conflict of interest

FDA tightens conflict-of-interest rules for advisers

Anne Zieger — Tue, 05 Aug 2008 11:31:51 -0400

The FDA has finalized new rules designed to screen out potential advisers if they or their family members have financial interests that conflict with their role in the process. Among other things, the new rules will prevent participation of an expert in advisory decisions if that person, their spouse or minor child has conflicting financial interests of more than $50,000. Until now, the FDA has screened committee members, but has sometimes given advisers with such conflicts a waiver allowing them to participate nonetheless.

Going forward, the FDA is unlikely to offer a waiver if the potential adviser or family member has interests falling above $50,000, and will avoid offering waivers for those with interests under $50,000 only if the FDA decides that the adviser's special expertise is needed. Generally speaking, however, the agency's officials want to cut back on issuing waivers.

To make sure it reaches enough qualified and unbiased advisers during their next round of recruiting, the agency has contacted almost 280 professional organizations, published six Federal Register notices on the subject and has attended a number of professional meetings. To date, these efforts have resulted in the FDA receiving 350 resumes, officials said.

To learn more about the FDA's plans:
- read this Wall Street Journal blog item

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Harvard psychiatrists fail to reveal millions in pharma pay

Mon, 09 Jun 2008 06:59:57 -0400

A Harvard child psychiatrist with a global reputation whose work has helped to promote the use of antipsychotic meds in children apparently didn't report most of the $1.6 million in drug maker consulting fees he earned over the last several years.

According to information given to Congressional investigators, Dr. Joseph Biederman failed to report much of this consulting income to university officials, which he took in between 2000 and 2007. According to Sen. Chuck Grassley (R-Iowa), this may have violated federal and university research rules that attempt to limit potential conflicts of interest. Also accused of such conflicts are Dr. Timothy Wilens, who took in $1.6 million from 2000 to 2007, and Dr.Thomas Spencer, who reported earning at least $1 million during that period.

Even these large numbers may understate the case, given that the researchers' alleged incomes sometimes conflict with drug company reports, some of which contend that they give the researchers far more money than was disclosed. Given these questions, the $287 million in federal grants won by Drs. Biederman and Wilens in 2005 may be restricted, or even suspended.

To get more background on this controversy:
- read this article from The New York Times

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FTC comes down on IL bill restricting retail clinics

Wed, 04 Jun 2008 06:59:58 -0400

The Federal Trade Commission has let it be known that it isn't thrilled with pending legislation that could place limits on the state's growing retail clinic industry. The agency found that the bill, which is backed by the Illinois State Medical Society, could "excessively restrict retail clinics to the detriment of Illinois healthcare consumers." The 12-page analysis, which was requested by state Rep. Elaine Nekritz, found a number of problems with the bill, including a definition it said could be interpreted to exempt retail clinics owned by hospitals or physicians from the rules.

It also objected to several other provisions, including proposed rules limiting medical directors to overseeing no more than two clinics; prohibiting payers from negotiating lower co-pays and deductibles for retail clinic services; barring retail clinics from opening in establishments that sell alcohol or tobacco; and requiring that retail clinics have a designated receptions and waiting area.

The controversy over this bill is not the first conflict over retail clinic regulations--a few states, including Massachusetts, have already seen heated battles over this issue--and it probably won't be the last. For example, the AMA continues to challenge the safety of retail clinic services, as well as their potential for posing a conflict of interest by being housed where prescription drugs are sold. Other critics (such as Boston's Mayor Thomas Menino) have proposed rules barring clinics from operating where tobacco is sold, which de facto prevents the clinics from operating in drugstores that rely on tobacco income.

To learn more about the FTC analysis:
- read this Modern Healthcare piece (reg. req.)

Related Articles:
AMA demands retail clinic regs, backs off ban
Kroger chain invests in retail clinic operator
MA doctors protest CVS retail clinic expansion
Wal-Mart plans 2,000 retail clinics

NJ AG investigating device maker

Wed, 06 Feb 2008 06:59:58 -0500

In recent weeks, observers have been challenging the results of a study on an artificial spinal disk, ProDisc, which concluded that the disk works better for patients than standard spinal-fusion surgery. Critics were dismayed by the fact that many of the physicians involved in the study had agreements with the disk's maker, Synthes Spine, which would cause them to make money if it were successful. Now, the New Jersey attorney general is raising the stakes. AG Anne Milgram has launched an investigation into whether the manufacturer, of West Chester, Pa., properly disclosed the financial interest of the surgeons involved in the research.

Milgram has subpoenaed documents from Synthes, as well as venture capital firm Viscogliosi Brothers, which provided initial funding for the development of ProDisc. Viscogliosi pulled the funding for the study, in part, by attracting investments from at least five of the physicians who took part in the study. Each invested between $100,000 and $250,000 in a fund operated by Viscogliosi. However, those investments were not adequately disclosed to patients participating in ProDisc clinical trials, according to some reports.

To learn more about the investigation:
- read this Modern Healthcare piece (req. req.)

Related Articles:
Conflict questions raised in spinal disc study. Report
Cardiac surgeon faces conflict-of-interest challenge. Report
Feds charge researcher over Pfizer consulting fees. Report
Physician-owned hospitals: A conflict of interest? Report
Cleveland Clinic to change conflict of interest policies. Report

Conflict questions raised in spinal disk study

Wed, 30 Jan 2008 06:59:57 -0500

Observers are raising tough challenges to a newly-released spinal disk study that suggests an artificial spinal disk, Prodisc, works better to improve patient functioning than conventional spinal-fusion surgery. Critics say that the fact that many physicians involved had a financial interest in the study's outcome makes this conclusion questionable. They also point to the fact that in study results submitted to the FDA, an unusually large number of patient results were not included, and some of those patients didn't do well.

The way the study was structured, doctors at about half of the 17 research centers involved in the study stood to make money if the Prodisc became a commercial success, according to information from a patient lawsuit which was settled last year. Surgeons interviewed by The New York Times contend that the financial potential of Prodisc had no impact on their research, and note that their findings were published in peer-reviewed medical journals. However, according to the Times, it's not clear whether the disk's maker, Synthes, met its legal obligation to let the FDA know about the researchers' financial interest before the agency approved the disk.

To find out more about this issue:
- read this article in The New York Times

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Cleveland Clinic to change conflict of interest policies. Report

UPMC plans rollout of drugmaker relationship limits

Mon, 12 Nov 2007 06:59:56 -0500

The University of Pittsburgh Medical Center is planning the rollout of a newly-tough conflict-of-interest policy which would greatly curtail traditional relationships between its providers and pharmaceutical companies. The new policy will not only set new rules for accepting drug samples, but will also restrict consulting deals, ban gifts from pharma reps and more. These changes would put UPMC on the cutting edge of a growing movement to limit pharma and device-maker influence on academic medical center campuses.

The new rules, which should become effective early next year, would set up a central facility to accept drug samples and distribute them to doctors--and reps wouldn't be allowed to visit clinical facilities unless they register with the administration. Reps that try to sidestep the rules and go straight to doctors could be banned from the campus for a year or more.

Other provisions of the new code would bar personnel from UPMC or is School of Health Sciences from accepting gifts from pharma reps, including tickets, food and even pens and note pads. Clinicians and others will not be able to accept industry-backed speaking engagements unless their fee is limited to a maximum of $2,500 and they present a balanced lecture. Also, Health Sciences personnel wouldn't be allowed to make consulting agreements with pharmas unless they were approved by a dean, department chair or administrator.

To get (a lot) more detail about UPMC's plans:
- read this Pittsburgh Post-Gazette article

Related Articles:
Henry Ford bans pharma perks, vendor drop-ins. Report
Stanford bans sales rep gifts to doctors. Article
UC Davis mulls pharma freebies ban. Article
"Let he who is without conflict-of-interest cast the first stone." Editor's Corner
Doctors reading FierceHealthcare weigh in on the pros and cons of accepting drug/device freebies is unethical. Things get pretty heated ... Letters
Group: Few med schools free of pharma influence. Report

Physician retail clinic protests miss the point

Thu, 28 Jun 2007 20:01:39 -0400

Physician retail clinic protests miss the point
Wow, the AMA is steamed about retail clinics. In my nearly 20 years of healthcare reporting, I can't think of an issue which has gotten members more worked up and ready to fight.

And the protests are all over the map. Apparently, retail clinics endanger patients. No, they endanger pediatric patients. They're not regulated enough. They have a conflict of interest in writing scripts their host retailer may fill. And so on. Why don't they just come out and say "It should be illegal to offer services we can't, at a price we can't?"

That being said, however, primary care practices are in an extremely unfair position. How many businesses have to contend with revenue streams which are as difficult to navigate, changeable and at risk for shrinkage as physicians? Given the challenges in coping with health plans--and limits on what plans will pay for--I'd argue that few practices are in a position to offer what retail clinics offer in terms of hours, convenience and flexibility. And it's just not their fault.

Here's an alternative. What if physician groups like the AMA stopped fighting the inevitable growth of the retail clinic sector and fought harder to foster financial situations that would allow PCPs to offer retail-clinic like options?

I'm thinking they could target government grants and loans at first, then probably, later, changes in reimbursement that explicitly acknowledge it's cheaper over the long term to pay for giving patients more access. (This way, a wheeze on Sunday won't turn into a hospitalized asthma patient on Monday.)

What do you think, folks? Is there any chance the primary care market could win support for building out its alternative to retail clinics? Or are the retail clinic operators serving a niche they'll never really be able to touch?- Anne

SPOTLIGHT: Are pharma relationship limits curbing research?

Mon, 28 May 2007 20:01:32 -0400

Are pharma relationship limits curbing research?
As pressure mounts to regulate physician relationships with pharmaceutical companies, some doctor have begun to push back, arguing that there are tangible, patient-friendly benefits to such relationships. Some say that conflict-of-interest rules are making legitimate medical research difficult. Article

Cardiac surgeon faces conflict-of-interest challenge

Mon, 18 Dec 2006 19:01:36 -0500

A University of Cincinnati researcher lured into town by a million-dollar private grant is under scrutiny by university and federal officials, dogged by charges that he failed to disclose a lucrative financial relationship with a medical device manufacturer. As a result of the controversy the researcher, Dr. Randall Wolf, has stepped down from his post as principal investigator of the heart device research program.

Dr. Wolf says that a recent FDA warning was triggered by confusion over two research projects, both which involved a procedure Wolf invented using a device created by manufacturer AtriCure. Wolf and his colleagues initiated one of the studies, which looked at how patients did after they received Wolf's procedure, while the other was a clinical trial sponsored directly by AtriCure. Wolf has substantial ties to AtriCure, which pays him royalties of $200,000 per year, plus providing him with stock options and monthly consulting fees. The FDA warning contends that Wolf failed to adequately disclose these ties during his retrospective study of patient outcomes.

OK, let me get this straight. So it's fine to have a researcher with stock in the company conduct a clinical trial of that company's device, but not to look into outcomes for patients he treated? Isn't something wrong with this picture?

Get more information on the conflict-of-interest issue:
- read this article from The Cincinnati Enquirer

Related Articles:
Feds charge researcher over Pfizer consulting fees. Report
Physician-owned hospitals: A conflict of interest? Report
Cleveland Clinic to change conflict of interest policies. Report

ALSO NOTED: NIH researcher pleads guilty; Nurse engagement key to quality; and much more...

Mon, 11 Dec 2006 19:01:30 -0500

> Former NIH geriatric psychiatry head Pearson "Trey" Sunderland pleaded guilty this week to violating conflict of interest rules. Sunderland had failed to disclose that he had accepted $285,000 in payments from Pfizer while serving as a researcher at NIH. Article

> Getting nurses deeply engaged with their work has an enormous impact on healthcare quality and safety, lowering rates of complications, mortality and infections, write two Gallup researchers. Article

> Aetna Behavioral Health has introduced a disease management program focused on improving the treatment of bipolar disorder. Article

> Consumers say they're not sure healthcare organizations are able to protect them against medical identity theft. Release

> Healthcare at Dallas County Jail found to be 'grossly inadequate' after 11 inmates die from poor medical care over the last three years. Blog

> Backers of a Virginia fund offering lifetime care for birth-injured babies put off a needed $140 million cash boost. Article

And Finally… Here's a fun trick: How a town father from the 17th century avoided taxes by running a medical practice. Blog