Cincotta’s Season: Getting a Drug to Market

Many of us are willing to spend some time working on a project that will have an expected outcome. We can spend a weekend working on the lawn because we know it will have a conclusion and we can enjoy the benefits while engaging in something new.

Athletes train to compete in a sport knowing that there is a ‘season’. There is a fixed start and stop date.

Teachers plan for a school year knowing they have certain objectives to meet in order to pass along specific skills to their students. This too will come to an end.

What if a season was 28 years long? Would athletes willingly sign up? Would they be able to endure? Would teachers enjoy having the same group of students for 28 years? Would the students enjoy the same class for so long?

Anthony Cincotta had to learn if he was made of the right stuff in living through his 28-year season.

According to Cincotta was a graduate student 28-years ago, “Working on Syrian hamsters. Intrigued by how the animals slip from their lean summer condition into a fat, nearly prediabetic state before their winter hibernation, he had found a way to tinker with their brain chemistry and effectively reset their metabolism. Cincotta was certain that he had discovered something big, and he wondered: Could he do the same thing in people?”

Cincotta’s brother Manny was his inspiration for a very personal project. Manny died from Leukemia. Cincotta’s project involved creating a drug to help treat diabetes. After 20 years of work the Food and Drug Administration (FDA) declined to approve the drug for use in America.

Twenty years. More time than Cincotta had been in school. This was roughly half of his life dedicated to a season of developing a drug that was denied by the FDA.

After a series of mergers, acquisitions and buy-backs Cincotta once again owns the rights to a drug known as Cycloset. This time he has FDA approval.

The report indicates, “Dr. Martin Abrahamson, medical director at the Joslin Diabetes Center, said the drug is not as effective at lowering glucose as other diabetes drugs on the market. He also said that a barrier to the widespread use of the drug might be one of its side effects, nausea, and noted that in a clinical trial of the drug, nearly half of the Cycloset-treated patients stopped taking the medication early.”

While this may sound negative Cincotta is used to delays, setbacks and negative feedback. However, he also has some positive backing as doctor’s that participated in the clinical trial express enthusiasm for the drug because unlike other diabetes related drugs it does not increase the risk of heart disease.

Because of Cincotta’s work with the brain chemistry of hamsters some doctors are intrigued by the neurologic component to Cycloset and its potential in treating diabetes.

Cincotta’s season was a long one. Now he waits to see if his work will be embraced in the treatment of diabetes.

Interestingly the wait endured by Cincotta and the continued pursuit of excellence that marked his journey really isn’t remarkably different than the struggle many diabetics face everyday. Their season isn’t short-term and the results are important. Like Cincotta they stick to their plan and continue working toward a desired result (improved blood glucose and a better quality of life).

Here’s to patient endurance for all.