Prescription for Paternalism

Published by - February 28, 2014 -

Prescription for Paternalism

Jenna Tynan[*]

 

Multiple commentators have weighed in on the relative merits of the long-awaited Obamacare implementation.[2] Both perspectives, however, have shown that any legislation’s impact is determined not only by the text of the act but also by the parties affected. A recent personal experience at the doctor’s office demonstrates the reactionary impact of legislation. After determining that I had a common eye infection well treated by oral antibiotics, the physicians chose a different antibiotic regimen, referring to their inability to dispense the antibiotic for fear that I may be pregnant. I firmly vouched that I was not pregnant, but the physicians responded that they would like to take my word but could not do so.

At first, I thought that antibiotic manufacturers were now taking the paternalistic approach that isotretinoin (acne medication) producers have taken. Isotretinoin producers now require patients, pharmacists, and physicians to join the iPledge program to prevent pregnancy during medication ingestion.[3] However, my physicians’ prescribing choice was not driven by such a formalized program, but the combination of a labeling restriction promulgated in 2013 and, as I opine, fear of medical malpractice suits. The particular regulations on their face appear benign: providing for updated labeling requirements. The Act, among other things, requires warnings that highlight increased risks of birth defects for drugs falling in the FDA’s pregnancy categories C, D, and X.[4]

(As a side note, the category system weighs the benefits of the drug in each category against potential pregnancy-related risks. Drugs in Category A have the greatest benefit per risk ratio. Category X drugs, conversely, carry substantial risk per unit of benefit; labels for category X drugs require “contraindication” instructions strongly advising against use if the patient is possibly pregnant.)

However, physicians seem to have responded to these labeling restrictions by tightening their own prescribing decisions. Further, radiologists have either begun or have been recommended to conduct pregnancy tests before administering x-rays.[5] This anecdote underscores that well-thought-out and even uncontested regulations can produce unsavory effects. Now, a female of childbearing age seems to have, as Carol Gilligan has put it, “lost her voice” to vouch for her own pregnancy status without independent verification.[6] Yes, physicians and pharmaceutical producers do have specialized knowledge that average consumers do not, but that knowledge should not impair the patient rights of a particular class of individuals. Car manufacturers could use the same rationale, taken to its extreme, to require pregnant women to occupy only the back seat of a car for fear of miscarriage liability due to faulty airbag deployment.

Though I doubt we’ll ever approach such a result, I do believe that one’s autonomy in health decision-making should not be reduced based on being a female in a particular fertility cohort. Perhaps this particular reaction will indeed reduce birth complications. However, I posit that such reactions are a prescription for paternalism whereas patients would be better served with a double dose of autonomy.

[*] J.D. Candidate, Harvard Law School, 2016.

[2] See, e.g., Jules Witcover, Obama’s crowning legislative achievement is now his albatross, Baltimore Sun (Feb. 14, 2014), http://www.baltimoresun.com/news/opinion/oped/bal-obamas-crowning-legislative-achievement-is-now-his-albatross-20140213-story.html [https://perma.cc/PXW9-5GQM].

[3] Safety Notice, iPledge, https://www.ipledgeprogram.com/iPledgeUI/home.u [https://perma.cc/7RDF-GNXT].

[4] See FDA Pregnancy Categories, Chemical Hazards Emergency Med. Mgmt., U.S. Dep’t of Health and Human Servs., https://chemm.nlm.nih.gov/pregnancycategories.htm [https://perma.cc/N4TT-LUJY], citing Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, 73 Fed. Reg. 30831 (May 29, 2008) (later codified at 21 C.F.R. pt. 201).

[5] See Kimberly E. Applegate, Pregnancy screening of adolescents and women before radiologic testing: does radiology need a national guideline?, 4(8) J. Am. Coll. Radiology 533–36 (2007).

[6] See Emily Eakin, Listening for the Voices of Women, N.Y. Times (Aug. 29, 2002), https://www.nytimes.com/2002/03/30/arts/listening-for-the-voices-of-women.html [https://perma.cc/MNW3-9XVM].

16 thoughts on “Prescription for Paternalism”

  1. As divisive as Obama-care can be the fact is that the majority of person bankruptcies in this country are due to medical expenses. Although this type of legislation is thought by some to be going too far as well.

    1. Interesting point of view Thomas on fact of person bankruptcies, it’s surely too complex problem of society in general!

  2. Maybe the physicians could have a standard written document where the patient declare (and sign) that she was not pregnant, so there’s no need to incur additional costs of doing the pregnancy test?

  4. Maybe the physicians could have a standard written document where the patient declare (and sign) that she was not pregnant, so there’s no need to incur additional costs of doing the pregnancy

  13. Category X drugs, conversely, carry substantial risk per unit of benefit; labels for category X drugs require “contraindication” instructions strongly advising against use if the patient is possibly pregnant.

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