Million-dollar payments to surgeons raise questions

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By Frederik Joelving

NEW YORK | Mon Oct 24, 2011 5:20pm EDT

NEW YORK (Reuters Health) - Orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers in recent years, according to a report released Monday.

In 2007, five device makers said they had paid surgeons more than $198 million, with 43 payments exceeding $1 million.

While the number of payments appears to have dropped since 2007, the average dollar amount has gone up, based on data from the three manufacturers that disclosed physician payments made in the last several years.

"There is a lot of money flowing back and forth," said Jason Hockenberry of Emory University, whose findings are published in the Archives of Internal Medicine.

Those financial ties represent anything from consulting fees to royalties to research support. Some argue they are necessary to drive medical innovations, but others fear they could end up harming patients as well.

Doctors getting industry money could be quicker to use implants from the companies paying them, for instance, or downplay the side effects of those products in their research.

The new results come as the U.S. Senate investigates whether surgeons paid by Medtronic, a medical device maker not included in the current study, failed to report sterility and other complications stemming from the company's bone-growth implant Infuse.

"There is evidence from other studies that these relationships drive practice one way or another," said Dr. Seth Leopold, of the University of Washington School of Medicine, who was not involved in the new work.

An orthopedic surgeon himself, Leopold chose to sever all ties to device makers in 2005.

"I felt there was no way I'd be able to convince people that these dollars did not affect my clinical decisions," he told Reuters Health.

After seeing the new report, Leopold added, he realized he was just "a smalltime guy."

Hockenberry's findings are based on data released after the five largest orthopedic implant makers -- Biomet Orthopedics, DePuy Orthopedics, Smith & Nephew, Stryker Orthopedics and Zimmer -- settled a kickback probe with the U.S. Department of Justice in 2007.

That year, the companies made more than 1,000 physician payments. In 2008, after the companies found out they'd have to disclose those relationships, the number fell by almost half.

But the three companies that continue to voluntarily disclose payments increased the amount of money they paid doctors by more than 40 percent between 2008 and 2010.

The mean, or mid-range, amount of individual payments also rose slightly, from $212,740 in 2007 to $233,108 in 2010.

"If you are concerned about your physician's loyalties you should by all means ask them," said Hockenberry, stressing that the majority don't have industry ties.

"The reality is, only four percent of all orthopedic surgeons are receiving funds," he said.

It is currently unclear what impact commercial relationships have on patient care. Hockenberry said he'd like to know more about the doctors who stopped taking industry money after the 2007 settlement and those who continued to do so.

"We would also love to be able to tie this to clinical practice," he said.

One way to do so would be to establish a universal device registry for all the implants patients get, so that it would be possible to look at the link between company payments and physician practice patterns.

According to the Patient Protection and Affordable Care Act passed last year, manufacturers must report payments of more than $10 by 2013, and this information will be freely available online.

But in an editorial on the new study, Dr. Robert Steinbrook of Yale School of Medicine in New Haven, Connecticut, said disclosure alone isn't enough.

"The disclosure of industry payments should not divert attention from the real issues with regard to conflict of interest," he writes.

"These are the minimization or elimination of financial ties between physicians and industry in areas other than research support, bona fide consulting related to basic and clinical research, and legitimate payments related to intellectual property. Although many well-publicized examples with regard to conflict of interest involve physicians in specific fields, such as orthopedics or psychiatry, the issues are similar for all specialties."

SOURCE: bit.ly/uJGWr9 and bit.ly/u0srxV Archives of Internal Medicine, October 24, 2011.

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Cloning Research Gives Way To Bioethics Questions

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Researchers in New York are reporting that, for the first time, they've used cloning techniques to successfully create human embryos in the lab. Guy Raz talks about the ethical implications of this research with Insoo Hyun, associate professor of bioethics at Case Western Reserve University.

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GUY RAZ, host: Now that scientists have used cloning techniques to create a human embryo, there's sure to be debate about the ethics of all this. Insoo Hyun is an associate professor of Bioethics at Case Western Reserve University, and he joins me now. Welcome to the program.

INSOO HYUN: Good to be here. Thank you.

RAZ: A we just heard from Joe Palca, some people are morally opposed to this kind of research. What is their argument?

HYUN: Well, some people may think that we are now down a slippery slope toward getting cloned babies. And that's certainly a major concern for policymakers and the public.

RAZ: Well, what about the possibility, though, of reproductive cloning? I mean, are we going down that slope?

HYUN: Well, as the research shows, human reproductive cloning is a really, really long ways away because human research clinics, just to get stem cells, is so difficult. And every technology has a good use and has a bad use. And the reasonable response to this fact is not to ban this technology altogether, but it's to prevent the abuses of this technology.

Reproductive cloning violates all international guidelines for stem cell research and all U.S. guidelines.

RAZ: But of course, every time new research like this comes out, that's the first thing people think about.

HYUN: Exactly. Many people go right to the science fiction scenarios of how this technology might spin out of control.

RAZ: Now, to make these cloned embryos, the ones that Joe was reporting on, scientists needed a supply of human eggs. These were researchers in New York. They seem to be able to get all they needed. But other researchers in other states have had problems convincing women to become egg donors. What did the researchers in New York do differently?

HYUN: The researchers in New York followed New York State laws in allowing for compensation for time, effort and inconvenience of the egg donors. Prior to that, all other attempts to recruit egg donors were miserable failures because women simply were not willing to provide their eggs under all that stress for free.

What's curious is that in all research locales, healthy research volunteers that give up part of their bodies for research - whether it's a little bit of a lung, a little bit of a liver or bone marrow - are very often paid for their time, effort, and inconvenience in recognition of that sacrifice and that effort they had to put in, to help the research team. Egg donors for stem cell research are the glaring exception in these states.

RAZ: So in New York, women can be paid. In other states, they can't be paid for donating eggs for research?

HYUN: Yes. In other states, they can get their expenses covered - whether it's cafeteria meals or parking tickets or babysitting fees - but they can't get any further financial recognition of their sacrifice.

RAZ: But in other instances, in those same states, they can get paid for donating eggs, right, if it's for other purposes?

HYUN: In all other states, women donors can get paid to donate their eggs to a couple who's seeking fertility treatment, that's certainly true.

RAZ: So explain the thinking behind the restrictions on paying women to donate eggs for this kind of research.

HYUN: The main concern is that when you put money on the table, women would not give a fully voluntary choice to participate. So the idea is that paying women for the time and inconvenience may be exploitative of women who are in desperate need of money. That's the main concern, that it undermines people's voluntary choice.

RAZ: Now, this research was done with private money. During the administration of George W. Bush, there were strict limits on federal funding for research on human embryonic stem cells. Many of those restrictions have been lifted by the Obama administration. Could this work today, that it was announced today, could it have been done with federal dollars?

HYUN: No, it could not have. One restriction is still in place, and that is that you cannot use federal funds to do research where embryos are created and destroyed in the process. But more importantly, researchers today cannot even study these new stem cell lines using federal funds because it came from a research embryo.

RAZ: If researchers are willing to use private money, are there still limitations on what kinds of stem cell research they can carry out in the U.S.?

HYUN: There are. You cannot, for example, put these cloned human embryos into a uterus to try to produce a pregnancy.

RAZ: But they still have greater leeway, right, and fewer restrictions than they would if they used federal money.

HYUN: That's absolutely correct. And that's why this research was able to get done in New York State.

RAZ: Insoo Hyun is an associate professor of Bioethics at Case Western Reserve University.

Professor Hyun, thank you so much.

HYUN: Thank you.

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Questions over virus link to ME

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22 September 2011 Last updated at 19:14 GMT By James Gallagher Health reporter, BBC News The XMRV link to chronic fatigue syndrome has come under further questioning. Scientists who first linked chronic fatigue syndrome, also known as ME, to a virus have withdrawn some of their findings.

They have said some of their findings were based on "contaminated data".

Meanwhile, a study in Science claimed the virus could not be reliably detected in ME patients, even in the labs which originally made the link.

Understanding of chronic fatigue syndrome is poor. It may be many diseases and the causes are uncertain.

There was a sense of hope for many patients when a study published in Science in 2009 showed that DNA from a mouse virus, XMRV, was present in 67% of patients with the illness, but only 4% of the general population.

Yet other scientists around the world could not find evidence of the virus. Many researchers began to argue that the most likely explanation was contamination of the laboratory samples.

It led to Science asking the authors to withdraw their findings and it published an editorial "expression of concern" saying that the validity of the study was "seriously in question".

Continue reading the main story The disease is thought to affect some 250,000 people in the UKSymptoms include extreme tiredness, problems with memory and concentration, sleep disturbances and mood swingsThere is currently no accepted cure and no universally effective treatmentSource: ME AssociationThe authors have now issued a partial retraction after some of the scientists involved reported contamination, but this only calls into question the information in one table and two diagrams, not the rest of the paper and not the final conclusion.

One of the labs involved, the Whittemore Peterson Institute in Nevada, is standing by the conclusion. One of its lead researchers, Dr Vincent Lombardi, said it was "participating" in the retraction but: "We want to make it very clear that we are continuing the important work of studying retroviruses in association with ME/CFS and other similarly complex illnesses.

"WPI's more recent retroviral work, although still in the early stages of discovery, continues to warrant additional investigations."

Meaningless

Dr Jonathan Stoye, virologist at the Medical Research Council National Institute of Medical Research in the UK, said: "I don't think this partial retraction has any meaning, it would have been nice to have a complete rather than a partial retraction.

"They're saying the rest of the paper still stands, but that is becoming increasingly difficult for them to maintain."

A fresh study on XMRV published in Science, which the researchers behind the original study participated in, again questioned the link.

Samples of blood were collected from 15 patients who had previously tested positive for XMRV, 14 of whom also had chronic fatigue syndrome, and from 15 patients without XMRV.

These samples were sent to nine laboratories, including two which had found the link previously. No lab knew which samples were from which patients.

Only two laboratories, the two which initially proposed the link, detected any cases of XMRV. However, the virus was detected at "similar rates" in both groups of patients, the study said.

The results from the two laboratories were also "inconsistent" even when testing blood from the same patient.

Dr Charles Shepherd, medical adviser to the ME Association said: "These are very emphatic negative or inconsistent findings from the Blood Working Group study, along with the retraction of some of the original supporting data that was published in Science.

"So it is now looking extremely unlikely that XMRV is either linked to ME/CFS or that it has a disease-causing role.

"Having had their hopes raised that a treatable component to ME/CFS had been identified, it's not surprising that people are becoming increasingly disappointed at the way things are turning out.

But it's too early to send out the scientific jury to make a final definitive decision on XMRV and ME/CFS - we still need the results from the other major multi-centre study on XMRV and ME/CFS being carried out in America by Prof Ian Lipkin."

View the original article here

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