#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.

 

 

Former NEJM editor Arnold Relman dies at 91

RelmanSee Storify for updates. 

Arnold Relman, the former New England Journal of Medicine editor, has died. From Bryan Marquard at the Globe: 

Eloquent and forceful on the page or the podium, Dr. Arnold Relman led the New England Journal of Medicine for more than 13 years, raising a sometimes lonely voice to warn about the dangers of for-profit medicine when many in politics and his profession raced to embrace a free market approach.

Dr. Relman also was one of the nation’s foremost writers about the rising cost of health care. Persistent to the end, he received the galleys of his final article just a few days before he died of cancer in his Cambridge home early Tuesday, on his 91st birthday.

 

When he suffered a catastrophic fall last year, he wrote about it in The New York Review of Books:

 

Since then, I have made an astonishing recovery, in the course of which I learned how it feels to be a helpless patient close to death. I also learned some things about the US medical care system that I had never fully appreciated, even though this is a subject that I have studied and written about for many years.

 

What he reported was not flattering to Spaulding Rehab, the hospitals that has won praise for working with so many marathon bombing survivors.

What did this experience teach me about the current state of medical care in the US? Quite a lot, as it turns out. I always knew that the treatment of the critically ill in our best teaching hospitals was excellent. That was certainly confirmed by the life-saving treatment I received in the Massachusetts General emergency room. Physicians there simply refused to let me die (try as hard as I might). But what I hadn’t appreciated was the extent to which, when there is no emergency, new technologies and electronic record-keeping affect how doctors do their work. Attention to the masses of data generated by laboratory and imaging studies has shifted their focus away from the patient. Doctors now spend more time with their computers than at the bedside. That seemed true at both the ICU and Spaulding. Reading the physicians’ notes in the MGHand Spaulding records, I found only a few brief descriptions of how I felt or looked, but there were copious reports of the data from tests and monitoring devices. Conversations with my physicians were infrequent, brief, and hardly ever reported.

What personal care hospitalized patients now get is mostly from nurses. In the MGHICU the nursing care was superb; at Spaulding it was inconsistent. I had never before understood how much good nursing care contributes to patients’ safety and comfort, especially when they are very sick or disabled. This is a lesson all physicians and hospital administrators should learn. When nursing is not optimal, patient care is never good.

More on that piece from The NYTimes. 

 

Relman often commented on the influence of money on medicine. In 20o9,  he crashed the inaugural meeting of the Association of Clinical Researchers and Educators (ACRE) “an organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts.”

So, we asked for his thoughts about the presentations. Here they are:

“I sat through the whole program, which was a sustained diatribe against conflict-of-interest regulations rather than a scholarly, balanced discussion of the issues. There was practically no time for audience questions or comments, but instead an almost unrelenting barrage of ideological and anecdotal criticism of what was said to be a misguided “belief system” that worries excessively over relations between industry and the medical profession. There was an occasional informative and reasonable contribution, but for the most part sarcasm and anger prevailed.
 
The heavily industry-related audience loved the performance, but the obviously biased, self-serving, and often grossly flawed presentations should have embarrassed the organizers. Although neither Harvard Medical School nor the Brigham & Women’s Hospital sponsored or formally endorsed the meeting, the HMS Dean did give the initial welcoming remarks, and the Hospital offered its facilities for the event. One can only hope that they are now having second thoughts.”
More here:

Boston docs on debate over cholesterol screening for kids

A couple of Boston-area docs weigh in on charges of industry influence in the debate over whether to test kids for cholesterol.  From the Globe:

CHICAGO — Should all US children be tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.

Fresh criticism was published online Monday in the journal Pediatrics by researchers who say the guidelines are too aggressive and were influenced by panel members’ financial ties to drug makers.

Other criticism was published earlier this year in the Journal of the American Medical Association. …JAMA included additional criticism from a dissenting member of the panel that produced the kids’ cholesterol guidelines, Dr. Matthew Gillman of Harvard Medical School. He recommends more narrow screening based on family history of cholesterol problems.

… Dr. Sarah De Ferranti, an American Academy of Pediatrics spokeswoman and director of preventive cardiology at Boston Children’s Hospital, said the question should be part of a conversation parents should have with their pediatrician about heart disease risks, including weight, blood pressure, and lifestyle. She said she would have her children tested.

Most of the Peds articles are behind the pay wall. But, UCSF put out a press release on the latest comments. And the NIH guidelines are online.

From NIH: Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents

From UCSF: New lipid screening guidelines for children overly aggressive, UCSF researchers say recommendations fail to weigh benefits against potential harms

Recent guidelines recommending cholesterol tests for children fail to weigh health benefits against potential harms and costs, according to a new commentary authored by three physician-researchers at UCSF.

Moreover, the recommendations are based on expert opinion, rather than solid evidence, the researchers said, which is especially problematic since the guidelines’ authors disclosed extensive potential conflicts of interest.

The guidelines were written by a panel assembled by the National Heart, Lung and Blood Institute (NHLBI) and published in Pediatrics, in November 2011. They also were endorsed by the American Academy of Pediatrics. The guidelines call for universal screening of all 9 to 11-year-old children with a non-fasting lipid panel, and targeted screening of 30 to 40 percent of 2 to 8-year-old and 12 to 16-year old children with two fasting lipid profiles. Previous recommendations called only for children considered at high risk of elevated levels to be screened with a simple non-fasting total cholesterol test.

The call for a dramatic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with so-called dyslipidemia, or bad lipid levels in the blood, according to the commentary by Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics and e-published on July 23 in Pediatrics.

“The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age,” said Newman. “They acknowledged that costs are important, but then went ahead and made their recommendations without estimating what the cost would be. And it could be billions of dollars.”

Some of the push to do more screening comes from concern about the obesity epidemic in U.S. children. But this concern should not lead to more laboratory testing, said Newman.

“You don’t need a blood test to tell who needs to lose weight. And recommending a healthier diet and exercise is something doctors can do for everybody, not just overweight kids,” he said

The requirement of two fasting lipid panels in 30 to 40 percent of all 2 to 8-year olds and 12 to 16 –year- olds represents a particular burden to families, he said.

“Because these blood tests must be done while fasting, they can’t be done at the time of regularly scheduled ‘well child’ visits like vaccinations can,” said Newman. “This requires getting hungry young children to the doctor’s office to be poked with needles on two additional occasions, generally weekday mornings. Families are going to ask their doctors, ‘Is this really necessary?’ The guidelines provide no strong evidence that it is.”

The authors note that the panel chair and all members who drafted the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.” Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.

“The panel states that they reviewed and graded the evidence objectively,” said Newman. “But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles.”

Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that “these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced.”

###

Newman and Hulley have no disclosures. Pletcher has NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.

Globe:More transparency needed from Harvard on misconduct

In a staff editorial, The Globe calls on Harvard to offer more information about the scientific misdeeds of  one of its star psychology researchers. For more on the case and other local news on scientific misconduct, click here for Nature Network Boston post.  

THERE’S CLEARLY something wrong with some of Harvard psychology professor Marc Hauser’s research, including an influential but now retracted 2002 paper on whether monkeys can learn rules and patterns. But neither the scholar nor the university is explaining the flaws in his work in any detail. This oblique approach might help Hauser and Harvard save face in the short term, but it avoids the duty that both have to the cause of open scientific inquiry.

Undoing: BU aging study, MA disclosure laws

The take-down of the BU study began Wednesday and continues. More here on Nature Network Boston.

Also, the Mass House of Representatives voted to repeal the state’s disclosure law, which requires drug makers to report donation to researchers. From AP via the Globe:

House leaders defended the vote to repeal the ban, approved just two years ago, saying it has made it harder to attract companies to Massachusetts. The Senate version of the bill did not include the repeal. The bill now heads to a committee to work out a compromise

More here from  State House News Service via Mass Device:

Critics of the ban said it was discouraging out-of-state interests from doing business in Massachusetts and said the ban had not led to demonstrable reductions in health care costs. Supporters of the ban said the state had already heavily invested itself in implementing it and needed to give the law more time to work itself out.

Some companies are already disclosing their support for scientists. The Wall Street Journal rerport that J&J is not making it easy. Eli Lilly offers a “faculty registry.”

Lilly-contracted faculty are doctors and other healthcare professionals who provide a variety of services for the company. When selecting faculty, Lilly chooses leading clinicians who have the knowledge and clinical expertise to understand Lilly medicines—and the conditions and disease states for which they are approved—and to educate other healthcare providers about their use.

 

Can a computer save you from an extra x-ray?

Two news round ups today.

First, check out the latest edition of the Health Wonk Review, hosted by Boston’s own David Williams at  The Health Business Blog.  As he reports: It’s a wonderful day in the wonkerhood, with so much health care policy fodder to chomp on. Let’s jump right in.

Also, here’s some local news of note:

Kaiser Health News and NPR report on an MGH study about HIT doing its job.

A funny thing happens when a computer challenges orders for medical scans that aren’t likely to help diagnose patients: Doctors often drop the test requests.

This morning’s Globe gives us this disturbing news:

At least 200 emergency medical technicians and paramedics in Massachusetts and New Hampshire have been practicing without legitimate certification, paying for fake credentials, rather than receiving medical training, state public health officials said.

 The Boston Review rounds up some of the usual and unusual suspects for a debate on industry influence on medicine.

 They start with pharma critic and former NEJM editor Marcia Angell, the run several responses:

Some of Angell’s respondents share her concerns and extend them to other areas of medical practice—including nursing and the identification of novel diseases. But not everyone agrees. Emma D’Arcy thinks that patients, newly empowered by modern information and communications technology, can make sensible judgments about treatments and drugs. And Thomas Stossel, writing separately, rejects the entire framework of analysis. For Stossel, results (what he calls “value”) are the only significant measure in assessing the nexus of academia and industry. The results that matter are longer lives of higher quality with less pain. And measured by these standards, the nexus looks pretty good.

Finally, here’s a little advance news — Tinker Ready is now the “Hub Leader” for Nature Network Boston

 The site comes via the Nature family of peer-reviewed research journals. She’ll be blogging and tweeting for this networking site for scientists, entrepreneurs, policymakers and others interested in the life sciences. Once they work the bugs out of the home page, we’ll have a more formal announcement.  In the meantime, feel free to browse and/or join up.

Radio Boston: The Influence of Pharma on Docs

WBUR’s Radio Boston takes on the ever-present issue of the influence of drug makers on docs. Listen on their web site or today at 3. Guests include:

Jerry Avorn, M.D., PChief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital and author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.

Leslie Jackowski, M.B.B.S. (M.D.), Exeuctive Director for Program at the ALOSA Foundation a nonprofit organization “dedicated to the dissemination of accurate, unbiased, evidence-based and non-commercial information about medications for health care professionals and patients by providing educational services (interactive outreach to physicians, classes, presentations, seminars, conferences) about the development, regulation, risks, and benefits of prescription drugs.” In other words, they come in after the drug companies pitch their drugs and give other docs more objective information about meds.  The scientific jargon for this is “counter-detailing,’ a reference to the term “detail man” used to describe drug reps who do direct sales to docs. That term is no longer relevant, especially since many detail men are now young, attractive women.

Thomas P. Stossel, M.D.,  American Cancer Society Professor of Medicine atHarvard Medical School, Director of the Translational Medicine Division at Brigham & Women’s Hospital, Founder of the Association of Clinical Researchers and Educators. For more on ACRE, see the BHN report on the group’s inaugural meeting, as well as a comment from former NEJM editor Arnold Relman. (Brother John Stossel, a crusading TV journalist who often takes on what he describes as “junk science,” just made the leap from ABC to Fox. )

Georgia Maheras,  Esq., Private Market Policy Manager at Health Care for All