The Affordable Care Act: What’s the Right Thing to Do?

July 3, 2012 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

The United States Supreme Court finally rendered its ruling on 2010’s Affordable Care Act (ACA), finding that its so-called mandate was indeed constitutional, inasmuch as the government is free to place a tax on U. S. citizens. While many thought that resting on the power of the federal government to control interstate commerce was the legal approach to move this law forward, the justices deemed that while the mandate was not a valid use of this power, the government can impose any tax it deems appropriate.

Unfortunately, all of this amounts to jockeying by our duly-elected officials in Washington, as they play election-year political football with subject matter that is of critical importance to the citizens of this country. The nine justices are even getting into the election game by suggesting that the government’s insistence upon everyone being covered by some form of health insurance can be implemented by imposing a tax on those that refuse to abide by the law. This ruling, especially in the manner that Chief Justice John Roberts articulated his concurrence with the majority opinion, easily permits the Act to be used as a target in the coming election by having either party debate the issue of a tax. Almost everyone is missing the point of this and other reforms ... read more »


Predictions for Healthcare in 2012

February 21, 2012 · Leave a comment

Industry Insights from Paul Meade, M. Sc., MPH

While the Mayans might have been good at developing a cosmic calendar with 27,000-year cycles, I will try to venture only one or two years out and predict some developments within the healthcare system.

I dare say the Mayans had great foresight about changes, even if they never invented the wheel, but clearly they missed the fact that 2012 was an election year in the United States, and that predicting change became no mean task with orders of magnitude of difficulty. Nonetheless, I will attempt to gaze into my crystal ball and give my predictions for the next little while.

The promise of personalized medicine has been swirling around in the minds of brilliant people for well over a decade now, but we are patiently awaiting the results to impact our daily lives. Throughout the past 10-15 years, advances in the personalized medicine field have been somewhat slow to appear on the landscape. We should not be too discouraged by this advancing timeline, since we are still waiting for a cure for cancer after many decades of highly-funded research. Yet, each day, scientists are discovering more and more biomarkers with the potential to move us closer the reality of personalized medicine.

These biomarkers are not only predicting diseases—they are identifying companion diagnostics, indicating response levels to ... read more »


Thought Leader Select Announces Key Opinion Leader Assessments in Chronic Pain, Colorectal Surgery, and Gastroenterology

February 2, 2012 · Leave a comment

New Press Release from the Offices of Thought Leader Select

February 2, 2012 (Chapel Hill, NC) Thought Leader Select is pleased to announce a pair of key opinion leader (KOL) identification and profiling projects to support the development pipeline of a leading pharmaceutical client focused in the therapeutic area of gastroenterology.

In the first research assessment, Thought Leader Select will identify and profile leading medical experts in the treatment of patients suffering from non-cancer-related chronic pain.  The company will identify the leading pain experts throughout the United States by examining the skills and experiences of physicians in multiple disciplines and specialties, including gastroenterologists, primary care physicians, nurse practitioners, and physician assistants.

For the second research assessment, Thought Leader Select will identify and profile 100 key opinion leaders in colorectal surgery, as well as 125 KOLs in gastroenterology. The cumulative group of 225 physician thought leaders will share vast experience in research and treatment of fecal incontinence.

Thought Leader Select will use its validated, objective deep profiling methodology to assess the skills and experience of the thought leaders chronic pain, colorectal surgery, and gastroenterology in multiple research categories, including their areas of expertise, medical/scientific journal publishing history, and participation in basic and clinical research.  The company’s research group is comprised of subject-matter experts in medicine, with decades of experience working in ... read more »


The Sunshine Act: The Good, the Bad, and the Ugly

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 »


Clinical Trial Ethics

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 »


The Sunshine Act: Who Pays for It Anyway?

April 27, 2011 · Leave a comment

Industry Insights from Paul Meade, M.Sc., MPH

By now, just about everyone involved in healthcare has heard about the Sunshine Provision (also known as the Sunshine Act). Starting January 1, 2012, any U.S. drug or device manufacturer that provides compensation to a physician or medical institution for any kind of services rendered will have to report it to the government.
The reporting benchmark is any amount over $10 for any single event. This means that if a sales representative for a pharmaceutical company buys a sandwich for a physician’s lunch and it costs $9.95, it doesn’t have to be reported, but if the physician adds a bottle of water to the sandwich, bringing the total to $11.95, it will need to be reported. Is it really to report sandwiches? Of course not, but it will! It’s really for some of the “big ticket” items, like compensation for conducting clinical studies, consulting on the development of new products, speaking at small meetings to colleagues that are sponsored by a company, etc.
So who pays for collecting, capturing, analyzing, and reporting all this information, and what will all of this monitoring activity cost? Let’s start by determining the number of active physicians in the United States. Well, there’s a problem right off the bat! According to the World Health Organization (WHO), there are ... read more »


Paul Meade Accepts Invitation to Speak at AACE Annual Meeting

March 31, 2011 · 1 comment

March 31, 2011 (CHAPEL HILL, NC)—Paul Meade, the president and founder of Thought Leader Select, a Research Triangle, NC company focused on facilitating medical expert collaborations with the biopharmaceutical and other healthcare industries, has accepted an invitation to speak at the annual meeting of the American Association of Clinical Endocrinologists (AACE).

The 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists will take place from April 13-17 in San Diego, CA.  At the invitation of AACE President-Elect Dr. Yehuda Handelsman, Meade will speak during the annual Corporate AACE Partner (CAP) meeting, an opportunity for physicians and representatives from partnering companies, including biopharmaceutical and medical device firms, to learn about emerging topics in inter-industry collaborations in medicine.  

Meade’s speech, “Interactions in the Age of Transparency,” will outline a new path forward for even better industry collaborations with medical experts based on a foundation of ethics and transparency.  “I am honored to accept the invitation from Dr. Handelsman and the AACE,” stated Meade. “I have built my career on the basis of an unwavering commitment to ethics and transparency.  We have to remember that we’re all in this together—health care providers, researchers, and people from industry—to promote better health for everyone in this country.  If we always keep patients’ best interest in mind and work together is an open ... read more »


Should Doctors Be Paid By Drug Companies?

March 30, 2011 · 1 comment

Industry Insights from Paul Meade, M.Sc., MPH

Should doctors be paid by drug companies? Well, I guess that depends on the reason for the payment. If a physician, known for her expertise in a given area, is asked by a pharmaceutical company to determine if a newly discovered drug compound would meet a medical need in healthcare, then the answer is clearly yes. Likewise, if a patient consults with an orthopedic specialist on whether to undergo a surgical procedure to repair a damaged cartilage, that consultation is paid for by the person’s health insurance.

In any profession based on an individual’s expertise—think lawyers, management consultants–a person’s informed opinion usually commands some form of payment.  Also, the level of expertise generally dictates the level of compensation. So why is it that when a physician gives advice to a patient, or even a group of patients during a patient advocacy lecture, we all feel compensation is fair and just, but when that same person provides his or her expertise to a pharmaceutical company seeking to make a decision on whether to continue the development of a new drug, many people cry foul? Should pharmaceutical companies be forbidden to seek out and pay for the expertise and knowledge of physicians?

In order for a new medicine to become available to the general population, regulatory authorities demand ... read more »


When Should Politics Stand in the Way of Healthcare?

March 25, 2011 · Leave a comment

Paul Meade, M.Sc., MPH

Well, there’s an easy answer: NEVER! I could stop there and be content with “enough said,” but I would like to expand on my concerns for a minute. The Obama administration has made some noble attempts at healthcare reform, and they made some small gains despite the need for a “major” overhaul in healthcare delivery in the United States. By the time the bill was passed, many argued it had become too watered-down to pass the House and Senate. In the end, the victories were small in relative comparison to what was truly needed to get healthcare back on track in this country.

Now, this new healthcare law has become a political ping-pong ball for grandstanding antics among politicians in Washington. When did “We the People” become “Me the Politician?” Elected officials are supposed to represent their constituents, not their self-interests for their own political survival.

What would be in the best interests of the American people with regard to healthcare? Most Americans want access to affordable and effective healthcare. Much like the tagline seen at Target stores–“expect more; pay less”–that’s what we all want. Do we want to be constrained by our healthcare insurance to lifetime limits? Do we want to be denied coverage based on pre-existing conditions? Do we want to continue to pay more and more ... read more »


Transparency and the Sunshine Provision – Is This a Good or Bad Thing?

March 17, 2011 · Leave a comment

Industry Insights from Paul Meade, M.Sc., MPH

The Physician Payment Sunshine Provision is a part of the Patient Protection and Affordable Care Act passed by the U. S. Congress in March of last year. The provision will go into effect on January 1, 2012. Many people in the healthcare industry are struggling to determine if this provision is a good thing or a bad one. Truth be told, it is a bit of both—good, in that it ensures complete transparency among health care providers and manufacturers of pharmaceuticals and medical devices, and bad, because it may expose the benefits some healthcare professionals gain from interacting with some manufacturers.

For years, healthcare professionals have been interacting with manufacturers in many ways; when providers offer their professional services, they expect and receive compensation for their time and knowledge, as would experts in any other industry. Every industry has its experts, and healthcare is no exception. There are healthcare experts in a variety of functional areas and in all therapeutic areas. These experts have medical information and knowledge that is valuable to healthcare manufacturers as they develop and commercialize their products and services. Acting as consultants to industry manufacturers, experts offer guidance in the development of new products, from determining unmet medical needs to suggestions on how to price new products.

Is it fair to compensate ... read more »


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