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Archive for the ‘Healthcare costs and reimbursement’ Category

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Dr. Peter Eisenberg, left, said people with less money were treated differently by doctors.
Credit Preston Gannaway for The New York Times

When Dr. Jeffery Ward, a cancer specialist, and his partners sold their private practice to the Swedish Medical Center in Seattle, the hospital built them a new office suite 50 yards from the old place. The practice was bigger, but Dr. Ward saw the same patients and provided chemotherapyjust like before. On the surface, nothing had changed but the setting.

But there was one big difference. Treatments suddenly cost more, with higher co-payments for patients and higher bills for insurers. Because of quirks in the payment system, patients and their insurers pay hospitals and their doctors about twice what they pay independent oncologists for administering cancer treatments.

There also was a hidden difference — the money made from the drugs themselves. Cancer patients and their insurers buy chemotherapy drugs from their medical providers. Swedish Medical Center, like many other others, participates in a federal program that lets it purchase these drugs for about half what private practice doctors pay, greatly increasing profits.

Oncologists like Dr. Ward say the reason they are being forced to sell or close their practices is because insurers have severely reduced payments to them and because the drugs they buy and sell to patients are now so expensive. Payments had gotten so low, Dr. Ward said, that they only way he and his partners could have stayed independent was to work for free. When he sold his practice, Dr. Ward said, “The hospital was a refuge, not the culprit.”

When a doctor is affiliated with a hospital, though, patients end up paying, out of pocket, an average $134 more per dose for the most commonly used cancer drugs, according to a report by IMS Health, a health care information company. And, the report notes, many cancer patients receive multiple drugs.

“Say there was a Costco that had very good things at reasonable prices,” said Dr. Barry Brooks, a Dallas oncologist in private practice. “Then a Neiman Marcus comes in and changes the sign on the door and starts billing twice as much for the same things.” That, he said, is what is happening in oncology.

Chemotherapy drug

Pertuzumab (breast cancer)
Rituximab (lymphoma, leukemia)
Bevacizumab (several cancers)
Cetuximab (head, neck, colorectal)
Trastuzumab (breast, stomach)
Fulvestrant (breast)
Leuprolide Acetate (prostate)
Epirubicin (breast)
Interferon alfa-2B (lymphoma, others)
Mitoxantrone (prostate, leukemia)
Doxorubicin (leukemia, others)
Goserelin (prostate, breast)
Daunorubicin (leukemia)
Idarubicin (leukemia)
Mitomycin C (stomach, pancreas)

Sources: IMS Institute for Healthcare Informatics; RxList
By The New York Times

A Quirk in Drug Pricing

Insurers pay hospitals and doctors affiliated with hospitals more to adminster chemotherapy drugs than they pay independent doctors.

 

Insurance reimbursment per dose in a hospital or hospital-affiliated office Reimbursment per dose in a private practice

Chemotherapy drug

(and some cancers it can treat)

SEE FIGURE in article

http://www.nytimes.com/2014/11/24/health/private-oncologists-being-forced-out-leaving-patients-to-face-higher-bills.html?_r=0

The situation is part of the unusual world of cancer medicine, where payment systems are unique and drive not just the price of care but what drugs patients may get and where they are treated. It raises questions about whether independent doctors, squeezed by finances, might be swayed to use drugs that give them greater profits or treat poorer patients differently than those who are better insured.

But one thing is clear: The private practice oncologist is becoming a vanishing breed, driven away by the changing economics of cancer medicine.

Practices are making the move across the nation. Reporting on the nation’s 1,447 independent oncology practices, the Community Oncology Alliance, an advocacy group for independent practices, said that since 2008, 544 were purchased by or entered contractual relationships with hospitals, another 313 closed and 395 reported they were in tough financial straits. In western Washington, just one independent oncology group is left.

Christian Downs, executive director of the Association of Community Cancer Centers, said that although there are no good data yet, he expected the Affordable Care Act was accelerating the trend. Many people bought inadequate insurance for the expensive cancer care they require. Community doctors have to buy the drugs ahead of time, placing a burden on them when patients cannot pay. The act also requires documentation of efficiencies in medical care which can be expensive for doctors in private practice to provide. And it encourages the consolidation of medical practices.

The American Hospital Association cites advantages for patients being treated by hospital doctors. “The hassle factor is reduced,” said Erik Rasmussen, the association’s vice president of legislative affairs. Patients can have scans, like CT and M.R.I., use a pharmacy and get lab tests all in one place instead of going from facility to facility, he said.

And, he added, there is a reason hospitals get higher fees for their services — it compensates them for staying open 24 hours and caring for uninsured and underinsured patients.

For doctors in private practice, providing chemotherapy to uninsured and Medicaid patients is a money loser. As a result, many, including Dr. Ward before he sold his practice, end up sending those patients to nearby hospitals for chemotherapy while keeping them as patients for office visits.

“We hate doing it, I can’t tell you how much we hate doing it,” said Dr. Brooks, the Texas oncologist. “But I tell them, ‘It will cost me $200 to give you this medication in my office, so I am going to ask you to go to the hospital as an outpatient for infusions.’ ”

Dr. Peter Eisenberg, in private practice in Marin County in Northern California, said: “The disgrace is that we have to treat people differently depending on how much money they’ve got. That we do diminishes me.”

Hospitals may be less personal and less efficient, said Dr. Richard Schilsky, chief medical officer at the American Society of Clinical Oncology. Many private practice oncology offices, he said, “Run on time, they are efficient, you get in, you get out, as opposed to academic medical centers where they may be an hour and a half behind.”

Dr. Ward and others in private practice said they tried for years to make a go of it but were finally defeated by what he described as “a series of cuts in oncology reimbursement under the guise of reform to which private practice is most vulnerable.”

Lower reimbursements have two effects. One is on overhead. Unlike other doctors, oncologists stock their own drugs, maintaining a sort of mini-pharmacy. If a patient gets too sick to receive a drug or dies, the doctor takes the loss. That used to be acceptable because insurers paid doctors at least twice the wholesale price of drugs. Now doctors are reimbursed for the average cost of the drug plus 4.3 percent, there are more and more drugs to stock, and drugs cost more.

“The overhead is enormous,” Dr. Schilsky said. “This is one of the reasons why many oncologists are becoming hospital-based.”

The second — and bigger — effect is less profit from selling drugs to patients. For years, chemotherapy drugs provided a comfortable income. Those days are gone, doctors say.

The finances are very different in hospitals, with their

  • higher reimbursement rates for administering drugs,
  • discounts for buying large quantities, and
  • a special federal program that about 30 percent of hospitals qualify for.
  • The program, to compensate research hospitals and hospitals serving poor people,
  • lets hospitals buy chemotherapy drugs for all outpatients at about a 50 percent discount.

In addition, Dr. Schilsky notes, cancer patients at hospitals use other services, like radiation therapy, imaging and surgery.

“A cancer patient is going to generate a lot of revenue for a hospital,” Dr. Schilsky said.

Health care economists say they have little data on how the costs and profits from selling chemotherapy drugs are affecting patient care. Doctors are constantly reminded, though, of how much they can make if they buy more of a company’s drug.

Celgene, for example, in a recent email about its drug Abraxane, told one doctor who had bought 50 vials that he could get a rebate of $647.51 by buying 68 vials. If he bought 175 vials he’d get $1,831.93

This hidden profit possibility troubles Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.

“When you walk into a doctor’s office you don’t know that in most cancer scenarios there are a range of therapeutic choices,” Dr. Bach said. “Unless the doctor presents options, you assume there aren’t any.”

While individual oncologists deny choosing treatments that provide them with the greatest profit, Dr. Kanti Rai, a cancer specialist at North Shore-Long Island Jewish Cancer Center, said it would be foolish to believe financial considerations never influence doctors’ choices of drugs.

“Sometimes hidden in such choices — and many times not so hidden — are considerations of what also might be financially more profitable,” he said.

A version of this article appears in print on November 24, 2014, on page A13 of the New York edition with the headline: Private Oncologists Being Forced Out, Leaving Patients to Face Higher Bills. 
SOURCE 

http://www.nytimes.com/2014/11/24/health/private-oncologists-being-forced-out-leaving-patients-to-face-higher-bills.html?_r=0 

 

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2:15PM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

 

2:15 p.m. Panel Discussion Reimbursement/Regulation

 

Reimbursement and Regulation

     Moderator:

Sheila D. Walcoff, J.D.
CEO and Founder, Goldbug Strategies, LLC

Panelists:

2. Catalina Lopez Correa, M.D., Ph.D.
Vice President/CSO, Scientific Affairs
Génome Québec

1. Michael Kolodziej, M.D.
National Medical Director for Oncology Strategies, Aetna

Clinical Utility Test is done cheap the drug used as therapeutics is $10,000 – without knowing if it will work or not

3. Bruce Quinn, M.D., Ph.D.
Senior Health Policy Specialist
Foley Hoag LLP

It is a whole ecosystem,

1. CMS – ACA

2. On diagnostics: clinical utility (six questions), clinical validity, analytical

$50 test kit from Abbott, 20,000 patients – $1 million market for test, Drug: $100,000 = $1 Billion for Pharma

Test coverage by Insurance:
  • If Patient sign Risks are known, Physician is educated, Patient is educated by Physician
  • Participation in Registry — test is covered
  • making information actionable to the Consumer

See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

@GenomeQuebec

@clopezcorrea

@Aetna (for Dr. Kolodziej)

 

@FoleyHoag (for Bruce Quinn)

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Remote Care Management of CHF Patients by Home Digital Technology and Continuous Access to NP – A Partnership of an Insurer with a Technology Company

 

Reporter: Aviva Lev-Ari, PhD, RN

 

CIGNA-HEALTHSPRING AND INTEL-GE CARE INNOVATIONS™ EXPAND REMOTE CARE MANAGEMENT PROGRAM TO REDUCE CONGESTIVE HEART FAILURE-RELATED COMPLICATIONS IN TENNESSEE

02 October 2014
  • Completion of successful pilot prompts statewide program expansion in TN
  • Program helps monitor and educate participants, promotes self-monitoring and empowers patient engagement with their health
  • Participants receive interactive tablet, blood pressure cuff and scale at no extra cost
  • Key to program success is customer’s direct access to dedicated Cigna-HealthSpring nurse practitioner with virtual connection enabled through interactive tablet

NASHVILLE – October 2, 2014 – In partnership with Intel-GE Care Innovations™, Cigna-HealthSpring® is expanding its population health program that utilizes interactive tablets – the Intel-GE Care Innovations™ Guide – and virtual connection to Cigna-HealthSpring nurse practitioners to partner and engage with patients diagnosed with congestive heart failure (CHF) to successfully manage their condition at home. Based on a successful pilot in Middle Tennessee that engaged 50 patients, the innovative remote patient management program is now being implemented with 250 patients statewide with potential for further expansion.

“We are dedicated to helping our customers get more from life and the success of the pilot program shows what an invaluable opportunity we have to truly make a positive impact in our customers’ lives,” said Dr. Jim Lancaster, senior medical director for Cigna-HealthSpring of Tennessee. “Many people with congestive heart failure find themselves back in the hospital within a matter of weeks after returning home so it’s important that we continue to seek new and innovative solutions to help them better manage their health. We are pleased by the early success of the pilot program and excited to implement it statewide to help more of our customers take control of their health with the convenience of virtual yet personalized medicine at home.”

Under the expanded program, participating Cigna-HealthSpring customers will be given a blood pressure cuff, scale and interactive tablet for a minimum of 90 days which will enable them to interact virtually with their Cigna-HealthSpring nurse practitioner, track their daily biometrics and complete an educational program to help them manage their CHF at home. Once they achieve specific milestones, participants will transition away from the tablet to a less intensive program where they will continue to monitor and log their weight and blood pressure with the help of a case manager. At the end of the program, customers should be able to recognize symptoms of CHF exacerbation and understand the impact of diet, education and medication on their condition. To participate in the program, customers must have received a CHF diagnosis and a previous ER visit or hospital admission. There is no cost to the customer to participate in the program but using the tablet requires a landline or internet connectivity.

“We have seen dramatic reductions in the need for hospitalization in our first year of the program pilot with Cigna-HealthSpring. We also recently worked with many hospitals across the country to create successful remote care management programs and have seen as high as a 75 percent reduction in hospital readmissions,” said Sean Slovenski, CEO of Intel-GE Care Innovations. “We’ve learned that a successful program is as much about the logistical details as it is about the technology. Helping consumers engage proactively in their own health is our mission at Care Innovations. By monitoring and engaging CHF patients as they go about their daily lives, we are able to catch problems early, involve the doctor immediately and ultimately avoid unnecessary ER visits, hospital stays and worsening of the patients’ health.”

Cigna-HealthSpring customer success examples:

When Elizabeth*, 74, started the program her blood pressure was extremely high, she was overweight and she had struggled with hospital admissions due to CHF complications. Since starting the program, she has lost 25 pounds, consistently had her blood pressure and heart rate in a healthy range and avoided the hospital. She says the program has helped give her better awareness of her condition and made her realize the positive impact she can make from simple daily monitoring of her biometrics. Elizabeth’s improvement has also helped her husband, who acts as her caregiver, gain more comfort and assurance that she has personal and direct access to her Cigna-HealthSpring nurse practitioner.

Margery*, 72, had struggled with controlling her CHF and frequently found herself in the hospital. Cigna-HealthSpring worked together with her cardiologist to enroll her in the program and create a personalized care plan to better manage her CHF. She says she now knows what to do and the program has helped educate and empower her to take better care of her herself and control her CHF. The program has helped her improve her biometrics, avoid the hospital for CHF-related complications and allowed her nurse practitioner to intervene early to prevent CHF exacerbation or a trip to the hospital.

*Names changed for privacy.

CHF is a chronic condition that affects 5.1 million people in the U.S.[1] and costs Medicare $17.4 billion per year in avoidable hospital readmissions.[2]. A companion piece to a recent study by Dartmouth University listed some of the reasons for hospital readmissions regardless of the condition, including patients not fully understanding their condition and being confused about medications.[3]

“What makes this program so special is that customers know they have easy and direct access to a Cigna-HealthSpring nurse practitioner, someone who truly cares about them and their health,” added Dr. Lancaster. “They feel empowered to learn how they can impact their own health.”

About Cigna-HealthSpring
Cigna-HealthSpring, a Cigna company (NYSE:CI), is one of the country’s leading health plans focused on delivering care to the senior population, predominately through Medicare Advantage and other Medicare and Medicaid products.  Based in Nashville, Tennessee, Cigna-HealthSpring offers a national stand-alone prescription drug plan and operates health plans in Alabama, Arizona, Arkansas, Delaware, Florida, Georgia, Illinois, Indiana, Maryland, Mississippi, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington, D.C. For more information, visitwww.cignahealthspring.com.

About Intel-GE Care Innovations™ 
Intel-GE Care Innovations, a joint venture between Intel Corporation and GE Healthcare, connects the care continuum to the home and makes it easier for patients, family caregivers, and professional caregivers to interact and achieve better health at home.

Experts in technology and behavior change, Care Innovations identifies the best methods for health care providers and health plans to capture and integrate real-time data from the home into care delivery. The company’s third-generation remote care management solution, Connect RCM, delivers insights for timely intervention and superior patient engagement with patients outside the formal care setting. The Connect RCM application is built with a smart filter and predictive analytics platform that sorts the complex array of aggregated data captured from a wide array of sensors and sources present in the daily lives of consumers. Visit www.careinnovations.com  to learn more.


[2] CMS National Medicare Readmission Findings. Available athttp://www.academyhealth.org/files/2012/sunday/brennan.pdf 
[3] Care About Your Care: Tips for Patients When They Leave the Hospital. Available atwww.dartmouthatlas.org/downloads/reports/Atlas_CAYC_092811.pdf 

 

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Imaging-guided cancer treatment

Imaging-guided cancer treatment

Writer & reporter: Dror Nir, PhD

It is estimated that the medical imaging market will exceed $30 billion in 2014 (FierceMedicalImaging). To put this amount in perspective; the global pharmaceutical market size for the same year is expected to be ~$1 trillion (IMS) while the global health care spending as a percentage of Gross Domestic Product (GDP) will average 10.5% globally in 2014 (Deloitte); it will reach ~$3 trillion in the USA.

Recent technology-advances, mainly miniaturization and improvement in electronic-processing components is driving increased introduction of innovative medical-imaging devices into critical nodes of major-diseases’ management pathways. Consequently, in contrast to it’s very small contribution to global health costs, medical imaging bears outstanding potential to reduce the future growth in spending on major segments in this market mainly: Drugs development and regulation (e.g. companion diagnostics and imaging surrogate markers); Disease management (e.g. non-invasive diagnosis, guided treatment and non-invasive follow-ups); and Monitoring aging-population (e.g. Imaging-based domestic sensors).

In; The Role of Medical Imaging in Personalized Medicine I discussed in length the role medical imaging assumes in drugs development.  Integrating imaging into drug development processes, specifically at the early stages of drug discovery, as well as for monitoring drug delivery and the response of targeted processes to the therapy is a growing trend. A nice (and short) review highlighting the processes, opportunities, and challenges of medical imaging in new drug development is: Medical imaging in new drug clinical development.

The following is dedicated to the role of imaging in guiding treatment.

Precise treatment is a major pillar of modern medicine. An important aspect to enable accurate administration of treatment is complementing the accurate identification of the organ location that needs to be treated with a system and methods that ensure application of treatment only, or mainly to, that location. Imaging is off-course, a major component in such composite systems. Amongst the available solution, functional-imaging modalities are gaining traction. Specifically, molecular imaging (e.g. PET, MRS) allows the visual representation, characterization, and quantification of biological processes at the cellular and subcellular levels within intact living organisms. In oncology, it can be used to depict the abnormal molecules as well as the aberrant interactions of altered molecules on which cancers depend. Being able to detect such fundamental finger-prints of cancer is key to improved matching between drugs-based treatment and disease. Moreover, imaging-based quantified monitoring of changes in tumor metabolism and its microenvironment could provide real-time non-invasive tool to predict the evolution and progression of primary tumors, as well as the development of tumor metastases.

A recent review-paper: Image-guided interventional therapy for cancer with radiotherapeutic nanoparticles nicely illustrates the role of imaging in treatment guidance through a comprehensive discussion of; Image-guided radiotherapeutic using intravenous nanoparticles for the delivery of localized radiation to solid cancer tumors.

 Graphical abstract

 Abstract

One of the major limitations of current cancer therapy is the inability to deliver tumoricidal agents throughout the entire tumor mass using traditional intravenous administration. Nanoparticles carrying beta-emitting therapeutic radionuclides [DN: radioactive isotops that emits electrons as part of the decay process a list of β-emitting radionuclides used in radiotherapeutic nanoparticle preparation is given in table1 of this paper.) that are delivered using advanced image-guidance have significant potential to improve solid tumor therapy. The use of image-guidance in combination with nanoparticle carriers can improve the delivery of localized radiation to tumors. Nanoparticles labeled with certain beta-emitting radionuclides are intrinsically theranostic agents that can provide information regarding distribution and regional dosimetry within the tumor and the body. Image-guided thermal therapy results in increased uptake of intravenous nanoparticles within tumors, improving therapy. In addition, nanoparticles are ideal carriers for direct intratumoral infusion of beta-emitting radionuclides by convection enhanced delivery, permitting the delivery of localized therapeutic radiation without the requirement of the radionuclide exiting from the nanoparticle. With this approach, very high doses of radiation can be delivered to solid tumors while sparing normal organs. Recent technological developments in image-guidance, convection enhanced delivery and newly developed nanoparticles carrying beta-emitting radionuclides will be reviewed. Examples will be shown describing how this new approach has promise for the treatment of brain, head and neck, and other types of solid tumors.

The challenges this review discusses

  • intravenously administered drugs are inhibited in their intratumoral penetration by high interstitial pressures which prevent diffusion of drugs from the blood circulation into the tumor tissue [1–5].
  • relatively rapid clearance of intravenously administered drugs from the blood circulation by kidneys and liver.
  • drugs that do reach the solid tumor by diffusion are inhomogeneously distributed at the micro-scale – This cannot be overcome by simply administering larger systemic doses as toxicity to normal organs is generally the dose limiting factor.
  • even nanoparticulate drugs have poor penetration from the vascular compartment into the tumor and the nanoparticles that do penetrate are most often heterogeneously distributed

How imaging could mitigate the above mentioned challenges

  • The inclusion of an imaging probe during drug development can aid in determining the clearance kinetics and tissue distribution of the drug non-invasively. Such probe can also be used to determine the likelihood of the drug reaching the tumor and to what extent.

Note: Drugs that have increased accumulation within the targeted site are likely to be more effective as compared with others. In that respect, Nanoparticle-based drugs have an additional advantage over free drugs with their potential to be multifunctional carriers capable of carrying both therapeutic and diagnostic imaging probes (theranostic) in the same nanocarrier. These multifunctional nanoparticles can serve as theranostic agents and facilitate personalized treatment planning.

  • Imaging can also be used for localization of the tumor to improve the placement of a catheter or external device within tumors to cause cell death through thermal ablation or oxidative stress secondary to reactive oxygen species.

See the example of Vintfolide in The Role of Medical Imaging in Personalized Medicine

vinta

Note: Image guided thermal ablation methods include radiofrequency (RF) ablation, microwave ablation or high intensity focused ultrasound (HIFU). Photodynamic therapy methods using external light devices to activate photosensitizing agents can also be used to treat superficial tumors or deeper tumors when used with endoscopic catheters.

  • Quality control during and post treatment

For example: The use of high intensity focused ultrasound (HIFU) combined with nanoparticle therapeutics: HIFU is applied to improve drug delivery and to trigger drug release from nanoparticles. Gas-bubbles are playing the role of the drug’s nano-carrier. These are used both to increase the drug transport into the cell and as ultrasound-imaging contrast material. The ultrasound is also used for processes of drug-release and ablation.

 HIFU

Additional example; Multifunctional nanoparticles for tracking CED (convection enhanced delivery)  distribution within tumors: Nanoparticle that could serve as a carrier not only for the therapeutic radionuclides but simultaneously also for a therapeutic drug and 4 different types of imaging contrast agents including an MRI contrast agent, PET and SPECT nuclear diagnostic imaging agents and optical contrast agents as shown below. The ability to perform multiple types of imaging on the same nanoparticles will allow studies investigating the distribution and retention of nanoparticles initially in vivo using non-invasive imaging and later at the histological level using optical imaging.

 multi

Conclusions

Image-guided radiotherapeutic nanoparticles have significant potential for solid tumor cancer therapy. The current success of this therapy in animals is most likely due to the improved accumulation, retention and dispersion of nanoparticles within solid tumor following image-guided therapies as well as the micro-field of the β-particle which reduces the requirement of perfectly homogeneous tumor coverage. It is also possible that the intratumoral distribution of nanoparticles may benefit from their uptake by intratumoral macrophages although more research is required to determine the importance of this aspect of intratumoral radionuclide nanoparticle therapy. This new approach to cancer therapy is a fertile ground for many new technological developments as well as for new understandings in the basic biology of cancer therapy. The clinical success of this approach will depend on progress in many areas of interdisciplinary research including imaging technology, nanoparticle technology, computer and robot assisted image-guided application of therapies, radiation physics and oncology. Close collaboration of a wide variety of scientists and physicians including chemists, nanotechnologists, drug delivery experts, radiation physicists, robotics and software experts, toxicologists, surgeons, imaging physicians, and oncologists will best facilitate the implementation of this novel approach to the treatment of cancer in the clinical environment. Image-guided nanoparticle therapies including those with β-emission radionuclide nanoparticles have excellent promise to significantly impact clinical cancer therapy and advance the field of drug delivery.

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The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Reviewer and Curator: Larry H. Bernstein, MD, FCAP and

Curator: Aviva Lev-Ari, PhD, RN

 

 

 

About Arnold Relman


 

Arnold Relman (1923–2014) was Professor Emeritus of Medicine and Social Medicine at Harvard Medical School and a contributor of many articles and essays to The New York Review. Marcia Angell is a Senior Lecturer in Social Medicine at Harvard Medical School. Arnold Relman was her husband.

 

 SOURCE

http://www.nybooks.com/contributors/arnold-relman/

 

This is a posting of Relman’s just published review of the new publication  by Elizabeth H. Bradley and Lauren A. Taylor, in the prestigious Public Affairs (AUGUST 14, 2014 ISSUE)

The American Health Care Paradox: Why Spending More Is Getting Us Less

The US spends much more per person on medical care than any other country. And yet,

  • by commonly accepted measures of the quality of its national health system, it ranks only in the middle of the other advanced countries

belonging to the Organization for Economic Cooperation and Development (OECD).

Elizabeth Bradley and Lauren Taylor argue that

  • this “American health care paradox” is resolved when expenditures on other social services that undoubtedly contribute to improved national and personal health are taken into account.

These expenditures include support for such services as housing, education, maternal and child care, disease prevention, nutrition, environmental safety, and unemployment benefits. They also involve subsidies for the very poor, the disabled, and the elderly.

  • The US spends a much smaller percentage of its GDP on these programs than other OECD countries. Thus,

when these expenditures are added to what is spent for medical care, the total, expressed as a percentage of GDP, places our country in the middle of the other OECD countries.

That is consistent with the ranking of our health care system, and so the authors claim

  • the “paradox” is resolved.

To increase the quality of our health care system to the level now achieved by France, Germany, Switzerland, and Sweden,

  1. we would need not only to expand our investment in other social services, but also
  2. to practice what Bradley and Taylor call “a more holistic approach” to the medical care of each patient.

That means more attention to preventing illness and to modifying patients’ behavior in ways that promote health.

Their argument has intuitive appeal, made even stronger by the warm endorsement given by Dr. Harvey Fineberg, outgoing president of the Institute of Medicine (IOM) of the National Academy of Sciences, in the foreword he has written for the book, and by recent reports from committees of the IOM. It is generally agreed that

  • poor and disadvantaged populations, such as teenaged single mothers and their children, or
  • unemployed, uneducated, and ill-housed minorities,

suffer relatively poor health.

So it might seem entirely reasonable to conclude with the authors

  • that the answer to what ails our national health system lies in paying more attention to
  • social welfare programs, preventive measures, and education.

Relman dissatisfied:

Their argument is made more attractive by their clear prose and by their many helpful descriptions and historical explanations of US health care policy. Nevertheless, it does not persuade me, and
I don’t believe it will satisfy many critics who look closely at the issues.

In the first place, Bradley and Taylor pay insufficient attention to the great value Americans place on

  • the immediate diagnosis and treatment of personal illnesses and injuries, as compared with
  • public measures to enhance national health such as disease prevention and nutrition.

In the US, prompt medical care is given

  • far greater priority than improved public health, and
  • it commands much greater resources.

Research on personal medical care is also given a high priority, but  (political reality)

  • new large investments in social welfare programs are not a legislative or political necessity now or in the foreseeable future,
  • so long as conservative Republican opposition to governmental spending of this sort persists.

Moreover, the long-range economic benefits of social welfare and preventive measures are generally misunderstood. For example,

  • prevention of heart attacks in early life through exercise, better diet, and elimination of smoking would extend life into later decades.

That is certainly a desirable goal, but then the multiple

  • incurable disabilities of old age and the need for long-term care after retirement begin to increase total health costs.

Second, the evidence presented by Bradley and Taylor to support their claim of resolving the American health care “paradox” is not as strong as their rhetoric implies. This is well illustrated by their Figure 1.3, which shows

  • aggregate health care and social welfare spending in OECD countries for 2007, and

is supposed to demonstrate that when all costs are considered,

  • the US is no longer as inferior to European countries as many have claimed.

The figure shows that American total expenditures place it just about

  • in the middle of all the countries shown, in accord with the quality of its health care system.

Nevertheless, while total expenditures on health and social welfare in France, Sweden, Switzerland, and Germany exceed those in the US (which would be expected given their generally superior health systems), the figure shows

  • total expenditures for Canada, New Zealand, and Australia to be well below those in the US, even though
  • these countries are widely acknowledged to have better health systems than the US.
  • Similarly, total expenditures in Norway are roughly equal to those in the US, although the Norwegian national health system is generally recognized to be of much higher quality.

Their Table 4.1 (see below) also illustrates this lack of congruence between health care outcomes such as

  • infant mortality and life expectancy in selected countries and
  • their ranking in total expenditures (as shown in Figure 1.3).

In short, total expenditures (social welfare plus medical care) do not seem to be as consistently related to health outcomes as Bradley and Taylor would have us believe. But they are certainly correct in arguing that in general, more attention to welfare programs would improve the quality of life in the US.

American Health Care Paradox

American Health Care Paradox

My final reason for skepticism is the authors’ dependence on personal interviews with

  • a selected and limited number of sources for much of their original data on attitudes about health care.

Bradley, the senior author, is a professor of public health at Yale; Taylor was trained in public health and medical ethics. They would therefore be expected to use

  • the methods of descriptive social science in developing their arguments.

They state that they conducted interviews with “more than eighty health and social policy experts, researchers, practitioners, and consumers.” Anyone who has been involved in such interviews knows how variably the results can be interpreted. Bradley and Taylor were commendably diligent in recording and transcribing their interviews, but

  1. they took a relatively small sample, and
  2. much of it was limited to Scandinavian countries,
  3. which are very different from the US, for example
  • in their levels of taxation and their guarantees of medical care and public welfare generally.

As a result, the reader can never be quite sure how comprehensive and balanced a picture this book presents of the American health system, when compared with other OECD countries.

Nevertheless, it is hard to deny two basic and fairly obvious points the authors want to make.

First, inadequate social services in the US contribute to our poor national health.

Second, adding welfare expenditures to those of medical care does help to some extent to resolve the American “paradox” of high medical expenditures and relatively poor health outcomes. But the resolution

  • is not as complete or convincing as claimed, and
  • there is no evidence that expanding welfare programs,

as Bradley and Taylor argue,

  • would more effectively improve national health than directly reforming the payment and organization of medical services.

In fact, the evidence suggests the contrary. The US currently

  1. wastes vastly more resources on a dysfunctional medical care system than it would ever consider spending on social welfare, so
  2. the likelihood of bettering national health through major expansion of welfare programs is remote.

As difficult as it may be, trying to reform the medical system is a better bet;

  • this would free up resources that could be used to improve other social services.

In addition, most Americans will inevitably become ill or injured at some time in their lives, no matter how adequate the US social services, and for them at that time,

  • a good medical care system is essential. Therefore, it makes sense to consider

how reforming the payment and organization of medical care could reduce the heavy burden of

  • unnecessary waste, fraud, and bureaucratic overhead on our medical care system.

This looks like the best way to begin to resolve this book’s “paradox.”

There is widespread and growing recognition that the best way of improving the delivery of medical service and reducing its costs would be

  • a shift away from fee-for-service payment for medical care after it is received
  • to prepayment for comprehensive care.

The Affordable Care Act (ACA) attempts to move in this direction by establishing “accountable care organizations” that are paid

  1. small bonuses for bettering the treatment of Medicare patients (as defined by government guidelines). However,
  2. these organizations work mainly through private insurance plans, which, despite these intentions,
  3. still pay for the more expensive special procedures and services by fee-for-service.

The ACA is therefore not likely to control national health expenditures in the long term. Government actuaries and budget officers

  • predict that these expenditures will continue to rise at an unsustainable rate unless there is major reform.

To achieve better quality at lower costs, I believe we will have to progress beyond the ACA, and

  • the needed reforms will require more participation by the medical profession.

Physicians will have to join medical groups that accept a single payment for comprehensive care and

  • are willing to be paid mainly by salaries rather than the fees they bill and collect.

Although insurance companies will lobby hard to maintain their power, such a system does not need private insurance plans; it would be much better without them. Vast overhead expenditures would be saved if payment were to come from a single tax-supported agency. That’s why single-payer plans are getting increasing attention these days.

Recent changes in the medical care system have created forces that

  • both favor and inhibit the development of a single-payer arrangement.

Physicians who would formerly have started practicing solo or in small partnerships are rapidly becoming employees of large groups

  • in order to avoid the daunting economic risks of managing their own practices. Unfortunately,
  • most of these large groups are owned by hospitals that are primarily interested in furthering their own financial goals.

They use their physician employees to generate

  • more admissions and greater use of hospital-based procedures.

They want to defend the status quo and their own income, rather than press for reform.

An awakening interest in political affairs and a recent trend toward a preference for Democratic political candidates suggest that

  • the medical profession may soon wish to turn national health policy in a different direction.
    (this is a period of transition between generations)

No large-scale health reform is likely without broad support by physicians, so

  • their political awakening may be the most important factor in bringing about major change.

A united profession could influence the views of its patients, and this in turn could

  • influence legislators even more than the money of an army of lobbyists.
    (army of lobbyists is supported by an exhorbitant wealth disproportion unknown in history, or at least since reconstruction)

Legislators need votes most of all, and patients are the voters they need.
(assumes that patients are a homogeneous group; and thee is no difference between rural and municipalities)

Another recent change that may favor the arrival of single-payer health care is

  • the rapid increase in the number of women in active medical practice.

They will soon equal or outnumber men. Women physicians seem to be more interested in the

  • social services that are available in multispecialty medical group practices,
  • among them adequate child care and parental leaves.
  • They want to share practice responsibilities, and
  • they tend to have more liberal political views than most men.

This major demographic shift in the physician population, as well as its political movement toward more progressive policies, might put the profession in the forefront of health reform instead of the sidelines where it has usually been.

Without leadership by physicians, it is unlikely that we will see any major change in the system for payment and organization of medical care within the next decade or two. And

  1. without such change, the future of the American health system is bleak;
  2. either market forces or intrusive government regulations (or both)
  3. will control how physicians practice their profession.

Financial responsibility for health care coverage will increasingly fall on individuals, because

  • ‘neither government nor business employers will be able to afford the rising costs.

The greatest opportunities for reducing unnecessary costs and improving the quality of the American health system are to be found in

  • reforming the payment and organization of medical care
  • rather than in expanding social welfare programs.

Although these programs are of enormous importance for many reasons not only related to health, and well worth expanding, they cannot substitute for improving the effectiveness and efficiency of medical care for the sick and injured. That is where we are likely to see the most hopeful future development.

Epicrisis:

In my reading of Arnold Relman, I find that there is validity and unrealistic assumptions in his criticism.  It will take a generational change in the profession, which is currently avolving and making some of the changes he notes.

1. There is at least two generations of physicians who entered the profession in the post WWII era, when the Flexner model was in full force, and exemplified by William Osler, the Oslerian model..

Over a century ago, the Quaker merchant Johns Hopkins did more than provide in his will for the construction of a university, a hospital and a medical school.  He provided a vision of a unique university-based health center, one with a vital mission: to create a learning, training and caring environment where the quest for new knowledge would continuously yield more effective and compassionate care for all. Today, after a century of progress that even its founder could not have envisioned, the quest for new knowledge leading to better health care remains the defining mission of Johns Hopkins Medicine.

The original faculty of The Johns Hopkins University School of Medicine, including such pioneers of modern medicine as William H. Welch, William S. Halsted, William Osler and Howard A. Kelly, created a revolutionary new medical curriculum that integrated a rigorous program of basic science education with intensive clinical mentoring. With the opening of The Johns Hopkins Hospital in 1889, followed four years later by the School of Medicine, these founding physicians ushered in a new era in medical education marked by rigid entrance requirements for students, a vastly upgraded curriculum with emphasis on the scientific method, the incorporation of bedside teaching and laboratory research as part of the instruction, and integration of the School of Medicine with the Hospital through joint appointments. 

Notable faculty have included:  John Jacob Abel – Pharmacologist, John Shaw Billings – Civil War surgeon, pioneering leader in hygiene, Alfred Blalock – Developed field of cardiac surgery, Max Brödel – Acclaimed medical illustrator, William R. Brody – Radiologist, President of the Salk Institute, former President of Johns Hopkins UniversityBen Carson – Pediatric Neurosurgeon, awarded the Presidential Medal of Freedom, Denton Cooley – Renowned Cardiovascular surgeon, Harvey Cushing – Father of modern neurosurgery, Catherine Clarke Fenselau – Biochemist and mass spectrometrist,  William Halsted – Father of modern surgery, Leo Kanner – Father of child psychiatry, Albert L. Lehninger – Biochemist, Victor McKusick – Developed field of medical genetics, William Osler – Father of modern medicine, Wilder Penfield – Pioneer of epilepsy neurosurgery; developed the cortical homunculusPeter Pronovost – Anesthesiologst, MacArthur Fellow, Julie A. Freischlag, M.D., the director of the Department of Surgery

2. The large inroads in genetics, genomics and the Human Genome Project attests to the incredible growth in the knowledge base required from which physicians make decisions.  But despite the huge competition for entry, a shortage of primary care physicians, and a brain drain for less developed countries, the multicultural profession has had to adjust to a multicultural society into which it has to be integrated.  As much as a half century ago, candidates competed for entry on the basis of correlation with their undergraduate performance in organic chemistry.

3.  A half century ago, the poor could obtain emergency room care as a primary root of admission, which was likely late in the progression of the illness. This was not then, and is not now an acceptable system.

4. When Medicare came in, physicians accepted it as a reliable source for patients.  The same had to be true for hospitals.

5. Managed care began with the building of the Golden Gate Bridge, finished early, and supported by physicians employed by Henry Kaiser. This became a model taken seriously by Eastman Kodak and IBM.

6. It appears be be difficult to predict what will be in place a decade from now.  The Republican party is in default mode, and the Supreme Court has appointments that have not earned a lifetime appointment.

7.  I can’t see how the reorganizing of medicine, even with NPs and PAs can deal with the healthcare burden without attending to..

  • children in broken families
  • a substantial population in prison confinement
  • dealing with white collar corruption
  • supporting a minimum standard of living
  • an improvement in education at a very young age (with parental involvement)
  • a population that is more than 70% literate

8. There is a young physician population that has a dream and life style that is larger than the ALL MEDICINE and early to rise, late to bed than I have seen for so many years, and compassion has become important, as we don’t have all the answers, or all of the control.

 

 

 

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Larry H Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence/7/8/2014/Proteins and cellular adaptation to stress

There are two recent articles that are, if not interesting, possibly important in the direction of cellular regulation, adaptation, and decline.  One deals with apoptosis, or cell death, which is synchronized with recovery of membrane and protein breakdown for reuse in synthesis and maintenance.  The other is a new perspective to Alzhemier’s Disease, for which there is no effective pharmacotherapy. In both cases, the stresses of the cell are critical to the responce to the environment.  This is not just about the classical transcriptomics story. This is a perfect followup to the just posted research on the regulatory role of a small RNA that is related to, but distinct from silencing RNA, and also the revelations about lncRNA.

Protein Helps Cells Adapt—or Die

Scientists show how cell stress both prevents and promotes cell suicide in a study that’s equally divisive.

By Ruth Williams | July 3, 2014

A cellular stress pathway called the unfolded-protein-response (UPR) both activates and degrades death receptor 5 protein (DR5), which can promote or prevent cell suicide, according to a paper published in Science today (July 3). The theory is that initial stress blocks cell suicide, or apoptosis, to give the cell a chance to adapt, but that if the stress persists, it eventually triggers apoptosis.

“This work has made the most beautiful simplification of all this big complex mess. Basically, they identified and pinpointed the specific protein involved in the switching decision and explain how the decision is made,” said Alexei Korennykh, a professor of molecular biology at Princeton University, who was not involved in the work.

But Randal Kaufman of the Sanford-Burnham Medical Research Institute in La Jolla, California, was not impressed. He questioned the physiological relevance of the experiments supporting the authors’ main conclusions about this key cellular process.

Protein folding in a cell takes place largely in the endoplasmic reticulum (ER), but if the process goes awry, unfolded proteins accumulate, stressing the ER. This triggers the UPR, which shuts down translation, degrades unfolded proteins, and increases production of protein-folding machinery. If ER stress is not resolved, however, the UPR can also induce apoptosis.

Two main factors control the UPR—IRE1a and PERK. IRE1a promotes cell survival by activating the transcription factor XBP1, which drives expression of cell-survival genes. PERK, on the other hand, activates a transcription factor called CHOP, which in turn drives expression of the proapoptotic factor DR5.

Peter Walter of the University of California, San Francisco, and his colleagues have now confirmed that CHOP activates DR5, showing that it is a cell-autonomous process. But they have also found that IRE1a suppresses DR5, directly degrading its mRNA through a process called regulated IRE1a-dependent degradation (RIDD). Inhibition of IRE1a in a human cancer cell line undergoing ER stress both prevented DR5 mRNA decay and increased apoptosis.

However, in an e-mail to The Scientist, Kaufman expressed concern that “the significance of RIDD has not been demonstrated in a physiologically-relevant context.”

Walter insisted that the evidence for RIDD’s existence is “crystal clear.” His only concession was that “the effects aren’t 100 percent,” he said, because “RIDD degrades mRNA by a few-fold,” making it difficult to measure.

This RIDD debate aside, the researchers have also sparked a rumpus with their finding that IRE1a expression switches off just 24 hours after ER stress initiation, leaving PERK to drive the cell toward apoptosis. “We and others have evidence that suggests another model,” said Scott Oakes, a professor of pathology at the University of California, San Francisco, “which is that both PERK and IRE1a under high stress will send out death signals.”

Whether IRE1a promotes or inhibits apoptosis under extreme stress “is controversial,” said Ira Tabas, a professor at Columbia University in New York City. But it’s essential that scientists figure it out. Cell death from ER stress is a pathological process in many major diseases, Tabas said, and there are IRE1a inhibitors in pharmaceutical development. “It is very important because under high stress you have two different views here,” said Oakes. “One is that you want to keep IRE1a on, the other is that you want to shut it off.”

Because ER stress is central to many diseases, “a lot of people are passionate about it,” said Tabas, explaining the polemic views. “Who’s right? . . . I think it depends on the context in which the experiments are done—one pathway may be important in some settings, and another pathway may be important in different settings,” he suggested. What might help to resolve the issues, he said, will be “in vivo causation studies using actual disease models.”

Researchers will continue to debate. So, said Walter, “we’ll have to see what holds-up five years from now.”

M. Lu et al., “Opposing unfolded-protein-response signals converge on death receptor 5 to control apoptosis,” Science, 345:98-101, 2014.

Tags stress responseprotein foldingdisease/medicinecell & molecular biology and apoptosis

 

Protein May Hold the Key to Who Gets Alzheimer’s

 

By PAM BELLUCK     MARCH 19, 2014

 

It is one of the big scientific mysteries of Alzheimer’s disease: Why do some people whose brains accumulate the plaques and tangles so strongly associated with Alzheimer’s not develop the disease?

 

Now, a series of studies by Harvard scientists suggests a possible answer, one that could lead to new treatments if confirmed by other research.

 

The memory and thinking problems of Alzheimer’s disease and other dementias, which affect an estimated seven million Americans, may be related to a failure in the brain’s stress response system, the new research suggests. If this system is working well, it can protect the brain from abnormal Alzheimer’s proteins; if it gets derailed, critical areas of the brain start degenerating.

“This is an extremely important study,” said Li-Huei Tsai, director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, who was not involved in the research but wrote a commentary accompanying the study. “This is the first study that is really starting to provide a plausible pathway to explain why some people are more vulnerable to Alzheimer’s than other people.”

An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.

An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.

 

 

 

The research, published on Wednesday in the journal Nature, focuses on a protein previously thought to act mostly in the brains of developing fetuses. The scientists found that the protein also appears to protect neurons in healthy older people from aging-related stresses. But in people with Alzheimer’s and other dementias, the protein is sharply depleted in key brain regions.

Experts said if other scientists could replicate and expand upon the findings, the role of the protein, called REST, could spur development of new drugs for dementia, which has so far been virtually impossible to treat. But they cautioned that much more needed to be determined, including whether the decline of REST was a cause, or an effect, of brain deterioration, and whether it was specific enough to neurological diseases that it could lead to effective therapies.

“You’re going to see a lot of papers now following up on it,” said Dr. Eric M. Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, who was not involved in the study. “While it’s a preliminary finding, it raises an avenue that hasn’t been considered before. And if this provides a handle on which to understand normal brain aging, that will be great, too.”

REST, a regulator that switches off certain genes, is primarily known to keep fetal neurons in an immature state until they develop to perform brain functions, said Dr. Bruce A. Yankner, a professor of genetics at Harvard Medical School and the lead author of the new study. By the time babies are born, REST becomes inactive, he said, except in some areas outside the brain like the colon, where it seems to suppress cancer.

While investigating how different genes in the brain change as people age, Dr. Yankner’s team was startled to find that REST was the most active gene regulator in older brains. The researchers have found that this protein, normally active in fetuses, may also protect the neurons in older people.  It is not yet possible to measure the levels of this protein that is a gene regulator called REST, in living people.

“Why should a fetal gene be coming on in an aging brain?” he wondered. He hypothesized that it was because in aging, as in birth, brains encounter great stress, threatening neurons that cannot regenerate if harmed.

His team discovered that REST appears to switch off genes that promote cell death, protecting neurons from normal aging processes like energy decrease, inflammation and oxidative stress.

Analyzing brains from brain banks and dementia studies, the researchers found that brains of young adults ages 20 to 35 contained little REST, while healthy adults between the ages of 73 and 106 had plenty. REST levels grew the older people got, so long as they did not develop dementia, suggesting that REST is related to longevity.

But in people with Alzheimer’s, mild cognitive impairment, frontotemporal dementia and Lewy body dementia, the brain areas affected by these diseases contained much less REST than healthy brains.

This was true only in people who actually had memory and thinking problems. People who remained cognitively healthy, but whose brains had the same accumulation of amyloid plaques and tau tangles as people with Alzheimer’s, had three times more REST than those suffering Alzheimer’s symptoms. About a third of people who have such plaques will not develop Alzheimer’s symptoms, studies show.

REST levels dropped as symptoms worsened, so people with mild cognitive impairment had more REST than Alzheimer’s patients. And only key brain regions were affected. In Alzheimer’s, REST steeply declined in the prefrontal cortex and hippocampus, areas critical to learning, memory and planning. Other areas of the brain not involved in Alzheimer’s showed no REST drop-off.

It is not yet possible to analyze REST levels in the brains of living people, and several Alzheimer’s experts said that fact limited what the new research could prove.

John Hardy, an Alzheimer’s researcher at University College London, cautioned in an email that information from post-mortem brains could not prove that a decline in REST caused dementia because death might produce unrelated damage to brain cells.

To investigate further, the team conducted what both Dr. Tsai and Dr. Reiman called a “tour de force” of research, examining REST in mice, roundworms and cells in the lab.

“We wanted to make sure the story was right,” Dr. Yankner said. “It was difficult to believe at first, to be honest with you.”

Especially persuasive was that mice genetically engineered to lack REST lost neurons as they aged in brain areas afflicted in Alzheimer’s.

Dr. Yankner said REST appeared to work by traveling to a neuron’s nucleus when the brain was stressed. In dementia, though, REST somehow gets diverted, traveling with toxic dementia-related proteins to another part of the neuron where it is eventually destroyed.

Experts said the research, while intriguing, left many unanswered questions. Bradley Wise of the National Institute on Aging’s neuroscience division, which helped finance the studies, said REST’s role needed further clarification. “I don’t think you can really say if it’s a cause of Alzheimer’s or a consequence of Alzheimer’s” yet, he said.

Dr. Samuel E. Gandy, an Alzheimer’s researcher at Mount Sinai Medical Center, wondered if REST figured only in neurodegenerative diseases or in other diseases, too, which could make it difficult to use REST to develop specific treatments or diagnostic tests for dementia.

“My ambivalence is, is this really a way that advances our understanding of the disease or does this just tell us this is even more complicated than we thought?” he said.

Dr. Yankner’s team is looking at REST in other neurological diseases, like Parkinson’s. He also has thoughts about a potential treatment, lithium, which he said appears to stimulate REST function, and is considered relatively safe.

But he and other experts said it was too early. “I would hesitate to start rushing into lithium treatment” unless rigorous studies showed that it could forestall dementia, said Dr. John C. Morris, an Alzheimer’s researcher at Washington University in St. Louis.

Still, Dr. Morris said, the REST research the team conducted so far is “very well done, and certainly helps support this idea that we’ve all tried to understand about why Alzheimer’s is age-associated and why, while amyloid is necessary for the development of Alzheimer’s disease, it certainly is not sufficient.”

He added, “There have to be some other processes and triggers that result in Alzheimer’s.”

Correction: March 19, 2014 
Because of an editing error, an earlier version of this article misstated the gender of Dr. Li-Huei Tsai. Dr. Tsai is a woman.

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Reason in Hobby Lobby

Curator: Larry H. Bernstein, MD, FCAP

 

This is a Part 4 followup of the Hobby Lobby legal precedent.

  • Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

 Reason in Hobby Lobby

 

 

Reason #1 SCOTUS Will Regret Hobby Lobby byMan from Wasichustan

After oral arguments in the Hobby Lobby case, I wrote a very misnamed but widely read diary in which I echoed Attorney and Ring of Fire radio host Mike Papantonio’s argument that the SCOTUS would never rule in favor of Hobby Lobby for a really Big Business reason: It pierces the corporate veil.  If Hobby Lobby’s owners can give their Corporation religion, their religion gives Hobby Lobby’s owners–and any other owner, shareholder, officer, whatever–liability for the actions of the corporation.  Mr. Papantonio, who happens to be one of America’s preeminent trial lawyers, sees it as an opportunity to sue owners for the company’s negligence. Some other people, it turns out, agree with his assessment and expand on what it means….

That separation is what legal and business scholars call the “corporate veil,” and it’s fundamental to the entire operation. Now, thanks to the Hobby Lobby case, it’s in question. By letting Hobby Lobby’s owners assert their personal religious rights over an entire corporation, the Supreme Court has poked a major hole in the veil. In other words, if a company is not truly separate from its owners, the owners could be made responsible for its debts and other burdens.  So says Alex Park, writing in Salon today.

“If religious shareholders can do it, why can’t creditors and government regulators pierce the corporate veil in the other direction?” Burt Neuborne, a law professor at New York University, asked in an email. That’s a question raised by 44 other law professors, who filed a friends-of-the-court brief that implored the Court to reject Hobby Lobby’s argument and hold the veil in place. Here’s what they argued: Allowing a corporation, through either shareholder vote or board resolution, to take on and assert the religious beliefs of its shareholders in order to avoid having to comply with a generally-applicable law with a secular purpose is fundamentally at odds with the entire concept of incorporation.

Creating such an unprecedented and idiosyncratic tear in the corporate veil would also carry with it unintended consequences, many of which are not easily foreseen. This is definitely going to complicate things for the religious extremists on the SCOTUS and empire wide as these lawsuits inevitably proliferate.  Putting on the popcorn….now.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

byVyan   THU JUL 03, 2014 AT 09:12 AM PDT “The ruling elevates the rights of a FOR-PROFIT CORPORATION over those of its women employees and opens the door to all manner of claims that a company can refuse services based on its owner’s religion,” Takei wrote.

(O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability.

Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion.  Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about     byteacherken

in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception.

 Free Birth Control is Emerging Standard for Women   RICARDO ALONSO-ZALDIVAR, Associated Press       07/07/2014

WASHINGTON (AP) — More than half of privately insured women are getting free birth control under President Barack Obama’s health law, a major coverage shift that’s likely to advance. This week the Supreme Court allowed some employers with religious scruples to opt out, but most companies appear to be going in the opposite direction. Recent data from the IMS Institute document a sharp change during 2013. The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269. “It’s a big number,” said institute director Michael Kleinrock. The institute is the research arm of IMS Health, a Connecticut-based technology company that uses pharmacy records to track prescription drug sales. The core of Obama’s law — taxpayer-subsidized coverage for the uninsured — benefits a relatively small share of Americans. But free preventive care— from flu shots to colonoscopies —is a dividend of sorts for the majority with employer coverage.

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Justice Ginsberg Written Dissent

Curator and Reporter: Larry H. Bernstein, MD, FCAP

 

This is the third of a series of four articles on Hobby Lobby and the consequences.

 

  • Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

 

Justice Ginsberg Written Dissent

The dissenters deride as unfounded the Court’s new recognition of religious rights for for-profit corporations: Until this litigation, no decision of this Court recognized a for-profit corporation’s qualification for a religious exemption from a generally applicable law, whether under the Free Exercise Clause or RFRA.

The absence of such precedent is just what one would expect, for the exercise of religion is characteristic of natural persons, not artificial legal entities. As Chief Justice Marshall observed nearly two centuries ago,   a corporation is “an artificial being, invisible, intangible, and existing only in contemplation of law.

 Trustees of Dartmouth College v. Woodward, 4 Wheat. 518, 636 (1819). Corporations, Justice Stevens more recently reminded, “have no consciences, no beliefs, no feelings, no thoughts, no desires.” Citizens United v. Federal Election Comm’n, 558 U. S. 310, 466 (2010) (opinion concurring in part and dissenting in part). The First Amendment’s free exercise protections, the Court has indeed recognized, shelter churches and other nonprofit religion-based organizations. “For many individuals, religious activity derives meaning in large measure from participation in a larger religious community,” and “furtherance of the autonomy of religious organizations often furthers individual religious freedom as well.”  The Court’s “special solicitude to the rights of religious organizations,” however, is just that. No such solicitude is traditional for commercial organizations.

Indeed, until today, religious exemptions had never been extended to any entity operating in “the commercial, profit-making world.”  The reason why is hardly obscure. Religious organizations exist to foster the interests of persons subscribing to the same religious faith. Not so of for-profit corporations. Workers who sustain the operations of those corporations commonly are not drawn from one religious community. Indeed, by law, no religion-based criterion can restrict the work force of for-profit corporations.

The distinction between a community made up of believers in the same religion and one embracing persons of diverse beliefs, clear as it is, constantly escapes the Court’s attention. One can only wonder why the Court shuts this key difference from sight. But even if these for-profit corporations can maintain religious beliefs, this doesn’t really burden them: Undertaking the inquiry that the Court forgoes, (dissent) would conclude that

the connection between the families’ religious objections and the contraceptive coverage requirement is too attenuated to rank as substantial. The requirement carries no command that Hobby Lobby or Conestoga purchase or provide the contraceptives they find objectionable.

Instead, it calls on the companies covered by the requirement to direct money into undifferentiated funds that finance a wide variety of benefits under comprehensive health plans. Those plans, in order to comply with the ACA, must offer contraceptive coverage without cost sharing, just as they must cover an array of other preventive services.

Importantly, the decisions whether to claim benefits under the plans are made not by Hobby Lobby or Conestoga, but by the covered employees and dependents, in consultation with their health care providers.

Should an employee of Hobby Lobby or Conestoga share the religious beliefs of the Greens and Hahns, she is of course under no compulsion to use the contraceptives in question. But “[n]o individual decision by an employee and her physician—be it to use contraception, treat an infection, or have a hip replaced—is in any meaningful sense [her employer’s] decision or action.”

It is doubtful that Congress, when it specified that burdens must be “substantia[l],” had in mind a linkage thus interrupted by independent decisionmakers (the woman and her health counselor) standing between the challenged government action and the religious exercise claimed to be infringed. Any decision to use contraceptives made by a woman covered under Hobby Lobby’s or Conestoga’s plan will not be propelled by the Government, it will be the woman’s autonomous choice, informed by the physician she consults.

And let’s be clear: these are truly compelling governmental interests: To recapitulate, the mandated contraception coverage enables women to avoid the health problems unintended pregnancies may visit on them and their children.The coverage helps safeguard the health of women for whom pregnancy may be hazardous, even life threatening. See Brief for American College of Obstetricians and Gynecologists et al. as Amici Curiae 14–15. And the mandate secures benefits wholly unrelated to pregnancy, preventing certain cancers, menstrual disorders, and pelvic pain. …

It bears note in this regard that the cost of an IUD is nearly equivalent to a month’s full-time pay for workers earning the minimum wage; that almost one-third of women would change their contraceptive method if costs were not a factor; and that only one-fourth of women who request an IUD actually have one inserted after finding out how expensive it would be. See also Eisenberg, supra, at S60 (recent study found that women who face out-of-pocket IUD costs in excess of $50 were “11-times less likely to obtain an IUD than women who had to pay less than $50”); Postlethwaite, Trussell, Zoolakis, Shabear, & Petitti, A Comparison of Contraceptive Procurement Pre- and Post-Benefit Change, 76 Contraception 360, 361–362 (2007) (when one health system eliminated patient cost sharing for IUDs, use of this form of contraception more than doubled).

As for the “let the government pay” alternative, the dissenters find it lacking: Impeding women’s receipt of benefits “by requiring them to take steps to learn about, and to sign up for, a new [government funded and administered] health benefit” was scarcely what Congress contemplated. Ibid. More-over, Title X of the Public Health Service Act  “is the nation’s only dedicated source of federal funding for safety net family planning services … Safety net programs like Title X are not designed to absorb the unmet needs of . . . insured individuals.”

And where is the stopping point to the “let the government pay” alternative? Suppose an employer’s sincerely held religious belief is offended by health coverage of vaccines, or paying the minimum wage, or according women equal pay for substantially similar work? Does it rank as a less restrictive alternative to require the government to provide the money or benefit to which the employer has a religion-based objection?… Conestoga suggests that, if its employees had to acquire and pay for the contraceptives (to which the corporation objects) on their own, a tax credit would qualify as a less restrictive alternative.

A tax credit, of course, is one variety of “let the government pay.” In addition to departing from the existing employer-based system of health insurance, Conestoga’s alternative would require a woman to reach into her own pocket in the first instance, and it would do nothing for the woman too poor to be aided by a tax credit.

In sum, in view of what Congress sought to accomplish, i.e., comprehensive preventive care for women furnished through employer-based health plans, none of the proffered alternatives would satisfactorily serve the compelling interests to which Congress responded. And, in conclusion, the dissenters warn about what’s next: Hobby Lobby and Conestoga surely do not stand alone as commercial enterprises seeking exemptions from generally applicable laws on the basis of their religious beliefs.

See, e.g.,Newman v. Piggie Park Enterprises, Inc., 256 F. Supp. 941, 945 (SC 1966) (owner of restaurant chain refused to serve black patrons based on his religious beliefs opposing racial integration); In re Minnesota ex rel. McClure, 370 N. W. 2d 844, 847 (Minn. 1985) (born-again Christians who owned closely held, for-profit health clubs believed that the Bible proscribed hiring or retaining an “individua[l] living with but not married to a person of the opposite sex,”

“a young, single woman working without her father’s consent or a married woman working without her husband’s consent,” and any person “antagonistic to the Bible,” including “fornicators and homosexuals” (internal quotation marks omitted)), appeal dismissed, 478 U. S. 1015 (1986) ; Elane Photography, LLC v. Willock, 2013–NMSC–040, _ N. M. _, 309 P. 3d 53 (for-profit photography business owned by a husband and wife refused to photograph a lesbian couple’s commitment ceremony based on the religious beliefs of the company’s owners), cert. denied, 572 U. S. _ (2014).

Would RFRA require exemptions in cases of this ilk? And if not, how does the Court divine which religious beliefs are worthy of accommodation, and which are not? Isn’t the Court disarmed from making such a judgment given its recognition that “courts must not presume to determine . . . the plausibility of a religious claim”? Would the exemption the Court holds RFRA demands for employers with religiously grounded objections to the use of certain contraceptives extend to employers with religiously grounded objections to blood transfusions (Jehovah’s Witnesses); antidepressants (Scientologists); medications derived from pigs, including anesthesia, intravenous fluids, and pills coated with gelatin (certain Muslims, Jews, and Hindus); and vaccinations (Christian Scientists, among others)?

According to counsel for Hobby Lobby, “each one of these cases . . . would have to be evaluated on its own . . . apply[ing] the compelling interest-least restrictive alternative test.” Not much help there for the lower courts bound by today’s decision. … There is an overriding interest, I believe, in keeping the courts “out of the business of evaluating the relative merits of differing religious claims,” or the sincerity with which an asserted religious belief is held. Indeed, approving some religious claims while deeming others unworthy of accommodation could be “perceived as favoring one religion over another,” the very “risk the Establishment Clause was designed to preclude.”

The Court, I fear, has ventured into a minefield by its immoderate reading of RFRA. I would confine religious exemptions under that Act to organizations formed “for a religious purpose,” “engage[d] primarily in carrying out that religious purpose,” and not “engaged . . . substantially in the exchange of goods or services for money beyond nominal amounts.” ORIGINALLY POSTED TO ADAM B ON MON JUN 30, 2014 AT 09:05 AM PDT. TAGS  1st Amendment Affordable Care Act contraceptive mandate Health Care Hobby Lobby   Religious Freedom SCOTUS Supreme Court

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Physicians’ View of Supreme Court on an Issue of Public Health

Curator: Larry H. Bernstein, MD, FCAP

  • Where has the reason gone?

http://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

http://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

http://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

http://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

Physicians’ View of Supreme Court on an Issue of Public Health

The physicians are under considerable stress.  They have a minimum of 8 years of post graduate university education to practice as a generalist or  in a medical, pediatric, gynecological or surgical related specialty.  A significant loss is incurred in the cost of loans for education to many. A significant sacrifice is made in time for family.  A primary obligation is incurred toward the wellbeing of the patient, and the community that has to be respected and protected by civil law.

 

Supreme Court Issues Hobby Lobby Decision

By Joyce Frieden, News Editor, MedPage Today  Published: Jun 30, 2014

The Supreme Court has struck down the Affordable Care Act requirement that employers must include no-cost contraceptive coverage in employee health insurance plans. The 5-4 decision decision issued today in the Hobby Lobby case (Burwell v. Hobby Lobby Stores, Inc.) follows conflicting appellate court rulings in cases involving businesses that objected to the ACA’s birth control requirement on religious grounds. The businesses said the ACA stepped on their religious freedoms.

The 2010 health law mandates that all health plans provide preventive services — including birth control — free of cost-sharing. But some corporations — most notably arts-and-crafts giant Hobby Lobby and its sister company Mardel, a Christian bookstore chain — sued the Department of Health and Human Services to be exempted from having to comply with the mandate. In its 5-4 decision, written by Justice Samuel Alito, the Court ruled that the mandate violates the Religious Freedom Restoration Act of 1993, “which prohibits the ‘Government [from] substantially burden[ing] a person’s exercise of religion’” unless it shows that doing so is “in furtherance of a compelling governmental interest” and “is the least restrictive means” of doing do. The decision summary also notes that the Department of Health and Human Serivces (HHS) “argues that the companies cannot sue because they are for-profit corporations, and that the owners cannot sue because the regulations apply only to the companies, but that would leave merchants with a difficult choice:

  • give up the right to seek judicial protection of their religious liberty or forgo the benefits of operating as corporations.

RFRA’s text shows that Congress designed the statute to provide very broad protection for religious liberty and did not intend to put merchants to such a choice.” Donna Harrison, MD, executive director of the American Association of Pro-Life Obstetricians & Gynecologists (AAPLOG), noted that Hobby Lobby was in particular objecting to very specific contraceptives — the emergency contraceptive Ella and intrauterine devices, which she noted are capable of killing embryos, either by preventing their implantation or killing them after they have been implanted.

Art Caplan, PhD, director of the medical ethics division at the NYU Langone Medical Center in New York City, oberved “decision could have a very negative impact” on women’s ability to obtain contraception,  and “it could affect many women even if only a small percentage of companies followed suit.” “The other problem,” he told MedPage Today in a video interview, “is that if your employer says ‘I’m not covering contraception,’ you may decide to go with methods that don’t involve pharmaceutical control, or you may rely on something like emergency contraception” — decisions that could lead to more abortions, which would be

  • an ironic outcome since many employers’ objections to contraception revolve around their objections to abortion.

Harrison, of AAPLOG, noted that the decision should be reassuring to physicians who object to prescribing particular forms of contraception that they see as abortifacients, since insurers may have been considering excluding such doctors from their provider networks if the mandate had been upheld. “This will help incentivize insurers to not exclude ‘conscientious doctors’ from their networks,” she said.

More Physician Groups Weigh In

Many of the other physician groups issuing statements today expressed disappointment in the ruling.

“Allowing for-profit employers to exclude coverage for contraception is itself deeply concerning because of the demonstrated adverse impact it will have on women’s health,” David Fleming, MD, president of the American College of Physicians, said in a statement. “And, “the ruling clearly does not preclude for-profit employers from challenging such mandates (vaccinations), or the courts from granting further coverage exemptions.”

Rebecca Sokol, MD, president of the American Society for Reproductive Medicine in Washington, said in a statement that her organization “profoundly disagrees” with the decision. “Allowing an employer to impose their beliefs about reproduction on their staff is simply wrong, particularly when those beliefs are

  • so clearly misinformed on the scientific and medical facts,” Sokol said.

“In no other field of medicine do we allow employers to substitute their judgment for that of patients and physicians; it should not be allowed just because the subject matter is reproduction.”

Between Women and Their Physicians

Lin-Fan Wang, MD, reproductive health advocacy fellow at Physicians for Reproductive Health in New York City, said in a video interview that

  • “decisions about contraception should really be made between a woman and her doctor, and not by her employer.”

Wang recounted the story of one of her own patients, a woman who had recently had a baby and then went back to work, and was having trouble remembering to take her birth control pills. “She chose one of the intrauterine devices … because it was one of the most effective forms of contraception and she didn’t have to think about it every day,” she said. “Luckily her insurance plan covered the cost of this very expensive form of contraception, but

  • under the ruling today, patients like [her] might not be able to choose that method

and she may end up having to choose a method that is hard for her to take or she’s not happy with.” Reproductive rights groups also expressed their concerns. Bebe Anderson, JD, director of the U.S. Legal Program at the Center for Reproductive Rights in New York City, called the decision “an affront to women of this country.”

“As Justice [Ruth Bader] Ginsburg recognized in her dissent, this decision makes it very difficult for women to get some of the best long-acting reversible forms of contraception,” Anderson told MedPage Today in a video interview. “For example, IUDs are as expensive as 1 month’s pay for someone working at minimum wage.”

Cecile Richards, president of the Planned Parenthood Action Fund, called the ruling “stunning.” On a call with reporters she said it was no coincidence that the majority opinion was decided by five male justices. “It is endlessly frustrating for women that decisions about their healthcare are being made by people who never need to use birth control, and it is no coincidence that all three women on the court signed today’s dissent,” Richards said. On the same call, Marcia Greenberger, co-president of the National Women’s Law Center, said the decision was “a bitter pill for women to swallow …These [plaintiffs] and other closely held companies

  • will now have license to harm their female employees in the name of the company’s religion, and
  • ignore the moral and practical considerations of women themselves.”

Other Implications

Several commenters noted that, although the majority opinion specifically states that this ruling does not apply to religious objections to other healthcare benefits such as vaccinations and blood transfusions, this opens up the way for plaintiffs to sue about those as well. “Regardless of what they said, they’ve opened Pandora’s box and set a precedent,” said Ilyse Hogue, president of NARAL Pro-Choice America. The Tenth Circuit Court of Appeals in Denver ruled in June 2013 that

  • Hobby Lobby should be given the opportunity to show its religious beliefs would be violated by either complying with the law or being forced to pay large fines.

Hobby Lobby faced penalties amounting to $1.3 million a day starting in the summer of 2013 if it didn’t provide FDA-approved contraceptive methods in its self-insured health plans, which cover 13,000 employees. But a court issued an injunction in July that prevented the penalty from taking effect.

A rule from HHS finalized last summer exempted churches and other nonprofit religious organizations that object to contraceptive coverage. But private businesses such as Hobby Lobby weren’t exempt. UPDATE: This article, originally published on June 30 at 10:18 EDT, was updated with new material at 19:12 EDT.  

When Religious Freedom Clashes with Access to Care

Glenn Cohen, J.D., Holly Fernandez Lynch, J.D., M.Bioethics, and Gregory D. Curfman, M.D.

July 2, 2014 DOI: 10.1056/NEJMp1407965

At the tail end of this year’s Supreme Court term, religious freedom came into sharp conflict with the government’s interest in providing affordable access to health care. In a consolidated opinion inBurwell v. Hobby Lobby Stores and Conestoga Wood Specialties Corp. v. Burwell (collectively known as Hobby Lobby) delivered on June 30, the Court sided with religious freedom, highlighting the limitations of our employment-based health insurance system.

Hobby Lobby centered on the contraceptives-coverage mandate, which derived from the Affordable Care Act (ACA) mandate that many employers offer insurance coverage of certain “essential” health benefits, including coverage of “preventive” services without patient copayments or deductibles. The ACA authorized the Department of Health and Human Services (HHS) to define the scope of those preventive services, a task it delegated to the Institute of Medicine, whose list included all 20 contraceptive agents approved by the Food and Drug Administration. HHS articulated various justifications for the resulting mandate, including the fact that many Americans have difficulty affording contraceptives despite their widespread use and

  • the goal of avoiding a disproportionate financial burden on women.

Under the regulation, churches are exempt from covering contraception for their employees, and nonprofit religious organizations may apply for an “accommodation,” which shifts to their insurance companies (or other third parties) the responsibility for providing free access. However,

  • HHS made no exception for for-profit, secular businesses with religious owners.

Hobby Lobby, a craft-store chain with more than 13,000 employees, is a closely held, for-profit corporation owned by a Protestant family that operates the business in accordance with its Christian principles — for example, donating a portion of proceeds to Christian missions and remaining closed on Sundays. The family does not object to providing coverage for some contraceptives, but

  • it challenged the mandate because it includes contraceptive methods that the family believes cause abortion by preventing implantation of a fertilized egg.

The challenge in Hobby Lobby was not about the Constitution or its First Amendment. Rather, it hinged on the Religious Freedom Restoration Act of 1993 (RFRA), which was Congress’s response to a Supreme Court decision holding that

  1. even if a law in fact burdened religion, it could stand as long as it was not intended to burden religion (was “neutral”),
  2. applied without regard to religious beliefs or practices (was “generally applicable”), and
  3. was rationally related to a legitimate government interest — a low bar.

RFRA applies when a federal law is deemed to “substantially” burden a person’s exercise of religion, even if it is neutral and generally applicable. Such laws may be enforced against religious objectors only when they further a compelling government interest using the least restrictive means available. This is the most demanding standard of judicial review, and few laws meet its requirements. In a 5-to-4 decision the Court found that the contraceptives-coverage mandate did not.

In its RFRA analysis, the Court had to address several key questions:

  1. Are closely held, for-profit corporations “persons” for the purposes of RFRA protection?
  2. Can corporations exercise religion?
  3. Does the contraceptives-coverage mandate substantially burden religion?
  4. Does the mandate advance a compelling government interest? And
  5. are there less restrictive alternatives that would achieve the same result?

In a ruling in which Justice Samuel Alito wrote for the majority (joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas), the mandate came up short. The majority concluded that RFRA was intended to protect even for-profit corporations and that

  • corporations may exercise religion,
  • rejecting as unreasonable any definition of “person” that would include some but not all corporations.

The majority also concluded that the mandate did place a substantial burden on the companies’ religious beliefs, given the dramatic financial consequences of noncompliance (for example, Hobby Lobby would have faced a fine of $475 million per year) and

  • the fact that the government had extended other exemptions and accommodations in recognition of that burden.

The majority assumed that the government has a compelling interest in promoting free access to contraceptive agents, but it held that

  • the government had failed to advance that interest in the least restrictive way, given
  • the possibility of extending its existing exemptions and accommodations to for-profit corporations

Thus, the Court held that as applied to closely held, for-profit corporations with religious objections, the mandate violates RFRA. It was careful, however, to restrict the decision to the case before it, refraining from opining on the implications for other types of employers or objections to other health care services, which it cautioned must be addressed on a case-by-case basis. Nonetheless, the case may have broad practical impact, since

  • approximately 90% of all U.S. companies are closely held, and
  • “closely held” is not synonymous with “small.”

Justice Ruth Bader Ginsburg issued a sharp dissent, in which she was joined by Justice Sonia Sotomayor and in large part by Justices Elena Kagan and Stephen Breyer. Delivering her opinion from the bench, Justice Ginsburg underscored the burden that the majority decision would allow to be placed on women in favor of religious objectors:

“Today’s potentially sweeping decision . . . discounts the disadvantages religion-based opt outs impose on others, in particular, employees who do not share their employer’s religious beliefs.”

Hobby Lobby‘s outcome is of concern to U.S. health care professionals because

  • our health insurance system is still largely dependent on employers.
  • Employers and employees may have fundamentally different perspectives on which medical interventions are acceptable,
  • particularly when the employer’s fundamental mission is not to advance specific religious beliefs and
    • its employees are therefore unlikely to be drawn exclusively from its own religious group.

The Court’s decision allows the beliefs of employers of various sizes and corporate forms to trump the beliefs and needs of their employees, potentially influencing the types of care that will be affordable and accessible to individuals and permitting employers to intrude on clinician–patient relationships.

The case also has important implications for efforts to achieve compromise between religious freedom and health care access. The Obama administration’s attempts to compromise on the contraceptives-coverage mandate ultimately backfired, since its efforts were used to demonstrate that

  • applying the mandate even to secular employers was not necessarily the only way to achieve the government’s interests.

In the future, regulators may be less willing to seek compromise lest their efforts be similarly used against them — and it is bad news for all of us if health policy can be made only through polarization and rancor rather than compromise. On the other hand, in other contraceptives-mandate cases working their way through the courts, nonprofit religious employers argue that the government’s accommodations do not go far enough in protecting their religious freedom, essentially requiring them to deputize a third party to commit what they think is a sin on their behalf.

Finally, in the wake of Hobby Lobby, we may anticipate challenges to other medical services that some religions find objectionable, such as vaccinations, infertility treatments, blood transfusions, certain psychiatric treatments, and even hospice care. Hobby Lobby‘s implications may also extend into civil rights law, with employers asking to “opt out” of laws intended to protect people from employment and housing discrimination based on religion, race, sex, national origin, or pregnancy status. Although the majority deemed these slippery-slope concerns unrealistic, the dissent expressed serious concerns.

Though the decision applies only to closely held, for-profit corporations, it sets a precedent for religious exemptions that could have sweeping implications — and reflects the Supreme Court’s great potential impact on U.S. health care. Yet the Court was applying Congress’s statute, and

  • Congress could, if it chose, scale back the protection offered to religious objectors — a good reason to share public reactions to the decision with our elected representatives.

BUFFER ZONES, BUBBLE ZONES, AND ABORTION CLINICS — ANOTHER WOMEN’S HEALTH CASE

In 2000, concerned about clashes between antiabortion protesters and women seeking abortions, the Massachusetts legislature established an 18-ft radius around the entrances and driveways of facilities providing abortions and specified that within that area, no person could, without consent, approach within 6 ft of another person (a so-called “bubble zone”) for the purpose of protesting, leafleting, counseling, or education. In 2007, the legislature concluded that law was not effective enough and increased its stringency, imposing a 35-ft fixed buffer zone with few exceptions. The law was challenged on free-speech grounds in a case called McCullen v. Coakley, and on June 26, 2014, the U.S. Supreme Court unanimously struck it down as unconstitutional.

The lead opinion by Chief Justice John Roberts, joined by four other justices, noted that sidewalks and public ways hold a “special position in terms of First Amendment protection because of their historic role as sites for discussion and debate.” Although it was abortion that had motivated the statute, the Court held that the law was content- and viewpoint-neutral: it did not focus on what was said but on where it was said, and it burdened all speech, not merely disfavored speech.

On this point, the four remaining justices disagreed. Nevertheless, the Court held that the statute failed the second part of the relevant constitutional test because it was not “narrowly tailored to serve a significant governmental interest.” In particular, though the Court recognized that the buffer zones furthered the state’s interests in “ensuring public safety” on streets and sidewalks and in “preserving access to adjacent healthcare facilities,” it determined that

  • the law problematically criminalized not only protests,
  • but also sidewalk counseling, which could not be done at a distance of 35 ft.
  • It also found that the buffer zones burdened “substantially more speech than necessary to achieve” the state’s interest

and suggested a plethora of less intrusive means the state could have used instead, some of which are used in other states.

Although the decision deals another blow to abortion rights, that blow is not as substantial as some had feared: the finding that the law was content- and viewpoint-neutral allows for the possibility that Massachusetts and other states could pass similar but narrower laws. Moreover, the Court left open the future of the floating “bubble zone” around women approaching clinics for abortions — the strategy that Massachusetts had used from 2000 to 2007 and one that the Court upheld in a Colorado case in 2000. Several justices, however, indicated a willingness to revisit that decision in future litigation.

See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

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Larry H. Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence.com/6/7/2014/Immune activation, immunity, antibacterial activity

This segment is an update on activation of innate immunity, which has had a great amount of basic science resurgence in the last several decades.  It also addresses the issue of antibiotic resistance, which shall be covered more fully in later segments. Antimicrobial resistance is a growing threat, and a challenge to the pharmaceutical industry.  Moreover, worldwide travel increases the possibility of transfer of strains of virus and microbiota to distant communities.

 

8-OH-dG: A novel immune activator.

Innate immunity against viral or pathogenic infection involves sensing of non-self-molecules, otherwise known at pathogen-associated molecular patterns (PAMPs).  This same sensing mechanism can be applied to damaged self-molecules, which are called damage-associated molecular patterns (DAMPs).  One type of molecular pattern, for both groups, is cytosolic or extracellular DNA.  However, there is not an extensive amount of research showing specifically what type of DAMP DNA molecule is best at activating this immune sensing response.  A recent study investigated the mechanism behind how oxidized DNA from UV damage activates an immune sensing response.

A group of researchers found that, compared to a variety of types of cellular damage, damage from UV irradiation created a strong immune response (type I IFN response), seen across different types of immune regulatory cells.  This was compared with freeze/thaw, physical damage and nutritional deprivation, each of which did not produce a noticeable immune response. Additionally, this immune response was seen when DNA was exposed to UV-A and UV-B (the type of radiation produced by our sun) and UV-C radiation.

DNA can be damaged by UV light directly, or through reactive oxygen species (ROS) caused by UV light.  A well-known mark of DNA damaged by ROS is the oxidation of guanine to create 8-hydroxyguanine (8-OH-dG).  These researchers saw an increase in 8-OH-dG dependant on the level of UV dose, and this also correlated with an increase in immune response; showing that DNA damage created by UV light in the form of 8-OH-dG is sufficient to activate an immune response. This study shows that 8-OH-dG can be classified at a DAMP.

Next, this group wanted to place a mechanism to these observations. They found that the ability of oxidation-damaged DNA to activate an immune response was dependant on cGAS and STING.  Free DNA in the cytosol binds cGAS, a cGAMP synthase.  This action produces a messenger molecule which proceeds to bind to and activate STING, an endoplasmic reticulum protein.  STING activation will ultimately stimulate a type I IFN response.

When a cell’s own DNA is damaged, the cell’s machinery does all it can to repair it.  This sometimes involves erasing, or degrading, the DNA that has been damaged.  The enzyme, TREX1 exonuclease, has this job in a cell.  However, this group found that when DNA was modified with an 8-OH-dG, it was resistant to this degradation by TREX1.  This implies that the observed increase in immune response due to the presence of 8-OH-dG occurred because of an accumulation of damaged DNA, because it was not being degraded by TREX1 and could therefore sufficiently activate cGAS and STING.

This type of study has important implications for autoimmune diseases like lupus erythematosus (LE), which is characterized by its abnormally high number of autoantibodies against DNA.  It is possible that this uncontrollable immune response is activated by oxidation-damaged DNA.  Studies in this area, therefore, hold great importance.

– See more at: http://www.stressmarq.com/Blog/November-2013/8-OH-dG-A-novel-immune-activator.aspx#sthash.CvSdK0H1.dpuf

 

Oxidative Damage of DNA Confers Resistance to Cytosolic Nuclease TREX1 Degradation and Potentiates STING-Dependent Immune Sensing

Nadine Gehrke, Christina Mertens, Thomas Zillinger, Jörg Wenzel,…,Winfried Barchet

DOI: http://dx.doi.org/10.1016/j.immuni.2013.08.004

Highlights

  • •UV or ROS damage potentiates immunorecognition of DNA via cGAS and STING
  • •The oxidation product 8-OHG in DNA is sufficient for enhanced immunorecognition
  • •Oxidized self-DNA acts as a DAMP and induces skin lesions in lupus-prone mice
  • •Oxidized DNA is resistant to cytosolic nuclease TREX1-mediated degradation

Summary

Immune sensing of DNA is critical for antiviral immunity but can also trigger autoimmune diseases such as lupus erythematosus (LE). Here we have provided evidence for the involvement of a damage-associated DNA modification in the detection of cytosolic DNA. The oxidized base 8-hydroxyguanosine (8-OHG), a marker of oxidative damage in DNA, potentiated cytosolic immune recognition by decreasing its susceptibility to 3′ repair exonuclease 1 (TREX1)-mediated degradation. Oxidizative modifications arose physiologically in pathogen DNA during lysosomal reactive oxygen species (ROS) exposure, as well as in neutrophil extracellular trap (NET) DNA during the oxidative burst. 8-OHG was also abundant in UV-exposed skin lesions of LE patients and colocalized with type I interferon (IFN). Injection of oxidized DNA in the skin of lupus-prone mice induced lesions that closely matched respective lesions in patients. Thus, oxidized DNA represents a prototypic damage-associated molecular pattern (DAMP) with important implications for infection, sterile inflammation, and autoimmunity.

ribonuclease TREX1 and immunity

ribonuclease TREX1 and immunity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Immunity 19 Sep 2013;39(3), p482–495,

New Weapon in Fight Against ‘Superbugs’

Some harmful bacteria are increasingly resistant to treatment with antibiotics. A discovery might be able to help the antibiotics treat the disease.

By  ANN LUKITS  June 30, 2014 8:47 p.m. ET

 

Some harmful bacteria are increasingly resistant to treatment with antibiotics. This common fungus found in soil might be able to help the antibiotics combat diseases. Corbis

A soil sample from a national park in eastern Canada has produced a compound that appears to reverse antibiotic resistance in dangerous bacteria.

fungus with antimicrobial activity

 

 

 

 

 

 

 

 

 

 

 

 

Scientists at McMaster University in Ontario discovered that the compound almost instantly turned off a gene in several harmful bacteria that makes them highly resistant to treatment with a class of antibiotics used to fight so-called superbug infections. The compound, called aspergillomarasmine A, or AMA, was extracted from a common fungus found in soil and mold.

Antibiotic resistance is a growing public-health threat. Common germs such asEscherichia coli, or E. coli, are becoming harder to treat because they increasingly don’t respond to antibiotics. Some two million people in the U.S. are infected each year by antibiotic-resistant bacteria and 23,000 die as a result, according to the Centers for Disease Control and Prevention. The World Health Organization has called antibiotic resistance a threat to global public health.

The Canadian team was able to disarm a gene—New Delhi Metallo-beta-Lactamase-1, or NDM-1—that has become “public enemy No. 1” since its discovery in 2009, says Gerard Wright, director of McMaster’s Michael G. DeGroote Institute for Infectious Disease Research and lead researcher on the study. The report appears on the cover of this week’s issue of the journal Nature.

“Discovery of a fungus capable of rendering these multidrug-resistant organisms incapable of further infection is huge,” says Irena Kenneley, a microbiologist and infectious disease specialist at Frances Payne Bolton School of Nursing at Cleveland’s Case Western Reserve University. “The availability of more treatment options will ultimately save many more lives,” says Dr. Kenneley, who wasn’t involved in the McMaster research.

The McMaster team plans further experiments to determine the safety and effective dosage of AMA. It could take as long as a decade to complete clinical trials on people with superbug infections, Dr. Wright says.

The researchers found that AMA, extracted from a strain of Aspergillus versicolor and combined with a carbapenem antibiotic, inactivated the NDM-1 gene in three drug-resistant superbugs—Enterobacteriaceae, a group of bacteria that includes E. coli;Acenitobacter, which can cause pneumonia and blood infections; and Pseudomonas, which often infect patients in hospitals and nursing homes. The NDM-1 gene encodes an enzyme that helps bacteria become resistant to antibiotics and that requires zinc to survive. AMA works by removing zinc from the enzyme, freeing the antibiotic to do its job, Dr. Wright says. Although AMA was only tested on carbapenem-resistant bacteria, he expects the compound would have a similar effect when combined with other antibiotics.

AMA was first identified in the 1960s in connection with leaf wilt in plants and later investigated as a potential drug for treating high blood pressure. The compound turned up in Dr. Wright’s lab a few years ago during a random screening of organisms derived from 10,000 soil samples stored at McMaster. The sample that produced AMA was collected by one of Dr. Wright’s graduate students during a visit to a Nova Scotia park. It was the only sample of 500 tested that inhibited NDM-1 in cell cultures.

“It was a lucky hit,” says Dr. Wright. “It tells us that going back to those environmental organisms, where we got antibiotics in the first place, is a really good idea.”

The McMaster team developed a purified form of AMA for experiments on mice injected with a lethal form of drug-resistant pneumonia. Treatment with either AMA or a carbapenem antibiotic alone proved ineffective. But combining the substances resulted in more than 95% of the mice still being alive after five days. The combination was also tested on 229 cell cultures from human patients infected with resistant superbugs. The treatment resensitized 88% of the samples to carbapenem.

Still, bacteria could someday find a way to outwit AMA. “I can’t imagine anything we could make where resistance would never be an issue,” he says. “At the end of the day, this is evolution and you can’t fight evolution.”

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