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Author Archive: Bernard W Freedman, JD, MPH

About Bernard W Freedman, JD, MPH

01/14/2016

Declining Life Expectancy – Gene Uzawa Dorio, M.D. – Guest Commentary

Declining Life Expectancy Many nations proudly tout “Life Expectancy” as a reflection of healthcare.  In our country, this statistic has continually edged upward due to expanding technology, doctors/patient education, and vibrant emphasis on healthy lifestyles.  A shift is occurring though as this number is destined to decline with hospital administrators, not physicians, making medical decisions impacting those who are the most vulnerable:  Elder seniors in the ICU. These patients have been targeted by unscrupulous business people converting them to palliative care, with a gateway into hospice.  Why would this be financially beneficial to these administrators? Hospitals are paid a fixed...

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06/04/2014

Death Panels are Alive

In a major medical center in California a 74-year-old patient who suffered a stroke had been in a coma and on a ventilator for one month. There were a variety of complications and comorbidities. According to his physicians the patient was not in a persistent vegetative state, but in a coma. The physicians recommended that the son and surrogate decision maker, consent to withdrawing the vent and allowing his father to die peacefully. His son was also admonished that if he did not consent he would then have 10 days to get his father out of the hospital or his...

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01/09/2014

Exploiting despair – the death of Jahi McMath

  With the onslaught of media coverage of the Jahi McMath case it is time for a public debate on whether or not the loss of upper and lower brain function should determine death.  Brain death is the cessation of any brain activity in the uppe...

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01/08/2014

Exploiting despair – the death of Jahi McMath

With the onslaught of media coverage of the Jahi McMath case it is time for a public debate on whether or not the loss of upper and lower brain function should determine death.  Brain death is the cessation of any brain activity in the upper brain as well as the lower brain or brain stem. The McMath case should be distinguished from the Terri Schiavo case where only upper brain function was in question. Ms. Schiavo was not determined to be brain dead, but rather a living person in a persistent vegetative state. Brain death is established by numerous objective...

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12/30/2013

Making Choices

  New Year resolutions are sometimes easy to make but hard to keep. Resolutions are choices, choices to live on and to better ourselves. For patients who are critically ill, resolve is often in short supply.  So, to physicians reading this I ...

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12/30/2013

Making Choices

New Year resolutions are sometimes easy to make but hard to keep. Resolutions are choices, choices to live on and to better ourselves. For patients who are critically ill, resolve is often in short supply.  So, to physicians reading this I ask that one of your resolutions this coming year is to speak with patients about their end of life choices and help other physicians do the same. Many physicians are either reluctant to broach the subject, or not very good at discussing these issues, or both. Many feel that they will “cross that bridge when they get to it,”...

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08/03/2013

The Problem with POLST – Physician Orders for Life-Sustaining Treatment

  The Problem with POLST Over the years, informed consent has been given short shrift. There is, however, a growing understanding of the importance of obtaining an actual and legitimate consent before  having a patient accept or reject m...

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08/02/2013

The Problem with POLST – Physician Orders for Life-Sustaining Treatment

The Problem with POLST Over the years, informed consent has been given short shrift. There is, however, a growing understanding of the importance of obtaining an actual and legitimate consent before  having a patient accept or reject medical treatment. Autonomy, transparency, respect, dignity, and other similarly recognized human rights are increasingly recognized as legal and ethical requirements. “POLST” (Physician Orders for Life-Sustaining Treatment) however, makes it easy and even inviting to avoid these requirements with the stroke of a pen on a conclusionary form. POLST only makes sense in cases of patients with terminal illnesses, in end stage disease with no...

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06/18/2013

A Fight Against Providing Informed Consent in SUPPORT- Part II

 

There have been a number of articles written by well-known physicians and bioethicists expressing great concern over the recent Office for Human Research Protection, OHRP, letter of criticism with respect to the SUPPORT clinical trial. This blog discussed this controversy in the post of May 23, 2013. This controversy has turned dark with efforts to intimidate the OHRP.. Not attractive in the arena of customarily well reasoned debates in the bioethics community.

The latest in this saga is a plea signed off on by, as they describe themselves, a group of scholars and leaders in bioethics that was published in the New England Journal of Medicine of June 5, 2013. Yet these otherwise noted scholars’ plea is remarkably devoid of academic integrity and disciplined analysis. They “protest too much” when they should be supportive of these criticisms issued by the OHRP for the safety and benefit of all research subjects. 

The OHRP is absolutely correct in their findings and should stand fast in their criticism  of the informed consent process in this clinical trial.

The parents of these research subjects, infants less than 28 weeks, were not provided with complete information or a clear understanding of the information available and the  risks involved in this clinical trial. This group of scholars and leaders in bioethics, which indeed they are, accuses the OHRP of being “both foolish and risky” in their criticism. They say this while at the same time admitting that the consent forms could be improved.  How? They don’t say.

They ignore the legally mandated full disclosure owed to the parents involved in this study. They instead assert that the criteria for disclosure should not be the full disclosure because it is unfair to the investigators and institutions involved in this clinical trial. Their worry that full disclosure will  “impede the ongoing and future patient centered outcome studies. Such studies are crucial for advancing medial practice, reducing risks…” So, these scholars wish to sacrifice full disclosure and a legitimate informed consent process for the sake of conducting admittedly critically important research that might not be conducted if full disclosure is provided.

They argue that the informed consent process for human research subjects could be better dealt with by “relevant stakeholders” instead of the OHRP.  It is, however, hard to imagine a greater “stakeholder” than the research subjects themselves. It is the job of the OHRP to protect research subjects. These scholars therefore want the OHRP to quiet themselves and allow researchers to decide what research subjects should or should not be told. It does not work that way, at least not ethically.

This august group of scholars did not raise or discuss - in any fashion whatsoever – the specific criticisms set forth by the OHRP. They do not factually challenge or quarrel with the conclusions of the OHRP as to the available information that should have been provided to the parents. They merely argue that the findings of the OHRP lack merit, and claim that the process of determining proper informed consent be left in the hands of  “properly constituted IRBs” behind closed doors and if logic follows, have the Office of Human Research Protection close their doors.It is damning to note that in this clinical trial the IRB was told by the principle investigators in the clinical trial protocol that  oxygen restriction could result in damage to neurodevelopment. They failed, seemingly by design, to tell the parents the same thing in the consent form given to the parents.

When explaining the proposed SUPPORT trial the investigators told the IRB:

"However, oxygen toxicity can result in increased risk for CLD, [chronic lung disease] retinopathy of prematurity (ROP) and other disorders. Alternatively, oxygen restriction may impair neurodevelopment.”(emphasis added).

Their argument that "properly constituted IRBs" will provide sufficient protection to research subjects is conspicuously contradicted in the purposeful failure in this same clinical trial. They apparently feel strongly that if full disclosure is demanded of them their research will be threatened. This is precisely why we need the OHRP for the protection of patients whom we try to recruit for research. 

 

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06/18/2013

A Fight Against Providing Informed Consent in SUPPORT- Part II

There have been a number of articles written by well-known physicians and bioethicists expressing great concern over the recent Office for Human Research Protection, OHRP, letter of criticism with respect to the SUPPORT clinical trial. This blog discussed this controversy in the post of May 23, 2013. This controversy has turned dark with efforts to intimidate the OHRP.. Not attractive in the arena of customarily well reasoned debates in the bioethics community. The latest in this saga is a plea signed off on by, as they describe themselves, a group of scholars and leaders in bioethics that was published in...

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This entry was posted in Health Care and tagged , . Posted by Bernard W Freedman, JD, MPH. Bookmark the permalink.