Angelina Jolie and Celebrity Health Advocacy

This week’s celebrity health health advocacy headlines have been dominated by the sensational NY Times article by Angelina Jolie going public after her prophylactic double mastectomy and her BRCA1 gene mutation.  When famous people are forced to deal with difficult medical decisions, as Ms. Jolie certainly had to face, their decisions and consequences are influential to others in similar situations.  This has positive and potentially negative public health consequences. The public may assume that since these celebrities have nearly unlimited access to information and expert advice, and the cost of care is not a major factor for them, that their decisions and care must be the best choices for anyone in similar or related situations.

As the physician husband of a woman with ovarian cancer who has a BRCA2 gene mutation I’ve thought a bit about how to express my feelings as a physician and as one who loves and cares for a woman in a similar situation, and have been unable to put my feelings and opinions in writing.  I’ve read several editorial pieces about the topic and none really addressed the issues I want to highlight.  Then today I saw an article by Dr. Kenny Lin.  Dr. Lin is one of the thought leaders in public health, a former member of the USPSTF and an outspoken advocate of public health policy that is thoroughly researched and based on the best evidence available.  In his article he talks about the aftereffects of the Katie Couric crusade to promote colonoscopy for screening of colorectal cancer after her husband’s death from that disease, and he addresses some of the difficult issues surrounding BRCA genetic testing. I found his article better than anything I could write, and urge you to see his discussion:

Breast Cancer and the Angelina Jolie Effect

Published at his blog  Common Sense Family Doctor on May 15, 2013

“There is nothing like a celebrity to call attention to a preventable disease, especially if that disease is cancer.  …”           This is well worth the read.  See the rest of his article.

One issue he did not discuss is the patent law surrounding the BRCA gene testing.  If you are interested see a previous post: BRCA Gene Patent

First-Hand Anecdotal Evidence

Today my wife and I started down the path of hoping against hope that the anecdotal evidence for the use of curcumin for ovarian cancer allows her to become one more first- hand anecdote.  As a physician part of my responsibility is to be able to differentiate beween treatments with well documented scientific evidence for their efficacy and those where there is only anecdotal evidence to support their use.  Most of the time the anecdotal evidence, when put to more rigerous analysis does not stand up to critical investigation. Still, often I hear patients ask me about whether a medication, supplement or activity that they have been using with seemingly beneficial results is really helping them. I clearly understand that their success is anecdotal, and usually the there is at best anecdotal evidence to support the treatment.  Often it is something like glucosamine-chondroitin sulfate for osteoarthritic pain or vitamin D or Airborne® for prevention of the common cold.  In these cases where I know that the whatever evidence there is to support the use of these supplements is at best anecdotal, but where the individual using them has the belief that they help I try to quickly first think of whether there is any known serious risks to their use.  If the answer is no I honestly and hopefully with some enthusiasm tell them that although the reports of the benefits of the supplement is anecdotal, in their case it seems to be helping and that unless they have concerns or reasons to stop they may want to continue. Exceptions may be when cost, known risks or known drug interactions are concerns, but whether the help is directly related to the product they are using, a placebo effect, or just unrelated is of little relevance.  Their personal anecdote is that it helps, so they are justified in continuing. If the benefits are due to the powerful known benefits of placebo therapy I certainly want then to continue that benefit, and if they are truly benefiting from some poorly understood effects of the treatment I want that to continue as well.  Today Kay and I joined the legions of patients with an anecdote.

Kay has ovarian cancer, and like many cancer patients who have had recurrence, lack of benefits, or miserable side effects of accepted cancer treatments Kay asked her consulting oncologist about any supplements or other non-prescription remedies she might try during this time she is off chemotherapy but has had a relapse of her cancer.  Kay finished her third course of aggressive treatment after relatively early recurrences after the first two courses a year ago.  Within months once again her reliable tumor marker, called CA-125 began to rise again. Consensus was that waiting for symptoms to develop or demonstrable tumor growth on scans was safer and more likely to maximize quality of life than early chemo. So she has been waiting. Every 3 months she has had the CA-125 checked and the rate of rise was discouragingly steady, from the low normal range, to the high normal range, to elevated.   So like many of my patients, Kay asked Dr. Swisher at the Seattle Cancer Care Alliance if she had any herbal other supplements that might be helpful while she waited to start chemo again. Dr. Swisher told her of an anecdote with one patient who after consulting with oncologists at MD Anderson had been put on  Curcumin C3, a turmerick extract and it had seemed to be helpful.  We intensively researched curcumin use for ovarian cancer.  I even used this blog to crowd-source for helpful info on the subject of curcumin for ovarian cancer.  I was pleasantly surprised when a local cardiologist replied with a link to the best available article published by an Indian physician, and another blogger acquaintance, Kenny Lin MD referred me to the twitter feed of the American Cancer Association site @OCNA and I now follow them on my twitter feed @DrEdPullen.  A few weeks ago Kay started the Curcumin C3 daily, and today she had her CA-125 rechecked.  To our surprise and delignt the level has dropped from 70 three months ago to 50 (repeat 55) today. We were expecting a much higher number and it struck me that when the anecdotal success story is your own it seems a lot more credible than when it is someone else’s.

As a physician I will continue to try my best to critically analyze evidence for treatments and interventions, and will encourage patients to adopt proven and efficacious treatments for their specific conditions.  Still when the door is open to considering potentially helpful, but unproven and anecdotal remedies I may be more open to “studies of one” to hope my patient can join the occasional person to have a successful first-hand anecdote to tell their friends, family and doctors.   This is the first paragraph of the first chapter of our anecdote, but join us in hoping this develops into a full-fledged success story.

Welcome to the Medical Community Myron Rolle

I had largely forgotten about Myron Rolle until I read this week about him leaving professional football to go to medical school.  You may remember him as the former all-American safety from Florida state who deferred an NFL carreer to accept a Rhode’s scholarship.  Mr. Rolle has certainly had an extraordinary life to so far, with his stint in the NFL being the only apparent less than  spectacular success.  For those of you who don’t know the story Rolle was a high school All-American football player from New Jersey, an African American with family roots in the Bahamas who went to Florida State University as a football player. He graduated with a degree in Exercise Science in 2 ½ years, a 3,75 GPA, and became even more famous for his charter flight to a Rhodes Scholarship interview in the morning and flying back to Tallahassee in time to play the second half in his teams win over Maryland.  He turned down the NFL after his third year in college to accept a Rhodes Scholarship and attend Oxford.

MyronrolleThere is a wonderful article in ESPN.com titles “The Burdon of Being Myron Rolle” discussing his time at Oxford and his struggles with living up to expectations of his friends, family and seemingly much of the African American fan base who followed his career.  He appears to gracefully and successfully have managed to deal with these expectations.  If looks like his decision to leave professional football and pursue the medical career he anticipated to start a bit later in his lifetime was sped up by the lack of success in the NFL.  He was a 6th round draft choice, failed to  play in any regular season games in 3 years with NFL teams, and I suspect this made the prospects of medicine seem like a better option sooner than later.

He is awaiting word on acceptances to medical schools as of the last I can see online, likely because of late applications prompted by just making his decision to leave pro football.  Undoubtedly he will get acceptances to most schools he applies to, as his credentials seem extraordinary.  Rhodes scholars are not common in med school applicant classes, and he seems to be a thoughtful and brilliant young man.

Medicine and his future patients are likely to be the beneficiaries of his entry into medicine.  I hope that he keeps his mind open as to his choice of specialty.  He seems to be a person who values intellect, personal interactions and he has apparently long been interested in neurosciences.  He has been quoted as anticipating a career in neurosurgery, but I hope he also considers neurology and other options as he will learn about the nuances of some of these choices over the next few years.

Good luck in your med school and future training Myron Rolle, and welcome to the medical profession.  May your family, friends and supporters continue to be at your back, expectations be realistic,  and support be there when you need it.

Crowd source help Requested: Turmeric -Curcumin for Ovarian Cancer

This post is an attempt to crowd source for information on turmeric with curcumin in ovarian cancer. Kay, my wife, has ovarian cancer that despite the best efforts of Kay and her various oncologists and surgeons has to this point had only fairly transient responses to traditional and some experimental treatments.  Kay is in a position now of feeling well off therapy, but knowing that her biomarker, CA-125 is rising and that her cancer is on the way back again.  She is essentially between traditional treatments right now, and living with cancer. At our last consultation with Dr. Elizabeth Swisher at the Seattle Cancer Care Alliance Kay asked if during this time where she is off treatments, really just waiting for her cancer to grow to a point where treatment is necessary, there are any non-traditional supplements that might offer hope. Kay is not looking to circumvent the types of treatment that have kept her alive for the last 4 years, but is looking for anything else that might help.

Dr. Swisher suggested we look into and try using Turmeric with Curcumin, a Chinese herbal extract that is purported to have some modulation on apoptosis, the process of planned cellular death that may be not functioning properly in cancer cells.  I’ve done what on-line homework I can on Curcumin, and there is in fact a good deal of research going on in the use of curcumin for multiple medical conditions.  When I looked on the clinicaltrials.gov website I find 40 studies using the search keyword curcumin and another 37 on searching for turmeric.  None of these are looking at ovarian cancer, most are looking at bioavailability, pharmacokinetics or benefits in Alzheimer’s Disease, colon cancer or numerous other conditions.

I’ve done a reasonably detailed search for information on turmeric and curcumin for ovarian cancer, and not unexpectedly find good data lacking.  On a search of Pubmed for turmeric cancer 747 articles come up, but I find none that give much useful information, at least in their abstracts.  When narrowed by adding ovarian cancer 15 articles are found looking at mostly in vitro (i.e. outside the living person) studies on ovarian cancer cells and seem to show some promise.  The biggest issues with using curcumin seem to be lack of bioavailability of this highly water insoluble substance and lack of controlled blinded studies of curcumin in living cancer patients.  I don’t expect to see much of the latter, but am hoping that by putting this request out to readers and asking you to ask help from your friends I can hear feedback on the following questions:

  1. I’d love to hear anecdotal experience from anyone who has used turmeric/curcumin for ovarian cancer.
  2. Has anyone seen any hard evidence on bioavailability of commercially available products?  Kay is using the one recommended by Dr. Swisher: Turmeric Extract Curcumin C3 complex 1160 mg, 3 daily with fatty food like peanut butter.
  3. If anyone has had positive results with turmeric/curcumin what exact product and what dose did you find helpful?
  4. Anything else readers have on turmeric or curcumin that you feel may be helpful is welcome.

Please just leave any feedback in the comments section.  I’m also going to reach out on twitter for any helpful information followers may be able to offer. Thanks in advance.  This is my first try at crowd sourcing using DrPullen.com and I’m hopeful to hear back from readers. Please send on this request to anyone you think may have helpful input.

What Causes Obesity: The Real Answer

We just don’t know.  Simply put that’s the answer.  I came across a recent long and detailed essay in in this week’s issue of  the British Medical Journal that reviews the history of obesity research and theory.  Anyone interested in this topic, and really many of us should be interested, should read this essay.  It outlines in great detail what we don’t know, and proposes that we go about the rigorously designed studies needed to find answers to the question, “What Causes Obesity?” without prejudicing the findings with flawed logic and biased presuppositions.

The Science of Obesity: What do we really know about what makes us fat?  An essay by Gary Taubes

The history of obesity research is a history of two competing hypotheses. Gary Taubes argues that the wrong hypothesis won out and that it is this hypothesis, along with substandard science, that has exacerbated the obesity crisis and the related chronic diseases. If we are to make any progress, he says, we have to look again at what really makes us fat.  read more

Achilles Tendon Rupture Diagnosis and Treatment Primer

With the Achilles tendon rupture Kobe Bryant sustained in the game last night this is a good time to talk about how a primary care or emergency physician can tell if a patient has an Achilles tendon rupture.  This can sometimes be a challenging diagnosis, but most of the time it is relatively easy to tell if a patient has a complete Achilles tendon rupture. Achilles tendon rupture is more common in men than in women, is most common in the 30’s though can occur at any age, and is usually though not always quite painful.  The history is helpful.  Most people who sustain an Achilles rupture feel like they were kicked or hit in the back of the ankle/heel area, and sometimes hear or feel a loud pop.  Typically the mechanism of injury is a forceful or violent push-off on the affected foot, though a direct blow to the Achilles or a fall onto the affected foot can also cause Achilles tendon rupture.

Clinically there are three tests we can use that make the diagnosis of an Achilles tendon rupture likely.  The most sensitive test is the calf squeeze test, also called the Robert’s test.  In this test you lie prone (on your belly) with your feet hanging off the exam table.  The examiner squeezes the calf and if the Achilles tendon is intact the foot moves the foot downward, i.e. plantar flexes.  If the Achille’s tendon is completely ruptured the foot does not move downward. This  test is reported to have a 96% sensitivity, meaning it is negative in only 4% of cases of Achilles rupture.  Most of these cases are probably in older injuries where some degree of healing may have occurred.

The second test is called the knee flexion test, or Matles test.  In this test the patient is also lying prone and they are asked to actively (using their own leg muscles) flex the knees to 90 degrees. If the Achilles tendon is intact the foot naturally remains in a slightly plantar flexed position throughout the movement. If the foot falls to neutral or less flexion it is a sign of Achilles tendon rupture.  This test has a sensitivity of 88%. It has the advantage that even in older injuries it tends to remain abnormal because healing tends to result in a longer Achilles tendon.

The least sensitive clinical test is simple palpation of the Achilles tendon, feeling carefully for a disruption of the tendon itself.  Sensitivity of this is reported to be 73% and is less sensitive the older the injury.

Remarkably in some cases the Achilles tendon is not very tender, and the injury may not be terribly painful.  Diagnostic testing for Achilles tendon rupture include ultrasound and MRI imaging, though MRI is certainly more commonly done in most settings today because of the increased accuracy that is less technician dependent.

Although treatment over the last few years has generally been surgical, recent evidence suggests that non-surgical treatment with modern physical therapy modalities can be a good alternative for some individuals. Surgical repair is more often used in younger and more active patients and tends to result in earlier return to full activity.  The belief that rerupture rates are lower with surgical repair and that better functional outcomes favor surgical care have been challenges recently.  A large meta-analysis of 10 studies using functional rehabilitation and early range of motion showed similar rates or rerupture, lower rates of complications other than rerupture, but longer periods of time to return to work (19.6 days longer off work on average).

New Avian H7N9Influenza Cases in China: Perspective

I just read an extremely well written and thought out article in the New England Journal of Medicine entitled a Perspective on the topic of the recent fatal cases of Avian Influenza H7N9 in China.  The authors raise more questions than provide answers, but the pace of research already done or underway is encouraging.

I am not a virologist, and don’t pretend to be expert enough to give great perspective on this issue.  It remains very early in the investigation, and I expect this novel new influenza strain will remain in the news for the next few months or more. This new H7N9 Avian influenza strain could turn out to be anywhere from a rare zoonosis to the next terrible influenza pandemic.  Most likely it will be somewhere in between.  I will try to stay up on the investigations as they unfold and become public and will report here as well as on my Facebook page  and twitter feed @DrEdPullen for shorter relevant info.  Please “like” or follow me on these social media outlets if you use them to stay up on these and other hopefully informative health issues.

The big questions that are as of yet unknown include:

  1. Is human to human transmission possible, probable, already happening?
  2. Are the severe lethal cases reported just the tip of the iceberg, i.e. are there lots of subclinical and mild cases too, or are there just a few cases most of which are severe?
  3. Are animals other than birds, especially mammals, capable or likely to carry this new strain of influenza?
  4. Is this new strain likely to be susceptible to existing antiviral drugs like Tamiflu (oseltamivir).
  5. How fast can a vaccine be developed and is this strain likely to be immunogenic enough for a vaccine to be effective?
  6. Will any existing influenza A antibody related resistance transfer from prior influenza A virus infections or vaccinations or is this strain different enough to make nearly all humans highly susceptible?

I encourage readers to look at the NEJM Perspective piece.  They give insight into clues to the answers to many of the questions posed above based on DNA sequencing and prior experience with related influenza strains. The review ends with the following summary:

“The detection of human H7N9 virus infections is yet another reminder that we must continue to prepare for the next influenza pandemic. The coming weeks will reveal whether the epidemiology reflects only a widespread zoonosis, whether an H7N9 pandemic is beginning, or something in between. The key is intensified surveillance for H7N9 virus in humans and animals to help answer important questions. We cannot rest our guard.”

 

The article is fairly brief, I think pretty readable for non-physician audience, and gives a nice insight into how this type of public health issue is being addressed.

Bendectin resururected as Diclegis

Finally a Canadian pharmaceutical company has received FDA approval to market Diclegis, a medication for treatment of morning sickness that has been commonly used in the U.S. for over 40 years.  This is only newsworthy because finally a company has chosen to take on the risk of lawsuits that led to the removal of Bendectin from the market despite solid evidence of its safety in pregnancy. Who knows how many women or babies may have been harmed by trying and using poorly researched or untested remedies out of fear of this fairly effective and proven safe choice. It’s a sad state of affairs in our country when solid scientific evidence cannot trump emotion in courts when it comes to a trial by jury.  I cannot find any evidence of settlements or awards to plaintifs not subsequently overthrown in appeals in lawsuits alleging fetal harm from Bendectin.  Still the cost of defending these suits led to the removal of the drug from market as profits were not adequate to pay litigation expenses.

For my years in med school and residency training the use of the morning sickness pill Bendectin, a combination of vitamin B6, pyridoxine, and the antihistamine doxylamine was common practice.  Then just as I finished residency training in 1983 Bendectin was withdrawn from the market.  Although this combination drug has been more extensively studied than nearly every other drug in pregnancy and has been shown not to affect the incidence of birth defects or adverse outcomes of pregnancy it was withdrawn from the market by Merrill Dow Pharmaceuticals because of the high cost of defending against lawsuits. This led to use of many other antihistmines, antiemetics, and sedatives being used out of fear of using the easily available OTC componenets of Bendectin.  It also has very likely  led to many pregnant women requiring hospitalization and IV fluid support from dehydration.  Certainly huge mistakes have been made in treatment of pregnant women with drugs that did lead to terrible problems, thalidamie comes immediately to mind. Still fear of litigation is the wrong reason to make medical decisions.  We should rely on the best available evidence.  Diclegis, a.k.a. Bendectin, has the best data of any available option for treatment of refractory morning sickness.

The combination of vitamin B6 50 mg combined with the over the counter sleep aide Unisom continued to be commonly used by women for management of morning sickness once Bendectin became unavailable.  This off-label generically available option has been recommended by the American Congress of Obstetricians and Gynecologists (ACOG) for years as first line therapy for morning sickness refractory to non-pharmaceutical measures for years.

“Treatment of nausea and vomiting of pregnancy with vitamin B6 or vitamin B6 plus doxylamine is safe and effective and should be considered first-line pharmacotherapy”  (1)

This week a Canadian pharmacy has applied for and gained U.S. FDA approval to market Diclegis.  It will be interesting to see how commonly Diclegis is recommended to U.S. patients with morning sickness that is refractory to the usual recommendations to avoid fatty foods, to eat bland food like crackers before getting up in the morning, or whether other less well studied treatments continue to be used out of continued fear of litigation.

Generic Cymbalta, Lyrica and Celebrex Coming Soon

Generic Options for Pain Management Coming Soon

Treatment of pain, especially chronic pain, is a frustrating and difficult part of primary care.  Opioid therapy is problematic for many reasons, not the least of which is that there is just not much evidence that it is effective for long term pain control.  The epidemic of opioid diversion, addiction and abuse has been all over the press in the last couple of years.  One of the problems in trying to treat pain without opiods is the high cost of several branded non-opioid alternatives.  The good news is that three medications that play a small but important role in pain management, Cymbalta (duloxetine), Celebrex (celicoxib), and Lyrica (pregabalin) will lose their patents in the next two years.

Cymbalta, a Serotonin-Norepinephrine receptor inhibitor (SNRI) used occasionally for the treatment of depression is more often used to treat neuropathic pain in patients with diabetic, post-herpetic (after shingles), chemotherapy induced, or idiopathic peripheral neuropathy.  It more recently received an FDA approval for the treatment of chronic pain, especially low back pain.  It seems to work in both depressed and non-clinically depressed patients.  A major problem with use of Cymbalta is that it is expensive and either not covered or at a very high tier copay by insurance. This will change since the Eli Lilly patent on Cymbalta is set to expire in Dec. 2013.  By mid 2014 we can expect generic competition for duloxetine, and I expect its use to go way up as it becomes affordable.  We will need to watch for the uncommon hepatic toxicity of this drug, but it will be good to have another affordable option.

Celebrex (celecoxib) is another medication that for some patients is a good option for pain treatment.  Celebrex is the only remaining COX-2 anti-inflammatory drug left on the market after Vioxx and Bextra were removed for their cardiac risk side effects.  Although little proof exists showing that Celebrex causes less gastrointestinal bleeding or works better than currently available generic NSAIDS like ibuprofen or naproxen, I certainly see some patients who don’t tolerate other NSAIDS and find Celebrex very effective for pain of osteoarthritis.  The patent for Celebrex expires in May 2014, so by the end of 2104 we should expect generic competition for this drug too.

Lyrica (pregabalin) is yet one more drug used to treat pain, especially pain from fibromyalgia and neuropathy that is set to lose its patent in 2013.  The indication for Lyrica that loses its patent is seizure therapy, but it is sure to gain market share off label for other indications too.  Lyrica has some advantages over gabapentin, the most common alternative generic available.  Hopefully generic pregabalin will be affordable.  Generic gabapentin remains moderately expensive.

Maybe as these three drugs to treat pain become more affordably available we will have more success treating pain with non-opioid drugs.

Holy Matrimony is not the same as Civil Marriage

You may ask why as a family physician writing a medical blog I’m diving into this issue on this blog. It’s because the issue directly affects the basic health care of some of my patients.  Holy matrimony is a religious sacrament many religious organizations confer on members who choose to ask for this blessing from their church.  The constitution guarantees individuals and religious organizations the right to their own beliefs and practices.  Churches can and should be able to restrict the sacrament of holy matrimony to persons who share their beliefs.  Marriage is a civil contract recorded by our state governments between two individuals, and confers on them a large number of both state and federal rights, responsibilities and protections.  This has nothing to do with God, religion, or majority beliefs.  The constitution also guarantees the separation of church and state and civil marriage is not a religious issue.  

To prohibit same-sex unions from the federally guaranteed rights and protections married partners enjoy is simply discriminatory and wrong.  Labeling these relationships as “civil union” is an alternative to marriage proposed by some to protect the definition of marriage from being corrupted by allowing same-sex marriage, and I’ve heard lots of people say since it’s the “same thing” as a civil marriage we should stop arguing and just call same-sex unions something other than marriage.  Unfortunately this option does not confer many federal rights and protections to these partners. 

Some of those rights and protections that affect my patients from a health care standpoint include at least the following:

  1. Social Security survivor benefits:  The surviving partner in a heterosexual marriage is eligible for survivor benefits, but not in the case of a civil union or non-recognized marriage.
  2. FMLA: Family and Medical Leave Acts protections are federally mandated for married couples protection, but not for civil unions.
  3. Federal Worker Employee Benefits:  Federal workers married partners are eligible for benefits, but not unmarried civil partners.
  4. COBRA eligibility:  Federal law required employers to offer extended health care benefits to former employees, but not to unmarried civil partners.  This can be a major impediment to some persons retaining health care insurance.

God bless holy matrimony, and by all means we need to protect the first amendment rights to worship as we please.  We need to not confuse the religious sacrament of holy matrimony with the civil contract called marriage.  The majority does not have the right to impose its values in a way that limits the civil rights or privileges of minorities.  By refusing to label the civil unions of same-sex couples as marriage we are in reality making our gay citizens unable to share the same civil rights as heterosexual individuals.  It’s just wrong and we need to get over the misconception that marriage and holy matrimony are synonyms.