Editorial Note: This post in the AbbVie series is by Johanna Ryan from the RxISK Community Advisory Board
I recently read a legal complaint filed against AbbVie by a New York woman named Cynthia Di Bartolo. She’s a successful corporate lawyer who had undergone various treatments for psoriasis over the years, including medications and ultraviolet light therapy. In November 2008 she started Humira injections on the advice of a dermatologist, Dr. Cui.
What’s a little red patch between friends?
Five months later, a dentist spotted a worrisome red-and-white patch on her tongue and told her to have it tested immediately. It turned out to be squamous cell carcinoma, a potentially fatal skin cancer – and it had advanced to the point that simply excising the sore on her tongue would not cure it. Instead, she had to endure a massive operation that sawed into her face and neck to remove lymph nodes and other surrounding tissue. The surgery and its aftereffects came close to killing her – and she still faces the lifelong risk of recurrence.
This skin cancer was a known and confirmed, if relatively rare, side effect of Humira. It’s more common in patients like Cynthia who had previously had light therapy. However, neither the doctor nor AbbVie warned her of the risk. Had she known, she says, it is unlikely she would ever have agreed to take Humira.
Even if she had, she would have insisted on frequent follow-up visits to the doctor, and watched herself carefully for any sign of a skin lesion. Had the cancer been found earlier, it could have been treated with a much less drastic procedure. Now she can no longer work, struggles with fatigue and speech problems and has endured far more pain and disfigurement than her psoriasis would ever have caused her.
A duty to warn
You might think that Cynthia DiBartolo had an airtight case – unless you know about a feature of American law called the Learned Intermediary Doctrine. This doctrine, accepted in most U.S. courts, holds that in most circumstances a drugmaker has no duty to warn the patient directly of possible adverse effects.
Its only duty is to properly warn the patient’s doctor – the “learned intermediary” between drug company and patient who, it’s assumed, will determine what’s best for the patient and tell her what she needs to know in language she can understand. This rule took shape long before the days of direct-to-consumer drug ads, but it has remained largely untouched in recent years. No matter what sales pitches companies use to lure patients, most courts have ruled the doctor is still the decider.
Cynthia and her lawyers don’t agree that AbbVie did an adequate job of warning Dr. Cui and his colleagues about the risks of Humira. But beyond that, they contend that AbbVie offered physicians so many incentives to prescribe Humira that they fundamentally changed the doctor-patient relationship. These included everything from scholarships for aspiring dermatologists, to elaborate free continuing-education seminars, to actual cash payments for doctors willing to enroll patients in “clinical studies” of Humira that were actually little more than marketing campaigns. In that kind of environment, they argue, a patient like Cynthia can no longer count on her dermatologist to put her interests first.
In other words, the doctor – that learned man or woman in the middle – may have commitments to the drug manufacturer that equal or exceed their sacred commitment to the patient. It’s an explosive charge, but the facts brought out by Cynthia Di Bartolo and her lawyers give it a lot of backing.
There’s another issue touched on in the complaint, however, that may raise even bigger questions about AbbVie’s responsibility. I’ve come to think of it as the Humiraverse – a growing colony of AbbVie employees who establish direct relationships with the patient as well as her doctor. Some of the Humiraverse’s denizens are indisputably offering medical advice, while others are just getting awfully damned close. They include:
- Patient Advocates employed by AbbVie who help psoriasis patients navigate the healthcare system. The advocates, we’re told, do not give “medical advice” – but they do offer to be “your go-to resource for psoriasis education” and teach you “how to have more productive conversations with your doctor.” That’s a very fine line. It’s not hard to imagine that, in the mind of an AbbVie Patient Advocate, a “productive conversation” with your doctor might mean Getting to Yes on Humira.
- Your Advocate will also intervene with your insurance company to help you resolve your coverage and co-pay problems (which can be large and complicated when the treatment costs as much as $25,000 a year). In many cases AbbVie will step in to cover your insurance copayment for Humira if you have trouble affording it. This can make a HUGE difference to the patient, but is arguably a no-brainer for AbbVie. If offering a $100 per month subsidy will enable a patient to get on a $2,000-a-month drug long-term, that amounts to a mere 5% discount.
- Then there are the Humira Nurses – RN’s employed by AbbVie who will come out to your home or doctor’s office to teach you how to inject Humira correctly and help you get comfortable with doing this. The nurses are also available on a hotline you can call for help when your doctor’s office is closed. Inevitably, they will provide “medical advice” to patients whose Humira experience is going badly. What will they tell the patient with a serious infection who wonders if it’s linked to Humira? Will they advise patients to go to the local emergency room if that’s appropriate, even at the risk of getting medical advice from outside the Humiraverse? And what would they have told a patient like Cynthia Di Bartolo, if she had called to report a small white bump on her tongue?
- Until recently AbbVie also provided “peer support” via phone or email from Humira Mentors, who were alleged to be fellow patients on Humira volunteering their time to be your guides. These Mentors were pictured on the website with first names attached, much as the Patient Advocates are now, and you were encouraged to pick the one who seemed like the best fit for you. Noticing that resemblance, I have to wonder: Were they actually AbbVie employees, like the current Patient Advocates – or were they really patients and volunteers as advertised? If so, why were they volunteering with the company that made their drug, rather than one of the many peer-to-peer programs run by groups like the National Psoriasis Foundation or the Spondylosis Association of America? And if you were having a rough time on Humira, would they be free to shoot the breeze with you about alternatives? The Mentor Program was shut down about six months ago and all mention of it was scrubbed from AbbVie’s websites.
- Finally, there’s the physician directory provided on AbbVie’s website, psoriasis.com, which will help you find “the right dermatologist.” It seemed obvious to me that these would be providers chosen by AbbVie for their Humira-friendliness. Just out of curiosity, however, I compared the providers offered in my area with the listings of dermatologists at the nearest teaching hospital. Only a couple of the seven dermatologists on the hospital’s website were on AbbVie’s list of the “right” doctors.
Hey doc: Are you in or are you out?
Take the Humiraverse tour. [http://www.pharmaphorum.com/articles/implementing-innovation-in-pharma-overview-of-the-2012-life-science-forum].
All these services are huge incentives to the patient to start and stay with Humira – and it’s also hard to deny that they insert AbbVie employees in between the patient and doctor.
But in my opinion they are also huge gifts to the doctor in the form of “in-kind” goods and services. The doctors and their nurses or PA’s no longer have to do patient teaching. Their office staff no longer have to spend endless hours filling out insurance forms and arguing with adjusters (and this is a BIG personnel expense for most U.S. medical practices).
As a doctor you no longer have to deal with all the drama from patients who skip their meds because they can’t afford the co-pays. Sweetest of all, no more after-hours calls from sick, cranky and frightened patients! The Humira Nurses will hold the fort for you until the patient’s next appointment. That’s not to mention the new business you may get from patients who found your name while searching a Humira website for the “right” doctor.
For a busy rheumatology or dermatology practice, this is like AbbVie providing two or three extra staff members free of charge. It’s hard to overestimate the incentive this provides for the practice to use Humira. AbbVie is not alone in this – most other makers of expensive biological drugs are getting into offering similar services. How can older generic medications, ultraviolet light treatments or therapeutic diets possibly compete – even if they offer a better, safer option for an individual patient?
An alarming picture
On the one hand, the drug company builds a relationship with your doctor that may be strong enough to overwhelm his or her relationship with you, the patient. Is the doctor still a Learned Intermediary – a sort of educated bodyguard standing between you and those whose only focus is to make money selling you medicines? Or are they a different kind of intermediary – a conduit which the drug company uses to get next to you? Will specialist medical practices who sign on with such elaborate “patient support” plans someday end up branding themselves as “Humira” or “Enbrel” doctors, in much the same way insurance brokers now list themselves as Hartford or State Farm agents?
On the other hand, the company is assembling a team of “healthcare” workers who are drug company employees, pure and simple. Today they promise to lead you to “the right doctor” and help you have “more productive conversations” when you get there. Tomorrow they may replace your doctor altogether. When that happens, you will know you have been demoted from a “patient” to a “customer.” Or maybe a “buyer” – as in, Let the buyer beware.
Stuffed into a corner of my bookshelf at home is a small political pamphlet I bought long ago, a red-hot indictment of what you might call the 1%.
“The bourgeoisie has stripped of its halo every occupation hitherto honored and looked up to with reverent awe,” it says. “It has converted the physician, the lawyer, the priest, the poet, the man of science, into its paid wage laborers.”
Back in 1848 when this was written, I’m sure that particular line struck a lot of people as wild-eyed paranoia. I’m not sure I took it seriously myself when I first read it in the 1970’s. Lately, I find myself pulling that old pamphlet off the shelf more and more, and wondering when someone will make a smartphone app out of it. It just seems that handy.
I know what I’d say to the author if he logged on to the current discussion: Welcome to the Humira-verse, Karl. Does it look like you thought it would? Or are even you amazed?