After 7 years of university (5 in pharmacy school), and just 6 months after passing my pharmacy board exams, the sickening realization that had been creeping up out of my gut–the one that I kept trying to hide from my brain and my heart–could be repressed no longer.
I stood in the middle of another 16-hour shift as pharmacist on duty at CVS desperately wishing I were anywhere but there. Emotionally and mentally fried already at the ripe old age of 25, I didn’t want to take another doctor’s call. Or spend another half hour on the phone with some insurance company in efforts to find out which cholesterol medication WAS actually covered by the patient’s plan. My skin hadn’t toughened up enough yet, because snide comments from some customers about my slowness, or my failing to know that they ALWAYS get brand, and NEVER generic, began to get to me. Didn’t I know that generic antibiotics don’t work as well as brand?
And I loved it when people would ask me if they could talk to the “actual” pharmacist. They couldn’t believe that I was an actual pharmacist. (OK, so I did look more like a 14-year-old when I was 25, which is not a good thing when you’re a woman trying to be taken seriously as a professional). Often, customers thought the 18-year old, 6’5”, male pharmacy technician better fit the bill. Sometimes I was so tempted to just let him advise them on how to clear up that angry rash on their nether-regions. I vividly remember when it was just me behind the counter, apologizing for the wait that would surely melt the ice cream that they left in their hot car in mid-July while they “ran in” to get three new prescriptions filled. Seven years of study for this?
Pharmacy school means semester after semester of medicinal chemistry, pharmacokinetics, pharmacology, pharmacy law, practical labs, pharmacotherapy, and clinical rotations. Summers working in various pharmacy settings to gain practical experience in patient care. Years of studying mechanisms of disease and mechanisms of action, appropriate dosing, drug interactions, efficacy, safety, side effects, absorption, distribution, metabolism, elimination. Years of learning how medications can alleviate symptoms, cure infections, prevent heart attacks, slow cancer progression, and yes, “correct chemical imbalances.” And lots of practice counseling patients on their medications, and the importance of adhering to those medications.
What I really wanted to do was to educate people about their medications–and to find out more about why they actually needed them in the first place. Most of all, I wanted to live up to the profession of pharmacy as one of the most trusted and respected professions—a ranking that still holds true according to a 2014 Gallup poll. But deep down I felt like my work made no difference, and I was terribly disappointed that I had worked so hard for a job I despised.
After a few more months I was a burned-out pharmacist who hadn’t even made it a full year in the workforce. Finally, after much searching, I happened to find what sounded like the perfect job as a member of the first Medical Science Liaison team at a major pharmaceutical company. Just a few years previously, that same company had flown my entire pharmacy school class of 150 to its US headquarters so that we could marvel at the inner workings of the industry. It was truly amazing. We learned how recombinant human insulin was made using bacteria housed in giant fermentation vats and watched a movie about revolutionizing the treatment of type 1 diabetes. And we saw thousands of blockbuster-antidepressant-filled capsules cruising towards stock bottles on assembly lines. The dream of one day working for a company like this was happening for me!
If you Google “Medical Science Liaison” or “MSL,” you can get a pretty good picture of what the role entails. You’ll also see that there is an actual MSL Society with its own journal, and an MSL Institute. The MSL concept has been around since the late 1960’s–Upjohn is credited with its creation. Only in the last couple of decades, however, has the MSL role really exploded. With increasing restrictions on sales representative activity and accessibility–imposed by both regulatory agencies and also by individual clinical practices and institutions–MSLs are more important than ever.
MSLs are medical professionals typically with PharmD, MD, or PhD degrees who work in “Medical Affairs” departments at pharma and biotech companies. They are not to be associated with sales and marketing.
We struck a non-promotional tone. We were to never use brand names and were not allowed to use “detail aids”, those beautiful, art-directed layouts used by sales reps.. Instead, MSL’s used articles published in “respected” journals, or abstracts from scientific meetings, or other “unbranded” resources.
Many job descriptions state, “MSLs utilize their deep therapeutic area expertise to respond to unsolicited requests for medical/scientific information received from research physicians and other health care professionals”. So it was perfectly legal for me, as an MSL, to speak to our customers about “off-label” information, or to chat about the latest studies or emerging trends, or to share (or even create) slide presentations that contained information that would be proscribed for the sales and marketing teams. So, who were these customers I was “targeting”?
They were an elite set of physicians deemed worthy of special attention–the Key Opinion Leaders (KOLs) in their fields. KOLs are so designated because their opinions influence the masses of practicing physicians, i.e. the “prescribers” who ultimately help determine market share.
Imagine a triangle of influence. At the base are prescribers and as you work upward, there are local KOLs, then regional KOLs. And finally, there are national and international KOLs who are the “global influencers”. As you climb the tiers, the KOLs decline in number, but increase in power. It is impossible to overinflate the importance of KOLs to pharma and biotech companies. There are entire agencies for hire that focus on “KOL identification and influence mapping”. For example, one such agency offers services that enable KOL influence to be evaluated on size (how many peers may be reached) and depth (to what degree each KOL influences peers)”. This agency’s website explains, “aligning with KOLs who possess reputational expertise and an expansive sphere of influence will maximize your marketing investment.” When gauging the level of “KOL-ness”, one typically considers journal publication history, association strongholds, board spearheading, and speaking at major association meetings. There are also efforts to identify “rising stars” that could potentially be molded into advocates for the company’s brand.
The job of an MSL is to build relationships with regional and national KOLs. I would fulfill information requests from KOLs in order to get my foot in their doors because these physicians are rarely accessible to sales reps. The real value of MSLs lies in their ability to gain insights that help inform the company’s strategic directions for research and commercialization. MSLs can also get leads on competitors and therapeutic market trends if they’re clever enough. The hope is that your company’s MSLs become a favorite of those KOL targets so that they will turn to you first when they need something from industry. The hope is that your MSLs become that bridge to the great sphere of prescribing influence.
MSLs can be aptly described as pharma and biotech’s “special forces” almost analogous to drones because they are highly trained and equipped to go where few can go, and to capture really valuable “intelligence” for their companies. A drug doesn’t even have to be FDA-approved before MSL deployment. Once it hits Phase III clinical trials and sometimes even earlier, companies dispatch MSL teams to forge those powerful relationships.
Alas, I was not a great forger of KOL relationships. No surprise, really, as I am quite the introvert. My schmoozing skills were pitiful at best. I had the knowledge to share, but just didn’t have the knack for getting a KOL to spill the beans, or for instigating some stellar idea for research collaboration. My compassionate boss soon realized this, and in a very tearful meeting in a crowded airport, she offered me the chance to create an “internal MSL” position of sorts. Thank heavens I wasn’t getting fired.
In my new role, it was awe-inspiring to pull into the parking lot of my company’s national headquarters everyday. There was a majestic fountain. I could always smell something “cooking” as I trekked from my far away parking space to the main entrance. I liked to think it was the insulin-producing bacteria in those big vats, because the odor had a sort of fermented note to it. I was largely responsible for developing the curriculum for MSL training sessions, so I was constantly scouring the medical literature and meeting with company physicians and team leaders so that I could keep the field MSL team up to date.
I began to learn much more about branding and marketing. Terms like “total Rx volume,” and “message retention” became familiar. I was the interface between marketing and the MSLs so that their strategies with KOLs would align more with the strategies of the brand’s marketing team. I attended meetings of major medical associations to score competitive intelligence and to hear about therapeutic trends. I went to the company’s KOL advisory board meetings which were always at fabulous locations. During incredible 3-hour dinners, I would hear quite a lot of valuable information from KOLs.
In years past, pharma companies were allowed to hold “market research” meetings that targeted top-prescribing physicians in a particular therapeutic category. Again, these were always held at desirable destinations, and the attendees were invited to bring their families along, which most did. Several hundred physicians would arrive to a lavish welcome reception on Friday evening, and then attend “working sessions” for about 5 hours on Saturday and 3 hours on Sunday. Activities at theme parks or other attractions were provided for spouses and kids while the doctors were in session.
During these sessions, company physicians would present mostly off-label, unpublished, and “confidential” data and then ask very strategic questions, with answers from each attendee collected via hand-held audience response systems. What was billed as a market research endeavor was really a clever way to legally provide off-label information about a brand-name medication to physicians who could otherwise not receive it. And more importantly to find out how that off-label information influenced prescriber perceptions about the drug. How likely would this information shift their prescribing habits away from the top competitors in the market and toward our brand? At the time, I was entrenched in the culture, and just thought it was part of the job and I truly believed the drugs we brought to market were helping people.
Or maybe they weren’t. But I wasn’t quite ready to really admit that, yet.
Fast forward to December 2001 when I moved to New York and landed a position as “Vice President, Associate Medical Director” at one of the top pharmaceutical advertising agencies in the city. While my prior experience at a pharmaceutical company was eye opening in terms of how the industry worked, I’d have to say that my time on the “agency” side– now serving those clients–was positively mind-blowing.
At first, agency life felt so glamorous! Advertising is all about image, even in the healthcare realm. When I stepped off the elevator to my 9th floor office (which happened to be conveniently facing Pfizer US headquarters across the street), I walked into a polished, super sleek reception area, with attractive receptionists and beautiful, giant bouquets of fresh flowers. Award-winning agency work lined the walls. If we had to work late, private cars were called. If we flew further than 3 hours, it was in business class. We took clients to posh dinners when they were in the city on business. No expense was spared. After all, the clients were spending a boatload of money on us. How much during my time there, I’m not sure. According to Medical Marketing & Media’s report on the top 100 agencies’ revenue rankings for 2014, the agency group that I worked for generated at least $250 million. That’s not surprising when you consider that each person working on a particular brand is operating at billable rates ranging from $100 to $500+ per hour. And there are lots of people working on big brands at any given moment and usually for LOTS of hours.
As a medical director, I was assigned to specific brands. I helped copywriters and art directors create a credible and accurate “story” for those brands, and also helped craft hundreds of “key messages.” I wrote speakers’ notes for presentations given by outside physicians paid to “educate” health care professionals at dinner symposia, helped art directors bring a product’s mechanism of action to life, sat in countless brainstorming sessions on how to “grow the market.” I helped identify “unmet needs” in the treatment of a particular disease, and helped highlight the “limitations of current therapy” if our brand was on the cusp of regulatory approval. I delved into “pipeline analyses” to stay abreast of pending competition. I occasionally participated in publication planning, a process of mapping out which medical meetings and prestigious journals would best serve the brand, although this service wasn’t my focus. But I was involved enough to know all about “ghost writing.” Overall, this position suited my skillset, and in a surprisingly creative sort of way.
Thinking back, it was, in reality, too creative. Reading Robert Whittaker’s Anatomy of an Epidemic for the first time really reminded me of this fact.
There is one sentence in chapter 4 of Anatomy that sums up much of the work I saw–and participated in–during my agency life. Although I worked very little on psychiatric drugs, this excerpt from Mr. Whitaker’s book applies to virtually any drug category:
“All that was missing from this story of magic-bullet medicine was an understanding of the biology of mental disorders, but with the drugs reconceived in this way, once researchers came to understand how the drugs affected the brain, they developed two hypotheses that, at least in theory, filled in this gap.”
In the ad agencies where I worked, we were constantly retro-fitting.
In essence, this is how we approached our work: “Here are the clinical data for Brand X. Now how do we create a story that makes these results extremely relevant and valuable to prescribers and patients?” Even with disappointing clinical data, or data that really isn’t relevant, it’s not that hard to tell a compelling story–one which really provides that all-important “reason to believe” that Brand X is the best option available. Highly respected journal publications are often pulled together to validate and lend credibility to the story that’s been crafted. Our goals were to prove that unmet needs existed, to highlight shortcomings of current therapies, and to provide rationales for why Brand X show promise as a “novel” treatment for a given condition.
One of the key roles of an agency medical director is helping win new business. As in other advertising fields, this process is called “pitching.” We’d pitch our ideas for branding, campaigns, and driving market growth in the hopes of wowing potential new clients. Pitches are competitive, grueling, time-consuming and expensive. Usually, 4 to 5 agencies are each spending hundreds of thousands of dollars to vie for the prize. And after all that time and money is spent, there’s a good chance your agency won’t even make the cut. But it’s a risk worth taking to gain multi-million dollar accounts.
Once the pitch was a “go,” I immediately began setting up interviews with national and international KOLs, because the brand “story” we would create hinged largely on what we learned from them. The agency where I worked for most of my career built an impressive “KOL database” that captured everything we needed in order to identify the best consultants for a particular pitch. I would interview and pay 10 to 20 KOL so we could better understand the hot topics and trends in the field, how they thought Brand X would be positioned among the current treatments, what its potential opportunities and challenges would be. What we really wanted, however, were compelling quotes from those influential KOLs to plug into our pitch, to really make our “validated” story sing, and to wow the potential client with how smart we already were about their brand and the market overall. This illustrated how connected we were with the major influencers in the arena. And it was highly successful. Potential clients LOVE to hear KOLs say great things about their impending products. And KOLs help create great brand stories, whether they are fully aware of it at the time, or not.
Once we won the business, it was time to get to work bringing the brand to life. And for some products, this would begin a year or more before the drug was even approved by the FDA. If a product works in a “novel” way, there’s a lot of groundwork to be done to educate KOLs, prescribers, and other stakeholders about the science behind that new mechanism of action. There’s a lexicon to build, a status quo to challenge, and a new standard of care to envisage. A great way to achieve this is through “advertorial”-type pieces—a blend of advertisement and tutorial–disseminated through various channels before launching a new product to market. Advertorials are not designed to hard-sell a brand. They’re similar to a news article, but also include elaborate illustrations and detailed stories. Advertorials are scientific and educational in nature and are used to communicate an unmet need within a category, increase disease state awareness, influence or change a treatment paradigm (i.e., point out why current treatment options are inadequate), or explain a new mechanism of action (MOA).
When the “pivotal” (i.e., FDA-approval data) finally become available, many brains are working on how to best depict that data in the most compelling way. Some brands are easier than others. If we had to work with less-than-impressive clinical data, we could stretch a y-axis like nobody’s business. If Brand X reduced an event (like an asthma attack) from 0.4 events to 0.2 events, we made the y-axis go from 0.0 to 0.5. That seemingly minor reduction now looked pretty significant in a detail aid, especially when weaved in with compelling messages and story flow. And in some situations, we could get away with translating that 0.4 to 0.2 reduction into a whopping “50% reduction in relative risk.” This likely comes as no surprise, as we see this over-inflation of drug-induced benefit all the time–even in reputable sources like medical journals.
We are all familiar with the arguments that companies spend billions of dollars to bring a drug to market, that it takes at least a decade of research, and that thousands of entities never even make it to human testing. All of these points are used to justify skyrocketing drug costs in the name of altruistic endeavors such as “Working for a Healthier World” or “Where Patients Come First.” (These are actual company slogans.) What I’ve seen and participated in during my time in the industry is that patients really don’t come first.
The brainstorming sessions are never really about bringing value to the patient, even when that’s the big, bold agenda on the whiteboard. It’s about bringing “value” to the patient so that more prescriptions will be written, leading to bigger market share. It’s not really about improving patient outcomes. It’s about making the outcomes data look as compelling as possible so that more prescriptions will be written, leading to bigger market share. It’s not really about the company footing the $250,000 bill when the patient with the rare genetic disorder just can’t afford the medication. It’s about improving optics so that you can actually justify charging that much for a necessary medication in the first place, when its extremely similar predecessor costs 97% less.
It’s not really about patient tolerability, even though many patients in the real world stop taking drugs due to intolerable side effects.
Statin drugs are, in fact, a perfect example of the dynamics involved here. At one point, the industry claimed that most large, randomized, placebo-controlled trials just didn’t show that statin intolerability was really a problem—because at the time it wasn’t in the best interest of big statin brands to acknowledge it. But now, because almost all statins have gone generic, and other companies are racing to market with a “novel” class of cholesterol plummeters called PCSK9 inhibitors, it is finally time to tell the truth about statin intolerance. Now we see KOLs and publications highlighting the major limitation of statins–those intolerable side effects that for years were largely deemed a product of patients’ imaginations–and establishing a real unmet need, and spending millions of dollars to do big studies to prove just how intolerable statins REALLY are for a substantial subset of patients, compared to the potential new blockbuster. All of this is to sell the story that the $15,000 per year price tag is well worth it, compared to $100 to $200 per year for a generic statin.
Most pharmacists I know have hearts of gold and wholeheartedly want people to feel better and to be healthy and have longer, happier lives, and they see medication as a way to help people achieve those things. I know this because I was that person, too. I’m not saying that my post applies to every drug ever developed. I know there are some medicines that have truly saved lives. But I believe that far too many are making people worse, or at best are just covering up symptoms rather than addressing the roots of the problem.
I no longer work for the industry, and I’m never going back. When I learned about Mad In America and people like Robert Whitaker, Dr Irving Kirsch, Dr David Healy, and Dr Peter Breggin, I felt encouraged. All of these resources are confirming what I began to realize several years ago. Psychiatric drugs (and other over-prescribed drugs like statins and proton pump inhibitors) certainly don’t really fix us, and they often harm us.
I will soon be working as a health coach on a mission to help women in particular avoid, reduce, and potentially eliminate prescription medications. It’s quite a change in trajectory, especially for a pharmacist–we’re typically counseling people to take their medications. But I feel like I’ve come full circle, and I am grateful for my time in the industry. Without it, I may never have seen the way things actually work, which is now empowering me to inform people about their medications–to help them weigh any benefits against risks, to give them the full scoop, and to help them realize that most medications will not fix what ails them. I’m finally in a position to find out more about why they actually “need” medications in the first place, so that maybe we can work on habits around food, exercise, sleep, and stress that will eventually enable them to taper off prescription drugs.
Now I believe that I did choose the right profession, it just took a while to find out how to use my professional training in the right way.