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Posts Tagged ‘Medical Ethics’


8:30AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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

 

8:30 a.m. Harvard Business School Case Study: 23andMe

Harvard Business School Case Study: 23andMe

It is now a tradition and a unique feature of the Harvard Personalized Medicine Conference that Richard Hamermesh, a professor at Harvard Business School,  ‟teaches” a case as he does for the students at HBS. This year Professor Hamermesh has selected a couple of cases that were written about the company 23andMe. As usual, this case study will be highly interactive and educational. If you have not participated in one of these case studies at our Conference, you do not want to miss it!

23andMe – Harvard Business School Case Study

Leader:

Richard Hamermesh, D.B.A. @HarvardHBS

MBA Class of 1961 Professor of Management
Practice; Faculty Chair, HBS Healthcare Initiative, Harvard Business School

Two cases on 23andMe @23andMe

Active Group Discussion:

  • Customer very young in 20s and 30s – curiosity of sophisticated consumers
  • Personal interest in Private medical condition give illnesses in the family
  • Genotyping vs sequencing, only whole sequencing gives all variants
  • False Advertisement of the Service: on MNSBC, other
  • Do you allow your data to be used in Research vs and be sold to Pharma and be paid for sharing the data by the 23andMe
  • Price dropped from $250 to $99
  • 15 years from Now — No harm to Consumer, much data on Human Genome collected and Personal Medical Conditions improved by acting on information revealed by Genomics
  • 23andMe placed the Platform since genetic information was not otherwise available — They Pioneer with innovation on behalf of the Consumer
  • VC encourages Innovators to push the envelop – 23andMe did that with Private funding by Eugene Brin from Google
  • QUALITY OF INTERPRETATION OF GENOMICS information is key and it is improving

 

 

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

 

@HarvardPMConf

#PMConf

@SachsAssociates

@HarvardHBS

@harvardmed

@23andMe

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1:45PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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

 

1:45 p.m. Panel Discussion – Oncology

Oncology

There has been a remarkable transformation in our understanding of the molecular genetic basis of cancer and its treatment during the past decade or so. In depth genetic and genomic analysis of cancers has revealed that each cancer type can be sub-classified into many groups based on the genetic profiles and this information can be used to develop new targeted therapies and treatment options for cancer patients. This panel will explore the technologies that are facilitating our understanding of cancer, and how this information is being used in novel approaches for clinical development and treatment.

Oncology

Opening Speaker & Moderator:

Lynda Chin, M.D.
Department Chair, Department of Genomic Medicine
MD Anderson Cancer Center     @MDAnderson   #endcancer

  • Who pays for personalized medicine?
  • potential of Big data, analytics, Expert systems, so not each MD needs to see all cases, Profile disease to get same treatment
  • business model: IP, Discovery, sharing, ownership — yet accelerate therapy
  • security of healthcare data
  • segmentation of patient population
  • management of data and tracking innovations
  • platforms to be shared for innovations
  • study to be longitudinal,
  • How do we reconcile course of disease with personalized therapy
  • phenotyping the disease vs a Patient in wait for cure/treatment

Panelists:

Roy Herbst, M.D., Ph.D.    @DrRoyHerbstYale

Ensign Professor of Medicine and Professor of Pharmacology;
Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital     @YaleCancer

Development new drugs to match patient, disease and drug – finding the right patient for the right Clinical Trial

  • match patient to drugs
  • partnerships: out of 100 screened patients, 10 had the gene, 5 were able to attend the trial — without the biomarker — all 100 patients would participate for the WRONG drug for them (except the 5)
  • patients wants to participate in trials next to home NOT to have to travel — now it is in the protocol
  • Annotated Databases – clinical Trial informed consent – adaptive design of Clinical Trial vs protocol
  • even Academic MD can’t read the reports on Genomics
  • patients are treated in the community — more training to MDs
  • Five companies collaborating – comparison of 6 drugs in the same class
  • if drug exist and you have the patient — you must apply personalized therapy

 

Lincoln Nadauld, M.D., Ph.D.
Director, Cancer Genomics, Huntsman Intermountain Cancer Clinic @lnadauld @intermountain

  • @Stanford, all patients get Tumor profiles Genomic results, interpretation – deliver personalized therapy
  • Outcomes from Genomics based therapies
  • Is survival superior
  • Targeted treatment – Health economic impact is cost lower or not for same outcome???
  • genomic profiling of tumors: Genomic information changes outcome – adverse events lower
  • Path ways and personalized medicine based on Genomics — integration not yet been worked out

Question by Moderator: Data Management

  • Platform development, clinical knowledge system,
  • build consortium of institutions to share big data – identify all patients with same profile

 

 

 

 

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

@HarvardPMConf

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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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Reporter: Aviva Lev-Ari, PhD, RN

 

Spotted on

Exclusive: How US and UK Physicians’ Ethics Differ

Harris Meyer

Nov 20, 2012

 

Introduction

US and UK physicians receive medical training so similar that they can readily practice in either the United States or the United Kingdom. They share a common history and culture and speak the same language, more or less.

There were notable contrasts on attitudes toward what doctors regard as

  • futile care,
  • maintaining patient confidentiality in certain situations,
  • alerting patients about poor-quality physicians, and
  • telling patients the truth about terminal conditions.
  • Their biggest difference seen was about whether to defer to the treatment wishes of patients’ families (Table).

But a newMedscape survey of nearly 25,000 US and UK physicians found that doctors in the 2 nations hold markedly different views on some thorny medical ethics issues.

Table. Differences in Attitudes Between US and UK Physicians, Medscape 2012 Ethics Report

Question US Physicians UK Physicians
Would you ever go against a family’s wishes to end treatment and continue treating a patient whom you felt had a chance to recover? Yes: 23% Yes: 57%
Is it ever acceptable to perform “unnecessary” procedures due to malpractice concerns? Yes: 23% Yes: 9%
Is it right to provide intensive care to a newborn who either will die soon or survive with an objectively terrible quality of life? Yes: 34% Yes: 22%
Would you ever hide information from a patient about a terminal or pre-terminal diagnosis if you believed it would help bolster the patient’s spirit? Yes: 10% Yes: 14%
Would you give life-sustaining therapy if you believed it to be futile? Yes: 35% Yes: 22%
Should physician-assisted suicides be allowed in some situations? Yes: 47% Yes: 37%
Would you inform a patient if he or she were scheduled to have a procedure done by a physician whose skill you knew to be substandard? Yes: 47% Yes: 32%
Is it acceptable to breach patient confidentiality if a patient’s health status could harm others? Yes: 63% Yes: 74%
Would you ever decide to devote scarce or costly resources to a younger patient rather than to one who was older but not facing imminent death? Yes: 27% Yes: 24%

© Medscape 2012

Several factors contribute to the differences: different views toward patient-centeredness; different medical liability climate; the way physicians are paid; national religious attitudes; and the nature of the relationship between physicians, patients, and patients’ families.

The survey was conducted as part of Medscape’s Physician Ethics Report 2012. Survey questionnaires were sent to physicians in a wide range of medical specialties in each country. Completed questionnaires were received from more than 24,000 US physicians and 940 UK physicians. The statistical significance of the differences in responses between US and UK doctors was not calculated.

One obvious difference that could affect attitudes is that most US physicians work either independently or for private hospital and medical groups and receive fee-for-service payment, while most UK physicians work directly or indirectly for the country’s socialized National Health Service (NHS). In Great Britain, most medical specialists work as salaried staff in publicly operated hospitals, while most primary care physicians work independently and receive a mix of fee-for-service payments, per-patient global payments, and salary.

“The big difference is the way the system is funded and the culture of the United Kingdom,” says Brian Jarman, MD, a medical professor at Imperial College in London who serves on the NHS’s advisory committee on resource allocation. “I don’t think our decisions are as affected by financial considerations as in the US.”

Another major distinction: There’s less medical malpractice litigation in the UK. On top of that, UK medical specialists receive liability coverage through their hospital, while general practitioners have their premiums offset by NHS payments. In the US, physicians worry a lot more about malpractice suits, and doctors in independent practice are responsible for paying sizable liability premiums on their own.

The largest percentage difference in the survey — and one of the most provocative findings — was seen on the question of whether the doctor would ever go against a family’s wishes to end treatment and continue treating a patient who the doctor felt had a chance to recover. Most UK physicians in the survey — 57% — said yes, compared with just 23% of US physicians. That finding cut against the view that UK doctors are more likely to ration, and it also highlighted an important cultural gap.

“In most places in the world, doctors think they know the right treatment and do it,” says Dr. Lachlan Forrow, MD, a Harvard University medical ethicist and palliative care specialist. “My German friends say patients and families expect doctors to make decisions. In the US we might defer more to the patient and family.”

On top of that, he adds, families in the US probably express their wishes with more vehemence than in the UK and are more likely to file a lawsuit if the doctor goes against their wishes.

Differences Were Surprising

But differing attitudes and responses to survey questions didn’t always fall along lines predictable by economics.

It’s often thought that UK doctors are more cost-conscious and more apt to ration services than US doctors are, given that US doctors are paid more for providing more procedures and services, while UK doctors work in a budgeted, socialized medicine environment. The responses to the survey, however, suggest that this is true in some situations and not true in others.

Even so, the experts found more similarities than differences in the responses, with large percentages of doctors from both countries responding to many of these tough ethical questions by choosing “it depends.” Indeed, the responses of US and UK doctors were comparable on most of the questions, including informing patients about medical errors, reporting impaired colleagues, performing abortions regardless of personal beliefs, and notifying patients about risks of a procedure when obtaining informed consent.

“One of the findings is how remarkably small the differences are,” says Don Berwick, MD, a pediatrics and health policy professor at Harvard University and former head of the Centers for Medicare & Medicaid Services who has done extensive quality-improvement consulting work with the UK’s NHS.

For a majority of issues, US and UK physicians are generally in agreement. For example, on the question of whether it’s right to provide intensive care to a newborn who either will die soon or survive with poor quality of life, US physicians were more likely than UK physicians to say yes — 34% to 22% . But the largest group in both countries — about 40% — said that it depends.

Dr. Forrow says this finding shows that doctors in both countries properly base decisions on individual circumstances. “What if grandma wants to see the baby before she dies and the baby won’t suffer? So it does depend.”

Candor With Patients

Another intriguing difference came on the question of whether the doctor would hide information from a patient about a terminal or pre-terminal diagnosis if the doctor believed it would help the patient’s spirit. Far more US than UK doctors – 72% vs 54% — said, “No, I am always completely truthful about diagnoses,” while more UK than US doctors — 33% vs 18% — said that it depends.

Dr. Berwick says this difference may result from a stronger sense of customer focus in the US. “Patient-centeredness as a fundamental property is better developed in the US than in the UK,” he says. “US doctors say it’s the patient’s right to know, while British doctors might say, ‘In my judgment it would be better for patients for me to not always be completely truthful.'”

Doctors in the 2 countries also differed on the question of whether they would ever give life-sustaining therapy that they believed to be futile, with 35% of US doctors and just 22% of UK doctors saying yes. About 40% of both groups said that it depends.

“The implication is that there is a financial incentive in the US to maintain the end-of-life patient in the hospital, and that incentive is not there in the UK,” Dr. Jarman says.

Societal and Religious Differences

Similarly, US and UK doctors differed on the question of whether it’s right to provide intensive care to a newborn who either will die soon or survive with poor quality of life, with US physicians more likely to say yes.

Both Dr. Forrow and Dr. Jarman agreed that there likely are societal religious factors influencing these differences over whether to provide what could be called futile care.

“The US is a more religious society,” Dr. Forrow says. “We do all kinds of things that are not medically necessary but the patient thinks they are necessary. When doctors think something is futile, patients and families object more. They say, ‘Give God a chance.'”

In contrast, Dr. Jarman says, “The UK is not a religious country and people don’t go to church as much, so those considerations wouldn’t be there.”

Despite greater religiosity in the US, American doctors were somewhat more likely than UK doctors to say that physician-assisted suicide should be allowed in some situations — 47% to 37%. That could be related to the fact that physician-assisted death for terminally ill patients is legal in 3 US states but remains illegal in the UK.

Protecting Other Physicians?

US doctors also were more likely than UK doctors to say that they would inform a patient if they felt a doctor scheduled to perform a procedure on the patient had substandard skill levels — 47% to 32%. Nearly 40% in both countries said that it depends.

“British doctors are more protective of their colleagues than US doctors are,” Dr. Berwick says. “This implies that US doctors are getting a little more comfortable about transparency on clinical performance.”

Dr. Jarman said that this difference in attitude could be a holdover from his country’s old General Medical Council rule, abolished in the 1980s, under which a doctor who reported a colleague for doing something wrong risked being barred from practice.

Finally, the survey showed a difference in attitude toward patient confidentiality and reporting communicable diseases. UK doctors were more likely than US doctors to say that it’s acceptable to breach patient confidentiality if a patient’s health status could harm others — 74% to 63%.

Dr. Berwick explained that by saying that more UK doctors than US doctors receive public training that encourages reporting of communicable diseases, and that the US has a very strong patient confidentiality and privacy law.

Dr. Jarman noted that the General Medical Council rules encourage physicians to break confidentiality and report patients’ communicable diseases or other conditions posing harm or risk to others. “If someone is causing harm to others, doctors are correct in breaking confidentiality for the good of the state,” he says.

Dr. Berwick says that the results of the Medscape survey are complex, revealing some important differences between US and UK physicians. But overall he feels reassured by their shared ethical values.

“A significant portion in both countries say that they will make decisions based on the details of the case,” he says. “They are willing to consider treatment efficacy. They are sensitive to the social world of the patient and what the families are feeling. They are connecting in the most humane way to the patient’s entire circumstance.”

Dr. Jarman says he found the survey interesting and challenging. “You know the correct answers but you also know that with certain patients you’ve got to be human and not totally follow the rules,” he says. “You have to be a little bit human about it.”

SOURCE:

http://www.medscape.com/viewarticle/774737

 

 

 

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Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Author: Aviva Lev-Ari, PhD, RN

Real medical ethical dilemmas involved in physician assignment of patients to participate in Clinical Trials

Randomized controlled clinical trials have become the method of choice or the standard technique for obtaining scientific information to be used in changing diagnostic or therapeutic methods. The use of this technique creates an ethical dilemma (Hellman and Hellman, 1991).

Physicians using a randomized clinical trial are cast in two opposing roles at the same time: clinicians and researchers. As clinicians, they have an ethical commitment to individual patients: to practice professionally in an empathetic profession that is concerned with each patient as an individual. By entering into a relationship with an individual patient, the physician assumes obligations and commitments to act always in the patient’s best interest, derived from values of loyalty and the virtue of fidelity to his/her patients. Modifications of these relationships, otherwise dyadic relationship, occurs when a physician assumes legal obligations to report wounds of a suspicious nature and certain infectious diseases. Such obligations do not conflict with the physician’s ethical obligation to act in the best medical interests of his/her patient. Social concerns have pre-empted physician reporting of disease manifestations which are suspected to have public health bearing (Hellman and Hellman, 1991).

The other role assumed by a physician participating in randomized clinical trials, is that of a scientific researcher, committed to determine the validity of formally constructed hypotheses and their testing. Results of scientifically formulated studies using the methods developed in experimental design, derived from the disciplines of Statistics and Operations Research, are presumed to benefit humanity in general, and not only the individual patient participating in such a formally designed clinical trial. The goals of randomized clinical trials were stated by the Director of the National Institute of Allergy and Infectious Diseases, in these words: “It’s not to deliver therapy. It’s to answer a scientific question so that the drug can be available for everybody once you’ve established safety and efficacy” (as cited in Hellman and Hellman, 1991).

How do randomized clinical trials conflict with a physician’s duty towards his/her individual patients? It is a conflict between rights-based Moral Theories on one hand and Utilitarian Theory on the other.  Moral theories by Immanuel Kant and John Rowls assert that human beings, by virtue of their unique capacity for rational thinking, are bearers of dignity and ought to be treated as ends in themselves not as means to an end. In contrast, Utilitarianism by Stuart Mills defines what is right as the greatest good for the greatest number, known as social utility (Hellman and Hellman, 1991). Pleasures among them, health and well-being, need be counterbalanced by pain. The morally correct act is the act that produces the most pleasure and the least pain overall. Respectively, believers in Moral theory oppose conduct and self participation in randomized clinical trials, while believers in Utilitarianism support them in earnest.

However, since the distribution of pleasure and pain does have moral consequences, physicians must care about that distribution, since they enter into relationships with many patients. They can’t be indifferent to whether it is these patients or others that suffer for the general benefit of society, even though society might gain from the suffering of a few, even if the physician believes that the suffering by a few is worth the benefit to society. The doctor-patient relationship requires doctors to see their patients as bearers of rights who cannot be merely used for the greater good of humanity.

Consider a new agent that promises more effectiveness of treatment. The control group must be given either an unsatisfactory treatment or a placebo. Even though the therapeutic value of the new agent is unproven, if physicians think it has promise, are they acting in the best interest of their patients in allowing them to be randomly assigned to the control group?

Ethical validity of the assignment of patients to randomized clinical trials involves the following three matters in medical ethics (Hellman and Hellman, 1991, Markman, 1992):

  • If the physician has no opinion about whether the new treatment is acceptable, then random assignment is ethically acceptable. Lack of enthusiasm does not lore patients to participate or support the merit of conducting the study anyway. Treatment may show promise of beneficial results but also present undesirable complications (Markman paraphrased)
  • Physician believes that the severity and likelihood of harm and good are evenly balanced, randomization may be ethically acceptable. If the physician has no preference for either treatment, he or she are in a state of equipoise (Freedman, 1992), then randomization is acceptable.
  • If the physician believes that the new treatment may be either more or less successful or more or less toxic, the use of randomization is NOT consistent with fidelity to the patient.

After patient assignment to a Clinical Trial — What are the risks involved in participation in First-In-Man Stent Implantation as a treatment for cardiovascular diseases?

Dr. R. Stack, professor emeritus of medicine at Duke University, Durham, NC, and president of Synecor, a company developing Bioabsorbable stent, traced the evolution of interventional cardiology from inflation of the first angioplasty balloon to implantation of the first Bioabsorbable stent, in a Founders’ Lecture entitled, “How Can You Get Out of a Full-Metal Jacket?” at the Society for Cardiovascular Angiography and Interventions (SCAI), 29th Annual Scientific Sessions in Chicago, May, 2006, and said:

“In the early days of percutaneous transluminal coronary angioplasty (PTCA), each procedure took three to four hours to complete, and fully one in 20 patients suffered a heart attack in the catheterization laboratory. There was little an interventional cardiologist could do, other than rush the patient to surgery. Introduction of the steerable guidewire made PTCA easier to do and shortened procedure times. Development of the perfusion catheter meant that interventional cardiologists could re-establish blood flow to the heart and stabilize patients in case of a sudden arterial blockage. “(cited in David, 2006).

Risks of Participation in Randomized and Non-randomized Clinical Trials: Technology and Procedural Considerations

  • Assignment to a “control group” means implantation of a stent that is gold standard, rather than having the chance of benefiting from an innovative technology such as bioabsorabable stents (Guidant Corporation, 2006) or bioengineered stents (Chadwick, 2006).
  • During the clinical trials manufacturing defects in the device are identified after the device has been implanted in the participants but not in the control group. Wood (2006) reports that: Guidant Corporation has voluntarily stopped enrolling patients in several arms of the nonrandomized portion of its SPIRIT III clinical trial, because one out of every 100 Xience V everolimus-eluting stents may have been manufactured in substandard conditions. The Xience V everolimus-eluting stent received CE Mark approval in 1/2006. Earlier in March 2006, the company announced that it has completed enrollment of 1002 patients in the randomized US portion of the SPIRIT III trial, comparing the Xience V with the TAXUS paclitaxel-eluting stent. Company intents to restock investigators’ supplies and relaunch the trial.
  • Shortcomings of an entire generation of stent technology which is the Gold Standard in major hospitals in US – Drug Eluting Stents (DES)

Drug-eluting stents, introduced just a few years ago, markedly reduce the risk of restenosis. These stents have quickly become a mainstay of interventional therapy, but their use to treat large segments of the coronary circulation has created new challenges. (ABSORB, 2006, Menichelli, 2006, Pfisterer, 2006, Simonton, 2006, Turco, 2006)

Pfisterer, P.E. (2006) at American College of Cardiology 55th Annual ScientificSession, March 11 – 14, 2006, Atlanta, Georgia in his presentation on Basel Stent Cost-Effectiveness Trial-Late Thrombotic Events (BASKET LATE) Trialcompared Drug-eluting stents (DES) with Bare metal stents (BMS) and told the largest audience of interventional cardiologists in the US that

“The results of this small study and the conclusions reached by the authors are certainly a cause for concern. As has been demonstrated by previous studies, the rate of late stent thrombosis after DES implantation was not significantly higher than the rate associated with BMS, but, nevertheless, the consequences are dire. What I find especially troublesome is the fact that we cannot predict with certainty which patients are prone to develop late stent thrombosis and when stent thrombosis is likely to occur — the latter of which is extremely variable in relation to clopidogrel discontinuation. I am not completely convinced that we should advise all patients treated with a DES to continue dual antiplatelet therapy indefinitely, especially when considering high costs and the potential for bleeding complications. This issue generated plenty of debate at the ACC meeting and is far from being resolved” (Pfisterer, 2006).

Does his message have any impact on Cath Labs in US where thousand of drug-eluting stents are stocked and implanted everyday in thousands of cardiovascular patients, and patients with peripheral vascular diseases?

Risk Sources for Complication during Cardiac Catheterization: Patient participation in a randomized or non-randomized Clinical Trial for a new generation of stent devices

  • Clinical – iatrogenic, induced inadvertently by the medical treatment or procedures or activity of a physician
  • Procedural – no change in practice induced, though scientific evidence is available
  • Idiopathic,of the nature of an idiopathy, self originated, of unknown causation.

The first two risk types are addressed, below.

Clinical – iatrogenic, induced inadvertently by the medical treatment or procedures or activity of a physician

  • Access site complications

The most frequently observed complications are related to access site. Such complications, albeit rarely life-threatening, may require additional treatment, including further compression or thrombin injection (for pseudoaneurysms), blood transfusions or vascular surgery. Access site complications may also expose patients to further discomfort, a longer hospital stay and higher hospital costs. For local vascular complications, established predictors are older age, female gender, body surface area, peripheral vascular disease, some antithrombotic regimens and access site (Agostoni, et al. 2006).

  • Expertise level of the physician operator

A recent paper from a non-university hospital showed that expert operators (> 500 procedures performed) had an overall complication rate lower than cardiologists-in-training (despite the fact that it is not clear if they were cardiology fellows or interventional cardiologists-in-training), with a relative risk reduction of approximately 40%, Ammann, et al.(2003). This result is not confirmed by our report. Indeed, fellows, whose maximum caseload is around 300 procedures during the training period, can safely perform cardiac catheterizations, with a complication rate very similar to that of attending physicians. We focused, in particular, on local vascular complications, as arterial puncture is the first procedure step in the training of fellows and usually the only part of the examination they perform alone. An attending physician, who is directly responsible for the whole procedure, supervises the rest. In a recent registry on postcatheterization complications, it was stated: “the involvement of fellows-in-training may have contributed to some complications, especially local” according to Chandrasekar, B., et al.(2001). A study may well complement that report, suggesting the opposite conclusions (Agostoni, et al. 2006).

We report that for Procedural and during Procedure – no change in practice introduced though scientific evidence is available.

  • Extensive use of antithrombotic therapy

The majority of the patients reported in Agostoni, et al.(2006), underwent left heart catheterization because of suspected or known CAD. Thus, they were taking at least one antiplatelet drug despite the fact that it is common practice at our institution to administer a double antiplatelet regimen (aspirin associated with either ticlopidine or clopidogrel) at least 2 days prior to coronary angiography. And for patients with unstable symptoms, they routinely administer subcutaneous unfractionated or low-molecular-weight heparin, which has been shown to significantly increase the risk of local complications. Moreover, in these unstable patients, intravenous heparin was always administered during the procedure, irrespective of the concomitant administration of subcutaneous heparin. Nevertheless, the complication rate in catheterizations performed for reasons other than CAD remained particularly high (3.1%) (Agostoni, et al., 2006).

  • Selection of Access Site

In terms of arterial access site, the radial approach clearly reduced the rate of local complications, with an overall incidence of 0.8% compared to 3.4% after transfemoral catheterizations. A recently published meta-analysis comparing the radial versus the femoral approach for percutaneous coronary diagnostic and interventional procedures, including patients with similar overall characteristics, yielded results comparable to those of the present study. The radial artery approach was electively performed by one senior cardiologist and only occasionally by the others, while cardiology fellows did not perform any transradial procedures (Agostoni, et.al. 2006) [italics added].

If radial artery is implicated with less site access-related complications, why is radial artery used in 30% of the cases, and femoral artery in 70% of percutaneous coronary interventions (PCI)?

  • Additional Risk Factors for Complication during Cardiac Catheterization that are not routinely Checked or Used Peri-procedure.

Percutaneous left heart catheterization, including pressure measurements, left ventriculography, coronary angiography and percutaneous coronary interventions (PCI), is nowadays considered the gold standard for the diagnosis, evaluation and treatment of several cardiac diseases (coronary artery disease [CAD], valvular and congenital heart diseases, cardiomyopathies, status post-heart transplant) (Agostoni, et al. 2006).

Other variables may increase the probability of complication during Cardiac Catheterization.

These intermediate variables are not routinely checked or used.  Thus, they compromise the patient’s chance of achieving the optimal medical results and the best of care. That is after playing the odds of obtaining an assignment in the clinical trial to the “Treatment Group” if a patient was not assigned to either the “Control Group” to be implanted a traditional device or to the “Placebo Group” calling for no device implantation on this round.

Among these variable one finds:

  • antithrombotic regimens other than GP IIb/IIIa inhibitors
  • body surface area calculation
  • identification and consideration of presence of peripheral vascular disease
  • absence of testing for  systematic screening of serum CK-MB levels needed for detection of postprocedural myocardial infarction.
  • absence of cardiac enzymes measurement: before, after, follow up: 2 weeks, 1 month, 6 month, 12 month

Discussion

The first part of the paper deals with the physician’s medical dilemma of assigning patients to randomized clinical trials. The Moral Theory was contrasted with the Utilitarian one. My chosen side/stand on this matter is to identify my values with the Utilitarian group that will participate in randomized clinical trials if medical conditions so require.

In the second part of the paper, I dealt with a realm of risk factors the patient is exposed to after he/she has signed an informed consent and has no longer control. Noteworthy, the risk factors discussed in the paper are not included on any informed consent form. These risks call for modifications to current practices involved in stent implantation technology requiring an immediate consideration.

Two sources of risks were addressed: Clinical and Procedural. These sets of risks are identical for any patient in the Cath Lab, regardless of being assigned to the Treatment Group or to the Control Group. One may not assume that the implantation procedure for a traditional device vs. a new generation device, carries similar risk.  Though the risk of complication during the procedure is very low, when it occurs to someone you care for or to yourself, it is very dire.

Major adverse cardiovascular and cerebrovascular events (MACCE: death, myocardial infarction, cerebrovascular event) were also assessed. The overall access site complication rate was 2.6%. On multivariate regression analysis, the only two predictors of local complications were female gender (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.6–6.5) and femoral approach (OR 3.9, 95% CI 1.2–12.1). The rate of MACCE  (major cardiovascular and cerebrovascular events was 1.2%, mainly after percutaneous coronary interventions, with only 1 death overall (0.07%)(Agostoni, et.al. 2006).

Like most medical ethics issues, there is no single right answer. I would recommend every Cath Lab to revisit every risk factor listed above, discuss them with the Ethics Committee in the Hospital and initiate new procedures to address the clinical and procedural risk factors identified in the context of First-In-Man Stent Implantation.

As other interventional cardiologists, we are looking forward to Generation Five of Stenting Technology that will include the following innovations:

(a) Stents eluding Nitric Oxide (Verma and Marsden, 2005);

(b) stents with coating of an antibody specific (anti-CD34) to the antigen cells that are in the blood, therefore capturing the patient’s circulating endothelial progenitor cells (cEPCs) in order to accelerate the natural healing process (Chadwick, 2006),(Aoki et al., 2005), (Ben-Shoshan & George, 2007), and

(c) EPC-covered intravascular stents deployed for prevention of stent thrombosis and restenosis as well as for rapid formation of normal tissue architecture (Shirota et al., 2003).

Patient safety will be improved if the risk factors identified will raise awareness and will be addressed — preferably, before the next procedure starts in Angiography/Angioplasty Suite #14, ten minutes from now!

According to Rogers & Edelman (2006), “the spectacular success of drug-eluting stents is still plagued by an aura of unease and an insistent drumbeat demanding evidence of success and safety…dramatic reduction in restenosis attended by enhanced rates of thrombosis.” The performance of the two FDA-approved drug-eluting stents (Taxus and Cypher) varies. Cypher is associated with lower restenosis risk. Both devices are pushed into very complex settings to include patients diagnosed with diabetes (different diabetic states may affect restenosis after stenting in different ways). Percutaneous interventions routinely performed in small-vessels, multilesions, diffuse disease, acute coronary syndrome settings and stent-inside-stent as followed up therapy to restenosis. Other failure modes are stent thrombosis, post-procedural myonecrosis, plaque rupture, enhanced disease at a distance and excitation of patients’ already heightened immune state. Other predictors of device failure include lesion type, patient demographics, prior history of coronary bypass surgery, calcification, degree of pre-stent and post-stent stenosis. The variation in performance is critical for patient care decisions and physician’s discrimination between alternative therapies. In most cases the device is selected by the interventional cardiologist with little or no input from the patient.

Research of Clinical/Ethical issues, to emerge in the context of development of clinical trials for First-In-Man Stents, as well as medical ethical issues, to arise during the implantation procedure of the device, and during the period of follow up of the installed base of the device in humans, requires formalization of the data collection and standardization of the statistical analysis procedures. The two leading conferences, where research findings are reported, in the US in 2006 [American College of Cardiology, Annual Scientific Session] and in Europe in 2006 [The European Paris Course on Revascularization (EuroPCR)] are currently presenting challenges for comparative analysis of safety and efficacy.

Development of a schematic rubric, a conceptual proposal for a future study on the “Ethical Medical Issues involved in Clinical Trials for Next Generation Stent Technology.” Implementation of such a study will be most beneficial to all parties involved: physicians, patients, FDA, device manufacturers and medical ethicists. It will involve the following comparative criteria:

  • Medical Ethical Issue
  • Clinical Trial Name
  • Stent Type
  • Number of Patients
  • Major adverse cardiac events
  • Treatment Efficacy
  • Follow up  Studies
  • Clinical Trial Sites
  • Safety of Risk Factors
  • Study Discontinued

REFERENCES

ABSORB (2006). Everolimus Eluting Coronary Stent System First in Man Clinical Investigation. ClinicalTrials.gov Identifier: NCT00300131

Study start: March 2006; Expected completion: June 2011

Last follow-up: March 2011; Data entry closure: May 2011

http://www.clinicaltrials.gov/ct/gui/show/NCT00300131?order=1

Agostoni, P., Anselmi, M., Gasparini, G., Morando, G., Tosi, P., De Benedictis, M.L., Quintarelli, S., Molinari, G., Zardini, P., Turri, M. (2006). Safety of percutaneous left heart catheterization directly performed by cardiology fellows: A cohort analysis. The Journal of Invasive Cardiology, 18 (6), 248-252.

Ammann, P., Brunner-La Rocca H.P., et al. (2003). Procedural complications following diagnostic coronary angiography are related to the operator’s experience and the catheter size. Catheter Cardiovasc Interv , 59, 13–18. 

Aoki, J., Serruys, P.W., van Beusekom, H., Ong, A.T., McFadden, E.P., Sianos, G., et al. (2005). Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol 45 (10), 1574–1579.

Ben-Shoshan, J. George, J. (2007). Endothelial progenitor cells as therapeutic vectors in cardiovascular disorders: From experimental models to human trials. Pharmacology & Therapeutics, 115, 25-36.

Chadwick , D.(2006) OrbusNeich’s Genous Bioengineered R-stent . Cath Lab Digest, 14 (1), 20-26

Chandrasekar, B., Doucet, S., Bilodeau, L., et al. (2001). Complications of cardiac catheterization in the current era: A single-center experience. Catheter Cardiovasc Interv , 52, 289–295.

David, K.B. (2006). Impressive Progress In Interventional Cardiology – From 1st Balloon Inflation To First Bioabsorbable Stent, Society for Cardiovascular Angiography and Interventions, http://www.scai.org, http://www.medicalnewstoday.com/medicalnews.php?newsid=43313

Freedman, B. (1992). A response to a purported ethical difficulty with randomized clinical trials involving cancer patients.Journal of Clinical Ethics, 3 (3), 231-234.

Guidant Corporation, (2006). Guidant Announces Enrollment of First Patient in Clinical Trial of the World’s First Fully Bioabsorbable Drug Eluting Coronary Stent, 3/9/2006, Source: Guidant Corporation, Indianapolis, IN, www.guidant.com

Hellman, S. and D.S. Hellman (1991). Of mice but not men: Problems of the randomized clinical trial. New England Journal of Medicine, 324 (22), 1589-1592.

Markman, M. (1992). Ethical difficulties with randomized clinical trials involving cancer patients: Examples from the field of gynecologic oncology. Journal of Clinical Ethics, 3 (3), 193-193.

Menichelli, M. (2006). Sirolimus Stent vs. Bare Stent in Acute Myocardial Infarction Trial. Presented at The European Paris Course on Revascularization (EuroPCR), May 16-19, 2006, Paris, France Paris, France. http://www.medscape.com/viewprogram/5505?rss

Pfisterer, P.E. (2006). Basel Stent Cost-effectiveness Trial-Late Thrombotic events (BASKET LATE) Trial. Presented at American College of Cardiology 55th Annual Scientific Session, March 11 – 14, 2006, Atlanta, Georgia. http://www.medscape.com/viewprogram/5185 

Rogers, C. Edelman E.R. (2006). Pushing drug-eluting stents into uncharted territory, Simpler then you think – more complex than you imagine. Circulation, 113, 2262-2265.

Shirota, T., Yasui, H., Shimokawa, H. & Matsuda, T. (2003). Fabrication of endothelial progenitor cell (EPC)-seeded intravascular stent devices and in vitro endothelialization on hybrid vascular tissue. Biomaterials 24(13), 2295–2302.

Simonton, C. (2006). The STENT Registry: A real-world look at Sirolimus- and Pacitaxel-Eluting Stents. Cath Lab Digest, 14 (1), 1-10.

Turco, M. (2006). TAXUS ATLAS Trial – 9-Month results: Evaluation of TAXUS Liberte vs. TAXUS Express. Presented at The European Paris Course on Revascularization (EuroPCR), May 16-19, 2006, Paris, France Paris, France. http://www.medscape.com/viewprogram/5505?rss

Verma, S. and Marsden, P.A. (2005). Nitric Oxide-Eluting Polyurethanes – Vascular Grafts of the Future? New England Journal Medicine, 353 (7), 730-731.

Wood, S. (2006). Guidant suspends release of Xience V everolimus-eluting stent due to manufacturing standards http://www.theheart.org/article/679851.do 

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