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Blog Posts (28)

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.

March 1, 2016

Senator Markey and the Unfortunate Politicization of the F.D.A.

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

Moreover, Markey is not alone. At least two other senators agree that Califf is not a good choice for F.D.A. commissioner and also place “holds” on the nomination: Senator Bernie Sanders (Ind.-Vt.) believes that Califf is too close to the pharmaceutical industry and lacks commitment in controlling drug prices; and Senator Lisa Murkowski (R.-Alaska) objects because the F.D.A. approved a genetically modified salmon which is a competitor in the marketplace to “natural” Alaska salmon.  Because of these member “holds,” Dr. Califf’s nomination may never come to the Senate floor for a confirmation vote. And with the Obama Administration in its last year, it may not really matter that much anyway. Dr. Califf is presently serving as Deputy Commissioner for Medical Products and Tobacco; and the F.D.A.'s chief scientist, Stephen Ostroff, MD, is serving as acting head of the agency.  Both Drs. Ostroff and Califf are relatively recent F.D.A. administrative additions and probably will collaborate in effecting Obama policy directives.

Regardless, the question remains: Should senators hold up F.D.A. appointments for what appear to be personal political views? Views that are clearly are important, but grounded more in policy disagreements with agency actions that may not be related to the qualifications of the candidates nominated to manage the agency? Surely there are more civil and direct ways of expressing opinions without attempting to grind government to a halt?

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

February 5, 2016

The FDA Should Have No Role in Setting Prices for Off-Patent Pharmaceuticals

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

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

Green, Anderson, and Sharfstein are appropriately outraged by the unbelievably high prices charged for some off-patent drugs.  But for the most part, the decreased availability is a function of market forces. As drugs age – and loose their patent protections – newer drug entities are approved and take their place in medicine’s armamentarium. The example the authors cite of the wide availability of amoxicillin is good example of an off-patent drug that still available because the market has yet to find a safer, more effective, low cost alternative for the millions of patients in the US that need a first line broad spectrum antibiotic. Few off-patent drugs have have the same broad use and hence the same wide availability. There are some but their use and availability is a function of the market, not FDA oversight. The shortages or limited supplies of most drugs result not from reduced competition but from the fact that fewer patients need them.

In those situations, in which unscrupulous marketeers and venture capitalists step in the raise the prices of drugs in short supply – even when there are many patients need and can benefit from them – the circumstances are more similar to price-gougers taking advantage of an unfortunate situation. Some states define this as criminal behavior and the alleged misconduct is prosecuted and guilty parties are punished. This would be true if the product were drugs, or milk or gasoline, whether shortly after a natural disaster or some other similar calamity.

Moreover, the recommendations Green, Anderson, and Sharfstein make regarding the FDA’s role are poorly thought out and inconsistent with current commonly accepted practices: (1) The authors think the FDA should allow more “drug compounding” by pharmacists to meet any shortages. Any “compounding” of the volumes necessary to meet shortages would clearly be “manufacturing” as defined in the Food, Drug and Cosmetic Act (FDCA). “Compounding” is typically undertaken by an individual pharmacist for an individual patient; larger scale production is “manufacturing” and FDA oversight would be mandatory. For many years, the FDA has sought greater oversight of “compounding” over the objection of state pharmacy regulators. They have achieved that goal of sorts with the enactment of the Drug Compounding Quality Act (which was Title I of the Drug Quality and Security Act of 2013). (2) The authors also suggest that the FDA “temporarily permit the importation of drug products reviewed by competent regulatory authorities and approved for sale outside the United States.” It’s generally understood that India already manufactures about 80% of the world’s generic drug supply. Most drugs available in the US are already manufactured in India and China. Drug manufacturers moved to these countries over time for economic reasons, because it’s just too expensive to manufacture drugs in the continental US anymore. Of course the approval process for those products that will be marketed here is still handled by the FDA, but the actual product manufacture is elsewhere. It’s particularly curious that Dr. Sharfstein – as a former Principal Deputy Commissioner within FDA from 2009 to 2011 – should advocate for such FDA roles when it was the FDA that was actively involved in drafting the Drug Supply Chain Security Act (which was Title II of the Drug Quality and Security Act of 2013) to better assure the quality of drugs available in the US regardless of point of manufacture. 

Even more curious, the authors recommend the FDA speed up it’s generic drug regulatory approval process. Again, as Principal Deputy Commissioner for the FDA, it seems that Dr. Sharfstein and other FDA officials could have done that already if there had been political will to do so.

Regardless, the FDA should be left alone to assure the safety and efficacy of drugs, and not be involved with drug pricing.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

 

December 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>

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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 (87)

June 23, 2016 8:47 am

Birth Control via App Finds Footing Under Political Radar (New York Times)

A quiet shift is taking place in how women obtain birth control. A growing assortment of new apps and websites now make it possible to get prescription contraceptives without going to the doctor.

June 21, 2016 8:48 am

Even Cheap Meals Influence Doctors’ Drug Prescriptions, Study Suggests (Wall Street Journal)

It doesn’t take much to get a doctor to prescribe a brand-name medication, a new study suggests. The study found that U.S. doctors who received a single free meal from a drug company were more likely to prescribe the drug the company was promoting than doctors who received no such meals. Meals paid for by drug companies cost less than $20 on average.

June 2, 2016 9:51 am

We’re spending $107 billion on cancer drugs, but is it worth it? (Washington Post)

A flood of innovative cancer treatments helped fuel an 11.5 percent surge in spending on oncology drugs over the past year — to $107 billion globally, according to a new report. But there’s a crucial question the study can’t quite answer: How much are patients benefiting from this expanding arsenal of high-priced drugs?

June 1, 2016 8:00 am

Why taking morphine, oxycodone can sometimes make pain worse (Science)

There’s an unfortunate irony for people who rely on morphine, oxycodone, and other opioid painkillers: The drug that’s supposed to offer you relief can actually make you more sensitive to pain over time.

May 31, 2016 8:41 am

Infection Raises Specter of Superbugs Resistant to All Antibiotics (New York Times)

American military researchers have identified the first patient in the United States to be infected with bacteria that are resistant to an antibiotic that was the last resort against drug-resistant germs.

April 26, 2016 9:05 am

Advisers to F.D.A. Vote Against Duchenne Muscular Dystrophy Drug (New York Times)

In a confrontation between the hopes of desperate patients and clinical trial data, advisers to the Food and Drug Administration voted on Monday not to recommend approval of what would become the first drug for Duchenne muscular dystrophy.

April 4, 2016 10:10 am

Exclusive: Makers took big price increases on widely used U.S. drugs

Major drug companies took hefty price increases in the U.S., in some cases more than doubling listed charges, for widely used medications over the past five years, a Reuters analysis of proprietary data found.

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.

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