Topic: Pharmaceuticals
April 11, 2016 | Posted By Bruce White, DO, JD

In the March 18, 2016, AMA Wire Practice Perspective entitled “When Patient Satisfaction Is Bad Medicine” , Drs. Joan Papp (Case Western Reserve University) and Jason Jerry (Cleveland Clinic) make the argument that the institutional drive for higher patient satisfaction scores on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) questionnaires may be contributing to the opioid prescription drug crisis nationwide. They note the results of an Ohio State Medical Association-Cleveland Clinic Foundation survey 1,100 Ohio physicians:

… 98 percent of the physicians who participated reported that they felt increased pressure to treat pain, and 74 percent reported that they felt an increased pressure to prescribe opioids because of the perverse pain management incentives in the patient satisfaction surveys.

Additionally, 67 percent of respondents “agreed that, in general, physicians in the United States over-prescribe controlled substances to treat pain.” Drs. Papp and Jerry pointed to HCAHPS questions 2 and 3 specifically that may be a factor:

(1) “During this hospital stay, did you need medicine for pain?” Patients can answer “yes” or “no.” (2) “During this hospital stay, how often was your pain well controlled?” Patients can answer “never,” “sometimes,” “usually” or “always.” (3) “During this hospital stay, how often did hospital staff do everything they could to help you with your pain?” Patients can answer “never,” “sometimes,” “usually” or “always.”

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 1, 2016 | Posted By Bruce White, DO, JD

Senator Edward (Ed) John Markey (D.-Mass.) announced on January 24, 2016, that he was exercising one of his prerogatives as a United States Senator and placing a hold on the confirmation vote for Food and Drug Commissioner nominee Robert Califf, MD.  President Obama nominated Dr. Califf on September 15, 2015, to succeed Margaret Hamburg, MD, who left the position last year Interestingly, Dr. Califf won unanimous approval by the Senate Committee on Health, Education, Labor, and Pensions. However, Senator Markey questions Dr. Califf’s fitness to serve not because he lacks credible individual qualifications, but because he is upset with the way the agency deals with prescription opioid medicine approvals, and specifically the manner in which the F.D.A. handled adding a label indication for the narcotic pain killer OxyContin (Purdue Pharma LP) to treat children’s 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.

February 5, 2016 | Posted By Bruce White, DO, JD

An article that appeared in the Journal of the American Medical Association on January 4, 2016, written by Johns Hopkins Institute of the History of Medicine and Bloomberg School of Public Health professors Jeremy A. Green, Gerard Anderson, and Joshua M. Sharfstein recommended that the Food and Drug Administration (FDA) act to improve access to approved generic drugs that are becoming scarce because of a lack of competition. It’s surprising that respected historians and health policy educators believe that the FDA should have any such governmental role. As highly regarded as they are, the authors appear neither to fully understand FDA and drug regulation history or health care delivery competition oversight. The FDA has never had statutory authority to regulate drug prices, period. And, they rightly shouldn’t have.

The FDA exists to protect the public safety, health, and welfare by assuring that drugs marketed in the US are safe and effective. The reasonableness of the prices for these drug products is of no concern to the FDA as a regulatory body. In the general scheme of federal oversight, fair business and trade practices are the responsibility of the Federal Trade Commission (FTC) and the Civil and Criminal Divisions of the Department of Justice. These governmental authorities are responsible for the enforcement of the anti-competition and antitrust laws. The FDA has enough to do already; drug pricing should be left in the regulatory hands that are charged with this duty without involving the FDA. There’s no real value of involving the FDA here, except perhaps to muddle the waters more.

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 28, 2015 | Posted By Valerye Milleson, PhD

This month’s blog is going to be a bit of a rant. I don’t generally consider myself a rant-y person, but some of the commentary surrounding the recent FDA approval of the sexual desire disorder drug Addyi has proven too much for my delicate constitution.

First, what I am NOT doing: I am NOT denying the existence of hypoactive sexual desire disorder (HSDD), or that for women who are so afflicted it can cause serious distress or otherwise negative consequences. I am NOT challenging the notion that HSDD is a medical problem that warrants seeking a medical treatment or medical solution. I am NOT arguing against pharmaceuticals in general, or here specifically, as a potentially viable medical treatment for HSDD. I am NOT saying all pharmaceuticals should have absolutely no risks or side effects, or should be required to produce overly substantial benefits for it to be appropriate for them to be FDA-approved and released to the market. I am NOT calling into question the claims that there are very real sex and gender disparities in medicine, human medicalization, and medical treatment. And I am NOT disputing the value of empowering women with greater control over their own bodies and their own healthcare.

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 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. 

SEARCH BIOETHICS TODAY
SUBSCRIBE TO BIOETHICS TODAY
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.
TOPICS