From Bloomberg news
"Johnson & Johnson hid or altered data on the health risks of its Ortho Evra birth-control patch and flaws in the manufacturing of the device, lawyers for women suing the company claim in court papers."Also of interest in the article is the reference to "preemption" rules. This is part of the attempt in the US to create a legal landscape in which it would be impossible for a consumer to sue if a drug is FDA approved. For companies that claim to be "science-based" and to believe in the "free market", this is a complete inversion of both. Such protection for commercial entities would seemingly still apply in the usual scenario where the FDA approves on the basis of misleading, fraudulent or missing data. It would also apparently apply if the scientific literature is distorted through company interference, and if that leads to mis-prescribing. Preemption subverts the free market, throws science out of the window, and places all the responsibility for prescribing in the hands of an unaccountable big-brother government agency. How convenient. No one is then responsible for the consequences of scientific misconduct or hidden science. The company would claim that they couldn't possibly be held responsible because the FDA dictated what they had to tell doctors. The prescribing doctor could not be held responsible (so long as they do what the FDA tells them to do) because they are not permitted to do or see anything else, and the data is not available to the scientific community.
"Manufacturing defects made the patch unstable and the dosage unpredictable, according to the filing. Tests showed in 2003 that the patch produced 60 percent more estrogen than oral contraceptives, it said. A company pharmacologist, Dr. Larry Abrams, applied a "correction factor" to lower estrogen results given to the FDA by 60 percent, according to the filing."
"Through a sleight of hand, and altering of numbers,'' Abrams ``presented a truly misleading picture of the amount of estrogen delivered by the patch," the filing said.
"The FDA warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with use of the pill."
"The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the filing. Abrams, who is now retired, applied his ``correction factor'' to lower the results, and the company obscured his method in reports to the FDA."
"The company also couldn't replicate in its commercial patch the results obtained in clinical trials, it said. The levels of estrogen also varied from batch to batch, it said. The company hid those problems from the FDA, it said."
Preemption is also based on a deliberate misunderstanding of medicine. Prescribers don't prescribe a random drug as a reflex simply because a patient has a "disease" and because a drug is "approved" for that "disease". If only the algorithm were so simple. There is a complex decision making process involved in any act of prescribing, and that process depends on the availability of honest information. If that information is not honest and not complete, then the process cannot work. The FDA cannot pre-empt that decision process, unless they provide guidance for every possible complex clinical scenario, and indeed dictate which drug to prescribe.
This is the law dictating to our profession that science, logic and honesty should not be permitted to operate in medicine.
Plaintiffs responded to a company motion to dismiss the cases that argued that FDA approval of the device and its label supersedes, or preempts, the ability of patients to seek damages under state laws.
Hat tip Pharmagossip
See also Drug Makers Near an Old Goal: A Legal Shield (NYT April 6, 2008)
and a series of great posts on the legal problem of Preemption at Drug Injury Watch