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Topic: Drug Safety
August 3, 2012 | Posted By Ricki Lewis, PhD

On Sunday morning, July 21, I faced a room of people from families with Leber congenital amaurosis (LCA), an inherited blindness caused by mutations in any of at least 18 genes. It was the final session of the Foundation for Retinal Research’s bi-annual LCA family conference, and I was there to discuss the history of gene therapy. But I zapped through that quickly, because the future is much more intriguing.

The excitement pervading the room that day was palpable, following a day of scientific updates, and not only because those with young children were soon to visit Sesame World and the sights of Philadelphia.


E
xome sequencing identified the rare mutation that causes Gavin Stevens’ hereditary blindness (Leber congenital amaurosis, or LCA). (Photo: Jennifer Stevens)

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 2, 2012 | Posted By John Kaplan, PhD

It was reported in the New York Times earlier this month that GlaxoSmithKline was fined three billion (yes billion!) dollars by the feds to settle civil and criminal penalties for illegally promoting ten of its drugs. In Maythe drug firm Abbott Laboratories was fined 1.6 billion (yes billion!) dollars for illegally promoting their drug Depakote. In April Johnson & Johnson was fined 1.2 billion (yes billion!) dollars in Arkansas for marketing practices of their drug Risperdal. We can keep this short by primarily reporting fines from this year and those in the billion-plus range. I do feel the need to recall Pfizer’s 2.3 (yes billion!) dollar fine in 2009 for illegal marketing of Bextra. Taxpayers Against Fraud reports over ten billion in such settlements and civil and criminal penalties during the current fiscal year.

How can pharmaceutical companies engage in such costly activities on an ongoing basis? It turns out that what seems like a lot of money to you and me is not so much to these huge corporations. Avandia, Paxil, and Wellbutrin, just three of the ten drugs that GlaxoSmithKline was marketing this way had sales of over 25 billion (again, yes billion!) during the ten year period covered by the settlement. According to Patrick Burns, spokesman for Taxpayers Against Fraud, this “can be rationalized as the cost of doing business.” The market apparently agrees that this is a reasonable cost to do business as these fines barely registered in terms of the valuation of stock in these companies. Implicit in this conclusion is that these companies are making a purposeful decision to act in this manner and thus could be considered criminal enterprises.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

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.

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.

June 11, 2012 | Posted By Bruce D. White, DO, JD

Is helping the lay public better understand how to interpret health information accurately – in the face of widely disseminated misinformation – one of the pressing challenges for today’s bioethicists?

The June 6, 2012 New York Times carried an article that may illustrate this point perfectly: “Abortion Qualms on Morning-After Pill May Be Unfounded.” The article highlights how politics-driven misinformation is so difficult to counter or contradict, even with sound medical and scientific data. Apparently, for some politicians just saying that emergency contraceptives are “abortive pills” is enough to make it so. Of course, there are other recent examples of this phenomenon too, such as Michele Bachmann claiming that HPV vaccine might cause “mental retardation.”

Regardless, if nothing else, clinical ethics is all about informed consent. Informed consent – in a nutshell – is met when the physician shares with the patient information about the working diagnosis, the available intervention options and prognoses, the benefits and burdens of each option (including the possibility of no intervention at all) and the likely outcomes, and the physician and patient – using a shared-decision making model – agree on an immediate course or plan to implement.

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 9, 2012 | Posted By Posted By David Lemberg, M.S., D.C.

For 500 years science has built an ever-increasing knowledge base, proceeding in fits and starts and yet moving inexorably toward improved explanations of the universe in which we live. But science has reached a crossroads. Thus society, too, is similarly positioned.

Years ago, during the Enlightenment and the subsequent Industrial Revolution, Nature as such was vast and apparently infinitely replenishable. It was inconceivable that harm was being done to the environment on a large scale.

But as Inigo Montoya remarks to Vizzini in The Princess Bride, "You keep using that word [inconceivable]. I do not think it means what you think it means."

What was inconceivable then is now, appallingly, very conceivable. The outcomes of many scientific fields of inquiry have the potential to destroy the biosphere.

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 2, 2012 | Posted By Posted By David Lemberg, M.S., D.C.
Dr. Ricki Lewis The Forever Fix
Download Podcast Click the icon to play the podcast

Dr. Ricki Lewis is a science writer with a Ph.D. in genetics. Her newest book, The Forever Fix: Gene Therapy and the Boy Who Saved It, a narrative nonfiction book from St. Martin’s Press, is arriving in stores on March 13.

In our wide-ranging interview, Dr. Lewis discusses

  • How gene therapy can extend a child’s life, in some cases by years
  • Issues encountered in deciding whether a child should enroll in a gene therapy trial
  • How participants should be chosen for clinical trials
  • How problems with the informed consent process initially derailed gene therapy
  • "Therapeutic misconception"
  • How gene therapy may benefit patients with Parkinson's disease and macular degeneration

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 14, 2011 | Posted By Bruce D. White, DO, JD

Last week, Health and Human Services Secretary Kathleen Sebelius overruled the decision of Food and Drug Commissioner Margaret A. Hamburg to allow the wider availability of Plan B One-Step® (levonorgestrel, Teva Women’s Health, Inc.) without a prescription to all women of child-bearing age, more specifically to adolescent girls under age 17. This was the first time that a health secretary has ever publically exercised statutory authority to reverse an FDA commissioner. Moreover, Secretary Sebelius was fully supported by President Obama in this action.

However, today’s headline – “Sebelius: Decision to keep Plan B age restrictions not political” – is difficult to believe. Particularly, when Plan B decisions have almost always been political. See here and here.

It’s difficult when a career politician dismisses the professional advice of experts and claims that the decision did not involve political considerations. But what gives credence to the Secretary’s stand is: (1) her pro-choice positions as governor of Kansas, (2) the fact that she’s facing considerable opposition from well-known Democratic leaders around the country, and (3) her willingness to reconsider the issue if the manufacturers of Plan B reapply with additional data about the “significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”

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 20, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

In 2008 prescription medications accounted for $291 billion in sales in the United States. In 2000, the drug industry employed more than 625 lobbyists (there are only 535 members of Congress). Big business. Big money. Big power. Power versus principles — this is an eternal dialectic. If power rules, we might as well shred the Belmont Report right now.

Universal ethical standards are meant to apply universally — not locally and selectively, at the whim of the more powerful agency. They are designed to protect the more vulnerable among us — us referring to the international community. And in an ethical world, standards of care should refer to the highest, not the lowest, common denominator.

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.

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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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