October 14, 2011 ·
Leave a comment
Industry Insights from Paul Meade, M. Sc, MPH
The Sunshine Act is on the horizon, and all we know for certain is that things will be different. Will the changes be good, bad, or ugly for healthcare and the biopharmaceutical industry? Well, a bit of all three. But it is a bit like the Y2K scare, or the coming of the end of the world in December 2012 predicted by the Mayans—people in healthcare and biopharma are on alert, and no one really knows for certain how this will all play out.
Let’s start with the good, since there will be greater transparency in the interactions between manufacturers and physicians. The intended outcomes will be greater standards of remuneration for services rendered by healthcare professionals to various manufacturers, some defined threshold limit of activities (type and quantity) deemed permissible by institutions for their affiliated physicians, and a greater sense of awareness of the interactions between healthcare professionals and manufacturers, presumably by a concerned public.
With regard to the first outcome, it is hoped that some kind of industry standard for Fair Market Value will be established for the activities physicians are often engaged in when dealing with manufacturers. It will likely serve to “level the playing field,” so some manufacturers will not pay excessively for a given activity, such as consultative services. As ... read more »
TAGS: 
academic institutions biopharmaceutical industry centers of excellence clinical studies fair market value healthcare healthcare innovation innovation in medicine key opinion leaders media witch hunt medical community medical ethics medical experts Paul Meade pharmaceutical companies pharmaceutical manufacturers Physician Payment Sunshine Provision physicians public scrutiny of pharmaceutical industry public trust remuneration scientific advisory boards scientific community scientific conferences Sunshine Act Thought Leader Select thought leaders transparency US healthcare legislation US healthcare regulations Y2K
July 7, 2011 ·
2 comments
Industry Insights from Paul Meade, M. Sc, MPH
According to an article published in the Archives of Internal Medicine, Dr Joseph Ross claimed a study conducted by Parke-Davis, before it was acquired by Pfizer, using gabapentin (Neurontin), as the drug under investigation, appeared to be a “seeding” trial. And while the author states that seeding trials are not illegal, he states that they are unethical. There are really two separate issues at stake here: first, what is really an unethical trial, and second, what is really a “seeding” trial?
About 25 years ago, when a pharmaceutical company launched a new drug and wanted to get as many physicians as possible to have some experience in using this drug for appropriate patients, they would provide samples packaged in a box to resemble supplies you might receive if you were a clinical investigator. There would be cards to report on one’s experience with the new drug, such as efficacy and side effects. But these sample cards were rarely collected and reported back to the head office. The goal was really to have physicians become familiar with this new drug, and for their own information record some information. These were not formal clinical trials, not required by the regulatory authorities, and did not need the scrutiny of an Institutional Review Board. These ersatz trials became ... read more »
TAGS: academic institutions Archives of Internal Medicine clinical investigators clinical trial clinical trial data collection clinical trial design clinical trial protocol Dr Joseph Ross drug efficacy drug samples drug side effects drugs ethical review committees ethics in healthcare gabapentin healthcare hospitals institutional review board marketing trial medical ethics Neurontin Parke-Davis patients Paul Meade Pfizer pharmaceutical Phase IV clinical studies physician behaviors physicians prescribing habits of physicians sample cards seeding trial surveillance studies Thought Leader Select
January 6, 2011 ·
6 comments
The International Diabetes Federation Atlas (http://www.diabetesatlas.org) reports that 285 million people aged 20-79 years globally have diabetes, a disease impacting most countries. According to the Centers for Disease Control (CDC) 2007 National Diabetes Fact Sheet, diabetes affects 23.6 million people or 7.8% of the U.S. population. It is no wonder, then, that millions of dollars are spent every year to fund research that will treat and perhaps cure the disease.
Certainly, endocrinologists and a host of other specialty physicians participate in basic and clinical research sponsored by government entities, academic institutions, professional societies and biopharmaceutical companies. However, primary care physicians (PCPs) are also widely involved in diabetes research. The diversity of patient populations and illnesses treated by PCPs make them desirable investigators, especially when the research seeks to understand diabetic co-morbidities, how the disease affects different populations, and better ways to help patients manage their diabetes.
Thought Leader Select recently studied the research activities of more than 150 primary care thought leaders (TLs) in the United States and identified several interesting trends about their research activities in general, as well as those related to diabetes research. We found that 86% of primary care TLs are regularly involved in basic and clinical research efforts. Of those 134 actively conducting research, more than half are involved in diabetes-related projects (see Chart 1). More ... read more »
TAGS: academic institutions basic research biopharmaceutical cardiovascular risk CDC Centers for Disease Control chronic disease management clinical research diabetes East Harlem Diabetes Center of Excellence endocrinologists glycemic control International Behavioral Research in Diabetes Group Exchange International Diabetes Federation Atlas key opinion leaders KOL engagement KOL identification KOL profiling KOLs Massachusetts General Hospital Diabetes Clinical Research Center Michigan Diabetes Research and Training Center National Diabetes Fact Sheet obesity patients PCPs pharmaceutical biotechnology physicians primary care physicians professional societies thought leaders type 2 diabetes University of Chicago Diabetes Research and Training Center University of Texas Health Science Ceneter of San Antonio Diabetes Studies VA Quality Enhancement Research Initiative for Diabetes Mellitus Vanderbilt Diabetes Research and Training Center
July 27, 2010 ·
Leave a comment
Industry Insights from Paul Meade, M. Sc, MPH
Academic institutions across the United States are placing physicians affiliated with those institutions under an “industry capitation.” What this essentially means is that there are limits to what such physicians can accept from biopharmaceutical companies for services rendered to those companies.
In other words, a physician working with an academic medical institution can only accept a specified amount of remuneration from a biopharmaceutical company for participating in company-sponsored activities, such as advisory boards, speaking engagements, consultative sessions, and travel reimbursement to scientific conferences. Therefore, when an internationally renowned thought leader reaches that maximum allowable limit, he can no longer provide any consultative services for the company.
What’s next? Deciding how many automobiles a thought leader can personally own? Limiting the number of secondary residences a physician can purchase? Deciding which companies they are permitted to work with?
To be sure, an academic institution wants to establish some ethical rules for their affiliated physicians and have some reasonable assurances that these physicians do not compromise their objectivity by exhibiting a conflict of interest, especially one that appears in the front page of a nationally recognized newspaper. But where do you draw the limits? Who decides what the right amount of remuneration is for services rendered for a known thought leader interacting with a biopharmaceutical company?
As long as ... read more »
TAGS: academic institutions academic medical centers advisory boards biopharmaceutical biotechnology captitation consultation key opinion leaders medical devices medical ethics pharmaceutical physicians scientific conferences speaking engagement thought leaders United States
