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. 

Third Time’s the Charm?

I am now in the process of finding a new doctor to treat my carcinoid cancer.  This new doctor will be my third since my initial diagnosis in August 2010.  I started with Dr. Jekyll at Memorial Sloan Kettering Cancer Center. That lasted about 15 months.  Then I went to Dr. Ratner at Mount Sinai who works with Dr. Warner – I’ve been with him just over a year.

I have never had any trouble with doctors before I had cancer.  However, I have not had a really serious medical issue like cancer before either.  

A few months ago in the magazine “Consumer Reports on Health”, the editor wrote a note called “Why I like my doctors”.  In it she says, “I like my doctors because they are smart, compassionate and punctual.  They take time to answer my questions and address my many concerns”.  Research has shown that a doctor who connects with a patient is often successful in encouraging them to comply with medical advice and regimens that can lead to a healthier life.  She says she likes her doctors because “I believe they have my best health in mind.  It’s easy for me to listen to them because I know they listen to me.”

 

When one has cancer, I believe it is important to go to a multidisciplinary center where they have oncology, radiology and surgery departments and everyone works together.  My first doctor was at Memorial Sloan Kettering Cancer Center (MSKCC) which is a very strong multidisciplinary center.  My doctor, however, was neither smart,  compassionate nor punctual.  After he told me I could not make a doctor change, I fired him and moved on to Mount Sinai.  Currently, I go to Dr. Ratner who is not a carcinoid specialist but who works with Dr. Warner who is.  I am comfortable with Dr. Ratner, but not as comfortable with Dr. Warner.  Dr. Ratner is smart, compassionate and punctual but defers to Dr. Warner when I need to think about a different treatment plan or make an important decision.  Dr. Warner is recommending exploratory surgery to perhaps find my primary tumor and to reduce the tumor burden.  That’s all the information I can get on this potential procedure. He says I should go talk to a surgeon at Mt. Sinai if I want more detail on what the procedure will entail.  My opinion is that the doctor who is treating me should be able to at least outline what will occur during the surgery, explain why it needs to be done and when, as well as offer an explanation of other treatment alternatives and their pros/cons.  After 3 appointments with Dr. Warner, I do not feel comfortable with the proposed treatment plan because I can’t get enough clarity on what will happen to feel like an informed patient.  I have not found a good doctor-patient connection with Dr. Warner and have decided that I need to make a change for the following reasons:

1)   I believe it is important to have one doctor who I feel comfortable with managing my care.

2)   I really need my doctor to talk clearly about the options, how we would define success and what the risks are for each suggested treatment.

3)   After 2.5 years with diagnosed cancer, I am getting much more competent at understanding what my needs are.  I have developed biases in favor of doctors who are on their way to success and against those that have achieved success but forgotten how to be smart, articulate, compassionate and punctual.

Over the past several weeks, I have visited with two new carcinoid cancer doctors as part of my search for a more effective doctor-patient relationship.  Even though I have become pretty jaded on oncologists and cancer, I was pleasantly surprised with both doctors.  Both were smart, compassionate and articulate.  They explained all the issues with my case and spent time answering questions. 

After this 2.5 year struggle, I am glad to finally find some hope of achieving a good doctor-patient relationship.  I’m taking a well needed vacation and will report back on my medical situation after I return.

Bitter Pill and Gorillas in CT Scans - Unrelated Topics

There is an interesting article in the March 4, 2013 edition of Time magazine called " Bitter Pill - How outrageous pricing and egregious profits are destroying our health care" by Steve Brill.  This is a long and sometimes wonky article about many of the things that are messing up the US Healthcare system.  I'd highly recommend reading it - the link is on the Interesting Articles/Information section of this blog.  

In other interesting news, I just had another CT scan and on the report it says "The large bowel is normal in course and caliber.  The bladder and uterus appear normal."   The regenerative powers of the uterus are amazing!  I had a hysterectomy in 2010 and this is the first CT scan since then to find a normal uterus!  The radiology department might want to evaluate its peer review process.  This reminds me of the gorilla in the CT scan that 84% of radiologists could not find.  See link below.

http://www.cbsnews.com/8301-204_162-57568784/can-you-spot-the-gorilla-in-this-ct-scan-most-radiologists-couldnt/

The good news is that my carcinoid tumors have remained stable since diagnosis in August 2010.

Healthcare’s Trick Coin

In today’s "New York Times", there is an opinion column by Dr. Ben Goldacre, author of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients.  (Disclosure:  I have not read the book and this editorial seems timed to correspond with his book tour) 

Dr. Goldacre writes about a Johnson & Johnson (J&J) artificial hip that had a 40% failure rate and now has generated over 10,000 lawsuits.  Various versions of this artificial hip had been sold both inside and outside the US since 2003.  In 2008, a senior consultant to J&J suggested that the device be redesigned and in 2010, the artificial hip was recalled.  We, the patients are only finding out about these issues now that the court cases are starting.

Dr. Goldcare states: “It would be nice to imagine that this kind of behavior is exceptional, but in reality, the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with J&J.  More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.”

The doctor also writes that “this problem has been going on for decades and there are laws on the books such as The Food and Drug Administration Amendments Act of 2007 which is the most widely cited fix.  It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied.”

He goes on to outline other examples of issues similar to the J&J artificial hip. 

Dr Goldcare states,”if I toss a coin, but hide the result every time it comes up tails, it looks as if I always throw heads.  This cannot be acceptable.  Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge”.

Unfortunately, this cynical patient doesn't t think that these problems will be fixed anytime soon. An example for us NETS would be the PROMID study that was supported by grants from Novartis, the maker of Sandostatin LAR, which found that the maximum recommended monthly dose of Sandostatin LAR (30 mg) given monthly increased the time to progression of tumors to 14.3 months versus 6 months for the placebo group.  This study, published in 2009, only had 85 patients in it.  Many doctors use the PROMID study to justify the use of Sandostatin LAR.  I’m wondering if there have been other studies done on this drug and suppressed either before or after 2009. I am and will always be concerned when the drug company sponsors a study that has the best results in patients using the highest dose of their drug.  In my opinion, it’s an enormous conflict of interest and should not be relied on as the basis for treatment without some independent studies or evidence.

Sandostatin LAR – Follow Up

Yesterday I had my monthly Sandostatin shot.  I mentioned to my doctor that I still had hematomas from the last two shots. He said that sometimes happens and I should not worry about it.  I’ve been going to this doctor for about 11 months now.  During the the first four months I had Nurse 1 who gave perfect sandostatin shots. For the next six months, I had Nurse 2 and three of the six shots gave me hematomas, including two shots in a row in November and December.  Today, much to my surprise, Nurse 1 was back!  I was so excited I almost hugged her.  She was perplexed that I was so happy – it was pretty funny – probably not her typical reaction when giving a shot.  I asked her if I could specifically request her in the future. She said that she usually works Wednesday and Friday.  Now I know when to schedule my shot appointments. Hopefully the hematoma problem is now solved.

New York Noids Carcinoid Support Group - Upcoming Luncheon

The above carcinoid support group will be getting together informally with fellow carcinoid patients and medical experts in the field.   We will share our experiences, observations, questions and concerns.  We will learn about recent developments of interest. Attending this discussion will be 3 doctors from Mount Sinai Medical Center as follow:

Dr. Richard Warner, carcinoid expert

Dr. Lynn Ratner, oncologist

Dr. Celia Divino, surgeon

Date:  Sunday January 27, 2013

Time:  12:30 pm

Location:  Carino restaurant, 1710 2^nd Avenue in Manhattan between 88^th and 89^th streets.  Menu can be seen by clicking the link below:

 http://www.menupages.com/restaurants/carino/menu

If you plan to attend, contact Emily Zuckerberg at ezuckerber@aol.com or call 917 689 1980.  Because of space limitations, attendance will be limited to 24 people. There will probably be a waiting list. Patients may invite one guest.  If you reserve and then find that you’re unable to make it, please contact Emily immediately so others can attend.  Please RSVP to Emily by January 20^th so she will have an idea of who/how many people will be attending.

A Happy and Healthy New Year to all and I hope to see some of the New York area patients/caregivers on January 27^th.