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Harms of Cancer Blood Tests? FTC Healthcare Crackdown: More Smoke Than Fire?

— This past week in healthcare investigations

Ƶ MedicalToday
INVESTIGATIVE ROUNDUP over an image of two people looking at computer screens.

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

New Blood Tests for Cancer May Carry Risks

New blood tests, which look for tiny shards of cancer DNA or proteins, are "a new frontier in screening," . However, some experts say the risks of making the tests widely available at this point in time are substantial.

The companies developing the tests say they can find dozens of cancers, and supporters say they can "slash cancer death rates by finding tumors when they are still small and curable," the article stated. A bill in Congress with more than 250 cosponsors would authorize Medicare to pay for the tests as soon as FDA approves them.

However, companies are not waiting for regulators, the Times reported. One developer, GRAIL, is selling its annual test with a list price of $949, and another company, Exact Sciences, expects to follow suit.

"The companies would like to get the tests approved with studies less rigorous than the FDA typically requires, and they stand to make huge profits if that happens," according to the Times.

Critics say that finding cancers sooner could mean just as many deaths because, with current treatments, cancers destined to kill are not necessarily cured if found early, the Times reported. Additionally, some people will have a positive test, but their doctors will be unable to locate the cancer. And others will be treated aggressively with surgery or chemotherapy for cancers that would not have grown and spread.

Barnett Kramer, MD, MPH, a member of the Lisa Schwartz Foundation for Truth in Medicine and former director of the Division of Cancer Prevention at the National Cancer Institute, told the Times that he fears the tests will become widely used without evidence they are beneficial. Once that happens, "it is difficult to unring the bell," he told the outlet.

"I hope we are not halfway through a nightmare," he said.

Antitrust Experts Question FTC's Tougher Stance on Hospital Consolidation

The Federal Trade Commission (FTC) recently announced it was suing to block two hospital mergers, and as such, it can be tempting to think the agency is living up to pledges to get tougher on healthcare consolidation. But experts told .

"When this new progressive FTC announced two hospital cases in one day, it felt like they were finally moving from rhetoric to action," Ken Field, a former FTC lawyer and current co-chair of Jones Day's global healthcare practice, told STAT. "But the complaints themselves are more smoke than fire."

Specifically, antitrust attorneys and academics described the recently challenged hospital mergers -- those of HCA Healthcare and Steward Health Care System in Utah, and RWJBarnabas Health and Saint Peter's Healthcare System in New Jersey -- as low-hanging fruit, STAT reported. Experts told the outlet that truly ramping up scrutiny would take going after vertical mergers, such as instances of hospitals or insurers buying physician groups, or cross-market mergers, in which hospitals combine across state lines.

A spokesperson for the FTC declined to comment on the agency's strategy regarding hospital consolidation, STAT reported.

Meanwhile, some experts theorized that the FTC's decision to announce two cases the same day the American Bar Association's Antitrust in Healthcare Conference commenced was "meant to signal a more aggressive approach," STAT wrote.

At the same time, those interviewed by STAT agreed that, whether the FTC takes up a merger challenge depends more on existing case law and its recent winning or losing streak than on what political party controls the agency or the White House.

Of the potential that the FTC brings a cross-market case, for which there isn't established case law, Erin Fuse Brown, a law professor and director of Georgia State University's Center for Law, Health & Society told STAT, "If it never tries, it's going to miss half the mergers that are out there, and that would be a problem."

Doctors Seek to Change Race Being Used as Medical Shorthand

Several months ago, Alphonso Harried needed a kidney, and Pat Holterman-Hommes, his former colleague, hoped to give him one. They waited for a lab technologist at Barnes-Jewish Hospital in St Louis, Missouri to test their blood in hopes of a match. Harried is Black, and Holterman-Hommes is white. Their families admitted that questions swirled in their heads about whether race would get in the way of their plans before learning that Harried and Holterman-Hommes were indeed a match, . They're hardly alone.

"It's not just laypeople -- it's in the medical field as well. People often conflate race with biology," Marva Moxey-Mims, MD, chief of pediatric nephrology at Children's National Hospital in Washington, D.C., told KHN.

"Race has been used as a shorthand for how people's bodies work for years across many fields -- not out of malice but because it was based on what was considered the best science available at the time," KHN wrote. "The science was not immune to the racialized culture it sprung from, which is now being seen in a new light."

Race does have its place during a doctor's visit, KHN noted. For instance, medical providers who give patients culturally competent care often see improved outcomes. And race is a useful tool for identifying population-level disparities. However, experts now say race is not very useful in making decisions about how to treat an individual patient.

"Because using race as a medical shorthand is at best imprecise and at worst harmful, a conversation is unfolding nationally among lawmakers, scientists, and doctors who say one of the best things patients can do is ask if -- and how -- their race is factored into their care," KHN wrote.

When it comes to kidney care, doctors and researchers have been active in reevaluating their use of race-based medical guidance, KHN reported.

But there is still work to be done. "The perception that there is such a thing as a "Black" or "white" kidney quietly followed patient and donor as Harried and Holterman-Hommes were on the path to the transplant -- in their medical records and in the screening tests recommended," KHN wrote.

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    Jennifer Henderson joined Ƶ as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.