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.

Doctors are evaluated on patient throughput, not the depth of their engagement. Pharmaceutical and medical device companies create and perfect new products for patients but often neglect their preferences, stated needs, and lived experiences in recruitment and development efforts.

Real-world evidence (RWE), a promising frontier in health settings from innovation to care decisions, is poised to change this dynamic. If we are open to acting upon it, it can become the basis for centering efforts directly on the patient experience.

As a father and caregiver, I’ve walked this journey firsthand. My child’s health challenges have brought me face-to-face with the limitations of a system that often measures success in drugs prescribed rather than resolutions achieved. I’ve seen the toll that rushed consultations and fragmented care take on families searching for answers. It is a stark reminder that even as the science of medicine advances, the art of listening lags.

Recently, we visited a doctor’s office to consult about our young adult’s rare disease. We hired a patient advocate to bridge the chasm between clinical expertise and lived experience. They translate medical jargon, connect patients with appropriate specialists, and, most importantly, validate the patient’s voice.

Listening to the advocate prompted me to ask a critical question about this complex clinical case: “What is the underlying cause of the symptoms?”When our non-medically trained patient advocate suggested surgery to address the root causes of our child’s GI problems, one doctor we consulted, who came from a noted teaching hospital, confronted us.

“Who are you going to believe,” he asked. A patient or me?”  Ultimately, the patient advocate, who consulted with other patients and their physicians, was spot-on. The operation took place; the outcome was outstanding. That is the power of RWE as a catalyst for objective conversation.

Real-World Evidence: A Catalyst for Change

The Food and Drug Administration (FDA) defines RWE as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD).” These data include electronic health records, insurance claims, and patient-generated information from mobile health apps and wearable devices. Unlike randomized controlled trials, which too often exclude diverse populations, RWE provides a more comprehensive view of how treatments perform in real-world settings.

Physicians face immense pressure to see more patients in less time. Emergency physicians, for example, are expected to see 2.4 to 3.3 patients per hour, while family doctors might handle 3.3 patients or more per hour in high-volume settings. These metrics may boost productivity, yet at the same time, often come at the expense of meaningful patient interactions. The result? Missed opportunities to understand the full scope of a patient’s experience and even the true nature of the problem.

Empowering Patients and Data

One possible example of how RWE can prioritize the patient’s voice is StuffThatWorks, a platform founded by Yael Elish, one of the founders and executives of the consumer navigational company WAZE. Like WAZE, StuffThatWorks uses AI-powered crowdsourcing to connect individuals with similar diagnoses, enabling them to share experiences and generate actionable insights into treatments and outcomes. It’s a patient-led approach that democratizes data collection, making it richer and more representative. For sponsors of medical trials, the platform offers the chance to harness a massive customer focus group, gaining access to the voices of millions of people struggling with health concerns ranging from treatment to anxiety around illness to the cost burden of sickness.

StuffThatWorks – collaborating with companies and patient organizations, recently began collaborating with The Marfan Foundation, highlighting the potential to engage non-profits in leveraging RWE to benefit global disease communities. Similarly,  The StuffThatWorks partnership with Advanced Clinical, a major research services and clinical resourcing organization, allows project teams to engage with patients directly through surveys and focus groups, enhancing patient participation in clinical research. These initiatives demonstrate the transformative power of intentionally centering patient experiences in healthcare innovation.

More and more, leading academic hospitals such as Weil Cornell Medical Center’s Genetics and Personalized Cancer Prevention Department in New York City are recognizing that care extends beyond cutting-edge medicine and outstanding physicians—it calls for experts who have been on frontlines—as patients and counselors.

“I feel fortunate to bring my real-world experience as a patient to my work as a provider,” says Emily Epstein, LMSW, Genetic Social Worker/Clinical Behavioral Health Care Specialist at Weill Cornell. “This deep understanding of the patient journey inspired me to create a role where I can offer the very support I once advocated for, rooted in true empathy and knowledge. Real-world patient experience is essential to transforming healthcare, infusing it with humanity, compassion, and meaningful change—ensuring we honor and serve both the science of medicine and humanity at its heart.”

Chief Patient Officers

Several pharmaceutical and clinical research companies have established Chief Patient Officer (CPO) roles, recognizing the importance of patient engagement. Parexel, for example, appointed Stacy Hurt as a CPO to lead patient advocacy efforts. Hurt says, “Parexel’s priority focus is on providing patient-centered solutions that enhance the clinical trial experience and make participation more accessible to everyone.”  A health professional who is both a cancer survivor and a caregiver for her son, Hurt brings a patient’s perspective to the work.  Companies like Merck, Pfizer, Sanofi, and Astellas have also created similar roles, signaling a broader industry commitment toward integrating patient insights into drug development.

The National Health Council emphasizes that as RWE becomes a cornerstone of health decision-making, the experience and needs of patients must be prioritized, not addressed as an afterthought. Integrating RWE into the health system can enhance treatment efficacy, safety, and patient satisfaction. However, this requires more than technological innovation; it demands a cultural shift within the healthcare ecosystem.

Now What?

Reflecting on my child’s medical journey and the rise of patient advocacy communities that began to take form during the HIV epidemic and that patient community’s vocal demand to be included in conversations about drug development and news flow, it’s clear that the journey toward patient-centered care is still at an awkward early stage.

Platforms like StuffThatWorks offer a glimpse into what’s possible when prioritizing patient voices. By fostering communities where individuals can share their experiences, these tools generate valuable data and empower patients to take an active role in their care.

Let us commit to creating a health system where every patient’s story is heard, valued, and acted upon. By doing so, we honor the science of medicine and humanity at its heart.

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After yielding promising results in a clinical trial, an LSD formulation aimed at treating generalized anxiety disorder has been awarded Breakthrough Therapy status by the U.S. Food and Drug Administration.

This essay explores the remarkable finding that a single dose of MM120 (lysergide d-tartrate) led to a 48 percent remission rate from generalized anxiety disorder at 12 weeks following the drug’s administration.

“When the light turns green, you go. When the light turns red, you stop. But what do you do when the light turns blue with orange and lavender spots?”
― Shel Silverstein, A Light in the Attic

Anxiety: It’s common

Fortunately, I do not suffer from anxiety. As you will soon learn, the age group with the lowest prevalence of anxiety is 60 or older.

But many do.

Approximately one in five (19 percent) of U.S. adults report experiencing any anxiety disorder in the past year.

The prevalence of any anxiety disorder was higher for females (23 percent) than males (14 percent).

Finally, an estimated 31 percent of U.S. adults experience any anxiety disorder at some point in their lives.

New LSD study

I am going to cut to the chase and give you the takeaway message from a recent study:

A single dose of MM120 (lysergide d-tartrate) led to a 48 percent rate of remission from generalized anxiety disorder at 12 weeks following the drug’s administration.

For those receiving a single dose of MM-120, nearly eight out of 10 (78 percent) of those receiving 100 or 200 µg dose measured as having a clinically significant response to the drug.

Half of the participants who received the 100 µg dose were in clinical remission at week 4, meaning that the patient no longer suffered from clinically significant symptoms of generalized anxiety disorder.

These findings are all rather stunning. Let’s turn to why I am impressed.

Standard treatment for anxiety

To get a sense of the power of LSD for anxiety, we should look at the current standard of care for generalized anxiety disorder.

Here are some of the traditional tools:

• Cognitive behavioral therapy
• Medications (including selective serotonin reuptake inhibitors, SSRIs, and buspirone). These drugs impact brain neurotransmitter (serotonin) levels. Sedatives (benzodiazepines) are sometimes offered.

But here’s the problem: These medicines need time to work. Moreover, patients may need to use a trial-and-error approach to dosing.

New study details

Let’s get back to the new study.

Researchers enrolled 198 participants, all suffering from generalized anxiety disorder. Twenty clinical sites in the U.S. participated.

Each volunteer entered one of five study arms. All received a single dose of a lysergide-based drug candidate called MM-120 (lysergide d-tartrate) or a placebo.

Here are the doses in the LSD arms:

• Group 1: 25 µg of MM-120
• Group 2: 50 µg of MM-120
• Group 3: 100 µg of MM-120
• Group 4: 200 µg of MM-120

Nobody had additional therapy.

One more quote

“Taking LSD was a profound experience, one of the most important things in my life. LSD shows you that there’s another side to the coin, and you can’t remember it when it wears off, but you know it. It reinforced my sense of what was important — creating great things instead of making money, putting things back into the stream of history and human consciousness as much as possible.” ― Steve Jobs.

My take

First, while a single dose of LSD (at the higher doses) led to an 80 percent response rate, we should corroborate the research findings through real-world evidence.

Second, the clinical trial was small and short (four weeks).

Third, some (31 percent) of the placebo group got better.

Fourth, there are potential side effects. Please go here to learn more:

LSD: Effects, Risks, Tips, and More

Lucy, acid, dots – whatever you want to call it, LSD is one of the most well-known hallucinogens. Here’s a look at what…

www.healthline.com

Finally, MindMed evaluated the effects of MM-120 on study participants 12 weeks after the dose. The results should be available in early 2024.

With all of those caveats,

A single dose of LSD appears to have a powerful and rapid effectiveness for those with generalized anxiety disorder. Many of these individuals are not adequately served by our current approaches.

What say you?

Thank you for reading “Groundbreaking Study Reveals Single LSD Dose Offers Instant and Sustained Anxiety Relief.”

The post Groundbreaking Study Reveals Single LSD Dose Offers Instant and Sustained Anxiety Relief appeared first on Medika Life.

This has gone on for years but isn’t confined to food containers like the one on your desk, but also to the wrapping that may be used where you pick up your sandwiches or the packaging used in the supermarket for all the items you purchased there or even for shipping food products.

Every time you eat one of the products that has been wrapped, shipped, or slipped into a container with a specific chemical in it, you are, in effect, damaging your health, or endangering yourself or your children, if they also use those containers or wrappers.

What do you think should have been done decades ago when it was known that this was not a safe material to have near food? And what’s the stuff that’s so dangerous? It’s PFAS, the forever chemicals, and they are endocrine disrupters.

The information we have shows that people who are most likely to be subjected to endocrine disruptors (EDs) are more likely to have cancer, reproductive problems (like infertility, endometriosis, and miscarriages), metabolic problems (like diabetes), and/or immune system problems. Children who are exposed to endocrine disruptors also show behavioral and psychological problems. The disturbing results in children, in utero, and after birth, are particularly disturbing.

In the US, The Endocrine Society has indicated that hormonal disrupters put unborn children at the highest risk. Animal studies show that even small amounts during pregnancy can lead to obesity later on. Some disrupters directly affect cells in the pancreas and fat and liver cells. This can all cause insulin resistance and type 2 diabetes.

The EU has made rules about these chemicals with Regulation 2017/2100 and Regulation 2018/605. But these scientific factors are not a way to find EDs and do not fully protect people’s health.

For food contact purposes, the FDA said that makers can no longer sell grease-proofing substances containing PFAS. When these chemicals are used on food packaging paper and paperboard are taken off the market voluntarily, they will no longer be a major source of dietary exposure to PFAS from approved food contact uses. Where do we find PFAS used?

Paper and paperboard packaging is treated with grease-proofing chemicals to stop grease and oil from leaking and to make the packaging resistant to water. Materials with PFAS were used to make fast food wrappers, microwave popcorn bags, take-out paperboard cases, pet food bags, and other similar kinds of packaging.

The FDA had given manufacturers three years to exhaust their supply of products containing this material. During the three-year moratorium, however, consumers continued to be exposed to these substances, and we do not know the long-lasting results of such exposure in terms of human health. Some manufacturers have already removed themselves from markets requiring them not to use this material in their products. We do not have information regarding which manufacturers have left the markets where they would have used PFAS. But this is only one small part of the equation; what about shipping food products or ingredients?

The issue now becomes one of finding safe wrapping and packaging materials that are not problematic should they come in contact with food either for us or animals, even in animal feed. How do we know which ones are safe and which ones still contain PFAS? We don’t, which leaves us with a quandary regarding how much exposure we will accept if we do not know where the exposure may be.

A question lingers in my mind regarding PFAS and food. While the FDA has indicated manufacturers can no longer make products containing this material for food packaging, what about all of the facilities that still have these kinds of packaging materials on hand? No one told them they had to discard all of these materials and purchase new ones without the dangerous PFAS in them. Who knows how much stock they had on hand?

Can we believe that all of the packaging materials in all of the shops or all of the food preparation companies are now free of PFAS? I know these are disturbing questions, but we must consider that the food is still unsafe because it may still be placed in packaging or wrappings containing the now-forbidden material. This can happen at the packaging level, whether at the manufacturer or retail level.

The post PFAS Is a Culprit Affecting Health, and It’s in Packaging — But No More in the USA appeared first on Medika Life.

Changes and damage linked to formaldehyde have made people wonder what role it plays in controlling diseases of the central nervous system (CNS), like neurodegenerative disease (NDD) and brain tumors (BT). When humans breathe in formaldehyde, it can damage neurons and cause problems with learning and memory. Several statistical studies have looked at the link between formaldehyde exposure and brain cancer in professional workers like anatomists, pathologists, embalmers, and funeral home workers, as well as in industrial workers. The skin also is vulnerable to formaldehyde penetration, which would be a concern in any shampoo or skincare product.

One major concern related to a specific type of cancer has now come to the surface, and the FDA must address it. As part of the Sister Study, it was found that teens and adults who used hair products were more likely to get breast cancer, and adults who used straighteners were more likely to get ovarian cancer.

So, there is an established empirical problem now with cosmetics. They do have guidelines on the FDA website. Cosmetics and their ingredients do not need FDA approval before they can be sold in the U.S., but color additives (other than those used in coal-tar hair dyes) do need to be approved for their use. Businesses that sell cosmetics are legally responsible for making sure their products are safe. But you will notice that certain types of hair dyes require no prior approval—until now. New FDA guidelines are anticipated.

For many decades, formaldehyde and DMDM hydantoin have been recognized as products that are dangerous to health. It was removed from popular brands of shampoo and any beauty product with it is withheld from distribution in many countries. Currently, lawsuits have alleged that this chemical remains in products, and is responsible for several health issues, including dermatitis and hair loss, and is a known carcinogen. Specifically, the FDA is now concentrating on regulations related to hair relaxers.

Because formaldehyde is linked to cancer and other long-term health problems, the Food and Drug Administration wants to stop its use as an ingredient in hair relaxers. The new rule would stop colorless and very harmful chemicals from being used in high-straightening and hair-smoothing products, which are also called relaxers.

Why are these dangerous materials still being used in any products? They act as stabilizers, and formaldehyde is often added to creams, lotions, and other goods to prolong their shelf life and make them last longer.

Some additives slowly release small amounts of formaldehyde into the air. Low levels of formaldehyde can be harmful to health, even at levels as low as 250 parts per million and even lower levels in people who are already sensitive to it. This is why even the slow release of small amounts of formaldehyde is a problem; it’s a health hazard.

A list of products to avoid is available online, but, as the site states, you may not see all the ingredients listed as such since some may have different names or be capable of releasing harmful materials. Do we have to be chemists to protect ourselves from dangerous products? We do expect the FDA to have taken on this task on our behalf.

The post Questions About FDA Protection From Dangerous Beauty Products appeared first on Medika Life.

The Covid pandemic has been the first true global outbreak our modern society has endured. Our responses to contain it were neither swift, nor effective, perhaps reflecting a fundamental flaws in our preemptive planning and a lack of cohesion a united global health federation would have offered. Governments faltered, floundered and then did what anyone does when they see the ship sinking. They panicked.

What followed was a textbook example of how not to deal with a pandemic that cannot be contained. The public was cajoled, coerced, forced, frequently misled, and perhaps even lied to, often intentionally so. Current Covid policy suggests we have learned nothing in the past three years or have chosen to blithely ignore our missteps.

Many claim that it is easy to be critical of our pandemic strategy utilizing the perfect science of hindsight, that we were in uncharted waters and that “we didn’t know”.

These arguments are of course condescending, an easy out for the cold, harsh reality of how science and politics cohabited to produce the pandemic from hell. Many voices sounded caution in our response, many voices urged restraint, and more still, questioned the wisdom of advice issued by our bastions of health, the WHO, the CDC, the FDA and other global health infrastructures. These voices of dissent, without exception, were silenced in favor of an official global narrative.

You were either on board with this Covid policy or you were sidelined, silenced or discredited. An unprecedented global health dictatorship was born, impervious to logic, medical safety and long established ethical precedents for public health and patient safety. At the end of the day, pandemic policy, not science or common sense, dictated our miserable management of the pandemic.

Information, Facts and Fictions

Dealing with the the distribution of information on a global scale in an internet enabled world is an art form, a science on it’s own, that is in its infancy. Poorly understood and even more poorly applied, the act of sharing accurate, trustworthy and believable information on a global scale suffers from what some would suggest is an insurmountable obstacle. Humanity and its proclivity toward tribes.

Push information publicly to promote an agenda and you are assured of two things. Large swathes of the public will buy into your narrative. Large swathes of the public will not.

And so it was with Covid, and still is, with one exception. There is migration occurring in the tribes, an exodus from the Village of Blind Obedience to the Village of Skepticism, and it is growing daily. It is a migration that governments and healthcare willfully ignore and should this trend continue, it will, once and forever, sever any remaining trust the general public still holds for healthcare.

The migration is driven by one simple thing. Facts, the lack of, or their emergence. To underscore this point allow me to provide an example, one I recently wrote on, relating to advice provided globally on the risks posed by the Covid inoculations to nursing mothers. the following advice is offered by the CDC website. Emphasis added by author.

“CDC recommends COVID-19 vaccines for everyone ages 6 months and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future and getting boosters, if eligible.”

The fact that zero data existed (verified on the same page) to support the CDC opinion on the safety of nursing infants to the Covid inoculations didn’t stop the Strategic Advisory Group of Experts on Immunization (SAGE) or the WHO from offering identical advice. This advice persists even now despite mounting evidence of harm to nursing infants. So to facts then, and willfully ignoring them in pursuit of a plan.

The Covid agenda ignored the most basic of human rights, the premise of self autonomy, that we are in charge of our own health and that we enjoy that very human luxury of choice. The public have been subjected to mandates, coerced, pressured, shamed and manipulated like sheep, herded with intent into a pen for the largest clinical trial in the history of humanity. A trial which remains ongoing, possibly fueled by the flawed logic of “in for a penny, in for a pound”.

I cannot speak to the specifics of the global agenda on Covid. I can freely speculate about profit, mismanagement, political gain, economics and even indulge in wild conspiracy theories, but it is a pursuit without point. What really matters now is where this gross mismanagement of information has led us and how, if at all, the situation can be remedied.

Even doctors use Dr. Google

For generations, doctors have been revered as people of science, these learned folk that would cure us of our myriad afflictions. Many patients would feel better simply from sitting in front of their doctor and describing their symptoms. A simple combination of trust and lack of public knowledge has served the industry admirably for centuries. Doctors shared that rarified air enjoyed by those we place on pedestals. For many, technology and the free flow of information have shattered this illusion. It was and is, in many ways, simply an illusion.

Doctors are fallible and the scope of knowledge required to discern a medical condition, given the breadth of our expanding understanding of human anatomy, is beyond the scope of an individual person, justifying the existence of specialized doctors. The odds of a correct diagnosis for your condition are staggeringly low and are dependent on the skill, empathy, level of education and interest (yes, interest) your doctor takes in your case. Sadly, your insurance status and financial standing also affect outcomes.

Even doctors resort to Google to access literature, not only to assist them forming a diagnosis, but for information on health policy and practice.

A sound approach, assuming the information you obtain from “trusted sources” reflects advice based on solid science and is ethically in the best interest of the practitioner/patient relationship. Needless to say, doctors require scientific and medical fact to safely treat their patients. In 2020 the internet was inundated by “medical information” relating to the SARS-COV2 virus and the associated disease we called Covid. Medical information and opinion (most of it of questionable origin) was the order of the day, rather than medical fact.

We were in the dark, facing an unknow enemy and much of what transpired in 2020 was trial and error, best guesses from a completely overwhelmed medical industry, horrendously equipped and fielding practitioners who were as terrified as their patients. Many medical staff resorted to the quickest pandemic updates they could find, turning to “trusted” outlets such as CNN and other mainstream media.

In the age of Internet Information Dissemination, we had just committed the cardinal sin, one that would single handedly destroy the credibility of treatments, of doctors, scientists and once revered healthcare institutions among large segments of our society.

We ignored fact in favor of assumption and then, to compound our error, we lied.

The art of Internet Information Dissemination (IID)

IID sounds like some IED (Improvised Explosive Device) but in many ways, it is far more deadly. It is a tool that if wielded incorrectly, irresponsibly and with impunity can result in disaster, and even death. We see the devastating impact of this so clearly in America’s fragmented political system, overwhelmed by those who abuse their digital privilege and responsibility.

To avoid having information appropriated and misinterpreted in our digital age, a simple, yet difficult to adhere to, mantra must be followed faithfully.

Tell the truth, share only verifiable fact and acknowledge when you simply “don’t know”.

Share information that doesn’t adhere to the above, that is disseminated for the purposes of furthering an agenda, that draws erroneous conclusions and manipulates fact, and you are faced with the current debacle healthcare grapples with. The erosion of trust, coupled with any loss of goodwill your predecessors may have built up.

As an analogy, it’s like Apple bringing out a new phone that does none of what it’s marketing suggests. The company would suffer irreparable damage to its reputation and destroy hard won trust with its customer base. This is the predicament healthcare now faces. Their phone isn’t holding up to the marketing they’ve published.

Not to put to fine a point on it, but it turns out their phone (the vaccine) isn’t actually even a phone (an inoculation). The Covid “vaccines” are not a multi-dose treatment regime for at risk patients. They form the backbone of the worlds largest and ongoing clinical trial, one that patients have in most instances been coopted into joining. You bought the phone based on a misleading pamphlet.

Unlike Apple however, Governments keep changing their sales ploy, seemingly blissfully unaware of the indelible footprint left by their previous pitches. The accepted and favored Covid narrative is unwinding in real time as facts emerge to conflict with “expert opinion” and questionable manipulation, interpretation and presentation of data to support the narrative.

Unfortunately for healthcare, this event is occurring in the public arena and everyone is able to participate in its demise. The naysayers are circling, waiting to claim their pound of flesh and the justification is self-evident. No one likes being told what to do, no one likes their freedom compromised and least of all, no one enjoys being forced to participate in clinical experimentation, no matter the scale.

How do we fix this?

Healthcare is one of the most lucrative industries we have created and therein lies the problem. It is infinitely complex in it’s subject matter, continuously evolves and it is subject to huge financial and political influences, most of which are self-serving and rarely align with the interests of public health or the patient. Healthcare also uses a multi-layered approach to risk management by spreading accountability where possible. The WHO will assign their policies to SAGE documents, while SAGE will reference the CDC or FDA, who in turn will reference the WHO for the identical policies.

Medical-speak protects the industry and practitioners by erring on the side of caution and avoiding offering specific advice. Medical literature is overwhelmed with non-committal safe terms such as “may lead to”, “unlikely to”, “more likely” and my all time favorite, “when in doubt consult your doctor” Unfortunately, in times of crises, such as global pandemics, these factors all conspire to produce an industry that is incapable of producing clear, concise and honest medical advice to the planet’s denizens. There is a thoughtful piece on the subject from Medika’s editor regarding the CDC and their communication calamities that I recommend reading.

In short, the medical and healthcare professions are their own worst enemies when it comes to engaging the general public. Add the internet to the mix, and the results are calamitous, particularly when the industry attempts to promote an agenda by publishing questionable information.

After three years and billions spent on marketing, many members of the public still do not understand that the so called Covid “vaccines” do not offer any protection against infection from the SARS-COV2 virus. To have portrayed the treatments as inoculations rather than treatments would have been truthful, rather than trying to profit falsely from the established reputation of vaccines, now all but ruined.

Truth bears up under scrutiny, fictions do not, well intentioned or otherwise. Lie in the digital world and you will be found out.

Truth is the only way forward for the industry to regain trust and rebuild its relationship with the general public. Sadly, for this to occur, healthcare would need to free itself from the shackles imposed by political, pharmaceutical and other corporate interests seeking to benefit or enrich themselves at the expense of public health. Currently healthcare communication considers manipulation and marketing as being mutually inclusive. Neither are conducive to re-establishing trust. Manipulation reeks of an agenda and is easily exposed, while marketing suggests you are trying to sell something.

Healthcare exists to serve the patient and its sole communicative duty is to inform, factually, truthfully and accurately. That is all.

The post Restoring Credibility. Can We Ever Trust Healthcare Again? appeared first on Medika Life.

Opioid addiction and pain relief require massive health professional, patient, payor, policy and product innovator engagement.  The Food and Drug Administration has launched a new Overdose Prevention Framework, targeting unnecessary prescriptions, prolonged prescribing and counterfeit drugs, and supporting new treatments for substance use disorders and physician education.

But how can innovation be part of the public health and policy solution to create a balance between the imperative to monitor and reduce addiction risks?  How can innovation be part of the solution if regulators and payers do not partner with innovators?

Medika Life Editor-in-Chief Gil Bashe talks with serial entrepreneur and investor Jay Schiff, co-founder and CEO of Addinex Technologies, Inc., a young company focusing on one of the nation’s most pressing issues – opioids – to explore the possibilities and opportunities.

Jay is a Wall Street veteran who has invested more than $1 billion in small and mid-sized businesses. He has managed private investment businesses for Merrill Lynch, a $1 billion private equity firm, and a venture-backed finance company. Jay earned his BA in Economics from Cornell University and an MBA in Finance from New York University.

[Medika Life and FINN Partners have no business ties to Addinex Technologies.  This interview focuses on the critical role health innovators serve in exploring new paths to long-standing problems unaddressed.]

Gil Bashe: I understand you have engineered a dispensing system for opioids. Is that correct?

Jay Schiff:  Yes. I read several articles on the opioid epidemic and it struck me as odd that controlled substances like opioids were highly regulated and monitored until they got to the patient. From production to the pharmacy, they are treated as dangerous, with a high potential for abuse, but they were being dispensed with the same level of protection as Tylenol.

The child cap was invented in 1967. That’s more or less where the innovation stopped in terms of keeping the wrong people from accessing medication. And then what do you do with excess meds if you aren’t supposed to flush them down the toilet or throw them in the garbage, given 3.3 billion excess pills prescribed a year?

Bashe: The pill mills were, at first, just distributors filling the demand of the local marketplace of pharmacies. It’s sad how many people misuse opioids, how many people are addicted, and how many people tragically die each year. It’s one of the most significant causes of death in the United States. We can deal with this from a legal standpoint; we can deal with this from a policy standpoint; we can deal with this from an oversight standpoint, governance standpoint – you’ve chosen to deal with this from an engineering standpoint.

Schiff: Some things have been done from a legal and prevention standpoint. Certain states have limitations on initial opioid prescriptions – in New York; you can only get a seven-day supply. New Jersey is five days.

I talked to a doctor about that, and they said that’s not a limitation. If you prescribe a patient two pills every four hours, that’s 12 pills per day. Over seven days, that’s 84 pills: not much of a limitation. The reality is that doctors overprescribe opioids through no fault of their own.

Bashe: But we know that’s because many patients are in pain, and obviously, the doctors don’t want them to be in pain. But they also lack data.

Schiff:  Doctors don’t want their patients to be in pain, but does that mean they should give their patients 30 or even 90 pills? They can’t make an informed decision because that usage and pain level data is unavailable. Believe me. I searched everywhere.

If colleagues are prescribing 30 pills because they think that’s the correct number based on experience, that suddenly becomes the basis by which everyone prescribes.

But it’s not the correct method because we already know that doctors overprescribe after surgery, on average, by 70%, leading to 3.3 billion excess pills out there.

Good data is not available. The CDC put out guidelines in 2016. They’re now going back to the drawing board and coming up with updated guidelines. Again, it’s not based on actual usage data from the hundreds of millions of annual prescriptions; if it is based on some data, it’s just a tiny percentage of the whole picture.

Pain levels are also important. We did a study with Columbia University Medical Center where patients were asked, “What’s your pain level on a scale of zero to 10?” If their pain was a self-reported four or below, our app would automatically send them a message that their doctor would like them to switch to over-the-counter medication. At no time would we limit access, so the patient had no incentive to lie. We barely had any usage at those pain levels.

This feedback is essential because stats have shown that the longer you’re initially on opioids, the more likely you will become dependent on them. We can shorten that duration and therefore minimize the risk of dependency.

Opioids are supposed to be reserved for people suffering from severe pain. Other countries don’t use the same number of opioids as we do here. So, I think that data will help doctors more accurately prescribe and patients understand the risks of taking opioids for moderate pain versus switching to an OTC painkiller.

Bashe: Your dispenser system is password protected. The patient has a unique passcode for each dose they enter to get the medication dispenser as prescribed. How does that help? In other words, what’s to stop a cancer patient from accessing their meds and simply giving them away to other people?

Schiff: In its simplest form, you can think of our dispenser as a speed bump. If the prescription is one pill every four hours, the patient could put the code in, get the dose, set it aside, and wait four hours for each dose. That is a tedious way to collect the medication for diversion. Worst case scenario, they’re back to where they started since there are currently no protections.

Bashe: Let me clarify – you’ve developed a specially engineered pill, tablet, or capsule container, correct?

Schiff: Yes, and we’ve patented it. It’s entirely mechanical, and keeping the price as accessible as possible was essential. It can’t be zero, but we can get it out there to as many people as possible and then collect enough data to enable doctors to determine, “Here is the right amount to prescribe.”

Once we have enough data, a doctor can see, “I have a male patient between the ages of 20 and 30 weighing between 160 and 190 pounds. He’s had surgery to repair a torn ACL, and I want to prescribe him 10 milligrams of oxycodone every 4-6 hours a week.”

We can produce a graph of what similar patients have taken, and based on that information, combined with how similar patients have reported their pain level –  – the doctor can determine how much to prescribe. The doctor can always choose another amount, but they will have access to objective data to decide the right amount for their patient.

Bashe: And the dispenser itself is locked. In other words, the pills are placed in the dispenser and closed at the pharmacy. They are only accessible by way of the timed passcode, which releases a drug based upon the indication of use, according to the physician’s recommendation.

Schiff: Correct. It doesn’t automatically unlock every four hours, for example. The patient gets the unique code for that individual dose in the app, and they can’t get the next dose code until it’s been four hours and it’s time for that dose.

One important distinction for those taking opioids is that those drugs are not ones of adherence. They should be taken as needed, but the goal is to reduce the amount. That’s unlike many other drugs, where you want to keep them on a set schedule.

We can accommodate both, but for opioids, we don’t want to send reminders to take them when they are not necessarily needed. We want patients to use the app to request access when pain levels warrant another dose, and if the time is appropriate per the prescription, it will give them the code.

Bashe: So, this is not just a one-time code for a patient. It’s a one-time dose passcode, assuming pills are left in the dispenser.

Schiff: Yes. Releasing one dose at a time has multiple benefits. It makes overdose more difficult because patients can die if they take too many opioids at once. Tragically, we have a family friend who died after an overdose following major surgery. Also, the individual dose codes keep other people out of your medicine. Even if the interloper figures out a code, they can only access one dose.

Another significant benefit is that the patient must engage with the app to get each dose. This allows the app to provide education and collect information to help with their treatment and future patients. Many app-only solutions suffer from poor engagement with the app, but that is not a problem with our system.

Bashe: And is it purchased by pharmacy chains or drug manufacturers? Who is the customer for your dispensing system?

Schiff: The patient is the customer. We want to get it reimbursed by insurance, but we don’t have that today. It’s something we’re working on. The doctor prescribes and the patient receives it.

Bashe: Often, when we look at growth hormone and the injector, or insulin and the injector, the therapy is generic. Insulin is generic; the injector is the brand, growth hormone is the generic the injector is the prescribed product.  In this case, if someone prescribes a specific opioid, is the opioid generic, and the device itself is prescribed?

Schiff: Yes. It doesn’t go to any pharmacy; it has to be a pharmacy we’ve partnered with. They have to know not just to give a bottle with the pills but to get the pills in our system so we can monitor and dispense when appropriate, along with the disposal mailer.

When the patient is done taking their opioids, we remind them to return the dispenser with excess pills. The pharmacy doesn’t just send our device with the pills in it but also sends a DEA-approved disposal mailer.

After the pain is gone or low enough to use an OTC painkiller, the patient is asked to use the disposal mailer: close it up, drop it into a mailbox, or bring it to the post office. It goes back to a disposal company we have a partnership with, and upon receipt, they scan the mailer and a confirmation of receipt goes back into our app. Our partner then correctly disposes of the excess medication.

In the Columbia University Medical Center study I mentioned earlier, 80% of patients returned the device, representing 84% of excess pills. Compare that success rate with a Johns Hopkins meta-study, for example, where 4% and 9% of pills were correctly disposed of. 

Bashe: So the customer – the patient – receives the medication via Federal Express? “Sign here, please.”  The patient signs for the drug in the device and has to activate it; in other words, after I’ve received the device and registered on the app, I’m now letting Addinex Technologies, and the doctor know the device is in my hands.

Schiff: Because it’s a controlled substance, delivery requires a signature.  The patient then goes into the app, puts in their patient ID and the device ID, and if that matches up, the app gives them a unique code for each dose as it becomes available based on their prescription.

.Bashe: So you talked earlier about the challenge of payers. Is this because the device is not on the formulary with the medication? Payers are dealing with this challenge of effective pain management, and they get concerned about misuse, abuse, or addiction, putting them in the spotlight. What’s your specific challenge to the reimbursement?

Schiff: There isn’t a CPT code for a dispenser. It’s much more than a dispenser. We spoke with some of the payers early on in our process, and they expressed interest but wanted us to come back with hard data that shows our device achieves what we know it can. That is why we’ve been doing clinical studies. Columbia is now doing a phase II study and we’re working with two other major medical centers on other studies.

Bashe:  It sounds like your app provides the code like many security or multi-factor authentication systems. You’re emailed a code if you want to access PayPal on a new device. Sometimes they give you a one-time code for sending money as a security measure. It’s basic cyber security.

You’re operating in an area where people can accidentally misuse or intentionally abuse a product. Your work gives us data on what is going on between the patient and access to the pill.

Schiff: Yes, and I would add to that. We’re adapting our system to be able to dispense a drug called suboxone, which is widespread opioid addiction treatment. It comes in a film strip, and nobody could dispense it effectively before us.

For addiction patients, instead of asking them, for example, “What’s the pain level,” we can ask them, “What’s your craving level right now?”

If their craving levels are high the app can contact their doctor to alert them that the patient needs support.  We’ve added a video recording component, as well. It’s optional, but because the only way that doctors can currently confirm that patients who take suboxone or methadone are adhering to their prescription and not diverting it, is that they are required to get a urine analysis once a week or every other week. We can have the patient take a video of every dose that shows they’re taking it each time they say they are so their provider can track it.

It reduces liability for the doctor and keeps patients on track, knowing they’re accountable. Up to 28% of suboxone prescriptions get diverted, and we can help keep those patients on track. It’s hard to break an addiction, and if we can help keep them on medication-assisted treatment, that’s highly valuable.

Bashe: There is a saying that culture crushes innovation. What’s the culture around this topic, in your opinion?

Schiff: Glacial inertia. It’s a very slow process to change anything in this space.  

For example, many people have endorsed using the device for methadone treatment. Patients on methadone must go to a clinic every day and stand in line, sometimes requiring a long trip. It’s time-consuming and stigmatizing. Our system can provide more comfort than take-home methadone is properly used, but current regulations stand in the way.

I’ve been trying to speak with politicians to get their take on it, but it’s not easy. One of the things that we’re exploring is tapping into this vast amount of money coming from the opioid settlements.

Many states and localities plan to use the money to pay for Naloxone. Naloxone is a great drug to reverse overdoses, but there’s only so much money to spend on Narcan. There’s money available in these settlements to try new methods to prevent and treat opioid addiction.

Bashe:  My last question deals with technology and the digital divide. As you said, this dispensing technology is based on an app with a smartphone that connects to the device. Is that correct?

Schiff: It is, and I know where you might be going with your questions. It’s available on any smartphone, Android or iPhone. We’ll also soon be developing a version of our system for text and phone so that you don’t need a smartphone.  You text or call, put your information in, and it gives you back your code. The doctor can ask whatever questions they want to monitor your progress, just like with a smartphone. We want to make it as accessible as possible. We are also offering Spanish language in addition to English.

Bashe: How about seniors?

Schiff: That’s where the phone option comes in. That would make it easier. I will caveat that our study did not involve seniors, and though that’s typical for a study like this, that’s data we should get.

One of the interesting pieces of feedback that we got is that with a child-proof bottle, you have to push and turn it, which can be difficult for an older patient or one with an upper extremity injury or weakness. Our system solves that issue, but you’re right: we have to study this more with older people, people with arthritis, and other disabilities. We’re trying to make it as straightforward as possible, but it will not be perfect immediately. Also, doctors don’t have to prescribe it to patients who can’t easily use it.

Bashe: Yours is an exciting story of innovation. Historically we’ve looked at controlled drug monitoring systems that cast a suspicious eye on the patient. This system is not set up as, “Hey, I know you’re trying to scam the system, so I’ll make it super hard for you to get too drunk.”

This is “How do I make it appropriate to understand when you’re taking the drug and when you no longer need it.”

Schiff: That’s what we’re trying to do. Not everybody feels that way when they see the device, but the feedback was very good from the research, and people appreciated that someone was looking out for them.

Along with medical devices, technology can play a major role in helping health professionals overcome some of the pain medication addiction challenges.  However, the obstacles may not be engineering or generating sufficient clinical data from in-real world patient studies.  Federal regulators and payers need to jump aboard as allies. The barriers facing Jay Schiff and other innovators are similar – obtaining reimbursement coding, securing conversations with health professional associations and finding provider partners to test new ideas.  Along with innovation, collaboration may be among the essentials to success.

The post Policies and Policing Didn’t Stem Opioid Abuse – Can Tech Be A Solution? appeared first on Medika Life.

If you listen to the nation’s largest Alzheimer’s disease advocacy organizations, you might think everyone living with Alzheimer’s wants unfettered access to Aduhelm, a controversial new treatment.

But you’d be wrong.

Opinions about Aduhelm (also known as aducanumab) in the dementia community are diverse, ranging from “we want the government to cover this drug” to “we’re concerned about this medication and think it should be studied further.”

The Alzheimer’s Association and UsAgainstAlzheimer’s, the most influential advocacy organizations in the field, are in the former camp.

Both are pushing for Medicare to cover Aduhelm’s $28,000 annual cost and fiercely oppose the Centers for Medicare & Medicaid Services’ January proposal to restrict coverage only to people enrolled in clinical trials. Nearly 10,000 comments were received on that proposal, and a final decision is expected in April.

“With respect, we have no more time for debate or delay,” the Alzheimer’s Association national Early-Stage Advisory Group wrote in a Feb. 10 comment. “Every passing day without access to potential treatments subjects us to a future of irreversible decline.” For its part, UsAgainstAlzheimer’s called CMS’ proposal “anti-patient.”

Yet the scientific evidence behind Aduhelm is inconclusive, its efficacy in preventing the progression of Alzheimer’s remains unproved, and there are concerns about its safety. The FDA granted accelerated approval to the medication last June but ordered the drugmaker, Biogen, to conduct a new clinical trial to verify its benefit. And the agency’s decision came despite a 10-0 recommendation against doing so from its scientific advisory committee. (One committee member abstained, citing uncertainty.)

Other organizations representing people living with dementia are more cautious, calling for more research about Aduhelm’s effectiveness and potential side effects. More than 40% of people who take the medication have swelling or bleeding in the brain — complications that need to be carefully monitored.

The Dementia Action Alliance, which supports people living with dementia, is among them. In a statement forwarded to me by CEO Karen Love, the organization said, “DAA strongly supports CMS’s decision to limit access to aducanumab to people enrolled in qualifying clinical trials in order to better study aducanumab’s efficacy and adverse effects.”

Meanwhile, Dementia Alliance International — the world’s largest organization run by and for people with dementia, with more than 5,000 members — has not taken a position on Aduhelm. “We felt that coming out with a statement on one side or another would split our organization,” said Diana Blackwelder, its treasurer, who lives in Washington, D.C.

Blackwelder, 60, who was diagnosed with early-onset Alzheimer’s in 2017, told me, “To say that millions of people afflicted with a disease are all up in arms against CMS’s proposal is just wrong. We’re all individuals, not a collective.”

“I understand the need for hope,” she said, expressing a personal opinion, “but people living with dementia need to be protected as well. This drug has very serious, frequent side effects. My concern is that whatever CMS decides, they at least put in some guardrails so that people taking this drug get proper workups and monitoring.”

The debate over Medicare’s decision on Aduhelm is crucial, since most people with Alzheimer’s are older or seriously disabled and covered by the government health program.

To learn more, I talked to several people living with dementia. Here’s some of what they told me:

Jay Reinstein, 60, is married and lives in Raleigh, North Carolina. He was diagnosed with early-onset Alzheimer’s disease three years ago and formerly served on the national board of directors of the Alzheimer’s Association.

“I understand [Aduhelm] is controversial, but to me it’s a risk I’m willing to take because there’s nothing else out there,” Reinstein said, noting that people he’s met through support groups have progressed in their disease very quickly. “Even if it’s a 10% chance of slowing [Alzheimer’s] down by six months, I am still willing to take it. While I am progressing slowly, I want more time.”

Laurie Scherrer of Albertville, Alabama, was diagnosed with early-onset Alzheimer’s and frontotemporal dementia in 2013, at age 55.

Early on, she was prescribed Aricept (donepezil), one of a handful of medications that address Alzheimer’s symptoms. “I became totally confused and disoriented, I couldn’t think, I couldn’t concentrate,” she told me. After stopping the medication, those symptoms went away.

“I am not for CMS approving this drug, and I wouldn’t take it,” Scherrer said. At discussion groups on Aduhelm hosted by the Dementia Action Alliance (Scherrer is on the board), only two of 50 participants wanted the drug to be made widely available. The reason, she said: “They don’t think there are enough benefits to counteract the possible harms.”

Rebecca Chopp, 69, of Broomfield, Colorado, was diagnosed with early-onset Alzheimer’s in March 2019. She’s a former chancellor of the University of Denver.

Chopp is a member of a newly formed group of five people with dementia who meet regularly, “support one another,” and want to “tell the story of Alzheimer’s from our perspective,” she said.

Two people in the group have taken Aduhelm, and both report that it has improved their well-being. “I believe in science, and I am very respectful of the large number of scientists who feel that [Aduhelm] should not have been approved,” she told me. “But I’m equally compassionate toward those who are desperate and who feel this [drug] might help them.”

Chopp opposes CMS’ decision because “Aduhelm has been FDA-approved and I think it should be funded for those who choose to take it.”

Joanna Fix, 53, of Colorado Springs was diagnosed with early-onset Alzheimer’s disease in October 2016. She, too, developed serious complications after taking Aricept and another dementia medication, Namenda (memantine).

“I would love it if tomorrow somebody said, ‘Here’s something that can cure you,’ but I don’t think we’re at that point with Aduhelm,” Fix told me. “We haven’t been looking at this [drug] long enough. It feels like this is just throwing something at the disease because there’s nothing else to do.”

“Please, please take it from someone living with this disease: There is more to life than taking a magic pill,” Fix continued. “All I care about is my quality of life. My marriage. Educating and helping other people living with dementia. And what I can still do day to day.”

Phil Gutis, 60, of Solebury, Pennsylvania, has participated in clinical trials and taken Aduhelm for 5½ years after being diagnosed with early-onset Alzheimer’s in 2016.

He’s convinced the medication has helped him. “I don’t know how to describe it other than to say my head feels so much clearer now,” he told me. “I feel much more capable of doing things now. It’s not like I’ve gained my memories back, but I certainly haven’t deteriorated.”

Gutis thinks CMS’ proposed restrictions on Aduhelm are misguided. “When the FDA approved it, there was this sense of excitement — oh, we’re getting somewhere. With the CMS decision, I feel we are setting the field back again. It’s this constant feeling that progress is being made and then — whack.”

Christine Thelker, 62, is a widow who lives alone in Vernon, British Columbia. She was diagnosed with vascular dementia seven years ago and is a board member for Dementia Advocacy Canada, which supports restrictions on Aduhelm’s availability.

“Most of us who live with dementia understand a cure is not likely: There are too many different types of dementia, and it’s just too complicated,” Thelker told me. “To think we’re just going to take a pill and be better is not realistic. Don’t give us false hope.”

What people with Alzheimer’s and other types of dementia need, instead, is “various types of rehabilitation and assistance that can improve our quality of life and help us maintain a sense of hope and purpose,” Thelker said.

Jim Taylor of New York City and Sherman, Connecticut, is a caregiver for his wife, Geri Taylor, 78, who has moderate Alzheimer’s. She joined a clinical trial for Aduhelm in 2015 and has been on the drug since, with the exception of about 12 months when Biogen temporarily stopped the clinical trial. “In that period, her short-term memory and communications skills noticeably declined,” Jim Taylor said.

“We’re convinced the medication is a good thing, though we know it’s not helpful for everybody,” Taylor continued. “It really boosts [Geri’s] spirits to think she’s part of research and doing everything she can.

“If it’s helpful for some and it can be monitored so that any side effects are caught in a timely way, then I think [Aduhelm] should be available. That decision should be left up to the person with the disease and their care partner.”

[Also related to this story, please see: “Were the Billions Invested in Alzheimer’s Research Worthwhile?” by Medika Life editor-in-editor Gil Bashe.]

The post Patients Divided Over Alzheimer’s Drug: Is It a ‘Risk I’m Willing to Take’ or Just a ‘Magic Pill’? appeared first on Medika Life.

The drug industry, patient advocates, and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for patients taking the drug in a clinical trial.

The drug, Aduhelm, with a listed price tag of $28,500 a year, has had few takers in the medical world. Brain doctors are leery of administering the intravenous drug because it appears dangerous and largely ineffective. Many of the nation’s most prestigious hospitals — such as the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston — have declined to offer it to patients.

While groups representing the pharmaceutical industry and patients press to undo Medicare’s decision, industry critics applaud the Centers for Medicare & Medicaid Services for throwing obstacles in the way of a drug they think the FDA should never have approved in the first place.

For the industry, the campaign has a broader existential target: to prevent CMS from using its payment decisions to keep FDA-approved drugs off the market. In recent years, FDA programs to speed approval of new drugs have led to a rash of entries with often minimal scientifically sound evidence to prove they work, critics say.

The FDA’s own expert panel recommended against approving Aduhelm for that reason. Last June, the agency approved it anyway.

CMS then announced Medicare would pay only when the drug was used in further clinical trials to assess its true benefit. That Jan. 11 announcement has drawn more than 9,000 comments to the agency’s website — a tsunami compared with most approval decisions. The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer’s Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.

“If the FDA were doing its job, CMS wouldn’t have had to step in. But good for the CMS, they are helping to protect the public from drugs whose harms outweigh benefits,” said Dr. Adriane Fugh-Berman, a Georgetown University professor of pharmacology who directs PharmedOut, a group that publicizes what it sees as poor industry practices.

Aduhelm is the first FDA approval for a class of laboratory-made antibodies designed to clear away so-called amyloid plaques, which gradually accumulate in the brains of people with Alzheimer’s disease.

In clinical trials, Aduhelm did well dissolving the plaques, but its impact on the functioning of patients in earlier stages of Alzheimer’s was so meager that an expert panel voted 10-0 (an 11th panelist was uncertain) in November 2020 to advise FDA to reject it. The science is unclear about whether the presence of such plaques — a so-called surrogate marker — correlates with the mental functioning of patients.

As such, the FDA gave “provisional approval” to Biogen, the maker of Aduhelm, allowing it nine years to provide evidence that the drug slows the progression of Alzheimer’s. In that period, Biogen would make far more money than if the application had been rejected. Even under the CMS decision, it would reap Medicare payments from whatever is used in clinical trials, which would need to include thousands of participants to assess the drug’s performance.

Drug companies and pharma investors have responded to CMS’ ruling with special alarm because they have spent decades improving their relationships with the FDA, only to have CMS seemingly pull the rug out by exerting its own power over an expensive drug.

“The drug companies are worried that this could be a precedent for other drugs. And it should be,” Fugh-Berman said. “This isn’t just about money; it’s about protecting the public.”

This “accelerated approval” employed for Aduhelm got its start in 1992 and is aimed at moving promising new classes of drugs to the public faster. Companies whose drugs go through the process — more than 250 drugs or vaccines have been approved so far — are supposed to quickly gather evidence that the products likely improve health once they’re on the market. But such follow-up studies often lag or are never performed. For example, the makers of the Duchenne muscular dystrophy drug eteplirsen, approved in 2016, didn’t start recruiting patients into a post-marketing trial until 2020 and don’t expect results until 2026.

Biogen originally said it would get confirmatory results for Aduhelm within seven years of approval. In response to the Medicare decision, it promised to trim that to four years. The company also hinted that it might sue the agency, calling its decision “arbitrary and capricious.”

In the meantime, patients eager to get access to the drug are furious about the coverage decision. Jim Taylor, a New Yorker whose wife, Geri, says she improved on Aduhelm during a clinical trial, said Medicare had made an “unconscionable decision” that puts Alzheimer’s patients “on a dark roller coaster.”

Many patients’ groups are organized or at least funded and fueled by drugmakers, providing sympathetic stories that buttress a manufacturer’s commercial interests. Advocacy groups also receive large donations from the makers of certain drugs. A 2020 report by UsAgainstAlzheimer’s shows at least $900,000 in donations from monoclonal antibody producers. The Alzheimer’s Association’s top corporate donors — Biogen, Lilly, Eisai, and Genentech — all have monoclonal antibody candidates and have provided the group $1.6 million in fiscal year 2021.

These donations are a tiny part of the group’s funding, its policy director, Robert Egge, told KHN, and any alignment of its position with industry is “coincidental, because of what we and our constituents believe is right.”

The Taylors appeared at an online news event with activists from UsAgainstAlzheimer’s and the National Minority Quality Forum, a group focused on health inequities, who argued that the decision discriminated against Black and Hispanic patients, who are more likely to suffer from Alzheimer’s and less likely to join clinical trials. In fact, CMS demanded that evidence for Aduhelm be collected more extensively from minority patients. Biogen’s two major trials of the drug included only 19 Black patients out of a total of 3,285.

Groups representing people with Down syndrome wrote more than 1,000 letters to CMS because its decision requires that confirmatory trials exclude people who have additional neurological conditions. Rep. Cathy McMorris Rodgers, a top drug industry cash recipient and the leading Republican on the House Energy and Commerce Committee with significant sway over pharma issues, said at a hearing last week that it was “extremely concerning and unacceptable” that Down syndrome patients would be ineligible.

But neither Biogen nor any other drug company has recruited Down syndrome patients for a major trial of a monoclonal antibody treatment. AC Immune, a Swiss company, conducted a safety study last year on 16 people with Down syndrome.

It’s not surprising that groups representing those suffering from Alzheimer’s placed high hopes on the monoclonal antibody drugs, which have seemed like a ray in the darkness for the estimated 2 million Americans with early Alzheimer’s symptoms.

When asked why his group is so gung-ho about a product in which the medical profession shows such little confidence, Egge said the drug seems to have some benefits and that its risks — especially to patients who lack other means to slow a miserable, deadly disease — may be exaggerated. He acknowledged that 40% of patients in the biggest Aduhelm trial experienced brain swelling or bleeding, but Biogen’s research showed these resolved with no apparent harm in most cases.

That said, the sluggish purchases of the drug — which earned a modest $1 million in the last quarter of 2021 — signal the market is responding to its deficiencies.

In response to the lackluster response, Biogen halved its initial $56,000 price to $28,500. If CMS had granted full approval, that would have been followed by “marketing, marketing, marketing,” said Dr. Joseph Ross, a public health professor at Yale University. Hospitals that wanted to attract patient business for a lucrative infusion — patients receiving the drug also require brain scans and other tests and monitoring — could advertise their willingness to give Aduhelm.

CMS’ decision came under a policy called coverage with evidence development. Though the program began in 2005, Aduhelm is by far the most important product CMS has declined to reimburse without further study.

The agency’s decision “is a little inelegant” because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but “it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong.”

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“…the breakthroughs behind the vaccines unfolded over decades, little by little, as scientists across the world pursued research in disparate areas, never imagining their work would one day come together to tame the pandemic of the century.”

Scientific discovery doesn’t happen in an instant. It almost always results from bringing together knowledge accumulated over time. Coronavirus vaccines were actually the result of some two decades of research, 20 years of blood, sweat, tears and disappointment. That process, with its frustrations and eventual triumphs, is seen in the development of therapeutics for countless other diseases, Alzheimer’s among them.

We Stand to Lose Public Health Impact

Despite the nature of the drug development process, we’re now seeing naysayers gloat over deceleration of Biogen’s Alzheimer’s therapy, Aduhelm. There’s no lack of trade media obituaries and Monday-morning quarterbacks casting blame generously. It’s hard to understand their glee, since all of us — scientists, regulators, patients, caregivers, physicians, media and yes, even private and public payers who foot the health bills of people with dementia — stand to lose dearly if we don’t fully explore the drug’s potential impacts.

Adulhelm isn’t an isolated example. Remember Merck’s Mevacor? The first cholesterol-reducing statin to reach the market and precursor of more effective blockbusters, Mevacor finally passed regulatory muster after much FDA Advisory Committee hand wringing. The drug was marginally effective compared to later statin entries. Today, science has generated data from more than 20 statin trials with some 135,000 patients showing how statins compare to placebo or no medication. The results show an impressive 23 percent reduction in heart attacks — a truly meaningful result. Mevacor, substandard to follow-on statins, was the door-opener that saves millions of lives globally. Then the health system embraced its possibility.

Amyloid Plaque the Holy Grail for Alzheimer’s Drug Targets

Is there be a similar path forward for Alzheimer’s? The FDA concluded there could be, when in April 2021, they approved Adulhelm, the first drug cleared for Alzheimer’s use since 2003. But regulatory approval of the medicine meant more than hope for patients and their caregivers, and more than market success. Adulhelm offers the potential to finally, definitively identify the clinical catalyst for Alzheimer’s, and the opportunity to data from real-world use that could pave the way for other therapies.

We can’t afford not to solve the Alzheimer’s puzzle and to study this medication in a real-world setting. We are facing a veritable tsunami onslaught of Alzheimer’s cases as the vast generation of baby boomers ages, and this epidemic of dementia could bankrupt us. In the absence of effective medicines, the estimated cost of Alzheimer disease management in 2020 alone was $305 billion, expected to increase to more than $1 trillion in the next generation. That astronomical figure accounts for skilled nursing care, home healthcare and hospice care, among other expenses.

For close to 25 years, the theory that amyloid plaque is the primary cause of Alzheimer’s disease has dominated clinical research and drug development. For that quarter-century, scientists have neither been able to confirm or disprove that theory. We are at an inflection point where we must either confirm amyloid plaque as the cause of Alzheimer’s, or move on.

Approval of Aduhelm set the stage to do that, at last. When FDA decided to accelerate approval for Aduhelm, the first drug to reduce amyloid plaque, perhaps they did so in large part to stimulate the generation of sufficient data to inform our path forward on addressing dementia-related illnesses. In this way, Aduhelm may be more important to the future of Alzheimer’s drug development and public health than its very vocal critics realize.

Despite the critical role Aduhelm is poised to play in the future of Alzheimer’s research, the media has gleefully focused on making it a “poster drug.” When the Centers for Medicare and Medicaid Services (CMS) issued draft National Coverage Determination (NCD) for Aduhelm use and reimbursement for patients in randomized controlled trials it opened the door for the cascade of players around the table to think differently. While the CMS pathway for use creates a significant stumbling block to access for the Medicare patient population, it is also a call to organize around making clinical research economically possible. Balance for patient access must be struck.

Neurology’s Who Moved My Cheese Moment

There should be no celebration that CMS has narrowly defined how Alzheimer’s patients can gain access to Aduhelm. We should be disappointed. And yet, CMS’s action could actually be a catalyst for decision-makers in drug development companies, government agencies, academia, medicine and payers to work together. It is a collective opportunity to unite in a massive public health research project to determine if amyloid plaque is or is not a worthwhile surrogate target. This may be a “Who Moved My Cheese” moment.

In fighting COVID-19, a combination of competitive spirit and collaborative mindset made breakthrough treatments possible. The world community — fractured on many other things –recognized a common threat and mobilized. Here, the Federal government rallied to support drug developers through public funds, flexible regulatory decisions to speed access to experimental treatments and fostering collaboration to accelerate therapies for the virus. Just as we are succeeding in protecting lives from the virus, we can collaborate to overcome Alzheimer’s.

Have We Chased a Surrogate Target Clue for Naught?

For decades, we have studied Alzheimer’s disease and chased our tails. We have spent billions on research, yet our progress in this category is still defined by what doesn’t work. We mustn’t let this opportunity pass us by; too much is at stake. If Aduhelm is struggling to gain traction with private and public payers, we must work together to find a path to getting it to the patients who need it for their benefit and for the generation that follows. This could become a massive public health real-world evidence effort and in doing so provide answers to questions we have pondered for decades. We must harness data, talent and resources, working across political and geographic boundaries to better serve the people we seek to help.

Appearances can deceive. Just as the COVID-19 mRNA discoveries are not the result of the past two years but are the outcome of two decades of arduous trial and error in research, Alzheimer’s research is on a long path, that will also have setbacks and successes. The proven collaborative approach to addressing COVID-19 provides a lesson we must now apply to Alzheimer’s if we’re to meet the coming wave of cases that, if unchecked, will undoubtedly cripple us.

[My thanks to colleague John Bianchi for his review of this article.]

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