Policy and Medicine

Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the Beholder

 
Advertising is a crucial component of pharmaceutical industry marketing around the world and plays an important role in educating physicians and other prescribers about new drugs.  However, there is concern that physician exposure to advertisements increases prescribing of advertised drugs and critics have raised concerns about the quality of the information presented in these physician-directed advertisements, including a focus on relative, not absolute, benefit and poor referencing.

The Food and Drug Administration (FDA) through its Division of Drug Marketing, Advertising and Communications (DDMAC), regulates physician-directed pharmaceutical advertising in the United States.  However, ensuring advertisement adherence is challenging and FDA resources dedicated to this task are limited. DDMAC’s fiscal year 2008 budget of $9 million is dwarfed by the pharmaceutical industry’s $58 billion marketing budget.

"The limited resources of DDMAC are a major barrier to successful regulation of the pharmaceutical industry's multi-billion dollar marketing budget," said lead author Dr. Deborah Korenstein of Mount Sinai School of Medicine.

While the FDA can require that companies change or remove non-adherent advertisements, given DDMAC’s size and the volume of marketing materials it regulates, it would be unreasonable to expect each individual pharmaceutical advertisement to be reviewed.

Acknowledging this regulatory challenge, the FDA has recently asked physicians to report non-adherent or misleading advertisements through its ‘‘Bad Ad’’ program, explaining that ‘‘With your valuable assistance, FDA can be more effective in limiting the number of misleading promotional messages directed to health care professionals.”

Despite the recent efforts of this program to identify grossly misleading advertisements, there has been no systematic assessment of the adherence of physician-directed advertisements to FDA regulations in the last 20 years and none to current standards, which were last updated in 2001.

As a result, authors from a recent study published in PLoS sought to determine adherence rates to the 2001 FDA guidelines among current print advertisements directed at physicians within biomedical journals and to describe content important for safe prescribing.

The study found that from a small sample that “nearly half of physician-directed advertisements fail to adhere to at least one FDA guideline regulating content.”

Study Design and Methods

The authors performed a cross-sectional analysis of November 2008 advertisements for prescription pharmaceuticals in top biomedical journals published in issues over a single month and hypothesized that rates of non-adherence to FDA guidelines would be high and that many advertisements would not present complete information important for safe prescribing.  The authors excluded advertisements for devices, over the counter medications, and disease awareness.

The authors also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. The authors’ advertisement assessment tool included items based on FDA Prescription Drug Advertising Guidelines. FDA guidelines describe 21 unique items used to classify advertisements as ‘‘false, lacking in fair balance, or otherwise misleading.” The authors categorized advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. Advertisements were considered: 

• Adherent if they contained none of the 21 features used by FDA to classify advertisements as misleading,
• Non-adherent if they contained one or more of the features used by FDA to classify advertisements as misleading, and
• Possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete. 

Prior to initiating the reviews, the authors examined advertisements which had received FDA warning letters in 2008 (of which none was in our sample) to determine the approach of FDA to the regulations. All advertisements were reviewed between January and December of 2009. 

All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. The final sample included 89 unique advertisements for 82 products.  Thirty-six manufacturers advertised products in our sample, with a median of 3 advertisements (range 1–21) and 2 unique advertisements (range 1–7) per company. 

Adherence to FDA guidelines 

Among the 83 unique full advertisements: 

• 15 (18.1%) were fully adherent to FDA guidelines,
• 41 (49.4%) were non-adherent to at least 1 FDA mandated item, and
• 27 (32.5%) were possibly nonadherent due to incomplete information

Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. 

There were statistically significant differences in non-adherence rates to FDA guidelines by item content. Nine (10.8%) advertisements were non-adherent to at least 1 FDA item focused on safety, whereas 18 (21.7%) advertisements were non-adherent to at least 1 FDA item focused on efficacy, 16 (19.3%) to at least 1 FDA item focused on references, and 23 (27.7%) to at least 1 FDA item focused on other issues. 

Safe Prescribing Content                                          

Many advertised drugs in the sample presented potential risks to patients, with 31 (37.3%) containing black box warnings and 33 (39.8%) placing patients at risk for death or serious morbidity. However, when evaluating advertisement content important for safe prescribing, the study found that many physician-directed advertisements lacked important information. The majority (57.8%) did not quantify serious risks and 24 (28.9%) failed to present appropriate numbers to quantify benefits. Thirty-six advertisements (43.4%) referenced ‘‘data on file’’ and 40 (48.2%) lacked verifiable references, due either to an absence of any references or to the presence of references only to ‘‘data on file’’ or the product’s package insert. 

Discussion 

Based on the above findings, the authors noted that, “physician-directed advertisements contained bias with regard to a wide variety of issues across content areas addressed by FDA guidance.”  The authors also asserted that, “advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks, more than one quarter failing to quantify benefits and nearly half providing no verifiable references.” Accordingly, the authors maintained that their study provides a context to inform the FDA’s new ‘‘bad ad’’ program. 

However, the authors recognized that, despite the high rates of FDA non-adherence, “the mean number of biased features in each advertisement was low and most advertisements we reviewed satisfied the majority of FDA guidelines despite a general absence of content important for safe prescribing.” 

Nevertheless, the authors noted that although FDA guidelines are detailed, they do not target many of the ad features most important for providing prescribers with useful information. For instance, FDA emphasizes avoiding frankly false information and balancing efficacy and safety information but does little to encourage the presentation of useful and accurate information. An advertisement containing no specific efficacy claim, no quantification of drug safety and no verifiable references would adhere fully to FDA guidelines, despite presenting no practical information for clinicians. 

Consequently, the authors maintained that, “physicians should ensure that their prescribing is informed by the clinical literature and not by marketing materials.”  This means more interaction and more CME.  They added that, if “FDA is truly committed to improving prescribing and protecting the health of the public it should demand that content important for safe and effective prescribing be consistently presented in physician-directed advertisements.” 

In addition, the authors recommended that FDA update and simplify its guidelines for physician advertisements to facilitate the review process. They noted that, updated FDA guidelines should be straightforward and objective, and should include requirements that physician advertisements present clear risk quantification, absolute benefit information, description of the appropriate population to receive the drug, and verifiable references, either to the peer-reviewed published literature or to studies registered within federally-sponsored internet sites such as ClinicalTrials.gov in the case of unpublished data. 

The authors noted that these new guidelines might be applicable only to physician-directed advertisements, with separate guidance for DTC material, with greater focus on safety issues. Additionally, they asserted that new objective requirements would serve to enhance prescribing and public health by improving the quality, accuracy and transparency of advertisements, simplify at least part of the FDA review process, and facilitate physician participation in reporting ‘‘bad’’ advertisements. 

Study Limitations 

The authors noted that a major challenge of the study was performing advertisement evaluations given the subjectivity of the current FDA guidelines. For instance, the FDA describes that advertisements are misleading if they use ‘‘a quote or paraphrase out of context to convey a false or misleading idea’’ or ‘‘headline, subheadline, or pictoral or other graphic matter in a way that is misleading’’, without providing explicit definitions. Another limitation was the subjectivity of determinations of adherence. 

The study was also limited because the sample of advertisements was from a single month in 2008, so they cannot comment on trends in advertisement characteristics over time. The authors also focused on high-impact biomedical journals publishing original research, excluding lower-impact and more narrowly focused publications and those publishing clinical reviews, which may also be frequently read among clinicians. 

Conclusion 

In the end, the authors noted that FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information. This change is necessary according to the authors because current FDA guidelines are subjective and challenging to enforce and do not emphasize transparency and the inclusion of basic information relevant to prescribing. 

But as John Kamp, Executive Director of the Coalition for Healthcare Communication noted, no one knows for sure what's compliant until the FDA says so, most often in a FDA warning letter.  This serves no one including doctors, patients, FDA and industry.  Everyone loses under the current standards because the rules prevent good communication and subject the industry to unwarranted criticism from the press, politicians and medical professionals and uneven, unpredictable enforcement from FDA.  Accordingly, Kamp argued that, “better regulations would enable better informed patients and doctors, thus better patient care.”

 

Continuing Education Reform: Are We Throwing the Baby Out With the Bathwater?

Recent evaluations of professional societies and accredited continuing medical education (CME) providers have “further questioned the legitimacy of industry physicians and biomedical scientists providing scientific information or participating in educational program planning.” These evaluations have “deemed that such participation is in violation of ACCME guidelines,” according to a recent article in Clinical Pharmacology & Therapeutics titled Continuing Education Reform: Are We Throwing the Baby Out With the Bathwater?

Specifically, the article looked at the practices of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), who underwent a CME review in 2009. As a result of that review, the Society will no longer be in a position to provide CME and continuing pharmacy education (CPE) after the 2010 Annual Meeting. Accordingly, the article goes on to explain why such a decision was made, and how it affects the overall understanding of continuing education (CE).

 

Continuing Education

 

As we have written many times, CE or CME “is the process by which health professionals keep current with the latest knowledge and advances in health care.” Without CME, doctors and patients would continue to suffer from old and new diseases and symptoms, and be forced to choose outdated treatments, devices and medicines to help with their disorders and illnesses. Over the past few decades, the collaboration of industry and physicians who provide CME has resulted in numerous breakthroughs in patient care. Despite the obvious benefits gained from these relationships, the claim that “there are major flaws in the way CE is conducted, financed, regulated, and evaluated” raises serious concerns.

 

Such a claim is misguided, and to suggest that the numerous providers, researchers, physicians and accredited CME providers are “not optimally prepared to provide the highest quality of care to patients or to meet public expectations for quality and safety” is problematic.

 

As the authors trace the history of CME, they note its importance for addressing the issue of improperly trained practitioners (prior to World War I), and its use for helping well-trained physicians keep current with advancing knowledge (after World War II). It was shortly after this time that the pharmaceutical industry became involved with CME, and “professional product representatives were an important resource for providing physicians with new information.” Consequently, the present “construct of using CME to improve performance began in the late 1970s, when CME was suggested to be a continuous process based in practice settings.”

 

Over the years, criticism has gained momentum about the interactions industry has with CME, and as a result, a process of regulation “began largely as a method for the American Medical Association and state medical societies to monitor the pharmaceutical industry’s influence on physician education.” Another result from this regulation was that “CME increasingly became provided by a combination of specialty societies, state and local medical organizations, and pharmaceutical companies,” and not just one singular source.

 

In the arena of continuing pharmacy education (CPE), the landscape is a bit different, with “approximately 43% of CE programs for pharmacists receiving commercial support.” Such “high levels of support” have resulted in some to assert that CPE “are dependent on industry to assist them in covering administrative, educational, and non-educational expenses.” As a result, the “most recent iteration of these regulations from the Accreditation Council for Pharmacy Education assert that “the provider must plan all CPE activities independent of commercial interest.”

 

The result of such regulations have “systematically stripped CE programs of content that is necessary to ensure education and performance improvement of practitioners.” Consequently, CE programs have also suffered from these kinds of regulations because their goals have “been grossly misplaced such that the passive participation of professionals who must demonstrate evidence of CE to maintain certification/licensure is fostered more than the actual delivery of information amenable to translation into working knowledge.”

 

Industry Support

 

Criticisms that industry support biases or conflicts CME programs are unwarranted because the current CME “system has integrated sources of financial support, accreditation mechanisms, and CE methods in such a way that it is nearly impossible to analyze any of them independently.” In other words, critics cannot just point the fingers at industry because “CE funding comes from numerous sources.”

 

For example, “health professionals themselves, employers, commercial entities, and, to a much smaller extent, the government” all fund CE programs. “In 2007, physicians paid 42% ($1.05 billion) of the total $2.54 billion spent on CME, which resulted in approximately $1,400 per year of out-of-pocket costs per physician.” Such investments prove how “many organizations and employers see CE as an important investment in staff development and thus provide financial support for at least a portion of CE costs.”

 

What critics and opponents are not happy with is the reality of a glooming economy over the past year or two, and an economic crisis that saw rapidly “shrinking resources and increasing costs associated with both providing and obtaining CE credits.” As a result, while the need for CME only continues to grow as more patients fill our hospitals and more diseases are found, “continuing professional education within the health-care arena is quickly becoming a non-sustainable venture.” So then, as the authors ask: what could happen if commercial funding was totally withdrawn and no subsidies were provided by other sources?

 

On average, physicians would have to invest approximately $3,500 annually to continue to attend the same types of CME activities that are currently offered, with similar figures for nurses, pharmacists, etc. Of course these numbers don’t account for travel, lodging, and other associated expenses.

 

Potential for Conflict

 

Just because there is a “potential for conflict” does not mean there are conflicts within industry funded CME. Although countless efforts to develop safeguards meant to ensure that CME providers are free from conflicts of interest have been developed, “widespread skepticism remains about the intentions of entities that provide CME.”

 

This kind of worrying is misguided because CME providers need to “appropriately support the real costs (e.g., travel and lodging expenses, modest honoraria to compensate for effort in developing content of CE presentation) associated with the development of unbiased, high-quality CE.” Supporting these legitimate and legal costs is essential for medical education and pharmaceutical companies to “be able to retain the services of true experts capable of providing current and credible educational programs.”

 

Accordingly, “the considerable progress that has been made in the past 5 years toward protecting educational content from potentially corrupting influences and promotional intent, rigid, industry-wide adherence to current guidelines can eliminate commercial bias.” Examples of these protections include detailed regulations from ACCME to “ensure that commercial well interests are kept separate from learning activities and course content.”

 

“The regulations require CME providers to disclose conflicts of interest and resolve relevant financial relationships with any commercial interest among those in a position to control CME content. They also require that CME providers give a balanced view of therapeutic options and, with respect to education in clinical pharmacology and therapeutics, that any description of off-label drug use be disclosed as such, and that use of proprietary (trade) names for drugs be avoided.” These example clearly demonstrate that eliminating industry support is and overreaction, and would only hurt patients and doctors.

 

Moreover, the process for CME providers to become accredited also eliminates the potential for bias and conflict significantly because companies must be evaluated annually by the accrediting body with associated annual fees that increase each year. This “institution of processes enables continuous quality improvement (most of which introduce progressively increasing allocation of resources to ensure compliance), and continuing contact between the accrediting body and providers.” In fact, both ACCME and the ACPE adopted new accreditation policies and standards that went into effect in January 2009. These new policies require that “no employees of a commercial interest can serve as planners or speakers in any accredited CME activities if the content relates to the “business lines and products of its employer.”

 

Conclusion

 

With a growing population, and increasing number of elderly and sick, America needs “a workforce of competent health professionals” that can use and learn the best health-care practices that effectively cure and prevent disease and promote well-being. In order to achieve this success, an “integrated system of CE is an important contributing factor to knowledge and performance deficiencies that occur at individual and systemic levels in the United States,” one which includes industry support.

 

Today, it’s not just about short-term profits because companies are “funding programs that have the most impact on physician performance.” This kind of industry support provides immense value for all involved. Any attempts to “ban industry contribution from CE in a manner that lacks insight and careful planning is sure to be detrimental to academic medicine and, ultimately, to patients.”

 

Ultimately, “discounting legitimate and high-quality science and not offering it as part of CE because it originates from industry is not necessarily a good plan with the potential of disastrous long-term consequences.

 

Likewise, to imply that scientist’s present biased material merely because they are employed by industry is inaccurate and ill thought out.” As the author of this article correctly asserts, “some of health care’s greatest contributions have originated from industry-sponsored science,” and to eliminate them now would be detrimental to patients.

Nature Editorial: Building Bridges not Barriers

An editorial in Nature used the recent appointment of William Chin as a perfect example of why “industry talent should be welcomed into academia, not seen as a corrupting influence.” In his new role as executive dean for research at Harvard Medical School, Dr. Chin, who was a top executive at the pharmaceutical giant Eli Lilly, will use his experience to create new treatments that will help numerous patients and help educate thousands of doctors.

 

Particularly interesting about Dr. Chin is that he spent 25 years at Harvard and its affiliated hospitals before moving to Eli Lilly 11 years ago. Critics believe that moving between companies and academia creates a conflict that taints the academic enterprise. Such opponents use the few examples that exist academic researchers' failed (mostly did not understand because of complex and different rules) to disclose their industry income.

 

As the editorial correctly asserts, such critics are misguided, and have “have conflated the very existence of industry–academia collaborations with failure to disclose those links.” In fact, critics need to be more mindful of the ongoing efforts of pharmaceutical companies, ACCME, and other health care providers who are constantly updating codes of ethics to increase transparency. As a result of such endeavors, those against industry and academic collaboration must abandon the view that “any and all cooperation between industry and academics is inherently suspect.”

 

Such a perspective “has created a poisonous atmosphere that has driven some young investigators to take up other careers,” which means less treatments and studies will be done that could help cure diseases today and in the future. One example the authors noted of such a stigmatized atmosphere took place last week, “Robert Califf, vice-chancellor for clinical research at Duke University Medical Center in Durham, North Carolina, told a conference at NIH headquarters in Bethesda, Maryland, about a recent meeting where the leaders of major academic medical centers were afraid to sit in the same room with industry leaders — with the goal of enhancing understanding and cooperation — for fear of an outcry either in Congress or the media.”

 

This kind of fear undermines the true value and significance of industry-academic collaboration: helping patients find new treatments through clinical studies, research and development. The reality is, appointments such as Dr. Chin’s and meetings with industry and academia “are not only appropriate, but essential for strengthening university research and for bridging the gap between lab and clinic — a gap that has bred a justifiable public impatience for cures at the advent of the century of biology.”

 

Like many physicians and researchers who have worked in/with industry and academia, Dr. Chin “has both a physician's appreciation of illness and an enviable scientific pedigree.” In fact, any significant, ethical or legal worries about his work with industry are nonexistent as “the chairs of the medical school's basic-science departments endorsed his hiring unanimously.”

 

The experience physicians like Dr. Chin gain allow researchers and physicians to find and connect laboratory discoveries to human disease. Discovering such connections gives doctors “the kind of management experience and insights into discovery and translation that can be got only in industry.” More importantly, having worked inside and with industry for so long, Dr. Chin and others with similar experience will use their knowledge “to inform their efforts to guide a medical school's scientific interactions with industry, in the drive to meet critical medical needs.”

 

To exclude people like Dr. Chin from working in academia would truly hurt patients, and physicians seeking highly needed training and experience with industry, and not just free lunches. In addition, Harvard is not the only example, as the University of California, San Francisco (UCSF), last year named Susan Desmond-Hellmann, previously president of product development at biotech company Genentech, as its chancellor. Using her experience over the past six months since taking over, UCSF announced last week “collaboration with Genentech aimed at generating small-molecule drug candidates, a step that has proven a major obstacle in drug discovery.”

 

Ultimately, critics “fail to understand that industry–academia cooperation is essential if we are to speed the medical progress that everyone seeks.” Evidence of this progress will likely be seen in the coming years from the works of Dr. Chin and Ms. Desmond-Hellmann.  Accordingly, critics of such collaboration must reevaluate their oppositions to consider what society will benefit from more: less interaction and experience with industry or more partnerships, such as those that have led to reducing heart disease, increasing cancer survival rates, and fighting HIV.

Editorial: The New Form of Abuse “Bias Information”

 

Recently an editorial was published on CME and Bias in a publication of the Joint Implant Surgery and Research Foundation.  The author Timothy McTighe PhD, Executive Director Joint Implant Surgery & Research Foundation has extended his permission to publish the editorial in it’s entirety:

There is a significant movement within the Continuing Medical Educational process to avoid any “bias information”. The recent Justice Department probe and Congressional investigations into the medical device industry has everyone (professional medical societies) running scared and overreacting. There is significant discussion of removing commercial funding from CME to eliminate any bias information. This, in my professional opinion, is an overreaction and will create more problems than it could possible solve.

Let’s look at a few facts that benefit our current system of education. The health Care Industry supports educational activities to the tune of about one billion dollars ($1,000,000,000) a year within the United States (WSJ’s blog on health & the business of health 11/15/09). Our first assumption should be this is good because dollars are necessary to put effective teaching and learning tools into place. Imagine for a moment that we did not have this money available to education. How much longer would it take to train and educate our health care professionals? How many patients would suffer longer than necessary if our information on drugs, devices and techniques slowed down?

Who would pick up the financial slack, or would there just be a lag in training and education. The concern should not be that there is an industry supporting education, (thank God we have an industry that can help support educational activities) but focus should be on the process of disclosure not on elimination of funding sources.

I think we should be challenging our industries to increase their funding not looking at demonizing them because they do. We have with the Accreditation Council for Continuing Medical Education (ACCME® www.accme.org) procedures in place that are effective and do an adequate job with-regard to disclosure of commercial funding. These guidelines and standards need to be living documents that undergo their own review and modifications on an incremental schedule. Drastic or radical change is rarely beneficial.

It is time we challenged the proponents against “Bias Information” to back down and acknowledge all bias information is not bad. This is a term that is being misused and I for one look towards my selection of medical professionals to have strong biases within their practice of medicine. I just want them to disclose their biases.

Lets look at this term: bias A term used to describe a tendency or preference towards a particular perspective, ideology or result.

The key is that bias information should be balanced with other or different perspective “Bias” information so there is a balance of information presented within the content of a given subject matter.

I suggest we all want to hear bias information because this information is often the result of training, experience and results. We don’t necessarily want to hear bias information that is based on monetary reward. However, often presentations and/or publications can have multiple biases within any given subject material. The proper way to inform individuals of “bias” information is through disclosure not by elimination. Only by disclosure can the audience determine if the quality of the information has true merit.

Just the fact of monetary interest does not suggest that the bias presentation does not have significant merit in its content, method and conclusions. The fact that there is a disclosure with regard to monetary benefit to the author should be considered and reviewed from that point of reference.

Example:
A Total Hip Arthroplasty performed with the selection of femoral component being fully porous coated like the “AML® Stem”, suggest that the use of this device demonstrates a preference towards a device with extensive porous coating over the length of a cylinder style stem. Over the years, some surgeons that have lectured on their use of this stem have disclosed the fact that they had a financial interest in the device. This disclosure in no way changed the fact of the long-term clinical results, benefits and/or potential problems related to this device.

In my 39 years in the orthopaedic health care field I have never known any surgeon that has switched his selection of product and/or technique as a result of hearing one bias talk.

I have found just the opposite. Surgeons, because of their own biases due to their training and experience, are reluctant to change. They only change as a result of significant information that addresses a problem or concern they have experienced.

I am bias towards bias information remaining as part of our educational activities and I also continue to indorse the use of commercial funding for CME activities and wish the industry would increase its budget for balanced CME activities.

This is a subject that should be important to all of us involved with health care. Please feel free to contact us with your thoughts, JISRF welcomes all points of view.

 

Boston Magazine Features Thomas Stossel, MD Co-Founder of Association of Clinical Researchers and Educators

Last week Boston Magazine feature the Association of Clinical Researchers and Educators in an article titled: Bitter Pills: Harvard Medical School is under fire from critics for its ties to Big Pharma. While the school tries to sort it all out, two professors battle for its soul.

They feature two Harvard Professors Marcia Angell-Relman, MD a former acting editor and chief at the New England Journal of Medicine who wants Harvard to adopt a policy of basically cutting all ties to drug makers.  In her words doctors "should have no financial interest in companies whose products they are evaluating," she argues. No stocks. No money for speaking or writing for industry forums. Drug reps shouldn't be allowed on campus.

In combating her cut all ties approach is Thomas Stossel, MD  a Harvard hematologist  and brother of libertarian journalist John Stossel. When Angell wrote an op-ed in the Globe several months ago, Stossel promptly penned a rebuttal in Forbes. When Stossel was invited to speak at a 2007 public panel on pharma influence issues, Angell blasted the choice, saying that to include him amounted to "standing the whole thing on its head." The two are "matter and antimatter," says one acquaintance. "Put them in the same room and the universe might explode."

In fact, Angell and Stossel have been in the same room at least once. At what should have been a fairly dry meeting of the American Society of Hematology in 2002, they gave dueling talks. Angell spoke in broad terms about the "dissolving" boundaries between academia and industry; the fact that medical meetings had become "a massive trade show...with free goodies." Stossel got more personal. "I don't need to feel morally superior to drug companies," he said. "Let's object to sanctimony." Today, in person, he's even more barbed: When it comes to research credentials, he says, "I don't even consider myself in the same universe as Marcia Angell."

Like Angell, Stossel is well aware that Harvard physicians pull in a lot of money from drug companies. Unlike Angell, he sees that as a good thing. Stossel traces improvement in Americans' health directly to breakthroughs funded by the pharmaceutical industry. Limit doctors' interactions with that industry, he argues, and you limit the power of the market to drive innovation.

Stossel also argues that the various controversies concerning Harvard and Big Pharma are overblown. The Pfizer rep with the cell phone wasn't plotting a corporate takedown of the student protesters; he was taking photos of a public event out of personal interest. The professor who didn't reveal his links to cholesterol drugs wasn't technically doing anything wrong; Harvard only now requires that doctors disclose conflicts of interest in all public venues, including classrooms. 

Stossel even refuses to condemn Biederman, the child psychiatrist, though he won't quite defend him, either. "The second you show me solid evidence that he should have backed off on some conclusion and didn't, he's toast," says Stossel. "But I bet what [the ongoing investigation] will find is that he didn't do anything wrong." Besides, he points out, having one bad apple among almost 10,000 faculty members is a risk worth taking. "We have to tolerate some bad behavior if we want progress," he says. 

This past summer Stossel cofounded the Association of Clinical Researchers and Educators (ACRE), an advocacy group for doctor/drug company partnerships. It has been ruthlessly parodied—most notably as Academics Craving Reimbursement for Everything—but it has also attracted some followers, even among Harvard med students, some of whom say they're uncomfortable with the protesters' divisive stance. Angell's acolytes are "a vocal minority," says Vijay Yanamadala, a med student who sides with Stossel. "We all agree on more than we disagree."

This article outlines that Harvard is currently revising their conflict of interest policies but will not be cutting back on all ties to industry as some like Angell-Relman would like.

Milwaukee Journal Sentinel: Doctors’ Presentations Help Patients

Today’s Milwaukee Journal Sentinel includes an editorial by Thomas Stossel, MD titled Doctor’s Presentations Helps Patients.   The editorial is in response to a series of articles and editorials in the newspaper critical of physician industry collaboration. 

Despite arguments to the contrary, doctors should be paid (Editorials, "Get off the gravy train," Oct. 7). They should be paid to bring specialized knowledge and experience to their patients. They also should be paid to bring specialized knowledge and experience to their colleagues.

Both exchanges create value and improve patient health. Hollow accusations should never obscure this fact. Promotional presentations by physicians should not be banned; they should be celebrated, for patients' sake.

Medicine, although rooted in science, is still an art. Ask any physician. And like every art, mastery comes from experience, not from simply reading manuals. Physicians are no different from other artists.

They need more than voluminous texts to practice their art. They need to hear from colleagues who have real-world experience with the medicines, devices and diagnostic tools that provide the foundation of modern medical care. Banning promotional presentations, where a presenter and the audience are allowed to engage in free and open dialogue about the benefits and risks of medical products, limits the opportunities to exchange these experiences.

The Journal Sentinel Editorial Board claims that when physicians promote products, "they risk their credibility with patients, risk clouding their judgment, risk overusing a treatment and risk driving up the cost of medicine." Everyone can agree that these risks do exist - nothing in life is without risk. The more important question, however, is whether these risks translate into harmful behaviors or consequences to patients? The resounding answer is no.

Polls repeatedly show that physician credibility is based on the care they provide, not the sources of information they access or how they educate their colleagues. Moreover, there is near consensus that non-financial factors such as gaining tenure, publishing and climbing the academic hierarchy are much more likely to prompt unethical behavior among academic physicians, who represent the majority of promotional speakers. These influences require much closer examination.

Of even greater importance, however, is how these activities affect patient care and patient health. Contrary to what critics would have us believe, under-treatment due to limitations in physician knowledge and experience is more detrimental to patient health and more likely to drive up costs.

Take diabetes as an example. The prevalence is skyrocketing, its causes and consequences are well understood and treatment options are many. Nonetheless, under-treatment is the rule, rather than the exception.

Although 71% of diabetic patients have high blood pressure, less than half get sufficient treatment to reach treatment targets. Failures such as these impart enormous costs on the quality of life, productivity and our nation's financial health. Severing physician interactions only contributes to these unnecessary costs.

The University of Wisconsin has a rich history of leadership in the medical field, and it has the opportunity to continue to lead. We hope it will foster a culture that values exchange of information and experience and puts patients back at their rightful place as the focus of medical policies.

Thomas P. Stossel, M.D., is ACRE co-founder and executive committee member, an American Cancer Society professor of medicine at Harvard Medical School, director of the Translational Medicine Division at Brigham & Women's Hospital. He is a founding scientist and director of Critical Biologics Corp. and a director of Velico Corp. He has contributed his views on physician-industry collaboration as a consultant to Merck, Pfizer, Amgen, Bristol-Myers Squibb and IMS Health.

AAFP Policies on Industry Relations Well Established - Well Managed

 

The American Academy of Family Physicians (AAFP) recently addressed some of the reports and opinion pieces that call on medical professionals to keep their distance from pharmaceutical companies in terms of industry support  in an editorial titled: AAFP Policies on Industry Relations Well Established, Well Managed

 

Particularly for Continuing Medical Education (CME) the AAFP specifically addressed:

 

· The so-called Macy Report (243-pages);

· A one page report from the AMA's Council on Ethical and Judicial Affairs;

· A special communication in the Journal of the American Medical Association; and

· A 360-page report from the Institute of Medicine addressing "conflicts of interest in medical research, education and practice," all lead members to ask, "What is the position of the AAFP regarding interactions with pharmaceutical companies?"

 

The problems with these reports and opinions, according to the AAFP, are that they “start from a basic premise that any engagement with the pharmaceutical industry is a conflict and must be eliminated.”

 

Contrary to this belief, the AAFP does not accept this "good money/bad money" hypothesis, and neither do most professional associations because “pharmaceutical and other companies have a significant role to play in informing health care professionals about the availability and proper use of medications and other therapies.”

 

As “the nation's first recognized accreditor of CME the AAFP has an established membership and renewal criteria requiring accredited CME. In addition, “the AAFP has consistently demonstrated its dedication to supporting physicians in their obligation to learn and advance scientific knowledge by engaging in lifelong learning.” Consequently, after years of such experience, the AAFP, as do many professional associations know that “that potential conflicts of interest and relations with industry can and must be managed consistently and effectively.

 

Particularly, the AAFP feels that physicians and physicians-in-training have the responsibility to be trained in the appropriate use of medicine and devices when “industry's products are based on solid medical science and best clinical practices.” In order to manage these responsibilities, the AAFP has many policies in place to manage relationships between CME providers and funders, beginning with full disclosure. In fact, the Academy makes sure to prevent any potential conflict between content and funding and to resolve conflicts as needed.

 

As a result of such prevention for over 60 years, a study performed by the Accreditation Council for Continuing Medical Education, or ACCME, in 2007 demonstrated that there is no difference in the level of bias between pharmaceutical company-funded CME and nonfunded CME, as long as the CME is accredited according to the ACCME Standards for Commercial Support. Ways that the AAFP ensures transparency include:

 

· Training staff members to make sure conflict of interest forms for leaders and CME are standardized, consistent and clearly understood;

 

· Enhancing its faculty database reporting and searching functionality to prepare for organization-level reporting of faculty with industry relationships;

 

· Involving faculty and staff members in the AAFP CME educational National Faculty Education Initiative program offered by the Alliance for CME and the Society for Academic CME that clarifies the differences between promotional and educational activities; and

 

· Pursuing ways of incorporating patient, practice and clinical data into the needs assessment and outcome evaluation of AAFP-produced CME.

 

The AAFP also noted that it “does receive funds from pharmaceutical companies for an array of activities, from advertising in its journals to exhibits at the annual Scientific Assembly to grants for CME." According to AAFP, since these two categories do not apply, the AAFP's level of pharmaceutical industry funding is 11 percent, which is well below the "acceptable threshold" of 25 percent proposed by the authors of the JAMA article.

 

With over 94,000 members, the Academy, along with many other professional associations have a high degree of confidence in the ability doctors to know right from wrong and to refuse to let their professional judgment be influenced by trivial contacts that some individuals and government types now seek to criminalize. Trusting your doctor to make the best decisions for patients means getting the continuing medical education they need to stay up to date with new breakthroughs, research, clinical studies, medicine and devices.

 

As many CME supporters continue to ask: if industry support is lost or reduced, who will pay for continuing medical education?

 

The AAFP asserts that physicians will have to pay for CME if industry funding is removed. This is already a problem because doctors who need the education and individual learners or organizations, such as the AAFP, already pay more than 50 percent of CME costs. Without CME support, the “burden will shift even more” causing “added stress on family physicians in clinical practice” who cannot financially afford such programs.

 

If CME is less available to practicing physicians and more funds are shifted to promotional spending, such as direct-to-consumer ads, patients and providers will both suffer. Doctors need CME to learn about the medicines and treatments they use with their patients so they are prepared to effectively diseases they will encounter.

 

By taking a leading step in supporting industry-physician relationships, the AAFP has given a clear message that patients should support: the need for CME is only growing with the discovery of new treatments and medicines, and family physicians consider commercial support of CME a vital part in delivering quality patient care.

University of Wisconsin CME: Dean Directs Sunshine on Journal Sentinel Attacks

In this weekend’s Milwaukee Journal Sentinel, Robert N. Golden, MD dean of the University of Wisconsin-Madison School of Medicine and Public Health and vice chancellor for medical affairs sets the record straight on their CME program. 

Contrary to articles written in that paper that attempt to discredit the program the University shows that after significant review the CME program at Wisconsin they are being wrongly attacked. 

 

Bellow is the editorial in its entirety.

Academic integrity in UW's CME program

 

The Milwaukee Journal Sentinel has lauded its recent coverage of the continuing medical education program at the University of Wisconsin School of Medicine and Public Health (Editorials, Aug. 16). These articles may mislead readers into viewing our CME program as little more than a paid mouthpiece for commercial interests that seek to manipulate physicians.

Nothing could be further from the truth.

An objective, unbiased assessment confirms that the academic integrity of the UW School of Medicine and Public Health's Office of Continuing Professional Development is not in question. The Accreditation Council for Continuing Medical Education, the nonpartisan organization that sets and monitors the standards for CME programs across the country, recently completed an independent inquiry, which was triggered by the Journal Sentinel's first article about our CME activities.

The ACCME wrote that we had "implemented a careful and deliberate process to ensure that large amounts of commercial support do not in any way compromise the integrity of the university or the integrity of the continuing medical education program."

This assessment of our Office of Continuing Professional Development is consistent with other recent evaluations of our approach to identifying and managing apparent conflicts of interest.

Within the past few years, we have received public praise from the Institute on Medicine as a Profession at Columbia University and have been cited in the Journal of the American Medical Association for our leadership in managing physician conflicts of interest.

We have never rested on our laurels in this vital area. We always note the constantly changing landscape of medical education and implement cutting-edge standards of excellence. In fact, just a few days after the publication of a Journal Sentinel editorial that criticized our CME programs, the American Association of Medical Colleges cited a UW-produced CME activity that provided a comprehensive primer on swine flu as an example of "best practice" in Web-based CME.

From the very beginning, we have supported U.S. Sen. Herb Kohl's Physician Sunshine Act, legislation that would grant the public unprecedented access to information on outside activities by physicians nationwide.

If Sen. Kohl's efforts are successful, patients will be able to make their own determinations as to whether their physician's activities present a problematic conflict of interest - rather than having the news media make that judgment for them.

The UW School of Medicine and Public Health is committed to setting the standard in Wisconsin, and through the country, in transparency. For more than a century, our medical education programs have reflected the ideals of the Wisconsin Idea - we embrace a heartfelt commitment to meet the needs of the people of our state.

Journal Sentinel readers would be better served by reporting that presents the complete picture and acknowledges our successes as well as the challenges that we and our peer institutions must address.

Medical Device Safety Act: Senate HELP Hearing

In light of a Senate Health Education Labor and Pensions (HELP) Committee hearing on the ill-advised Medical Device Safety Act of 2009 (MDSA), Forbes Magazine published an editorial by Richard Epstein, JD with the University of Chicago of the impact this bill will have on patients and industry.

MDSA, which is now moving forward in both the House and Senate, “will overrule, retroactively for all pending cases, the Supreme Court's 2008 decision in Riegel v. Medtronic, Inc., which held that a specific statutory provision in the 1976 Medical Device Act explicitly blocked (or "expressly pre-empted" in technical jargon) state courts from allowing personal injury litigation to attack any device's design or warnings to which the FDA has given, after exhaustive inspection, its pre-market approval.”

Under the 2009 MDSA, the same type of tort suits against medical device manufacturers would be allowed against drug manufacturers.

Unlike medicines, in which patents are created to produce approved drugs that have been clinically tested, device companies face a serious obstacle: the mistakes of “downstream actors whose actions take place outside of their control. For example, while all doctors have to do is write a prescription for drugs and medicine, while noting the side effects and risks, device companies must worry about whether a physician properly uses and installs a device.

Interestingly, testimony given at the Protecting Patients from Defective Medical Devices Hearing was heard from various sources on both sides.

 William H. Maisel, M.D., M.P.H., supported the MDSA, noting that it “will restore the consumer safeguards that are necessary to ensure the safety of medical devices for the millions of patients who enjoy their benefits.” On the other hand, Dr. Maisel did not consider how many patients will be harmed if this act passes because they will never receive the chance to try new breakthroughs and devices, such as the case of Michael G. Roman.  Mr. Roman testified against the bill because of his lifelong experience from a spinal device that has helped him, as well as helping thousands of others, control their pain, and other side effects.

Dr. Maisel instead talked about the unfortunate results of an implantable defibrillator manufactured by Medtronic Sprint Fidelis. One patient who had a tragic experience with such a device, Michael Mulvihill, testified as well.

Dr. Maisel also talked about how the FDA reported that they “couldn’t find” 22% of the required post-market medical device studies for the years 1998-2000, and acknowledged that some of the studies were never started.

Interestingly, Dr. Maisel also maintained that manufacturers have an inherent financial conflict of interest, which causes the timing and extent of the product recalls to be controversial. Contrary to his belief, there are no inherent conflicts. America was founded on entrepreneurship, and free enterprise. While device companies certainly have the right to keep profits in mind, we must remember what the purpose of these companies are: to make devices to save the lives of Americans. Moreover, it is the responsibility of the government to ensure device reliability and performance, and if the FDA cannot do it, business should not suffer, nor should patients. Lastly, although there have been some technical difficulties with devices, “implanted medical devices have enriched and extended the lives of countless people.”

Professor Thomas O. McGarity also supported the legislation by asserting that “manufacturers of defectively designed or manufactured products must compensate innocent persons who have been injured by such products.”

The professor also emphasized the importance of device companies to collect data on the harm-producing potential of their products and activities in order to prevent future harm. Consequently, this recommendation was to prevent future litigation that could hurt companies more than not using such data wisely.

Ultimately, while it is the duty of the FDA to inspect devices, they are almost entirely dependent upon information submitted by medical device manufacturers at the initial approval stage. Although critics believe that this information is easily manipulated by unscrupulous companies and their consultants, there is no evidence to support these claims. The FDA is a “resource-starved federal agency that does not have sufficient personnel to keep up with ongoing technological developments, and they are generally very reluctant to revisit previous decisions in light of new information.”

Finally, Peter Barton Hutt, Esq., spoke against the legislation by acknowledging that the act, which will install rigorous standards of pre-market approval (PMA devices), will only comprise less than one-half of one percent of all the medical devices authorized by FDA for marketing since 1976. He asserted that:

The half percent of devices that are the subject of full premarket review and approval, however, represent cutting edge science. They are the new life-saving and life-sustaining devices that are critical to the public health. They are the highest priority devices -- those for which we should do everything we can to encourage investment in research and development.

Mr. Hutt emphasized that America cannot let judges and juries throughout the country to impose requirements that are inconsistent with FDA determinations, because they will differ from one Court to another, causing “regulatory chaos.” Moreover, if judges and juries can summarily disregard FDA decisions on Class III PMA devices, why should physicians, hospitals, or anyone else pay attention to them? Ultimately, the bill undermines the credibility and authority of the country’s most important public health agency.

In addition, as Justice Breyer stated during the oral argument in Warner Lambert v. Kent, “who would you rather have make the decision that this [product] is, on balance, going to save people or, on balance, is going to hurt people? An expert agency, on one hand, or 12 people pulled randomly for a jury role, who see before them only the people whom the [product] hurt and don’t see the people who need the product] to cure them?”

Instead, the solution is not to farm FDA’s work out to juries, but rather, to provide adequate funding for FDA.

Furthermore, MDSA will force manufacturers to label their products with additional or unsubstantiated warnings, which can result not only in underutilization of valuable treatments but also by confusing both physicians and their patients.

The MDSA would also remove devices approved by the FDA and would severely deter innovation. Therefore, “it is important to focus not only those who may be harmed by approved devices, but also those who are helped by those same devices, and who might be harmed if the devices were removed from the market.”

In the end, the words of a male patient who has lived a better life everyday since the use of his medical device are well put:

To me, that choice is clear. We need safe products, we need innovation, and the best way to achieve both goals is not through litigation created by this bill, but through a strong, well funded FDA.

The MDSA is not a panacea or solution to problems that may or may not arise with medical devices. Passage of this bill will have a significant negative effect on medical device innovation. Instead of punishing medical device manufacturers, of which many are small companies, for operator errors, Congress should be looking at offering pharmaceutical companies the same level of protection from unnecessary lawsuits that the device industry now receives.

Obama Administration: Collins and Benjamin Clearly Understand the Value of Collaboration

This morning, a colleague opened up the August Medical Marketing and Media and reminded me about an editorial that I recently wrote entitled:  “As I see it: Don't knock new drugs until you try them.”

Often, we hear of the dangers surrounding industry physician collaboration—that drugs can be “over prescribed,” and that new drugs cost more than old ones, but there is another side to that story—new drugs save lives.

As I take my cholesterol medicine each day, I am comforted in knowing that the blockage in my arteries will be slowed down by reducing my cholesterol. Education on issues around hypertension and cholesterol may not sound “exciting,” even if these drugs prevent a cardiovascular event 20-30 years in the future, but saving lives in the long run is beneficial.

President Obama's selections of Francis Collins, M.D., as Director of the National Institutes of Health, and Regina Benjamin, M.D., as Surgeon General, suggest he is not the anti-industry protagonist that some make him out to be.

As Director of the Human Genome Project, Collins happily received help from hundreds of industry physicians and researchers who participated in that project either on loan or working from their own labs.

Benjamin, who practices in coastal Alabama, serving under privileged patients, was grateful for the assistance of drug and device companies as her clinic sought to recover from multiple hurricanes.

This past year, I was able to work closely with Benjamin on the Continuing Medical Education Report from the Council on Judicial and Ethical Affairs at the AMA. It was clear that she wanted what was best for patients and was not an anti-industry zealot.

We can all learn from both Collins and Benjamin that there is room for collaboration. The debate needs to move away from accusations and toward how can we all help each other. When that happens, all the finger-pointing on both sides will fade away.

Tom Sullivan is president of CME provider Rockpointe