Hot Topics: Pharmaceuticals

Blog Posts (18)

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>
October 6, 2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

<p><span style="line-height: 22.3999996185303px;">The September 24, 2014, issue of </span><em style="line-height: 22.3999996185303px;">USA Today</em><span style="line-height: 22.3999996185303px;"> carried a story titled, “<a href="http://www.usatoday.com/story/news/nation/2014/09/24/addiction-painkillers-fda-margaret-hamburg/16150421/">Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.</a>” </span><span style="line-height: 22.3999996185303px;">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, “<a href="http://abcnews.go.com/Health/print?id=25717411">Anti-Addiction Groups Call for New FDA Chief.</a>” </span><span style="line-height: 22.3999996185303px;">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 <a href="http://www.zogenix.com/content/products/zohydro.htm">Zohydro</a> [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], </span><span style="line-height: 22.3999996185303px;">against the recommendation of its own medical advisers.” Both the print and newscast reports came from an <a href="http://bigstory.ap.org/article/fda-chief-defends-approval-hydrocodone-drug">Associated Press report</a> written by Matthew Perrone about a controversy that has been brewing for sometime. </span><span style="line-height: 22.3999996185303px;">The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is <a href="http://feduprally.org/wp-content/uploads/2014/09/Burwell-Letter-completed-with-signature-Final.pdf">available online</a> and states their position clearly. </span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">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></p>
October 1, 2014

Life Enhancement Pills: Did you take yours today?

<p><span style="line-height: 19.0400009155273px;">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 (</span><a style="line-height: 19.0400009155273px;" href="http://www.nytimes.com/2014/09/22/us/selling-prozac-as-the-life-enhancing-cure-for-mental-woes.html?action=click&amp;contentCollection=Health&amp;region=Footer&amp;module=MoreInSection&amp;pgtype=Blogs">selling-prozac-as-the-life-enhancing-cure-for-mental-woes</a><span style="line-height: 19.0400009155273px;"> )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.</span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">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></p>

View More Blog Entries

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 (76)

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.

December 5, 2012 7:13 pm

Bigger Role Seen for Breast Cancer Drug (NYT)

The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long could upend the standard that has been in place for about 15 years.

View More News Items