The Pill Should Really Be Over-The-Counter

Time Magazine published a piece this morning entitled Women Should Not Have to Visit a Doctor For Birth Control about the legislation that goes into effect this year allowing women in Oregon and California to get a prescription for oral contraceptives from their pharmacist rather than first scheduling a doctor appointment. The article further went on to say that while these laws are a step in the right direction they don’t go far enough because ideally women should be able to get oral contraceptives without a prescription. For years, according to the author, the American College of Obstetrics and Gynecology (ACOG) has recommended that oral contraceptives be made available over-the-counter, which is how contraceptives are sold in 102 other countries in the world. 

So it would appear that if ACOG, the physician group with the most experience with the pill, supports selling it over-the-counter, there would be no reason not to go ahead and make the pill available over-the-counter. It may sound obvious, but it isn't happening (very quickly)- and it appears to be due to health insurance and the Affordable Care Act (ACA).

One of the mandates of the ACA is that it is necessary to have a prescription, even for an over-the-counter medication, for insurance to cover the medication or for the patient to be able to pay with Health Savings Account (HSA) or Flexible Spending Account (FSA) funds. The Affordable Care Act also mandates that all FDA-approved contraception is fully covered by health insurance.

California and Oregon have finagled their way out of this tangle of regulations by having pharmacists prescribe oral contraception, thus women have easier access to the drugs while guaranteeing that oral contraceptives continue to be covered in full by health insurance companies. Replacing physicians with pharmacists does lower the barrier, but it doesn’t completely eliminate it. For example, Oregon’s law requires pharmacists to consult with women who wish to obtain hormonal contraceptives and ensure that the woman has a primary care physician for follow-up.   We don’t have these requirements for Tylenol yet taking more than the recommended amount of it can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death. Why do we place obstacles in the way of purchasing oral contraceptives but not Tylenol? I don’t have hard evidence but I would bet that women are more likely to discuss proper administration and any potential side effects of oral contraception than of Tylenol with physicians or pharmacists.

Now, on to cost. Many democrats argue that by making the pill available over-the-counter, patients would be responsible for the full cost of the medication, thus circumventing the portion of the ACA which mandates that all FDA-approved contraception is fully covered by insurance. Due to this Senator Patty Murray of Washington recently introduced the Affordability Is Access Act which would require insurance companies to cover all FDA approved contraception, even if some forms of contraception, like birth control pills, become available without a prescription.

However, we know from past experience that when prescription drugs become available over-the-counter, prices fall dramatically. When the allergy medication Claritin became available over-the-counter in 2002 the cost of the drug fell by one-half or even more to about $1 a pill so that a months supply cost roughly $30. When the generic version came on the market it sold for about $0.35 a pill, or $10.50 a month. I checked the price of generic Claritin at Walmart and it now sells for $0.124 a pill, or $3.71 for a thirty-day supply. And this is the result of transferring just one drug to over-the-counter status, not transferring a whole category of drugs! There are currently 218 brand-name birth control pills and 21 generic birth control pills available so if all of those suddenly became available over-the-counter cost would be driven down quickly and dramatically. In fact, for those without health insurance, Walmart right now offers a cash price of $9 for a one-month supply on nine different generic oral contraceptives. So there is no reason to believe that oral contraception has to cost $600 a year.

It may appear that birth control pills are now “free” for those with health insurance, but just because there is no exchange of money when a woman picks up her oral contraception doesn’t mean that the cost has vanished. It is naïve to think that health insurance companies just eat the extra cost of paying for all FDA-approved contraception in full. Instead of continuing to hide the inflated price of oral contraceptives from consumers, now is the time to bring access to oral contraceptives to every woman who is able to get herself to a pharmacy and to bring down the true cost of oral contraception to a level that is affordable for every woman.

The Mammogram Debate Continues

The Wall Street Journal’s article, published this morning, Final Recommendations on When to Start Getting a Mammogram, continues the trend of highlighting the risk of under screening while mitigating the harms of overtreatment in the mammogram debate.

The article does a good job explaining that right now three different advisory groups, the American College of Obstetricians and Gynecologists (ACOG), the U.S. Preventative Services Task Force (USPSTF), and the American Cancer Society, have different recommendations for when women of average risk should commence mammograms, how often the mammograms need to be done and at what age women should cease doing routine, preventative mammograms. 

"Final Recommendations on When to Start Getting a Mammogram" published by the Wall Street Journal

However, the article really drops the ball when it comes to explaining the origin of these different recommendations. The article explains that the controversy is centered on the balance of doing enough screening to save women’s lives, while not over-screening which leads to false positives and unnecessary treatment. One of the physicians quoted in the article, Dr. Therese Bevers, chairwomen of the breast cancer screening and diagnosis guidelines panel for the National Comprehensive Cancer Network, stated, “Harms such as false positives requiring a repeat ultrasound or a needle biopsy are outweighed by the potential for lives saved.” This is short sighted. If overtreatment were just about ultrasounds and needle biopsies, there simply would not be any controversy. The controversy stems from a combination of (i) false positives which can lead to emotional stress, financial strain due to follow-up testing and sometimes unnecessary, invasive procedures including mastectomies, and (ii) catching early stage, or “stage zero” cancers such as Ductal Carcinoma In Situ (DCIS), which no one really knows how to appropriately treat.

DCIS refers to clusters of abnormal cells confined to milk ducts which may later develop into an invasive breast cancer. Before the implementation of widespread mammography in the 1980’s, DCIS accounted for just 3% of breast cancers diagnosed. Now DCIS accounts for nearly a third of breast cancer diagnoses annually. It was thought that treating DCIS (and it is treated the same as breast cancer, typically with lumpectomy and radiation) would cause the rates of invasive breast cancer to plummet, but the data has failed to support this hypothesis. Everyone agrees that some cases of DCIS will eventually become an invasive breast cancer, but the exact proportion is widely debated. The data is causing many prominent physicians and researchers such as Dr. Laura Esserman, a breast surgeon at the University of California, San Francisco, to question whether DCIS is in fact a risk factor for invasive cancer rather than a precursor. Dr Esserman believes that for some women a more effective treatment to decrease the risk of developing invasive breast cancer in the future may be hormonal or immunological therapies.

 The future will bring more information about how to best interpret and treat DCIS but at the moment the issue is not a question of data interpretation but rather a matter of individual risk tolerance. Each woman must decide whether she feels more comfortable having mammograms earlier and more frequently, which may save her life but also puts her at higher risk for potentially unnecessary, costly treatment and all the baggage that comes with that treatment (anxiety, for example) or limiting mammograms to when they are more likely to be beneficial, but then possibly missing cancer in its early stages. One of the physicians, Dr. Nancy Keating, quoted in the article says that she tries to give patients an idea of whether they are at average or above average risk for developing breast cancer and lets them know the pros and cons of getting mammograms early and often. The patients are then able to make an informed decision about how to proceed. That sounds about right.