Tuesday, November 24, 2009
Over at Kevinmd.com cardiologist and blogger Dr. Joel Sherman posted an excellent piece called Informed consent is missing from Pap smears and cervical cancer screening. His post points out that many women were simply told to have a pap without discussing the potential pros and cons of doing the test or not doing the test. I was impressed, though not entirely surprised by the many comments of frustrated and angry women who felt like they have been forced to have cervical cancer screening unnecessarily, especially when the doctor mandates this as a pre-requisite to refilling birth control prescriptions. Below is the comment I posted, which I decided to put on my own blog:
"Screening for any disease, whether a pap smear for cervical cancer, rectal exam for prostate cancer, mammogram, colonoscopy etc. is a complicated decision. With the recent release of changed guidelines for cervical cancer and breast cancer, the public is now becoming more aware of this issue. The best thing for both patient and doctor is a conversation about the risk and benefits for both screening and not screening. This is now more important than ever since now there are several guidelines with very conflicting recommendations. The problem is that our current health care system reimburses quite well for procedures and diagnostic tests. It does not reimburse well for important conversations. This is why patients who use their health insurance to see their primary care physician (as most people in the US do) have only brief and what must seem like rushed visits with their doctor. True informed consent about these important matters will only happen if we change the current structure of our reimbursement system. Paying doctors to discuss the pros and cons of screening, testing, and treatment will actually save money because (especially as evident by many of the comments already posted by women angered by likely unnecessary pap smears), it will likely lead to fewer tests and procedures."
I am hopeful that the screening controversy is in the public domain, the public will start to place more value on having these conversations with their health care providers. Once people realize that the reason why these conversations are lacking is because of our broken health care system, this will move more people to help support health care reform.
Monday, November 23, 2009
Generic substitution is when your doctor writes for a prescription medication, but the pharmacists substitutes this with a generic medication. This is perfectly legal and, in general, a good thing for patients. For the most part, and for most drugs, the generic is just as good as the brand drug. However, as the news piece points out, there are some instances where the small difference between the generic and the brand name medication may make a difference. These are usually medicines where doses are very small such as hormones (thyroid medications, birth control pills) and medicines that have to be closely monitored. This does not necessarily mean that the generic is worse than the branded medication, but that switching from one to the other could have potential adverse effects.
One of the things that I spoke with the reporter about that is not in the above video (I have control over what I say, but not what they choose to sue), and only got a brief mention by the new anchor after the video was shown was about therapeutic substitution. This is a completely different ball game and a major concern of mine.
Therapeutic substitution is when your doctor writes a prescription for a branded drug and the pharmacist substitutes it not with the generic equivalent, but with a completely different generic drug in the same class. In this case, you are getting a totally different medication. For example, let's say your doctor writes a prescription for Crestor or Lipitor, both very potent cholesterol lowering drugs. You bring this prescription to the pharmacist, but instead of getting Crestor or Lipitor, you get simvastatin, a generic cholesterol medication. The difference here is that where the brand and generic equivalent will work about the same, this is not the case with a therapeutic substitution. Simvastatin will work in many patients but is not nearly as good as lowering cholesterol as Crestor or Lipitor. Thus, if the patient got switched and needed more cholesterol lowering than the simvastatin could provide (which is why I would write Crestor or Lipitor in the first place), that patient's cholesterol levels could be too high despite medication, potentially leading to heart attack and strokes. This is just one of many examples.
The practice of therapeutic substitution is currently illegal, but this could change. In Washington, DC where I practice, there is current legislation pending that would not only allow, but might compel a pharmacist to switch patients to cheaper medication, whether or not they were the same. In the case of DC, this is designed to save the government money from the millions of dollars its spends on prescription medications for our Medicaid patients.
With health care costs so high, physicians should do their best to try and write generic medications when possible. In additions, our pharmacist colleagues can be a tremendous help in figuring out ways to lower the costs of medications by using generics, whether it be a direct generic substitution or even therapeutic substitution. Pharmacist and blogger Mr.Medsaver has been doing this for quite some time, and I routinely read his helpful posts. However, pharmacists are not trained clinicians and do not know (and can not know) all the details of the patient's history or the rationale for the doctor choosing one drug over another. Though the pharmacist's suggestions are always welcome, I do not believe the should be allowed, and certainly not compelled or heaven forbid incentivized, to switch medications within the same therapeutic class. This could be very dangerous for patients.
Sunday, November 15, 2009
Here is the actual study published ahead of press online in the New England Journal of Medicine. Essentially, the enrolled over 200 patients from Walter Reed and Washington Adventist (right in my home town!) who had known heart disease or were at very high risk. These patient were already on a stable dose of a statin (40-50% on simvastatin -half of the Vytorin combination, and 40-50% on Lipitor) with LDL cholesterols (bad cholesterol) under 100 and HDL (good cholesterol) under 50 for men/55 for women. These patients were randomized to receive either Zetia (the other half of Vytorin) or Niacin (though you can get this vitamin over the counter, patients received the extended release prescription version, whose maker is also the sponsor of the study). They were looking to see whether or not there would be difference in progression of atherosclerosis (clogging of the arteries) over 14 months as measured by carotid intima-medial thickness (CIMT), and ultrasound of the neck arteries which seems to be a good measure of plaque buildup in the coronary or heart arteries. News broke earlier this year that the study was stopped early because there was a clear winner, but we didn't know which drug won until now.
Patients who got the Niacin had their good cholesterol raised by close to 20%. bad cholesterol lowered by close to 10%. The Zetia group lowered bad cholesterol by close to 20% but also lowered the good cholesterol too. More importantly, those patients taking the Niacin had a reduction in the plaque buildup, whereas patients taking the Zetia had no change in plaque build up. Surprisingly, and inexplicably, the more Zetia lowered your cholesterol, the more plaque build up patients had. Finally, and most importantly, only 1% of patients in the Niacin group had major cardiovascular events, compared to 4% in the Zetia groups. This was statistically significant.
This trial has broader implications than just the Vytorin issue (which I will get to in a second). It suggests that patients at high risk for cardiovascular disease may have additional benefit beyond lowering their bad cholesterol. Though the addition of Niacin was proven to show benefit, it might be possible that other drugs which raise HDL such as fish oil and fenofibrate (Trilipix) might benefit at risk patients as well.
I have posted extensively on Vytorin in the past. Most of the controversy had to do with the ENHANCE trial which I discussed in my post Vytorin and Zetia: What to do now? Briefly, whereas multiple statin trials have shown that lowering LDL with a statin led to decreased heart attacks and stroke, Vytorin only had data showing it lowered the LDL. Merk, the makers of Zocor (simvastatin), Zetia, and Vytorin (Zocor + Zetia) funded a trial that, similar to the HALT study, looked at CIMT to measure plaque buildup. It compared simvastatin to the same dose of simvastatin plus Zetia, or Vytorin. Though Vytorin lowered cholesterol more that the simvastatin alone, there was no difference in plaque buildup. Defenders of Vytorin said that ENHANCE was not an outcome study (designed to study actual heart attacks and strokes) and that there were no differences in outcomes between the two groups. Though the HALT study was also not designed as an outcome study, findings were consistent AND there was a difference in heart attacks and strokes: about triple the number in the Vytorin group. My initial recommendation was that though Vytorin was really useless, if patients couldn't reach their goal with a potent statin or couldn't tolerate the statin, then using or adding Zetia was reasonable. This is probably still the case. However, in the HALT study differences were seen in HDL (went up for Niacin and down for Zetia), and this may account for some of the difference. For patients whose HDL was low, I will probably be a little more cautious of using or adding Zetia, which may make their HDL go down in addition to their LDL.
Bottom Line: There is no good use for Vytorin, and it may even cause harm, not because of safety, but because the LDL goals achieved with Vytorin may lead to fewer heart attacks that could be prevented with a more potent statin. If you are on Vytorin, ask you doctor about considering a switch.
Tuesday, November 3, 2009
The results of the study are not surprising to me, as I have seen this in clinical practice. The more I thought about why this is occurring, the more I thought about the pap smear as a symbol of our health care system's problems. So why so many pap smears?
1. Pap smears have saved lives. Cervical cancer used to be a major killer of US women. Now it is rare to hear about a women who has died of cervical cancer. Not true in third world countries when screening is not possible. The fact that we have virtually gotten rid of a cancer with early detection is truly amazing. But the danger here is that it has set up the paradigm that this is true for all diseases and cancers. Recently, breast cancer and prostate cancer screening have come under fire for not really saving any lives. However, even with the data, patients and advocacy groups will not likely take a screen only if proven life saving approach. Breast self-examination has absolutely no data to support this practice, and in young women who are likely to find non-cancerous bumps, may actually be harmful. Yet, this practice is routinely recommended for many young women.
2. Women (and many men) want/expect a yearly physical, and most women believe that a pap smear is part of this. Similar to other types of cancer screenings, there is very little evidence that a routine check up is beneficial. This is not to say that you shouldn't visit your doctor regularly. However, many of the things doctors do during a physical have limited to no value. There are some things that have tremendous value, such as checking blood pressure and weight, and talking about diet, exercise, smoking cessation, etc. However, having the doctor check your whole body every year when your feeling just fine is unlikely to be helpful. Yet, the American public expect a full exam every year. After all, their health care premiums are quite high, so they might as well get checked out. This extends to the pap smear. It saves lives (as above), is part of my regular check up, and I am paying a lot of money for this; so therefore I expect my yearly pap.
3. Physicians have little disincentive to refuse to do a pap smear. The pap smear only takes a few minutes. Trying to take the time to explain #1 and #2 above makes little sense for the primary care physician who is not paid by time spent counselling a patient, but by how many patients she can see. In other words, talking a patient out of an unneeded test actually costs the primary care doc money, because that time could be used for seeing another patient. More importantly, if the physician refuses the pap smear, and the patient goes elsewhere to get the pap smear and is found to have cervical cancer; the physician could get sued placing her entire career in jeopardy!
If pap smears save lives, patients expect/demand them, talking a patient out of an unnecessary pap smear only costs me money and not doing the pap could get me sued, why wouldn't I do a pap smear on every women that wanted one?
4. The pap smear rep reminded me to get the test. The drug companies are not really the problem any more. Every day you read about a drug company laying off employees. This is because most drugs are or will soon go generic and there is little in the pipeline. This is not the case for devices and testing. Big labs have reps that come to physician's offices to discuss the latest fancy new test. Like the drug reps, they bring lunch too. The difference: medical devices and testing though FDA approved are not nearly has heavily regulated as the drug companies when it comes to selling to physicians. Drug reps by law are restricted to saying only what is in their label to physicians. It works a little bit differently for the lab and device reps. As newer tests and devices become available, watch for more of a focus on selling these products. Don't be surprised to see direct to consumer advertisements asking patients to ask their doctors about such and such a test.
5. The experts don't agree. It is very hard to keep up with evidence based guidelines in primary care. It's even harder when there are multiple guidelines, and harder still when they don't agree. For prostate cancer, the American Cancer Society and the American Urological Society say that doctors should test for prostate cancer. The US Preventative Health Task Force guidelines say that we shouldn't. Initially, some of the groups recommended more frequent pap smears, but recently decreased the interval due to evidence that less frequent screening was better. However, with all multiple guidelines that often differ, it is not surprising that so few primary care physicians actually knew what all the experts actually did agree upon. Another issue is that reasons behind differing guidelines have to do primary with politics and money. The Urologists want primary care docs to test for prostate cancer because they make money when the test comes back positive. The government doesn't want you to test for prostate cancer, because testing leads to more testing and treatment which costs them (you the taxpayer) more money.
6. Doctor's don't follow guidelines anyway. Even if there was one clear and definitive guideline for docs to follow, they probably wouldn't. There are likely multiple reasons. Our current Continuing Medical Education system (CME) that is supposed to keep docs up to date is horrible and funded by commercial interest. The stimulus package already gave some money for comparative effectiveness research and there will likely be more money for this in any health care reform bill that passes. However, if docs don't know the results of what is best or what actually works, then the data is not all that useful. It is unlikely that a drug company is going to fund a CME program that shows their drug is not useful. So who is going to fund the dissemination of comparative effectiveness findings? There is also no real incentive to follow guidelines. Again, docs get paid for how many patients they see, not by how beneficial their advice was to patients or whether they gave guideline appropriate care.
Since pap smears don't cost a substantial amount of money, it is unlikely that getting rid of all these unnecessary pap smears is going to put a dent in health care spending. However, the underlying reasons behind the many unneeded pap smears is a symbol of what what's right and wrong about our health care system. We should give this study's findings, and more importantly the reasons behind these findings, a critical look.