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.
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.
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:
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?
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?Share this:
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Just a technical note: Cynthia DiBartolo’s suit is actually against Abbott Laboratories, which spun off its drug division in January 2013 creating AbbVie Corp. Abbott was in charge at the time she took Humira. However, AbbVie is the successor to all the Humira promotion activities pre-2013 and continues them today, so I called the company “AbbVie” throughout.
With $2.6 billion in sales for the first quarter of 2013, Humira is on target to reach sales of $10 billion this year, a world record. The stakes are high, both for AbbVie’s profits and patients’ lives.
Anti-depressants, a parallel situation, are at world records highs for the most prescribed.
Doctors have been warned repeatedly to stop bringing out the prescription pad.
They are not doing this.
We are in the midst of a cliff-hanger; do doctors, repeatedly prescribe drugs they know nothing about and force upon the patient, or do patients try and talk to the people that make these drugs.
If, I was a young enthusiastic individual with more energy, I would almost have a revolution – a revolt.
I would organise every single person with an adverse reaction to a prescription drug, all over the world, to communicate their adverse event to the manufacturer of said drugs.
I would then send in a reporter.
I would just cut out doctors all together…..
I never thought the word genocide would occur to me, either, enough of that with the Jews, but is this really happening? OK, this is not mass genocide, but would you not think that perhaps 2 in 100, or whatever the stats are, the manufacturers would step in, to, perhaps, even discuss it.
The silence is deafening……I was not herded into a bus on my way to be gassed, but I was herded into a terrifying situation, by my doctor……. is silence a fabulous way to deny this?
Do we understand why pharmaceutical companies refuse to talk to us, I think we understand very well….
AbbVie appears to play an identical marketing game with Crohn’s patients. The commercials appearing on TV in the U.S. for Humira are almost identical for Crohn’s and psoriasis. The entire marketing of drugs via “patient advocacy” is appalling.
I took Humira for 5 years. I am now battling three cancers. The two worse cancers are Lymphoma which started out inside my heart. At the same time I was diagnosed with multiple myeloma, and breast cancer. The lymphoma has become aggressive so I am on aggressive chemo treatments. I do not have a lot of money and my bills are going up because my insurance doesn’t always cover my treatments and/or tests. I am widowed and not able to work as I am to tired after al the treatments. I really wish my Dr. would have explained the side effects better. She just grazed over them like these never happen. Now I am living day to day and don’t know what to do. I check with several Attorneys, but no one is taking on Humira anymore.
Ken, it’s all a marketing game.
If you sit in front of a doctor, and it’s different for me because I live in the country and doctors here have more time, here, than you think.
You sit in front of the doctor and you explain all the horrific symptoms which are happening to you and they, are, not polite, not understanding, not actually very interested. But, a certain civility prevails.
And, then, behind your back, referrals are sent off. Pages of denigration of your character.
This strikes me as two-faced and trickery.
You are not told that they are doing this, behind your back.
I was even invited to stay with my doctor for a week on the Isle of Bute, with my daughter, and when I read all her referrals in my medical records, I am shocked at her hypocrisy, ingenuity and audacity that she played with me like this.
It’s not often you come up against a lying, scheming doctor, and mine took the biscuit.
But, is it morally defensible that doctors are writing dangerous words, in your medical records for perpetuity, but, being, pleasant to your face.
Facebook is full of internet trolls, at present, targeting little children and teenagers, with bullying, but is it right and proper that a ‘trusted individual with status’ is sitting right next to you and, perpetrating, the same sort of ‘trolling idea’ with some sort of fixation that she is doing you good.
Is this their duty of care and attention?
Is it credible that doctors do this, day in and day out?
Ken, as someone who has been enormously helped by legit volunteer “peer-to-peer” work, on the giving & receiving end, I agree it’s horrible to see it hijacked & perverted for drug marketing purposes. Check out these PR firms:
Looks like these are the people behind the (extinct) Humira Mentors Program! I love the endorsement of HAStrategies by an industry client: “I can always count on HAS to deliver exactly who I need.” “Harnessing patient passion… ” indeed. Harnesses are for beasts of burden aren’t they?
As a practitioner of Alternative Medicine (Acupuncture) it is been my repeated and disheartening experience to see the effects of this debacle.
In fact, one of my first patients many years ago was a 17 year old boy, brought to the clinic by his father. As it turned out, the boy had a form of social anxiety, for this his physician prescribed Cymbalta. When he told me this, I nonchalantly asked what warnings the physician gave him in regards to side effects, ‘nothing,’ he said ‘he just said to make sure not to skip a dose.’
It should be said that the boy came to the clinic because he had been suffering from suicidal ideation (with intense litigation at the time), tachycardia (also a listed side effect) and an increase in social anxiety as a result of these ‘side’ effects.
I would like to say that this case was rare, but in fact, I would say it is the norm as there appears no consequence for a lack of proper informing by physicians or the industry.
In the modern age we see the myopic discussion concerning only trials, for me, in my experience, this is far more concerning and far more damaging than whether a drug or supplement was shown to be efficacious against placebo.
It would be a great thing if health care professionals were ‘allowed’ to develop wisdom in their practice. The body heals itself, not surgery or medication. For example stitches may help a good healing of a wound but it is the body itself that knits back the tissue and skin and bone. No healing can happen without the body’s systems being allowed to work and they need fresh air, sunshine, good food, peaceful sleep, and exercise within the bounds of possibility.
Hospital tends to provide drugs, recycled air, dubious food, disturbed sleep with changing light, alarms, clatter of new arrivals or incidents on the ward and little exercise, taken mostly indoors. This costs a fortune compared to the provision of a convalescent home or holiday that might really help a body to recover health and spirits.
The constant searching for problems in children and adults, the screening which allows healthy people to be diagnosed as needing treatment, has engendered a feeling of fear with regard to health so that our expectation is no longer of a life of health until we get old, but of a long career of treatment and frailty ending in early death for those who take the most drugs or treatments such as radio therapy. I’m not saying they can’t ever help, but they are too much used before the simpler ways of healing are tried.
The tempting of medical practitioners into harmful ways is not helped by the fake science that is published as research, funded openly or covertly by big pharma, and the huge amount of good research that is suppressed and never heard by the public.
The conspiracy is to suck money from the tax payers to the super rich tax avoiders.
Our freedom to refuse treatment is also coming greatly under threat.
[…] Here is an excellent blog post about how Humira can kill, and how it is marketed – https://davidhealy.org/welcome-to-the-humiraverse/ […]