Don't ask, don't tell: Financial disclosure lacking in literature on stents

Most published research about coronary stents does not reveal information about authors’ financial relationships that might bias their interpretation of scientific data, according to researchers at Duke University Medical Center.

Coronary stents are the basis of a multi-billion dollar industry, yet the scientific community remains divided over if, when and how they should be used.

Dr. Kevin Weinfurt, a member of the Duke Clinical Research Institute, tracked every article written about stents in biomedical literature in 2006. He found 746 articles written by 2985 authors in 135 journals. Eighty-three percent of those articles did not contain any disclosure statements at all.

Weinfurt says he was astonished by the extent of the problem.

“We actually did our own, informal Internet search on authors who expressly stated they had no interests to disclose and found that some of them held membership on stent manufacturers’ advisory boards, or were consultants for stent makers and companies that made drugs related to stent use. One person had even founded a company that made stents, and yet had not disclosed that information,” says Weinfurt.

The study appears in the online journal PLoS ONE.

Weinfurt says the study results are troubling because disclosure and transparency in research reports may be more important than ever. While two respected professional organizations representing medical editors’ interests – the International Committee of Medical Journal Editors and the World Association of Medical Editors – encourage disclosure of authors’ financial interests, Weinfurt notes that some journals don’t ask for the information and some authors don’t volunteer it.

When potential conflicts aren’t reported, policy makers and the public lose their trust in medical research, says Weinfurt. This may be especially critical for those seeking trustworthy information about potentially life-saving devices, like coronary stents.

Stents are flexible metal tubes inserted into coronary arteries that help maintain healthy blood flow, often used in the wake of a heart attack. There are basically two types of stents: bare metal stents and drug-eluting stents, and the medical and scientific communities have been debating for years over which may be superior.

Weinfurt says that researchers’ statements about the efficacy and propriety of stents are closely evaluated because they directly affect not just stent makers, but also products that support stents and companies that produce alternatives to stents.

But he adds that they found little consistency in how author disclosures are made. “We feel this is symptomatic of a systemic problem that leaves patients and health care professionals with big gaps in knowledge and the inability to properly interpret important information,” says Weinfurt.

Researchers found that a total of 168 authors had a disclosure statement in at least one article. Five companies were cited as the most frequent source of support: Johnson & Johnson, Boston Scientific, Medtronic, Sanofi-Aventis and Bristol-Myers Squibb, with support most often given in the form of research support (25 percent), speaker fees (17 percent) and consulting (15 percent).

The study did contain one upbeat note, however. The researchers found that there was generally greater author disclosure in the more highly respected journals and in those that endorsed the International Committee of Medical Journal Editors’ guidelines for manuscripts submitted to medical journals.

Dr. Robert Califf, director of the Duke Translational Medicine Institute, vice chancellor for clinical research at Duke and senior author of the study, says the findings point to the need for an Internet-based national repository of information – something analogous to the Web’s clinicaltrials.gov for trials registration.

“We can’t really tell if the problem resides with the authors or the journals, but it’s likely a systems problem. A common repository of industry interactions could be a standardized source of conflict of interest information for all purposes,” he says.

Source: Duke University Medical Center

Related stories:

Drug-releasing stents linked with decrease in procedures to unblock coronary arteries
The widespread adoption of the use of drug-releasing coronary artery stents into routine practice is associated with a decrease in the need for repeat procedures to unblock coronary arteries and also do not appear to increase the risk of death, compared to bare-metal stents, according to a study in the June 25 issue of JAMA.
Landmark study reveals superiority of bivalirudin in heart attack patients at 30 days
The Cardiovascular Research Foundation (CRF) announced today that the New England Journal of Medicine published results of the HORIZONS AMI trial which showed the use of the anticoagulant bivalirudin following angioplasty in heart attack patients reduced net adverse clinical events by 24 percent compared to the standard treatment, as well as reduced the risk of overall mortality by 33 percent and cardiac mortality by 38 percent.
Bypass not to blame for heart patients' mental decline
Heart patients often experience lasting problems with memory, language, and other cognitive skills after bypass surgery. However, these problems aren’t caused by the surgery itself or the pump used to replace heart function during surgery, a new study by Johns Hopkins researchers suggests. The findings may lead to better approaches to prevent cognitive decline regardless of which treatment heart disease patients receive.
MIT crafts bacteria-resistant films
Having found that whether bacteria stick to surfaces depends partly on how stiff those surfaces are, MIT engineers have created ultrathin films made of polymers that could be applied to medical devices and other surfaces to control microbe accumulation.
Boosting 'mussel' power: New technique for making key marine mussel protein
Researchers in Korea report development of a way to double production of a sticky protein from marine mussels destined for use as an antibacterial coating to prevent life-threatening infections in medical implants. The coating, produced by genetically-engineered bacteria, could cut medical costs and improve implant safety, the researchers say. Their study is scheduled for the June 6 issue of ACS’ Biotechnology Progress.
Drug-releasing stent shows promise for improving outcomes in patients with coronary artery disease
For patients who underwent angioplasty to open narrowed coronary arteries, the use of stents releasing the drug everolimus reduced the rate of renarrowing of the arteries and significantly reduced the risk of major cardiac events, compared to the widely-used paclitaxel-releasing stents, according to a study in the April 23/30 issue of JAMA.
It's neck-and-neck down the long stretch for 2 stroke-prevention procedures
Like horses running down the long stretch of a race track, two different artery-opening treatments appear to be running neck-and-neck when it comes to preventing stroke among people with clogged neck arteries and other health problems.
The Lancet publishes first clinical trial data of a fully bioabsorbable drug-eluting stent
Data published today in The Lancet from ABSORB, the world’s first clinical trial of a fully bioabsorbable drug eluting stent for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations (re-treatment of a diseased lesion), and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year.

News discussion:

Medicine & Health news