Category Archives: Politics

The Cost of a Cure: What’s the Right Price?

Recently, two significant pharmaceutical breakthroughs have resulted in a renewed debate about the costs of drug therapy. In the last year, a new drug class for the treatment of Hepatitis C has been released by two different manufacturers and has been found to cure a once incurable chronic liver disease for nearly 90% of patients who are treated with a full course of therapy. The drug appears to be safe and highly effective—however, the cost of a curative course of therapy is nearly 80K dollars. As you might imaging, there are already barriers to access for many patients including those treated in the Veterans’ Affairs (VA) system as well as those on government based insurance programs such as Medicaid.

In the last several months, another remarkable, potentially “game changing” drug has been approved and released into the market. These drugs, made by Regeneron and Sanofi, are intended for patients who do not achieve adequate cholesterol reduction with standard statin therapy (the current standard of care).   According to some analyses, these drugs, when used in the appropriate patient population, may result in the prevention of thousands of cardiovascular related deaths. However, just as seen with the new hepatitis C drugs, the price tag for therapy is exorbitant—nearly 15K dollars annually. With the Hepatitis C drug, therapy is only required for approximately 12 weeks and then is no longer needed—with the cholesterol drug, the therapy will most likely be lifelong.

This month a study examining the cost effectiveness of these new cholesterol drug has been published and concluded that the drugs are far over-priced (nearly 3 fold) for the benefit that they produce. Based on a pure economic analysis, researchers concluded that the drugs should actually cost between 3K and 4K dollars annually rather than the current 15K price tag.

Did Healthcare Reform Forget Big Pharma?

The purpose of the Affordable Care Act (ACA) (as touted by supporting politicians and its authors) is to make health care accessible and affordable to all Americans. Certainly this is a noble goal and one that we should continue to strive to achieve. However, the legislation has failed to meet this mark. While addressing physician reimbursement and clinical behaviors (and limiting choice and physician autonomy), the ACA has done nothing to regulate the high price of pharmaceuticals. Big pharma is allowed to charge exorbitant prices (whatever the market will bear) without regulation. It is clear that pharmaceuticals must reclaim their research and development investments and make a profit—however, many of these drugs are far overpriced and pricetags are simply designed to exploit the system and maximize corporate (and CEO profits). IN addition, many of the most expensive drugs in the US are sold overseas and in Canada at a fraction of the cost. This seems to me to be clear evidence of the pharmaceutical industry taking full advantage of the inherent wealth in the US today.

However, Would it not follow that if we placed limits on the prices of new drugs and paid “fair and equitable” charges, that healthcare costs would significantly decline?

It seems our politicians have sought to attack the problem from a few angles and have failed to address other significant sources of excessive healthcare spending. While reimbursement for physicians and physician groups are set clearly in the crosshairs of the ACA, it appears industry and litigators are not even on the radar. There is hope—legislation is being introduced that will allow legal purchase of drugs from Canada for Americans. In addition, pharmaceutical companies would be required to disclose what they charge for the same drugs in other countries. I believe this is a step in the right direction. Lets continue to innovate and provide new therapies for ALL Americans. But lets do it in a way that is cost effective. The latest studies make it clear that these drugs are overpriced. We must find a way to negotiate a fair and reasonable price that promotes and rewards innovation BUT also provides access to the newest and most effective therapies for all who need it.

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Reflecting on Medicine in 2014: Sailing Rough Seas and Finding Uncharted Waters Ahead

As we close out on a tumultuous 2014 in healthcare, many physicians are looking forward to a better and more stable 2015. For most of us, 2014 has been marked by significant change. Many healthcare providers have seen their jobs and their patient care roles transform completely. Physician autonomy has diminished and regulation and mandated electronic paperwork has more than doubled. Many physicians find that they are spending far less time caring for patients and a greater proportion of their available clinical time is now being spent interfacing with a computer—both at work and at home on personal time.

During the last year, we have all been affected by the rollout of the Affordable Care Act (ACA), changes in reimbursement, as well as the implementation of a new billing and coding system (ICD-10). For many of us, it also marked a year of transition to system wide electronic medical record systems such as Epic and the growing pains associated with such a major upheaval in the way in which medicine is practiced.   Many practices have continued the trend of “integration” with larger healthcare systems in order to remain financially viable. The American College of Cardiology estimates that by the end of 2014, nearly 60% of all physician members have integrated with hospital systems and this number is expected to rise even further in 2015—ultimately defining the death of private practice as we know it.

Why have these changes occurred?

Ultimately, I believe that the changes to the way in which healthcare is delivered has come about due to 3 distinct reasons:

 1. Declining Reimbursement

Currently reimbursement continues to fall. Multiple government budgetary “fixes” have led to much uncertainty and instability in medical practices (much like seen in any small business with financial and market instability). In addition, the implementation of the ACA has resulted in the expansion of the Medicaid population in the US—now nearly 1 in 5 Americans is covered under a Medicaid plan. Traditionally, Medicaid plans reimburse at levels 45% less than Medicare (which is already much lower than private insurance payments). While the Obama administration did provide a payment incentive for physicians to accept Medicaid, this incentive expires this week. Many practices are becoming financially non viable as overhead costs are risking to more than 60%. As for the ACA, many exchanges have set prices and negotiated contracts with hospital systems—leaving many practices out of network. Both patients and doctors suffer—longtime relationships are severed due to lack of access to particular physicians.

2. Increasing Administrative/Regulatory Demands

With the implementation of the ICD-10 coding system, now physicians are confronted with more than 85, 000 codes (previously the number of codes was approximately 15,000). In addition, “meaningful use” mandates for payment have resulted in increasing documentation requirements and even more electronic paperwork. In addition, the implementation of new billing and coding systems has required increasing staff (more overhead) as well as intensive physician training. Sadly, the new coding system that has been mandated by the Federal government includes thousands of absurdities such as a code for an “Orca bite” as well as a code for an “injury suffered while water skiing with skis on fire”.

3. Electronic Medical Record Mandates

Federal requirements for the implementation of Electronic Medical Records and electronic prescribing have resulted in several negative impacts on practices. While in theory, the idea of a universal medical record that is portable and accessible to all providers is a noble goal, the current reality in of EMR in the US is troubling. There are several different EMR systems and none of them are standardized—none of them allow for cross talk and communication. Many small practices cannot afford the up front expenditures associated with the purchase and implementation of the EMR (often in the hundreds of thousands of dollars).   In addition, the EMR has slowed productivity for many providers and resulted in more work that must be taken home to complete—not a good thing for physician morale. Finally, and most importantly, the EMR often serves to separate doctor and patient and hinders the development of a doctor-patient relationship. Rather than focusing on the patient and having a conversation during an office visit, many physicians are glued to a computer screen during the encounter.

So, What is next in 2015?

While I have probably painted a bleak picture for Medicine in 2014, it is my hope that we are able to move forward in a more positive way in 2015. I think that there are several very exciting developments that are gaining momentum within medicine and healthcare in general.  Innovation and medical entrepreneurship will be critical in moving healthcare forward in 2015.  Physicians must continue to lobby for the tools and freedoms to provide better patient care experiences for all stakeholders in the healthcare space.

2015 begins with much promise. I am excited to see what we as healthcare professionals will be able to accomplish in the coming year. We must continue to put patients first and strive to provide outstanding care in spite of the obstacles put before us. While 2014 provided challenges, we must rise above the fray and continue to advocate for a better healthcare system in the US today and in the future.

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Obama’s Latest Bait and Switch for Docs: Medicaid Payments to be Cut by 40%

As we enter year two of the Affordable Care Act, we have seen many issues arise during implementation.  Through both executive order and executive memorandum, President Obama has unilaterally changed the law more than 100 times in order to advance his own political agenda.  When it became important to publicize enrollment and increased coverage of the uninsured, the President and the ACA provided for an increased payment scale for patients with Medicaid.  With the rapid increase of Medicaid insured patients due to the implementation of the ACA, the administration utilized the increased payments as an incentive to attract more physicians to participate in Medicaid programs.  According to the New York Times, the ACA has resulted in the largest increase in Medicaid covered patients in history–now nearly 20% of all Americans are covered under this plan.  Attracting physicians to cover Medicare patients has been critical in order to meet the demand for access to care and  to adequately cover the newly insured.  Now, unless changes are made this week, Medicaid reimbursements will be cut once again leaving many physicians to wonder if they can continue to treat the increasing numbers of Americans covered thru these programs.

Traditionally, Medicaid has reimbursed physicians at rates significantly lower than Medicare–making practices with large numbers of Medicaid patients financially non viable.  As the ACA was rolled out, a provision provided for significantly better Medicaid payment rates to physicians in order to help provide larger networks of care for the newly insured.  Now, there looms an automatic payment rate cut of nearly 43% for Medicaid payments to primary care physicians–many of these are the same physicians who agreed to expand Medicaid within their practices in order to meet demand.  According to Forbes, traditional Medicaid reimbursement averages just 61% of Medicare reimbursement rates (which is often significantly lower than private insurance rates).  In addition, many Medicaid patients require a disproportionate amount of time and resources from the office–doctors are caught between a “rock and a hard place”–between a moral obligation to treat these patients and a desire to avoid financial ruin.  These patients tend to be sicker, have multiple medical problems and have suffered from a long time lack of preventive care.

Finances are not the only piece of the Medicaid puzzle. Government regulation and paperwork and processing often delays payments to physicians and impacts their ability to run a financially sound business.   Interestingly, a study from 2013 published in Health Affairs suggested that while physicians welcomed an increase in reimbursement rates as incentive to treat Medicaid patients that quicker payment times, reduced paperwork and simplified administrative processes would also need to be a part of any type of reform.  (of course, none of these items were included in the incentive package).

Many primary care physicians stepped up to answer the call for increasing coverage of Medicare patients when the ACA was initially rolled out.  Now, these same physicians are contemplating the need to drop these patients from their clinics with the pending change in reimbursement.  As mentioned above, in addition to lower reimbursement rates, the Medicaid program requires an enormous amount of administrative work in order to file claims and these claims are often paid very late–those running a small practice are forced with more work for less pay and often have to make difficult budgetary decisions in order to  payroll for their staff each week.   While the administration touts the swelling numbers of Medicaid covered patients–nearly 68 million currently–I suspect access to quality care will soon become an issue.  Just as with every other manipulation of the ACA over the last two years, legacy and political agendas have taken precedent over what really should matter–providing quality medical care AND prompt, easy access to care for the formerly uninsured.  In an effort to tout swelling numbers of “covered” Americans, the Obama administration has failed to anticipate the impact of short term financial incentives for primary care physicians to accept increasing numbers of Medicare patients.  Even in states such as California, officials are bracing for a large number of physicians who have announced that they will likely drop out of Medicaid plans if the planned cuts are implemented as scheduled.

It is time for the Obama administration to stop playing political games with our healthcare.  If the mission of the ACA is to provide affordable quality healthcare for all Americans, then we need to ensure that there are quality, dedicated physicians available to provide that care.  The Medicaid “bait and switch” is just one example of our President’s shortsightedness and lack of connection to those dedicated physicians who work tirelessly to ensure that ALL patients have access to care (regardless of insurance type).  It is my hope that the new Congress will engage with the physician community and find real solutions to the US healthcare crisis–and no longer allow the President to place his perceived legacy over the healthcare of those Americans who are in need.

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Image adapted from The Peanuts comic strip by Charles Shultz

The Supreme Court Tackles Social Media: The First Amendment and the Rule of Law on the Internet

Social Media and the internet have often been compared to the “Wild West” at times when it comes to the posting of ideas, opinions and beliefs.  There has been very little regulation of what is posted and how it is utilized–which may actually be a good thing.  However, many of us have learned (often the hard way) that many posts on Facebook, Twitter or other social media sites can be taken out of context and misinterpreted by the masses whom the information may not have been intended for.  As physicians who are active on social media we have even more to consider when taking to the internet.  We must be very careful to choose our words for posts wisely and make sure that we leave very little open to interpretation.  We must be mindful of the legal implications of what we say and do online and must be mindful of patient confidentiality issues as well as standards for professional conduct.  Medical boards across the country have developed guidelines for physicians on social media and academic papers have been published on the subject in the Annals of Internal Medicine.  Now, even the nation’s highest court is venturing into the regulation of social media and the intricacies and legal implications of both the subjective and objective interpretation of online posts.

This week, the Supreme Court will be hearing arguments concerning the classification of social media posts as “free speech.” Unlike face to face interactions, cyber interactions can often be interpreted many different ways.  Social media posts can lack context, facial expression and inflection.  Last year a man was sent to prison for posting threats to harm his estranged wife on Facebook.  His posts were absolutely violent and inappropriate in nature and–when simply read out loud–conveyed a sense of intent.  While no crime was committed and no act of violence occurred the defendant was prosecuted and convicted based on a Federal statute involving the criminality of the interstate communication of threats to harm others.  The defendant argued that he was simply writing a “rap” on his Facebook page, expressing his feelings and had no real intention of harming his wife or acting on any of the perceived threats.  However, the interpretation of these comments by the estranged wife and others constituted a criminal offense and resulted in his imprisonment.  While I do not in any way condone this type of online behavior and speech, I do think that it may greatly influence rules the internet “playground” in the future.

Because of its national attention and the fact that arguments will be held in front of the nation’s highest court, this case will have lasting impact on social media and the classification of what is considered free speech in cyberspace.  As outlined in an article published in the New York Times earlier this year, at issue is whether or not posts on social media should be interpreted “objectively” or “subjectively”.  If you interpret the threatening words objectively, you may conclude that the threat is real and that most reasonable individuals would see this as an imminent danger–however, as the counsel for the defendant argues, if you subjectively interpret the words you may be convinced that it was simply the musings of an artist creating a poem or a rap song in response to a life crisis and posed no danger.

Regardless of the outcome of this Supreme Court case, it should serve as a wake up call to all of us who are active on Social Media.  We must continue protect our rights to free speech and expression on the internet.  However, we must also be mindful of our words and how they may be interpreted by others.  Social media is an important tool for all of us to use in order to positively impact others and influence opinion–certainly free speech is protected but we must take care not to abuse these protections.  The individual involved in the criminal case–regardless of intent–showed poor judgement in his public posting and is now dealing with the consequences of his decisions.  However,  I certainly hope that the Supreme Court carefully considers the impact of any opinion they may render in this case. The internet and social media must remain a place for creative expression and innovation–too much regulation and any limits to our right to free speech in cyberspace would have serious negative consequences for all of us.  This case should serve to remind us of one important fact–As physicians and healthcare professionals active on social media, we must hold ourselves to a higher standard of online behavior and continue to remain professional in all that we do online.

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Controlling the Costs of Innovation: Let’s Refocus and Remember The Patient

In a controversial study released this week, Tufts University’s Center for the Study of Drug Development estimates that the cost to bring a new drug to market exceeds nearly 2.6 billion dollars.  The study, which was 40% funded by industry has been criticized for over estimating these costs in favor of industry and misrepresenting some cost estimates.  While we will not know fully the extent of the methodology of the study until later in 2015 when it is published in a peer reviewed journal, these preliminary findings were released in advance and have already begun to spur debate.

However, irrespective of these criticisms, I believe that the study does have merit and brings an important issue forward—is the FDA stifling innovation with excessive fees and paperwork?  Are smaller, less well funded researchers/corporations unable to significantly contribute without partnering with big pharma? Who will ultimately bear the increased cost of drug development?

Innovation is what has always made healthcare in the US great–it is what separates us from the rest of the world.  For decades, the US has been able to attract talent from throughout the world and this has resulted in numerous “game changing” breakthroughs in medicine.  Through continued development of new drugs, new technologies and new ways to better treat disease, we are able to improve outcomes and reduce death from preventable disease.  The US has always been a place where others from around the world have come to incubate and grow ideas.  Now, it appears that innovation must come at a substantial cost–the increasing capital required for drug development as well as taxes on medical device companies only serve to squeeze out the “small guys with big ideas” and limit our ability to continue to produce new, more effective therapies and cures.  In addition, these additional costs to the pharmaceutical industry are not simply added to their bottom line–they are pushed on to the healthcare consumer as well as Federally funded healthcare plans.  Ultimately, the taxpayer bears the brunt of the increased cost.

The process of drug development is long and arduous.  Government regulation, politics and greed have served to make it even more difficult.  Physicians in academic medicine, scientists, pharmacologists and leaders in industry have learned to partner and share ideas in order to bring basic science principles from the bench to the bedside—ultimately translating ideas into cures.  Certainly, big pharma is in place to make profits and increase market share.  But as costs increase, many drug makers are putting less and less profit back into research and development.  Growth can become stagnant and new ideas may never reach the bench or bedside.  Federally funded research–such as NIH grants–face big cuts and budgets are often embroiled in political battles.  Legislators use research dollars as bargaining chips and fund projects that appeal only to a particular interest group or a group of favored donors.  We must find a better way to promote medical innovation and reward research.  We must find better ways to choose the most promising projects for funding.  We must be good stewards of the R & D dollar and make every single investment count.

As with most things in medicine, we must always pause and remember to focus on the patient.  Advocating for the patient suffering with disease is the reason most of us became involved in medicine in the first place.  Whether the study from Tufts over-estimates the cost of development or not, it should still serve as a wake up call to us all.  We must work to control the cost of developing new therapies—we must limit excessive taxation, we must promote entrepreneurship and begin to fix the current system of FDA approval for new therapies.  We must separate politics from medicine and streamline processes—eliminate paperwork and promote efficiency–if we are to continue to lead the world in medical innovation.  We must continue to make room for the “small guy with the big ideas”–If we do not–ultimately it will be our patients that suffer in the end.

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Heads in the Sand: Obama, the CDC and Claims of Ebola Preparedness

Thousands of people have travelled from West Africa to the US in the last 6 months.  While the CDC and others throughout the Obama administration continue to reassure everyone that the US is 100 percent prepared for an outbreak,  potential cases and exposures continue to surface all across the country.  In Dallas, the first confirmed case of Ebola remains in critical condition.  Even more concerning is the fact that the patient initially presented to the Emergency Room with a fever at Texas Health Presbyterian Hospital (and even though he provided a high risk travel and exposure history) we was sent HOME.  Initially, the hospital blamed the fact that he was sent home with high risk features (his records documented the fact that he had just travelled from Liberia) was that there was a “technical glitch” in the electronic medical record and that physicians were unable to access the data obtained by the triage nurse.  Days later, the hospital rescinded their comments and admitted that the data was there for anyone involved in the case to see but in fact, no one even noted his West Africa travel history and released him from the ER.  These missteps resulted in the potential exposure of nearly 100 contacts AND the isolation of several family members.  But today, the director of the CDC, Dr. Tom Frieden, continues to proclaim on the national media that the US is well prepared and that all local healthcare agencies have policies and procedures in place to avoid major outbreaks and exposures.

Really?  Its Time for the CDC and our administration to get its collective head out of the sand!  

According to the WHO, the number of Ebola cases is expected to continue to rise sharply in the month of October.  The CDC estimates that there may be as many as 1.4million cases before the current outbreak is over.  Others worry that the disease is now so far out of control in West Africa that it will soon become endemic.  Currently, most families in West African countries actually spend nearly 80% of their monthly income on food–now prices are increasing and food is becoming even more scarce.  As West African nations become increasingly economically challenged by the outbreak, it is likely that many will flee the country illegally (and untracked and unscreened)–resulting in further spread of disease and wider contact with individuals from other nations.  The first US case admitted to lying on his immigration forms before fleeing Liberia and would have been considered high risk due to close contact with family members with documented Ebola.  At this point, the CDC and its leadership continue to proclaim that they are “looking at possible actions” to help prevent the entry of Ebola into the US.  However, there are no specific plans in place and no real travel protocols have been established.  US air carriers admit to confusion about what to do and how best to screen passengers.  One particular airline has told its employees to treat all bodily fluids on flights as potentially infectious.

Now certainly, we should not panic.  I agree that the US is better equipped to handle an outbreak of an infectious disease than any other country in the world.  We have state of the art isolation facilities, an abundance of medical resources and the wisdom of many of the worlds’ brightest physicians.   Our advantages in treating any potential Ebola cases in the US are huge—However, we must put policies and procedures in place NOW–not after more cases appear stateside.

What steps can we take to prevent Ebola spreading in the US?  First, we need to make sure the virus does not arrive here–and when it does we must have a plan in place to isolate and contain any potential carriers

 

  1. Initial standardized screening of people travelling from endemic countries must be set into place now.  We must consider travel bans and Pre Flight 21 day quarantines prior to travel to the US in order to ensure that no patients with disease are inadvertently admitted to the US.
  2. Airline personnel must have standard protocols in place should a passenger become sick–isolation equipment and protective gear must be readily available and crews should be provided with specific training designed at protecting themselves as well as other passengers.
  3. Improved education for healthcare providers, emergency department personnel and first responders.  We must put protocols for response in place that are easily implemented when confronted with a suspected case.  Travel history and exposure history must become the first line of defense–we cannot afford to send a high risk patient home again.
  4. Immigration and Passport control should also screen all high risk travelers (from endemic countries) upon entering the US as well.  Those that are considered to pose a risk must be quarantined upon arrival for 21 days.
  5. Private industry resources must be focused on the mass production of vaccines such as ZMAPP and other potentially life saving drugs. While government should play a role in development and deployment, the private sector should be leading the charge in order to avoid the inevitable slow downs associated with government led initiatives.  These drugs should be fast tracked and studied while being put to use in West Africa.  While the science behind their effectiveness is solid thus far, there have not been nearly enough clinical trials and standard safety and efficacy trials put in place.   However, these drugs must be tested in practice in areas of outbreak.  We do not have time to await months to years of clinical trials in healthy subjects.

So, where is our government in all of this?

At present, both the Obama administration and the CDC continue to downplay the threat of Ebola in the US.  I fear that while government rhetoric continues to highlight the absolute preparedness of the US in the case of an outbreak, the reality of Ebola cases in the US (the one documented case thus far was sent home from the Emergency Room with a fever) are quite concerning.  I wonder if we could quickly coordinate an effective response should more cases arise?  The situation in Dallas–while contained now, had the potential to spread to more than 100 people during the initial presentation of the patient.  Today, the President will meet with the director of the CDC.  It is my hope that we will soon put policies in place to protect Americans from the spread of the disease.

We must Act rather than discuss.  We must Prevent rather than respond.

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The Cost of Childhood Obesity: Setting an Example for (Hope) & Change

Obesity and obesity related illness accounts for an enormous healthcare expenditure in the US today–approaching 150 billion dollars annually.  In an era of healthcare reform and cost containment, preventative medicine is essential to success.  Rather than rearranging networks, separating doctors from patients and limiting choice, our government may be more effective in reducing healthcare costs by focusing on slimming waistlines throughout the US.

According to a recent study in the Journal of the American Medical Association, nearly 30% of adults and 17% of children are classified as obese. According to the Centers for Disease Control, obesity in children has more than doubled in children and quadrupled in adolescents in the last 30 years.  Obesity rates in adults have remained constant–if not increased–over the study period.  In fact, in women over age 60, obesity rates have increased from 31 to 38%.   It is clear that obesity directly results in the development of diabetes, heart disease and other potentially debilitating chronic illnesses.

Data from previous studies clearly identifies habits developed in childhood as a primary determinant of obesity as an adult.  In fact, childhood obesity is almost always associated with obesity and health problems during adulthood.  This week, a study published in Pediatrics provided a specific cost analysis of childhood obesity and found that each obese child results in an individual $19,000 healthcare cost increase as compared to a child of normal weight.  Moreover, when the researchers multiplied the &19,000 figure by the number of 10 year olds who were estimated to be  obese in the US today, they calculated the total lifetime healthcare expenditure in this age group alone to be more than 14 billion dollars.

The adverse effects and negative impacts of obesity on our children stretch far beyond the staggering dollar figures that are illustrated in this most recent study.  Obese children are more likely to have risk factors for heart disease and are at increased risk for certain types of cancers.  Pre-diabetes is common in obese children and many develop Type 2 diabetes before adulthood.  Children with weight problems are more likely to suffer from depression and other mental health disorders including poor self esteem.  Development of such significant medical problems at an early age can prevent a child from truly enjoying the process of growing up and can limit choices and opportunities later in life.

Children of obese parents are far more likely to be obese themselves.  America is becoming a culture of sedentary adults (and now children)–increased calorie intake and diminished calorie output.  Our children model behaviors that they witness in adults and other mentors.  Modeling healthy habits such as regular physical activity and healthy eating can directly impact children and significantly reduce the chances of becoming obese.  Habits developed during childhood become part of our daily routine and are incorporated into our system of values and become second nature. If we, as adults, put a priority on diet and exercise early in life, we make it much easier for our children to develop and maintain a healthy lifestyle well into adulthood.

This most recent study should serve as a call to action–Americans are fat and are getting fatter.  The time to intervene is now.  We must set better examples for our children.  In a world full of fast food and calorie dense meal choices, we must do a better job demonstrating responsible lifestyle choices.  Fill the house with fruits and healthy snacks and avoid fast food meals whenever possible.  Help children learn to choose wisely.  Parents must encourage more outdoor activities, regular exercise and limit screen time.

As healthcare costs continue to rise,  we must focus on prevention.  Cardiovascular disease, diabetes, and high blood pressure are significant contributors to our overall healthcare costs and ALL of these diseases are more likely to occur in those who are obese.  As a nation, we must become more health conscious and make daily exercise and healthy eating part of our culture–only then will we be able to impact obesity and set an example for change.  Only then will we begin to reverse the obesity epidemic of the last 30 years and improve the lives of our children and the generations to come.

 

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Obamacare Delays and Rearranging Deck Chairs on the Titanic: Old People Can’t Surf

This week the White House announced yet another Obamacare delay–actually, to be precise, they termed it an “accommodation”.  The reason given for the delay was that there were concerns voiced by the Obama administration that the “rush” to sign up during the final days may cause delays and result in a website crash.  Therefore, it was proclaimed that those who were “trying to sign up” would be given an extension to mid April to complete the process.  Overall there have been more than 20 unilateral changes/delays/exceptions made by the President without Congressional approval or oversight.  Exceptions have been provided for businesses and those who serve and work in our Congress BUT the individual mandate remains in place.   In the meantime, many that have been counted as “signing up” have no insurance and a large number have not yet paid their premiums.  However, the biggest problem with the manipulation of the Affordable Care Act (ACA) may actually be the commentary of one of its greatest supporters–Senator Harry Reid.

With the 2014 Midterm elections looming, many of those in Congress who are facing reelection have commented on the latest delays in an effort to positively spin the news.  As you might expect, those in leadership roles such as Senator Harry Reid have tried to minimize the impact of repeated Obamacare failures and fixes on his part (a desperate attempt to cling to a majority). In an effort to explain the need for the latest delay Senator Reid has shown his complete lack of connection with the nation.  He publicly proclaimed and was quoted in the Washington Times as saying that “some [old people] may not be educated about [or understand] the internet”.  In reality, more seniors than ever before are utilizing the internet in order to maintain medical information.  Pew Research Center data indicates that as of 2013, nearly 60% of all Americans in the 50-65 year old age group are actively engaged in internet based social media.  Even more telling is the fact that 50% of those over the age of 65 are involved in AT LEAST one internet based social media outlet.  It is clear that the internet and medicine will be intimately connected in the future.  Twitter, a popular site for micro-blogging in 140 characters or less has seen a 79% increase in utilization by users in the 50-65 year old age group.  When you carefully examine the Senator’s comments he is clearly referring to those in the 50-65 year old range–those over 65 will be enrolled in Medicare and have no need to go to the exchanges.  The younger populations-such as the millennials–are assumed to be web savvy from birth.

The delivery of healthcare is already evolving digitally–particularly in the areas of the electronic patient and in mobile health applications.  For Senator Reid to make such a statement concerning the inability of older Americans to “understand” the internet not only is insulting but  shows a complete lack of connection to and respect for the very people he claims to want to protect.  Seniors are more web savvy now and are able to access the web in a variety of ways–there is data from non biased scientific surveys (such as those conducted last year by Pew) to substantiate my statement.  In reality, his comments are a sad attempt to explain the inexplicable–why do the Democrats in Congress continue to hang on to a system that is clearly failing?

The ACA continues to suffer setbacks–most of them at the hands of the President who has dedicated his legacy to its success.  The latest delay (or accommodation, as the Obama Administration prefers to call it) is more about the lack of enrollees and less about the ability of older Americans to successfully interact with the internet.  Many seniors are surfing on a daily basis.  The internet is not the problem with the ACA and healthcare reform–rather it is the legislation that is broken and badly in need of a fix.

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Demanding More Transparency in Big Pharma: The Battle to Force Disclosure of Data in Negative Trials

Research and development is critical to battling disease.  Now, more than ever, technology can rapidly impact a patient and their disease process in a very positive way.  The process of developing a new drug or device is expensive and can be very time consuming.  As government funding for projects continues to decline, more funding is coming from private sponsorship according to a recent New York Times piece.  Another critical source of research funding comes from the pharmaceutical and medical device industries. Partnerships with industry can provide additional opportunities for meaningful research.  When handled objectively and with clearly stated endpoints, these studies can produce impactful results.  However, as reported in both the New York Times and the Wall Street Journal (discussing two separate issues), these relationships can also begin to blur lines between academic endeavours, patient care and profit–often calling in to question the validity of the research.

In order to stay current and provide patients with the best available therapies, physicians dedicate many hours to reading new publications that evaluate novel treatments in peer reviewed journals or hearing about new therapies when data is presented at national academic meetings.  When data is compelling, most clinicians will change practice in order to incorporate what is perceived to be a superior treatment into our therapeutic regimen. Transparency of research–whether conducted through government sponsored grants or through industry funded projects–is critical to providing patients with the best available treatments.  The evaluation of the drug must be complete and we must be allowed to see all of the steps in the development process.  However, if there is more data “behind the curtain” we may not be getting an absolutely accurate picture of the safety and efficacy of the new therapy.  Lack of clarity in medicine when treating patients can result in unintended harm.

This week in the Wall Street Journal, author Hester Plumridge reports on groundbreaking European legislation concerning the regulation of pharmaceutical companies and their drug trials. The European Parliament is voting next month to consider requiring all data for all trials conducted in pharmaceutical research to be released for public consumption.   For years, pharmaceutical makers have been able to conduct clinical trials without reporting negative results if they choose not to do so. Most drug companies conduct numerous trials in an effort to develop new (and profitable) drugs to treat disease.  The process of drug development is tedious and can take many years to go from concept, to bench to clinical trials–and eventually to market in the US via FDA approval.  Now, for the first time, European legislators are working to approve a measure that would require all studies to be publicly reported within a year of completion–irrespective of the outcome.  Obviously, publicly held corporations are less than enthusiastic about publishing failures and disappointing stockholders.  However, there well documented reports of negative data that has been withheld from review and buried within emails and confidential paperwork within commercial organizations.  Many of these have led to litigation in the US and abroad.

Data from 2009 indicates that only around 50% of all trials conducted by pharmaceutical companies is actually published and released for review by the scientific community.  According to the Wall Street Journal, only 41% of over 600 studies sponsored by the National Institutes of Health (NIH) were published within 3 years of completion.  Many clinicians are concerned that the motivation for profit may ultimately do patients harm.  Withholding negative results related to a drug in development may result in incomplete data being presented to regulatory agencies such as the FDA–for example if a drug has one positive trial and two others that showed less benefit statistically, the drug could be approved without examining all of the evidence.  This approval may lead physicians to believe the drug is more effective than it actually is.  A well known example from the recent past involved pharmaceutical giant Merck and their drug Vioxx–in a well reported case, the drug maker was accused of failing to report cardiovascular related deaths, burying negative data and hiding risks to patients in order to gain approval and profit—ultimately they withdrew the drug in 2004 and have suffered significant legal consequences since then.

We must continue to innovate.  As the healthcare industry continues to scramble to control costs in the era of the Affordable Care Act (ACA) we must continue to put patients first.  Scientists and clinicians–whether in academia, private practice as well as in industry–must continue to work together and  disclose all data concerning the development of novel therapies.  It is essential to maintain absolute transparency when dealing with human lives.  Industry is a business and will always be driven by intense pressure to develop the next billion dollar revenue “blockbuster” drug–But we must be allowed access to the data surrounding the failures as well as the successes in order to protect the lives of the very patients we strive to heal.  Companies such as Johnson and Johnson as well as GlaxoSmithKline are beginning to lead the way in terms of openness and data publication.  Healthy partnerships between clinicians interested in performing rigorous research and industry leaders who are interested in innovation are key to success going forward.  It is my hope that the European legislation passes next month and that the United States will follow the lead of our European colleagues.

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Healthcare and the Ukraine: Politics, Suffering and Disease

 ****Written in response to the recent crisis  in Ukraine.

Certainly, the world’s eyes are focused on the political unrest in the Ukraine this week.  As a physician, I am concerned about the health and well being of the Ukrainian people. Healthcare in Ukraine is substandard at best.  Life expectancies in this region are well below standards that we see in the US and other developed nations.  For many throughout the world, the tensions and threat of military violence have created a great deal of anxiety.  After years of cooperation with Russia, it appears we may be on the brink of more Cold War type diplomacy.  Although the world is more interdependent and connected than ever, the international political events of the last week remind many of us of the events leading up to other world encompassing conflicts such as the second World War.  While the attention of the media and the world is focused on the military action and political rhetoric associated with the coup de etat in Ukraine and the Russian invasion of Crimea, the people of the region continue to suffer.  I wonder if the world’s leaders would feel the same way about the region if they had friends and family in Ukraine and knew first hand of the suffering and senseless deaths (due to the broken healthcare system).  It is easy to sit in power and remain out of touch with those that you claim to want to help.

Government Managed Healthcare in Ukraine

Healthcare in Ukraine is certainly far from what we in the US expect.  Overall, the healthcare system is neglected and there is an extreme shortage of adequate facilities, medicines and qualified physicians.  While some physicians are highly skilled and well trained, the majority of clinicians in practice never completed full courses of study but are thrust into service prematurely due to extreme need.  I am appalled by the lack of competency and training and I am concerned about the impact these practitioners may have.  Ultimately, I believe that the responsibility to provide adequate care in this particular system lies with the single payor–the government.  By law, all employed citizens contribute to the cost of the national helathcare system and all citizens have a legal right to healthcare access.  However, in reality, access to care is a significant issue.  The healthcare system is funded almost entirely by government revenues–citizens must play a fee for dependents and those who are self employed must also pay additional premiums.  For the most part, the government funds all healthcare fees.  However, physician wages are very low and many clinicians charge additional fees to patients, thus further limiting access to care for many citizens.  I believe that the lack of coordination of healthcare and the lack of reimbursement to providers significantly contributes to the poor state of care in the Ukraine.

Physicians and Facilities

Physicians in Ukraine are not well compensated.  General practitioners are the first point of contact for Ukranian citizens with the healthcare system.  According to the law, citizens may choose a physician they wish to see but must make sure that each provider is covered as part of the state controlled network.  Most doctors require additional fees for care that are collected from the patient at the time of surgery.   Waiting times are significant and urgent care may be difficult to obtain and may also require pre-payment.   I understand, given the poor wages, the need for physicians to collect fees up front.  However, it is difficult to imagine a system where compensation comes before care.  Hospitals throughout Ukraine are substandard facilities.  Even though there is a great need, there are few locations that have advanced equipment and supplies.  Hospitals are often very dirty and poorly staffed.  I believe this is another reason for the poor state of health in the Ukraine and the fact that the death rate continues to exceed the live birth rate–resulting in depopulation of the region over the last decade.

For those with means, there are private clinics that are funded either through cash payments or private insurance.  These clinics provide better access to care as well as better availability of specialists and specialized services or procedures.

Disease and Life Expectancy

Since achieving independence in 1991, Ukraine has seen one of the most significant demographic declines in the world–the population has been reduced by nearly 6 million.  The overall population has been reduced by nearly 12%–higher death rates are outpacing female fertility rates and depopulation has been the result over the last decade.  Men are dying prematurely and suffer very high disability rates due to chronic, non communicable disease.  Nearly one third of the population dies before age 65 and there are a disproportionate number of working age males with chronic, non communicable diseases.

Diseases such as HIV/AIDS and Tuberculosis are rampant and occur at much higher rates than anywhere else in Europe or Asia–these diagnoses account for nearly 90% of deaths from communicable disease   Due to government bias against homosexual behavior as well as high rates of prostitution, drug abuse and addiction, HIV rates in the Ukraine continue to rise.  There are virtually no programs in place for treatment or prevention of HIV related illness and many who are infected have little hope for treatment.  I believe that in order to succeed in reducing deaths and improving health status, the government of Ukraine must make treatments for HIV available and remove the negative legal and political stigma associated with the disease.

In addition, there is a very high rate of alcoholism (the highest in all of Europe in Asia) and many of the alcohol related premature deaths also occur in men.  I believe that much of this is due to the overall poverty in the nation and the associated depression of its citizens.  The average life expectancy of a male adult in the Ukraine is only 64 years old–72 for women.  Birth rates in the country continue to decline and live births are virtually outpaced by the premature deaths.

According to the WHO and World Bank, nearly 50% of all premature deaths in Ukraine could be prevented by regular and adequate preventative healthcare.  This is an astounding number and I see this as a real call to action for international healthcare agencies

What’s next?

Unfortunately, the political unrest and potential Russian occupation is going to do very little to improve care for the Ukrainian people.  Prior to the current uprising, the previous regime had a plan to revamp and reform the broken healthcare system beginning in 2014.  I worry that unless wholesale changes are made soon, Ukranian citizens will continue to suffer premature death and battle with chronic and preventable disease.  It is my hope that as the world focuses on the politics of the region that we also focus on the people and their plight.  Healthcare is just one issue that must be addressed but is essential to the recovery of the nation.

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