Increasing confusion about mammograms

Everyone is getting confused about mammogram guidelines. The U.S. Preventive Services Task Force (USPSTF) recently came out with new guidelines and these cancer screening recommendations are quite different from those published by the American Cancer Society (ACS). Now, the Senate is dealing with amendments of amendments. What do I mean by that? There was an amendment by Mikulski. Then, there was one by Vitter. Then the Murkowski amendment got rejected (I'm not sure if all this chronology is correct, but I think you get the picture). Soon, we won't remember what the original amendment said.

So what's with all these amendments? One key question is: how will insurance plans (including a possible public option) pay for screening mammograms? Who will need to pay a copay? What is the appropriate age to start breast cancer screening? 40? 50? How often should women get a mammogram?

I've heard some people argue that the USPSTF came up with these revised guidelines to reduce the number of mammograms the government would need to cover under the proposed public option. Does this make sense? Well, if the government can find a way to reduce health care costs, it would be to eliminate expensive tests. A mammogram isn't super expensive, but if you could stop all those women who are ages 40-49 from getting a mammogram, you would save a huge amount of money.

Are screening guidelines published to save costs or save lives? Where do you draw the line to declare that a screening test is indeed "cost effective?" How is that term even defined? At this point, I think that most of us have more questions than answers.

Wait until 50 for mammograms

We seem to make cancer screening recommendations only to realize that we are wrong. Breast self-exams are not beneficial so we should not be telling out patients to do them. Mammograms should start at age 50, not 40. False positive results end up leading to further unnecessary tests, biopsies, etc. However, what about those few people who get diagnosed with breast cancer early? At what point is screening "cost-effective?" That's a critical question since screening tests cost money.

So, who do we follow? The U.S. Preventive Services Task Force (USPSTF) or the American Cancer Society (ACS)? Who's right? Could they both be right?

As these issues are debated, patients and health care professionals will be left confused. Without the presence of a clear consistent message, people will be left to interpret things for themselves and we will end up with chaos.

FDA finally approves Effient (prasugrel)

The FDA has finally approved Effient (prasugrel), a thienopyridine that is similar to Plavix (clopidogrel). In fact, prasugrel has been compared to clopidogrel. The TRITON-TIMI 38 study (comparing prasugrel against clopidogrel) was published in the New England Journal of Medicine (NEJM) back in November 2007! That's not a typo. 2007. The FDA wanted more safety data (which is why they launched the TRILOGY ACS study). I guess the FDA got what they needed. Here are the details straight from the FDA (with a few of my comments):

FDA Approves Effient to Reduce the Risk of Heart Attack in Angioplasty Patients

The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery. (it's about time, isn't it? The TRITON-TIMI 38 study came out in November, 2007! OK, you wanted more safety data because of bleeding. Fine.)

During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque. Often, a tiny wire mesh scaffold (stent) is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death.

Effient (prasugrel) was studied in a 13,608-patient trial (this is the TRITON-TIMI 38 study) comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty.

The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 percent in patients who received Effient.While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient. (So, Effient may be more effective than Plavix in certain patients, but it also appears to have a higher risk for bleeding)

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” said John Jenkins, M.D., director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research.“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.” (in other words, doctors now have to choose between Plavix vs. Effient. How are they to make this decision? Bleeding risk? Anti-platelet resistance?)

The drug’s labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding. The drug should not be used in patients with active pathological bleeding, a history of mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery. (we all know that blood thinners can cause serious bleeding, so this is plain common sense)

So, Effient is an alternative to Plavix. Now, the big question now is: who should get Effient and who should get Plavix? If you need a thienopyridine, which would you prefer? I'm not going to get started about anti-platelet resistance on this blog post.

• Effient is manufactured by Eli Lilly and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd.
• Plavix is marketed by a sanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.

There are many other acute coronary syndrome (ACS) drugs on the horizon, including thrombin receptor antagonists (TRAs) like SCH 530348 and novel anti-platelet drugs like cangrelor and AZD6104. I wonder if (or when) we'll see these new agents get approved.

Breastlight and Breast Self-Exams

Medgadget has a story on a fancy flashlight-type medical device called the Breastlight. It shines a light through breast tissue so that you can almost see inside your breasts and look for suspicious areas that might suggest breast cancer. This device is produced by PWB Health Ltd out of Dumbarton, UK, and was developed by Highland Innovation Centre (Inverness , UK). Looks like a very interesting product, but I wonder if it will do more harm than good. What do I mean by that? Well, let's consider what's happening in the world of breast self-exams (BSEs). Are BSEs even recommended these days? Let's see:

• The 3rd US Preventive Services Task Force (USPSTF) concluded that there was insufficient evidence to recommend for or against BSEs. That's very helpful.
  
• In 2003, the American Cancer Society (ACS) changed its previous recommendation in favor of monthly BSE to a recommendation that women be educated about the benefits and limitations of BSE by their healthcare provider. Once again, that's very decisive, isn't it?
  
• The American College of Obstetricians and Gynecologists (ACOG) recommends that healthcare providers routinely teach patients about BSE.

So, we should all teach patients about BSE, but should we be telling them that it's helpful or that it's harmful because it may lead to false positives and more invasive tests? Do BSEs really reduce mortality caused by breast cancer? What about other countries doing?

• The Canadian Task Force on Preventive Health Care concluded that "there is fair evidence to recommend that routine teaching of BSE be excluded from the periodic health examination of women aged 40 to 49 (grade D recommendation)" because of excessive work-ups for false-positive examinations and lack of firm evidence that BSEs decrease breast cancer mortality. Now, we finally have someone taking a stand instead of straddling the fence!
  

• The Advisory Committee on Cancer Prevention in the European Union states that there is "no convincing evidence for the effect of screening based on breast self-examination or clinical breast examination."
  

So where does this leave us on BSE? How will this new Breastlight impact breast cancer screening? I don't suggest that you share this device with hypochondriacs. To read the full article, click here. Image source: Medgadget