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.

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.

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.

The Problem with Insulin- Part 2

In my previous post- The Problem With Insulin - I mention concerns about a recently published consensus statement from the ADA (essentially the new ADA 2009 guidelines) which no longer recommends the new drugs Avandia and Januvia, suggest that other newer drugs (Actos and Byetta) are less preferred, and essentially leaves the recommended options to treat type 2 diabetes as metformin, sulfonylurea and insulin. I have also previously mentioned that though the older, generic medications do work, most patients will eventually fail the pills. This means that the "new" guidelines essentially recommend using old pills until they fail, and then everyone goes on insulin. The problem is that insulin is not benign, and it may not be the best way to go.

Three studies presented June 2008 the ADA (VADT, ACCORD and ADVANCE which I have blogged about before-here and here) not only failed to show cardiovascular benefit with aggressive diabetes control, but there was substantial hypoglycemia in the intervention arms (which used more insulin) and in ACCORD, the study was stopped early because of increased deaths. Regarding ACCORD, some the experts stated that " it is biologically plausible that severe hypoglycemia could increase the risk of cardiovascular death in participants with high underlying CVD risk.

Two new studies give further evidence to this hypothesis. The first is from the New England Journal of Medicine and has been mentioned in multiple news reports. The NICE-SUGAR trial randomly assigned 6100 medical-surgical ICU patients to intensive control (sugars between 81 to 108 mg/dL) or to conventional control ( sugars 180 mg/dL or less) and achieved these targets with the use of intravenous insulin. Patients who were in the intensive group had about a 14% increase in death. Not surprisingly, severe hypoglycemia (sugars less than 40) occurred in 206 of 3016 patients (6.8%) in the intensive-control group and 15 of 3014 (0.5%) in the conventional-control group (P<0.001).

Another study, not given the same degree of media attention, was also published in today's Archives of Internal Medicine. This study looked at close to 400 outpatient diabetics on insulin, and gave half metformin in addition to insulin (the other half got placebo). Doctors could increase the insulin in both groups and both groups tried to achieve the same targets for sugar control. After 4.3 years' follow-up, there was no difference between groups in the composite outcome of microvascular disease (e.g., progression of retinopathy, nephropathy, or neuropathy) and macrovascular disease (e.g., MI, heart failure, stroke, or diabetic foot). However, macrovascular disease by itself showed a nearly 40% reduction for the patients taking metformin. By treating just 16 patients with metformin on top of insulin, as opposed to insulin alone, you could prevent one heart attack, stroke, etc. Though you can read this study as "metformin is good," I read the study as "insulin may be bad." The patients on metformin, not only achieved better sugar control, but did so using LESS INSULIN, and heart attacks were prevented.

Don't get me wrong. Insulin is a wonder drug, particularly for Type 1 diabetics who would die without it. However, for Type 2 diabetics there are other choices. Besides the fact that insulin seems to be linked with heart attack and deaths, patients can suffer even from mild hypoglycemia, they have to check their sugars much more regularly, and they have to inject themselves, which can't be too much fun.

My concern is that despite having other options, despite the burden on patients, and despite more and more evidence showing that insulin (in type 2 diabetics) can be harmful; the new ADA guidelines continue to promote insulin use even more than a few years ago. Why would they do this? Instead of pushing type 2 diabetics to insulin earlier and earlier, shouldn't we be saving this as a last resort (like surgery or dialysis) once all other options have failed? As I have speculated before, it is the endocrinologists that make the guidelines, and they may have a bias toward keeping patients on injectable agents.

An aspirin a day does keep the doctor away.

Though not picked up that much by the print media, you have probably seen on the news or the web new recommendations for taking daily aspirin to prevent heart attacks and strokes. You may know about the potential heart benefits from aspirin, since the folks at Bayer continue to remind the public of this. However, the benefits are real, and newer recommendations should help.

The new recommentation from the U.S. Preventive Services Task Force which is published in the Annals of Internal Medicine is that most men between 45 and 79 and most women between 55 and 79 should take an aspirin a day.

For men, aspirin was found to prevent heart attacks, and for women it was found to prevent strokes. The optimal dose of aspirin is not clear, but benefit was seen as low as 75 mg was about as effective as higher doses. Thus, a generic baby aspirin a day is probably the cheapest and most effective dose.

The reason why everyone should not take this is that even aspirin has some side effects, mainly gastrointestinal bleeding. GI bleeds can be serious, require hospitalizations, surgery and can even cause death. The older you are the higher your risk for heart attack and stroke, but the higher you risk is for GI bleeds. For example, if you took 1000 65 year old women, each with about a 7% risk of having a stroke, your would probably prevent 12 of them from having a stroke, but cause and equal number of GI bleeds. Thus, even if you fall within the age range, if your risk of heart attack and stroke is low, aspirin may not be for you. Patients older than 79 were not routinely recommended for this because of the higher risks of GI bleeds, even though some patients older than 79 may be good candidates. Similarly, people younger than 45 were not recommended because there was not clear enough evidence of benefit.

If you are not taking an aspirin a day, and think you might benefit, please discuss this with your doctor.

Electronic Cigarettes

I appeared on the local news regarding electronic cigarettes. This is a follow up to a piece on the CBS morning show (see video below). The more closely I investigated this issue, the more I became concerned.






Electronic cigarettes are nicotine delivery systems that look like actual cigarettes. When the user inhales, the nicotine in cartridges within the elecrtonic cigarettes vaporizes the nicotine and it is inhaled. In addition, part of the process leads to the appearance of "smoke," though this is not really smoke, it is essentially water vapor. Though the lack of actual tobacco in these products is theoretically better than cigarettes in some way, mainly decreasing the carcinogenic effect and eliminated harms from second hand smoke, the electronic cigarette is dangerously being promoted as safer alternatives to cigarettes that contain tobacco as well as possible aids to smoking cessation. Make no mistake: these products are not safe, in some ways could be riskier than cigarettes, will not be effective smoking cessation aids, and are scarily unregulated by the FDA and far too available in the US.

Manufacturers and sellers will claim that there is research to support that they are safe, but these are mouse and not human studies, and they are done not by goverment agencies like the FDA, but by the products manufacturers. Thus, there is not good evidence that these products are safe. Though tobacco cigarettes are known to be dangerous, these should not be considered a safe alternative.

Unlike other nicotine products sold in the US like the patch, gum, and lozenge which has gone through intestive testing, the e-cigarette has not. More importantly, the purpose of these approved products is that they slowly release nicotine to help people quit tobacco, and they have studies that prove they work. By vaporizing nicotine, and inhaling it, this will lead to very rapid absorption, and high levels of addiction; possibly even higher than real cigarettes themselves.

Currenlty, most e-cigarettes are made in China and bought on the internet, where it is very difficult for federal agencies to regulate. However, unlike tobacco, which does not (yet) come under FDA jurisdiction, these products are clearly drugs. Though the FDA may have limited ability to stop what is being sold on the Internet from other countries, they must do a better job in regulating what is sold here. These products are being sold in shopping malls in the US, and this must be put to a stop. The World Health Organization has called for the manufacturers of these products to stop making and promoting them.

The good news, is that the rate of smoking in the US has decreased. More importantly, there are very effective ways of quitting. If you are a smoker and interested in quitting, the best thing to do is to speak with your doctor, who can help you work on changing habits and behaviors. There is now very good evidence and current guidelines recommend that EVERY smoker interested in quitting be offered medication. This can be in the form of nicotine replacement such as the patch or gum. Pills have be shown to be even more effective and both bupropion and Chantix are available by prescription. Finally, call 1-800- QUITNOW, a free 24/7 counselling service.

video

Watch CBS Videos Online

Blogger Tara Parker-Pope in today's NY Times' Well section entitled A Hurdle for Health Reform: Patients and Their Doctors, discusses that in order to cut health care costs, doctors and patients are going to have realize that the newest treatments and medications don't always equate to the best care.
Though I disagree somewhat with her focus on prescription drugs ( her example that "most hypertension patients still use costlier drugs marketed by pharmaceutical companies" is not entirely accurate since most hypertension drugs are now generic, and insurers have made it much more difficult lately to get the newer, more expensive drugs); however, her sentiment is right on target. If we want to lower health care costs, then everyone can't get everything. In certain cases, some degree of rationing is going to have to occur. However, in many cases just using good scientific evidence will do the trick. Here are just a few things that patients can do to reduce health care costs now:
1. Don't demand antibiotics. As I have written before, colds are caused by viruses which do not respond to antibiotics. Most viruses take a week or so to resolve. Just because you still feel bad after a few days does not mean you need an antibiotic. A common thing I hear from patients is "when I get this sick, the only thing that makes me better is an antibiotic." Remember that colds resolve on their own, so if you start the antibiotic on day #7, was it the antibiotic working or the cold resolving on its own? Also, the placebo effect is about 30%. Doctors realize that the reason patient come in when they are sick is that they have tried the usual remedies and want to feel better. However, in most cases, rest, fluids and over the counter medications, as well as time, is what works best when you are sick.
2. MRI doesn't necessarily mean best test. Some patients have a notion that a CT scan is better than an X-ray and an MRI is best. MRI is certainly one of the most expensive tests, but not necessarily the best. One of the best imaging studies to look at bones are plain old X-rays. Imaging is based more on what you are looking for, not which is the best test. One of the biggest drivers of health care costs is diagnostic imaging. Many studies are simply not needed. In addition, especially in the case of CT scans, exposure to radiation is not necessarily without potential harm.
3. Patients have to accept watchful waiting. There are certainly true emergencies where hours or even minutes are critical and some study or procedure must be done right away. However, these situations are rare. Demanding that studies be done ASAP adds to costs because often symptoms resolve on their own. Though reassurance and peace of mind may be worth something, in many instances this is breaking the health care bank.
4. Spend out of pocket money on things that work. There's no question that health care is just too expensive for the average American, and asking the general population to help foot the bill seems ridiculous. However, while patients are paying a lot in premiums and co-pays, they are also spending billions of dollars on thing that have not been proven to work, and in some cases may be harmful. I have blogged before about vitamins and natural cold remedies that likely do nothing to improve health. If we took all the money that patients spent on vitamins, supplements, diet pills, pills that enlarge your penis, etc. (excluding things known to be useful like Calcium and Vitamin D), this would add up to billions of dollars that could be used for things proven to save lives like mammograms, colonoscopies, and smoking cessation treatments. I believe if we regulated all health products like medications and devices, this would decrease costs in the long run. Given that the manufactures of these products gave $3 million in campaign contributions in 2008, I doubt that this is going to happen any time soon.
5. We need malpractice reform. It is hard to measure the number of unnecessary tests doctors order because they fear getting sued. Part of this has to do with the fact that, in general, the public feels that every test ought to be ordered even when there is only the smallest possibility of a potential disease. More importantly, bad things do happen, even when the correct decision is made, and we currently have no system set up to compensate patients when bad things do happen, other than to sue their doctor. This is not something that patients can do per se, but they can support a system that replaces our current one.