Wednesday, April 1, 2009

For those wishing to ban industry sponsored CME, please come up with an alternative.

Given our crumbling economy and failing health care system, it is not a surprise that the media and bloggers alike continue to criticize the pharmaceutical industry. Though many would like to paint this as a black and white issue, our health care system (research, education, patient care) is so wedded to the pharmaceutical industry, for better or for worse, that the issue is far more grey. Industry funding of CME is a current hot topic and perfect example of how tricky the issue really is.

With recent scandals in the news, and the AAMC's call for virtually eliminating non-research relationships between industry and academia, the issue has become front and center of the debate. The American Psychiatric Association just ended its industry financed seminars, and most recently, the current and past leaders of several major medical society have also called for eliminating industry sponsored CME in week's JAMA.

When it comes to industry sponsorship of physician education, the FDA has two categories: promotional and CME. Promotional programs are funded by the industry for the purpose of promoting a drug company's product. Rules and regulations about what can and can't be said are strict: no off-label promotion, side effects must be discussed (fair balance), etc. Promotional programs in any format (dinners, conferences, web casts) are viewed (from an FDA standpoint) as commercials, because despite having potential educational value, they are clearly biased, which is why they are regulated by the FDA.

Continuing Medical Education (CME) comes under a different set of rules. CME is not controlled by the FDA, but rather the Accreditation Council for Continuing Medical Education (ACCME). The ACCME is a group whose board is represented by all the major medical institutions including the AMA and AAMC. According to their website, their role is "the identification, development, and promotion of standards for quality continuing medical education (CME) utilized by physicians in their maintenance of competence and incorporation of new knowledge to improve quality medical care for patients and their communities." There are also rules for industry sponsored CME, but the rules are different. One the one hand, content is less restricted. For example off-label promotions are allowed. On the other hand, the industry, even though it is funding the program, is supposed to have no input into the content of the program. The recent criticism surrounding industry funding CME is that 1) despite these rules industry does have influence into CME content it funds and 2) even if it doesn't, the perception of a potential conflict of interest errodes the publics trust.

The logical conclusion reached by many is for physicians to avoid all promotional educational and industry sponsored CME, and only get their information from reputable medical journals and non-industry sponsored CME. Anti-industry sites like PharmedOut, which does an excellent job of educating physicians about conflicts of interest, list "more than 200 free web-based CME credits are available without cost." However, all of these sources are Internet only, and most are from the CDC and one not for profit group which provides non-industry sponsored CME. This doesn't exactly help a primary care physician like myself who wants the latest updates on asthma, diabetes and hypertension. In fact, a vast majority of non-industry sponsored CME are from for profit companies, not affiliated with a medical school, that attract doctors to exoctic locations to combine business (CME credits) with pleasure. Is a for-profit, non-academic CME in a vacation resort spot better for the public interest then an industry supported medical school program given at the school's hospital? The reality is that most CME is industry supported. Medical schools, who are struggling to make ends meet due to lower clinical revenues, are not going to give out CME for free. Physicians, especially primary care physicians, who are also struggling to stay afloat, are reluctant to shell out hundreds of dollars to attend non-industry sponsored conferences, many of which are not necessarily of high quality. It is a noble gesture that the leaders of major medical groups want to eliminate industry sponsorship, but these groups represent only a minority of the CME that is available.

In most states, physicians need a certain number of CME hours to maintain liscensure. Unlike other professionals like accountants and lawyers, who also need continuing education to stay on top of changes in their field; continuing education for physicians is critical due to almost daily changes in medical knowledge, recommendations, and guidelines which may have life or death implications. Billions of dollars are spent on keeping physicians up to date, most of which is currently funded by the drug companies. I assume that most Americans would like their doctors to be knowledgeable and up to date on the current research. If you propose eliminating industry sponsored CME, then who is going to foot the bill?

Even if we eliminate CME, and have physicians go at it on their own, there is limited unbiased resources available for physicians. Pharmed Out once again provides a great list of unbiased resources for physicians to use (I have in particular found myself looking more and more across the pond to the National Institute for Health and Clinical Excellence (NICE)). However, even this list is limited in the information available, and because it is mostly from government sources, is not the easiest to use or the most up to date. More importantly, even these unbiased sources rely on primary research that is funded by, you guessed it, the drug companies. Physicians can't just read JAMA or the New England Journal of Medicine and claim they are staying up to date in an unbiased way, because most studies published (regarding therapeutics) are funded by the drug companies, and the journals that publish these papers receive ad revenue from those companies. The pharmaceutical industry's budget for research dwarfs the NIH's budget, which spends most of its efforts in basic research and not research on therapeutics.

The fact is that, like it or not, we as a society have allowed the industry to fund virtually all medical research and physician education. I am not claiming this to be good or bad, but a fact that needs to be dealt with. Simply stating that all industry sponsored CME should be banned is avoiding this central issue. If we don't want the industry to be so involved with our health care, then someone else is going to have to pay. Are you, the taxpayer, willing to pay more in taxes to fund this? Not just doctors, but the public has gotten a "free lunch" for a long time. Are we now willing to pay for that lunch? In the case of research and CME, it's going to be a lot more than just a slice of pizza.

Here are some of my suggestions for solving this problem. I am sure there are many others, and many others that are better than mine. None are mutually exclusive.

1. Pay Up. One way to have unbiased research and an unbiased way to educate health practitioners about the latest developments is to have an unbiased organization doing both of these activities. For example, you could create a new institute at the NIH, called the National Institute of Therapeutics Research and Education. Though this would take billions of dollars to fund, we are already spending billions bailing out the banks and the auto industry. What's a few billion more? I honestly don't advocate this option by itself, but the point is that billions and billions of dollars are spent on these activities by one of the most profitable industries in our country. If we remove industry from the picture, filling this void will be a very tall order and would take a Herculean effort as described above.

2. Expand the role of the center comparative effectiveness research. The stimulus package gave $1.1 billion to set up a center for comparative effectiveness research. Additional funding is proposed in upcoming bills. The idea is to look at both old and new treatments and see which ones work best, and are most cost effective. Though primary therapeutic research and physician education is not a proposed role of this group, it certainly could be. If they find that an old drug is just as good as a fancy new one, how are they going to let the docs know? This would avoid the need for an entirely group, as proposed in suggestion #1. Since they will probably need more than a few billion dollars, one might consider allowing the industry to contribute, in the form of taxes, similar to the way that the FDA is funded.

3. Change the way drugs are approved and promoted. This is a slightly different issue, but so closely linked. Currently, most research on medications is done and funded by the drug companies, and most of this research is designed to get a drug approved for use and for adding claims the drug companies can make to sell their drugs. To get a drug approved, all the companies need to do is show that there drug is better than nothing (placebo). Research beyond approval is usually designed to get a promotional (see above) claim. For example, the JUPITER study, which continues to get press, showed that treating patients with relatively normal LDL's but high CRP's prevented heart attacks and strokes. However, Astra Zeneca, the company that funded the study and the makers of Crestor which was used in the study can not tell doctors to use Crestor in patients with high CRP because Crestor is not indicated for the treatment of high CRP. However, it will likely be soon have this indication because AZ will submit this data to the FDA to get this additional claim. The point is that there is no way that Astra Zeneca would have funded this study if it hadn't planned on getting this new indication or claim. In other words, the drug approval process and promotional regulations drive research. When you change this process, research will be more valuable, regardless who is funding it.

4. Fix the current method. We already have a method to allow industry to fund CME and ensure there is no commericial bias or influence. It's called the ACCME. Clearly, it is not currently working, but why not try to fix it? Through the LCME and RRC, which oversees polices medical schools and residency programs respectively, the AAMC has proven it can hold medical schools accountable to strict regulations. Though there are certainly examples of medical schools having industry funded CME that has been shown to have some commericial bias, most of the real culprits are ACCME accredited medical educational companies. Pfizer has actually decided to stop funding these 3rd party CME vendors, and only provide CME support for medical schools. Why not have all CME run through the medical schools, but be heavily policed by either the ACCME or the AAMC? Given the importance of the issue, the scope of the problem, and the difficulties in solving it; seems that fixing the current method makes more sense than banning all industry funded CME altogether.


Anonymous said...

In many of the cases at UW, Harvard, Emory and other esteemed academic centers the problems created by unresolved conflicts of interest have not resulted in "some" commercial bias. These have been serious cases. And even though you go on to say that "most of the real culprits are ACCME accredited medical educational companies" you don't really have no data to support this since it's untrue.

The problem in these cases is physician greed. On the the presenter side Pharma is the bankroll but those doctors who have betrayed their colleagues and their own integrity are the bigger villains.

On the participant side, why are you hining about who's going to pay for CME? Just pay for it yourself. The many other professionals who need continuing education - accountants, insurance agents, financial planners, IT specialists, etc. etc. - have no pharmaceutical industry to subsidize them...and their conference fees are often double and triple what physicians pay.

The real answer to the problem is for docs to simply do what most other professionals do. With you, and not others, footing the bill the issue will be largely resolved. And don't worry so much about the price. Pharma support bloats the budget of most CME programs.

Dr. Matthew Mintz said...

If you read this blog, I am assuming that you are familiar with the daily changes in medical research, guidelines and recommendations.
Just today:
1. Obesity increases risk for restless leg sydrome
2. Intensive managment yields higher smoking cessation rates
3. Oral contraceptives are linked to higher lupus rates
4. The current recommended 1st line treatment for high blood pressure may be wrong
5. New DNA test is better than a pap smear
6. Higher risk of birth defects if you conceive in spring or summer
And that's just today!
Add some very recent important studies/recommendations such as the role for the poly pill and data that prostate cancer screening may not save any lives, and hopefully you can see that staying up to date is a little different for a doctor, then a lawyer or accountant.
Also, for physicians who counsel patients on what to do in these various circumstances, watching the evening news or getting twitter feeds simply is not enough. Physicians must have the data, preferrably presented by experts, and then make recommendations to their patients based on their experience, understanding of the data and patients' preferences.
Thus, CME is more than just getting accredited for liscensure. It is how docs stay up to date.
CME is important, and even if the price is inflated by the drug companies, it is going to cost more than a few hunderd dollars for physicians to get just the bare minimum CME.
You are correct that I do not have data on medical education companies vs. medical schools. There is really no way to compare the two objectively other than to have a pre-determined group survey a handful or both programs and compare the amount of bias. The cases you point out are much more high profile because they are medical schools. Most CME from a medical school is created by full time faculty at that school, many of which are not for profit or state schools. Most CME from a medical education company, which are designed to make a profit, is created by non-physicians with the input of physicians which may or may not be full time facutly from a medical school.
I believe that CME is important for the public good. I also believe that either that the medical schools would be the best to deliver this. How this gets paid for is the real question. I am fine with the government creating its own CME branch, or paying the medical schools to do this. However, this is going to cost a lot of money.

Brian Wolstenholme, Pharm.D. said...

Pay for it.

Paul Alldredge said...

Drug companies need to get their info out to practitioners of the medicine. The rub is what they charge the public in advertising, promotion and marketing along with the acutual cost of their products.

My answer is they can charge USA citizens any amount they choose. But then can't sell it any cheaper anywhere else. They can charge more but not less. US citizens are getting the shaft on drug costs and we all know it.

Dr. Gourmet said...

I agree with Paul, pay for one's own CME. Simple.

Timothy S. Harlan, M.D.