[Maggie's original post, which I missed, can be found at HealthBeat.]
After following the developments of the small biotech company, Questcor Pharmaceuticals, Inc. which has sought FDA approval of H.P. Acthar Gel for the indication of Infantile Spasm, I definitely see the obscene importance placed on squeezing as much profit from a product as possible in the eyes of investors and executives.
Gawande may be too polite to say this, but the answer seems to me clear. There is no profit to be made on a checklist. What do you sell? Any experienced intensive care specialist knows what should be on the list. All anyone needs is a few pieces of paper and a pencil. Pronovost has invented a process for delivering health care—not a new hi-tech procedure, not a new product. And like Jonas Salk, who invented the polio vaccine, he is willing to give his idea away for free.
If there were something to sell, Johnson & Johnson or Genentech would have turned Pronovost and his idea into a new medical breakthrough long ago. The story would be reported in U.S.A. Today, trumpeted on the Evening News, splashed on billboards across the nation. Hospitals would be spending millions on ads bragging that they had this new breakthrough product: “At Mount Hope, Where We Care About Your Safety…”
In our for-profit healthcare system, people become truly excited about an idea when someone sees way to make a fortune. So Merck’s new vaccine, Gardasil, that protects against 70 percent of the viruses that cause cervical cancer has gotten extended play in the press, on TV, and on Wall Street. Meanwhile, the Pap Smear—a test that detects virtually all cases of cervical cancer and has, in fact, made this type of cancer a “rare disease” in the U.S., gets little notice. No national campaign to make sure every woman gets annual Pap Smears. It’s not a high-profit procedure.
In the U.S. the idea that the point of healthcare is better health seems to have been lost in the rush to make money. As Harvard’s Dr. Arnold Relman wrote in the most recent issue
of JAMA, ours is “the only health system in the world” where “investors and business considerations play such an important role. In no other country are the organizations that provide medical care so driven by income and profit-generating considerations.”
Acthar is a 55-year old drug indicated for use in treating multiple sclerosis exacerbations. However, using its orphan drug status for Infantile Spasm, Questcor raised the price 15-fold from $1650 per vial to $23,265 per vial in August. Only in the U.S. does it seem a company can get away with such greed and price-gouging.
I recommend that you go over to The Health Care Blog and read Maggie's full post. I think that it just may change the way folks view improving processes in medicine which will ultimately save lives and save money.
Today (Sunday, Dec. 30) the New York Times published a shocking op-ed by Dr. Atul Gawande revealing that a U.S. government agency has stopped an enormously successful "checklist" program that was being used to reduce infections in intensive care units at Johns Hopkins and throughout the state of Michigan.
Below, an excerpt from today's op-ed:
" In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.
"A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. . .
"The results were stunning. . . . Over 18 months, the program saved more than 1,500 lives and nearly $200 million
"Yet this past month, the Office for Human Research Protections shut the program down. . .
"The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations," Gawande explains. "Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
"The government’s decision was bizarre and dangerous," he adds. "But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.
[However] "Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger.
"If the government’s ruling were applied more widely," Gawande notes, "whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease . . .
"Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. . . . The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to," Gawande concludes.
Maggie asks, WHAT IS GOING ON HERE?
I agree with her doubt that the decision had anything to do with medical ethics or patients' rights. Perhaps, someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is. Maggie plans to try to find out more about what motivated this decision, who runs the agency in question, etc. and welcomes your ideas. You may e-mail her confidentially at email@example.com.
Twenty-one (21) years ago my younger brother was in the Intensive Care Unit for two weeks after having been runover. He had moments that were dangerously close to death, but was most afraid of sleeping at night. Since he was on a ventilator and could not speak, we resorted to mouthing words, gesturing a little, and writing notes. For the first time in our lives, we were able to communicate clearly and understood each other.
During the night shift he was most afraid because when a particular nurse was on duty, it took just a little too much time to response to problems with the machines he was hooked up to. He had moments where breathing stopped and he was powerless to do anything about it but to press the alarm button and wait for help.
My parents and I would tear those notes out of the notepad so that other nurses would not see his fear and anger. Looking back, I think we tried to keep from rocking the boat too much and should have asked more questions. As it was, I was only 18, my brother was 14, and my parents were younger than I am now at 36 years of age.
We didn't fully understand exactly how close to death my brother was at the time and how unbelievably fortunate he was as his injuries most resembled the type one would experience being crushed against a steering wheel in a major car accident.
Errors or no errors. Hospitals and nurses must not be afraid to examine their processes and the care they provide. Doctors must not be afraid of following simple steps to ensure the best care for their patients. And patients and parents should not be afraid of questioning the care they receive especially when they are most vulnerable in the I.C.U.