Thursday, April 30, 2009

Please Don't Ask Me for Tamiflu

On the one hand, our 24/7 news cycle which includes the Internet.etc has made people more aware of the threat of Swine Flu. One advantage of having the latest, up to date information is that it may actually be able to help prevent the spread and diminish the effects of what is likely a pandemic. On the other hand, it has the potential to create confusion and hysteria.
I am not trying to trivialize the seriousness of this. The World Health Organization continues to raise the threat level on Swine Flu, and it is having a devastating effect in Mexico. However, many patients want to do something to protect themselves. This is not helped when the Vice President warns that folks should stay off airlines and subways.

I have already received several requests from patient for prescriptions for Tamiflu and Relenza, "just in case." This is a BAD idea. First, though the CDC has reported that the Swine Flu is likely susceptible to these agents, hording drugs may make them unavailable to the folks who really need them. For the regular flu, these medications work, but without a substantial effect and there is no good data that taking such medications will actually prevent serious complications of the Swine Flu. Most importantly, unnecessary use of antibiotics and anti-viral medications cause resistance and make these medications less useful. Less than 2 months ago, we found out that the dominant strain of the regular flu virus was becoming resistant to Tamiflu. Thus, we need to reserve these medications for people who really need it.

What can you do now?
Don't ask your doctor for Tamiflu or Relenza prescriptions.
Stay informed. The CDC website it the best place to go.

(from the CDC)

Take everyday actions to stay healthy.

  • Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

  • Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.

  • Avoid touching your eyes, nose or mouth. Germs spread that way.

  • Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.

Sunday, April 19, 2009

Asthmatics Need to Understand Control

The preliminary results of a study I had a role in were recently released to the public (the final results will soon be presented and published). I am pleased to see that this got some press, though I am hopeful there will be more when the final paper is published as I believe the findings are important.

The Asthma G.A.P. in America II: General Awareness and Perceptions study surveyed about 1000 asthma patients by phone to learn more about their understanding about asthma. Though most new that asthma is a serious disease, many asthmatics stop their medication because they believe their asthma is under control, when in fact it is not.

Like diabetes and hypertension, asthma is a chronic disease, which means you always have it. The underlying factor in asthma is inflammation in the lungs which leads to asthma symptoms. However, inflammation is present in the lungs even when symptoms are not occurring. This is why asthmatics with persistent asthma need to take daily medicines to stop inflammation, just like patients with hypertension or diabetes need to take their medicines everyday. However, in this study nearly half (42 percent) of patients surveyed incorrectly believe that when asthma symptoms subside, their controller medicine can be taken less regularly.

Asthma, considered one of the most serious chronic diseases in the United States, affects more than 22 million Americans. Despite having medications and other treatment that can keep most asthmatics under control, sudden uncontrolled asthma episodes account for an estimated 1.8 million emergency room visits and nearly 500,000 hospitalizations each year.

One possibility is that though (from the study) asthmatic patients seem to understand that asthma is serious, since they stop taking their medications when they have no symptoms, they must believe that the risk of asthma goes away, which is not the case. The other possibility is that patients associate asthma symptoms with asthma control. Though symptoms are an important component of control, there are other factors such as being able to do normal activity without limitations, getting a good night's sleep, and having the lungs function as well as they can. There are tools available, such as the Asthma Assessment and Asthma Control Test, which can help patients track their asthma control and discuss with their doctor.

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.