Life Science Compliance Update

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25 posts from June 2011

June 30, 2011

FDA: First Year Report on Bad Ad Program

Bad Ad Program 

Last year, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.” Under current law, prescription drug marketing must be truthful and balanced. To enforce this, FDA staff routinely checks ads on television or in magazines and medical journals, but “it is tough to track closed-door sales tactics such as a chat inside a doctor's office or a sales presentation over a meal.”

The agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research (CDER), administered the FDA-sponsored educational outreach effort. According to FDA’s press release, the program is being rolled out in three phases:

- Phase 1, DDMAC will engage health care providers at specifically-selected medical conventions and partner with specific medical societies to distribute educational materials; (Brochure) and

- Phases 2 and 3 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.

Thomas Abrams, director of DDMAC, asserted that, “The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”  The effort was primarily designed to inform health care providers about what constitutes misleading promotion —from both a legal and clinical perspective — and provide them an easy process for reporting suspected violations to FDA. 

After its first year, the FDA released an annual report of the statistics and data it had collected regarding the Bad Ad program. Some of the key highlights from the program’s activities during its first year include:

  • FDA Commissioner Margaret Hamburg, M.D., kicked off the Bad Ad Program with a letter to more than 33,000 physicians, announcing FDA’s efforts to “collaborate with health care professionals to address misleading promotion, wherever it occurs.” 
  • Concurrently, FDA released a press announcement marking the program’s launch. 
  • DDMAC created an informational video about Bad Ad, citing examples of untruthful and misleading promotions. And how to report suspected violations.
  • DDMAC created a Bad Ad brochure designed to educate HCPs about prescription drug promotion.
  • Throughout the year, DDMAC representatives staffed exhibits at 15 medical conferences across the country, speaking with HCPs about how they can help stop misleading drug promotion.  DDMAC representatives also conducted extended presentations at two U.S. teaching hospitals.
  • On April 28, 2011, FDA hosted a live Bad Ad webinar for medical and pharmacy professionals with more than 400 attendees. 

All of these efforts were intended to raise awareness in the medical community that HCPs can play a valuable role in helping FDA prevent untruthful and misleading prescription drug promotion. Additionally, of the 328 reports of potentially untruthful or misleading promotion:

-          188 were submitted by HCPs

-          116 were submitted by consumers, and

-          24 were submitted by representatives of regulated industry 

FDA noted that prior to the Bad Ad launch, the agency received an average of about 104 reports per year.  As a result, FDA asserted that this number and diversity of reports received after the Bad Ad program was launched indicates to the agency “that the program was successful in raising awareness of untruthful and misleading promotion.” However, such an assertion may be premature because FDA did not indicate what outcomes were achieved by these reports (i.e. warning letters, legal action, etc.). In addition:

-          Of the 188 reports submitted by HCPs, 87 were identified for a comprehensive review, demonstrating a relatively strong level of knowledge in the medical community about what constitutes misleading promotion. 

-          Of the 116 reports submitted by consumers, 24 were identified for a comprehensive review. 

-          Of the 24 reports submitted by industry, 14 were identified for a comprehensive review. 

FDA asserted that many of the other reports helped to focus FDA’s surveillance efforts in other ways or were referred to other FDA Centers (i.e., potentially misleading ads for dietary supplements sent to the Center for Food, potentially misleading ads for devices sent to the Center for Devices and Radiological health, etc.). 

In addition, the agency also recognized that despite criticism of the programs use of anonymous reporting, only 4% of all reports of potentially untruthful or misleading promotion during the first year of the Bad Ad program were submitted anonymously. What is problematic about the number of reports however is that a recent survey showed that only 30% felt absolutely confident that they were qualified to determine what constitutes inappropriate advertising that could be deemed false, misleading, or off-label.

Consequently, FDA noted that this data indicated success because it has heightened the sense of awareness of misleading promotion among HCPs throughout the health care community and it has created a useful deterrent for drug promoters who might run afoul of regulation absent of such messaging.

Accordingly, FDA noted that the Bad Ad program expects to continue and expand in coming years. Expansion includes the development of a web-based continuing education program.  Aligned with the program’s primary goal of educating HCPs, FDA will focus additional efforts on students and early career HCPs.  FDA will also be actively seeking opportunities to collaborate with the nation’s medical, pharmacy, and nursing schools to enhance student education and will continue conducting presentations at U.S. teaching hospitals.  Future activities will also include continued attendance of DDMAC representatives at trade shows across the country, including those of the:

  • American Academy of Physician Assistants
  • American Academy of Nurse Practitioners
  • American Academy of Family Physicians
  • American Academy of Pediatrics
  • American College of Gastroenterology
  • American Society of Health System Pharmacists

Highlights of Bad Ad Enforcement Actions

  • Derma-Smoothe Warning Letter issued 12/03/2010. The first action resulting from a Bad Ad complaint was on a particularly egregious website promoting a product for use in a vulnerable population.
  • Infergen Warning Letter issued 03/21/2011.  A promotional piece was mailed directly to a clinical pharmacist who was concerned that the information overstated the effectiveness of the promoted product.
  • Savella Notice of Violation issued 04/28/2011.  This Bad Ad complaint is representative of the types of promotion we hope to curtail in field-based settings.  This regulatory action was supported by a signed statement from a physician outlining violative oral statements that were similar to statements made directly to DDMAC reviewers during the same time period.
  • Atelvia Notice of Violation issued 05/05/2011.  This video footage of a violative product detail that occurred in a physician’s office was posted to YouTube.com.  Of note, is that this violation was reported to Bad Ad when the posted video had less than 20 views.  As a result of this early reporting, DDMAC was able to prevent the violative video from being viewed by a much larger audience.
  • Vyvanse Warning Letter issued 05/06/2011.  This Bad Ad report came from an astute nurse, who noticed that a promotional piece that was likely viewed everyday by the office’s HCPs was misleading in that it was designed to hide the important risk information from plain view.

Conclusion

While the goals of this program are important and reasonable, as the FDA noted in their letter to doctors, “responsible promotions can provide doctors with valuable information about new therapies.” DDMAC must continue to ensure that physicians are trained properly and make careful considerations when evaluating advertisements that many patients and physicians depend on.

Physicians are already busy with patients, conducting research and tests, and dealing with day-to-day activities. As the emphasis in health care access and delivery shifts to better outcomes and coordinated care, doctors may have less and less time to deal with evaluating manufacture rep visits. Accordingly, we should be encouraging doctors to improve patient care first, before worrying about drug reps who are already heavily regulated.

Top Clinical Trial Websites

Cliniical trial websites 
A recent post on the blog, Clinical Researchers, provided a wealth of information for health care providers and stakeholders interested in all kinds of research. Specifically, the post provided a reference of 40 useful sites for readers to learn more about clinical trials, as well as sites that include helpful case studies and journals and publications that report results from different areas of clinical research.  The sites are listed below. 

Clinical Trials

Find out more about clinical trials. Learn where the trials are being held, and their purposes. A great reference to different trials happening now, or scheduled to happen in the future.

  1. ClinicalTrials.gov: The government puts together information on clinical research trials, including instructions, background and more.
  2. Vaxnet.com: A network of clinical trials and research centered around vaccines. Find out more about the latest research in vaccinations.
  3. CenterWatch: Resources and information on clinical trials and clinical research. A great, global reference.
  4. ClinicalTrials.com: Learn more about different trials available, and what is available. Solid information on clinical research.
  5. Clinical Trials: Get information on research currently being conducting throughout the U.S. from the National Institute of Mental Health.
  6. Clinical Connection: Learn about different clinical trials, and the research going on right now.
  7. Clinical Trials at MD Anderson Cancer Center: Insight into different cancer clinical trials.
  8. WHO ICTRP: The World Health Organization includes a look at clinical trials and registration.
  9. Clinical Trials at the Mayo Clinic: Find out what clinical research is happening at one of the most prestigious institutions.
  10. IFPMA Clinical Trials Portal: Learn more about clinical research, and what sorts of trials are being conduct. Get results as well.
  11. Clinical Trials: Duke Health offers information on clinical trials, results and other information that is great to reference.

Some of the best reference materials can be case studies. If you are interested in seeing what has been done in the past, and if you are interested in seeing how different strategies hold up in real world situations, you can visit these clinical case study sites.

  1. Clinical Case Studies: Great information, research and reference from Medical Gross Anatomy at the University of Michigan.
  2. Clinical Cases and Images: Use this site as a reference for your own clinical research.
  3. Case Studies: The Virtual Health Care Team at the University of Missouri-Columbia has a great look at different cases.
  4. Case Studies in Science: Great clinical research studies and results that can help you in your own clinical research.
  5. Cases: IPLAB.net offers helpful case studies that you can use for reference in your own efforts.
  6. Clinical Grand Rounds: Reference these studies from the NIH Clinical Center. Great resources from a respected and reliable source.
  7. Case Studies by Subject: A great compilation of clinical research case studies. Plenty to keep you busy with ideas for your own clinical research.
  8. CME Cases: Medscape offers you access to great clinical reference points.
  9. Clinical Decisions: This reference can help you learn to make better decisions in your clinical settings and research.
  10. Challenging Cases: Great, interactive studies that can be used for reference in clinical research.

Journals and Publications Dealing with Clinical Research

Find out more about the latest breakthroughs in clinical research. Get ideas, join the debate, and keep up with the literature. Helpful resources and references.

  1. Clinical Trials: This is the Journal of the Society for Clinical Trials. It’s a peer-reviewed journal full of good reference information.
  2. Clinical Chemistry: Interesting articles and discussions on clinical research related to chemistry.
  3. PubMed: Get access to a number of publications that include clinical research. One of the best reference sites on the Internet.
  4. First Clinical: Offers access to different clinical research pubs. A number of options to choose from.
  5. Journal Watch: Articles from medical journals around the world, including those related to clinical research.
  6. Publications about Clinical Research and Trials: Find out what you need to know about referencing clinical research.
  7. Applied Clinical Trials Online: A look at applied clinical trials and research.
  8. Journal of Clinical Research & Bioethics: Access to information about clinical research, as well as great references on ethics.
  9. Open Access Journal of Clinical Trials: Great journal offering access to articles about clinical trials and research results.
  10. JP-CCR: The Journal of Pre-Clinical and Clinical Research is a great reference for researchers around the world.
  11. Clinical Medicine & Research: Insightful articles, information, and highlights from current issues. Great reference for what’s the latest in clinical research.

Clinical Research Ethics, Policies and Procedures

Whenever you are involved in clinical research, it is important to understand best practices and have a good idea of ethics. You should be able to learn more about policies and procedures, and learn about what makes for solid, respectable research.

  1. Clinical Trials Networks Best Practices: Find out more about best practices in clinical research, getting an idea of patient management, as well as ethics and procedures.
  2. Clinical Research Site Training: Get information and training related to running clinical trials and performing research properly.
  3. Clinical Trial Ethics: A great resource to help you understand what’s ethical in clinical research.
  4. Center for Clinical Research Ethics: This center is a partnership between the Washington University Institute of Clinical and Translational Sciences and the Department of Health Care Ethics at St. Louis University in Missouri. A great reference and resource for anyone interested in clinical research.
  5. Clinical Research Policy Analysis and Coordination: A great resource from the Office of Biotechnology Activities at the National Institutes of Health.
  6. Clinical Research Ethics Key Function Committee: Find out more about quality assessment of IRB organizations, as well as collaboration ethics and more. A great reference and useful resource.
  7. Joint Study Committee on Clinical Research Ethics: Find out more about clinical research ethics, best practices and policies.
  8. Research Ethics: Great references and resources related to research, including clinical research.

June 29, 2011

Nature Medicine: Encouraging New Models of Industry Physician Collaboration

ECA_042 
A recent commentary from Nature Medicine explained how recent “concerns about conflicts of interest have driven a wedge between academia and the pharmaceutical and devices industries.” 

The article, written by three researchers from the University of California, San Francisco, noted that, “Although elevated concern for bias is justified, particularly when academics may affect drug sales, partnerships between industry and academia are essential to achieve the full promise of health improvement from the public investment in biomedical research.” 

Instead of creating further separation between academia and industry, the authors asserted that, “new models for such partnerships should be encouraged” and policies should be created to ensure that these relationships continue to develop. 

“Conflicts of Interest”

Over the past several years, a few rare cases of “conflicts of interest” have occurred involving undisclosed financial ties between faculty at academic medical centers and industry, some with multimillion-dollar payouts to prominent experts.  These cases “have led to pillorying of the academics and, by association, their home institutions, putting a chill on ties between academia and industry.”

The chill has come from strict policies and rules prohibiting physician-industry relationships.  The problem with such changes is that “not all such ties are nefarious, and much value may be lost if collaboration is discouraged.”

There is no doubt that conflicts of interest have important consequences, particularly when bias could affect the approval or use of therapeutics.  For example, when a “lecturer recommends a treatment from a manufacturer with which he or she has undisclosed ties, a breach of trust has occurred. Similarly, conflicts may subvert the objectivity of guideline development.  Accordingly, the authors noted “the need for greater transparency and control of potential conflicts.” 

While increasing transparency is certainly appropriate to ensure that academic-industry relationships are viewed favorably, academic institutions have responded to revelations of conflicts of interest by setting policies that are more explicit. These policies include requiring full public disclosure of all financial ties, limiting campus access of pharmaceutical company employees and setting strict limits on the types of ties and amounts of compensation. However, in the heat of apprehension and sometimes embarrassment, “such policies may have unintended negative consequences, driving a wedge between academia and industry.”

For example, the need to declare travel reimbursement as a conflict of interest for attendance at an industry-sponsored professional meeting (the current policy at our institution) “seems an excessive regulation that stigmatizes useful and mutually beneficial relationships.” However, there is no place for promotional junkets, gifts and expensive entertainment, and personal compensation should never be the primary motivation for academics to work with industry.

Alternatively, the authors noted that, “relationships with industry that are not financial in nature but valuable to the academic investigator’s career—for example, deals involving access to industry-owned technology, use of databases or leadership of clinical trials—may not require disclosures in the current academic environment but probably should, as these are potentially significant sources of bias.” 

Consequently, policies at academic medical centers have created an “atmosphere of inquisition that has forced distance, causing many faculty to avoid contacts with industry in fear of being called out as corrupt.” And the press has continued to fuel this concern by publishing sensationalist articles discussing many prominent experts “for reasons other than glorious discoveries.” 

Physician-Industry Relationships 

Critics of industry cannot deny the importance of academic-industry collaboration in improving health.  “Academic researchers judge their relationships with industry to be very meaningful, and nonfinancial relationships may be as important as financial ones.” 

Physician-industry relationships include many examples of discoveries made and patented by universities, now licensed by pharmaceutical and device companies, and. several of these are blockbuster drugs with major health benefits and financial returns to academia. The discovery and development of imatinib— a highly effective and widely used cancer drug—is a compelling example. 

A scientist from industry, Nicholas Lydon, partnered with an academic investigator, Brian Druker, to identify novel compounds to inhibit a tyrosine kinase inhibitor implicated in chronic myelogenous leukemia (CML). The identification and early clinical testing of imatinib was recognized by their selection, along with Charles Sawyers, as Lasker-DeBakey Clinical Medical Research Award recipients in 2009. Imatinib is now recommended as first-line therapy for many patients with CML and has been credited with substantial improvements in quality of life. 

Although “Academic medical centers are a natural engine for biomedical discovery … academics also tend to be inefficient and distractible, and may not be focused on a mission of improving health.” Moreover, “academia is not charged or organized to bring therapies to the public … and faculty members often lack the knowledge and interest to identify discoveries that could form the basis for new therapies and to shepherd an agent forward through development.”  In addition, access is limited to funding and infrastructure to support the practical steps of translation. 

The role that academia and industry have in improving health through biomedical sciences is critical, considering the rate of new drug approvals continues to decrease.  Even with a profound increase in the funding of medical research over the last 20 years, the rate of new drug approvals has not increased. “Given that translation is generally dependent on passing the baton to industry, discouraging free discourse between academia and industry is likely to result in an even slower rate of new drug discovery.”

While some have suggested eliminating intellectual property concerns from academic discoveries to improve translational research, the authors asserted two reasons why this notion is problematic. 

“First, given the low yield of candidate drugs in development, the inability to control intellectual property would become a major disincentive for companies to invest the money required to take a potential drug through clinical testing to market, recently estimated to average $171 million; when failures are considered, the cost of development is estimated at $1.2 billion for a drug that ultimately is approved by the US Food and Drug Administration.” 

“Second, without free transfer of knowledge, skill sets and reagents between academia and industry, the energy of activation to move some discoveries into further development may be too great.” 

Conclusion  

The biomedical industry and academic investigators share the same goal of improving health and patient outcomes. For example, preclinical research, early-phase clinical trials, and incentives to produce reliable evidence and report it accurately are important to both industry and academics. However, several incidents in the past have impaired public trust in academic medical centers, which is troublesome because trust is a chief predictor of successful university-industry partnerships. 

To restore the trust in academic-industry relationships and collaboration, academic medical centers have begun to fully disclose and carefully manage research collaborations. These relationships should be disclosed “not as scarlet letters but as medals of pride.” Those capitalizing most on academic-industry collaborations are more likely to improve public health through new discoveries, a major accomplishment and the truest measure of success. 

Consequently, “new partnerships will need to reduce barriers, improve trust, preserve scientific freedom and deliver adequate returns for both parties: a tall order that will require careful planning and management.” 

Ultimately, the public benefits of discoveries made in academia are realized only when they have been translated into use through industry. Unlike academia, “industry is designed to effectively and efficiently produce and distribute therapies. Thus, academia and industry each have an essential role in improving health through biomedical discoveries.” Accordingly, we should be searching for ways to promote strategic research interactions between academia and industry, not setting policies that prevent them.

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