media impacts such reporting.  

Coalition for Healthcare Communications

Also presenting at the meeting was John Kamp, Executive Director of the Coalition for Healthcare Communication. Mr. Kamp’s  remarks were also on behalf of The American Association of Advertising Agencies (AAAA).

Mr. Kamp propsed that FDA’s policy should foster increased, more reliable health information on the Internet. Such an increase is necessary because professionals consumers, companies and social media sites are relying on industry partnerships to support provision of trusted health information.

These health care providers, through industry support, are using social media to have conversations online to improve patient care, and provide a venue for persons to have group discussions regarding treatments and emotional needs.

Since industry information and financial support are so vital to different forms of social media, Mr. Kamp called for transparent industry involvement. Sites should include places for consumers and professionals to find FDA regulated information (FRI), and use new intra-industry and inter-agency efforts to fight widespread Web healthcare inaccuracy and fraud.

Organizations like the Coalition and AAAA recognize the power and public health promise of social websites, and would use these new efforts to show consumers and professionals that industry promotion on these sites is overseen by FDA.

Accordingly, Mr. Kamp noted that when dealing with potential problems, not all of the blame should be placed on industry, especially when many of the social media sites are in control by the individual user. New efforts must control the information being shared. There should not be a feeling of big brother where there is already control by FDA regulations for company sites and advertising.

Concluding his presentation, Mr. Kamp asserted that the best way of addressing these issues is to enable and strengthen the incredible information and conversations on the Internet these social media allow through industry support and collaboration that has clear guidance for users. These standards should be applied on a national level, and regulatory policies should be supported by linking techniques to make  FDA regulated details more accessible to  professionals, patients and care givers.