March 27, 2012 ·
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Industry Insights from Kristen Smithwick
Albeit a bit late, the U. S. Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on the Patient Protection & Affordable Care Act’s Physician Payments Sunshine Provision (also known as the “Sunshine Act”) to implement it as law.
CMS invited comments on the proposed rule through mid-February 2012, and a recent webcast, sponsored by PharmaLive’s Pharmalot, featured key facts and summaries of comments on the proposed rule. Working for a provider of research and consulting to the biopharmaceutical, medical device, and diagnostics industries on relationships with physicians and other health care providers, I enjoyed the opportunity to join the webcast, led by experts from Buchanan Ingersoll & Rooney, P.C., and am eager to share some of my key takeaways.
As mentioned in previous Thought Leader Select Blog posts, the Sunshine Act, as with many laws and regulations, is full of unintended consequences – some positive and some negative. Lance K. Stell, medical ethics teacher at Davidson College and Carolinas Medical Center, reports in his USA Today op-ed piece that the “Sunshine Act will cost far more than the $224 million estimated for just the first year of compliance” and that “the biggest cost will be the valuable, socially useful physician-industry collaborations that simply won’t occur.” Of course, the idea of ... read more »
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AdvaMed BIO biopharmaceutical biotechnology Buchanan Ignersoll & Rooney CMS Davidson College Carolinas Medical Center diagnostics HCP payments health care providers Kristen Smithwick Lance Stell medical device medical ethics OTC manufacturer Patient Protection and Affordable Care Act pharmaceutical PharmaLive Pharmalot PhRMA Physician Payments Sunshine Provision physicians Sunshine Act Thought Leader Select Thought Leader Select Blog US Centers for Medicare and Medicaid Services veterinarians veterinary schools
December 22, 2011 ·
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Clients and Friends,
After another successful year, we wish you a holiday season filled with joy and fun times with family and friends.
The month of December causes many to reflect on the successes and challenges they have experienced throughout the year, and we’re no different. In any business, you win some and you lose some, but we find ourselves very thankful for all of the new friends we’ve made this year and the times we’ve shared with old friends, too.
Our work remains more fulfilling than ever, even with the constant ratcheting of regulation and legislation in the industry we serve. This increasing scrutiny demands that we bring our “A game,” keeping our clients ethical and compliant in all that they do with thought leaders and centers of excellence.
We hope all of you, as you take time to reflect this year, have as many reasons to be thankful as we do. We are grateful for your business, your friendships, and your continued faith in us.
Happy Holidays from all of us at Thought Leader Select.
TAGS: centers of excellence compliance healthcare legislation healthcare reform healthcare regulations Holidays key opinion leaders medical ethics Thought Leader Select thought leaders
October 21, 2011 ·
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Company News
Thought Leader Select announces the delivery of a multi-specialty key opinion leader assessment in aging. The firm, based in Chapel Hill, North Carolina, was retained by a top 10 global pharmaceutical company to assess the skills and experiences of physicians specializing in the treatment of the following diseases and conditions that primarily affect the over-65 population:
• Chronic Pain
• Osteoarthritis
• Alzheimer’s Disease
• Parkinson’s Disease
The company will be collaborating with a host of medical experts to gain further development of a portfolio of new medicines in these areas. Thought Leader Select has identified key opinion leaders in each of these areas in order to reach a roster of 100 U.S. key opinion leaders in diseases and conditions affecting the senior population.
“We are very pleased that this company has chosen to work with us on this fascinating project,” stated Neil Mellor, Thought Leader Select’s global business development consultant. “They chose us because they wanted to do two things—work with skilled physicians who have high quality, relevant experience in treating the aging population in the U.S., and they wanted to do that in the most compliant manner possible. Our validated, objective methodology, in-depth profiling, ensures that they will be working with the right physicians at the right times for the right reasons.”
TAGS: aging Alzheimer's disease biopharmaceutical company chronic pain in-depth KOL profiling key opinion leader assessment key opinion leaders KOLs medical ethics medical experts medicine Neil Mellor objective research osteoarthritis Parkinson's disease pharma compliance pharmaceuticals physicians scientific experts Thought Leader Select Thought Leader Select company news thought leaders
October 14, 2011 ·
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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 ·
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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
July 27, 2010 ·
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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
June 17, 2010 ·
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Industry Insights from Paul Meade, M. Sc, MPH
A recent decision by the Accreditation Council for Continuing Medical Education to not allow scientists employed by pharmaceutical, diagnostics, and devices companies to give educational presentations to physicians at medical meetings has “stirred up a bee’s nest.” In other words, if you graduated from an accredited university, conducted sound research within academia for several years, then joined a pharmaceutical company to carry on your research and were invited to a scientific congress to present your research findings to physicians, you are now being banned to do so because your work might be tainted and biased by your employer. Instead of addressing concerns of biased reporting or misrepresentation of the facts, the ACCME has decided to “throw the baby out with the bath water.”
I have known brilliant scientists who have spent their lifetimes conducting impeccable research within the halls of academia, only to be asked to come into the private sector to complete their research. Is the ACCME now saying those dedicated individuals have “sold their souls to the devil” and suddenly lost all integrity and objectivity? Have there never been researchers within academia that have falsified their data for personal gain and been exposed to the public? Should we ban all researchers in academic centers from presenting their research to physicians at ... read more »
TAGS: academia ACCME Accreditation Councile for Continuing Medical Education bioethics biotechnology continuing medical education ethics medical ethics medical researchers pharmaceutical physicians research findings scientific congress scientists transparency universities
June 10, 2010 ·
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Key opinion leaders (KOLs) are health care leaders who make a high-impact footprint while advancing medical science. Thought Leader Select specializes in delivering objective, validated data on the skills and experiences of KOLs, so that pharmaceutical companies can seek their appropriate advice and guidance in the development of new medicines.
Thought Leader Select measures many areas where KOLs leave their respective marks in the medical community, including conducting clinical research studies, publishing articles in leading journals, and presenting breakthrough knowledge at scientific conferences.
In a recent assessment of over 300 North American specialists in atrial fibrillation, Thought Leader Select measured the frequency of these global key opinion leaders’ respective participation in regulatory and reimbursement activities. Using keywords to link these KOLs with such activities covering a six-year period, Thought Leader Select found that only 50 of the 300 physicians had any significant, relevant experience related to regulatory and reimbursement issues, such as participation on Pharmacy and Therapeutics Committees, FDA Advisory Boards, etc.
While the overall pool of 300 medical experts in atrial fibrillation showed significant diversity in skills and experience in a variety of areas, there are only a small number of these experts that have any experience in regulatory and reimbursement issues. Pharmaceutical companies wishing to seek consultative advice from these highly specialized thought leaders need to find effective ways to differentiate ... read more »
TAGS: atrial fibrillation biotechnology clinical research studies clinical trials drug development FDA FDA advisory boards health care providers healthcare reimbursement key opinion leaders KOLs medical ethics medical journals medicines Payer KOLs pharmaceutical pharmacy and therapeutics committees physicians regulatory agencies scientific conferences Thought Leader Select transparency US Food and Drug Administration
June 9, 2010 ·
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Cammie Brannan joined Clear Point Health and Thought Leader Select as a research associate in 2005. In her current role managing thought leader relations at Thought Leader Select, Cammie works directly with physicians and other health care professionals to ensure the accuracy and integrity of the data for each key opinion leader assessment. Cammie spent a decade working in accounting and financial management, earning a reputation as a leader in compiling data and optimizing its presentation for decision-makers in a variety of industries. Prior to joining Thought Leader Select, Cammie worked for a North Carolina firm that provided research and consulting services to the pharmaceutical industry, with emphasis on the drug-naming process.
The Thought Leader Select Blog sat down with Cammie to discuss her industry experience and her professional contribution to Thought Leader Select.
TLS Blog: Good morning, Cammie. Why did you join Thought Leader Select?
Cammie Brannan: I had been doing contract market research for a company in Raleigh, NC. We specialized in all of the aspects of naming new pharmaceutical products—market research, market testing, etc. I interacted quite a bit with health care professionals—we surveyed them.—gaining their valuable feedback on potential new names for drugs. For instance, were the names appealing, memorable, and would they be confused with other products on the market. It was a pretty interesting business.
While I was ... read more »
TAGS: accounting Asperger's syndrome biotechnology Cammie Brannan Clear Point Health data optimization drug naming financial planning fishing health care professionals key opinion leaders KOL engagement KOL identification KOL profiling KOLs Laura Nufire Lisa Smith medical ethics medical experts music nurse practitioners nurses Paul Meade pharmaceutical physician assistants physicians research surveying thought leader relations Thought Leader Select thought leaders transparency
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