Favre-backed drug company overstated benefits

TWO CONCUSSION DRUG companies backed by Brett Favre and enmeshed in a massive welfare fraud case overstated their NFL connections and exaggerated the known effectiveness of their drugs during efforts to raise money, according to interviews and documents reviewed by ESPN.

As well, court filings show the companies and their founder, Jake VanLandingham, faced substantial debts over the past several years, even as VanLandingham was pressing potential investors to help get his drugs to market.

Two of VanLandingham’s Florida-based companies — Prevacus and PresolMD — are alleged to have received more than $2.1 million in Mississippi funds that were earmarked for welfare families, according to a civil lawsuit filed by the state.

VanLandingham told ESPN in an interview, “I had no idea this was welfare money, and I’ve always been an upstanding person when it comes to research.” Favre declined to comment.

Favre, according to the lawsuit, is the top outside investor in Prevacus, and the Hall of Fame quarterback has said he put $1 million of his own money into the companies, which are developing a nasal spray to treat concussions and a cream to prevent or limit them.

Six people were arrested and charged in 2020 as part of what the state called a “multimillion-dollar embezzlement scheme.” They included Mississippi’s welfare director and the head of a nonprofit, both of whom have entered guilty pleas.

Neither Favre nor VanLandingham was charged, but they are among 38 individuals and companies named earlier this year in the civil lawsuit, which seeks the return of more than $20 million that had been designated for needy families.

The two men waged a marketing campaign to encourage investors to back VanLandingham’s companies — a campaign that ultimately led Favre to tap some of his connections in his home state.

The lawsuit alleges some of the funds were funneled through the Mississippi Community Education Center, a nonprofit run by Nancy New. New pleaded guilty in April to bribery of a public official, fraud against the government, wire fraud and racketeering. The civil lawsuit alleges a “sham” agreement was crafted for the financial benefit of several defendants, including New, Favre, VanLandingham and his two drug companies.

Favre also has said he was unaware the money was intended for needy families.

A 2019 marketing document used to raise money for Prevacus and PresolMD boasts several connections to the NFL. Dr. Allen Sills, the league’s chief medical officer, and Jeff Miller, the NFL’s executive vice president for health & safety innovation, are among those identified as “other contacts” on a list of “Key Advisory Members and Associates” to Prevacus. The marketing document also listed Dr. Brian Hainline, the NCAA’s chief medical officer, among “other contacts.”

An NFL spokesperson wrote in an email, “The league office was contacted by this organization but provided no funding or any resources in support of its efforts.” The spokesperson added that neither Miller nor Sills was an advisory member or associate for Prevacus, and the league was unaware of any teams using samples of PresolMD’s cream.

An NCAA spokesperson told ESPN that neither Hainline nor the NCAA has any connections with Prevacus or VanLandingham. “[Hainline] never had any advisory role or association with the company. And he never agreed to be listed on any marketing materials,” the spokesperson said.

VanLandingham said Favre had connected him with Sills and Miller to discuss the concussion drugs, but he said the document wasn’t intended to suggest Prevacus was working with the NFL or the NCAA, simply that the company had contacted the people and organizations.

“These are other contacts that we had made,” VanLandingham said. “I’m just making people aware that these are other contacts. Perhaps it would’ve been better separated out. … I’ve never told anybody that Allen Sills was an adviser for Prevacus. Or Jeff Miller. They provided feedback, and there’s been calls with both of them.”

Under the heading, “Milestones Achieved to Date,” the document also says that PresolMD has “provided product samples and cultivated relationships with 6 NFL Active Teams.” Elsewhere, under the heading, “Sales & Marketing Strategy & Financial Projections,” the document says PresolMD is working in “partnership with the NFL Affiliate Groups.”

VanLandingham said Favre had made connections with some team doctors and trainers, and “I think we did send out samples to different groups.” VanLandingham said he didn’t remember which teams were contacted nor did he know whether the samples had been used. He also said he couldn’t recall what the reference to “NFL Affiliate Groups” was about.

(The 2019 document also names 15 sports figures among its key advisers; one of those is ESPN NFL reporter Ed Werder, who was not employed by the network at the time.)

The marketing document, first obtained by the Clarion Ledger of Mississippi, says PresolMD is seeking $2 million in capital and claims the “Pre-Market Valuation” of the company is $20 million.

The document also says PresolMD has cultivated relationships with “100 NFL Retired Players,” and, in a 2020 podcast, VanLandingham says the company has had the “support” of the NFL Players Association during clinical trials. According to court documents, VanLandingham wrote in a text to another person who would later plead guilty in the Mississippi fraud case that “we partnered with the NFLPA for the clinical trials. No side effects.”

A spokesperson for the NFLPA said “there is no affiliation with that company or person,” adding, “If this person is representing that they have our support, that’s false.”

VanLandingham told ESPN the characterization of partnering with the NFLPA stemmed from a relationship PresolMD established with Byron Williams, a former NFL player who runs youth football camps. Williams is past president of the Dallas chapter of Retired NFL Players and a member of the NFLPA’s Former Player Advisory Board. VanLandingham said he believed Williams helped set up a trial of the cream product with youth players in an NFL Flag Football league in Dallas.

But Williams told ESPN the partnership had nothing to do with the NFLPA, he never spoke with anyone at the union about the product and he was helping solely as part of a business contract to connect PresolMD with youth players to test the cream. He also said the players were from his camps, not an NFL Flag league.

Williams has since filed a lawsuit in Texas, saying PresolMD breached the contract.

“I got my attorney trying to collect the rest of my contract agreement with [VanLandingham],” Williams said.

Neither Williams nor his lawyer would discuss how much they believe is owed Williams.

WHEN FOOTBALL’S CONCUSSION crisis exploded into the public consciousness in the mid-2010s, it not only opened the floodgates to new money for research, but it also unleashed a torrent of entrepreneurs trying to capitalize on the issue. There were no drugs or products proven to prevent, diagnose or treat concussions — there still aren’t — and a rush ensued to find answers for parents fearful their kids could wind up with long-term brain damage, like many of their heroes.

In 2012, according to Florida business records, VanLandingham incorporated Prevacus, Inc. His idea was to develop a drug that could be introduced to the brain through a nasal spray. The suggestion was that if a football player — or anyone, really: your young child, your elderly parent, a NASCAR driver — suffered a concussion, this drug could act as an anti-inflammatory, reducing the brain swelling that can come from a blow to the head.

The idea appeared to stem from research VanLandingham and others had conducted several years earlier at Emory University. While working as a postdoctoral researcher, VanLandingham was the lead author on two scientific papers — one in 2006, the other in 2008 — that described how progesterone and a related steroid had shown positive results on concussed rats.

VanLandingham told ESPN that after he left Emory, he worked with a chemist to develop a “new chemical entity” that allowed “Prevacus to have its own patent position.”

The use of the drug would require approval by the Food and Drug Administration, a process that can take a decade, cost millions of dollars and require multiple clinical trials to show the drug is safe and effective.

By 2014, VanLandingham was on the faculty at Florida State, raising money for Prevacus and promoting his idea — along with one of the greatest NFL quarterbacks in history. VanLandingham said he and Favre had been introduced through “a friend of a friend.” A year earlier, Favre had gone on the “Today” show and said if he had a son, he would be “real leery” of letting him play football.

VanLandingham said Favre initially was issued stock options for joining Prevacus’ “Sports Advisory Board.” Since then, Favre has become “a fairly large shareholder” in the company, VanLandingham said.

The two worked together to get the word out about Prevacus’ breakthrough drug.

“After you have a concussion, you have temporary energy crisis in the brain,” VanLandingham told WDAM-TV in Mississippi in 2014. “But by using our drug as soon as possible, and for many days afterward to manage the condition, you can reduce the secondary damage that occurs after the concussion.” VanLandingham told the station the drug was safer to use than Tylenol, and Favre touted the drug’s effectiveness, saying, “As far as stopping the advancement of a concussion, I think it’s unbelievable.”

In 2018, VanLandingham, Favre and several other Prevacus athlete investors appeared on NBC’s “Megyn Kelly Today” and promoted the drug, even though it was yet to be FDA approved, its efficacy had never been tested on humans and it still was potentially years from making it to the market. VanLandingham told Kelly and the audience that the drug was “a neurosteroid, given nasally, so we can get more into the brain very quickly. It’s formulated in a way where it can stay stable to over 125 degrees, so in Afghanistan, Iraq, on a football field, a soccer field. And we’re able to get it [to the brain] because we give it nasally through this applicator here. We’re able to get it into the brain in less than 5 minutes.”

Kelly asked if the drug had been FDA approved, and VanLandingham responded, “No, we’re in the process of clinical trials now.”

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

Within months of that appearance, according to the Mississippi lawsuit, Favre was urging VanLandingham to contact Nancy New to get funds from the state’s Department of Human Services. Favre, the lawsuit said, let VanLandingham know New had “previously provided substantial funds on his behalf.”

In January 2019, Favre hosted New and several other people at his Mississippi home to hear a business proposition from VanLandingham. Present at that meeting were three people who would later go on to be charged and plead guilty in the welfare fraud case.

Within a year of that meeting, Prevacus and PresolMD had received a total of $2.1 million of the state funds, according to the lawsuit. VanLandingham and Favre continued their promotional efforts. In a 2020 radio interview, they even suggested their nasal spray could save football players from the ravages of chronic traumatic encephalopathy (CTE), the long-term brain disease that posed an existential crisis to the sport.

Favre told the host, “We’re here to save the future.” And VanLandingham added, “We believe if we can stop this pathological cascade early on, then we’re going to end up having a lot less of what’s called post-concussion syndrome, post-traumatic stress disorder. And, ultimately, we believe by treating it early, our future players will not be enduring CTE.”

In reality, there was no research on humans to suggest anything of the sort. In fact, beyond the research he conducted at Emory, VanLandingham hadn’t been a part of any published studies related to the drug’s efficacy, according to a search of PubMed. And while the rat studies might have provided some optimism, that was a far cry from showing it would work to mitigate concussions in humans, let alone eliminate CTE.

“I looked to see what the evidence was, that it really does what they say it does. And there is none,” said Dr. Steven DeKosky, the deputy director of the McKnight Brain Institute at the University of Florida and a leading researcher in Alzheimer’s disease and traumatic brain injury (TBI).

Asked about the two earlier papers, DeKosky said the leap from that data to touting an untested drug using an untested method of delivery for that drug “is not reasonable. And there’s no proof that it would help ameliorate injury, much less prevent it.”

Said Dr. Daniel Weinberger, the director of the Lieber Institute for Brain Development and a professor of neuroscience at Johns Hopkins: “I don’t believe there’s any scientific evidence to support this claim for human use.”

VanLandingham told ESPN that it was never his intention to suggest the drug definitely would work, but rather that it had worked on animals and he predicted it might work on humans. He said he always made it clear the drug was yet to be approved by the FDA.

“There’s plenty of researchers and companies out there that promote their drug and their mechanism of action as they’re trying to get funding to get it through the FDA process,” VanLandingham said. “We clearly tell people it’s got to go through [the trials]. Nobody’s sitting here [saying] this drug works in humans. That’s never been the case for me.

“… So it takes little guys like me spinning stuff out of universities, sometimes doing these startups. You have to hunt and you have to scratch to try to get money.”

Last year, VanLandingham sold his drug to Odyssey Health, a privately held medical company that describes itself as “focused on the development and commercialization of life-saving medical products and health related technologies.” As part of the deal, VanLandingham was named Odyssey’s vice president of drug development.

Asked about the dearth of published research around Prevacus’ drug, Odyssey president and CEO Mike Redmond said, “One thing that we are careful about, we have been counseled on from our patent attorneys and everybody else is that the more you publish, the less likely, or the weaker your patent position. So, I know that Prevacus was certainly concerned about protecting their patent position and not putting too much information into the public domain, and I’m of the same mindset. So, we want to just be careful about that.”

In July 2019, VanLandingham incorporated PresolMD as a joint venture with Prevacus to bring to market PreVPro, a cream designed to prevent or limit concussions. The cream didn’t require FDA approval, and VanLandingham was looking for a quicker way to get a drug to market, while continuing with the long, expensive regulatory process for his nasal spray.

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

In one podcast interview, VanLandingham described putting a dab of the cream on each side of the neck, around the carotid artery.

“All you gotta do is take a little bit on your index finger, rub it on the left side of the trachea, then take a little bit and rub it on the right,” he said. “And in less than 30 minutes, that small anti-inflammatory will be in your brain, I promise. And it will be working. Yep.”

“Wow! I am so glad I asked you that,” the interviewer said.

In fact, at that point, the drug had been tested only on dogs, and its efficacy on humans had not been assessed.

Again, VanLandingham argued that he was speaking in the context of the drug working on animals, not necessarily on humans, and never led an investor to believe otherwise.

“If there’s a podcast that we’re trying to help the layperson understand how the drug works, that’s probably, maybe the way my mind was thinking,” he said.

In another interview, Favre said that within seven minutes of applying the cream, it would provide “seven hours of anti-inflammatory protection [to the brain].”

“That’s amazing!” the interviewer replied.

Regarding Favre’s statements about the efficacy of the drug, VanLandingham said, “Now. Brett’s not as sophisticated as me [on] these talks, and Brett is not a scientist. So, if he missteps or something, I don’t know. I try to correct him, if that’s the case. I always have.”

DeKosky, Weinberger and other experts expressed even more skepticism about the cream than the nasal spray, again noting the absence of any data to support the claims.

“[With] the physical changes that occur with acute injury,” DeKosky said, “it’s very hard to say that you could interrupt them by giving some kind of treatment before it happens.”

DeKosky said many people have tried for years and suggested they had something that worked, but “then, of course, when they give it to a person after the trauma, it doesn’t seem to make any difference.”

As with the nasal spray, Weinberger said he doesn’t believe there’s any scientific evidence to support the claims about the cream: “I don’t believe it is prophylactic against concussion. And then the question becomes what makes their combination of nutrient agents more effective than aspirin?”

During a January 2020 podcast, VanLandingham suggested PreVPro would be on the market the following month and that Prevacus’ nasal spray was “probably about two years” away from going to market.

A website for PreVPro, which described the cream as “like an ice pack that goes on the brain,” said that the product would cost $39.99 per tube, and prospective buyers could add their name to a pre-order list. The website is now expired, and VanLandingham acknowledged that PresolMD has “kind of fallen by the wayside.” He cited the Mississippi indictments, the pandemic and a deal that fell apart with a manufacturer among reasons the product never made it to market.

Both PresolMD and Prevacus are currently inactive corporations, according to Florida Secretary of State records. Prevacus also established itself as a Delaware corporation in 2012.

THROUGH ITS LAWSUIT, the state of Mississippi is seeking to recover millions of dollars, including $2.1 million it alleges went to Prevacus and PresolMD. In his response to the lawsuit, VanLandingham denied any illegal activity and argued, among other things, that if Prevacus or PresolMD received any funds incorrectly, Mississippi’s Department of Human Services or others connected to the case should make restitution.

It seems unlikely that even if he were found responsible, VanLandingham would be able to pay the state.

Over the past six years, VanLandingham and his companies have faced liens and court judgments totaling more than $400,000. That includes a 2020 judgement for $151,060 to Capital City Bank and a 2017 personal federal tax lien for $158,353.

VanLandingham said the federal tax lien stemmed from a company failing to come through on a promised $15 million investment in Prevacus. He said he ended up selling his home to help pay the tax bill. He said the judgment to Capital City stemmed from an unrelated business, although Prevacus is named in the lawsuit as a potential garnishee.

“I’ve scratched and clawed,” VanLandingham told ESPN. “I’ve given every dollar I have back to this company. … You know, the story is how hard this stuff is to do. And it gets a lot harder when you don’t know it’s welfare money, and now you get your life exposed — an honorable life, an honorable life!”

VanLandingham’s compensation for selling his nasal spray drug to Odyssey is primarily in the form of stock; its value is largely predicated on the drug making it through additional clinical trials and ultimately getting to market.

In September, Odyssey announced the completion of Phase I testing that had been conducted in Australia, saying the drug proved safe in a trial of 40 healthy test subjects. Redmond, the Odyssey CEO, said the company still needed to raise money for the next phase, which he expected to cost about $12 million.

The next trials would be conducted to determine whether the drug, in fact, works on concussed patients; that testing would require FDA approval before it could be performed in the United States. Redmond said Odyssey was pursuing approval, while, at the same time, considering starting the next set of trials in Australia.

“[Jake’s] a very smart scientist,” Redmond said. “You stick him in front of any other scientist or doctor that’s well-versed in neurology, and he does very well. And they get that this drug has promise.”

Odyssey’s two scientific advisers, Dr. Dallas Hack and Dr. James Kelly, did not respond to requests for comment. ESPN asked Redmond to see if they would agree to be interviewed. He said they declined. In the past week, Hack was removed from the list of advisers on Odyssey’s website. Redmond said Hack’s contract had ended and the company was hoping to renew him for the next set of trials.

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IN AN EFFORT to learn about VanLandingham as a researcher, ESPN reached out to several of his former colleagues at Florida State, where he initially earned his Ph.D. in neuroscience and later worked as an assistant professor; and at Emory, where he spent three years as a postdoctoral researcher.

In his bio and a 2013 résumé, VanLandingham said he was the “Assistant Director” of the Emory lab. And in his bio, he said he oversaw the ProTECT clinical biomarker study using progesterone to treat TBI.

Most of his former Emory colleagues were critical, suggesting that VanLandingham took more credit for some work than he deserved. They also disputed that he was the assistant lab director.

“I was the assistant lab director … Anybody who says otherwise could kiss my ass,” VanLandingham said. “If they forgot, so be it. But I was named that by Donald Stein, who was the head 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 at the time and is currently the interim head of the lab, also said VanLandingham was not the assistant director, nor did he lead the ProTECT study.

One former researcher who also worked in the lab, Sarah Cutler Tew, said that VanLandingham was a “big-hearted” person who would “do anything for a friend” and that his work was exemplary.

“The work and the science is legit,” she said. “He has been doing it for 10 years, doing it in a scientifically appropriate way. It takes this long to do it right. He’s a scientist who saw it as an opportunity. The only way to do that is if you have that entrepreneurial spirit that a lot of us don’t have.”

Former Florida State colleagues contacted by ESPN either declined to discuss VanLandingham or did not respond.

George Schmidt, VanLandingham’s lawyer in the Mississippi case, suggested his client was misled and wrongly tied to the welfare fraud. If not for that, Schmidt added, “I’m sure you’d have a lot more people who are willing to say good things about Jake.”

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