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Topic: Drug Safety
June 4, 2015 | Posted By Bruce White, DO, JD

On May 7, 2015, The New York Times reported that Johnson & Johnson (New Brunswick, New Jersey) had asked Arthur Caplan, PhD, Professor of Bioethics at New York University School of Medicine to create a new panel “that will make decisions about patients’ requests for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved [by the FDA].” 

Compassionate use” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.” Of late, several states have enacted “Right to Try” statutes in an attempt to craft a legally-recognized right to early access to drugs still in clinical trials.

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 7, 2015 | Posted By Bruce D. White, DO, JD

On March 30, 2015, the American Pharmacists Association (APhA) House of Delegates – the group’s representative assembly – adopted a policy discouraging pharmacists from participating in executions. The APhA policy is only one sentence long: “The American Pharmacists Association discourages pharmacist participation in executions on the basis that such activities are fundamentally contrary to the role of pharmacists as providers of health care.”

In defending the new policy, APhA Executive Vice President and CEO, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, stated, “Pharmacists are health care providers and pharmacist participation in executions conflicts with the profession’s role on the patient health care team. This new policy aligns the APhA with the execution policies of other major health care associations including the American Medical Association, the American Nurses Association, and the American Board of Anesthesiology.”

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. 

February 13, 2015 | Posted By Bruce White, DO, JD

The US controlled substances prescription abuse statistics are simply staggering and they’re only getting worse:

·         America has 4.5% of the world’s population; America’s doctors prescribe more than 80% of the world’s opioid drug supply annually.

·         Each day 46 persons in the US die from a prescription pain killer overdose.

·         Ten of the states that have the highest narcotic drug-prescribing rate are in the South.

·         Prescription pain medicine abuse in the US is so bad that addicts who can’t get their opioid prescriptions any longer are turning to street heroin to get their narcotic fixes.

However, the federal government and the states have been responding to stop the prescription drug abuse epidemic with marginal success to date:

·         Over 35 states now have prescription drug monitoring programs (PDMPs) that require physicians and pharmacists to check databases before writing or filling some controlled substances prescriptions.

·         At least one nationwide pharmacy chain has instituted policies to avoid filling some controlled substances prescriptions that are suspect.

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. 

December 9, 2014 | Posted By Bruce White, DO, JD

On November 28, 2014, The New York Times broke another story about Big Pharma marketing extremes. Reported by Katie Thomas and titled “Using Doctors With Troubled Pasts to Market a Painkiller, the article reveals that one drug manufacturer is taking usual and customary sales strategies beyond the reasonable.

It is independently reported that pharmaceutical manufacturers spent as much as $27 billion in 2012 to promote their products.  (Curiously during the same year, Big Pharma itself reported spending about $48 billion on the research and development of new drugs.  However, some believe the research and development costs are overstated because government grant support and marketing and other expenses are included in the totals.)

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. 

November 6, 2014 | Posted By Bruce D. White, DO, JD

The cover story of the October 27, 2014, issue of PEOPLE Magazine featured Brittany Maynard, a 29-year-old Oregon woman with terminal brain cancer. In the article, Ms. Maynard announced that she would end her life on November 1, 2014, on her own terms, availing herself of the physician-assisted suicide option under the 1997 OregonDeath With Dignity Act (DWDA). As planned, and according to her own schedule and timetable, she died peacefully at home – surrounded by family and friends – on Saturday, November 1. She had signaled earlier in the week that she might delay taking her own life, but in the end, it occurred as she originally planned.

In electing assisted suicide, Ms. Maynard said, “I’m choosing to put myself through less emotional and physical pain.” She continued, “I don’t want to die, but I’m dying. My cancer is going to kill me, and it’s a terrible, terrible way to die. … When I look at both options I have to die [dying from the cancer versus dying from an overdose], I feel this [a fatal dose] is far more humane.” But rethinking the possibilities after developing a rather extensive plan in orchestrating one’s death with a terminal illness is not that unusual either. Roughly 40% of those who obtain the lethal doses of medicine under Oregon’s DWDA in the end die not from suicide but disease. According to an article in The New Atlantis, written to report a 10-year experience under the DWDA, author Courtney Campbell wrote, “In ten years, 541 Oregon residents have received lethal prescriptions to end their lives; of this number, 341 patients actually ingested the drugs.”

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 6, 2014 | Posted By Bruce D. White, DO, JD

The September 24, 2014, issue of USA Today carried a story titled, “Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.” The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “Anti-Addiction Groups Call for New FDA Chief.” In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], against the recommendation of its own medical advisers.” Both the print and newscast reports came from an Associated Press report written by Matthew Perrone about a controversy that has been brewing for sometime. The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is available online and states their position clearly. 

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 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.

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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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