I met Alexis at the recent BDI luncheon for women with Type 1 diabetes. She seemed bubbly and smart, and I felt an instant connection. When I discovered her job title was “Compliance Analyst,” I just had to hear more about that. Turns out it’s not quite what you think, but fascinating nevertheless.
Compliance. It’s not a word people with diabetes are fond of. “He’s not compliant.” “She’s a non-compliant patient.” These phrases get thrown around pharmaceutical companies and doctors offices all the time. As if we should all be graciously agreeing to have diabetes and all the responsibilities that come with it. But since taking on the role of “Compliance Analyst” at Amylin Pharmaceuticals, the word now has a completely different meaning to me.
I have had type 1 diabetes for 15 years, and as I entered the confusing decade known as your 20s, I knew I wanted diabetes to be incorporated in my career. Through trial and error, I finally found my niche in the pharmaceutical industry at Amylin, the company that makes Symlin and Byetta. Both drugs are groundbreaking, first in class medications that have given people with diabetes new options that are truly changing the way people care for the disease. This company was a perfect fit for me: dynamic, challenging, up-and-coming, and on the cutting edge of diabetes treatment. However, if anyone had told me a year ago that taking any position with the word “Compliance” in the title would be dynamic, challenging, and even fun, I think I would have laughed in their face!
What I did know about the position initially was that the manager was one of the best in the company, the title was a step up from my current position, and it had “room for growth.” What I didn’t know is that it would open my eyes to the core of the healthcare struggle in America, in particular to people with diabetes. My job duty as a compliance analyst is to maintain knowledge of the various regulating laws and policies around pharmaceutical activities, and ensure that the company stays within those guidelines. Regulating bodies include the FDA, the Department of Health and Human Services, and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code. Most regulations center around training for sales and marketing teams, as well as keeping a close watch on the interactions that sales reps have with physicians.
Long gone are the days of extravagant vacations and golf trips paid for by pharma companies. Over the years there have been companies that have abused the system, attempting to influence the prescribing habits of physicians by bankrolling a luxurious lifestyle. Providing information about products, safety information, and appropriate patient profiles became secondary to who could spend the most money. Finally, in 2002, the pendulum began to swing the other direction. The Federal government, the PhRMA Code, and a new wave of regulations-individual state governments-began to intervene.
Meals with healthcare providers now have to take place in an environment conducive to education (e.g. no baseball games or golf tournaments), caps are placed on fees for doctors who speak on behalf of the company, and funding for educational programs is limited. All of these restrictions have been put in place to ensure that there is no influence (whether real or perceived) on the physicians prescribing habits. And quite frankly, I’m all for it.
Why should any physician be prescribing any product based on what vacation he or she gets out of it? No doctor should increase prescriptions according to the name of the company on the pen he writes them with. And most importantly perhaps, these new restrictions have leveled the playing field, so that small companies are no longer in the shadow of pharmaceutical juggernauts that try to wine and dine prescriptions out of physicians. It is important for all companies to have a voice, so that all information about all drugs is available, not just the drugs made by the five largest companies.
But just as the pendulum swung too far years ago towards reckless spending, the pendulum is in danger of swinging so far towards “compliance” such that the most important part of this equation is now at risk: the patient. Individual states and medical societies are now creating their own rules and regulations about interactions between pharma reps and doctors. At best, they require certifying that the company follows a code of ethics, at worst, they ban all pharmaceutical detailing. The Wisconsin Medical Society has established guidelines that ban all gifts to physicians. Though this sounds wise at first glance, we have to remember that “gifts” includes meals. It is common for pharmaceutical representatives to bring a modest lunch to a doctor’s office to discuss their products without taking time away from patients during their working hours.
With American healthcare set the way it is, physicians are seeing more patients every day than ever before, packing people in to 5 minute time slots to review their entire health status and make a best attempt to start them on medications to help their conditions. After seeing 40 patients in a day from 7am to 7pm with almost no break, how often do you think doctors go home and read 500 pages worth of medical journals about the latest medications and their indications? 30 seconds with a rep may be all he gets to hear about a new medication that could save or improve the lives of hundreds of his patients.
Just as any other industry in which interactions occur between the manufacturer and the customer, pharmaceutical representatives need time and attention from the physician, and it is reasonable to expect that we would offer something such as a small lunch in exchange for that doctor’s valuable time and attention.
In no way am I saying that prescriptions should ever be written in exchange for anything of value, but I am saying that for meaningful education to occur, taking away opportunities like discussions over a meal is not the answer. And at the end of the day, the person not getting the information about their drug options is the patient, and there is no benefit that can come from that. Making matters worse, the public opinion of pharmaceutical companies continues to dive as they are trashed in the media. Recently, the Vermont Attorney General published a report of the “annual expenses” of drug companies on physicians in the state of Vermont, with several companies topping out at millions.
Nowhere in the report is there a break-down of these costs, including the fact that hundreds of thousands of those dollars are spent on creating educational programs where physicians can further their education on specific disease states and drugs. Nowhere does the report indicate how much of that money was used for investigator initiated clinical trials, in which the doctors receive grants to explore medication indications. All of the information about those “payments” is reduced to a headline that indicates pharmaceutical companies are simply pouring millions into marketing tactics to increase prescriptions. It’s no wonder that public has such a poor perception of pharmaceutical companies! There is no explanation of where our money goes, or that the cost of creating a new drug averages around a billion dollars, or that pharmaceutical representatives are generating millions of dollars of revenue for local establishments when they utilize resources in the area for educational exchanges. None of that gets published. Just a headline claiming we pay for prescriptions.
If pharmaceutical selling had been outlawed in my state, my doctor may have not known about Symlin and how to effectively use it. I would have never been told about the drug and never experienced its post-prandial glucose lowering effects. And I am one of the lucky people with diabetes — I see an endocrinologist and have good insurance allowing me to pay for the barrage of medications that keep me alive every day.
What about the folks who are, at best, seeing a primary care physician who has only 30 seconds to assess their diabetes care and continues to put patients on the same medication even though they may have very different profiles? It’s terrifying to think about a world without pharmaceutical reps, because it would literally halt the flow of information in its tracks. And at the end of that flow of information is a patient, who is counting on that doctor to make the best and most informed decision about the medications he or she needs. Doctors, pharmaceutical companies, payer groups and all the regulating bodies surrounding medicine will need to strike a balance between safety and information, and ensure the most important people, the patients, do not get left in the dark.
Compliance Analyst. Diabetes. I never thought they had so much to do with each other. Being in this role has made me more concerned than ever about the state of healthcare in America. But it has also impassioned my fight for people with diabetes by giving me the opportunity to vocalize where all of this legislation leaves the patient. We folks with diabetes are used to fighting for our rights, and now more than ever, we are challenged to tease out the truth among so much fodder.
Hopefully, at the end of the day, the needs of the patient are what outweigh any other intent.
Interesting perspective, Alexis, considering pharma reps are the folks we love to hate. Anyone else out there have a different perspective on the world of pharma from the inside?
[Editor's Note: Alexis is a pumper, on the OmniPod, who apparently was already on Symlin before she joined the company.]