{"id":1630,"date":"2014-02-28T18:13:22","date_gmt":"2014-02-28T23:13:22","guid":{"rendered":"http:\/\/www3.law.harvard.edu\/journals\/jol\/?p=1630"},"modified":"2018-08-29T01:07:36","modified_gmt":"2018-08-29T05:07:36","slug":"prescription-for-paternalism","status":"publish","type":"post","link":"https:\/\/journals.law.harvard.edu\/jol\/2014\/02\/28\/prescription-for-paternalism\/","title":{"rendered":"Prescription for Paternalism"},"content":{"rendered":"

Prescription for Paternalism<\/strong><\/p>\n

Jenna Tynan<\/strong>[*]<\/strong><\/a><\/p>\n

 <\/p>\n

Multiple commentators have weighed in on the relative merits of the long-awaited Obamacare implementation.[2]<\/a> Both perspectives, however, have shown that any legislation\u2019s impact is determined not only by the text of the act but also by the parties affected.\u00a0A recent personal experience at the doctor\u2019s office demonstrates the reactionary impact of legislation.\u00a0After 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.\u00a0I firmly vouched that I was not pregnant, but the physicians responded that they would like to take my word but could not do so.<\/p>\n

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]<\/a>\u00a0However, my physicians\u2019 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.\u00a0The 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\u2019s pregnancy categories C, D, and X.[4]<\/a><\/p>\n

(As a side note, the category system weighs the benefits of the drug in each category against potential pregnancy-related risks.\u00a0Drugs 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 \u201ccontraindication\u201d instructions strongly advising against use if the patient is possibly pregnant.)<\/p>\n

However, physicians seem to have responded to these labeling<\/em> restrictions by tightening their own prescribing<\/em> decisions.\u00a0Further, radiologists have either begun or have been recommended to conduct pregnancy tests before administering x-rays.[5]<\/a>\u00a0This anecdote underscores that well-thought-out and even uncontested regulations can produce unsavory effects.\u00a0Now, a female of childbearing age seems to have, as Carol Gilligan has put it, \u201clost her voice\u201d to vouch for her own pregnancy status without independent verification.[6]<\/a> 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.<\/p>\n

Though I doubt we\u2019ll ever approach such a result, I do believe that one\u2019s autonomy in health decision-making should not be reduced based on being a female in a particular fertility cohort.\u00a0Perhaps 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.<\/p>\n

\n

[*]<\/a> J.D. Candidate, Harvard Law School, 2016.<\/p>\n

[2]<\/a> See, e.g.<\/em>, Jules Witcover, Obama\u2019s crowning legislative achievement is now his albatross<\/em>, 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].<\/p>\n

[3]<\/a> Safety Notice<\/em>, iPledge, https:\/\/www.ipledgeprogram.com\/iPledgeUI\/home.u [https:\/\/perma.cc\/7RDF-GNXT].<\/p>\n

[4]<\/a> See<\/em> FDA Pregnancy Categories<\/em>, Chemical Hazards Emergency Med. Mgmt., U.S. Dep\u2019t 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).<\/p>\n

[5]<\/a> See<\/em> Kimberly E. Applegate, Pregnancy screening of adolescents and women before radiologic testing: does radiology need a national guideline?<\/em>, 4(8) J. Am. Coll. Radiology 533\u201336 (2007).<\/p>\n

[6]<\/a> See<\/em> Emily Eakin, Listening for the Voices of Women<\/em>, 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].<\/p>\n","protected":false},"excerpt":{"rendered":"

Prescription for Paternalism Jenna Tynan[*]   Multiple commentators have weighed in on the relative merits of the long-awaited Obamacare implementation.[2] 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