ACP Leadership Day 2011

Last month I attended the American College of Physician’s Leadership Day at the Capitol. The American College of Physicians is a national organization of internists--physicians who specialize in the prevention, detection and treatment of illnesses in adults. ACP is the largest medical-specialty organization and second-largest physician group in the United States after the AMA.

ACP Leadership Day brings together primary care physician advocates from all over the country to discuss national health policy and to lobby for key health regulation. I went as a representative of the Georgia Chapter along with six other physicians from our state, including our Chapter Governor, Jacqueline Fincher, MD, MACP, a medical resident and a medical student from Emory University School of Medicine and Executive Director of the Georgia Chapter, Mary Daniel.  The event included a learning session in which we reviewed the ACP’s priorities.  We heard from ACP president Virginia Hood and Bob Doherty, SVP, Governmental Affairs & Public Policy for ACP. Dr. Doherty also summarizes the day in his blog ACP Advocate.

Nancy Nielsen, MACP, Senior Advisor, Center for Medicare & Medicaid Innovation spoke, appealing to physicians to provide feedback to the Center on the recently proposed rule for Accountable Care Organizations, which has been criticized for its complexity and for being out of reach for smaller medical practices.  We also heard from a bipartisan congressional panel that discussed the ACP priority issues in the context of current legislative considerations. As one might imagine, much of this year’s discussion focused on the national budget crisis and lack of available funds for key Accountable Care Act programs.  Later in the evening, after a keynote address by Alex Castellanos, Political Strategist and Analyst at CNN, Max Baucus was awarded the Joseph F. Boyle Award for Distinguished Public Service. 

The ACP supports the following legislative action:

•  Fix the Sustainable Growth Rate:  The "SGR" is the formula used to determine physician payment by Medicare. The formula is linked to the GDP. However, with advances in technology and the aging population, health expense has outpaced inflation leading to a series of short term fixes to avoid drastic cuts in physician payment.  The "fixes" continuously threaten to expire. The next expiration date is January 1^st, 2012 when physician payment will be cut by 29.5% unless action is taken.  As reported recently in Modern Medicine: 

"Wiping out Medicare’s accumulated debt would cost almost $300 billion, according to the Congressional Budget Office, and maintaining it with 0% updates until the end of the decade would cost more than $275 billion. With the current focus on reducing the deficit, neither of those options looks appealing."

• Fund programs that support expansion of the primary care workforce:   the National Health Service Corps, Section 747 Training in Primary Care Medicine and the National Health Care Workforce Commission.   

• Strengthen access to primary care, improve quality and lower cost by funding: 
• The Medicare Primary Care Incentive Program, which preserves primary care incentive payment through 2015, while enacting further reforms to strengthen primary care (Medical Homes and Accountable Care Organizations).
• The Medicaid Comparability Program (ties Medicaid payment rates to Medicare rates--currently they are significantly lower).
• The Center for Medicare and Medicaid Innovation.  The new Center needs adequate resources to accelerate broad pilot testing of new health care delivery models to improve access, quality and value)
• The Patient Centered Outcomes Research Institute, which researches the clinical effectiveness of different treatments to better inform patients and physicians in decision-making.

• Improve Health Reform by supporting:
• Empowering States to Innovate (allows states to opt out of ACA requirements three years early if they enact a program with equivalent coverage, i.e. Vermont).
• Patient’s Freedom to Choose Act, which repeals a provision of the ACA that requires that physicians provide written authorization for over the counter drugs reimbursed by a flexible spending account or a health savings account.
• State pilots to test health courts (would have medical liability cases heard by expert judges rather than lay juries).

On Thursday the Georgia Chapter broke out into small groups to speak with our legislators about these priorities.  Among others, our chapter met personally with Senator Saxby Chambliss and Representative Tom Price.  I was struck by various things I learned while at Leadership Day.  As I spoke with a local physician who is employed by the Piedmont Physician’s Group in Atlanta I learned that this large multispecialty group is no longer accepting new Medicare patients who are enrolled in Medicare Advantage programs, and that many Piedmont physicians are also closed to new traditional Medicare patients. This speaks to the significant access issue that patients of the future will have unless Medicare is able to successfully reform, while still guaranteeing stable reimbursement for physicians. 

In Washington there was significant discussion about Medicare innovation and the proposed new models of care delivery—Medical Homes and Accountable Care Organizations.  Whether or not participation in such models will be feasible for small independent physician practices remains to be seen—and many are fearful.  At present most physicians cannot get health insurance funding for being “Medical Home” certified.  Locally, in Atlanta, several hospital-based groups are experimenting with Medical Home Pilots:   Wellstar participates in a Medical Home pilot with Humana, Piedmont Physicians Group participates in a Medical Home pilot with Cigna, and Emory will soon launch a Medical Home pilot with Aetna. However, none of these pilots involve more than a single payer.

While I sensed bipartisan support for fixing the SGR, there was significantly less agreement about how to best reduce Medicare cost while improving quality of care and access.  

CMS’ Administrator Don Berwick recently stated in the Health Affairs blog that health care transformation

"won’t yield to a massive top-down national project...Successful redesign of health care is a community by community task. That’s technically correct and it’s also morally correct, because in the end each local community – and only each local community – actually has the knowledge and the skills to define what is locally right"

This being said, Dr. Berwick will need to work to succeed in convincing many that implementing these ACA programs can make a positive difference on a community level in improving health care. To help reach consensus from both sides of the aisle, ACP Leadership Day was a good opportunity for practicing internists from around the country to tell their local stories, illustrating how federal policy impacts day to day practice on a micro-level. I hope that some of our messages were heard.

Osteoporosis: What about Men?

Treating reduced bone density in women is a big business—from its detection with bone density screening (DXA), to its treatment with medications, such as the blockbuster bisphosphonates, to the medical care that the condition generates through referrals to specialists.  It seems curious to me that men have been neglected as the objects of this frenzy.  

It’s estimated that the lifetime risk of an osteoporotic fracture in women is 1 in 2, and in men that it’s 1 in 5. With our aging population, hip, femoral and vertebral fractures are a significant source of morbidity and mortality in the elderly.  I’ve written about treating bone loss in women: “Osteopenia: to treat or not to treat.”  A study published last year in the Annals of Internal Medicine demonstrated that although hip fractures are more common in women, they lead to higher mortality in men. In general, the onset of osteoporosis is ten year delayed in men compared with women.

Recently a middle-aged man consulted with me about osteoporosis.  Several years prior a gastroenterologist had been worried about my patient’s chronic use of omeprazole, a proton pump inhibitor. Proton pump inhibitors reduce acid secretion in the stomach. Their use has been linked to reduced absorption of calcium and possibly to an increased risk of osteoporotic fractures, though this is still controversial.  A bone density test was ordered and my patient’s bone density was found to be low, in fact, in the “osteoporosis” range (T score <-2.5).  My patient was sent to an endocrinologist and was determined to have no secondary risk factors for osteoporosis.  However, my patient was prescribed alendronate.  With no clear end in sight for treatment with this medication, he asked me whether I felt it was necessary to continue.

The fact is little is known about treating men’s bones--that is, the ones in their skeletons.  

A few trials have looked at DXA screening in men and found that T-scores, the measurement used to define bone loss (a “T-score” is the standard deviations from the mean for peak bone density), are as predictive of fracture risk in men as they are in women. However, the data is very limited. Bisphosphonate use has not been widely studied in male patients, particularly not in younger men with idiopathic osteoporosis.  A couple of trials have looked at alendronate use in men with secondary risk factors and found it to have efficacy in preventing fractures.  Best practice guidelines for treating osteoporosis in men were published in April 2011 by Gielen in BEST PRACTICE & RESEARCHCLINICAL ENDOCRINOLOGY & METABOLISM , which states:

 “With the ageing of the population, male osteoporosis is an increasingly important health problem:  from age 50 onward, one in three osteoporotic fractures occurs in men and fracture-related morbidity and mortality is higher than in women. In men with low BMD, 50% have an underlying cause, most often glucocorticoid excess, hypogonadism or alcohol abuse.  DXA is recommended in all men from 70 years of age on and in men age 50–70 with a prior fragility fracture or clinical risk factors.  Treatment decisions should be based on assessments of absolute fracture risk and not on  BMD alone.  Supplementation of calcium and vitamin D is essential in ageing men to prevent age-related secondary hyperparathyroidism.  Bisphosphonates and PTH seem to be as effective in men as in women and should be given to men with DXA-documented osteoporosis, a prior fragility fracture or high absolute fracture risk as assessed by FRAX.  Testosterone replacement can only be recommended in older men with osteoporosis who have symptoms of hypogonadism as well as total testosterone values below 250 ng/dL(9 nmol/l).”

Experts acknowledge that while bone mineral density testing may be useful, it is just one piece of the equation when it comes to assessing a person’s fracture risk. Clinical risk calculators take into account clinical risk factors and project a person’s ten year risk of suffering an osteoporotic fracture. The most widely known risk calculator is called FRAX,  a tool developed by the World Health Organization.  Clinical factors that contribute to fracture risk include age, body mass index, tobacco use, glucocorticoid use, alcohol use (>3 drinks per day), parental history of hip fracture, “secondary” causes of osteoporosis (low testosterone, hyperparathyroidism, hyperthyroidism and certain drugs),  and the presence of rheumatoid arthritis.

In their recently released Guidelines on the Treatment of Osteoporosis the USPSTF concludes that there is insufficient evidence to support screening men for osteoporosis. 

The case of my patient is a good example of how the well-intentioned use of testing may lead to information that we just don’t have good answers for yet.  In the absence of firm data, the question becomes, does one opt to treat with medication, for how long, and with what sort of monitoring? And if not, then what should one suggest?  Frankly, I find the relative lack of data about male osteoporosis surprising.

Henrietta Lacks, Ethical Dilemmas Then and Now

Recently I read the book The Immortal Life of Henrietta Lacks by Rebecca Skloot.  This book is a must read for anyone involved in medical research.  The book tells the story of a woman, Henrietta Lacks, and her family.  Ms. Lacks was treated for cervical cancer at John’s Hopkins in 1951. Her malignant cervical cells were harvested and disseminated to become the first "immortal" cell line widely used for scientific research, including their use in the development of the polio vaccine.  The story details what occurred in the aftermath of Ms. Lacks’ death to her family, a poor African-American family living in Maryland. A family, which in today’s lingo, had very poor “health literacy.” The account brings up key ethical issues of biomedical research, which were evolving during that era.

At the time of Henrietta Lacks the concept of informed consent was still in its infancy.  Institutions, such as John’s Hopkins, where Ms. Lacks received her care, did not have Institutional Review Boards (IRBs) to govern and approve their research protocols. The story of the HeLa cells began after the Nuremberg trials of World War II, which involved  experimentation on concentration camp prisoners of the Holocaust and the eventual Nuremberg Code and World Medical Association’s Declaration of Helsinki in 1964, which described a code of ethics for research involving human subjects.  The events of the Lacks family took place in the same era as the ”Tuskegee Experiment” (1932 -1974), conducted by the U.S. Public Health Service. Tuskegee gained notoriety by studying the natural history of untreated syphilis in poor African-American sharecroppers in Tuskegee, Alabama.  Its participants were led to believe that they were receiving syphilis treatment from the Public Health Service, when in fact the treatment (penicillin) was being withheld for the sake of research.  Nuremberg and Tuskegee shaped the precedent for federal regulation of biomedical research involving human subjects with the creation of the Belmont Report in 1979, which describes the core ethical principles that must be met in conducting  biomedical research on human subject. At this time federal regulation was enacted calling for the implementation of IRBs to oversee human subject research in all institutions involved in conducting research.  Those of us who have participated in research at academic institutions should be well aware of this history, which we all review in our IRB certification process.

What is interesting to me about the Henrietta Lacks story is comparing the evolution of biomedical research ethics in that era (1940s-70s) with the ethical dilemmas that face us today.   At the time of HeLa cell dissemination informed consent was at the forefront of discussion, whereas in our current era we have struggled with two core elements of ethics in biomedical research: privacy and managing conflicts of interest.  In 1996 the HIPAA privacy rule was enacted establishing nationwide security standards and safeguards for the use of electronic health care information as well as the creation of privacy standards for protected health information.  HIPAA went through various iterations prior to its evolution into its current version issued in 2002.  Similar to the response that occurred in reaction to federal policy outlining requirements for informed consent, researchers of today have oft complained that HIPAA has been an impediment to scientific progress and research.  The latest HIPAA debate has revolved around federal requirements that medical providers and insurers notify patients in the event of discovering a privacy breech. Multiple examples of such privacy breaches have been described in the media ranging from stolen laptops to identity theft. Interestingly, in 2010 a health plan, Cignet Health, in Maryland was sued over non-compliance with HIPAA and fined a monetary penalty of 4.3 million dollars. However, the suit was not over a breach of confidentiality; rather, it was over Cignet’s refusal to allow 41 of their patients access to their own medical records.

In addition to sorting out privacy at is relates to biomedical research, medical care, and electronic communications, the other core ethical issue defining our era is conflict of interest.   In 2008 Senator Charles Grassley, Republican of Iowa, brought to light conflicts of interest that were prevalent in the world of psychiatry.  At the time, according to Grassley’s investigation, 30 percent of funding for the American Psychiatric Association, the premier professional organization in the field of psychiatry, came from the pharmaceutical industry.  What followed suit was an unveiling of pharmaceutical ties that were reported to contaminate the thought leaders of many research institutions in all fields of medicine.  My own institutional affiliate was not immune and in 2008 Charles Nemeroff, renowned researcher in psychiatry and chair of the Department of Psychiatry at Emory University gave up his title and eventually left Emory after being investigating by Grassley.    Academicians can attest to the changes that have occurred in the past several years with respect to disclosures of financial interest in research centers.  Is it a witch-hunt, or is the cleansing of these relationships based in true ethical conflict? After all, isn’t conflict of interest inherent in all of business? 

The story of Henrietta Lacks was interesting from a historical perspective.  It took decades to sort through informed consent.  In contrast, the debates over health privacy and conflict of interest are still in their infancy.  The fact that remains similar, however, is that the underprivileged, and medically “illiterate” are far more likely to be the subject of ethical violations than others—even in today’s era.   In the case of the Lacks family, poor communication and lack of confidence on the part of the medical establishment that the family would be able to grasp the content of the discussion, resulted in a lack of informed consent.  Today, who is more likely to be deidentified appropriately in a medical blog, a Hispanic patient at a county hospital, or a wealthy business executive?  No wonder the underprivileged are often suspicious of traditional medicine.