A Clear-Headed Defense of Comparative Effectiveness Research

We have tried to argue why comparative effectiveness research is a good idea. To cut and paste what I wrote in a previous post,

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.

Because I believe that comparative effectiveness studies could be very useful to improve patient care, it upsets me to see this particular kind of clinical study get caught in political, ideological, and economic battles.

In particular, we have discussed a number of high profile attacks on comparative effectiveness research, which often have featured arguments based on logical fallacies. While some of the people making the attacks have assumed a conservative or libertarian ideological mantle, one wonders whether the attacks were more driven by personal financial interests. For example, see our blog posts here, here, here, and here.

Therefore, it was refreshing to see this defense of comparative effectiveness research in the opinion pages of the New York Times, which demonstrated that the issues here are really not ideological.

Drawing upon the ideas of the Harvard economist David Cutler, the Obama administration talks of empowering an independent board of experts to judge the comparative effectiveness of health care expenditures; the goal is to limit or withdraw Medicare support for ineffective ones. This idea is long overdue, and the critics who contend that it amounts to 'rationing' or 'the government telling you which medical treatments you can have' are missing the point. The motivating idea is the old conservative chestnut that not every private-sector expenditure deserves a government subsidy.

This was written by Tyler Cowen, a well known academic economist, a Professor in that department at George Mason University with impeccable libertarian credentials. (Prof Cowen also blogs on Marginal Revolution.) Prof Cowen reminded us how the current health care reform debate could benefit from some clear thinking that eschews ideological posturing.

Post Title → A Clear-Headed Defense of Comparative Effectiveness Research

You Can't Tell the (Health Care Policy Op-Ed) Players Without a Scorecard

With the run-up to the US presidential election starting in earnest, public discussion of health care policy issues is ramping up. As has occurred before, we hear a lot from people apparently on the right who advocate for a laissez faire approach to health care free of government involvement. Such people often tend to approve of much of what health care corporations do. We also hear a lot from those apparently on the left who favor government operation of particular segments of the health care system, particularly health insurance. They tend to be very critical of corporate health care, but to approve of much of what the government does.

These discussions often take place in the most prominent fora in the main stream media. For example, last week Dr Scott Gottlieb wrote "Stop the War on Drugs," a commentary for the Wall Street Journal. Gottlieb focused on how the US Food and Drug Administration and the Department of Justice challenge off-label marketing by pharmaceutical companies. He noted cases in which he contended that the government prosecuted companies for "educational" dissemination of information already widely available in the medical literature. Further, he implied that these attempts are part of efforts to make "off label" into "dirty words in the conventional lexicon." Gottlieb did not address cases in which companies promoted off-label use which was not supported by good evidence, e.g., the Neurontin case, and seemed to conflate marketing with education. His main point seemed to be that overly strict regulators were hindering physicians' education and hence keeping people from getting the drugs they need.

Also last week, Dr David Himmelstein and Dr Steffie Woolhandler wrote "I Am Not a Health Reform," a commentary for the New York Times. The thrust of this article was to discredit the employer mandate approaches now advocated by some presidential candidates to reform health care. They called the "mandate model" "economic nonsense." Instead, they asserted "only a single-payer system of national health care can save what we estimate is the $350 billion wasted annually on medical bureaucracy and redirect those funds to expanded coverage." Himmelstein and Woolhandler did not address any deficiencies in how our current national single-payer system, Medicare, allocates money, in particular how it follows reccommendations by the secretive, proceduralist-dominated RBRVS Update Committee (RUC) that have lead to a relentless squeeze on primary care. Their main point seemed to be that only government run health insurance will solve our current problems.

Thus, much of the debate seems to be between those who see any government involvement in health care as ill-conceived or worse, and those who see government operation of whole health care segments as the only solution. Rarely discussed are ways in which government could better regulate health care to improve health and safety, without actually running it; or ways to re-invigorate the involvement of not-for-profit organizations in health care so they actually fulfill their missions, or revitalize the health professions so they can rediscover their professional values.

Perhaps this domination of the debate by those on the extreme ends of the spectrum would lessen if the audience knew more about who was trying to sway them.

Dr Scott Gottlieb, for example, was described in the WSJ as "a practicing physician and resident fellow at the American Enterprise Institute, [who] was deputy commissioner of the FDA from 2005 to 2007." However, Dr Gottlieb has more relationships with health care corporations than were revealed by this one-sentence biography.

Just before he took that job, the Seattle Times reported, "Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors." Also, "he also has consulted for, and written positively about, a major matchmaking firm that links doctors with Wall Street investors, the Gerson Lehrman Group in New York."A few months later, the Boston Globe reported that as FDA Deputy Commissioner, Dr Gottlieb had to recuse himself from discussions about dealing with an avian flu epidemic

because his past consulting work for [large public relations firm] Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic. Gottlieb's former clients include Roche -- manufacturer of the highly sought antiviral Tamiflu -- and Sanofi-Aventis, parent company of the nation's sole flu vaccine manufacturer.

Manning Selvage & Lee paid Gottlieb a $12,500 monthly retainer for nine months for business development projects that included eight companies. Other firms regulated by the FDA he was involved with include Inamed Corp., one of two companies seeking to return silicone gel implants to the market. He also did private consulting work for VaxGen Inc., a California firm that won a $878 million federal contract to supply 75 million doses of anthrax vaccine for the nation's protective stockpile. The $9,000 he accepted from VaxGen for consulting work between May and July prevents him from doing FDA work related to that company until August 2006.

Furthermore, Gottlieb was recently appointed to 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, Gottlieb is supposed to have "unyielding loyalty" to the company's stock-holders.

Readers of Gottlieb's opinions about health care, especially those that favor a laissez faire approach to regulating pharmaceutical companies, need to wonder the extent that these beliefs are influenced by his former and current ties to the industry.

On the other hand, Dr Himmelstein and Dr Woolhandler were identified as "professors of medicine at Harvard and co-founders of Physicians for a National Health Program." While Dr Himmelstein and Dr Woolhandler have long used the friendly Canadian example of single-payer government health insurance to buttress their arguments to the public,(1) in the past, and did so again in their latest op-ed, they previously acknowledged that their approach was frankly "Marxist," rather than Canadian.

They authored apparently pure Marxist analyses of health care in the late 1980s.(2-3) Previously, they had openly advocated for "socialized medicine."(4) They praised the operations of the communist health care system under Tito in what was then Yugoslavia.(5)

Readers of Dr Himmelstein's and Dr Woolhandler's opinions about health care, especially those that favor the government running health care insurance, need to wonder about the extent that these beliefs are influenced by their ideological ties to Marxist and communist theories that in retrospect have been discredited.

Those who opine on major health policy issues should at least reveal where they are coming from. In any case, the debate would benefit from some fresh voices not tied either to health care corporations or Marxist ideology.

References

1. Woolhandler S, Himmelstein DU. A national health program: northern light at the end of the tunnel. JAMA 1989; 262: 2136-2137.
2. Himmelstein DU, Woolhandler S. The corporate compromise: a Marxist view of health maintenance organizations and prospective payment. Ann Intern Med 1988; 109: 494-501.
3. Woolhandler S, Himmelstein DU. Ideology in medical science: class in the clinic. Soc Sci Med 1989; 28: 1205-1209.
4. Himmelstein DU, Woolhandler S. Socialized medicine: a solution to the cost crisis in the United States. Int J Health Services 1986; 16: 339-354.
5. Himmelstein DU, Lang S, Woolhandler S. The Yugoslav health system: public ownership and local control. J Public Health Policy (9) 1984; 423-431.

Post Title → You Can't Tell the (Health Care Policy Op-Ed) Players Without a Scorecard

Censored Surgeons General

Several major newspapers (including the Los Angeles Times, New York Times, and Washington Post) just reported on testimony of three former US Surgeons General about politically based attempts to censor them. Most of the emphasis was on the testimony of Dr Richard H Carmona, former Surgeon General under President George W Bush. To quote the Washington Post's story,

Former surgeon general Richard H. Carmona yesterday accused the Bush administration of muzzling him on sensitive public health issues....

Political appointees in the administration routinely scrubbed his speeches for politically sensitive content and blocked him from speaking out on public health matters....

'Anything that doesn't fit into the political appointees' ideological, theological or political agenda is often ignored, marginalized or simply buried,' he said. 'The problem with this approach is that in public health, as in a democracy, there is nothing worse than ignoring science or marginalizing the voice of science for reasons driven by changing political winds.'

Particular issues about which Carmona charged he was censored included stem cell research,

He was told not to speak out during the national debate over whether the federal government should fund embryonic stem cell research, which President Bush opposes.

'Much of the discussion was being driven by theology, ideology, [and] preconceived beliefs that were scientifically incorrect,' said Carmona, one of three former surgeons general who testified at yesterday's hearing. 'I thought, 'This is a perfect example of the surgeon general being able to step forward, educate the American public.' . . . I was blocked at every turn. I was told the decision had already been made -- 'Stand down. Don't talk about it.' That information was removed from my speeches.'

Also, there was sex education,

Carmona said that when the administration touted funding for abstinence-only education, he was prevented from discussing research on the effectiveness of teaching about condoms as well as abstinence. 'There was already a policy in place that did not want to hear the science but wanted to just preach abstinence, which I felt was scientifically incorrect,' Carmona said.

And second hand smoke, according to the New York Times,

Top officials delayed for years and tried to 'water down' a landmark report on secondhand smoke, he said. Released last year, the report concluded that even brief exposure to cigarette smoke could cause immediate harm.

Carmona was even warned about attending the Special Olympics,

And administration officials even discouraged him from attending the Special Olympics because, he said, of that charitable organization’s longtime ties to a 'prominent family' that he refused to name.

'I was specifically told by a senior person, ‘Why would you want to help those people?’ ' Dr. Carmona said.

The Special Olympics is one of the nation’s premier charitable organizations to benefit disabled people, and the Kennedys have long been deeply involved in it.

When asked after the hearing if that 'prominent family' was the Kennedys, Dr. Carmona responded, 'You said it. I didn’t.'

And some reports are still on ice, according to the New York Times,

Dr. Carmona said drafts of surgeon general reports on global health and prison health were still being debated by the administration. The global health report was never approved, Dr. Carmona said, because he refused to sprinkle the report with glowing references to the efforts of the Bush administration.

Two other Surgeons General testified. They were Dr David Satcher, who served under President Bill Clinton, and briefly under President George H W Bush and Dr C Everett Koop, who served under Ronald Reagan. Both also cited politically driven attempts to censor them. As the Post put it,

Two other former surgeons general, David Satcher and C. Everett Koop, said at the hearing that political interference appears to have grown worse under Bush, although they noted that this administration has not been the only one to take a political approach toward the office.

Under Clinton, Satcher was censored about health and sexuality,

Satcher, Carmona's predecessor, who served from 1998 to 2002, said that under President Bill Clinton he could not release a report on sexuality and public health, in part because of sensitivities triggered by the Monica Lewinsky scandal.[WaPo]

The Washington Post article also noted,

Clinton also forced out Joycelyn Elders as surgeon general in 1994 after her controversial remarks that public schools should consider teaching about masturbation.

Satcher also was censored about substance abuse,

Dr. Satcher said that the Clinton administration discouraged him from issuing a report showing that needle-exchange programs were effective in reducing disease. He released the report anyway.

Under Reagan, Koop was told of political pressures on Reagan, but apparently was shielded from them by the President,

Koop, who served as surgeon general under President Ronald Reagan, spoke out on AIDS, despite political pressure not to do so. He said Reagan was pressured to fire him every day -- but he did not.

'If he had not been the kind of person he was, I would not be here today,' Koop said [WaPo]

On Health Care Renewal, we often discuss cases in which research results have been suppressed, or discussion of various health care issues has been discouraged. Often those doing the censoring in these cases appeared to have been acting out of economic self-interest.

These new and not so new stories remind us that people with political vested interests may also be eager to shape the debate about health care issues, and even try to completely shut up people whose positions offend them.

On the other hand, as we have said many times, for patients and doctors to make the best possible clinical decisions, they need access to the best possible evidence about tests and treatments. Furthermore, to make the best possible health policy decisions, people and policy-makers need access to all relevant evidence and view-points.

Stifling dissemination of information or debate to serve vested interests, whether these interests are primarily economic or political, is bad for patients and bad for people in general.

Post Title → Censored Surgeons General

BLOGSCAN - Ideologic Conflicts of Interest?

A post on Notes from Dr RW suggested an example of how a health policy article can be affected by ideologic, rather than financial conflicts of interest. A post on DB's Medical Rants suggested that the problem was not so much ideologic conflicts of interest, but "political commentary masquerading as evidence."

Post Title → BLOGSCAN - Ideologic Conflicts of Interest?