Mainstream Media "Discovers" Conflicts of Interest of Prominent Health Policy Pundit

The main-stream media, in this case the San Francisco Chronicle, just "discovered" an important case of a conflicted health policy pundit,

Uwe Reinhardt, a Princeton economic professor who often writes about health care for the New York Times' Economix blog, earns more than $500,000 a year working for a number of health care companies. He also holds more than $5 million worth of related stock.

Reinhardt's NYT bio does not mention these financial relationships.

As the NYTPicker points out, Reinhardt's various incomes break the New York Times rules, which ban anyone who writes for the paper from having any financial interest 'in a company, enterprise or industry that figures or is likely to figure in coverage that he or she provides, edits, packages or supervises regularly.'

We asked the New York Times for comment. They sent us this email:

'Professor Reinhardt is a leading expert on the economics of health care, and has provided valuable and independent insights in his blog posts. He has mentioned his service on corporate boards in the blog, but we are reviewing how to more fully describe his activities for readers of Economix.'

We also asked Reinhardt for comment. He is working on one for us and we will post it here as soon as possible.

Here's the breakdown of what he owns, according to NYTPicker:

* Reinhardt either earns an income or stock options from the five different private health care companies for which he sits on the board of directors/serves as a trustee.
* He has sat on the board of health care company, Amerigroup, since 2003. This tenure has resulted in Reinhardt's accumulation of 144,558 shares in the company and $226,531 in cash-and-stock compensation. These shares are currently valued around $4.8 million.
* Reinhardt also holds 75,625 shares of Boston Scientific (worth more than $500,000 in value) and earned $213,132 from the company in 2009. He has sat on the board of this medical device manufacturing company since 2005.
* Reinhardt serves as a trustee for H&Q Healthcare Investors and H&Q Life Science Investors. His 2008 income from the companies included $43,000 in income and between $1 and $10,000 worth of securities.
* He also made $2.3 million from the 2007, $5.1 billion sale of Triad Hospitals to Community Health Systems.

It only took four years for this to get into the main-stream media. The reason "discovered" is in quotes is that we have been writing about Reinhardt's conflicts of interests vis a vis his prominent opinions on health policy since 2006 on Health Care Renewal.

As I wrote in a comment on the original NYTPicker post, in 2006, we first wrote about a letter to the editor of the NY Times by Reinhardt dismissing a physician op-ed writer's concerns about what has gone wrong with health care.  Reinhardt's letter failed to disclose the board memberships he held at that time. In 2009, we wrote about how Reinhardt left out some crucial facts in his discussion in the Economix blog of how physicians are paid. That year we also wrote about how Reinhardt defended Ms Karen Ignagni, CEO of America's Health Insurance Plans (AHIP) in an interview quoted in a Washington Post article.

In neither case above did Reinhardt or the newspaper reveal his conflicts.

Note that Reinhardt is not the only case of a prominent health policy expert with undisclosed conflicts of interest. See this post for some examples we had found in 2006.

In fact, in my humble opinion, the public discourse about health care policy in general, and health care reform in particular has been seriously distorted by various commentators, pundits, and experts who have major conflicts of interest, usually in the form of important financial relationships with large health care organizations.  In many cases, these conflicts are not disclosed.  A related problem is the influence of various non-profit organizations that are heavily funded by those with vested interests, usually in selling particular health care products or services.  Such funding is also rarely disclosed. 

I further submit that this distortion has overwhelmingly been in favor of various aspects of the status quo that have been so profitable for the discussants, and their commercial sponsors.  This distortion has meant that certain important problems, especially those that we discuss on Health Care Renewal, are rarely even mentioned in the mainstream media, in journals on health care and services research and health policy, and in political discussion.  Try, for example, to find any discussion of the impact of ill-informed, self-interested, conflicted or corrupt leadership of prominent health care organizations on costs, access and quality, or on patient outcomes.  It is simply not done to discuss the shortcomings of leadership, maybe because it is this leadership who subsidizes many of the pundits, commentators and experts. 

At a minimum, participants in the health policy discussion, starting with the most prominent, should fully disclose all financial relationships that could constitute conflicts of interest. 

Meanwhile, those listening to the discussion should be extremely skeptical about the opinions expressed. 

An Alliance on Mental Illness or for Pharmaceutical Companies?

A recent article by Gardner Harris in the New York Times focused on the financial links among health care corporations and not-for-profit disease (or patient) advocacy groups.

A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

However, he tried to downplay the influence of the pharmaceutical industry on the Alliance.

'I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,' Mr. Fitzpatrick said. 'It’s simply not true.'

Note the careful wording of this denial, though. He did not deny that most of what NAMI cares about is pharmaceuticals.

Moreover, the article suggested how cozy pharmaceutical companies and the Alliance's leadership have become.

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

'For the past five years, Bristol-Myers has sponsored this dinner at the highest level,' Dr. Feinstein said.

He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that 'now, more than ever, our enduring relationship with NAMI must remain strong.'

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits.

In a letter today to the NY Times, NAMI Executive Director Fitzpatrick tried again to correct "misimpressions."

First, the National Alliance on Mental Illness, or NAMI, has always disclosed corporate and foundation sources of revenue. Until this year, specific amounts remained private for competitive fund-raising reasons.

Second, your estimate that pharmaceutical companies account for three-quarters of “donations” has been misinterpreted as a share of NAMI’s total annual budget — which is actually about 50 percent.

Perusal of the 2008 NAMI Annual Report does include this impressive list of "Corporate Partners":

Abbott
Alexza Pharmaceuticals
Amazon
AstraZeneca
Blue Cross Blue Shield
Bristol-Myers Squibb
College of Psychiatric and Neurologic
Pharmacists
Corcept Therapeutics
Cyberonics
Delivery Agent, Inc.
Forest Laboratories
GEO Care
GoodSearch.com
The Health Central Network
Janssen Pharmaceutica
Eli Lilly and Company
Magellan Health Services
McNeil Pediatrics
Neuronetics
Novartis
Otsuka America Pharmaceuticals
Pfizer
PhRMA
RF Binder
Sanofi-Aventis
Shire
Solvay
Validus Pharmaceuticals
WellPoint
Wyeth
YTB Travel Network

The NAMI web-site now includes lists of specific corporate donations that individually exceeded $5000 since the beginning of 2009. So far this year, the biggest pharmaceutical corporate donors appear to be AstraZeneca ($350,000), Bristol-Myers-Squibb ($506,205), and Eli Lilly ($675,500). 

Looking at the latest Form 990 filed on behalf of NAMI with the US Internal Revenue Service (available from GuideStar here)  provides more interesting detail. (Keep in mind that the 2008 form covers July 1, 2007 to June 30, 2008.)   This form listed the organization's total revenue as $13,788,288, and expenses as $12,796,205.  These expenses included $1,785,060 (13.9%) for management and $1,520,637 (11.9% ) for fund-raising.  The form listed eight NAMI executives who made more than $100,00 a year, including Mr Fitzpatrick ($210,685 total compensation).

So, in summary, it appears that corporate donations, mainly from a few large pharmaceutical companies, supply a substantial portion, (maybe half, if I read the letter by Mr Fitzpatrick correctly) of the annual budget of NAMI. About one-quarter of that budget is spent on administration and fund-raising, including six-figure salaries for at least eight executives.  So who do you expect would more easily get access to the $200K+/year NAMI Executive Director, an executive of a pharmaceutical firm that supplies more than $500,000 a year, or a NAMI member who pays $35 dues?

Here we have another example of a respected patient advocacy organization which gets a substantial portion of its revenue from (presumably the marketing departments of) a few large pharmaceutical companies.  (See another example here.)  Its well-paid executive director can at best bring himself to deny that the only purpose of the organization is to support pharmaceutical marketing and lobbying.  It seems reasonable that for supplying half the budget, the pharmaceutical companies expect considerable help not only with marketing but also with advocacy of policies that favor their corporate goals. 

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy.  If ostensibly not-for-profit disease (or patient) advocacy organizations like NAMI want to continue to accept corporate money, they should make it clear that they speak for their corporate donors as well as, and probably with priority over their members and patients with the diseases of interest.  Well-intentioned people who pay their dues, and/or make small contributions to NAMI to help the mentally ill might want to consider whether they are likely to have any influence compared to the individual pharmaceutical executives who oversee $500,000+ a year corporate donations.

ADDENDUM (2 November, 2009) - See also comments on the Furious Seasons blog.

How "Independent" a Source of Health Care Reform Data?

This week, a Washington Post article discussed who provides the data being cited in the ongoing US debate about health care reform.

The political battle over health-care reform is waged largely with numbers, and few number-crunchers have shaped the debate as much as the Lewin Group, a consulting firm whose research has been widely cited by opponents of a public insurance option.

To Rep. Eric Cantor (Va.), the House Republican whip, it is 'the nonpartisan Lewin Group.' To Republicans on the House Ways and Means Committee, it is an 'independent research firm.' To Sen. Orrin G. Hatch (Utah), the second-ranking Republican on the pivotal Finance Committee, it is 'well known as one of the most nonpartisan groups in the country.'

But how independent is the Lewin group?

Generally left unsaid amid all the citations is that the Lewin Group is wholly owned by UnitedHealth Group, one of the nation's largest insurers.

More specifically, the Lewin Group is part of Ingenix, a UnitedHealth subsidiary that was accused by the New York attorney general and the American Medical Association of helping insurers shift medical expenses to consumers by distributing skewed data. Ingenix supplied UnitedHealth and other insurers with data that allegedly understated the 'reasonable and customary' doctor fees that insurers use to determine how much they will reimburse consumers for out-of-network care.

In January, UnitedHealth agreed to a $50 million settlement with the New York attorney general and a $350 million settlement with the AMA, covering conduct going back as far as 1994.

Ingenix's chief executive, Andrew Slavitt, said the company's data was never biased, but Ingenix nonetheless agreed to exit that particular line of business. 'The data didn't have the appearance of independence that's necessary for it to be useful,' Slavitt said.

Lewin Group Vice President John Sheils said his firm had nothing to do with the Ingenix reimbursement data. Lewin has gone through 'a terribly difficult adjustment' since it was bought by UnitedHealth in 2007, he said, because the corporate ownership 'does create the appearance of a conflict of interest.'

'It hasn't affected . . . the work we do, and I think people who know me know that I am not a good liar,' Sheils said.

Is it only an appearance of conflict, and how objective is the Lewin Group's work?

Lewin's clients include the government and groups with a variety of perspectives, including the Commonwealth Fund and the Heritage Foundation. A February report by the firm contained information that could be used to argue for a national system known as single-payer, the approach most threatening to insurers, Sheils noted.

But not all of Lewin's reports see the light of day. 'Let's just say, sometimes studies come out that don't show exactly what the client wants to see. And in those instances, they have [the] option to bury the study,' Sheils said.

So, in summary, a group providing ostensibly "independent" data and opinions about an important health care policy debate is actually a subsidiary of a commercial managed care organization/ health care insurance company which clearly has vested interests in certain policy options. While the consulting group apparently struggles to be objective, its top leader reported that is fashions its reports at the behest of its clients, and that clients can "bury" reports that offend them, possibly because they do not serve their vested interests.

It is not surprising that participants in the current, noisy debate about health care reform, like many other health policy debates, have vested interests, and that their positions are likely to promote these interests. However, what should at least be disturbing is how often those with vested interests try to appear to be disinterested and independent. Should we trust "independent" voices that actually are conflicted, or those who cite "independent" views that actually come from interested parties?

By the way, we first posted about the Lewin Group's actual status as an Ingenix, and hence UnitedHealth subsidiary here in January, 2009, and first posted about how its contribution to the current health care reform debate was being touted as independent here in April, 2009. That a news organization with the status of the Washington Post is now picking up this story suggests a little optimism that the anechoic effect might be weakening.

What Influenced a Paean to Karen Ignagne?

As the discussion here in the US about health care reform gathers steam, the Washington Post published a rather uncritical profile of one of the prominent participants, Ms Karen Ignagni, CEO of America's Health Insurance Plans (AHIP), the trade group for the health insurance/ managed care industry. It included some compliments from Princeton Professor and prominent health care economist Uwe Reinhardt:

'Whatever AHIP pays her, it's not enough. She's unbelievably effective,' said Princeton economist Uwe Reinhardt. 'It's just amazing what she's achieved for them against all odds.'

Ignagni's total compensation, according to AHIP's most recent filing from 2007, was $1.58 million, which includes $700,000 in base salary, $370,000 in deferred compensation and a bonus. Ignagni won't say how many hours a week she works. The number's so high it's embarrassing, she said.

Among successes cited by Reinhardt and others is helping persuade the Bush administration to develop private insurance plans within Medicare that are producing unexpectedly high payments for private insurers.

What the Washington Post article did not bother to mention was that in addition to being on the Princeton faculty, Professor Reinhardt is a member of the board of directors of Amerigroup, a health insurance company specializing in providing Medicaid and Medicare managed care (see this previous post), and a member of AHIP. Former Amerigroup CEO Jeffrey McWalters was on the board of AHIP. According to Amerigroup's 2009 proxy statement, Professor Reinhardt controls (via ownership or options) 144,558 shares of Amerigroup stock, and received $226,531 in compensation from Amerigroup in 2008.

Perhaps Professor Reinhardt's enthusiasm for Karen Ignagne's performance as CEO of AHIP derived more from his leadership of Amerigroup than a scholarly analysis.

Note also that Professor Reinhardt is a member of the board of directors of Boston Scientific, a medical device company. Furthermore, per proxy statements from the above companies, Professor Reinhardt is on the board of two funds from H&Q Healthcare Investors, and is a Trustee of Duke University and the Duke University Health System.

Professor Reinhardt's leadership roles in US publicly traded corporations are public, but not easily found unless one knows where to look. We had first discussed these relationships on Health Care Renewal in 2006. However, many of the more academically tinged biographies of him publicly available omit his leadership roles in the for-profit world. At the moment, biographies of Professor Reinhardt on the Princeton web-site, and furnished by the Princeton Bioethics Forum, the Commonwealth Fund, and the Henry J Kaiser Foundation did not note these relationships.

This illustrates once more participation in the current health policy debate may be driven by vested interests, rather than ideology, much less dispassionate analysis. Were the participants yo disclose, at least, their financial interests, the debate would become that much clearer. Meanwhile, when listening to the debate, always ask, "cui bono?" (Who benefits?)

Hat tip to the Health Care Blog.

BLOGSCAN - Comparative Effectiveness Research, the Partnership to Improve Patient Care, and PhRMA

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody dissected a campaign to redirect comparative effectiveness research by making it responsible to a new governing board that would include "insurance" and "industry" members. And surprise, surprise, the campaign is run by the Partnership to Improve Patient Care, a group that seems to have multiple connections to PhRMA, the pharmaceutical industry trade organization. More stealth health policy advocacy?

"A Breach of Trust"

This new variation on a now old theme first appeared in the New York Times:

A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday.

An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.

'It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,' Colonel Coots said in a telephone interview on Tuesday. 'So this really was all falsified information.'

The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.

Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.

Army investigators found that Dr. Kuklo forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army’s required permission to conduct the study.

In its March edition, at the Army’s request, the journal retracted the article — something that has gone largely unnoticed outside orthopedic circles.

While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.

A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a paid consultant to the company and that the company financially supported some of his research at Walter Reed, through a foundation affiliated with the hospital.

During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.

Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records.

'It is a significant breach of academic protocol,' Colonel Coots said. 'It’s a breach of trust.'

This story has several familiar elements, but combines them in some interesting ways.

We have discussed how health care corporations, particularly pharmaceutical manufacturers, cultivate "key opinion leaders," and use them to market their products. This may amount to stealth marketing, since KOLs rarely disclose in detail their relationships with corporate sponsors, and instead further their marketing objectives cloaked as academics.

We have also discussed how health care corporations, particularly pharmaceutical manufacturers, may sponsor clinical research on their own products. However, such sponsors often manipulate the research projects' design, implementation, analysis, and dissemination so as to favor their products. While the sponsorship may be disclosed, the extent of the sponsors' control over the project may not be. Furthermore, scientific investigators running such projects may have their own personal financial relationships with the sponsors.

This case apparently shows how a medical academic can both be a paid "key opinion leader," and manipulative clinical researcher. While many examples of key opinion leaders as stealth marketers, and manipulated research involved pharmaceutical companies, this one involves a medical device company. In addition, this research project was not just manipulated, but allegedly falsified.

This variation has at least one other interesting element. Again, from the New York Times,

A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was “strong” and the episode had been overblown.

According to the Center for Public Integrity Paper Trail blog,

A former colleague of Kuklo’s at Walter Reed Army Medical Center, Dr. David W. Polly Jr., took even more expensive trips than Kuklo. Polly went on at least 12 Medtronic-sponsored trips costing about $30,000, including a $10,000 trip to Switzerland.

Furthermore, the New York Times reported,

[Senator Charles] Grassley, the ranking Republican [from Iowa] on the Senate Finance Committee, has been investigating since last year whether Medtronic illegally promoted unapproved uses for Infuse. Medtronic, which has denied that accusation, provided him last year with a list of Infuse consultants.

After Dr. Kuklo’s links to Medtronic and Infuse came to light last week in a New York Times article, Mr. Grassley’s staff checked the consultants list and noted that Dr. Kuklo’s name was not on it. In reaction, he wrote a letter to Medtronic’s president and chief executive, William A. Hawkins III, asking why Dr. Kuklo had been omitted. Mr. Grassley entered that letter and the list he had received into The Congressional Record.

'In the future, I hope that instead of not providing me with the name of the physician involved in Infuse, or any other matter that I am looking into, that Medtronic contact me to avoid the situation in which we find ourselves,' Mr. Grassley wrote to Mr. Hawkins.

So, as soon as this case came to light, the spinning of public discussion to favor Medtronic and its key opinion leaders began. Thus, this case also involved stealth policy advocacy. Stealth marketing, clinical research manipulation, and stealth advocacy all in one case, we seem to have hit the jackpot.

The most recent development, again according to the NY Times, is

Dr. Timothy R. Kuklo, a former Army physician accused of falsifying research involving injured soldiers, has taken a leave of absence from the Washington University School of Medicine in St. Louis and its affiliated hospitals, the medical school said Friday.

Dr. Kuklo, an associate professor of orthopedic surgery, will not be performing operations, conducting research or teaching students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo 'can focus on responding to queries about his research and consulting.'

At least his absence was not ascribed to the need to spend more time with his family or pursue other opportunities.

Finally, note that we posted last year that Medtronic had submitted to a corporate integrity agreement after the US Department of Justice accused it of defrauding Medicare in connection with activities by its Kyphon subsidiary. So this case additionally suggests that such agreements have little effect on the actual integrity of corporate leaders.

Hat tip to and see further commentary by Prof Margaret Soltan on the University Diaries blog.

ADDENDUM (24 May, 2009) - see further comments by Prof Soltan on the University Diaries blog.

Who Is Warning Us About the Perils of a Government-Run Public Health Insurance Plan?

There has been considerable discussion lately about whether the US government should offer a publicly run health insurance plan similar to the current Medicare program for the elderly and disabled. A recent report has thrown a bit of cold water on the idea, as noted in this AP article:

A public health insurance option for middle class families could help cover the uninsured but it may well put private insurers out of business, a respected consulting firm concluded in a study released Monday.

The report by the Lewin Group, a numbers-crunching firm that serves government and private clients, said it all depends on details that lawmakers are far from deciding. Nonetheless, the report could provide ammunition for critics who say a public plan would move in the direction of government-run medicine.

President Barack Obama and many Democrats want to create a government insurance plan to compete with private plans that now cover about 170 million Americans. The issue is major sticking point for Republicans and the insurance industry.

The Lewin study found that if such a plan were open to all employers and individuals, and if it paid doctors and hospitals the same as Medicare, the government plan would quickly grow to 131 million members, while enrollment in private insurance plans would plummet.

'The private insurance industry might just fizzle out altogether,' said John Sheils, a Lewin vice president and leading author of the study.

By paying Medicare rates the government plan would be able to set premiums well below what private plans charge. Monthly premiums for family coverage would be $761 in the government plan, compared with an average of $970 in private plans, the study estimated. Employers and individuals would flock to the public plan to cut costs.

This new report by the Lewin group also provided more ammunition to politically conservative commentators opposed to a public health insurance plan, e.g., see this link.

I am not going to comment on the substance of the report, or the argument over the merits of a public health insurance plan, save to note that in my humble opinion, the biggest danger of such a plan would be to further exaggerate differences in payments made to primary care and other "cognitive" physicians and to physicians who mainly do procedures. We have posted before (e.g., here) on how Medicare has come to fix payments to favor procedures and disfavor primary care and other cognitive services. Increasing the number of patients covered by Medicare or a Medicare-like plan, without changing the current Medicare payment system, would only make these discrepancies worse. Note that this potential problem with the public health insurance plan was not mentioned in the Lewin Group report.

Perhaps the nature of the Lewin Group influenced what this report did and did not emphasize. The group was described above as an independent consulting firm. Its web-site says it is "a premier national health care and human services consulting firm." It also claims:

The Lewin Group is committed to independence and integrity in our work. We combine professional expertise with extensive knowledge and a rigorous approach to analyzing and solving problems to deliver value to each of our clients and to the larger community as well.

That's a somewhat self-contradictory assertion. It seems that delivering "value" to specific clients might be hard to do while maintaining "independence."

Perhaps considering the nature of the Lewin Group's clients would clarify things. The group says its clients include "hospitals, health systems and providers;" "payers / insurers;" and "pharma/bio/device." The middle group seems most germane to a debate about The services provided to them include:

The Lewin Group helps payers and insurers succeed in complex government, commercial, and long-term care markets.

Based on our more than 20 years of experience, The Lewin Group offers our clients detailed understanding of the competitive marketplace and the expectations of purchasers. Based on rigorous, data-driven research, we provide our clients with actionable information grounded in practical, real-world advice.

Our understanding of public policy through our work with government entities, including Medicaid and SCHIP, helps us understand how policies are shaped and how they impact our clients. With this insight, we help our clients strategize and succeed in public programs and new product offerings.

So, the Lewin Group specifically offers to help insurers succeed in a complex market partially controlled by government. Maybe this orientation had some influence on the report they published now being used to support arguments for private, commercial health insurance.

Finally, who owns the Lewin Group? The description provided in the news story above suggests it is independent, and perhaps is even not-for-profit. Per Lewing Group web-site, it is neither:

The Lewin Group is an Ingenix company. Ingenix, a wholly-owned subsidiary of UnitedHealth Group, was founded in 1996 to develop, acquire and integrate the world's best-in-class health care information technology capabilities.

Ingenix has been in the news lately. See our posts here, here, and here about legal settlements of charges that large health care insurance companies used a database created and allegedly manipulated by Ingenix to underpay out of network claims. So, the Lewin Group is a part of Ingenix, an organization that just settled claims that it manipulated data about insurance payments.

Furthermore, Ingenix is in turn part of UnitedHealth. It is amazing how often UnitedHealth's antics have provided grist for the Health Care Renewal mill. See this post for a summary of the company's more recent escapades.

For balance, I must note that the Lewin Group web-page asserts:

The Lewin Group operates with editorial independence and provides its clients with the very best expert and impartial health care and human services policy research and consulting services.

But again, note that the focus is on making clients happy, not providing the public with unbiased knowledge.

So a report being used to support arguments against government-run health insurance was published by a subsidiary of one of the largest commercial health care insurance companies and managed care organizations, a subsidiary that just settled charges that it manipulated data to increase insurance company profits.

With a new administration in the White House, there is new interest in health care reform. It is not surprising that this has inspired some vigorous discussion. Nor is it surprising that some of the discussion comes from those with vested interests to protect. They have, of course, every right to make their views known. But it would be a more honest discussion if everyone were willing to put their vested interests on the table.

The Attack on Government Funded Comparative Effectiveness Research

A provision in the massive US stimulus bill passed by the US Senate to fund comparative effectiveness research has generated considerable criticism. As Alicia Mundy, reporting in the Wall Street Journal, wrote:

The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.

The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. 'We should focus on producing the best unbiased science possible,' said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.

Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.

Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.

A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used 'in an inappropriate manner that may limit treatment options for patients.'

A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.

In an op-ed column for Bloomberg News that got wide attention, Betsy McCaughey, who is described as, "former lieutenant governor of New York and is an adjunct senior fellow at the Hudson Institute," wrote:

Tragically, no one from either party is objecting to the health provisions slipped in without discussion. These provisions reflect the handiwork of Tom Daschle, until recently the nominee to head the Health and Human Services Department.

Senators should read these provisions and vote against them because they are dangerous to your health.

In his book, Daschle proposed an appointed body with vast powers to make the 'tough' decisions elected politicians won’t make.

The stimulus bill does that, and calls it the Federal Coordinating Council for Comparative Effectiveness Research (190-192). The goal, Daschle’s book explained, is to slow the development and use of new medications and technologies because they are driving up costs.

The elderly will bear the brunt.

Medicare now pays for treatments deemed safe and effective. The stimulus bill would change that and apply a cost- effectiveness standard set by the Federal Council.

And a Wall Street Journal editorial warned:

The true political goal is cost control. For the Pete Stark Democrats whose ambition is Medicare for all -- no exceptions -- giving government exclusive control over electronic health information and reporting is a step toward "comparative effectiveness" research. That in turn will be used to impose price controls and deny some types of medical treatment and drugs. And because government is able to skew the whole health system through Medicare and Medicaid, comparative effectiveness could end up micromanaging the practice of medicine.

Of course, it is one thing to put comparative effectiveness research funding in a bill, and another thing to implement those funds to support research. There are all sorts of ways comparative effectiveness could go wrong. There is room for debate about how it ought to be done.

However, comparative effectiveness research, done right, has the potential to help doctors make better decisions that will help patients have better outcomes of care. As I have argued before,

Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compared individual treatments to placebos, and when even those were restricted to narrow patient populations unlike those patient usually seen in daily practice, physicians are left juggling oranges, tomatoes, and carburetors.

Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients.

It may be that some who protest comparative effectiveness are more worried about promoting products which good comparative effectiveness research might find are not as effective as their advertising says they are, than about physicians being hassled and micro-managed. We posted previously (here and here) about some particularly poorly crafted arguments against comparative effectiveness research. Some especially illogical arguments against it were made by people with important, albeit sometimes indirect financial relationships with health care corporations whose products may not prove so comparatively effective (here and here).

As Alicia Mundy's article noted above, the Partnership to Improve Patient Care seems to be at least partially controlled and funded by elements of the pharmaceutical, biotechnology, and device industries. Not only does its steering committee include the Advanced Medical Technology Association, the Biotechnology Industry Organization, and the Pharmaceutical Research and Manufacturers of America (PhRMA), but spot checks reveal that several of the disease advocacy organizations in its steering committee have significant relationships with pharmaceutical, biotechnology and/or device companies. For example, the 2007 annual report from the Alliance for Aging Research listed the organization's board as including executives of Omnicare Clinical Research, GlaxoSmithKline, Procter & Gamble, Guidant, Merck, Johnson & Johnson, and Novartis. The 2007 annual report of the National Alliance for Mental Illness (NAMI) lists corporate partners including Abbott Laboratories, AstraZeneca, Bristol-Myers-Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Janssen (part of Johnson & Johnson), McNeil, Otsuka America Pharmaceutical, Pfizer, PhRMA, Solvay Pharmaceuticals, Vanda Pharmaceuticals, and Wyeth.

Not noted in Betsy McCaughey's op-ed article was that she is currently on the board of directors of Cantel Medical, a device company, and formerly on the board of Genta, a biotechnology company.

Comparative effectiveness research controlled by government bureaucracies could be done clumsily. Government oversight has the potential to tilt comparative effectiveness research more towards cost-containment than to finding the best tests and treatments for individual patients. But if oversight of government comparative effectiveness is transparent, and its leadership excludes people with vested interests in the research producing particular results, we can be hopeful that its results could be unbiased and helpful.

Up to now, however, we have left industry to fund, control, and too often suppress and manipulate clinical research about its own products, so that the results are better at putting particular products in a good light than providing doctors and patients with the best, most unbiased information needed to make decisions. Unless we really make a hash of its leadership and governance, government funded comparative effectiveness research has the potential to improve health and health care.

Who Supports Fibromyalgia Patient Advocacy?

The Associated Press just published a story on the marketing of drugs for fibromyalgia, which provided a window into relationships among pharmaceutical companies and not-for-profit disease advocacy groups. One example was the National Fibromyalgia Association:

The drug industry's grants also help fill out the budgets of nonprofit disease advocacy groups, which pay for educational programs and patient outreach and also fund some research.

'If we have a situation where we don't have that funding, medical education is going to come to a screeching halt, and it will impact the kind of care that patients will get,' said Lynne Matallana, president of the National Fibromyalgia Association.

Matallana founded the group in 1997 after she was diagnosed with fibromyalgia. A former advertising executive, Matallana said she visited 37 doctors before learning there was a name for the crushing pain she felt all over her body.

A decade later, her patient advocacy group is a $1.5 million-a-year operation that has successfully lobbied Congress for more research funding for fibromyalgia. Forty percent of the group's budget comes from corporate donations, such as the funds distributed by Pfizer and Eli Lilly.

Pfizer gave $2.2 million and Lilly gave $3.9 million in grants and donations related to fibromyalgia in the first three quarters of last year, the AP found. Those funds represented 4 percent of Pfizer's giving and about 9 percent of Eli Lilly's.

Another example was the National Fibromyalgia Research Association:

Dr. Daniel Clauw of the University of Michigan said pharmaceutical industry market research shows roughly half are undiagnosed. People with fibromyalgia experience widespread muscle pain and other symptoms including fatigue, headache and depression.

Research by the University of Michigan's Clauw suggests people with fibromyalgia experience pain differently because of abnormalities in their nervous system. Brain scans show unusual activity when the patients experience even minor pain, though there is no abnormality common to all.

Clauw's work, however, illustrates the knotty issues of drug company funding. He has done paid consulting work for the drugmakers, and he's received research funding from the National Fibromyalgia Research Association, which receives money from the drugmakers.

By the way, the National Fibromyalgia Association's list of sponsors includes quite a few pharmaceutical companies in addition to Pfizer and Lilly:

Acorda Therapeutics
Cause Marketing, LLC
Citrucel
Cuddle Ewe
Eli Lilly
Fibronol
Forest Laboratories, Inc.
Ortho McNeil Pharmaceutical, Inc.
Pacific Life
Pfizer
Wyeth

The National Fibromyalgia Research Association's web-site is not so forthcoming, although I did find an acknowledgement that Lilly supported one NRFA conference in 2007 in the amount of $46,500.

This case illustrates the willingness of pharmaceutical companies (and likely other health care corporations) to support what appear to be grass-roots, not-for-profit disease advocacy groups when doing so coincides with corporate marketing objectives. Such "astroturf" organizations may help raise the profile of diseases for which the corporations market products, thus also helping to increase the market for these products, and may help further corporate health policy objectives.

With health care in flux due to new leadership in the US, and the global financial meltdown, look for stealth marketing and stealth health policy advocacy to increase.

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy.

Who Is Warning Us About a Shortage of Gastroenterologists?

We have frequently discussed the worsening shortage of primary care physicians and the current crisis in primary care. Now, in the NY Times is a story of a different kind of physician shortage:

The United States will face a severe shortage of gastroenterologists as the population ages and the demand for colorectal cancer screening increases, a health care consulting firm has projected.

At current rates of cancer screening, the United States will need an additional 1,050 gastroenterologists by 2020, according to the study by The Lewin Group.

Note that this isn't the proclamation of a current shortage, but the forecast of one to come. The Times did not provide a link to the report, nor explain the rationale for its prediction. Given that gastroenterologists are remunerated much better for their time spent doing colonscopies than primary care physicians are spend for their time spent taking care of patients sans procedures (see: Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here. ) , it is a little hard to believe that we will not be able to recruit sufficient gastroenterologists in the future, barring any radical change in how physicians are paid.

However, the NY Times article did note:

The projections were reviewed by outside experts and commissioned by Olympus Corporation of the Americas, which manufactures cameras used to screen for colorectal cancer.

Actually, Olympus manufactures not just the cameras, but the colonoscopes themselves (see their web-site, which states the company manufactures "a full line of diagnostic, therapeutic, slim and adult colonoscopes with the highest resolution available.")

Moreover the study was done by the Lewin Group, which was not further characterized in the NY Times article, but does often seem to be a source of authoritative pronouncements on health care policy. So what is the Lewin Group?

It's web-site says it is "a premier national health care and human services consulting firm." It also claims:

The Lewin Group is committed to independence and integrity in our work. We combine professional expertise with extensive knowledge and a rigorous approach to analyzing and solving problems to deliver value to each of our clients and to the larger community as well.

That's a somewhat self-contradictory assertion. It seems that delivering "value" to specific clients might be hard to do while maintaining "independence."

Who are Lewin's clients? We already know that Olympus, a company that makes more money if it sells more colonoscopes, sponsored this study of demand for colonoscopy. The Lewin Group says its clients include "hospitals, health systems and providers;" "payers / insurers;" and "pharma/bio/device." Furthermore, its explanation of its services to the latter group includes:

We provide analysis and results-focused strategies demonstrating the value of medical products to public and private sectors payers, clinicians, health care facilities, patients, and policymakers. We also provide policy insight and guidance to industry clients on evolving trends and their impacts.

"Results-focused strategies demonstrating the value of medical products" somehow seems more akin to marketing than objective policy analysis.

Finally, who owns the Lewin Group? It is not a not-for-profit, and it is not even an independent for-profit corporation. In fact, per the web-site,

The Lewin Group is an Ingenix company. Ingenix, a wholly-owned subsidiary of UnitedHealth Group, was founded in 1996 to develop, acquire and integrate the world's best-in-class health care information technology capabilities.

So, the Lewin Group is in fact part of UnitedHealth, a corporation that was until recently run by a CEO who became known for the more than a million of apparently back-dated stock options he received (see our post here).

For balance, I must note that the same web-page asserts:

The Lewin Group operates with editorial independence and provides its clients with the very best expert and impartial health care and human services policy research and consulting services.

But again, note that the focus is on making clients happy, not providing the public with unbiased knowledge.

One might further argue that it is not in the interests of UnitedHealth, as a commercial managed care organization, to pay for more and more colonoscopies. However, in the current US health care system, in which there have been more and more procedures, UnitedHealth has prospered, perhaps because it has been easy for it to simply past the costs of these procedures along.

At any rate, once again it's hard to tell who the players are in health care policy without a scorecard. As the health reform debate heats up, expect to see more authoritative proclamations coming from groups with vested interests other than simply providing unbiased expertise. Such groups, of course, have the right to make their views known. But it would be a more honest discussion if everyone were willing to put their vested interests on the table.

Thanks to one of our scouts for a tip on the ownership of the Lewin Group, and hat tip to KevinMD.

Astroturf Grows in Britain

This is just in case anyone thought this was only an American pheonomenon. As reported by the Independent.

The rising tide of protest over the refusal by the NHS to provide expensive drugs for cancer and other conditions is being funded by the pharmaceutical industry, an investigation by The Independent has revealed.

Patient groups that have been among the most vocal in spearheading attacks on the National Institute for Clinical Excellence (Nice) over decisions to restrict access to drugs on the NHS depend for up to half of their income on drug companies, but details are often undisclosed.

Protests have been launched by charities including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society. All of these charities received sums of up to six figures from drug companies in 2007.

The extent of the drug companies' support for the smaller charities has led to criticisms that supposedly grassroots patient organisations are puppets of the pharmaceutical industry, being used to bludgeon Nice into making the drugs available on the health service.

Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns.

The National Kidney Federation (NKF) accused Nice of taking a "barbaric, damaging and unacceptable" decision when it turned down four kidney cancer drugs for NHS use this year and pledged to campaign against the decision. It did not criticise the cost of the drugs, at more than £3,000 for a 30-tablet pack. Half the NKF's £300,000 budget comes from the pharmaceutical and renal industries.

The Arthritis and Musculoskeletal Alliance (Arma) organised a protest letter from 10 professors of rheumatology, published in The Sunday Times last month, over a recent Nice decision to restrict access to arthritis drugs. The letter made no mention of the cost of the drugs but Ros Meek, chief executive, admitted that "half, or more" of the charity's £147,000 income came from the drug industry.

The National Rheumatoid Arthritis Society described the same Nice decision as "another nail in the coffin" for arthritis treatment and launched an appeal against it this week, with Arma and three drug companies. The society received 49 per cent of its £300,000 budget from the pharmaceutical industry in 2005-06, reducing to 26 per cent of its £472,000 budget in 2006-07.

We have heard physicians and leaders of not-for-profit organizations funded by pharmaceutical companies and other commercial health care organizations protest again and again that their activities and decisions are uninfluenced by the source of their money. For example, we recently posted about the President of the US American College of Cardiology who revealed that this medical society receives 38% of its funds from the pharmaceutical industry, but has "firewalls" that prevent this sum of money from having any effect on how the organization operates. Yet, as the saying goes, "he who pays the piper calls the tune."

The current example, from the UK, highlights how organizations that get substantial commercial support never seem to manage to criticize the policies or actions of those who provide the support. One would think a charity devoted to the interests of patients with a particular disease might protest when drug companies charge outrageous prices for treatments for that disease, but as noted above, not one of the charities listed above did so.

So in the absence of transparency, accountability, and clear and enforced codes of ethics, those with health care goods or services to sell are more than happy to plow substantial funds into non-profit, "grassroots" organizations with the not unreasonable hope that such organizations will then promote the requisite marketing or policy agenda. Thus these supposed "grassroots" organizations are really astroturf, and allow their sponsors to engage in stealth health policy advocacy.

Hat tip to Ed Silverman on PharmaLot.

Another Industry-Supported Physician Defends Industrial Support of Medical Societies

The President of the American College of Cardiology (ACC), W Douglas Weaver MD, has written a second editorial on relationships between the ACC and industry, continuing medical education, and conflicts of interest. In his first editorial [ Weaver WD. President's page: disclosures, transparency, and firewalls protect integrity. J Am Coll Cardiol 2008; 52(11): 964-965. Subscription required.] his major points were:

Major activities of the ACC require industry funding - "the Annual Scientific Session would not be possible in its current form if it were not for industry grants and fees from the Exposition."

"Firewalls" provided by the society prevent influence by industry on educational or scientific programs -

Let me assure you that we have very strong firewalls around industry support.

As part of our firewall structure, the College has long-established policies that require strict segregation between the source of commercial support and the use of industry funding. The College adheres to internal and external policies that prohibit companies that provide support from exercising any influence or control over programmatic content, speaker/faculty selection, program format, planning, partnering arrangements, program evaluation methods, and related matters.

Most of the College's commercial support from pharmaceutical and medical device/equipment companies is used for a new or ongoing initiative. For example, the College may solicit support for an educational program on the management of patients with congenital heart disease. Commercial support, in cases such as this, is dedicated or directed to that special objective but with the contractual understanding by the supporter that they will have no influence on how the College uses the funds to support the objective. Unlike unrestricted educational or charitable grants, directed funds are restricted to the designated objective, but the College determines how to use them in accomplishing the objective.

My comment is that is well and good, but it is possible for financial sponsors to exert subtle pressure that such firewalls would not prevent. Sponsors are likely to support educational activities which address topics which can fulfill marketing objectives. In particular, it is often in the interests of such sponsors to highlight, or exaggerate the prevalence of a disease which the sponsor's product can be used to diagnose or treat; to emphasize, or over-emphasize the importance of that disease; and to emphasize, or over-emphasize the benefits and deemphasize the harms of treating the disease. Presentations and publications which have such effects can help the sponsor's marketing objectives, without making crass, overt pitches for its products. It is likely that a professional society which needs substantial support from commercial sponsors will somehow end up providing educational and research presentations that help, or at least do not conflict with sponsors' marketing objectives. It is also likely that a society which needs such support will rarely provide presentations that are critical of these sponsors, their products, and their actions.

In a second article just out [Weaver WD. President's page: understanding the implications of conflict of interest issues. J Am Coll Cardiol 2008; 52(15): 1274-1275] Dr Weaver quantified the amount of support the ACC gets from industry, and again advocated such support as necessary:

Many of you are probably aware that industry supports a broad array of College activities including professional education, quality programs, the Annual Scientific Session Expo, and digital products through educational and other types of grants. This support, which constitutes about 38% of the College's revenues, enables the College to provide programs that we would otherwise not be able to offer. In addition, without this support, the registration fees for the Annual Scientific Session and i2 Summit would have to be more than double their present amount, and member dues would have to increase significantly.

My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete "firewall?"

Actually, it was not clear why so much external support was really necessary. The argument was not that the College could not continue its activities without the support. It was, instead, that the College would have to increase membership dues and meeting fees to do so. Perhaps College members would be willing to pay more to continue these activities to questions about industry influence on them? If College members, however, would not think that these activities are not worthy of their support via dues and fees, maybe these activities are not so important after all?

At the end of this first editorial, Dr Weaver declared:

The College does everything possible to ensure that our scientific and educational activities are protected from conflict of interest. Disclosure, transparency, and secure firewalls between commercial support and program content and implementation enable us to use such funding for education and other programs aimed at improving the quality of care to patients without sacrificing our integrity.

I would urge him to reconsider that. I do not have sufficient time or resources to scrutinize all the activities of the College, but I would not be surprised if an impartial assessment might show that they may tend to emphasize clinical areas most of interest to the College's commercial sponsors, while perhaps slighting other areas that are not of interest to them, but are still important to patient care. They may also want to take a skeptical look to see if these activities really are fully balanced in their assessment of the harms and benefits of sponsors' products and activities.

For example, a while back, we posted about an ACC statement that patients taking ezetimibe for cholesterol reduction should continue to take the drug after a controversy about a study which failed to show that the drug had any benefits. At that time, ezetimibe had never been shown to have any clear benefits on clinical outcomes, that is, it had never been shown to decrease symptoms, improve function, prevent morbid events, or prolong life. So why would the ACC advocate that patients continue to take a drug which may do no good? Could it have to do with previous funding the society had received from a company that makes the drug?


Finally, I urge Dr Weaver to take to heart his vigorous defense of transparency and disclosure. As noted above, he has now written two editorials that defend the substantial industry funding his organization receives, and deny the possibility that the large infusion of money could possibly affect organizational decision making. Yet in these editorials he did not disclose any of his own relationships with industry, which appear to be not insubstantial.

Several papers which he authored in the last few years disclosed that he had apparently significant financial relationships with pharmaceutical companies.

• Mahaffey KW, Granger CB, Nicolau JC et al. Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy in fibrinolysis in acute myocardial infarction. Circ 2003; 108: 1176-1183. Subscription required. This disclosed "Drs Mahaffey, Granger, Nicolau, Ruzyllo, Weaver, Theroux, Hochman, and Armnstrong have received consultation fees and/or research grants from Procter & Gamble Pharmaceuticals and Alexion Pharmaceuticals."
• Hudson MP, Armstrong PW, Ruzyllo W et al. Effects of selective matrix metalloproteinase inhibitor (PG-116800) to prevent ventricular modeling after myocardial infarction: results of the PREMIER (prevention of myocardial infarction early remodeling) trial. J Am Coll Cardiol 2006; 48: 15-20. Subscription required. This disclosed "this study was funded by Procter & Gamble Pharmaceuticals...." Furthermore, "Drs Ruzyllo, Quinones, Theroux, and Weaver received consultancy fees for participating on PREMIER Trial Expert Panel."
• The APEX AMI Investigators. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA 2007; 297: 43-51. Dr Weaver was listed as a member of "authors and steering committee members." The paper disclosed "members of the Steering Committee received honoraria for their participation." "The study was jointly funded by Procter & Gamble and Alexion Pharmaceuticals."
• Prisant LM, Thomas KL, Lewis EF et al. Racial analysis of patients with myocardial infarction complicated by heart failure an/or left ventricular dysfunction treated with valsartan, captopril or both. J Am Coll Cardiol 2008; 51:1865-1871. Subscription required. It disclosed "all of the authors have received grant support or consulting fees from the sponsor of the VALIANT (VALsartin in Acute myocardial iNfarcTion) study, Novartis, as well as from multiple other manufacturers of cardiovascular drugs."

In addition, a recent news articles in which Dr Weaver was interviewed also disclosed relationships with industry. This MedPage Today 2008 article disclosed "Dr Waver declared grant support from Proctor and Gamble and Schering-Plough and equity or stock interest in Acorn Cardiovascular."

So Dr Weaver seems to be another in a series of defenders of financial ties between physicians and medical societies and industry written by people who fail to disclose their own personal financial ties to industry. Perhaps having one's own cozy relationships with industry makes it hard to realize why people without such relationships may see them as a source of influence, if not outright bias. For other recent examples of stealth health policy advocacy, see this and this (which involved Dr Weaver's colleague, the editor of the JACC.)

I would submit that if medical societies want to avoid questions about their integrity, they ought to find ways to fund their activities through their members' dues and contributions, and without lavish contributions from industry, supposed "firewalls" notwithstanding.

An "Unfashionable" Pitch for More Academic-Industry Collaboration

The Wall Street Journal Health Blog reported

Marc Feldmann and Ravinder Maini, scientists from the Kennedy Institute of Rheumatology at Imperial College London ... [were] feted by Johnson & Johnson for work that paved the way for drugs called TNF inhibitors, used to treat rheumatoid arthritis and other inflammatory diseases.

The scientists won the second Dr. Paul Janssen Award for Biomedical Research, which carries a $100,000 prize and honors a legendary drug researcher at J&J.

Feldmann took the opportunity to opine on health science policy, making a pitch for even more cooperation between biomedical science and pharmaceutical and biotechnology companies.

From the podium at the New York Academy of Sciences, Feldmann made the case for closer collaboration between the drug industry and academia, not exactly the fashionable thing to say these days. Science, he said, is meant to be original and novel, while medicine is conservative and needs to be safe. The melding of the two is necessary for medical progress, but the process for doing so is 'ill-defined' and 'difficult.'

More efficient academic-industry interactions, he argued, would help increase the success rate for translating lab work into real-life medicine. The hurdles in the development of a drug that eventually became Remicade spoke to this notion. He and his colleague Maini approached several companies with their research on TNF before Centocor, bought by J&J in 1999, took them seriously.

Feldman said scientists understand the course of disease and how to make the most of innovative clinical trial methods, while companies understand products, regulatory requirements and marketing. The knowledge and skills are complementary, he said, and can 'augment success' for development of new therapies.

It was not clear from the article whether Prof Feldmann was only talking about collaboration on bench research, but the examples above suggest he was also talking about clinical research. In that case, he did not address the downsides of too much entanglement between companies who want to sell products and academics who are supposed to pursue the truth. These downsides, frequently discussed on this blog, include manipulation and suppression of clinical research by firms seeking results favorable to their marketing goals.

Feldmann's advocacy of policies to increase academic-industry collaboration ought to be viewed in light of his own relationships with industry. A quick Google search revealed that he is on the scientific advisory boards of multiple biotechnology companies, including Nuon Therapeutics, Receptor BioLogix Inc (note that only a cached version of their relevant web-site is available at the moment), and Trillium Therapeutics. He is a consultant to the research programme of Genesis Research and Development Corporation (see page 10 of this annual report.) He was also on the Roche Bioscience Advisory Board.

In my humble opinion, those who advocate particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who advocate particular approaches to clinical problems. Policy positions ought to be skeptically evaluated taking into account whether those expressing them stand to gain personally from what they advocate. Failure to adequately disclose conflicts of interest ought to inspire even more skepticism.

I fear much that too much the health policy debate amounts to stealth health policy advocacy.

What Influences Advocates of Providing "More, Not Less, Truthful Information" About Off-Label Drug Use?

Last week's New England Journal of Medicine included a letter [Troy DE, Gottlieb S. Pharmaceutical promotion and first amendment rights. N Engl J Med 2008; 359: 536. ] supporting pharmaceutical companies' rights to promote their products for uses not approved by the US Food and Drug Administration (FDA). The letter applauded "the robust, sound constitutional protection the U.S. Supreme Court affords truthful, nonmisleading commercial communication such as that embodied in reprints of scientific articles discussing off-label uses." It asserted "appropriate off-label use that informs proper patient care is fostered by more, not less, communication of truthful, nonmisleading information."

Policy discussions about issues such as this, I believe, would also benefit from the provision of "more, not less, communication of truthful, nonmisleading information."

The first author of this letter, Daniel E. Troy, identified his affiliation with the law firm Sidney Austin LLP, and disclosed that he "represents manufacturers who submitted comments to the Food and Drug Administration (FDA) on its draft reprint guidance."

Mr Troy did not disclose that he is the future general counsel of UK-based international pharmaceutical company GlaxoSmithKline. This appointment, effective September 2, 2008, was announced the week before the NEJM letter was published. (See this article in the Wall Street Journal.)

The second author, Dr Scott Gottlieb, did not disclose any potential conflicts of interest.

Thus, Dr Gottlieb did not reveal that he is on the board of directors of Molecular Insight Pharmaceuticals, a "a biopharmaceutical company specializing in the emerging field of molecular medicine." As a member of the board, Dr Gottlieb is expected to have "unyielding loyalty" to the stockholders and their financial interests.

I admit that as a strong advocate of free speech, I too have trouble with the idea that the FDA can restrict simple written or oral communication by a drug company's representatives about their products. (Gifts or payments to physicians as part of marketing efforts are very much another story.) So I do not have a big problem with the policy position Troy and Gottlieb took on this.

But I do believe that as advocates of more "truthful, nonmisleading information" they should disclose financial relationships that might influence the policy positions they are advocating. As it stands, without such disclosures, their letter to the NEJM amounted to stealth health policy advocacy, something we now see all to much of.

Criticism of Surrogate Endpoints in Whose Interests?

Last week, in an op-ed in the Wall Street Journal, Mark Thornton, lit into an inquiry launched by US Senator Charles Grassley (R-Iowa). Dr Thornton's concern was that Grassley was attacking the use of surrogate endpoints in clinical trials of drugs used to treat life-threatening conditions. Thornton was described as a "former medical officer in the Office of Oncology Products at the Food and Drug Administration," who also volunteers as "president of the Sarcoma Foundation of America."

Before discussing Dr Thornton's points, let me take a brief detour to explain surrogate endpoints. Ideally, physicians ought to prescribe treatments to alleviate pain and suffering, improve function, and delay death. So ideally treatments ought to be assessed on the degree they affect such endpoints. Often, however, trials designed to measure such endpoints are difficult, and often require prolonged observation of multiple patients. Thus, surrogate endpoints, which are those thought to correlate with such clinical endpoints, are studied instead.

Here is what Dr Thornton wrote about such endpoints:

At issue is the concept of 'surrogate endpoints' and the FDA's 'accelerated approval' regulations.

New laws and regulations ... created an accelerated approval mechanism by which a drug could be allowed on the market if it showed early evidence of an effect on a surrogate endpoint. For cancer, examples of surrogate endpoints are tumor shrinkage or a delay in the disease's progression.

This kind of measurement – as opposed to an assessment of a drug's impact on a patient's overall survival – has dramatically increased the pace of cancer clinical trials. It also has won near-universal acceptance within the cancer community.

The FDA does require follow-on studies to assure that a surrogate finding shows clinical benefit. But if all cancer clinical trials were required to show a survival benefit from the get-go, progress in cancer-drug development would slow to an absolute crawl.

The damage done by Mr. Grassley's decision to make an issue of this decision cannot be understated.

U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last. Companies may decide it is not financially viable to even bother developing new drugs, and the pipeline for new products to treat cancer could slow even more. Mr. Grassley's legacy could be thousands of additional cancer deaths.

I cannot comment on the political or bureaucratic issues raised.

But I do question Dr Thornton's uncritical acceptance of surrogate endpoints, and his assertion that any questioning of the use of such endpoints could lead to death and disaster.

The problem with surrogate endpoints is that they are surrogates for the real thing. In many cases, a treatment may appear beneficial when measured by its affect on such endpoints, but not turn out to be beneficial when measured by its affect on real clinical outcomes, e.g., alleviation of symptoms, improvement of function, and prolongation of survival. There are many reasons why this may be the case.

Consider, for example, cancer "progression-free surival," cited by Dr Thornton in his article. Progression-free survival means the time a patient survives without measurable evidence that his or her tumor has gotten worse. There are some obvious reasons why progression-free survival may not correlate with overall survival. First, a tumor may progress but its progression may go undetected. Second, although a treatment may inhibit progression for a while, a tumor could escape its effects, and thereafter progress more rapidly than it did before. Third, a treatment might retard tumor growth, but cause severe adverse effects that hasten death on their own.

Thus, the FDA usually requires studies not only of progression free survival, but eventually of overall survival. Approving a drug only on the basis of its effects on progression-free survival risks allowing the use of a drug that may eventually prove to have no effect on overall survival, and hence whose benefits may not outweigh its harms.

So, regardless of the politics involved, Dr Thornton's dire warning that Senator Grassley's inquiry could lead to "thousands of additional cancer deaths" appears way over the top.

Incidentally, soon after the article came out, Ed Silverman on the Pharmalot blog reported that Dr Thornton, in addition to his voluntary post with the Sarcoma Foundation of America, serves as Senior Vice President of Product Development for the biotechnology firm GenVec, which is attempting to develop drugs to treat cancer. Also, the Sarcoma Foundation of America is supported in part by pharmaceutical and biotechnolgy companies including Ariad, Ziopharm, Bristol Myers Squibb, Ortho Biotech, and Novartis.

So readers of Dr Thornton's op-ed on health policy vis a vis how treatments for cancer and other life-threatening diseases are evaluated by the FDA deserved to know that Dr Thornton works for a biotech companies whose products could end up being evaluated by the FDA, and that Dr Thornton leads a not-for-profit organization which appears to be sponsored in part by other drug and biotech companies whose products also are being evaluated by the FDA.

Whether or not these firms' concerns that limitation of the use of surrogate endpoints in drug approval could affect their profts affected Dr Thornton's thinking is unknown. However, this question would not likely have even occurred to readers who did not know about Dr Thornton's ties, direct and indirect, to these firms.

In lieu of such disclosures, Dr Thornton's original op-ed, appears to be a new and prominent example of stealth health policy advocacy.

Health care is in crisis in many ways. Policy-level solutions deserve to be discussed widely by all sorts of people representing all sorts of opinions, with all sorts of expertise and backgrounds. However, the discussion would be a lot more productive if those taking part were completely transparent about who they are, for whom they work, and whose interests they may serve.

What Influenced Derision of Evidence-Based Medicine as "One-Size-Fits-All?"

There he goes again. An op-ed a little while back by Peter J Pitts in the Washington Times took another whack at evidence-based medicine (EBM).

He started by saying all the current US Presidential candidates want to control health care costs using EBM.

One plan they all favor is ramping up federal funding for so-called 'evidence-based' medicine.

Pitts gave his own definition of EBM.

The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.

Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.

Furthermore, Pitts derided what he asserted was evidence-based medicine's "one-size-fits-all approach."

Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.

He concluded thus,

The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.

It is just amazing how little Mr Pitts' concept of EBM resembles that promoted by most EBM proponents. Contrast his concept of EBM with this one, written by one of the founders of the movement, Dr David Sackett, and colleagues [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens.

And here is a direct refutation, written 12 years ago, for Pitts' "one-size-fits-all" criticism.

Evidence based medicine is not 'cookbook' medicine. Because it requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.

One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient's clinical characteristics and personal values.

It makes no sense to call EBM a "one-size-fits-all" approach.

So Pitts' op-ed was basically one long straw man argument. He made up his own version of EBM, and then proceeded to knock it down. Why did he make the effort to give EBM a bad name?

Readers of the Washington Times op-ed were deprived of some clues to the motivation for his approach. The op-ed identified Mr Pitts as "president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration."

The Washington Times did not note that the Center for Medicine in the Public Interest, CMPI, received considerable industry support, as the NY Times did when it published an op-ed by Pitts lambasting comparative effectiveness research (see that article here, and our relevant post here.)

Furthermore, as we have noted before when he publicly criticized Dr Steve Nissen during the Avandia affair (see post here), and when he warned against restricting people with conflicts of interest from FDA advisory panels (see post here), Mr Pitts holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view. The Washington Times left all that out.

Presumably, Mr Pitts' pharmaceutical industry public relations clients may be worried about evidence-based medicine because rigorous EBM informed consideration may show that some of their products are not as good as their marketing hypes them to be. Perhaps that is the reason Mr Pitts had such an odd view of what EBM is, and felt so negative about what EBM might be able to do for health care.

At least, if Mr Pitts could be bothered to disclose where CMPI gets its financial support, and what his day job is, readers could make their own judgments about where his interests lie.

It is disappointing that a newspaper as influential as the Washington Times would publish a health policy article without disclosing all the author's relevant financial interests, particularly one so relevant and direct. Fostering more stealth health policy advocacy in ever more influential venues will just make the already confusing clamor about health care and its reform even muddier.

ADDENDUM (28 April, 2008) - See also these comments by Dr Alan Schwartz on the Making Medical Decisions blog.