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Topic: Drug Safety
April 3, 2014 | Posted By Bruce D. White, DO, JD

A March 24, 2014, article in the New York Times about the dangers of liquid nicotine used in e-cigarettes and the lack of Food and Drug Administration (FDA) involvement in its regulation emphasized a decades old problem.

Before 2009, Congress prohibited the FDA from regulating tobacco products as customarily marketed. When the Food, Drug, and Cosmetic Act (FDCA) was enacted in 1938, Congress specifically defined drugso as to exclude tobacco products. In effect, Congress reserved the regulation of tobacco products to itself. More than likely, Congress – understanding the economic impact of tobacco at the time – preferred to retain a direct hand. This singular control by Congress was reiterated by the US Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (1990) when the FDA asserted itself and attempted to prohibit the sale of tobacco products to minors by regulation. In Brown & Williamson, the Court struck the regulation down.

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.

March 7, 2014 | Posted By Bruce White, DO, JD

New York Times article by Katie Thomas published on December 16, 2013 led with this sentence: “The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest.” Might one ask: Are these really conflict of interests problems?

conflict of interest (so sometimes, conflict of interests) is often defined as: “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.”  In a short introduction to conflicts of interests, written for a business ethics class at the McCombs School of Business at the University of Texas at Austin, Dr. Lamar Pierce (Associate Professor of Strategy, Olin Business School, Washington University, St. Louis) said:

Incentives are pervasive in every aspect of society. People are rewarded for taking certain actions, and not rewarded for taking others. Workers are paid for their effort and productivity, salespeople are paid for their sales, and small business owners are rewarded with profits for successful ventures. So long as these incentives are well-understood by everyone, they work reasonably well. They motivate effort, performance, and social welfare. But sometimes, individuals have incentives that conflict with their professional responsibilities, often in ways that are not transparent to the public or in their own minds. These conflicts of interest produce serious economic and social problems.

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.

October 14, 2013 | Posted By Bruce White, DO, JD

Enrollment with the new Affordable Care Act [ACA] exchanges appears to be off to a bad start. It may be that by the time the insurance exchanges and plans take effect early next year, all the glitches may be worked out. However, even at this relatively late date, many questions remain unanswered. Some of the more distressing unanswered questions relate to the availability of expensive medicines

According to The New York Times, several of the states administering exchanges have yet to release information about drug formularies or fully explain which drugs might be excluded. Of the few states that have released this kind off information, some have options that will require patients to pay as much as 50 percent of the costs of the most expensive drugs covered. Of course, there’s no guarantee that some drugs will be included at all.

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 5, 2013 | Posted By Bruce D. White, DO, JD

At a conference a few days ago I sat beside a former deputy commissioner of the Food and Drug Administration (FDA). We were in a small group that was discussing the need to help interested parties in Brazil, China, and India learn more about US drug regulatory affairs and compendial science. As best I could understand, the food and drug regulatory infrastructure in China and India appears to be much the same as it was in the US around the 1930s and 1940s. However, everyone agreed that China and India have some of the best medicinal chemists, pharmaceutical formulations engineers, and pharmacy plant manufacturing and pharmacokinetics specialists in the world.

During the conversation I learned that the vast majority of the world’s commercially available antibiotic products are manufactured in China and India. This information struck me as a shock! Until then, I had been under the impression that when the last antibiotic manufacturing plant closed in the US in 2004 and the industry moved off-shore, that the companies had gone to Puerto Rico and Europe. But China and India?

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 1, 2013 | Posted By Bruce D. White, DO, JD

Recently, The New York Times in a series of reports has alerted the world to many of the ethical difficulties in marketing drugs globally. The titles of the articles alone hint at many of the issues: “Drug Research in China Falls Under a Cloud; “Glaxo Says Executives May Have Broken Chinese Law; “For Global Drug Manufacturers, China Becomes a Perilous Market.

Moreover, phrases used contextually in the articles are even more alarming: “Glaxo’s problems may go beyond the sales practices that are currently at the center of a bribery and corruption scandal”; “the company fired the head of research and development in China after discovering that an article he helped write in the journal Nature Medicine contained misrepresented data”; “[research] supervisors did not always ensure that the work done there was of high quality”; “auditors came across six [animal] studies whose results had not been reported, even though early trials in humans were already underway”; “auditors found that Glaxo employees failed to record whether the [human subject] research participants had signed new consent forms”; “Glaxo said that employees were properly monitored trials but that they were not adequately documenting their work”; “[Glaxo] used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales.”

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 25, 2013 | Posted By Benita Zahn, MS

The law in the United States is clear that once a person has completed their prison sentence and parole they are free to go on and live their lives. The state does not have continued control over them. While some might argue that for sex offenders and regulations regarding where they may live impinges on this, that narrow issue is not the focus of this paper. I will argue that castration, chemical or physical, is antithetical to our society. 

The eighth amendment prohibits cruel and unusual punishment. Mutilation would be considered cruel and unusual punishment and castration clearly falls under that banner. It involves a surgical procedure to remove the testicles or in women, the removal of their ovaries. One need to look no further than to realize physical castration to control sexual predators should not be permitted.    

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 2, 2013 | Posted By Bruce D. White, DO, JD

Recall the June 7, 2013 New York Times article by Andrew Pollock titled “An Experimental Drug’s Bitter End”? The author reminds us again about how difficult it is for patients and those involved in their care to understand that new drug clinical trials are experiments and not therapeutic interventions.

The goals of researchers in conducting new drug clinical trials – experiments – are clearly not the same as the goals of a physician who prescribes an approved drug as a therapeutic modality. How better can we help patients and their families understand this primary goal of medical research? In clinical trials, when the experiment ends, the patient may worsen clinically, or the patient may get better clinically, and the improving patient probably will no longer have access to the perceived beneficial drug as a therapy option. Regardless, after sufficient data is collected – whether good or bad – the experiment ends.

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.

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.

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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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