Americans Fell for a Theranos-Style Scam 100 Years Ago. Will We Ever Learn?
The huckster understands what people want – an easy route to good health -- and figures out just how to provide it as long as no one asks too many questions.
"Americans are very much prone to this sort of thinking: Give me a pill or give me a magical bean that can make me lose weight!"
The keys to success: Hoopla, fancy technology, and gullibility. And oh yes, one more thing: a blood sample. Well, lots and lots of blood samples. Every testing fee counts.
Sound familiar? It could be the story of the preternaturally persuasive Elizabeth Holmes, the disgraced founder of Theranos who stands accused of perpetrating a massive blood-testing fraud. But this is a different story from a different time, one that dates back 100 years but sounds almost like it could unfold on the front page of The Wall Street Journal today.
The main difference: Back then, watchdogs thought they'd be able to vanquish fake medicine and scam science. Fat chance, it turned out. It seems like we're more likely to lose-weight-quick than make much of a dent into quackery and health fraud.
Why? Have we learned anything at all over the past century? As we sweep into a new decade, experts says we're not as advanced as we'd like to think. But the fight against fraud and fakery continues.
Quackery: As American As America Itself
In the 17th century, British healers of questionable reputation got a new name -- "quack," from the Dutch word "quacksalver," which originally referred to someone who treats others with home remedies but developed a new meaning along the lines of "charlatan." And these quacks got a new place to sell their wares: the American colonies.
By 1692, a Boston newspaper advertised a patent medicine that promised to cure "the Griping of the Guts, and the Wind Cholick" and – for good measure – "preventeth that woeful Distemper of the Dry Belly Ach." A couple centuries later, the most famous woman in the United States wasn't a first lady or feminist but a hawker of nostrums named Lydia Estes Pinkham whose "vegetable compound" promised to banish "female complaints." One advertisement suggested that the "sure cure" would have saved the life of a Connecticut clergyman whose wife killed him after suffering from feminine maladies for 16 years.
By the early 20th century, Americans were fascinated by electricity and radiation, and both healers and hucksters embraced the new high-tech era. Men with flagging libidos, for example, could irradiate their private parts with the radioactive Radiendocrinator or buy battery-powered electric belts equipped with dangling bits to supercharge their, um, dangling bits.
The Rise of the Radio Wave 'Cure'
Enter radionics, the (supposed) science of better health via radio waves. The idea was that "healthy people radiate healthy energy," and sickness could be reversed through diagnosis and re-tuning, write Dr. Lydia Kang and Nate Pedersen in their 2017 book "Quackery: A Brief History of the Worst Ways to Cure Everything."
Detecting illness and fixing it required machinery -- Dynamizers, Radioclasts and Oscillocasts – that could cost hundreds of dollars each. Thousands of physicians bought them. Fortunately, they could work remotely, for a fee. The worried-and-potentially-unwell just needed to send a blood sample and, of course, a personal check.
Sting operations revealed radionics to be bogus. A skeptic sent a blood sample to one radionics practitioner in Albuquerque who reported back with news of an infected fallopian tube. In fact, the blood sample came from a male guinea pig. As an American Medical Association leader reported, the guinea pig "had shown no female characteristics up to that time, and a postmortem examination yielded no evidence of ladylike attributes."
When Quackery Refused to Yield
The rise of bogus medical technology in the early 20th century spawned a watchdog industry as organizations like the American Medical Association swept into action, said medical historian Eric Boyle, author of 2012's "Quack Medicine: A History of Combating Health Fraud in Twentieth-Century America."
"When quackery was recognized as a major problem, the people who campaigned for its demise were confident that they could get rid of it," he said. "A lot of people believed that increased education, the truths of science, and laws designed to protect consumers would ultimately drive quackery from the marketplace. And then throughout the century, as modern medicine developed, and more effectively treated one disease after another, many observers remained confident in that prediction."
There's a bid to "flood the information highway with truth to turn the storm of fake promotional stuff into a trickle."
But fake medicine persisted as Americans continued their quest to get- healthy-quick… or get-rich-quick by promising to help others to get- healthy-quick. Even radionics refused to die. It's still around in various forms. And, as the Theranos scandal reveals, we're still hoping our blood can offer the keys to longevity and good health.
Why Do We Still Fall for Scams?
In our own era, the Theranos company rose to prominence when founder and CEO Elizabeth Holmes convinced journalists and investors that she'd found a way to cheaply test drops of blood for hundreds of conditions. Then it all fell apart, famously, when the world learned that the technology didn't work. The company has folded, and Holmes faces a federal trial on fraud charges this year.
"There were a lot of prominent, very smart people who bought into the myth of Elizabeth Holmes," a former employee told "60 Minutes," even though the blood tests never actually worked as advertised.
Shouldn't "prominent, very smart people" know better? "People are gullible," said Dr. Stephen Barrett, a psychiatrist and leading quack-buster who runs the QuackWatch website. But there's more to the story. According to him, we're uniquely vulnerable as individuals to bogus medicine.
Scam artists specifically pinpoint their target audiences, such as "smart people," desperate people and alienated people, he said.
Smart people, for example, might be overconfident about their ability to detect fraud and fall for bogus medicine. Alienated people may distrust the establishment, whether it's the medical field or government watchdogs, and be more receptive to alternative sources of information.
Dr. Barrett also points a finger at magical thinking, which comes in different forms. It could mean a New Age-style belief that our minds can control the world around us. Or, as professional quack-buster Alex Berezow said, it could refer to "our cultural obsession with quick fixes."
"Americans are very much prone to this sort of thinking: Give me a pill or give me a magical bean that can make me lose weight! But complex problems need complex solutions," said Berezow, a microbiologist who debunks junk science in his job as a spokesman for the American Council on Science & Health.
American mistrust of expertise makes matters worse, he said. "When I tell people they need to get vaccinated, I'm called a shill for the pharmaceutical industry," he said. "If I say dietary supplements generally don't work, I'm a shill for doctors who want to keep people sick."
What can ordinary citizens do to protect themselves from fake medicine? "You have to have a healthy skepticism of everything," Berezow said. "When you come across something new, is someone trying to take advantage of you? It's a horrible way to think about the world, but there's some truth to it."
"Like any chronic disease, we will have to live with it while we do our best to fight it."
The government and experts have their own roles to play via regulation and education, respectively. For all the criticism it gets, the Food & Drug Administration does serve as a bulwark against fakery in prescription medicine. And while celebrities like Gwyneth "Goop" Paltrow hawk countless questionable medical products on the Internet, scientists and physicians are fighting back by using social media as a tool to promote the truth. There's a bid to "flood the information highway with truth to turn the storm of fake promotional stuff into a trickle," said Dr. Randi Hutter Epstein, a writer in residence at Yale School of Medicine and author of 2018's "Aroused: The History of Hormones and How They Control Just About Everything."
What's next? Like death, taxes and Cher, charlatans are likely to always be with us. Boyle quoted the late William Jarvis, a pioneering quack-buster in the late 20th century who believed health fraud would never be eradicated: "Like any chronic disease, we will have to live with it while we do our best to fight it."
Podcast: Pfizer's Head of Medicine Design Discusses the Newly Authorized Anti-Covid Pill
The "Making Sense of Science" podcast features interviews with leading medical and scientific experts about the latest developments and the big ethical and societal questions they raise. This monthly podcast is hosted by journalist Kira Peikoff, founding editor of the award-winning science outlet Leaps.org.
This month, Pfizer's Head of Medicine Design shares timely insights on this important breakthrough, including how the pill works, the impressive results of the recent studies, its encouraging profile against Omicron, its expected ability to be effective for both vaccinated and unvaccinated individuals, and why it could alter the trajectory of the pandemic in 2022.
Watch the 60-second trailer
LISTEN TO THE WHOLE EPISODE:
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
People With This Rare Disease Can Barely Eat Protein. Biotechnology May Change That.
Imagine that the protein in bread, eggs, steak, even beans is not the foundation for a healthy diet, but a poison to your brain. That is the reality for people living with Phenylketonuria, or PKU. This cluster of rare genetic variations affects the ability to digest phenylalanine (Phe), one of the chemical building blocks of protein. The toxins can build up in the brain causing severe mental retardation.
Can a probiotic help digest the troublesome proteins before they can enter the bloodstream and travel to the brain? A Boston area biotech start up, Synlogic, believes it can. Their starting point is an E. coli bacterium that has been used as a probiotic for more than a century. The company then screened thousands of gene variants to identify ones that produced enzymes most efficient at slicing and dicing the target proteins and optimized them further through directed evolution. The results have been encouraging.
But Christine Brown knew none of this when the hospital called saying that standard newborn screening of her son Connor had come back positive for PKU. It was urgent that they visit a special metabolic clinic the next day, which was about a three-hour drive away.
“I was told not to go on the Internet,” Christine recalls, “So when somebody tells you not to go on the Internet, what do you do? Even back in 2005, right.” What she saw were the worst examples of retardation, which was a common outcome from PKU before newborn screening became routine. “We were just in complete shell shock, our whole world just kind of shattered and went into a tail spin.”
“I remember feeding him the night before our clinic visit and almost feeling like I was feeding him poison because I knew that breast milk must have protein in it,” she says.
“Some of my first memories are of asking, ‘Mommy, can I eat this? There were yes foods and no foods.'"
Over the next few days the dedicated staff of the metabolic clinic at the Waisman Center at the University of Wisconsin Madison began to walk she and husband Kevin back from that nightmare. They learned that a simple blood test to screen newborns had been developed in the early 1960s to detect PKU and that the condition could be managed with stringent food restrictions and vigilant monitoring of Phe levels.
Everything in Your Mouth Counts
PKU can be successfully managed with a severely restricted diet. That simple statement is factually true, but practically impossible to follow, as it requires slashing protein consumption by about 90 percent. To compensate for the missing protein, several times a day PKU patients take a medical formula – commonly referred to simply as formula – containing forms of proteins that are digestible to their bodies. Several manufacturers now add vitamins and minerals and offer a variety of formats and tastes to make it more consumer friendly, but that wasn't always the case.
“When I was a kid, it tasted horrible, was the consistency of house paint. I didn't think about it, I just drank it. I didn't like it but you get used to it after a while,” recalls Jeff Wolf, the twang of Appalachia still strong in his voice. Now age 50, he grew up in Ashland, Kentucky and was part of the first wave of persons with PKU who were identified at birth as newborn screening was rolled out across the US. He says the options of taste and consistency have improved tremendously over the years.
Some people with PKU are restricted to as little as 8 grams of protein a day from food. That's a handful of almonds or a single hard-boiled egg; a skimpy 4-ounce hamburger and slice of cheese adds up to half of their weekly protein ration. Anything above that daily allowance is more than the body can handle and toxic levels of Phe begin to accumulate in the brain.
“Some of my first memories are of asking, ‘Mommy, can I eat this? There were yes foods and no foods,’” recalls Les Clark. He has never eaten a hamburger, steak, or ribs, practically a sacrilege for someone raised in Stanton, a small town in northeastern Nebraska, a state where the number of cattle and hogs are several-fold those of people.
His grandmother learned how to make low protein bread, but it looked and tasted different. His mom struggled making birthday cakes. “I learned some bad words at a very young age” as mom struggled applying icing that would pull the cake apart or a slice would collapse into a heap of crumbs, Les recalls.
Les Clark with a birthday cake.
Courtesy Clark
Controlling the diet “is not so bad when you are a baby” because that's all you know, says Jerry Vockley, Director of the Center for Rare Disease Therapy at Children's Hospital of Pittsburgh. “But after a while, as you get older and you start tasting other things and you say, Well, gee, this stuff tastes way better than what you're giving me. What's the deal? It becomes harder to maintain the diet.”
First is the lure of forbidden foods as children venture into the community away from the watchful eyes of parents. The support system weakens further when they leave home for college or work. “Pizza was mighty tasty,” Wolf' says of his first slice.
Vockley estimates that about 90 percent of adults with PKU are off of treatment. Moving might mean finding a new metabolic clinic that treats PKU. A lapse in insurance coverage can be a factor. Finally there is plain fatigue from multiple daily dosing of barely tolerable formula, monitoring protein intake, and simply being different in terms of food restrictions. Most people want to fit in and not be defined by their medical condition.
Jeff Wolf was one of those who dropped out in his twenties and thirties. He stopped going to clinic, monitoring his Phe levels, and counting protein. But the earlier experience of living with PKU never completely left the back of his mind; he listened to his body whenever eating too much protein left him with the “fuzzy brain" of a protein hangover. About a decade ago he reconnected with a metabolic clinic, began taking formula and watching his protein intake. He still may go over his allotment for a single day but he tries to compensate on subsequent days so that his Phe levels come back into balance.
Jeff Wolf on a boat.
Courtesy Wolf
One of the trickiest parts of trying to manage phenylalanine intake is the artificial sweetener aspartame. The chemical is ubiquitous in diet and lite foods and drinks. Gum too, you don't even have to swallow to receive a toxic dose of Phe. Most PKUers say it is easier to simply avoid these products entirely rather than try to count their Phe content.
Treatments
Most rare diseases have no treatment. There are two drugs for PKU that provide some benefit to some portion of patients but those drugs often have their own burdens.
KUVAN® (sapropterin dihydrochloride) is a pill or powder that helps correct a protein folding error so that food proteins can be digested. It is approved for most types of PKU in adults and children one month and older, and often is used along with a protein-restricted diet.
“The problem is that it doesn't work for every [patient's genetic] mutation, and there are hundreds of mutations that have been identified with PKU. Two to three percent of patients will have a very dramatic response and if you're one of those small number of patients, it's great,” says Vockley. “If you have one of the other mutation, chances are pretty good you still are going to end up on a restricted diet.”
PALYNZIQ® (pegvaliase-pqpz) “has the potential to lower the Phe to normal levels, it's a real breakthrough in the field,” says Vockley. “But is a very hard drug to use. Most folks have to take either one or two 2ml injections a day of something that is basically a gel, and some individuals have to take three.”
Many PKUers have reactions at the site of the injection and some develop anaphylaxis, a severe potentially life-threatening allergic reaction that can happen within seconds and can occur at any time, even after long term use. Many patients using Palynziq carry an EpiPen, a self-injection devise containing a form of adrenaline that can reverse some of the symptoms of anaphylaxis.
Then there is the cost. With the Kuvan dosing for an adult, “you're talking between $100,000 and $200,000 a year. And Palynziq is three times that,” says Vockley. Insurance coverage through a private plan or a state program is essential. Some state programs provide generous coverage while others are skimpy. Most large insurance company plans cover the drugs, sometimes with significant copays, but companies that are self-insured are under no legal obligation to provide coverage.
Les Clark found that out the hard way when the company he worked for was sold. The new owner was self-insured and declined to continue covering his drugs. Almost immediately he was out of pocket an additional $1500 a month for formula, and that was with a substantial discount through the manufacturer's patient support program. He says, “If you don't have an insurance policy that will cover the formula, it's completely unaffordable.” He quickly began to look for a new job.
Hope
It's easy to see why PKUers are eager for advances that will make managing their condition more effect, easier, and perhaps more affordable. Synlogic's efforts have drawn their attention and raised hopes.
Just before Thanksgiving Jerry Vockley presented the latest data to a metabolism conference meeting in Australia. There were only 8 patients in this group of a phase 2 trial using the original version of the company's lead E. coli product, SYNB1618, but they were intensely studied. Each was given the probiotic and then a challenge meal. Vockley saw a 40% reduction in Phe absorption and later a 20% reduction in mean fasting Phe levels in the blood. The product was easy to use and tolerate.
The company also presented early results for SYNB1934, a follow on version that further genetically tweaked the E. coli to roughly double the capacity to chop up the target proteins. Synlogic is recruiting patients for studies to determine the best dosing, which they are planning for next year.
“It's an exciting approach,” says Lex Cowsert, Director of Research Development at the National PKU Alliance, a nonprofit that supports the patient, family, and research communities involved with PKU. “Every patient is different, every patient has a different tolerance for the type of therapy that they are willing to pursue,” and if it pans out, it will be a welcome addition, either alone or in combination with other approaches, to living with PKU.
Author's Note: Reporting this story was made possible by generous support from the National Press Foundation and the Fondation Ipsen. Thanks to the people who so generously shared their time and stories in speaking with me.