with Alexandra Ellerbeck

The Food and Drug Administration sparked furious debate when it approved a controversial Alzheimer’s treatment in June that some doctors worry is a dead end for patients.

The controversy is so intense and unprecedented that the agency’s watchdog is now stepping in — a relief to critics concerned about undue industry influence and potentially steep costs for the government for a drug that is still, in the minds of some, unproven.

The Department of Health and Human Services inspector general says it will investigate how Aduhelm was approved.

The investigation was prompted, in part, by allegations of “an inappropriately close relationship between the FDA and the industry,” the IG wrote in a notice posted to its website yesterday —  a reference to a Stat News report that Aduhelm’s maker Biogen engaged in a secretive, behind-the-scenes effort to pressure FDA officials to grant approval.

The notice also mentioned this impetus: concerns about the accelerated pathway used to approve the drug.

Aduhelm was cleared via an accelerated pathway which the FDA has often used for other medications, such as cancer drugs thought to shrink cancer tumors. But while companies are supposed to conduct follow up studies to see whether the drug has worked as intended, that doesn’t always happen — and the agency has sometimes been slow to yank approved drugs from the market.

“We will assess how the FDA implements the accelerated approval pathway,” the IG wrote. “This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes.”

The FDA chief says she’ll comply with the investigation.

In a series of tweets, acting FDA commissioner Janet Woodcock wrote that the agency intends to “fully cooperate” with the investigation and “welcomes the opportunity to provide clarity regarding the science-based application of the accelerated approval pathway.”

Janet Woodcock, acting FDA commissioner:

Aduhelm may be the most controversial drug ever approved by the FDA.

The drug’s approval was “procedurally questionable,” Harvard University professor Daniel Carpenter wrote in a recent op-ed for The Post. 

Its road was certainly rocky. The Post’s Laurie McGinley recently explained the research conducted on the drug:

“In 2019, Biogen halted two late-stage trials halfway through after an assessment concluded the studies would not reach their goals of slowing cognitive and functional impairment in Alzheimer’s patients. But in a sharp reversal, a company analysis with additional data released several months later came to a different conclusion.

In one of the clinical trials, that analysis found, people given the drug declined 22 percent more slowly than those who received a placebo. The other trial failed to reach its goal, though the company was encouraged by data from a subset of study participants who got more of the drug. Biogen concluded a key to effectiveness was giving patients a high enough dose for a long enough time.

Critics, however, said the data had been selected to make the drug look better than it was. In an acrimonious meeting last fall, an FDA advisory committee recommended against the drug’s approval and harshly rebuked the agency’s review staff for supporting the medication so strongly and working closely with the company.”

The approval prompted a flurry of headlines questioning the FDA’s approval process, such as “The FDA Is Broken,” “The FDA Is a Melting Iceberg” and “The F.D.A. Has Reached a New Low.”

This investigation won’t assess whether Aduhelm actually works. 

The review won’t consider the “scientific appropriateness” of any of the drugs to be reviewed, the IG wrote. Instead, investigators will be peering into whether there was any undue influence and whether the approval process was followed as intended.

It's an important question. As Laurie reported, an FDA advisory committee recommended against the drug’s approval in an acrimonious meeting last fall, where it also harshly rebuked the agency’s review staff for supporting the medication so strongly and working closely with Biogen.

Ahh, oof and ouch

AHH: The World Health Organization is calling for a moratorium on vaccine boosters.

“We cannot and we should not accept countries that have already used most of the global supply of vaccines using even more of it while the world’s most vulnerable people remain unprotected,” WHO Director General Tedros Adhanom Ghebreyesus said at a Wednesday news conference.

Tedros said the focus for now should be meeting the U.N. health agency’s goal of 10 percent vaccination coverage in every country by the end of September, The Post's Emily Rauhala, Hannah Knowles, Lena H. Sun and Laurie McGinley report.

Citing global disparities, the World Health Organization on Aug. 4 called for a halt on coronavirus vaccine boosters until at least the end of September. (Reuters)

The WHO announcement comes after Germany and France have announced that vaccine boosters will be available to the elderly and other at-risk groups starting in September. Hungary is allowing anyone to get a booster.

More than 4 million people worldwide have died of covid-19, with the majority of those deaths occurring this year, after the release of highly effective vaccines. So far more than 80 percent of vaccines have gone to wealthy countries.  

In the United States, boosters have not yet been approved, although some officials and experts have said they may be necessary for immunocompromised patients. Meanwhile, some Americans seem to be trying to get extra doses anyway, physicians told The Post.

OOF: Arkansas’s governor regrets banning masks.

Arkansas Republican Gov. Asa Hutchinson has called on the legislature to amend a statewide ban on mask mandates that he signed into law in March.

“In hindsight, I wish that it had not become law,” he said Tuesday.

When Hutchinson signed the law, coronavirus cases in the state were fast declining. But the rise of the delta variant has caused cases in the state to skyrocket, and Arkansas now has one of the highest hospitalization rates in the country for covid-19, according to The Post’s coronavirus tracker.

While Hutchinson opposes a statewide mask mandate, he says he regrets that the ban prevents school districts from having the flexibility to require masks. 

“The local school districts should make the call, and they should have more options to make sure that their school is a safe environment during a very challenging time for education,” he said.

OUCH: Barack Obama is scaling back his 60th birthday bash on Martha’s Vineyard.

The party, planned for Saturday, was supposed to draw a star-studded guest list, but is now going to be much smaller-scale in light of surging coronavirus cases.

“The outdoor event was planned months ago in accordance with all public guidelines and covid safeguards in place,” Hannah Hankins, a spokeswoman for the former president, said in a statement. “Due to the new spread of the Delta variant over the past week, the President and Mrs. Obama have decided to significantly scale back the event to include only family and close friends.”

“The decision followed a spate of news coverage Tuesday that raised questions about both the safety and optics of an event that was expected to draw hundreds of former Obama administration officials, Democratic donors and celebrities, reportedly including George Clooney, Steven Spielberg and Oprah Winfrey,” The Post’s John Wagner and Lateshia Beachum report.

On the Hill

Congressional negotiations have slashed pandemic preparedness spending.

When the novel coronavirus reached the shores of the United States, the CDC was spending only $500 million a year on programs to tackle emerging diseases —  a minuscule amount compared to the $21 billion increase Congress approved in the Pentagon's budget in late 2019.

“In other words: The U.S. government treated preparing for a pandemic as a nigh-trivial concern, or a matter roughly 0.01 percent as important as modernizing the nation’s stockpile of nuclear warheads,” New York magazine’s Eric Levitz reports.

It’s not clear that a pandemic that has killed more than 614,000 in the United States has shifted priorities. While Biden proposed $30 billion in pandemic preparedness, the Senate’s bipartisan infrastructure bill includes no significant investment in public health. Meanwhile, congressional Democrats are already reportedly starting to scale back Biden’s proposed investment in pandemic preparedness by more than 80 percent in their reconciliation bill. The move comes as Democrats are trying to reduce the cost of the $3.5 trillion package.

“Pandemic preparedness is an easy line-item to shrink for the same reason that it was an easy one to underfund pre-COVID: The constituency with the greatest stake in preventing or mitigating the next public health crisis is unidentifiable, let alone, organizable,” Eric writes. “The 600,000 Americans who died of COVID-19 over the past 17 months did not know in 2019 that they had a potentially life-or-death stake in the size of the CDC’s budget. Democrats go small on pandemic preparedness, the victims of the next novel virus will not light up Congress’s phone lines.”

More in coronavirus news

  • The delta variant now accounts for 93 percent of new cases in the United States, the CDC reported. In the Midwest, including Iowa, Kansas, Missouri and Nebraska, delta accounts for more than 98 percent of all cases, Voice of America reports.
  • A county coroner in Missouri removed covid-19 as a cause of death on some death certificates to please grieving families. The undercount in Macon County, home to 15,000, is relatively small,  but “it comes amid broader recognition that the number of covid fatalities in the United States is probably higher than the official tally of 614,000,” The Post’s Andrew Jeong reports.
     
  • Los Angeles city officials have unveiled legislation that would require residents to show proof of vaccination to participate in indoor activities. The move comes after New York became the first city to order an indoor vaccine mandate, the Hill’s Celine Castronuovo reports.

Sugar rush