Hot Topics: Pharmaceuticals

Blog Posts (20)

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.…

March 11, 2015

“Right to Try” Laws, Compassionate Use, and Adverse Events: A Second Cautionary Tale

by Alison, Bateman-House, Ph.D., MPH

In 2014, Colorado became the first state to debate and then pass a so-called “Right to Try” law.…

March 8, 2015

Drug Development, Compassionate Use, and Adverse Events: A Cautionary Tale

by Alison, Bateman-House, Ph.D., MPH

In late September 2014, a man was admitted to the hospital due to vomiting, diarrhea, and fever.…

March 4, 2015

Will the US Ever Control Drug Prices Like the Rest of the World?

<p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">Probably not. It’s just not the <a href="http://www.nytimes.com/1991/05/24/business/why-drugs-cost-more-in-us.html">American way</a>.</span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">And, it is true that <a href="http://www.ncbi.nlm.nih.gov/pubmed/22392823">Americans pay more</a> out-of-pocket for prescription drugs than citizens in other developed countries. Other nations use <a href="http://lawdigitalcommons.bc.edu/iclr/vol26/iss2/8/">government cost controls</a> and aggressive cost containment strategies to regulate prescription drug costs. Historically, the US Congress has deliberately and consistently <a href="http://www.amazon.com/Taking-Your-Medicine-Regulation-United/dp/0674867254">refused to regulate</a> prescription drug pricing directly.</p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">The American pharmaceutical industry often has been accused of gouging consumers and profiteering. Its investor return on equity is <a href="http://www.bbc.com/news/business-28212223">usually much higher</a> than other industries. And prescription <a href="https://host1.medcohealth.com/art/pdf/kap19Medications.pdf">drug pricing differentials</a> have always been difficult to understand, whether at the local pharmacy or within similar hospitals in the same locale.</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><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.0400009155273px;"> </span></p>
December 8, 2014

Marketing Extremes That Even Give Big Pharma Supporters Pause

<p class="MsoNormal" style="line-height: 22.3999996185303px;"><span style="line-height: 22.3999996185303px;">On November 28, 2014, </span><em style="line-height: 22.3999996185303px;">The New York Times</em><span style="line-height: 22.3999996185303px;"> broke another story about Big Pharma marketing extremes. Reported by Katie Thomas and titled “<a href="http://www.nytimes.com/2014/11/28/business/drug-maker-gave-large-payments-to-doctors-with-troubled-track-records.html">Using Doctors With Troubled Pasts to Market a Painkiller</a>”</span><span style="line-height: 22.3999996185303px;">, the article reveals that one drug manufacturer is taking usual and customary sales strategies beyond the reasonable.</span></p> <p class="MsoNormal" style="line-height: 22.3999996185303px;"><span style="line-height: 22.3999996185303px;">It is </span><a style="line-height: 22.3999996185303px;" href="http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients">independently reported</a><span style="line-height: 22.3999996185303px;"> 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 </span><a style="line-height: 22.3999996185303px;" href="http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf">development of new drugs</a><span style="line-height: 22.3999996185303px;">.  However, some believe the research and development </span><a style="line-height: 22.3999996185303px;" href="http://www.sciencedaily.com/releases/2008/01/080105140107.htm">costs are overstated</a><span style="line-height: 22.3999996185303px;"> because government grant support and marketing and other expenses are included in the totals.)</span></p> <p class="MsoNormal" style="line-height: 22.3999996185303px;"><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="text-decoration: underline; color: #000099;" 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>
December 2, 2014

Marketing Extremes That Even Give Big Pharma Supporters Pause

<p style="line-height: 19.0400009155273px;"><span style="line-height: 19.0400009155273px;">On November 28, 2014,The New York Times broke another story about BigPharma marketing extremes. Reported by Katie Thomas and titled “<a href="http://www.nytimes.com/2014/11/28/business/drug-maker-gave-large-payments-to-doctors-with-troubled-track-records.html">Using Doctors With Troubled Pasts to Market a Painkiller</a>”, the article reveals that one drug manufacturer is taking usual and customary sales strategies beyond the reasonable.</span></p> <p style="line-height: 19.0400009155273px;">It is independently reported that pharmaceutical manufacturers spent as much as <a href="http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients">$27 billion in 2012</a> to promote their products. (Curiously during the same year, Big Pharma itself reported spending about <a href="http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf">$48 billion</a> on the research and development of new drugs. However, some believe the research and development costs are overstated because government grant support and marketingand other expenses are <a href="http://www.sciencedaily.com/releases/2008/01/080105140107.htm">included in the totals</a>.)</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></p>

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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 (77)

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.

November 8, 2013 1:41 pm

Feds Have Beaten Pharma Into Submission Over Off-Label Drug Use, But At What Cost?

Regulatory policy should be based on rules that are clear, with a process that is transparent, and on decisions that are accountable and reviewable, and that are congruent with other public policy imperatives.

August 14, 2013 6:27 pm

Safety First? How the Current Drug Approval System Lets Some Patients Down

Licensed drugs have to go through rigorous trials. Even if an unlicensed drug works in some way, it might kill you in another way or cause problems.

June 18, 2013 2:47 pm

Supreme Court lets U.S. regulators challenge generic-drug deals

The Supreme Court rattled the pharmaceutical industry Monday when it ruled that antitrust regulators should be able to challenge the arrangements that allow rival drugmakers to delay the sale of a generic drug.

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