The Washington Post reports that "off-label" use of prescription drugs in patients is significant ("Consumers should be wary when a doctor prescribes a drug for 'off-label' treatment"). That's not to say that doctors are necessarily wrong by default if they prescribe a drug to a patient for off-label use, but the point is that prescription drugs aren't completely safe-no drug is completely safe-which can put some patients at risk.
It's not unusual for money to get in the way of science.
Jennifer Levitz for the Wall Street Journal reports that San Francisco gynecologist Andrew Brill stepped down from his position as adviser to the U.S. government regarding the safety of a medical device known as a laparoscopic power morcellator.
The superbug Clostridium difficile, or C. diff, is an infectious diarrhea that causes roughly 15,000 deaths in the U.S. every year, and sickens roughly 500,000. As Matthew Perrone with the Associated Press reports, patients on the verge of death, who remain uncured by antibiotics, may turn to what Perrone characterizes as "a low-cost treatment for a life-threatening infection that could cure up to 90 percent of patients with minimal side effects."
It's unsurprising that the chief of a medical device company would say of the FDA that its policies are too restrictive on the industry. That's the essence of Laura Pavin's Sun Times Media report: "The U.S. Food and Drug Administration needs to change if it wants America's patient care to be on par with the rest of the world."
To paraphrase Sysmex CEO John Kershaw, if we were to guarantee total safety for everyone every time, we'd never have any innovative medical devices.
Allen Frances, a retired professor from Duke University, recently made his case on the Huffington Post against Big Pharma and its ability to market addictive prescription drugs ("Does Pharma Have a Constitutional Right to Push Dangerous Drugs?"). Frances doesn't really answer his own question, other than to say that Big Pharma should not have such a constitutional right; specifically, the free speech protections of the First Amendment to market and sell prescription drugs.
As Scott Glover and Lisa Girion report for the Los Angeles Times ("Counties sue narcotics makers, 'alleging campaign of deception'"), two counties in California (Orange and Santa Clara) have filed a 100-page lawsuit against five major drug manufacturers. The lawsuit alleges a "campaign of deception," as Glover and Girion report, waged by the drug manufacturers in an effort to broaden the market for their strong opiate-based painkillers.
Kim Zetter with Wired.com writes that it is "insanely easy" to conduct a cyber attack on medical equipment - hack into them, in other words - and manipulate devices like drug infusion pumps from a remote computer. If you're not familiar with drug infusion pumps, it's enough for us to say, in terms of delivering the bad news, that these pumps deliver the drugs that could keep you alive, and too much or too little of these drugs could mean the difference between life and death.
According to reporters with Bloomberg News, a Texas jury handed down the first verdict against Johnson & Johnson in the vaginal mesh cases. There are roughly 12,000 of these cases, in which injured women generally allege that the defective devices caused them physical harm.
Esha Dey and Susan Kelly with Reuters report that the Food and Drug Administration, or FDA, is proposing that the medical device approval process be "speeded up" when it comes to patients who have no other options. The new process would involve greater collaboration between the FDA and the companies that ultimately hope to bring their medical devices to market, presumably in an effort to bring new devices to the patients who might benefit from them.
Last week, the FDA's Christopher Hickey wrote about efforts to ensure medical-product safety when it comes to imported medical products from China. Hickey is the FDA's country director for the People's Republic of China. It's his job to make sure that medical devices and related products made in China and imported into the U.S. meet our standards for quality and safety.
The risks are somewhat obvious.