New Yorker: Former NEJM editor dismisses placebo claims

Arnold Relman writes in this week’s New Yorker.  He argues that researchers claiming placebos can cure are driven by “substantial financial support for their anti-establishment views”  from NIH and private donors. From the letter’s page:

There is simply no evidence that physical diseases, such as cancer,  atherosclerosis, or organ disorders, can be cured or measurably improved by  placebos. Experienced physicians know that sympathetic concern and reassurance  can often allay subjective symptoms—at least temporarily—but only appropriate  medical treatment has a chance of curing physical disease. I suspect that the  main reason advocates of “alternative medicine” like Kaptchuk are receiving such  a friendly reception in many leading medical schools these days is that there is  substantial financial support for their anti-establishment views from one part  of the National Institutes of Health and from a few very wealthy private donors.

Understanding science news: Infectious disease edition

 

A Harvard student group holds monthly seminars to explain complex scientific topics to the public. They usually fill an auditorium and they always videotape their presentations. Check out “Science in the News” here. The session on dog science didn’t have much of a news hook, but their current “Flash” newsletter does. As a nod to World AIDS Day, they put together a special edition on infectious disease. Check it out.

 

 

FlashSpecial Edition Contents: 

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.

Lots of New England in the NE Journal of Medicine

The latest NEJM includes lot of New Englanders:

Researchers from Harvard asked – What motivates “whistleblowers” who report health care fraud?

This study identified several commonalities in whistle-blowers’ experiences. Generally, whistle-blowers’ first move was to try to address problems internally; they became litigators either accidentally (while pursuing other claims) or as a last resort. The most prevalent motivations reported were personal values and self-preservation rather than financial incentives. These findings provide a number of useful insights into the qui tam mechanism as a tool for addressing health care fraud.

MIT’s Jonathan Gruber comments on costs.

In summary, analysis by both the Congressional Budget Office and the CMS actuary show that the ACA (Affordable Care Act) will substantially reduce the federal deficit, only slightly increase national medical spending (despite an enormous expansion in insurance coverage), begin to reduce the growth rate of medical spending, and introduce various new initiatives that may lead to more fundamental reductions in the long-term rate of health care cost growth. The ACA will not solve our health care cost problems, but it is a historic and cost-effective step in the right direction.

Jon Kingsdale from the Commonwealth Connector  on health insurance exchanges.

I believe in exchanges’ potential to help manage competition. But I’m a realist: I know that controversies will arise over their proper function and mission. The opponents of change will try to hobble exchanges, market skeptics will try to convert them into purely regulatory schemes, and even when exchanges succeed in increasing transparency and demand for value, other critical links must be forged in the supply chain of managed competition. After all, an accessible, customer-friendly, easy-to-use market is still only as good as the products it offers. Whether an insurance exchange looks more like a Walmart than a flea market will depend on whether doctors organize themselves into efficient, patient-responsive systems of care. In the United States, reforming the organization and delivery of medical care has always been the biggest challenge in the struggle to produce better care at sustainable cost.

 

A team led by folks from the Dartmouth Institute for Health Policy and Clinical Practice asks – in places where patient receive much more care that usual, are the patients sicker or are they being overtreated?

To address this question, we followed Medicare beneficiaries for 2 years before and 3 years after a move and found that a move to a region with a higher intensity of practice as compared with a move to a region with a lower intensity of practice was associated with greater increases in diagnostic testing, the number of recorded chronic conditions, and HCC risk scores, with no apparent survival benefit.”

Tufts doc warns of industry influence on health reform

The pharma watchdogs at Gooz News point out that: 

The latest New England Journal of Medicine contains a scathing perspective denouncing the Senate’s health care reform bill for giving industry too much control over a new comparative effectiveness research (CER) agency, an issue I tried to call attention to in Health Tech Review (Sept. 28, 2009). The Senate bill guarantees at least three of 15 slots on the new CER agency’s board to industry representatives, and would involve those board members in designing studies.

For the uninitiated, comparative effectiveness research (CER) is the study of what works and what doesn’t in health care. So, while industry should have a seat at the table, know that they are likely to take this position — the stuff I sell works. 

One of the authors is Dr. Harry Selker  of Tufts, who “studies the factors that affect clinical care and its outcomes, and develops treatment strategies, decision aids, and computer-based systems for improving care.  He is known for a series of studies of the factors influencing emergency cardiac care, including clinical, socioeconomic and gender issues, and is particularly known for the development of cardiac “clinical predictive instruments.”  These decision aids provide emergency physicians with predictions of their patients’ key outcomes for real-time use in clinical care.”

 So, he knows this stuff and it may have saved you life if you ended up in the New England Medical Center with a heart attack

 Here’s what he says in NEJM.

 If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected.

 

Academics, industry, health reform and medical devices

The NYTimes business section has an update on academic/industry partnerships and explains new transparency rules in the Senate reform bill. Massachusetts has had a state law on this but it’s only been in effect for a few months. A group of doctors who oppose the law held a meeting in Boston this summer.

Also, read on and find that for first time I my career, I found a device (or drug) maker list payments to med school docs, In this case Mass General.

From the NYTimes:

 Health Bills Aim a Light on Doctors’ Conflicts 

As part of the health care overhaul under consideration by Congress, lawmakers have included so-called sunshine provisions intended to shed light on the financial relationships between the medical industry and doctors.

The targets are common business practices like drug company payments to doctors for speeches and consulting services, which have the potential to influence patient care and drive up the nation’s medical bills.

For more about industry sponsorship of academic research, see the article in the latest issue of Health Affairs. where a group of Boston area researchers found that “52.8 percent have some form of relationship with industry.”

There are many potential impacts of these data. First, given that industry relationships are frequent and diverse, close scrutiny of researchers’ industry relationships is likely to be a major undertaking for institutions—especially among those with large numbers of researchers. Second, relationships are most common among productive, senior faculty members who contribute substantially to their research community. This finding supports the belief that it is difficult, but not impossible, to find academic scientists without industry relationships to serve in advisory roles for organizations such as the Food and Drug Administration, the NIH, or the Institute of Medicine. Third, the widespread nature of these relationships will raise serious concerns regarding the integrity of the academic research enterprise (either rightly or wrongly) on the part of elected officials, university officials, and perhaps the American public.

In a related story, James Ridgeway comments on a Mother Jones story on medical devices on his excellent “Unsilent Generation” blog. Read both. THe MJ story mentions two companies with ties to the state and, in one case, to Mass General doctors.

These companies makes things like artificial joints and heart valves, which are often needed by older people—and paid for by Medicare.

In recent months, these companies have launched a huge lobbying blitz  in response to provisions in the health care reform bills that would levy fees on their high-profit enterprise. The efforts apparently have not been wasted: In the latest versions of the legislation, the level of fees has dropped considerably (though that hasn’t stopped the manufacturers’ whining).

In the Mother Jones story,  DePuy, is based in Raynham, is one of four companies that in 2007 “said they would pay $311 million to settle federal charges that they gave doctors millions of dollars in kickbacks, often in the guise of consulting fees. The government deferred prosecution of the four companies so long as they complied with the settlement terms.

Another company settling was Indiana-based  Zimmer, which has been a player  at Mass General. On the company website , they list more than $9 million in consulting fees paid to eight doctors at Mass General Hospital since 2007 and another $19 million to some of those docs and others for a total of 14 who  listed under MGH Corporation.  More on MGH’s role in licensing right to material to the company that was used for orthopedic implants.

 For news about the medical device industry, see Mass Device, a website devoted to news about local companies and national trends.

More on journalist Gary Schwitzer’s Health News blog.

Meantime, it doesn’t take the NY Times to dig into conflict of interest issues. A student journalist with the Minnesota Daily points out how medical students receive free textbooks from drug companies promoting their products. Case in point: an otolaryngology text given out by a company making an ear infection drug – with the company’s logo on it, and with the beginning of each chapter crediting the drug company.

My brush with medical ghostwriting

kincputerI went to session at a science writers’ meeting a few years back on how to make a six-figure living. The session leader talked about getting  jobs from drug companies to write  review articles. They’ll give you all the medical studies you need. The pay, at the time, was exponentially higher than any other science writing work.

Um.  So, you can’t include any other studies? No. And, a doctor’s name goes on it? Yes.  As I recall, a few people in the room said they made a good living that way. The session then turned into a tense debate about the ethics of this kind of work.

So, when someone pointed out the story in the Times this week about evidence of ghost written scientific articles, I said — old news.

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

BHN exclusive: Relman on ACRE conflict of interest meeting

RelmanDuring his 14 years as editor of the New England Journal of Medicine – most of the 80’s and some change – Dr. Arnold S. Relman often commented on the influence of money on medicine. He still doesn’t like it. BHN noticed him at last week’s meeting of 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.”  (See previous blog post about the meeting.)

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 offerred its facilities for the event. One can only hope that they are now having second thoughts.”
 
here are some other reports on ACRE and the meeting: Policy and Medicine, Postscript and The Carlat Psychiatry Blog

Harvard students have drinking problem: bisphenol A

And, when it comes to BPA, the FDA has a little problem with objectivity, according to a report in the Milwaukee Journal Sentinal.

First to Boston. The Globe reports that a Harvard prof was inspired to do a new study on the suspect by-product of some plastics when she saw her student drinking out of bottles.

Led by Jenny Carwile, a Harvard School of Public Health doctoral student, 77 Harvard students in the study drank all cold beverages from stainless steel bottles for a week to wash BPA out of their bodies and minimize exposure. Most BPA is flushed from people’s bodies within a matter of hours. During that week, the students gave urine samples.

Then the students were given two refillable polycarbonate bottles made with BPA to drink all cold beverages from for one week. Urine samples taken over that week showed the students’ BPA levels spiked the second week to levels normally found in the general population.

Here’s a link to the actual study:

Use of Polycarbonate Bottles and Urinary Bisphenol A Concentration

On the FDA end of this story, The Journal Sentinal says it has emails that “show how government regulators relied on the trade association to do much of their work for them. The FDA relied on two studies – both paid for by chemical makers – to form the framework of its draft review declaring BPA to be safe.”

Here’s a take on BPA from that trade association, the American Chemistry Council.

The scientific evidence supporting the safety of bisphenol A has been repeatedly and comprehensively examined by government and scientific bodies worldwide. In every case, these assessments support the conclusion that bisphenol A is not a risk to human health at the extremely low levels to which people might be exposed.

The Council states the current thinking of regulators — now we know why. The environmentalists say the evidence of harm is clear – BPA has to go.

For that point of view, see The Alliance for a Healthy Tomorrow : “A broad coalition in Massachusetts working to pass laws and policies that prevent harm to our health from toxic chemicals.” Here’s why they think the Harvard study is important.  

Well, it has been thought that BPA is mostly a danger when heated, but this study shows that BPA also leaches out of polycarbonate plastic when cooled. This is particularly relevant to the adult population that drinks mostly cold beverages in polycarbonate containers, while it is mostly polycarbonate baby bottles that contain warm liquids.

This Globe story details the group’s effort to get BPA banned in the state.

 

Health news from and about The Boston Globe

 My weekly news review for MassDevice.com bemoans the potential loss of our daily broadsheet as a source of health news. Here’s more evidence to support my case. 

Beth Israel faulted for staph outbreak in mothers, babies

Over the past six months, 18 mothers and 19 newborns have become sick with a dangerous bacterial infection soon after being released from Beth Israel Deaconess Medical Center, triggering a state investigation that uncovered serious problems with the hospital’s infection control practices.

 Ten of the infected patients became so ill that they required hospitalization. Two of those had serious complications.

The most recent of the staph bacterial infections, a type resistant to many common antibiotics, was identified earlier this week.

State authorities have asked the US Centers for Disease Control and Prevention for help in determining what caused these infections, which are generally spread by skin-to-skin contact. Based on research from similar outbreaks in maternity wards in other cities, a CDC investigator said the cluster at Beth Israel Deaconess is probably related to someone – such as a healthcare worker, patient, or visitor – who brought the bacteria into the hospital, and the institution’s hygiene practices failed to stop it from spreading.

Partners curbs doctors’ drug industry ties

Doctors at Partners HealthCare may no longer accept gifts and meals from drug and device firms, or travel the country as paid members of company “speakers bureaus,” as the state’s largest hospital and physician network adopts tougher restrictions to counter industry’s influence over the drugs and treatments physicians prescribe…

Many Mass. General and Brigham physicians are top researchers, making drug and device companies eager to collaborate with them on developing new treatments for patients – relationships that Partners executives said they want to preserve. But it’s because of their status as “thought leaders” that these doctors also are attractive targets for helping companies spread their marketing messages through speakers bureaus and medical education.

More on research integrity from BHN

More on the plight of The Boston Globe

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