Prescription for disaster

It's hard to turn on the TV or open a magazine without seeing an advertisement for pharmaceutical products of one type or another. It's even harder not to be amused by the litany of warnings ("Don't take this medication if you take nitrates for chest pain, if your name begins with the letter F, if you cannot sit or stand for thirty minutes…") and possible side effects ("including but not limited to headache, temporary memory loss while staring at waterfalls, dry mouth…"). As an attorney representing plaintiffs in pharmaceutical products liability cases, my job has included reading package inserts that go into even more detail about the potential dangers of a medication and its indications for use. I've also pored over hundreds of pages of materials describing the process of clinical trials and Food and Drug Administration (FDA) review prior to approval. If anything, it made me wish that the drug companies had to be more thorough in their TV and print ads. 

In fact, that used to be the case. Direct-to-consumer advertising has been legal in the U.S. since 1985, but was initially restricted to print media due to the stringency of FDA regulations regarding content. Back then, an ad was required to convey every risk detailed in the drug's packaging, as well as a "fair balance" of information concerning both these risks and the benefits. Television commercials became popular in 1997, when the regulations were relaxed to require merely an "adequate provision" of the "major risks." Over the next ten years, pharmaceutical advertising budgets exploded, topping $5 billion in 2006 and 2007. 

Accompanying this boom has been the seeming invention of  diseases purely for drug marketing purposes. One of my favorite health documentaries, Forks Over Knives, includes discussion of the ever-marketed erectile dysfunction (ED); namely, that ED itself is not a medical disorder but rather a symptom of other health problems, including heart disease and diabetes. Dr. Terry Mason, a Chicago public health official, suggests that instead of using medication simply to improve sexual function, ED sufferers should change their diets to alleviate the underlying maladies and improve overall health, including "below the equator".

On other occasions, pharmaceutical companies have marketed their products for completely different disorders than the ones they were intended to treat, and unlike the invention of penicillin, it’s no happy accident. The New York Times reported on Shire Pharmaceuticals' recent efforts to promote awareness of binge-eating disorder. The company recently received FDA approval to market one of its preexisting medications in advance of releasing a new drug to treat the disorder, which was officially recognized by the American Psychiatric Association in 2013. The drug, Vyvanse, had previously been approved to treat attention deficit hyperactivity disorder (ADHD); as a result, it was approved for its new indication without FDA advisory committee input. Nonetheless, medical professionals remain concerned that the drug - a powerful amphetamine - will be overprescribed and misused. And with good reason, considering the FDA charged Shire with improperly promoting Vyvanse and Adderall by downplaying their addictiveness and touting questionable benefits.

This cycle of activity gives way to suspicion of the merits of identifying every quirky behavior as a disease or disorder. Then again, far be it for me to pass judgment on the legitimacy and seriousness of a medical condition, since I'm not a doctor. 

But that's just it - hawking pharmaceuticals directly to the people undermines the ability of medical professionals to treat our ailments with a variety of tools. It's human nature to look for the easiest way to accomplish a goal, and pharmaceutical drugs easily present themselves as a quick-fix for numerous conditions. One psychiatrist expressed to the Times his concern that, as effective as Vyvanse may be, talk therapy and other treatments have been the subject of more research. Nonetheless, until there's big money in marketing visits to a therapist, drug companies will continue to tell us that pills are the answer for all of our problems... and what those problems are in the first place.

Given my prior experience, I have a bit more to say about the pharmaceutical industry and its influence. For instance, I've been to FDA advisory committee meetings, and can't say for sure that holding one would have made any difference in the decision to expand approved uses of Vyvanse. For now, though, I'd love to hear your thoughts on this new development. Am I unnecessarily concerned about the perils of pharmaceutical advertising? Should we simply be grateful that pharmaceuticals can help us manage our medical problems? Sound off in the comments, or email me at nylawmom@gmail.com.

C-sections, freedom, gender... and how none of it is anyone's business, really.

As a new mom and New York Mets' fan (hold your boos, please), my ear's perked up when I heard Boomer Esiason's suggestion that Daniel Murphy's wife should have scheduled a C-section to better accommodate the team's schedule. I don't want to repeat what's been said in the numerous insightful, well-reasoned articles covering this topic, especially now that the former NFL quarterback has apologized, but I do have a few thoughts to share.

We're fortunate to live in a time and place where numerous life-saving medical procedures are available and performed every day. The important aspect of this issue is that all health-related decisions are a matter to be adjudicated between an individual, his/her family members, and his/her doctor. Some women give birth at home in their bathtubs under the supervision of a midwife with no pharmaceutical assistance; others go in fully expecting to be hooked up to an epidural catheter. Personal preferences and ideals aside, no one way is "better" than another. And I'm willing to bet that there are people (wives of professional athletes included) who have scheduled C-sections or labor inductions for the sake of convenience. Other women not in the public eye may elect to push or delay a C-section or induction so as not to interfere with their partners' work obligations or other commitments. A friend of mine was due to give birth at the end of August. When she remained pregnant on September 8th her doctor scheduled her for an induction the next day... then bumped it to the following day because the labor and delivery ward was full - too many women scheduling their C-section/induced births for the 9th, to avoid delivering on September 11th.

The point, which both Murphy and Esiason espoused in their comments subsequent to the initial discussion, is that the approach to childbirth and decisions about subsequent care are matters of individual choice. As long as someone with medical training approves of and can provide or arrange for any subsequent care, the patient's decision is what governs.

By the way, the same argument can be made for the availability of abortion and the use of stem cells. If these medical interventions violate someone's religious beliefs or personally-held moral ideals, he or she needn't utilize them. But calling for the elimination of the procedures altogether, depriving other people of autonomy in deciding whether or not to pursue those treatments, misapplies the First Amendment's clause protecting the free exercise of religion. In this arena, as in many others, "freedom" means that we get to believe in and practice the principles we choose, but it does not extend so far as to allow the imposition of one group's beliefs on outsiders.

Another angle to the paternity leave issue involves gender itself. Lots of people on Twitter shared the sentiment that, as a man, Esiason was somehow not equipped to make an informed assessment of the situation nor entitled to have an opinion at all because he himself cannot give birth. Nonetheless, I believe that despite being a man, he had every right to formulate an opinion and voice it accordingly... with the understanding that the world would view his opinion with the appropriate grain of salt and react critically. The notion that Esiason's sex makes him ill-equipped to form a reasoned opinion on the subject of birth is insulting to all men, and thereby undermines any attempt at "feminist" argument by being unnecessarily antagonistic toward an entire gender.

What do you all think? Where do we draw the line about who can say what about others' medical procedures? Is this whole ordeal being overblown? Will the Mets ever win a game?! I eagerly await your comments.