Conflicts-of-Interest

How journal editors can detect and deter scientific misconduct
How journal editors can detect and deter scientific misconduct ? Retraction Watch


How journal editors can detect and deter scientific misconduct, part 2, from COPE’s Liz Wager
http://retractionwatch.wordpress.com/2011/05/11/how-journal-editors-can-detect-and-deter-scientific-misconduct-part-2-from-copes-liz-wager/ (How journal editors can detect and deter scientific misconduct, part 2, from COPE’s Liz Wager Retraction Watch)
 
Opening up data at the European Medicines Agency
Widespread selective reporting of research results means we don’t know the true benefits and harms of prescribed drugs. Peter Gøtzsche and Anders Jørgensendescribe their efforts to get access to unpublished trial reports from the European Medicines Agency


Gotzsche PC, Jorgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342. http://www.bmj.com/content/342/bmj.d2686.full.pdf

Doctors cannot choose the best treatments for their patients despite the existence of hundreds of thousands of randomised trials. The main reason is that research results are being reported selectively. Comparisons of published drug trials with unpublished data available at drug regulatory agencies have shown that the benefits of drugs have been much over-rated and the harms under-rated. Comparisons of trial protocols with published papers have also shown widespread selective reporting of favourable results.

Selective reporting can have disastrous consequences. Rofecoxib (Vioxx) has probably caused about 100?000 unnecessary heart attacks in the United States alone, and class 1 antiarrhythmic drugs probably caused the premature death of about 50?000 Americans each year in the 1980s. An early trial found nine deaths among patients taking the antiarrhythmic drug and only one among those taking placebo, but it was never published because the company abandoned the drug for commercial reasons.

Allowing researchers access to unpublished trial reports submitted to drug regulatory agencies is important for public health. Such reports are very detailed and provide more reliable data than published papers, but it has been virtually impossible to get access to them. We eventually succeeded in getting access to reports held by the European Medicines Agency (EMA) after three years of trying. Our case has set an important precedent, and we summarise here the process and the arguments.
 

Attachments

Psychology Today apparently retracts Kanazawa piece on why black women are “rated less physically attractive”
http://retractionwatch.wordpress.com/2011/05/16/psychology-today-apparently-retracts-kanazawa-piece-on-why-black-women-are-rated-less-physically-attractive/ (Psychology Today apparently retracts Kanazawa piece on why black women are “rated less physically attractive” ? Retraction Watch)

Psychology Today has apparently yanked a blog post ( http://creativeseven.files.wordpress.com/2011/05/satoshi-kanazawa-article.pdf ) by London School of Economics evolutionary psychologist Satoshi Kanazawa that wondered why black women were considered less attractive than other women.

Kanazawa is no stranger to controversy. Last year, he published a study claiming that liberals and athiests were smarter than conservatives and believers. And yet P.Z. Myers, an avowed “godless liberal,” called him the “great idiot of social science,” according to a story in AlterNet.
 
Deeply conflicted
How can we insulate ourselves from conflicts of interest? The most popular solution—disclosing them—turns out not to help
Deeply conflicted - The Boston Globe

If your doctor recommended a drug whose manufacturer’s consulting fees financed his summer home, would that give you pause? Would you trust a stockbroker who wanted to sell you on a risky mutual fund that gave him a commission for every sale? How about a public official touting a new energy technology made by a company she invests in?

They’re questions worth asking, because conflicts of interest like these are commonplace. In just about any profession?—?medicine or real estate, accounting or academia?—?people giving information and advice may carry agendas that bias their judgments, or find themselves in situations where duty and personal benefit clash.

Within many fields, one solution has emerged: require people to disclose any ties that might sway their judgment. Such transparency, the rationale goes, encourages those in authority to behave more ethically, and lets those relying on their guidance take the bias into consideration.

But recent research by experimental psychologists is uncovering some uncomfortable truths: Disclosure doesn’t solve problems the way we think it does, and in fact it can actually backfire. Coming clean about conflicts of interest, they find, can promote less ethical behavior by advisers. And though most of us assume we’d cast a skeptical eye on advice from a doctor, stockbroker, or politician with a personal stake in our decision, disclosure about conflicts may actually lead us to make worse choices.

“None of us are saying that transparency is a bad thing,” says Daylian Cain, a behavioral economist at Yale University. “But almost always, it fails to work as well as we think it does.” By assuming that disclosure is always a benefit, he and his colleagues argue, regulators may be failing to address the real problems caused by conflicts of interest. In fact, biases are rooted deep in our psychology, and can’t be dispelled with a simple confession. Policies of disclosure, far from being a panacea, may be drawing attention away from the much harder work of removing conflicts and making sure that people’s advice and their interests align.

Ideally, all of us would be unconflicted actors, working in the best interests of the people we serve. In reality, though, we all navigate a sea of competing desires, and some of these create financial or social pressures that interfere with our objectivity. In some cases, the consequences of these conflicts are severe enough that industries have established rules for managing them.

One of the most popular?—?and least costly?—?solutions is disclosure. The notion is that requiring experts to put everything on the table should give them an incentive to behave ethically and avoid tarnishing their reputation: Transparency begets honesty. But work by Cain, in collaboration with Don Moore at the University of California Berkeley and George Loewenstein at Carnegie Mellon University, finds that disclosure can have the opposite effect.

Cain, Loewenstein, and Moore conducted a series of experiments meant to mimic a situation in which a person in authority?—?such as a doctor, consultant, or real estate broker?—?is giving advice that influences another person’s decision. Certain study participants were required to make an estimate?—?evaluating the prices of houses, for instance. Meanwhile, other participants were selected to serve as experts: They were given additional information with which to advise the estimators. When these experts were put in a conflicted situation?—?they were paid according to how high the estimator guessed?—?they gave worse advice than if they were paid according to the accuracy of the estimate.

No surprise there: People with a conflict gave biased advice to benefit themselves. But the twist came when the researchers required the experts to disclose this conflict to the people they were advising. Instead of the transparency encouraging more responsible behavior in the experts, it actually caused them to inflate their numbers even more. In other words, disclosing the conflict of interest?—?far from being a solution?—?actually made advisers act in a more self-serving way.

“We call it moral licensing,” Moore says. “After having behaved honestly and virtuously, you then feel licensed to indulge in being a little bit bad.” Other recent findings on ethical behavior, he says, show that people compensate for virtuous acts with vice, and vice versa. “People behave as if they have a moral ‘set point,’?” Moore says. Indeed, it appeared that disclosing a conflict of interest gave people a green light to behave unethically, as if they were absolved from having to consider others’ interests.

What, then, about the other half of disclosure’s supposed benefits? In effect, what the experts were doing was passing the buck on managing their bias to the people they were advising. So does disclosing a conflict of interest enable the people receiving advice to take that information with the proper grain of salt? Research again suggests the answer is no.

Sunita Sah, a researcher at Duke University’s Fuqua School of Business, has conducted experiments focusing on doctor-patient interactions, in which a doctor prescribes a medication but discloses a financial interest in the company that makes the drug. As expected, most people said such a disclosure would decrease their trust in the advice. But in practice, oddly enough, people were actually more likely to comply with the advice when the doctor’s bias was disclosed. Sah says that people feel an increased pressure to take the advice to avoid insinuating that they distrust their doctor.

Sah sees people complying with biased advice as a way of helping their advisers, even in one-off interactions between strangers participating in a study. “People feel pressure to behave generously even if it’s not in their best interest,” she says. In these situations, she says, “instead of being a warning, disclosure places this burden on the very people it’s supposed to protect.”

At a recent conference on conflicts of interest at Harvard Law School, Harvard psychologist Mahzarin Banaji said that the core problem is a fundamental misunderstanding about the pervasiveness and power of bias. We assume we’re in command of our preferences and decisions, but psychology and cognitive science have shown that much of our decision-making occurs unconsciously. Banaji pointed out that we have preferences for everything from politically similar people to the letters in our own names. “There is no ‘neutral’ at the implicit or unconscious level,” she said.

This disconnect results in policies that underestimate not only the prevalence of bias, but also its burden on society. “The big missing ingredient is that people don’t understand how dangerous conflicts of interest are in the first place,” Cain says. He points out that people’s decisions are easily influenced by information they receive beforehand, even if they know the information to be incorrect, irrelevant, or biased. This phenomenon, called anchoring, has been shown time and again in psychological experiments. Thus, experts can’t simply overlook their own personal interests, and those who get advice can’t easily discount experts’ prejudices, even if they want to.

Personal connection adds a further layer of complexity. Francesca Gino and her colleagues at Harvard Business School have found that people who are prescribed medicines by personal doctors are less likely to recognize the potential dangers of their doctors’ conflict of interest. Although most of us recognize that conflicts of interest are a problem in the abstract, we don’t want to acknowledge them in people we know. That’s because we don’t see bias as something that affects good, intelligent people. But in fact, Gino says, “there are lots of very subtle factors that can push us to cross ethical boundaries without us realizing that these factors are having an effect.”

If disclosure is as ineffective?—?or even counterproductive?—?as these studies suggest, is there any hope for it as a tool? Some studies suggest that disclosure of conflict of interest works better when people on the receiving end are well informed?—?it might, for example, work better among colleagues than for doctors and patients. Sah’s research, meanwhile, points to a number of ways disclosures can be improved. She found that people were more likely to discount biased advice from doctors if disclosures were made by a third party, if they were not made face-to-face, or if patients had a “cooling off” period to reconsider their decisions.

Even if these fixes make disclosure more effective, the true implication of these studies is that transparency is not a blanket solution to problems of corruption. “Regulators should be looking harder at eliminating conflicts,” Cain says. Unfortunately, requiring disclosure is much easier than changing the status quo. As he puts it, “I’d rather tell you I’m on the gravy train than get off it.”

Furthermore, as Moore admits, in some cases the high costs of eliminating conflicts of interest may not be worth the effort. But in circumstances where conflicts cause harm, changing the system could be worthwhile. Regulators, Moore says, need to look for ways to structure systems so that experts’ personal interests are matched with the interests of those they are helping. “Restructuring to align interests is difficult,” he says, “but when you do it, it can be beautiful.”


Cain, Daylian M., Loewenstein, George F. and Moore, Don A., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest (December 1, 2003). Available at SSRN: The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest by Daylian Cain, George Loewenstein, Don Moore :: SSRN / http://www.princeton.edu/chw/lectures-conferences/lectures/past-lectures/spring2005/conflicts.pdf

Conflicts of interest can lead experts to give biased and corrupt advice. Although disclosure is often proposed as a potential solution to these problems, we show that it can have perverse effects. First, people generally do not discount advice from biased advisors as much as they should, even when advisors' conflicts of interest are honestly disclosed. Second, disclosure can increase the bias in advice because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further. This means that while disclosure may [insufficiently] warn an audience to discount an expert-opinion, disclosure might also lead the expert to alter the opinion offered and alter it in such a way as to overcompensate for any discounting that might occur. As a result, disclosure may fail to solve the problems created by conflicts of interest and it may sometimes even make matters worse.


Cain, Daylian M., Loewenstein, George F. and Moore, Don A., When Sunlight Fails to Disinfect: Understanding thePerverse Effects of Disclosing Conflicts of Interest (July 7, 2010). Journal of Consumer Research, Forthcoming. Available at SSRN: When Sunlight Fails to Disinfect: Understanding the Perverse Effects of Disclosing Conflicts of Interest by Daylian Cain, George Loewenstein, Don Moore :: SSRN / https://apps.olin.wustl.edu/cres/research/calendar/files/LoewensteinG.pdf

Disclosure is often proposed as a remedy for conflicts of interest, but it can backfire, hurting those whom it is intended to protect. Building on our prior research, we introduce a conceptual model of disclosure’s effects on advisors and advice recipients that helps to explain when and why it backfires. Studies 1 and 2 examine psychological mechanisms (strategic exaggeration, moral licensing) by which disclosure can lead advisors to give more-biased advice. Study 3 shows that disclosure backfires when advice recipients who receive disclosure fail to sufficiently discount and thus fail to mitigate the adverse effects of disclosure on advisor bias. Study 4 identifies one remedy for inadequate discounting of biased advice: explicitly and simultaneously contrasting biased advice with unbiased advice.
 
Clinician Attitudes About Commercial Support of Continuing Medical Education

Pharmaceutical and medical device industry funding supports up to 60% of accredited continuing medical education (CME) costs nationwide. There is increasing pressure to limit the size, scope, and potential influence of this support. A 2008 report from the Josiah Macy Jr Foundation on continuing education in the health professions recommended that all commercial support of CME activities be eliminated within the next 5 years. The implications of such an approach were discussed in recent reports by the Institute of Medicine (IOM) on conflict of interest in medical research, education, and practice. This report recommended that "a new system of funding accredited continuing medical education should be developed that is free of commercial influence, enhances public trust in the integrity of the system, and provides high-quality education." The committee recognized "that such a system may involve higher costs for physicians and require cost-cutting steps by education providers." The perceptions of health care practitioners on the importance of these changes, practitioners' preference for change, and their understanding of the implications remain unclear.

In this study, researchers sought to determine whether participants at live CME activities understand some of the costs involved, whether they would be willing to pay higher registration fees or accept fewer amenities to avoid or decrease the need for commercial funding, and how that willingness relates to their perception of bias related to commercial support.


Tabas JA, Boscardin C, Jacobsen DM, Steinman MA, Volberding PA, Baron RB. Clinician Attitudes About Commercial Support of Continuing Medical Education: Results of a Detailed Survey. Arch Intern Med 2011;171(9):840-6. Arch Intern Med -- Abstract: Clinician Attitudes About Commercial Support of Continuing Medical Education: Results of a Detailed Survey, May 9, 2011, Tabas et al. 171 (9): 840

Background Pharmaceutical and medical device company funding supports up to 60% of accredited continuing medical education (CME) costs in the United States. Some have proposed measures to limit the size, scope, and potential influence of commercial support for CME activities. We sought to determine whether participants at CME activities perceive that commercial support introduces bias, whether this is affected by the amount or type of support, and whether they would be willing to accept higher fees or fewer amenities to decrease the need for such funding.

Methods We delivered a structured questionnaire to 1347 participants at a series of 5 live CME activities about the impact of commercial support on bias and their willingness to pay additional amounts to eliminate the need for commercial support.

Results Of the 770 respondents (a 57% response rate), most (88%) believed that commercial support introduces bias, with greater amounts of support introducing greater risk of bias. Only 15%, however, supported elimination of commercial support from CME activities, and less than half (42%) were willing to pay increased registration fees to decrease or eliminate commercial support. Participants who perceived bias from commercial support more frequently agreed to increase registration fees to decrease such support (2- to 3-fold odds ratio). Participants greatly underestimated the costs of ancillary activities, such as food, as well as the degree of support actually provided by commercial funding.

Conclusion Although the medical professionals responding to this survey were concerned about bias introduced from commercial funding of CME, many were not willing to pay higher fees to offset or eliminate such funding sources.
 
Sales Tactics on Implants Raise Doubts

Sales Tactics on Implants Raise Doubts
http://www.nytimes.com/2011/06/01/health/01device.html?_r=1&partner=rss&emc=rss

Mr. Brown’s charge came in an e-mail last year to fellow Biotronik executives, one of scores of documents involving the company that offer a portrait of an implant industry where producers seek to influence the brand of device that patients receive long before a diagnosis.

The documents show, for example, that device makers recruit not only implant specialists as consultants but also general cardiologists who refer patients. Those cardiologists, called feeders in one of the documents, can benefit by enrolling the referred patients in a company-financed study that can pay a cardiologist up to $4,800 a patient.

...sales tactics, rather that scientific data, can determine which company’s device a patient gets because doctors have no independent source of information about which implants work best or last longest, several experts said.

“There is no reliable way to compare different devices on an independent basis,” said Dr. Alan H. Kadish, a cardiologist who is the president of Touro College in Manhattan.

The company’s relationship with a general cardiologist in Tucson, Dr. Monty C. Morales, is the subject of several memos.

In mid-2008, Biotronik retained Dr. Morales as a consultant under an arrangement that paid him up to $2,000 a month, company records indicate. And about that same time, Dr. Morales, who does not implant devices, expressed strong opinions about the implant brand his patients should get, according to a report apparently written by a sales representative for a Biotronik distributor called Western Medical.

In that memo, Dr. Morales is described as saying that he would not refer patients to an implant specialist in his same Tucson-area practice, Dr. Darren Peress, unless Dr. Peress started implanting Biotronik devices.

“Currently, Peress does not get any of Morales’ business,” the memo stated. “Monty will strongly support use and send Peress business if he uses Biotronik.”

The company’s relationship with a general cardiologist in Tucson, Dr. Monty C. Morales, is the subject of several memos.

In mid-2008, Biotronik retained Dr. Morales as a consultant under an arrangement that paid him up to $2,000 a month, company records indicate. And about that same time, Dr. Morales, who does not implant devices, expressed strong opinions about the implant brand his patients should get, according to a report apparently written by a sales representative for a Biotronik distributor called Western Medical.

In that memo, Dr. Morales is described as saying that he would not refer patients to an implant specialist in his same Tucson-area practice, Dr. Darren Peress, unless Dr. Peress started implanting Biotronik devices.

“Currently, Peress does not get any of Morales’ business,” the memo stated. “Monty will strongly support use and send Peress business if he uses Biotronik.”

http://www.nytimes.com/2011/04/03/business/03implant.html
Tipping the Odds for an Implant Maker
 
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Penkowa Journal of Physiology Expression of Concern turns into a retraction
Penkowa Journal of Physiology Expression of Concern turns into a retraction ? Retraction Watch

We’ve been trying to follow the complicated case of Milena Penkowa, who resigned her post at the University of Copenhagen in December amidst allegations that she had committed scientific misconduct and misused grant money. Today, we learned that one of the three papers that Penkowa had coauthored and were subject to Expressions of Concern has been retracted. Here’s the notice:

Retraction of ‘Exercise induces interleukin-8 expression in human skeletal muscle’, by Thorbjorn CA Akerstrom, Adam Steensberg, Pernille Keller, Charlotte Keller, Milena Penkowa and Bente Klarlund Pedersen, published in The Journal of Physiology 563(2): 507-516. Akerstrom T, Steensberg A, Keller P, Keller C, Penkowa M, Pedersen BK.


The paper has been cited 54 times, according to Thomson Scientific’s Web of Knowledge.
 
HHS Seeks to Enhance and Modernize Human Subjects Research Protections
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/08/hhs-seeks-to-enhance-and-modernize-human-subjects-research-protections.html (FDA Law Blog: HHS Seeks to Enhance and Modernize Human Subjects Research Protections)

The Department of Health and Human Services, Office of the Secretary, along with the Office of Science and Technology Policy, has issued an advance notice of proposed rulemaking (“ANPRM”) requesting comments on how to update current regulations on the protection of human subjects who participate in research.
 
Two papers to be retracted after ORI finds misconduct by Boston University cancer researcher
http://retractionwatch.wordpress.com/2011/08/09/two-papers-to-be-retracted-after-ori-finds-misconduct-by-boston-university-cancer-researcher/ (Two papers to be retracted after ORI finds misconduct by Boston University cancer researcher Retraction Watch)

The U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) has found that a Boston University cancer researcher made up experiments reported in two papers funded by National Cancer Institute and National Institutes of Health grants.
 
How Industry Uses the ICMJE Guidelines to Manipulate Authorship

Summary Points

• Academic authorship boosts the credibility of industry publications and masks their commercial function.

• Alongside traditional “guest authorship” and ghostwriting, industry may simply exaggerate the contribution of named academic authors and downplay that of commercial writers, who are excluded from authorship but listed as contributors in the small print.

• Rather than obstructing industry, the current International Committee of Medical Journal Editors (ICMJE) authorship guidelines provide a ready tool for misattributing authorship. Industry also relies on selective interpretations of key authorship concepts.

• The ICMJE guidelines should be fundamentally revised and the concept of origination given comparable importance to authorship and contributorship.

• Companies and writers who work on industry publications should be listed as byline authors.


Rather than ensure the proper attribution of authorship, rules set up by leading medical journals to define and credit authorship of published articles are exploited by the pharmaceutical industry in its attempt to conceal and misrepresent industry contributions to the literature.

This is a perspective contained in an article by Alastair Matheson, a medical writer based in the UK and Canada, who argues in this week's PLoS Medicine that the current International Committee of Medical Journal Editors (ICMJE) authorship guidelines allow for industry to exaggerate the contribution of named academic authors and downplay that of commercial writers who are excluded from authorship but listed as contributors in the small print.

Matheson contends that the ICMJE guidelines should be fundamentally revised and the concept of origination given comparable importance to authorship and contributorship. Pharmaceutical companies and writers who work on industry publications should be listed as byline authors, he says.


Scientists and clinicians need to know the authorship, author interests, and origination of the articles they read to judge them appropriately. Since 1985, the International Committee of Medical Journal Editors (ICMJE) has provided evolving guidance on how authorship should be managed in the complex setting of modern biomedical science to the benefit of the published literature. Issues such as accountability, fraud, conflicts of interest, trial registration, and access to data have been considered by this voluntary, self-funded, closed-membership group of select general medical journal editors (ICMJE: Uniform Requirements for Manuscripts Submitted to Biomedical Journals). However, certain industry practices, including publications planning, ghostwriting, and guest authorship, have yet to be adequately addressed. On the basis of industry publications and documents, textual analysis, and direct working experience in the “medical communications” sector, I show here how pharma has succeeded not merely in outmaneuvering the ICMJE guidelines, but is able to use them as the basis for inappropriate attributions of authorship.

Matheson A. How Industry Uses the ICMJE Guidelines to Manipulate Authorship - And How They Should Be Revised. PLoS Med 2011;8(8):e1001072. PLoS Medicine: How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised

Based upon his 15 years of experience as a medical writer, Alastair Matheson argues that rather than obstructing industry, the current ICMJE authorship guidelines have become its preferred tool for misattributing authorship.



In another perspective article, Linda Logdberg of Fernbank Science Center, USA, who worked in the medical communication industry for 11 years, offers her personal view of her work and why she did it, writing that "ethical concerns about medical ghostwriting have been directed primarily at ''guest'' authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product."


Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.

For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.

Logdberg L. Being the Ghost in the Machine: A Medical Ghostwriter's Personal View. PLoS Med 2011;8(8):e1001071. PLoS Medicine: Being the Ghost in the Machine: A Medical Ghostwriter's Personal View

Linda Logdberg, a medical ghostwriter for 11 years, provides a personal view of her former work and what she believes should be done about the problem of fraud in authorship.
 
Hip Implant Complaints Surge, Even as the Dangers Are Studied
http://www.nytimes.com/2011/08/23/b...r-on-hip-implants-as-dangers-are-studied.html

August 22, 2011
By BARRY MEIER and JANET ROBERTS

The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers.

An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Hip replacement is one of the most common procedures in the United States and, until a recent sharp decline, all-metal implants — one in which both the artificial ball and cup are made of metal — accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints reviewed by The Times. A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency’s overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries.

“They are grasping at how they are going to get this information,” said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente.

In addition, researchers are struggling to understand the tissue damage caused by the metallic debris. While some patients experience pain, other patients with the same damage have no pain, complicating decisions about whether to remove devices.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

“There is not an existing infrastructure for studying this kind of information,” Dr. Maisel said.

For many patients, it is too late. In 2008, Ann Morrison, a physical therapist from Newark, Del., received all-metal replacements for both of her hips. But Ms. Morrison, 50, soon experienced pain, rashes and inflammation.

Last year, the devices were replaced, but by then, she said, debris-caused tissue damage was so extensive that she now needs a brace to walk and still cannot work. She called the F.D.A.’s order for medical studies a “joke.”

“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.

To conduct its analysis, The Times reviewed complaints filed with the F.D.A. from 2007 through this June for several implants, including the A.S.R. and the Durom cup, a component sold by Zimmer Holdings.

Typically, the number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the A.S.R. and the Durom cup probably reflects a surge of lawsuits filed against their makers.

The Times review found some 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

Because complaints to the F.D.A. are not uniform, it is impossible to say how many adverse reports about all-metal hips have been submitted. For example, the Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

A spokesman for Zimmer Holdings said the Times review was “in the ballpark” of the company’s assessment of the drug administration’s filings. A DePuy spokeswoman declined to disclose the number of A.S.R. complaints that the company forwarded to the F.D.A. She maintained that the Pinnacle was performing well.

DePuy, Zimmer and another producer of metal hips, Wright Medical, declined to discuss the study proposals they had submitted to the F.D.A. to comply with its May order. A fourth company, Biomet, said it had proposed mounting a study of 400 patients who received its devices that would draw in part on studies already under way. The F.D.A. declined to release producers’ proposals, saying that they contained “confidential commercial information.” The agency has until November to decide on the plans’ adequacy.

In an effort to recruit patients, companies have recently contacted, researchers said, health systems like Kaiser Permanente and hospitals that operate their own implant registries.

Meanwhile, researchers say it may be a year before standard protocols are formulated that may be central to the future studies, like a uniform procedure to measure metallic ions in a patient’s blood or how to calibrate diagnostic equipment to best detect tissue damage.
 
HHS Tightens Financial Conflict of Interest Rules for Researchers
Increased Reporting, Transparency to Ensure Scientific Objectivity and Integrity
HHS Tightens Financial Conflict of Interest Rules for Researchers, August 23, 2011 News Release - National Institutes of Health (NIH)

The U.S. Department of Health and Human Services today issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process.
http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf
 
This guy, Nemeroff, is probably singularly responsible for so much misery, including DEATH!

How An Ethically Challenged Researcher Found A Home at the University of Miami
How An Ethically Challenged Researcher Found A Home at the University of Miami - Forbes

Three weeks ago, the National Institutes of Health announced new rules to govern federally-funded researchers and their financial conflicts of interest. Three years in the making, the policy will affect over 38,000 scientists at 2000 organizations as the NIH attempts to ensure that biomedical research, paid with taxpayer dollars, remains objective.

But none of these changes might have happened were it not for Dr. Charles Nemeroff.

A renowned chairman of psychiatry at Emory University, Nemeroff was a proponent for drugs sold by GlaxoSmithKline, such as the antidepressant Paxil. While earning hundreds of thousands of dollars jetting around the country and giving talks about Paxil to doctors at fancy restaurants, Nemeroff also managed a multi-million dollar grant from the NIH to research drugs under development by Glaxo.

The ensuing scandal became central to an investigation by Senator Charles Grassley into undisclosed payments from companies to prominent physicians—a practice that puts patients at risk and drives up healthcare costs. As Grassley’s lead investigator on the matter, I had a ringside seat as arguably the most powerful psychiatrist in the country was forced from prominence, eventually leaving Emory.
 
New heart medication study was too flawed for publication, former journal editor says
New heart medication study was too flawed for publication, former journal editor says | Alison Bass

At a Harvard event last night honoring the former Grassley investigator Paul Thacker, someone in the audience wanted to know how the topic of Thacker’s talk — Dollars for Doctors: Who owns your physician? — was related to the soaring cost of medical care in this country.

As Thacker noted at the outset of his talk, Medicare and Medicaid are now a larger portion of the federal budget than the Pentagon and health care now equal 23 percent of all federal expenditures. Part of the problem, he noted, is the fact that our medical system is stacked towards the widespread adoption of expensive new drugs over older generics even when the new agents are not necessarily safer or more effective than cheaper drugs.

It was left to Dr. Arnold Relman, professor emeritus at Harvard Medical School, to showcase a fresh-off-the-page example of how studies that are funded by drug makers and conducted by researchers who have financial ties to the industry present skewed research results that favor expensive new drugs over generics.

His case in point: The New England Journal of Medicine published a study last week concluding that a new anticoagulant known as apixiban (brand name: Eliquis) was superior to the generic drug warfarin in preventing stroke and deaths in patients with atrial fibrillation (abnormal heart rhythm). The study was funded by Bristol Myers Squibb and Pfizer, which jointly manufacture Eliquis, and featured a lengthy roster of authors, many of whom have extensive financial ties to the drug industry (in the form of speaking and consulting fees). At least three of the authors were Bristol Myers Squibb employees, as the fine print at the end of the study disclosed.

The issue Relman, a former editor of he New England Journal, raised was how these financial conflicts may have influenced the way the paper itself was skewed in favor of the new drug. He noted two major omissions in the discussion section of the study. One was the fact that the anticoagulant showed no efficacy over the much cheaper warfarin generic in the 7,000 patients recruited in Europe (this was a multi-center trial involving 18,000 patients from the U.S., Latin America, Asia and Europe). Two, 35 percent of the patients on warfarin were not taking a therapeutic dose of the drug, which, he said, could explain why they had a higher rate of blood clotting and stroke than patients taking the new anticoagulant.

Yet neither of these key limitations were mentioned in the study’s discussion, a glaring omission, according to Relman. He said that the journal itself was remiss in publishing the study without mentioning these limitations.

“This study was not well peer reviewed,” Relman said. “Neither [Dr. Marcia Angell, also a former editor of NEJM] nor I would have accepted this paper for publication.”

Yet as a result of its publication, many heart doctors will now be steered toward prescribing a much more expensive drug when the cheaper generic would do just as well in many cases.

The study, Relman said, is a prime example of why the disclosure of conflicts of interest (which most leading journals now require) is not enough to curb bad or biased science. He suggested that medical institutions simply prohibit their faculty from doing research on drugs when they are receiving lucrative speaking and consulting payments from industry. (Research shows a clear link between a company funding a trial and favorable results for that company’s drug — see here and here.)

“The real solution is for medical institutions to get rid of these unethical practices,” Relman said. “Disclosure is not a solution.”

Thacker, who is now an investigator for the Project on Government Oversight (POGO), agreed. The Physician Payment Sunshine Act, which he helped shepherd into law and requires drug companies to disclose all payments to doctors, should be considered a first step, he said.

“It’s a way to get a handle on just how widespread the problem of financial conflicts of interest are, so we can start to make real changes,” he said.

If the documented harm to patients from such conflicts of interest is not enough of a reason, perhaps the unsustainable costs to our overburdened health care system will eventually tip the balance toward change.
 
IMO, this was manslaughter! And it is going on in all aspects of medicine.

Taking Double Cut, Surgeons Implant Their Own Devices
http://online.wsj.com/article/SB10001424053111904106704576582621677354508.html

JACKSON, Miss.—On April 7, a 48-year-old Baptist preacher named Gary Steve Moore had spinal-fusion surgery at St. Dominic Hospital here. Hours later, he was dead.

Mr. Moore had been suffering from a degenerating disk in his lower back. Two spine surgeons who later reviewed his medical records say his history of heart disease and bowel obstructions made him a poor candidate for a 360-degree spinal fusion, a complex operation that involved opening up both his abdomen and his back.

His neurosurgeon, Adam Lewis, felt that "surgery was indicated" given Mr. Moore's worsening back pain and the fact that more conservative treatments he had tried, such as physical therapy, had provided no relief, says Dr. Lewis's lawyer, Whit Johnson.

However, there was one element of the surgery that Dr. Lewis didn't mention to the patient, according to his widow: The surgeon was part-owner of the company, Spinal USA, that makes the devices he implanted in Mr. Moore's spine.


Dr. Lewis never told the Moores of his involvement in Spinal USA, according to Ms. Moore. A treatment authorization signed by Mr. Moore says patients might be referred to "a health care facility" with which their physician could have a "financial relationship." It says nothing about medical devices.

Ms. Moore says she would have liked to know that Dr. Lewis stood to profit from the implants he planned to insert in her husband's back. "It might have caused me to ask: Is the surgery really necessary, or is he out to make more money?" she says.
 
McCain-BigPharma-Supplements Bill

I think this died in commitee but the attempt just goes to demonstrate the lengths that greedy corporations and corrupt politicans will stoop to in order to feed their insatiable love of money.
Esisode 453
http://www.superhumanradio.com/core/shr_archive.htm
 
National Lipid Association Expert Panel Has Many Deep Ties To Industry
National Lipid Association Expert Panel Has Many Deep Ties To Industry - Forbes

An “expert panel” assembled by the National Lipid Association (NLA) is recommending a dramatic expansion in the use of new biomarkers for the diagnosis and management of cardiovascular disease. The recommendations, if widely adopted, would significantly increase not just the use of these diagnostic tests but also lead to much greater use of lipid-lowering drugs. But every member of the panel has extensive ties to industry, and the “consensus conference” that led to publication of the guidelines was funded by an array of diagnostic and drug companies that stand to gain from the new recommendations.

The NLA panel recommends a greatly expanded role for 5 out of 6 new biomarkers– CRP, Lp-PLA2, Apo B, LDL particle number, Lp(a), and HDL or LDL subfractions. However, these same biomarkers received a much more critical review in the ACCF/AHA guidelines for cardiovascular risk assessment and in the USPSTF guidelines. The ACCF/AHA guidelines, for example, allow a very modest role for CRP; the other biomarkers are simply not recommended:

Measurement of lipid parameters, including lipoproteins, apolipoproteins, particle size, and density, beyond a standard fasting lipid profile is not recommended for cardiovascular risk assessment in asymptomatic adults.

Panel members, along with the NLA itself, have a dizzying number of industry relationships. The chair of the panel, Michael Davidson, “has received research grants from Abbott Laboratories, Daiichi Sankyo, GlaxoSmithKline, Merck & Co. and Roche… has received consulting fees from Abbott Laboratories, Aegerion Pharmaceuticals, Amgen, AstraZeneca, Atherotech Inc., Daiichi Sankyo, DTC MD, Esperion, GlaxoSmithKline, Intelligent Medical Decisions, Kinemed, LipoScience, Merck & Co, Novo Nordisk, Roche, Sanofi-Aventis, Synarc, Takeda Pharmaceuticals, and Vindico Medical Education…. has received honoraria related to speaking from Abbott Laboratories, GlaxoSmithKline and Merck & Co…. [and] has served on the Board of Directors of DTC MD, Omthera, Professional Evaluation Inc., and Sonogene.”

Chrystie Ballantyne, a co-chair of the panel, has a disclosure list even longer than Davidson’s. Another member of the panel, W. Virgil Brown, is the editor of the Journal of Clinical Lipidology, the NLA journal in which the expert panel appears. He “has received consulting fees from Abbott Laboratories, Amgen, Anthera, Genzyme, Pfizer Inc., LipoScience, and Merck & Co…. [and] has received honoraria related to speaking from Abbott Laboratories, LipoScience, and Merck & Co.”

One of the 17 panel members, James McKenney, had no disclosures in the paper, but this may not tell the entire story. A Pharm.D, McKenney is a former president of the NLA, and a faculty disclosure statement online indicates that McKenney has had extensive ties with industry in the past.

An NLA webpage about the document includes the statement that “contributors to this paper have provided full disclosures and their thoughts on this matter were discussed in advance and the contributors have affirmed that their participation has not been influenced by bias or commercial interest….”

The authors acknowledge financial support to produce the document in the form of “unrestricted grant funding” from 9 companies, all of whom stand to benefit from the changes endorsed by the panel: Abbott Laboratories, Atherotech Diagnostics Laboratory, Berkley Heart Lab, Inc., Boston Heart Diagnostics, diaDexus, Inc., LipoScience, Merck & Co., Inc., and Spectracell Laboratories. After thanking the companies for their support the authors then assert that the document is free from commercial influence:

The NLA would like to thank each company for its support of this endeavor. In accordance with the National Lipid Association Code for Interactions with Companies, the NLA maintained full control over the planning, content, quality, scientific integrity, implementation, and evaluation of the consensus conference and this inflammatory markers and advanced lipoprotein testing consensus document. All related activities are free from commercial influence and bias.

At least one company has already gone ahead and started to use the document to promote its product. Even before the paper had a chance to receive wide distribution, LipoScience, which markets a test that measures LDL particle number (LDL-P), issued a press release announcing the publication, and trumpeting the new indications for its product:

The consensus panel recommends that the use of LDL particle number for initial clinical risk assessment of CVD is reasonable for many patients at intermediate risk, including patients with a family history of coronary heart disease (CHD) and recurrent cardiac events. In addition, LDL particle number should be considered in the risk assessment of selected patients with known CHD or CHD risk equivalent.

The panel also recommends that LDL particle number for on-treatment management of CVD risk is reasonable for many patients at intermediate risk, including patients with coronary heart disease, a CHD risk equivalent and in patients with recurrent cardiac events. LDL particle number should be considered in the management of selected patients with a family history of CHD.

Here’s another question worth asking: how much of the paper did the expert panel actually write? The end of the paper acknowledges “Biofortis-Provident Clinical Research for writing and editorial assistance.” This company has extensive connections with the NLA and the lipid community (some of its current employees were also involved with an Abbott marketing study that was published in the American Journal of Cardiology). In fact, two “non-panel scientists” who are listed as co-authors of the expert panel paper are Kevin C. Maki, PhD and Mary R. Dicklin, PhD. In addition to their numerous other relationships with industry, the disclosures section of the paper states that they receive “salary support from Biofortis.” In fact, they are employees of the company, and a cursory look at Maki’s resume reveals that he is the President and Chief Science Officer of Provident Clinical Research.

Here is how one researcher in this field, who asked not to be identified, analyzed the situation:

Almost every writer has multiple relationships with companies that will benefit from more testing and more drug use. There are the direct relationships, including writers with direct stakes in the companies that do the testing, like Diadexus, which has a test for LpPLA2, and LipoScience and Atherotech, which make lipoprotein tests. But even more insidious are the relationships with pharma companies, since use of these tests broadens the market– ie, tends to increase the number of people eligible for drug treatment. Getting docs to use new tests– be they blood or imaging tests– is a tried and true way to increase drug use.

Also, how were these people chosen? Most have multiple conflicts. Why are they experts? Most (not all) are big pharma players and are not federally funded researchers who performed seminal research on the development of the tests or their evaluation in large epidemiological studies or clinical trials. Many are in private practice and their research experience is participating as a site in a clinical trial. These are the key opinion leaders– ie, experts who become experts through industry backing, getting together, and making an expert panel. To be more pointed, the NLA leaders got together to write a document.

A recent study in BMJ examined the role of conflict of interest in published guidelines for diabetes and cardiovascular disease over the past decade and found numerous problems with the way most organizations manage conflicts of interest on these panels. But, says Mt. Sinai’s Jennifer Neuman, lead author of the study, the NLA paper is an egregious example of these problems:

The Institute of Medicine has made a number of recommendations on how to manage conflicts of interests on guideline panels in order to limit potential bias, and the NLA appears to have disregarded most of these recommendations. This flies in the face of national and international efforts to improve the credibility of the guideline development process.


Click here to read the first part of a series of articles from earlier this year about the NLA.

Part 1: The National Lipid Association and the FH Guidelines
http://cardiobrief.org/2011/05/17/part-1-the-national-lipid-association-and-the-fh-guidelines/
 

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