Novartis To Conduct Malaria Drug Study Even As Early Data Hint That It Doesn’t Fully Protect Against Coronavirus
The study will be a randomized, double-blind placebo-controlled study, unlike the research being done on the fly treating severely ill patients. The decision was announced as emerging data show people who are taking hydroxychloroquine are still becoming infected with the virus. Meanwhile, President Donald Trump's tendency to tout possible cures in the early stages of testing is upending pharma's traditional PR machine. And Reuters offers an overview of where we stand on drug and vaccines.
Stat:
Novartis Steps Up To Study Of Hydroxychloroquine In Covid-19
The drug giant Novartis said Monday it would conduct a 450-person study to determine if hydroxychloroquine, the malaria drug touted by many pundits and President Trump, can effectively treat Covid-19, the disease caused by the novel coronavirus. The study will be a randomized, double-blind placebo-controlled study, the medical gold standard in which patients will be assigned one of three options: hydroxychloroquine, the combination of hydroxychloroquine and the antibiotic azithromycin, or placebo. (Herper, 4/20)
Reuters:
Novartis, U.S. Drug Regulator Agree To Malaria Drug Trial Against COVID-19
The decades-old generic medicine got FDA emergency use authorization this month for its unapproved use for coronavirus disease, but so far there is no scientific proof it works. There are currently no approved COVID-19 medicines. Novartis plans to start recruiting 440 patients for its Phase III, or late-stage, trial within weeks at more than a dozen U.S. sites. Results will be reported as soon as possible, the company added. (Miller, 4/20)
The Wall Street Journal:
Hydroxychloroquine And Other Autoimmune Drugs Don’t Fully Protect Against Coronavirus, Early Data Suggest
Dozens of people taking hydroxychloroquine and other treatments for chronic rheumatologic diseases have become infected with Covid-19, according to an analysis of emerging data that is a sign the drugs may not protect people from the new coronavirus. More than five dozen people with chronic ailments like lupus and rheumatoid arthritis were taking medications such as hydroxychloroquine before being diagnosed with the coronavirus, according to data compiled by the Global Rheumatology Alliance, a coalition of rheumatologists, researchers and patients, and published in a medical journal Thursday. (Hopkins, 4/18)
Boston Globe:
'Balancing The Potential For Benefit With The Potential For Harm’: How Boston Hospitals Are Using Hydroxychloroquine On Coronavirus Patients
Although there are no proven cures or treatments for COVID-19, the respiratory illness caused by the novel coronavirus, one drug has drawn more attention and controversy than the rest: the antimalarial drug hydroxychloroquine. Touted as a potential “game changer” by President Trump, the drug has gained widespread use as an experimental therapy for COVID-19 patients, despite meager evidence of its effectiveness. (Pan, 4/17)
Politico:
Trump’s Wild West Approach To Virus Cure-Alls Is A Game-Changer For Drugmakers
President Donald Trump’s habit of touting potential coronavirus cures during daily White House briefings has changed the game for drugmakers, who are dropping their usually secretive ways to aggressively court public opinion. From Gilead releasing anecdotal results on the drug remdesivir to Johnson & Johnson’s new reality series on the making of its experimental vaccine, pharmaceutical companies are seeking to shape the narrative like never before. The PR push could raise false hope about therapies that don't end up working, or even put pressure on the Food and Drug Administration to approve drugs and vaccines whose effectiveness isn't clear. (Owermohle, 4/17)
WBUR:
NIH Launches Effort To Speed Up Development Of COVID-19 Treatments
In an bid to help speed up the development of potential treatment options and a vaccine for COVID-19, the National Institutes of Health on Friday announced a new public-private research partnership. The new initiative will be spearheaded by the NIH but also include the Food and Drug Administration, other parts of the federal government and a list of 16 companies that includes some of the biggest players in the pharmaceutical industry. Among the companies participating in the effort are Pfizer, Johnson & Johnson and Merck. (Pao, 4/17)
Kaiser Health News:
Amid Pandemic, FDA Seizes Cheaper Drugs From Canada
The Food and Drug Administration in the past month has stepped up seizures of prescription drugs being sent to American customers from pharmacies in Canada and other countries, according to operators of stores in Florida that facilitate the transactions. While seizures at the nation’s international mail facilities have periodically spiked during the past two decades, the latest crackdown is distressing many older customers whose goal is to stay home during the coronavirus pandemic. (Galewitz, 4/20)
Reuters:
Status Of Upcoming Vaccines, Drugs And Other Treatments In The Battle Against COVID-19
With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of April 18, 2.4 million had been infected and 165,000 killed by COVID-19, the disease caused by the virus. While a safe, effective vaccine is still more than a year away, researchers are rushing to repurpose existing drugs and non-drug therapies as well as testing promising experimental drugs that were already in clinical trials. Even moderately effective therapies or combinations could dramatically reduce the crushing demand on hospitals and intensive care units, changing the nature of the risk the new pathogen represents to populations and healthcare systems. (Soares, 4/13)
USA Today:
'Tuskegee Always Looms In Our Minds': Some Fear Black Americans, Hardest Hit By Coronavirus, May Not Get Vaccine
David Graham is a nurse practitioner who spends his days and nights treating coronavirus patients. He's a 41-year-old black man who learned in high school how doctors failed to treat hundreds of black men in a federal study for their syphilis, so he isn't inclined to trust the government to get a vaccine for the pandemic right. African Americans, who are being infected and killed by COVID-19 at a much higher rate than whites, are 40% less likely to get flu shots,a study out last year showed, and some fear they will be reluctant to get the coronavirus vaccine when one is released. A historical distrust of the health care system, which has far fewer physicians of color and a record of discrimination and mistreatment, gets much of the blame, experts said. (O'Donnell, 4/19)