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Tag: Pharmaceuticals

  • The dark side of the weight-loss-drug craze: eating disorders, medication shortages, dangerous knockoffs

    The dark side of the weight-loss-drug craze: eating disorders, medication shortages, dangerous knockoffs

    A national obsession with a new class of weight-loss drugs is turning dangerous, doctors and researchers say, as many patients are inappropriately prescribed Wegovy, Ozempic and similar medications and supply shortages generate a market for unauthorized, potentially risky copycat versions of these drugs. 

    Social media buzz about the drugs has promoted the mistaken perception that the medications are appropriate for a broad swath of people who may want to shed a few pounds–with disastrous consequences for some patients, doctors say. Patients who previously recovered from eating disorders, for example, are coming in for treatment because they “have had their eating disorder reactivated by use of these medications,” said Dr. Elizabeth Wassenaar, a regional medical director at the Eating Recovery Center, which specializes in treating the disorders. Some patients have wound up in the hospital, she said, and in some cases the providers who prescribed the drugs were unaware of the patients’ eating-disorder history. “It’s a real warning to people who prescribe these medications that it’s not without risk,” she said.

    Some doctors also question whether the safety of the drugs has been adequately studied in older adults, who may have an undesirable loss of lean muscle mass when taking the medications. That complicates an ongoing debate about whether Medicare should cover these drugs for weight loss.  

    And patients of all types are put at risk, experts say, by the illegal production of knock-off versions of the medications. The Food and Drug Administration and several state pharmacy boards in recent weeks have warned that some compounding pharmacies are producing unauthorized versions of the drugs–which poses particular safety concerns for injectable drugs such as Wegovy, said David Margraf, a pharmaceutical research scientist with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy. “It’s not just a victimless crime,” he said. “People can be severely injured.” 

    Novo Nordisk
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    the maker of Wegovy and Ozempic, itself sought to tap the brakes on the craze around these drugs in a statement posted on its website this month, saying it’s concerned about reports of the drugs being used “for purely cosmetic or aesthetic weight loss,” unauthorized versions of the drugs hitting the market, and “insufficient clinical evaluations by some telehealth providers” promoting the drugs. 

    Drugs such as Novo Nordisk’s Wegovy, Ozempic and Rybelsus and Eli Lilly’s
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    Mounjaro mimic the effects of a gut hormone known as GLP-1, which can help control blood-sugar levels and reduce appetite. (Mounjaro also affects another hormone called GIP.) Ozempic, Rybelsus and Mounjaro are FDA-approved for treatment of type 2 diabetes, while Wegovy is approved for people with obesity and certain people with excess weight combined with weight-related medical problems. 

    Billions of dollars in drug sales hinge on the breadth of the patient population prescribed these medications. Last year, more than 5 million prescriptions for Ozempic, Mounjaro, Rybelsus or Wegovy were written for weight management, up from just 230,000 in 2019, according to data and analytics firm Komodo Health. Obesity drugs could be a $54 billion market by 2030, up from $2.4 billion in 2022, Morgan Stanley said in a report last year. Reports of GLP-1 drug users seeing improvements in addictive behaviors such as smoking and drinking have lately amplified interest in the medications.  

    The drugs have become such a cultural phenomenon that Walmart during its quarterly earnings call last week blamed the medications for a shift in consumer-spending patterns that pressured its margins. In the first quarter, the company saw “a shift to health and wellness,” John Rainey, Walmart Inc.’s
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    executive vice president and chief financial officer, said on the call with analysts. “And part of that is related to these GLP-1 drugs that are to treat diabetes,” he said, adding that the shift “comes at a lower margin, and so that has some impact on our business as well.” 

    Noom, a digital health company that for years has emphasized a behavioral approach to weight management, this week announced a new program that will make Ozempic, Wegovy, Mounjaro and other medications available to eligible patients. “Prescriptions are not the goal of our program. They’re very much an adjunct,” Dr. Linda Anegawa, Noom’s chief of medicine, told MarketWatch. Medical professionals will review patients’ entire health history, order labs to assess their metabolic health, and engage in video visits with patients as they determine what treatments might be appropriate, she said. 

    Telling your brain you’re not hungry 

    The reason GLP-1 drugs help control weight is pretty straightforward, said Dr. Daniel Drucker, who helped discover GLP-1 and is senior scientist at Lunenfeld-Tanenbaum Research Institute in Toronto. When people take these drugs, he said, they simply eat less because they feel more full. “GLP-1 will tell your brain that you’re not hungry,” he said, and people taking these medications may feel less stressed about food or find themselves thinking less about food. And the effects may go beyond eating, he said, as some people also see improvements in smoking, drinking, and other addictive or compulsive behaviors. “These are really interesting areas for further investigation,” he said. Drucker has been a consultant or speaker for Novo Nordisk, Pfizer
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    and other pharmaceutical companies. 

    Novo Nordisk said in a statement to MarketWatch that it is not conducting any dedicated clinical studies to evaluate Ozempic, Rybelsus or Wegovy in patients with substance-use disorders or addiction-related illnesses, and Eli Lilly said it does not have any studies planned for investigating tirzepatide–the active ingredient in Mounjaro–for treatment of addiction. 

    Adolescents’ use of the drugs for weight loss is a particular concern for some doctors. Wegovy is approved for treatment of obesity in children 12 and older. “The adolescent mental health crisis is unprecedented,” said Wassenaar, with many teens suffering severe mood disorders, eating disorders, and suicidality, and teens struggling with depression may think, “if I lose weight, I’ll feel better and people will like me. There’s this magic drug, and all I have to do is inject it.” And if patients can start taking these drugs as early as 12 years of age, “we just don’t know what that’s going to do to them in 10 or 20 years,” she said, because there’s not enough long-term data. 

    Novo Nordisk said in a statement to MarketWatch that “teenage obesity is linked to weight-related health problems such as high blood pressure, high cholesterol and type 2 diabetes,” and that cutting calories and increasing physical activity may not be enough for some patients. “The decision to prescribe an anti-obesity medication is at the discretion of the physician and the patient/parents,” the company said. 

    Eli Lilly said that tirzepatide is not currently being studied for chronic weight management in children or adolescents. 

    Many patients may have trouble filling lower-dose Wegovy prescriptions through September, according to drugmaker Novo Nordisk.


    Novo Nordisk via AP

    Some doctors are also concerned about broad use of the drugs among older adults. Many older adults have sarcopenia, an age-related loss of muscle mass and strength that can contribute to frailty and fall risk later in life–and losing weight can mean an additional loss of muscle mass that may not be advisable for some patients, doctors and researchers say.

    While “there’s a huge push to get Medicare to cover these drugs, it’s not really certain whether they would be helpful in this population or actually more harmful,” said Judy Butler, a research fellow at PharmedOut, a research and education project at Georgetown University Medical Center. Noom is not enrolling patients over age 60 in its new program, Anegawa said, partly because “we really don’t have enough data yet with many of these drugs in the geriatric population.” 

    In the pivotal clinical trials for Wegovy, 9% of the Wegovy-treated patients were between 65 and 75 years of age, and 1% were 75 and older, Novo Nordisk said in a statement. “No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients,” the company said. In an ongoing cardiovascular outcomes trial, about 38% of patients are 65 or older, the company said. 

    By law, Medicare generally does not cover drugs prescribed for weight loss–although some drugmakers and industry groups are pushing to change that. Some of the drugs now generating intense demand also come with a hefty sticker price: Wegovy, for example, has an estimated annual net cost of about $13,600, according to the Institute for Clinical and Economic Review. If Medicare coverage rules changed and 10% of beneficiaries with obesity used Wegovy, total annual Medicare Part D spending on the drug could be as much as $26.8 billion, according to a recent study published in the New England Journal of Medicine. That’s more than 18% of the net total Part D spending by beneficiaries and the Medicare program in 2019.

    Dangerous copycats 

    There are potential physical as well as financial costs. Side effects of the drugs can range from nausea and vomiting to gallbladder problems, inflammation of the pancreas, and thyroid cancer.

    More broadly, some doctors question the prescribing of drugs solely based on obesity, absent other risk factors. “If somebody is obese and has diabetes, high blood pressure, and high cholesterol, losing weight may improve those parameters, but obesity on its own does not need to be treated,” said Dr. Adriane Fugh-Berman, a professor at Georgetown University Medical Center and director of PharmedOut. “It’s cardiovascular fitness that is important, no matter what weight you are,” she said. “We should stop focusing on the weight itself as a risk factor.” 

    Dr. Robert Gabbay, chief science and medical officer at the American Diabetes Association, counters that “obesity is a disease, and therefore needs to be treated as such.” Although there are people with obesity who don’t have other serious conditions, he said, “that’s relatively uncommon.” 

    Despite the concerns, shortages of the drugs persist. Novo Nordisk says it anticipates that many patients will have trouble filling lower-dose Wegovy prescriptions through September. 

    For patients who are relying on GLP-1 drugs for treatment of diabetes, even a short-term interruption in access to the drugs can cause blood-glucose levels to rise and result in serious complications, Gabbay said. Patients also tend to gradually ramp up dosage of these drugs to get to the effective dose, he said, and if they lose access to the medication “they might have to start back at the beginning again,” putting them several months behind on their treatment. 

    The shortages can also create risks for a broader set of patients, experts say, as they spur demand for copycat versions of the drugs. The approved active ingredient in Wegovy and Ozempic is semaglutide in its base form, but some compounding pharmacies may be using salt forms of semaglutide, the FDA said in a late April letter to the National Association of Boards of Pharmacy. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements” restricting the types of active ingredients used in compounding, the FDA said in the letter. Boards of pharmacy in several states, including West Virginia, North Carolina and Mississippi, have also recently issued warnings about compounded semaglutide. 

    Novo Nordisk said in the statement posted on its website this month that it is “actively monitoring and taking action against” entities unlawfully selling compounded semaglutide, adding that no FDA-approved generic versions of semaglutide currently exist. 

    Unauthorized compounded versions of the drugs could raise serious concerns about sterility and other quality-control issues, the Resilient Drug Supply Project’s Margraf said. “If this drug is in high demand and there isn’t enough supply, people will find a way to get it from a gray-market source,” he said. “People are going to find ways around the laws and potentially harm patients.” 

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  • Pfizer wins full FDA approval for oral COVID therapy Paxlovid for adults at high risk of developing severe illness

    Pfizer wins full FDA approval for oral COVID therapy Paxlovid for adults at high risk of developing severe illness

    Pfizer Inc.
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    said Thursday it has received full Food and Drug Administration approval for its Paxlovid oral treatment for COVID-19 for use in adult patients with high risk of developing severe disease. The treatment has been available in the U.S. since December of 2021 under an Emergency Use Authorization. To date, more than 11.6 million treatment courses have been prescribed. There are still about 14,500 reported cases of COVID in the U.S. every week, but many others are not reported. The U.S. ended the COVID public health emergency on May 11. Pfizer’s stock was down 2% Thursday, and has fallen 26% in the year to date, while the S&P 500 has gained 8%.

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  • Chemical ‘supercharger’ solves molecular membrane mystery

    Chemical ‘supercharger’ solves molecular membrane mystery

    More than 60% of market drugs aimed at fighting disease target molecular proteins in the cell membranes – but techological limitations have previously limited researchers’ ability to observe these proteins in their natural environment.

    Now, scientists in the lab of Yale School of Medicine’s Kallol Gupta, PhD, have identified a class of chemicals, called “superchargers,” that gently destabilize the cell membrane while leaving cell proteins intact. The team was able to show how cell membranes regulate the speed of neurotransmitter release, a key step in central nervous system signaling.

    Traditional methods of isolating proteins from the membrane environment with mass spectrometry have damaged the proteins and their ability to bind with other molecules – including those with potentially therapeutic value. This breakthrough technology will allow scientists to screen future therapeutics precisely and directly at the point where proteins encounter new drugs.

     

    Yale University School of Medicine

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  • Failed antibiotic now a game changing weed killer for farmers

    Failed antibiotic now a game changing weed killer for farmers

    Newswise — Weed killers of the future could soon be based on failed antibiotics.

    A molecule which was initially developed to treat tuberculosis but failed to progress out of the lab as an antibiotic is now showing promise as a powerful foe for weeds that invade our gardens and cost farmers billions of dollars each year.

    While the failed antibiotic wasn’t fit for its original purpose, scientists at the University of Adelaide discovered that by tweaking its structure, the molecule became effective at killing two of the most problematic weeds in Australia, annual ryegrass and wild radish, without harming bacterial and human cells.

    “This discovery is a potential game changer for the agricultural industry. Many weeds are now resistant to the existing herbicides on the market, costing farmers billions of dollars each year,” said lead researcher Dr Tatiana Soares da Costa from the University of Adelaide’s Waite Research Institute.

    “Using failed antibiotics as herbicides provides a short-cut for faster development of new, more effective weed killers that target damaging and invasive weeds that farmers find hard to control.”

    Researchers at the University’s Herbicide and Antibiotic Innovation Lab discovered there were similarities between bacterial superbugs and weeds at a molecular level.

    They exploited these similarities and, by chemically modifying the structure of a failed antibiotic, they were able to block the production of amino acid lysine, which is essential for weed growth.

    “There are no commercially available herbicides on the market that work in this way. In fact, in the past 40 years, there have been hardly any new herbicides with new mechanisms of action that have entered the market,” said Dr Andrew Barrow, a postdoctoral researcher in Dr Soares da Costa’s team at the University of Adelaide’s Waite Research Institute.

    It’s estimated that weeds cost the Australian agriculture industry more than $5 billion each year.

    Annual ryegrass in particular is one of the most serious and costly weeds in southern Australia.

    “The short-cut strategy saves valuable time and resources, and therefore could expedite the commercialisation of much needed new herbicides,” said Dr Soares da Costa.

    “It’s also important to note that using failed antibiotics won’t drive antibiotic resistance because the herbicidal molecules we discovered don’t kill bacteria. They specifically target weeds, with no effects on human cells,” she said.

    It’s not just farmers who could reap the benefits of this discovery. Researchers say it could also lead to the development of new weed killers to target pesky weeds growing in our backyards and driveways.

    “Our re-purposing approach has the potential to discover herbicides with broad applications that can kill a variety of weeds,” said Dr Barrow.

    This research has been published in the journal of Communications Biology.

    Dr Tatiana Soares da Costa and her team are now looking at discovering more herbicidal molecules by re-purposing other failed antibiotics and partnering up with industry to introduce new and safe herbicides to the market.

    Funding for this research was provided by the Australian Research Council through a DECRA Fellowship and a Discovery Project awarded to Dr Tatiana Soares da Costa.

    The first author on the paper is Emily Mackie, a PhD student in Dr Soares da Costa’s team, who is supported by scholarships from the Grains and Research Development Corporation and Research Training Program. Co-authors include Dr Andrew Barrow, Dr Marie-Claire Giel, Dr Anthony Gendall and Dr Santosh Panjikar.

    The Waite Research Institute stimulates and supports research and innovation across the University of Adelaide and its partners that builds capacity for Australia’s agriculture, food, and wine sectors.

    University of Adelaide

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  • FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

    FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

    Respiratory syncytial virus viral vaccine under research.

    Hailshadow | Istock | Getty Images

    The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus, but raised safety concerns over premature births that may be tied to the shot. 

    The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not.

    “If the vaccine actually lives up to the data we’ve seen today, I can guarantee many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot.

    Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” 

    “If you’re in any sense risking premature births with this vaccine, I think there’ll be a big price to pay,” said Offit, who voted against the shot’s safety data. 

    Adam Berger, the director of clinical and healthcare research policy at the National Institutes of Health, voted in favor of the shot’s safety and efficacy, but said Pfizer’s post-marketing studies need to examine the risk of premature births.

    Post-marketing refers to studies conducted on a product after it receives FDA approval.

    The FDA typically follows the advice of its advisory committees but is not required to do so. The agency is slated to make a final decision on the shot in August, right before RSV season in the fall. 

    If approved, Pfizer’s jab would become the world’s first vaccine that protects infants against RSV, a goal scientists have been working toward for decades.

    The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected to make a decision within weeks on Pfizer’s other RSV shot for that same age group.

    RSV is a common respiratory infection that causes cold-like symptoms. Older adults and younger children are particularly vulnerable to more severe RSV infections. 

    Each year, the virus kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to the Centers for Disease Control and Prevention. About one out of every 100 children younger than 6 months of age with an RSV infection may need to be hospitalized, the CDC said.

    Pfizer’s shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy. The single-dose vaccine triggers antibodies that are passed to the fetus, which provides it with protection against RSV from birth through the first six months of life.

    Weighing safety and efficacy data

    A phase three trial found Pfizer’s shot was nearly 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life. The shot was also about 70% effective during the first six months of the baby’s life.

    But the advisory panel’s concerns stemmed from safety data in that trial. 

    A slightly higher number of premature births occurred among mothers who took the shot compared to those who received a placebo: 5.7% versus 4.7%, respectively. 

    Both Pfizer and the FDA said the difference does not appear to be statistically significant. 

    Most infants, even when born prematurely, were also delivered after 34 weeks of pregnancy, just a few weeks shy of their due dates.

    But Dr. Hana El Sahly, who chairs the FDA advisory committee, said “even if it is late preterm delivery, the fact that we’re putting them into preterm delivery while we’re sitting here debating the matter intellectually is not trivial.”

    Premature deliveries aren’t a new issue when it comes to RSV vaccines for infants.

    Pfizer’s rival GSK halted its own trial on its RSV shot for newborns after noticing concerning data on preterm births and neonatal deaths, or when a baby dies during the first 28 days of life.

    Offit also said GSK’s trial is “hanging over” Pfizer’s own RSV shot for infants. 

    “If GSK truly abandons a program on a similar, almost identical vaccine, that is going to hang over [Pfizer’s] program,” he said during the meeting. “I think it does need to be addressed.”

    Portnoy added preterm deliveries could potentially dampen the benefits of the shot. 

    “The problem is if the child is born earlier, that also reduces the efficacy of the treatment because earlier birth means less antibodies are transferred,” he said. “So, this is a very complex thing because now the harm actually makes the benefit less so. There’s an interaction between the two.” 

    But some panel members cast doubt on whether there’s a clear causal relationship between the vaccine and preterm births. 

    “Am I concerned about the preterm birth imbalance? Yes. Am I convinced that it’s real? No,” said Dr. Daniel Feikin, a scientific advisor and respiratory diseases consultant, who voted in favor of the shot’s safety. 

    Representatives from Pfizer also pushed back on the safety concerns, emphasizing the benefits of the shot outweigh the risks.

    “Certainly, in our eyes, there is no definitive evidence to suggest there is a risk of prematurity,” said Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development. “So the question is, do you hold hostage the potential benefits of the vaccine for something which you have no statistical significance at this point?”

    Some of the participants’ children also had low birth weights and experienced developmental delays, the FDA staff review said.

    Most of the more than 3,000 mothers who received the shot in the trial experienced mild to moderate adverse reactions, according to the FDA staff’s review of data.

    The most common reactions were fatigue, muscle pain, headache and pain at the injection site. Most reactions resolved within three to four days after vaccination, the staff review noted.

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  • Novel Antibiotic Succeeds in Trial Against Hospital-Acquired Pneumonia

    Novel Antibiotic Succeeds in Trial Against Hospital-Acquired Pneumonia

    Newswise — A Rutgers researcher leading a trial found that the novel combination antibiotic sulbactam-durlobactam combats dangerous pneumonia at least as well as the best currently approved treatment.

    The findings have led a unanimous expert committee to recommend that the Food and Drug Administration (FDA) approve the new drug, which could be available this summer to combat the often-fatal pneumonia strain known as carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC), typically acquired in hospitals.

    “Antibiotic-resistant infections are a serious and persistent problem at healthcare facilities, and the [Centers for Disease Control] ranks ABC at the highest level on its threat list,” said Keith Kaye, chief of the Division of Allergy, Immunology and Infectious Disease at Robert Wood Johnson Medical School and first author of the trial report in The Lancet Infectious Diseases. “An estimated 8,500 hospital-acquired cases killed 700 patients and cost $280 million in 2019, so we greatly needed a breakthrough treatment like sulbactam-durlobactam.”

    The trial gave imipenem–cilastatin to 181 patients with laboratory-confirmed ABC and then randomized them to additional treatment with either sulbactam–durlobactam or the best existing treatment, an antibiotic called colistin. Mortality due to multiple causes after 28 days was 12 of 63 (19 percent) in the sulbactam–durlobactam group and 20 of 62 (32 percent) in the colistin group.

    The trial was large enough to prove that sulbactam-durlobactam prevents at least as many fatalities as colistin but not large enough to prove its superiority in this trial will persist in real-world use, though it may.

    The trial results did prove that sulbactam-durlobactam beats colistin in one crucial respect: tolerability. Kidney injury, serious adverse events and all treatment-related adverse events were significantly lower for patients who received sulbactam-durlobactam than for patients who received colistin.

    Another advantage of the novel antibiotic is dosing. All patients receive the same injectable dose of sulbactam–durlobactam. Doses of colistin in the study, on the other hand, varied with patient weight, so it’s considerably easier for providers to prescribe or administer the wrong amount.

    As its name implies, sulbactam-durlobactam combines two drugs. Sulbactam has been approved for use since 1986, but durlobactam is new and has yet to win approval. That could change soon, however. The FDA’s Antimicrobial Drugs Advisory Committee reviewed advance results of the new trial, along with earlier studies, and recommended on April 17 that the FDA approve the new combination for ABC treatment.

    FDA officials are free to reject such recommendations but almost always follow recommendations from advisory committees, which comprise independent experts on particular classes of disease and medication.

    “If all moves quickly, infected patients could begin receiving sulbactam-durlobactam as part of normal clinical care the second half of this year,” Kaye said. “Unfortunately, sulbactam-durlobactam isn’t the sort of wide-spectrum antibiotic that could prove effective in treating a wide variety of antibiotic-resistant infections, but it’s very good at treating this particularly dangerous one, and that’s a significant win.”

    Rutgers University-New Brunswick

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  • Q&A: Update on mifepristone, federal court actions

    Q&A: Update on mifepristone, federal court actions

    Newswise — Dr. Sarah Prager, a UW Medicine OB-GYN, offers context to the recent U.S. Supreme Court decision, which ordered that mifepristone remain available in the United States while legal challenges work their way through the federal courts. Here is that discussion.

    Q: What is mifepristone and how does it work?

    Prager: Mifepristone works as a progesterone blocker. Without progesterone, the lining of the uterus breaks down and the pregnancy doesn’t continue. The second medicine, misoprostol, makes the uterus contract.

    Q: Can I still get mifepristone in Washington state?

    Prager: Yes, as of right now, there is access to mifepristone for patients in need of this drug for abortion or miscarriage care.  

    Q: Can I get it via telehealth? Or do I have to see a doctor in person?

    Prager: There are some clinical sites locally which are supplying telehealth, such as Planned Parenthood clinics in Washington, as well as the Cedar River Clinics in Renton. UW Medicine does not offer telehealth visits for medication abortions yet, but we hope to provide these services starting in June of this year. But for now, you have to go to a clinic and see a doctor or nurse at UW Medicine sites.

    Q: Can a faculty member or UW clinician dispense an abortion-inducing medication across state lines to a patient in a state that makes abortion illegal? 

    Prager:  No. If a state prohibits abortion by medication, faculty and UW employees must abide by the laws of that state when treating a patient who is physically present in that state.

    Q: Can a faculty member or UW clinician dispense an abortion-inducing medication to a patient located in Washington, or who came to Washington to receive abortion services?

    Prager:  Yes. Washington law allows Washington clinicians to provide abortion services to patients who are located in Washington, regardless of what state they live in. A patient presenting in Washington for services may be treated in Washington, consistent with the laws of Washington. Faculty must dispense abortion inducing medication in Washington and only issue the prescriptions to pharmacies located in Washington.

    Our recommendation to patients is that the drugs should be taken in Washington before returning to their home state. If there is a complication, it is preferable for them to still be in a state where abortion is legal.

    Q: What do we need to know about post-abortion care?

    Prager:  While complications from abortion or miscarriage are rare, conditions such as retained pregnancy tissue in the uterus, bleeding and infection can occur. It is critical for patients seeking post-abortion care services to be treated with care and dignity and to have their medical issues addressed upon presentation.

    Post-abortion care may happen in a clinic or an emergency department setting and includes: managing residual side effects or complications of abortion, emotional support, and providing comprehensive birth control services without discrimination or coercion.

     UW Medicine provides confidential post-abortion care; patient information remains private for post-abortion care services in the same way other services remain private. It is generally not necessary for patients to disclose that they have had an abortion. Moreover, healthcare professionals are unable to determine whether the complications occur from abortion or miscarriage.

    The real take-home for me, is that post-abortion care hasn’t changed. We still need to be providing comprehensive care for miscarriage or an abortion. There is no way for clinicians to know the difference, so let’s treat patients with respect in providing this care.

    Q: How available is the second drug in the regimen, misoprostol, if mifepristone is banned?

    Prager:  Misoprostol is widely available and will likely stay that way. Part of reason why mifepristone is targeted for court challenges and bans is that its only FDA [Food and Drug Administration] approval is for use in medication abortion. Misoprostol was approved by the FDA for treating stomach ulcers, and is used off-label for other medical treatments including abortion. Therefore it’s much more difficult to attack misoprostol in the courts or with the FDA.

    Q: What is the difference between the two-drug regimen and taking only misoprostol? Is the efficacy different? How does the patient experience differ?

    Prager: There are two main differences if you switch from the two-drug regimen to the one-drug regimen using only misoprostol.

    When you use mifepristone prior to using the misoprostol, there are exceptionally good success rates, and it helps to minimize side effects. The success rates with mifepristone/misoprostol regimen are about 95% to 98%, and about 78% with a single dose of misoprostol. With multiple doses of misoprostol, the success rate increases to approximately 95%. 

    When you just use misoprostol, patients have to take more doses of the misoprostol, which increases the side effects such as cramping, gastrointestinal distress, vomiting and diarrhea. Repeated doses of misoprostol mean prolonging the amount of time that somebody is potentially experiencing these side effects.The patient may worry and wonder if they have to go to an emergency department, whether or not they clinically need to do so. It also could potentially increase their need for more pain medications. You might see more patients requesting narcotic medications, and we don’t typically need pain meds for medication abortion. So it really just punishes pregnant people for having a miscarriage or an abortion.  

    A misoprostol-only regimen is eliminating an evidence-based best practice tool for healthcare providers. Mifepristone has been approved by the FDA for 23 years and has been shown in numerous clinical studies to be both safe and effective.

    Q: What advice would you give to pregnant women traveling in the U.S. at this time?

    Prager: For anyone who is pregnant, I would be cautious traveling to states where abortion is illegal. In these states, there are a number of pregnancy complications that may not be managed in an evidence-based way that supports the health of the pregnant person. Most people will not experience pregnancy complications while traveling, however this can be something factored into travel decisions. 

    University of Washington School of Medicine and UW Medicine

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  • Methylated cyclodextrin prevents drug crystallization effectively

    Methylated cyclodextrin prevents drug crystallization effectively

    Newswise — When new drugs or drug candidates are introduced in the market, they often have low water solubility, which makes it difficult for them to be absorbed in the body. This limits their effectiveness. To improve solubility, cyclodextrins (CDs) are commonly used as solubilizing agents. CDs have a unique structure with a hydrophilic exterior and a hydrophobic cavity inside that can enclose drug molecules to form inclusion complexes. However, even with enhanced solubility, drugs may not be efficiently absorbed in the body as they cannot easily pass through biological membranes.

    Increasing the concentration of drugs in a solution can improve their permeability through biological membranes, but this leads to an unstable supersaturated state where the drug precipitates and forms crystals. To prevent this, effective crystallization inhibitors need to be added. CD derivatives are a useful option as they can solubilize drugs and inhibit crystallization. However, the mechanism by which CD derivatives inhibit crystallization is not well understood.

    A recent study conducted by researchers from Chiba University in Japan looked into the effects of 12 different CD derivatives, which have varying hydrophobic cavity sizes, on inhibiting the crystallization of two poorly water-soluble drugs, carvedilol (CVD) and chlorthalidone (CLT).

    Their work was made available online on March 22, 2023, and published in Volume 637 of the International Journal of Pharmaceutics on April 25, 2023. It involved contributions from Professor Kunikazu Moribe, Associate Professor Kenjirou Higashi, and Assistant Professor Keisuke Ueda.

    The ability of different CD derivatives to dissolve drugs varies, which affects how much of the drug remains dissolved in a solution. This can cause errors in estimating the strength of their ability to stop the drug from crystallizing. Therefore, it is important to analyze the drug crystallization inhibition effect of CD derivatives while also considering their ability to dissolve drugs. This is according to Mengyao Liu, the lead author of the study and a Ph.D. student at the Laboratory of Pharmaceutical Technology at the Graduate School of Pharmaceutical Sciences at Chiba University.

    To study the effect of different CD derivatives on two drugs, the researchers conducted two tests. First, they performed phase solubility tests, which involved dissolving the drugs in solutions of different concentrations of CD derivatives to measure how well they dissolve. Second, they measured the crystallization induction time, which is the time it takes for a solution to form crystals, by adding drops of the drugs to create supersaturated solutions and then tracking their concentrations over time.

    The researchers found that β-CD and γ-CD derivatives helped improve the solubility of CVD, while β-CD derivative was the only one that enhanced CLT’s solubility. They also discovered that the solubility improvement relied on the ability to form stable inclusion complexes, which was determined by the fit between the drug molecule and the CD cavity size.

    The study found that there was no connection between the ability of different CD derivatives to increase solubility and their ability to prevent drug crystallization. The researchers discovered that the methylated CD derivatives were more effective than their unmethylated counterparts in keeping the drug in a supersaturated state, which is important for enhancing drug absorption in the body. The researchers believe this is due to the highly hydrophobic outer surfaces of the methylated CD derivatives, which hinder the formation of crystals and thus maintain the supersaturated state of the drug.

    In conclusion, these findings shed light on the potential application of CD derivatives in drug-supersaturated formulations, which, in turn, could facilitate the clinical use of poorly water-soluble drug candidates.

    About Professor Kunikazu Moribe

    Dr. Kunikazu Moribe is a Professor at the Laboratory of Pharmaceutical Technology at the Graduate School of Pharmaceutical Sciences at Chiba University in Japan. His research focuses on physical pharmacy, pharmaceutical technology, and drug delivery systems. He has published over 183 papers on pharmaceutics, which have been cited over 3,000 times. In recognition of his contributions to the field, he was conferred the Asahi Kasei Pharmaceutical Technology Research Award for Young Scientists in 2013 by the Academy of Pharmaceutical Sciences and Technology Japan.

    Chiba University

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  • A mother was raising her son in a city she loved. Then San Francisco changed and stole her boy | CNN

    A mother was raising her son in a city she loved. Then San Francisco changed and stole her boy | CNN

    Watch how drugs, homelessness and crime have changed a city, and what is being done about it. CNN’s Sara Sidner asks “What Happened to San Francisco?” on “The Whole Story with Anderson Cooper,” Sunday at 8 p.m. ET.


    San Francisco
    CNN
     — 

    Tanya Tilghman moved to the Bay Area as a teenager to live with her mom. Later, she married, had two sons and made a home in San Francisco’s historically Italian North Beach district, up the hill from the tourist and financial centers.

    Even when her marriage broke down, she never thought of leaving. This was her city, her people. Liberal like her, with a mix of income levels and a general sense of community. She didn’t worry about her growing boys going out on the streets where she herself always felt safe.

    But those streets have changed, she says. She believes policies from City Hall and even groups who advocate for the homeless have exacerbated some of the problems and the community she once felt a part of has gone, she says. And her son got caught up in a scene you can almost not avoid in the city: the drug scene.

    Roman Vardanega first tried illegal drugs at the start of high school, Tilghman said, taking a prescription medication at a friend’s house.

    He quickly became hooked, his mother said, moving on to cocaine, heroin and later fentanyl, all available in the city’s seedy Tenderloin area.

    Tilghman admits she was uneducated about the prevalence of hard drugs, even naïve. But it was not something she encountered every day. Back then “I think it’s a lot worse now than when I was growing up here,” she said. “We used to come to the Tenderloin when I was a teenager because we thought it was just kind of fun, edgy and I never as a teenager felt unsafe. But I also don’t remember people coming up to me and asking me if I want to buy drugs.”

    One of her first clues that her son was getting in deep was when she was with him on a tour outside City Hall while he was in high school. It was a few blocks from the Tenderloin and some of the unhoused people on the street knew him by name, as if he spent a lot of time out there with them – which is what he was doing, scoring his drugs.

    She tried to help. Vardanega spent the 11th grade in rehab but persuaded his mom to let him return. She welcomed him home, but so did the streets.

    Roman Vardanega showed musical talent from a young age, his mother said, before his addictions consumed him.

    By then, her neighborhood had changed, with drugs seemingly freely available, even just heading home on the Bay Area Rapid Transit (BART) local transport system.

    “When I got out of the BART station, the first thing that I was asked is if I wanted to buy drugs,” Tilghman said. The ease of getting and using drugs made the city a dangerous and sometimes deadly playground for people like her son.

    Vardanega started to live on the streets full-time when the Covid pandemic hit in 2020. The city shut down, residents either left or stayed inside and at the height of the pandemic, more people died of drug overdoses than Covid-19.

    “All the tents started going up in the city,” Tilghman said. “The open-air drug market became a lot worse. And so it became easier for him to buy drugs and to use it out in the open.”

    And confusingly to Tilghman, the city just seemed to look away.

    “The city’s policies have absolutely hurt my son, has hurt us, and has caused him to, I would say go into his addiction even a lot more,” she said.

    “If you got busted with drugs, most likely you’re not going to jail, the police officers would just let you go,” she said. “That made the situation a lot worse, especially for my son because he’s really young, and still kind of in that party state of mind.”

    Tilghman’s state of mind was focused on one goal: finding her son. She knew he was an addict. She knew she loved him so much it hurt. And she knew she would not stop searching until she found him even if that meant putting herself in danger.

    She would walk the streets looking at things most people try to avoid, looking directly into the eyes of the people living on the streets. Sometimes she got back blank stares. Other times a sympathetic ear or a hopeful hint about where her son might be.

    She didn’t find him, but so many people were like him. “What makes me sad is that I see my son’s face in everybody’s faces … out on the streets,” Tilghman said.

    As Covid descended, many housed residents began disappearing and the tent cities exploded onto the sidewalks, along with the drugs, the addictions and signs of mental illness.

    Rectangles are painted on the ground to encourage homeless people to keep social distancing at a city-sanctioned homeless encampment across from City Hall in San Francisco in May 2020.

    Mayor London Breed declared a state of emergency in the city, to include a “linkage center” in the Tenderloin, promoted as a place where addicts could get services to help them.

    When it opened in January 2022, Tilghman was hopeful it could be somewhere her son would find himself, and one day she went to take a look. When she got there, she heard music blaring and tried to get a look inside.

    “I saw people doing drugs. I couldn’t believe it. I’m like, this is a place where people are supposed to get help. And they’re actually doing drugs?” Tilghman said.

    A little later, she posed as an addict and went to the center for a closer look.

    “I said to them that I wanted to get off drugs, and that I needed help,” she said. “And they laughed at me. And the guy at the door said, ‘We can help you do drugs. But if you want help getting off drugs, you’re gonna have to come back tomorrow’,” Tilghman said.

    The center had what was supposed to be an area where overdoses could be treated, but it became known as a place to take drugs, not seek other services.

    “The most upsetting thing … was that the harm reduction area was more like a party scene,” Tilghman said. “If my son were to go there wanting to access services, him being addicted to drugs, if he were to see a party scene with people dancing and singing and doing drugs, and most likely selling drugs inside, there’s just no way he would access services. Because he would get so distracted, and be so triggered that he would go and use.”

    The city’s laissez-faire philosophy had just gone too far, she felt.

    “When you could walk into a store and steal under $1,000 worth of merchandise and get away with it – that’s going way too far,” she said. “It’s going too far when you could smoke crack in front of a police officer and the police officer just looks at you and doesn’t even arrest you.”

    The struggle to try to save her son wore her down. Not once, but three times Tilghman says she got so low and so hopeless she attempted suicide.

    The situation is beginning to change, both for Tilghman personally, and perhaps her city.

    The Tenderloin Linkage Center, which was later renamed to just the Tenderloin Center, closed last December. Tilghman has found new support and a mission working with Mothers Against Drug Addiction and Deaths. A new district attorney took over after the previous one was recalled by voters who perceived him as soft on crime. Tilghman’s son Vardanega got in trouble with the law, served jail time and was sent to a court-mandated rehab program.

    Incarceration is a good thing for him in Tilghman’s mind – keeping him alive, off the streets and giving him a chance in a treatment program.

    San Francisco is still beautiful to her – with the Golden Gate Bridge, the Presidio and Fisherman’s Wharf, the Italian enclave of North Beach. But it has become scarier, and she feels some of the blame has to go to politicians whose job it is to clean up the streets.

    “I’m liberal,” Tilghman said. “My politics have stayed the same and things have gone crazy around me.”

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  • Americans in most states will no longer receive Covid exposure notifications on phones

    Americans in most states will no longer receive Covid exposure notifications on phones

    Americans in most states will no longer receive Covid exposure notifications on their smartphones now that the U.S. public health emergency has ended. 

    Since 2020, nearly 30 states have used a Bluetooth system developed by Apple and Google to track the spread of Covid infections and send push alerts to any smartphone user who came in close contact with a person who tested positive for the virus. 

    The Association of Public Health Laboratories hosted the national server that the system ran on. 

    On Thursday, the organization said “the majority of states” stopped using the exposure notification system after the Biden administration ended the public health emergency on May 11. 

    APHL added it will no longer support the system, which aimed to help millions of Americans trace their exposures and make decisions about isolating and testing for the virus.

    In a joint statement, Apple and Google did not address states’ decisions to stop using the system.

    The tech giants told CNBC the system helped public health departments fight Covid in a way that preserves privacy, referring to how it tracks infections without collecting the location or identity of users. 

    California, New York, Massachusetts, Washington, Virginia, New Mexico and Colorado are among the states that said they will no longer use the system after the end of the U.S. emergency declaration. 

    “These systems were timed to shut down on the same date that the nation’s COVID-19 State of Emergency ends,” the California Department of Public Health said in a statement late Thursday. 

    Several states used the system to create apps that smartphone users could download, such as CA Notify and WA Notify.  

    States also provided exposure notifications through a built-in feature on Apple and Google’s operating systems. 

    For that method, state health departments had to submit a configuration file with their contact information and Covid guidance to Apple and Google. The two tech companies would use the file to set up a feature on phones that users could activate to receive notifications. 

    On Friday, some Apple users who opted in for that feature received push alerts informing them that their iPhones “will no longer log nearby devices and you won’t be notified of possible exposures.” 

    One Apple user shared in a Twitter post that their alert said, “Your Health Authority Turned Off Exposure Notifications.”

    But not all Apple and Google users in states that stopped using the exposure notification system have received similar alerts, as of Friday afternoon.

    Neither Apple or Google addressed why some users received alerts while others did not.

    There is no clear tally of how many Americans activated the exposure notification feature on their phones or downloaded apps over the past three years. 

    Virginia estimates that more than 3 million users have downloaded the state’s app or used the notification feature since those tools launched in 2020.

    New Mexico said the “majority” of residents activated the notification feature on their phones. More than 1.5 million alerts were sent to users who may have been exposed to Covid, according to the state. 

    Washington said the state generated more than 2.5 million exposure alerts through its app or the notification feature. 

    Researchers in Washington found that the state’s notification tools saved an estimated 30 to 120 lives and likely prevented about 6,000 Covid cases during the first four months after they launched in November 2020. 

    Despite these benefits, some Americans have been skeptical of the Covid exposure notification tools. 

    A 2021 report by the U.S. Government Accountability Office said that the public expressed concerns about privacy. The report said the public may not trust both local governments and technology companies to handle sensitive health information.

    State decisions to end Covid exposure notifications are part of a broader shift in how the country responds to the pandemic. 

    Health departments last year loosened Covid restrictions like masking and social distancing as more Americans got vaccinated and boosted against the virus. 

    That culminated in the end of the public health emergency, which phased out much of the funding and flexibility that helped expand Covid testing, insurance coverage and access to care during the pandemic.

    Still, more than 1,000 Americans are still dying each week from Covid, according to the Centers for Disease Control and Prevention.

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  • Eli Lilly nears J&J market cap

    Eli Lilly nears J&J market cap

    Eli Lilly & Co.’s market cap neared Johnson & Johnson’s market cap on Friday, as the stock has benefited from a slew of positive data in trials for key treatments.

    Earlier Friday, Lilly stock
    LLY,
    +0.00%
    was on track to close with a greater market capitalization than J&J
    JNJ,
    -0.13%    ,
    which would have marked the first time since 1997. Lilly stock ended flat, however, for the session at $434.43.

    The stock has been steadily rising since the release of positive data from a trial of a treatment for Alzheimer’s disease in early May, showing significant slowing of cognitive and function decline in patients with early symptomatic Alzheimer’s disease.

    Nearly half, or 7% of participants, had no clinical progression at one year, compared to 29% on placebo. The drug, called donanemab slowed clinical decline by 35% compared to a placebo and resulted in 40% less decline in the ability to perform activities of daily living, including managing finances, driving, engaging in hobbies and conversing about current events, the company said.

    The company is planning to proceed with global regulatory submissions as quickly as possible and expects to make a submission to the U.S. Food and Drug Administration this quarter.

    For more, see: Eli Lilly stock jumps 5% after Alzheimer’s treatment slows disease progression in major trial

    That’s not all. In April, Eli Lilly released data on its new obesity drug tirzepatide that showed patients in a trial losing up to 15.7% of their body weight, or about 34.4 pounds.

    More than 80% of people taking tirzepatide lost at least 5% of their body weight, the company said, compared with about 30% of those taking a placebo. 

    The degree of average weight reduction seen in the trial “has not been previously achieved” in similar Phase 3 trials, Dr. Jeff Emmick, senior vice president for product development at Lilly, said in a statement. 


    Source: FactSet, Dow Jones Market Data

    The company is planning regulatory submissions for that drug later this year. Tirzepatide was approved by the FDA last year as Mounjaro, a treatment for Type 2 diabetes.  

    Lilly has several other pipeline prospects, including lebrikizumab, a treatment for atopic dermatitis; mirikizumab for ulcerative colitis; empagliflozin, a treatment for chronic kidney disease; and pirtobrutinib for relapsed/refractory mantle cell lymphoma.

    Lilly’s stock is up about 20% in the year to date and up 50% in the past 12 months.

    Johnson & Johnson’s stock, meanwhile, has fallen 9% in the year to date and is down roughly the same over the past 12 months.

    The company swung to a first-quarter loss as it booked a multibillion-dollar charge to settle lawsuits stemming from its talc-containing powders.

    J&J booked a $6.9 billion one-time litigation charge relating to lawsuits filed by people alleging the company’s talc-containing powders caused cancers, asbestos poisoning and other illnesses. The company has offered to pay at least $8.9 billion to settle the suits, and remove an overhang on the stock.

    Read more: J&J’s proposal to settle talc lawsuits for $8.9 billion sends stock up the most in more than a year

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  • New peanut-allergy skin patch shows promise: ‘This would fill a huge unmet need’

    New peanut-allergy skin patch shows promise: ‘This would fill a huge unmet need’

    An experimental skin patch may soon allow increased protection for toddlers who are allergic to peanuts, according to a new study published in the New England Journal of Medicine.

    The patch, named Viaskin, is coated with a small amount of peanut protein that is absorbed into the skin and would offer some protection against an accidental peanut ingestion that so many parents fear at birthday parties, in school cafeterias or on play dates.

    If additional testing pans out, “this would fill a huge unmet need,” Dr. Matthew Greenhawt, an allergist at Children’s Hospital Colorado who contributed to the study, told the Associated Press.

    There is no cure for food allergies. The number of Americans who are allergic to peanuts is estimated at 6.1 million, according to FARE, one of the largest private funding sources for food-allergy research.

    About 2% of U.S. children are allergic to peanuts, some so severely than even a tiny exposure can cause a life-threatening reaction. Their immune systems overreact to peanut-containing foods, triggering an inflammatory cascade that causes hives, wheezing or worse. Some youngsters outgrow the allergy, but most must avoid peanuts for life and carry rescue medicine to stave off a severe reaction if they accidentally ingest an allergen.

    In 2020, the Food and Drug Administration approved the first treatment to induce tolerance to peanuts — an “oral immunotherapy” named Palforzia that children ages 4 to 17 consume daily to keep up the protection.

    The new study, which featured work from dozens of medical professionals in the U.S. and abroad, took samples from 362 toddlers with a peanut allergy. The toddlers were initially tested to see how high a dose of peanut protein they could tolerate. Then they were randomly assigned to use the Viaskin patch or a lookalike placebo patch every day.

    After a year of treatment, they were tested again, and about two-thirds of the toddlers who used the Viaskin patch could safely ingest more peanut protein safely. One in three of the toddlers who were given the dummy patch also could safely ingest more peanuts, but Greenhawt said it’s likely those children had outgrown the allergy.

    Deaths from allergic reactions to any food numbed a few hundred per year, according to the CDC. But each year there are about 200,000 emergency-room visits caused by allergic reactions to food.

    The Associated Press contributed to this report.

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  • FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

    FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN



    CNN
     — 

    Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

    Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

    The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

    Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

    “Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

    The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

    If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

    At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

    “I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

    The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

    Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

    In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

    “This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

    A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

    About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

    Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

    “We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

    Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

    Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

    Murray said the lack of sufficient information from the study poses challenges for approval.

    “It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

    Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

    “I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

    Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

    Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

    “The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

    Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

    “The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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  • Swedish Orphan Biovitrum to acquire CTI BioPharma in a deal valued at $1.7 billion

    Swedish Orphan Biovitrum to acquire CTI BioPharma in a deal valued at $1.7 billion

    Swedish Orphan Biovitrum AB SE:SOBI on Wednesday announced that it has entered into an agreement to acquire U.S.-based CTI BioPharma Corp. CTIC in a deal valued at $1.7 billion. The Stockholm-based drugmaker said it will offer $9.10 for each share of CTI, which focuses on blood-related cancers and rare diseases. The offer represents a premium of 88.8% over CTI’s the Tuesday closing price of $4.82 per share. “CTI represents a perfect fit for Sobi’s haematology franchise today, adding a powerful and highly differentiated new product that will make a significant difference for patients”, said Guido Oelkers, president and…

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  • First microbiome-targeting drug using CRISPR created by scientists

    First microbiome-targeting drug using CRISPR created by scientists

    Newswise — Many people have experienced infections from E. coli, which are primarily seen as inconvenient and unpleasant. For some patients, like those with blood cancer, however, there is a risk that the bacteria will travel into the bloodstream. In those cases, an E. coli infection is too often fatal. The mortality rate is 15-20%.

    The predominant cure for such infections is the use of antibiotics that have detrimental effects on the patient’s microbiome, which play a key part in our physical and emotional well-being, and other side effects. Furthermore, growing problems with antibiotic resistance render such treatments less effective in treating infections.

    An international team of scientists has now engineered the first published CRISPR-based candidate (see fact box) for a drug that targets E. coli directly and leaves the microbiome intact. A new paper in Nature Biotechnology titled ‘Engineered phage with antibacterial CRISPR–Cas selectively reduce E. coli burden in mice’ describes the development of the drug candidate to a stage where it is ready for tests on humans.

    Through extensive use of synthetic biology, the team designed four bacterial viruses that use CRISPR technology to kill the unwanted bacteria precisely.

    “We believe that a narrow spectrum drug with these properties could be very useful to cancer patients, among others, who often get serious infections that are difficult to treat with current antibiotics,” says Morten Otto Alexander Sommer, a professor at DTU Biosustain, Co-founder of SNIPR Biome, and lead author of the paper.

    The work was carried out in collaboration with JAFRAL (Slovenia), JMI Laboratories (US), and Division of Infectuous Diseases at Weill Cornell Medicine (US).

    Engineering phages to target E. coli

    The team, primarily based at SNIPR Biome, screened a library of 162 naturally occurring phages (viruses that kill specific bacteria; see fact box). They found that eight of these phages showed promise in targeting E. coli. They then engineered the phages through gene editing to improve their ability to target E. coli.

    A cocktail of four of these phages, which they named SNIPR001, very effectively targeted bacteria in biofilms and reduced the number of E. coli in a manner that surpassed that of  naturally occurring phages. Further, they showed that the cocktail of phages was tolerated well in the gut of mice and mini pigs while reducing the emergence of E. coli. SNIPR001 is now in clinical development and has been granted a Fast-Track designation (expedited review) by the US Food and Drug Administration.

    FACT BOX: An overview of the SNIPR001 creation process:

    1. Naturally occurring phages are screened against a panel of E. coli strains.
    2. Phages with broad activity against E. coli are tail fibre engineered and/or armed with CRISPR–Cas systems containing sequences specific to E. coli, creating CAPs (Cas-armed phages).
    3. These CAPs are tested for host range, in vivo efficacy, and CMC specifications.

    SNIPR001 comprises four complementary CAPs and is a new precision antibiotic that selectively targets E.coli to prevent bacteremia in haematological cancer patients at risk of neutropenia (low levels of white blood cells).

    Blood cancer patients are first in line

    The reason this new development is exciting for blood cancer patients has to do with side effects stemming from their chemotherapy treatment. It causes the patient’s bone marrow to produce fewer blood cells and inflammation of the intestines. The latter increases the intestines’ permeability allowing bacteria from the gut to travel into the bloodstream. This combination of side effects leaves the patient vulnerable to infections from bacteria like E. coli. In such cases, the

    Today, patients at risk (i.e., with low levels of white blood cells) receive antibiotic treatments ahead of their chemotherapy, but in some cases, E. coli shows very high resistance to commonly used antibiotics. Also, the antibiotics themselves have several side effects that in some cases reduce the effect of the cancer treatments.

    “We need a wider variety of options available to treat these patients, preferably ones where we can specifically target the bacteria responsible to avoid side effects and that do not add to the problem of antibiotic resistance,” says Morten Otto Alexander Sommer.

    In recent years, researchers have been looking back towards using phages to treat infections because of the increase in antibiotic resistance. Before antibiotics were broadly available, phages were widely used and studied in countries that were then part of the Soviet Union. Still, there are few clinical trials, and the results haven’t been convincing, according to the paper.

    “Through emerging technologies like CRISPR, the use of phages in treating infections has become a viable pathway. As our results show, there is potential for enhancing naturally occurring phages through genetic engineering. It is my hope that this approach may also serve as a blueprint for new antimicrobials targeting resistant pathogens,” says Morten Otto Alexander Sommer.

    FACT BOX: CRISPR, phages, and phage therapy

    CRISPR technology is a way for scientists to edit DNA sequences in cells. It’s based on a defence mechanism bacteria naturally use to protect themselves. CRISPR technology uses a molecule called Cas9, which works like a pair of scissors to cut DNA at a specific spot.

    After the cut, the DNA can be fixed, or a new piece can be added. Scientists can use this tool to create genetically modified organisms, find new ways to treat genetic diseases, and learn more about how genes work.

    Phages are tiny viruses that can kill specific bacteria. They’re everywhere on Earth and help regulate bacterial populations and nutrient cycling. They infect and kill bacteria, and when the bacteria die, they release nutrients into the environment.

    Scientists use phages to treat bacterial infections, which is called phage therapy. They identify and isolate phages that can kill a specific bacterial strain and use them to fight infections caused by that strain.

    Phage therapy has some advantages to antibiotics, like targeting specific bacteria without side effects and potentially reducing antibiotic resistance.

    Technical University of Denmark (DTU)

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  • Foreign businesses in China fear they’re being targeted in a ‘campaign’ of government crackdowns. It’s probably not that simple.

    Foreign businesses in China fear they’re being targeted in a ‘campaign’ of government crackdowns. It’s probably not that simple.

    Foreign investors and businesspeople with exposure to China are becoming increasingly unnerved. And for good reason.

    In March, Chinese authorities detained an employee of Japanese drug manufacturer Astellas Pharma JP:4503 ALPMY for alleged espionage violations. The Chinese seem confident in their case. Beijing’s ambassador to Japan said there was ample evidence of wrongdoing, and, despite the uproar, the Astellas employee remains detained.

    That…

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  • Apixaban vs. Warfarin in Patients with an On-X Mechanical Aortic Valve

    Apixaban vs. Warfarin in Patients with an On-X Mechanical Aortic Valve

    Newswise — Although the On-X aortic valve and apixaban have been approved for use by the U.S. Food and Drug Administration (FDA), they had not been approved to be used together. Between May 2020 and September 2022, the PROACT Xa randomized, multicenter, open-label trial compared the direct factor Xa inhibitor apixaban (Eliquis) with warfarin in patients with bileaflet carbon aortic valves.

    A total of 863 patients from 60 sites who were at least 3 months out from aortic valve replacement (AVR) were randomized 1:1 to receive apixaban 5 mg twice daily or warfarin with a target INR of 2–3. Enrolled patients had a median age of 56 years; 24% were female. Among participants, 46% had AVR in the 12 months prior to randomization, 17% had AVR along with an aortic root graft, and 16% were reoperations on the aortic valve. Most patients (93%) received 81 mg of aspirin daily with the assigned anticoagulant.

    The study was discontinued on Sept. 21, 2022, at the recommendation of the PROACT Xa Data and Safety Monitoring Board based on observed higher rate of thromboembolic events (valve thrombosis and thromboembolism) in patients randomized to apixaban than warfarin.

    Lars Svensson, MD, of the Cleveland Clinic, will present the results of this study Saturday, May, 6, at the American Association for Thoracic Surgery (AATS) 103rd Annual Meeting in Los Angeles, detailing the events that led to the discontinuation.

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    Attribution to the American Association for Thoracic Surgery (AATS) 103rd Annual Meeting is requested in all coverage.

     

    ABOUT AATS

    The American Association for Thoracic Surgery (AATS) is an international organization that encourages, promotes, and stimulates the scientific investigation of cardiothoracic surgery. Founded in 1917 by a respected group of the earliest pioneers in the field, its original mission was to “foster the evolution of an interest in surgery of the Thorax.” Today, the AATS is the premier association for cardiothoracic surgeons in the world and works to continually enhance the ability of cardiothoracic surgeons to provide the highest quality of patient care. Its more than 1,500 members have a proven record of distinction within the specialty and have made significant contributions to the care and treatment of cardiothoracic disease. Visit aats.org to learn more.

    American Association for Thoracic Surgery (AATS)

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  • Chegg, Arista, Uber, Pfizer, DuPont, and More Stock Market Movers

    Chegg, Arista, Uber, Pfizer, DuPont, and More Stock Market Movers

    This copy is for your personal, non-commercial use only. To order presentation-ready copies for distribution to your colleagues, clients or customers visit http://www.djreprints.com.

    https://www.barrons.com/articles/stock-market-movers-7c17b0b6

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  • Researchers identify cause of cancer drug-related heart damage

    Researchers identify cause of cancer drug-related heart damage

    Newswise —

    A new study led by researchers from UCL (University College London) has found the likely reason why some cancer treatments can cause damage to the heart. This development brings safer cancer drugs one step closer.

    Modern cancer drugs are effective in treating cancer, but some of them can cause damage to the heart, known as cardiotoxicity. The damage can range from slight changes in the heart’s ability to pump blood to severe heart failure. The exact mechanisms by which these drugs cause damage have not been fully understood so far.

    A new study, supported by the British Heart Foundation, has found certain proteins in the blood that can increase the chances of developing heart diseases, including heart failure. These proteins are also affected by cancer drugs that can cause damage to the heart. The study was published in the journal Science Advances.

    The study found proteins in the blood that are connected to heart diseases and can be affected by cancer drugs, which explains how some cancer treatments damage the heart. By identifying those at risk, better cancer treatments can be developed that avoid affecting these proteins.

    The study has found new possible targets for drugs to treat heart diseases such as heart failure. These drugs could work by stopping proteins that increase the risk of developing heart diseases or by activating proteins that lower the risk.

    To begin their research, the scientists conducted a study called genome-wide association. This involved analyzing the DNA of almost 37,000 individuals who did not have heart disease and were part of the UK Biobank study. Through this analysis, they identified genetic variations that were associated with changes in the ventricles, which are the heart’s pumping chambers.

    Our genes have instructions to make proteins, which are important for the body. By analyzing the DNA of almost 37,000 people without heart disease, researchers found 33 proteins linked to the risk of developing different heart diseases. These proteins are present in the blood and are coded for by genetic variants. Some of these proteins are also targeted by cancer drugs.

    Dr. Floriaan Schmidt, the lead author from UCL Institute of Cardiovascular Science, said that the proteins identified in the study can help in developing new drugs for cancer and heart diseases. The findings can provide a blueprint for drug development, making scientists more confident in designing drugs that can shrink tumors without causing damage to the heart or improve the heart’s pumping action.

    Professor Sir Nilesh Samani from the British Heart Foundation has said that although there have been advancements in cancer treatment, there is a risk of heart damage caused by some cancer drugs.

    Professor Sir Nilesh Samani explained that this study has paved the way for the development of safer and more targeted drugs, reducing the risk of heart problems after cancer treatment. He believes that this research can help to make worries about heart damage after cancer treatment a thing of the past.

    This research was also supported by the UKRI/NIHR Multimorbidity fund Mechanism and Therapeutics Research Collaborative and the Rosetrees Trust.

    University College London

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  • Enhancing survival odds in elderly with head, neck cancer

    Enhancing survival odds in elderly with head, neck cancer

    Newswise — As a result of demographic change, more older people need cancer treatment, doctors must treat them differently than younger people due to their other health problems, frailty, and decreased physical ability. Doctors need to think about how the treatment could affect their quality of life. To treat head and neck cancer, doctors usually remove the tumor with surgery and then use radiation therapy, or they use radiation therapy and chemotherapy together to preserve the affected organ. Using chemotherapy at the same time can be risky for older patients because of its side effects. However, there isn’t much information about the best treatment for older people yet.

    A research project was carried out by twelve university hospitals in Europe and the US to study the effectiveness of different treatments for older people with head and neck cancer. They looked at combining radiotherapy and chemotherapy or using a drug that targets a growth factor receptor called EGFR. The study found that adding chemotherapy to radiotherapy improved survival rates compared to radiotherapy alone. This was especially true for patients aged between 65 and 79 who were in good general health and had fewer other health problems. Professor Nils Nicolay, who led the study, explained that fit older patients with minor health problems should not be denied this effective treatment simply because of their age. However, using the growth factor antibody drug alongside radiotherapy did not improve survival rates compared to radiotherapy alone.

    The researchers examined the medical records of 1,044 older patients with head and neck squamous cell carcinoma, a type of cancer that affects the mouth, throat, or voice box. These patients were treated with radiotherapy, sometimes with the addition of a drug, between 2005 and 2019. The study was led by Leipzig University Hospital, and they are now creating an international registry for older patients diagnosed with head and neck cancer. More than 20 centres from Europe, the US and Australia have shown an interest in taking part. This registry will not only record oncological data but also include other information, such as a comprehensive geriatric assessment, health-related quality of life data, and the frequency of patients regretting their treatment decisions. Dr Alexander Rühle, the lead author and co-leader of the study, said that they will work with other international research groups to further understand which older patients will benefit from combined radiotherapy and chemotherapy. They will also create tools to help doctors make joint therapy decisions based on individual patient data.

    Professor Nils Nicolay and Dr Alexander Rühle began the study while they were working at the University of Freiburg Medical Center and finished it after they moved to Leipzig. Nicolay is currently a Professor of Radiotherapy and Radiooncology at Leipzig University’s Faculty of Medicine, starting from September 1, 2022. This appointment also involves leading the Department of Radiooncology at Leipzig University Hospital.

    Universitat Leipzig

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