For years, Harm Reduction Ohio, the state’s biggest distributor of lifesaving overdose reversal drugs, always tried to steer clear of Kloxxado, a controversial, brand-name version of naloxone.
The president of the nonprofit organization saw the drug as way too expensive compared to an available generic version, and its high dosage as at least medically unnecessary if not dangerous.
Harm Reduction Ohio orders federally funded overdose reversal drugs from the state health department to distribute to a network of volunteers who try to get them to people who use opioids.
After the nonprofit put AmandaLynn Reese, its chief program officer, in charge of its distribution contract, its orders of Kloxxado surged fivefold compared to the same time frame with her predecessor at the helm, state records show.
Neither the state nor the nonprofit’s director knew that Harm Reduction Ohio wasn’t the only one paying Reese.
Velocity Bio Group, an Arizona-based consultancy representing Hikma Pharmaceuticals, which manufactures Kloxxado, was paying her more than twice as much as the nonprofit was, court documents say.
In other words, Reese was receiving two salaries: one from Harm Reduction Ohio for procuring overdose reversal drugs, and another from a firm representing the manufacturer of the Kloxxado that Reese was buying on the federal government’s dime.
Dennis Cauchon, a former newspaper reporter who started Harm Reduction Ohio and built it from a scrappy startup to a major distributor of lifesaving drugs, saw what he believed to be a blatant conflict of interest in Reese’s dual roles. Given that the nonprofit’s contract with the state forbids any such conflicts, he reported it to the health department after he caught wind of it.
Things didn’t go as he planned.
Harm Reduction Ohio’s board of directors ultimately fired Cauchon, not Reese, accusing the nonprofit’s founder of creating a “hostile work environment.” Cauchon responded with a lawsuit, accusing the nonprofit’s board of retaliating against him as a whistleblower.
The lawsuit has forced into the halls of a federal courtroom the myopic world of intra-nonprofit politics and a questionable intersection between publicly funded harm reduction and corporate lobbying. And it’s all playing out amid an ongoing overdose crisis that kills thousands of Ohioans each year.
After at first declining to comment, the Ohio Department of Health said via spokesman on Friday that it will refer the matter to the Ohio Inspector General’s office.
Harm Reduction Ohio, in court filings and communications with the Ohio Department of Health, has acknowledged Reese’s work for Velocity Bio Group but denied the existence of any conflict of interest and said her work had nothing to do with Kloxxado.
The nonprofit, Reese, Hikma Pharmaceuticals and Velocity Bio Group all declined repeated requests for comment.
What is Kloxxado?
Most non-fatal overdoses in America are treated with 4 milligram doses of the drug naloxone, which first came to market in 1971. It’s commonly sold as a generic or under the brand name Narcan.
One unit of Kloxxado instead provides a double dose – 8 milligrams of naloxone. And as a name-brand, heftier counterpart to its peer drugs, Kloxxado, first authorized for use in 2021, is far more expensive.
The double dose has proved controversial. Some say overdoses these days require multiple single doses of naloxone as potent synthetic opiates like fentanyl and carfentanil have grown more prevalent. Others say the double dose is not only medically unnecessary but imposes nastier withdrawal symptoms on its recipients, which could lead to a higher risk of a relapse.
Researchers with Tennessee Harm Reduction recently reviewed 23 available studies of high-dose formulations and found no apparent benefit. A study out of New York’s state health department found the same. And both warned of nastier withdrawal symptoms.
“Early research suggests that these high dose drugs are unnecessary and pose significant risks and side-effects, raising concerns over the commercialization of harm reduction efforts in the U.S.” warned an article from the Network for Public Health Law.
That said, the opinion is not universal. Some, especially associations representing the police officers who are often responsible for administering naloxone, have insisted on the higher dosage.
Cauchon files whistleblower lawsuit against Harm Reduction Ohio
At first, all Cauchon could see was the appearance of a conflict of interest.
Harm Reduction Ohio has worked with Ohio’s Project DAWN (Deaths Avoided With Naloxone) for years. But in July 2023, the nonprofit applied for and won what would become an $850,000 per year contract with the Ohio Department of Health to distribute overdose reversal drugs statewide.
That’s no simple task. Last year, Project DAWN moved 371,000 boxes of overdose reversal drugs, which officials say saved more than 18,000 known lives.
Cauchon said he learned of Reese’s work for Velocity Bio Group when he noticed a post on social media showing Reese at an out-of-state conference during hours he thought she was working for the nonprofit. But Cauchon said when he asked Reese about Velocity Bio Group, she refused to provide documents relating to the scope of her work for the firm.
Velocity Bio Group’s precise relationship with Hikma Pharmaceuticals is hazy. Some of its employees identify themselves as working for both entities. Cauchon referred to Velocity Bio Group as a lobbying firm that promotes Kloxxado. Both companies declined comment.
“We’ve distributed 13,000 Kloxxado kits since December 2022. An undisclosed financial relationship with the manufacturer’s lobbyist seems problematic to me,” Cauchon texted Dwayne Steward, a board member of the nonprofit, in a message attached to court filings.
As the clash at the nonprofit escalated, the rest of the board came to side with Reese. Tasha Turner Bicknell warned that the disclosure could “become a barrier to employment for some,” according to internal emails Cauchon filed. Steward said disclosure would risk the nonprofit’s biggest grant along with “blocking the earning potential” of staff and that they should take a “people-first” approach.
“Personally, I believe that we should be supporting any employee that chooses to bring their work with a nonprofit into their personal advocacy and board work,” he said.
Cauchon plodded forward with his disclosure to the Ohio Department of Health in September 2024.
At the time, the department “consulted with the Ohio Ethics Commission,” according to spokesman Ken Gordon. After Cauchon updated his lawsuit with new information obtained in the legal process (and questions from Signal Ohio), the department referred the matter to the inspector general.
“The Ohio Department of Health (ODH) takes these types of allegations seriously,” Gordon said.
The board summarily fired Cauchon soon after he told the health department about the alleged conflict. In written notice of his firing, Steward said several unidentified employees accused Cauchon of creating a “hostile work environment,” but he provided no specifics.
Steward wrote the Ohio Department of Health on behalf of the nonprofit’s board. He said that Cauchon’s allegations were unsubstantiated, that Cauchon reported the conflict to the department in “bad faith,” and that his telling of events was full of lies or distortions.
The nonprofit has acknowledged, in court documents and private emails attached to court filings, that Reese worked for Velocity. But its staff insisted her work there had nothing to do with promoting sales of Kloxxado. And Steward brushed off Cauchon’s interest in how much Velocity Bio Group was paying Reese.
“I don’t think the amount of money matters, truthfully,” Steward texted Cauchon.
Kloxxado sales surged under Reese
Cauchon, trained as an investigative reporter, began filing public records requests for Project DAWN’s orders of overdose reversal drugs soon after his ouster. The data, which he provided to Signal Ohio, clearly show a dramatic increase in Kloxxado orders after Reese took over managing the nonprofit’s contract with the state.
Harm Reduction Ohio’s procurement policy under his watch was simple enough: go with the cheapest drug and avoid Kloxxado when possible. Medical problems aside, Kloxxado cost about $58 per dose at the time versus $37 for generic naloxone or $46 for Narcan.
In two years of orders before Reese took over procurement duties, Harm Reduction Ohio had only bought about 3,450 doses of Kloxxado.
But in 12 months starting July 2023, it ordered 11,500 doses of Kloxxado, with all orders executed by Reese. That’s more than $600,000 in costs to the federal government.
The pharmaceutical industry is full of conflicts of interest and suspect financial arrangements, said Antonio Ciaccia, an industry consultant with 3 Axis Advisors and longtime lobbyist for the Ohio Pharmacists Association. But generally speaking, he said, you go with the cheapest one that works.
“Why on earth would we ever pay for an expensive, brand name drug when there are cheaper alternatives in the market?” he said.
‘She does not promote any specific company or product’
After forcing out Cauchon, the rest of the board of directors went about effectively recanting Cauchon’s disclosure of a conflict of interest.
Reese had no conflict, they said in a memo to the health department. Her job with Velocity Bio Group requires her to research different naloxone drugs, educate the company about communities’ needs and preferences related to naloxone, and advise Velocity on how to communicate with different communities about naloxone products.
“She does not promote any specific company or product, instead advocating for expanding access to naloxone and harm reduction services generally,” the board wrote.
Not so, Cauchon said. He wrote in court filings that he has obtained Reese’s W-2 and other employment records disclosing the generous salary plus an explicit job description. Those documents are under seal and not available to the public, but Cauchon described them in court filings.
He also laid it all out in a subsequent, 16-page 5,500-word memorandum to the Ohio Department of Health, dated Aug. 12.
“Her role was a management-level position directly tied to advocacy efforts aimed at increasing government purchases of Kloxxado,” he said.
‘Autonomy of choice to all forms of FDA approved naloxone’
Reese declined several interview requests. In an interview with the Ohio Capital Journal, she described losing two parents to overdoses and at times struggling with substance use herself.
In 2023, Reese appeared at the Statehouse in Maryland, testifying in support of legislation to allow entities requesting overdose reversal drugs to obtain higher-dose formulations if they wish.
The legislation didn’t identify Kloxxado or Hikma by name. But several parties testified for the need for stronger doses, given how many victims require two doses of naloxone.
Reese didn’t register as a lobbyist for her testimony, and states vary in what triggers a requirement for a person to do so. But it’s not about Kloxxado, she said in testimony to lawmakers. It’s about choice for the entities that order the drugs.
“We promote total autonomy of choice to all forms of FDA approved naloxone,” she said, according to her written testimony. “Naloxone does not seem to create life-threatening side effects, even at higher doses.