June 16th, 2010

• Industry Employees May Not Be Allowed to Speak at the AHA
• New-Generation Stent Tested
• BMS Versus DES for STEMI

Industry Employees May Not Be Allowed to Speak at the AHA: Industry employees may no longer be allowed to speak at the AHA scientific sessions and other CME-accredited events, according to an article by John Fauber in the Milwaukee Journal Sentinel. The ruling by the the Accreditation Council for Continuing Medical Education (ACCME) is being appealed by the AHA. The ruling was harshly condemned by NIH Director Francis Collins and other biomedical leaders.

New-Generation Stent Tested:
 In the Resolute All Comers Trial, Patrick Serruys and colleagues randomized 2,292 PCI patients to either the Resolute zotarolimus-eluting stent or the Xience V everolimus-eluting stent. At 12 months, the rate of target lesion failure was 8.2% in the Resolute arm and 8.3% in the Xience V arm, thereby demonstrating noninferiority of the new Resolute stent (P<0.001 for noninferiority). There were no significant differences in death from cardiac causes, MI, or revascularization between the two groups. Stent thrombosis occurred in 2.3% of the Resolute group compared to 1.5% of the Xience V group (P=0.17).

A key feature of the trial is that it enrolled many patients excluded from previous stent trials, such as those with coexisting illnesses, acute MI, and multivessel disease. In their report in the New England Journal of Medicine, the investigators conclude that “the new-generation zotarolimus-eluting stent was found to be as safe and effective as the everolimus-eluting stent in a group of patients for whom the procedure was considered to be predominantly off-label.”

BMS Versus DES for STEMI:
 Kaltoft and colleagues randomized 626 STEMI patients to a drug-eluting or a bare-metal stent. At 3 years, the rate of major adverse cardiac events was 11.5% in the DES group versus 18.2% in the BMS group (P=0.02). Although there was no difference in all-cause mortality, there was a significant difference in cardiac death (6.1% for DES vs. 1.9% for BMS, P=0.01). In their report in the Journal of the American College of Cardiology, the investigators observe that “the very low cardiac mortality rate in our BMS group is hard to interpret, and the excess cardiac DES mortality should be interpreted accordingly and might have occurred by chance.”

2 Responses to “• Industry Employees May Not Be Allowed to Speak at the AHA
• New-Generation Stent Tested
• BMS Versus DES for STEMI”

  1. little benefit and possible harm?

    Since industry employees make up such a small proportion of presenters at conferences — and also provide a rare window into what type of science is being conducted within that sphere — it doesn’t seem clear what benefit this ban would overall achieve…

  2. Doctor paid by the company is in position of industry employee

    Industry employees should have their say in what has to do with industry itself. No other speakers can better explain what they have devised than themselves (either drugs or devices). They should be allowed to refer to particulars limited to a drug (e.g., drug disposition, drug interactions, adverse effects and mechanism of action…) or a device (e.g. pacemaker interrogation, the type of sensors, longevity…). Industry employees should not substitute doctors of medicine in expounding on pathology of disease and how to treat any disease. This task is for those practising medicine and its research. Doctors involved in this process just declare conflicts of interest, but they are truly „industry employees“. Are they not the persons who should be banned from speaking in conferences? Distinction between doctor and industry employee is difficult to set. I have an idea to solve this problem. Each trial should be conducted by two groups – investigators with ensuing conflicts of interests (doing their job for the company, paid by the company and therefore in position of industry employees) and independent surveyors without conflicts of interest (paid by independent organisation e.g. ACC or national institute of health, that would get the money from the company). Though this would entail bigger costs for the company, the results of the trial would be made unbiased in this way. Drug or device companies could publish their reports only when the trial has been conducted this way. Another step to be taken is to ask some money for basic research or the research to solve practical issues since a lot of practical questions in medicine is to be answered and lack of money is the obstacle.
    Doctor of medicine has but one of two choices – either to embark a career of investigator and hold the position industry employee or to hold the position of independent doctor without conflicts of interest.