Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

I have never minded spending any amount of time when a patient needed me or to do anything that bettered patient care. I am sure that none of you have ever minded being awakened at night by a patient who was ill and needed attention: hey, we’re ObGyns. I would not object to spending any amount of time on the conversion to an electronic medical records (EMR) system if I thought it would really benefit patient care. But I am convinced that it does not.

I knew that I would have problems with our new electronic medical record (EMR) system on the first day of training. The initial training was conducted by a programmatic, not medically trained “yuppette” from the IT Department, who extolled to a 60-year-old Mac user the wonders of the EMR system: you should right click here, single click there (oops, don’t double click!), and then enter some esoteric bit of medical history.

The FDA’s most recent response to the anti-cancer drug shortage crisis may be a perfect example of “too little, too late.” What follows will not be a rant about offshore outsourcing or the regulatory climate in general. However, the FDA decision (See FDA’s Press Release regarding shortages of anti-cancer drugs here) to allow Sun Pharma’s version of Doxil (doxorubicin HCl liposome injection) into the United States to replace the approved Ben Venue product may be a dangerous one for patients with ovarian cancer.

As a health care professional I see that many women are now becoming more active in their own sexual satisfaction and discussing issues of sexual health concerns; however, it is remarkably amazing how different the media sees the difference between male and female sexuality. It is not uncommon to pick up a lay magazine or watch a prime time television show and see an advertisement for a male erectile medication. The media has essentially embraced male erectile dysfunction and even use the word erection. But when was the last time we saw an ad about vaginal dryness or female sexual pain or a woman’s loss of sexual interest?

Although my patients have very diverse backgrounds (ie, in class, age, ethnicity, race, education, language, health literacy), they are quite similar in what they fear and what they don’t fear. For my female patients, breast cancer is at the top of the list. Somewhere beneath that is diabetes, then heart disease, stroke, and others that you would expect. I’m pretty sure that for most of my patients, lung cancer doesn’t even make it on the list.

Most would agree that mapping of the human genome during the last few years of the 20^th century was a key technological advance in a century that saw the most technological advances in history. Knowledge of the human genome makes pharmacogenomics possible, and pharmacogenomics makes personalized medicines possible. Personalized medicine—hype not withstanding—is a model for pharmacotherapeutics that cannot be ignored by those interested in advancements in the treatment of disease. It most often refers to use of an individual’s genetic information to optimize treatment or prevent disease for that individual. Crizotinib (Xalkori) and vemurafenib (Zelboraf) are notable personalized medicines approved by the FDA in 2011.