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Topic: Pharmaceuticals
September 26, 2012 | Posted By Hayley Dittus-Doria, MPH

An article about the concept of overtreatment recently caught my eye. We live in a world of excess-bigger houses and larger food portions, among others. These are necessarily bad, just perhaps more than we need. The same goes for medical treatment. Like many things in the U.S., people equate “more” or “bigger” with “better.”

The problem with this mentality when it comes to healthcare procedures is the large cost that comes with it. According to the article, overtreatment is costing the U.S. healthcare system $210 billion each year. And spending that money doesn’t earn us high marks in terms of our health outcomes compared to the rest of theworld. Between “one fifth and one third of our health care dollars” are spent “on care that does nothing to improve our health” according to Shannon Brownlee, author of “Overtreated.” In a 2009 New Yorker article, Dr. Atul Gwande also points out the fact that simply because you’re receiving more aggressive healthcare doesn’t necessarily mean you’re healthier. 

Overtreatment has additional, non-financial ramifications as well. Emotional consequences can be quite serious. What if you had a cough for a few weeks? And when looking into the cough, you discover something else? And when looking into that new diagnosis, yet another problem comes to light? When your expectation was just to be treated for your cough, would you want to find out all of the other illnesses you might have? Maybe. But maybe not. Perhaps, other than your cough, you felt fine, but now your days are spent getting test done, blood work run, procedures scheduled.

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 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.

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.

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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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