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Topic: Pharmaceuticals
January 20, 2012 | Posted By Ricki Lewis, PhD

In this age of expiring drug patents and stalled pipelines, I was pleasantly surprised to find in my morning batch of news releases four reports of promising, eclectic ways to fight diverse diseases. The efforts represent the entire trajectory in drug discovery, from the most basic research to a stage 3 clinical trial. Read on!

STRATEGY: Alter the insect vector
genetically modified mosquito might sound like something from a science fiction film, but it is a powerful intervention in the horrific cycle that is malaria. George Dimopoulos and colleagues from the Johns Hopkins Malaria Research Institute altered a gene in the Anopheles mosquito in a way that ramps up its immune response against the parasite that causes malaria. The GM mosquitoes live as long as and lay as many eggs as their non-manipulated brethren. Perhaps with a few more tweaks they can take over, biting but not infecting.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

December 15, 2011 | Posted By Lisa Campo-Engelstein, PhD

In August of this year, the Department of Health and Human Services announced that, as part of its preventive health initiative under the Patient Protection and Affordable Care Act, insurance companies would be required to provide birth control with no co-pay beginning in August of next year. This decision empowers women to have more control over their reproduction and should (hopefully) decrease the percentage of unintended pregnancies, which currently stands at a shockingly high 50 percent. Evidence shows that the medicalization of contraception—that is, positioning physicians as gatekeepers to contraception—increases cost and decreases access. In evaluating what contributes to unplanned pregnancy, 54 percent of women stated cost as an obstacle to contraception use and 66 percent claimed that an inability to obtain contraception played a role.

Today there are eleven contraceptive options for women: female condom, tubal ligation, cervical cap, diaphragm, implant, injectable, IUD, patch, pill, ring, and sponge. On the whole, female methods tend to be more expensive than male methods because most require at least one physician visit and some involve a renewable prescription. Only two of the eleven female-only contraceptives—the sponge and the female condom—do not require seeing a physician. This means that 82 percent of female methods require at least one physician visit in order to acquire the contraceptive. Moreover, 36 percent of female methods require a prescription (injectable, patch, pill, and ring), which means women must continually renew their contraceptive by going to the pharmacy or doctor. Most doctors will not continue renewing prescriptions without seeing their patients yearly, so the initial visit when the doctor prescribes the contraceptive is not enough to ensure continued access to the contraceptive.   

Due to the expense of initiating and maintaining contraception, women spend 68% more out of pocket toward their reproductive health care than men of the same age. Currently 28 states mandate insurance companies to cover contraception to the same extent as they do for other prescription medications. However, 20 of these states have provisions in place for providers, plans, or employers to deny contraceptive coverage for religious or moral reasons.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

November 7, 2011 | Posted By Ricki Lewis, PhD

Gene therapy is experiencing a renaissance, with many of the recent successes in children. For some conditions, the younger the child, the better the genetic correction, because affected tissues degenerate with time. This is the case for adrenoleukodystrophy (ALD), the “Lorenzo’s Oil” disease that strips the insulation from brain neurons. One goal of the not-for-profit Stop ALD is to team gene therapy with newborn screening, to help boys before they begin to lose abilities. 

Should gene therapy be attempted even earlier? Before birth?

Fetal gene therapy is already being done in non-human animals, presumably in preparation for phase 1 clinical trials. Gene therapy is technically more challenging than inserting a shunt to drain a hydrocephalic brain or repairing an open spine, because it entails delivering gene-carrying viruses to affected cells and not anywhere else. It is fetal medicine on a different scale. 

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

May 19, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

Preliminary results from a large clinical trial demonstrate that persons with HIV are "96% less likely to pass on the infection" if they are taking antiretroviral medications.1 Based on the substantial protection afforded by early treatment, an independent safety review panel "recommended that the drug regimens be offered to all participants". The randomized clinical trial, known as HPTN 052, was scheduled to run until 2015, but is being ended early. Formulating public policy on the basis of these compelling findings would seem to be a slam dunk. But there are various stumbling blocks, both ethical and fiscal.

Physicians treating patients infected with HIV may face an ethical quandary. Initiating antiretroviral treatment as soon as a person becomes infected would substantially lower the risk of that person infecting others. But some patients are concerned about the potential side effects of AIDS drugs. Such persons avoid taking medication until they become obviously ill or until their CD4 count falls below 350 cells per cubic millimeter of blood (an accepted indicator of severity of infection).

Such a waiting game may satisfy the needs and desires of the infected person, but places the life of his sexual partner(s) at grave risk. Thus, the request to delay treatment poses an ethical dilemma for the doctor in the case. From the perspective of autonomy, it appears that the patient is exercising his right to make his own choice. But such a choice ongoingly threatens the lives of others.

If the doctor acquiesces, believing he is supporting the patient's right to an independent choice, he is necessarily violating the bioethical principle of nonmaleficence, i.e., do no harm. Beyond the direct, life-threatening harm that will be done to the HIV-infected person's sexual partners, serious burdens are placed on society in the form of increased utilization of costly services. Medical services, institutional facilities, health care workers, supplies, and medications, as well as social services and possibly hospice services, will all need to be funded and paid for by an ever-diminishing supply of available tax dollars. The physician who supports his patient's refusal to begin an early regime of antiretroviral medication fails to prevent an ongoing substantial drain of resources that could have been used elsewhere.

The response by concerned journalists to the breaking news was immediate. In an Op-Ed in The New York Times the following day,2 Charles Blow emphasized that federal and state governments have been "starving or restricting support, services and prevention efforts" for HIV-infected persons and those at risk of contracting HIV. He noted the vulnerability of those most dependent on AIDS Drug Assistance Programs (ADAP). Three-quarters of those enrolled in ADAPs have incomes less than 200% of the national poverty level. Fifty-five percent of those enrolled are black or Hispanic.

Blow doesn't hesitate or hold back his challenge, stating "it is morally reprehensible to restrict or deny life-saving drugs to those who need them". Such penny-wise budget cuts are "a colossal miscalculation of public health policy". Slashing funding for social welfare programs such as AIDS Drug Assistance may help squeeze dollars out of government budgets in the short term, but limiting or denying care to chronically ill persons will impose substantial financial costs in the long term.

The convincing evidence of HPTN 052 in supporting early treatment of HIV infection highlights another ethical issue with profound global implications. For many years HIV medications have been scarce or unavailable in the countries and regions that need them the most, including sub-Saharan Africa, South and Southeast Asia, and Central and South America. Of course, in the United States, too, many poor people without health insurance are on waiting lists to receive HIV medications.

The pharmaceutical corporations manufacturing these drugs can easily make them affordable to endemic communities. For example, GlaxoSmithKline's net profit in FY 2010 was almost $3 billion.

How much profit is enough? What if GSK's profit was capped at $1 billion annually? Does that seem draconian? One billion dollars is an unfathomable amount to the billions of persons on the planet who struggle to subsist on less than $2 per day. Surely $1 billion profit is sufficient for a corporation's executives and shareholders? The $2 billion left over (give or take) would go far toward providing HIV medication at cost to those who cannot afford such care on their own.

Such beneficence would have a meaningful impact in "winning the fight against AIDS".

1"Early H.I.V. Therapy Sharply Curbs Transmission", The New York Times, May 12, 2011

2"H.I.V. SOS", The New York Times, May 13, 2011

May 10, 2011 | Posted By Danielle Holley, JD, MS

In March, Congress reintroduced a bill: the “Part D Off-Label Prescription Parity Act.” (H.R. 1055) (See info here)  Currently, Part D covers off-label drug treatments for cancer but not for those patients who suffer other chronic conditions.  These patients can seek payment for off-label use under Medicare Part B, for those off-label drugs that are supported by peer-reviewed medical literature or in a compendium.  The goal with the Part D legislation is to adopt the standard under Part B to allow for chronic conditions, including others than cancer, to have payment for off-label drugs that not only are listed in compendia but also are supported in peer-reviewed literature.  Currently, the bill is still stuck in the Subcommittee on Health.

This is important legislation to create parity across the Medicare plans but also to recognize the balance needed in allowing for off-label drug use.  It has been shown that off-label drug use varies somewhere between 21% to 50% depending upon the drug and classification (1).   It is important that this legislation recognizes that off-label drug use can be beneficent for patients, but may also have harmful effects.  I have argued elsewhere  (2) that we need to have some regulation for off-label drug use because of the potential for harmful side-effects, and the legislation proposed along with Medicare Part B regulations demonstrate that need for off-label drug use to be governed by the standard of care either as noted in a compendia or supported in peer-reviewed literature.  A case heard by the federal court in the Southern District of New York, upheld this by stating that Medicare must cover off-label drug use for treatment that is medically necessary as supported by compendia or peer-reviewed literature.  

Off-label drug use can be extremely beneficial and it is important to not the overly limit the art of medicine.  It is equally important that we not draw arbitrary lines by not allowing patients to access and be covered for these important off-label drug uses that have been supported in the literature or compendia.  The healthcare system already has enough hurdles to jump through and Congress creating more hurdles by singling out certain diseases or not being consistent in their coverage is unjust and detrimental to patients, physicians, and the physician-patient relationship.  We need to set regulations to both protect patients and physicians but also respect the physician-patient relationship by being consistent and allowing for innovative uses that have been established as effective treatment.  

(1) Danielle Holley, Comment, Balancing on the Edge: The Implications and Acceptability of Off-Label Drug Use, 19 ALBANY J. SCI & TECH 633, 633 (2009).  
(2) Id.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

March 30, 2011 | Posted By Bruce D. White, DO, JD


The March 25th New York Times carried an article titled “Approval for Drug That Treats Melanoma” which reported the benchmark FDA approval of a new drug that benefits patients with almost-always fatal skin cancer. Click the photo below to be taken to the article. 

 


(photo from www.nytimes.com)

 

The novel infusion drug, YERVOY™ (ipilimumub, Bristol-Myers-Squibb), “is really the first time in the melanoma field that there is a drug that extended survival in a meaningful way,” as stated in the article by Dr. Gerald P. Linette, an Assistant Professor of Medicine at Washington University in St. Louis, who participated in the clinical trials.

In the prospective randomized studies that led to FDA approval, patients with metastatic melanoma lived about 10 months as compared with 6.4 months for those patients in the control group that received standard therapy.

January 17, 2011 | Posted By John Kaplan, PhD


How much damage can one fraudulent researcher do, especially when supported by well-intentioned but misinformed celebrities? The answer it seems is quite a lot. By now most everyone is familiar with the study published in the Lancet in 1998 by no-longer Dr. Andrew Wakefield.

I say no longer "Dr." because his medical license has been revoked. This occurred as well as denunciation of the paper by his coauthors and retraction of the paper by the Lancet. It turns out as documented in the British Medical Journal and accompanying editorial that the study was an elaborate fraud committed under a major financial conflict of interest. Wakefield had received payment from a law firm undertaking legal action against vaccine manufacturers.

By now numerous expensive large-scale studies have settled the science failing to find the autism vaccine link. This is settled science; we have an answer. I will note, however, that well-intentioned celebrity champions of Wakefield remain unconvinced. It is the alliance between Wakefield and his celebrity advocates that is particularly insidious. Time and resources that could have addressed the real causes of autism instead went to refuting these fraudulent claims. The public relations initiative they led resulted in a significantly decreased rate of childhood vaccinations, an increase in children becoming sick and sometimes dying from preventable illnesses. Wakefield bears responsibility for this. His ill-advised supporters share that responsibility.

December 13, 2010 | Posted By Bruce White, DO, JD


When it comes to medical care, Americans want the best. The collective opinion of thought leaders in the field – often published by national groups as consensus expert guidelines and recommendations by seasoned, well-schooled, respected, and thus authoritative physician peers – is one the gold standards of professional practice. But, sometimes the experts, the respected authorities, get it wrong. And, the argument may be made that, as a consequence of the wrong advice – regardless of how well intentioned and widely regarded, patients may have been harmed. And when harmed, patients want someone held responsible for the perceived damages.

One example of this phenomenon has appeared in the news recently. The Los Angeles Times reported on November 24 that the “Nevada Supreme Court Upholds $58M Judgment Against Wyeth Over Hormone Drugs."  See the report here [accessed December 1, 2010].

Estrogen replacement (HRT) for menopause symptoms was recognized therapy – it was standard of care treatment – in the late 20th Century.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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