TOBYHANNA, PA—With preclinical studies of an in-development cholesterol-reducing medication now complete, Food and Drug Administration officials confirmed Monday they would be conducting initial trials of the new drug at a large party house they had rented in upstate Pennsylvania.
According to the FDA, around a dozen researchers will participate in the experimental pharmaceutical’s weekend-long test, which is taking place in the Poconos at a 2,500-square-foot lakeside cottage the agency found on Airbnb. The participating scientists will reportedly be the first humans to take the drug known as Bisovastatin, studying its effects in a variety of settings, from the indoor hot tub to the spacious deck out back.
“Let’s get this fucking phase-zero trial started, baby!”
“Clinical testing is a vital step in the process of approving a medication, and that’s why we’re up at this sweet cabin seeing if this shit’s the real deal,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, as her arriving colleagues passed around a joint, “pregaming” before the new cholesterol treatment’s randomized, controlled study began. “Whenever a drug makes it this far in the evaluation process, we pack up [biochemist Simon F.] Hadley’s car, grab some brews, and head up here for a nonstop weekend of pharmacological safety and efficacy assessments.”
“Let’s get this fucking phase-zero trial started, baby!” Woodcock added.
Sources confirmed that before traveling upstate, FDA scientists obtained several hundred pills of Bisovastatin from pharmaceutical company AbbVie Inc. and stored them inside an empty bottle of ibuprofen. Upon reaching the five-bedroom house, the researchers are said to have determined that its outdoor fire pit would provide the ideal clinical environment for staying up all night to observe the effects of the new drug on themselves and one another.
The FDA stated that Dr. William Slikker Jr., director of the National Center for Toxicological Research, volunteered to remain sober and babysit the others, providing orange slices in the event the side effects of the drug became too overwhelming and one of the researchers needed to chill out. Officials said they wanted to avoid a repeat of an unfortunate 2015 incident in which a scientist who had taken way too much of a new myeloma treatment drug freaked out, jumped through a third-floor window, and broke both legs.
“I’m definitely going to lie on the front lawn, analyze how this drug inhibits the HMG-CoA enzyme, and just stare up at the clouds,” Woodcock said as the researchers all sat down on beanbag chairs in the party house’s loft to take their first dose of Bisovastatin together. “And I can’t wait to go into the woods where there are no distractions and you can really enjoy being out in nature as the stuff kicks in and your LDL levels start to go down.”
“Of course, part of our job is to observe how the drug interacts with other substances, which is why we have this 30-pack of Bud Light and handle of Jim Beam,” continued Woodcock, noting that other researchers would try combining the drug with blood pressure medications and immunosuppressants. “Most of us are just sticking with the regular dose, but [Dr.] Patrick [Caldwell] has a way higher tolerance, so he’s going to take double to see if that does anything.”
Several researchers said they planned to test Bisovastatin’s efficacy while lying in hammocks on the porch and using the house’s sound system to blast a Spotify playlist that had been created by the FDA’s Division of Pharmacometrics and was said to include selections from Animal Collective, Black Lips, and MGMT. Giuseppe Randazzo, a director in the Office of Pharmaceutical Quality, announced that he would be willing to take the new drug and have sex with a colleague at the same time in order to study “just how crazy that would be.”
Woodcock remarked that you could never be sure what would happen during a night at the party house, recalling that the last time they experimented with a cholesterol medication, one of the researchers tried mixing it with a high dose of Klonopin and they later found him passed out on the dock in a diabetic coma.
“We hope to emerge from the weekend with a clearer picture of whether this shit is good to go or whether we’ll have to decline approval of Bisovastatin for U.S. markets,” Woodcock said. “But right now we got, like, 800 milligrams per person, and we’re all ready to just kick back and enjoy two incredible days of mind-blowing research.”
“Except for the people who got placebos,” Woodcock added. “It sucks to be them.”