U.S. health regulators have warned Pfizer Inc. over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.
Drugmakers encouraged doctors to prescribe these drugs for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.
Ironically, the FDA is approving these drugs for use in children at the same time that the Justice Department has been fining drug companies for illegally marketing these drugs to children. The illegal marketing corrupted and contaminated medical practice, encouraging physicians to prescribe off label, eventually leading the FDA to then approve off label prescribing. The studies used to justify this approval have been wholly developed and supervised by these same drugs companies using handpicked doctors who have often been involved in encouraging off label use. Drug companies commonly ghostwrite the research publications that appear under the names of these doctors.
The lawsuit, filed by Dr. Stefan Kruszewski of Harrisburg, Pa., alleges that three of the researchers who helped conduct Geodon clinical trials – Dr. Richard Borison, Dr. Bruce Diamond and Dr. Louis Fabre – have been sanctioned by regulatory authorities. Borison and Diamond were debarred by the U.S. Food and Drug Administration and received prison time, according to the suit, and Fabre earned sanctions in Texas for research misconduct.
Pfizer’s $2.3 billion health care fraud settlement with the government announced this month by the US Department of Justice adds some firsts to the world’s biggest pharmaceutical company. It covers Pfizer’s kickbacks to health care providers and false claims submitted to government health care programs, also known as our tax dollars, in violation of the Food, Drug and Cosmetic Act. Forty-three states will share in the “give backs.”