In Rare Move, FDA Tells Drugmakers To Redo Studies Because Of Data Errors
Meanwhile, Bloomberg reports that rates of clinical trials not related to covid are taking longer to recover in the U.K. than in some European countries. Separately, a new study shows that rates of cannabis use during early pregnancy shot up by 25% early in the pandemic.
Stat:
FDA Tells Drug Makers To Redo Studies Run By Two Contract Research Firms
In a rare move, the U.S. Food and Drug Administration has notified an untold number of drug makers that some of their clinical trials must be repeated due to serious data problems at a pair of companies in India that run studies for the pharmaceutical industry. The action stems from inspections at two clinical research organizations — Synchron Research Services and Panexcell Clinical Lab — that were conducted in 2019. After running its own analyses, the agency found “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA,” according to a Sept. 16 statement posted by the FDA. (Silverman, 9/28)
Bloomberg:
U.K. Clinical Drug Trials Slow To Recover After Pandemic Hiatus
U.K. clinical trials for diseases other than Covid-19 fell significantly during the pandemic and are taking longer to recover than in some European countries, a blow to research on ailments such as cancer. Enrollment in trials in Britain fell more than 80% during the first wave of the crisis last year, according to research from the Association of the British Pharmaceutical Industry published Wednesday. The number of participants was still 15% lower this June than in June 2019, while in Spain and Italy enrollment rose by more than a third between those two periods. (Ring, 9/29)
In news about cannabis and marijuana —
CIDRAP:
More Pregnant Women Turned To Cannabis In California Amid COVID-19
Rates of cannabis use by women in early pregnancy shot up 25% early in the COVID-19 pandemic, according to a Kaiser Permanente study of more than 100,000 pregnancies in Northern California. The study, published yesterday in JAMA, analyzed routine urine tests for cannabis at the first (8-week) prenatal visit for 100,005 pregnancies of 95,412 women from Jan 1, 2019, to Dec 31, 2020. Positive test results were compared with those from the 15 months leading up to the pandemic. (Van Beusekom, 9/28)
The Hill:
Former NBA Star Chris Webber Opening $175M Cannabis 'Compound' In Detroit
Former NBA star Chris Webber announced he’s opening a multimillion-dollar cannabis "compound" in his native city of Detroit, the Detroit Free Press reported. The Webber Wellness Compound, which officially broke ground on Tuesday, will include marijuana operations and a training facility, a cultivation facility, a dispensary and a cannabis consumption lounge. (Oshin, 9/28)
Mississippi Clarion Ledger:
Mississippi Medical Marijuana Regulations Concern Black Lawmakers
With Mississippi poised to pass medical marijuana into state law, some state lawmakers are concerned the proposed program may not give Black farmers a fair shake at the magnolia state's new supposed cash crop. "It's going to be difficult for Black farmers because of the investment it will take to get started," said state Sen. Barbara Blackmon, D-Canton. The Mississippi Legislative Black Caucus held hearings in the state Capitol Tuesday about the proposed medical marijuana program, centering the discussion about how it may impact people of color in the state. The caucus consists of most of Mississippi's elected Democrats, and while the political party holds little power in the Capitol, Black people account for nearly 38% of the state's population. (Sanderlin, 9/29)
In updates on the Theranos trial —
CNBC:
Elizabeth Holmes's Defense Questions Ex-Theranos Lab Director's Credibility
In the first dramatic showdown at the Elizabeth Holmes’ trial, defense attorney Lance Wade aggressively questioned the company’s former lab director about his credibility. “Did you offer lab tests that you knew at the time were inaccurate or unreliable?” Wade asked Adam Rosendorff inside the courtroom on Thursday. “No, I ordered the laboratory to discontinue testing and I raised concerns to management,” Rosendorff replied. (Khorram, 9/28)
