Healthcare Headlines Worldwide - States, National, International

How are your high-stakes healthcare chess skills?

Follow government and big industry moves with select headlines from MedPage Today.

https://www.medpagetoday.com/criticalcare/generalcriticalcare/105500

by Sophie Putka, Enterprise & Investigative Writer, MedPage Today July 17, 2023

Anti-vax presidential candidate Robert F. Kennedy Jr. disputed a report that he implied COVID-19 was "ethnically targeted" to spare Jewish people. (CNBC)

Britain's National Health Service is in crisis. (New York Times)

Canada's expanded criteria for medically assisted death will include those with incurable conditions, including anorexia. (Reuters)

Federal investigators have arrested members of what they say is a national network for buying and selling human remains stolen from Harvard Medical School and a mortuary in Arkansas. (AP)

Mississippi will now allow childhood vaccination exemptions for religious reasons. (AP)

In Kentucky, a ban on gender-affirming care in youth will now take effect after a judge lifted an injunction. (The Hill)

Iowa Gov. Kim Reynolds (R) signed into law a bill that bans abortions as early as 6 weeks into pregnancy. (CNN)

The FDA has expanded the approval of remdesivir (Veklury) to include COVID-19 patients with severe renal impairment, Gilead Sciences announced.

Health insurance plans may not cover norgestrel (Opill) -- now approved as an over-the-counter birth control pill -- without a prescription. (CNBC)

Fueled by device companies, doctors are performing more risky atherectomies than ever, costing some patients with peripheral artery disease their legs. (New York Times)

Did U.S. hospitals take more COVID relief funds than they needed? (JAMA Health Forum)

Indiana police are asking the state to revoke the license of a new addiction treatment center after three patients died within a week. (AP)

A Maryland doctor is pleading guilty to charges of fraud and conspiracy over a kickback scheme involving bribes to Medicaid beneficiaries in exchange for visits to her mental health clinic, the U.S. Attorney's Office, District of Maryland announced.

The CDC expects a $1.3 billion slash to their funding following debt ceiling negotiations, a move expected to strain many public health departments, according to CNN.

Though perhaps not in Indiana, which just boosted funding to local health departments by 1,500%. (Politico) {See previous Forum post}

New research on celiac disease uncovers possible explanation for gluten's effects on the immune system. (Science Immunology)

Researchers in Africa, Asia, and South America continue their push to share mRNA technology after being denied enough COVID-19 vaccines while wealthier nations stocked up. (Washington Post)

Nearly half of tuberculosis cases in prisons globally go undetected, according to new research in Lancet Public Health.

In addition, a MedPage Special Report tallies up a healthcare freedom win against pharmaceutical monopoly.

Turns out the public, once aware and active, can impact the practice of extending patents known as "evergreening." 

I excerpt the core story below; bolded text is the most relevant to healthcare freedom advocacy.

After Pushback, J&J Allows Generics of Its TB Drug
— A Swiss non-profit will be allowed to bring generic bedaquiline to lower-income countries
July 14, 2023

... Bedaquiline was approved by the FDA in 2012, and its primary patent -- which covers its composition -- was set to expire on July 18, according to S. Sean Tu, PhD, JD, professor of law at West Virginia University in Morgantown. But the company also has a secondary patent that covers its formulation -- a strategy described as "patent evergreening" -- that could extend its monopoly even longer.

Tu said the patent expiration is closer to December 2026, which is the date listed in the FDA's "Orange Book," also known as the "Approved Drug Products with Therapeutic Equivalence Evaluations." But critics said J&J could choose not to enforce this patent.

J&J tweeted a statement in response to the allegations of evergreening. In a separate statement emailed to MedPage Today, a J&J spokesperson said the company had "been in lengthy discussions with the Global Drug Facility regarding access to bedaquiline. We had our first meeting with them at the beginning of this year and reached an agreement on June 13."

The spokesperson also emphasized that J&J believes patented drugs and their generics are "part of the normal, balanced and healthy lifecycle for a product," and that the current intellectual property framework stimulates innovation.

"[Intellectual property] protections make it possible for companies to make the sustained financial commitments to discover and develop new and improved medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries and protect the effectiveness of existing ones," the spokesperson added. "Generic manufacturers, which do not typically reinvest in the development of new medicines, will be able to begin supplying bedaquiline once patents expire."

Tu said Green and others "publicly shamed J&J, and I think it actually moved the ball."

"What really should infuriate people is that this is all public-sponsored research, right? So we're paying twice for it as taxpayers -- once when we invest in the research, because NIH grants are all funded by taxpayer dollars, and then we pay for it again when we buy it off the shelf," Tu added.

Green gave credit to organizations like PIH, MSF, and Stop TB Partnership, who have long been raising awareness of TB, as well as TB survivors and activists like Phumeza Tisile and Nandita Venkatesan who successfully challenged J&J's 2019 attempt to extend their bedaquiline patent in India.

Jennifer Karnakis, JD, director of intellectual property programs at Suffolk Law School in Boston, noted that there's a "louder voice these days for the public interest, whereas in the past it might have just been the most prevailing interest was the exclusive rights in the corporate welfare as opposed to the social welfare."

The remainder of the article is equally informative. 

https://www.medpagetoday.com/special-reports/features/105479

Rachael Robertson is a writer on the MedPage Today enterprise and investigative team, also covering OB/GYN news. Her print, data, and audio stories have appeared in Everyday Health, Gizmodo, the Bronx Times, and multiple podcasts.