Hot Topics: Pharmaceuticals
by Craig Klugman, Ph.D.
Federal kickback rules state that a pharmaceutical manufacturer or medical device producer cannot pay providers or patients to recommend or prescribe their products.…Full Article
by Craig Klugman, Ph.D.
“Exploring ethical issues in TV medical dramas”
Jump to The Resident (Season 2; Episode 5): Buying Thought Leaders and Handsy Docs; Jump to New Amsterdam (Season 1; Episode 5): Gun shootings; Jump to Chicago Med (Season 4; Episode 5): Genetic secrets and duty to inform
Bell negotiates a deal with a new start-up medical device company: For a substantial discount, he will make the company the sole source of medical devices at the hospital.…Full Article
by Craig Klugman, Ph.D.
Jump to The Resident (Season 2; Episode 2): Rising drug costs Jump to New Amsterdam (Season 1; Episode 2): Cultural accommodation; medicating schoolkids Jump to Chicago Med (Season 4; Episode 2): Withholding support; withdrawing support
In its sophomore year, this show seems to be shying away from ethical issues and the gross incompetence of its fictional hospital and exchanging it for hope; hope that hospitals can cover their costs and meet patient needs.…Full Article
by Craig Klugman, Ph.D.
Last week, I was interviewed by an academic news serviceabout antimicrobial resistance (AMR) after a study reported that giving antibiotics to children in selected African towns led to a decreased mortality rate. …Full Article
by Craig Klugman, Ph.D.
The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…Full Article
by Craig Klugman, Ph.D.Full Article
by Craig Klugman, Ph.D.
Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies.…Full Article
The development of ‘specialty drugs’ in the health care industry has created legal, ethical, and public policy issues because patients are not able to get access to their prescribed medications based on the expense. Specialty drugs are usually biologicals, treat serious conditions, and are very expensive with no cheap alternatives. Although there is debate about how much finances should influence medical decision making, it is a conversation that can not be ignored when patients can not get access to treatment based on ability to pay. There should be increased access to these drugs but how to increase access is up for debate.
One posed solution has been the creation of biosimilar which are the generic version of a specialty drug. A biological medication is different from a traditional drug in molecular make up. “A biologic drug is ‘a substance that is made from a living organism or its products[,]’” while a traditional prescription drug is made up of simple molecules. This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary. This also means making a generic form, known as a biosimilar, is more expensive and harder to make. Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.” There also are patent infringement concerns when making biosimilar.
From ethics perspective, one of the key aspects of justice is ensuring equal access to healthcare or at least fairly allocating available resources. For biosimilar drugs, it truly depends on what insurance company, what insurance plan, and what pharmacy benefit manager the patient has as to whether the patient will even have a chance to get these drugs. One could argue that it is hard to say we have a fair allocation system when it dependent on what backroom deals pharmaceutical companies have with insurance companies. On the other side, fairness includes ensuring that pharmaceutical companies are properly compensated for their time, energies, and resources used to develop these drugs. Yes, they are cheaper than brand name biologics but they are still expensive and arguably unaffordable. Competition has been the suggested method for decreasing prices to ensure better access. However, patents exclusivity and the Food and Drug Administration approval process make competition slow.
On April 27, 2017, The United States Supreme Court heard a case that addresses exactly this issue of access. The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up. Amgen, a California pharmaceutical company who makes the name brand version Neupogen, had challenged the early release. The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. The case revolves around a provision in the Affordable Care Act which aimed at creating an expedited path for approval of biosimilar drugs. The goal was to increase access of new innovations to the public as well as increase competition to decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost 15 percent less than Neupogen, which is a decrease in cost but not a substantial in cost. Part of the issue is health insurance companies expect biosimilar drugs to work like generic medications and they do not. Biosimilars themselves are still innovation and companies charge for the research and development that goes into innovations. The final decision is due to come in June and this case could determine whether justice will be respected in regards to how quickly consumers can get access to biosimilars.
 Joseph J. Hylak-Reinholtz & Jay R. Naftzger, Is it Time to Shed a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April 26, 2008) http://healthcareorganizationalethics.blogspot.com/2008/04/how-us-rations-specialty-drugs.html.
 Michael Callam, Who Can Afford it?: The Patient Protection and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of Prescription Biologic Drugs, 27 J.L. & Health 99, 103 (2014).
 Id. at 104.
 Callam, supra note 2, at 105.
 Andrew Chung, U.S. Top Court Grapples Over Making Copycat Biologics Available Sooner, Reuters (Apr. 26, 2017), http://mobile.reuters.com/article/idUSKBN17S2BF.
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.
Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)
The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.
Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.
In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).
Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).
It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]
Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.
A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place.
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.Full Article
To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials
Undisclosed conflicts of interest among biomedical textbook authors
Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility
The Ethics of Advertising for Health Care Services
As investigators closed in on Purdue Pharma, the maker of the opioid painkiller OxyContin, more than a decade ago, members of the family that owns the company began shifting hundreds of millions of dollars from the business to themselves through offshore entities, the state of New York alleged in a lawsuit on Thursday.Full Article
Pfizer Inc. PFE 0.43% has agreed to pay as much as €560 million ($636 million) for the rights to gene therapies under development at French company Vivet Therapeutics, as it seeks to build its pipeline in this cutting-edge treatment.Full Article
Invisibilia, the show about the invisible forces that shape human behavior, is back with Season 5. The first episode of the new season looks at pain in our culture through a medical mystery — and a bizarre treatment program that offers a counter-intuitive treatment approach.Full Article
More than 300 health-care experts told the Centers for Disease Control and Prevention Wednesday that the agency’s landmark guidelines for the use of opioids against chronic pain are harming patients who suffer from long-term pain and benefit from the prescription narcotics.
The health-care providers, including three former U.S. drug czars, said the CDC recommendation of a daily numerical threshold for opioid use has led insurers to refuse reimbursement, pharmacies to erect obstacles to obtaining drugs and risks for doctors who want to give out more.Full Article
Doctors welcomed federal approval this week of a new, fast-acting nasal spray for depression. But also they expressed concerns about its cost and long-term effects, as well as the logistics of administering it in accordance with safety requirements.
The new drug, esketamine, made by Janssen Pharmaceuticals, won approval from the Food and Drug Administration on Tuesday for people who have received little or no relief from other antidepressants. The F.D.A.’s decision followed months of anticipation; esketamine, which will be marketed under the name Spravato, is the first prescription for depression derived from ketamine, an old and widely used anesthetic.Full Article
It’s only a matter of time until the first million-dollar drug arrives in a deeply dysfunctional health-care system. With the new drugs come painful questions: Who is stuck with the bill, do they have the cash to pay it and how can they avoid the obligation?Full Article
BOSTON — The former head of sales for an opioid manufacturer took the stand in federal court here Friday to describe how he followed directions to recruit and bribe doctors for years to increase sales of the company’s highly addictive drug.
The testimony of Alec Burlakoff, the former vice president of sales for Insys Therapeutics, closed the fifth week of a trial of five former company executives. The group was charged with multiple conspiracies in October 2017, including racketeering, kickbacks and fraud, along with two other former executives who pleaded guilty and have become cooperating witnesses.Full Article
The Food and Drug Administration will require drug companies to study whether prescription opioids are effective in quelling chronic pain — another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.
Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.Full Article