Of Course There’s a Florida Connection: McDonnell Trial

There’s an old saying in newsrooms found in the Sunshine State: Of course there’s a Florida connection.

The trial of Virginia Gov. Bob McDonnell proved that. This story shared those connections in the Sarasota and Bradenton communities.

It involved a relocated pharmaceutical company, a local medical research lab known for its Alzheimer’s studies, a tennis coaching legend and a reader who contacted me to share her experience testing the drug at the center of the trial.

SEPTEMBER 14, 2014

In Bradenton and Sarasota, Anatabloc crossed many paths before McDonnell trial

A Sarasota woman shares her story of being in the clinical trials for the drug Anatabloc, which suspended its sales in the midst of the corruption trial of Gov. Bob McDonnell and wife Maureen McDonnell. The McDonnells were found guilty of accepting bribes to promote the drug while leading Virginia.

MANATEE — Ten days before Jonnie R. Williams stepped down as chief executive of drug company Star Scientific, Janet Wilmink got the OK to be part of a clinical trial for Williams’ wonder drug, Anatabloc.

Wilmink, a Sarasota retiree, didn’t know anything about the company, the drug or an impending indictment of Virginia Gov. Bob McDonnell when she was approved last December to participate in the clinical trial. To her, it was another test for science, this time at Manatee County’s Roskamp Institute. That’s what she does to fill time: volunteering her body to test new pharmaceuticals and supplements.

“This may sound patriotic, but I believe in these clinical studies. Somebody has to be willing to test these things,” said Wilmink, a former Department of State foreign services secretary. “There have to be institutes like the Roskamp and pharmaceutical companies, and there have to be people that are willing to risk a little bit.

“I didn’t risk much,” she added. “I was careful in what I took part in.”

But this drug, she learned months later, was at the center of a criminal trial of the Virginia governor, who along with his wife Maureen McDonnell have been found guilty of multiple counts of corruption. The jury found that the governor accepted a Rolex watch, Ferrari car rides, loans and more from Williams in exchange for exclusive access to state resources in Virginia for Anatabloc.

The McDonnells and Williams have strong ties to Manatee and Sarasota counties — beyond the board rooms and court rooms. From legendary tennis coach Nick Bollettieri who was convinced to pitch Anatabloc for his good friend Williams, to Roskamp’s financial investment in the company, Bradenton and Sarasota have helped pave the way for the drug’s research.

The trial and guilty verdict perplexes Wilmink, who has participated in at least a dozen medical studies for various organizations in the last 14 years.

“They only gave me $200 for four visits. Now wait a minute. If they can give cars and furs, where’s my new convertible? Where’s my $50,000?” Wilmink said, laughing.

“If this Jonnie, if he’s paying these people off and he’s promoting this drug by bribing people and paying them off, then am I really getting the proper drug? Am I just getting something this Jonnie thinks he can get money on?” Wilmink speculated. “It did bother me that they hadn’t looked into this a little bit more before they contracted Roskamp and other places before they tested it.”

In the national spotlight

Politicos and cable TV stations were glued to the trial for weeks up to the Sept. 4 verdict in Richmond, where a federal jury found the governor guilty on 11 corruption-related counts and his wife guilty of eight such counts plus obstruction of justice. Sentencing for both is scheduled for Jan. 6.

Williams served as a star witness after he was granted immunity from potential charges of Securities and Exchange Commission violations in relation to the trial. He hasn’t faced any other charges and, since December, has been a consultant for the renamed Star Scientific: Rock Creek Pharmaceuticals.

Rock Creek publicly announced it was moving to Manatee County earlier this year. But the company had strong connections to the area before calling Roskamp home.

Williams and his wife, Celeste Williams, have made both Bradenton and Sarasota their home when not in Virginia. Many of their real estate investments have been made through family trusts and corporations.

Property records show Starwood Trust, operated by Williams’ brother Donnie O. Williams, owns a 56,000-square-foot mansion compound on Bay Shore Road in Sarasota’s Indian Beach neighborhood, assessed at $4.2 million. Starwood Trust is the same trust that wrote checks and a loan totaling nearly $100,000 to the governor’s family. The Virginia jury based part of the guilty verdicts for the McDonnells on those gifts. Jonnie Williams sold a 3,572-square-foot condo in Bollettieri Villas near IMG Academy last year for $1.08 million after paying $725,000 in 2004. In 1990, he sold homes on Bird Key and Lido Pointe in Sarasota. Donnie Williams, of Spotsylvania, Va., also maintains a second home in Whitfield, according to land records.

According to the indictment, Jonnie Williams used his Virginia connections to influence the McDonnells to help promote Anatabloc.

Maureen McDonnell and her chief-of-staff flew on Williams’ private jet to the Roskamp Institute on June 1, 2011, to talk to the drug makers’ investors, and she purchased stock in the company the same day, according to the indictment. A launch party for the drug at the Virginia governor’s mansion soon followed.

That same private jet company operated by Williams is based at Sarasota-Bradenton International Airport, business records show.

In the 1980s and 1990s, Williams had business ties with a Sarasota stock broker, Victor Kashner. Both were codefendants in a stock fraud case involving another pharmaceutical company. Williams settled the case out of court, while Kashner faced sanctions and fines by the SEC and National Association of Securities Dealers. Kashner later won an appeal to avoid paying certain losses.

Today, Williams is named as a defendant in four civil cases, with Rock Creek being named in two of those. Another case in January against Rock Creek from Illinois resident Howard T. Baldwin accuses the drug maker and GNC making false claims about Anatabloc while bottles of the pills were sold for $99 each. The complaint said Baldwin purchased the drug at a GNC and through an online subscription, and said he was deceived by the advertisements as the drug didn’t work.

Williams resigned as Star Scientific’s CEO in December, in part, because the company wanted someone with a medical background to lead the company. Roskamp’s Dr. Michael J. Mullan was named CEO.

As much as what’s been said about Williams’ business dealings in the media, tennis coaching legend Nick Bollettieri considers Williams a good friend.

“I play golf with Jonnie all the time,” Bollettieri said, adding that Williams’ son attended IMG Academy in Bradenton.

“The only thing I know about Jonnie Williams is he is a generous and kind man,” Bollettieri said. “We fight like cats and dogs on the golf course.”

Rock Creek declined to answer the Herald’s questions last week about the company’s future relationship with Williams and other plans for Anatabloc.

“We are not going to comment on anything concerning Mr. Williams or the activity that occurred in Virginia,” Rock Creek spokesman Ted Jenkins said. “As a company, we continue to move forward from past legacies and are narrowly focused on our scientific research and drug development plans.”

Bollettieri also said he didn’t pay any attention to the trial.

“I was at the U.S. Open, and if you read my book and heard my hall-of-fame speech, you know I don’t read (the news),” Bollettieri said. “I just do what I know, baby, and have fun.”

The Roskamp Institute was also financially invested, having long ties to the company doing research on the drug.

Robert G. Roskamp, founder of the Roskamp Institute, purchased more than 769,000 shares of Star Scientific and also included a deal where Star Scientific/Rock Creek paid Roskamp Institute 5 percent in royalties from Anatabloc sales. That deal saw Roskamp Institute bring in $301,000 in 2012, according to regulatory filings.

The company reported a net loss of about $12.7 million during the second quarter, partly because of a 71 percent decrease in sales of Anatabloc from the same period last year.

The drug

During the trial that began July 28, coverage of the drug Anatabloc hit a peak, even earning a solid eight minutes Aug. 7 on “The Daily Show with Jon Stewart,” in which the comedian mocked the drug, the governor and Williams for the theatrics playing out in a Virginia courtroom.

Anatabloc, offered as a nutritional supplement, was being touted for its anatabine compound, which is made by microwaving cured tobacco to kill the carcinogens. It was touted as a pill and facial cream that had anti-inflammatory properties, and was mainly being sold at GNC through a marketing partnership.

Roskamp, an institute known for its Alzheimer’s Disease research, was testing the drug for its effectiveness on inflammatory diseases, which can include Alzheimer’s, osteoarthritis and multiple sclerosis.

The indictments revealed that Maureen McDonnell pitched the unproven drug to Ann Romney, wife of Gov. Mitt Romney, telling her it could cure her M.S.

The U.S. Food and Drug Administration sent a warning letter to Williams on Dec. 20, saying the company had failed to file notification with the FDA that its products including anatabine would be marketed in Anatabloc and CigRx. The product Anatabloc should be considered an unapproved new drug instead of a supplement, the FDA said, because marketing materials said it would be used for treatment or cure of a disease like Crohn’s disease and ulcerative colitis.

“Your product Anatabloc is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners,” the warning letter said.

Anatabloc was also dispensed in a facial cream form, and sample tubes were distributed in goodie bags for Longboat Key Triathlon participants last May. The label of the small tube reads “Rare Cellular Facial Creme.” No materials or description of the product’s use were given with the samples.

Star Scientific/Rock Creek objected to the FDA requirement, though some marketing materials were removed from its website. But Anatabloc’s website is still active.

As of last week, Bollettieri was still pictured on Anatabloc’s website endorsing the drug with the line, “It could bring a lot of joy to people — help them ski, play tennis — and take away the aches and pains.”

Other athletes giving endorsements on the website include PGA professional Fred Couples, former Carolina Panthers’ tight end Jeremy Shockey, and tennis stars with IMG Academy connections: Jimmy Arias, Robert Seguso and Aaron Krickstein.

On the site, Arias states the drug “changed my life. I’ve got my physicality back.” Krickstein, a former top tennis pro, said it helped him “recover from various injuries with my joints.”

Rock Creek eventually submitted the paperwork requested by the FDA, but suspended sales of the drug on Aug. 11 along with CigRx to resolve allegations in the warning letter, according to Rock Creek’s regulatory filings with the SEC.

The medicinal trials

For the Anatabloc testing, Wilmink saw a Roskamp Institute advertisement in the Herald seeking non-smokers from ages 35 to 75 for a 12- to 13-week study of an investigational dietary supplement.

The FDA has lengthy requirements for drug companies and labs to disclose information to patients signing up for a medicinal trial, including forms being in “understandable” language, explaining scientific and medical terms and guidelines for compensation.

What drew Wilmink in was the possibility that the drug might help her bronchiolitis, where the air passages of her lungs are inflamed, causing some mucus build-up. She also has some arthritis, sinus issues and allergies.

The retiree said she doesn’t do such trials as a way to get rich, but because she wants to help science.

“As long as it covered my gas, I wasn’t looking to make a fortune,” she said.

She said she’s done other drug trials, including one in North Dakota, where she was housed at University of North Dakota in 1998 and a college student had to follow her everywhere to make sure she didn’t eat the wrong food or put on perfume as the Department of Agriculture wanted to test the interaction of zinc and copper in the body. Not all of tests she does are glamorous. One Southwest Florida company housed her in a bunk bed with strangers and staff members were fighting with each other, so she decided to leave because she didn’t feel safe.

“If it looks too risky, I use my own common sense,” she said.

In the Roskamp Anatabloc study, Dr. Andrew Keegan led the investigation for a new formula of anatabine, according to Wilmink’s clinical trial documents. Wilmink’s pills were given as a sustained-release formula in which anatabine would be sent through her body over time. Doses were increased from 12mg per day, to 18mg per day then to 24mg per day, according to the study. Each night she would take notes about how the drug was reacting and record her blood pressure.

She dropped out Jan. 31, saying her body couldn’t take the increased doses. She felt hot at night and her legs felt weak. The doctors were understanding, Wilmink told the Herald, and she didn’t find anything wrong with her experience except that the drug didn’t work for what she hoped it could do.

“They thanked me and said it has been helpful and showed them at least what they thought the limit of tolerance was for people just like me,” Wilmink said. She called the protocol fair, staff professional and facilities clean.

Wilmink said she has never met Williams and didn’t know his story while she was going through the clinical trials. Still, she retains some sympathy for him because she believes in the importance of testing pharmaceuticals to find potential cures.

“In a way, I don’t blame Jonnie. If it’s the only way he could get support for something he believes in — assuming he believed in this product — it’s a shame he felt he had to bribe somebody,” Wilmink said. “Or maybe they came to him. That bothers me.”

Future in doubt

By the time clinical trials ended in March, the McDonnells were indicted, and Star Scientific had made plans to change its name to Rock Creek Pharmaceuticals, move from Virginia to Roskamp Institute in Manatee County and keep Williams on as a paid adviser for $1 per month until the company reached profitability.

In June, Manatee County officials heralded the company’s move to Roskamp Institute’s Tallevast headquarters and announced it would provide $48,000 in performance-based economic incentives if the company creates 16 jobs over five years.

In August, the McDonnell trial reached a fevered pitch with testimony of love triangles, lavish gifts and bribery, even as Anatabloc was taken off shelves when it was in the news more than any other time.

The future of the drug is uncertain, but some clarity came Friday. The FDA has informed Rock Creek that the compound anatabine citrate is intended to provide anti-inflammatory support and should be treated as a drug and not a food-related ingredient. At the same time, another FDA application is on clinical hold as the agency needs more information; trials are also being sought in the United Kingdom.

“We are conducting an internal review of our nutritional supplement business and will embark on the course best suited for the company, its shareholders and customers,” CEO Mullan said Friday in a statement. “Concurrently, we are advancing our lead compound as a drug into human clinical trials.”

Charles Schelle, Herald business reporter, can be reached at 941-745-7095. Follow him on Twitter @ImYourChuck.

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