The Scientific Activist

As part of the stimulus package passed by Congress last Friday (H.R. 1: American Recovery and Reinvestment Act of 2009), the US will be ramping up efforts to encourage evidence-based medicine. This is a very good thing.

Specifically (from The New York Times):

The $787 billion economic stimulus bill approved by Congress will, for the first time, provide substantial amounts of money for the federal government to compare the effectiveness of different treatments for the same illness.

Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments. Supporters of the research hope it will eventually save money by discouraging the use of costly, ineffective treatments.

The soaring cost of health care is widely seen as a problem for the economy. Spending on health care totaled $2.2 trillion, or 16 percent of the nation’s gross domestic product, in 2007, and the Congressional Budget Office estimates that, without any changes in federal law, it will rise to 25 percent of the G.D.P. in 2025.

Just to put things into context, although $1.1 billion sounds like a lot of money, this is only 0.14 % of the bill, and the potential long-term savings are many times that.

So, we’re going to spend a little bit of money to make sure our medical treatments are actually effective, thus saving us a lot of money (and wasted effort) down the road. Who would have a problem with that?

As Congress translated the idea into legislation, it became a lightning rod for pharmaceutical and medical-device lobbyists, who fear the findings will be used by insurers or the government to deny coverage for more expensive treatments and, thus, to ration care.

In addition, Republican lawmakers and conservative commentators complained that the legislation would allow the federal government to intrude in a person’s health care by enforcing clinical guidelines and treatment protocols.

So, enforcing good medical practice is a bad thing? Really?

I’m not even going to attempt to link to every reactionary right-wing screed against this provision, but you can read about them–and why they’re totally off base–at various other locations. And, if you’re feeling really brave, you can try to actually wade through the full text of the bill. Good luck with that. Suffice it to say, though, that nothing in this bill gives any credence to the idea that the bill will lead to the US rationing health care.

Of course, the question of whether the US should take cost into account in determining the effectiveness of a medical treatment is a totally different issue. Despite some people’s gut reaction to the contrary, the only rational answer to that is of course “yes”. The government most certainly should not pay $100,000 to provide a patient with a brand spankin’ new drug offering dubious benefits at the expense of treating many more with well-validated therapies. And, if that sounds heartless, just keep in mind that the buck has to stop somewhere. The government (and health insurers) won’t be able to keep up with exponentially rising health costs without making some tough decisions somewhere.

For such a system to work, though, somebody has to make the tough decisions. And, of course, these decisions need to be made scientifically, requiring an organization capable of synthesizing the needed information from available studies and commissioning its own when necessary. The prototypical example is the United Kingdom’s National Institute for Health and Clinical Excellence (NICE), which you can read more about in a recent feature The Times did on it back in December. It’s not surprising that the UK boasts this achievement, given that the centralized nature of the NHS paves the way for such an organization to operate with maximum efficacy.

NICE really is evidence-based medicine to the extreme, and if the idea makes some Americans uneasy, don’t worry: I wouldn’t expect anything so efficient to emerge within the American health care system anytime soon. And, that’s a shame, because by drawing a line in the sand, NICE has been able to negotiate much reduced prices for some drugs and has–needless to say–saved UK taxpayers a bunch of money.

Of course, NICE has problems, and those problems, like almost any other issue with the NHS, stems from chronic underfunding. Remember, the US spends the most per capita on health care out of any nation in the world ($6,700 per person per year, which is more than twice what the UK spends), and we don’t even have universal health care. If the UK spent that much, there would be many fewer tough decisions. And, in such an evidence-based-medicine-friendly environment, that money would go much further than it does in the US.

Comments

  1. #1 ray
    February 16, 2009

    EVIDENCE BASED MEDICINE and not whim based medicine or reimbursement based medicine should be the way medicine should have been in the first place. All reputable doctors and organisations agree with this concept. Of course, some big pharma would like us to believe otherwise by shoving down those expensive meds down our throat. This agency will have reputable, intelligent researchers who will have NO strings attached to any outside money and congress will have NO direct say in this. They will report on their findings and it is upto physicians and patients, insurances to decide based on the findings. Come think of it if your public school students score the same or better than the students those being sent to private school in your area, it tells you that you can save a ton of money sending to public schools in that area. Likewise in some areas sending to private school have benefis and so it is worth the money spent there. It is a NO BRAINER but vested interests obviously like to twist it and confuse americans.

  2. #2 John
    February 16, 2009

    Evidence based medicine is great. It isn’t stimulus. Your “right-wingers” are upset because this POS bill is a compilation of a few good programs and 40yrs worth of democrat wet dreams.

    Fund things like a transition to common electronic records, increased NIH support, etc, the right way.

    It’s not too much to ask that Congress doesn’t try to play a shell game, showing you the good stuff while passing the crap in the- literal- dead of night, hoping that nobody notices.

  3. #3 Sam C
    February 16, 2009

    NICE is trying to do its best, and it is good to see that it is prepared both to justify its decisions quite robustly yet will reconsider both its decisions and its approach when appropriate.

    I think I’m right in saying that NICE funded trials on a drug aimed at some other problem that was found to be effective in minute quantities for wet macular degeneration of the eye. The drug company wasn’t interested in funding trials, presumably because they’d prefer to introduce a new ultra-expensive drug differing in some minor chemical detail. Well done NICE.

    NICE has also reconsidered its approach on some other drugs where it was effectively saying that the patient could not have an expensive drug until their health had irretrievably suffered (for example, they could not get treatment for an eye complaint until they had completely lost the sight of one eye). Good for them.

    But NICE is always going to have problems when people understandably don’t accept that it’s not good value for the state to pay many tens of thousands of pounds to defer an inevitable death by a few miserable weeks or months.

    And NICE has also done really good work in identifying protocols that work and discouraging ineffective protocols.

  4. #4 Paul Browne
    February 17, 2009

    A good article, and I agree that a system such as NICE is very valuable tool for ensuring that patients get effective treatments and taxpayers get good value for money. The recebt deal that NICE brokered with Novartis over the drug Lucentis for wet age-related macular degeneration is an excellent example of what they can do
    http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4120458&c=1

    NICE doesn’t fund its own clinical trials, so it relies on data from trials funded by other organizations, and while some trials are funded by the NHS and charities the majority (about 75%) are totally funded by pharmaceutical companies while the majority of the remainder (another 15%) are part funded by industry. This isn’t ideal since it could (and does) lead to clinical trail design being influenced by the needs of company accountants as well as scientists. A case in point is the early-stage HER2-positive breast cancer drug Herceptin where NICE still recommends a 52 week course despite strong evidence from Phase II/III trials that a shorter nine or ten week course is as effective and carries a far lower risk of thecardiac side effects frequently observed with the 52 week course. Of course Roche don’t want to pay for a larger trial of the 9 week course, so it’s up to taxpayer funded organizations and charities to fund them.

    So while I would welcome an American version of NICE, after all the decisions made by US regulators carry a lot of weight in other countries, I hope that a large proportion of the funding will go to primary clinical trials as well as to systematic reviews and meta-analysis.

  5. #5 ryan
    March 11, 2009

    I like the math around .14% of the bill going to efficacy – I can’t believe that such a small relative allocation has caused such a kerfulffle.

    The other number that stood out for me is the panel of 15. Will this few establish the rules for data collection and analysis, case closed?

  6. #6 tnomeralc web design toys
    March 24, 2009

    Evidence based medicine.. It’s not too much to ask that Congress doesn’t try to play a shell game, showing you the good stuff while passing the crap in the- literal- dead of night, hoping that nobody notices.

  7. #7 Fda Clinical Trial
    April 28, 2009

    Thanks for this post.