Tag: Therapy

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Health

New Remedy for Aggressive Prostate Most cancers Improves Survival

New Therapy for Aggressive Prostate Cancer Improves Survival

An experimental therapy has prolonged life in men with aggressive prostate cancer that has resisted other treatments, offering new hope to patients with advanced illness and opening the door to a promising new form of cancer therapy.

Among men who received the new therapy, there was a nearly 40 percent reduction in deaths over the course of the clinical trial, compared with similar patients who received only standard treatment, researchers reported on Wednesday.

Prostate cancer is the second-leading cause of cancer death among American men, after lung cancer; an estimated 34,130 men will die of prostate cancer this year. One in eight men will be diagnosed with the disease at some point in their lives. The risk increases with age, and the cancer is more common in Black men.

The new treatment relies on a radioactive molecule to target a protein found on the surface of prostate cancer cells. The study, which followed 831 patients with advanced disease in 10 countries for a median period of 20 months, was published in The New England Journal of Medicine.

“This is something new — you’re driving radiation right to the cancer itself,” said Karen Knudsen, president and chief executive of the American Cancer Society. “It’s a much more sophisticated strategy for targeting the tumor.”

“You’re not just destroying the cancer cells — you’re smart-bombing the place that the tumor has found for itself to live.”

There is no definitive cure for metastatic prostate cancer, and there is an urgent need for new therapies, Dr. Knudsen said. Most life-extending treatments rely on suppressing or blocking androgens, the male hormones that fuel prostate cancer.

“This opens the door to precision radiotherapy targeted at other molecules that are on the surface of other cancer cells,” said Dr. Philip Kantoff, chairman of medicine at Memorial Sloan Kettering Cancer Center in New York.

The investigational treatment, called lutetium-177-PSMA-617, combines a compound that targets a protein on the surface of prostate cancer cells, called prostate-specific membrane antigen, or P.S.M.A., with a radioactive particle that attacks the cells.

The P.S.M.A. protein, which can be detected by imaging scans, is almost exclusively on prostate cancer cells, and so the treatment causes less damage to surrounding tissue, said Dr. Oliver Sartor, the trial’s co-principal investigator and medical director of Tulane Cancer Center in New Orleans.

Though the protein is not ubiquitous in prostate tumors, it is found in more than 80 percent of cases. Among patients screened for the trial, 87 percent were P.S.M.A.-positive. Only those men who were positive for the marker were included in the trial.

The study enrolled men with a form of metastatic prostate cancer called castration-resistant prostate cancer. All the patients had disease that progressed despite treatments with chemotherapy and hormonal therapy to suppress and block androgens.

Participants were randomly assigned to receive the experimental treatment, given every six weeks in up to six doses along with standard treatment, or to continue standard care alone, but without chemotherapy or other isotopes.

After a median follow-up period of 20.9 months, patients given the experimental treatment survived for a median of 15.3 months, compared with 11.3 months for those who received only standard care, a reduction of 38 percent.

Their tumors were more likely to shrink, their prostate-specific antigen levels were more likely to fall, and the risk of their cancer progressing was reduced by 60 percent.

Side effects — most commonly fatigue, dry mouth and nausea — were more prevalent among those receiving the compound than among those who did not, but did not appear to significantly affect quality of life, the researchers said.

The study had some limitations. It was a randomized trial, but because of the difficulties of running a double-blinded trial with a radioactive treatment, the trial was open-label: Both patients and physicians knew whether or not they were getting the treatment. That caused some problems early on, as patients who were disappointed by their assignment withdrew from the trial.

The investigational drug worked where other approaches had failed, Dr. Sartor emphasized. “These patients had received essentially all the available therapies,” he said. “This is the first drug targeted to the tumor that actually results in overall survival benefit among incredibly, heavily pretreated patients.”

Dr. Sartor was a co-principal investigator of the trial, along with Dr. Bernd Krause, of Rostock University Medical Center in Germany. The trial was sponsored by Endocyte Inc. and Advanced Accelerator Applications, which are Novartis companies; Dr. Sartor is a paid consultant to the company. The data were analyzed by the sponsor and provided confidentially to the authors.

Officials with Novartis said the company will apply to the Food and Drug Administration for approval of the new treatment later this year.

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Health

Biogen’s Alzheimer’s drug accredited by FDA, first new remedy in almost 20 years

Biogen’s Alzheimer’s drug approved by FDA, first new therapy in nearly two decades

The Food and Drug Administration approved Biogen’s Alzheimer’s drug aducanumab on Monday, making it the first U.S. regulator-approved drug to slow cognitive decline in people with Alzheimer’s and the first new drug for the disease in nearly two decades.

The FDA’s decision was eagerly awaited. The drug, which is marketed under the name Aduhelm, is also expected to generate billions in sales for the company offers new hope to friends and families of patients living with the disease.

Biogen stock was on hold for the announcement. The stocks later resumed trading, rising more than 60% at times before reducing that gain by 40% to $ 400.83.

“We are aware of the attention associated with this approval,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “We know that Aduhelm has drawn the attention of the press, the Alzheimer’s patient community, our elected officials and other interested stakeholders.”

“With treatment for a serious, life-threatening disease in balance, it makes sense that so many people followed the outcome of this review,” added Cavazzoni.

The FDA said it would continue to monitor the drug when it hits the US market. The agency granted approval on the condition that Biogen conduct another clinical study. The Massachusetts-based biotechnology company announced Monday that the list price of aducanumab is $ 56,000 a year; $ 4,312 per infusion.

Biogen CEO Michel Vounatsos told CNBC’s “Power Lunch” later Monday that he thought the price of the drug was “fair,” but also vowed the company would not raise its price for four years.

It reflects “two decades without innovation” and will also allow the company to continue investing in its pipeline of drugs for other diseases, he said.

Alzheimer’s disease is a progressive neurodegenerative disease that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates that more than 6 million Americans live with it. According to the group, this number is expected to rise to almost 13 million by 2050.

“It’s a new day,” said Harry Johns, CEO of the Alzheimer’s Association, in a statement. “This approval gives people with Alzheimer’s more time to live better. For families, it means being able to hold onto loved ones longer. It’s about resuscitating scientists and companies in the fight against this scourge of disease. It’s about hope it. “

To date, there have been no FDA-approved drugs that can slow the mental decline of Alzheimer’s, the sixth leading cause of death in the United States. The agency has approved Alzheimer’s drugs that are aimed at relieving symptoms rather than slowing the disease itself down.

Federal agencies have come under intense pressure from friends and family members of Alzheimer’s patients to speed up aducanumab, but the road to regulatory approval has been controversial since it showed promise in 2016.

In March 2019, Biogen withdrew from development of the drug after analysis by an independent group found it was unlikely to work. The company then shocked investors a few months later by announcing that it would apply for regulatory approval for the drug after all.

Biogen’s shares soared in November after the company received support from FDA officials who said the company had very “compelling” evidence of aducanumab’s effectiveness and “an acceptable safety profile that would make its use in individuals would assist with Alzheimer’s disease “, submitted.

But two days later, a panel of external experts advising the US agency unexpectedly declined to approve the experimental drug, citing inconclusive data. It also criticized the agency’s staff for rating it too positively.

When Biogen filed for approval for the drug in late 2019, its scientists said a new analysis of a larger data set showed that aducanumab “reduces clinical decline in patients with early-stage Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it difficult for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab when it hits the market because the mixed data package helps the company’s use.

Supporters, including advocacy groups and family members of patients desperately looking for a new treatment, have admitted the data is not perfect. However, they claim it could help some patients with Alzheimer’s, a progressive and debilitating disease.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid that scientists expect to play a role in the devastating disease. The company previously estimated that approximately 1.5 million people with early-stage Alzheimer’s in the United States could be candidates for the drug, according to Reuters.

The approval is “interesting because the FDA is essentially confirming that the beta-amyloid hypothesis has been validated,” said Salim Syed, a senior biotech analyst at Mizuho Securities, on Monday, adding that the decision had a major impact will have future clinical trials. Some experts are not convinced that targeting the compound will slow cognitive decline.

The FDA’s decision is expected to reverberate across the biopharmaceutical sector, RBC Capital Markets analyst Brian Abrahams said in a June 1 announcement to customers.

That prognosis was apparently confirmed on Monday by comments from Dr. Vas Narasimhan, CEO of Novartis, confirmed.

“I think it is a reflection of the immense unmet needs of these patient populations that regulators are looking for ways to advance therapeutics, and it certainly opens doors,” Narasimhan said in an interview with CNBC’s The Exchange.

“We have a lot of neurodegenerative research and development and will certainly be putting pens on paper – or at least hammering on our computers – this coming weekend to really think about how we can speed up our own programs.”

The FDA said Monday it found there was “substantial evidence” that the drug is helping patients. “With Aduhelm approved by the FDA, an important and critical new treatment is available to patients with Alzheimer’s disease to combat the disease,” the statement said.

– CNBC’s Kevin Stankiewicz contributed to this report.

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Health

Digital Actuality Remedy Plunges Sufferers Again Into Trauma. Right here Is Why Some Swear by It.

Virtual Reality Therapy Plunges Patients Back Into Trauma. Here Is Why Some Swear by It.

“V.R. is not going to be the solution,” said Jonathan Rogers, a researcher at University College London who has studied rates of anxiety disorders during the pandemic. “It may be part of the solution, but it’s not going to make medications and formal therapies obsolete.”

Virtual reality treatments aren’t necessarily more effective than traditional prolonged exposure therapy, said Dr. Sherrill. But for some patients, V.R. offers convenience and can immerse a patient in scenes that would be hard to replicate in real life. For some people, the treatment can mimic video game systems they’re already familiar with. There’s also a dual awareness in patients who use virtual reality — the images on the screen are almost lifelike, but the headset itself functions as proof that they’re not real.

Months after the Sept. 11 terrorist attacks, Dr. Difede and Dr. Hunter Hoffman, who is the director of the Virtual Reality Research Center at the University of Washington, tested virtual reality treatments in one survivor with acute PTSD, one of the first reported applications of the therapy. Dr. Difede said that the first time the patient put on the headset, she started crying. “I never thought I’d see the World Trade Center again,” she told Dr. Difede. After six hourlong sessions, the patient experienced a 90 percent decrease in PTSD symptoms. Dr. Difede later tested V.R. exposure therapy in Iraq War veterans; 16 out of the first 20 patients no longer met the diagnostic criteria for PTSD after completing treatment.

At the University of Central Florida, a team called U.C.F. Restores has been building trauma therapies using V.R. that allows clinicians to control the level of detail in a simulation, down to the color of a bedspread or a TV that can be clicked on or off, in order to more easily trigger traumatic memories. The program offers free trauma therapy, often using V.R., to Florida residents and focuses on treating PTSD.

Dr. Deborah Beidel, a professor of psychology and executive director of U.C.F. Restores, has broadened the treatments beyond visuals, customizing sounds and even smells to create an augmented reality for patients.

Jonathan Tissue, 35, a former Marine, sought treatment at U.C.F. Restores in early 2020 after talk therapy and medication failed to alleviate his PTSD symptoms, which included flashbacks, anxiety and mood swings. In the end, it was the smells pumped into the room while he described his military service to a clinician that helped unlock his memories. There was the stench of burning tires, diesel fumes, the smell of decaying bodies. He heard the sounds of munitions firing. His chair rumbled, thanks to the center’s simulated vibrations.

“It unlocked certain doors that I could start speaking about,” he said. He talked through his newly uncovered memories with a therapist and a support group, processing the terror that had built in his body for years.

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Health

After a Traumatizing Yr, Black Folks Flip to Remedy

After a Traumatizing Year, Black People Turn to Therapy

Dr. Lewis said that due to news media coverage of the George Floyd case and other high profile police shootings, some blacks experienced some form of “shared trauma” that sometimes led to heightened anxiety or nervousness.

“We are repeatedly inundated with these things,” he said, “and what I think exacerbates and exacerbates these problems is that black Americans in the United States are already having difficulties associated with the race already in their daily lives, too seem to be. “

Racism, economics, and parenting are sometimes topics of discussion for Str8 Mental, a virtual group that provides space for black men across the country to discuss issues that affect their lives, said Brad Edwards, the community organizer for Dear Fathers, a platform the stories about black tells fatherhood. Str8 Mental meets monthly and sessions with a minimum of 30 participants are led by two black male therapists.

“Often times, as blacks, because we haven’t been taught to open up and discuss what we’re up to, we often think that we are only concerned with these things,” said Mr. Edwards, who is Black. “These people really bond. They are purely strangers who come together, are an open, vulnerable and safe space and flow into one another. “

Mr Edwards said Str8 Mental started almost a year ago and emerged from the impact the pandemic had on the black community. “We created this to give the guys a chance to come in and start unpacking,” he said. “I think the conversations about therapy and therapists in the black community have become more and more frequent in recent years.” At least 700 men took part, he said.

A number of large pharmacy chains have recently entered the mental health market. Since January, CVS has added licensed clinical social workers trained in cognitive behavioral therapy in more than a dozen locations, and Walmart and Rite Aid are working to offer similar services.

Additionally, there is a growing chorus of celebrity voices advocating for mental health treatment, including actress Taraji P. Henson, who set up a foundation to help eradicate the stigma surrounding mental health issues in the black community.

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Entertainment

‘Comfortable Face’ Assessment: Various Remedy

‘Happy Face’ Review: Alternative Therapy

“Happy Face” is a defiant, generically unclassifiable film that dares viewers to question its sensitivity. The focus is on a 19 year old named Stan (Robin L’Houmeau) who wraps gauze around his head and joins a support group for people with atypical facial appearances. When the enforcement exercises suggested by group leader Vanessa (Debbie Lynch-White) don’t do much good, Stan takes command and shows his new friends that cognitive behavioral therapy is nowhere near as cathartic as dumping trash in a gaping restaurant patron. Stan’s vision for the cohort is a cross between an intrusive version of the talk cure and a fighting club.

In Montreal, Happy Face stars as Alison Midstokke, who has a rare disease that affects the bones and tissues of the face. She plays a hand-held model with full-body shots in its sights, and ER Ruiz as a police officer whose appearance has changed as a result of a car accident during a chase. They project nuanced, charismatic mixtures of confidence and wounded pride. But is it problematic to make a movie in which they need an implausible cheater to lead them to personal breakthroughs using character building lessons derived from Dungeons & Dragons?

The director Alexandre Franchi, who wrote the script with Joëlle Bourjolly, safeguards himself against this accusation by drawing a tense comparison between Stan and Don Quixote and presenting Stan himself with unsolved challenges. (His mother, played by Noémie Kocher, with whom he is worryingly close – she is shown scrubbing him in the bathtub – dies of multiple brain tumors.)

“Happy Face” dares to be distinctive, and that’s something even if the demeanor – especially Stan’s – isn’t always convincing.

Happy face
Not rated. Running time: 1 hour 40 minutes. Watch virtual cinemas.