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Topic: Drug Safety
September 9, 2014 | Posted By Bruce D. White, DO, JD

On August 30, 2014, cardiovascular drug researchers managing the PARADIGM-HF Study and its Committees announced that they were terminating their Phase III trial of LCZ696 because of observed “overwhelming benefit.” As reported in The Daily Mail: “Thousands of lives could be saved by a new drug for heart failure that researchers claim outperforms the current best treatments. … Research on more than 8,000 patients found that it saved 20 per cent more lives than the current ‘gold standard’ treatment – the ACE inhibitor enalapril.” The findings were announced at the annual meeting of the European Society of Cardiology and published the same day in the The New England Journal of Medicine. In a news release, the Switzerland-based Novartis International AG – the drug manufacturer sponsor – said that it would submit an FDA application to market the drug in the US by the end of 2014. Novartis anticipates submitting a similar application to the European Union by early 2015.

Analysts say “that [the new drug] might cost $7 a day in the United States, or about $2,500 a year. Existing [standard] drugs are generic, costing as little as [$48 a year] … .”

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 4, 2014 | Posted By Bruce D. White, DO, JD

In December 2013, the FDA approved Sovaldi® (sofosbuvir, Gilead Sciences, Inc.) for treatment of hepatitis C. A truly wonderful medical breakthrough, the oral drug effectively cures 90% of patients who take it correctly. The online physician resource Web site Medscape has referred to this drug as a “game changer.” Clearly it will change the health care delivery game in any number of ways.

But the miracle comes with a catch: the cost is prohibitive. The full treatment course is so expensive that very few can afford it even with good health insurance. Each pill costs about $1000; patients will need to take the medicine once a day for about 12 weeks for a full course. The total cost will be about $90-120,000 per patient. Many are asking how is it possible to justify the cost? Is this fair?

Of course, the principal difficulty at first glace is that the costs will strain the system to a degree never before seen with the introduction of a new drug. The strain may break the bank. Recently Reuters has reported that one Florida health insurer – WellCare Health Plans – has sustained significant corporate losses attributable to the fact that Florida requires insurers to prove sofosbuvir to Medicaid patients. It has been reported that 47 state Medicaid programs are covering the drug, and about half have some form of preauthorization. Illinois Medicaid has recently changed its preauthorization criteria to provide the drug only to those patients with advanced liver disease, and to those who can tolerate interferon as an adjunctive treatment, and to exclude individuals with a history of alcohol or drug abuse. It has been projected that drug availability to California residents alone will add $18 billion to health care costs in one year.

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 14, 2014 | Posted By Bruce D. White, DO, JD

On the very last day of the 2014 legislative session, the New York Senate passed “The Compassionate Care Act” (S.1682-A, Savino) approving the legalization of medical marijuana.  The Assembly had previously passed a companion bill (A.6357-A, Gottfried). The Senate bill has been sent to Governor Cuomo for his signature. The governor endorsed the bill in the legislature, but as of July 4, 2014, has yet to sign it.

New York medical marijuana proponents have been advocating for the availability of cannabis for several years. Neighboring states Connecticut, New Jersey, and Vermont, and 18 other states and the District of Columbia currently allow medical marijuana. However, last minute compromise changes to the New York law will severely restrict access to medical cannabis. In fact, the limitations are so rigid that some might say the bill is a hallow shell, a sham, one designed to appear to allow medical marijuana yet really not. Regardless of how one feels about medical cannabis, to hype the public into believing that marijuana will be available for medical purposes and then establishing barriers to its accessibility that is a fraud. It would be unconscionable to raise the hopes of distressed patients, many suffering with chronic and painful conditions, only to see those hopes dashed.

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 6, 2014 | Posted By Kathleen O’Connor, MSW, MBA, MS

The governor of Massachusetts placed an emergency ban on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. 

Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The battle began when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. Practioners are recommended to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    

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.

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.

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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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