The newspapers and television are reporting that the FDA is reviewing reports of death and drug reactions from Botox after the Washington consumer group Public Citizen asked U.S. authorities to require the strongest possible warning highlighted in a black box on Allergan's Botox. Really? Do you think that the pharmaceutical companies, the $200 billion dollar a year industry, the most profitable industry in the U.S. by a long shot, will give up their control of U.S. health policy and the influence on the FDA?
I had a quick lesson on this industry with my lawsuit against Botox. We need to restore impartiality to clinical research and sever the ties between drug companies and medical education. Clearly, the pharmaceutical industry and the medical profession need complete reform, and Congress and the Food and Drug Administration need to be reminded that they exist to serve the public, not drug companies. I am also raising the flag that we must listen to Marcia Angell, who as a nationally-recognized authority in the field of health policy and medical ethics is the outspoken critic of the health care system. Time magazine named her one of the 25 most influential people in America.
When my trial ended, there were two significant issues that we raised: first, the safety levels of the drug at what was considered tolerable recommended doses, and second, the issue of the relationship between pharmaceutical companies that manufacture drugs and the doctors who prescribe those drugs. We must also begin to demand that if any doctor is a paid consultant to the drug company, they cannot speak or give quotes without revealing that relationship to the general public. Also when you are being treated by a drug, the doctor should reveal to the patient if he is a paid consultant to the drug company. Marcia Angell, MD, former editor-in-chief of The New England Journal of Medicine and now a member of Harvard Medical School's Department of Social Medicine, in her 2004 book, The Truth About the Drug Companies and How They Deceive Us and What They Do, suggests on page 261:
"Ask your doctors, "Do you have any financial ties with the company that makes this drug. For example, do you consult for the company? Are you being paid to put me on this drug? Do you make time for visits from drug company representatives? If the answer to any of these questions is yes, you should consider changing doctors. You need to know your doctor's decisions are based solely on what is best for you. And doctors need to be weaned from their dependence on drug company largesse."
Mitchell Brin on the stand finally had to admit "that the risks of Botox were unknown in doses higher than 20 units" and that the DRUG CAN SPREAD TO OTHER AREAS OF THE BODY affecting neuromuscular transmission. He also admitted that Allergan's own clinical studies "suggested Botox may be associated with headaches, sinusitis, pain, flu-like symptoms and respiratory problems" (page 47, Beauty Junkies, by Alex Kuczynski). Alex Kuczynski reports in her book that Paulette Delcourt's father suffered serious side affects after receiving Botox in the back of the neck in a Botox clinical trial in 1995. Delcourt's father lived on a ventilator for two months and then he died. (Page 50.)
Carol Staub, Laura Dunn, Debbie Suzle, Karen Hicks: there are many whose voices were never heard. We must demand a strong, unbiased FDA. Watching Michael Clayton, I relived it. When George Bush won his second term, one of the inaugural balls was sponsored by Allergan. It all seemed such a perfect fit.