Magic elixirs and cure-all tonics have been around for a long time. But never before has the potential for outright fraudulent claims or subtle misrepresentation of alleged therapeutic medications been so great. Individual con artists are slicker and more sophisticated than ever, and the powerful advertising/ public relations industry has climbed into bed with pharmaceutical giants. If you’re searching for a cure for your disability, or even improvement, it’s a good time to keep a close watch on your wallet, and your dreams.

Forget walking–Steve Crowder says he’ll settle for just one night of painless, uninterrupted sleep. Even a solid six hours would be fine. Ever since he became a C4-5 incomplete quadriplegic in a 1995 swimming pool accident, his nights are filled with spasms, cramps and pain. The slightest touch can feel like fire. He’d like to have full use of his hands again, but the pain–if the pain alone would go away–he would be a much happier man.

Of course walking would be fine, too.

Like most computer-savvy people diagnosed with something doctors say won’t go away, Crowder, 45, spent long hours in his San Diego home searching the Web for new and more effective treatments, especially in those early years of his disability. “I was not obsessed, but driven to find the info that I could,” he says. I’ve grown beyond that now and have a lot of other interests, but while I was doing that searching, I came across a treatment called Neuralyn.” This was back in 1999–a few years before Neuralyn was exposed as a scam.

The Neuralyn Web site claimed that Neuralyn, a pink lotion applied in beadlets to the skin, could help people with spinal cord injuries, multiple sclerosis, cancer and many other ailments. In some cases, claimed the site, the concoction helped people regain control of their bowels, walk again and live pain-free. “There were testimonials and all kinds of info, so I contacted Thomas Vigil. He had two clinics at the time, Salt Lake and Idaho. I spoke to his wife, Beverly, on the phone several times and she reiterated marvelous results. She said Neuralyn had a higher than 85 percent success rate, and she said it repairs the myelin sheath.” Not to mention, she told Crowder, the drug had no known side effects.

For $10,000 Crowder could get three two-week treatments of Neuralyn at the Alternative Medicine and Biophysics Research Institute, Vigil’s clinic in Nampa, Idaho. Following each treatment, a period of six weeks would pass before the next one would begin. “I flew to Idaho on April 3, 1999 … spent two weeks, paid $10,000 up front and was more than happy to hand them that check.”

The Secret Formula
No one knew for sure exactly what was in Neuralyn, only that Vigil claimed it was a dilute solution of natural extracts, vitamins and amino acids. The formula was revealed to him in a dream, Vigil told San Diego Union-Tribune reporter Scott Lafee in 1999, “The dream was quite lucid. I could see exactly how to make the compound. In fact, some of the elements were revealed down to the 1,000th and 10,000th of a grain.”

The pink formula was drawn into a syringe and applied along Crowder’s spine, legs, chest, arms, feet, hands, neck and face. When in the hands of Vigil, the needle gently pressed against a pore opening and a tiny beadlet of the formula was squeezed out onto the pore’s surface. In the hands of other practitioners, such as Vigil’s wife, assistant or–occasionally–the office manager, the needle would push in a bit deeper. Crowder reported the treatment made his feet swell, but the office workers assured him it couldn’t be from the Neuralyn, as there were no known side effects.

Crowder, who could stand with support from a helper and even walk a few steps with a walker, told Lafee that he noticed his legs moved more fluidly after the first round of treatment. Lafee asked an expert if Neuralyn could be the reason for Crowder’s reported improvement. “There are lots of different mechanisms that can account for feeling better,” William Jarvis, founder of the National Council for Reliable Health Information told Lafee. “People with chronic problems, for example, frequently suffer severe, persistent depression. Anything that changes their situation, like a new treatment that gives them hope, is going to provide powerful relief from depression.” It’s possible that Crowder felt better emotionally, and this influenced the way he felt physically.

Betrayed
Crowder’s first treatment group consisted of 23 people, and he says bonding with them was the highlight of his Nampa experience. In July 1999 Crowder flew to Vigil’s Salt Lake City clinic for his second two weeks of treatment. “We were hopeful, just like before,” says Crowder.

He told everyone how he thought he saw improvement after his two weeks of treatment at the Nampa facility. But his enthusiasm waned when he didn’t see any improvement during the first week at Salt Lake City. “I started noticing the clinic was bragging about people with improvement in the morning session and how great the results had been in other clinics, yet I had seen nothing and noticed nothing [new] with myself.” He also saw the practitioners pushing pressure points to elicit movement. “They did it to me and to a couple of other guys. You can push a part of a body and something will twitch. They were claiming it was brought on by the Neuralyn.”

One afternoon, as Crowder was sitting in the parking lot and watching the sun go down, he had a realization. “That’s when it hit. The only thing people suspected of Vigil was that he had pirated the formula. But they were way off-base. The only thing that could explain all the inconsistencies was that Neuralyn was fake and the workers were actors, snake-oil salesmen.”

He thought of the movie The Sting, and realized he was caught up in a scam just as elaborate as the one Hollywood dreamed up. “I started running different questions through that equation, the ‘It’s all fake’ equation. It was like all the pieces in a big puzzle fit together perfectly. … It’s amazing what desperation and hope will do to you.”

Crowder called the FBI, but the agency didn’t call him back. “I put together a 25-page report with all the facts, theories and comments I could get, even from other Neuralyn patients. I then went to cureparalysisnow.com where all the fuss [discussion] was about Neuralyn.” Crowder had updated the Web site’s regulars throughout his experience with the drug and now he went on the site trying to expose the scam. “There was a lot of argument at the site before I went to Salt Lake City,” he recalls. “I kept saying, ‘Calm down, chill out, wait for me to come back and I’ll fill you in.’ When I came back I wrote, ‘It’s fake, don’t go, they’re all actors.'” Although his post led some to avoid Neuralyn, others hoped he was wrong. “They went and lost their money,” he says.

Crowder tried to convince both national media and federal agencies to investigate Neuralyn. “I sent out e-mails to 48 Hours and all those shows, and to the attorney generals in Idaho and Utah, and I didn’t get any response,” he says. But then a friend of Crowder’s mentioned the Union-Tribune article to a man in a weight-training class he taught. That friend of a friend just happened to work for the Department of Justice, and he was interested in reading Crowder’s 25-page document. “I gave him the report, he sent it to Idaho, and that’s what started the investigation.”

Neuralyn Exposed
The DOJ worked with the FBI, the Food and Drug Administration and the Office of Criminal Investigations to discover what the Vigils were really doing in their AMBRI clinics, and what the secret recipe really was for Neuralyn. The investigators found enough evidence against the Vigils for the DOJ to convene a federal grand jury in Boise, Idaho. On Jan. 10, 2002, the grand jury indicted the Vigils on 28 charges of conspiracy, wire fraud and shipping a misbranded drug in interstate commerce. In addition to their clinics, the Vigils also sold Neuralyn for home use via Orange County, Calif., pharmacist David Taylor, who was also indicted.

The indictments alleged the Vigils’ claims regarding Neuralyn were false. It turned out Neuralyn was mostly composed of the temporary pain relievers lidocaine and procaine, not natural extracts, vitamins and amino acids. Thomas Vigil was not a doctor–although he did complete a 27-day mail-order course in biochemistry from a since-closed diploma mill in Louisiana. And, although the Vigils regularly charged $300 to $500 for a 1.8-milliliter vial of Neuralyn, the ingredients cost only $1.12 to $3 a vial–the total cost to the Vigils was no more than $15 a vial. The indictments also alleged that the Vigils regularly made false promises to people receiving the treatment. They told one father that his daughter with a spinal cord injury would soon walk again–and the Vigils, along with their employees, physically manipulated the bodies of people being treated and then claimed the movement was due to Neuralyn.

“Anytime there is an allegation of consumer fraud, it gets our attention, as it should,” said U.S. Attorney for the District of Idaho Tom Moss at the time of the indictments. “But when someone takes advantage of other people’s vulnerabilities the way the Vigils are alleged to have done in this case, we take it very seriously indeed.”

The Vigils, who divorced in 1999, made a run for it before the indictments even came down. Beverly was picked up in Fresno, Calif., a week before the grand jury indicted her, and on Sept. 24, 2002, she pleaded guilty to one count of conspiracy to commit wire fraud and one count of conspiracy to ship a misbranded drug in interstate commerce. As part of a plea agreement, the 26 other charges were dropped and Beverly agreed to testify against Thomas Vigil if the authorities ever find him.

“Thomas Vigil is still a fugitive,” says Jean McNeil, spokesperson for the DOJ. “He is believed to be in Mexico, and we are still going through the extradition process with the Mexican government.”

David Taylor, the pharmacist who helped push the phony drug, entered a guilty plea to one count of conspiracy to deliver a misbranded drug into interstate commerce and has also agreed to testify against Thomas Vigil. On Oct. 16, 2002, he was sentenced to five years of probation, ordered to pay a $5,000 fine and to pay restitution of $36,907.18 to his 100 victims. “Taylor has cooperated with the investigation all along, and we expect to be able to collect the restitution,” says McNeil.

Crowder says he feels foolish for having to learn such an expensive lesson. “I could really use that money right now. I think about what I could be using it for–I could have a walking pool and Jacuzzi. … Shoot, I could have another high maintenance trophy girlfriend just like in the old [pre-injury] days.” He realizes he’s not the only one who lost a lot of money. One family mortgaged their farm, and a church even raised money for a parishioner’s child to receive the treatment.

But, as the cliché goes, hope springs eternal. Crowder’s still open to the possibility of a cure and says, “there’s a good chance I will be walking within the next six months.”

The Big Four
In retrospect Neuralyn was an obvious scam. No respected medical journal published a study on the substance, no legitimate clinical trials were conducted and the only “solid evidence” of proof were testimonials of people who underwent the treatment. No big-name doctors or other medical specialists ever endorsed Neuralyn and the FDA never granted its imprimatur.

The Neuralyn scam was successful because the people who bought the treatment wanted to believe their disabilities might disappear or at least improve, and this hope cancelled out their skepticism and left them vulnerable to snake-oil salesmen like Thomas Vigil. Hope also motivates those who take prescribed medications to improve, such as people with MS. And although they, too, may be vulnerable, by definition the four drugs developed to slow down the progression of relapsing-remitting MS–Avonex, Betaseron, Copaxone and Rebif–are not scams. All four are approved by the FDA for treating relapsing-remitting MS, many big-name doctors and medical specialists recommend relapsing-remitting MSers to take at least one of the meds, and published studies on the drugs abound in respected medical journals. Even the National Multiple Sclerosis Society, which previously never endorsed any medications, endorses “the big four.”

Still, there is evidence of hype in how the drugs are represented to people with MS. Avonex, Betaseron and Rebif are forms of interferon, a protein found in the human body. Researchers aren’t actually sure how the drugs work, but they think the interferon-based drugs help regulate the body’s immune system, which in turn seems to inhibit the immune system’s onslaught against the myelin sheath. Non-interferon Copaxone is thought to work as a decoy–its makers think it draws the immune system’s attack away from the myelin sheath.

Collectively these drugs are touted by most MS researchers, doctors and organizations as the biggest breakthrough in MS treatment since the disease was discovered in the 1800s. Each seems to cut down exacerbations in MSers by one-third. For proof the drug companies point to the MRIs of the brains of MSers taking the medications, which often show fewer lesions following drug therapy.

Researchers think MS is caused by white blood cells attacking the myelin sheath, which is the fatty substance that protects the central nervous system. During the attacks an MSer can temporarily lose eyesight, continence, use of limbs and so on. In relapsing-remitting MS, the MSer usually regains all function once the attack is over and the body heals. The attacks leave lesions on the central nervous system and the lesions can sometimes be seen on MRIs. Although some studies show correlation between number of lesions seen on an MRI and disability, others do not.

Research by Press Release
I’ve been on Avonex for almost two years now,” says Lisa Arthurs, 40, from Kiezer, Ore. “I was diagnosed with MS over three years ago and I find I haven’t had as many problems with my MS since I have been on the shots. It took about six months before I really noticed a difference, and now I won’t be changing, I’ll stay on them.”

Kiezer’s experience is common among people taking one of the four meds. Just having a way to fend off an incurable disease empowers MSers, makes them feel they’re doing something proactive to help themselves. But the drugs don’t treat existing MS–at least not as far as researchers can prove. Instead studies show the drugs may prevent one out of three future exacerbations for some people.

Merle L. Spector-Korejwo runs the forum and listserv of the Web-based MSOnly (MSOnly.com), one of the few MS organizations that does not receive any funding from an MS drug company. “The MS drugs may work for some people. Nobody knows that they don’t, but they also don’t know if they really do.” says Spector-Korejwo, an MSer since 1983. “In the meantime, the drug companies make billions.”

When the headline of a recent press release by Copaxone-maker Teva Neuroscience read, “Early Treatment of MS With Copaxone Delays Accumulation of Brain Lesions,” MSOnly disseminated Teva’s last “new” press release on the subject. This is research by press release and is only meant to bolster stock prices, says Spector-Korejwo. “Look at the month these press releases come out, because when they get ready for their quarterly reviews, like in March, you’ll start to see a lot of the PR stuff. They want their numbers up.”

And when the FDA reprimanded Biogen for exaggerating the effects of Avonex, it was MSOnly that put the word out to the MS community. Biogen has been reprimanded twice in the few months since its newest competitor, Rebif, was approved for American markets. The FDA reprimanded Biogen for claiming Avonex is still effective after three years. Biogen was also reprimanded for such unproved statements as “cognitive dysfunction [in MS] is significantly correlated with brain atrophy.”

“It’s all PR and now it’s even going to get funnier because [Rebif-maker] Serono is partnering with Pfizer,” says Spector-Korejwo. It’s too early in the Serono-Pfizer relationship to know what tactics will be used to push Rebif, but Pfizer–the largest drug company in America–has a reputation for violating FDA advertising rules.

According to a Dec. 4, 2002, study by the General Accounting Office, Pfizer habitually floats misleading advertisements for its prescription drugs, even though the company is repeatedly cited for violations. Take Pfizer’s cholesterol-lowering drug Lipitor–over the last four years the FDA has sent Pfizer several reprimand letters about its misleading claims in Lipitor ads, yet Pfizer has simply replaced old ads with new ads.

Serono’s off to a shaky ethical start. As a reprimand for mild violations, the company was banned from having a presence at last year’s American Association of Neurology meeting, according to “A Battle for Wallets and Minds,” a Nov. 10, 2002, Boston Globe article about the competition between Biogen and Serono. Serono’s partnership with Pfizer may bring more such violations and reprimands.

The first drug said to slow down the progression of MS, Betaseron, is based on a slightly different form of interferon than Avonex or Rebif. Betaseron-maker Berlex is still king of the MS-drug market and seems to have taken a “watch and see” approach to the Biogen-Serono skirmishes. When asked about the fierceness of competition between the MS drug companies, Berlex responded with promotional statements such as, “our leadership in the U.S. market has been proven by Betaseron’s unsurpassed clinical efficacy for more than a decade.”

Teva Neuroscience says it is unfazed by the extra competition. “Being the one non-interferon out there has been very interesting,” says John Congleton, Teva spokesperson. “I think the most interesting thing that I’ve seen over the course of 2002 is that even with the introduction of another interferon, we still grew in the number of patients taking our product.”

It’s all about the numbers.

The Skeptics
It’s hard to publicly criticize a new class of drugs that seem to hold so much hope for so many MSers, and Spector-Korejwo acknowledges MSOnly’s questions sometimes make her unpopular. “We don’t get a lot of thank you mail,” she says, laughing. “Instead we get a lot of, ‘How dare you dash my hopes, why are you so critical, you nasty person, why don’t you look on the bright side of this?’ But we tell it like it is.”

MSOnly was founded by Richard Korejwo in 1979 with a grant from the National Institutes of Health. Before being diagnosed with MS that same year, Korejwo was a lieutenant-colonel with the Air Force and worked in the Department of Defense on the budding Internet project. Korejwo’s a psychologist and also holds a degree in computer engineering, so it is not too surprising that NIH approached him about creating a database of peer-reviewed research on MS. For over 20 years, Korejwo has pored over every MS-related abstract and study published worldwide.

“When I met him I was at a very bad point … thinking about suicide … going through a tremendous depression, and then I read some of his work,” says Spector-Korejwo. Her first marriage had ended in large part because her husband couldn’t accept her MS–she says he couldn’t even define MS–and he was angry she couldn’t keep pace with him anymore. “I went on CompuServe and just by chance I came across some of Richard’s work, his pieces on accepting his disability. Reading those that night kept me from pulling the plug, and I said I’ve got to find out who this guy is, he should know exactly how I’m feeling.”

To give back a little of what he gave her, Spector-Korejwo helped Korejwo convince CompuServe to sponsor an online MS forum. Thus began a friendship, partnership, romance and–finally–marriage between the two. MSOnly is operated from their home in Tampa Bay, Fla.

Spector-Korejwo says her post-graduate degrees are in the “warm and fuzzy” fields of education and social work, while her husband’s are more on the tech end. “If I need to know about a cytokine or a lymphocyte, or need him to read a research paper because he has a background in statistics, then he can look at the papers … like the CHAMPS study from Biogen and point out where the fallacies are.”

Biogen’s CHAMPS study, published in the Sept. 28, 2000, issue of the New England Journal of Medicine, suggests people should be prescribed Avonex immediately after experiencing their first MS-like attack. A small percentage of people experience only one MS-like attack in their entire lifetimes, so the accepted protocol is for people to have at least two separate incidents before they are either diagnosed with MS or given any long-term treatment. It is impossible to know who will develop MS and who will only have the one exacerbation, but the study calls for all of them to be treated, just in case. If doctors follow this suggested new protocol, then people who will never develop MS will needlessly purchase and regularly self-inject the medication. Avonex, like the other three big MS drugs, sells for around $10,000 a year.

It’s impossible to know for certain exactly what MS will do to anyone, and not even lesions visible on an MRI help much. “You can have two lesions and be in bed forever or you can have a hundred and be fine,” says Spector-Korejwo. “There is no correlation between a person’s MRI and disability.” Yet the four big MS drug companies each point to fewer lesions on a person’s MRI as proof their products work.

“Everyone thinks, ‘How can we be smarter than a drug company, and how did it get published if it’s wrong?” says Spector-Korejwo. “But the only person you can really trust is you. So you have to be a skeptic, ask the questions, and if it doesn’t make sense, don’t just accept it.” Even if six neurologists disagree with a decision you make or an experience you’re having, don’t feel bad, she says. “They’re people like us, they can only know what they know, and it’s not always their fault.” Case in point: It wasn’t too long ago most neurologists insisted MS does not cause pain. They now admit they were wrong.

The Hungarian Restaurant Diet
Maybe the four big MS drugs do exactly what their PR firms say they do, or maybe they’re not quite as effective as the firms say they are. But even though they wear a medical-like mantle, the drug companies’ salespeople aren’t doctors. They’ve been accused of playing doctor, though. The Nov. 22, 2002, New York Times article, “Madison Ave. Plays Growing Role in Drug Research,” reports 11 percent of journal-published studies are actually ghostwritten by drug company PR firms. “Some experts think the practice continues to grow, even as the best journals take steps to prevent it,” writes reporter Melody Petersen.

Neurologists get much of their information on new treatments from studies published in medical journals and write prescriptions based on what they think is legitimate scientific research. They also get information from their conferences, where drug companies have a strong presence. And they get information from the drug salespeople who drop by their offices with “exciting new finds.”

“The marketing is fierce,” said Dr. Daniel D. Mikol in “A Battle for Wallets and Minds.” Mikol is the director of the MS center at the University of Michigan. “I hear one thing from one drug rep and a totally different thing from another. The average neurologist sees many different kinds of patients. They don’t have time to delve into the data. So whichever rep is more aggressive, whichever is around more … that’s the one who’ll have the most influence.”

So who should people with MS trust for good medical advice? And what is the most effective way to treat MS? That depends on who you ask. Korejwo will tell you the best treatment he has found, in all his decades of research, is the Hungarian Restaurant Diet. He says his first MS attack left him full movement in only his eyelids, but over time his condition improved and all he took was Solumedrol. Instead of getting worse over the years, his MS has gotten better. “People ask me, ‘What’s your secret?’ … There is no secret, but I tell them if they eat once a month in a Hungarian restaurant, they’ll get better,” he laughs.

“You can take one of the new MS drugs and they may work for you,” adds Spector-Korejwo. “But the Hungarian Restaurant Diet is a lot more fun.”