Friday, June 22, 2007

Hear No Evil? - Conflicts of Interest Affecting Research on Hearing Loss

The Wall Street Journal today carries a report on research on occupational hearing loss carried out by Prof William W Clark of the Department of Otolaryngology of the Washington University School of Medicine. Prof Clark has studied hearing loss in a variety of occupational settings, often finding little evidence for this problem. For example, he has studied fire fighters.

Thousands of firefighters ... have sued the maker of the sirens, contending they caused hearing loss.

A study ... [Dr Clark] published in 2005 concluded that 'firefighters are not at risk for occupational noise-induced hearing loss, even though they work nonstandard shifts and are occasionally exposed to high levels of noise.'

The siren manufacturer, Federal Signal Corp., told a court the study 'directly refutes plaintiffs' argument that siren noise exposure causes hearing loss in firefighters.'

What the study didn't mention was that Dr. Clark was a paid expert for the company helping it with its litigation at the same time as he was doing his research. Not only that, but the company gathered data that were the basis of the study.

Readers of Dr. Clark's study, which ran in Ear & Hearing Journal, were told only that the researcher 'has provided consulting services for manufacturers of emergency firefighting equipment.' There was no mention that such a manufacturer was being sued for causing hearing loss.

Dr Clark has also studies hearing loss in railroad workers.

Union Pacific railroad ... was defending a slew of suits claiming trainmen were losing their hearing from noise.

In 1989, ... [Dr Clark] published a peer-reviewed article concluding that 'trainmen are not typically exposed to hazardous occupational noise.'

After its publication, cases began to be settled on less-generous terms, according to affidavits from rail workers and the railroad. They were settled for 80% less, on average, than before the Clark study appeared.

The journal that published the trainmen report, called Laryngoscope, didn't disclose that Dr. Clark was consulting for Union Pacific. Dr. Clark says it didn't require such disclosure. Laryngoscope says it doesn't know what its disclosure policy was in the late '80s.

[Dr Clark] also ran a 'hearing hotline' for Union Pacific workers that, among other things, counseled them on results of their hearing tests.

To run the railroad's hearing hotline, Union Pacific paid $850,000 to a partnership of Dr. Clark and his co-author of the railroad hearing-loss study, according to a deposition Dr. Clark gave in Cook County, Ill., Circuit Court.

Dr Clark also studied hearing loss in miners.

In 1997, the U.S. Mine Safety and Health Administration was considering tougher noise guidelines. An industry group called the National Mining Association hired Dr. Clark to do a critical analysis of another federal body's noise data. He testified before the mine agency against tougher guidelines.

Two years later, Dr. Clark published a study concluding that miners did not have significant occupational hearing loss. The study was done "at the request of the National Mining Association," he acknowledged in the article. He didn't mention that the association had paid him as a consultant.

This is a reminder that conflicts of interest affecting medical researchers are not limited to those due to their financial relationships with pharmaceutical, biotechnology, and device manufacturers. In this case, the conflicts were generated by financial relationships a medical researcher had with a manufacturer of sirens, a railroad, and a mining trade association.

In all cases, though, such conflicts throw doubt on the interpretation of the resulting research. One wonders whether conclusions of research studies done by researchers with conflicts, particularly conflicts that are not clearly disclosed, may have been influenced by the relevant financial relationships, and thus to what extent the research should not be trusted. The questions raised by such conflicts are almost impossible to answer unless one can find clearly unconflicted research that addressed the same question.

This just expands the rationale for what we have said before: pervasive conflicts of interest in health care make figuring out what is best for patients even harder. And this just strengthens our previous argument that physicians, other health care professionals, and leaders of health care organizations should rid themselves of conflicts of interest that might influence their professional, academic, or research work on behalf of patients or public health.

1 comment:

Anonymous said...

Ear and Hearing editors rebuke Dr. William Clark for failing to disclose conflicts of interest:


Medical Journal Rebukes Researcher
September 12, 2008; Page B3

The Ear & Hearing journal has rebuked a Washington University researcher for failing to disclose that he was working as a paid expert for a siren manufacturer when he published a study saying firefighters weren't at risk for job-related hearing loss.

The journal chastises William W. Clark, a hearing scientist at the university's medical school in St. Louis, in a lengthy editorial note. Such rebukes are unusual in medical journals but signal a growing concern with ensuring that researchers fully disclose any potential conflicts of interest.

Dr. Clark's ties to the siren company, Federal Signal Corp., were detailed in a front-page article in The Wall Street Journal in June 2007. (See previous article on William W. Clark)

Dr. Clark had reported to the medical journal that he "has provided consulting services for manufacturers of emergency firefighting equipment." He didn't disclose that he was a paid expert helping Federal Signal defend itself from lawsuits by firefighters with hearing problems. Federal Signal told a court that the study by Dr. Clark "directly refutes plaintiffs' argument that siren noise exposure causes hearing loss in firefighters."

Dr. Clark, in a letter accompanying the editors' note, said he did nothing wrong and "fully met the requirements of the journal at the time of submission in 2004." The study was published in 2005.

The editors, however, said his disclosure was "incomplete and misleading." They said Dr. Clark's specific work for Federal Signal, of Oak Brook, Ill., should have been disclosed.

In addition, the editors said Dr. Clark should have disclosed that the company and a law firm defending it in the firefighter cases helped with his research.

Federal Signal gathered data from fire departments for Dr. Clark, according to court records. Dr. Clark said in a deposition that he welcomed the company's help because he "did not have the time, or the energy, or the resources to try and talk every fire company in the country into participating in a study."

Dr. Clark also has said in an interview that he had suggested to Federal Signal that it hire Thomas Jayne, a lawyer he had worked with on previous cases, to defend the firm against lawsuits from firefighters. Invoices show that from 2000 through at least 2004, Mr. Jayne and Dr. Clark frequently discussed the hearing study in progress. In August and September 2003, Mr. Jayne billed Federal Signal for eight sessions with Dr. Clark. Several invoices indicate the lawyer was reviewing a draft of Dr. Clark's proposed research article. In 2004, Mr. Jayne billed for time to "review comments of reviews re Clark article," according to one invoice.

Mr. Jayne couldn't be reached to comment Thursday.

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