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Good morning. I’m Arthur Allen and I write about the drug industry and its regulation for KFF Health News. Today’s topic is the suffering caused by drugs used to treat millions of U.S. cancer patients — and what might or might not be done about it. Send tips on pharma and the Food and Drug Administration to <a href="mailto:aallen@kff.org">aallen@kff.org</a>.

Not a subscriber? <a href="https://www.washingtonpost.com/newsletters/the-health-202/">Sign up here.</a>

Today’s edition: Sen. Bill Cassidy (R-La.) wants more details on the Biden administration’s bird flu response. The White House plans to expand Medicaid and Affordable Care Act access to about 100,000 immigrants covered by the Deferred Action for Childhood Arrivals, or DACA, program. But first …

Cancer patients endure awful drug side effects. Could lower, cheaper doses work?

Life in View

The lung cancer drug Lumakras, made by Amgen, has kept Don Crosslin alive since 2021, he said. But for the retired medical technician in Ocala, Fla., there’s been a price.

“My appetite has been minimal. I'm very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July,” said Crosslin, 76, who has Stage 4 lung cancer.

He wonders whether he’d do better on a lower dose. “But I do what my oncologist tells me to do,” he said. Every day, Crosslin takes eight 120-milligram pills.

Turns out a quarter-dose of the drug may be nearly as effective — and with fewer side effects, according to a study Amgen conducted at the Food and Drug Administration’s behest. But the company still markets Lumakras only at the higher dose — which nets it four times as much revenue per patient from Medicare. Amgen’s lower-dose study was part of an FDA effort called Project Optimus aimed at making cancer drugs less toxic and more effective.&nbsp;

The cancer drug development structure emerged from chemotherapy — which destroys cancer cells but also wrecks plenty of healthy tissue.&nbsp;

Typically, a company’s first series of cancer drug trials involves escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and it goes on the drug’s label.

But often <a href="https://www.nature.com/articles/s41571-023-00776-9">patients become so ill</a> that they skip doses or stop taking the drugs — risking resurgence of their cancers. So the FDA has urged companies to pinpoint the right dosage before their drugs reach patients, agency spokesperson Lauren-Jei McCarthy said.

Out of 46 types of cancer treated with drugs approved under an accelerated process from 2013 to 2017, 19 didn’t improve survival or quality of life after five years, according to a <a href="https://jamanetwork.com/journals/jama/fullarticle/2817337">study published in April</a> in JAMA. Project Optimus began in 2021, just as Amgen was seeking to market Lumakras. The FDA’s leading cancer drug regulator, Richard Pazdur, co-wrote an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”

The FDA nonetheless conditionally approved the drug but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial results, published in November, showed that the 960 mg dose may give patients a month more of life, on average, but it causes more severe side effects.&nbsp;

Amgen is keeping the 960 mg dosage as it conducts further tests to get final approval for the drug, said spokesperson Elissa Snook. She said the heavier dose showed more efficacy in some trials.&nbsp;

It also means more revenue from Lumakras, which brought in nearly $200 million in the United States last year.

University of Chicago oncologist Mark Ratain, a<a href="https://cancerletter.com/guest-editorial/20230908_4/"> critic</a> of Amgen’s handling of<a href="https://ascopost.com/issues/february-25-2024/sotorasib-the-poster-child-for-project-optimus-truths-and-fantasies/"> Lumakras</a>, told Centers for Medicare and Medicaid Services officials at a recent meeting that Medicare should pay for the drug on the basis of a 240 mg daily dosage — or about $5,000 a month. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.

Cassidy seeks more information on Biden’s bird flu response

Ricky Carioti

The top Republican on the Senate’s health panel is calling on the Biden administration to “swiftly publish” a list of its research into a highly pathogenic strain of bird flu circulating in dairy cattle for the first time, our Post colleague Rachel Roubein writes.&nbsp;

Sen. Bill Cassidy (R-La.) <a href="https://www.help.senate.gov/imo/media/doc/20240503_final_bc_avian_letter_to_bidenpdf.pdf">sent a letter</a> Friday to <a href="https://www.washingtonpost.com/elections/candidates/joe-biden-2024/" target="_blank" class="contextual_link">President Biden</a>, as well as key administration officials, seeking a “prioritized list of research activities,” including timelines for generating results and sharing those findings with the public. He also asked for such data and methodologies to be made available to scientists outside the federal government.&nbsp;

Federal officials are racing to learn more about the H5N1 bird flu first detected in dairy cows in late March that has been found in <a href="https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/livestock">herds in nine states.</a> The administration didn’t immediately respond to a request for comment.

“While I have no doubt that scientists around the country are diligently working to try to answer these and other questions, your administration must communicate its research plans in a coordinated way,” Cassidy wrote in the letter, adding that a failure to do so could have “severe unintended consequences” for the nation’s agriculture and food sectors.&nbsp;

NEJM details bird flu-infected worker’s symptoms

The Post’s Lena H. Sun sent the following update:

The Texas dairy worker sickened with H5N1 bird flu could have become infected by touching his eyes with hands contaminated from handling milk or cow respiratory secretions, or from exposure to respiratory droplets or aerosols from sick cows, according to <a href="https://www.nejm.org/doi/full/10.1056/NEJMc2405371">a report Friday in the New England Journal of Medicine</a>.

Scientists from the Centers for Disease Control and Prevention and Texas provided new details <a href="https://www.washingtonpost.com/health/2024/04/01/bird-flu-human-case-cow-texas/">about the case</a>, only the second human bird flu infection in the United States and the first presumed from a cow. The person worked with sick and healthy cows, and wore gloves, but not respiratory or eye protection, the report said. His only symptom was eye inflammation, rare but not uncommon in influenza.

The worker was treated with antiviral medication and recovered. His household contacts, who were also provided antiviral medication, did not get sick.

The report doesn’t explain the extreme redness in the worker’s right eye. But Albert Ko, a Yale University epidemiologist and infectious-diseases clinician, said in an email that, while the redness was somewhat unusual, it can happen “when inflammation is severe enough to cause a relatively small amount of bleeding.”

Officials were not able to gain access to the farm to conduct follow-up investigations of the worker or others, or collect samples from cows.

CDC and state and local health officials have monitored <a href="https://www.cdc.gov/flu/avianflu/h5-monitoring.html">at least 220 people</a> exposed to infected cattle and tested at least 30. Only the Texas worker has tested positive for H5N1.&nbsp;

White House announces expansion of health insurance to DACA recipients

Jacquelyn Martin

The Biden administration announced Friday that it will move forward to expand access to health insurance for about 100,000 immigrants covered by the Deferred Action for Childhood Arrivals, or DACA, program, <a href="https://www.washingtonpost.com/politics/2024/05/03/biden-daca-health-care/">The Post’s Amy B Wang reports</a>.

In a statement, President Biden touted his administration’s efforts to “preserve and fortify” the DACA program, which allows “dreamers” — those who were brought into the country without documentation as children — to work and live in the United States. The program was created in 2012 under President Barack Obama when Biden was vice president.

Under the plan, DACA participants who have previously been excluded from enrolling in a qualified health plan or a basic health program through the Medicaid and Affordable Care Act marketplaces will be allowed to do so.

The new policy will become effective Nov. 1, according to the Department of Health and Human Services.

Nominees for this year’s Sammies – a.k.a., the <a href="https://servicetoamericamedals.org/honorees/?_year=2024">Service to America Medals</a> for federal employees – include <a href="https://servicetoamericamedals.org/honorees/andrea-fletcher/">Andrea Fletcher</a> of the Centers for Medicare and Medicaid Services, and <a href="https://servicetoamericamedals.org/honorees/janet-woodcock/">Janet Woodcock</a> of the Food and Drug Administration. For more on the awards, see our colleague <a href="https://www.washingtonpost.com/politics/2024/05/05/service-to-america-medals-federal-workers-2024/?itid=lk_inline_manual_61">Joe Davidson’s story</a>.

CMS <a href="https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation">released draft guidance</a> Friday for public comment on the second cycle of Medicare drug price negotiations. Comments are being accepted through July 2.&nbsp;

Aetna agreed to settle a lawsuit over coverage of LGBTQ+ customers seeking fertility treatment, <a href="https://apnews.com/article/lgbtq-fertility-coverage-aetna-c7a6687c882236e9b0cf8df765dbe20a">Tom Murphy of the Associated Press reported</a>. The insurer will make coverage of artificial insemination standard for all customers nationally, the National Women’s Law Center, which represented plaintiffs in the case, told the AP.

📅 The House and Senate are in session this week. Here’s what we’ll be watching:

On Wednesday: The full Senate Budget Committee will hold a hearing on “alleviating administrative burdens in health care.” On a somewhat related note, the House Small Business Committee is also scheduled to hold a hearing that day titled “Stifling Innovation: Examining the Impacts of Regulatory Burdens on Small Businesses in Healthcare.”&nbsp;

Also Wednesday: A Senate Appropriations subcommittee meets to review the Biden administration’s fiscal 2025 budget request for the Food and Drug Administration. FDA Commissioner Robert M. Califf is on the witness list.&nbsp;

On Friday: The American Public Health Association’s D.C. symposium on innovative tools to <a href="https://www.apha.org/Events-and-Meetings/APHA-Calendar/2024/05-Health-in-All-Policies">integrate health and equity</a> takes place at the Johns Hopkins University Bloomberg Center.&nbsp;

<a href="https://www.washingtonpost.com/business/2024/05/03/assisted-living-homes-senior-falls-911/" target="_blank">Senior homes refuse to pick up fallen residents, dial 911. ‘Why are they calling us?’ (By Todd C. Frankel | The Washington Post)</a>

<a href="https://apnews.com/article/abortion-help-navigators-pills-roe-v-wade-f760b2817126d56e6cfa5144c9f7e547" target="_blank">After Roe, the network of people who help others get abortions see themselves as 'the underground' (Laura Ungar | Associated Press )</a>

<a href="https://www.washingtonpost.com/health/2024/05/06/ultrasound-addiction-treatment/" target="_blank">Ultrasound technology is used in many ways. Addiction is the next frontier. (By David Ovalle | The Washington Post)</a>

How Doctors Walk Through a the Hospital #doctorlife #scrublife #medicalhumor

Thanks for reading! See y'all tomorrow.