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Posts Tagged ‘blood transfusion’


Treatments other than Chemotherapy for Leukemias and Lymphomas

Author, Curator, Editor: Larry H. Bernstein, MD, FCAP

2.5.1 Radiation Therapy 

http://www.lls.org/treatment/types-of-treatment/radiation-therapy

Radiation therapy, also called radiotherapy or irradiation, can be used to treat leukemia, lymphoma, myeloma and myelodysplastic syndromes. The type of radiation used for radiotherapy (ionizing radiation) is the same that’s used for diagnostic x-rays. Radiotherapy, however, is given in higher doses.

Radiotherapy works by damaging the genetic material (DNA) within cells, which prevents them from growing and reproducing. Although the radiotherapy is directed at cancer cells, it can also damage nearby healthy cells. However, current methods of radiotherapy have been improved upon, minimizing “scatter” to nearby tissues. Therefore its benefit (destroying the cancer cells) outweighs its risk (harming healthy cells).

When radiotherapy is used for blood cancer treatment, it’s usually part of a treatment plan that includes drug therapy. Radiotherapy can also be used to relieve pain or discomfort caused by an enlarged liver, lymph node(s) or spleen.

Radiotherapy, either alone or with chemotherapy, is sometimes given as conditioning treatment to prepare a patient for a blood or marrow stem cell transplant. The most common types used to treat blood cancer are external beam radiation (see below) and radioimmunotherapy.
External Beam Radiation

External beam radiation is the type of radiotherapy used most often for people with blood cancers. A focused radiation beam is delivered outside the body by a machine called a linear accelerator, or linac for short. The linear accelerator moves around the body to deliver radiation from various angles. Linear accelerators make it possible to decrease or avoid skin reactions and deliver targeted radiation to lessen “scatter” of radiation to nearby tissues.

The dose (total amount) of radiation used during treatment depends on various factors regarding the patient, disease and reason for treatment, and is established by a radiation oncologist. You may receive radiotherapy during a series of visits, spread over several weeks (from two to 10 weeks, on average). This approach, called dose fractionation, lessens side effects. External beam radiation does not make you radioactive.

2.5.2  Bone marrow (BM) transplantation

http://www.nlm.nih.gov/medlineplus/ency/article/003009.htm

There are three kinds of bone marrow transplants:

Autologous bone marrow transplant: The term auto means self. Stem cells are removed from you before you receive high-dose chemotherapy or radiation treatment. The stem cells are stored in a freezer (cryopreservation). After high-dose chemotherapy or radiation treatments, your stems cells are put back in your body to make (regenerate) normal blood cells. This is called a rescue transplant.

Allogeneic bone marrow transplant: The term allo means other. Stem cells are removed from another person, called a donor. Most times, the donor’s genes must at least partly match your genes. Special blood tests are done to see if a donor is a good match for you. A brother or sister is most likely to be a good match. Sometimes parents, children, and other relatives are good matches. Donors who are not related to you may be found through national bone marrow registries.

Umbilical cord blood transplant: This is a type of allogeneic transplant. Stem cells are removed from a newborn baby’s umbilical cord right after birth. The stem cells are frozen and stored until they are needed for a transplant. Umbilical cord blood cells are very immature so there is less of a need for matching. But blood counts take much longer to recover.

Before the transplant, chemotherapy, radiation, or both may be given. This may be done in two ways:

Ablative (myeloablative) treatment: High-dose chemotherapy, radiation, or both are given to kill any cancer cells. This also kills all healthy bone marrow that remains, and allows new stem cells to grow in the bone marrow.

Reduced intensity treatment, also called a mini transplant: Patients receive lower doses of chemotherapy and radiation before a transplant. This allows older patients, and those with other health problems to have a transplant.

A stem cell transplant is usually done after chemotherapy and radiation is complete. The stem cells are delivered into your bloodstream usually through a tube called a central venous catheter. The process is similar to getting a blood transfusion. The stem cells travel through the blood into the bone marrow. Most times, no surgery is needed.

Donor stem cells can be collected in two ways:

  • Bone marrow harvest. This minor surgery is done under general anesthesia. This means the donor will be asleep and pain-free during the procedure. The bone marrow is removed from the back of both hip bones. The amount of marrow removed depends on the weight of the person who is receiving it.
  • Leukapheresis. First, the donor is given 5 days of shots to help stem cells move from the bone marrow into the blood. During leukapheresis, blood is removed from the donor through an IV line in a vein. The part of white blood cells that contains stem cells is then separated in a machine and removed to be later given to the recipient. The red blood cells are returned to the donor.

Why the Procedure is Performed

A bone marrow transplant replaces bone marrow that either is not working properly or has been destroyed (ablated) by chemotherapy or radiation. Doctors believe that for many cancers, the donor’s white blood cells can attach to any remaining cancer cells, similar to when white cells attach to bacteria or viruses when fighting an infection.

Your doctor may recommend a bone marrow transplant if you have:

Certain cancers, such as leukemia, lymphoma, and multiple myeloma

A disease that affects the production of bone marrow cells, such as aplastic anemia, congenital neutropenia, severe immunodeficiency syndromes, sickle cell anemia, thalassemia

Had chemotherapy that destroyed your bone

2.5.3 Autologous stem cell transplantation

Phase II trial of 131I-B1 (anti-CD20) antibody therapy with autologous stem cell transplantation for relapsed B cell lymphomas

O.W Press,  F Appelbaum,  P.J Martin, et al.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(95)92225-3/abstract

25 patients with relapsed B-cell lymphomas were evaluated with trace-labelled doses (2·5 mg/kg, 185-370 MBq [5-10 mCi]) of 131I-labelled anti-CD20 (B1) antibody in a phase II trial. 22 patients achieved 131I-B1 biodistributions delivering higher doses of radiation to tumor sites than to normal organs and 21 of these were treated with therapeutic infusions of 131I-B1 (12·765-29·045 GBq) followed by autologous hemopoietic stem cell reinfusion. 18 of the 21 treated patients had objective responses, including 16 complete remissions. One patient died of progressive lymphoma and one died of sepsis. Analysis of our phase I and II trials with 131I-labelled B1 reveal a progression-free survival of 62% and an overall survival of 93% with a median follow-up of 2 years. 131I-anti-CD20 (B1) antibody therapy produces complete responses of long duration in most patients with relapsed B-cell lymphomas when given at maximally tolerated doses with autologous stem cell rescue.

Autologous (Self) Transplants

http://www.leukaemia.org.au/treatments/stem-cell-transplants/autologous-self-transplants

An autologous transplant (or rescue) is a type of transplant that uses the person’s own stem cells. These cells are collected in advance and returned at a later stage. They are used to replace stem cells that have been damaged by high doses of chemotherapy, used to treat the person’s underlying disease.

In most cases, stem cells are collected directly from the bloodstream. While stem cells normally live in your marrow, a combination of chemotherapy and a growth factor (a drug that stimulates stem cells) called Granulocyte Colony Stimulating Factor (G-CSF) is used to expand the number of stem cells in the marrow and cause them to spill out into the circulating blood. From here they can be collected from a vein by passing the blood through a special machine called a cell separator, in a process similar to dialysis.

Most of the side effects of an autologous transplant are caused by the conditioning therapy used. Although they can be very unpleasant at times it is important to remember that most of them are temporary and reversible.

Procedure of Hematopoietic Stem Cell Transplantation

Hematopoietic stem cell transplantation (HSCT) is the transplantation of multipotent hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood. It may be autologous (the patient’s own stem cells are used) or allogeneic (the stem cells come from a donor).

Hematopoietic Stem Cell Transplantation

Author: Ajay Perumbeti, MD, FAAP; Chief Editor: Emmanuel C Besa, MD
http://emedicine.medscape.com/article/208954-overview

Hematopoietic stem cell transplantation (HSCT) involves the intravenous (IV) infusion of autologous or allogeneic stem cells to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective.

The image below illustrates an algorithm for typically preferred hematopoietic stem cell transplantation cell source for treatment of malignancy.

An algorithm for typically preferred hematopoietic stem cell transplantation cell source for treatment of malignancy: If a matched sibling donor is not available, then a MUD is selected; if a MUD is not available, then choices include a mismatched unrelated donor, umbilical cord donor(s), and a haploidentical donor.

Supportive Therapies

2.5.4  Blood transfusions – risks and complications of a blood transfusion

  • Allogeneic transfusion reaction (acute or delayed hemolytic reaction)
  • Allergic reaction
  • Viruses Infectious Diseases

The risk of catching a virus from a blood transfusion is very low.

HIV. Your risk of getting HIV from a blood transfusion is lower than your risk of getting killed by lightning. Only about 1 in 2 million donations might carry HIV and transmit HIV if given to a patient.

Hepatitis B and C. The risk of having a donation that carries hepatitis B is about 1 in 205,000. The risk for hepatitis C is 1 in 2 million. If you receive blood during a transfusion that contains hepatitis, you’ll likely develop the virus.

Variant Creutzfeldt-Jakob disease (vCJD). This disease is the human version of Mad Cow Disease. It’s a very rare, yet fatal brain disorder. There is a possible risk of getting vCJD from a blood transfusion, although the risk is very low. Because of this, people who may have been exposed to vCJD aren’t eligible blood donors.

  • Fever
  • Iron Overload
  • Lung Injury
  • Graft-Versus-Host Disease

Graft-versus-host disease (GVHD) is a condition in which white blood cells in the new blood attack your tissues.

2.5.5 Erythropoietin

Erythropoietin, (/ɨˌrɪθrɵˈpɔɪ.ɨtɨn/UK /ɛˌrɪθr.pˈtɪn/) also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or red blood cell production. It is a cytokine (protein signaling molecule) for erythrocyte (red blood cell) precursors in the bone marrow. Human EPO has a molecular weight of 34 kDa.

Also called hematopoietin or hemopoietin, it is produced by interstitial fibroblasts in the kidney in close association with peritubular capillary and proximal convoluted tubule. It is also produced in perisinusoidal cells in the liver. While liver production predominates in the fetal and perinatal period, renal production is predominant during adulthood. In addition to erythropoiesis, erythropoietin also has other known biological functions. For example, it plays an important role in the brain’s response to neuronal injury.[1] EPO is also involved in the wound healing process.[2]

Exogenous erythropoietin is produced by recombinant DNA technology in cell culture. Several different pharmaceutical agents are available with a variety ofglycosylation patterns, and are collectively called erythropoiesis-stimulating agents (ESA). The specific details for labelled use vary between the package inserts, but ESAs have been used in the treatment of anemia in chronic kidney disease, anemia in myelodysplasia, and in anemia from cancer chemotherapy. Boxed warnings include a risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor recurrence.[3]

2.5.6  G-CSF (granulocyte-colony stimulating factor)

Granulocyte-colony stimulating factor (G-CSF or GCSF), also known as colony-stimulating factor 3 (CSF 3), is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.

There are different types, including

  • Lenograstim (Granocyte)
  • Filgrastim (Neupogen, Zarzio, Nivestim, Ratiograstim)
  • Long acting (pegylated) filgrastim (pegfilgrastim, Neulasta) and lipegfilgrastim (Longquex)

Pegylated G-CSF stays in the body for longer so you have treatment less often than with the other types of G-CSF.

2.5.7  Plasma Exchange (plasmapheresis)

http://emedicine.medscape.com/article/1895577-overview

Plasmapheresis is a term used to refer to a broad range of procedures in which extracorporeal separation of blood components results in a filtered plasma product.[1, 2] The filtering of plasma from whole blood can be accomplished via centrifugation or semipermeable membranes.[3] Centrifugation takes advantage of the different specific gravities inherent to various blood products such as red cells, white cells, platelets, and plasma.[4] Membrane plasma separation uses differences in particle size to filter plasma from the cellular components of blood.[3]

Traditionally, in the United States, most plasmapheresis takes place using automated centrifuge-based technology.[5] In certain instances, in particular in patients already undergoing hemodialysis, plasmapheresis can be carried out using semipermeable membranes to filter plasma.[4]

In therapeutic plasma exchange, using an automated centrifuge, filtered plasma is discarded and red blood cells along with replacement colloid such as donor plasma or albumin is returned to the patient. In membrane plasma filtration, secondary membrane plasma fractionation can selectively remove undesired macromolecules, which then allows for return of the processed plasma to the patient instead of donor plasma or albumin. Examples of secondary membrane plasma fractionation include cascade filtration,[6] thermofiltration, cryofiltration,[7] and low-density lipoprotein pheresis.

The Apheresis Applications Committee of the American Society for Apheresis periodically evaluates potential indications for apheresis and categorizes them from I to IV based on the available medical literature. The following are some of the indications, and their categorization, from the society’s 2010 guidelines.[2]

  • The only Category I indication for hemopoietic malignancy is Hyperviscosity in monoclonal gammopathies

2.5.8  Platelet Transfusions

Indications for platelet transfusion in children with acute leukemia

Scott Murphy, Samuel Litwin, Leonard M. Herring, Penelope Koch, et al.
Am J Hematol Jun 1982; 12(4): 347–356
http://onlinelibrary.wiley.com/doi/10.1002/ajh.2830120406/abstract;jsessionid=A6001D9D865EA1EBC667EF98382EF20C.f03t01
http://dx.doi.org:/10.1002/ajh.2830120406

In an attempt to determine the indications for platelet transfusion in thrombocytopenic patients, we randomized 56 children with acute leukemia to one of two regimens of platelet transfusion. The prophylactic group received platelets when the platelet count fell below 20,000 per mm3 irrespective of clinical events. The therapeutic group was transfused only when significant bleeding occurred and not for thrombocytopenia alone. The time to first bleeding episode was significantly longer and the number of bleeding episodes were significantly reduced in the prophylactic group. The survival curves of the two groups could not be distinguished from each other. Prior to the last month of life, the total number of days on which bleeding was present was significantly reduced by prophylactic therapy. However, in the terminal phase (last month of life), the duration of bleeding episodes was significantly longer in the prophylactic group. This may have been due to a higher incidence of immunologic refractoriness to platelet transfusion. Because of this terminal bleeding, comparison of the two groups for total number of days on which bleeding was present did not show a significant difference over the entire study period.

Clinical and Laboratory Aspects of Platelet Transfusion Therapy
Yuan S, Goldfinger D
http://www.uptodate.com/contents/clinical-and-laboratory-aspects-of-platelet-transfusion-therapy

INTRODUCTION — Hemostasis depends on an adequate number of functional platelets, together with an intact coagulation (clotting factor) system. This topic covers the logistics of platelet use and the indications for platelet transfusion in adults. The approach to the bleeding patient, refractoriness to platelet transfusion, and platelet transfusion in neonates are discussed elsewhere.

Pooled Platelets – A single unit of platelets can be isolated from every unit of donated blood, by centrifuging the blood within the closed collection system to separate the platelets from the red blood cells (RBC). The number of platelets per unit varies according to the platelet count of the donor; a yield of 7 x 1010 platelets is typical [1]. Since this number is inadequate to raise the platelet count in an adult recipient, four to six units are pooled to allow transfusion of 3 to 4 x 1011 platelets per transfusion [2]. These are called whole blood-derived or random donor pooled platelets.

Advantages of pooled platelets include lower cost and ease of collection and processing (a separate donation procedure and pheresis equipment are not required). The major disadvantage is recipient exposure to multiple donors in a single transfusion and logistic issues related to bacterial testing.

Apheresis (single donor) Platelets – Platelets can also be collected from volunteer donors in the blood bank, in a one- to two-hour pheresis procedure. Platelets and some white blood cells are removed, and red blood cells and plasma are returned to the donor. A typical apheresis platelet unit provides the equivalent of six or more units of platelets from whole blood (ie, 3 to 6 x 1011 platelets) [2]. In larger donors with high platelet counts, up to three units can be collected in one session. These are called apheresis or single donor platelets.

Advantages of single donor platelets are exposure of the recipient to a single donor rather than multiple donors, and the ability to match donor and recipient characteristics such as HLA type, cytomegalovirus (CMV) status, and blood type for certain recipients.

Both pooled and apheresis platelets contain some white blood cells (WBC) that were collected along with the platelets. These WBC can cause febrile non-hemolytic transfusion reactions (FNHTR), alloimmunization, and transfusion-associated graft-versus-host disease (ta-GVHD) in some patients.

Platelet products also contain plasma, which can be implicated in adverse reactions including transfusion-related acute lung injury (TRALI) and anaphylaxis. (See ‘Complications of platelet transfusion’ .)

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Peer Review and Health Care Issues

Larry H. Bernstein, MD, FCAP, Reporter

https://pharmaceuticalintelligence.com/12/1/2014/Peer-Review-and-Health-Care-Issues

(Medscape – Dec 1, 2014)

Peer-reviewed journals retracted 110 papers over the last 2 years. Nature reports the grim details in “Publishing: the peer review scam”.

When a handful of authors were caught reviewing their own

papers, it exposed weaknesses in modern publishing systems.

Editors are trying to plug the holes.

 

The Hill reports that the FDA may lift its ban on blood donations from gay men. The American Red Cross has voiced its support for lifting of the ban.

Advisers for the Food and Drug Administration (FDA) will meet this week to decide whether gay men should be allowed to donate blood, the agency’s biggest step yet toward changing the 30-year-old policy.

If the FDA accepts the recommendation, it would roll back a policy that has been under strong pressure from LGBT advocates and some members of Congress for more than four years.

“We’ve got the ball rolling. I feel like this is a tide-turning vote,” said Ryan James Yezak, an LGBT activist who founded the National Gay Blood Drive and will speak at the meeting. “There’s been a lot of feet dragging and I think they’re realizing it now.”

Groups such as the American Red Cross and America’s Blood Centers also voiced support of the policy change this month, calling the ban “medically and scientifically unwarranted.”

The FDA will use the group’s recommendation to decide whether to change the policy.

“Following deliberations taking into consideration the available evidence, the FDA will issue revised guidance, if appropriate,” FDA spokeswoman Jennifer Rodriguez wrote in a statement.

This reporter has more than 20 years of Blood Bank experience.  The factor in favor of the recommendation is that the HIV 1/2 and other testing is accurate enough to leave the question of donor lifestyle irrelevant.  However, it remains to be seen whether the testing turnaround time is sufficient to prevent the release of units that may be contaminated prior to transfusion, which is problematic for platelets, that have short expirations. In all cases of donor infection, regardless of whether units are released, a finding leads to not releasing the product or to recall.

 

Democrats made a strategic mistake by passing the Affordable Care Act, Sen. Charles Schumer (N.Y.), the third-ranking member of the Senate Democratic leadership, said Tuesday.

Schumer says Democrats “blew the opportunity the American people gave them” in the 2008 elections, a Democratic landslide, by focusing on healthcare reform instead of legislation to boost the middle class.

“After passing the stimulus, Democrats should have continued to propose middle class-oriented programs and built on the partial success of the stimulus,” he said in a speech at the National Press Club.

He said the plight of uninsured Americans caused by “unfair insurance company practices” needed to be addressed, but it wasn’t the change that people wanted when they elected Barack Obama as president.

“Americans were crying out for an end to the recession, for better wages and more jobs; not for changes in their healthcare,” he said.

This reader finds the observation by Senator Schumer very perceptive, regardless of whether the observation in hindsight might have had a different political outcome.  It has been noted that President Obama had a lot on his plate.  Moreover, we have not seen such a poor record of legislation in my lifetime.  There are underlying issues of worldview of elected officials that also contribute to the events.

 

THE PEER-REVIEW SCAM

BY CAT FERGUSON, ADAM MARCUS AND IVAN ORANSKY

N AT U R E |  2 7 N O V  2 0 1 4; VO L 5 1 5 : 480-82.

Most journal editors know how much effort it takes to persuade busy researchers to review a paper. That is why the editor of The Journal of Enzyme Inhibition and Medicinal Chemistry was puzzled by the reviews for manuscripts by one author — Hyung-In Moon, a medicinal-plant researcher then at Dongguk University in Gyeongju, South Korea.

The reviews themselves were not remarkable: mostly favourable, with some suggestions about how to improve the papers. What was unusual was how quickly they were completed — often within 24 hours. The turnaround was a little too fast, and Claudiu Supuran, the journal’s editor-in-chief, started to become suspicious.

In 2012, he confronted Moon, who readily admitted that the reviews had come in so quickly because he had written many of them himself. The deception had not been hard to set up. Supuran’s journal and several others published by Informa Healthcare in London
invite authors to suggest potential reviewers for their papers. So Moon provided names, sometimes of real scientists and sometimes pseudonyms, often with bogus e-mail addresses that would go directly to him or his colleagues. His confession led to the retraction of 28 papers by several Informa journals, and the resignation of an editor.

Moon’s was not an isolated case. In the past 2 years, journals have been forced to retract more than 110 papers in at least 6 instances of peer-review.

PEER-REVIEW RING
Moon’s case is by no means the most spectacular instance of peer-review rigging in recent years. That honour goes to a case that came to light in May 2013, when Ali Nayfeh, then editor-in-chief of the Journal of Vibration and Control, received some troubling news. An author who had submitted a paper to the journal told Nayfeh that he had received e-mails about it from two people claiming to be reviewers. Reviewers do not normally have direct contact with authors, and — strangely — the e-mails came from generic-looking Gmail accounts rather than from the professional institutional accounts that many academics use (see ‘Red flags in review’).
Nayfeh alerted SAGE, the company in Thousand Oaks, California, that publishes the journal. The editors there e-mailed both the Gmail addresses provided by the tipster, and the institutional addresses of the authors whose names had been used, asking for proof of identity and a list of their publications.ew rigging. What all these cases had in common was that researchers exploited vulnerabilities in the publishers’ computerized systems to dupe editors into accepting manuscripts, often by doing their own reviews. The cases involved publishing behemoths Elsevier, Springer, Taylor & Francis, SAGE and Wiley, as well as Informa, at least one of the systems — could make researchers vulnerable to even more serious identity theft. “For a piece of software that’s used by hundreds of thousands of academics worldwide, it really is appalling,” says Mark Dingemanse, a linguist at the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who has used some of these programs to publish and review papers.

A 14-month investigation that came to involve about 20 people from SAGE’s editorial, legal and production departments. It showed that the Gmail addresses were each linked to accounts with Thomson Reuters’ ScholarOne, a publication-management system used by SAGE and several other publishers, including Informa. Editors were able to track every paper that the person or people behind these accounts had allegedly written or reviewed, says SAGE spokesperson Camille Gamboa. They also checked the wording of reviews, the details of author-nominated reviewers, reference lists and the turnaround time for reviews (in some cases, only a few minutes). This helped the investigators to ferret out further suspicious-looking accounts; they eventually found 130.

SAGE investigators came to realize that authors were both reviewing and citing each other at an anomalous rate. Eventually, 60 articles were found to have evidence of peer-review tampering, involvement in the citation ring or both. “Due to the serious nature of the findings, we wanted to ensure we had researched all avenues as carefully as possible before contacting any of the authors and reviewers,” says Gamboa. When the dust had settled, it turned out that there was one author in the centre of the ring: Peter Chen, an engineer then at the National Pingtung University of Education (NPUE) in Taiwan, who was a co-author on practically all of the papers in question.

PASSWORD LOOPHOLE
Moon and Chen both exploited a feature of ScholarOne’s automated processes. When a reviewer is invited to read a paper, he or she is sent an e-mail with login information. If that communication goes to a fake e-mail account, the recipient can sign into the system under whatever name was initially submitted, with no additional identity verification. Jasper Simons, vice-president of product and market strategy for Thomson Reuters in Charlottesville, Virginia, says that ScholarOne is a respected peer-review system and that it is the responsibility of journals and their editorial teams to invite properly qualified reviewers for their papers.

ScholarOne is not the only publishing system with vulnerabilities. Editorial Manager, built by Aries Systems in North Andover, Massachusetts, is used by many societies and publishers, including Springer and PLOS. The American Association for the Advancement of Science in Washington DC uses a system developed in-house for its journals Science, Science Translational Medicine and Science Signaling, but its open-access offering, Science Advances, uses Editorial Manager. Elsevier, based in Amsterdam, uses a branded version of the same product, called the Elsevier Editorial System.

Usually, editors in the United States and Europe know the scientific community in those regions well enough to catch potential conflicts of interest between authors and reviewers. But Lindsay says that Western editors can find this harder with authors from Asia — “where often none of us knows the suggested reviewers”. In these cases, the journal insists on at least one independent reviewer, identified and invited by the editors.

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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?

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

  • Justice Ginsberg written dissent – Third Part

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

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

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

  •  Reason in Hobby Lobby

https://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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