Tag: drug safety

Blog Posts (17)

June 24, 2016

Zeke Emanuel May Not Be Right This Time: Increasing Costs Will Probably Not Slow Antibiotic Resistance

Ezekiel J. (Zeke) Emanuel, MD, PhD, is chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. On May 30, 2016, the Washington Post published an opinion piece by Dr. Emanuel titled “Want to Win $2 Billion? Create the Next Antibiotic.”

In the article, Dr. Emanuel makes two key points: (1) the low cost of antibiotics may be one of the principal factors that have led to doctors over-prescribing these drugs; (2) the low cost of antibiotics with the resulting low rate of return on investment for pharmaceutical companies dis-incentivizes drug manufacturers from allocating more resources for the research and development of new antibiotics to combat evolving “superbugs” (bacteria resistant to current antibiotics). He offers ideas to help solve the problem including: (1) mandating that all hospitals create antibiotic stewardship programs to monitor antibiotic use within institutions; (2) require that all antibiotic prescriptions written be reviewed to assure that the prescribing is warranted according to national guidelines; (3) increasing the charges for antibiotics; and (4) creating a $2 billion prize with additional taxes or surcharges to be awarded to individuals or entities that develop new antibiotics to counter identified microbial threats.

One should be very careful in challenging any suggestions Dr. Emanuel might make – after all he is an internationally recognized health policy and medical ethics expert – but in this case I think he is mistaken about issues and that his ideas may have unintended negative consequences that will make matter worse.

Decades years ago, antibiotics were far more expensive than they are today. Loss of patent protection and generic substitutes have substantially lowered antibiotic costs. But the cost of the antibiotics a few years back had little to do with the development of resistant organisms. One might argue that antibiotics perhaps are far more readily available than is good for man. (One example is farmers using antibiotics to improve their beef cattle and dairy herds.) Antibiotic resistance is as evitable as natural selection; resistance evolves from appropriate and inappropriate use.

Without question, antibiotics are too freely used and are unnecessarily available. The Centers for Disease Control and Prevention has estimated that over half of the outpatient antibiotic prescriptions written are medically unnecessary. Some might suggest that they be available without prescription. If it were safer to use antibiotics without proper provider oversight, certainly they would be marketed as over-the-counter drugs in the US. But with evolving resistance, it is also apparent that antibiotics should be accessible only with better foresight and oversight.

But even if we in the United States were to dramatically curtail antibiotic use by prescribing drugs more appropriately, one should still ask “What about the rest of the world?” The US has 4% of the world’s population. In the US (and more developed countries), we are very concerned about the availability of antibiotics and appropriate use; but most of the world is not. Antibiotics are readily available in Central and South America and Asia and Africa without a prescription. Clearly resistant organisms will continue to evolve in the world whether we decrease the rate of resistance in the US or not. Moreover, the more recent worldwide epidemic health scares have been from viruses – Ebola, Zika, and Chikungunya – for which antibiotics are of no help.

The very best strategy in combating resistant organisms remains prescribing antibiotics appropriately. Successful ideas to help prescribe antibiotics more appropriately have been proposed. Somehow, we need to get providers to practice evidence-based medicine. Of course, we should be doing this in every aspect of providing care, not just in prescribing antibiotics. Our primary ethical obligation as providers is to practice competently. Radical ideas – like increasing the cost of antibiotics, mandating that all hospitals have antibiotic stewardship programs, asking more knowledgeable peers to review every single antibiotic prescription, and taxing Medicare hospitals to create prize money to award successful antibiotic developers – may work; but the formula seems too extreme. If we need peers watching everything that other providers do, is this really the solution that will assure best practice over the long haul?

April 11, 2016

Patient Satisfaction and the Possibility of Bad Medicine

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.”

 

Unless patients answer “always” to these last two questions, the hospital is considered an “underperformer” by Centers for Medicare & Medicaid Services (CMS) and may be financially penalized.

            With these survey results, one may reasonably wonder if a “cultural paradigm of overly aggressive pain management … exists and will continue to be a barrier to efforts to address the opioid epidemic.”

            Drs. Papp and Jerry offer three suggestions that might help: (1) Perhaps CMS should consider giving “partial credit” for responses for HCAHPS questions 2 and 3? It is very difficult clinically to “always” relive acute and chronic pain. (2) In the introductory question attention is directed toward “medicine”; there are many other pain modalities such as ice packs, improved positioning, physical therapy, and surgical intervention, that are not addressed. (3) Perhaps CMS should use “discomfort” rather than “pain” in the questions? As worded, there is little room for patients and doctors reflecting on other pain control options for rapid pain relief.

            The opioid prescription drug crisis in America is real. During the month of March 2016 alone, a great deal of attention has been directed to the problem. The U.S. Senate recently passed S.B. 524, the Comprehensive Addiction and Recovery Act (CARA) to provide “money for various treatment and prevention programs for a broad spectrum of addicts, including those in jail. It also strengthens prescription drug monitoring programs to help states and expands the availability of the drug naloxone, which helps reverse overdoses, to law enforcement agencies.”

The Massachusetts and Wisconsin legislatures enacted laws establishing new prescribing rules and allowing for the better disposal of controlled substances. And the Centers for Disease Control and Prevention (CDC) published their Guideline for Prescribing Opioids for Chronic Pain with advice for primary care clinicians not dealing with end-of-life or palliative care situations. Even so, much still needs to be done to improve pain control while minimizing risks of addiction and abuse. All the more reason to align as many forces as possible – including a revision of the CMS HCAHPS patient satisfaction questionnaires – to maximize best practices in prescribing opioids.

 

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 12, 2015

An F.D.A. Commissioner With Ties to the Pharmaceutical Industry? Heaven Forbid?

<p style="font-size: 11.2px; line-height: 19.04px;"><span style="font-size: 11.2px; line-height: 19.04px;">On September 16, 2015, </span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.nytimes.com/2015/09/16/health/cardiologist-nominated-to-be-head-of-fda.html">President Obama nominated</a><span style="font-size: 11.2px; line-height: 19.04px;"> the internationally known Duke University cardiologist-researcher </span><a style="font-size: 11.2px; line-height: 19.04px;" href="https://medicine.duke.edu/faculty/robert-m-califf">Robert M. Califf, MD</a><span style="font-size: 11.2px; line-height: 19.04px;">, to be Commissioner of Food and Drugs. He will replace</span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.nytimes.com/2015/02/06/health/margaret-hamburg-fda-commissioner-stepping-down.html">Margaret Hamburg, MD</a><span style="font-size: 11.2px; line-height: 19.04px;">, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as </span><a style="font-size: 11.2px; line-height: 19.04px;" href="http://www.fda.gov/AboutFDA/CentersOffices/ucm452317.htm">Deputy Commissioner at the F.D.A.</a><span style="font-size: 11.2px; line-height: 19.04px;"> since February. The Senate must confirm the commissioner.</span></p> <p style="font-size: 11.2px; line-height: 19.04px;">Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.</p> <p><span style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 19.04px;"><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: 19.04px;">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>
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>
June 3, 2015

Can Bioethics Panels Fix the Problems With the Availability of “Compassionate Use” Experimental Drugs?

<p class="MsoNoSpacing" style="font-size: 11.1999998092651px; line-height: 19.0400009155273px;"><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">On May 7, 2015, <a href="http://www.med.nyu.edu/pophealth/faculty/caplaa01">The New York Times reported</a> that <a href="http://www.jnj.com">Johnson &amp; Johnson</a> (New Brunswick, New Jersey) </span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">had asked Arthur Caplan, PhD, Professor of Bioethics at New York University School of Medicine </span><span style="line-height: 22.3999996185303px; font-size: 11.1999998092651px;">to create a new panel “that will <a href="http://www.nytimes.com/2015/05/07/business/company-creates-bioethics-panel-on-trial-drugs.html">make decisions about patients’ requests</a> for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved [by the FDA].” </span></p> <p class="MsoNormal" style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;"><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">“</span><a style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;" href="http://www.mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/compassionate-use/faq-20058036">Compassionate use</a><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.” Of late, several states have enacted “</span><a style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;" href="http://www.nytimes.com/2015/01/11/us/patients-seek-right-to-try-new-drugs.html">Right to Try</a><span style="font-size: 11.1999998092651px; line-height: 22.3999996185303px;">” statutes in an attempt to craft a legally-recognized right to early access to drugs still in clinical trials.</span></p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; line-height: 19.0400009155273px; 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="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></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>
February 13, 2015

Should Doctors Photograph Patients Who Receive Opioid Prescriptions?

<p class="MsoNormal" style="line-height:200%"><span style="line-height: 200%; font-size: 11.1999998092651px;">The US controlled substances <a href="http://www.cdc.gov/vitalsigns/opioid-prescribing/">prescription abuse statistics</a> are simply staggering and they’re only getting worse</span><span style="line-height: 200%; font-size: 11.1999998092651px;">:</span></p> <p class="MsoListParagraphCxSpFirst" style="margin-left:.75in;mso-add-space:auto; text-indent:-.25in;line-height:200%;mso-list:l0 level1 lfo1"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span>America has 4.5% of the world’s population; America’s doctors <a href="http://www.asipp.org/documents/ASIPPFactSheet101111.pdf">prescribe more than 80%</a> of the world’s opioid drug supply annually.</p> <p class="MsoListParagraphCxSpMiddle" style="margin-left:.75in;mso-add-space: auto;text-indent:-.25in;line-height:200%;mso-list:l0 level1 lfo1"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span>Each day <a href="http://www.usatoday.com/story/money/business/2013/07/28/deadly-epidemic-prescription-drug-overdoses/2584117/">46 persons in the US die</a> from a prescription pain killer overdose.</p> <p class="MsoListParagraphCxSpMiddle" style="margin-left:.75in;mso-add-space: auto;text-indent:-.25in;line-height:200%;mso-list:l0 level1 lfo1"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span>Ten of the states that have the <a href="http://www.cdc.gov/vitalsigns/opioid-prescribing/">highest narcotic drug-prescribing rate</a> are in the South.</p> <p class="MsoListParagraphCxSpLast" style="margin-left:.75in;mso-add-space:auto; text-indent:-.25in;line-height:200%;mso-list:l0 level1 lfo1"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span><a href="http://time.com/4505/heroin-gains-popularity-as-cheap-doses-flood-the-u-s/">Prescription pain medicine abuse</a> in the US is so bad that addicts who can’t get their opioid prescriptions any longer are turning to street heroin to get their narcotic fixes.</p> <p class="MsoNormal" style="line-height:200%">However, the federal government and the states have been responding to stop the prescription drug abuse epidemic with marginal success to date:</p> <p class="MsoListParagraphCxSpFirst" style="margin-left:.75in;mso-add-space:auto; text-indent:-.25in;line-height:200%;mso-list:l2 level1 lfo3"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span>Over 35 states now have <a href="https://www.fas.org/sgp/crs/misc/R42593.pdf">prescription drug monitoring programs</a> (PDMPs) that require physicians and pharmacists to <a href="http://oklahomawatch.org/2014/05/02/drug-overdoses-fall-in-states-with-required-prescription-checks/">check databases</a> before writing or filling some controlled substances prescriptions.</p> <p class="MsoListParagraphCxSpMiddle" style="margin-left:.75in;mso-add-space: auto;text-indent:-.25in;line-height:200%;mso-list:l1 level1 lfo2"><span style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family: Symbol">·<span style="font-stretch: normal; font-size: 7pt; line-height: normal; font-family: 'Times New Roman';">         </span></span>At least one nationwide pharmacy chain has instituted policies to <a href="http://www.wthr.com/story/23469086/2013/09/18/walgreens-secret-checklist-reveals-controversial-new-policy-on-pain-pills">avoid filling some controlled substances</a> prescriptions that are suspect.</p> <p class="MsoNormal" style="line-height:200%"><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 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>
November 5, 2014

Brittany Maynard: A Terminal Cancer Patient’s Controversial Choice

<p class="MsoNormal" style="line-height: 19.0400009155273px;"><span style="line-height: 22.3999996185303px;">The cover story of the October 27, 2014, issue of <a href="http://www.people.com/article/terminally-ill-brittany-maynard-decision-to-die">PEOPLE Magazine</a> featured Brittany Maynard, a 29-year-old Oregon woman with terminal brain cancer. </span><span style="line-height: 22.3999996185303px;">In the article, Ms. Maynard announced that she would end her life on November 1, 2014, on her own terms, availing herself of the physician-assisted suicide option under the 1997 Oregon<a href="http://public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Pages/index.aspx">Death With Dignity Act</a> (DWDA). </span><span style="line-height: 22.3999996185303px;">As planned, and according to her own schedule and timetable, she <a href="http://www.usatoday.com/story/news/nation-now/2014/11/02/brittany-maynard-/18390069/">died peacefully at home</a> – surrounded by family and friends – on Saturday, November 1. </span><span style="line-height: 22.3999996185303px;">She had signaled earlier in the week that she might <a href="http://www.usatoday.com/story/news/nation-now/2014/10/30/brittany-maynard-puts-off-ending-her-life/18166161/">delay taking her own life</a>, but in the end, it occurred as she <a href="http://www.washingtontimes.com/news/2014/oct/30/brittany-maynard-terminally-ill-cancer-patient-ret/">originally planned</a>.</span></p> <p class="MsoNormal" style="line-height: 19.0400009155273px;"><span style="line-height: 22.3999996185303px;"></span><span style="line-height: 22.3999996185303px;">In electing assisted suicide, Ms. Maynard said, “I’m choosing to put myself through less emotional and physical pain.” She continued, “I don’t want to die, but I’m dying. My cancer is going to kill me, and it’s a terrible, terrible way to die. … When I look at both options I have to die [dying from the cancer versus dying from an overdose], I feel this [a fatal dose] is far more humane.” But rethinking the possibilities after developing a rather extensive plan in orchestrating one’s death with a terminal illness is not that unusual either. Roughly 40% of those who obtain the lethal doses of medicine under Oregon’s DWDA in the end die not from suicide but disease. According to an article in </span><em style="line-height: 22.3999996185303px;"><a href="http://www.thenewatlantis.com/publications/ten-years-of-death-with-dignity">The New Atlantis</a></em><span style="line-height: 22.3999996185303px;">, written to report a 10-year experience under the DWDA, author Courtney Campbell wrote, “In ten years, 541 Oregon residents have received lethal prescriptions to end their lives; of this number, 341 patients actually ingested the drugs.”</span></p> <p class="MsoNormal" style="line-height: 19.0400009155273px;"><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="http://www.amc.edu/Academic/bioethics/index.cfm">website</a>.</strong></p>

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May 14, 2012 10:06 am

IOM calls for more thorough safety monitoring of drugs (American Medical News)

To track a medicine’s safety, the FDA should create a comprehensive benefit and risk assessment and management plan that is readily accessible to the public and easy to understand, according to the report, issued May 1. Such a document would give physicians and others greater access to information about drugs on the market than they had in the past, said Eric M. Meslin, PhD, a member of the 12-person IOM committee that wrote the report.

May 1, 2012 5:07 pm

Better Ways Needed to Track Drug Safety: Report (US News)

A management plan to gather, assess and respond to data about all medications’ risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.