‘It gives people hope’

A man with ALS welcomes the chance to take part in a clinical trial that aims to speed up the development of new treatments.

‘It gives people hope’

When John Wilkinson sat down with his neurologist, he did not wait to hear his diagnosis.

Before the doctor could speak, John jumped in with the hard truth.

“I have ALS,” he said. “I have two to five years to live. There is no cure.”

Months of mysterious symptoms, visits to several doctors and test results led John and—his neurologist—to the diagnosis.

That was 18 months ago.

There is still no cure for amyotrophic lateral sclerosis—known as ALS or Lou Gehrig’s disease.

But John hopes an innovative new research program will speed the search for effective treatments.

In February, John became the first person at Spectrum Health to take part in the HEALEY ALS Platform Trial, a national study led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. Spectrum Health is one of 54 sites of the Northeast ALS Consortium approved by the U.S. Food and Drug Administration to administer the trial drug regimens.

A platform trial allows researchers to test multiple treatments simultaneously. This cuts the trial time by half and reduces the cost by 30%.

And people who take part in a platform trial are more likely to receive an investigational drug—instead of a placebo—than in a typical clinical trial.

The platform trial model has been used in cancer research, but this is the first time investigators have used the approach to test ALS treatments.

“Since this is a disease that has urgency to it, there has been a clamoring for a better way to move promising compounds and other therapies through the pipeline more efficiently,” said Paul Twydell, DO, the director of neuromuscular medicine for Spectrum Health.

“It is our hope that the trial will bring us closer to the development of advanced treatments for ALS.”

ALS is a lethal disorder that affects the nerves that control the muscles. It affects about 30,000 people in the U.S. and 500,000 worldwide.

Speeding up research is crucial for those with the condition. As John noted to his doctor, people who have ALS live, on average, two to five years after their diagnosis.

Three ALS treatments have received approval from the FDA.

“Only two of them actually slow the disease down,” Dr. Twydell said.

The third medication treats the emotional outbursts that sometimes occur with ALS.

“That is all we have,” he said. “There have been a lot of medicines looked at over the years. And a lot of failures.”

‘The most active person’

John, 64, grew up in Oklahoma and moved to Michigan in the early 1980s for a job in the oil and gas industry. Now retired, he lives in Grand Rapids with his fiancee, Barbara Harvey.

“He used to be the most active person I know,” Barbara said. “He averaged 25,000 steps a day.”

John shook his head and laughed.

“It was only about 19,000 steps a day,” he said.

There is no doubt John loved to be active. On a typical day, he played pickleball for several hours in the morning and then headed to the YMCA for a workout.

In early 2019, he noticed weakness in his left hand. He underwent carpal tunnel surgery, but his hand strength did not improve. In fact, it grew worse.

After consulting other specialists, he met with a neurologist and underwent an electromyography test to assess his muscles and the motor neurons that control them.

A couple of months later, he had a second EMG to compare with the first.

That test led to the diagnosis of ALS.

He knew little about the disease until that moment. As he researched it, he became overwhelmed by what he learned.

When his neurologist suggested he get a second opinion, John replied: “No. I’ll just pretend like you’re wrong.’”

But John continued to learn all he could about ALS. He receives care from the ALS-Neuromuscular Disease Clinic at Spectrum Health, a multidisciplinary clinic designated a Certified Treatment Center of Excellence by the ALS Association.

The clinic brings together specialists in neurology, respiratory therapy, nutrition, social work, nursing and occupational, speech and physical therapy.

Patients typically meet with the team every three months.

“We address things before they become an issue,” Dr. Twydell said. “We are thinking three to six months ahead of the disease.”

John has equipment to adapt to the changes brought by ALS. Breathing treatments help clear his lungs. He has specially designed plates and silverware that make it easier to eat since he has weakness in both hands now.

He and Barbara recently moved into a condominium with the kitchen, bedroom and living areas all on one floor.

Although he can still walk, a power wheelchair is ready in his den for the day when his mobility is more affected.

He also plans to get a feeding tube, knowing that the disease will continue to make swallowing more difficult.

“We try to live one day at a time and not worry about the future,” Barbara said. “On the other hand, people say to get ahead of this.”

Maintaining that balance is not easy with a disease that causes progressive deterioration of abilities.

“ALS stands for ‘you are always losing something,’” John said.

“There’s never a good time to get a terminal disease diagnosis. It’s hard at first. But you get over it after a while.

“You try to make the best of every day.”

An experimental treatment

Through social media, John connected with other people who have ALS and their caregivers. That is how he learned about the Healey platform trial, which began enrolling its first patients in August 2020.

The research team now is testing four medications, while evaluating other experimental treatments for possible inclusion in the trial.

The medications include: Zilucoplan, a small macrocyclic peptide inhibitor of complement component 5 [C5]; Verdiperstat, an oral myeloperoxidase inhibitor; CNM-Au8 nanocrystalline gold, an intracellular nanocatalyst to support cellular bioenergetics; and pridopidine, a highly selective Sigma-1 receptor.

The trial will include 160 patients in each regimen. Patients are randomly assigned to receive either the investigative treatment or a placebo for 24 weeks.

In a typical clinical trial, half the patients receive a placebo and half receive the investigational medication.

In the Healey platform trial, for every three patients receiving active treatment, one additional patient receives a placebo.

For John, that means, “There is a 75% chance that I have the drug.”

On a table in his kitchen, John has a box that holds 32 smaller boxes. Inside each one are two small bottles containing a dark liquid—either the investigational drug, CNM-Au8 nanocrystalline gold, or a placebo.

Every morning, he pours the liquid into a wineglass and drinks it.

“It tastes like paper,” he said.

At first, John hoped he was taking the investigational drug—not the placebo. After 14 weeks, he is not so sure.

“As it turns out, I am progressing, which in ALS is a bad word,” he said. “I have almost changed my opinion. I kind of hope I have the placebo because the real drug might be better.”

After their 24 weeks in the clinical trial ends, patients have the option to take the experimental drug. And that is another unusual feature of the Healey trial—and a big plus for John.

“We need a cure or better treatments. It was 80 years ago that Lou Gehrig had this,” he said, referring to the New York Yankees baseball player who died of ALS in 1941. “And we are as bad off as he was 80 years ago—in terms of a cure.”

It is good that researchers are evaluating other treatments through the Healey platform trial, he said.

“The Healey trial is so much better than every other trial,” he said. “We are lucky that Spectrum Health is involved. It gives people hope.”

Source : Health Beat More   

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We Have a Way Bigger Problem Than “Disinformation”

This article was originally published here. My Jewish father was an old country lawyer who believed deeply in fairness and justice for all living people, so I was curious what he thought about the Nazis. It was spring of 1977, and the American Nazi Party had announced their intention to hold a July 4th rally in the town of Skokie, a predominantly Jewish community in Illinois. Not surprisingly, the town of Skokie had sought an injunction to ban the rally, and the Nazis had, ironically, sought the help of the American Civil Liberties Union (ACLU) to fight the injunction. The subject at the family dinner table was this: Should the American Civil Liberties Union protect the free-speech rights of Nazis? Remember, we’re of Jewish heritage, so it’s hard to look at the philosophical issues involved objectively because there’s so much emotion attached to the subject matter. Nonetheless, I’ll never forget my father’s response: “They have to defend them,” he said of the ACLU’s decision to fight the ban on behalf of the Nazi Party. “Free speech isn’t just for people you agree with.” It isn’t. Free speech is about vigorously defending the rights of people with whom you disagree. “Censorship almost always creates more damage than whatever’s being censored would’ve caused,” my father told me. Right now, the country is bitterly and tragically divided over the challenges associated with COVID. I want to suggest that we’re facing a bigger challenge — equally terrifying, but one on which we can and should be united: the quietly emerging challenges to our free speech. There’s a below-the-radar increase in censorship and “de-platforming” taking place right now, and it’s making disturbing inroads into our First Amendment rights. Exhibit A: Last month, Dr. Joseph Mercola — one of the most influential voices in integrative medicine and the owner of the number one natural health website in the world — felt he had no choice but to remove over 20 years of content from his website, content that I and many other people have found immensely valuable over the past two decades. Among other things, Dr. Mercola was known for exposing his readers to brilliant but renegade thinkers like Kilmer McCully, M.D., the professor who was basically de-platformed out of his lab at Harvard for advocating the view that homocysteine was as serious a risk factor for coronary heart disease as cholesterol, a piece of “disinformation” that did not sit well with the establishment. Postscript: Dr. McCully was welcomed back to Harvard after about two decades of subsequent research essentially proved he was right all along.1 But I digress. Dr. Mercola explained why he’s taking down the content on his site in a disturbing video on YouTube,2 the crux of which is that he could no longer endure the backlash (some might say persecution) he was enduring for publishing information that questioned conventional narratives on nutrition and health — information that has been come to be branded “disinformation”. By backlash, I’m talking threats on his life. He believes this is probably due to a New York Times hatchet piece — and I don’t use that term lightly — that labeled him number one on its list of top “disseminators of disinformation” on health-related issues. If you’d like an example of the dangerous misinformation that brought death threats to members of the Mercola organization, take a look at one of the FDA’s warning letters to Dr. Mercola, which states that he is illegally selling products — specifically vitamin C, vitamin D and quercetin — intended to “mitigate, prevent, treat, diagnose or cure COVID-19”.3 Never mind a recent published paper entitled “Vitamin D Insufficiency May Account for Almost Nine of Ten COVID-19 Deaths: Time to Act”4 or that, according to Medscape, vitamin D deficiency quadruples the death rate from COVID.5 Apparently, the FDA and the NY Times have decided that Joe Mercola is guilty of what’s turning out to be the defining sin of the 21st century: Disinformation. I wonder if that word scares you as much as it does me. See, I was a kid during the cold war, and one of the things we used to read about was how the Soviet Union would send dissidents to “re-education” camps. They had to be “re-educated” because they were filled with all sorts of subversive ideas (like communism was terrible) and had to be “set straight” and rehabilitated before they could be allowed to re-enter society. Re-education? Disinformation? It sounds like North Korea to me. The entire concept should be chilling to any American, and I don’t care where you stand on vaccination — or on anything else! Look, I know there are exceptions to the free speech rule — my father always used to say that free speech doesn’t include the right to yell “Fire!” in a crowded theatre — but we’re not talking about those one-off cases. We’re talking about something much, much more insidious. Who Decides What’s Disinformation? The minute y

We Have a Way Bigger Problem Than “Disinformation”

This article was originally published here.

My Jewish father was an old country lawyer who believed deeply in fairness and justice for all living people, so I was curious what he thought about the Nazis.

It was spring of 1977, and the American Nazi Party had announced their intention to hold a July 4th rally in the town of Skokie, a predominantly Jewish community in Illinois. Not surprisingly, the town of Skokie had sought an injunction to ban the rally, and the Nazis had, ironically, sought the help of the American Civil Liberties Union (ACLU) to fight the injunction.

The subject at the family dinner table was this: Should the American Civil Liberties Union protect the free-speech rights of Nazis? Remember, we’re of Jewish heritage, so it’s hard to look at the philosophical issues involved objectively because there’s so much emotion attached to the subject matter. Nonetheless, I’ll never forget my father’s response:

“They have to defend them,” he said of the ACLU’s decision to fight the ban on behalf of the Nazi Party. “Free speech isn’t just for people you agree with.”

It isn’t. Free speech is about vigorously defending the rights of people with whom you disagree.

“Censorship almost always creates more damage than whatever’s being censored would’ve caused,” my father told me.

Right now, the country is bitterly and tragically divided over the challenges associated with COVID. I want to suggest that we’re facing a bigger challenge — equally terrifying, but one on which we can and should be united: the quietly emerging challenges to our free speech. There’s a below-the-radar increase in censorship and “de-platforming” taking place right now, and it’s making disturbing inroads into our First Amendment rights.

Exhibit A: Last month, Dr. Joseph Mercola — one of the most influential voices in integrative medicine and the owner of the number one natural health website in the world — felt he had no choice but to remove over 20 years of content from his website, content that I and many other people have found immensely valuable over the past two decades.

Among other things, Dr. Mercola was known for exposing his readers to brilliant but renegade thinkers like Kilmer McCully, M.D., the professor who was basically de-platformed out of his lab at Harvard for advocating the view that homocysteine was as serious a risk factor for coronary heart disease as cholesterol, a piece of “disinformation” that did not sit well with the establishment.

Postscript: Dr. McCully was welcomed back to Harvard after about two decades of subsequent research essentially proved he was right all along.1 But I digress.

Dr. Mercola explained why he’s taking down the content on his site in a disturbing video on YouTube,2 the crux of which is that he could no longer endure the backlash (some might say persecution) he was enduring for publishing information that questioned conventional narratives on nutrition and health — information that has been come to be branded “disinformation”.

By backlash, I’m talking threats on his life. He believes this is probably due to a New York Times hatchet piece — and I don’t use that term lightly — that labeled him number one on its list of top “disseminators of disinformation” on health-related issues.

If you’d like an example of the dangerous misinformation that brought death threats to members of the Mercola organization, take a look at one of the FDA’s warning letters to Dr. Mercola, which states that he is illegally selling products — specifically vitamin C, vitamin D and quercetin — intended to “mitigate, prevent, treat, diagnose or cure COVID-19”.3

Never mind a recent published paper entitled “Vitamin D Insufficiency May Account for Almost Nine of Ten COVID-19 Deaths: Time to Act”4 or that, according to Medscape, vitamin D deficiency quadruples the death rate from COVID.5

Apparently, the FDA and the NY Times have decided that Joe Mercola is guilty of what’s turning out to be the defining sin of the 21st century: Disinformation. I wonder if that word scares you as much as it does me.

See, I was a kid during the cold war, and one of the things we used to read about was how the Soviet Union would send dissidents to “re-education” camps. They had to be “re-educated” because they were filled with all sorts of subversive ideas (like communism was terrible) and had to be “set straight” and rehabilitated before they could be allowed to re-enter society.

Re-education? Disinformation? It sounds like North Korea to me. The entire concept should be chilling to any American, and I don’t care where you stand on vaccination — or on anything else!

Look, I know there are exceptions to the free speech rule — my father always used to say that free speech doesn’t include the right to yell “Fire!” in a crowded theatre — but we’re not talking about those one-off cases. We’re talking about something much, much more insidious.

Who Decides What’s Disinformation?

The minute you accept the notion of “disinformation” you automatically buy into the notion that there’s one truth. (In fact, if you google “opposite of disinformation,” the first word that appears is “truth,” followed by “facts”).

Now, you might say, “What’s wrong with that?” But the problem is, facts don’t “speak for themselves.” Facts are impartial, and always have to be interpreted. Otherwise, they’re just numbers without context — they have to be woven into a narrative. And as we all know, it’s possible for intelligent people, acting in good faith, to look at the exact same facts and come up with very different narratives.

As the Nobel-prize winning psychologist Daniel Kahneman, Ph.D., has taught us, we rarely if ever make decisions based on facts and data.6 Our decisions, conclusions and interpretations are subject to cognitive distortions such as confirmation bias, hindsight bias, and availability bias. It’s been well-documented that people see what they expect to see — if you doubt it, look at the results of the classic “invisible gorilla” experiment, which you can actually watch on YouTube.7

The fact that there are multiple “readings” of the same data, multiple perspectives and interpretations of facts may be confusing, but is ultimately a good thing. And guess what? I want to be able to hear all those interpretations. And so should you. Be suspicious — and frightened — when the powers that be don’t want you to hear them.

When you buy into the notion that there is one clear-cut truth in science, health, and medicine, without nuance, shading, or consideration of alternate perspectives — you have to answer a very uncomfortable question: Who decides what the “truth” is going to be? And … for how long it’s going to be “true”?

I’d like anyone reading this who is familiar with the history of science and has read The Structure of Scientific Revolutions8 to tell me that they think that what we now think is absolutely true about the Coronavirus — or any other health issue, for that matter — is likely to remain “absolutely true” 100 years from now.

Few things in health and medicine pass that test. Remember, as recently as 50 years ago, we thought it was “absolutely true” that low-fat diets prevented obesity and heart disease. To say otherwise was to be spreading disinformation. You remember how well that worked out.

Cholesterol “Disinformation?”

I know this all to be true from personal experience. For the past decade or so, I’ve been making the case that cholesterol does not cause heart disease, that too many people are on statin drugs unnecessarily, that saturated fat does not clog arteries, and that our myopic focus on an outdated HDL-LDL lab test is causing us to take our eye off the ball when it comes to doing what we can actually do to prevent heart disease.

When cardiologist Steven Sinatra, M.D., and I originally appeared on The Dr. Oz Show, a committee of doctors wrote in saying we should be banned from television. (“Cancel culture” hadn’t come into vogue yet, but that’s what they were asking for!)

I appeared — with a dozen smart, credentialed people, including professors from places like Harvard Medical School — in a documentary9 produced by the Australian Broadcasting Company and hosted by a television journalist with a Ph.D. from Columbia Journalism School that reasonably questioned the conventional wisdom of cholesterol and statin drugs.

There was a coordinated campaign in Australia to remove the video from YouTube — a campaign that was briefly successful. A PR firm planted headlines in the local papers saying essentially that “31,000 people would die” if they followed the disinformation in the documentary. We were essentially cancelled and de-platformed.

And when Dr. Timothy Noakes — one of the most respected medical researchers and professors in South Africa — began to question the high-carb diet and recommended high-fat for his patients, the powers that be attempted to take his license and deplatform him for going against “standard medical practice” and giving advice that was “unscientific.”

This resulted in a four-year trial, thousands of pages of scientific articles entered as evidence, and two international witnesses being flown in, all of which led to the total vindication of Dr. Noakes and the restoration of his license.10 Turns out Dr. Noakes was right all along — and we’d never have known it if he had been silenced.

It doesn’t matter if you agree with me about cholesterol, or if you agree with the people who disagree with me, or if you agree with Dr. Noakes about the benefits of high-fat diets, or with Dr. Mercola about the benefits of vitamin D3, and it doesn’t matter where you stand on vaccinations. The cost of silencing dissident voices is simply greater than whatever damage could be done by people spouting ideas that the establishment does not agree with.

If you don’t object vehemently to the censorship of ideas expressed in writing, speaking, and video, you are essentially agreeing to the idea of a Truth Police, because somebody’s got to make the decision on what constitutes disinformation.

Who shall that be? The people who work at YouTube and Facebook? The government? The American Heart Association? The Scientologists? The Anti-Scientologists? The Vegans? The Carnivores? Democrats? Republicans? I vote for none of the above!

The only way to not have to solve the awful Rubik Cube problem of who shall be the “Truth Police” is this: Eliminate the position. We don’t need truth police. We need to be able to hear all lawful points of view on any subject and we need to start reading up on things and trusting ourselves to make our own judgements.

And, as long as I’m dreaming, wouldn’t it be nice for us to all make our judgements and arrive at our opinions without being so attached to our tribe’s version of the truth? Wouldn’t it be nice if we could hold our positions on health matters in a space that allowed us to modify our positions when new data and interpretations present themselves?

OK, I know that’s a fantasy, but it’s how science actually works. Science is the practice of questioning things, constantly — offering alternative hypotheses to accepted “wisdom,” and then testing those new hypotheses. If you don’t hold “conventional wisdom” up to examination, then you’re not doing science, you’re doing propaganda. Questioning is how we grow our knowledge base in the first place.

You can’t do that if you silence the questioners. “Disinformation?” Bring it on! I want to hear all points of view. I’ll disregard the ones I think are crazy, but I want the opportunity to decide for myself what makes sense and what doesn’t, and I want you to have that same opportunity.

No matter where we stand on other matters, I hope we can stand together for “open borders” in the marketplace of health information.

Source : Mercola More   

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