The Food and Drug Administration promised yesterday to heighten oversight of providers of experimental stem cell treatments, as a Post report detailed the agency’s slow response to a leading stem cell company whose treatments blinded some patients.
U.S. Stem Cell had $6.7 million in revenue last year, operates three clinics and has trained doctors at 150 others, making it a leading stem cell treatment provider in the burgeoning industry. In an unusually aggressive action, the FDA is suing to stop its treatments after several reports of serious harm, our colleagues Laurie McGinley and William Wan report.
The lawsuit targets just one type of procedure the company offers, a fat-based therapy that involves “extracting a patient’s belly fat, mixing it with an enzyme to break down the tissue and spinning the mixture in a centrifuge to isolate mesenchymal stem cells, which can morph into a variety of cell types. Those cells are then injected into patients’ spinal fluid, bloodstream or joints.”
For years, scientists called on the FDA to investigate the clinics. In the meantime, the company has still been allowed to operate; four patients have been blinded and one woman ended up in a coma. Now, a judge is expected to rule any day on the government’s charge that U.S. Stem Cell is “openly violating the law and endangering patients.”
Here's what happened to several patients after receiving stem cell injections, from this deeply reported piece by Laurie and William:
- In 2015, a 78-year-old woman visited ophthalmologist Thomas Albini after she received stem cell injections made from her belly fat from a Miami clinic. Instead of her macular degeneration getting better, the woman had suddenly lost vision in both eyes, and Albini said he discovered clumps of blood floating inside.
- Another patient visited Alibini's emergency room the next day suffering from vision loss and severe pain after getting eye injections from the same company. After seeing both patients, Albini reported the cases to the FDA.
- Two more women have since reported being similarly blinded after being treated by U.S. Stem Cell.
- Last year, weeks after the government filed its suit, a 59-year-old woman ended up in a coma after receiving injections for arthritis pain. Hours after getting treatment at a South Miami clinic associated with U.S. Stem Cell, the woman felt faint and was vomiting. She was taken to the hospital and spent more than a month in a coma. This is the first time her case been reported.
“It’s frustrating that these clinics are still operating, and surprising that authorities aren’t moving faster — even now,” Albini said. It was more than two years after his initial complaint to the FDA before a warning letter was sent to the company. Gottlieb said after he became FDA commissioner in 2017, he met with agency officials who put regulating stem cell clinics “at the top of the list” of priorities.
Later that year, the FDA sent its first warning letter to U.S. Stem Cell, charging the company with selling an illegal, unapproved product and of ignoring safe manufacturing practices. The agency also finalized guidance that says the fat-derived treatment is a drug and requires agency approval.
The company called the allegations "blatantly false," after the 2017 warning letter. It has also pushed back on the FDA's lawsuit, per William and Laurie:
Over the past year, it has hired a top law firm to defend against the lawsuit, and cultivated formidable allies with close ties to President Trump, including GOP operative Roger Stone and Newsmax chief executive Christopher Ruddy.
Kristin Comella, the company’s chief scientific officer, said she met late last year with a White House official, whom she declined to identify, to press the administration to get the FDA to back off. The White House did not respond to a request for comment.
In a long interview at her company’s main clinic in Weston, Fla., an hour north of Miami, Comella accused the FDA of overstepping its authority — which, she said, does not extend to any of her treatments. She said that adverse events are rare, and that doctors trained by U.S. Stem Cell have provided relief to more than 10,000 people, many of them suffering from intractable conditions.
Gottlieb is scheduled to leave his post at the FDA tomorrow, a decision he announced several weeks ago saying he wanted to spend more time with his Connecticut-based family. Laurie reports this morning that he'll return to the American Enterprise Institute to work on drug prices.
“The 46-year-old physician, who has been commuting weekly to Washington from his home in Connecticut, said he plans to spend a half-dozen days a month in Washington as a resident fellow at the conservative think tank,” she writes. “Besides that, he said, he has no commitments for now other than taking his family to Disney World.”
Gottlieb was previously a resident fellow at AEI before he joined the Trump administration. During his tenure as FDA commissioner, he has shown an interest in tackling skyrocketing drug prices, an issue that’s not traditionally part of the agency’s portfolio. He has pushed for quicker approvals of cheaper generic drugs as a way to increase competition and reduce costs for consumers, and has also pressed for developing innovative treatments that could have long-term benefits for patients.
Gottlieb told Laurie he plans to write about FDA-related issues in his new gig. But he stressed he doesn’t want to “be on the sidelines causing grief for Ned" Sharpless, the National Cancer Institute director who will become acting commissioner.
When our colleagues asked Gottlieb about the stem cell procedures in question, he acknowledged the agency hasn't always aggressively enforced its regulations. But as the lawsuit continues, he has said the FDA will take action against other such companies that put patients at risk.
Yesterday, the agency sent warnings to 20 separate manufacturers and health care providers in the stem cell industry, saying they are selling an unapproved product in violation of federal laws. The letters are “part of an ongoing attempt by the FDA to rein in the booming industry, which critics say has injured dozens of patients and cheated thousands more. In recent years, hundreds of clinics have popped up selling stem cell procedures — not covered by insurance, unproven by science and unauthorized by the government,” our colleagues write.
“We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients,” the FDA wrote. “And we will not shy away from taking further steps when we see bad actors taking advantage of patients, and putting them at serious risk, for their own financial profit.”
The FDA also said it's almost halfway through an “enforcement discretion” period after warning the industry broadly in 2017 that it had three years to comply with its rules. So far, however, the agency says it's seen just “modest progress” by the industry to do so.
Read the full report from our colleagues here:
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AHH: Eight Republican lawmakers joined Democrats in condemning the Trump administration’s decision to support a federal case seeking to eliminate the Affordable Care Act.
In a 240 to 186 vote, the Democratic-led House passed a resolution calling on the Justice Department to “halt its new advocacy for abolishing the Affordable Care Act, a move the measure calls ‘an unacceptable assault' on Americans’ health care,” our Post colleague John Wagner writes.
One Democrat, Rep. Collin C. Peterson (D-Minn.) voted against the resolution, which calls on the Justice Department to reverse its position in the case challenging the law’s constitutionality.
The resolution is largely symbolic, as the Republican-led Senate is not expected to advance the measure. “Once again, House Republicans have shown that they are full accomplices in President Trump’s campaign to destroy protections for people with preexisting conditions and take away Americans’ health care,” House Speaker Nancy Pelosi (D-Calif.) said in a statement after the vote.
OOF: The president’s latest surrender on Obamacare, now saying he always intended for lawmakers to hold off voting on a health-care plan until after the 2020 election, is an acknowledgment from the Republican Party that the ACA is “here to stay,” our Post colleague Aaron Blake writes in this analysis.
Even still, the president seems unwilling to give up the fight entirely. In a pair of tweets yesterday, he insisted he never wanted a vote on the issue before the election.
I was never planning a vote prior to the 2020 Election on the wonderful HealthCare package that some very talented people are now developing for me & the Republican Party. It will be on full display during the Election as a much better & less expensive alternative to ObamaCare...— Donald J. Trump (@realDonaldTrump) April 3, 2019
...This will be a great campaign issue. I never asked Mitch McConnell for a vote before the Election as has been incorrectly reported (as usual) in the @nytimes, but only after the Election when we take back the House etc. Republicans will always support pre-existing conditions!— Donald J. Trump (@realDonaldTrump) April 3, 2019
“It is worth taking stock of this moment. What we are seeing here is the marking of a willful GOP capitulation to Obamacare,” Aaron writes. “They are trying to dress it up and put a good face on it for Trump, given that he apparently is not willing to concede the point. But it appears their long-emphasized push to get rid of this allegedly destructive law is effectively over.”
And with Trump’s latest move to punt the issue, they are “not really pretending this is their priority anymore,” Aaron adds.
OUCH: The National Institutes of Health now requires all visitors to disclose citizenship in order to enter its facilities. It's a policy that recently led to disputes with two Iranian scientists invited to make presentations who were blocked when trying to enter one of the institute's buildings, our colleagues Lenny Bernstein, Lena H. Sun and Lisa Rein report.
Both of the men had green cards and U.S. driver’s licenses and had previously gone to NIH without any issues. “In one incident, a Georgetown University graduate student arriving for a job interview was held up at security, then allowed to proceed to one of the campus buildings,” our colleagues write. “But as he prepared to make a presentation, NIH police arrived, removed him from a lab and escorted him off campus.”
“In another, a brain researcher said he was told to leave, then delayed at security for nearly an hour filling out online forms. After interventions by NIH police and other officials, he was told an exception had been made that would allow him to deliver his presentation to the two dozen waiting researchers.”
Although NIH officials say the policy is not new, people who work at the Bethesda, Md. campus said they had never heard of it until the past few weeks. Officials said they posted a sign recently saying visitors needed to disclose citizenship.
Our colleagues write the pair of researchers seemed to have come under “particular scrutiny as citizens of Iran, one of four countries classified as state sponsors of terrorism by the State Department.”
— The FDA is looking into nearly three dozen reports of e-cigarette users having seizures, although the agency stressed it’s not sure whether there is a direct relationship.
The reports include seizures possibly linked to e-cigarettes starting in 2010, and the reports were mostly in young vapers, Stat’s Megan Thielking reports.
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases,” Gottlieb and the FDA’s Principal Deputy Commissioner Amy Abernethy said in a statement. “We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure. We can’t yet say for certain that e-cigarettes are causing these seizures.”
Seizures and convulsions are known potential side effects of nicotine poisoning, and the FDA says vaping products may make it possible for people to inhale nicotine quickly, or for users to inhale more nicotine than usual, which could be leading to the seizures.
Health officials are calling on users who experience health issues related to e-cigarettes to report them to a federal portal.
— The House Energy and Commerce Committee last night advanced six bills that aim to lower prescription drug prices after the panel’s leaders came to an agreement. The approved bills include the CREATES ACT, which would prevent drugmakers from guarding samples of their medications to delay other companies from developing alternatives.
Following the vote, the committee’s top Republicans Rep. Greg Walden (R-Ore.) and Michael Burgess (R-Tex.) released a statement saying the six bipartisan bills “will help reduce drug prices by bringing more generic competition to market. This will make a real difference for many Americans and this just goes to show that when we work together, we can achieve real results.”
In a subsequent statement, however, the pair criticized six other health care-related bills that passed with only Democratic support, including measures to reverse the Trump administration’s expansion of short-term, limited-duration health plans and a measure to protect patients with preexisting conditions.
“None of the bills Democrats passed today are paid for and none of the bills make structural changes to significantly lower costs or improve access to care,” they said in a statement. “Their takeover of health care will lead to delay in accessing health care and fewer choices for consumers. We should work together to lower health care costs, increase access to private health insurance, and make sure our health care system works better for all Americans.”
From the committee’s chairman Rep. Frank Pallone (D-N.J.):
Just now, my committee advanced 6 bills that reverse the Trump Administration’s sabotage of our health care system, protect people with pre-existing conditions and make health care more affordable. #ProtectOurCare pic.twitter.com/VU5E39oFLz— Rep. Frank Pallone (@FrankPallone) April 4, 2019
— Sen. Bill Cassidy (R-La.) announced he’s working on a paid family leave bill with Sen. Kyrsten Sinema (D-Ariz.), the first such bipartisan effort.
The issued has gained traction with Republicans recently, with other lawmakers introducing paid family leave proposals. The Health 202 wrote last month about a bill from Sen. Marco Rubio (R-Fla.) and Rep. Ann Wagner (R-Mo.) that draws on existing retirement benefits.
In response to a question about why Republicans are seizing on the issue of paid family leave, Cassidy explained Republicans “take a different approach.”
“Instead of a government handout which ends up serving more like fly paper, which traps somebody in dependency, because if they earn too much they lose their benefit, Republicans are more about a trampoline: How do we get somebody out of the unemployment role into the working role,” he said.
Sinema chimed in on Twitter about the plan:
— Maine Gov. Janet Mills (D) announced the Trump administration has approved the state's request to expand Medicaid retroactively, after more than a year of obstacles for the state's program.
The greenlight means retroactive funding for the program that was originally set to take effect last July. "The Wednesday move means that the federal government will pay roughly 90 percent of expansion costs for the low-income adults already in the program and those joining in the future. The Democratic governor began expanding the program in January using surplus Medicaid funds," the Bangor Daily News's Michael Shepherd reports. "That step was taken in anticipation of the federal approval of an application submitted under a 2018 court order by former Gov. Paul LePage, a Republican who opposed the expansion approved by voters in 2017 and urged the federal government to reject the application."
As of Friday, 18,000 residents in the state were covered under expansion, including thousands who were blocked from covered as expansion lingered in a lawsuit between the state's former governor and expansion advocates, Michael writes.
The U.S. Centers for Medicare & Medicaid Services (CMS) has approved Maine’s State Plan Amendments to expand Medicaid (MaineCare). This marks the culmination of a long-overdue effort to fulfill the will of Maine voters and help tens of thousands of people access health care. pic.twitter.com/QzAsRACEWo— Governor Janet Mills (@GovJanetMills) April 3, 2019
— And here are a few more good reads:
Late Night with Seth Meyers: