What Would a Republican or Democrat Win Mean for Health Policy and is It Already Predetermined?

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Do you all remember Dr. Gail Wilensky? She was in charge of the role out of the Affordable Care and Protection Act (ACA). Her husband was a plastic surgeon in Washington, D.C. and since I was a plastic surgeon my doctor friends harassed me because I wasn’t doing more for the defeat of the ACA. And now we find Gail Wilensky, PhD discussing, in the New England Journal of Medicine, the Republican possibility of victory and that although it’s not unreasonable to ask how a Republican victory in the 2016 presidential election would affect health policy, it’s important to remember how policy becomes law. Presidents can propose policies — but preferably not in the form of legislative language, as President Bill Clinton did in 1993, when he sent a 1342-page proposal to Congress. Even though Democrats were in control of both the House of Representatives and the Senate, Clinton’s Health Security Act never came up for a vote — largely because of opposition to the policies it contained, but also because resistance was exacerbated by the way the executive branch had dealt with Congress. Only Congress can pass legislation enacting domestic policy, although as President Barack Obama has shown, substantial change can also be enacted through executive action. Of course, such changes can be undone in the same manner.

So understanding what a party “win” would mean requires not only understanding what a presidential candidate has proposed and what his or her party has included in its platform, but also guessing the outcome of the congressional elections and what the combined outcome of all national races means for health policy.

As a candidate, Donald Trump has supported several policy changes commonly proposed by Republicans. These include repealing the Affordable Care Act (ACA), though with little indication of what would replace it; expanding the availability of health savings accounts (HSAs, nontaxable money that can be used to cover medical expenses not covered by insurance and that can be rolled over from one year to the next, unlike flexible spending accounts); permitting insurance to be sold across state lines; turning Medicaid into a block-grant program; protecting people from large increases in insurance premiums or exclusions because of preexisting conditions, as long as they maintain continuous coverage; and allowing people without employer-sponsored insurance to deduct their premiums from their taxes. Unlike other Republicans, Trump has also proposed allowing drug importation and permitting Medicare to negotiate drug prices (though he hasn’t provided any details about what that would mean).

The Republican platform committee adopted policies that reflect some of the positions advocated by House Speaker Paul Ryan (R-WI) and the House Republicans, which are more expansive in some ways than Trump’s proposals. The platform’s wording more clearly recognizes the limits of presidential power, stating that the president should use “legitimate waiver authority . . . to halt [the advance of the ACA but] then, with unanimous support of Congressional Republicans, [should] sign its repeal” — a distinction that congressional Republicans have not always made. Ending the tax discrimination against non–employer-sponsored insurance, block-granting Medicaid, allowing the purchase of insurance across state lines, capping through tort reform the noneconomic damages for malpractice, and expanding the availability of HSAs are also included in the platform.

In the House, Ryan discussed alternative visions of health care reform both before and after the passage of the ACA, and he promised as speaker to release a House Republican health care plan. This plan was released in June, a month before the Republican convention.

Though not as specific as legislative language would be, the proposal provides much more detail than had previously been available about what a Republican replacement for the ACA would include. It also tackles some politically thorny issues, proposing gradually raising the Medicare-eligibility age to 67 and converting Medicare to a premium-support program that would include traditional Medicare as well as private-plan alternatives.

Some of the ideas in Ryan’s plan are traditional Republican proposals, such as selling insurance across state lines and expanding the use of HSAs. Existing ACA premium subsidies would be replaced by a refundable tax credit available to people not covered by Medicare, Medicaid, or employer-sponsored insurance. The credit would be financed by limiting the currently unlimited tax exclusion for employer-sponsored insurance — a more progressive answer to the “Cadillac tax,” a flat 40% excise tax on plans costing more than a specified threshold, because the tax imposed above the threshold level would be based on the individual’s tax rate and would thus be higher for higher-income employees.

Exclusions for preexisting conditions and higher-than-normal premiums would be prohibited for individuals who maintained continuous coverage. Premium prices would be allowed to vary by age, with the price for the oldest family member permitted to be five times that for the youngest (which is estimated to be closer to the actuarially calculated variation in health care costs) rather than the currently allowed 3-to-1 ratio, whereby younger enrollees implicitly subsidize the care of the just-pre-Medicare population. Medicaid would become a per-person block grant to states, and states would have more power, including the ability to require able-bodied adult recipients to work.

Senate Republicans have not collectively released a comparable proposal, but individual Republican senators such as Orrin Hatch (UT) and Richard Burr (NC) and former Senator Tom Coburn (OK) have been involved with proposals to reform Medicare or enact an ACA alternative.

Predicting election outcomes is always risky, and this year’s outcome seems more unpredictable than usual. Voter anger and dissatisfaction with political parties and traditional candidates has made political polling challenging. It is hard to forget the unexpected Brexit vote, which contradicted the results of polls conducted right before the vote, which had suggested that a majority of the population wanted Britain to stay in the European Union.

The easiest call in the 2016 U.S. elections is that split government seems highly likely. The House will probably remain in Republican control, according to most polls. The control of the Senate is likely to switch to the Democrats, if for no other reason than 24 Republican seats but only 10 Democratic seats are up for election. Whenever there’s such an imbalance (reflecting a lopsided election 6 years earlier), change in control becomes likely; a similar imbalance will occur again in 2018, when more Democratic than Republican seats are up for election. Political analysts such as Charlie Cook expect a relatively close split between parties, which means that the Senate will be subject to filibusters.

Democratic nominee Hillary Clinton is currently ahead in the polls, both nationally and in the “swing states,” and so appears to be the more likely winner — but polls have been wrong this cycle, and complacency is always a concern for frontrunners.

So what will split government mean for health policy? Any changes will have to be reached with bipartisan support — because Republicans and Democrats are each likely to control one house of Congress and there’s unlikely to be a supermajority in the Senate.

Republicans may be willing to provide support for strategies to help stabilize the ACA insurance exchanges — such as continued use of risk corridors (which limit the amounts that insurers can gain or lose through risk sharing) after 2016, perhaps with some increased funding from existing appropriations in exchange for increased flexibility using innovation waivers (1332 waivers), such as allowing budget neutrality to be measured over 3 years rather than 1 and allowing states to pool savings from Medicaid with those from exchanges. Agreement that states that have not previously expanded Medicaid should be given 100% federal funding for Medicaid for 3 years after 2016 might be attractive to both Republicans and Democrats. The government could also smooth transitions between Medicaid and exchange coverage by letting people use their Medicaid subsidies to buy insurance in the exchanges and their exchange subsidies to buy Medicaid coverage.

Ultimately, the biggest question is whether, if Republicans lose the presidency, the Senate, or both, they will be willing to work to “fix” the ACA, rather than focusing all their messaging and energy on repealing it.

And then Jonathan Oberlander, PhD, also in the same issue of the New England Journal of Medicine, went on to discuss what happens to Obamacare after its namesake leaves the White House? The Affordable Care Act (ACA) has faced fierce opposition from congressional Republicans and many GOP-led state governments, survived unexpected legal challenges, and overcome a disastrous rollout of healthcare.gov. Through it all, ACA supporters could count on President Barack Obama to defend the law. But come January 20, 2017, that will change. If Donald Trump becomes president and Republicans maintain congressional majorities, the GOP could seek to repeal major ACA provisions, though Trump’s health care agenda is uncertain.

If Hillary Clinton wins the presidency, however, Democrats can advance the ACA. For decades, reformers sought to enact universal health insurance. Now that they’ve taken a major step toward that goal, what happens next? Victory in the 2016 elections could allow Democrats to shift their focus from preserving the reforms to strengthening and improving them. The ACA’s record reflects both substantial accomplishments and significant shortcomings. One priority should be to make health plans more affordable and thereby achieve further gains in coverage.

The ACA has had remarkable success in reducing the uninsured population — from 48.6 million in 2010 to 27.3 million in January–March 2016, according to the National Health Interview Survey. But many Americans with modest means have not signed up for coverage in the insurance exchanges (marketplaces) created under the ACA

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(see graph Percentage of Potential Exchange-Plan Enrollees Who Selected Exchange Plans in 2016, by Income Level.).

Even with government subsidies, insurance premiums can still amount to a substantial share of enrollees’ income. In addition, ACA marketplace plans generally have high deductibles and cost-sharing requirements, and people with incomes above 200% of the federal poverty level (FPL; in 2016, $11,880 for an individual and $20,160 for a family of three) receive only limited subsidies to offset such costs.  Given limited financial assistance and the modest penalty for not obtaining insurance, many Americans have declined to buy coverage. That is one reason why exchange enrollment is much lower than projected, though many people are buying policies outside the exchanges and fewer than expected have lost employer-sponsored coverage. More than 6 years after the ACA’s enactment, insurance affordability remains problematic.

Even as the ACA substantially reduces the uninsured population, underinsurance persists. Many Americans are paying more out of pocket for medical care, especially for deductibles. This trend, which began before the ACA was passed, extends beyond the exchanges. For workers with employer-sponsored insurance, the average annual deductible increased from $303 in 2006 to $646 in 2010 and $1,077 in 2015. Clinton has proposed a refundable tax credit (up to $2,500 for an individual and $5,000 for a family) for Americans with high out-of-pocket costs. She’s also outlined a plan to cap out-of-pocket prescription-drug costs for persons with serious or chronic health conditions. Yet if major gains are to be made in marketplace enrollment, ACA plans may have to be made more attractive, with larger premium subsidies and better cost-sharing protections. Higher enrollment could also be achieved by increasing the penalty charged for not obtaining insurance, but that would be controversial.

A related priority is stabilizing the marketplaces. Premiums are rising for ACA plans, and some insurers are requesting large increases for 2017, though state experiences vary widely and through 2016, exchange plans’ premiums have been much lower than expected. Three major insurers — UnitedHealthcare, Humana, and Aetna — have decided to curtail participation in the exchanges, citing financial losses and risk pools of people who are sicker and more expensive than anticipated (though Aetna’s announcement followed an Obama administration challenge to its proposed acquisition of Humana). Other insurers are doing well financially with their marketplace plans, and in some states insurance competition remains strong. But in a growing number of geographic areas, consumers shopping for insurance on the exchanges have little choice, since one insurer has a monopoly.

Ironically, private insurers’ withdrawals could revive interest in a reform they intensely oppose: creation of a Medicare-like government insurance plan that would compete alongside private plans in the marketplaces. Clinton has endorsed such a public option. Although it will face an uphill struggle in Congress unless (and even if) Democrats regain House and Senate majorities, some states could use innovation waivers, which will be newly available in 2017, to create their own public options. Democrats could also pursue another policy Clinton supports: enabling people 55 years of age or older to enroll in Medicare — though that proposal, too, faces considerable political barriers.

As use of state innovation waivers begins, policies aiming to stabilize the marketplaces will end. Reinsurance and risk corridors, which protect insurers against the costs of enrolling expensive patients and potentially large financial losses, are scheduled to expire later this year (and because of restrictions passed by Congress in 2014, insurers have actually received only 12.6% of the risk-corridor payments the government owes). The expected expiration may be contributing to 2017 premium increases, which might dampen enrollment. One fix would be to maintain these policies — which are already a permanent feature of Medicare’s Part D prescription-drug program that relies on private insurers. The Obama administration has taken steps to steady the marketplaces and improve insurers’ risk pools, including limiting the use of special enrollment periods outside of scheduled open enrollment. The next administration may have to consider additional stabilization measures. Indeed, this could emerge as Clinton’s most pressing health policy challenge.

Making marketplace health plans more affordable would help stabilize insurer participation and ensure further progress in reducing the uninsured population. Democrats could also remedy the “family glitch”: under the ACA, people deemed to have unaffordable options for employer-sponsored coverage can receive premium tax credits to buy marketplace plans, but many people are ineligible for such subsidized coverage because affordability is evaluated on the basis of the premium cost for an individual worker, not on the price for family coverage.

Another way to boost coverage rates would be to persuade more states to expand Medicaid. Three million uninsured low-income people would become Medicaid-eligible if their state accepted the ACA expansion (19 states have declined to do so). A Democratic victory in November could convince some GOP-governed states that the ACA is here to stay and that they should heed Medicaid expansion’s economic and fiscal logic, as well as political pressures from health care provider lobbies. As an incentive, Clinton has proposed extending provision of 100% federal funding for the first 3 years to any state expanding Medicaid. Making that funding level permanent — it’s scheduled to phase down to 90% by 2020 — could further entice states. There are also about 9 million uninsured Americans who are eligible for but not enrolled in Medicaid or the Children’s Health Insurance Program. Vigorous outreach and enrollment efforts are needed to reach these people and those eligible for subsidized marketplace coverage — together, they account for nearly half the remaining uninsured population.

Although the challenges in extending coverage gains are drawing attention, the cost of medical care could also become a prominent issue in coming years. Growth in health care spending has been remarkably moderate since 2008, and the ACA has cost much less than initially forecast. Obamacare has produced considerable Medicare savings, though its precise contribution to the spending slowdown outside that program is unclear. We don’t know how effectively the ACA’s payment and delivery reforms will slow medical spending over the long term. If spending accelerates, policymakers could consider strengthening those reforms or adopting alternative approaches, which are already in the wings with payment bundling, MACRA, MIPS and Meaningful Use. You wonder why more and more physicians are getting burned out??!! Implementation of the Cadillac tax on high-cost private plans, a cost-containment policy favored by many economists but opposed by much of the public, has been delayed from 2018 to 2020. Clinton supports its repeal, a call that’s likely to grow louder if she is elected president and is running for reelection in 2020.

The biggest obstacle to building on the ACA’s achievements and addressing its flaws is hyper-partisanship. Lawmakers are deeply polarized, and public attitudes about health care reform are divided. Even modest changes can become existential struggles in this environment. If Clinton is elected, her chances of strengthening the ACA will depend on whether Democrats have congressional majorities — and on her ability to advance reform in this extraordinarily polarized time.

But what these writers are forgetting is that Hillary has already “promised” a Medicare For All or the public option. Either will result in a system more like the Canadian or European system and we all know the failures, delays, and restrictions.

The Republicans with all the possibilities of alternatives and the threat of repeal of the ACA have not really proposed a worthy alternative to the ACA.

I would be very surprised if Mr. Trump can pull it off and win the election, therefore we will be looking at a public option or Medicare For All health care system.

I will be discussing and dissecting this public option in a future post and what we really need for a sustainable healthcare, which is fair to the majority delivering the best health care for all. Is this even a possibility?

Tune in again in the weeks to follow and send me your comments and suggestions.

 

Clinton, Trump Release More Health Info Should We Care and is it Really About the Heath of the Candidates or About We Americans and Our Health?

14317555_970886899707636_8500770228802268880_nAs the presidential election draws closer, controversy continues over how the two major presidential candidates have handled the release of their personal health information, as well as what experts are saying about the candidates’ health. The interesting thing is that our nation is poised to elect one of its oldest presidents. Trump at 70 would be months older than Ronald Reagan on his election day, and Clinton will have just turned 69.

Joyce Frieden the News editor for MedPage expanded on the issues that the Presidential candidates Donald Trump and Hillary Clinton have both revealed more information about their own health, although it is unclear whether they’ll satisfy critics — and the method of delivery may also raise additional questions. Actual knowledge of the candidates’ physical fitness has come so far from letters released by their personal physicians.

Clinton recently released a letter from her physician and Trump took to the airwaves: handing “Dr. Oz” a two-page document detailing the results of his latest exam.

“On Friday, September 2nd, I evaluated Mrs. Clinton for a 24-hour history of a low grade fever, congestion and fatigue,” Lisa Bardack, MD, wrote in a letter released by the Clinton campaign. “On examination, she was noted to have a temperature of 99.4; her vital signs were otherwise normal as was her physical exam. She was advised to rest, put on a short course of antibiotics and continued on her allergy medications for an upper respiratory tract infection in the setting of her seasonal allergies. Over the next several days as she traveled, her congestion worsened and she developed a cough. She was advised to see me when she returned from her travels for further testing.”

Bardack continued: “On Friday, September 9th, she was seen and evaluated in my office. A non-contrast chest CT scan, including a CTA calcium score, was performed. This test allowed for specific imaging of her lungs while also following up on cardiac risk stratification from 2010 given her family history of heart disease. The results of the CT scan revealed a small right middle lobe pneumonia; her coronary calcium score was again zero. She was treated with antibiotics for pneumonia and advised to rest. This was a mild non-contagious bacterial pneumonia.”

“On Sunday, September 11 at the 9/11 Memorial event, she became overheated and dehydrated and as a result felt dizzy,” Bardack wrote. “I examined her immediately upon her return home; she was rehydrating and recovering nicely. I advised her to stay home and rest for the next several days. Mrs. Clinton has since been evaluated by me several times and continues to improve.” The letter also addressed other areas of Clinton’s medical history, noting “Mrs. Clinton’s current medications include Armor Thyroid, Coumadin dosed as directed, Levaquin (for a total ten days), Clarinex, as well as B12 as needed. … She remains up to date on all of her immunizations, including Prevnar and Pneumovax. Her Coumadin levels have been adjusted as needed according to regular lab testing. She had a normal mammogram and breast ultrasound.”

In terms of lab tests, “Her laboratory testing … was normal, including cholesterol of 189, LDL of 103, HDL of 56 and triglycerides of 159,” Bardack said. “Her vital signs showed blood pressure of 100/70, heart rate of 70, respiratory rate of 18, temperature of 97.8 and pulse-oximetry of 99%. The remainder of her complete physical exam was normal and she is in excellent mental condition.”

Several physicians weighed in on the results. “From a cardiovascular risk point of view, she is low-risk with her coronary calcium score of 0 and her excellent lipid levels,” Christopher Cannon, MD, professor of medicine at Harvard Medical School, in Boston, wrote in an email to MedPage Today.

However, he added, “It is not specified why she is taking warfarin/Coumadin. This would be additional information that would be helpful to fully understand her health status.”

Stephen Cook, MD, MPH, an internist at the University of Rochester (N.Y.), applauded Clinton’s disclosures. “I’m remarkably pleased with the objective and open information that was provided by Mrs. Clinton’s doctor, and assuming with her permission,” Cook wrote in an email. “I’m very much into prevention, so hearing that candidates are up to date with immunizations and cancer screening is great to hear.”

Remember, that we were also previ to another letter from her physician. The first letter to be released came in July 2015 from Lisa Bardack, MD, an internist in Mount Kisco, N.Y. and Hillary Clinton’s personal physician. Bardack’s letter, which was eight paragraphs long, contained both specific and general information about Clinton — for example, it said that Clinton’s most recent physical, in March 2015, found that her blood pressure was 100/65 and that her total cholesterol was 195, with an HDL of 64 and triglycerides of 69. It also noted that she is taking vitamin B12, antihistamines, and Armour Thyroid for hypothyroidism.

More generally, the letter said that Clinton “does not smoke and drinks alcohol occasionally. … She eats a diet rich in lean protein, vegetables, and fruits. She exercises regularly, including yoga, swimming, walking, and weight training.” Question: How does she do these exercises with her schedule?

The letter also makes note of two episodes of deep vein thrombosis in 1998 and 2009, and an incident in December 2012, in which Clinton “suffered a stomach virus after traveling, became dehydrated, fainted, and sustained a concussion.” Clinton had follow-up evaluations that found a transverse sinus venous thrombosis, and she was given anticoagulation therapy as well as glasses with a Fresnel prism to treat double vision resulting from the concussion.

“She had follow-up testing in 2013, which revealed complete resolution of the effects of the concussion as well as total dissolution of the thrombosis,” the letter continued. “As a precaution, however, it was decided to continue her on daily anticoagulation” in the form of warfarin (Coumadin). Bardack concluded by saying that Clinton “is in excellent physical condition and fit to serve as president of the United States.”

First, regarding Mr. Trump, lets start with his physician’s letter. Donald Trump’s physician, Harold Bornstein, MD, of New York City, released a letter in December 2015 that was much shorter and lighter on details. “Mr. Trump had a recent complete physical examination that showed only positive results,” Bornstein wrote in a four-paragraph letter. “Actually, his blood pressure, 110/65, and laboratory results were astonishingly excellent.”

Bornstein wrote that Trump had lost 15 pounds in the past year and that he takes 81 mg of aspirin daily along with a low dose of a statin. “His PSA test score is 0.15 … His physical strength and stamina are extraordinary.” Trump’s cardiovascular status is “excellent,” and he has no history of alcohol or tobacco use, Bornstein added.

After noting that Trump has no cancer and has never had any orthopedic surgery, Bornstein concluded, “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.”

That last line raised concerns for Peter Whitehouse, MD, PhD, and professor of neurology at Case Western Reserve University, in Cleveland. “The physician who wrote this letter undermined his credibility by saying that,” he said in a phone interview. “The physician who wrote this letter undermined his credibility by saying that,” he said in a phone interview. “Based on reading the letter, I would have doubts about referring to that physician; he has limited knowledge of the [health of] the 40-odd presidents we have had.”

These health disclosures should be seen in the same light as candidates’ income tax disclosures, Whitehouse continued. “I’d do it on a voluntary basis” — that is, candidates shouldn’t be required to disclose their health records, “but if you don’t … you’re subject to scrutiny as to why not.”

Meanwhile, Trump appeared on the “Dr. Oz” syndicated television show on Thursday with his own medical report. The show’s host, Mehmet Oz, MD, went through a brief review of systems with Trump, who answered “no” to questions about whether he had any history of neurologic problems, stroke, cancer, stomach problems, or other ailments. As far as his family medical history, Trump mentioned that his father developed “what was probably Alzheimer’s” during the last few years of his life; he died at age 93.

Trump also handed Oz two pages that the candidate said included results of his latest exam and test results from a series done at Lenox Hill Hospital last week. Oz read the results to the audience and Trump campaign released the documents.

  • Height: 6’3″                                         PSA: 0.15 ng/mL
  •          Weight: 236 lbs.                                 Blood pressure: 116/70 mmHg
  • Total cholesterol: 169 mg/dL         Blood sugar: 99 mmol/L
  • Calcium score: 98 HU                       HDL: 63 mg/dL
  • LDL: 94 mg/dL                                   Testosterone level: 441 ng/dL
  • Triglycerides: 61 mg/dL

As for exercise, Trump said he was “speaking in front of 15,000 or 20,000 people and I am up there using a lot of motion; in its own way it’s a pretty healthy act. A lot of times these rooms are very hot, like saunas, so I guess it’s a form of exercise.”

His doctor, Harold N. Bornstein, MD, wrote that Trump takes rosuvastatin (Crestor) and low dose aspirin, but he did not indicate the exact dose in either case. Trump said he has never needed much sleep and noted, “I feel as good today as I did when I was 30. When I play golf, I feel may be a better golfer today than I was 15-20 years ago … I hit the ball better; I putt just as well.”

According to the American College of Cardiology/American Heart Association’s cardiovascular disease risk calculator, Trump’s numbers put him at about a 13% risk of developing cardiovascular disease in the next 10 years, Cannon wrote. Using that same risk calculator, Robert Eckel, MD, professor of medicine and director of the lipid clinic at the University of Colorado Denver Anschutz Medical Campus, noted that Clinton’s 10-year risk score comes out to 4.7%. “Her coronary calcium score by CTA is zero — good news. I don’t feel that I have sufficient information to comment on her need for Coumadin or thyroid hormone.”

Greg Rosencrance, MD, chairman of the Cleveland Clinic Medicine Institute, said that overall, “The health information on the candidates is useful, but it’s important to recognize that it’s in the form of a summary, not the full records, and therefore we would be reliant on others for interpretation. The details included along with the vital signs are good indicators of someone’s overall current state of health.”

Maybe, besides the full disclosure of the Candidates’ health information we need to know what type of REAL exercise program they engage in daily, not just standing up in front of a crowd and hand motioning, or whatever! Although Mrs. Clinton’s doctor did say that she engaged in swimming and yoga regularly. Doctors often tout how exercise can help ward off disease, but previous research hasn’t concluded just how much physical activity is needed to reap those benefits. I was going to discuss the benefits of exercise as research has proven, but that would only deflect our discussion about relevance of these other issues.

We all know that this is all a distraction from the real issues….. and yes if you want to stay on the subject… the real issues of the health of the healthcare delivery system and the health of we Americans.

I think that we all agreed that some degree of medical disclosure for candidates was necessary — the question is, how much information should they disclose? “Candidates for very high office, like president, do have an obligation to disclose if they have a serious health problem, like if they have cancer or have had a stroke.” said Doug Brugge, PhD, professor of public health and community medicine at Tufts University in Boston. “If they just have risk factors — like high cholesterol — most of us have risk factors, so that is not such a big deal.”

“As a matter of public policy, public interest and what may remain of a ‘right to know’ for the electorate, the medical fitness of a prospective U.S. president is important,” Jay Wolfson, D.Ph., JD, professor of public health, medicine, and pharmacy at the University of South Florida, in Tampa, wrote in an email to MedPage Today. “Prospective and actual public officials lose some of the private prerogatives they may have enjoyed (or presumed) prior to their entrance on the stage of public service. And being a candidate is being on that stage.”

Clinton’s concussion and its aftermath have been the subject of much speculation, including from physicians. Drew Pinsky, MD, discussed Clinton’s medical record on his TV show in January, saying that as a result of the concussion, “she had to wear these prism glasses. … That is brain damage, and it’s affecting her balance.”

Some mental health specialists have weighed in on Trump as well. Trump has “textbook narcissistic personality disorder,” Ben Michaelis, PhD, a clinical psychologist in New York City, told The Atlantic last November. Howard Gardner, PhD, a professor of cognition and education at Harvard, agreed, calling Trump “remarkably narcissistic.”

I have discussed this in a previous post that many such pronouncements have been made in the press that the American Psychiatric Association reminded its members earlier this month of the association’s “Goldwater Rule” — named for the late Republican presidential candidate Barry Goldwater — which prohibits psychiatrists from offering opinions for someone they haven’t personally evaluated.

Experts were generally in agreement that clinicians of any kind should not be diagnosing either candidate from afar. “I do think it is questionable for physicians to make comments about anyone as it pertains to their health without actually personally evaluating them,” said Mohana Karlekar, MD, medical director for palliative care at Vanderbilt University, in Nashville, Tenn. “Physicians must be mindful that any statement they make that includes a medical assessment will be interpreted by the general public as a valid assessment.”

Neil Wenger, MD, MPH, professor of medicine at the University of California Los Angeles, agreed. “A professional would not act as a physician in this way,” he said in an email. “When doing so, a physician has become a media personality or entertainer or is fulfilling some role, as did Senator Frist in the Schiavo case.” Wenger was referring to Terri Schiavo, a woman in a persistent vegetative state whose husband wanted her life support removed; former senator Bill Frist, MD (R-Tenn.) argued against doing so and suggested that Schiavo might not be in a vegetative state. Schiavo’s life support was eventually removed following a lengthy court battle; she was found on autopsy to have had severe, irreversible brain damage.

As bioethisist Arthur Caplan stated this morning in the Washington Post, “if we really care about Trump’s or Clinton’s health, the way to find out about it is not to ask them, their staff, their doctors, Dr Oz, etc. It is to have them supply their medical histories and submit to a thorough examination by an independent panel of doctors in areas such as internal medicine, oncology, geriatrics, psychiatry and neurology.”

I like his idea. Then the National Academy of Health would appoint the panel of doctors and tell the candidates to show up in August for a 2 day physical, with the results to be reported before the end of the month, not like an IRS audit and take years for the public to see, read or hear about it in the press.

He  also said that although diagnosis from afar is never appropriate, there is a role for historical analysis: “Historians can take a look at people’s behavior and comment on likely pathologies, whether it’s Woodrow Wilson’s stroke or Ronald Reagan’s memory loss; it’s not appropriate to preclude historians from examining how the health of leaders can affect their behavior. What I’m objecting to is clinicians who don’t know the person putting on clinical labels with any degree of certitude.”

“Age always matters” when it comes to risk for disease, said well-known aging researcher S. Jay Olshansky of the University of Illinois at Chicago, but he cautions that it shouldn’t be a litmus test for the presidency.

Trump at 70 would be months older than Ronald Reagan on his election day, and Clinton will have just turned 69. With life expectancy at a record high and a generation of more active seniors, older presidential candidates are no surprise. But older age also raises concern about the risk of Alzheimer’s disease. Reagan, who turned 70 shortly after his first inauguration, was diagnosed with Alzheimer’s several years after leaving office.

Olshansky’s research found many presidents outlived the life expectancy of their time, likely thanks to wealth and access to top medical care that Clinton and Trump also have. Hey, what happened to the excellent health care that we are supposed to get with the Affordable Care Act?

Possibly the factor most promising for longevity is that both candidates’ parents lived into their 80s and 90s, Olshansky noted. “We have sufficient information to believe the two of them are both likely to be healthy long enough to survive eight years in office,” Olshansky said.

Even with Dr. Caplan’s suggestion for a 2 day examination, etc….is this solution going to happen? We all know that it isn’t because while discussions of Clinton’s pneumonia and Trump’s weight make for employment for media TV idiots and help fill the empty air time on cable news channels, you really don’t need to be all that healthy to be president, much less a politician and more importantly…… the voters really don’t care.                                                                                                                      Caplan went on to point out that we have had people in or near the White House with bad hearts, consider President Eisenhower and Dick Cheney who both had heart attacks while in office. We have had presidents who have abused alcohol and pain medications, such as John Kennedy and Richard Nixon, and before he took office, George Bush. And at least one president surpassed any missteps exhibited by Clinton, frequently stumbling, tripping or banging his head, Gerald Ford.

I think that we all can agree that most if not all politicians are crazy and as Americans have health concerns. But as I have said earlier, we should be focusing on real policy- economic, health care, educational and social issues and more importantly the health of the average American, who is obese, rides motorcycles and bicycles without helmets, doesn’t exercise regularly, eat billions of dollars of junk foods and doesn’t follow the “suggestions” of their own doctors.

So, how much do we know — and should we know — about how physically fit Donald Trump and Hillary Clinton are for the job?

Maybe we should be more concerned about the V.P. candidates (Republican vice presidential candidate Mike Pence released a letter by his campaign, Saturday from his doctor Saturday stating that he is in “excellent general and cardiovascular health,”) or more importantly our own health and more importantly, how our health will be effected by a Single Payer Health Care System?????

Obese patients ‘surgery ban’ in York, England and is the future?

14192739_961430727319920_9123964988708776032_nInteresting fact, there is a move that could see obese patients refused surgery in an attempt to save money is to be reviewed after Britain’s national NHS bosses intervened. This article (3 September 2016
From the section 
York & North Yorkshire) peaked my interest because it could and probably will happen here in the U.S.A. if and when the single payer system is finalized.

It is a known fact that cigarettes are highly addictive, but they are legally available without limitation to the public. Users do pay a tax for use but it does not come anywhere close to paying for their overall increased health care cost due to smoking. Obesity is rapidly increasing in this country- by 250% incidence over the past 20 years. While the causes of obesity are multifactorial, there is no doubt the singularly major factor is consumption of excess calories. The sources of these excess calories frequently are sugary foods and fast foods, yet there is no limit on what may be consumed nor is there any tax on these foods to help offset the increased costs associated with obesity. If there were a way to require those who engage in ill-advised health behaviors to pay for their impending increased utilization of the health care system, then this may be a viable alternative. To penalize those who have already developed these conditions by withholding care seems foolish and punitive unless there are outcome studies demonstrating specific procedures or interventions have a high failure rate in these patients. A proposed restriction by the NHS Vale of York Clinical Commissioning Group would have seen non-life threatening procedures delayed by a year for those with a body mass index exceeding 30.

The rule would also apply to smokers. NHS England, which can intervene as the CCG is under special measures, said the group had agreed to rethink the move.

Under the move, obese patients in the Vale of York area could have secured a referral in less than a year if they shed 10% of their weight.

Similarly, if smokers refused to quit they would face having procedures delayed for up to six months, which could be accelerated if they stopped smoking for eight weeks.

The CCG said the proposals, announced as part of a package of measures being considered to reduce costs, came at a time when the local system was under “severe pressure”.

The new rules would only apply to elective surgery for non-life threatening procedures, for example hip and knee operations.

‘No blanket bans’

But a spokesman for NHS England said: “Reducing obesity and cutting smoking not only benefits patients, but saves the NHS and taxpayers millions of pounds.

“This does not and cannot mean blanket bans on particular patients such as smokers getting operations, which would be inconsistent with the NHS constitution.”

Chris Hopson, the head of NHS Providers representing acute care, ambulance and community services, said he was worried about plans such as this being made.

NHS bosses now believed they had reached the point at which the health service was simply being asked to deliver too much for the funding that was available, he told BBC Radio 4’s Today programme.

He said rather than commissioning groups making “piecemeal decisions”, there should be a national debate about the future of the healthcare system.

Robert Pigott, BBC health correspondent analyzed this possibility looking at the financial impact.

When front-line health services revealed a deficit of £460m for the first three months of the financial year, hospital trusts said it was time for a national debate about what the NHS could now afford to do if it were to remain free.

Although it is now under review, the proposal by the Vale of York Clinical Commissioning Group to exclude obese people and smokers from non-emergency surgery has started that debate in earnest.

The CCG estimates obesity cost the NHS in the Vale of York £46m in 2015, but is it right to target obese people to bring costs down?

There is a clinical rationale. Obese patients suffer more complications during and after surgery than those of “normal” weight.

Despite this, some might see the decision as sending a signal of disapproval to those who are overweight.

The implication could be that being overweight is a personal lifestyle choice, adopted at the expense of the wider community.

Obesity has been linked with being poorer, and living in so-called “obesogenic” environments, where unhealthy, fattening, food is easier to get than more expensive, healthy, alternatives.

It is often hard to lose weight to which the body has adapted itself, and delaying operations on hips and knees might further limit the prospect of success.

The proposal could have benefited obese people as well as the health service if it succeeded in persuading them to lose weight.

Whatever the rights and wrongs of the Vale of York approach, it does, in effect, suggest a revised contract with patients – a new deal that requires people to take reasonable steps to preserve their own health, rather than expecting the NHS to pick up the pieces.

Shaw Somers, a bariatric surgeon based in Portsmouth, said it was a fairly logical step to save money, but was short-term and discriminatory.

“Obesity is an illness and for these people, they are not deliberately waking up each morning thinking ‘how do I stay fat?’,” he told the Today programme.

“They are trying to lose weight in the vast majority of cases and to deny them treatment that they need on the basis of their weight, without then offering them effective help to help them lose weight is rather like discriminating [against] a segment of the population on the basis of their colour or religious persuasion.”

Body Mass Index

  • Body mass index (BMI) is used to calculate whether a person is underweight, a healthy weight, overweight or obese for their height
  • It is calculated by dividing someone’s weight in kilograms by the square of their height in metres
  • Generally the higher your BMI, the greater your risk of a large range of medical problems
  • A BMI above 30 is medically classified as obese
  • Some doctors say it can be inaccurate if you’re an athlete or very muscular

The Royal College of Surgeons (RCS) described the proposed restrictions as “some of the most severe the modern NHS has ever seen”.

Clare Marx, RCS president, said: “Smokers and overweight patients should unquestionably be helped to stop smoking or lose weight prior to surgery for their overall health.

“We would support any attempts by Vale of York to expand its weight loss and smoking cessation programmes, but introducing blanket bans that delay patients’ access to what can be life-changing surgery for up to a year is wrong.”

A major study of the global obesity problem by Imperial College scientists found there were 6.8 million obese men in the UK in 2014, and 7.7 million obese women.

Former health minister Norman Lamb said: “This is just the latest in a growing list of local decisions to ration care – any rationing not based on clinical need is outrageous.”

A statement from the Vale of York Clinical Commissioning Group said: “NHS England has today asked us to review the draft approach, which we will now do, and will hold off implementing anything until we have an agreed way forward.

“We will ensure any plans are implemented in line with national guidance, are in the best interests of our patients and are clinically robust.”

It said the group wanted to support work to help people in the community to stop smoking and, where needed, lose weight.

Clinical Commissioning Groups were introduced in 2013 and became responsible for commissioning or buying local health and care services but are overseen by NHS England, a national body formed by the same parliamentary act.

A number of studies showed various conclusions such as The influence of body mass index on functional outcome and quality of life after total knee arthroplasty authored by J. Y. Chen, N. N. Lo, H. C. Chong, H. R. Bin Abd Razak, H. N. Pang, D. K. J. Tay, S. L. Chia, S. J. Yeo investigated the influence of body mass index (BMI) on the post-operative fall in the level of haemoglobin (Hb), length of hospital stay (LOS), 30-day re-admission rate, functional outcome and quality of life, two years after total knee arthroplasty (TKA) studying a total of 7733 patients who underwent unilateral primary TKA between 2001 and 2010 were included. The mean age was 67 years (30 to 90). There were 1421 males and 6312 females. The patients were categorised into three groups: BMI < 25.0 kg/m2 (normal); BMI between 25.0 and 39.9 kg/m2 (obese); and BMI ≥ 40.0 kg/m2 (morbidly obese).

They concluded that though morbidly obese patients have a longer LOS and higher 30-day re-admission rate after TKA, they have a smaller drop in post-operative Hb level and larger improvement in OKS and KSKS at two years follow-up. The ten-year rate of survival of TKA was also comparable with those with a normal BMI.

Take home message: Morbidly obese patients should not be excluded from the benefits of TKA from the article: Bone Joint J 2016;98-B:780–5.

Another study (http://www.ncbi.nlm.nih.gov/pubmed/25232084#) concluded that morbid obesity significantly increased the risk of subsequent revision, reoperation, and reinfection following two-stage revision total knee arthroplasty for infection. In addition, these patients had worse pain relief and overall function at intermediate-term clinical follow-up. Although two-stage revision should remain a standard treatment for chronic periprosthetic joint infection in morbidly obese patients, increased failure rates and poorer outcomes should be anticipated.

As well as another study (http://www.ncbi.nlm.nih.gov/pubmed/25845948#) that also saw a higher complication rate Morbid obesity is associated with increased rates of re-revision, reoperation, and PJI after aseptic revision TKA. As the time-sensitive nature of revision surgery may not always allow for patient or comorbidity optimization, these results emphasize the need for improving our care of patients with morbid obesity earlier on during the osteoarthritic process. Additional studies are needed to risk stratify patients in the morbidly obese population to better guide patient selection and effective optimization.

There are 2 separate issues here, firstly is it reasonable to deny treatments where risk variables can be changed, especially where the outcomes are measurably poorer. I suspect that most people would accept this premise, and if patients are unable to alter their weight, or habits, then perhaps the treatment thresholds should vary to reflect the changed risk profile.

The second question is however, should we consider those less perfect people ‘undeserving’ of publicly funded healthcare, the modern equivalent of the victorian ‘undeserving poor?’

Before answering that, consider that in almost every country in the world, smokers and drinkers would have contributed far more in voluntary taxes than economically matched controls, and are likely to have a reduced life expectancy, mainly in retirement, saving pension payments by the public purse.

Deciding who is and is not deserving of treatment is not something that anyone should have to do, and particularly not a doctor, whose obligation is to treat the patient to the best of his or her ability.

The important issue here in US is that we are soon to be payed on outcomes and “value”. CMS/Medicare will not pay for re-admissions for surgical complications and so the surgeon and the hospital will have to “eat” the cost of the admission and the cost of treatment.

However, as one learns in a very litigious society if we do not limit elective procedures to those who have a lower complication risk, we heath care providers and society will suffer.

I also consider blood sugars in my own criteria. If the patient has a blood sugar higher than 200 the patient’s elective surgery gets delayed until their weight is below a BMI of 39.5 and their blood sugars are controlled below 200. I have canceled cases just before surgery in those who do not comply. A surprisingly large number of patients remain tobacco-free 6 and 12 months after surgery. I have had a few patients (very few) get angry with me about this policy in my 33 years of practice, but it is not rare to have someone call me 1-2 years later and thank me for my insistence. Most smokers say they “knew” they should quit, but never had a physician demand quitting before helping them.

Research findings published in the December issue of the Journal of the American College of Surgeons, Chicago, December 3, 2013, confirm that factors such as smoking and obesity increase the odds of early implant loss in women who undergo mastectomy and immediate breast reconstruction with implants. Further studies concluded that smoking, obesity, and hypertension were similarly associated with reconstructive failure.

An additional multiple logistic regression analysis of complications following microsurgical breast reconstruction from the Department of Plastic Surgery, Georgetown University Hospital, Washington, DC, USA corroborates findings from previous studies. Tobacco use was demonstrated to be a significant risk factor for infection, seroma, and pneumonia. Obesity was demonstrated to be a significant risk factor for infection.

With these considerations and that it all goes to a financial bottom line set of decisions, if a single payer government health care system is what we end up with we will see these panels, whatever you want to call them, making broad decisions restricting surgical care and eventually medical care in general.

Is this what we really want? It is already what is seen in other single payer government run health care systems. Beware!!!

What do you think about this plan? Would this decision affect you?

Suicide in Our Youth and What Is Being Done About the Epidemic!

unnamed-2I saw this article in nprEd by Kavitha Cardoza regarding teen and even younger suicide victims and was truly scared. Every day, thousands of teens attempt suicide in the U.S. — the most extreme outcome for the millions of children in this country who struggle with mental health issues.

As we’ve reported all week, schools play a key role, along with parents and medical professionals, in identifying children who may be at risk of suicide. And one of the biggest challenges: myths that can cloud their judgment.

“People are afraid of the whole topic,” says David Jobes, the head of Catholic University’s Suicide Prevention Lab. “It just feels like something that’s left unsaid or untouched.”

Jobes says one of the most common — and most dangerous — myths about suicide is that young children just don’t kill themselves.

It’s just not true.

Children as young as 5 take their own lives every year.

Another myth? Suicides are an impulsive decision, made in the heat of the moment.

Again, not true.

Jobes says kids can spend weeks thinking about and planning for their own deaths. And that, he says, is where schools have a role to play.

“They’re going to be letting their friends know, dropping hints, writing essays that their English teacher might pick up, telling coaches,” Jobes says. The one thing teens considering suicide won’t do are tell their parents.

Jobes was asked to walk the author through a few other common misperceptions of suicide.

Myth 1: Asking someone about suicide will cause him to become suicidal

“There’s already issues and struggles around mental illness within our culture and society. It’s highly stigmatized, and suicide is even more stigmatized. It feels like something that’s just best left unsaid or untouched, kept under the rug, and that’s a problem in terms of saving lives. Because we need to ask, and we need to intervene to actually save lives. You need to be direct. ‘Sounds like you’re really down, have you thought about taking your life?’ Just be very direct. The more direct the better.”

Myth 2: Depression causes all suicides

“That’s just not true. So, we have millions of Americans who are depressed. A small fraction of them take their lives, a very small fraction. So depression and suicide are not synonymous.

“On average, about a hundred and some Americans die each day [from suicide]. About 40 to 50 of them might be depressed. Other diagnoses are relevant — like schizophrenia, psychotic disorders, substance abuse, anxiety disorders. It’s not just all about depression.”

Myth 3: We cannot really prevent suicides

“We know very clearly that, with proper identification, proper support and treatments that are suicide-specific, we absolutely can make a difference and save lives. Most suicidal people who talk about suicide don’t really want to be dead. They’re giving other people lots of indications, lots of warning signs, lots of communications that this is something that they would like to not do, but it requires people identifying that and getting them the proper help.

“Some of the warning signs would certainly be depression and … loss of concentration. People not seeming like themselves. Insomnia can be a big risk factor. Other warning signs might include irritability, withdrawal. And the thing that’s really critical: Lots of people have those symptoms and are not thinking about suicide. It’s really when the symptoms add up in the mind of that person, where they think ‘The way I deal with this is to take my life.’ ”

Myth 4: Suicides always happen in an impulsive moment

“People contemplate, think about it, imagine it, fantasize about it, write suicide notes, post things on the Web. After many days or weeks, [they] then perhaps make a fatal attempt. There is a major theory in the field that says that no suicides are impulsive. That there is always a history if you dig deep enough.

“The idea that they come out of the blue may happen, but it’s actually quite rare. A small number of people, especially among adolescents or school kids, are not going to communicate their intent. But that’s the exception. They’re going to be mostly letting their friends know, dropping hints, writing essays that their English teacher might pick up, telling teachers and coaches. So when people say this, they’re not crying wolf. It’s something to take seriously.

“Kids telling other kids is really critical because that’s who they’re gonna tell. They are not going to typically tell their parents. They get oftentimes a very negative reaction, even a punitive reaction. So, schools are in a position to try to communicate to kids that talking to your friends is fine, but if you really are a friend of this person, keeping a secret about something as serious as suicide is not in their best interest. And they need to pass that information up to teachers or the principal or to guidance counselors who are in a position to get professional help involved.”

Myth 5: Young children, ages 5 through 12, cannot be suicidal

“Young children do take their lives. In the United States each year, about 30 to 35 children under the age of 12 take their own lives.

“It’s hard for a lot of us to imagine that a child that young — a 5-, 6-, 7-year-old — could actually know what it means to say, ‘I want to kill myself.’ But we do research with young children and know that kids are saying these words.

“They do intend it, and they do sometimes take their lives. Oftentimes, by running into traffic and getting hit by a car. We don’t know a lot about young children taking their lives. The suicide prevention literature kind of begins at age 12 to 14. It’s almost as if, even in the professional literature, young children can’t be suicidal. And it’s just not the case.”

Myth 6: When there has been a suicide, having a school assembly seems like a good idea

“There’s literature and a professional take on all this that in post-vention, which is intervening after a suicide has occurred in a school, you want to find a response that is not overreacting, which would cause other kids to copycat or to follow that behavior.

“Alternatively, you don’t want to underreact. And so there is a very useful literature out there, professional associations that provide guidelines where we try to find that sweet spot of attending to the fact that this happened, providing necessary information and then resources, but not letting the whole school out to go to the funeral. Or not having an assembly where everybody comes to hear from an expert about suicide.

“We really want to have these conversations in smaller groups, especially among those kids who were most affected by the suicide. So, just a wholesale didactic event is not necessarily in the school’s best interest and not necessarily the best way to prevent copycat suicides or additional suicides.

“The American Foundation for Suicide Prevention does have very useful guidelines that are specific to schools. The American Association of Suicidology has also had a task force. There is extensive literature that is accessed through those organizations about what is optimal, school-based post-vention.

“We certainly know that children and adolescents are heavily influenced, especially teenagers, by their peers. And that’s developmentally normal. So one of the things that we do worry about with kids is the idea of copycat effects, or modeling effects. That a child in a school system who may seem sort of invisible takes his or her life raises awareness and then suddenly everybody is abuzz about this horrific event.

“For other kids who look at that, they might say, ‘Wow, that’s something I could do, too.’ And that’s the nature of the suicidal mind in a child — to not really think about this in a rational way. And that’s where modeling effects are especially worrisome. And then we, of course, worry about clusters or contagion effects. And there is an extensive literature on how to manage that modeling effect so that there aren’t additional suicides to add on top of what is a tragic event in most school systems.

“High school guidance counselors are mostly focused on getting kids into college or getting them registered for courses. They don’t typically — in fact rarely do they — have a mental health background. So when a suicide does occur, a lot of these counselors are naturally approached assuming that they have a mental health background, and they don’t.

“That’s where school systems need to have access to mental health professionals and to people who really know what they’re talking about. And that’s where different guidelines [come in] — for example, the ones from the American Foundation for Suicide Prevention or Sources of Strength. There are different programs that are out there, especially Sources of Strength, which have an excellent evidence base that have been shown to be effective in adolescent populations.”

My question is why are kids as young a 6 or 6 attempting suicide. There must be some really difficult challenges for them or they don’t have the necessary skills to manage daily problems, which are thought to be minimal as compared to adult challenges. What are we missing in these kids? Do these children have underlying mental problems that are not being diagnosed or is their a hostile environment with physical or mental abuse, no role models or a living situation that none of us would even put an animal in?

Also, do we have the necessary man and womanpower and finances to search and find these “lost children” and care for them? Will the Affordable Care Act be able to support programs for these needy children?

But then I was encouraged by this article about some positive actions to help with firearms and suicide. John Daley wrote in his Public Health article about the Centennial Gun Club.

It’s ladies night at the Centennial Gun Club in a suburb of Denver. More than 80 women are here for safety instruction and target practice.

Tonight the club is offering more than shooting, though. The women rotate through the firing range, and in another large room, they hear a sobering presentation from emergency room doctor Emmy Betz. She’s part of a collaboration between gun shops and public health leaders in the state to help prevent suicide.

“If you’ve been touched by suicide somehow, if you could, raise your hand,” she asks. About half the hands go up.

Colorado has the nation’s seventh-highest suicide rate. In a typical year, more than half involve guns. Research suggests suicide is often an impulsive act, Betz says, and attempts are much more likely to be lethal when a firearm is used. If people survive a suicide attempt, they are far less likely to eventually die from suicide.

“Unfortunately, with firearms typically there’s not that second chance,” she says.

There’s a new push in the national conversation about gun violence that is attempting to sidestep the political rancor, to find common ground on one thing — guns and suicide. The campaign in Colorado is called the Colorado Gun Shop Project.

Centennial Gun Club is one of 46 on board. The project formally started in the summer of 2014, modeled after a similar one by the New Hampshire Firearm Safety Coalition.

During Betz’s talk, organizers hand out Life Savers candies to drive home the message. Gun owner Lily Richardson says she thinks the information could do just that: save lives. “I think those who are aware and taking the initiative to talk about it can help make the difference,” she says.

Nancy Dibiaggio, a new gun owner, agrees. “It’s a big issue, and I think it’s great Colorado is jumping on the wagon with this.”

Dick Abramson, Centennial’s owner, says he welcomes the opportunity to facilitate the discussion. “The difficulty is that it’s not a topic people want to just bring up and talk about over the cocktail table, right?”

He says workers at his store have refused to sell a gun to someone they’re concerned about or feel is having an especially bad day. “My honest feeling is this is a nonpartisan issue,” he says. “This is something that everybody can get behind. It should be a universal concern of everyone.”

In another Denver suburb, the Bristlecone Shooting, Training and Retail Center is also part of the project. At its range, shooters take target practice at bowling pins lined up on the far wall.

In the shop’s showroom, store owner Jacquelyn Clark shows off literature on display “that talks about suicide prevention and what to do if somebody you know or you yourself are in crisis,” she says.

A poster reads, Gun Owners Can Help! Under a photo of a lone elk in the mountains, it lists signs someone may be suicidal and a phone number for the National Suicide Prevention Lifeline.

Clark says there’s now an 11th commandment on gun safety rules: Consider off-site storage — family, friends, some shooting clubs, police departments or gun shops — if a family member may be suicidal. Clark says most people don’t realize that the majority of gun deaths are not homicides but suicide.

A survey of hospital emergency rooms by the Centers for Disease Control and Prevention in 2011 found an estimated 21,175 suicides involving firearms compared with 11,208 homicides involving guns.

“The gun community itself is more at risk than the regular community, not because gun owners tend to have more mental health issues but just because they have more access [to firearms],” Clark says.

Jarrod Hindman, director of the Suicide Prevention Resource Center in Colorado, says he appreciates that local gun advocates are taking the lead. “This is their project,” he says. “We’re just helping to facilitate the process.”

Look at these statistics: more than 500 Coloradans took their own lives with a firearm in 2014, says Hindman, but talking about the role of guns is hard.

“Obviously this is a very contentious topic, and we’ve found a way to find middle ground in a topic where we didn’t think there was a middle ground,” he says.

And now, a large trade association for the firearms industry, the National Shooting Sports Foundation, is teaming up with the American Foundation for Suicide Prevention to develop a suicide prevention campaign for the gun group’s 13,000 members. Their goal is to reduce the annual suicide rate by 20 percent in the next decade.

This topic of suicide is worrisome and it was my contention to pursue more discussion of physician involvement. Remember my discussion of the high suicide rate in physicians and in the medical students and the interns and residents training for their eventual medical practice. But suicide in teens and the children is chilling.

We need to become more aware of this severe problem and dedicate whatever finances necessary to save our children. I will, in another post, discuss the mental health problems in our children and our lack of support in the education and health care systems to care for these children.

Happy Labor Day!

Is the EpiPen Price Elevation Just the Tip of the Iceberg in the Pharmaceutical Industry?

14089039_950180028444990_5005403533221290633_nIs it really true that manufacturers of pharmaceuticals really take advantage of the US population. A comparison study of cash prices of several drugs was done a few years ago in the US vs Canada: the Canadian non-subsidized drugs (same manufacturers as in the US) cost 1/3 as much as the US drugs, for both generics and name brands. Why do the manufacturers do this? Is it because they can. The US Government believes it is perfectly acceptable for the pharmaceuticals to charge whatever they want while maintaining their government monopoly on name brand drugs. Generic manufacturers have in the past 10 years followed suit- escalating their prices sometimes to within a few dollars of the name brand. In the US, it is all about $$$$$$$$$$. Nothing else matters to pharmaceutical manufacturers. Nothing. Not even people whose lives depend on rapid availability of injectable epinephrine.

Consider that latest insult, Members of Congress are in an unusual position as they demand an explanation for Mylan NV’s 400 percent price hike for the EpiPen and focus attention squarely on its CEO: Heather Bresch.

If lawmakers follow the usual script, Bresch could get called up to Capitol Hill next month to explain her company’s justification for raising the price on the life-saving allergy shot. But that could be awkward, since she’s the daughter of Democratic Senator Joe Manchin of West Virginia.

The scrutiny on EpiPen intensified Wednesday after Democratic nominee Hillary Clinton called the price increase “outrageous,” sending Mylan’s stock down as much as 6.2 percent. The intense political pressure could lead regulators to speed up their review of a rival product by Teva Pharmaceutical Industries Ltd., according to some analysts, or force Mylan to curb prices — in both cases hurting revenue and profits.

While CEO Bresch’s family ties may mute the ire of some lawmakers, others are already asking the company about taxpayers having to foot the bill for these price increases — particularly after Bresch and the company successfully pushed legislation to encourage use of the EpiPen in schools nationwide.

Mylan is the latest drug maker to provoke congressional ire for steep price hikes. Martin Shkreli and executives from the company he used to lead, Turing Pharmaceuticals AG, and executives from Valeant Pharmaceuticals International Inc. were called before congressional committees earlier this year to explain why they bought the rights to older drugs that lacked competition and raised the prices.

The Mylan controversy fits a similar pattern. Mylan has increased the price of its EpiPen from about $57 a shot when it took over sales of the product in 2007 to more than $600 for two auto-injectors. But the company’s EpiPen is a more mainstream drug used to treat life-threatening allergic reactions from bee stings, food allergies or other triggers, which could give the issue a larger constituency.

Mylan declined to comment when asked to explain the price hike or Bresch’s role in promoting legislation. Manchin’s office also didn’t respond to requests for comment. Members in both chambers expressed outrage this week. “I am deeply concerned by this significant price increase for a product that has been on the market for more than three decades, and by Mylan’s failure to publicly explain the recent cost increase, which places a significant burden on parents, schools and other purchasers of the EpiPen,” Senator Mark Warner, a Virginia Democrat, said Tuesday in a statement, noting that he is a parent of a child with severe allergies.

On Wednesday, the Senate Special Committee on Aging asked Bresch to turn over information used by Mylan’s board of directors related to the price increases. The panel wrote a letter to Bresch asking her to “provide a briefing to Committee staff on the pricing of EpiPen at a mutually convenient time no later than two weeks from today.” The committee’s chairman, Republican Senator Susan Collins of Maine, and its top Democrat, Claire McCaskill of Missouri, signed the letter.

Senator Richard Blumenthal, a Connecticut Democrat who has asked the company to lower its prices, is holding an event on Wednesday where he will call for investigations by the Senate Judiciary Committee and the Federal Trade Commission into potential antitrust violations and deceptive and illegal trade practices.

The issue of the price increase became presidential campaign fodder after Clinton issued her statement. “Since there is no apparent justification in this case, I am calling on Mylan to immediately reduce the price of EpiPens,” Clinton said in a statement from her campaign.

Mylan’s shares, which have dropped this week as the scrutiny increased, fell further after Clinton’s comments. The stock was down 6.1 percent to $42.86 at 3:25 p.m. in New York, bringing the three-day losses to more than 11 percent.

The company’s tactics in pushing legislation that helped boost the use of EpiPens may fuel congressional anger.

Mylan spent about $4 million in 2012 and 2013 on lobbying for access to EpiPens generally and for legislation, including the 2013 School Access to Emergency Epinephrine Act, according to lobbying disclosure forms filed with the Office of the Clerk for the House of Representatives. Mylan also was the top corporate sponsor of a group called Food Allergy Research & Education that was the key lobbyist pushing for the bill encouraging schools to stock epinephrine auto-injectors, of which EpiPen is by far the leading product.

But Bresch’s connections to Capitol Hill already have some lawmakers tiptoeing around the usual Washington blame game. For example, Blumenthal, a member of the Senate Judiciary Committee and a co-sponsor of the 2013 schools bill, asked Bresch in a letter Monday to explain the “shocking price increases.”

However, in an interview Tuesday, he was less eager to talk about Bresch herself or the prospect that she might soon be testifying to the committee.

He initially answered during one telephone call that he was unaware that she had any direct involvement in the pricing. Then, in a follow-up call, Blumenthal responded when asked again about the possibility of her coming before Congress by saying, “I am just not going to comment on that.”

Bresch, 47, has been CEO of Mylan since 2012 and previously held other senior posts at the company, including as head of government relations. Last year, she had to defend the company after it moved its corporate address overseas to lower its U.S. taxes in a transaction known as an inversion. Now incorporated in the Netherlands, its principal executive office is in Canonsburg, Pennsylvania.

Ross Baker, a political scientist at Rutgers University in New Jersey, said Tuesday that he assumes Bresch’s father, Manchin — who is not on the Judiciary Committee — would recuse himself “and put a lot of distance between himself and any investigation” into the matter. “He’d be unwise to rise to the defense of Mylan,” Baker said.

Senate Judiciary Chairman Chuck Grassley of Iowa, who is running for re-election, also wrote a letter to Mylan saying he was “concerned that the substantial price increase could limit access to a much-needed medication,” asking for an explanation by Sept. 6, the day the Senate returns from its seven-week summer recess. Jill Gerber, Grassley’s spokeswoman, said in an e-mail that he wants to hear back from Mylan before considering holding a hearing.

Mylan has given away more than 700,000 free EpiPen’s to schools since 2012 under a program that allows them to receive four free auto-injectors, the company said in a statement. Yet schools have to use their own funds to purchase additional pens. Mylan declined to comment on the price increases coinciding with legislation to encourage EpiPen use.

Senator Amy Klobuchar, a Minnesota Democrat, asked the Federal Trade Commission on Monday to look into whether Mylan had done anything to deny competitors access to the market in order to keep raising prices. She pointed to a competitor product, Adrenaclick, that she said is less expensive but has only minimal sales. Klobuchar was also a co-sponsor of the schools bill.

In the House on Tuesday, majority and minority staff members of the Oversight and Government Reform Committee held a meeting after receiving a letter from Representative Grace Meng, a New York Democrat, requesting the panel hold a hearing.

The majority staff scheduled a call with the company, though Democrats on the committee said they were waiting to hear back on whether a hearing will be scheduled.

A spokeswoman for committee Chairman Jason Chaffetz of Utah, said that as of Tuesday afternoon no hearing was scheduled. “And no comment beyond that,” said the spokeswoman, M.J. Henshaw.

The top Democrat on the Oversight Committee, Elijah Cummings of Maryland, said Tuesday that he wants a hearing when lawmakers return from their summer break to Washington in September.

“The recent price increase for EpiPens places a financial burden on those who desperately need this drug to prevent life threatening allergic reactions, which is why we have expressed our desire for an investigation of this issue and for the Committee to hold a hearing in September,” Cummings said Tuesday in a statement.

Liz Claman published an article pointing out that the Pittsburgh-based pharmaceutical giant at the center of a major drug pricing storm over the EpiPen, managed to pull off a tax-ducking corporate inversion just a year and a half ago.

And now the FOX Business Network has learned that allergy advocates are preparing to use the inversion strategy to convince lawmakers to investigate the company’s EpiPen.

“I definitely think Congress needs to get involved.  There needs to be an investigation,” Robyn O’Brien, founder of Allergy Kids Foundation told FOX Business Network.

O’Brien represents millions of families in America who depend on EpiPens to save lives in the case of deadly exposure to allergens.  The EpiPen is an auto-injecto device that delivers epinephrine, the drug that counters the effects of a fatal allergic reaction.  When Mylan bought the company that manufactures the EpiPen back in 2007, the cost for a single EpiPen was $57 dollars.

Today, just 9 years later, the cost has skyrocketed to as much as $700 for a pack of two. Many insurance companies cover some or most of the cost; however, Medicare, which is paid for by the American taxpayer, must cover millions of children of families who cannot afford insurance. Others saddled with high deductibles find themselves shelling out thousands of dollars for just a few packs of the device.

Mylan’s corporate inversion could now be used as a weapon against it.

Known officially as Mylan N.V., Mylan bought the small generic specialty drug arm of Abbott Labs (ABT) in early 2014.  That estimated $5 billion dollar purchase enabled the much larger Mylan (which has a current market cap of $24 billion dollars) to ‘move its headquarters’ to the Netherlands, a more tax-friendly country.

Mylan was able to complete one of the last corporate inversions before Congress, President Obama and Republican presidential nominee Donald Trump launched a full court press to demonize the practice which involves Company A (in this case Mylan) buying Company B (usually based in a foreign country with a lower tax rate) in order to lower Company A’s tax bill.

In Mylan’s case, it appears the company moved its corporate address to the Netherlands, but still maintains most of its offices in a suburb of Pittsburgh, PA, enjoying the benefits of taxpayer-funded police, fire and other city services.

President Obama has lashed out against the practice of inversion, calling it “one of the most insidious tax loopholes out there.” Trump, too, has ripped corporate inversions, calling them a “huge problem.”  What makes the Mylan case so problematic is that the company CEO Heather Bresch is the daughter of Democratic Senator Joe Manchin of West Virginia. Democrats, led by Democratic presidential nominee Hillary Clinton, have loudly denounced corporate inversions.

“They’ve built the business model on the backs of our kids, moving the headquarters to the Netherlands to avoid paying taxes into the US and as her own father said, something like that should be illegal,” said O’Brien. Calls by FOX Business to Mylan’s press department were not returned.

Complaints about onerous price hikes in the pharmaceutical industry are age-old and often go unanswered by the companies who hold the patents.  As patents expire, generic drug companies often jump in. But oddly, Israeli-based Teva Pharmaceuticals (TEVA) attempted to present a generic version but was soundly swatted down by the FDA, which cited “certain major deficiencies” to Teva’s product.  O’Brien smells a rat.

“There is no competition. They have a monopoly. The barriers to entry are really high and right now there’s a low cost alternative trying to work its way through the FDA. I’ve been in this for 11 years. We’ve seen Twin-ject come and go, Auvi-Q (by Sanofi US) come and go. Auvi-Q was recalled because of 26 unconfirmed reports. There needs to be an investigation into how (Mylan) has been able to maintain this monopoly that it has and yes, these are life saving devices but they can come in a lot of different forms and a healthy marketplace means healthy competition,” said O’Brien.

For now, Mylan has remained relatively silent after issuing an initial statement blaming insurance companies, co-pays and deductibles while offering coupons of $100 for the device. Investors, however, have done anything but remain silent. Milan shares fell 4.7% during Tuesday’s session and have lost 11% over the past 12-months.

Matt Krantz in his article last week pointed out that people might be shocked at how high drug prices have gotten. But equally lucrative are the compensation packages hauled in by drug company CEOs.

CEOs of the 14 biotech and pharmaceutical companies in the Standard & Poor’s 500 that served all of 2015 pulled down median compensation packages valued at $18.5 million in 2015, according to a USA TODAY analysis of data from S&P Global Market Intelligence. That was 71% greater than the median $10.8 million hauled in by S&P 500 executives in all industries in 2015, according to an analysis by Equilar.

“We all know drug prices are high,” says Eleanor Bloxham, CEO of compensation analysis firm The Value Alliance. “Companies award (the CEOs) very generous packages.” Health care CEOs received the highest median pay packages of any of the 10 sectors, according to the Equilar analysis.

Seeing such staggering pay packages for the titans of companies producing life-saving drugs stands out as lawmakers take a closer look at prices for drugs. Most recently, Mylan (MYL) found itself in the center of the controversy over drug prices following its roughly 500% increase in prices for its popular EpiPen allergy drug since 2007. Heather Bresch, who has been CEO of Mylan since early 2012, was paid $18.9 million last year, well above the median for the S&P 500 and up 109% since 2013.

But Bresch is far from being the highest paid among the ranks of drug company CEOs. Leonard Schleifer, CEO of biotech Regeneron Pharmaceuticals (REGN), wins there. He was awarded a compensation packaged valued at $47.5 million last year. The 63-year-old executive has been CEO of the company since 1988 and got a 13% raise in his total pay last year. The company makes treatments for a number of serious medical conditions, including its drug to deal with macular degeneration.  The company’s pay has been subject of controversy before. Investors can vote on the suitability of the company’s compensation plan every three years. In June 2014, only 62% of shareholders approved of the 2013 compensation plan. In its proxy statement released this year, the company says it has “spent a significant amount of time speaking with some of our key shareholders about executive compensation” and says it has made modifications.

Jeffrey Leiden, CEO of Vertex Pharmaceuticals (VRTX), is the drug maker CEO with the next largest compensation package. Leiden, 60, has been CEO of the company since 2012 and pulled down $28 million last year. Last year, investors expressed less confidence in the company’s pay structure causing the company to respond, “we increased our level of engagement in response to the decline in support for our advisory say-on-pay proposal at our 2015 annual meeting.” A say-on-pay proposal is a non-binding vote to allow investors to say if they approve of the way executives are paid.  The company, in its proxy statement, says, “We have designed the company’s compensation programs to closely align management’s incentives with Vertex’s strategic long- and short-term goals and with the interests of Vertex’s shareholders.”

While drug maker CEOs might get paid more than the typical CEO, last year wasn’t a great one for raises. CEOs at the 13 biotech and pharmaceutical companies in the S&P 500 who served both 2014 and 2015 saw their median pay fall nearly 19%. That’s a much steeper drop than the 5% decline experienced by S&P 500 CEOs in 2015, Equilar says.

Meanwhile, shares of drug companies were flat last year on average and this year they’re down 6.3% as investors worry about the sustainability of profit growth and rumblings from Capitol Hill about drug prices.  “Considering how fast medical costs are rising, this is becoming a public policy issue,” Bloxham says.

Untitled.blog.1aSo, as pointed out in the lead into this post Canada and other countries have Epi-Pens, etc. at lower prices, so why not purchase them over the Internet? Another alternative is to order 1:10,000 epinephrine preloaded syringe and have the patient keep it in a small zipped medical kit. Epipens have 0.3mg of epinephrine so 3ml of the 1:10,000 IM should suffice in an emergency. These cost about $12 from Henry Schein. Another option is $144 for 0.3mg epinephrine in 3ml auto injector made by Lineage Therapeutics or Greenstone Ltd.

It is time for the US pharmaceutical patents to be voided completely or shortened to 2 years. The pharm industry screws Americans because it can. It is not based on the incomes of people in different countries, insurance coverage, socialized vs capitalist health systems, or any other metric other than the US citizen has no other choice. Congress has granted patent exclusivity that through legal maneuvers is extended for decades, and there are absolutely no limits on what can be charged or the rate of escalation of prices, even on critical lifesaving medications.

The expiration of patents produces huge spikes in prices before the generics come onto the market. For decades, drug manufacturers have engaged in collusion in violation of the Sherman Antitrust Act to control prices by agreeing to pay generic manufacturers to not bring their products onto the market. This happened because the FDA does not allow multiple generics to come on to the market initially…it restricts the generic to a single manufacturer for a period of time before allowing others onto the market. This created a system whereby the name brand manufacturer paid off the generic manufacturer approved by the FDA to enter the market for a product or created a co-conspiracy situation where the generics would buy the product from the manufacturer and brand it as a generic. The courts have recently ruled this behavior is illegal, so now we are seeing massive spikes in name brand prices prior to patent expiration. The FDA and the courts have also made the situation much worse by colluding with the name brand manufacturer to extend patents as in the case of Oxycontin, where the manufacturer successfully argued before the courts that the formulation they manufactured for over a decade was unsafe, and therefore generics using that formulation should be prevented from entering the market.

There are more culprits that just the FDA. The FDA is one of the big ones, but so is a system where the end user doesn’t pay for the product but rather a third party pays, and the third party owns the distributors, and the third party (the insurance company) is able to pass the end user price to the funding of the pool from which the end user cost comes from. The third party doesn’t care what the product costs because they raise the money from insurance premium payers while the distributors, which they own make money on the margin mark up. There are many culprits although if there were more manufacturers,clearly the problem would not be as acute.

But there is more blame to go around. Why the huge prices? Blame the litigious patients who demand complication free everything and the darn lawyers who will sue any company, suggesting that it is to save another victim.

 

Trumpism!! Do We Need a Psychiatrist Here???

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I thought that it would be interesting to pursue that question that many are considering when we hear Mr., possibly future President, Donald Trump, lash out or just simply insult his nest victim. Is he really crazy???

Carey Benedict wrote an interesting article last week in the New York Times (Aug. 15) that I thought was provoking, “Is it fair to Analyze Donald Trump from Afar” psychologically that is? In the midst of a deeply divisive presidential campaign, more than 1,000 psychiatrists declared the Republican candidate unfit for the office, citing severe personality defects, including paranoia, a grandiose manner and a Godlike self-image. One doctor called him “a dangerous lunatic.”

But interestingly enough is to consider that many others running for that same office have had their personalities questioned.

The year was 1964, and after losing in a landslide, the candidate, Senator Barry Goldwater of Arizona, sued the publisher of Fact magazine, which had published the survey, winning $75,000 in damages.

But doctors attacked the survey, too, for its unsupported clinical language and obvious partisanship. In 1973, the American Psychiatric Association adopted what became known as the Goldwater Rule, declaring it unethical for any psychiatrist to diagnose a public figure’s condition “unless he or she has conducted an examination and has been granted proper authorization for such a statement.”

And now enter Donald J. Trump.

The 2016 Republican nominee’s incendiary, stream-of-consciousness pronouncements have strained that agreement to the breaking point, exposing divisions in the field over whether such restraint is appropriate today.

Psychiatrists and psychologists have publicly flouted the Goldwater Rule, tagging Mr. Trump with an assortment of personality problems, including grandiosity, a lack of empathy, and, I loved this diagnosis-“malignant narcissism.” The clinical insults are flying so thick that earlier this month, the psychiatric association posted a reminder that breaking the Goldwater Rule “is irresponsible, potentially stigmatizing, and definitely unethical.”

Putting a psychiatric label on a candidate they oppose can be a “seemingly irresistible tool for some in the field,” said Dr. Paul Appelbaum, a professor of psychiatry, medicine and law at Columbia University who disapproves of the practice. “This year, perhaps more than most, they’re persuaded they’re saving the nation from a terrible fate.”

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A 1964 article in Fact magazine led to what is known as the Goldwater Rule, the American Psychiatric Association’s declaration that it is unethical for any psychiatrist to diagnose a public figure’s condition “unless he or she has conducted an examination and has been granted proper authorization for such a statement.”

William Doherty, a psychologist at the University of Minnesota, believes exactly that. In June, Dr. Doherty posted an online manifesto against “Trumpism” that has been signed by more than 2,200 mental health specialists.

“Yes, for me this is an exception,” Dr. Doherty said. “What we have here is a threat to democracy itself.”

Supporters of the Goldwater Rule have cited three main rationales for adhering to it: Most diagnoses made from a distance turn out to be wrong; the labels themselves can cause real harm to the person and family members; and the practice undermines the field’s credibility, particularly its commitment to confidentiality. Not to mention, others say, that it could expose a left-leaning bias in the field.

But the psychoanalyzing of public figures by commentators, columnists and pop psychologists has had a long bipartisan history. Concerns about grandiosity and narcissism dogged Lyndon B. Johnson’s presidency. Suspicions of a deepening paranoia clouded the end of Richard Nixon’s. Accusations of manipulation, deceit and a sense of entitlement have trailed the Clintons for years, prompting speculation about deeper personality problems.

Mr. Trump himself has recently tried to turn the tables, accusing Hillary Clinton of being “unstable” and “unhinged.”

While the vast majority of therapists’ comments remain focused on Mr. Trump, some in the profession say that if public psychoanalyzing is going to be done, it should be directed at both candidates.

“Do those things rise to a diagnosable level? I sure don’t know,” said Don Sizemore, a family therapist in Lexington, Ky. “But if we’re diagnosing him, we should be doing the same for her.”

Yet history cautions against the armchair analysis of either one. Psychiatrists point to Goldwater himself as a prime example of getting it wrong. By the time he died in 1998, Mr. Goldwater was regarded as “one of his party’s most respected elder statesmen,” The Washington Post said in its obituary.

In the wake of the Monica Lewinsky scandal, many people longed for a diagnosis to explain or denounce President Bill Clinton’s behavior, said Dr. Nada Stotland, a psychiatrist at Rush Medical College in Chicago. “I remember getting all these media calls asking if he was a narcissist or a sex addict,” she said. “Well, sex addiction wasn’t a recognized disorder at the time. (Oh, my goodness…another narcissist?) And if it had been, was the behavior then not his fault? I ended up dancing around these questions, because this idea that we should go around, willy-nilly, putting diagnoses on people is just wrong.”

But those using clinical language to describe Mr. Trump’s behavior contend that this presidential election is vastly different, for a big reason: The proliferation of social media comments and video clips, which afford direct, unscripted access to candidates, was simply not available in previous races. The depth of that material creates a public persona complete enough to analyze on its own merits, they say.

More than 2,200 mental health professionals had signed an online manifesto at citizentherapists.com as midday Monday.

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Dr. Doherty said he and the therapists who signed his manifesto were not diagnosing Mr. Trump’s personal traits, but his public persona. The manifesto characterizes “Trumpism” as reinventing history, never apologizing, demeaning critics and inciting violence. “One can talk about his public behavior without knowing whether he is fully that way with his children, his wife, his friends,” Dr. Doherty said.

Dr. Steven Buser, a psychiatrist who with his colleague, Dr. Leonard Cruz, coedited a new book, “A Clear and Present Danger: Narcissism in the Era of Donald Trump,” stressed, “We are careful not to make a clinical diagnosis here, to say that Donald Trump has narcissistic personality disorder.” The contributing writers include psychiatrists and psychologists, but Dr. Buser said, “We are focused on the image he projects, on TV, in tweets, in quotes.”

Dr. Appelbaum calls this distinction a convenient splitting of hairs. “It takes a skilled therapist months, sometimes longer, seeing a person regularly and asking probing questions to make a determination of whether a disorder is present,” Dr. Appelbaum said.

And there is more, the stigma of mental vulnerability is especially damaging in politics. In the 1972 presidential race, Senator Thomas F. Eagleton of Missouri withdrew as George McGovern’s running mate after 18 days — at Mr. McGovern’s request — in the wake of revelations that he had undergone psychiatric counseling and electroshock therapy. In 1988, the Democratic nominee, Michael S. Dukakis, released his medical records to counter rumors that he had undergone psychiatric treatment. He had not.

During his libel trial, Mr. Goldwater was mystified by some of the psychiatrists’ comments about his personality, including one calling him an “anal character.” “I don’t know what an anal character would be,” he testified, according to news accounts. “I tried to look it up in the dictionary, but couldn’t find it.”

He took particular exception to a psychiatrist’s comment that he was “a counterfeit figure of a masculine man.” Such a charge “weighs several tons, and the effect is rather depressing,” he said.

If there are exceptions to the Goldwater Rule, psychiatrists apparently cannot agree on them. More distant historical figures tend to be fair game; “Lincoln’s Melancholy,” a book by Joshua Wolf Shenk making the case that Lincoln had suffered from depression, was well received.

Leaders of hostile nations may or may not qualify, depending on who is judging. A psychiatrist who provided a personality assessment of Saddam Hussein at the request of the George W. Bush administration was criticized by some in the psychiatric community, but not formally censured.

Retired politicians fall into a gray area. Therapists have penned books on George W. Bush, as well as Bill Clinton. Not all of their colleagues approve.

But in an era when private moments and comments are increasingly available for public consumption, some argue that the Goldwater Rule is due for an update.

“There’s another perspective on this altogether,” said John D. Mayer, a University of New Hampshire psychologist who has written widely on the rule. “The ethicists who wrote the rule have been entirely focused on the negative side of commentaries. But there’s a positive, adaptive side to every personality trait.

“If you call someone deceitful, whether Clinton or Trump,” Dr. Mayer said of this year’s nominees, “it needs to be said that, for a good politician, there are reasons you can’t always say everything you know, or exactly what you think.”

The most obvious assessment is that one has to be at least slightly crazy to run for President. It is difficult to assess Mr. Trump as to his psychiatric stability. But we all are concerned that if he is manic do we want him with his finger on the controls of a possible nuclear invasion? I have begged my connections to the campaign to get control of their candidate. Lately there seems to be a more controlled candidate.

Is this all part of the playbook of the Trump strategy? Is Trump actually continuing to play his TV game show? And more important, does Trump really want to be President or was this all part of the game to prove his power over the GOP and the GOP’s future destruction?

What a tangled web they weave! Who do we trust and are any of the politicians really sane?

Silliness-First Vaccinations and Now We Question Flossing and Believe Pokémon Go will the Correct Obesity Epidemic

13882216_943389095790750_4891677781261928741_nIt’s one of the most universal recommendations in all of public health: The dictum-Floss daily to prevent gum disease and cavities. Except there’s little proof that flossing works. Still, the federal government, dental organizations and manufacturers of floss have pushed the practice for decades. Dentists provide samples to their patients; the American Dental Association insists on its website that, “Flossing is an essential part of taking care of your teeth and gums.”

The federal government has recommended flossing since 1979, first in a surgeon general’s report and later in the Dietary Guidelines for Americans issued every five years. The guidelines must be based on scientific evidence, under the law.

Last year, the Associated Press asked the departments of Health and Human Services and Agriculture for their evidence, and followed up with written requests under the Freedom of Information Act. When the federal government issued its latest dietary guidelines this year, the flossing recommendation had been removed, without notice. In a letter to the AP, the government acknowledged the effectiveness of flossing had never been researched, as required.

The AP looked at the most rigorous research conducted over the past decade, focusing on 25 studies that generally compared the use of a toothbrush with the combination of toothbrushes and floss. The findings? The evidence for flossing is “weak, very unreliable,” of “very low” quality, and carries “a moderate to large potential for bias.”

“The majority of available studies fail to demonstrate that flossing is generally effective in plaque removal,” said one review conducted last year. Another 2015 review cites “inconsistent/weak evidence” for flossing and a “lack of efficacy.”

One study review in 2011 did credit floss with a slight reduction in gum inflammation — which can sometimes develop over time into full-fledged gum disease. However, the reviewers ranked the evidence as “very unreliable.” A commentary in a dental magazine stated that any benefit would be so minute users might not notice it. Remember, this was a commentary only.

The two leading professional groups — the American Dental Association and the American Academy of Periodontology, for specialists in gum disease and implants — cited other studies as proof of their claims that flossing prevents buildup of gunk known as plaque, early gum inflammation called gingivitis, and tooth decay. However, most of these studies used outdated methods or tested few people. Some lasted only two weeks, far too brief for a cavity or dental disease to develop. One tested 25 people after only a single use of floss. Such research, like the reviewed studies, focused on warning signs like bleeding and inflammation, barely dealing with gum disease or cavities.

Wayne Aldredge, president of the periodontists’ group, acknowledged the weak scientific evidence and the brief duration of many studies. In an interview at his private practice in New Jersey, he said that the impact of floss might be clearer if researchers focused on patients at the highest risk of gum disease, such as diabetics and smokers. Still, he urges his patients to floss to help avoid gum disease. “It’s like building a house and not painting two sides of it,” he said. “Ultimately those two sides are going to rot away quicker.” Aldredge also said many people use floss incorrectly, moving it in a sawing motion instead of up and down the sides of the teeth. Pressed about the origins of his organization’s endorsement of flossing, he said it may simply have “taken the ADA’s lead.” This is part of the problem and the studies need more time and a scientifically based study.

When the ADA was asked for proof of its claim that flossing helps prevent early gum disease and cavities, the group cited the 2011 review and a 2008 two-week study that measured bacteria and did not even consider gum disease.

In a later statement to the AP, the ADA said flossing “removes plaque” and “is proven to help remove” debris from between teeth. A video on its website proclaims that flossing “helps prevent gum disease.” When pressed, Matthew J. Messina, a practicing dentist and spokesman for the dental association, acknowledged weak evidence, but he blamed research participants who didn’t floss correctly.

Even companies with a big market share of the flossing business — by next year, the global market is predicted to reach almost $2 billion, with half in the United States, according to publisher MarketSizeInfo.com — struggled to provide convincing evidence of their claims that floss reduces plaque or gingivitis. Yet the industry has paid for most studies and sometimes designed and conducted the research.

Procter & Gamble, which claims that its floss fights plaque and gingivitis, pointed to a two-week study, which was discounted as irrelevant in the 2011 research review.

Johnson & Johnson spokesman Marc Boston said floss helps remove plaque. When the AP sent him a list of contradicting studies, he declined comment. The floss-making companies partner with the ADA through its Seal of Acceptance program. The ADA promotes the seal to companies as something that “directly affects the purchase decisions of consumers;” each manufacturer is charged $14,500 for the evaluation. If it approves the product, the ADA then charges an additional annual fee of $3,500. The ADA says it rigorously evaluates products and makes no profit from the program. However, floss companies themselves are allowed to design the studies.

“The funding can come from companies — no problem at all,” said dentist Marcelo W.B. Araujo, vice president of the ADA’s Science Institute, who joined the organization after serving as an executive for Johnson & Johnson. “The design can start from the company.”

When flossing first gained acceptance, no proof was required of remedies. Dentist Levi Spear Parmly is credited with inventing floss in the early 19th century. By the time the first floss patent was issued, in 1874, the applicant noted that dentists were widely recommending its use.

The ADA has been promoting floss universally since 1908. “They just looked into what they did every day in their clinical practice and what they would recommend for patients,” said Araujo.

Count dentist Damien Walmsley, scientific adviser to the British Dental Association, among the skeptics. “It’s important to tell people to do the basics. Flossing is not part of the basics.” And you are going to believe a British dentist when the British dental health is rated as some of the worse parts of their care and overall health.

Floss can occasionally cause harm. Careless flossing can damage gums, teeth and dental work. Though frequency is unclear, floss can dislodge bad bacteria that invade the bloodstream and cause dangerous infections, especially in people with weak immunity, according to the medical literature.

National Institutes of Health dentist Tim Iafolla acknowledged that if the highest standards of science were applied in keeping with the flossing reviews of the past decade, “then it would be appropriate to drop the floss guidelines.”

Regardless, he added, Americans should still floss. “It’s low risk, low cost,” he said. “We know there’s a possibility that it works, so we feel comfortable telling people to go ahead and do it.”

But discussing this with dentists, my wife and others, there is the question of where does this come and why now? They know the benefits and its effects on dental health it is just a bunch of flawed studies. These are not even acceptable research studies. But the technique has to be performed properly and when done decreases gum disease allowing patients to keep their teeth and avoiding the spread of bacteria to other sites such as heart valves. We, dentists and physicians, know the science behind flossing. It’s just hard to prove it and interestingly the company selling water flossing-The Water Pic Pro- are advertising like crazy.

And now Niantic Corporation has released Pokémon Go promoting it for increased physical activity. Niantic’s new smartphone game has unleashed a Pokémon fever that is spreading around the globe faster than swine flu. Now, researchers at Johns Hopkins are scrambling to study how Zubats and Pikachus might be affecting populations—possibly helping to combat another ongoing public health crisis: the global obesity epidemic.

From med students to middle-school kids, tens of millions have suddenly taken to the streets, phone in hand, in search of elusive virtual beasts.  The more you walk, the more likely you are to find these pixel critters, gain expertise and “level up.” With its incredible worldwide popularity, this immersive, augmented-reality game has the makings of a social, or health, experiment on a global scale.

As the obesity epidemic continues to grow and physical activity continues to decline worldwide, could chasing Pokémon be part of the solution? Each day in the US, only 1 in 3 children are physically active and less than 5% of adults get the recommended 30 minutes of physical activity. Over the past 5 years, hundreds of wearable technologies have emerged, but the jury is still out on whether these actually improve physical activity, especially among the sedentary. Public health studies have sought answers to these tough questions: Do wearables actually enhance physical activity? Can they replace expensive gym memberships or exercise equipment? Will people keep using them once the novelty wears off? Roughly 13 million Americans bought smart activity trackers in 2015, but 1/3 abandoned those New Year’s resolutions within 6 months.

Maybe the secret sauce is not trying to be a healthy app, but instead focus on a game that gets people off the couch, into the real world, with inadvertent health effects. In 2006, Microsoft’s Kinect and Nintendo’s Wii game consoles were heralded by many as the solution to getting a nation of young gamers off their couches—but in this case, only as far as the carpet in front of the TV. In just a week, more people have downloaded and used Pokémon GO than have ever bought the Wii Fit game. Even major fitness giants such as Nike have tried, unsuccessfully, to capture users in NikeFuel “Missions,” powered by a digitally-enhanced sneaker, only to dissolve most of their Digital Sports division 2 years after launch.

As a commercial digital game, Pokémon GO may be better at engaging users, especially currently sedentary ones, than health apps disguised as games. Pokémon GO not only builds on the appeal of a massively successful gaming franchise but also adds a hefty dose of 21st century tech. Kids and adults alike seem to be having no problem walking for city blocks when it doesn’t seem like exercise—like hiding broccoli in a smoothie. The best high-def video games may be no match for the hybrid game + real world mix when it comes to propelling users out of the house. Pokémon GO’s augmented reality superimposes Charizards and Squirtles on once-familiar buildings and sidewalks and turns churches and parking lots into state-of-the art Pokémon Gyms, allowing this exciting virtual environment to attract users out into the real world. On the other hand, embracing fast-food chains as Pokémon Gym sponsors could negate gains as players are drawn to the nearest McDonalds to fuel more than just their virtual menagerie. It seems clear that the game could be very useful in prevention and health promotion in a variety of ways.

Gamified health and fitness apps don’t seem to share the “stickiness” of the best digital games. Already fans are discovering nature trails they never knew existed, or historic landmarks they’d never noticed, thanks to the lure of another wild Pokémon. Active games like Dance, Dance Revolution! are based on high-energy, frenetic jumps and twists, but so far haven’t shown evidence they reduce body mass index (BMI). The shininess of an exergame quickly wears off. But GO is a commercial franchise, likely to build momentum and keep players hooked well beyond the proverbial chasm of long-term adoption. Savvy physical therapists have already incorporated GO into therapy for hospitalized children. Most public health agencies trying their hand at digital health can hardly dream of competing on this level.
Many parents express surprise at screen-bound preteens’ sudden desire to head outdoors since wild Pokémon appeared in our neighborhoods. Getting kids out in the open has clear health advantages, like increased Vitamin D levels (which helps strengthen bones), strengthened immune systems, lower stress levels (Head Start Body Start), and reduced ADHD symptoms (NIH). Following specific routes and checking in at points of interest along the way could encourage people to explore their communities, allowing them to rediscover unappreciated real-world landmarks. Niantic could even partner with state and national park systems to host ‘Pokémon
Many multiplayer online games, from Farmville to World of Warcraft, promote (or even require) virtual socialization, but it is intriguing to see how Pokémon GO fosters real-world, face-to-face interactions—a strong predictor of both mental and physical health. This interaction could be useful, especially for those who otherwise have difficulty in social situations; some users are already reporting improvements in depression and anxiety. In fact, Niantic could capitalize on this through new features that could encourage social interactions—perhaps by increasing the chances of rare Pokémon sightings or speeding progress when traveling with a group.

Of course, as public health professionals, we are also wary of a few potential areas of concern. As concerns about potential problems mount, we question whether guidelines for use might be needed, such as those proposed alongside the game’s release in Japan. Pokemon’s intro screen warns players to stay alert, but media reports are flooding in of people injured while focusing on Bulbasaur and not the busy traffic intersection. We wouldn’t be surprised to see hospitals adopting a new injury billing code in the near future, or officers writing tickets for driving while Pokémon hunting. Safety features, which completely disable interaction when in a moving vehicle may be warranted in future releases.

GO’s game mechanics have already been used to rob players of their phones and money by luring unwitting players to attractive ‘virtual’ locations. Reports of malware, piggybacked on illegally-downloaded copies have emerged, potentially able to intercept a user’s communications and locations. And, people may be less vigilant than usual while playing—venturing into areas they might not otherwise, alone or during times of day where they might be at increased risk of crime. Some have even warned of the risk of racial bias affecting how police or the neighborhood watch might misinterpret game-inspired wandering.

As noted with other highly engaging games, some users might find GO interfering with real life, causing relationship conflicts, low bank balances, and possibly neglect of work, school or sleep–problems common to behaviors that spiral out of control. It’s the very elements of GO and other games that are so fascinating and engaging that also make them potentially problematic. Attention to basic theories of behavioral reinforcement is integral to game design, and newer free-to-play games (like GO) use the enormous amounts of data they collect to develop analytics. These analytics are often used to identify and exploit “social whales”—those 0.15% of players who account for 1/2 of the in-app purchases, creating an ethical embarrassment. To offset this quandary, developers and scientists could collaborate over these data to prevent problematic gaming and to extend insights into public engagement.

There is no doubt that we, in the health community, have a lot to learn from the Pokémon playbook— whether it’s the way GO captures and motivates players, or the social element of a shared gaming experience. Alternatively, this is an opportunity for the health community to identify existing commercial games with the potential to have real world health impacts.

Collecting information about benefits and risks is important to public health scientists the same way monitoring use and demographic data is critical to a game’s marketing analysts (and capturing Pokémon is for 30 million Pokémon GO users). The FDA is joining other health agencies worldwide to pave the way for apps to be allowed to make health claims, but this will require plenty of evidence. If Pokémon GO or other games can be used to prevent obesity or improve social anxiety and depression, we’ll need evidence to encourage their use as “digiceuticals.”

Public health and clinical investigators can design the studies that will figure out if a future prescription should read, “Capture 60 Pokémon and call me next month.” But studies cost money, and the time it takes to get a study done, from conception to funding to published guidelines, can take a decade or more, by which time we’ll likely be talking about Pokémon GONE. Intentional collaborations between the gaming industry, gamers and global health could shrink this timespan dramatically.

It’s not clear yet what impact (or duration) this Pokémon epidemic will have in terms of societal benefits and consequences. Certainly, Pokémon GO is challenging public health scientists to rethink how to leverage mobile technologies and video games to engage a clearly willing gaming public to combat the looming and very-real epidemics of childhood obesity, depression and other noncommunicable diseases. The staggering $190 billion spent currently on obesity, and the projected costs of over $1 trillion from cardiovascular diseases by 2030 demands that we identify new solutions. Beyond healthy bodies, the ability of wild Pikachus to unite crowds of strangers may be just the prescription-strength app for the socially tense and politically divided times we live in.

Alain Labrique, PhD, MHS, MS, is an associate professor in the Department of International Health at JHSPH and the director of the JHU Global mHealth Initiative, a University-wide Center of Excellence in digital health research. Yorghos Carabas is a marketing and communications specialist and creative designer at the Johns Hopkins University Global mHealth Initiative. Michelle Colder Carras is a postdoctoral research fellow in the Department of Mental Health at the Johns Hopkins Bloomberg School of Public Health who studies media and mental health. Bruce Y. Lee, MD, MBA, is an associate professor of International Health at the Johns Hopkins Bloomberg School of Public Health, director of the Global Obesity Prevention Center, and director of Operations Research at the International Vaccine Access Center.

The Pennsylvania hospital system is one of several that see the popular game as a threat to patients’ physical safety and privacy, and a threat to hospital data security. Outside of the presidential race, perhaps no topic has been as divisive in our culture this summer as Pokémon Go. Proponents of the video game sensation say it’s bringing people together—some towns sponsoring Pokémon walks and it’s encouraging physical activity. Mental health advocates say the game can help some persons with mental illness. Michigan’s Mott Children’s Hospital is one of several healthcare organizations that encourage young patients to get out of bed and play the popular game. But the tide may be quickly turning. Many dislike the fact that the game is a distraction, causing people to crash their cars and even walk off the edges of cliffs. And, on top of that, some oblivious players have been trying to catch Pokémon in inappropriate locations, such as Arlington National Cemetery and at the Holocaust Museum. So it’s no surprise that, despite the fitness and possible behavioral health benefits, some hospitals are beginning to ask that patients abstain from playing the game while in their facilities. Pennsylvania-based Allegheny Health Network, a division of Highmark Health, recently asked Niantic, Pokémon Go’s manufacturer, to remove all AHN locations from the app.

“Because Allegheny Health Network hospitals and other facilities are technically public places, they are open to being identified as Pokémon gym locations,” stated a memo to all AHN employees. “The presence of Pokémon Go players in our facilities compromises physical safety, patient privacy, computer security, and personal safety.”

The Pokémon gyms mentioned in the memo are locations where players can pick up helpful items and battle other players. The gyms can be anywhere the game manufacturer considers to be public, which apparently included some AHN facilities.

“Watch out for people walking around focused on their smartphone virtual world and not on their immediate surroundings—which is a concern for patients and visitors in our facilities,” the memo continued.

“Remind players that unauthorized photography is prohibited on AHN premises. Immediately contact physical security to report anyone observed taking unauthorized pictures on AHN premises.”

ANH isn’t the only health system to come out against Pokémon Go. Massachusetts General Hospital recently asked staff to stop using the app while at work, and the American Hospital Association requested that Niantic remove its locations from the game.

Are we all crazy! First we tell people that flossing is worthless and then we encourage people to use an APP to improve the health and wellbeing of our patients.