First Opinion readers on Hatch-Waxman, new-patient visit times, mpox, and more

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

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The story

 “I’m a pediatrician. My bosses want me to cut new-patient visit times in half,” by Frances Quee

This is a good example as to why a private practice setting is best. Yes, there are many headaches, but the freedom to set one’s own rules trumps the above problems.

Mark Diamond

I have practiced pediatrics for over 40 years. A significant portion of the patient visit is used for collecting patient data, documenting procedures, and reviewing various vaccinations. A new patient visit could easily stretch over an hour when multiple health issues need to be addressed. The recommendation [to cut visit times in half] is setting up the providers for failure and liability.

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Shailesh Shah


the story

40 doesn’t look good on Hatch-Waxman,” by Tahir Amin and Timi Iwayemi

The Bolar exemption from patent infringement, the ANDA approval process, resolving patent disputes before launching, and first-filer market co-exclusivity are also part of Hatch-Waxman. Throw out patent listing and patent term extension, you need to throw out those, too. That may kill generic drugs. If the goal is a robust and sustainable innovative and generic drug ecosystem, thank Hatch-Waxman and solve the real problems, like preventing the biggest purchaser of drugs (using U.S. taxpayer funds and prioritizing taxpayers’ interests) from having real price negotiations at the time of approval.

— Paul Fehlner


The story

How the next president should reform Medicare,” by Paul Ginsburg and Steve Lieberman

As a quicker though partial solution, why not simply have CMS require all Medicare supplemental plans allow Medicare Advantage plan members to switch back to standard Medicare and a medigap supplement, without any underwriting restrictions? Four states (Connecticut, Maine, Massachusetts, and New York) require this now and yet many carriers still happily offer such plans. The cost impact to the medigap carriers should not be very minor, since members don’t make frequent changes anyway, it’s not like these members have no existing coverage and have been withholding all treatment, and Medicare Parts A and B would pick up the bulk of any new costs. Many Medicare Advantage carriers are also the ones offering medigap plans anyway and thus would have sufficient profits to absorb what little adverse selection still occurs. Allowing Medicare Advantage participants to switch back to Medicare with medigap at least during annual enrollments would improve competition between traditional Medicare and Medicare Advantage. This could incent the latter to reduce the excessive preauthorizations and denials that Advantage patients and their physicians frequently complain about.

— George Faulkner


The story

WHO pandemic threat director: Here’s what needs to happen to combat mpox,” by Maria D. Van Kerkhove

I agree with the author that a “swift, coordinated, and equitable response” is absolutely necessary. However, collaboration should start much sooner than vaccine distribution. Open communication, as highlighted toward the end of the article, can significantly impact not only treatment administration, but coordinated efforts to identify strains and mitigate outbreaks to begin with. Leading disease control initiatives with an open-science approach enables quicker intervention so that far fewer people are affected by outbreaks. 

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Open science is a movement that aims to reduce various barriers to scientific collaboration by improving the accessibility and transparency of research for everyone. It has been supported internationally by academics and scientists alike for over a decade now, with thousands of researchers, bioinformaticians, and computer engineers collaborating on efficient and highly secure modes of sharing critical data and software analysis tools for a common good, and is an incredible resource for the field of epidemiology. 

For example, researchers at the Institute of Tropical Medicine in Antwerp, Belgium, leveraged open-source pipelines and viral sequencing protocols to quickly understand an outbreak of mpox in Central and West Africa in 2022. With these tools, they delivered rapid evidence of asymptomatic infections, a significant contribution to effectively controlling that outbreak and preventing further spread of this variant. 

While improving access to vaccines is certainly one area we can take lessons from moving forward, I urge the U.S. life sciences industry to start thinking about how the open-science movement and its global community of champions can be leveraged to minimize future outbreaks by investing more resources into early response collaborations rather than sinking consequently higher costs into later stages of outbreak control. Working together, we can better meet the complex challenges of evolving viruses and diseases leveraging the power of Open Science. 

Evan Floden, CEO and co-founder of Seqera


The story

Long Covid feels like a gun to my head,” by Rachel Hall-Clifford

I really appreciated your article, as it made me feel less alone in this battle.

Jennifer Powers