Jury: Double-booked surgery did not lead to injury

From The Globe.

A Boston jury on Monday found that a spine surgeon at Massachusetts General Hospital failed to i

nform a Westwood financial analyst that he planned to operate on two patients at once, but the jury concluded that the doctor’s divided attention did not cause the man’s quadriplegia.

As a result the jury awarded Tony Meng, a 45-year-old father of two, no financial damages…

Meng’s disastrous operation figured prominently in a Globe Spotlight Team investigation of simultaneous surgeries at MGH and other teaching hospitals. Many hospitals have since restricted the practice, also known as “concurrent surgery,” and a US Senate committee recently sought to curb it.

Two other former patients of Wood’s have sued him for medical malpractice alleging that double-booking contributed to their complications. One of the patients is former Red Sox relief pitcher Bobby Jenks, who blames Wood for what he alleges was a botched back operation in 2011 that ended his career.

For more on the Globe series, click on the link above or see this interview with Spotlight Team editor Scott Allen

From Health Leaders: Shame, fear and medical errors

From a recent talk 978-080703330-2at Harvard by Danielle Ofri, MD, author of What Doctors Feel.

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. “

Click here for full story from Health Leaders Media 

Health Leaders: #Lacks family members now have a say in #Henrietta’s immortal scientific legacy

My report from Health Leaders on a recent talk by members of Henrietta Lacks’ famfile_000-4ily.

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.

Two Boston meetings look at the role of patient advocates. They offer two very different perspectives.

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Pharmaceutical manufacturers often  look to patient advocates for help winning approval for new drugs. Their most recent success in this area was the FDA’s approval of a new drug for Duchenne muscular dystrophy. That decision came despite recommendations against approval from FDA staff.

In an editorial, the Boston Globe questioned the FDA’s move while noting that eteplirsen’s “entry into the marketplace represents a major victory for the patient advocacy movement, and is bound to encourage more such engagement in the drug-approval process. Based on the infighting that went on over the Duchenne treatment, that’s going to be challenging for the FDA. It has to find a balance between public opinion and what’s truly in the public interest.” (The Globe also featured a story this week about one of those patient advocates.)

Today, drug makers in Boston are hosting a conference for patient advocates. The “Patient Advocacy Summit 2016 – Sharing Our Stories: Building a Patient-Centered Ecosystem” is underway at Novartis facility near MIT.

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.

Contacted after the panel, Zuckerman, president of the National Center for Health Research in DC,  offered these thoughts:

  1. 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?
  2. 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.

 A few more tweets worth noting.

 

#Massachusetts cares if #doctors have conflicts of interest, but do #patients care?

The Globe offers a peek at the drug company marketing/meals at smaller hospitals

Years after many big academic medical centers cracked down on industry perks, drug companies still regularly buy meals bll-leg-pix-webfor 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

Also worth noting that a 2013  UConn study found the following

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.

Finally, a Health Affairs blog post on patients and COI noted:

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.

 

 

NEJM: One man’s tragic try at “stem cell” therapy. Will we soon be seeing ads for overseas CRISPR clinics?

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Ad for one program.

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.

Here’s the technical explanation from The New England Journal of Medicine:

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

This from the Globe story

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.

 The NYTimes also has a story. 

Science writer on his two #opioid battles

Health writers know Seth Mnookin has the author of the book “the Panic Virus,” but he has a much more personal story to tell in this week’s Globe.

. 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 wFile_000ho 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.

The Times New Old Age had a post on this topic this week.