Favre-backed drug company overstated benefits

TWO CONCUSSION DRUG companies backed by Brett Favre and enmeshed successful a monolithic payment fraud lawsuit overstated their NFL connections and exaggerated the known effectiveness of their drugs during efforts to rise money, according to interviews and documents reviewed by ESPN.

As well, tribunal filings amusement the companies and their founder, Jake VanLandingham, faced important debts implicit the past respective years, adjacent arsenic VanLandingham was pressing imaginable investors to assistance get his drugs to market.

Two of VanLandingham's Florida-based companies -- Prevacus and PresolMD -- are alleged to person received much than $2.1 cardinal successful Mississippi funds that were earmarked for payment families, according to a civilian suit filed by the state.

VanLandingham told ESPN successful an interview, "I had nary thought this was payment money, and I've ever been an upstanding idiosyncratic erstwhile it comes to research." Favre declined to comment.

Favre, according to the lawsuit, is the apical extracurricular capitalist successful Prevacus, and the Hall of Fame backmost has said helium enactment $1 cardinal of his ain wealth into the companies, which are processing a nasal spray to dainty concussions and a pick to forestall oregon bounds them.

Six radical were arrested and charged successful 2020 arsenic portion of what the authorities called a "multimillion-dollar embezzlement scheme." They included Mississippi's payment manager and the caput of a nonprofit, some of whom person entered blameworthy pleas.

Neither Favre nor VanLandingham was charged, but they are among 38 individuals and companies named earlier this twelvemonth successful the civilian lawsuit, which seeks the instrumentality of much than $20 cardinal that had been designated for needy families.

The 2 men waged a selling run to promote investors to backmost VanLandingham's companies -- a run that yet led Favre to pat immoderate of his connections successful his location state.

The suit alleges immoderate of the funds were funneled done the Mississippi Community Education Center, a nonprofit tally by Nancy New. New pleaded blameworthy successful April to bribery of a nationalist official, fraud against the government, ligament fraud and racketeering. The civilian suit alleges a "sham" statement was crafted for the fiscal payment of respective defendants, including New, Favre, VanLandingham and his 2 cause companies.

Favre besides has said helium was unaware the wealth was intended for needy families.

A 2019 selling papers utilized to rise wealth for Prevacus and PresolMD boasts respective connections to the NFL. Dr. Allen Sills, the league's main aesculapian officer, and Jeff Miller, the NFL's enforcement vice president for wellness & information innovation, are among those identified arsenic "other contacts" connected a database of "Key Advisory Members and Associates" to Prevacus. The selling papers besides listed Dr. Brian Hainline, the NCAA's main aesculapian officer, among "other contacts."

An NFL spokesperson wrote successful an email, "The league bureau was contacted by this enactment but provided nary backing oregon immoderate resources successful enactment of its efforts." The spokesperson added that neither Miller nor Sills was an advisory subordinate oregon subordinate for Prevacus, and the league was unaware of immoderate teams utilizing samples of PresolMD's cream.

An NCAA spokesperson told ESPN that neither Hainline nor the NCAA has immoderate connections with Prevacus oregon VanLandingham. "[Hainline] ne'er had immoderate advisory relation oregon relation with the company. And helium ne'er agreed to beryllium listed connected immoderate selling materials," the spokesperson said.

VanLandingham said Favre had connected him with Sills and Miller to sermon the concussion drugs, but helium said the papers wasn't intended to suggest Prevacus was moving with the NFL oregon the NCAA, simply that the institution had contacted the radical and organizations.

"These are different contacts that we had made," VanLandingham said. "I'm conscionable making radical alert that these are different contacts. Perhaps it would've been amended separated out. ... I've ne'er told anybody that Allen Sills was an advisor for Prevacus. Or Jeff Miller. They provided feedback, and there's been calls with some of them."

Under the heading, "Milestones Achieved to Date," the papers besides says that PresolMD has "provided merchandise samples and cultivated relationships with 6 NFL Active Teams." Elsewhere, nether the heading, "Sales & Marketing Strategy & Financial Projections," the papers says PresolMD is moving successful "partnership with the NFL Affiliate Groups."

VanLandingham said Favre had made connections with immoderate squad doctors and trainers, and "I deliberation we did nonstop retired samples to antithetic groups." VanLandingham said helium didn't retrieve which teams were contacted nor did helium cognize whether the samples had been used. He besides said helium couldn't callback what the notation to "NFL Affiliate Groups" was about.

(The 2019 papers besides names 15 sports figures among its cardinal advisers; 1 of those is ESPN NFL newsman Ed Werder, who was not employed by the web astatine the time.)

The selling document, archetypal obtained by the Clarion Ledger of Mississippi, says PresolMD is seeking $2 cardinal successful superior and claims the "Pre-Market Valuation" of the institution is $20 million.

The papers besides says PresolMD has cultivated relationships with "100 NFL Retired Players," and, successful a 2020 podcast, VanLandingham says the institution has had the "support" of the NFL Players Association during objective trials. According to tribunal documents, VanLandingham wrote successful a substance to different idiosyncratic who would aboriginal plead blameworthy successful the Mississippi fraud lawsuit that "we partnered with the NFLPA for the objective trials. No broadside effects."

A spokesperson for the NFLPA said "there is nary affiliation with that institution oregon person," adding, "If this idiosyncratic is representing that they person our support, that's false."

VanLandingham told ESPN the characterization of partnering with the NFLPA stemmed from a narration PresolMD established with Byron Williams, a erstwhile NFL subordinate who runs younker shot camps. Williams is past president of the Dallas section of Retired NFL Players and a subordinate of the NFLPA's Former Player Advisory Board. VanLandingham said helium believed Williams helped acceptable up a proceedings of the pick merchandise with younker players successful an NFL Flag Football league successful Dallas.

But Williams told ESPN the concern had thing to bash with the NFLPA, helium ne'er spoke with anyone astatine the national astir the merchandise and helium was helping solely arsenic portion of a concern declaration to link PresolMD with younker players to trial the cream. He besides said the players were from his camps, not an NFL Flag league.

Williams has since filed a suit successful Texas, saying PresolMD breached the contract.

"I got my lawyer trying to cod the remainder of my declaration statement with [VanLandingham]," Williams said.

Neither Williams nor his lawyer would sermon however overmuch they judge is owed Williams.

WHEN FOOTBALL'S CONCUSSION crisis exploded into the nationalist consciousness successful the mid-2010s, it not lone opened the floodgates to caller wealth for research, but it besides unleashed a torrent of entrepreneurs trying to capitalize connected the issue. There were nary drugs oregon products proven to prevent, diagnose oregon dainty concussions -- determination inactive aren't -- and a unreserved ensued to find answers for parents fearful their kids could upwind up with semipermanent encephalon damage, similar galore of their heroes.

In 2012, according to Florida concern records, VanLandingham incorporated Prevacus, Inc. His thought was to make a cause that could beryllium introduced to the encephalon done a nasal spray. The proposition was that if a shot subordinate -- oregon anyone, really: your young child, your aged parent, a NASCAR operator -- suffered a concussion, this cause could enactment arsenic an anti-inflammatory, reducing the encephalon swelling that tin travel from a stroke to the head.

The thought appeared to stem from probe VanLandingham and others had conducted respective years earlier astatine Emory University. While moving arsenic a postdoctoral researcher, VanLandingham was the pb writer connected 2 technological papers -- 1 successful 2006, the different successful 2008 -- that described however progesterone and a related steroid had shown affirmative results connected concussed rats.

VanLandingham told ESPN that aft helium near Emory, helium worked with a chemist to make a "new chemic entity" that allowed "Prevacus to person its ain patent position."

The usage of the cause would necessitate support by the Food and Drug Administration, a process that tin instrumentality a decade, outgo millions of dollars and necessitate aggregate objective trials to amusement the cause is harmless and effective.

By 2014, VanLandingham was connected the module astatine Florida State, raising wealth for Prevacus and promoting his thought -- on with 1 of the top NFL quarterbacks successful history. VanLandingham said helium and Favre had been introduced done "a person of a friend." A twelvemonth earlier, Favre had gone connected the "Today" amusement and said if helium had a son, helium would beryllium "real leery" of letting him play football.

VanLandingham said Favre initially was issued banal options for joining Prevacus' "Sports Advisory Board." Since then, Favre has go "a reasonably ample shareholder" successful the company, VanLandingham said.

The 2 worked unneurotic to get the connection retired astir Prevacus' breakthrough drug.

"After you person a concussion, you person impermanent vigor situation successful the brain," VanLandingham told WDAM-TV successful Mississippi successful 2014. "But by utilizing our cause arsenic soon arsenic possible, and for galore days afterward to negociate the condition, you tin trim the secondary harm that occurs aft the concussion." VanLandingham told the presumption the cause was safer to usage than Tylenol, and Favre touted the drug's effectiveness, saying, "As acold arsenic stopping the advancement of a concussion, I deliberation it's unbelievable."

In 2018, VanLandingham, Favre and respective different Prevacus jock investors appeared connected NBC's "Megyn Kelly Today" and promoted the drug, adjacent though it was yet to beryllium FDA approved, its efficacy had ne'er been tested connected humans and it inactive was perchance years from making it to the market. VanLandingham told Kelly and the assemblage that the cause was "a neurosteroid, fixed nasally, truthful we tin get much into the encephalon precise quickly. It's formulated successful a mode wherever it tin enactment unchangeable to implicit 125 degrees, truthful successful Afghanistan, Iraq, connected a shot field, a shot field. And we're capable to get it [to the brain] due to the fact that we springiness it nasally done this applicator here. We're capable to get it into the encephalon successful little than 5 minutes."

Kelly asked if the cause had been FDA approved, and VanLandingham responded, "No, we're successful the process of objective trials now."

During the segment, each of the athletes worked Prevacus into their responses and spoke astir its large promise.

Within months of that appearance, according to the Mississippi lawsuit, Favre was urging VanLandingham to interaction Nancy New to get funds from the state's Department of Human Services. Favre, the suit said, fto VanLandingham cognize New had "previously provided important funds connected his behalf."

In January 2019, Favre hosted New and respective different radical astatine his Mississippi location to perceive a concern proposition from VanLandingham. Present astatine that gathering were 3 radical who would aboriginal spell connected to beryllium charged and plead blameworthy successful the payment fraud case.

Within a twelvemonth of that meeting, Prevacus and PresolMD had received a full of $2.1 cardinal of the authorities funds, according to the lawsuit. VanLandingham and Favre continued their promotional efforts. In a 2020 vigor interview, they adjacent suggested their nasal spray could prevention shot players from the ravages of chronic traumatic encephalopathy (CTE), the semipermanent encephalon illness that posed an existential situation to the sport.

Favre told the host, "We're present to prevention the future." And VanLandingham added, "We judge if we tin halt this pathological cascade aboriginal on, past we're going to extremity up having a batch little of what's called post-concussion syndrome, post-traumatic accent disorder. And, ultimately, we judge by treating it early, our aboriginal players volition not beryllium enduring CTE."

In reality, determination was nary probe connected humans to suggest thing of the sort. In fact, beyond the probe helium conducted astatine Emory, VanLandingham hadn't been a portion of immoderate published studies related to the drug's efficacy, according to a hunt of PubMed. And portion the rat studies mightiness person provided immoderate optimism, that was a acold outcry from showing it would enactment to mitigate concussions successful humans, fto unsocial destruct CTE.

"I looked to spot what the grounds was, that it truly does what they accidental it does. And determination is none," said Dr. Steven DeKosky, the lawman manager of the McKnight Brain Institute astatine the University of Florida and a starring researcher successful Alzheimer's illness and traumatic encephalon wounded (TBI).

Asked astir the 2 earlier papers, DeKosky said the leap from that information to touting an untested cause utilizing an untested method of transportation for that cause "is not reasonable. And there's nary impervious that it would assistance ameliorate injury, overmuch little forestall it."

Said Dr. Daniel Weinberger, the manager of the Lieber Institute for Brain Development and a prof of neuroscience astatine Johns Hopkins: "I don't judge there's immoderate technological grounds to enactment this assertion for quality use."

VanLandingham told ESPN that it was ne'er his volition to suggest the cause decidedly would work, but alternatively that it had worked connected animals and helium predicted it mightiness enactment connected humans. He said helium ever made it wide the cause was yet to beryllium approved by the FDA.

"There's plentifulness of researchers and companies retired determination that beforehand their cause and their mechanics of enactment arsenic they're trying to get backing to get it done the FDA process," VanLandingham said. "We intelligibly archer radical it's got to spell done [the trials]. Nobody's sitting present [saying] this cause works successful humans. That's ne'er been the lawsuit for me.

"... So it takes small guys similar maine spinning worldly retired of universities, sometimes doing these startups. You person to hunt and you person to scratch to effort to get money."

Last year, VanLandingham sold his cause to Odyssey Health, a privately held aesculapian institution that describes itself arsenic "focused connected the improvement and commercialization of life-saving aesculapian products and wellness related technologies." As portion of the deal, VanLandingham was named Odyssey's vice president of cause development.

Asked astir the dearth of published probe astir Prevacus' drug, Odyssey president and CEO Mike Redmond said, "One happening that we are cautious about, we person been counseled connected from our patent attorneys and everybody other is that the much you publish, the little likely, oregon the weaker your patent position. So, I cognize that Prevacus was surely acrophobic astir protecting their patent presumption and not putting excessively overmuch accusation into the nationalist domain, and I'm of the aforesaid mindset. So, we privation to conscionable beryllium cautious astir that."

In July 2019, VanLandingham incorporated PresolMD arsenic a associated task with Prevacus to bring to marketplace PreVPro, a pick designed to forestall oregon bounds concussions. The pick didn't necessitate FDA approval, and VanLandingham was looking for a quicker mode to get a cause to market, portion continuing with the long, costly regulatory process for his nasal spray.

In radio, TV and podcast interviews that often sounded much similar infomercials, Favre and VanLandingham touted PreVPro.

In 1 podcast interview, VanLandingham described putting a dab of the pick connected each broadside of the neck, astir the carotid artery.

"All you gotta bash is instrumentality a small spot connected your scale finger, hitch it connected the near broadside of the trachea, past instrumentality a small spot and hitch it connected the right," helium said. "And successful little than 30 minutes, that tiny anti-inflammatory volition beryllium successful your brain, I promise. And it volition beryllium working. Yep."

"Wow! I americium truthful gladsome I asked you that," the interviewer said.

In fact, astatine that point, the cause had been tested lone connected dogs, and its efficacy connected humans had not been assessed.

Again, VanLandingham argued that helium was speaking successful the discourse of the cause moving connected animals, not needfully connected humans, and ne'er led an capitalist to judge otherwise.

"If there's a podcast that we're trying to assistance the layperson recognize however the cause works, that's probably, possibly the mode my caput was thinking," helium said.

In different interview, Favre said that wrong 7 minutes of applying the cream, it would supply "seven hours of anti-inflammatory extortion [to the brain]."

"That's amazing!" the interviewer replied.

Regarding Favre's statements astir the efficacy of the drug, VanLandingham said, "Now. Brett's not arsenic blase arsenic maine [on] these talks, and Brett is not a scientist. So, if helium missteps oregon something, I don't know. I effort to close him, if that's the case. I ever have."

DeKosky, Weinberger and different experts expressed adjacent much skepticism astir the pick than the nasal spray, again noting the lack of immoderate information to enactment the claims.

"[With] the carnal changes that hap with acute injury," DeKosky said, "it's precise hard to accidental that you could interrupt them by giving immoderate benignant of attraction earlier it happens."

DeKosky said galore radical person tried for years and suggested they had thing that worked, but "then, of course, erstwhile they springiness it to a idiosyncratic aft the trauma, it doesn't look to marque immoderate difference."

As with the nasal spray, Weinberger said helium doesn't judge there's immoderate technological grounds to enactment the claims astir the cream: "I don't judge it is prophylactic against concussion. And past the question becomes what makes their operation of nutrient agents much effectual than aspirin?"

During a January 2020 podcast, VanLandingham suggested PreVPro would beryllium connected the marketplace the pursuing period and that Prevacus' nasal spray was "probably astir 2 years" distant from going to market.

A website for PreVPro, which described the pick arsenic "like an crystal battalion that goes connected the brain," said that the merchandise would outgo $39.99 per tube, and prospective buyers could adhd their sanction to a pre-order list. The website is present expired, and VanLandingham acknowledged that PresolMD has "kind of fallen by the wayside." He cited the Mississippi indictments, the pandemic and a woody that fell isolated with a shaper among reasons the merchandise ne'er made it to market.

Both PresolMD and Prevacus are presently inactive corporations, according to Florida Secretary of State records. Prevacus besides established itself arsenic a Delaware corp successful 2012.

THROUGH ITS LAWSUIT, the authorities of Mississippi is seeking to retrieve millions of dollars, including $2.1 cardinal it alleges went to Prevacus and PresolMD. In his effect to the lawsuit, VanLandingham denied immoderate amerciable enactment and argued, among different things, that if Prevacus oregon PresolMD received immoderate funds incorrectly, Mississippi's Department of Human Services oregon others connected to the lawsuit should marque restitution.

It seems improbable that adjacent if helium were recovered responsible, VanLandingham would beryllium capable to wage the state.

Over the past six years, VanLandingham and his companies person faced liens and tribunal judgments totaling much than $400,000. That includes a 2020 judgement for $151,060 to Capital City Bank and a 2017 idiosyncratic national taxation lien for $158,353.

VanLandingham said the national taxation lien stemmed from a institution failing to travel done connected a promised $15 cardinal concern successful Prevacus. He said helium ended up selling his location to assistance wage the taxation bill. He said the judgement to Capital City stemmed from an unrelated business, though Prevacus is named successful the suit arsenic a imaginable garnishee.

"I've scratched and clawed," VanLandingham told ESPN. "I've fixed each dollar I person backmost to this company. ... You know, the communicative is however hard this worldly is to do. And it gets a batch harder erstwhile you don't cognize it's payment money, and present you get your beingness exposed -- an honorable life, an honorable life!"

VanLandingham's compensation for selling his nasal spray cause to Odyssey is chiefly successful the signifier of stock; its worth is mostly predicated connected the cause making it done further objective trials and yet getting to market.

In September, Odyssey announced the completion of Phase I investigating that had been conducted successful Australia, saying the cause proved harmless successful a proceedings of 40 steadfast trial subjects. Redmond, the Odyssey CEO, said the institution inactive needed to rise wealth for the adjacent phase, which helium expected to outgo astir $12 million.

The adjacent trials would beryllium conducted to find whether the drug, successful fact, works connected concussed patients; that investigating would necessitate FDA support earlier it could beryllium performed successful the United States. Redmond said Odyssey was pursuing approval, while, astatine the aforesaid time, considering starting the adjacent acceptable of trials successful Australia.

"[Jake's] a precise astute scientist," Redmond said. "You instrumentality him successful beforehand of immoderate different idiosyncratic oregon doc that's well-versed successful neurology, and helium does precise well. And they get that this cause has promise."

Odyssey's 2 technological advisers, Dr. Dallas Hack and Dr. James Kelly, did not respond to requests for comment. ESPN asked Redmond to spot if they would hold to beryllium interviewed. He said they declined. In the past week, Hack was removed from the database of advisers connected Odyssey's website. Redmond said Hack's declaration had ended and the institution was hoping to renew him for the adjacent acceptable of trials.

IN AN EFFORT to larn astir VanLandingham arsenic a researcher, ESPN reached retired to respective of his erstwhile colleagues astatine Florida State, wherever helium initially earned his Ph.D. successful neuroscience and aboriginal worked arsenic an adjunct professor; and astatine Emory, wherever helium spent 3 years arsenic a postdoctoral researcher.

In his bio and a 2013 résumé, VanLandingham said helium was the "Assistant Director" of the Emory lab. And successful his bio, helium said helium oversaw the ProTECT objective biomarker survey utilizing progesterone to dainty TBI.

Most of his erstwhile Emory colleagues were critical, suggesting that VanLandingham took much recognition for immoderate enactment than helium deserved. They besides disputed that helium was the adjunct laboratory director.

"I was the adjunct laboratory manager ... Anybody who says different could buss my ass," VanLandingham said. "If they forgot, truthful beryllium it. But I was named that by Donald Stein, who was the caput of the lab."

Stein told ESPN, "That was not the case." Told of Stein's response, VanLandingham said, "Well, Don's getting old."

Iqbal Sayeed, who was a postdoc astatine the clip and is presently the interim caput of the lab, besides said VanLandingham was not the adjunct director, nor did helium pb the ProTECT study.

One erstwhile researcher who besides worked successful the lab, Sarah Cutler Tew, said that VanLandingham was a "big-hearted" idiosyncratic who would "do thing for a friend" and that his enactment was exemplary.

"The enactment and the subject is legit," she said. "He has been doing it for 10 years, doing it successful a scientifically due way. It takes this agelong to bash it right. He's a idiosyncratic who saw it arsenic an opportunity. The lone mode to bash that is if you person that entrepreneurial tone that a batch of america don't have."

Former Florida State colleagues contacted by ESPN either declined to sermon VanLandingham oregon did not respond.

George Schmidt, VanLandingham's lawyer successful the Mississippi case, suggested his lawsuit was misled and wrongly tied to the payment fraud. If not for that, Schmidt added, "I'm definite you'd person a batch much radical who are consenting to accidental bully things astir Jake."

Reporter Anthony Olivieri and researcher John Mastroberardino contributed to this report.