TWO CONCUSSION DRUG firms backed by Brett Favre and enmeshed in an enormous welfare fraud case overstated their NFL connections and exaggerated the recognized effectiveness of their medication throughout efforts to lift cash, in response to interviews and paperwork reviewed by ESPN.
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As effectively, courtroom filings present the businesses and their founder, Jake VanLandingham, confronted substantial money owed over the previous a number of years, at the same time as VanLandingham was urgent potential traders to assist get his medication to market.
Two of VanLandingham’s Florida-based firms — Prevacus and PresolMD — are alleged to have obtained greater than $2.1 million in Mississippi funds that have been earmarked for welfare households, in response to a civil lawsuit filed by the state.
VanLandingham advised ESPN in an interview, “I had no thought this was welfare cash, and I’ve all the time been an upstanding particular person in the case of analysis.” Favre declined to remark.
Favre, in response to the lawsuit, is the highest outdoors investor in Prevacus, and the Corridor of Fame quarterback has stated he put $1 million of his personal cash into the businesses, that are growing a nasal spray to deal with concussions and a cream to forestall or restrict them.
Six folks have been arrested and charged in 2020 as a part of what the state known as a “multimillion-dollar embezzlement scheme.” They included Mississippi’s welfare director and the pinnacle of a nonprofit, each of whom have entered responsible pleas.
Neither Favre nor VanLandingham was charged, however they’re amongst 38 people and firms named earlier this 12 months within the civil lawsuit, which seeks the return of greater than $20 million that had been designated for needy households.
The 2 males waged a advertising marketing campaign to encourage traders to again VanLandingham’s firms — a marketing campaign that finally led Favre to faucet a few of his connections in his house state.
The lawsuit alleges a number of the funds have been funneled via the Mississippi Group Schooling Middle, a nonprofit run by Nancy New. New pleaded responsible in April to bribery of a public official, fraud towards the federal government, wire fraud and racketeering. The civil lawsuit alleges a “sham” settlement was crafted for the monetary advantage of a number of defendants, together with New, Favre, VanLandingham and his two drug firms.
Favre additionally has stated he was unaware the cash was supposed for needy households.
A 2019 advertising doc used to lift cash for Prevacus and PresolMD boasts a number of connections to the NFL. Dr. Allen Sills, the league’s chief medical officer, and Jeff Miller, the NFL’s government vp for well being & security innovation, are amongst these recognized as “different contacts” on a listing of “Key Advisory Members and Associates” to Prevacus. The advertising doc additionally listed Dr. Brian Hainline, the NCAA’s chief medical officer, amongst “different contacts.”
An NFL spokesperson wrote in an e-mail, “The league workplace was contacted by this group however offered no funding or any sources in help of its efforts.” The spokesperson added that neither Miller nor Sills was an advisory member or affiliate for Prevacus, and the league was unaware of any groups utilizing samples of PresolMD’s cream.
An NCAA spokesperson advised ESPN that neither Hainline nor the NCAA has any connections with Prevacus or VanLandingham. “[Hainline] by no means had any advisory position or affiliation with the corporate. And he by no means agreed to be listed on any advertising supplies,” the spokesperson stated.
VanLandingham stated Favre had related him with Sills and Miller to debate the concussion medication, however he stated the doc wasn’t supposed to counsel Prevacus was working with the NFL or the NCAA, merely that the corporate had contacted the folks and organizations.
“These are different contacts that we had made,” VanLandingham stated. “I am simply making folks conscious that these are different contacts. Maybe it might’ve been higher separated out. … I’ve by no means advised anyone that Allen Sills was an adviser for Prevacus. Or Jeff Miller. They offered suggestions, and there is been calls with each of them.”
Underneath the heading, “Milestones Achieved to Date,” the doc additionally says that PresolMD has “offered product samples and cultivated relationships with 6 NFL Energetic Groups.” Elsewhere, below the heading, “Gross sales & Advertising and marketing Technique & Monetary Projections,” the doc says PresolMD is working in “partnership with the NFL Affiliate Teams.”
VanLandingham stated Favre had made connections with some workforce docs and trainers, and “I believe we did ship out samples to completely different teams.” VanLandingham stated he did not bear in mind which groups have been contacted nor did he know whether or not the samples had been used. He additionally stated he could not recall what the reference to “NFL Affiliate Teams” was about.
(The 2019 doc additionally names 15 sports activities figures amongst its key advisers; a kind of is ESPN NFL Reporter Ed Werder, who was not employed by the community on the time.)
The advertising doc, first obtained by the Clarion Ledger of Mississippi, says PresolMD is in search of $2 million in capital and claims the “Pre-Market Valuation” of the corporate is $20 million.
The doc additionally says PresolMD has cultivated relationships with “100 NFL Retired Gamers,” and, in a 2020 podcast, VanLandingham says the corporate has had the “help” of the NFL Gamers Affiliation throughout scientific trials. In line with courtroom paperwork, VanLandingham wrote in a textual content to a different one that would later plead responsible within the Mississippi fraud case that “we partnered with the NFLPA for the scientific trials. No negative effects.”
A spokesperson for the NFLPA stated “there isn’t a affiliation with that firm or particular person,” including, “If this particular person is representing that they’ve our help, that is false.”
VanLandingham advised ESPN the characterization of partnering with the NFLPA stemmed from a relationship PresolMD established with Byron Williams, a former NFL participant who runs youth soccer camps. Williams is previous president of the Dallas chapter of Retired NFL Gamers and a member of the NFLPA’s Former Participant Advisory Board. VanLandingham stated he believed Williams helped arrange a trial of the cream product with youth gamers in an NFL Flag Soccer league in Dallas.
However Williams advised ESPN the partnership had nothing to do with the NFLPA, he by no means spoke with anybody on the union concerning the product and he was serving to solely as a part of a enterprise contract to attach PresolMD with youth gamers to check the cream. He additionally stated the gamers have been from his camps, not an NFL Flag league.
Williams has since filed a lawsuit in Texas, saying PresolMD breached the contract.
“I received my legal professional attempting to gather the remainder of my contract settlement with [VanLandingham],” Williams stated.
Neither Williams nor his lawyer would focus on how a lot they consider is owed Williams.
Prevacus founder Jake VanLandingham, proven testifying earlier than a U.S. Senate committee in 2014, says he has all the time made it clear that the nasal spray designed to deal with concussions wasn’t but authorised by the Meals and Drug Administration. Win McNamee/Getty Photographs
WHEN FOOTBALL’S CONCUSSION disaster exploded into the general public consciousness within the mid-2010s, it not solely opened the floodgates to new cash for analysis, nevertheless it additionally unleashed a torrent of entrepreneurs attempting to capitalize on the problem. There have been no medication or merchandise confirmed to forestall, diagnose or deal with concussions — there nonetheless aren’t — and a rush ensued to search out solutions for folks fearful their children may wind up with long-term mind injury, like lots of their heroes.
In 2012, in response to Florida enterprise information, VanLandingham integrated Prevacus, Inc. His thought was to develop a drug that might be launched to the mind via a nasal spray. The suggestion was that if a soccer participant — or anybody, actually: your younger little one, your aged mother or father, a NASCAR driver — suffered a concussion, this drug may act as an anti-inflammatory, lowering the mind swelling that may come from a blow to the pinnacle.
The concept appeared to stem from analysis VanLandingham and others had carried out a number of years earlier at Emory College. Whereas working as a postdoctoral researcher, VanLandingham was the lead creator on two scientific papers — one in 2006, the opposite in 2008 — that described how progesterone and a associated steroid had proven optimistic outcomes on concussed rats.
VanLandingham advised ESPN that after he left Emory, he labored with a chemist to develop a “new chemical entity” that allowed “Prevacus to have its personal patent place.”
The usage of the drug would require approval by the Meals and Drug Administration, a course of that may take a decade, price hundreds of thousands of {dollars} and require a number of scientific trials to indicate the drug is protected and efficient.
By 2014, VanLandingham was on the college at Florida State, elevating cash for Prevacus and selling his thought — together with one of many biggest NFL quarterbacks in historical past. VanLandingham stated he and Favre had been launched via “a pal of a pal.” A 12 months earlier, Favre had gone on “The At this time Present” and stated if he had a son, he could be “actual leery” of letting him play soccer.
VanLandingham stated Favre initially was issued inventory choices for becoming a member of Prevacus’ “Sports activities Advisory Board.” Since then, Favre has turn out to be “a pretty big shareholder” within the firm, VanLandingham stated.
The 2 labored collectively to get the phrase out about Prevacus’ breakthrough drug.
“After you will have a concussion, you will have non permanent vitality disaster within the mind,” VanLandingham advised WDAM-TV in Mississippi in 2014. “However through the use of our drug as quickly as doable, and for a lot of days afterward to handle the situation, you may cut back the secondary injury that happens after the concussion.” VanLandingham advised the station the drug was safer to make use of than Tylenol, and Favre touted the drug’s effectiveness, saying, “So far as stopping the development of a concussion, I believe it is unbelievable.”
In 2018, VanLandingham, Favre and several other different Prevacus athlete traders appeared on NBC’s “Megyn Kelly At this time” and promoted the drug, regardless that it was but to be FDA authorised, its efficacy had by no means been examined on people and it nonetheless was doubtlessly years from making it to the market. VanLandingham advised Kelly and the viewers that the drug was “a neurosteroid, given nasally, so we are able to get extra into the mind in a short time. It is formulated in a method the place it will possibly keep steady to over 125 levels, so in Afghanistan, Iraq, on a soccer discipline, a soccer discipline. And we’re in a position to get it [to the brain] as a result of we give it nasally via this applicator right here. We’re in a position to get it into the mind in lower than 5 minutes.”
Kelly requested if the drug had been FDA authorised, and VanLandingham responded, “No, we’re within the means of scientific trials now.”
Through the phase, every of the athletes labored Prevacus into their responses and spoke about its nice promise.
Inside months of that look, in response to the Mississippi lawsuit, Favre was urging VanLandingham to contact Nancy New to get funds from the state’s Division of Human Providers. Favre, the lawsuit stated, let VanLandingham know New had “beforehand offered substantial funds on his behalf.”
In January 2019, Favre hosted New and several other different folks at his Mississippi house to listen to a enterprise proposition from VanLandingham. Current at that assembly have been three individuals who would later go on to be charged and plead responsible within the welfare fraud case.
Inside a 12 months of that assembly, Prevacus and PresolMD had obtained a complete of $2.1 million of the state funds, in response to the lawsuit. VanLandingham and Favre continued their promotional efforts. In a 2020 radio interview, they even advised their nasal spray may save soccer gamers from the ravages of power traumatic encephalopathy (CTE), the long-term mind illness that posed an existential disaster to the game.
Favre advised the host, “We’re right here to save lots of the longer term.” And VanLandingham added, “We consider if we are able to cease this pathological cascade early on, then we’ll find yourself having lots much less of what is known as post-concussion syndrome, post-traumatic stress dysfunction. And, finally, we consider by treating it early, our future gamers is not going to be enduring CTE.”
In actuality, there was no analysis on people to counsel something of the type. The truth is, past the analysis he carried out at Emory, VanLandingham hadn’t been part of any printed research associated to the drug’s efficacy, in response to a search of PubMed. And whereas the rat research might need offered some optimism, that was a far cry from exhibiting it might work to mitigate concussions in people, not to mention get rid of CTE.
“I appeared to see what the proof was, that it actually does what they are saying it does. And there’s none,” stated Dr. Steven DeKosky, the deputy director of the McKnight Mind Institute on the College of Florida and a number one researcher in Alzheimer’s illness and traumatic mind damage (TBI).
Requested concerning the two earlier papers, DeKosky stated the leap from that information to touting an untested drug utilizing an untested technique of supply for that drug “just isn’t affordable. And there is not any proof that it might assist ameliorate damage, a lot much less stop it.”
Mentioned Dr. Daniel Weinberger, the director of the Lieber Institute for Mind Improvement and a professor of neuroscience at Johns Hopkins: “I do not consider there’s any scientific proof to help this declare for human use.”
VanLandingham advised ESPN that it was by no means his intention to counsel the drug positively would work, however reasonably that it had labored on animals and he predicted it’d work on people. He stated he all the time made it clear the drug was but to be authorised by the FDA.
“There’s loads of researchers and firms on the market that promote their drug and their mechanism of motion as they’re attempting to get funding to get it via the FDA course of,” VanLandingham stated. “We clearly inform folks it is gotta undergo [the trials]. No one’s sitting right here [saying] this drug works in people. That is by no means been the case for me.
“… So it takes little guys like me spinning stuff out of universities, generally doing these startups. It’s important to hunt and it’s important to scratch to attempt to get cash.”
Final 12 months, VanLandingham bought his drug to Odyssey Well being, a privately held medical firm that describes itself as “centered on the event and commercialization of life-saving medical merchandise and well being associated applied sciences.” As a part of the deal, VanLandingham was named Odyssey’s vp of drug growth.
Requested concerning the dearth of printed analysis round Prevacus’ drug, Odyssey president and CEO Mike Redmond stated, “One factor that we’re cautious about, we have now been recommended on from our patent attorneys and everyone else is that the extra you publish, the much less possible, or the weaker your patent place. So, I do know that Prevacus was definitely involved about defending their patent place and never placing an excessive amount of data into the general public area, and I am of the identical mindset. So, we need to simply watch out about that.”
In July 2019, VanLandingham integrated PresolMD as a three way partnership with Prevacus to convey to market PreVPro, a cream designed to forestall or restrict concussions. The cream did not require FDA approval, and VanLandingham was searching for a faster option to get a drug to market, whereas persevering with with the lengthy, costly regulatory course of for his nasal spray.
In radio, TV and podcast interviews that usually sounded extra like infomercials, Favre and VanLandingham touted PreVPro.
In a single podcast interview, VanLandingham described placing a dab of the cream on either side of the neck, across the carotid artery.
“All you gotta do is take somewhat bit in your index finger, rub it on the left facet of the trachea, then take somewhat bit and rub it on the fitting,” he stated. “And in lower than half-hour, that small anti-inflammatory might be in your mind, I promise. And it will likely be working. Yep.”
“Wow! I’m so glad I requested you that,” the interviewer stated.
The truth is, at that time, the drug had been examined solely on canine, and its efficacy on people had not been assessed.
Once more, VanLandingham argued that he was talking within the context of the drug engaged on animals, not essentially on people, and by no means led an investor to consider in any other case.
“If there is a podcast that we’re attempting to assist the layperson perceive how the drug works, that is in all probability, possibly the way in which my thoughts was pondering,” he stated.
In one other interview, Favre stated that inside seven minutes of making use of the cream, it might present “seven hours of anti-inflammatory safety [to the brain].”
“That is wonderful!” the interviewer replied.
Concerning Favre’s statements concerning the efficacy of the drug, VanLandingham stated, “Now. Brett’s not as refined as me [on] these talks, and Brett just isn’t a scientist. So, if he missteps or one thing, I do not know. I attempt to appropriate him, if that is the case. I all the time have.”
DeKosky, Weinberger and different consultants expressed much more skepticism concerning the cream than the nasal spray, once more noting the absence of any information to help the claims.
“[With] the bodily modifications that happen with acute damage,” DeKosky stated, “it is very laborious to say that you could possibly interrupt them by giving some type of therapy earlier than it occurs.”
DeKosky stated many individuals have tried for years and advised that they had one thing that labored, however “then, after all, once they give it to an individual after the trauma, it does not appear to make any distinction.”
As with the nasal spray, Weinberger stated he does not consider there’s any scientific proof to help the claims concerning the cream: “I do not consider it’s prophylactic towards concussion. After which the query turns into what makes their mixture of nutrient brokers simpler than aspirin?”
Throughout a January 2020 podcast, VanLandingham advised PreVPro could be in the marketplace the next month and that Prevacus’ nasal spray was “in all probability about two years” away from going to market.
A web site for PreVPro, which described the cream as “like an ice pack that goes on the mind,” stated that the product would price $39.99 per tube, and potential patrons may add their identify to a pre-order checklist. The web site is now expired, and VanLandingham acknowledged that PresolMD has “type of fallen by the wayside.” He cited the Mississippi indictments, the pandemic and a deal that fell aside with a producer amongst causes the product by no means made it to market.
Each PresolMD and Prevacus are at present inactive firms, in response to Florida Secretary of State information. Prevacus additionally established itself as a Delaware company in 2012.
Nancy New, who ran the Mississippi Group Schooling Middle, pleaded responsible in April to bribery of a public official, fraud towards the federal government, wire fraud and racketeering. AP Picture/Rogelio V. Solis
THROUGH ITS LAWSUIT, the state of Mississippi is in search of to get well hundreds of thousands of {dollars}, together with $2.1 million it alleges went to Prevacus and PresolMD. In his response to the lawsuit, VanLandingham denied any criminality and argued, amongst different issues, that if Prevacus or PresolMD obtained any funds incorrectly, Mississippi’s Division of Human Providers or others related to the case ought to make restitution.
It appears unlikely that even when he have been discovered accountable, VanLandingham would be capable to pay the state.
Over the previous six years, VanLandingham and his firms have confronted liens and courtroom judgments totaling greater than $400,000. That features a 2020 judgement for $151,060 to Capital Metropolis Financial institution and a 2017 private federal tax lien for $158,353.
VanLandingham stated the federal tax lien stemmed from an organization failing to come back via on a promised $15 million funding in Prevacus. He stated he ended up promoting his house to assist pay the tax invoice. He stated the judgment to Capital Metropolis stemmed from an unrelated enterprise, though Prevacus is called within the lawsuit as a possible garnishee.
“I’ve scratched and clawed,” VanLandingham advised ESPN. “I’ve given each greenback I’ve again to this firm. … You understand, the story is how laborious these items is to do. And it will get lots tougher when you do not know it is welfare cash, and now you get your life uncovered — an honorable life, an honorable life!”
VanLandingham’s compensation for promoting his nasal spray drug to Odyssey is primarily within the type of inventory; its worth is basically predicated on the drug making it via extra scientific trials and finally attending to market.
In September, Odyssey introduced the completion of Part I testing that had been carried out in Australia, saying the drug proved protected in a trial of 40 wholesome check topics. Redmond, the Odyssey CEO, stated the corporate nonetheless wanted to lift cash for the following part, which he anticipated to price about $12 million.
The subsequent trials could be carried out to find out whether or not the drug, the truth is, works on concussed sufferers; that testing would require FDA approval earlier than it might be carried out in america. Redmond stated Odyssey was pursuing approval, whereas, on the similar time, contemplating beginning the following set of trials in Australia.
“[Jake’s] a really good scientist,” Redmond stated. “You stick him in entrance of every other scientist or physician that is well-versed in neurology, and he does very effectively. And so they get that this drug has promise.”
Odyssey’s two scientific advisers, Dr. Dallas Hack and Dr. James Kelly, didn’t reply to requests for remark. ESPN requested Redmond to see if they’d comply with be interviewed. He stated they declined. Up to now week, Hack was faraway from the checklist of advisers on Odyssey’s web site. Redmond stated Hack’s contract had ended and the corporate hoped to resume him for the following set of trials.
IN AN EFFORT to find out about VanLandingham as a researcher, ESPN reached out to a number of of his former colleagues at Florida State, the place he initially earned his Ph.D. in neuroscience and later labored as an assistant professor; and at Emory, the place he spent three years as a postdoctoral researcher.
In his bio and a 2013 résumé, VanLandingham stated he was the “Assistant Director” of the Emory lab. And in his bio, he stated he oversaw the ProTECT scientific biomarker research utilizing progesterone to deal with TBI.
Most of his former Emory colleagues have been essential, suggesting that VanLandingham took extra credit score for some work than he deserved. In addition they disputed that he was the assistant lab director.
“I used to be the assistant lab director … Anyone who says in any other case may kiss my ass,” VanLandingham stated. “In the event that they forgot, so be it. However I used to be named that by Donald Stein, who was the pinnacle of the lab.”
Stein advised ESPN, “That was not the case.” Advised of Stein’s response, VanLandingham stated, “Nicely, Don’s getting outdated.”
Iqbal Sayeed, who was a postdoc on the time and is at present the interim head of the lab, additionally stated VanLandingham was not the assistant director, nor did he lead the ProTECT research.
One former researcher who additionally labored within the lab, Sarah Cutler Tew, stated that VanLandingham was a “big-hearted” one that would “do something for a pal” and that his work was exemplary.
“The work and the science is legit,” she stated. “He has been doing it for 10 years, doing it in a scientifically applicable method. It takes this lengthy to do it proper. He is a scientist who noticed it as a possibility. The one method to do this is you probably have that entrepreneurial spirit that a variety of us do not have.”
Former Florida State colleagues contacted by ESPN both declined to debate VanLandingham or didn’t reply.
George Schmidt, VanLandingham’s lawyer within the Mississippi case, advised his consumer was misled and wrongly tied to the welfare fraud. If not for that, Schmidt added, “I am positive you’d have much more people who find themselves keen to say good issues about Jake.”
Reporter Anthony Olivieri and researcher John Mastroberardino contributed to this report.
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