Last fall, before being named the senior U.S. health official, Robert F. Kennedy Jr. said the Trump administration would liberate Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances — ending the federal agency’s “war on public health,” as he put it.

In fact, the FDA can’t even require that supplements be effective before they are sold. When Congress, at the agency’s urging, last considered legislation to require makers of vitamins, herbal remedies, and other pills and potions to show proof of their safety and worth before marketing the products, it got more negative mail, phone calls, and telegrams than at any time since the Vietnam War, by some accounts. The backlash resulted in a 1994 law that enabled the dietary supplement industry to put its products on the market without testing and to tout unproven benefits, as long as the touting doesn’t include claims to treat or cure a disease. Annual industry revenues have grown from $4 billion to $70 billion since.

With Kennedy now in the driver’s seat, the industry will likely expect more: It aims to make bolder health claims for its products and even get the government, private insurers, and flexible spending accounts to pay for supplements, essentially putting them on an equal footing with FDA-approved pharmaceuticals.

On Feb. 13, the day Kennedy was sworn in as secretary of Health and Human Services, President Donald Trump issued a “Make America Healthy Again” agenda targeting alleged corruption in health regulatory agencies and instructing them to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.”

Kennedy has said exercise, dietary supplements, and nutrition, rather than pharmaceutical products, are key to good health. Supplement makers want consumers to be able to use programs like health savings accounts, Medicare, and even benefits from the Supplemental Nutrition Assistance Program, or SNAP, to pay for such items as vitamins, fish oil, protein powders, and probiotics.

“Essentially they’re seeking a government subsidy,” said Pieter Cohen, a Harvard University physician who studies supplements.

As the Senate Finance Committee questioned Kennedy during his Jan. 29 confirmation hearing, supporters in the Alliance for Natural Health lunched on quinoa salad in the U.S. Capitol Visitor Center and crowed that the moment had finally arrived for their health freedom movement, which has combined libertarian capitalism and mistrust of the medical establishment to champion unregulated compounds since the 19th century.

“The greatest opportunity of our lifetimes is before us,” said Jonathan Emord, the group’s general counsel, who has brought many successful lawsuits against the FDA’s restrictions on unproven health claims. “RFK has dedicated his whole life to opposing the undue influence” of the pharmaceutical industry and “assuring that our interests triumph,” Emord said.

In speeches and in a pamphlet called “The MAHA Mandate,” Emord and alliance founder Robert Verkerk said Kennedy would free companies to make greater claims for their products’ alleged benefits. Emord said his group was preparing to sue the FDA to prevent it from restricting non-pharmaceutical production of substances like biopeptides — complex molecules related to drugs like Ozempic.

HHS spokesperson Andrew Nixon did not respond to a request for comment on the agency’s plans vis-à-vis dietary supplements.

While the basic law governing the FDA establishes that a substance alleged to have treatment or curative effects is by definition a “drug,” and therefore comes under the agency’s requirements for high standards of scientific evidence, the new administration could reallocate money away from enforcement, said Mitch Zeller, former head of the FDA’s Center for Tobacco Products.

As a Senate aide early in his career, Zeller investigated a tainted L-tryptophan supplement that killed at least 30 people and sickened thousands in the U.S. in 1989. The scandal led the FDA to seek heavier regulation of supplements, but a powerful backlash resulted in the relatively weak supplements law of 1994.

Even that law’s enforcement could be undercut with a stroke of the pen that would keep FDA inspectors out of the field, Zeller said.

Sweeping changes couldn’t come too soon for Nathan Jones, founder and CEO of Xlear, a company that makes products containing xylitol, an artificial sweetener. The Federal Trade Commission sued Xlear in 2021 for making what it called false claims that its nasal spray could prevent and treat covid.

Jones points to a handful of studies evaluating whether xylitol prevents cavities and infections, saying the FDA would require overly expensive studies to get xylitol approved as a drug. Meanwhile, he said, dentists have been bought out by “Big Toothpaste.”

One can hardly find any products “without fluoride for oral health,” he said. “Crest and Colgate don’t want it to happen,” he said.

Kennedy’s desire to rid water supplies of fluoride because of its alleged impact on children’s IQ is welcome news, he said, and not only because it could highlight the value of his products. Jones stresses, as do many health freedom advocates, that clean air and water and unadulterated food do more to prevent and cure disease than vaccines and drugs. For example, he and other advocates claim, wrongly, that the United States eliminated the crippling disease polio through better sanitation, not vaccination.

The Alliance for Natural Health hopes that in lieu of strict FDA standards, Kennedy will enable companies to make expanded marketing claims based on evidence from non-FDA sources, Verkerk said, such as the National Institutes of Health’s nutritional information site, which describes the pros and cons of different supplements.

Kennedy has also called for relaxing the strictures on psychedelic drugs, which interest some veterans as potential remedies for such conditions as post-traumatic stress disorder. VETS, a San Diego-based organization, has paid for 1,000 veterans to get treatment with the powerful hallucinogen ibogaine at clinics in Mexico and other countries, said the group’s co-founder Amber Capone.

She got involved after her husband, a retired Navy SEAL, pulled out of a suicidal spiral after spending a week at an ibogaine clinic near Tijuana, Mexico, in 2017. She wants NIH, the Defense Department, and the Department of Veterans Affairs to fund research on the illegal substance — which can cause cardiac complications and is listed as a Schedule I drug, on par with heroin and LSD — so it can be made legally available when appropriate.

Coincidentally, the push for less onerous standards on supplements and psychedelics would come while Kennedy is demanding “gold-standard science” to review preservatives and other food additives that he has said could play a role in the country’s high rate of chronic diseases.

“Put aside the fact that there’s precious little evidence to support” that idea, said Stuart Pape, a former FDA food center attorney. “There’s been no indication they want the same rigor for supplements and nutraceuticals.”

Although most of these products don’t have major safety concerns, “we have no idea which products work, so in the best case people are throwing away a ton of money,” Zeller said. “The worst-case scenario is they are relying on unproven products to treat underlying conditions, and time is going by when they could have been using more effective FDA-authorized products for diseases.”

Supplement makers aren’t entirely unified. Groups such as the Consumer Healthcare Products Association and the Council for Responsible Nutrition have advocated for the FDA to crack down on products that are unsafe or falsely represented. The Alliance for Natural Health and the Natural Products Association, meanwhile, largely want the government to get out of the way.

“The time has come to embrace a radical shift — from reactive disease management to proactive health cultivation, from top-down public health diktats to personalized, individual-centric care,” Emord and Verkerk state in their “MAHA Mandate.”

The post With RFK Jr. in Charge, Supplement Makers See Chance To Cash In appeared first on Medika Life.

Medicine is pioneering new technologies that can identify patients at risk for cardiac events through the wireless connection in their hospital beds, alert physicians to possible drug prescribing errors, and enable consumers to use wearables to check their heart rate and rhythm. Yet, our health is too often determined by information technology most people long slated for their town’s dump heap or recycling center — the facsimile machine. Best known as “the fax.”

Would a student at any academic medical center today even know how to operate this tech dinosaur without training? Did they have one in their dorm or library when they first arrived at college? Would one of their peers have ever asked for the day’s class notes with the words: “fax it over?” Ridiculous. Yet, much of a person’s medical information — the stuff that influences life and longevity — is forwarded from provider to provider by way of outdated technology. How can we ever overcome the challenges of “interoperability” and information blocking when we continue to rely on fax to transmit timely patient information? How can patients gain timely access to their own data?

To implement the Cures Act rule and improve access to care, antiquated policies must be revised. Lack of consumer trust in data security inhibits the adoption of ideas that reduce costs, speed medical decision-making and help secure needed treatments. However, medicine’s unrequited love for the faxes is not love at all. 

It is legal anxiety related to staying safely inside the swim lanes of the Health Insurance Portability and Accountability Act (HIPAA). The Department of Health and Human Services (HHS) created HIPAA to set privacy standards for health information; providers recognized the fax and phone as preferred ways to share patient data between providers and among labs, hospitals, specialists, and payers. But, more and more, this system of data transfer limits patient access to the very information their lives depend on.

The Cures Act is designed to help give patients greater ownership and voice over their own medical intellectual property. Yet, the HHS website still lists fax as a preferred path to share medical records, test results, instructions, and treatments.

The Privacy Rule requires that covered health care providers apply reasonable safeguards when making these communications to protect the information from inappropriate use or disclosure. These safeguards may vary depending on the mode of communication used. For example, when faxing protected health information to a telephone number that is not regularly used, a reasonable safeguard may involve a provider first confirming the fax number with the intended recipient. Similarly, a covered entity may pre-program frequently used numbers directly into the fax machine to avoid misdirecting the information. When discussing patient health information orally with another provider in proximity of others, a doctor may be able to reasonably safeguard the information by lowering his or her voice.

Four years ago, faxing remained the “best” HIPAA–compliant way of sending and receiving sensitive patient information. Why? According to the experts: it “can be a more efficient form of written communication because of the trouble and accuracy issues involved with gathering multiple email addresses.” Convenience for patients? Physicians? Regulators? Who?

We need new ways — secure and fast — to share information. Interoperability embraces a world where a consumer’s health history is accessible whether they are at world-class medical centers or community care centers. At a time when we are handwringing about medical costs, diagnostics and blood tests are repeated multiple times because physicians need data that is not readily accessible, despite its existence elsewhere. Information saves lives and keeps costs down. Pioneer companies around the globe are creating Electronic Medical Record Systems (EMR) and cloud-based AI platforms that support interoperability. It’s possible — albeit unlikely — that these companies — some challengers to the behemoths — will be at the forefront of this sorely needed evolution. However, the system has built-in “security” obstacles that will continue to tie health professionals’ hands behind their backs. It is certainly frustrating for physicians. More so, to the people, they seek to heal.

Is HIPAA Advancing Patient Access to Information?

Years ago, when my mother lay dying of cancer, I learned that the OB/GYN at a major New York-metro medical academic center had discovered a new 14 cm tumor one week before her death. That physician told me that she was waiting for the department to “type up the clinical notes,” so that they could be “faxed” to my mother’s oncologist — working in the same hospital system. The oncologist, unaware of the deadly threat posed by the growing tumor, continued to treat as if it didn’t exist. As my mother transitioned from this world to the next, I asked both of these distinguished physicians — OB/GYN and Oncologist — what they had learned. Their answer speaks to the heart of this information challenge. In unison, they replied: “We should have communicated with each other immediately.” Lesson learned! Retire the fax.

HIPAA was created for an important purpose — to maintain people’s medical-record confidentiality. However, this system, created before encrypted email and password-protect communications, is now placing people’s lives at risk. The confirmed examples of HIPAA-snafus goes on and on…

Recently, my almost 90-year old mother-in-law struggled to schedule an appointment with her physician she had not seen for more than a year. At a time when even elderly people who are vaccinated are frightened to venture outside the security of their homes, the visit required her to fill in a multi-page medical update. The problem? The physician’s office insisted that she receive and return their document by fax! Who has a fax in their home today? The unwieldy solution was to send the document by mail and have a home-health aid return the forms prior to the in-office visit. How does that advance someone’s urgent care?

While the fax may be the safest way to keep physicians HIPAA compliant, it creates a behavior inconsistent with their chosen mission — to save lives. Data safety is a priority! No question! However, this outmoded technology is in direct conflict with the physicians’ Hippocratic oath: “Do no harm!” Playing it safe may be harming people. We can invent breakthrough vaccines and therapies that arrest viruses rare diseases and cancers. Somehow, we have yet to find an agreed policy pathway to share information with confidence and speed. This is not our finest moment in medicine.

CMS Administrators have called for an end to physician fax machines. Will our medical system be ready to finally enter the 21st century of medical information sharing? Not really!

While we live in an age of wonder at technological advancements such as fitness apps and precision medicine tailored to an individual’s genetic code, health information technology remains far behind all of the major industries. Healthcare remains in a 1990s-time warp.

Now is the time to use the Cures Act and recognize that information blocking — however it’s done — is no longer acceptable.

What would Dr. Leonard “Bones” McCoy, the famed Star Trek Enterprise’s chief medical officer, say about how we share data from doctor to doctor? Likely, a similar cry from his visit to a state-of-the-art 20th-century hospital: “What is this? The Dark Ages?” Health and Human Services did not deliver on its pledge to retire the fax by 2020. Our lives should not be dependent on the policies or antiquated technologies of the previous century.

Did you get my fax yet?

The post Cause of Death: Fax Not Delivered appeared first on Medika Life.