Mixed-opinions on ex-Army doc’s PTSD ‘cure’ - Military Health, military health and wellness, military physical fitness - Military Times

Mixed-opinions on ex-Army doc’s PTSD ‘cure’

Former Army physician Dr. John J. Prendergast is either a therapeutic prophet who has invented a miraculous cure-all for everything from clogged arteries to post-traumatic stress disorder or a modern-day snake-oil salesman making irresponsible, possibly dangerous claims about his vitamin supplement.

It all depends on who you believe.

Prendergast was a Vietnam-era Army doctor — military records he provided to Military Times confirm that. After that, much of his story doesn’t add up.

Prendergast says he helped invent ProArgi-9 Plus, a powdered multivitamin drink mix with a “proprietary blend” of the amino acid L-arginine, red wine extract and other ingredients. The mix is sold by Synergy WorldWide.

Described by the company’s president as a Synergy spokesman and member of its medical advisory board, Prendergast, or “Dr. Joe,” as he is known on the product’s numerous websites, claims he was influenced by world-renowned scientists and endorsed by the American Diabetes Association for “rolling back the ravages of diabetes.” He says his elixir has cleared the clogged arteries of thousands of diabetics.

But the scientists to whom Prendergast links himself say he is using their names and work against their wishes. And the American Diabetes Association says the only thing it has ever given him is a regional father-of-the-year award that had nothing to do with his medical practice.

Now, in the most recent and perhaps outlandish of his claims, Prendergast asserts that his concoction can cure PTSD.

When presented with research suggesting that L-arginine, his product’s key ingredient, could be dangerous, Prendergast scoffs.

“As we develop the data that confirms the strength of our special L-arginine in reversing cardiovascular disease and publish it continuously, all these spurious academic inconsistencies will disappear,” he wrote in a statement provided to Military Times.

But there is no data. Prendergast has no published studies, and when pressed, blamed a lack of funds. “It would have been good to do that, but we didn’t have the capital,” he says.

He says he “hopes” to conduct his own studies soon and to help others get started. Those studies, he promises, will demonstrate his formula’s effectiveness — not only for PTSD but also strokes, heart attacks, Alzheimer’s disease and hypertension.

“It’s an anti-aging product as well!” he says. “That’s part of the reason why the post-traumatic stress thing works so well, because it seems to make people really turn back the clock.”

Miracle cure?

The human body produces L-arginine on its own, and studies suggest it could be useful for a number of ailments from heart attacks and migraines to erectile dysfunction and breast cancer, the Mayo Clinic says.

But Mayo also notes the “possibility of serious side effects,” including stomach discomfort, nausea, cramps, low blood pressure and changes in chemicals and electrolytes in the blood.

There are many conflicting studies, and the jury is still out on L-arginine’s benefits and dangers.

But Prendergast insists L-arginine and ProArgi-9 Plus have helped save more than 7,000 of his patients from bypass surgery over the past 10 years. He says he is “pulling together” other studies on L-arginine for a book he hopes to self-publish in June.

His last book, “Dr. Joe’s Rx for Managing Your Health,” was self-published in 2006 through a nonprofit he founded called Endocrine Therapeutics.

Prendergast says he helped develop ProArgi-9 Plus after he was rebuffed by at least three major drug manufacturers. So he took his recipe to Synergy, a subsidiary of supplement manufacturer Nature’s Sunshine.

Synergy WorldWide reported $68.6 million in net sales in 2010, up 23 percent from 2009, according to the annual report of Synergy’s parent firm, Nature’s Sunshine Products Inc., in a recent filing with the Securities Exchange Commission. The filing says Synergy has a sales force of 78,400 independent distributors, which operate as independent businesses.

Synergy officials say ProArgi-9 Plus is its biggest seller, accounting for three-quarters of its U.S. sales.

The PTSD connection

Dr. Matthew Friedman, director of the Veterans Affairs Department’s National Center for PTSD, says marketing ProArgi-9 Plus as a treatment for troops with PTSD is “totally irresponsible” — and potentially dangerous, sharing concerns from studies that suggest L-arginine may hurt more than it helps.

The Food and Drug Administration doesn’t regulate or inspect the production of dietary supplements, says FDA spokeswoman Siobhan DeLancey.

The agency’s only role is to oversee supplement makers that violate federal law by marketing a product as a treatment or cure for a disease or disorder.

DeLancey said Synergy was cited in 2003 for improperly selling a supplement as an “anti-aging” product. It is unclear what happened after that, but the particular product no longer seems to be in Syngery’s lineup.

Dozens of websites operated by Synergy’s independent distributors tout ProArgi-9 Plus as a treatment or therapy for a broad range of ailments.

For example, Donhaverkamp .com lists more than 70 ailments, from herpes and hepatitis to swine flu and fibromyalgia, as “diseases that Pro-Argi-9 Plus has helped.”

Synergy President Dan Norman says such statements on distributor websites or marketing materials violate company policy.

“We have a compliance department that polices that, and when it comes to our attention, we do everything in our power to shut down the site,” Norman says. He was unable to provide details on how many distributors had been censured or why dozens of websites make similar claims.

But a company memo issued by Lynn E. Ohman, Synergy’s director of distribution services, indicates the company disavows any responsibility for claims made or used by independent distributors:

“Independently Created Advertising Materials are solely the responsibility of the Team Member who creates them and any person who uses them. Synergy disclaims any right or obligation to control” such content.

Norman sees no problem with distributors posting customer testimonials on their websites, however. “If an individual talks about how it affects them … there’s not a lot we can do,” he says.

He also says he has no problem with distributors associating ProArgi-9 Plus with a roster of top researchers, regardless of whether those scientists actually endorse the product.

Norman says he’s aware that one leading ProArgi-9 researcher, Stanford University’s Dr. John Cooke, does not endorse ProArgi-9 Plus and has asked repeatedly to have his name and image removed from distributor websites.

“We don’t police what [distributors] say about Dr. Cooke,” Norman says.

No Nobel

Visit any of the many ProArgi-9 Plus websites and you might be left with the impression that a prestigious group of A-list scientists support Prendergast and his product. You’d be wrong.

Front and center is Dr. Louis Ignarro, winner of the 1998 Nobel Prize in Medicine for his research into L-arginine’s role in the body’s production of nitric oxide.

“The Story of Nitric Oxide, L-arginine, ProArgi9 as told by Nobel Prize Winning Scientists, Doctors and Patients,” begins one such description on ProArgi-9 sales site www.urnbiz.com/the meekteam. The first two videos on the site feature Ignarro.

“Dr. Ignarro is not affiliated in any way with Dr. Prendergast or ProArgi-9,” says Ignarro’s spokesman Stephen Watts. “We frequently receive messages indicating that ProArgi-9 is using Dr. Ignarro’s image, videos, and writings so as to appear that Dr. Ignarro endorses ProArgi-9. This is inaccurate and appears to be misleading to consumers.”

Dr. Victor Dzau, Duke University medical system chancellor, has his name and quotes scattered throughout ProArgi-9 literature. But his spokesman says Dzau and Prendergast have “no working relationship” and that Dzau has not approved the use of his photo or any information on websites promoting ProArgi-9 Plus.

American Diabetes Association officials say they are investigating Prendergast for claiming his medical work is linked to his winning of an ADA regional Father of the Year award in 2008.

Echoing claims made on numerous ProArgi-9 websites, Prendergast told Military Times he received the award for his medical accomplishments, including the development of ProArgi-9 Plus.

Not so, says ADA’s chief of communications, Dayle Kern.

“The purpose of this award is to recognize those that have made family a priority,” Kern said. “The award has nothing to do with the awardee’s specific career related or medical accomplishments and is not an endorsement of their work or products.

“We are growing more and more concerned about the misuse of the association’s name and reputation, as well as misrepresentation as to what the Father of the Year award is about and why Dr. Prendergast received it a few years ago,” Kern said. “Our legal team is looking into this further.”

Cooke, the L-arginine researcher at Stanford University, told Military Times that he has “asked Dr. Prendergast multiple times to remove my name and image from these websites.”

Worse, Cooke says, is that Prendergast is selling a dangerous brew. Not only is there no evidence that L-arginine would help troops suffering from post-traumatic stress, he says, but his latest research — published in Journal of the American Heart Association — found that long-term use of L-arginine could be harmful.

In one randomized double-blind study involving 133 patients with clogged arteries, those taking a placebo fared better than the group taking an L-arginine supplement.

“Long-term administration of L-arginine may even impair functional capacity, perhaps through an adverse effect on vascular reactivity,” concluded Cooke and the other doctors who took part in the study.

Another study of L-arginine, reported in the January 2006 Journal of the American Medical Association had to be cut short after six of 78 patients taking L-arginine died; no deaths were reported in the placebo group.

That study, Prendergast notes, did not test his specific product, which contains not just L-arginine, but other ingredients.

But Tod Cooperman, president of ConsumerLab.com, a dietary supplement testing company, said those other ingredients are also worrisome. In particular, the amount of Vitamin D in ProArgi-9 Plus, he says, “is way too much.”

Following the twice-daily suggested serving on the drink mix label, you would get 5,000 international units per day.

The National Institutes of Health says 4,000 IUs per day “is the upper limit of what is now considered safe,” Cooperman says. “This blows that away.”

And while ProArgi-9 Plus is marketed as a cardiovascular booster, he says, “there is an increased risk of cardiovascular disease when you get too much Vitamin D.”

Prendergast and Synergy officials maintain that they are comfortable with the ingredients in the drink mix.

The nonprofit

Intimately tied to Dr. John J. Prendergast’s claim that PoArgi-9 Plus can cure PTSD is a little-known, self-proclaimed charitable organization called Stay Strong Nation.

Co-founded in Hawaii by a Gresford Lewishall, a Jamaican immigrant and tour bus operator, and Keith Crosby, a maintenance worker and Vietnam veteran, the organization helped produce a video featuring an Army staff sergeant who believes ProArgi-9 Plus helped cure her PTSD.

Lewishall says he and Crosby were aspiring hip-hop producers when they launched Stay Strong Nation in 2009 and began working on a CD to raise money and awareness for PTSD treatment. Around the same time, Lewishall says he became an independent distributor of ProArgi-9 Plus.

Then one day Staff Sgt. Melissa Cramblett, an Iraq war veteran, and mother of two who works as the Portland, Ore., Army recruiting battalion’s civilian public affairs officer, answered the phone in her office.

On the other end was Lewishall. He never retured Military Times’ calls to find out why he called the battalion that day, and Cramblett can’t remember. She says it’s not uncommon for nonprofits to call the battalion asking for help.

Cramblett, technically on temporary disabled retirement from injuries suffered during her 2004 tour in Iraq, including severe brain injury and post-traumatic stress disorder, is awaiting permission go back on active duty or to get placed on permanent medical retirement.

During their phone conversation, Lewishall brought up the subject of ProArgi-9 Plus and wondered if it might ease Cramblett’s symptoms.

He sent her s asmple. Cramblett, who says she was taking more than a dozen daily medications at the time, says she thought the new supplement helped and credited it with enabling her to cut her meds in half within a few weeks.

“I see a total difference when I take it,” she told Military Times.

Cramblett says that within a few weeks, Lewishall asked if he could fly her to a Synergy conference in Japan. Once there, she was asked to appear alongside Predergast and Lewishall — or “Lewis” as he likes to be called — in a testimonial video.

“It saved my life,” Cramblett tells the camera, wiping away tears. “I have my soul back.”

Prendergast nods as the video continues. “This is going to be really good for you from here on out,” he assures her. “Lewis and I are going to be working to get other projects together to prove that it’s useful for just everybody who would be in this situation.”

Stay Strong Nation now tries to sell ProArgi-9 Plus through its website.

“Our studies have shown that the L-arginine in ProArgi-9 Plus reduce [sic] levels of stress, anxiety, feelings of loneliness and depression,” the group claims on its homepage, under the banner “Treating PTS/TBI with ProArgi-9 Plus.”

But other than reports he says he got from seven users, he can point to no scientific study.

Even so, Prendergast supports the group’s claims and says he wants to help Stay Strong Nation get started on a study involving 75 to 100 combat veterans.

Lewishall insists he sells ProArgi-9 Plus only to civilians and has always given it away to troops. He says he would “never, ever” tell a veteran or service member to buy the product.

But he did exactly that when an Afghanistan veteran — at the urging of Military Times — contacted the group. In an e-mail exchange that followed, Lewishall provided detailed instructions on how to buy the product and wrote that Stay Strong Nation gets a “percentage of any sales” from Synergy.

So far, says Stay Strong Nation has only been able to raise pocket change. The group’s only recent event, a rally in New York City, flopped when organizers failed to secure the proper permits.

And rather than bring in donations, the only thing a $20,000 direct-mail fundraising campaign earned was a complaint. Vague plans for a “nationwide tour” never seem to materialize.

But Stay Strong Nation has scored one big success — on the public relations front. In February, the group distributed a press release on a pay-to-publish newswire claiming that playing certain video games can trigger PTSD symptoms.

A variety of video game sites and online news organizations, including MSNBC’s In-Game blog and the news website www.huliq.com, pounced on the report.

In January, Lewishall was interviewed as a PTSD expert on a national Fox News broadcast in which he described ProArgi-9 Plus as a promising treatment for troops. Fox News didn’t ask Lewishall about the studies he said he’d already done, but when Military Times asked, he had no data to share.

Lewishall said in a phone interview that he has given the supplement to “about 15” combat veterans and that seven reported significant improvement.

“It was very exciting,” he said.

The other eight? He says they never responded after getting their ProArgi-9 Plus shipments.

Stay Strong Nation, meanwhile, has aroused concern in the Hawaii Attorney General’s office because the group took two years to register as a charity under state law.

“I have had numerous email and phone contacts from Mr. Lewishall in the last seven days about their failure to register and to assist them with the registration process,” said deputy attorney general Hugh Jones.

The group completed that process on March 11, but Jones says he’s even more troubled now.

He sees no record that Stay Strong Nation has filed the annual financial report that the IRS requires of nonprofits.

Lewishall insists he filed last year’s report but admits being several months late this year “because we’ve been so busy with all the other work we’re doing.”

That surprises Jones, who says Stay Strong Nation “reports that during the last fiscal year they had no income/revenue and no expenses and spent nothing on fundraising activities. I am rather suspicious of this information and will be looking deeper into the matter.”

After two years of attempting to raise money by giving away CDs in exchange for donations — netting a total of $300 so far, though no official documentation is available — Lewishall said in a phone interview that Stay Strong Nation is now $250,000 in debt.

Crosby says the money for those and other efforts came in the form of loans from “friends, family and associates,” but declines to say exactly who spotted them that much cash.

The group lists only one “major supporter” on its website: former pro baseball player and two-time World Champion Dane Iorg, listed as an “Emerald Executive” on Synergy’s website.

Crosby says Stay Strong Nation has received no money from Iorg, but says Iorg has provided free ProArgi-9 Plus to the organization. Iorg could not be reached for comment.