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Topic: Pharmaceuticals
July 19, 2012 | Posted By Ricki Lewis, PhD

My mother-in-law’s arms look like she’s been in a fight. The bruises don’t hurt, but they’re embarrassing. They’re likely due to the drug Plavix, a trade-off for preventing clots. But we don’t know if the drug is actually helping, because she started it before the FDA urged physicians to use a pharmacogenetic (PGx) test to distinguish patients likely to respond to the drug from “poor metabolizers,” who won’t. And no one’s thought to test her since.

The original Plavix genetic test identified mutations in the CYP2C19 gene. More recent versions assess seven other genetic variants that affect metabolism of the drug. On June 29, the University of Florida Academic Health Center announced that it would use the wider genetic test to screen all cardiac catheterization patients for response to Plavix. And in the future, they’ll check additional DNA variants in the samples. According to the press release from the university, “researchers … will collect results for the other 249 gene variations to continue investigating which ones might be clinically actionable and become the basis for additional PGx tests for other treatments such as warfarin and statins.”

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.

July 5, 2012 | Posted By Bruce D. White, DO, JD

The Wednesday, June 27, issue of the Washington Post reported that the U.S. Senate passed a bill empowering the Food and Drug Administration (FDA) to collect about $6 billion over the next five years in new “user fees.” The bill passed the Senate 92 to 4 and now goes to the White House for President Obama’s signature.

The bill for the first time requires generic drug manufacturers to make payments to the FDA as part of the drug approval, manufacturing, and marketing process. “Innovator” (or what old-timers might recall as “ethical” or “brand name”) pharmaceutical manufacturers have been paying similar user fees since the passage of the Prescription Drug User Fee Act (PDUFA) of 1992. The user fees were seen as a “private industry” approach with manufacturers being required to shoulder some of the drug regulatory and safety processes costs. Generic manufacturers will contribute about $300 million annually. In return, the FDA has agreed to help speed the approval process for generics.

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.


June 21, 2012 | Posted By Bruce D. White, DO, JD

The front page of the Sunday, June 10, 2012, New York Times included an article by Alan Schwarz titled “Risky Rise of the Good-Grade Pill.” The one sentence teaser on the Internet copy read: “At high schools across the United States, pressure over grades and competition for college admissions are encouraging students to abuse stimulants.” The article also used a term that I had not heard or seen in some time: “study drugs.” The story describes how students are using prescription drug stimulants like Adderall XR® (mixed salts of a single entity amphetamine, Shire) so they can “focus” when preparing for examinations and taking tests, in hopes of achieving better scores. Sadly, in the article, one student compared taking stimulants as study drugs was just like taking a vitamin.

Amphetamines are indicated for attention deficit hyperactivity disorder and narcolepsy. They were first synthesized in 1887 as a chemical that was to be a substitute for ephedrine. In the US in the 1930s, the drug manufacturer Smith Kline & French sold a volatile base form of the drug as Benzedrine inhaler for nasal congestion. During World War Two, amphetamines were used extensively to combat fatigue and increase alertness.

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 29, 2012 | Posted By Ricki Lewis, PhD


Hannah Sames, here with her dog Ginger, awaits gene therapy. (photo: Dr. Wendy Josephs)

The pharmaceutical industry rightly calls the stage in drug development between basic research and clinical trials the “Valley of Death.” This is when a potential treatment that’s worked in mice, monkeys, and the like catapults to a phase 1 clinical trial to assess safety. It’s rare.

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, 2012 | Posted By Posted By David Lemberg, M.S., D.C.

We (in America) live in a capitalist society. That is a given. We also live in a democratic society. The Declaration of Independence states that all men [humans] are endowed by their Creator with certain inalienable rights including life, liberty, and the pursuit of happiness. It is not clear that any of these specific rights can be fulfilled when access to a minimum standard of health care is denied, obstructed, or otherwise not available. In the case when health care is available, that care needs to be delivered stripped of any considerations other than those related to providing assistance for that patient.

But in America many ancillary considerations intervene. Care of a patient is confounded by care for special interests, often involving kickbacks (whether in the form of travel expenses, gifts, complimentary lunches and dinners, or even cash payments) rendered by obsequious agents of big pharma or medical device corporations. Worse, on a broader scale, the recent phenomenon of the Patent and Trademark Office (PTO) blithely granting biomedical patents to any and all comers has seriously harmed medical practice and the health of Americans in need.

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 14, 2012 | Posted By Posted By David Lemberg, M.S., D.C.

Do we really need more drugs? We can gain some insight into this question by posing a qualifying question: “How’s it working out so far?” The answer is rather obvious: “Not all that well.” Despite spending $2.5 trillion in 2009 on health care, representing almost 18% of our gross domestic product, the life expectancy of Americans ranks #36 worldwide. Numerous developing nations enjoy longer lifespans than we do. (Costa Rica, for example, ranks #30.) On the other end of the spectrum, the New York Times recently reported that the U.S. rate of premature births is comparable to that of developing nations. Regarding this impactful public health issue with long-term consequences for society, the U.S. does worse than any Western European country. The U.S. premature birth rate of 12% is comparable with that in Kenya, and Honduras. In other words, on this measure the overweening technological superiority of our notoriously costly health care system fares no better than that of countries with per capita incomes of $2 a day.

With respect to chronic disease, it is not unreasonable to assert that medical treatment has obtained equivocal results in the population. Statins are a drug class that has demonstrated proven benefit. For persons who have risk factors for atherosclerotic coronary artery disease, statin use effectively reduces the risk of death due to cardiovascular disease, including stroke. Benefits of statin use increases over time. But drug companies want to extend the statin hegemony to include persons at low cardiovascular risk. In other words, global pharmaceutical corporations want physicians to prescribe statins for prevention in otherwise healthy persons.

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.

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

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.