Tuesday, March 24, 2009

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.

Tuesday, March 17, 2009

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.

Tuesday, March 10, 2009

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.


Watch CBS Videos Online

Monday, March 2, 2009

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.