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.


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?


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. 

#UMass study via KHN: Who is too sick for a #transplant?

downloadFrom Kaiser Health News

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.

organ transplant_770“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.”

Please contact Kaiser Health News to send comments or ideas for future topics for the Insuring Your Health column.

ProPublica: Yelp, #Health and #Privacy


Stung by Yelp Reviews, Health Providers Spill Patient Secrets

by Charles Ornstein ProPublica, May 27, 2016, 11 a.m.

CaptureBurned by negative reviews, some health providers are casting their patients’ privacy aside and sharing intimate details online as they try to rebut criticism.

In the course of these arguments 2014 which have spilled out publicly on ratings sites like Yelp 2014 doctors, dentists, chiropractors and massage therapists, among others, have divulged details of patients’ diagnoses, treatments and idiosyncrasies.

One Washington state dentist turned the tables on a patient who blamed him for the loss of a molar: “Due to your clenching and grinding habit, this is not the first molar tooth you have lost due to a fractured root,” he wrote. “This tooth is no different.”

In California, a chiropractor pushed back against a mother’s claims that he misdiagnosed her daughter with scoliosis. “You brought your daughter in for the exam in early March 2014,” he wrote. “The exam identified one or more of the signs I mentioned above for scoliosis. I absolutely recommended an x-ray to determine if this condition existed; this x-ray was at no additional cost to you.”

And a California dentist scolded a patient who accused him of misdiagnosing her. “I looked very closely at your radiographs and it was obvious that you have cavities and gum disease that your other dentist has overlooked. 2026 You can live in a world of denial and simply believe what you want to hear from your other dentist or make an educated and informed decision.”

Health professionals are adapting to a harsh reality in which consumers rate them on sites like Yelp, Vitals and RateMDs much as they do restaurants, hotels and spas. The vast majority of reviews are positive. But in trying to respond to negative ones, some providers appear to be violating the Health Insurance Portability and Accountability Act, the federal patient privacy law known as HIPAA. The law forbids them from disclosing any patient health information without permission.

Yelp has given ProPublica unprecedented access to its trove of public reviews 2014 more than 1.7 million in all 2014 allowing us to search them by keyword. Using a tool developed by the Department of Computer Science and Engineering at the NYU Tandon School of Engineering, we identified more than 3,500 one-star reviews (the lowest) in which patients mention privacy or HIPAA. In dozens of instances, responses to complaints about medical care turned into disputes over patient privacy.

The patients affected say they’ve been doubly injured 2014 first by poor service or care and then by the disclosure of information they considered private.

The shock of exposure can be effective, prompting patients to back off.

“I posted a negative review” on Yelp, a client of a California dentist wrote in 2013. “After that, she posted a response with details that included my personal dental information. 2026 I removed my review to protect my medical privacy.”

The consumer complained to the Office for Civil Rights within the U.S. Department of Health and Human Services, which enforces HIPAA. The office warned the dentist about posting personal information in response to Yelp reviews. It is currently investigating a New York dentist for divulging personal information about a patient who complained about her care, according to a letter reviewed by ProPublica.

The office couldn’t say how many complaints it has received in this area because it doesn’t track complaints this way. ProPublica has previously reported about the agency’s historic inability to analyze its complaints and identify repeat HIPAA violators.

Deven McGraw, the office’s deputy director of health information privacy, said health professionals responding to online reviews can speak generally about the way they treat patients but must have permission to discuss individual cases. Just because patients have rated their health provider publicly doesn’t give their health provider permission to rate them in return.

“If the complaint is about poor patient care, they can come back and say, 2018I provide all of my patients with good patient care’ and 2018I’ve been reviewed in other contexts and have good reviews,’ ” McGraw said. But they can’t “take those accusations on individually by the patient.”

McGraw pointed to a 2013 case out of California in which a hospital was fined $275,000 for disclosing information about a patient to the media without permission, allegedly in retaliation for the patient complaining to the media about the hospital.

Yelp’s senior director of litigation, Aaron Schur, said most reviews of doctors and dentists aren’t about the actual health care delivered but rather their office wait, the front office staff, billing procedures or bedside manner. Many health providers are careful and appropriate in responding to online reviews, encouraging patients to contact them offline or apologizing for any perceived slights. Some don’t respond at all.

“There’s certainly ways to respond to reviews that don’t implicate HIPAA,” Schur said.

In 2012, University of Utah Health Care in Salt Lake City was the first hospital system in the country to post patient reviews and comments online. The system, which had to overcome doctors’ resistance to being rated, found positive comments far outnumbered negative ones.

“If you whitewash comments, if you only put those that are highly positive, the public is very savvy and will consider that to be only advertising,” said Thomas Miller, chief medical officer for the University of Utah Hospitals and Clinics.

Unlike Yelp, the University of Utah does not allow comments about a doctor’s medical competency and it does not allow physicians to respond to comments.

In discussing their battles over online reviews, patients said they’d turned to ratings sites for closure and in the hope that their experiences would help others seeking care. Their providers’ responses, however, left them with a lingering sense of lost trust.

Angela Grijalva brought her then 12-year-old daughter to Maximize Chiropractic in Sacramento, Calif., a couple years ago for an exam. In a one-star review on Yelp, Grijalva alleged that chiropractor Tim Nicholl led her daughter to “believe she had scoliosis and urgently needed x-rays, which could be performed at her next appointment. 2026 My daughter cried all night and had a tough time concentrating at school.”

But it turned out her daughter did not have scoliosis, Grijalva wrote. She encouraged parents to stay away from the office.

Nicholl replied on Yelp, acknowledging that Grijalva’s daughter was a patient (a disclosure that is not allowed under HIPAA) and discussing the procedures he performed on her and her condition, though he said he could not disclose specifics of the diagnosis “due to privacy and patient confidentiality.”

“The next day you brought your daughter back in for a verbal review of the x-rays and I informed you that the x-rays had identified some issues, but the good news was that your daughter did not have scoliosis, great news!” he recounted. “I proceeded to adjust your daughter and the adjustment went very well, as did the entire appointment; you made no mention of a 2018misdiagnosis’ or any other concern.”

In an interview, Grijalva said Nicholl’s response “violated my daughter and her privacy.”

“I wouldn’t want another parent, another child to go through what my daughter went through: the panic, the stress, the fear,” she added.

Nicholl declined a request for comment. “It just doesn’t seem like this is worth my time,” he said. His practice has mixed reviews on Yelp, but more positive than negative.

A few years ago, Marisa Speed posted a review of North Valley Plastic Surgery in Phoenix after her then20133-year-old son received stitches there for a gash on his chin. “Half-way through the procedure, the doctor seemed flustered with my crying child. 2026,” she wrote. “At this point the doctor was more upset and he ended up throwing the instruments to the floor. I understand that dealing with kids requires extra effort, but if you don’t like to do it, don’t even welcome them.”

An employee named Chase replied on the business’s behalf: “This patient presented in an agitated and uncontrollable state. Despite our best efforts, this patient was screaming, crying, inconsolable, and a danger to both himself and to our staff. As any parent that has raised a young boy knows, they have the strength to cause harm.”

Speed and her husband complained to the Office for Civil Rights. “You may wish to remove any specific information about current or former patients from your Web-blog,” the Office for Civil Rights wrote in an October 2013 letter to the surgery center.

In an email, a representative of the surgery center declined to comment. “Everyone that was directly involved in the incident no longer works here. The nurse on this case left a year ago, the surgeon in the case retired last month, and the administrator left a few years ago,” he wrote.

Reviews of North Valley Plastic Surgery are mixed on Yelp.

Health providers have tried a host of ways to try to combat negative reviews. Some have sued their patients, attracting a torrent of attention but scoring few, if any, legal successes. Others have begged patients to remove their complaints.

Jeffrey Segal, a onetime critic of review sites, now says doctors need to embrace them. Beginning in 2007, Segal’s company, Medical Justice, crafted contracts that health providers could give to patients asking them to sign over the copyright to any reviews, which allowed providers to demand that negative ones be removed. But after a lawsuit, Medical Justice stopped recommending the contracts in 2011.

Segal said he has come to believe reviews are valuable and that providers should encourage patients who are satisfied to post positive reviews and should respond 2014 carefully 2014 to negative ones.

“For doctors who get bent out of shape to get rid of negative reviews, it’s a denominator problem,” he said. “If they only have three reviews and two are negative, the denominator is the problem. 2026 If you can figure out a way to cultivate reviews from hundreds of patients rather than a few patients, the problem is solved.”

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