On Disclosure, Transparency, and Firewalls: A Call for Uniform Standards

Since Patient POV was launched March 29, I have been struggling with how to deal with the issue of industry-supported patient advocacy groups. On Thursday, ProPublica released its paper: “Financial Ties Bind Medical Societies to Drug and Device Makers” with a splash. A billboard from a medical device company near the Moscone Center, site of the Heart Rhythm Society convention, opens the piece, stating that “thousands of cardiologists” attending the meeting have been “bombarded with pitches for drugs and medical devices.”I don’t doubt it. I have attended scores of medical meetings as a reporter and when I first started going to the meetings, I found the industry influence stunning.

Last Tuesday, I reported the American Academy of Ophthalmology’s (AAO) response to the finding that the cheaper Genentech age-related macular degeneration drug, Avastin, at $50 a dose, worked just as well as their high-cost drug, Lucentis, at $2,000 per injection. The AAO would not recommend for or against Avastin over Lucentis and cautioned that the drugs seem to work differently, that a safety signal must be explored further.
It is pretty easy, to say that we know where they are coming from. In fact, one of several stories on AAO’s website about the trial states emphatically—albeit near the bottom of one of the stories: “Congratulations to Genentech for developing the drugs and getting them to market, congratulations to all in Washington and particularly at the NEI who allowed the trial to go forward, and congratulations to the trials leaders (particularly Dan Martin, MD) and the investigators for designing and conducting a benchmark piece of science. And, finally, thank you to the 1,200 patients whose commitment to the importance of answering critical clinical questions led them to participate in the trial.”

There has already been spin from industry since this study was released in the New England Journal of Medicine, flagging of a possible safety signal in Avastin. That mounted to a crescendo last week. Genentech must be betting on safety throwing Avastin out of the water.
Nevermind, that Genentech flaunted a non-peer-reviewed study out of Johns Hopkins, claiming the “largest worldwide experience” and potential worrisome safety concerns with the cheaper drug. Not disclosed was that it was an unvetted study run primarily by Genentech authors.

But this wasn’t entirely my purpose in writing this today. I think big pharma and the medical device industry are out there. Medical apps, mobile, and software are also big and promoted by some patient advocates. Exactly what their relationships are to these companies is often obscure. I want patients to have transparent information to review, especially if someone is claiming to help them.

It hasn’t escaped me that big pharma and the medical device industry have their hand in media today. You can see ads for Novadisk and more sitting on top of NPR stories; Cleveland Clinic is up on Slate. They are not alone. Peer-reviewed medical journals get tons of money from industry.

Patient Advocacy Groups and Nonprofits

When it comes to patient advocacy and nonprofits, there is often even less transparency. Some don’t mention a single contributor on their website. Others openly provide the information. This raises so many questions. Do we reject them out of hand if they have money from industry? What is appropriate?

This inconsistency may result in pretty unreliable reporting. And sometimes I remember having read that company X operated outrageously in marketing a particular drug, and then I see that same company prominently advertised on a patient advocacy website. Should I discard that organization’s information out of hand?

If I ask some sites to speak with a patient on a disease condition, how do I know where that patient is coming from? What makes an honest patient anyway? Last week, I was working on a story on the NIH Stem Cell decision. The story was never written, but I spoke with the head of research at the Parkinson’s Disease Foundation in New York. I asked whether they could connect me with a patient. It turns out that they provided a patient, a cell biologist with Parkinson disease who was on disability, and had retired from the medical technology company Becton Dickinson. I wasn’t told this from the get-go, but I asked. Perhaps PDF gave me this person because this patient could answer questions about stem cells articulately. There was no incentive for PDF to tell me this, and I don’t fault them. You don’t have to be an investigative reporter to realize that patients with Parkinson’s disease might see limits with existing therapies. And you don’t need a brain surgeon or genius reporter to show you that a company like Becton Dickinson would benefit from the stem cell reprieve.

I am all for physician societies disclosing industry support. But that is just one aspect of the problem. How should media report? Can you watch a PBS show on the brain and not view it tainted because of financial support from a relevant funder? These issues need to be thought through.

I think that whether you are a physician society, media, or a patient advocacy or nonprofit group, the same rules should apply. In addition, if funding is given, the same firewalls should apply, and be transparent for all to see.

This entry was posted in American Academy of Ophthalmology, Avastin, disclosure, Drug costs, firewalls, nonprofits, Parkinson's Disease Foundation, patient advocacy groups, transparency and tagged , , , , . Bookmark the permalink.

9 Responses to On Disclosure, Transparency, and Firewalls: A Call for Uniform Standards

  1. Great post! This is an ongoing problem for both physician organizations and patient advocacy groups, which often are not fully aware of the ways their funders influence their message.

    There is one other set of institutions that have a conflict of interest that has been largely unexamined: academic medical centers. While NIH money provides the bulk of their funding, pharma and device manufacturers are significant sources of revenue. We know these institutions sometimes fail to protect patients adequately, especially those who participate in clinical trials. Many of the trials conducted by academic researchers are what psychiatrist and pharma critic Barney Carroll once dubbed “experimercials” — studies intended to expand market share, not answer a clinically relevant question. Institutional Review Boards are supposed to ensure that patients enroll in trials that mean something — that patients are not exposed to risks for no good reason. A marketing trial should not be considered meaningful. So why are academic researchers being permitted to enroll patients in such trials? I would argue its because academic medical centers cannot bear to lose the revenue.

  2. Norman says:

    I think you have the wrong link to the Pro Bublica site.

  3. Laura Newman says:

    Thank you very much for alerting me to the typo. I corrected the ProPublica link.

  4. Dolores Rogers says:

    Bravo for opening a complex subject, where trust in anything now is at such a low point. Look forward to ideas that can improve the current climate

  5. frances says:

    Thank you, Laura, for explicitly sharing some very complex and difficult issues regarding self interest among pharmaceutical companies, researchers, drug studies, and the like. Most of us interested in these subjects can successfully dissect them from here until doomsday, as there exists profound corruption in the industry. The essential issue, as I see it, is the outstanding self interest and greed factors that circumnavigate this whole mess. The logic required for ongoing public funding, support of humanitarian values for the greater good of the public is one that is being snuffed out before our very eyes. The almighty greed factor, based on insecurity that there is not enough to go around, will forever cause power struggles. If, on the other hand, we can renew a consciousness that may shift paradigms to I/Thou and away from mighty strong ego needs, we have a betting chance to restore sanity in this cockeyed world, including that of medical research.

  6. Trevor Kerr says:

    In Australia, key decision-makers are appointed by governments. Federal and State governments are currently embroiled in a rolling series of high-level reforms. One of these is for a National Health Performance Authority.
    My brief submission (#3) is that transparency, a principal aim of the Bill, will be enhanced if the major financial interests of NHPA members are published where they can be seen, on an accessible website.

  7. aidel says:

    This reminds me of a story: once there was a synagogue in which a large tzedakeh (not sure about the spelling, but it means something like justice + charity) box was placed in a discreet but easily accessible location. Members of the congregation donated as they were able and took from it as needed and nobody knew who was doing what, but somehow it worked.

    Now, I’ll refrain from commenting on what a sad day it is when science (not to mention science writing!) is dependent on charitable donations. However, if such a thing as a generic, bio-medical fund could be established (and managed neither by science nor industry) with contributors ranging from Big Pharma to individuals, either named or anonymous, then a well-qualified but disinterested board could make decisions about funding research based on the quality or merit of the research proposals. In fact, why not legally require every for-profit medical industry (Big Pharma, medical equipment and devices) to pay 20% of profits for research funding — and I DON’T mean for research that looks a whole lot like marketing. I mean research which may be totally irrelevant to the interests of the company.

  8. Very interesting post. I would love to know what the range of industry financing in advocacy groups, what is normative, and where the line should be drawn. Also, what the money is used for is important. Clearly, there are “front organizations” that claim to be patient groups and simply regarding these groups as “patient advocacy” groups is a problem for patients, who need a clear voice and credibility in healthcare reform.

    Also, the point raised by Shannon Brownlee is essential–it would be great to see some research in this area. This is particularly important because there is a hegemonic shift from the treating physician to expert panels populated predominantly with academic researchers and professionals. The recent IOM guidelines on trustworthy guidelines and the types of assessments required will make this shift toward epidemiological knowledge base for medicine more apparent. We need to consider what are the interests, biases (both intellectual and financial) brought to bear by this shift and what type of meaningful voice can patients have in making health care policy decisions that affect their lives.


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