When the Human Genome Project was finally completed with the mapping of the genetic sequences of our DNA, there were many predictions about how the face of medicine would change forever. We would finally figure out how to cure diseases linked to genetic aberrations, find ways to enhance our interaction with the environment, and develop medicines that are tailored to fit our unique genome. But a decade later, we are all aware of just how painfully slow progress has been to date. However, one area that is advancing steadily is the use of companion diagnostics.

Everyone was quick to point to Herceptin and the prototype example of a diagnostic test that was required to be use prior to prescribing this chemotherapeutic agent for women with breast cancer that over-expressed the HER2/neu gene. But now there are more examples of such companion diagnostics, and the list continues to grow.

What does all this mean for the future of medicine, and the interaction among the diagnostic and biopharmaceutical companies? When we can go to a physician’s office, be correctly diagnosed, and then given a medicine to take knowing in advance that we will have a high probability of responding, without suffering from annoying side effects, then we will have personalized medicine.

Does that mean that people will have their own “designer” drugs specific to their unique genome? No, of course not. But it does mean that based on your similarity to a known genetic type, or genotype, your response to the medicine will be highly predictable, and therefore “personalized” to your specific needs. Thus, many drugs introduced in the future will have a unique companion diagnostic that will inform a specific response, and the cost benefit of taking such a drug will increase tremendously. As the old saying goes, “the most expensive drug in the world is the one that doesn’t work!”

Does that mean that companion diagnostics will be forever married to new therapeutic agents? Not really. As our knowledge of population genetics expands, and our characterizing of many different genotypes increases, we will likely get to the point whereby known genotypes will be mapped to known therapeutic agents, and the need for each new product to have its own companion diagnostic will diminish with time. But until then, expect to be given both a test and a prescription when you are treated at your nearby physician’s office. The road from general to personalized medicine is a long one that will take a great deal of research. But once we get there, the administration of medicines will gain a huge leap forward in effectiveness and efficiency.

Within each medical discipline, certain physicians regularly advise government regulatory agencies and public and private insurers on which therapies meet unmet medical demands and have the lowest risk for adverse reactions as well as provide input into reimbursement considerations. Each key opinion leader (KOL) assessment conducted by Thought Leader Select includes an examination of KOL engagement in regulatory and reimbursement activities.

In an ongoing assessment of nearly more than 150 HIV key opinion leaders across the globe, Thought Leader Select has analyzed their participation in regulatory and reimbursement activities. Using keywords to link these KOLs with such activities, Thought Leader Select found that 33% of physicians regularly provide input into regulatory and reimbursement decisions. The 53 KOLs with regulatory and reimbursement involvement are split nearly in half according to their participation in general or HIV-related activities (see Chart 1). However, the majority of Thought Leaders studied are involved in public reimbursement efforts (see Chart 2). Common regulatory and reimbursement groups among studied KOLs include:

• European Medicines Agency (EMEA).
• Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS).
• The London Consortium.
• Food and Drug Administration (FDA).
• Italian Medicines Agency (AIFA).
• British National Formulary.
• Brazilian Ministry of Health.
• Swedish Medical Products Agency (MPA).
• Spanish Ministry of Health and Consumption.

The front page of the Wall Street Journal announced yesterday that several health insurance companies are raising the premiums on their plans, which are likely to impact small businesses and individual policyholders. The reason cited for this unusually high hike in premiums is recent healthcare reform. The net result of all this it that the taxpayer pays for the added costs of healthcare reform, and the taxpayer pays for increased premiums that the insurance companies add as a result of healthcare reform.

This is like having car insurance, having an accident, and then watching your premiums quadruple for three years before returning to what they originally were before the accident. Guess who just paid for the accident? So why do we have insurance to protect us against an accident when ultimately we end up paying for the accident anyway?

Health insurance, like any insurance, is a risk game. Not for the insurance company, but for the consumer. If the insurance company lost enough money from insuring people, they would go out of business. So the game is simply this: take in more money than you pay out. If you pay out more than you expected in a given year, raise the premiums. If you pay out less than you thought you would, pocket the profits. So whom do you suppose loses in this scenario?

The health insurance companies take in a given amount of money to insure their clients, and the difference between what they pay out to healthcare providers and what they bring in is called the “medical loss ratio.” Paying out to healthcare providers is considered a “medical loss.” So it works like this: collect more money than you have to pay out, and you get to stay in business. It seems reasonable to me that businesses should stand to be profitable. So why the sudden increase in premiums based on healthcare reform?

The health insurance companies had to give in to a few concessions in the new health law, such as lifetime limits and pre-existing conditions. Since they may be at a loss to predict how much these changes will likely cost them, they are hedging their bets. Rather than these companies take the risk, they simply pass on that risk to their customers by raising the premiums, and not to their big customers, but to small businesses and individuals. The big customers have enough clout to say, “No way!” So the people who are the backbone of America get hit once again in this economic downturn.

And besides, isn’t that a bit like paying for your own car accident? We buy health insurance to cover us against unexpected healthcare costs, but we pay extra in premiums in case we have unexpected healthcare costs. Does this sound like a circular argument to you? For the health insurance companies, this is called “having your cake and eating it, too.” So now you know how to win and lose at the same time.

During her time at the Ohio State University College of Nursing, Napier led National Institutes of Health-funded research on the effects of exercise on hypertensive women. More recently, her work at the Gillings School for Global Public Health at the University of North Carolina at Chapel Hill focused on quality and access to healthcare.

The Thought Leader Select Blog sat down with Rhonda to discuss her skills and experiences, as well as her contribution to the work of Thought Leader Select.

TLS Blog: Good afternoon, Rhonda. Why did you join Thought Leader Select?

Rhonda Napier: I had the good fortune of meeting the company’s leadership team through my husband, Chris, after he became acquainted with them. That was back in 2008, and they had an opportunity for me to come into the company as a researcher. The idea of exclusively doing research for me was odd, because I had been a clinician for so many years—but I became attached to it very quickly, because our work at Thought Leader Select reminded me of all the work I had done on clinical trials for Ohio State University and the National Institutes of Health.

When I was working in the world of clinical trials, I saw first-hand all the great work that pharmaceutical companies and medical professionals were doing to bring new medicines to the market and improve public health. These were great people to work for and work with—they really wanted to impact the lives of patients for the better. So I immediately saw working as a researcher at Thought Leader Select as a way to ensure that the very best people in pharma and the very best people in the medical community would benefit from our unbiased approach to KOL research. We connect the pharma world with those who treat patients in the most ethical way possible, and I love that about our company.

TLS Blog: How do your academic and/or professional backgrounds inform your work at Thought Leader Select?

Rhonda Napier: I’m a physiologist, and I am passionate about patient advocacy and patient care. In my work, I really try to translate what I learned working in the therapeutic area of cardiology to our thought leader research. Companies hire us to do research assessments—projects—to get to know the leading professionals in a particular therapeutic area.

A project is more than a set of keywords and subsequently throwing keyword-driven data in into a database. Our clients deserve better! They want to know the level of impact a certain KOL will have in clinical and advisory work—impact that means better medicines and better patient care. I know that I can really find the data that’s relevant to our clients’ needs. We could use web-crawlers and other tools, but I truly believe that having a set of scientifically trained eyes on all the data we find helps us to capture the best data and lose nothing.

And doctors are more than a keyword search. They are people with skills and experiences, passions and interests. Our research brings out who they are as people and gives them the proper standing they deserve.

TLS Blog: What do you enjoy most about your work at Thought Leader Select?

Rhonda Napier: What I like the most is that I never feel like I’m just a cog in some big research wheel, like I would imagine some of the project managers at more of our IT-driven competitors would feel. I really see and feel how our unbiased, highly ethical approach to our work brings out the very best collaborations among pharmaceutical companies and the medical community.

I also like how thorough we are, and the high standards we set for ourselves here. We never cut corners—we’re always expanding what we can do for our clients. We are always challenging ourselves to redefine what the standard is for “our best work,” and that value comes straight from the top of our company, from Paul Meade (president of Thought Leader Select).

TLS Blog: How do you spend your down time?

Rhonda Napier: Like everyone on my team, I work very hard. My number one passion is my family—I’m very lucky to have two beautiful sons and a great husband. Much of our lives revolve around youth sports, and nothing is better than sharing time with each of them—except maybe when we’re all together watching our OSU Buckeyes win!

And while I thrive on being a good mom, I think it’s important for me to set an example for my sons in my work. I want them to see what a strong person–a strong woman–can achieve working for a company like Thought Leader Select. My work is a source of great pride, and I want them to see that and know, one day when they are grown up, how hard I worked—not only for them, but for myself and my own fulfillment, too.

As I wander down the aisle of my local grocery store, I pause at the various stations anchored the end of these long rows with people offering a “freebie” of some food product, a bite of sausage, some aged cheese, a new fruit drink. Each passerby stops briefly for his free sample and then moves along deciding whether to buy the product or not. When I arrive at the checkout, I casually hand over the collection of coupons I received in the mail to reduce my final bill. The reason I am at the store today is because of the flyer I received inside my weekly newspaper announcing a bevy of “specials.” Has the grocery store tried to influence my buying decisions? You bet they have. That’s good business.

Have you ever gone to buy a new car? Does the salesperson do everything within her ability to make the sale before you leave the showroom, offering you discounts, incentives, free service, and a favorable trade-in value for your old car? You bet she does! She knows that if you leave the showroom, the chances are you won’t be back–so she throws everything she can at you. Is she trying to influence your buying decision? Of course she is!

So then why is it, when a pharmaceutical company representative attempts to influence a physician’s prescribing decisions, people cry foul? A recent prescription drug survey conducted by Consumer Reports National Research Center found that most people object to incentives pharmaceutical company representatives offer to physicians to influence their prescribing habits. Is this so bad, or is it business as usual like almost every other company in the world? If my doctor can offer me a new drug to cure a lingering ailment that was resistant to previous treatments because some pharmaceutical company representative gave her a sample to try, then am I not better off for it? To be sure, there is a negative side to all this, and one that perhaps most people fear: will my doctor give me a drug that I shouldn’t have just because some sales representative gave the doctor a pen? What if I get a prescription for a more expensive drug that I simply cannot afford? Gee, folks, have a little faith in your doctor!

I think it is unrealistic to believe that a company in the business of discovering and developing new medicines to treat diseases should not conduct “business as usual” like any other company. As consumers, we are influenced all the time by company advertisements for products. And do we reject coupons or grocery store “freebies” that entice us to purchase a company’s product because we feel they are unduly trying to influence us? There are enough regulations in place in the healthcare system to ensure this “influence” is not excessive or unethical. Have a little faith!

Older, subjective measures for selecting KOLs, such as prescribing habits or level of influence with other physicians, leave biopharmaceutical companies open to continued scrutiny and the possibility for legal action. These methods, like social network analysis (SNA), often lack the detail that industry decision-makers need to select the right KOLs for various types of engagement. Furthermore, it is also true that some objective means of identifying and selecting KOLs have their own limitations. Tracking conference involvement and publications alone is not enough to ensure you have found the top thought leaders in a given medical specialty.

Thought Leader Select has developed a methodology that uniquely provides biopharmaceutical decision-makers with the comfort that they’re identifying and selecting KOLs for the “right reasons”. Our “deep profiling” methodology tracks KOL activities across more than a dozen different areas and provides detailed participation data in a searchable framework that enables clients to select thought leaders in more sophisticated ways. Combining “deep profiling” with Thought Leader Select’s Professional Impact Network (PIN) enables decision makers to determine a map of KOL inter-relationships based on connected interactions, such as treatment guideline development and editorial board service.

In a recent TLS Blog post, Paul Meade discusses the importance of “finding the right thought leader with the right expertise at the right time.” Companies that employ more robust, objective methods for engaging thought leaders are able to do just that – and they show a determination to work with KOLs who have demonstrated expertise, not just close relationships with other health care professionals or with industry itself. When biopharmaceutical companies seek advice and counsel from KOLs with proven track records of thought leadership, they build respect in the medical community, among patients and with the public at large.

Just last week, the Mayo Clinic announced landmark research regarding the use of stem cells to repair damaged heart tissue. A significant breakthrough for people with heart damage is finally on the horizon, which will impact millions of people across the globe. But only a week later, a judge has ruled that, under the law passed by former President George W. Bush banning the federal funding of embryonic stem cell research, the use of destroyed embryos from fertility clinics violates a federal statute. Once again, the medical research community has had to deal with yet another setback with regard to the use of stem cells.

The opponents of stem cell research claim that using an embryo that has been destroyed by a fertility clinic to obtain stem cells amounts to “taking a human life.” It seems rather puzzling that some people, who devote their entire lives to doing good and serving the needy, stop short of allowing the medical research community to achieve significant advances in eliminating diseases because of an endless battle to define life. Many devoutly religious people travel to developing nations to become missionaries and offer help to those in need, yet they can somehow overlook the tremendous good from stem cell research that can help the medically disadvantaged. Of course, those very people would argue that all of this good comes without “taking a human life.” Once again, we are faced with an argument of definition.

For most of civilization, we have defined life as beginning at the birth of an infant. Then, with concerns over abortion, the United States Supreme Court in the Roe vs Wade ruling declared that life was defined as beginning at three months post-conception. A later revision re-defined life’s inception to be “when the fetus is viable,” and we have been struggling with that definition ever since. So, for the purposes of drawing up a working definition, we use a set number of weeks post-conception to define “viable.” Now we have moved considerably closer to the moment of conception by arguing once the sperm and egg have united to form an embryo, whether it be in vivo or in vitro, we have a human life. And destroying those few cells constitutes “taking a human life” in the minds of some people.

Of course, we are all entitled to our beliefs and our definitions, but when such definitions prohibit medical research from discovering cures for many diseases affecting millions of lives it can be perplexing as to who is “taking a human life.” If a young child dies from a rare illness that could have been cured through stem cell research and gene therapy, can we really equate that with the destruction of a few cells that were biologically programmed to unite? Would those opponents of stem cell research dying from a damaged heart that could have been saved from the stem cell research conducted at the Mayo Clinic willingly go to their graves because of their tenacity to hold on to a definition of life?

The irony of all of this debate is that those unused embryos from the fertility clinics are being destroyed anyway, whether the stem cells are being harvested for research or not. Since, according to the definition of some people, such destruction of these embryos amounts to “taking a human life,” wouldn’t it be nice to salvage some good from that destruction so this biological union of cells could actually save some lives?

When we visit a doctor and receive a prescription for a medication to treat our illness, we assume that this drug will work. But can we be sure? Well, most of the time the medicine you receive will do the job as prescribed. You might get an unexpected side effect from the medication, or even an expected one that is commonly found to occur with a particular drug–but they generally do the job.

We are learning more and more that some drugs just don’t seem to work for certain people in the population. We have learned recently that a popular drug to fight colon and lung cancer, bevacizumab (Avastin), is being considered for withdrawal from using it for breast cancer, despite some cancer patients responding to it. Why do some people respond to a drug and others don’t? The answer may be found in biomarkers.

Our genome, with its 3 billion base pairs and tens of thousands of genes, is basically the code for the many different ways people interact with their environment, from the food we eat to the drugs we take. And despite an amazing commonality among everyone’s respective genetic makeup, we all have enough differences to account for a variable response to many elements in our environment. Some people are more susceptible to air and water pollution, some are more prone to certain diseases, some are allergic to specific foods, and some respond to certain drugs.

Scientists have been diligently searching for those biomarkers that identify the genetic factors that may account for these idiosyncratic responses, or at the very least, predict who is likely to respond a certain way given their genetic biomarkers. So as it is with Avastin, some breast cancer patients have a set of biomarkers that predict a likely response to the treatment, while some patients do not have these biomarkers and are unlikely to respond as expected. Should the drug be prohibited for use in breast cancer patients? Well, of course, for those who are unlikely to respond, it’s a no-brainer. But stop it for everyone? It’s the proverbial baby and the bath water situation!

So how do you know which drug is right for you? Apart from obtaining a full genome sequencing of your DNA and mapping all known polymorphisms into a predictive health map, you will simply have to wait while scientists slowly unravel the mysteries of our genome and, bit by bit, gain some insight into the people who are likely to respond to a drug. Will it take some time? It sure will. Will we get there eventually? We sure will.

And when that day comes, you can rest assured that when a doctor gives you a prescription for a drug to cure your illness, it will have a very high probability to work as expected. That is personalized medicine, and it’s definitely on the horizon. Until that time, it’s an educated guess by some very bright clinicians looking carefully at the results of exhaustive clinical studies. But hang in there–it’s getting better than it was 100 years ago. At least we are not blood-letting and using leeches as routine procedures in doctors’ offices these days.

Lynda is no stranger to centers of excellence, having worked in clinical departments in radiotherapy and nuclear medicine in some of South Africa’s premier teaching hospitals and clinics. She holds a master of health science in medical radiation sciences from the University of Sydney (Australia).

Lynda has published research findings in the Journal of Nuclear Medicine Technology, as well as presenting her research at Duke University Medical Center.

The Thought Leader Select Blog sat down with Lynda to discuss her industry experience and her professional contribution to Thought Leader Select.

TLS Blog: Good afternoon, Lynda. Why did you join Thought Leader Select?

Lynda Scott: I’ve been involved in medical research, in both a large hospital setting and private practice, and many of my patients were involved in clinical trials. When an opportunity at Thought Leader Select came along, I wanted to remain in the medical field and still really make a difference in the lives of patients. I loved that I could achieve both of those aims in my work with the company.
I really enjoy research and teaching others how to do it, and Thought Leader Select feeds that desire in a flexible work environment.

TLS Blog: How do your academic and/or professional backgrounds inform your work at Thought Leader Select?

Lynda Scott: My background is in medical imaging and radiation therapy. This medical background—both diagnostic and therapeutic—helps to inform my research on a daily basis. To do this kind of work, you need to be very task-focused, but you have to be able to see how your tasks fit in with the big picture of a project, and the aims of the company. Also, like my clinical and research work in the medical field, my work at Thought Leader Select requires me to work independently and mesh well with a larger team to meet client needs. The professional parallels are abundant.

With regard to my education, the research aspect of my graduate degree taught me to analyze information critically. I learned to never take things at face value—question everything and verify to make sure you have the best information available to inform your decisions.

TLS Blog: What do you enjoy most about your work at Thought Leader Select?

Lynda Scott: That’s easy—working with the people on the research team at Thought Leader Select. The team is really dedicated to meeting client needs, and each person brings their own unique part of the package to the table. I’m continually amazed by everyone’s commitment to the cause. People really step in and step up for our clients when needed—you never hear, “That’s not my job.” And everyone is very open to changes in our process, especially as we keep adding new people who bring new perspectives. They are all very attentive to quality control (one of my pet causes) and ongoing training.

Also, I really enjoy leading work on centers of excellence in the medical community. Our approach brings a holistic perspective to thought leader research. We start at the university level, then bring our analysis to the hospital and research teams connected with the universities, and then provide analysis on thought leaders making an impact in these settings. For me, our centers of excellence research really completes the picture we are able to present to the client.

TLS Blog: How do you spend your down time?

Lynda Scott: I’m a dedicated distance runner, thanks to my husband, Trevor, who introduced me to running about 20 years ago. It’s obviously about keeping healthy and fit, and it’s a great stress reliever, too. But for me, I can honestly say that running has taught me a lot in life. There will always be ups and downs, but with determination you can always achieve your goals.

While I’ve run multiple marathons and ultramarathons in the past, I now stick to a regimen of running 5 miles per day, about three to four days a week. Trevor and I always run when we travel, too—it’s a great way to see new places, and we’ve run in some amazing places, like London, Paris, Sydney, New York, Rome, Milan, Boston, and San Francisco. I can tell you first-hand that there’s no better way to see the countryside in Tuscany and South Africa, much less the beaches of the Caribbean. They are all just wonderful to see.