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The Conflict of Interest Movement in Medicine. Part 2: Influence and Education

The Conflict of Interest Movement in Medicine. Part 2: Influence and Education

A Conversation between Harriet Rosenberg and Adrienne Shnier

May 18, 2016

 

HR: Your research also looks at financial conflicts of interest in Continuing Medical Education (CME) for practicing physicians.

AS: There are about 60 Canadian Professional Medical Association (PMAs) that host continuing professional education for doctors. We found their policies to be generally weak and they leave plenty of room for industry involvement. For example, a pharmaceutical company might co-sponsor an event with a professional association, or a speaker at an event might have financial conflicts of interest that are not declared—so industry presence is not always apparent to the audience. It is also the case that the presence of industry is viewed as so normal that it may be rare for doctors to ask questions about industry influence at these events billed as “education.”

We know that prescriptions for brand-name drugs increase after educational events at “hot destinations” —at vacation locations that are paid for by drug companies.

So doctors tend not to learn much about how to detect conflicts of interest in medical schools or what this might mean for their practice of medicine—yet when they are practicing physicians—they seem to assume that they are aware of industry presence and are not influenced by it. There is research that shows that they think that their colleagues may be influenced by financial conflicts, but they are not (see here, here and here).

HR: There have been attempts to make these industry payments to physicians more transparent. In Canada, at present the situation is moving towards voluntary disclosures by drug companies of what they pay to physicians.

But in the US things are different.

AS: The United States Physician Payment Sunshine Act (PPSA) was the first government-pursued and country-wide initiative to systematically identify and document for public access the financial relationships between medical professionals and the pharmaceutical and medical device industries. Alongside the PPSA, a group of US-based investigative journalists at ProPublica also created a database of financial interest disclosures that are publicly accessible.

HR: The influence of industry also extends to clinical practice guidelines from Canadian professional medical associations. These guide doctors in their prescribing habits and probably the public assumes that there are stringent standards to avoid conflicts of interest among the panels and the associations that write these guidelines.

In the US, there have been controversies over guideline writing panel members failing to make clear their financial connections to industry.

AS: The Institute of Medicine in the US (IOM) has recognized this and has provided recommendations in response to the nondisclosure of fCOIs in clinical practice guidelines in the US, and this problem is mirrored in Canada.

HR: This is very disconcerting—the omnipresence of industry in all these areas—from medical school, to clinical trials and journals, to continuing medical education, to clinical practice guidelines.

AS: It is not surprising considering the trend toward privatization, deregulation and belief in market authority for the regulation of information. This has contributed to an environment that is pro-commercial where medical information—medical knowledge—is now proprietary—it is viewed as a product in a deregulated regime.

HR: This is very different from our assumptions about science, especially medical science, which we think of as a public service. The neo-liberal win-win philosophy of public-private partnerships in medicine can, it seems, in practice, mean the domination of private, vested interests at the expense of the public interest and patient safety.

AS: Yes, this is about the commodification of science and the argument that science should be conducted for profit. There has been a structural shift in the way that medical research is being both considered and conducted and that is why looking at conflict of interest policies is so important.

HR: The prevalence of financial conflicts of interest in medicine would not be possible without a culture within the medical profession accepting this as normal—that is the belief that it is fine for scientific inquiry to originate with industry—okay that industry poses the research questions, does the research, analyzes the data, writes about the benefits and harms of its own products and partners in the education of doctors about these products.

AS: There are some that do not see this situation as conflict of interest at all—who do not feel that relationships with industry should be regulated at all. The study of fCOI relationships is a very contested area. There are attacks on the conflict of interest movement, but the movement has gained ground in Canada and around the world.

There is a push for disclosure of relationships with industry but at the same time many regard financial ties to industry as a sign of prestige. Disclosure in and of itself is a first step to achieving transparency, but as a solution, it doesn’t do much.

There needs to be a change in culture so that it is seen as exemplary for administrators in medical schools, faculty and students to avoid financial conflicts of interest. These views are, in part, dictated by the general funding model for medical research.

HR: Some have proposed expansion of public funding for health research and clinical trials.

AS: Industry has said that it should rightfully be a partner in medical research and education—that they are among those who want to promote better patient outcomes and better quality of life for patients.  This can be done through anonymous funding to a pot of money administered independently of pharma. If serving patient interests and not only shareholders is their goal, then this can be achieved by donating anonymously.

There have been many scandals and in the US, between 2006 and 2015 over $30 billion in fines where industry has overstated the benefits of their products and concealed information about harm.

 

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HR: It has also been pointed out that these fines do not really act as a deterrent but are thought of as a cost of doing business (see here). An interesting point was made by Ralph Nader’s watchdog group Public Citizen in the US. They pointed out in 2012 that Big Pharma was the leading defrauder of the US government having surpassed the defense industry.

Another interesting aspect of these legal approaches—prosecutions and fines—seem to be confined to the United States.

As far as I know, the Canadian government has never prosecuted any of the companies who paid huge fines for committing fraud in off-label promotion, and failure to disclose safety data like GlaxoSmithKline (GSK) or Pfizer. In the US, GSK paid a total of $3billion –$1billion in criminal charges and $2billion in civil charges in 2012. The drugs involved included anti-depressants like Paxil and Wellbutrin and the diabetes drug Avandia which are sold in Canada.

 

It is not clear to me why no actions were taken in Canada by the government.

 

AS: However, Health Canada itself has been sued for not protecting Canadians from a product that it “knew or ought to have known” had significant risks.

HR: All of the issues you have described in relation to financial conflicts of interest intersect with other reform movements in medicine—the data transparency movement and the regulatory reform movement. Knowledge activists in these arenas are pushing for a variety of reforms to make patient-level research data available and make regulatory activities more transparent and more patient-centered.

AS: Financial conflict of interest relationships are common within the medical profession, in medical research, and in medical education. These financial relationships have served as one method by which drug companies have been able to exert their influence and increase their involvement in the daily research and practice of medicine. While we can all agree that drug companies have produced life-saving and quality-of-life enhancing medications, there is also a substantial literature on dubious and outright illegal promotional activities, suppression of data, and behind-the-scenes management of medical science by for-profit companies. This has not gone unnoticed—it has been met with resistance.

There are mobilizations against the negative aspects of pharma influence that are engaging medical students, practicing physicians, journal editors, journalists, citizen scientists, watchdog groups, and members of the public questioning these relationships to industry. Their goal is simply to promote medical science in the interest of the public good.

HR: Can you name some examples?

AS: Interested readers can go to the website for AllTrials, and also COMPare which looks at discrepancies between registered trial outcomes and what is actually reported, articles in the BMJ about the work of RIAT (Restoring Invisible and Abandoned Trials). In 2009, newspapers like the New York Times carried articles on ghostwriting in medical journals as did PLOS Medicine. There have been medical student and practicing physicians who under the banner of “No Free Lunch” oppose freebies from industry. And also there are independent watchdog drug and device evaluators like the Therapeutics Initiative in British Columbia, Public Citizen’s Health Reform Group and Prescrire in France, for example.

In addition, an important source of information about drug safety can be obtained from going to Health Canada and the US FDA websites for publicly available information which does not get as much publicity as direct-to-consumer ads that we see on US TV or online.

Medical institutions should of course strive to disseminate information to healthcare professionals, patients and members of the public that are not influenced by industry marketing goals. And there are a variety of ways that this can be done including more stringent and enforceable conflict of interest policies.

But in addition, the public should seek out independent information, and use critical skills when assessing articles and guidelines. Much that reads like objective medical science may in fact have its origins in marketing.

 

Further readings:

Angell, M. The truth about the drug companies. Random House Trade Paperbacks. 2005

Ford AR and Saibil, D. The push to prescribe. Women’s Press. 2009

Goldacre, B. Bad Pharma: How medicine is broken, and how we can fix it. 2013

Gotzsche, P. Deadly medicines and organized crime. CRC Press. 2013

Healy, D. Pharmageddon. University of California Press. 2013

 

The Conflict of Interest Movement in Medicine, Part 1: A Conversation between Harriet Rosenberg and Adrienne Shnier

By Harriet Rosenberg and Adrienne Shnier

May 9th 2016

Part 1: Weak Policies and Ghostly Authorship

This blog is presented in interview form and is an amalgamation of an interview plus several subsequent conversations between Adrienne Shnier, a graduate student at York University and Harriet Rosenberg, a retired York University professor. Adrienne’s PhD thesis is titled Medical education and financial conflict of interest relationships with the pharmaceutical industry in Canada: An analysis of four areas of medical education and will be available online in August 2016.

HR: Your research is part of a reform movement within medicine that focuses on the influence and impact of conflicts of interest—especially financial conflicts of interest.

Your thesis research and publications have been about the education of Canadian physicians, broadly speaking, and the role that conflict of interest awareness and policies have played in shaping medical science and ultimately patient care. You argue that neo-liberal government policies, in Canada and around the world, over the last 3 decades have played an important role in transforming the practices and culture of medicine.

AS: Policies that are pro-business have contributed to an environment of commercialization of medical information and the protection of that information as proprietary. This has led to trends toward the privatization and commodification of science in ways that most people don’t realize.

For example, new for-profit research organizations have emerged in recent years. Relationships with these types of organizations are now embedded institutionally, and so the study of policies around conflict of interest (COI), especially, financial conflicts of interest (fCOIs) becomes very important. Pharmaceutical industry funding for research has expanded dramatically. For example, it is worthwhile noting that as of 2005 the pharmaceutical industry has provided 70% of total funding for clinical trials in the US (see here and here).

HR: The concept of conflict of interest, especially financial conflict of interest seems pretty straightforward. At a minimum, medical students, practicing physicians, and researchers should be aware of and avoid any potential for bias associated with taking money from the pharmaceutical industry. Yet the concept and associated policies have been fought over for decades. Those supporting close ties with industry argue that everyone has conflicts and that the term is itself disrespectful, pejorative and condescending.

They view those who want stringent conflict of interest policies as being sanctimonious moralizers. But those who want to separate medicine from the influence of the pharmaceutical industry point to a vast literature of revelations from investigations, lawsuits, legal documents, and academic articles and books that show how industry has manipulated clinical trials to exaggerate benefit and downplay harms.

AS: A solution to these debates about fCOIs, is to remove them from the personal, individualistic realm and have policies that apply to all rather than having to investigate and pursue case-by-case situations. Having clear, enforceable policies in the first place and then applying pre-specified penalties would help to protect the integrity of the profession.

HR: You looked at issues of fCOI within the Canadian context. There were four areas that came under the broad umbrella category of the education of doctors. You started with the education of medical students in your published 2013 paper.

AS: My co-authors and I looked at 17 Canadian medical schools to evaluate the presence of and stringency of fCOI policies.

HR: Your title says it all, “Too few, too weak.”

AS: We were concerned about the degree to which the schools protected their faculty and students against fCOI with industry. We were also curious about whether the potential for hidden fCOIs and commercial messages existed in medical school education — for example, did teaching faculty disclose their ties to industry? Were faculty permitted to have fCOIs with industry? Were medical students taught formally, as part of the curriculum, about how to identify fCOIs and behaviors and attitudes associated with engaging in them?

HR: You also asked about disclosures of financial links to industry in educational materials.

AS: The category of on-site education asked whether industry was permitted to provide direct financial support for educational activities, including Continuing Medical Education (CME). Approximately half of the schools did not address this category; whereas, approximately one-third of the schools had policies that allowed industry funding to be allocated to a specific topic, but that funding should be provided to the department rather than an individual. The remaining schools had policies that protected learners through prohibiting the provision of industry funds directly to educational activities, while still allowing unrestricted grants.

HR: Were freebies like lunches, pens and other trinkets examined for how they legitimated industry influence?

AS: No, but approximately half of the schools had policies on gifts, while the other half did not.

HR: What is the take-home message here?

AS: Most schools had weak policies. Commentators on our article in the press were surprised. After this study was published, some medical school administrators said they would tighten, or were in the process of tightening, their fCOI policies.

HR: Your research also includes the commercialization of medical journals and the concept of “honest publishing” in medical journals. The influence of industry on how clinical trials are conducted and written about in medical journals—including the highest profile medical journals— is an area of conflict of interest not very well known to the public.

People assume that medical science journals publish accounts of clinical trials that are conducted by academic researchers whose names appear on the title page and that these trials describe with care and honesty the potential benefits and harms of a drug —that they serve the public interest.

It is quite a shock to learn that things often don’t actually work that way and that leading physicians, including many medical journal editors themselves, warn of corruption in trials. These are people like Dr. Marcia Angell, former editor of the New England Journal of Medicine and long-time former editor of the British Medical Journal, Dr. Richard Smith among others, who wrote that the clinical trial was now the “marketing arm” of the pharmaceutical industry. A recent article by the redoubtable Stanford University Professor John Ioannidis argued that “evidence-based medicine has been hi-jacked” by commercial interests.

AS: It is also important to note that from the perspective of industry, data from clinical trials about the harms of their products can be considered to be commercially confidential information (CCI), which should not be released because it would give their competitors an advantage. In some cases, adverse event data is considered to be proprietary and, therefore, potentially inaccessible by the public see here).

HR: Some have called this the dominance of MBM—Marketing-Based-Medicine— over EBM, Evidence Based Medicine. In the now available documents from court cases we see “publication plans” with lists of numbered marketing messages to be inserted.

AS: The whole structure of clinical trials and journal publishing has been transformed by the creation of for-profit businesses that serve the pharmaceutical industry outside of the environment of academia.

There are companies called CROs—Contract Research Organizations—that are hired by pharmaceutical companies. Researchers have estimated that CROs are now responsible for conducting up to 75% of medical research (see here). The CROs are for-profit research businesses that conduct clinical trials—they have global reach—and recruit from around the world. They administer the trials, collect the data, and analyze the data. We know from documents from court cases that they are in close contact with the pharmaceutical companies who hired them throughout the process. Some of these documents that show the communications involving for-profit research and writing organizations are available on-line from the documents archive site called Industry Documents Library at the University of California San Francisco (see here and here).

These documents show memos and long-term marketing plans for about 5 year periods, and connections with other related businesses called Medical Education Communication Companies and Medical Writing Organizations. In this context, we have come to understand that the terms “medical writer” or “medical editor” indicate the involvement of a ghostwriter. Medical writers are hired through these organizations as contract workers to write up the results of trials, prepare conference posters and presentations, slide kits for physicians to present to colleagues, write letters to medical journal editors and develop a variety of “defense of product” communications when the product is challenged. There are important similarities between pharma, tobacco, and other industries in this regard.

These CROs and/or writing/editing businesses also seek out academic physicians as guest authors to put their names on the mastheads of trial write-ups and to be the face of the trial in medical journals. This practice has been revealed in legal transcripts and materials that judges may choose to unseal in court cases and are available on the Industry Documents Library. You can read the memos, the emails, the publication plans with proposed titles and slots for authors to-be-decided later (see here and here).

A recent 2016 publication by Cosgrove and colleagues shows that these practices continue into the present and contribute an additional dimension to research on financial conflicts of interest —those of medical journal editors themselves (see here).

HR: So this is why you use the term “honest publishing.” The work of these businesses —the CROs, the medical writers/editors, the medical education businesses are all associated with the pharmaceutical industry and seem to be generally hidden from the public. One could say “hidden in plain sight” because they are easily found on the internet and the medical editors even have their own professional organizations and do not see themselves in a negative way as ghostwriters even though their names do not usually appear in journal articles.

High profile medical journals around the world, including within Canada, have been grappling with this issue of “honest publishing” and the now complicated and unreliable term “author.”

What can you tell us about your research on “honest publishing” in Canada?

AS: There is very little written about this in the Canadian context; however, the issues seem to be the same for journals and for physicians, for medical students and for the public internationally because when articles are published in medical journals, they reach international physicians, medical students, and patient audiences.

HR: This leads to the question: How can you actually figure out what is going on with an article—even in the highest prestige journals—did the listed authors do the research and did they themselves write up the results?

AS: This is difficult to know without complete transparency about the roles of individuals and research and writing companies in the publications process. In one of my thesis chapters, I provide a preliminary research tool that can be used to gauge the fCOI disclosures and transparency of individuals’ roles required in medical journals.

HR: So some articles are published and it may be the case that the listed authors did not even see the raw data. There is really no way to tell outside of what may eventually come out in lawsuits.

AS: Correct. We do not know if authors had access to the raw patient-level data or only the already-analyzed data from these companies.

HR: Sometimes in the acknowledgments of an article an “editor” is thanked for assistance and this may be a clue that a ghostwriter had significant involvement in the drafting and development of a manuscript. One of the risks in this situation is that because the medical writer’s employer has been hired by a drug company, this creates an environment that incentivizes the development of medical manuscripts that are generally favorable to the drug company.

AS: There is no way to know what the named authors have actually contributed, outside of the problematic ICMJE requirements for disclosure, onto which many journals have voluntarily subscribed….so the answer is, no.

HR: The ICMJE (International Committee of Medical Journal Editors) is a group of leading medical journal editors who got together to try to tighten rules around authorship given the scandals about ghost authorship and the lack of transparency about who was responsible for what parts of the trial write-up and what the role of industry was in all of this, including not only the text but the statistical analyses. This was brought to a head when over 1500 pages of documents were unsealed in relation to breast cancer lawsuits (against Wyeth, now Pfizer) by women who had taken Hormone Replacement drugs. The documents (available on line in the Industry Documents Library) revealed an entire backstage system of industry involvement in promoting the benefits of HRT and downplaying harms.

The medical journals now have tighter guidelines around authorship but it has been pointed out that there are many ways of getting around them.

Furthermore, write-ups in medical journals—regardless of who the authors are—are just a fraction of the story. The issue of data transparency and how the full record based on all the raw data gets condensed and possibly distorted in the published version is also very important. For example, Dr. Ben Goldacre has argued for transparency because the published record falls short. About 50% of trials are just not published. He and allies in leading medical journals like the BMJ have started an initiative called AllTrials to correct this.

HR: We will be looking at this more fully in our discussion with Dr. Elia Abi-Jaoude in a future blog.

You have developed a glossary of terms that comprise 50 items that help explain what has now become normative in medical journal publishing. Tell us about them.

AS: The glossary includes terms that describe various fCOI relationships and the involvement of industry in the research, data collection, data analysis, and writing processes. For example, do they disclose consulting for pharma, honoraria for speaking engagements for particular companies, do they (or family members) disclose owning stock, and do they appear on scientific advisory boards of pharmaceutical companies—just what are their ties to industry? Have the named authors had access to the raw data? Have the trials been registered in a clinical trial registry? Have any trials been suppressed? The answers to these, and other, questions at least allow the reader to put articles in medical journals into some context about their origins.

More difficult in journals is to find policies that address other aspects of industry influence. Do journals have policy language that addresses behind the scenes behavior? Do they have ways of detecting ghostwriting and preventing ghosted articles from being published? Can they verify if the names on the article are the people who did the work? Do they have penalties for breaches of policy?

Analysis of medical journal policies, themselves, were not a part of this study, but I hope to use the research tool to do this in a future study.

HR: How widespread is this problem of authorship?

AS: I have seen figures that indicate that between 9% and 49% of published medical articles are ghostwritten. At some phases in product promotion, it has been argued that 90% to 100% of articles during these key phases or within certain specialties are written by industry hired writers and not the academics whose names appear.

The industry-originated and planned research studies, data collection, analysis, interpretation, writing, and publication of these studies, are all the while being potentially informed by a larger promotional campaign for a drug. Collectively these coordinated undertakings have been called “ghost management” and are related directly to the commercial nature of the pharmaceutical industry.

Simply put: the meaning of authorship has changed.

End of Part 1

Further readings:

Angell, M. The truth about the drug companies. Random House Trade Paperbacks. 2005

Ford AR and Saibil, D. The push to prescribe. Women’s Press. 2009

Goldacre, B. Bad Pharma: How medicine is broken, and how we can fix it. 2013

Gotzsche, P. Deadly medicines and organized crime. CRC Press. 2013

Healy, D. Pharmageddon. University of California Press. 2013