Life Science Compliance Update

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21 posts from November 2010

November 30, 2010

Nader Backed Consumer Groups File FTC Complaint on Pharma Social Media

The explosion of social media and its use are widespread in almost every industry. Each day, companies in all industries make use of social media in a number of ways to reach consumers to transmit information, support or service. However, according to several consumer groups, “consumers now confront a sophisticated and largely stealth interactive medical marketing apparatus that has unleashed an arsenal of techniques designed to promote the use of specific brand drugs and influence consumers about treatments for health conditions.”

Accordingly, these consumer groups filed a lengthy and nasty complaint at the Federal Trade Commission (FTC) last week charging far ranging wrongs about pharmaceutical companies using social media and digital marketing to reach consumers. These groups sent copies of their complaints to Capitol Hill, FDA and the media. It appears from their strategy that the groups are trying to get FTC and Congress to limit all digital marketing by pharmaceutical companies.

The filing groups include the Center for Digital Democracy, Consumer, US PIRG and the World Privacy Forum.   In interesting coincidence, all of these organizations except for the World Privacy Forum are either started by consumer advocate Ralph Nader or their executives worked for Nader.

Although it asks FTC to investigate health media, including WebMD, HealthCentral, Google and AOL, it is aimed also at pharma and pharma marketers and is designed to smear virtually all use of digital media to target patients and professionals. It calls out several digital targeting techniques and asserts that they are unfair and deceptive, thus subject to FTC jurisdiction.

According to a press release posted on the Center for Digital Democracy’s website, the 144-page complaint called on FTC to investigate and remedy unfair and deceptive digital marketing and advertising practices that consumers and patients face as they seek health information and services online. The Center also published an executive summary, detailing the techniques identified in the complaint, which the consumer groups believe “threaten consumer privacy and potentially put the public health at risk.” A summary of some of the techniques are listed below.

  • Medical or Disease Condition Targeting, in which consumers or patients who express a particular health concern or interest are digitally profiled, tracked, and served ads and content based on the collection and analysis of such information. Among the many sensitive categories used in condition targeting are depression, COPD, diabetes, and asthma.


  • Social Media Monitoring, through which health and drug marketers engage in online surveillance of the conversations consumers and their networks of friends have about brand pharmaceuticals, medical conditions, and treatments. 


  • Behavioral Targeting, based on online data collection that analyzes a consumer’s Internet activities (which some call the “patient online journey”), in order to deliver marketing and advertising that zeros in on their medical concerns. Health and medical condition behavioral targeting is also used by online ad auction exchanges that sell access to a particular consumer in real-time for advertising purposes.


  • Viral and word-of-mouth “buzz” marketing campaigns sponsored by pharmaceutical companies or health-related marketers that seek to drive sales of specific prescription and over-the-counter drugs.


  • Unbranded online medical condition websites that appear to provide independent information on a particular disease or condition, but which are actually sponsored by a company whose products include treatment for the medical condition or problem addressed by the site.


  • Seemingly independent testimonials or advice online, including through social networks and online video channels or sites, that are in fact the result of sponsorship arrangements and financial support by a pharmaceutical or health marketing company.


  • Free online newsletters (WebMD alone offers nearly 50, covering such topics as arthritis, cancer, and weight control) and discount coupons ( offers “hundreds of coupons for prescription and non-prescription drugs”) are used to collect personal and other digital information from consumers, which is then used for profiling and targeting.


  • The practice of “e-Detailing,” where physicians, nurses, and other health professionals are targeted via sophisticated digital marketing techniques designed both to influence their decision-making regarding specific drug brands and closely monitor their behaviors. These practices, unknown to patients and consumers, can have a direct effect on their healthcare costs and methods of treatment.


  • The growing promotion for the use of electronic medical records by online health advertisers, such as Google and Microsoft, that also have a significant business in digital health marketing.


  • Neuromarketing practices, which draw on the techniques of neuroscience to develop advertising campaigns for medical products that make direct appeals to the consumer’s subconscious.

Claims About Social Media & Pharma

For the groups who filed the complaint, their main concern seems to be that the pharmaceutical industry is spending approximate $1 billion on social media marketing without any sort of rules or regulations regarding its use. As a result, these groups feel that the “online marketing health industry has presented to the FDA and the public a fairytale version of digital marketing, where all consumers become empowered “e-patients,” able to form powerful helping communities. While some might view this as a positive thing—patients seeking out health information and ways to treat their conditions—consumer groups believe that medical information provided online thus far “has been structured to engage in aggressive tactics that threaten privacy, raise questions about the fair presentation of independent information, and advance the sales of prescription drugs and over-the-counter products.”

For example, Jeff Chester, executive director of the Center for Digital Democracy (CDD), stated that “By using powerful digital marketing tools, pharmaceutical and online health information companies now have unprecedented abilities to take advantage of consumers.” He further noted that the marketing techniques described above “have been purposely designed to tap into the concerns and anxieties of individuals who are going online to seek health information.” CDD believes that this puts patients at risk for unfair, deceptive and non-transparent practices,  that will only increase as the country moves to digital medical records. To others, “Online health marketers are taking advantage of consumers at time when they are most vulnerable--worried about their own or a loved one's health.” For consumer groups, this trend undermines patient privacy.

Accordingly, the consumer groups want FTC to “protect consumers by ensuring that their health and medical data--including their use of online health services -- receives the highest form of privacy safeguards.” Ed Mierzwinski, director, Consumer Program, USPIRG said that “No consumer should be forced to confront a vast system of invisible and unaccountable online profiles that label them as someone who has or is concerned about a life threatening disease, serious medical problem, and then be ‘condition-targeted’ across the Internet and likely off-line as well.”


The consumer groups expect that in its forthcoming new privacy report, new and effective safeguards will be proposed by the FTC to protect consumer health and medical privacy online. Nevertheless, the four groups called on the FTC to undertake the following actions:

  • Examine and analyze the data collection and usage practices of pharmaceutical advertisers, in order to assess the extent of consumer information collected through websites, social networks, online video sites, and other interactive means.


  • Require companies engaged in digital marketing of health products to provide information on the kinds of online targeting techniques and methods they employ, especially behavioral advertising and retargeting.


  • Conduct a review of the privacy policy pages on health and pharmaceutical websites and services, including the leading social networks promoting health products.


  • Analyze how health-related social media marketing influences consumer behavior and attitudes concerning drug use and various medical conditions.


  • Investigate whether there is a violation of the FTC’s Endorsement guidelines (which have been extended to the Internet) when advice is given to patients or consumers from seemingly independent health bloggers who fail to disclose that they are paid or sponsored by pharmaceutical or other companies.


  • Investigate the use of “unbranded” sites funded by pharmaceutical companies, in order to assess whether such sites are structured and designed to support the promotion of specific drugs.


  • Conduct an inquiry on the use of neuromarketing-related techniques designed to influence or measure subconscious responses.


  • Work with the Food and Drug Administration and other appropriate agencies to develop a set of policies for regulating the use of behavioral targeting, data collection, and other digital techniques in the marketing of drugs and health-related products.

A good recommendation for these groups is to conduct some research first. It would be interesting to see how patients used information conveyed through social media and what they thought about these practices. Given the use of social media is a recent tool in medicine, and the legitimacy unknown to many, one would assume that like commercials or advertisements, patients armed with information from social media would bring questions to their doctors about such drugs or treatments.

If that is the case, then social media serves an important purpose for connecting patients with their doctors to address their health concerns. This data would also prove valuable because it could show what forms or mediums of social media patients desire to receive information about drugs from, and which forms are most effective. Information such as this could provide a useful tool to health marketers to reform practices within their industry to provide more useful, unbiased and patient-centered information.


The impact of this complaint is significant because it represents a dangerous extension of the attacks on pharma marketing in Washington and will feed press attacks on the pharmaceutical industry. One commentator however, noted that the compliant is perhaps “the best review of healthcare-related digital marketing techniques” he has seen. While he recognized the innovativeness of many of these techniques, he noted that the consumer groups believe such practices are unfair and deceptive.

Consequently, the complaint could lead the FTC to open an investigation and create a protracted public relations problem. Presently, the online industry is already in a tough battle with some in Congress and the FTC over their proposals to increase regulation of behavioral targeting. This complaint will essentially extend this inquiry into professional marketing of health information and will increase the public visibility of many important marketing tools. The leading online marketing trade associations, including AAAA, the Direct Marketing Association, Association of National Advertisers and the Interactive Advertising Bureau, have created a significant self-regulatory program that has gained considerable government support, but is discounted by these consumer groups.  The health products industry will more than likely be joining these groups to find additional self regulation to protect online privacy

As all stakeholders in this process wait for guidance on the use of social media in drug marketing and advertising from the FDA or FTC, pharma and other health online marketers are pressing the FDA for new rules that would allow them to expand digital and social media advertising. The main thrust behind their argument is to reach populations of patients who do not adhere to their medications and to provide more resources for patients currently undergoing treatment to better understand the nature of their condition and any negative side effects or concerns that might create an obstacle to achieving the desired outcome.

Expanding the reach of social media is also seen as an important role in reaching patients who go untreated or spreading awareness about conditions that go undertreated or undetected. It is also seen as a potential resource for patients with chronic diseases who may decide to take “drug vacations” when symptoms from their illness disappear, although the underlying medical problems are still present. It is obvious that there are many good reasons why pharma wants to reach patients but there is also clearly a need for guidance about what is ethical and appropriate.

Before consumer groups call for a ban on truthful commercial speech that is likely to help patients, reduce health care costs, and lead to better detection, prevention, and treatment, a middle ground should be sought. Every industry uses social media and similar tactics to target populations, when the outcomes are clearly not as beneficial.

Given the rapid pace of society and the growing demand for health information from patients and practitioners, social media can act as a bridge to help the public access information in a convenient and reliable way. While demanding transparency and protection for privacy are legitimate claims, these consumer groups must realize that by attempting to eliminate or severely restrict an extremely valuable resource of information for patients could produce more harm to patients than good.

November 29, 2010

JAMA: Creating the Conflict of Interest Academic Police State – Thinly Veiled Threats and Accusations

Continuing his crusade to end all collaboration between physicians and industry, and in doings so, chilling the progress of research and discovery in medicine, David Rothman, PhD, wrote a commentary about academic medical centers’ conflict of interest policies. The commentary, which was published in the Journal of the American Medical Association (JAMA), discussed how “a number of academic medical centers (AMCs) have taken the lead in implementing new policies that more strictly manage the relationships between physicians and industry during the past 4 years.”

We have previously summarized many of these changes (Harvard, Minnesota, Wisconsin, Yale, Stanford, Michigan), which include “new measures to prohibit accepting gifts, food, and drug samples and restricting faculty consulting and speaking arrangements.” In light of these measures, Rothman recognizes that there is still a heated debate about these changes, with some feeling that they “are long overdue, and others complaining that the policies sully their reputations and reduce their income.”

He also acknowledges that because these “measures break new ground, uncertainties about their short- and long-term consequences are widespread.” Given this uncertainty, you would think that a member of academia, whose mission is to remain objective in searching for evidence, would call for more research to gain a better understanding of the wide ranging impact these policies could have and the unintended consequences and harm that are likely to result (i.e. MIT study).

Not surprisingly however, Rothman instead says that rather than do more research about the consequences of misguided conflict of interest (COI) policies, it would just be “simpler, more equitable, and more effective if all AMCs adopted $0 thresholds for all faculty, staff, and adjuncts.” He offers no empirical evidence or logical reasoning to how he arrived at such a conclusion, also not surprising, since to date, no evidence has been produced suggesting that physician-industry relationships have caused any harm to patients.


Given the various changes in AMC policies listed above, Rothman uses this commentary to discuss what he believes are “accomplishments at the leading institutions and evaluate prospects for future change.” Other than these institutions actually adopting or changing COI policies, he does not explain why this stands as an accomplishment. Have these policies improved patient care? Have they led to more discoveries of new drugs or treatments? How many more lives have they saved now that these policies are in place? Does the public trust AMCs more now than before?

The clear problem that Rothman identifies about COI policies, but strategically underscores, is that “Implementing conflict of interest policies demands substantial time and resources, as well as a deep commitment to effective oversight.” While many justify COI policies as a way to ensure professionalism and to keep public trust, others argue that they also serve to reduce health care costs. On the latter point, critics of industry-physician collaboration believe that physicians who work with industry can lead to overprescribing, extra tests, use of brand name drugs, and other things that lead to increased costs.

But how does creating a COI police state at an AMC reduce health care costs? As Rothman recognizes, “issuing a policy is merely the first step; next come the appointment and staffing of a faculty/administration committee that, together with an expanded compliance office, answers faculty queries, investigates violations, reviews disclosure forms, and develops and implements individual management plans that must become embedded in the institutions' governance and culture.” This all costs significant amounts of money on not only resources, but also training and compliance.

Based on the extremely limited budgets of most AMCs already, coupled with the threat that AMCs will prevent industry-funded research, grants or continuing medical education (CME), how can the overwhelming majority of these institutions expect to pay for all of this? Rothman does not answer that question.


To Rothman, COI policies should exist at AMCs to show “a deep sense of professional values and by the conviction that, left unregulated, industry marketing practices undermine patient well-being and scientific integrity.” He neglects however another equally, if not more important sense of professional value: the need for physicians to learn continuously about new advances and research to improve patient outcomes, and a duty to educate and train others with that information.

By focusing solely on what he sees as beneficial for patients, Rothman himself undermines patient well-being and scientific integrity by not realizing that patients will be the first to suffer when physicians can no longer collaborate with industry to discover new breakthroughs and treatments to continue the progress in medicine America has enjoyed for decades. Patient well-being will also suffer from biased proposals such as Rothman’s because once physician-industry collaboration begins to decrease, the training and education of physicians will be insufficient and inadequate to deal with the revolutionary pace of medicine and science. Doctors, who barely have enough time to see patients presently, will simply fall behind the standard of care in many areas because critics like Rothman want to impede the flow of truthful and valuable scientific information between physicians and industry.

Despite these contradictions, Rothman’s commentary reads more like a warning: since industry Web sites are reporting payments to physicians, there is the potential that an AMC may be the subject of “unflattering media coverage, and no institution wants to receive an inquiry from a senator's office about a faculty physician's ties to industry, which almost inevitably produces reputation-damaging media coverage.” But Rothman too quickly forgets that AMCs are constantly under a microscope on a number of unflattering media and legal issues such as malpractice, adverse events, clinical trials, research protocol, hospital borne infections, and so on.

While physician-industry payments are a popular topic in the media now, they are no more unflattering than the issues previously stated. Yet we still have hundreds of thousands of deaths in hospitals and AMCs from adverse events and hospital acquired infections. Why should AMC resources and staff be filling out and reading COI forms when they could be fixing real problems of life and death instead?

Essentially, Rothman reasons that AMCs should fear working with industry and should adopt his $0 threshold because “such an inquiry into payments may adversely affect funding from the National Institutes of Health and even spur investigations by state attorneys general.” This reasoning is both counterintuitive and counterproductive. The purpose of NIH funding is to bring tangible medical discoveries to the market for patients, and without the interaction and collaboration of industry, the chances of this happening are minimal. You can’t just have NIH funding and no industry support. And you can’t have industry support and no clinical trials or testing. This is why we need collaboration. Moreover, if an individual researcher is found in violation of COI policies, it is highly likely that only that person will be restricted from NIH funding, and not the institution as a whole.

Consequently, Rothman discusses a number of specific prohibitions and policies in place, most of which are reasonable. These include prohibition of gifts and food from industry. However, Rothman’s suggestion that there is “extensive literature on the effect of gifts on physician decision making” is inappropriate. There is only one such article by Wazana, that did not even use clinical outcomes to show if such gifts were harming patients. In other words, the study was meaningless.

Another problem with Rothman’s portrayal of such policies is that he does not explain the role of physicians on speakers’ bureaus adequately. Speakers are not salespeople because they use company slides. FDA requires, by law, that speakers must use slides from companies that the agency has approved to ensure that adequate risk/benefit information is included, there is no discussion of off-label use, and only clinical evidence is being presented.

In addition, Rothman’s suggestion that samples be “less frequently used, and detached from interactions between the drug representative and the physician” is also problematic. Many of these samples are given to doctors for the explicit purpose of giving to patients who do not have sufficient financial resources. Samples are also useful for doctors to test a patient’s tolerance and monitor for any side effects before deciding a specific and costly treatment.


Rothman’s commentary presents assumptions stated as fact, and uses a clear framing bias to suggest that physician-industry collaboration must be eliminated or heavily regulated. Throughout his entire commentary, he does not mention one benefit, of the thousands that have come from physician-industry collaboration (ones that he himself has probably personally benefited from i.e. vaccination). His ideas are not only problematic because of their extreme view and lack of objectivity in evaluating the significant role industry plays in advancing medicine and improving patient care, they are also conflicted. Specifically, Dr. Rothman is the president and a board member of the Institute on Medicine as a Profession (IMAP), which is funded by George Soros, a philanthropist with a very liberal agenda.

Ultimately, transparency is important, and AMCs should continue enforcing and creating policies that promote transparency to ensure a high sense of professionalism and public trust in academic institutions. This does not mean however, as Dr. Rothman suggests, that these measures should completely abolish physician-industry collaboration. Policies must strike the proper balance to ensure ethical collaboration without hindering innovation and creating obstacles. Since the consequences of these policies are unknown and will likely be widespread, AMCs have a duty to the public to first determine whether more harm than good will come from COI policies, and the potential negative consequences they could have on patient outcomes and physician training and knowledge.

November 24, 2010

BMJ: Neurointerventionalist and Innovation

Medical Innovation 
A recent article in the Journal of the Society of NeuroInterventional Surgery, published by the British Medical Journal (BMJ), examined the doctor-device industry relationship through the role of the neurointerventionalist and recent developments within the AdvaMed Code of Ethics. The article discusses a reasonable approach to manage conflict of interest while preserving opportunity for innovation with industry.

The authors explain how the specialty of neurointerventional (NI) surgery is one of the “most rapidly advancing and exciting areas of medicine today—in part based on close relationships with industry that ignite rapid advances.” Given these close relationships, they recognized however that there is a potential risk of conflict of interest.

Despite this concern, the authors clearly recognize that “if it were not for the ongoing collaboration between NI surgeons and the medical technology industry, many of the advanced treatments used every day in neurointerventional surgery would not exist.” This would certainly be detrimental to patients, and the training of future neurointerventional surgeons.

Advancing medical technology

The medical device industry, through advances in medical technology, have enabled neurointerventionalists “to treat a wide array of conditions that occur within the vessels of the brain or spinal cavity, such as aneurysms, strokes and spinal compression fractures.” As the authors explain, although NI is a relatively nascent specialty, “the NI field has developed in an era of technological innovation, and inherent in that development are continuing refinements in the tools used to image and treat patients with these technologies.” According to the authors, these advances in the NI field have emerged “alongside developments by a vibrant and intellectually active medical device industry,” that has thrived due to industry-physician collaboration.

Historically, “NI physicians have often worked collaboratively with their industry partners to help move the field forward to the benefit of patients.” For example, the authors cite Guglielmi detachable coils, an innovation that has led to significant improvements in care and quality of life for patients. Yet the authors note that the medical device industry presents “unique conflicts-of-interest considerations based on product complexity and constant product evolution,” in comparison with other life sciences sectors.

One of the reasons why the device industry-physician relationship is unique is because “neuroIntervention has at its core some of the most life-threatening disease states and high-risk treatment options.” To address these disease states, nuroIntervention involves a “dynamic process of innovation and factors such as product delivery technique refinement, education, testing and clinical trials, and product support, which all make it necessary for ongoing and close collaboration between neurointerventionalists and the device industry.”

As a results, the authors acknowledge that those “in healthcare understand how valuable these relationships are for continued innovation and also for patient safety.” Accordingly, they assert that it is “essential for the NI community and the device industry to proactively manage the potential for conflicts of interest while promoting the highest ethical standards.”

Increasing scrutiny

One of the reasons the authors address this potential for conflict of interest is “in part because the competing pressures from the multiple, overlapping roles as clinician/care giver/investigator/ innovator/customer are significant.” They recognize that “the structure and execution of various industry–physician interactions—such as consulting arrangements, CME funding, clinical trials, research grants, and other arrangements—possess the potential to alter prescription or device usage patterns.”

However, this “potential” has become more like a “perceived” conflict of interest because of recent “prosecutors' activity and media scrutiny in the area” that makes the “mere suggestion of a conflict of interest alarming to the public, which expects a doctor–patient relationship based on objectivity and transparency.” The increased scrutiny also comes in light of companies posting payments to physicians, and the future disclosure of such payments through the Physician Payment Sunshine Provisions.

To address the potential damage to the public's trust by physicians working with industry, the authors discuss the important role the device industry has played to ensure an ethical relationship between physicians and industry and the standards they have set. The elimination of such relationships, as some critics and proposals suggest, are not an option to the authors because they assert that “the physician community and industry must work together to seek a balanced approach and resist any one-size-fits-all conflicts-of-interest solution.” Otherwise, the beneficial collaborations that advance technology may be threatened.

Understanding the AdvaMed code

It is because these critical relationships are too often misunderstood that the Advanced Medical Technology Association (AdvaMed), the largest American medical technology association representing medical device and diagnostics companies, strongly encourages both industry and physicians to commit to openness and high ethical standards in the conduct of their business interactions. AdvaMed’s Code of Ethics, most recently revised in July of 2009, deals with new issues and provides guidance tailored to the unique collaborations in device development.

The authors explain that by “adhering to the AdvaMed Code, manufacturers are supporting physicians' obligation to ensure each patient is provided with the highest level of care, by receiving the treatment option most beneficial to their individual needs.”

The AdvaMed Code clarifies and distinguishes appropriate and inappropriate activity between healthcare professionals and manufacturers of medical devices. It is important to note, as the authors do, that because of this code and its many revisions, medical technology companies and their representatives no longer engage in activities that people once believed were customary. Changes to the Code include:

  • Royalty arrangement guidelines with healthcare professionals (HCPs) in exchange for substantial contributions that improve medical technologies.
  • Rules for providing no-charge products intended to educate both HCPs and patients receiving newer or improved medical technologies.
  • An explicit prohibition on providing entertainment, recreation, and gifts of any type—including all non-educational branded promotional items—of any value.
  • Objective reimbursement, coverage, and health economics information provided to HCPs in order to improve patient access to medical technologies.

Training and education

Additionally, AdvaMed has revised code sections to provide greater clarity and rigor in areas such as company-conducted training and education for physicians. These revisions mandate that educational programs for HCPs be conducted in clinical or educational settings that are conducive to exchange of information. The code requires that “Hands-on” training be held at facilities suitable for the type of training to be conducted, and instructors should be qualified and have the technical expertise to conduct the training. To appropriately facilitate exchange of information and product training some companies may have on their campus state-of-the art cadaver laboratories or other specialized training and education facilities to ensure the proper handling and use of these products.

The authors recognize that “because of the way in which medical device technologies are used, industry has a responsibility to make available to physicians education and training on the safe and effective use of their products.” This education and training is critical considering “the FDA mandates training and education to facilitate the safe and effective use of certain medical technologies.”

Going global

Another important development that emphasizes the need for physician-device industry collaboration is the fact that NI professionals are increasingly global. One of the factors contributing to this change is that many of the NI device companies with headquarters in the US are conducting testing abroad and American specialists travel as advisers on their behalf to foreign lands. Given new laws, disclosure, regulations, and reporting, the authors recognized the potential for “confusion that might impede collaboration beneficial to patients and medical technology advancements.”

To address the international nature of NI and the device industry, AdvaMed, and the European Medical Technology Industry Association (Eucomed), the voice of the medical technology industry in the European Union, developed what is now known as the Joint Trans-Atlantic Statement on Ethical Interactions between Medical Technology Companies and Healthcare Professionals. The authors acknowledged that this statement “shows the device industry's unwavering commitment to develop a cohesive international approach to ethical interactions between medical technology companies and HCPs,” while emphasizing transparency. Many of the provisions in this statement are similar to those in the AdvaMed Code of Ethics.


The authors in this editorial clearly highlight the importance of preserving industry-physician collaboration, and recognize the potential harm for hindering these relationships. While there is no doubt that transparency in such relationships is crucial, sacrificing progress and innovation in technology and patient care is not justified simply because of the “potential” for conflicts-of-interest or that such conflicts can be complex. Additionally, the authors recognize that “many specialty societies have active ethics committees of their own and have taken significant steps to provide meaningful and specialized guidance to their members,” further demonstrating the importance of physician-industry collaboration.

Given that the leadership of the Society of NeuroInterventional Surgery “believes that robust, ethical industry–healthcare professional interactions further patient safety and medical innovation,” and the numerous measures in place by AdvaMed and other specialty societies, it is clear that “physician–industry interaction is critical for continued innovation by our specialties.”



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