Life Science Compliance Update

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22 posts from July 2011

July 26, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Do your job!” he said to applause.


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

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

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

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

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

ACRE 2011 Slides (Underline and Green)

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

July 25, 2011

CVS Caremark Under Pressure to Dissolve from Their “Friends”

CVS Caremark is coming under increasing pressure from consumer groups and shareholders to split up, at the same time that federal and state regulators are looking into accusations of anticompetitive behavior by the merged company, according to a recent article from the New York Times.

The four-year-old merger of the drugstore chain and the pharmacy benefit manager is the subject of an investigation by the Federal Trade Commission (FTC) and a multistate inquiry by the attorneys general of 24 states, according to earlier disclosures by CVS Caremark.

Carolyn Castel, a company spokeswoman, asserted that the company is “cooperating fully” with the inquiries and “remains confident that their business practices and service offerings are being conducted in compliance with antitrust laws.”

Interestingly, the leadership team of CVS Caremark team includes an unexpected individual, Troyen A. Brennan, M.D., M.P.H., who serves as the Executive Vice President and Chief Medical Officer. What is somewhat surprising about his membership on this team is that Brennan is the author of the community catalyst paper, which called for the end of academic relationships with industry.  It is somewhat paradoxical that Brennan could be calling for an end of physician-academic relationships with industry, while at the same time sitting in an extremely influential position within the very industry he seeks to place severe restrictions on.

In fact, Brennan recently emphasized CVS Caremark’s emphasis on working with health care practitioners to improve non-adherence to prescription medication.  This kind of industry-physician collaboration seems at odd with the 2006 paper Brennan pen that called for the end of such relationships.

Consequently, last week, five consumer groups wrote a letter to Jon Leibowitz, FTC chairman, claiming “there is strong evidence that the CVS Caremark merger has harmed consumers.” The groups, which called for breaking up the $27 billion merger, also accused the company of using confidential patient information from Caremark, which manages prescription benefits for health plans, to steer consumers to CVS pharmacies.

“The company’s practices effectively gave CVS an unfair advantage over other pharmacies, reducing competition and limiting consumer choice, according to the letter, which was signed by Community Catalyst, Consumer Federation of America, Consumers Union, the National Legislative Association on Prescription Drug Prices and U.S. Pirg.”

Additionally, the consumer groups charged the merged company had engaged in unfair practices that favored company-owned pharmacies, including sharing information Caremark obtained in processing prescriptions to help solicit non-CVS customers to fill their prescriptions at CVS drugstores.

Sharon Anglin Treat, a Democratic legislator in the Maine House of Representatives, explained that the situation is one in which a pharmacy benefit manager, which manages prescription benefits, is “using the information to steer people to their own pharmacies.”  Tate, who is also the executive director of the National Legislative Association on Prescription Drug Prices, a consumer group that signed the letter, notted that, “it really does appear that CVS has been unable to avoid a very significant conflict of interest.”

Mark N. Cooper, the director for research at the Consumer Federation of America, one of the groups that signed the letter, said that the “merger was a mistake” and that FTC should review the original grounds — including efficiencies, cost savings and consumer benefit — for the merger and determine whether the union had been justified.

The Times noted that, “CVS Caremark denied accusations that it had engaged in improper business practices, saying the charges were “false, unfounded and misleading.” It defended its privacy protections, saying it maintained a firewall to ensure that Caremark and CVS did not share “certain competitively sensitive information,” Ms. Castel also told the Times that the company did not improperly steer patients to CVS pharmacies, and “there are no plans to split up the company.”

CVS Caremark says the merger is helping its customers by reducing costs and improving health outcomes. “The innovative products we have introduced into the marketplace since the merger are gaining traction,” Ms. Castel said, and will “enhance shareholder value.”

The company also said it “places a high priority on protecting the privacy of its customers and plan members.” Ms. Castel said CVS Caremark used patient data internally for “appropriate purposes,” like identifying potentially adverse drug reactions.

In addition, some investors say the sharing of patient information is central to any claims by CVS Caremark that the combination of the drugstore chain and pharmacy benefit manager can better serve patients by coordinating information and reducing costs

July 22, 2011

American Society of Plastic Surgeons Adopts Balanced Collaboration Policy

Plastic surgery 
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world.  Representing more than 7,000 physician members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery.  ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States. 

Consequently, the ASPS recently adopted new guidelines designed to promote ethical interactions between its member physicians and the medical industry.   

The new guidelines, published in a document entitled, “Considerations for Interactions with Industry,” provide detailed recommendations for appropriate collaborations between individual plastic surgeons and pharmaceutical, biotechnology, or medical device companies in an effort to prevent industry support from biasing a physician’s professional activities or judgments. 

In announcing the new recommendations, ASPS President Phillip Haeck, MD, recognized that, “collaborations between physicians and industry are necessary as they enhance the practice of medicine.” Accordingly, Dr. Haeck noted that, “following these new guidelines will help to ensure that interactions with industry will be for the benefit of patients and remain consistent with AdvaMed and PhRMA Industry guidelines.” 

The document details standards related to the acceptance of gifts, educational products, meals and entertainment from industry; protocols for seeking industry support for educational programs; consulting arrangements; promotional speaking -- and the regulations associated with each. 

Dr. Haeck further noted that, “the new guidelines are voluntary and serve as a recommendation for behavior that ASPS members should adhere to.”  He asserted that, ASPS “members’ primary duty is to act in the best interest of patients and it’s vital they be independent and industry’s ability to influence professional judgements be limited.” 

ASPS Recommended Guidelines 

In the preamble of the guidelines, ASPS recognized that, “pharmaceutical, biotechnology, and medical device companies (“Industry”) develop, produce, market, or distribute drugs, devices, therapies, or services used to diagnose, treat, monitor, manage, and alleviate health conditions that allow individuals to live longer and healthier lives.”  Moreover, ASPS acknowledged that, “industry can help serve the interests of patients through beneficial collaborations with Members.” 

Additionally, the preamble recognizes that, “ethical relationships between ASPS members and industry are necessary to ensure public confidence in the objectivity of ASPS members which is critical for them to carry out their mission of serving patients.”  Accordingly, ASPS adopted the Considerations for Interactions with Industry to reinforce the core principles that help ASPS maintain actual and perceived independence, and ensure ethical relationships between our members and industry. 

Basis of Interactions with Industry 

ASPS asserted that interactions and relationships with industry are already regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Accordingly, they noted that such interactions should be focused on receiving information about products, technologies and services that allow us to serve the best interests of ASPS Members’ patients. 

Receiving Items of Value from Industry 

The guidelines state that ASPS members should not accept the following from Industry: 

  • Items that do not advance treatment education, including pens, note pads, mugs, and similar “reminder” items with company or product logos.
  • Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs, or tickets to a sporting event) Payments in cash or cash equivalents (such as gift certificates) should not be accepted either directly or indirectly, except as compensation for bona fide services.  

It is appropriate to receive a reasonable quantity of product samples for patient use for purposes of product education, evaluation, and demonstration. 

Receiving Educational Items from Industry 

ASPS members, where permitted by law, may accept from Industry items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to Members outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is appropriate.  Items designed primarily for the education of patients or healthcare professionals should not be accepted by Members on more than an occasional basis. 

Entertainment and Recreation 

ASPS Members should not accept, any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or

vacation trips. Such entertainment or recreational benefits should not be accepted, regardless of (1) the value of the items, (2) whether Industry engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. 

Informational Discussions and Meals with Industry 

The guidelines recognize that “informational discussions with Industry representatives and others speaking on behalf of a company provide ASPS Members with valuable scientific and clinical information about products, technologies, treatments, and services that may lead to improved patient care. 

Accordingly, the guidelines state that In order to facilitate these “important scientific and medical discussions, while respecting Members’ abilities to manage their schedules and provide patient care, Industry representatives may take the opportunity to present information at mealtimes. 

Additionally, ASPS noted that, “in connection with such presentations or discussions, it is appropriate for occasional meals to be offered by Industry as a business courtesy to Members as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals

  • Are modest
  • Are not part of an entertainment or recreational event, and
  • Are provided in a manner conducive to informational communication.

ASPS members cannot bring a spouse or other guest in a meal accompanying an

informational presentation made by or on behalf of an Industry representative is not appropriate.  In addition, accepting “take-out” meals or meals to be eaten without an Industry representative being present (such as “dine & dash” programs) is not appropriate.

Continuing Medical Education

The ASPS recommendations acknowledge that continuing medical education (CME) “helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular product.”

Accordingly, ASPS recommends that any financial support from Industry should be given to the CME provider (ASPS), which, in turn, can use the money to reduce the overall CME registration fee for all participants. ASPS noted that, “industry should respect the independent judgment of the ASPS as the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME activity.”

In addition, this guideline recognizes that, “when companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the CME provider in accordance with their guidelines.” As a result, ASPS noted that,  “industry should not be asked to provide any advice or guidance to the CME provider or Members involved in the CME program regarding the content or faculty for a particular CME program funded by Industry.”

Additionally, ASPS recommends that Members should not accept direct financial support from Industry for the costs of travel, lodging, or other personal expenses related to attending CME programs. Similarly, funding should not be accepted by Members to compensate for the time spent by Members attending the CME program.

It is appropriate for Members serving as faculty at ASPS educational programs to receive honorarium and financial support for travel, lodging, and related expenses from ASPS (as the CME Provider) in accordance with its written policies governing faculty reimbursement. Members serving as ASPS faculty should not accept additional financial support directly from Industry for their role as faculty

Industry Support for ASPS Meetings

The guidelines also recognized that educational conferences or professional meetings of ASPS or its Members can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. A conference or meeting is any activity, held at an appropriate location, where:

  •  The gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and
  • The main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented.

Similar to CME, any financial support should be given to the conference’s sponsor (ASPS), which, in turn, can use the money to reduce the overall conference registration fee for all attendees.

Financial support should not be accepted by Members for the costs of travel, lodging, or other personal expenses of Members attending third-party scientific or educational conferences or professional meetings. Similarly, funding should not be accepted by Members to compensate for the time spent attending the conference or meeting.

Serving as a Consultant for Industry

The ASPS guidelines recognize that “consulting arrangements with Industry allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas, and the needs of patients. Industry uses this advice to inform their efforts to ensure that the products they produce and market are meeting the needs of patients.”

Accordingly, the guidelines assert that it is appropriate for Members who provide advisory services to be offered reasonable compensation based on fair market value for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services.

However, ASPS Members should not participate in recreational or entertainment events in conjunction with these meetings and it is not appropriate to accept honoraria or travel or lodging expenses for spouses or guests of Members attending Industry-sponsored consultant meetings.  Modest meals or receptions may be appropriate during Industry-sponsored meetings with healthcare professional consultants, but token consulting or advisory arrangements should not be used to justify compensating Members for their time or their travel, lodging, and other out-of-pocket expenses.

Serving as a Promotional Speaker for Industry

ASPS guidelines also recognize that members participate in Industry-sponsored speaker programs “in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of Industry products.”  The guidelines note that Member engaged by a company to participate in such external promotional programs should be selected based on their medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Industry and Members should not enter speaking arrangements as inducements or rewards for prescribing or using a particular medicine or product.

 Speaker training is an essential activity because the FDA holds speakers accountable for presentations made on behalf of Industry. It is appropriate for Members who participate in programs intended to train speakers for Industry-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be accepted by Members when

 The participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications (including prohibition of promoting “off label”)

  • This training will result in the participants providing a valuable service to the company; and
  • The participants meet the general criteria for bona fide consulting arrangements.

Any compensation or reimbursement for a speaking arrangement should be reasonable and based on fair market value. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. ASPS also recognized that speaker programs are distinct from CME programs, and speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.


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