According to interviews and documents reviewed by the sports network, the two drug companies backed by the quarterback overstated their NFL connections and exaggerated the effectiveness of their drugs.
The companies and their founder, Jake VanLandingham, faced substantial debts over the past several years, even as he was pressing potential investors to help get his drugs to market
According to the lawsuit, Prevacus and PresolMD received more than $2 million in Mississippi funds that were intended for welfare families.
I had no idea this was welfare money, and I've always been an upstanding person when it comes to research. The quarterback declined to speak.
According to the lawsuit, the Hall of Fame quarterback put $1 million of his own money into the companies, which are developing a spray and cream to prevent or limit concussions.
The state said that six people were arrested and charged in 2020 for their part in a multi million-dollar scam. The head of a nonprofit and the welfare director of Mississippi have entered guilty pleas.
The civil lawsuit, which seeks the return of more than $20 million that had been designated for needy families, was brought against 38 individuals and companies.
The two men waged a marketing campaign to encourage investors to back the companies
Nancy New is accused of funneling some of the funds through her nonprofit. In April, New pleaded guilty to a number of charges. Several defendants, including New, VanLandingham and his two drug companies, were accused in a civil lawsuit of creating a "sham" agreement.
The money was intended for families in need.
A marketing document used to raise money for Prevacus and PresolMD has links to the NFL. Dr. Allen Sills, the league's chief medical officer, and Jeff Miller, the NFL's executive vice president for health and safety innovation, are among those identified as other contacts. The NCAA's chief medical officer was listed as one of the other contacts.
The league office did not provide any funding or resources to support the organization's efforts. The league was not aware of any teams using samples of PresolMD's cream.
The NCAA has no connection with Prevacus or VanLandingham, according to an NCAA spokesman. Hainline was never associated with the company. He didn't agree to be listed on any marketing materials.
The document was not intended to suggest that Prevacus was working with the NCAA or the NFL, but that the company had contacted the people and organizations.
VanLandingham said that they had made other contacts. I want people to know that these are other contacts. It might have been better if it had been separated out. I haven't told anyone that Allen was an adviser for Prevacus. They could be either Jeff Miller or someone else. There have been calls with both of them after they gave feedback.
The document says that PresolMD has provided product samples and cultivated relationships with 6 NFL teams. The document says PresolMD is working with the NFL.
"I think we sent out samples to different groups because he made connections with some team doctors and trainers," VanLandingham said. He didn't know if the samples had been used. He couldn't remember what the reference was to.
One of the key advisers is Ed Werder, who was not employed by the network at the time.
PresolMD is looking for $2 million in capital and has a pre-market valuation of $20 million, according to a marketing document obtained by the Mississippi newspaper.
According to the document, PresolMD 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. There was no side effect.
"If this person is representing that they have our support, that's false, there is no affiliation with that company or person," said a spokesman for the football players' union.
PresolMD established a relationship with a former football player who runs youth football camps. Williams is a member of the former player advisory board. According to VanLandingham, Williams helped set up a trial of the cream product with youth players in a flag football league.
Williams said the partnership had nothing to do with the union and that he was helping PresolMD with youth players to test the cream. The players were from his camps.
PresolMD is accused of breaching the contract by Williams.
Williams said that his lawyer was trying to collect the rest of his contract.
Williams and his lawyer wouldn't talk about how much he's owed.
Football's scandal exploded into the public consciousness in the mid-2010s, unleashing a torrent of entrepreneurs trying to exploit the issue. There were no drugs or products proven to prevent, diagnose or treat concussions, and a rush to find answers for parents worried their children could end up with long-term brain damage like many of their heroes.
His idea was to develop a drug that could be sprayed on the brain. If a football player or anyone else suffers a concussion, this drug could act as an anti-Inflammatory, reducing the brain swelling that can come from a blow to the head.
Several years ago, VanLandingham and others conducted research at the university. The lead author on two scientific papers, one in 2006 and the other in 2008, was VanLandingham, who was a researcher at the time.
"Prevacus" had its own patent position after VanLandingham worked with a chemist to create a new chemical entity.
The use of the drug would require approval by the Food and Drug Administration, a process that can take a decade and cost millions of dollars.
Along with one of the greatest NFL quarterbacks in history, VanLandingham was on the faculty at Florida State raising money for Prevacus. The two men were introduced through a friend of a friend. If he had a son, he would be "real leery" of letting him play football, according to a year ago.
The stock options for joining Prevacus' "Sports Advisory Board" were HairMax's first choice. He has become a large shareholder in the company.
They worked together to spread the word about Prevacus.
A concussion can cause a temporary energy crisis in the brain. Secondary damage that occurs after a concussion can be reduced by using our drug as soon as possible and for many days afterwards. "As far as stopping the advancement of a concussion, I think it's unbelievable that the drug can do that," VanLandingham said.
The Prevacus athlete investors appeared on NBC's "Megyn Kelly Today" in order to promote the drug, even though it was not yet approved by the FDA and could take years to make it to humans. VanLandingham told Kelly and the audience that the drug was a neurosteroid and that it could get into the brain very fast. In Afghanistan, Iraq, and other places it can stay stable to over 125 degrees. We can get it to the brain through this method. It's possible to get it into the brain in less than five minutes.
VanLandingham said the drug was in the process of clinical trials.
Each athlete spoke about the great promise of Prevacus during the segment.
According to the Mississippi lawsuit, within months of that appearance, VanLandingham was urged to contact Nancy New to get funds from the state's Department of Human Services. The lawsuit said that New had provided substantial funds on his behalf.
New and several other people were invited to hear a business proposal from VanLandingham. Three people who were present at the meeting later pleaded guilty in the case.
The state funds went to Prevacus and PresolMD within a year. They continued to promote their products. They said in a 2020 radio interview that their spray could save football players from the ravages of chronic traumatic encephalopathy.
The host asked if they were here to save the future. "We believe if we can stop this cascade early on, then we're going to end up having less of what is called post-concussion syndrome, post-traumatic stress disorder." By treating it early, we believe our future players won't be affected by it.
There was no research done on humans to suggest that. According to a search of PubMed, VanLandingham hadn't been involved in any studies related to the drug's efficacy. The rat studies might have given some hope, but they didn't show that it would work to reduce concussions in humans.
I looked at the evidence to see if it was true. Steven DeKosky is a leading researcher in Alzheimer's disease and traumatic brain injury.
There is no proof that it would help injured people.
"I don't think there's any scientific evidence to support this claim for human use," said Dr. Daniel Weinberger, director of the Lieber Institute for Brain Development.
It wasn't his intention to suggest that the drug would work, but rather that it had worked on animals and that it might work on humans, he said in an interview. The drug was not approved by the FDA according to him.
"There's a lot of companies and researchers out there that promote their drug and their mechanism of action as they try to get funding to get it through the FDA process," he said. People are told it must go through the trials. Nobody is saying that this drug works in people. I've never been that way.
Is that correct? It takes small guys like me to do these things. To get money, you have to hunt and scratch.
Odyssey Health is a privately held medical company that focuses on the development and commercialization of life-saving medical products and health related technologies. VanLandingham was named the vice president of drug development.
When asked about the lack of published research around Prevacus' drug, Odyssey president and CEO Mike Redmond said, "One thing that we are careful about, is that the more you publish, the less likely you are." Prevacus was worried about protecting their patent position and not putting too much information into the public domain, and I'm the same person. We would like to be careful about that.
PresolMD was incorporated with Prevacus to bring to market PreVpro, a cream designed to prevent or limit concussions. VanLandingham was looking for a quicker way to get a drug to market, while continuing with the lengthy regulatory process for his spray.
PreVPro was promoted in radio, TV and podcasts interviews that were more like commercials.
VanLandingham said that he put a small amount of the cream on each side of the neck.
He said to rub it on the left side of the trachea and the right side of it. It will be in your brain in less than 30 minutes. It will work. Yes, that's right.
That's amazing!" The interviewer said he was glad to ask that.
The efficacy of the drug on humans had not been assessed at that time.
VanLandingham argued that he was speaking in the context of the drug being used on animals, not humans, and never led an investor to believe otherwise.
"If there's a show that helps the lay person understand how the drug works, that's probably the way my mind was thinking," he said.
Within seven minutes of applying the cream, it would provide seven hours of anti- inflammatory protection to the brain.
The interviewer said that it was amazing.
VanLandingham said, "Now" when he was asked about the efficacy of the drug. The talks are not as advanced as I would like them to be. I don't know if he makes a mistake or not. If that is the case, I attempt to correct him. I've always done that.
The experts were more skeptical about the cream than the spray because there was no data to back up the claims.
"With the physical changes that occur with acute injury, it's very hard to interrupt them by giving some kind of treatment before it happens," DeKosky said.
Many people have tried for years and thought they had something that worked, but it doesn't seem to make a difference when given to a traumatised person.
Weinberger doesn't think there's any scientific evidence to support the claims about the cream. What makes their combo of agents more effective than aspirin?
PreVPro would be on the market in the month of January 2020 and Prevacus' spray probably won't be on the market until two years later, according to VanLandingham.
Prospective buyers could add their name to a pre-order list if they wanted to pay more for the product, which was described on the website as an ice pack that goes on the brain. PresolMD has fallen by the wayside as the website is no longer active. The product never made it to market due to a number of reasons.
Florida Secretary of State records show that both PresolMD and Prevacus are inactive. Prevacus became a Delaware corporation in 2012
The state of Mississippi is trying to recover millions of dollars from Prevacus and PresolMD. In his response to the lawsuit, VanLandingham denied any illegal activity and argued that if Prevacus or PresolMD received any incorrect funds, Mississippi's Department of Human Services should make a payment.
Even if he were found responsible, it's unlikely that he would pay the state.
Over the past six years, VanLandingham and his companies have faced hundreds of thousands of dollars in liens. The judgement for Capital City Bank in 2020 is part of that.
The company failed to come through on a promised fifteen million dollar investment in Prevacus. He sold his home to pay his taxes. Although Prevacus is named in the lawsuit, he said the judgment to Capital City was not related to Prevacus.
"I've scratched andclawed," VanLandingham said. I have given everything I have to this company. The story is about how difficult this stuff is. It gets harder when you don't know that you're getting welfare money, and you get exposed as an honorable life.
VanLandingham's compensation for selling his drug to Odyssey is dependent on the drug making it through additional trials and eventually getting to market.
The completion of Phase I testing in Australia was announced by Odyssey in September. The next phase of the company would cost about $12 million according to the CEO.
The FDA would have to approve the testing before it could be done in the US. At the same time, Odyssey was considering starting the next set of trials in Australia.
Jake is a very smart scientist, according to Redmond. He does very well if you put him in front of a well-versed doctor or scientist. They know that this drug has promise.
Dr. Dallas Hack and Dr. James Kelly did not reply to questions. Redmond was asked if they'd be willing to be interviewed. He said they didn't want to. Hack was taken off the list of advisers on the website. According to Redmond, Hack's contract was ending and the company was hoping to get him back for the next trials.
In order to learn more about VanLandingham as a researcher, he was reached out to by several of his former colleagues at Florida State, where he initially earned his PhD.
He claimed in his bio and resume that he was the assistant director of the lab. He stated in his bio that he oversaw the ProTECT clinical biomarker study.
Most of his former colleagues thought that he took more credit than he deserved. He was not the assistant lab director, they said.
The assistant lab director was me. "Any person who says otherwise could kiss my ass." Be it, if they forgot, so be it. The head of the lab was Donald Stein.
Stein said that was not true. VanLandingham said, "Well, Don't get old."
Iqbal Sayeed, the interim head of the lab, said that VanLandingham wasn't the assistant director or leader of the ProTECT study.
She said that the work is legit. He has been doing it for a long time. This is a long time to do it right. He sees it as an opportunity. A lot of us don't have that entrepreneurial spirit, so that's the only way to go.
Several former Florida State colleagues were contacted by the sports network but did not respond.
The lawyer for VanLandingham suggested that his client was misled and wrongly tied to the welfare fraud. "I'm sure you would have a lot more people who are willing to say good things about Jake if not for that."
A reporter and a researcher contributed to the report.
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