Wednesday, February 11, 2009

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.


Anonymous said...

"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."

I understand the influence people with vested interest could have in such research, but I am more concerned about how the research is used by the government to constrain health care spending.

Significant savings are not realized by simply determining the comparative effectiveness of different procedures. The real savings is in determining the "value" of procedures as relating to cost. Where government is paying, rationing is the only directin this effort can be heading.

and it would be bad enough if those who only have government insurance to depend on are denied available coverages because of their age, it would be even worse if private insurance wasn't available to those who could afford better care.

Roy M. Poses MD said...

I don't see why comparative effectiveness research would necessarily lead to more or worse rationing.

The research would be of use to clinicians and patients when making decisions about how to manage particular medical problems. Such use would not require any government intervention, and would not amount to rationing.

Furthermore, were Medicare and Medicaid to use comparative effectiveness, they would not necessarily use it to make dichotomous coverage decisions. They could use it in making decisions about how much to pay for particular goods and services. It makes perfect sense to pay less for less effective tests and treatments.

To anyone horrified by the government deciding to pay less for certain services, the government in the US already fixes how much it pays physicians for particular services, and has done so since the early 1990s. How it does this is one major reason for the impending collapse of primary care. See this post and its links:

Where have those passionate foes of rationing and government price controls been? They mostly have not been protesting government control of payments to physicians.

But when there is any hint of discussion of government paying less for the health care goods and services marketed by big corporations, the horror of government price fixing and rationing suddenly appears.

Finally, we have been rationing health care for years in all sorts of ways. It's just that the rationing is covert. See the Covert Rationing Blog:

For an example, just talk to a patient who has lost his or her health insurance about rationing.

Anonymous said...

Typical fear mongering by the pro pharma agenda.

Notice they do not claim that Comparative Research *does* effect rationing. Only that it "may result" in rationing. Rationing is not in any way present in any definition of Comparative Research I have seen. Yet the pro pharma agenda are willing to spend millions to fight it because of "rationing". This simply goes to show what they do not want *is* Comparative Research. They prefer treatments be guided by their marketing campaigns, where they get away with selling drugs that are "good for you" except for minor side effects such as "sudden death". There is at least one drug that fits this description being marketed to the general public.

I would go further and demand from the administration that direct marketing of drugs to the general public be outlawed.