Higher Authorities? - Pharmaceutical Companies, Addiction Experts, and Marijuana Policy

We have often discussed the web of conflicts of interest that is draped over medicine and health care, and seems responsible for much of our current health care dysfunction.  We have discussed examples of conflicts of interest affecting clinical research, clinical teaching, clinical care, and health care policy.  Each time I think we must have cataloged all the useful examples, a striking new one appears.

So, let us get down into the weeds, so to speak, in the trendy new area of marijuana policy.

I am not about to express an opinion on whether marijuana will prove to be useful in health care, but certainly some people are advocating that it might be while others are advocating for the decriminalization or legalization of marijuana for social and health reasons.  Others, of course, do not agree.

Now Vice News, which advertises itself as "an international news organization created by and for a connected generation," has published an article by investigative journalist Lee Fang about conflicts of interest, key opinion leaders, and marijuana policy.  Its main premise was,

As Americans continue to embrace pot—as medicine and for recreational use—opponents are turning to a set of academic researchers to claim that policymakers should avoid relaxing restrictions around marijuana. It's too dangerous, risky, and untested, they say. Just as drug company-funded research has become incredibly controversial in recent years, forcing major medical schools and journals to institute strict disclosure requirements, could there be a conflict of interest issue in the pot debate?

VICE has found that many of the researchers who have advocated against legalizing pot have also been on the payroll of leading pharmaceutical firms with products that could be easily replaced by using marijuana. When these individuals have been quoted in the media, their drug-industry ties have not been revealed.

The article profiled three prominent physicians who advocate against easing rules on marijuana.  The first was Dr Herbert Kleber, a Professor of Psychiatry and Director of the Division of Substance Abuse at Columbia.  Per the article, he

has been quoted in the press and in academic publications warning against the use of marijuana, which he stresses may cause wide-ranging addiction and public health issues.

However,

what's left unsaid is that Kleber has served as a paid consultant to leading prescription drug companies, including Purdue Pharma (the maker of OxyContin), Reckitt Benckiser (the producer of a painkiller called Nurofen), and Alkermes (the producer of a powerful new opioid called Zohydro).

Then there was Dr A Eden Evins, Associate Professor of Psychiatry at Harvard and Director of the Center for Addiction Medicine at the Massachusetts General Hospital,  who

is a frequent critic of efforts to legalize marijuana. She is on the board of an anti-marijuana advocacy group, Project SAM, and has been quoted by leading media outlets criticizing the wave of new pot-related reforms. 'When people can go to a 'clinic' or 'cafe' and buy pot, that creates the perception that it's safe,' she told the Times last year.

But,

when Evins participated in a commentary on marijuana legalization for the Journal of Clinical Psychiatry, the publication found that her financial relationships required a disclosure statement, which noted that as of November 2012, she was a 'consultant for Pfizer and DLA Piper and has received grant/research support from Envivo, GlaxoSmithKline, and Pfizer.' Pfizer has moved aggressively into the $7.3 billion painkiller market. In 2011, the company acquired King Pharmaceuticals (the makers of several opioid products) and is currently working to introduce Remoxy, an OxyContin competitor.

Finally, there was Dr Mark L Kraus, described as a private practitioner and board member of the American Society of Addiction Medicine (ASAM).  He

submitted testimony in 2012 in opposition to a medical marijuana law in Connecticut. 

However,

 According to financial disclosures, Kraus served on the scientific advisory panel for painkiller companies such as Pfizer and Reckitt Benckiser in the year prior to his activism against the medical pot bill.

Mr Fang's argument that the relationships among these physicians who advocate against liberalized marijuana laws and pharmaceutical companies constitute conflicts of interest did not seem unreasonable

Studies have found that pot can be used for pain relief as a substitute for major prescription painkillers. The opioid painkiller industry is a multibillion business that has faced rising criticism from experts because painkillers now cause about 16,000 deaths a year, more than heroin and cocaine combined. Researchers view marijuana as a safe alternative to opioid products like OxyContin, and there are no known overdose deaths from pot.

Assuming the validity of this argument, the article also noted institutional conflicts of interest affecting organizations that publicly advocate against loosening marijuana restrictions,

I reported for the Nation that many of the largest anti-pot advocacy groups, including the Community Anti-Drug Coalitions for America, which has organized opposition to reform through its network of activists and through handing out advocacy material (sample op-eds against medical pot along with Reefer Madness-style videos, for example), has relied on significant funding from painkiller companies, including Purdue Pharma and Alkermes. Pharmaceutical-funded anti-drug groups like the Partnership for Drug-Free Kids and CADCA use their budget to obsess over weed while paying lip-service to the much bigger drug problem in America of over-prescribed opioids.

Summary

As we have discussed previously, narcotics addiction is a very difficult clinical and societal problem.  That makes it all the more distressing that research and teaching about, clinical practice affecting and health policy related to narcotics and narcotics addiction has been tangled up with the increasingly aggressive marketing of prescription narcotics.  Now it turns out that the companies that make and market narcotics seem to be tangled up with addiction medicine experts who are not such big fans of medical or recreational marijuana. (And it turns out once again that the physicians who claim expertise on treatment of addiction have financial relationships with the companies that market addictive medications.)

There seems to be no corner of medicine and health care untouched by the web of conflicts of interest.  So once again we call for all conflicts to be disclosed in the interests of honesty.  Beyond that, as we have been saying for years, patients' and the public's health would benefit from an aggressive effort to reduce conflicts of interest affecting clinical and health policy decision making.     

Put that in your pipe and smoke it. 

12:46 PM

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.

8:51 AM

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.

9:44 AM

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?

8:46 AM

"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.

11:55 AM

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.

12:11 PM