Novartis – At it Again with Kickbacks Disguised as Rebates and Discounts

Last week, the US Department of Justice (DOJ) filed 2 federal lawsuits against Novartis.  One complaint seeks damages and civil penalties for corrupting the dispensing process with multi-million-dollar ‘incentive programs’ that targeted doctors. The other involves kickbacks in the form of rebates and discounts to at least 20 pharmacies in exchange for switching transplant patients from rival medicines to its Myfortic, an immunosuppressant treatment used to prevent rejection of kidney transplants.

The allegations have a familiar ring, given that the feds have made similar charges against many drug makers over the past decade. Payments and ‘lavish’ dinners given to doctors were purportedly kickbacks to seminar speakers and attendees to induce them to prescribe different Novartis meds. However, the feds say, some programs never actually took place or, if they did, doctors never spoke about the drug at issue.

This is the second time Novartis itself has been hit with this type of lawsuit.  The first was settled in September, 2010.  It specifically included Sandostatin as one of the drugs that the company was paying kickbacks to doctors to prescribe.  I discussed this in my blog post titled “Who’s Paying Your Doctor?” on June 24 2012.

The link to the 2010 case is below:

http://www.justice.gov/opa/pr/2010/September/10-civ-1102.html

As part of the 2010 settlement, Novartis signed a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). The company is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of this CIA and subject to monetary penalties for less significant breaches. 

As the feds make clear in their recent lawsuits, the alleged kickbacks to doctors and pharmacists took place before and after the CIA was signed. This is a potentially huge problem, because it could mean that Novartis may face exclusion as defined above.

I am not sure exactly how exclusion works but if some of the Novartis drugs that were involved in these lawsuits, particularly Sandostatin, become excluded from the list of drugs used by Medicare/Medicaid, this would be devastating to cancer patients. Exclusion, while it is a strong motivator to change behavior, would seriously impact patients who rely on the Federal programs for their healthcare.  An alternative to exclusion might be to have the DOJ force Novartis to provide these drugs to Medicare/Medicaid at no cost.  This would hurt Novartis but would not cause patients to suffer.  I'm not sure if this is legal but it makes no sense to harm patients because of wrongdoing by Novartis, pharmacists and doctors.

Meanwhile, the DOJ goes on filing civil lawsuits against drug companies that continue to settle for higher and higher amounts of monetary penalties while denying any culpability.  Perhaps stronger remedies are needed including criminal penalties and prosecutions. 

This story is outrageous! Unfortunately, Novartis is not the only pharmaceutical company to face these charges.  It amazes me how these lawsuits/stories are filed on Fridays so there is not much media coverage of it over the weekend.  This is an age old public relations gimmick that still seems to mislead the public.

Source material:  Forbes: http://www.forbes.com/sites/edsilverman/2013/04/27/did-novartis-violate-its-corporate-integrity-agreement/

The New York Times:  http://www.nytimes.com/2013/04/28/opinion/sunday/another-alleged-drug-kickback-scheme.html?partner=rssnyt&emc=rss&_r=0

Dana Farber Cancer Institute

After several months of searching, I have decided to move my carcinoid cancer care to Boston’s Dana Farber Cancer Institute (DFCI).  It seems strange to go all the way to Boston for my care but I’ve had some difficulty in communicating effectively with the doctors I’ve seen in New York City.  I have family and business in Boston, so it’s not like I never go there.  I decided to look into DFCI for several reasons:

•  It is a large multidisciplinary system. I believe they may be a bit more conservative than some of the other carcinoid cancer treatment centers. 
• They have a large neuroendocrine tumor program.
• They have a reputation for an emphasis on patient care in addition to research. 
• Last year, I saw Dr. Kulke and Dr. Clancy speak at a conference sponsored by the New England Carcinoid Connection (see blog post from June 11, 2012). I was impressed with their knowledge.  I also met some of their patients at the conference. 
• It’s not that far from New York City.

I had my first consultation in January with Dr. Jennifer Ang Chan, an oncologist who works with Dr. Kulke, to discuss my circumstances.  I found her to be very articulate and clear.  I asked many questions at this appointment and she was very patient and spent time giving me thoughtful responses. I have been having trouble getting basic information from my other doctors, so her attitude was refreshing.  Dr. Chan is a straight talker – no abstract thinking, analogies or silly answers.  She reviewed my test results and scans and said that she would consult with Dr. Thomas Clancy, who is their neuroendocrine surgeon. She was concerned with the large tumor below my liver and in front of my kidney and thought it might need to be removed.  Dr. Chan said that DFCI does usually not do the very large exploratory surgeries that can take 6-8 hours trying to get everything out, especially when the surgery will not be curative.  They will target a certain potential risk and take tumors out of that area. 

I had two more appointments with Dr. Chan and Dr. Clancy, one in February and one last week.  Dr. Chan showed me an area of my abdomen from a CT scan that showed the large tumor already causing an indentation in my small bowel.  She said that they would normally not do surgery on an asymptomatic patient but since this tumor was already pressing up against the small bowel, any tumor progression could cause a bowel obstruction.  She also mentioned that the median time to progression for Sandostatin LAR users in the PROMID study was 14 months and that I have now been on Sandostatin LAR for over 24 months. The combination of these two factors was the concern in my case.

Dr. Clancy agreed with Dr. Chan and said that he normally wouldn’t do surgery on an asymptomatic patient, but that my large tumor (10x8 cm) pressing on my bowel, should be removed because any progression could cause a bowel obstruction.  He said that it was best to do the surgery while I was in good health and that the procedure would be much less complicated than if I had it done on an emergency basis after a bowel obstruction.  Dr. Clancy added there is a near certainty of future problems if I don’t have the surgery.  The surgery he is proposing will remove the large tumor, another large (6x3 cm) tumor in my pelvic area as well as some of my small intestine, affected lymph nodes, gall bladder and maybe my right colon.  Much of this would depend on what he encounters during the surgery.  He is quite confident that he will find and remove my primary tumor while operating on my small bowel.  The doctor plans to remove around 80% of my tumor load.  The surgery would last 3-4 hours. Recovery will take about 6 weeks. This is not different from what I heard from Dr. Liu and perhaps what Dr. Warner was trying to tell me.   Dr. Clancy seems very competent and concerned with quality of life issues after this surgery.  The surgery would be at Brigham and Women’s Hospital (BWH) in Boston.

This is a very difficult decision for me.  However, I am finally seriously thinking about it.  I have not scheduled it yet and I think I may wait until September to have this surgery unless someone gives me a good reason why I need to do it now.

I am very relieved to find doctors that I can talk to, who listen to me and that I feel comfortable with.  Both Drs. Chan and Clancy are smart, compassionate and punctual and listen to my questions and concerns.  It’s a welcome change.