Ofri’s talk centered on one emotion, shame, which she said overwhelms many doctors and is a major reason many medical errors go unaddressed.
When errors are not acknowledged, even those without bad outcomes, no one learns from them, she said. And, there is little incentive for doctors to point out their shortfalls. “We want to look like we know what we are doing. When in doubt, pretend. That’s what I learned in my internship. “
The ongoing story of the late Henrietta Lacks, the African-American
woman who unwittingly provided cells for years of medical research, has much to offer those battling disparities
in healthcare, according to family members who spoke in Boston last week.
That message, delivered at a panel discussion, came from Lacks’ grandson David Lacks, Jr. and her great granddaughter Victoria Baptiste, RN, as well as Joseph Betancourt, MD, director of the Disparities Solutions Center at Massachusetts General Hospital.
This event brings industry leaders together with patient advocates and other stakeholders to examine ways in which life sciences companies can more fully incorporate the patient voice into the work they do— not just approaching regulatory applications or at commercialization, but throughout the drug development cycle.
The day-long event will include panel discussions, case study presentations (spotlighting industry/patient partnerships), a keynote address, and awards ceremony, as well as a networking breakfast, lunch and cocktail reception. Expected attendance is 180 patient advocacy professionals, patient organizations and other stakeholders.
Worth noting that the same topic was the subject of yesterday’s panel at HUBweek, a science/tech/arts series ongoing in Boston. The title: “The FDA and the Drug Approval Process: Is it Really Broken?” Some made the point — we should listen to the parents of sick children. Others offered a different perspective: Patients might be better off in clinical trials with informed consent and free drugs, rather paying $300,000 per year for that same, unproven medication with unknown side effects.
Patient perspectives are crucial in helping us understand what scientific data mean, what the benefits and risks both mean to patients. So patients should be part of the process – what should the outcome measures be and how can they be measured?
The FDA is listening to patients who desperately want treatments but they are not listening well to patients who are harmed by ineffective or unsafe treatments. That’s partly because the former are funded by Pharma to attend FDA meetings and to lobby Congress, but the latter are on their own, often don’t have the money to attend FDA public meetings, and wouldn’t even know about them if they don’t read the Federal Register, which is the only place they are announced in advance.
Years after many big academic medical centers cracked down on industry perks, drug companies still regularly buy meals for doctors affiliated with smaller hospitals, a new analysis shows, with some physicians receiving dozens of lunches and dinners in a single year.
At a number of community hospitals, well over half of the affiliated doctorswere beneficiaries of industry payments, suggesting there may be fewer restrictions on meals there than at large teaching hospitals.
Worth noting a UMass led-research mentioned in an NYTimes column on medical conflicts of interest. The study by orthopedic surgeons reported that about 80 percent of patients “felt it was both ethical and either did not influence, or actually benefited their health care, if their surgeons were consultants for surgical device companies.”
Here’s a look at more data from the study:
Six hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort.
…Almost 40% of respondents felt the quality of care would be adversely affected if a surgeon received royalty payments for a medical device that would be implanted by that surgeon…. When questioned about who should be involved in regulation of COI, a majority of respondents (64.3%) felt that a combination of doctors, hospitals/universities, government, and company representatives should be involved; 34.9% of respondents felt that medical professional societies run by doctors should have the most control over COI regulation, almost two times more than the next most frequent answer; and 44.9% and 26.3% (70.2% combined) of respondents felt medical company representatives and government officials should not be involved in the regulation of COI….
Our survey found that 91% of respondents felt it was important for surgeons to disclose consulting agreements regarding devices in their
surgery (Table 3). Furthermore, 60% of respondents thought it was appropriate for surgeons to disclose consulting arrangements with all patients regardless of the planned usage of such devices in their own surgery
Also noted in the study
Leaders of the American Academy of Orthopedic Surgeons have recently made a consensus statement that the enhancement of patient care has and will continue to require orthopedic surgeons to collaborate productively with industry in the development of new technology and techniques
Overall, patients had a poor understanding of FCOI (financial conflict of interest.) Both level of education and previous discussions of FCOI predicted better understanding. This study emphasizes communication of FCOI with patients needs to be enhanced.
Physician ownership of orthopedic or spine hospitals has been correlated with higher rates of spine surgery. In these situations, doctors must keep these centers busy with procedures in order to generate profits and prevent losses; overhead costs are high, including financing, staffing, lease arrangements, and insurance. However, a busy center becomes a lucrative profit center for owning physicians.
A local man has been crippled by a growth on his spine that developed after he traveled overseas to a so- called stem cell clinic. The growth was not from his own cells. So, not only is the treatment untested, doctors don’t know what to do about the bad outcomes.
Commercial stem-cell clinics have been highly publicized in the lay press and operate worldwide with limited or no regulation. We report the case of a 66-year-old man who underwent intrathecal infusions for the treatment of residual deficits from an ischemic stroke at commercial stem-cell clinics in China, Argentina, and Mexico. He was not taking any immunosuppressive medications. In reports provided to him by the clinics, the infusions were described as consisting of mesenchymal, embryonic, and fetal neural stem cells. Progressive lower back pain, paraplegia, and urinary incontinence subsequently developed. Magnetic resonance imaging (MRI) revealed a lesion of the thoracic spinal cord and thecal sac; a biopsy specimen was obtained
Brigham pathologists tested the tissue taken from Gass’s spine and determined it was a tumor-like growth but did not have mutations associated with cancer and therefore could not be treated with chemotherapy. Most of the cells were not Gass’s but from another source.
“It’s hard to know what to call it,’’ Chi said.
Doctors have treated Gass with radiation to shrink the mass, which has helped somewhat, but they are also searching for other solutions.
Doctors have been increasingly warning that stem cell clinics are proliferating around the world with little oversight. They are promoting their methods to patients suffering from strokes, amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease), Alzheimer’s, and other conditions for which there are few good options. Professional athletes have helped popularize the clinics by seeking out stem cell therapy for strokes and shoulder and knee injuries.
…. throughout the course of my 43-hour stay at MGH at the end of April and into early May, I told everyone I could — from the ER doctor who informed me that I’d need surgery, to the anesthesiologist who prepped me for the procedure — that I was in recovery from a substance use disorder.
And while my doctors all said they were aware of the issue, it still felt as if no one was listening.
When you know an addict or alcoholic who bounces in and out of rehab for years — you wait for the final call. When he or she gets sober, it is a fragile gift for all involved — like someone coming back from the dead. I’m a big Marc Maron fan, but I’m not sure I can watch the new episodes of his television show — his sober character relapses badly after taking meds for back pain. At the same time, I could feel the character Don Gately’s pain as the recovering drug addict refused pain killers despite at the end of DFW’s Infinite Jest.
With all the opiate madness out there, here’s hoping we find a better way. Thank to Seth for sharing his tale.
Study Suggests Federal Standard May Be Thwarting Some Transplant Patients
By Michelle Andrews
For the roughly 15,000 people who need a liver transplant, it’s a waiting game. With demand for donated livers far outstripping supply, patients may spend months or years on a transplant waitlist, their position in the line gradually improving as they get sicker. A recent study suggests that this system may be changing but not necessarily for the better.
In an effort to get or keep a good performance rating from the federal government, transplant centers have been labeling some patients “too sick to transplant” and dropping from the waitlist some who may been viable candidates, the researchers found. In addition, despite removing more sick patients from the waiting list, one-year survival rates for patients who received transplants didn’t improve.
The study, published online in the Journal of the American College of Surgeons in April, examined trends in “delisting” at 102 liver transplant centers, including 90,765 waitlisted adults who died, between 2002 and 2012.
Midway through the time period under study, the federal Centers for Medicare & Medicaid Services implemented a new “Conditions of Participation” policy that established performance standards for heart, heart-lung, intestine, kidney, liver, lung and pancreas transplant centers that participate in the Medicare program.
In order to meet CMS standards, liver transplant centers have to meet expected patient and liver graft one-year survival rates. Those that don’t meet the performance standards, which CMS recently eased somewhat, may be flagged for poor performance and have to implement program improvements or risk their participation in the Medicare program. (In its letter describing the new guidelines, CMS noted that one-year patient survival for liver transplants increased from 87.7 percent to 90.8 percent between 2007 and 2014.)
But something happened when the new policy took effect in 2007: The percentage of patients that liver transplant centers considered too ill or unsuitable for a transplant rose by 16 percent, and the likelihood of delisting continued to increase each quarter through the end of the study period. Compared with the time period before, the patients who were taken off the waitlist after the CMS policy change were more likely to be age 55 or older and have more severe liver illness.
The study authors speculate that the new standards made transplant centers more averse to risk and encouraged them to drop sicker patients who might affect their patient survival rates.
“There’s no common definition for when someone is too sick to transplant,” said Natasha Dolgin, an M.D./Ph.D. candidate at the University of Massachusetts Medical School and the study’s lead author.
Some suggest a different way to look at the impact of the CMS policy. “Maybe centers are making the internal decision of trying to choose the best candidates,” said Dr. David Goldberg, medical director for living donor liver transplantation at the University of Pennsylvania.
The most common reason for a liver transplant is cirrhosis, or scarring of the liver, often caused by hepatitis C or alcoholic liver disease.
The severity of patients’ illness is evaluated based on their Model for End-Stage Liver Disease (MELD) score, a numerical score between 6 and 40 that predicts the risk of death within three months and is calculated based on three laboratory values.
Nationwide, 6,729 liver transplants were performed in 2014, but 1,821 patients died on the waitlist. Another 1,300 people were removed from the waitlist because they were considered too sick for a transplant. Patients’ health may deteriorate to the point that a transplant is no longer advisable, or they may contract an infection, for example, that makes delisting necessary. But those reasons don’t explain the increase in delisting following the introduction of the CMS policy, according to the study.
Still, Dolgin said she doesn’t blame transplant centers for their waitlist decisions. Once there is a “benchmark, you try to meet that.”
Kurt Schnier, an economist at the University of California, Merced who has conducted research examining the impact of the CMS policy on kidney transplant waitlisting practices, said the policy has increased the length of time patients are on the waitlist. That research is under review for publication. The CMS policy may also affect surgeon behavior at centers that don’t meet the condition of participation standards, leading them to conduct fewer transplants, for example.
“It’s a well-intended policy,” Schnier said. “The problem is that it creates perverse incentives at the physician level that may undermine the personal welfare of the general population.”
“This is part of the culture now,” said Dr. Hillel Tobias, medical director of New York University’s liver transplant service and chairman of the medical advisory committee of the American Liver Foundation. “You can’t take a chance because if your numbers go down you’re going to get canned.”
One of the goals of the CMS policy was to improve transplant outcomes because of concerns related to transplant center quality and service. Yet the study found its introduction didn’t have a statistically significant impact on mortality rates within a year of transplantation.
Liver transplants are complicated, and the fact that survival didn’t improve during the course of the study might reflect the fact that there may be complications that are not preventable, said Goldberg.
Asked to comment on the study, a CMS official said, “CMS is reviewing available evidence about the impacts of our policies on organ transplant centers. After thorough review we will determine a course of action.”