How  We Do Harm - A Doctor Breaks Rank About Being Sick in America

This book was written by Dr. Otis Webb Brawley, Chief Medical and Scientific Officer of the American Cancer Society as well as a professor of hematology, oncology, medicine and epidemiology at Emory University in Atlanta.  Overall Dr. Brawley is an advocate for evidence based medicine, as I believe every doctor should be.

How We Do Harm is one of the better books I have read on how cancer is treated in the US.  It covers some of the issues with overtreatment, the relationship between doctors and pharmaceutical companies as well as how different people get treated depending on their financial situation and insurance coverage.  The book may overlap with The Emperor of All Maladies and Overdiagnosed.  Nonetheless, it will give the reader a needed dose of skepticism as well as an incentive to be your own advocate.  Caveat Emptor!

Some of his terminology is funny in a sad way including:

Wallet Biopsy:  An analysis of the patient’s financial durability.  This is particularly relevant for cancer patients dealing with the high costs of their treatment.

GOMER:  Get out of my emergency room .This one came out of a book named The House of God that refers to “a person who has lost – often through age-what goes into being a human being.  A GOMER could be demented residents of nursing homes whose bodies wouldn’t die”.  Another category of GOMER is:

“LOL in NAD:  Little old lady in no apparent distress.  This refers to an elderly woman, perhaps a widow, who comes into the emergency room probably needing some psychiatric help - or more, likely, some simple human companionship".

I’m including these terms because I find them amusing. They may also help give the reader a flavor of the cynicism and humanity involved in being a doctor. 

A decent portion of the book is spent on pharmaceutical companies and their inherent conflicts of interests with doctors.  Specific examples are Procrit (Johnson & Johnson) and Aramesp (Amgen) that were used to build up hemoglobin in patients undergoing or subsequent to chemotherapy.  Procrit was approved by the FDA in 1993 based on a very small study of only131 patients.  It was introduced first and featured television advertising to patients talking about getting their strength back after chemotherapy.  This culminated with a Super Bowl ad in 2003

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Amgen responded with a competing drug (Aramesp) in the early 2000’s and struck a deal with oncology practices to buy the drug in bulk, offering rebates of up to 20% of the cost, depending on prescription volume.  By 2006, sales of the drug were $4.85 billion in the US.   Two larger randomized studies showed the placebo group lived longer than those being treated with these drugs!  The second trial was stopped due to this fact.   After 13 years on the market, the evidence showed that patients on these drugs had higher incidences of heart attack and stroke. The two drugs also caused “tumor promotion”, meaning they caused tumors to grow.  The FDA put severe restrictions on the use of both Aramesp and Procrit in 2010, but not before making many oncologists rich.

Another FDA approval was for a combination of Gemzar and Tarceva for use in pancreatic cancer because it increased median survival by a grand total of fourteen days!

This anecdote hit close to home for me: It is about doctors stricken with post traumatic stress disorder (PTSD) from treating so many patients who will die.  “Many of my colleagues have learned to ward off PTSD by becoming assholes”.

Another case depicted a patient who demanded treatment despite protocols against it.  The patient had 3 doctors, including Dr. Brawley, advise against chemotherapy.  The primary doctor treating the patient said “People like that get what they want.  If I hadn’t done it, someone else would have”.

At the other extreme is the family who wants to keep the patient alive when there is no hope for a cure or any quality of life.  The author touches on this and denotes statistics that seem to be all over the news these days such as:  “24% of Medicare spending and 15% of all health spending is in the last year of a patient’s life”.  This is unsustainable, causes unnecessary suffering and keeps others from getting decent healthcare. 

This was a very readable, enlightening yet disturbing book. I would highly recommend it to anyone with cancer or a chronic disease. 

Affordable Care Act and Cancer

On Thursday, the Supreme Court upheld the Affordable Care Act (ACA) by a 5-4 vote.  Surprisingly, John Roberts sided with the four liberal justices to make the majority.  Everyone was expecting that if it passed, Anthony Kennedy would have been the swing vote.  In today’s New York Times, Tom Friedman states about John Roberts “It’s the feeling that it has been so long since a national leader ‘surprised’ us...I think it was inspired by a simple noble leadership impulse at a critical juncture in our history – to preserve the legitimacy and integrity of the Supreme Court as being above politics” This post is not meant to be political – it is about the healthcare system and how it works when you have cancer or any other pre-existing condition.



Brian McFadden - The New York Times

Currently, my health insurance is mostly paid for by my employer. I contribute a portion to the cost through payroll deductions, insurance company deductibles and out of pocket expenses.  Since I am asymptomatic, I have told no one in my department that I have cancer and don’t intend to unless I need to take time off for sick leave.  My company’s benefits department must know that I have cancer since it shows up in the company’s insurance costs.  If my company downsizes and I am terminated, I could receive COBRA for 18 months. But due to the cancer diagnosis - a pre-existing condition, I am virtually uninsurable.  I am ineligible for Medicare for another 12 years (age 65) and I am not poor enough for Medicaid.  The Affordable Care Act (ACA) will allow me to get medical coverage should I be jobless and not out on disability.  This is a huge benefit and relief to me as a cancer survivor.  My cancer costs have been running about $70,000 annually and I am only taking monthly shots of Sandostatin and getting semi-annual scans – no surgery, chemotherapy or other treatments for the disease at this point.  I have no idea how much it will cost for me to get into one of the pre-existing condition insurance pools but I have to believe it will be substantially less than the $70,000 per year my insurance company is currently paying for my treatment.

There is another issue that is a concern to me as an employed cancer survivor and unrelated to the ACA: What might I need to do if I wanted to change jobs?  Suppose I interview for a new job and they want to do a pre-employment physical?  I know the new company will not hire me if they know I have cancer. Is it appropriate to handle it with something similar to “don’t ask, don’t tell”?  Should I not mention the cancer drugs I am taking if asked? This worries me as I am not sure if the new employer would know I have cancer before I got hired. But not disclosing my situation and then signing up for their health insurance could get me fired.  If I am in one of the pre-existing condition insurance pools that are part of the ACA, do I still have to worry about this?  These are things I think about as Wall Street continues to downsize and consolidate or if a better job prospect comes up.  Having a pre-existing condition is a big problem from an insurance and employment perspective. I am hoping the ACA will help me if I ever need insurance if I am unemployed or retired before age 65.

Who’s Paying Your Doctor?

Prior to being diagnosed with cancer, I did not have much interaction with doctors or the medical establishment.  I knew that the pharmaceutical industry paid doctors to prescribe drugs - with resulting conflicts of interest.  Since I was not taking any drugs, this did not really matter to me. 

Drug companies do indeed pay millions of dollars a year to physicians for speaking and consulting.

A series of “whistleblower” lawsuits brought by former employees of those companies allege those payments often were used for illegal purposes — financially rewarding doctors for prescribing their brand-name medications.  MultimediaIn several instances, the ex-employees say, the physicians were encouraged to push “off-label” uses of the drugs — those not approved by the U.S. regulators. This marketing tactic is banned by federal law.

After being diagnosed with cancer, but before I went to MSKCC to see a specialist, I looked into Sandostatin, the drug that Dr. L had recommended. I did not have to look too far. It had shown up on the front page of the Wall Street Journal and New York Times.  As a financial services employee, these are my regular reading materials.  On September 30, 2010, Novartis, the maker of Sandostatin, settled a whistleblower lawsuit filed by the Department of Justice regarding the payment of illegal kickbacks to health care professionals through mechanisms such as speaker programs, advisory boards, entertainment, travel and meals. These were inducements to prescribe Trileptal, as well as Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.  Novartis paid $422 million as a civil penalty without admitting any guilt.  As a result of this settlement, Novartis had to disclose payments to any doctor or medical institution receiving any compensation from the company on a quarterly basis.  The link to payments is at: 

http://www.pharma.us.novartis.com/info/corporate-responsibility/payment-to-hcp.jsp  

On November 2, 2010, I had my first appointment with Dr. Jekyll at MSKCC.  He wanted me to start Sandostatin immediately.  The following week he cited the PROMID study as a rationale for this treatment plan.  The PROMID study, funded by Novartis, found that patients taking a 30 mg monthly dose of Sandostatin had a median time to progression of 14 months longer than those on placebo.  Dr. Jekyll acknowledged the conflict of interest inherent in this study and said that there have been no independent studies to confirm these results.

I subsequently found a bio of Dr. Jekyll on a website where he had to disclose his conflicts of interest and it is below:

“Disclosure: Dr. Jekyll has disclosed that he has financial interests, arrangements, or affiliations with the manufacturer of products or devices to be discussed in this activity or who may financially support the activity: Consultant: Alchemia Limited; Bayer HealthCare; Delcath Systems; Genentech, Inc.; ImClone Systems Incorporated; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Roche Laboratories, Inc.; YM BioScience Inc. Grant/Research Support: Amgen Inc.; Bayer HealthCare; Bristol-Myers Squibb Company; Genentech, Inc.; ImClone Systems Incorporated; Merck & Co., Inc.; Pfizer Inc.; Roche Laboratories, Inc.; Taiho Pharmaceuticals Co., Ltd.”

No wonder he had no interest in treating patients! 

My intent with this post is just to inform others that doctors may have conflicts of interest. They can be influenced by outsiders who are paying them to do things which may not be in the best interest of their patients.  Knowing all this information, I continued with the treatment plan of Sandostatin LAR and am still getting monthly injections of this drug.   In a recent article by  Dr. K.E. Oberg from University Hospital in Uppsala, Sweden titled “The Management of Neuroendocrine Tumors:  Current and Future Therapy Options”, the author states the following: “There has been a dramatic improvement in survival of patients with NETS diagnosed between 1988 and 2004 compared with those diagnosed earlier, based on data from the SEER database.  Coincidentally, this survival improvement in the past 20 years corresponds with the introduction of Octreotide (Sandodatin) in 1987.  Historically, the 5 year survival rate was 18%, but it has improved to 67% in patients who have received Somatostatin analogs.”

There have been quite a few whistleblower lawsuits over the past few years.  There is also another website that one can check to see if your doctor is receiving payments from any drug company.  Propublica, an independent not for profit news room, has compiled a list of doctors receiving payments from those drug companies which were forced to disclose this information as a condition of settlement of these lawsuits.  Unfortunately, this list only covers about 40% of the drugs prescribed in the US.  There are plenty of other doctors taking funds from big Pharma that are not on this list.  The link below from Propublica will inform you if your doctor is receiving money from the pharmaceutical companies involved in these lawsuits:

http://www.propublica.org/series/dollars-for-docs

I think that the reason that Americans take so many drugs is because the drug companies have promoted their products aggressively through the medical community.  In the USA, we have higher mortality and take more drugs than others in the developed world. Yet, these other nations have a substantially longer life span. I believe this is due to these payments and incentives for doctors in the US to prescribe drugs.  I would like the system to be more transparent. I would like to know what percentage of my doctor’s income is coming from patient and insurance reimbursements compared with income from “speaking engagements and other work” from pharmaceutical companies.  Doctors can and do take offense from this line of questioning and are not very transparent about this even if asked.  I don’t expect this to change very soon but it is an important issue from a patient perspective. 

The Difference Between a Flush and a Hot Flash

In the book Fifty Shades of Grey, Anastasia Steele devotes a lot of time to flushing. This is not even close to one of the book’s themes.  I would probably not have noticed this particular feature if I did not have carcinoid cancer.  Skin flushing is a sudden reddening of the face, neck, or upper chest. Flushing is a normal body response that may occur when you are embarrassed, angry, excited, or experiencing some other strong emotion.  In the above book, Anastasia’s flushing is due to these reasons.

I started flushing in my mid-40’s; not very often – maybe once every 2-3 months. It would occur for a few minutes, almost always at mealtimes - either breakfast or lunch.  Since this was a seemingly random occurrence and I was starting to experience perimenopausal symptoms, I thought that the flushing was part of this hormonal change of life.  I could feel burning and the heat flow up to my face.  I could tell I was red even if no one said, as they sometimes did, “Wow Beth, your face is quite red”.  It was clear and noticeable but it only lasted a few minutes and then it would not recur for a few months.  There was no sweating involved, just a stinging/burning feeling, similar to getting slapped.   After a few instances of this flushing- and having some friends say that they don’t think it is from perimenopause - I considered that I might have a food allergy since it only happened around mealtime.  I tried to remember what I had eaten that would cause this flushing but I was not tracking closely. There did not seem to be any trigger foods. 
 
Below is a picture of me and my Aunt Judy – we had gone to lunch to celebrate her 80^th birthday.  This was in 2010, right around the time of my carcinoid diagnosis.  I am clearly red and it is right at lunchtime – a typical occurrence for me.

I started taking Sandostatin LAR in January 2011 and I have not had a flushing incident since, at meal or any other times.  I still get red and sweaty at the gym, as I always have. This redness is accompanied by sweating so I do not consider this flushing. 
  
I did not get the typical menopausal hot flashes until about 12 months ago at age 52.  This feeling is quite different than a flush.  When getting a hot flash, I get immediately sweaty, mostly around my hairline and neck and this can spread so that I feel sweaty all over.  The hot flashes seem to be worse when the weather is warm – i.e., they seem to take a break during the winter.  Hot foods, such as soup and tea can also exacerbate them.  I have moved to iced drinks instead of hot ones.  I also have hot flashes at night and they can disturb my sleep.  There is no flushing or redness associated with my hot flashes.
 

My ob-gyn said hot flashes can go on for 5-10 years and that it is good to wear layers so you can take them off, have heavy and light blankets on the bed so you can shed them and if you use an electric blanket, make sure it has dual controls.  I feel like my internal thermostat has gone haywire as the hot flashes can happen at any time with no notice.  This is quite normal and all my female friends in the same age range are having some version of this so we can all gripe together.

I think it is important to understand how to recognize flushing versus other symptoms.  Suntans, regular blushing/flushing as described above, rosacea or other conditions might cause you or your health care professional to think you are flushing due to carcinoid when you really may not be.  Alternatively, flushing due to carcinoid can be mixed up with other conditions as well. 

Patient Conferences and Support Groups – Part 2

There is good news to report -  the Boston conference was great and very informative. The support group was also quite interesting and not even close to a “pity party”. 

Owen (husband and caregiver) and I drove up to Boston on Thursday and stayed over for the conference on Friday.  We hit a ton of traffic getting from Manhattan to New Haven – it took us about four hours for a trip that should have taken about 1.5 – 2 hours!  Then it was another 2 hours to Randolph, MA where the conference was being held.  Needless to say, we were exhausted when we got there.  The Comfort Inn provided little comfort.

The conference featured three doctors from the Dana Farber Cancer Institute (DFCI):  Dr. Matthew Kulke, Dr. Matthew Schenker and Dr. Thomas Clancy.  There were also several breakout sessions. I attended one on the importance of nutrition to the neuroendocrine survivor, the other on integrative therapies for carcinoid survivors.  The first was not that interesting, covering basic nutrition and how to adjust one’s diet for gastronintestinal symptoms that some carcinoids have.  The integrative therapies discussion was much better. It was give by Stephanie Meyers, a registered dietician at DFCI. She spoke about how to integrate certain nutrients that carcinoids can be deficient in (vitamin D, niacin and omega 3’s) into the diet or how to use supplements. She also spoke about mindfulness and meditation into life to reduce stress associated with having cancer.  Ms. Meyers recommended a book by Danny Penman called Mindfulness – an 8 Week Plan to Finding Peace in a Frantic World.  She also noted that you can watch videos of the meditations at http://www.grooveshark.com/  by typing in Danny Penman and the videos might be more helpful than reading the book. 

I was impressed by the doctors and the breakout sessions.  I feel that I can go to DFCI if things in NYC do not work out.  The people at my table were Farber patients. They seemed happy with their care.  The woman sitting next to me had carcinoid surgery with Dr. Clancy and it went well.  Another woman has had carcinoid cancer since 1996 and has been going to DFCI since then.  No one said that they ever had to wait more than ½ hour to see a doctor.  Although she was not at this event, I’ve heard that Dr. Jennifer Chan at DFCI is also quite good.  The New England Carcinoid Connection did a very good job putting on this event.

Sunday was my first time at a support group.  Owen and I went up to the Bronx to attend a local support group. The host, Emily Zuckerberg told us it was the first such NYC group in 10 years!  There were eight people in attendance, 5 patients and 3 caregivers.  We all introduced ourselves; some of them are people I have emailed off the ACOR listserv but it was good to meet them in person.  We had an interesting discussion concerning treatment options and procedures that we had considered or undertaken.  Of the 5 patients, 2 had gone to Dr.Jekyll (My ex-MSKCC doc.) and fired him as well!  Three patients, including myself, were going to Mount Sinai, and 2 had been to New Orleans for surgery and were using local oncologists with Dr. Woltering supervising.  One of the group had been told by a Dr. at Mt. Sinai that she needed surgery.  She recently went for a second opinion with Dr. Steven Libutti at Montefiore and said that he was quite nice and professional. 

The group decided to meet again after the end of the summer. Hopefully, we will find a Manhattan location by that time.

In summary, I found this group very interesting and it has shattered the myths in my head about support groups.  The meeting was quite uplifting and there was no “pity party” to be had. 

Patient Conferences and Support Groups

Before I had cancer, I had been mostly uninvolved with the medical field, patient issues, or any sort of healthcare education.  My family has a history of heart disease. That is what I thought I would die of and I may yet.  I generally keep myself healthy, eating right and exercising.  The main reason was to prevent heart issues.  Instead I have neuroendocrine cancer. 

I had never heard of patient conferences before I was diagnosed with cancer in 2010.   Since then, I have been to three such events.  Usually these are either a half or full day, with both patients and caregivers as the primary audience and doctors, nurses, and nutritionists as speakers.  All three conferences have been quite informative. I was able to meet some of the more experienced carcinoid doctors to discuss the disease and treatment options, though sometimes the material is a bit too technical for me. I do not have much medical aptitude but I am learning the terminology. I also enjoy meeting other patients at these forums. I like discussing their treatments and issues in person, rather than over the internet. 

On June 8^th, I will be going to a patient conference in Randolph, MA that is being sponsored by the New England Carcinoid Connection  (http://www.carcinoid-newengland.org).  This is a little out of the way for me, being from NYC.  I look forward to seeing the doctors from Dana Farber Cancer Institute in case my situation with the NYC doctors does not work out.  It’s also been almost a year since I’ve been to such an event, so I am both hoping to learn something new and to meet other patients.

I have always heard about cancer support groups.  My general feeling is that I would not like it.  I assume it might be like a "pity party" where everyone talks about their pain and suffering.  My personality does not fit well with this type mentality - I tend to have an optimistic attitude.

I am not aware of any active support groups in NYC.  I'm not sure why. In a city of 8 million people, one would think that there would be plenty of carcinoid patients who might want to form a group.  Emily Zuckerberg, spouse of a carcinoid patient, is starting a support group in the Bronx.  I am planning on attending the first meeting which will be on Sunday June 10th at 1:00 pm at Riverdale Neighborhood House, 5521 Mosholu Avenue, Bronx, NY 10471.  If interested in attending, please email Emily at ezuckerberg@aol.com.  I am hoping it will be a valuable experience and that I can talk to people who may be using the same doctors and hospitals or can give me advice on alternatives.  

So, next week will be a double dose on carcinoid events for me.  I am hoping to learn something and to dispel some myths in my head about support groups.  If you will be at either event, please introduce yourself - I would love to meet you in person.

Medical Tourism? 

We are hearing more about people going to India and other parts of Asia to get hip replacement and other medical procedures due to the expense and lack of coverage available in the US.  This seemed like an interesting concept to me until I found I need to travel myself to find the type of treatment that is most appropriate for my disease.  I hear and read about other carcinoid patients traveling to Europe to get treatments that are not available in the US. 

On my last phone call with Dr. Ratner a few weeks ago, he said that he would like to do an octreoscan to help locate my primary tumor.  This procedure is the standard of care in the US for evaluation of tumor location. It also defines if the patient has the proper receptors for some of the radiopeptide therapies available as treatment. If I were diagnosed with carcinoid tumors and lived in Europe or Asia, my doctor would most likely recommend a PET with ⁶⁸Ga-DOTA-TOC instead of an octreoscan.  This scan has been used in Europe for the past several years and it is widely believed by most of the medical community that the ⁶⁸Ga-DOTATOC PET is superior to ¹¹¹In-DTPAOC SPECT (Octreoscan).

The FDA has not approved the PET with ⁶⁸Ga-DOTA-TOC in the US at this point.  There are however, two locations that are offering this scan as a clinical trial:   Vanderbilt University in Nashville and The University of Iowa in Iowa City.  The problem with the clinical trial is that it may not be covered by standard medical insurance. 

Last week I called Vanderbilt University to see if I would be eligible for a 68-GA PET scan.  I asked whether they would accept me since I had never had an octreoscan. Nor did I know if I had the proper receptors for this scan to work.  I needed to know whether it would be covered by my insurance and if not, how much it would cost.  Finally, I asked how long it would take to get the scan and what other information they required.  They informed they were scheduling for July. They also needed to confirm my diagnosis by having me submit the most recent CT scan report, the pathology reports, the most recent labs and medical notes from my Dr.  If I were deemed eligible, they would verify if my insurance would cover this.  If not, the cost would be about $2,600. I would need to be in Nashville for two days, one for the labs, Dr. appointment and scan and the next day for another Dr. appointment discussing the results.

After sending all this information, they informed me that I was indeed eligible and confirmed my July appointment.  I had an appointment with Dr. Ratner yesterday and told him I preferred the ⁶⁸Ga-DOTA-TOC scan to an octreoscan. He was quite happy that I had taken the initiative to do this and he agreed it was a much better scan.  He told me they were trying to raise the funds to get this technology at Mount Sinai Medical Center.  I now feel much better about the doctor after this appointment because he took the time to let me ask questions and does not object to having a patient that is interested in new treatments.  No arrogance or attitude there. 

I am hoping that this scan will help me to find the primary tumor.  While I am in Nashville, I will be meeting with Dr. Eric Liu who will examine my case and advise on future treatment.  I am now in a much better frame of mind about my situation, doctor and treatment, even though nothing has really changed since last week.

I understand that an octreoscan costs about $8,500, with insurance covering all of it.  The ⁶⁸Ga-DOTA-TOC scan costs $2,600, does a better job, is not widely available and is probably not covered by insurance.  Only in America…