In a wide-ranging scheme, AbbVie (ABBV) used a combination of old-fashioned kickbacks to doctors and a stealthy network of nurses to illegally boost prescriptions of its best-selling Humira treatment, according to a lawsuit filed on Tuesday by the California insurance commissioner.
Over a five-year period, the drug maker offered physicians a familiar menu of tempting items, from cash, meals and drinks, to gifts and trips, along with patient referrals, in hopes they would write more prescriptions for its Humira rheumatoid arthritis treatment, a $12.3 billion seller in the U.S. last year.
However, AbbVie also engaged in an allegedly more nefarious practice in which registered nurses were hired to act as “ambassadors” to visit patients at home and help with administering the drug, but instead were used to ensure that prescriptions were continually refilled, the lawsuit stated.
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I disagree with much of this. I chose to take Humira because nothing else I did helped. I have HS and Crohn’s. I have tried the AIP diet, the vegan diet, fish oil, turmeric, and every other “alternative” therapy. Nothing worked. The nurse ambassador program is a voluntary thing. You don’t have to have one. My nurse ambassador has been only helpful and kind. She has never pushed the drug or any medical advice on me. If I have a medical question, she refers me to my doctor. It’s still too early to tell if the drug is going to help. If it doesn’t, then I will most certainly stop it.
There really are two issues here that need to be teased apart. The first —whether nurses were used inappropriately, to promote Humira or to “cut out” patient-physician communication — is potentially remediable, through better compliance training, realigning the program with Medical Affairs rather than Marketing, etc.
The other, however, is whether nurse support programs, per se, constitute a kickback. Were California to prevail — and, worst case, were HHS to concur that they constitute a violation of the federal Anti-Kickback Statute — an entire swath of programs that, in principle, deliver a benefit to patients could be wiped out.
Once again, bad behavior stands to make bad law.
Worked as a nursing educator when this drug first hit the market. Initially the first year and a half it was just teaching patients how to give their meds, and trading private nurses how to give the drug and educate about it and refer pts to their Dr’s for any side effects and report to FDA. Then things changed by the 2nd year more conditions were approved for Humirs , and they were subtlety trying to use nurses as marketers of the drug i.e. Calling Dr’s offices, calling pts when pts were suppose to call us. Abbot was the manufacturer at the time and we were a large outsourcing pharmaceutical company who distributed the drug. Things radically changed. After I left because of medical reasons they got rid of the nurses working on this drug. There were bonuses associated with this drug. The practices of Humira became a direct conflict with the nurse practice act. Nurses are NEVER to market drugs or treatments in your role is not a drug rep. This was a new program and nurses were hired to be educators only. I had deep concerns with how nursing roles were changing and would not practice cold calling pts or anything about marketing. Nurses are suppose to be PT ADVOCATES NOT PUSHING DRUGS OR TREATMENTS. There were other things that violated nursing standards that came about later when Humira became a drug for several conditions. I maintained my practice as a nurse educator and push back on being something other than that.
I want to know when the employees’, and especially the executives who are responsible for the individuals who have been seriously affected by these bogus claims of the efficacy of the drugs, are all going to be imprisoned for their crimes against humanity? It’s one thing to bring a civil suit/ class action suit against these greedy companies, which is still providing them with a less costly way to get over the lawsuit from each individual, which would be more beneficial for the patients whose lives have been destroyed, and especially if they died because of a significant scam.
They are all involved with this egregious behavior. They all must be convicted in a court of law, and when found guilty, are placed in the prison, where anyone who has knowledge about this bogus drug, are not going to be allowed to continue to get away with this by throwing money at the patients. Ask yourselves, “How much is my life worth?” Then file a suit for yourself and let the prosecutor ask the question for you, in a court of law.
I think that we won’t have any changes with this egregious situation, until these greedy companies are going to be held responsible for what they have done, and what they are still doing to the individuals who are not aware of the deceitful practices of these companies. When they all are held accountable, and are placed in the prison system, then maybe they will cease and desist from their ongoing abuse of individuals and their physicians.
So many dirty marketing tricks, and deceitful methods used to exploit patients. This is probably the tip of the iceberg. These Pharma Corporations educate journalists, track patient groups on social media, while getting influencers to peddle their products for them. With so many industry insiders at regulatory boards it is no surprise that the state of California had to step in. There is no low too low for these parasites, and the full impact of the corruption, won’t be available until the criminals are out of power.
As more and more of these cases come to light, they are suppressed and treated as outliers, when they are the industry standard. The number of people who either died or experienced serious adverse events won’t be counted either.
Why is it that every time this happens no one mentions the physicians taking this compensation? At what point did the physician decide it made sense for 3rd party providers to consult with these patients within their facilities. Shouldn’t the insurers be worried about this mishandling of patient wellbeing?
It appears that the CIA, reduced to 3 years, would have expired in October 2015, right? Would these new charges bring up retrospective issues under the CIA? Also, how long will it take for the dust to settle on this new lawsuit? Potential of being excluded from federal health care programs would essentially cripple ABBV long term, and private health care programs follow policies of federal programs, so who would use ABBV products without insurance?
Ed
It appears to me the issue is not whether the patients received the drug inappropriately or for longer than they should have. The issue is the AbbVie nurses were doing the clerical work the doctors’ staff should have been performing. You don’t discuss patient harm.
Thanks
Brad
Hi Brad
The suit does note that nurses were doing work physicians staffs should have done, although while it does not specify patient harm, per se, it does note that patient concerns, questions and complaints were not passed along to doctors. To some extent, one could argue that constitutes harm, and again, that was mentioned.
Hope this helps and thanks for writing in.
ed at pharmalot
As employees or paid consultants of a pharmaceutical company, they would have been obligated by law to report adverse events initially to the manufacturer. Also, does it seems weird that removing the burden of paperwork that would otherwise cost the doctors time and money is positioned here as…bad? I realize it could be construed as a form of compensation, but judging from most of the comments, we seem more interested in looking for infractions to “get big pharma” than what is actually best serving the patient and heath care provider. If our high healthcare costs are being driven partly by the cost of pharmaceuticals, is this a service they /should/ be providing?
if true, this is damning to abbvie which has been operating under a CIA since 2012: https://www.sec.gov/Archives/edgar/data/1551152/000104746914001154/a2217723z10-k.htm
@Cellboy,
You raise an interesting topic, regarding the staff who are doing the physician’s paperwork, and wonder if the physician is receiving all the significant responses, questions and so on, about their experiences with the healthcare, especially with using a new prescription drug. I am unable to speak for any one physician, however I have been in the medical profession ( as a psychotherapist for years ), and attended a medical school for one of my post grad degrees, for two solid years.
Whilst there, we were obligated to attend some medical courses, as the medical students were obligated to attend a few non medical courses, such as psychology, art therapy, etc. I witnessed the majority of physicians who were often attending to their charting for the patients who were in hospital, and they didn’t have any thing like a computer to try to lighten the load of charting their patients experiences.
Then even with the pc, physicians who I have known as a patient, still never wrote anything, during our appointment time. The opposite experience was with one physician who never wrote, read, nor wrote prescriptions either; he relied upon the overworked and underpaid NPR. They all were so busy, and as an attempt to get the patient out the door, they almost always wrote scripts for the patients, that were much too overly prescribed opioids for which I refused to allow them to do so.
Back to the doctor, the next day ( he was in the surgery by the time I was leaving ), and I told the scheduling receptionist that I either see him the next day, or he could speak with his attorney to contact mine. This is totally out of character for me, yet it was the only way that I could get this doctor’s attention. The next day I told him ( he had a student with him, and asked if I was going to allow him to be a part of the appointment ), that I said from the beginning I wanted to get off the opioids because they made me ill, and some side effects included syncope, which is a rather frightening experience. If I required opioids, I would have been happy to have them. The current situation with patients who actually require opioids, and the government, insurance companies, and possibly some of the pharma organizations too, are now, uninvited, unwanted, and unnecessary to be between the professional physicians and their patients to determine what the physicians are able to do, and are responsible for limiting the only type of drugs that they have to endure their suffering, and still have a modicum of a quality of life experience!
The point is that the physician who was my primary physician always hired a phenomenal staff, and they were in sync with every aspect of the patients healthcare issues. My physician would have a tablet for writing down specific information that he needed to be aware of. His scribe, was then entered into the database for the physician, and on the occasion of his not having appointment hours for holidays and other functions, like all professionals who have patients to attend to, he and a few other physicians would cover for one another, so that database was a great resource for the physician and those who covered for him, especially. The physician is only as good as the staff who he has been with him for many years.
As a psychotherapist who eventually had my private practice, the same situation applies, coverage with a well known therapist for the times that I was on holiday or elsewhere. The charting of patients for our profession is different from the physicians; we have to keep our patients anonymous and our session notes private always. So I would have to make sure if a patient was having some serious issues with whatever they were at the time, and explain that I want them to be at ease with the therapist who was covering for me, as I did for them. Sometimes I would ask the patient if they would agree to meet with the therapists who were taking over for me, if they were in crisis and needed to see someone immediately. A great need there too. The difference being if the physician was a psychiatrist, then that professional of course had a final say over prescribing medications for the patients, and that was always a bonus. I could have gone another two years and had my license to prescribe too, but I knew so many good psychiatrists, with whom I worked with in this way. The charting is essential for every healthcare practitioner; and there are some physicians ( like the one we had, when living in a different state ), who was awesome and compassionate too.
The physician I have now, is an introvert, as am I, and we understand the dynamics of one another that one would think us to be extroverted in our appointments. He actually walks into the appointment with the huge computer that nurses in hospital have when they are giving meds to the patients in hospital. My physician uses the pc, only when I speak about medication, and for reading the report from a test that he prescribed at hospital. Otherwise, thankfully he gets the computer rolling table to the side of the room. Now that is a physician who multi tasks, and does so well by his patients.