UB has already been recognized as one of the institutions nationwide at the forefront of the fight against the opioid epidemic, but several new initiatives have recently further raised its profile.

One of the most unique collaborations to result is the creation of the first Opiate Crisis Intervention Court in the nation.

Funded through a grant from the Bureau of Justice Assistance in the U.S. Department of Justice, the pilot program was initiated in May in Buffalo City Court. It gives opioid-addicted defendants arrested for non-violent crimes an opportunity to enter treatment before going through the criminal court system.

The Erie County Department of Mental Health and UB family medicine jointly created the HOPE (Healthy Outcomes Partnership and Education) of Erie County program to provide critical time intervention for justice-involved individuals.

"UB has become the ‘go to' place for these highly unique services due to our tradition of community engagement," says John S. Taylor, executive director of development for the PCRI.

Protocols Seek to Provide Safety and Stability

"With individuals in the criminal justice system who are at risk of addiction or are opioid addicted, there is so much chaos in their lives," says Dede Berdine, program director of HOPE of Erie County at the PCRI.

"So many deaths were occurring between defendants' first court appearance and the next court date that officials realized they needed to do something different, and it led to the opiate intervention court," she says.

A special opioid docket was created, and participants must attend court every day for 30 days to meet with City Court Judge Craig Hannah for a 30-minute session - and they have 30 days to engage in treatment.

Hannah talks to each participant to make sure they are staying on track. The ultimate goal is to save lives.

"We want to make sure they stay alive and stabilize their treatment connection," Taylor says.

The offices of the district attorney and public defender have both agreed to delay criminal court proceedings until intervention is achieved.

"Everything is suspended until they know the individuals are safe," Berdine says.

Jeffrey Smith, treatment court liaison for the Eighth Judicial District, says the success rate of the opiate intervention court is measured in terms of survival.

"We have had almost 200 people in the program since May, and no one has died," he says. "It's a win if we can get them through the court system without them dying."

Smith says Judge Hannah has been the right man to oversee the new court.

"He is a very kind man, and he really cares about the work that he is doing," he says. "He calls the participants clients instead of defendants and treats them with dignity. He listens to them and is firm but fair."

Addictions Often Lead to Criminal Behavior

Richard D. Blondell, MD, professor of family medicine and vice chair of addiction medicine, is medical director of the opiate court program and determines what the rapid treatment connection protocols should be for its participants.

Blondell notes that people who have addictions often end up doing things that are illegal to support their habit.

"And many times these are not hardened criminals, but they are driven to commit these acts due to the nature of drug addiction and compulsion to use."

The prevailing thought is: As long as these individuals have an opiate addiction, they will remain involved in criminal activity.

RESEARCHERS MISREPRESENTED THE results of animal studies to gain funding and approval to conduct human trials to test a new tuberculosis vaccine, according to an investigation by the British Medical Journal.

The writers found a “pick and mix” approach to animal research which they said raises questions around a lack of oversight and transparency in the use of animal testing before progressing onto human trials.

As a result, drug developers can be selective about what data they use to justify the use of the medicine in humans, they wrote.

Their findings on the tuberculosis vaccine are said to be just one example of “a systematic failure” in animal testing, and urgent action is needed to make it “more fit for purpose”.

MVA85A

The BMJ investigation centred on a trial vaccine for tuberculosis called MVA85A. Researchers at Oxford University had developed it to boost the effectiveness of the existing vaccine.

It was reported to have been successful in animal studies, but failed to show a benefit when tested in a large clinical trial on infants in South Africa in 2009.

Apparently, the differences between the apparent success of the animal testing vs the human trials has slowed down research in the entire field, as it led major funders of tuberculosis research to rethink their funding strategy.

An independent review of what went on in 2015 showed that the results from testing the drug on animals had been overstated.

While the clinical trial was in the late stages of preparation, a study in monkeys should have raised doubts about MVA85A’s effectiveness. The study was too small to draw firm conclusion, but it did ring alarm bells in academic circles.

The results of this trial were not included when information was submitted to the appropriate regulatory body for approval to test the vaccine on humans.

They may have publicly relied on claims from their animal tests, but privately the researchers played them down.

“Riddled with flaws”

Jonathan Kimmelman, associate professor in biomedical ethics at Canada’s McGill University, said there were numerous bad examples the researchers found.

He said: “It’s widely recognised that animal studies intended to support drug development are often riddled with flaws in design and reporting.

But it sometimes feels as if regulators and ethics committees missed the memo. Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.

Malcolm Macleod, professor of neurology at the University of Edinburgh, in an accompanying editorial, said it is stories like this that erodes the public’s trust in science.

He said: “We need to develop better and more systematic ways to establish when a drug is ready for clinical trials in humans – and importantly, when it is not.

Until our institutions recognise that their core purpose is to produce research of value to society they risk a slow decline in their reputation, and possibly a faster and more serious erosion of public trust in science. In these troubled times, that public trust is more important than ever.

"So rather than just dealing with the criminal activity, we want to deal with the root cause of the activity," Blondell says. "The idea is if you fix that, the criminal activity will cease on its own."