Related: FDA pulls Zantac Late
Why is the FDA not held responsible for all those deaths for which it certainly shares a large measure of responsibility? Why is FDA not held responsible for the two to four million serious, disabling injuries caused annually by drugs the agency has approved?
And why do we not see news stories at least, oh, several times a year about the agency’s lethally bad batting average? Any other organization responsible for the deaths or serious injuries of so many people per year would be held accountable, would it not?
Those deaths and injury figures come from a British Medical Journal report published on June 7, 2012 (BMJ 2012:344:e3989) by Jeanne Lenzer. She noted that the Institute for Safe Medicine Practices calculated:
“Prescription drugs in 2011 were associated with two to four million people in the US experiencing ‘serious, disabling, or fatal injuries, including 128,000 deaths.’”
The ISMP report called the lethal threat, “One of the most significant perils to humans resulting from human activity.” The report was compiled by outside researchers who took their data from the FDA’s own database of “serious adverse [medical-drug] events.”
So we know the FDA is well aware of its less-than-stellar (to put it mildly) track record. The FDA knows the numbers, but is not saying anything about them. Why not?
It seems fair to ask, “Does the FDA work primarily for average Americans, or does it work primarily for the drug companies which make billions per year in drug profits?”
Is US Health Really the Best in the World?
In July 2000, the US medical community was shocked to its core when Dr. Barbara Starfield revealed her research on American healthcare in a study titled, “Is US Health Really the Best in the World?” It was published in the Journal of the American Medical Association. The conclusions are still shocking today, as little has changed in the last 20 years. Most health experts would say it has gotten worse. The yearly totals in 2000 showed:
- 12,000 deaths from unnecessary surgeries
- 7,000 deaths from medication errors in hospitals
- 20,000 deaths from other errors in hospitals
- 80,000 deaths from hospital-acquired infections
- 106,000 deaths from FDA-approved correctly prescribed medicines
- 225,000 deaths total medically-caused deaths
- Medical system is 3rd leading cause of death behind heart disease and cancer
Dr. Starfield was a pediatrician who worked at the Johns Hopkins School of Public Health until her death in 2011. She demonstrated beyond any doubt that though the U.S. Healthcare system is the most expensive in the world, it is far from the world’s best.
Mr. Rappoport fairly asks: “If, instead of drugs like warfarin, dabigatran, levofloxacin, carboplatin, and lisinopril (the five leading killers in the FDA database), the 100,000 deaths per year were led by gingko, ginseng, vitamin D, niacin, and raw milk, what do you think would happen?” (Related: FDA must stop banning supplements)
He suggests that if that happened, FDA itself would send police and SWAT teams to invade health food stores, arrest anyone involved, and send them to prison. FDA officials are rarely, if ever, punished for their mistakes. On the contrary, many former FDA officials end up moving into private industry through what has become known as the “revolving door.” Many former FDA employees later work for the same private drug companies they were once in charge of regulating. It’s a cozy relationship that may work for them. It doesn’t work as well for those 100,000 or so people who die from FDA-approved drugs each year.
So many dozens of FDA-approved drugs and medical devices have later been recalled from the market that many doctors recommend their patients wait at least seven years after a drug has been approved before taking it themselves. That extra time can give adverse events a chance to manifest. (Why not let others be the first guinea pigs, is apparently the thinking.)
As things now stand, Mr. Rappoport asks whether we need “100,000 smoking guns every year? Do we need relatives of the people who’ve all died in the span of merely a year, from the poisonous effects of FDA-approved medical drugs, to bring their corpses to the doors of FDA headquarters?”
Well, Mr. Rappoport, that’s what it might take before we wake up to the real threat the FDA business model poses for more than 100,000 of us every year.
As we wonder why we don’t see more mainstream news related to the dangers of FDA-approved drugs, it’s worth noting that 80 percent of television advertising revenue is paid for by drug companies. Consequently, we see a lot of drug ads, and lot of what editors term “complementary copy” for that advertising, stories about new drug “breakthroughs” and “blockbuster” drugs that promise to raise stock prices for multi-billion-dollar international drug companies.
It’s still safe to say that all that glitters is not gold in advertising world (no matter how they try to whisper-bury the drug’s “side effects” at the end of the drug commercials, it’s hard not to simply recall the happy images of people playing); but in the world of legal drugs, the more appropriate phrase might be, “Buyer, beware!”