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The 9-Question Survey Many Doctors Use to Diagnose Depression Was Actually Created by an Antidepressant Manufacturer
If your doctor suspects you might have depression, there’s a go-to questionnaire they might pull out with nine questions to answer about how you’ve been feeling over the past two weeks. The questions touch on a range of potential issues, from sleep disturbances to appetite changes, concentration issues, and your general enjoyment of life.
For primary care physicians strapped for time in the exam room, it is often used as a stand-in for a more in-depth clinical evaluation — a go-to prescribing tool for antidepressants. Critics say the issue is that this tool was developed by Pfizer, shortly after Zoloft came on the market.
As reporter Olivia Goldhill details in a wide-ranging Stat report out this week, the marketer who first dreamed up the idea for what later became the PHQ-9 — the quick tool that ultimately made many primary care doctors more comfortable prescribing antidepressants from exam rooms worldwide — was a “marketing man” working for Pfizer. Howard Kroplick convinced the company to invest in the pricey research required to develop the now-ubiquitous questionnaire.
Pfizer isn’t the only drug maker that developed such quick-draw screening tools in conjunction with researchers and clinicians, either. Eli Lily, the first company to get an SSRI on the market in the U.S., worked with researchers who made similar tools.
Doctors Bristle at New FDA Authority to Ban Off-Label Uses for Drugs
After a string of court losses concerning the ability of doctors to prescribe drugs for off-label uses for which they were not approved, Congress has quietly given the Food and Drug Administration (FDA) more power to prohibit off-label use.
Buried in page 3,542 of the 4,155-page omnibus appropriations bill is the authority to ban off-label uses, under a section that applies to “banned devices” that some doctors fear could be broadly interpreted to cover drug treatments, Just the News reports.
“FDA lobbyists got congress [sic] to grant the agency (not practicing doctors) the power to ban some uses of medications,” said Johns Hopkins medical professor and National Academy of Medicine member Marty Makary in a Tuesday tweet.
”Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well,” wrote Joel Zinberg, associate clinical professor of surgery at the Icahn School of Medicine and former Columbia law, who accused the FDA of “unwarranted intrusion into the physician-patient relationship.”
One Texas Judge Will Decide Fate of Abortion Pill Used by Millions of American Women
Now abortion rights advocates — galvanized by the reversal of Roe v. Wade — are girding for another decision from a Texas courtroom that could force the FDA to remove a widely used abortion pill from pharmacies and physicians’ offices nationwide.
The wide-ranging lawsuit, brought by a conservative Christian legal group, argues that the FDA’s approval process more than two decades ago was flawed when it authorized the use of mifepristone, which stops the development of a pregnancy and is part of a two-drug regimen used in medication abortions.
“The FDA has one job, which is just to protect Americans from dangerous drugs,” said Denise Harle, senior counsel with the Alliance Defending Freedom, part of a conservative coalition that brought the suit in federal district court in Amarillo, Texas. “And we’re asking the court to remove that chemical drug regimen until and unless the FDA actually goes through the proper testing that it’s required to do.”
A decision in the case was expected as soon as Friday. If successful, the lawsuit would force federal officials to rescind mifepristone’s approval, and manufacturers would be unable to ship the drug anywhere in the United States, including to states like California, Massachusetts, Illinois and New York where abortion remains legal.
After Long Delay, Moderna Pays N.I.H. for COVID Vaccine Technique
As Moderna racked up tens of billions of dollars in sales of its coronavirus vaccine, the company held off on paying for the rights to a chemical technique that scientists said it had borrowed from government-funded research and used in its wildly successful shot.
But Moderna and the government have now reached an agreement. The company said on Thursday that it had made a $400 million payment for the technique that will be shared by the National Institutes of Health and two American universities where the method was invented.
Moderna is still locked in a separate high-stakes dispute with the N.I.H. over who invented the central component of the vaccine, the genetic sequence that helps recipients produce an immune response.
The N.I.H. said its scientists, some of whom had been collaborating for years with Moderna, had helped to design that sequence. Moderna also received nearly $10 billion in taxpayer funding to develop and test the vaccine, and to provide doses to the federal government. The company has sold roughly $36 billion worth of coronavirus vaccines worldwide.
First Zantac Cancer Risk Trial in Calif. Postponed Five Months
The first scheduled trial over claims that GSK Plc’s (GSK.L) heartburn drug Zantac caused cancer, which had been set to begin Monday, has been postponed by five months. The case, brought by California resident James Goetz in Alameda County Superior Court, is now expected to go to trial on July 24, according to a spokesperson for GSK.
Goetz alleges he developed bladder cancer from taking Zantac, and his case will offer an early test of how Zantac cancer claims may fare in state courts.
A federal judge in December threw out all of the Zantac cases in federal court, some 50,000, after finding the opinions of the plaintiffs’ expert witnesses linking Zantac to cancer were not backed by sound science. Tens of thousands of cases still remain in state courts, many consolidated before Judge Evelio Grillo in Alameda. Grillo is currently considering what expert testimony to allow in Goetz’s trial.
Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer Inc (PFE.N), Boehringer Ingelheim and finally Sanofi SA (SASY.PA). All four drugmakers are facing Zantac lawsuits and have denied the pill causes cancer.
Ozempic Is a ‘Band-Aid’ on the Root of Childhood Obesity: Toxic Food, Former Pharma Consultant Says
A former Coca-Cola and pharmaceutical consultant said the push to put kids on weight-loss drugs ignores what he calls the root issue behind obesity — added sugars and processed food — and will fail to prevent more people from developing the disease.
Ozempic, one of the Food and Drug Administration-approved diabetes medications that doctors prescribe for weight loss, acts as an appetite suppressant. But an April 2022 peer-reviewed study published in Diabetes, Obesity and Metabolism found that patients who went off the drug regained two-thirds of the lost weight within a year.
“Ozempic will not decrease obesity long term,” Calley Means, TrueMed co-founder, told Fox News. “Making teenagers lifetime patients, that’s not good for kids.”
“Ozempic is a Band-Aid,” he added.
Moderna Forecasts COVID Sales Decline as Costs Rise, Shares Fall
Moderna Inc. (MRNA.O) on Thursday forecast declining COVID-19 vaccine sales and rising costs for 2023, raising concerns the U.S. biotech company could post a loss this year, and its shares fell 7%.
Moderna forecast $6 billion in costs for the year, $1 billion more than the revenue it expects to take in from sales of the COVID shot. The sales forecast implies a “possible EPS net loss” this year compared to the huge profit its COVID vaccines drove during its peak, Jefferies analyst Michael Yee said in a note.
However, there is a potential for positive cash flow this year if Moderna is able to get more advanced purchase agreements for its COVID shots, Yee said. Moderna expects additional sales from markets including the United States, Europe and Japan.
Moderna also reported a fourth-quarter profit that missed Wall Street expectations by a wide margin, saying the results were hurt by a newly-disclosed royalty payment to the U.S. National Institutes of Health (NIH) related to the development of the COVID-19 vaccine as well as other costs.
Is Reverse Aging Already Possible? Drugs That Could Treat Aging Might Already Be on the Pharmacy Shelves
At 67 years old, Dr. Nir Barzilai looks about the same as, if not younger than, he did 10 years ago. It’s apparent in side-by-side photographs, and it’s what most people who know him say. Barzilai lives a healthy lifestyle. He exercises every day, eats right and practices intermittent fasting.
He’s also been taking the diabetes drug metformin off-label for 10 years. He has never been diagnosed with diabetes or prediabetes — the conditions for which the drug is approved and prescribed — but takes it for a different off-label reason. “We know that it targets aging,” said Barzilai, who is a professor of medicine and genetics at Albert Einstein College of Medicine and director of the American Federation for Aging Research.
For now, the means to turn back the clock are mostly lifestyle changes. But Harvard Medical School professor and molecular geneticist David Sinclair, Ph.D., who has founded several biotechs, and others are researching and developing drugs that might slow or restart the clock so genes will act like they are young again.
But some drugs that could lower the risk for multiple age-related diseases at once and, perhaps, treat aging as a whole, might already be on the shelves of the pharmacy. Rapamycin, an mTOR inhibitor, got FDA approval in 1991 as an immune suppressor that prevents organ recipients from rejecting a new organ. By shutting off the mTOR protein, it prevents immune system cells from proliferating to attack the donated organ.
EU Regulator Recommends Against Approval for Merck’s COVID Pill for Adults
The European Union’s drug regulator said on Friday its Committee for Medicinal Products for Human Use has advised against the market authorization of the COVID-19 pill from Merck & Co Inc (MRK.N) for treatment in adults.
The antiviral pill, brand named Lagevrio, could not demonstrate benefits in the treatment of COVID patients who do not need oxygen support and are at risk of their disease worsening, the European Medicines Agency (EMA) said.
Merck and its partner Ridgeback Biotherapeutics said they will appeal the decision and request a re-examination of the committee’s opinion.
Flu Experts Gather With H5N1 Risk on the Agenda
The world’s leading experts on influenza met this week to discuss the threat posed to humans by a strain of H5N1 avian flu that has caused record numbers of bird deaths around the world in recent months. The group of scientists, regulators and vaccine manufacturers meets twice a year to decide which strain of seasonal flu to include in the vaccine for the upcoming winter season, in this case for the northern hemisphere.
But it is also a chance to discuss the risk of animal viruses spilling over to humans and causing a pandemic. At this week’s meeting, H5N1 clade 2.3.4.4b was a key topic, the World Health Organization (WHO) and global flu experts told Reuters. They will brief reporters on both the seasonal flu vaccine composition and spillover risks later on Friday.
Experts also discussed potential vaccine development. WHO-affiliated labs already hold two flu virus strains that are closely related to the circulating H5N1 virus, which could be used by vaccine manufacturers to create a human vaccine if needed. One of them was added after the previous WHO flu meeting in September 2022, and labs around the world are currently testing how closely both subtypes match the strain spreading among animals to determine whether any more updates are necessary.
A number of companies that produce seasonal flu vaccines can also make pandemic flu vaccines. For example, GSK and CSL Seqirus are already working with the United States Biomedical Advanced Research and Development Authority (BARDA) to test shots based on one of the closely-related strains.
