Recent Second Opinion:

FDA's Bad Ad Program
June 03, 2010

Obesity and Public Health
May 05, 2010

The Route to Reconciliation
March 05, 2010

Conflict of Interest
January 28, 2010

Analyzing the Healthcare Bills
November 18, 2009

President Obama's Plan for Reform
August 24, 2009

The Healthcare Reform Debate
July 23, 2009

Priorities for the New FDA Commissioner
December 19, 2008

PhRMA's New Marketing Code
August 28, 2008

Personal Genetics Testing
July 29, 2008

Where health care policy experts have their say
June 13, 2008

Sources of Medical Research Funding
April 24, 2008

Off-Labeling Marketing
March 17, 2008

Second Opinion:
Where health policy experts have their say

April 24, 2008: Sources of Medical Research Funding

The medical community has recently been debating the implications of new revelations that a major study regarding lung cancer survival rates was supported, in part, by funds from the cigarette maker Liggett Group.

We sent the following news story, Cigarette Company Paid for Lung Cancer Study (New York Times, 3/26/08), to leading health care scholars and asked them whether the source of medical research funding biases research findings.

This edition of our expert panel includes:

• Senator Tom Coburn, M.D, represents the state of Oklahoma in the United States Senate. Dr. Coburn is also a physician specializing in family medicine, obstetrics and the treatment of allergies. More information about Senator Coburn's achievements in the Senate can be found here. (Read Coburn's Second Opinion.)
• David Gratzer, M.D, is a senior fellow at the Manhattan Institute's Center for Medical Progress and a physician, licensed in both Canada and the United States. He is the author, most recently, of The Cure: How Capitalism Can Save American Health Care (Encounter Books, 2006). (Read Gratzer's Second Opinion.)
• Paul Howard, PhD. is a senior fellow at the Manhattan Institute's Center for Medical Progress and the managing editor of MedicalProgressToday.com. More writing by Paul Howard can be found here. (Read Howard's Second Opinion.)
• Sally Satel, M.D, is a resident scholar at American Enterprise Institute and the staff psychiatrist at the Oasis Clinic in Washington, D.C. Her most recent books include One Nation under Therapy (St. Martin's Press, 2005) and The Health Disparity Myth (AEI Press, 2006). (Read Satel's Second Opinion.)

"Increased congressional involvement is the wrong direction for scientific research. Politicians are focused on the next election and will direct funding based on what lobbyists and special interest groups tell them and what will get positive headlines rather than real results. Feel good legislation does not create medical breakthroughs-peer-reviewed scientific research does.

Patients and clinicians deserve the truth about the research that forms the basis for life and death decisions. Scientific researchers should be accountable for complete transparency of both the methodology they use and the source of funds for their work. There are scarce federal funds available for scientific research and it is imperative that these funds are used to yield the greatest results possible."

—Senator Tom Coburn, M.D, represents the state of Oklahoma in the United States Senate. Dr. Coburn is also a physician specializing in family medicine, obstetrics and the treatment of allergies. More information about Senator Coburn's achievements in the Senate can be found here.

"Funding doesn't necessarily bias findings. One of the most significant papers on using Cognitive Behavioral Therapy in the treatment of Major Depressive Disorder—a classic study that, literally, influences my practice every day—was funded by a pharmaceutical company. It suggests a significant role for talking therapy, as opposed to drugs, in some patients.

But funding can bias findings.

And, in this case, the results are certainly remarkable, so much so as to be suspect. Funded by the tobacco industry, the study contradicts sixty years of research suggesting that smoking can kill you. The whole episode seems to be like something out of a Chris Buckley novel: a dummy organization, millions of dollars in tobacco money, dubious findings. Next up for the Foundation for Lung Cancer: a paper, written in collaboration with the Columbian Center for Excellence in Health, arguing that cocaine isn't addictive.

What's to be done? Transparency. Authors should clearly state their funding sources and affiliations.

Dr. Claudia Henschke didn't do that. But then, why weren't the editors at the New England Journal of Medicine more skeptical of these incredible study conclusions and more curious as to the funding sources of the Foundation for Lung Cancer?"

—David Gratzer, M.D, is a senior fellow at the Manhattan Institute's Center for Medical Progress and a physician, licensed in both Canada and the United States. He is the author, most recently, of The Cure: How Capitalism Can Save American Health Care (Encounter Books, 2006).

"At the end of the day, there are many potential sources of research bias, from direct financial conflicts (owning stock in a company whose product you are reviewing) to subtle professional ones like attaining tenure or securing lucrative NIH grants. While we ought to prohibit direct financial conflicts of interest, we should not become so draconian in policing the others that we exclude promising research from the public domain. To that end, transparency and peer review are sufficient for policing the vast majority of serious conflicts of interest.

However, in the current political environment, there is an explicit anti-corporate bias that presupposes that funding from private firms is more likely to produce research bias than these other influences (even when disclosed), and more likely to lead to the corruption of clinical practice. This assumption is highly dubious, and, in any event, unproven. Rather than fixating on the source of funding, we ought to focus on the quality of the data, and the methodology of the underlying experiments. To put the focus on the funding as opposed to the findings is to engage in a quixotic witch hunt for "pure" money that obscures much more than it illuminates."

—Paul Howard, PhD, is a senior fellow at the Manhattan Institute's Center for Medical Progress and the managing editor of MedicalProgressToday.com. More writing by Paul Howard can be found here.

"I would never publish a paper dealing with lung cancer from a person who had taken money from a tobacco company," Dr. DeAngelis said to the New York Times this week.

DeAngelis is the editor of the Journal of the American Medical Association. In other words, even if the data show important, even path-breaking findings, they are banished from consideration solely because of sponsorship. How very dismaying to realize that someone charged with bringing scientific knowledge to the medical community and the public views pre-emptive censorship as the solution to potential conflict of interest matters.

Furthermore, why focus on corporate-funded researchers? Bias can also afflict those funded by the government and non-profit foundations. The solution lies in transparency for all. For consideration: JAMA and other journals could insist that authors make their data available to other researchers and statisticians for the purposes of replication only.* Those who request it must agree not to use those data to explore and test their own independent hypotheses for publication or dissemination unless they invite the original researchers (collectors of those data) to participate in new re-analyses. If the original authors refuse, then no new analyses may be undertaken as part of a pre-arranged agreement.

Should a troubling finding be uncovered in the course of re-analysis, it must be brought to attention of original researchers (in whose best interest it is to pursue it, report it to FDA, and/or release news of this important new data). Dr. Donald Klein, Director Research Emeritus at the College of Physicians & Surgeons at Columbia University, has suggested a 3 year "patent" on those data, after which any researcher may use them to pursue independent analysis even if original authors decline involvement.

Clearly, further elaboration on this idea is needed, but promotion of transparency is the most intellectually honest way to address questions about research findings. Blanket refusal to consider research for publication is an affront to good-faith investigators no matter who sponsors their work."

* see Data Availability Policy of the American Economic Review at http://www.aeaweb.org/aer/data_availability_policy.html

—Sally Satel, M.D, is a resident scholar at American Enterprise Institute and the staff psychiatrist at the Oasis Clinic in Washington, D.C. Her most recent books include One Nation under Therapy (St. Martin's Press, 2005) and The Health Disparity Myth (AEI Press, 2006).