Bioethics.net

June 20, 2017

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

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.…

June 9, 2017

Health care disparities: a pro-life issue

This month’s Health Affairs carries an article examining the correlation between one’s income and one’s perceptions about one’s own health and health care. Worldwide, those with the lowest incomes feel that their health is worse than those with the highest incomes do. They also are more likely than those with higher incomes to skip necessary treatment because they can’t afford it, and are more concerned that if... // Read More »

June 7, 2017

In Calls for Repeal Comes Opportunity for Universal Coverage

by Craig Klugman, Ph.D.

According to the conservative press, the Affordable Care Act is failing. They point to the number of insurance companies that have withdrawn from the marketplaces including Ohio, where there are 20 counties with no plans available.…

June 1, 2017

When Ideology Trumps Reason, Do The Life Sciences Resist or Capitulate?

by Craig Klugman, Ph.D.

The world of the life sciences and medicine is being changed radically in 2017. The proposed Trump budget cuts funding for the CDC, NIH, NSF, NEH, NEA, EPA, and PHS will radically change how science is done, how much science is done and by whom.…

May 1, 2017

Increasing Access to Biosimilar Drugs

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.[1] 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.[2]  “A biologic drug is ‘a substance that is made from a living organism or its products[,]’”[3]  while a traditional prescription drug is made up of simple molecules.[4]  This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary.[5]  This also means making a generic form, known as a biosimilar, is more expensive and harder to make.[6] Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.”[7] 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.[8] 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.

 

April 17, 2017

A Bioethics View of Executions in Arkansas

by Craig Klugman, Ph.D.

This week the state of Arkansas had planned to execute 8 death-row inmates in 4, back-to-back killings using lethal injection over 10 days.…

March 29, 2017

I am a refugee, an immigrant and an American

Our Managing Editor, Bela Fishbeyn published a very moving account of her experiences as an immigrant to the United States. This highlights the schizophrenic nature of our nation’s attitudes and history towards immigrants and refugees.…

March 17, 2017

Ethics of the Trump Budget: The Social Contract is Dead

by Craig Klugman, Ph.D.

President Trump released his blueprint for a 2018 federal budget. From an ethical standpoint, the President seems to operates from a Hobbesian standpoint—life is nasty, brutish and short.…

March 11, 2017

But at least we don’t have socialized medicine

I just read T. R. Teid’s 2009 book The Healing of America. It’s a timely read in light of the bar brawl over health care that’s brewing in the U.S. legislature this week. Of particular interest are his snapshots of the health care systems of the UK, France, Germany, Japan, Taiwan, Canada, and Switzerland, systems about which I held many cherished misconceptions. All of these countries... // Read More »

March 7, 2017

The Ethics of the New GOP Health Plan – Violating Justice & Solidarity

by Craig Klugman, Ph.D.

Whatever one may think of the Affordable Care Act (ACA), it began with noble intentions. The ACA was built on a philosophy of providing more people not only with access to health insurance but also with assistance to pay for it.…