PHYSICIANS IN GOVERNMENT: USUALLY GOOD, BUT SOMETIMES NOT

    This is a summary of an article appearing in the New England Journal of Medicine (Jan 12, 2017)§ With regard to the department of health and human services (HHS), only two previous secretaries have been physicians. For the most part, all of us physicians work to defend not only our own patients, but society at large against dangers to health, and in the process, usually eschew venal and self serving goals. That is why most of us chose this respected profession of care-giving in the first place.

Let us begin by describing the good doctors: Otis Bowen, our former Indiana Governor, was Ronald Reagan’s second HHS secretary, and he engineered the first major expansion of Medicare, championed comparative effectiveness research and, together with Surgeon General C. Everett Koop, another exemplary physician, led the fight against HIV-AIDS. Louis Sullivan, HHS secretary under President George H.W. Bush, focused his attention on care for vulnerable populations, campaigned against tobacco use, led the development of federally sponsored clinical guidelines, and introduced President Bush’s health insurance plan, which incorporated income-related tax credits and a system of risk adjustment. All these aforementioned physicians, serving in GOP administrations, drew on a long tradition of physicians as advocates for the most vulnerable, were defenders of public health, and enthusiastic proponents of scientific approaches to clinical care.

Now comes the bad: In sharp contrast with these previous examples, Tom Price, Trump’s pick for secretary of HHS, shows a record that demonstrates less concern for the sick, the poor, and the health of the public, in favor of greater concern for the economic well-being of the rich and the care-givers themselves.

To exemplify this point, let’s enumerate his previous positions.

  1. Price has sponsored legislation opposing regulations on cigars and has voted against regulating tobacco as a drug, in reality, this product is actually far worse than most drugs!
  2. In 2007, during the presidency of George W. Bush, he was one of only 47 representatives to vote against the Domenici-Wellstone Mental Health Parity and Addiction Equity Act, which improved coverage for mental health in private insurance plans.
  3. He voted against funding for combating AIDS, malaria, and TB, and against expansion of the State Children’s Health Insurance Program, and in favor of allowing hospitals to turn away Medicaid and Medicare patients seeking nonemergency care if they could not afford copayments.
  4. He favors converting Medicare to a premium-support system.
  5. He opposed reauthorization of the Violence Against Women Act, and has voted against legislation prohibiting job discrimination against LGBT people and against enforcement of laws against anti-LGBT hate crimes.
  6. He favors amending the Constitution to outlaw same-sex marriage.
  7. He opposes stem-cell research and voted against expanding the NIH budget and against the recently enacted 21st Century Cures Act, showing particular animus toward the Cancer Moonshot. Would he continue this stance if he were afflicted with cancer himself?
  8. He is a leader of the repeal of the ACA (“Obamacare”) in favor of a regressive “plan” which, without going into details, will offer much greater subsidies relative to income for purchasers with high incomes and more meager subsidies for those with low incomes. In effect, Price’s replacement proposal would make it much more difficult for low-income Americans to afford health insurance, diverting federal tax dollars to people who can already afford it, and also substantially reducing protections for those with preexisting conditions. The end result would be a shaky market dominated by health plans that offer limited coverage and high cost-sharing.
  9. Strongly anti-abortion and advocating the defunding of Planned Parenthood, Price has accepted the validity of the fraudulently modified videotapes used against this organization—despite their many pro-health programs for the poor.

CONCLUSION

   The HHS Department oversees a broad set of health programs that touch about half of all Americans. Over five decades covering nine presidential tenures of both parties, secretaries have used these programs to protect the most vulnerable Americans. The proposed nomination of Tom Price to HHS highlights a sharp contrast between this tradition of compassionate leadership and the priorities of the incoming administration.

I am not at all proud of this “fellow” physician!

  • Glied SA and Frank RG, Care for the Vulnerable vas Cash for the Powerful—Trump’s Pick for HHS. N.Engl J. Med. 376;2. 2017: 103-105.
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Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Bilks Both Patients and the Entire Public

high-drug-prices

In May 2015, when Isla Weston was just two months old, doctors diagnosed her with a life-threatening parasitic infection known as toxoplasmosis. Immediate treatment was needed to cure this infection; otherwise, the parasite would attack vital cells in the little girl’s brain, potentially leaving her with lifelong deficits in cognition and function—or even causing death. Isla was prescribed Daraprim, the standard of care, which would cure the active infection within a year. To the shock and dismay of the infant’s family, and other Americans who relied on this vital medicine, the price of the 63-year-old drug that this child desperately needed had just spiked from $13.50 a tablet to $750 a tablet, an increase of more than 5,000 percent, in just one day. Shocked by the astronomical price, Shannon Weston, Isla’s mother, sought desperately to come up with the almost $360,000 necessary to treat her daughter for a year with a drug that she needed. This family’s struggle sadly represents the struggle of thousands of Americans in the face of soaring prescription drug costs. In this instance, Isla ultimately received treatment, not through affordable access to Daraprim, but through the genius and goodwill of her health care team at the University of North Carolina. Mrs. Heyman ultimately found affordable treatment by switching to an alternate drug, but in doing so, she endures lifestyle restrictions and uncertainties about future effectiveness of the drug actually used.

Nearly 60 percent of Americans, including roughly 90 percent of seniors, take prescription drugs to treat conditions ranging from cancer and diabetes to high blood pressure and depression. Staggering increases in the price of some prescription drugs threaten not only the economic stability of American households, but also the health of individuals who discover that drugs they need are unaffordable. This year alone, Americans are expected to spend more than $328 billion on prescription drugs. Of this amount, individuals will pay about $50 billion out of pocket. The federal government will pick up another $126 billion in payments through Medicare, Medicaid, the Department of Veterans Affairs, and other programs. These price increases affect all Americans, whether they take prescription drugs or not, as taxpayers shoulder a substantial portion of the cost of federal health care programs.

In November 2015, Chairman Susan Collins (R-Maine) and Ranking Member Claire McCaskill (D-Missouri) formed a bipartisan Senate Special Committee on Aging to investigate the abrupt and dramatic price increases in prescription drugs whose patents had expired long ago. The Committee’s investigation centered on Turing Pharmaceuticals, Retrophin, Inc., Valeant Pharmaceuticals International, Inc., and Rodelis Therapeutics—companies that acquired decades-old, off-patent affordable drugs and then raised the prices suddenly and astronomically.

For many decades, federal policy has sought to strike the right balance between maintaining the incentives needed to promote innovation and development of new drugs, and keeping medicines affordable for patients. This balance has been struck by allowing a period of patent protection for innovative drugs, and then opening the market to generic competition to help drive down prices. On average, generics cost 80 percent less than brand-name drugs. That balance never anticipated companies acquiring off-patent drugs, for which they contributed not a single research dollar, and then dramatically increasing their prices in the absence of generic competitors.

The congressional investigation uncovered a business model that these four companies used (with some variation) to raise prices of generics excessively, which enabled them to identify and acquire off-patent sole-source drugs over which they could exercise de facto monopoly pricing power and a means to protect the astronomical price increases. The business model consists of five central elements: 1) Sole-Source. The company acquired a sole-source drug, for which there was only one manufacturer, and therefore faces no immediate competition, thus maintaining monopoly power over its pricing. 2) Gold Standard. The company ensured the drug was considered the “gold standard”—the best drug available for the condition it treats, ensuring that physicians would continue to prescribe the drug, even if the price increased. 3) Small Market. The company selected a drug that served a small market, which was not attractive to competitors and which had dependent patient populations that were too small to organize effective opposition. 4) Closed Distribution. The company controlled access to the drug through a closed distribution system or specialty pharmacy where a drug could not be obtained through normal channels, or the company used another means to make it difficult for competitors to enter the market. 5) Lastly, the company engaged in price gouging, maximizing profits by jacking up prices as high as possible. All the drugs investigated had been off-patent for decades, and none of the four companies had invested a penny in research and development to create or to significantly improve the drugs. Further, the Committee found that the companies faced no meaningful increases in production or distribution costs.

This investigation has shed light on why such companies can impose egregious price increases on off-patent drugs they have acquired and what federal policies should be considered to counter this disturbing practice. During the course of the Committee’s investigation, other companies raised their prices sharply. In April 2016, a study found that the mean price of insulin, a lifeline therapy for the 29 million Americans with diabetes, increased from $4.34 per milliliter in 2002 to $12.92 per milliliter in 2013, a 200 percent increase. In July 2016, a flurry of news stories reported another staggering price spike: the price of Naloxone, the antidote to prescription painkiller overdoses, increased by 1,000 percent, amid an opioid public health crisis. And in August 2016, news broke of a 500 percent price spike in the epinephrine auto-injector, EpiPen, which is used to save lives during allergy emergencies.

Facilitating such nefarious practices, investors and representatives from the business community often control company boards and policies which install such measures and, in the process, likely consider them business as usual, without regard to public welfare.

WHAT CAN BE DONE

The Senate Special Committee is committed to improving access and affordability of prescription medications. They strongly support continued efforts to stop the bad actors who are acquiring drugs that have been off-patent for decades, and they are considering a few counter measures noted below:

           To expedite entry into the market by potential challengers, In March 2016, senators Collins and McCaskill introduced The Increasing Competition in Pharmaceuticals Act. This legislation would take steps to incentivize competition and provide solutions to regulatory uncertainty, small market size, and other factors that serve as inherent limitations to generic entry. The bill proposes setting a reduced timeframe for the FDA to expedite the review of generic drugs that are in short supply, requiring this agency to act to approve such drug applications within 150 days. They would also encourage generic competition by allowing the FDA more latitude in approving potential individual generic competitors.

They would allow highly targeted temporary drug importation of off-patent drugs to combat major price increases.

They will study methods to prevent the misuse of patient assistance programs and co-pay coupons. Some patient assistance programs can be used to steer patients toward higher priced drugs, resulting in higher expenditures for beneficiaries, federal health care programs, and commercial providers.

The Federal Trade Commission (FTC) should be strengthened to enforce action when it comes to drug company mergers, operations, and drug market dynamics. The FTC should be allowed greater use of its authority to conduct studies of the marketplace and to consider partnerships with academia and other federal agencies. The FTC needs more resources to allow it to more vigorously oversee the off-patent prescription drug market.

Transparency in drug prices should be improved. Releasing, for example, the true price of a drug, the Average Manufacturer Price, could empower patients and doctors, prevent surprise costs at the pharmacy or on health bills, and provide Americans with a refreshing dose of reality.

By pursuing such reprehensible methods to line their own pockets, these and other companies behaving in this way—while currently operating within the limits of the law—could be controlled. We applaud efforts by governmental departments to control them. Despite the current prevailing political sentiment against governmental intervention, the ultimate salvation of the masses will likely be provided by—you guessed it—Uncle Sam!

 

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Big Tobacco’s Poisonous Legacy

tobacco

The comments below were taken from a recent blog by my cousin, Sheila Kennedy, (http://www.sheilakennedy.net/2016/12/big-tobaccos-poisonous-legacy/) and it corresponds closely to what I have been long maintaining: In essence, the strategy of climate science denial is taken directly from tobacco’s playbook! I was on the front lines in this battle at the time fighting as a volunteer for the American Heart Association and saw how extremely difficult it was to counter the political effects of big tobacco money!

In the years when tobacco companies were fighting emerging medical evidence of the links between smoking and deleterious health consequences, including cancer, they developed a diabolically effective strategy; rather than arguing that the science was wrong, they claimed it was inconclusive, that no one really knew whether cigarettes were the cause of people’s illnesses. The research was inconclusive.

That tactic worked for a long time, and as Senator Sheldon Whitehouse (D-RI) recently wrote, it has been the playbook for efforts by fossil fuel interests to delegitimize scientific consensus about climate change. In an essay for Inside Higher Ed, Whitehouse called upon universities to confront the tactic.

The threat is simple. The fossil fuel industry has adopted and powered up infrastructure and methods originally built by the tobacco industry and others to attack and deny science. That effort has coalesced into a large, adaptive and well-camouflaged apparatus that aspires to mimic and rival legitimate science. The science that universities support now has an unprecedented and unprincipled new adversary…

The science-denial machinery is an industrial-strength adversary, and it has big advantages over real science. First, it does not need to win its disputes with real science; it just needs to create a public illusion of a dispute. Then industry’s political forces can be put into play to stop any efforts to address whatever problem science had disclosed, since now it is “disputed science.” Hence the infamous phrase from the tobacco-era science denial operation — “Doubt is our product.”

Doubt is aided and abetted by the absence of universally trusted news sources (Where have you gone, Walter Cronkite? A nation turns its weary eyes to you…), increasingly sophisticated propaganda purveyors, and the very human tendency to engage in confirmation bias.

As Whitehouse says, the fossil-fuel apologists and climate-change deniers don’t waste their time in peer-reviewed forums. Instead, they go directly to Fox News and talk radio, to committee hearings and editorial pages. “Their work is, at its heart, PR dressed up as science but not actual science. So they go directly to their audience — and the more uninformed the audience, the better.”

Our universities and other organizations engaged in the enterprise of science struggle for funding. Not so for the science-denial forces. You may think maintaining this complex science-denial apparatus sounds like a lot of effort. So consider the stakes for the fossil fuel industry. The International Monetary Fund — made up of smart people, with no apparent conflict of interest — has calculated the subsidy fossil fuels receive in the United States to be $700 billion annually. That subsidy is mostly what economists call “externalities” — costs the public has to bear from the product’s harm that should be, under market theory, in the price of the product. These $700-billion-per-year stakes mean that the funding available to the science-denial enterprise is virtually unlimited… Make no mistake: in every dispute that this denial machinery manufactures with real science, it is determined to see real science fail. That is its purpose.

As Whitehouse points out, given the strong connections between the incoming Trump Administration and the fossil fuel industry, we can no longer depend on government to be an honest broker and a defender of legitimate science. Hence his plea to universities and other scientific organizations — to join together and step up a common defense.

Or, as these deniers are usually apt to say, “I’m not a scientist myself, but I’ve heard from some real scientists (who and how many?) that the issue is not settled”.

Sometimes, it all seems like a bad dream…..

 

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HOW WE CAN PREVENT ALZHEIMER’S DISEASE

alzheimer

Contrary to popular belief, many studies suggest that Alzheimer’s disease can be prevented, or at least delayed in onset. As I have previously presented, regular exercise diminishes the likelihood of developing this condition.  In addition, food intake such as Mediterranean diets can be helpful. Finally, regular mental stimulation of most types (note the picture above) can also retard the deterioration of brain function.

DIETARY FACTORS

     Let’s examine first the diets that can be helpful. Researchers have found that people who stuck to a diet that included foods like berries, leafy greens, and fish had a major drop in their risk for memory-sapping disorders, which affect more than 5 million Americans over age 65. This eating plan is called the MIND diet. Here’s how it works. MIND stands for Mediterranean-DASH Intervention for Neurodegenerative Delay. It’s similar to two other healthy meal plans, i.e., the DASH diet and the Mediterranean diet. This approach specifically includes foods and nutrients that medical literature and data show to be good for the brain, such as berries, but extending to these 10 food groups:

  • Green leafy vegetables (like spinach and salad greens): At least six servings a week
  • Other vegetables: At least one a day
  • Nuts: Five servings a week
  • Berries: Two or more servings a week
  • Beans: At least three servings a week
  • Whole grains: Three or more servings a day
  • Fish: Twice or more a week
  • Poultry (like chicken or turkey): Two times a week
  • Olive oil: Use it as your main cooking oil.
  • Wine: One glass a day

Foods to avoid:

  • Red meat: Less than four servings a week
  • Butter and margarine: Less than a tablespoon daily
  • Cheese: Less than one serving a week
  • Pastries and sweets: Less than five servings a week
  • Fried or fast food: Less than one serving a week

                  The Benefits

One study showed that people who stuck to the MIND diet lowered their risk of Alzheimer’s disease by 54%. That’s big. But maybe even more importantly, researchers found that adults who followed the diet only part of the time still cut their risk of the disease by about 35%.

Scientists need to do more research on the MIND approach, but it’s a very promising start. It shows that what you eat can make an impact on whether you develop late-onset Alzheimer’s, which is the most common form of the disease.

Simply reducing cholesterol, at least by the commonly prescribed “statin” drugs can also produce a similar desirable result.

One recent study showed that, based on a sample of 399,979 Medicare beneficiaries, men and women who took statins two years or more lowered their risk of Alzheimer’s in the period spanning 2009 to 2013. The incidence of Alzheimer’s disease was reduced for beneficiaries frequently prescribed statins (high users), compared to low users, USC and University of Arizona researchers found. Among women who were high users, the incidence rate was 15 percent lower. Among men, the rate was 12 percent lower.

These data further support the idea that many sufferers of Alzheimer’s disease may share a common origin with arteriosclerosis (hardening of the arteries), which likely means that controlling the various known risk factors provides a likely way to avoid not only Alzheimer’s disease, but also to reduce cardiovascular diseases such as heart attacks and strokes.

PUTTING IT ALL TOGETHER: Multifactor lifestyle modification

A recent study from Finland showed that an intervention that targets nutrition, exercise, and metabolic and cardiovascular risk factors can improve cognition and memory in older adults, and prevent them from developing Alzheimer’s disease. Most striking, this program produced the greatest change in those who carried the highest risk, i.e., those subjects with a strong hereditary predisposition for this disease.

The randomized, controlled FINGER (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) trial was designed to show how a multimodal lifestyle intervention might not only slow or prevent cognitive decline, but help improve cognition among patients who are already experiencing decline. It enrolled 1,260 participants aged 60-77 years who were cognitively normal at baseline but at increased risk for decline.

All participants were followed for two years and randomized to 1) a control group provided with usual care by their regular physicians, or 2) the intervention group, which consisted of the following::

  • Dietary counseling with recommendations to consume increased amounts of fruit, vegetables, whole grains, lean protein, and healthy fats.
  • Progressive aerobic exercise and weight training, conducted by physical therapists, several times each week.
  • Cognitive training several times a week with a computer program that targeted executive processes, working memory, episodic memory, and mental speed.
  • Managing metabolic and cardiovascular risk factors, including blood pressure, weight, and body mass index. This was addressed in group sessions and with visits to participants’ own physicians.

The primary endpoint was change in mental function, which was conducted at baseline and at months 12 and 24. Also assessed were memory and processing speed.

By the end of the study, subjects in the intervention group experienced a significant, 25% greater improvement on the overall score than did those in the control group. Improvements on the secondary measures were significant for the intervention group as well: 150% better than the control group in processing speed, and 40% better in short-term memory. Measures of cognitive decline increased by 30% in the control group, whereas subjects in the intervention group experienced no deterioration.

This study also included preliminary data on how the intervention improved overall function and quality of life. Although there was some decline after 2 years in the control group, the intervention group remained stable or showed a significant improvement in general health. Moreover, although general daily function was good for all subjects at baseline, by the end of the study, significant differences had emerged, for the control group actually had a 50% increased risk for at least one new difficulty with activities of daily living.

The program was not associated with any serious adverse events. The results also appeared to have a lasting impact, which boded well for better sustained later outcomes. At the end of the study, the intervention group participants had decreased their body weights by about 4-5 lbs, which was significantly more than for control group subjects. Most of the former group reported that they were still eating fish and vegetables every day, and exercising at least twice a week.

This was the first long-term trial to show that a multidomain intervention like this one can maintain and improve not only cognitive decline but also more robust physical outcomes and quality of life. Of special importance, it carries no risks.

WHAT NATIONAL TRENDS CAN TELL US

   Over the past 20 years, we have witnessed a gradual reduction of prevalence of cardiovascular disease in the U.S., attributable to lifestyle improvements mentioned above.  Also fitting well with this concept, a corresponding reduction in cognitive impairment was identified in a National Health and Retirement Study (HRS) surveyª. Although these latter trends were less clear, they seem to provide further optimism that we may have the means to ward off much mental deterioration in the future.

 

ª Rocca WA, et al. Trends in the incidence and prevalence of Alzheimer’s disease, dementia, and cognitive impairment in the United States. Alzheimers Dement. 2011 Jan; 7(1): 80–93. doi:  10.1016/j.jalz.2010.11.002

 

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HEALTH TIPS FOR THE HOLIDAY SEASON

holidays

Mashed potatoes and gravy, Grandma’s apple pie, and other holiday favorites can be a joyous part of any celebration. But to feel your best, you know you need to eat in moderation and stay active. How can you avoid temptation when delicious foods and calories abound?

From Halloween through New Year’s, there’s always a decision to make about food. . Tasty treats tend to appear more often at work and festive gatherings, and to come as gifts. They may also tempt you when grocery shopping. Thus as the holidays approach, it’s important to think ahead and make a plan.

Consider your health goals for the holiday season, whether it’s preventing weight gain through overeating, staying active, connecting with others, or reducing stress. You can plan to make time for buying healthy groceries, cooking at home, scheduling regular physical activity, and setting aside a little quiet time for yourself.

Begin by adopting a flexible mindset. Many people have an attitude of all or nothing: either I’m on a diet or I’m not on a diet.  This “either-or” thinking can lead to negative self-talk, or being hard on yourself for small indulgences, overeating, or weight gain.

Unfortunately most people just throw their plan out the window when they think they’ve slipped up once. Celebrations don’t have to derail your lifestyle. You’ll have plenty of opportunities to follow your plan and eat healthy and feel good about it. Small choices really can make big changes. Each moment that you put something in your mouth or choose to exercise adds up over time, which can be true for weight loss or weight gain.Around the holidays, we often find ourselves with too many food options, for too many days in a row. It can be challenging to decide what to eat and when to say no.

Eat what you love—but in moderation. Consider choosing items that are unique to the season, instead of eating foods you can have any time of the year. When you feel the urge to splurge in unhealthy ways, try something else first, like drinking a glass of water, eating a piece of fruit, or climbing a few flights of stairs. You might even consider walking around your house or office for 5 minutes or more. Such diversions might be enough to help you resist unhealthy temptations. You could also try eating more deliberately. Slow down to really taste and enjoy your food. Eating more slowly also allows your body time to signal your brain when you’re full, which takes about 20 minutes. If you eat too much too quickly, it’s easy to gobble up as much as twice what your body needs before your brain even gets the message. Also it’s a good idea to identify and avoid any “trigger foods”—foods that may spur you to binge or eat more than usual. Overeating can bring feelings of bloating, reflux, indigestion, and nausea. Some people can eat less healthy foods in moderation and be fine, or have “cheat days” where they allow themselves to eat whatever they want for a day and stay on track for the rest of the week.. Others may have to avoid certain “trigger foods” completely, or they’ll spiral into unhealthy eating patterns for the rest of the week or abandon their plan altogether. Everyone is different. Because of these differences, it’s important not to force food on other people. Even if you don’t have an issue with food, be aware of other people around you, and respect their choices.

What if you do fall to temptation?  Happily every day is a new day when it comes to eating. If you overeat one day, work to get back on track the next meal or next day.

While food is a big part of the holidays, remember that there are other paths to staying healthy. Don’t make the holidays be just about food. The key is not only what you eat, but how much you’re moving. Even little bits of extra exercise can be very helpful for everyone over the holidays.

Plan ahead for how you’ll add physical activity to days that might otherwise involve a lot of sitting. When possible, get the whole family involved. You have to make an effort to incorporate exercise into days of big eating. Otherwise the day will come and go.Sign up to walk or run a community race. Enjoy catching up with family or friends on a walk or jog instead of on the couch. In between meals, take a family hike at a nearby park or stroll around your neighborhood..

The emotions of winter celebrations come into this picture, too. Joy, sadness, and stress are often associated with overeating during the holidays. People who are emotional eaters may be particularly vulnerable to such temptations around the holidays. If holiday stress causes you to derail your healthy plans, consider ways to reduce stress and manage emotions. These might include talking to a trusted friend, meditation, physical activity, or just getting outside. If you know you have a difficult time during holidays, plan outings once or twice a week with people who make you feel happy. If it’s in your best interest, also feel okay about declining invitations without feeling guilty.

Support your family and friends, too. Encourage them to eat healthy during celebrations and throughout the year. If you’re serving dinner, consider baking, broiling, or grilling food instead of frying. Replace sour cream with Greek yogurt, and mashed potatoes with mashed cauliflower. Make take-home containers available ahead of time, so guests don’t feel they have to eat everything in one sitting.

So you needn’t adopt a defeatist attitude around the holiday season. Be proactive, and fight the flab at the same time.

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DOES IT EVER PAY TO BE FAT?

overweight-scale


During the past several years, a misconception—the so called “obesity paradox”—has been creeping into the medical literature. This paradox is a medical hypothesis which holds that obesity (and even high cholesterol), counter intuitively, may be protective and associated with greater survival in certain groups of people, such as very elderly individuals or those with certain chronic diseases. It further postulates that normal to low body mass index or normal values of cholesterol may be detrimental and associated with higher mortality in asymptomatic people.

But is there any truth to this hypothesis? As we note below, the answer to this question is, no!

    A large international study that included Harvard researchers links a high body mass index (BMI)-a calculation used to determine if a person is overweight-to a risk of early death, and contradicts the idea that it’s possible to be fat and fit. Researchers pooled the data from 239 studies of more than 10 million people in 32 countries. They excluded people who had smoked, had a chronic condition, or died within five years of follow-up, leaving about four million people. Of those, researchers analyzed people’s BMIs (Body Mass Indices). A healthy BMI (non-obese) is considered to be in the range from 18.5 to 24.9. Researchers observed that study participants with a BMI of 20 to 24.9 were the least likely to die during the study period; people with a BMI above that were significantly more likely to die during the study period, especially men with high BMIs. The findings, published Aug. 20, 2016, in The Lancet, don’t prove that high BMIs cause early death, but they do suggest being overweight matters.

The bottom line: Extra fat puts you at risk for developing diabetes, heart disease, and cancer, so make weight control a priority, and avoid making phony excuses for being fat!

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NEW CAUTION WHEN CONSIDERING ANTACID MEDICATION

prilosec

A popular group of antacids known as proton pump inhibitors, or PPIs, used to reduce stomach acid and treat heartburn may increase the risk of  the most common form of stroke (“ischemic stroke”), according to preliminary research presented at the American Heart Association’s Scientific Sessions 2016.

“PPIs have been associated with unhealthy vascular function, including heart attacks, kidney disease and dementia,” said Thomas Sehested, MD, study lead author and a researcher at the Danish Heart Foundation in Copenhagen, Denmark. “We wanted to see if PPIs also posed a risk for ischemic stroke, especially given their increasing use in the general population.”

Researchers analyzed the records of 244,679 Danish patients, average age 57. During nearly six years of follow up, they assessed stroke rates while patients were using 1 of 4 PPIs: omeprazole (Prilosec), pantoprazole (Protonix), lansoprazole (Prevacid) and esomeprazole (Nexium)., all being obtainable over the counter in the U.S.A.

For ischemic stroke, researchers found:

  • Overall stroke risk increased by 21 percent when patients were taking a PPI.
  • At the lowest doses of the PPIs, there was slight or no increased stroke risk.
  • At the highest dose for these 4 PPI’s, stroke risk increased from 30 percent for lansoprazole (Prevacid) to 94 percent for pantoprazole (Protonix).
  • There was no increased risk of stroke associated with another group of acid–reducing medications known as H2 blockers, which include famotidine (Pepcid) and ranitidine (Zantac).

The study corrected for age, gender and medical factors, including high blood pressure, atrial fibrillation (irregular heart beat), heart failure and the use of certain pain relievers that have been linked to heart attack and stroke. The authors suggested that their findings, along with previous studies, should encourage more cautious use of PPIs. .
“At one time, PPIs were thought to be safe, without major side effects,” he said, “This study further questions the cardiovascular safety of these drugs.”

Since it was an observational design, this study could not definitively establish cause and effect between PPIs and strokes. For this reason, the authors believe that a randomized controlled trial of PPIs and cardiovascular disease is warranted.

In the meantime, how should each of us respond to this information? First, we should carefully consider whether use of PPIs is warranted at all, and for how long:

Given the relative safety of the H2 blockers such as Zantac and Pepcid, they should be tried first after ordinary antacids such as Mylanta, Di-Gel, Gelusil, etc. are tried and found wanting. Only then should we consider the PPIs, and used for as brief a period as possible.

 

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UNIFYING THE NATION: A SUGGESTION

   As a physician, I have always been concerned with health—usually of the individual’s body and/or mind. Presented with a recent and blatant disregard for fairness in politics, I am very concerned about the health of our nation as a whole. What I write below should be of concern to all.

If you agree with me, please share this message with as many contacts as possible. Maybe we can make a difference!

                 OPEN LETTER TO DONALD TRUMP

After a divisive campaign that has threatened to leave sharp divisions in this country, you have now professed, in conjunction with your recent rhetoric, that you wished to unify this nation and provide a leadership for all Americans — no matter what race, religion, gender, or political party.

If this is your true wish, I have an important suggestion for you that will set you on this path and involve little risk to you or your party. Simply express your support for the appointment of Merrick Garland to the Supreme Court of the U.S.A.

Let’s look at the reasons for my suggestion: After graduating from Harvard College and Law School with high honors, he practiced corporate litigation and worked as a federal prosecutor in the U.S. Department of Justice, where he played a leading role in the investigation and prosecution of the Oklahoma City bombers. He later returned to public service in 1989, becoming an Assistant U.S. Attorney in the U.S. Attorney’s Office for the District of Columbia. As a prosecutor, Garland represented the government in criminal cases ranging from drug trafficking to complex public corruption matters.

In 1995, after being nominated to the vacated D.C. Circuit Court, the American Bar Association (ABA) Standing Committee on the Federal Judiciary gave Garland a “unanimously well-qualified” committee rating—its highest.   On January 7, 1997, Garland was renominated  for the Circuit Court, and he was confirmed in a 76–23 vote. The majority of Republican senators voted to confirm Garland, including Senators John McCain, Orrin Hatch, Susan Collins, and Jim Inhofe.

After the April 2010 announcement by Justice John Paul Stevens that he would retire, Garland was again widely seen as a leading contender for a nomination to the Supreme Court of the United States. President Obama interviewed Garland, among others, for the vacancy. In May 2010, Senator Orrin G. Hatch, Republican of Utah, said he would help Obama if Garland were nominated, calling Garland “a consensus nominee” and predicting that Garland would win Senate confirmation with bipartisan support. Obama instead nominated Solicitor General of the United States Elena Kagan, who was confirmed in August 2010.

On March 11, 2016, Senator Orrin Hatch, president pro tempore of the United States Senate and the most-senior Republican Senator, predicted that, although President Obama would name someone the “liberal Democratic base” wanted, he “could easily name Merrick Garland, who is a fine man”. Five days later, on March 16, Obama formally nominated Garland for Supreme Court Justice. Garland is considered a judicial moderate and a centrist. Tom Goldstein, the publisher of SCOTUSblog, wrote in 2010 that “Judge Garland’s record demonstrates that he is essentially the model, neutral judge. He is acknowledged by all to be brilliant”.

On March 16, 2016, President Obama nominated Garland to serve as an Associate Justice of the Supreme Court, to fill the vacancy created by the death of Antonin Scalia. To date, the Senate has not held a hearing or vote on the nomination, since the Senate Republicans have refused to consider it. Inasmuch he has already been vetted and believed to be highly qualified by both parties, his rejection has been clearly intended as a Republican repudiation of President Obama.

So now, Mr. Trump, the ball is in your court. Here is your chance to start the unification process by supporting the appointment of a truly gifted and centrally oriented justice, already recognized as an outstanding choice by both parties and providing a unifying force for all Americans! Put in your own parlance, what do you have to lose?

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DIETING: DON’T FORGET HUNGER

hunger

Throughout the evolution of all species, including humans, food intake has been governed primarily by the sensation of hunger. This may explain why obesity is seldom encountered in animals. Although records are obviously limited prior to the dawn of civilization, human obesity is likely also to have been rare. Thus it is likely that, when guided by the primordial sense of hunger, all bodies will likely respond with the attainment of a normal food intake and weight. Also, when combined with a large requirement of physical work through antiquity, humans were destined to keep food intake and caloric consumption in a delicate and proper balance.

For at least the past century, our dietary intake has been largely decoupled from hunger for a variety of reasons. We often adhere to regular “eating hours” such as noon for lunch, meals are often centered on social functions rather than hunger, snack foods are easily available when sitting to watch TV, with the addition of a “yummy” dessert, we often exceed eating requirements beyond the point of satiation, and the list goes on and on. Compounding this problem further, requirements for physical effort have been greatly reduced for obvious reasons.

So what am I trying to say? If our food intake were governed solely by hunger and limited by satiation, a large component of weight control would be in place, and any diet strategy would be more apt to succeed if this principle were observed.

This hypothesis has been recently tested by experimental data appearing in a 2016 study in the American Society for Nutrition entitled “Intuitive Eating Dimensions Were Differently Associated with Food Intake in the General Population.” The study compared the so-called “intuitive eating, i.e., eating in response to physiological hunger and satiety cues rather than emotional cues, termed “unconditional permission to eat”. Prior evidence had supported the idea that such intuitive eating was associated with lower body weights, but little was known about its association with food intake per se.

The study noted above included a total of 9581 men and 31,955 women aged ≥18 years. Eating patterns were assessed by using a validated version of a detailed intuitive eating scale derived from dietary records over a six year period. The associations were compared between intuitive eating and unconditional permission to eat, and food intakes were assessed by statistical analysis.

Results from this study were quite illuminating: In women, higher physical reasons scores were associated with lower caloric intakes. Also, a higher physical reasons score was associated with lower sweet- and fatty-food intake in both women and men, as well as lower intakes of dairy products, meat, fish, and eggs, and a higher whole-grain intake in women. In contrast, higher intuitive eating scores were generally associated with a higher caloric intake that contained lower fruit, vegetable, and whole-grain intakes.

The conclusion of the study: Physical hunger is associated with healthier dietary patterns with better weight control, whereas the so-called “unconditional permission to eat”, was associated with unhealthier diets. From a public health perspective, these findings suggest that we all should be eating primarily in response to hunger and satiety signals rather than the myriad of emotional/social signals. What remains to be proved, however, is, whether those individuals already controlled by emotional factors can be converted to a dominant pattern of food consumption in response to hunger

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EATING TIMES AND OBESITY

obese

The first human test of early time-restricted feeding is showing that this meal-timing strategy may help reduce swings in hunger and altered fat- and carbohydrate-burning patterns.

In early time-restricted feeding (eTRF), individuals eat their last meal by the mid-afternoon and do not eat again until breakfast the next morning. In a recent new study, researchers found that eating only during a much smaller window of time than people are typically used to may help with weight loss.

Researchers at the University of Alabama found that eating between 8 am and 2 pm followed by an 18-hour daily fast kept appetite levels more even throughout the day compared with eating between 8 am and 8 pm. The findings suggest that eating a very early dinner, or even skipping dinner, may have some benefits for losing weight. The body has an internal clock, and many aspects of metabolism are at their optimal functioning in the morning. It is theorized that eating in alignment with the body’s circadian clock by eating earlier in the day may positively influence health.

The current study of eTRF suggests this eating pattern may affect metabolism. This first test of eTRF in humans follows rodent studies of this approach to weight loss, which previously found that eTRF reduced fat mass and decreased the risk of chronic diseases in rodents.

The researchers conducted a study with 11 men and women between aged 20 to 45 years (mean age: 32 years). All participants were followed over 4 days of eating between 8 am and 2pm (eTRF), and 4 days of eating between 8 am and 8 pm (average feeding for Americans). The researchers then tested the impact of eTRF on calories burned, fat burned, and appetite.

To eliminate subjectivity, the researchers had all participants try both eating schedules, consuming the same number of calories both times, and completing rigorous testing under supervision. They found that although eTRF did not affect how many calories participants burned, it reduced daily hunger swings and increased fat burning during several hours at night. It also improved metabolic flexibility.

This type of information opens up an intriguing possibility for those wishing to lose weight—nearly the entire population. Early dining during the afternoon hours not only reduces eating to twice daily but also allows for the avoidance of later crowds in restaurants. But, to be successful, this approach must not include a bedtime snack, difficult for many people!

 

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Golf’s many benefits brought to the fore in health study

 

 

golf

You might be surprised that golf has physical and mental health benefits for people of all ages, genders and backgrounds, according to a study in the British Journal of Sports Medicine. Researchers reviewed 5000 studies into golf and well-being to build a comprehensive picture of the sport’s health benefits, as well as its potential drawbacks. Findings show that golf is likely to improve cardiovascular, respiratory and metabolic health. Playing golf could also help those who suffer chronic diseases including heart disease, type 2 diabetes, colon and breast cancer and stroke, the study found. The physical benefits of golf increase with age, researchers from the University of Edinburgh said. Balance and muscle endurance in older people are improved by playing the sport, the review also found. The study found that golfers typically burn a minimum of 500 calories over 18 holes. Golfers walking 18 holes can cover four to eight miles, while those using an electric golf cart typically chalk up four miles. Increased exposure to sunshine and fresh air were found to be additional benefits. The physical aspects of golf could also help reduce the risk of anxiety, depression and dementia, the researchers say.

Anyone who has played golf can attest to its physical benefits. However, these physical advantages could easily be overshadowed by its mental challenges; I’ve seen many a mature adult reduced to a “gibbering idiot” after missing a multitude of shots! Nevertheless, the net effects seem to be positive, provided your golf game doesn’t require confinement in a mental institution!

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TURMERIC: ANOTHER OF THE MANY SNAKE OILS?

curry

     I recently encountered a website touting the “tremendous’ health benefits of Turmeric. Having been intrigued, I decided to look into the background of its claims.

Turmeric (Cucurma longa) is a plant in the ginger family that is native to southeast India. It is also known as curcumin. The rhizomes are ground into an orange-yellow powder that is used as a spice in Indian cuisine. You probably know turmeric as the main spice in curry. It has traditionally been used in folk medicine for various indications; and it has now become popular in alternative medicine circles, where it is claimed to be effective in treating a broad spectrum of diseases including cancer, Alzheimer’s disease, arthritis, and diabetes. One website claims science has proven it to be as effective as 14 drugs, including statins like Lipitor, corticosteroids, antidepressants like Prozac, anti-inflammatories like aspirin and ibuprofen, the chemotherapy drug oxaliplatin, and the diabetes drug metformin.. Whenever one encounters such excessive claims that sound “too good to be true”, that’s exactly what they usually  prove to be.

The Natural Medicines Comprehensive Database has reviewed all the available scientific studies and has concluded that turmeric is “Likely Safe,” “Possibly Effective” for dyspepsia and osteoarthritis, with “Insufficient Reliable Evidence” to rate effectiveness for other indications, such as Alzheimer’s disease, colorectal cancer, rheumatoid arthritis, and skin cancer.

Mechanism of action

The pertinent preclinical studies, in animal models and in vitro, indicate that curcumin, the presumed active ingredient in turmeric, has anti-inflammatory properties; can induce apoptosis (death) in cancer cells and may reduce microscopic changes of Alzheimer’s brains; has antithrombotic effects; and displays activity against some bacteria,. These effects sound promising, but animal studies and in vitro laboratory studies may not be applicable to humans. Although you can kill cancer cells in the laboratory with a flame thrower or bleach, animal studies must always be followed by clinical studies in humans before we can make any recommendations to humans.

Preliminary clinical research

Preliminary pilot studies of turmeric in humans suggest the following:

  • it does not change mental state examination scores in Alzheimer’s
  • it might improve symptoms in anterior uveitis (eye inflammations)
  • it might stabilize some markers of colorectal cancer in some patients with treatment refractory colorectal cancer
  • high doses may decrease the number of aberrant focal abnormalities detected on colonoscopy
  • it might reduce some symptoms of rheumatoid arthritis.

Clinical research on turmeric is currently funded by the National Center for Complementary and Alternative Medicine (NCCAM), but the NCCAM website is not very encouraging. Under the section What the Science Says, it states:

  • There is little reliable evidence to support the use of turmeric for any health condition because few clinical trials have been conducted.
  • Preliminary findings from animal and other laboratory studies suggest that a chemical found in turmeric—called curcumin—may have anti-inflammatory, anticancer, and antioxidant properties, but these findings have not been confirmed in people.
  • NCCAM-funded investigators have studied the active chemicals in turmeric and their effects—particularly anti-inflammatory effects—in human cells to better understand how turmeric might be used for health purposes. NCCAM is also funding basic research studies on the potential role of turmeric in other diseases..

I might add parenthetically that NCCAM has, in its entire history, produced virtually nothing that might alter our current practice of science-based medicine.

Side effects

Turmeric is generally considered safe, but high doses have caused indigestion, nausea, vomiting, acid reflux, diarrhea, liver problems, and worsening of gallbladder disease. It may interact with anticoagulants and antiplatelet drugs to increase the risk of bleeding, that it should be used with caution in patients with gallstones or gallbladder disease and in patients with gastroesophageal reflux disease, and it should be discontinued at least 2 weeks before elective surgery. Purchasers of supplements are not given that information.

Conclusion

The scientific evidence for turmeric is insufficient for managing any human health problems. As with so many supplements, the hype has far exceeded the evidence, and this serves only to separate the public from its money. Although there are some promising hints that this substance may be useful, there are plenty of promising hints that lots of other supplements “may” be useful too. Given this monumental lack of substantive evidence, I see no reason to jump on the turmeric bandwagon. Stay tuned for further evidence, however, in the form of well-designed clinical studies in humans. Once in a very long while, we accidentally encounter a really effective drug such as quinine or aspirin, but usually we wind up instead in the “snake oil pit.”

 

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