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Pharmaceuticals

Not so trivial detail. “Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs.”

“Lawyers for generic drug companies say their clients are able to provide low-cost drugs because their primary task is replicating drugs. If the companies were expected to take responsibility for updating their labels, “we would effectively start to turn generic companies into brand companies, and of course the tremendous cost savings that American consumers have benefitted from would start to wane,” said Jay Lefkowitz, who served as the lead attorney representing generic companies before the Supreme Court.” Excerpted from: Generic Drugs Proving Resistant to Damage Suits, By Katie Thomas, NY Times 3-21-12


Drug pushers. “Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of their drugs.”

“But an investigation by ProPublica uncovered hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.”

“To vet the industry’s handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors.”

“A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.”

“More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes.”
Excerpted from: Docs on Pharma Payroll Have Blemished Records, Limited Credentials by Charles Ornstein , Tracy Weber and Dan Nguyen, ProPublica, Oct. 18, 2010


Lawsuits: "A Vital Deterrent" "The Food and Drug Administration "is in no position" to guarantee drug safety, the editors of the New England Journal of Medicine said in a friend-of-the-court brief."

"Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."
Excerpted from: Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugs By RICARDO ALONSO-ZALDIVAR, Associated Press, August 15, 2008


How do you spell relief? R-E-G-U-L-A-T-I-O-N.  Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations such as India and China has exploded in recent years, the Food and Drug Administration's budget for foreign inspections has not kept pace and will be lower in 2008 than it was in 2002, according to congressional investigators.

In addition, the investigators reported, FDA officials generally do not bring their own translators, and so in countries such as China they rely on company-supplied translators to conduct inspections. They also have to tell foreign manufacturers in advance that they are coming, while FDA inspectors can go into American plants at any time unannounced.
Excerpted from: FDA's Foreign Inspection Budget Lean, Washington Post, 11/1/07


Drug Safety Study: Losing Ground. The number of serious adverse events and deaths attributed to prescription medications has nearly tripled since the Food and Drug Administration initiated a system in 1998 to make it easier to report significant side effects according to the report in the Archives of Internal Medicine.

Researchers at the Institute for Safe Medication Practices in Huntingdon Valley, found twenty percent of drugs accounted for 87% of adverse effects, and the biggest offenders were painkillers and drugs that modify the immune system to treat arthritis. "The clear finding is that we are losing ground in terms of drug safety, and that ought to be of great concern," said Thomas J. Moore who led the study.

Adverse events are those defined as resulting in death, a birth defect, disability, hospitalization or requiring intervention to prevent harm. The number of such events grew from 34,966 in 1998 to 89,842 in 2005. During the same period, the number of deaths rose from 5,519 to 15,105.
Excerpted from: Adverse drug reactions rise sharply, study finds, LA Times, Thomas H. Maugh II, September 11, 2007