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Topic: Pharmaceuticals
August 6, 2015 | Posted By Bruce White, DO, JD

Do Americans always need an entire industry to hate or complain about? Big tobacco, big banks, big insurers, big brokerage houses, big oil and energy companies, big automakers, big for-profit hospital companies, big pharma, have all been easy targets in the past. More often than not because of big profits, abuses and excesses, and safety concerns. On July 23, 2015, The New York Times fired another salvo at big pharma when it published Andrew Pollack’s piece titled “Drug Prices Soar, Prompting Calls for Justification.” The article highlights an issue that has been smoldering off and on for years: how do drug companies arrive at prices for their new products? After reading the article more carefully and thinking about the pressured state legislators who are introducing “drug cost transparency” bills, one may wonder why this issue now? The specific trigger this time may be Gilead Sciences’s Sovaldi® (sofosbuvir).

The New York Times has written about the costs of this drug before and how it is straining Medicaid budgets. This may be the most likely reason that these state legislators are asking for drug cost transparency now. The costs of the hepatitis C cure for affected California Medi-Cal patients alone would equal the total education budget for the state.

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

In his last AMBI blog posted on June 18, 2015, Wayne N. Shelton, PhD, MSW, discussed recent movement toward the professionalization of clinical ethics consultants. He noted the adoption of a Code of Ethics for Health Care Ethics Consultants by the American Society for Bioethics and Humanities (ASBH), which has been praised as important milestone toward the professionalization of clinical ethics consultants. Moreover, Dr. Shelton listed several challenges that “professionals” who call themselves “clinical ethics consultants” currently face, including: “[1] how to make sense of the diverse educational backgrounds and training of those who perform clinical ethics consultations and how far to push such requirements; [2] the lack of a national body to set requirements that leaves local hospital leaders with little incentive to pay for highly qualified CECs and view this as a sound investment; and finally [3], most seriously, the way in which many problems in patient care are misidentified as clinical ethical problems while other serious clinical ethical problems may be entirely overlooked or if recognized, not viewed as requiring the expertise of a CEC.” He concluded his post with: “These challenges are indications that clinical ethics consultation will not likely achieve professional status in the healthcare system in the near future.” Of course, Dr. Shelton is correct in his analysis, but some might see the challenges he listed as surmountable if those who practiced clinical ethics consultation were to: (1) establish minimum uniform educational standards for new clinical ethics consultants; (2) create national certification and accreditation standards so employers would more fully understand the nature and value of their work; and (3) provide consultants themselves and other stakeholders unmistakable guidance on what clearly constitutes the work of clinical ethics consultants. (This third point sounds very much like a “scope of practice” definition found in state professional licensing statutes.) However, it may take something much more for clinical ethics consultants to be a separate professional category.

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 4, 2015 | Posted By Bruce White, DO, JD

With the recent success of the blockbuster drug Sovaldi© (Gilead Sciences, Inc.), the manufacturer’s stock price has quintupled in the last four years. This supports the views of some that pharmaceutical prices in America should be subject to greater government scrutiny and controls like other industrialized countries.

High profits within the pharmaceutical industry are nothing new. “Historically [before the recent recession], the drug industry in America has been the top performing [sector] in terms of return on revenues (average 18.6%) and return on assets (average 17.7%) compared to 4.9% and 3.9% respectively for median companies in the Fortune 500 industries.” 

The extremely high costs of drug research and development (R&D) are often cited as the principal rationale for allowing an above average return and minimizing government price controls. However, studies have shown that “[as t]o the question of whether pharmaceutical drugs costs are justified by R&D, the answer is no. Pharmaceutical firms do indeed invest money in R&D, as do other production and service firms, but this investment does not account for their large ongoing profit, which ranges from 2.5 to 37 times the non-pharmaceutical industry average over time.”

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. 

March 4, 2015 | Posted By Bruce White, DO, JD

Probably not. It’s just not the American way.

And, it is true that Americans pay more out-of-pocket for prescription drugs than citizens in other developed countries. Other nations use government cost controls and aggressive cost containment strategies to regulate prescription drug costs. Historically, the US Congress has deliberately and consistently refused to regulate prescription drug pricing directly.

The American pharmaceutical industry often has been accused of gouging consumers and profiteering. Its investor return on equity is usually much higher than other industries. And prescription drug pricing differentials have always been difficult to understand, whether at the local pharmacy or within similar hospitals in the same locale.

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. 

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.

October 2, 2014 | Posted By Jane Jankowski, DPS, LMSW

Who decides when a problem is worthy of clinical attention? Symptoms may prompt individuals to seek medical attention, but part of this recent review of the Prozac revolution (selling-prozac-as-the-life-enhancing-cure-for-mental-woes )in the US suggests that public perception of medication for some problems was launched into a new era when Prozac hit the market in 1987. Truly revolutionary in its ability to target serotonin in order to treat depression, the additional impact of rolling out Prozac was the perhaps unintended consequence of marketing drugs to address issues which enhance people’s daily life.

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.

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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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