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Topic: Drug Safety
May 7, 2013 | Posted By Bruce D. White, DO, JD

The FDA has banned generic availability of the original formulation of OxyContin® (Purdue Pharma LP’s brand of oral controlled-release oxycodone). OxyContin® was approved by the FDA in 1995 and was first marketed in the US in 1996. Within a very short time, OxyContin® was the most frequently prescribed brand name analgesic with annual sales in the billions of dollars. By 2005 retail purchases were six times the 1997 volume; by 2008, sales totaled $2.5 billion.

Purdue was very effective in marketing OxyContin®. The manufacturer used several “sales strategies” that have since been roundly criticized by regulators and some physicians: aggressive off-label detailing; technically misbranding the product so as to mislead prescribers and patients regarding abuse potential; applying “significant political pressure” to gain state Medicaid formulary approvals; and engaging nationally recognized pain management thought leaders which “encouraged more liberal prescribing of opioids, based on debatable evidence.” With the increased prescribing, more of the drug was available for potential diversion to illegitimate channels. Not surprisingly, the number of accidental deaths from opioid drugs – licit and illicit – have grown in just a few years into a national crisis of epidemic proportions.

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.

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 20, 2012 | Posted By Lisa Campo-Engelstein, PhD

A recent New York Times article shares the story of Debra Demidon, who developed severe ovarian hyperstimulation syndrome (OHSS) after undergoing IVF. This potentially life-threatening condition caused her to gain more than 30 pounds of fluid and have trouble breathing, and ultimately landed her in the hospital for 5 days. OHSS is much more common in the US and UK than in Europe and Japan because the former countries rely on high-dose hormones for IVF where the latter countries use lose-dose hormones. Although rare, OHSS following high-dose hormone IVF is now one of the leading causes of maternal mortality in parts of the UK. OHSS is not the only adverse side effect of high-dose IVF for women; there are myriad other possible side effects including increased cancer risk, memory loss, and liver disorders.  Furthermore, there can also be increased risk for children born from high-dose IVF, such as low birth rate. 

Knowing these serious potential health-related outcomes, why is high-dose IVF the dominant and default method used in the US? The main reason is that high-dose IVF produces many more eggs (often 20-30 eggs and sometimes even more) than low-dose IVF produce (8-10 eggs). Given that most insurance companies do not cover infertility treatments (only 15 states have laws mandating insurance companies to cover infertility treatments and there are many exemptions and caveats), many people pay out of pocket for IVF. In order to save money – IVF costs $15,000 - $30,000 a cycle – people are often willing to increase their risks to themselves (choosing high-dose IVF or low-dose IVF) if it means they’re likely to generate more eggs. Individuals in time pressure situations who may only have one shot at gathering eggs, such as cancer patients wanting to preserve their fertility before undergoing treatments that will hopefully save their lives but may render them infertile, may also opt for high-dose IVF.  

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.

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.

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ABOUT BIOETHICS TODAY
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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