Login
No Testing, No Inspections: Contaminated Eyedrops Blinded and Killed Americans
Pseudomonas aeruginosa is a rod-shaped bacterium a fraction of a millimeter long. In a petri dish, it smells of corn tortillas. It’s opportunistic, invading any tissue that’s already compromised, and can be lethal: Among the especially vulnerable, the mortality rate can be as high as 50%. But perhaps the bacterium’s most notable characteristic is how hard it is to kill. The hardiest of pseudomonas are antibiotic-resistant superbugs that rage on no matter what drugs doctors throw at them.
In May 2022, an unusually virulent strain appeared for the first time in the U.S., in a hospital patient in Los Angeles. Over the summer three more local cases emerged. As doctors tried to fight the bug, the Centers for Disease Control and Prevention began to track it, reviewing every location and item the patients had in common.
Pseudomonas aeruginosa can spread even among people who never came into contact with the original source. The bacteria showed up in Connecticut, then Utah. It was found in people’s lungs and in their blood. It took eight months for the agency to determine the culprit: over-the-counter eyedrops.
The two affected brands were widely available for less than half the price of better-known ones. They weren’t counterfeit. They weren’t imported illegally. They were made in India and sold by two U.S. distributors in boxes stamped with the drug inventory numbers that the Food and Drug Administration issued.
Second Alzheimer’s Drug in Pipeline Can Slow the Disease by a Few Months but With Safety Risk
Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months, researchers reported Monday.
Eli Lilly and Co. is seeking Food and Drug Administration approval of donanemab. If cleared, it would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease — after the recently approved Leqembi from Japanese drugmaker Eisai.
Lilly announced in May that donanemab appeared to work, but on Monday the full results of a study of 1,700 patients was published by the Journal of the American Medical Association and presented at the Alzheimer’s conference.
Both donanemab and Leqembi are lab-made antibodies, administered by IV, that target one Alzheimer’s culprit, sticky amyloid buildup in the brain. And both drugs come with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths.
Many Patients Take to Online Forum to Vent About SSRIs — Half Said They Ditched Their Antidepressant Mostly Due to Side Effects
Discontinuation or dosage change of selective serotonin reuptake inhibitors (SSRIs) may be more common than one would think, according to a qualitative study of online drug reviews.
Out of 667 SSRI reviews posted to an online health forum by patients or caregivers, 335 posts were about discontinuing their medication — the most common type of medication change reported Su Golder, Ph.D., of the University of York in England, and colleagues.
The most common reason for discontinuing SSRIs was adverse events, which were cited 231 times. Among the seven SSRIs included — escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluvoxamine (Luvox), vortioxetine (Trintellix), and fluoxetine (Prozac) — discontinuation rates ranged from 41% to 54% among the WebMD health forum reviews.
Of the adverse events mentioned in the reviews, the most common were psychiatric-related, the researchers noted in JAMA Network Open. Nervous system disorders, with symptoms like dizziness, headache, and somnolence, were the second largest source of adverse events leading to medication changes. Gastrointestinal disorders and weight gain were also commonly reported.
The Rise of POTS in the COVID and Vaccine Era
The COVID-19 pandemic casts a concerning shadow in the form of Postural Orthostatic Tachycardia Syndrome, or POTS. This perplexing health issue, marked by a significant surge in heart rate when standing, is gaining increasing attention in the medical community due to a rise in cases.
Postural Orthostatic Tachycardia Syndrome (POTS) falls within the wider category of disorders called dysautonomia. It signifies a malfunction in the autonomic nervous system, which quietly controls crucial functions such as breathing, digestion, and heart rate. When this system falters, as in POTS, it can undermine health and daily quality of life.
Historically, POTS has been viewed as a rare disorder. Dysautonomia International, a key non-profit organization dedicated to dysautonomia research and awareness, estimates that POTS affects around 6 million Americans. This number, they report, has doubled since the COVID-19 pandemic began. However, due to the elusive nature of the disease and limited awareness in the healthcare community, the actual prevalence may be significantly higher.
Childhood Vaccination Rates Begin to Recover Post-Pandemic — but Not Everywhere, U.N. Says
Efforts to vaccinate children worldwide against deadly diseases such as measles and diphtheria began to recover in 2022 after a historic backslide caused by the COVID-19 pandemic, according to new figures from the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF).
But the recovery remains uneven, with strong bouncebacks in large lower-middle income countries such as India and Indonesia masking ongoing problems in many smaller and poorer countries, the agencies said in a statement released on Tuesday.
In 2022, 20.5 million children missed out on one or more routine childhood vaccines, down from 24.4 million children in 2021. Despite the progress, the numbers are still higher than in 2019, when 18.4 million children were not fully protected.
Sanofi Expands Research Deal With Gene Editing Startup Scribe
Sanofi is upping its investment in gene editing, expanding an existing collaboration with California-based Scribe Therapeutics with a $40 million deal.
Scribe and Sanofi initially inked a partnership in September for the pharmaceutical company to gain access to the startup’s ex vivo gene editing technology. Its plan was to use the platform to develop cancer cell therapies.
Under the new deal, Sanofi gets to use Scribe’s CRISPR-based gene editing technology to develop in vivo therapies as well.
FTC Asks Pfizer, Seagen for More Information on Proposed $43 Billion Merger
The Federal Trade Commission (FTC) has asked Pfizer and Seagen for more information on their proposed $43 billion merger, the Seattle biotech revealed in a Securities and Exchange Commission (SEC) filing Friday.
This is the second round of documentation the antitrust regulator has requested from the companies since their deal was announced in March.
“Second requests require both parties to provide additional information to assess the legality of the transaction, though they can be broad in nature, investigating issues such as existing or potential competition, drug pricing or off-label usage of certain products,” SVB Securities wrote in a note to investors.
Scrutiny of the deal comes as no surprise considering the FTC filed a lawsuit in May to block Amgen’s proposed $27.8 billion buyout of Horizon. That case will be heard in September.
