Tag: robert f. kennedy jr.
Abandoning 'Transparency,' RFK Jr Initiates Shady Drug Approval Scheme

Abandoning 'Transparency,' RFK Jr Initiates Shady Drug Approval Scheme

HHS Secretary Robert F. Kennedy Jr. at first promised “radical transparency” at all agencies within his department. Then he fired almost all the freedom of information staff at the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health; cancelled meetings of FDA and CDC advisory committees that review vaccines and vaccine policies; and held meetings of his Make America Healthy Again Commission behind closed doors.

Marty Makary, the new head of FDA, boldly promised to purge all physicians and scientists on the agency’s 49 outside advisory committees with ties to private industry. The move, he said, heralded a new era where advisory committees with a diversity of opinions would offer advice free from industry influence.

Then, on Tueday, he announced a new program that will set up internal committees to rapidly approve experimental drugs within two months of receiving a company’s application. Given the short time frame, this will effectively bypass the agency’s advisory committee process.

The usual FDA review process often includes holding advisory committee meetings, especially when the clinical trial evidence on safety and efficacy for an experimental therapy is borderline. The review usually takes anywhere from ten months to a year.

As for speeding up the process, the agency already offers priority review vouchers for new drugs that meet unmet medical needs, treat rare diseases or are considered a breakthrough therapy. Those vouchers can then be used on any future drug application even if it doesn’t meet any of those criteria. It can also be sold to another company seeking rapid approval of a drug that isn’t critical.


Some products receiving priority reviews by agency scientists also benefit from the FDA’s accelerated approval process, where approvals are based an improvement in surrogate markers — biomarkers like elevated amyloid plaques in Alzheimer’s patients or tumor shrinkage in cancer patients that aren’t necessarily associated with a better outcomes when the final results of those clinical trials are in (which sometimes are never submitted because the drug companies fail to complete the trials).

What’s new here?

The new program layers on an immediate rapid review to any company developing a new drug or device that meets one of four criteria: Does it address a health crisis; deliver an innovative cure; meet an unmet public health need; or increase the nation’s domestic drug manufacturing capacity?

The first three criteria are so vague as to be essentially meaningless. Virtually every drug and device company claims their new products are innovative and address unmet needs, even when they’re the sixth drug in a class that treats an already well-managed condition.

As Aaron Kesselheim, a professor of medicine and member of the Center for Bioethics at Harvard Medical School, told STAT News yesterday: “It sounds like a way of giving out political favors rather than actually meaningfully changing or enhancing the regulatory process.”

The internal process for making decisions after awarding these new priority reviews will be equally problematic. Makary, a surgical oncologist, plans to convene experts from various FDA offices for a “1-day” team review that he compared to the tumor boards hospitals use when faced with a critically ill cancer patient. “This voucher harnesses that model to deliver timely decisions for drug developers,” he said in his statement.

That ignores the fact that many new drugs to treat chronic conditions like dementia, cancer, autoimmune disorders, and rare genetic diseases are often barely effective. They often have troubling safety profiles requiring careful weighing of minimal rewards against serious risks. These are the areas where FDA reviewers are most in need of advice from outside experts through the advisory committee process.

Prior to advisory committee meetings, the FDA publishes much of the data submitted by the companies seeking a new drug approval. It posts on its website its own analysis as well as the companies’ presentations of the data, which the public can review prior to the meeting. The meeting itself — often stretching over several days — are open sessions where the advisors hear from clinicians who treat patients suffering from the disease as well as consumer and safety advocates who urge the agency to give careful consideration to the risk-reward ratio.

Will these one-day “tumor board”-like sessions be open to the public? Will internal documents be published? Will they hear from interested parties?

If the goal of the new program is to shorten the FDA’s review time, the agency needn’t come up with another work around. The simplest solution is to hire additional staff.

Instead, HHS at the urging of Elon Musk’s DOGE and the Russell Vought’s Office of Management and Budget announced the FDA will be laying off 3,500 of its 19,000 staffers, exempting for the time being new product reviewers. Why not use the savings to hire more internal reviewers? That’s the surest path to shortening review times.

This new program also ignores the fact that the FDA is already heavily dependent on industry user fees to fund its review staff, which is the biggest conflict of interest at the agency. Why don’t Kennedy and Makary go to Vought and his boss in the Oval Office to demand they include more taxpayer funding for FDA reviewers instead of giving more tax breaks to the wealthy and large corporations?

Reprinted with permission from Gooz News.

In Los Angeles, We Don't Need The Marines To Bust A Few Hooligans

In Los Angeles, We Don't Need The Marines To Bust A Few Hooligans

I'm fine. Thanks for asking. Other than the endless and awful worries that come with caring for my daughter with long Covid, and the very real fear that Robert F. Kennedy Jr. and his boss will cut all the research programs that are the best and only hope for the millions (and there will be millions more) suffering from this now incurable disease, I'm OK. To tell the truth, I haven't seen a single protester, or any Immigration and Customs Enforcement agents for that matter. The protests have not taken over the city. I've lived through riots. These aren't riots.

I know. You've seen the pictures of the burning Waymo taxicabs. All three of them. I've seen them too — on TV, literally hundreds of times. What does that prove? That there are hooligans who will take advantage of any situation that will possibly give them cover for wrongdoing? The hooligans should be arrested and punished. The LAPD is fully qualified to do that. We don't need the Marines or the National Guard to round up a handful of hooligans.

The Chief of the LAPD told the City Council on Tuesday that LAPD officers arrested 114 people at protests Monday night — 53 for allegedly failing to disperse and 15 on suspicion of looting. The potential looters were stopped. One person was arrested for alleged assault with a deadly weapon on an officer, and another was arrested on suspicion of attempted murder. They will be punished. The LAPD arrested 27 people at protests on Saturday and 40 on Sunday.

The problem is not the protesters. They have every right to be protesting the wholesale roundup of people with brown skin who have committed no crimes. ICE doesn't like to release the numbers, for obvious reasons, but what's come out so far suggest that half the people ICE has detained were not subject to warrants for their arrests and have committed no crimes.

On Tuesday, the mayor of Los Angeles imposed a curfew on exactly one square mile of downtown LA in an effort to stop the hooligans who were looting. Downtown LA was quiet on Tuesday night. Los Angeles is a city of nearly 500 square miles. One-five hundredth of the city was under a curfew, hardly reason to send in an invading military force, which Trump has done.

And there is certainly no reason to attack the organizers of the peaceful protests, which is what Republican grandstanders are doing. On Wednesday, Missouri Republican Sen. Josh Hawley threatened an investigation of one of our city's most respected immigrant organizations, the Coalition for Humane Immigrant Rights, which he accused of "bankrolling the unrest." Hawley, who chairs the Senate Judiciary Subcommittee of Crime and Counterterrorism, wrote to the leader of the group that they should "cease and desist any further involvement in the organization, funding, or promotion of these unlawful activities."

What he called, but didn't identify, as "credible reporting now suggests that your organization has provided logistical support and financial resources to individuals engaged in these disruptive actions. Let me be clear: bankrolling civil unrest is not protected speech. It is aiding and abetting criminal conduct."

No, it's not. Organizing and supporting peaceful protests against mass, untargeted roundups and the misuse of the military is fully protected by the First Amendment.

Trump wants race riots. He wants people to be terrorized. He wants to exercise absolute authority. The protests will continue, and they will spread. Trump railed against the rapists and murderers he claimed were invading our country. He promised to remove them. Fine. Now that he's president, he can't find enough of them to fulfill his quotas. So instead, he is going after law-abiding neighbors with force and without due process. He has triggered this unrest, and it is his fault. The organizers of the protests in Los Angeles are doing everything they can to ensure that the protests are peaceful and lawful. The same cannot be said of Trump and his minions.

Reprinted with permission from Creators.

Robert F. Kennedy Jr.

Besides Food Dyes, What Endangers Children's Health? Bobby's Hypocrisy

Nobody should have trusted Health and Human Services Secretary Robert F. Kennedy Jr. to "make America healthy again," especially after he sold the slogan to President Donald Trump for a cabinet position. But the events of recent days have exposed the cynicism and contradictions behind that sonorous pledge.

On May 22, the Make America Healthy Again Commission, named by Trump and chaired by Kennedy, delivered an ambitious report on children's health, which warned that our kids are "the sickest in the world" and loudly blamed ultraprocessed foods, environmental poisons, prescription drugs and lack of exercise for their condition. While the report offered few specific solutions to the problems identified, Kennedy promised that policy recommendations would be forthcoming in the next 100 days.

Unsurprisingly, the lengthy MAHA report promoted the HHS secretary's obsessive opposition to vaccines, despite their proven track record in saving millions of lives of both children and adults — and the recent horrific incidents of unnecessary deaths from measles in communities with low vaccination rates. Despite that troubling feature, other aspects of the report — in particular its focus on encouraging consumption of whole foods and reducing the food industry's most destructive production and marketing processes — won praise from respected scientists who otherwise harbor grave doubts about Kennedy (and Trump).

While the nation awaits Kennedy's vague initiatives on child health, however, the Trump administration is moving rapidly to thwart whatever progress might result from banning a toxic food dye or two. The Environmental Protection Agency, with the full support of the president, under the leadership of a far-right former congressman from New York, has set out to prove that its title is a misnomer. EPA Administrator Lee Zeldin has announced that his agency will drop much of its historic effort to prevent dangerous pollution of air and water.

What Zeldin really aims to protect are the commercial interests of coal, oil and other dirty industries. Boasting that he will oversee "the biggest deregulatory action in U.S. history," the EPA chief plans to roll back dozens of regulations designed to prevent particulate matter, smog, nitrogen oxides, lead and mercury from entering the bloodstreams of Americans and inflicting deadly effects on their brains, lungs and hearts, causing disease and premature deaths.

While he mulls the most efficient means to destroy the regulatory structures that have reduced pollution over the past 50 years, Zeldin is offering special favors to polluting firms on request. His agency has set up a dedicated email account where industrial polluters can request a "presidential exemption" from regulations that are meant to curtail their dumping of poisons under the Clean Air and Clean Water acts. In practice this will mean increased exposure for vulnerable Americans, especially children, to the same toxic chemicals decried by the MAHA report.

Let's recall at this point how Trump, during his campaign last fall, urged the oil industry to give his campaign "a billion dollars" to ensure his victory — so that he could provide policy favors and pliant officials like the execrable Zeldin.

Among the glaring ironies, as noted in Scientific American, is that Kennedy himself suffered a bout of mercury poisoning years ago from contaminated canned tuna. Eight years ago, when he was still working as an environmental lawyer, he railed against the first Trump administration's attempt to roll back mercury regulations of coal-burning power plants. And even during his HHS confirmation hearings, he touted his record fighting polluters. "The same chemicals that kill fish make people sick," he warned last January.

Kennedy was right, but now he is silent about the ruinous policies pursued by Zeldin, who sits beside him on the MAHA Commission. He complains constantly about fluoride in state and local water supplies, but mercury is a far more potent menace to children's physical health and intellectual development. At its core, Make America Healthy Again is a deception — and it is Kennedy's hypocrisy that now endangers children's health.

Joe Conason is founder and editor-in-chief of The National Memo. He is also editor-at-large of Type Investigations, a nonprofit investigative reporting organization formerly known as The Investigative Fund. His latest book is The Longest Con: How Grifters, Swindlers and Frauds Hijacked American Conservatism (St. Martin's Press, 2024).

Reprinted with permission from Creators.

Viral Fury: Fourth Grader Puts RFK Jr. On Blast Over 'War On Autism'

Viral Fury: Fourth Grader Puts RFK Jr. On Blast Over 'War On Autism'

Advocacy groups are outraged over Health and Human Services Secretary Robert F. Kennedy Jr.'s war on Americans with autism.

They say Kennedy uses the disorder as a political tool and pushes damaging stereotypes that spread misinformation.

“The U.S. Secretary of Health, RFK Jr., made false comments about autism, like people with autism are broken, that autism is caused by vaccines, and that people with autism will never have jobs or families,” said Teddy, a fourth grader from New Jersey whose statement at a school board meeting went viral earlier this month.

“I have autism and I’m not broken,” Teddy said. “And I hope that nobody in Princeton Public Schools believes RFK Jr.'s lies.”

The New Jersey schoolkid and autism awareness groups felt the need to speak out after Kennedy’s vile comments last month about U.S. autism rates, where he repeated his false claim that autism is an epidemic that “destroys families.”

Kennedy also mischaracterized autism as a “preventable disease” and falsely asserted that 25% of autistic people are non-functioning—ridiculous notions that experts say are inaccurate.

“His comments were incorrect, but more to the point, they were eugenic,” Colin Killick, executive director of the Autistic Self Advocacy Network, told the Boston Globe. “Talking about autistic people as themselves being destroyed but also having destroyed their families is a horrific argument.”

“There’s an unscrupulous industry of alternative medicine providers who exploit families by charging them tens of thousands of dollars to ‘recover’ people with autism,” Ari Ne’eman, who is autistic and an assistant professor of health policy and management at Harvard’s T.H. Chan School of Public Health, told NBC News. “The way that industry works is by terrifying families.”

David Mandell, a University of Pennsylvania psychiatry professor and director of the Penn Center for Mental Health, told PBS News that Kennedy’s “fixed, myopic view” stems from needing to interface with parents of autistic children and scientists who work in the field.

Julie DeFilippo, a social worker with an autistic son, told the Boston Globe that “as a parent of an autistic kid, I get hundreds of moments of joy every day. That’s the easy part—being at home and supporting him.”

Kennedy’s characterization of autism as a preventable tragedy also appears connected to his notorious anti-vaccine crusade. In a recent interview with Dr. Phil McGraw, he repeated the vigorously debunked claim of a link between autism and vaccines.

“Many of the parents have reported that their kid, that their child, developed autism immediately after [childhood vaccinations],” Kennedy told the psychologist-turned-TV star.

Kennedy has used his position as America’s chief public health official to launch what he claims is a scientific study into the cause of autism, to be led by an anti-vaccine activist with heinous ideas about treatments for the condition that include experimenting with chemical castration drugs.

“I have seen a lot of people treat [Autism Spectrum Disorder] as some sort of disease that needs to be ‘cured,’ which is very offensive towards people like me,” John Trainor, a high school student, told the Boston Globe. ”We are normal people who have a much harder time socially.”

Kennedy has also announced plans to create an autism database, using the private medical information of millions of Americans, promising Trump in a surreal Cabinet meeting in April that he’d be able to identify the cause of autism by September.

Kennedy announced on May 7 that he intends to direct the National Institutes of Health to use Medicare and Medicaid insurance claims related to autism diagnoses to build his database.

Critics point out that Kennedy’s plan amounts to an autism registry, and experts add that Kennedy’s promises are unrealistic.

"If you just ask me, as a scientist, is it possible to get the answer that quickly? I don't see any possible way,” Dr. Peter Marks, a former top vaccine scientist for the FDA, said on Face the Nation last month.

Kennedy’s talk about investigating autism is extra hypocritical considering the Trump administration’s slashing of funds for scientific research and haphazard dismantling of America’s public health institutions.

Reprinted with permission from Daily Kos.

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