This post is designed to be read with the Drugs and Smell post on RxISK. Click on the image to read the small text.
The second drug in the Anosmia Table in the Drugs and Smell post is Zinc Gluconate which was traded under the name Zicam. For anyone concerned about adverse events this is one of the most important drugs in History.
Zicam was marketed by Matrixx Pharmaceuticals. The company’s shareholders became concerned about reports it could produce anosmia and parosmia and asked to “look at the books”. The Board said no. The shareholders took them to court and ultimately to the Supreme Court. The company defense was that all it had were animal studies that were not statistically significant and some anecdotal reports of a problem, but as nothing had been properly linked to treatment there was no need to tell the shareholders. The Supreme Court disagreed.
If you are going to gamble with your money, the Supremes figure you are entitled to make up your own mind what the data means but not it seems if you are someone gambling with your life or your child’s life or perhaps the life of child yet to be born or a doctor gambling with your patient’s life.
The Supreme Court decision doesn’t stand quite alone though. There is an extraordinary legal case from 1981, Oksenholt vs. Lederle Laboratories, which no one seems to have picked up on.
Dr Oksenholt was sued by a patient whom he had put on a treatment for tuberculosis, Myambutol. This had caused her to go blind. He settled the case with her for $100,000 and then sued the drug company for withholding information from him that their drug could cause someone to go blind. He won the case. He also won $50,000 damages and an unspecified amount for future loss of earnings and $5 million punitive damages. See Oksenholt.
None of the doctors who gave medication to any of the Mass Shooters of recent years or Airline Pilots who have crashed – and there have been many on antidepressants – have interrogated companies legally about the with-holding of data. There is a precedent there for them.
This is the third post in the Magna Carta series, a place-holder while we try to FOIA or otherwise find the missing Crusoe Report mentioned in the Witty Report last week. It’s the twenty-first post in the Persecution series.
Illustration: Magna Farta, 2015 created by Billiam James