Hot Topics: Justice

Blog Posts (34)

August 17, 2017

The Aftermath of Charlottesville: What’s a bioethicist to do?

by Craig Klugman, Ph.D.

Figuring out how to respond to one of the most egregious displays of racism in modern times (U.S.)  is not an easy task.…

August 2, 2017

Sterilization for Prisoners Is Not New and Shows That Studying History is Essential

by Craig Klugman, Ph.D.

In 1927, Supreme Court Justice Oliver Wendell Holmes ruled that Carrie Buck and her baby could be sterilized because of a perception that they were “mental defectives.” In the 20th century, 32 states had federally funded programs that sterilized “undesirable” populations.…

July 21, 2017

Ethical Health Care Reform

Recently I heard a Christian TV personality refer to Obamacare as “iniquitous.” This started me thinking, What would make a health care funding reform scheme “iniquitous”? Or, although the words aren’t synonymous, what would make such a scheme unethical? What should go into ethical health care reform? The answers to these questions are legion and conflicting. There are some who see government intervention as inherently... // Read More »
July 12, 2017

Forget the DNR, Time for Opt-In CPR

by Craig Klugman, Ph.D.

A nurse in the UK was sanctioned with a ”caution order” (a warning or demerit) on her record for 24 months after she did not perform CPR on a patient who presented as “waxy, yellow and almost cold” when she was called to look at him in his hospital room.…

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.

 



[1] 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.

[2] 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).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] 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.

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.…

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Published Articles (5)

American Journal of Bioethics: Volume 17 Issue 5 - May 2017

Ethics, Refugees, and the President's Executive Order Nancy E. Kass

American Journal of Bioethics: Volume 17 Issue 4 - Apr 2017

Psychiatric Genomics and Mental Health Treatment: Setting the Ethical Agenda Camillia Kong, Michael Dunn & Michael Parker

American Journal of Bioethics: Volume 17 Issue 4 - Apr 2017

Psychiatric Genetics in a Risk Society Nicole Martinez-Martin

American Journal of Bioethics: Volume 16 Issue 11 - Nov 2016

The Ethics of Organ Donor Registration Policies: Nudges and Respect for Autonomy Douglas MacKay & Alexandra Robinson

American Journal of Bioethics: Volume 16 Issue 10 - Oct 2016

Governance of Transnational Global Health Research Consortia and Health Equity Bridget Pratt & Adnan A. Hyder

News (19)

June 27, 2017 9:00 am

Scientists in limbo as US Supreme Court allows modified travel ban (Nature)

Justices overturn lower court rulings on policy targeting people from six majority-Muslim countries.

May 31, 2017 9:00 am

Colombian biologist cleared of criminal charges for posting another scientist’s thesis online (Nature)

A Colombian biologist who faced a criminal trial for posting another scientist’s thesis online has been cleared of copyright violation — an offence that, under Colombian law, might have brought him a jail sentence.

May 5, 2017 9:00 am

Artificial intelligence prevails at predicting Supreme Court decisions (Science)

“See you in the Supreme Court!” President Donald Trump tweeted last week, responding to lower court holds on his national security policies. But is taking cases all the way to the highest court in the land a good idea? Artificial intelligence may soon have the answer. A new study shows that computers can do a better job than legal scholars at predicting Supreme Court decisions, even with less information.

April 13, 2017 9:00 am

US regulators test organs-on-chips for food safety monitoring (Nature)

The US Food and Drug Administration (FDA) has started testing whether livers-on-a-chip — miniature ‘organs’ engineered to mimic biological functions — can reliably model human reactions to food and foodborne illnesses. The experiments will help the agency to determine whether companies can substitute chip data for animal data when applying for approval of a new compound, such as a food additive, that could prove toxic. It is the first time a regulatory agency anywhere in the world has pursued organs-on-chips as an alternative to animal testing.

April 3, 2017 9:00 am

Donald Trump believes the solution to the opioid crisis is talk (Vox)

President Donald Trump will soon sign an executive order to tackle what he’s called the “total epidemic” of opioid abuse and addiction. The main objective of the order is to create a commission that’s tasked with publishing a report on what to do about America’s deadliest drug crisis ever.

March 23, 2017 9:00 am

San people of Africa draft code of ethics for researchers (Science)

The San people of Southern Africa are among the closest living relatives of our hunting and gathering ancestors. Scientists have flocked to study their age-old rituals and ancient genetic fingerprints. Now, after more than a century of being scrutinized by science, the San are demanding something back. Earlier this month the group unveiled a code of ethics for researchers wishing to study their culture, genes, or heritage.

March 16, 2017 9:00 am

Should hospitals — and doctors — apologize for medical mistakes? (Washington Post)

Spurred by concerns about the “deny and defend” model — including its cost, lack of transparency and the perpetuation of errors — programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular.

February 27, 2017 9:00 am

U.S. researchers guilty of misconduct later won more than $100 million in NIH grants, study finds (Science)

Overall, 23 of the scientists (roughly 8% of sanctioned researchers) received NIH funding after receiving an ORI sanction. Of that group, 17 researchers won more than $101 million for 61 new projects. Thirteen continued to receive funding from NIH grants that had been awarded before being sanctioned.

February 23, 2017 9:00 am

How Silicon Valley Is Trying to Hack Its Way Into a Longer Life (Time)

Rather than wait years for treatments to be approved by federal officials, many of them are testing ways to modify human biology that fall somewhere on the spectrum between science and entrepreneurialism. It’s called biohacking, and it’s one of the biggest things happening in the Bay Area.

February 21, 2017 9:00 am

Harvard and M.I.T. Scientists Win Gene-Editing Patent Fight (The New York Times)

The Broad Institute in Cambridge, Mass., will retain potentially lucrative rights to a powerful gene-editing technique that could lead to major advances in medicine and agriculture, the federal Patent and Trademark Office ruled on Wednesday.

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