Hot Topics: Pharmaceuticals

Blog Posts (25)

December 23, 2015

A Suggestion To Make Prescription Medicine Behind-the-Counter

by Craig Klugman, Ph.D.

I recently returned from a vacation to Central America. Besides having some adventures, I also noticed that the local towns had a large number of pharmacies—far more than would be expected of towns with small populations.…

October 20, 2015

Gov. Brown’s veto of right-to-try bill

by Lisa Kearns, MS, MA

The conservative press’s reaction to Gov. Jerry Brown’s veto of California’s “right-to-try” bill recently was surprising—not because of the vitriol expressed, or because the writers strongly supported the legislation, which was overwhelmingly popular in the state.…

October 5, 2015

Your Biology is in My Technology

by Craig Klugman, Ph.D.

The PBS series Open Mind has been on television for nearly 60 years. The program “is a thoughtful excursion into the world of ideas.” The December 30 episode was an interview with Dr.

September 25, 2015

Drug Price Hikes and the Misguided Profit Imperative

by Craig Klugman, Ph.D.

Headlines this past week were abuzz with news that Daraprim—a drug that has fought parasitic infections such as toxoplasmosis for 62 years—saw its price hiked by 5500%, nearly overnight.…

August 28, 2015

Marketing Trumps Science, or How the Pink Pill Does Not Even the Score

<p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">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 </span><a style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;" href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm">FDA approval</a><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"> of the sexual desire disorder drug Addyi has proven too much for my delicate constitution.</span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">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.</span></p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; font-size: 12px;">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 <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
August 6, 2015

“Bad Guy” Big Pharma: An Easy Target?

<p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">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 “<a href="http://www.nytimes.com/2015/07/23/business/drug-companies-pushed-from-far-and-wide-to-explain-high-prices.html">Drug Prices Soar, Prompting Calls for Justification.</a>” 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 <a href="http://www.huffingtonpost.com/jeffrey-sachs/the-drug-that-is-bankrupt_b_6692340.html">Gilead Sciences’s Sovaldi</a>® (sofosbuvir).</span></p> <p style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;">The New York Times has <a href="http://www.nytimes.com/2015/05/20/business/high-cost-of-hepatitis-c-drug-prompts-a-call-to-void-its-patents.html">written about the costs</a> 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 <a href="http://www.sacbee.com/news/politics-government/article7058828.html">costs of the hepatitis C cure</a> for affected California Medi-Cal patients alone would equal the total education budget for the state.</p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;"><strong>The Alden March Bioethics Institute offers a Master of Science in Bioethics, a</strong> </span><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;">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 <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
July 7, 2015

Clinical Ethics Consultant Professionalization: A Response to Dr. Shelton

<p><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">In his <a href="/BioethicsBlog/post.cfm/does-the-work-clinical-ethics-consultation-lend-itself-to-professionalization">last AMBI blog</a> </span><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">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] </span><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px; color: #273049;">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.</span></p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;">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 <a style="color: #000099; text-decoration: underline;" href="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>
May 3, 2015

“Reasonable Profits” For Pharmaceutical Manufacturers?

<p class="MsoNormal" style="line-height:200%"><span style="line-height: 200%; font-size: 11.1999998092651px;">With the recent success of the blockbuster drug Sovaldi© (Gilead Sciences, Inc.), the manufacturer’s <a href="https://www.google.com/#q=gilead+sciences+stock+price">stock price</a> has quintupled in the last four years. </span><span style="line-height: 200%; font-size: 11.1999998092651px;">This supports the views of some that pharmaceutical prices in America should be subject to <a href="http://www.nytimes.com/2015/04/28/us/obama-proposes-that-medicare-be-given-the-right-to-negotiate-the-cost-of-drugs.html">greater government scrutiny</a> and controls like other industrialized countries.</span></p> <p class="MsoNormal" style="line-height:200%"><span style="line-height: 200%; font-size: 11.1999998092651px;">High profits within the pharmaceutical industry are nothing new. “Historically [before the recent recession], the drug industry in America has been the </span><a style="line-height: 200%; font-size: 11.1999998092651px;" href="http://www.cluteinstitute.com/ojs/index.php/JBER/article/view/2640">top performing</a><span style="line-height: 200%; font-size: 11.1999998092651px;"> [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.” </span></p> <p class="MsoNormal" style="line-height:200%"><span style="line-height: 200%; font-size: 11.1999998092651px;">The <a href="http://www.pnhp.org/sites/default/files/docs/2011/Biosocieties_2011_Myths_of_High_Drug_Research_Costs.pdf">extremely high costs</a> of drug research and development (R&amp;D) are often cited as the principal rationale for allowing an above average return and minimizing government price controls. </span><span style="line-height: 200%; font-size: 11.1999998092651px;">However, studies have shown that “[as t]o the question of whether pharmaceutical drugs costs are justified by R&amp;D, the answer is no. Pharmaceutical firms do indeed invest money in R&amp;D, as do other production and service firms, but this investment <a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1536-7150.2011.00820.x/abstract">does not account for</a> their large ongoing profit, which ranges from 2.5 to 37 times the non-pharmaceutical industry average over time.”</span></p> <p class="MsoNormal" style="line-height:200%"><span style="line-height: 200%; font-size: 11.1999998092651px;"><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;">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 <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;"> </span></span></p>
April 6, 2015

American Pharmacists Association Votes to Discourage Pharmacists from Participating in Executions

<p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;"><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">On March 30, 2015, the American Pharmacists Association (APhA) House of Delegates – the group’s representative assembly – <a href="http://www.pharmacist.com/apha-house-delegates-adopts-policy-discouraging-pharmacist-participation-execution">adopted a policy</a> discouraging pharmacists from participating in executions. </span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">The APhA policy is only one sentence long: “</span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">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.”</span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;"><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">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.”</span></p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;">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 <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;"> </span></p>
March 25, 2015

A Pill for Compassion or Misunderstood Science?

by Craig Klugman, Ph.D.

For at least a decade, studies have shown that empathy and compassion decline in medical students.…

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Published Articles (1)

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

News (80)

January 27, 2016 7:10 pm

Big Pharma's bet on Big Data creates opportunities and risks

The Swiss drugmaker has teamed up with U.S. technology firm Qualcomm to develop an internet-connected inhaler that can send information about how often it is used to remote computer servers known as the cloud.

October 29, 2015 3:48 pm

Popular cholesterol drugs may make flu vaccine less effective

Millions of people who take statins to lower cholesterol may not get maximum protection from flu vaccines, two new studies suggest.

October 12, 2015 3:52 pm

Exclusive - Transatlantic divide: how U.S. pays three times more for drugs

U.S. prices for the world’s 20 top-selling medicines are, on average, three times higher than in Britain, according to an analysis carried out for Reuters.

July 30, 2015 4:33 pm

Romania investigates suspected drug company bribes

Romanian anti-corruption prosecutors have conducted a series of searches at drug companies, hospitals and clinics this week to investigate suspected bribes paid to doctors for prescribing cancer drugs.

March 12, 2015 6:31 pm

FDA proposal to allow drug reps to circulate data draws protests

Consumer watchdog Public Citizen has called on U.S. health regulators to withdraw a proposal that would allow pharmaceutical companies to distribute medical literature suggesting a drug’s risk is less than stated on the label.

December 1, 2014 3:22 pm

Exclusive: First gene therapy drug sets million-euro price record

The Western world’s first gene therapy drug is set to go on sale in Germany with a 1.1 million euro ($1.4 million) price tag, a new record for a medicine to treat a rare disease.

July 28, 2014 4:30 pm

Drugs to increase 'good' cholesterol may not cut deaths

Drugs that have been investigated to increase so-called “good” cholesterol may not prevent deaths, heart attacks or strokes as many hoped, according to a new analysis.

March 25, 2014 2:53 pm

Marijuana pills and sprays ease MS symptoms

There is no cure for the condition, and therapies have proven difficult, as many have serious side effects. But now, relief may come in the form of a medical marijuana pill.

March 24, 2014 2:34 pm

Crowdsourcing medical decisions: Ethicists worry Josh Hardy case may set bad precedent

Just hours after social-media supporters of a dying 7-year-old boy pressured a reluctant biotech company into giving him an experimental medication, the backlash began.

March 13, 2014 3:41 pm

Company Makes Drug Available To Ailing Boy Following Public Outcry

Chimerix, a small and unprofitable biotechnology company, will make an experimental drug available to a young Virginia boy who is suffering from an infection he contracted while being treated for cancer.

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