Tempering Expectations of Breakthrough Therapy Designated Drugs

Journal of Clinical Pathways, June 10, 2018
Interviewing Jonathan J. Darrow (Student Fellow Alumnus)

From the interview: A recent study published in the Journal of Clinical Oncology (online June 20, 2018; doi:10.1200/JCO/2017.77.1592) sought to evaluate the United States Food and Drug Administration (FDA) breakthrough therapy designation…

Read More

Precision Medicines Approved More Quickly, With Less Data

MedPage Today, May 25, 2018
Shannon Firth, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found.  The less rigorous design makes it more…

Read More

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

JAMA Forum, May 23, 2018
Austin Frakt, citing paper co-authored by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average, a drug in an expedited program reaches market almost a year sooner…

Read More

Trump unveils plan to cut drug prices

The Lancet, June 2, 2018, vol. 391, no. 10136
Susan Jaffe, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A trade association that represents PBMs disagrees. Eliminating rebates would leave patients and insurers “at the mercy of drug manufacturer pricing strategies”, according to a statement from the Pharmaceutical Care Management Association.…

Read More

Is Trump giving the EU higher drug prices too?

DW, June 1, 2018
Lindsey Rae Gjording, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Through single-payer health care systems the EU is able to regulate consumer costs at reasonable levels. It also makes decisions about what new drugs are worth spending taxpayer money on and how to fairly value them. Without…

Read More

Trump Wants Medicaid to Push for Lower Drug Prices – But Will Patients Be Hurt?

PEW, May 30, 2018
Michael Ollove, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: While 74 percent of closed formularies result in lower prices, 21 percent result in price increases, a 2016 report in the American Journal of Managed Care found. And 29 percent of patients were affected by formulary exclusions. …

Read More

Vermont legislators pass a drug importation law. So what?

Salon, May 27, 2018
Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope he’ll reverse these positions. But few are optimistic that…

Read More

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Chemistry World, June 5, 2018
Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article:  The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law passed by Congress on 22 May will apply to patients who have exhausted…

Read More

Pro-life groups cheer Supreme Court’s refusal to hear medication-induced abortion ban in Arkansas

The Washington Times, May 29, 2018
Alex Swoyer, quoting I. Glenn Cohen (Faculty Director)

From the article: Planned Parenthood of Arkansas and Eastern Oklahoma sued, arguing the law would halt operations at two of the state’s remaining three abortion clinics. The organization said that would force women to drive hundreds of miles to obtain legal…

Read More

Facebook’s Health Groups Offer A Lifeline, But Privacy Concerns Linger

Huffington Post, May 28, 2018
Sarah Elizabeth Richards, quoting I. Glenn Cohen (Faculty Director)

From the article: It’s impossible to expect a true sense of privacy among 55,000 people, but users and bioethicists alike have lingering questions about Facebook’s use of data. “How much of Facebook is truly closed?”…

Read More

HIPAA and Protecting Health Information in the 21st Century

JAMA, May 24, 2018
I. Glenn Cohen (Faculty Director) and Michelle M. Mello

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of the Trump administration's…

Read More

What If The NFL Were Regulated By OSHA?

Deadspin, May 22, 2018
Nicole Wetsman, quoting I. Glenn Cohen (Faculty Director)

From the Article: Last month, 253 men got new jobs. The process was highly publicized, and employers announced new hires to an audience of millions on live television. It’s likely that no one in the Cowboys’ stadium, where the 2018 NFL Draft took place,…

Read More

ALS patients losing time and hope as they wait for insurers to cover a pricey new drug

STAT, May 21, 2018
Ed Silverman, quoting I. Glenn Cohen (Faculty Director)

From the article: For the past two years, Sarah Benoit has been getting around with the help of a walker, waiting for a medicine that’s out of reach. Benoit, a former congressional aide, has ALS, a fatal neurological disease…

Read More

On the Human Right to Health: Statistical Lives, Contingent Persons, and Other Difficult Questions

Cambridge University Press, May 18, 2018
I. Glenn Cohen (Faculty Director)

From the article: In ethics and political philosophy, it is not uncommon to distinguish the question of who is a moral agent (one who bears moral responsibility) from the question of who is a moral patient (one to whom moral obligations are owed). The two need not…

Read More

Trump official on defensive as critics scoff at drug plan

The Hill , May 19, 2018
Peter Sullivan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump's health chief is struggling to show that the administration is serious about taking on drug companies after its proposals for lowering prices last week left big companies relieved and even spurred an uptick in their stock prices. …

Read More

Vermont Legislators Pass A Drug Importation Law. So What?

Kaiser Health News , May 18, 2018
Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s effort to tackle head-on the issue of constantly climbing…

Read More

Trump spoke on lowering drug prices. The tweets rolled in

Stat, May 11, 2018
Andrew Joseph, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Given that President Trump is famous for his Earth-shaking tweets, it seems appropriate to comb through Twitter reactions to his administration’s new drug pricing plan, which was unveiled Friday. Many…

Read More

ICER Weekly View 05-18-18

Institute For Clinical and Economic Review, May 18, 2018
Mitchell Stein, citing Rachel Sachs (Academic Fellow Alumna)

From the article: Weekly View favorite (and Midwest CEPAC member) Rachel Sachs reviews the specific proposals in the speech in this Health Affairs blog.

Read More

FDA website to post names of drug makers blocking development of cheaper generics

Marketplace, May 17, 2018
Dan Gorenstein, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The FDA plans to unveil a website today naming pharmaceutical companies that have blocked the development of generic drugs by failing to provide samples to competitors. This public posting is part of FDA Commissioner Scott Gottlieb's larger crackdown…

Read More

Little Benefit to Breakthrough Cancer Drugs

Cancer Discovery, May 16, 2018
Catherine Caruso, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In 2012, the FDA created the breakthrough therapy designation to speed up the development and review of drugs intended to treat serious or life-threatening diseases when preliminary clinical evidence indicates a possible substantial improvement over…

Read More