Off-label administering of Botox for Migraines

My name is Caitlin Mooney and I am 22 years old.  I am currently a graduate student at Quinnipiac University in Hamden, CT in the Public Relations program.  This blog is part of my Public Relations Research course and I will be discussing issues within healthcare and public relations research each week.


This week, I will be discussing off-label administering of Botox for a variety of medical conditions.  According to an article in the NY Times written by Natasha Singer, so far, the Food and Drug Administration has approved the use of Botox to alleviate uncontrolled blinking, muscle spasms and stiffness, excessive sweating and, most famously, wrinkles.  However, the maker of Botox, Allergan, has been promoting the use of Botox for uses unapproved by the F.D.A. such as pain, muscle spasticity, cerebral palsy in children and most recently, migraines. While it is legal for doctors to prescribe drugs for medical conditions unapproved by the F.D.A. as they see fit, it is illegal for drug companies to promote the off-label uses.


"Court filings have described an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as a headache treatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors; and paid kickbacks to doctors to induce them to prescribe Botox" (Natasha Singer, After Fine, Botox Awaits Approval for Migraine - NY Times).


I find this to be highly unethical practice because according to the principal deputy commissioner of the F.D.A., these drug companies, such as Allergan, are promoting these off-label uses without proof or evidence that the drug is in fact safe to use for the medical condition they are promoting.  This puts patients at high risk for serious side effects.  I think that the drug companies and the doctors that are administering the drugs and accepting kickbacks are being negligent.  This is a public relations problem because if there is a large number of serious side effects from prescription of drugs for off-label uses, a serious crisis could occur for the drug companies and the medical practices where the doctors are administering these drugs.  This shows that the drug companies do not care about the well being of their customers, but are only interested in money, which severely tarnishes a reputation.


Throughout the article by Natasha Singer, it also mentions that Allergan has spent "hundreds of millions of dollars in medical research and development of new uses for Botox;" however, according to Earl Babbie in The Basics of Social Research, it is impossible for research to be totally objective because the researchers are human.  Therefore, if the drug company is conducting the research, obviously they will find and report evidence that supports the usage of their drug, not the opposite.  The drug company values sales and money, and it is hard to put that aside while conducting research, especially when "...Wall Street analysts have estimated that sales of the drug for migraines could reach $1 billion or more annually worldwide by 2016" (Natasha Singer, After Fine, Botox Awaits Approval for Migraine - NY Times).  "...researchers should not let their own values interfere with the quality and honesty of their research..." (Earl Babbie, The Basics of Social Research 5th ed. pg. 89).  In my eyes, this makes the research being done by Allergan to be unethical, and I would say that the off-label uses of the drug are unsafe.  Only when the F.D.A. conducts research and comes to a conclusion would I say that it's okay to prescribe the drug for off-label uses, because they are an objective party in this research.