Sat Mar 23, 2024 11:33 pm by globalturbo
06/26/23
A Son Died, His Parents Tried to Sue. How U.S. Courts Protect Big Pharma + More
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.
By
The Defender Staff
Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Nicholas England, a healthy 22-year-old from Virginia, shot himself in the head in 2017, less than two weeks after he started taking an allergy medicine that had been linked for years to episodes of depression and suicidal thinking.
His parents soon started exploring a lawsuit against Merck, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. Nicholas had no history of mental health problems, they said.
The Englands were shocked to learn from legal advisers that they had no case. Like countless other potential plaintiffs, they had run into one of Corporate America’s most effective liability shields: the legal doctrine of preemption, the principle that federal law supersedes state law.
These legal dynamics left the England family with no legal remedy at all. A pair of U.S. Supreme Court rulings, in 2011 and 2013, essentially barred lawsuits against generic drugmakers based on state laws that enabled claims over design defects or a failure to warn consumers of potential dangers. The court’s reasoning: Such claims were preempted by federal regulations preventing generic drugmakers, when copying name-brand drugs, from changing the formulation or the warning label.
That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair.
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, [url=https://www.pfizer.com/sites/default/files/plsr-studies/C3991002 Plain Language Study Results Summary %28PLSRS%29 Phase 1 PK Primary Endpoint.pdf]lotiglipron[/url], due to elevated liver enzymes in patients who took the drug once a day in mid-stage clinical studies.
Those elevated enzymes often indicate damage to cells in the liver, but the pharmaceutical giant said no patients experienced liver-related symptoms or side effects.
New York-based Pfizer said it will instead focus on its other oral obesity drug, danuglipron, which is in a fully enrolled phase two clinical trial.
The company expects to finalize plans for the phase three clinical trial program on danuglipron by the end of 2023. Pfizer added that it is also developing a version of danuglipron that patients take once a day instead of twice.
The next big advance in cancer treatment could be a vaccine. After decades of limited success, scientists say research has reached a turning point, with many predicting more vaccines will be out in five years.
These aren’t traditional vaccines that prevent disease, but shots to shrink tumors and stop cancer from coming back. Targets for these experimental treatments include breast and lung cancer, with gains reported this year for deadly skin cancer melanoma and pancreatic cancer. More than ever, scientists understand how cancer hides from the body’s immune system.
Cancer vaccines, like other immunotherapies, boost the immune system to find and kill cancer cells. And some new ones use mRNA, which was developed for cancer but first used for COVID-19 vaccines.
Drugmakers Moderna and Merck are jointly developing a personalized mRNA vaccine for patients with melanoma, with a large study to begin this year. The vaccines are customized to each patient, based on the numerous mutations in their cancer tissue. A vaccine personalized in this way can train the immune system to hunt for cancer’s mutation fingerprint and kill those cells. But such vaccines will be expensive.
The CDC‘s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children.
“Pneumococcal vaccines at the moment are messy, and we’re trying to make them a little bit coordinated with what’s already out there,” ACIP member Sarah Long, MD, of St. Christopher’s Hospital for Children in Philadelphia, explained prior to the voting.
Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and chair of ACIP’s work group on pneumococcal vaccines, expressed concern over the lack of clinical data for the new vaccines: “I think it’s very important to remind everybody that all we have is immunogenicity data,” she said. “We have no effectiveness and no efficacy data on either PCV15 or PCV20.”
ACIP chair Grace Lee, MD, MPH, of Stanford University School of Medicine in California, said the multiple vaccine options were important, given the lack of data available on efficacy, particularly in children.
Novo Nordisk, Eli Lilly and Pfizer have all entered the race for FDA approval of a first-in-class oral weight loss and diabetes drug, and because pills are cheaper to manufacture, these oral weight loss drugs may signal a more affordable (and easier) alternative to drugs — like Ozempic, Wegovy and Mounjaro — that require injections.
The heightened popularity of weight loss medications has caused an increase in investor interest in the weight loss treatment market, which is estimated to reach $100 billion by the end of the decade.
On Sunday, Novo Nordisk presented findings from a new phase three trial that focused on oral semaglutide tablets. The study, published in the Lancet, lasted 68 weeks and followed 667 participants. 85% of the participants who took the semaglutide tablet lost at least 5% of their body weight compared to just 26% of those who took the placebo. On average, participants who took semaglutide saw a loss of about 15% of their body weight, around six times more than the placebo.
The U.S. Department of Agriculture will spend $502 million to ensure its rapid response to any future bird flu cases as the country’s worst-ever outbreak of the virus levels off, the agency said Friday.
Bird flu has killed 58.7 million chickens, turkeys, and other birds across 47 states since January 2022, a record number in the U.S., according to June 7 data from the Centers for Disease Control and Prevention.
The new funding will allow USDA’s Animal and Plant Health Inspection Service (APHIS) to prepare for the possibility of future outbreaks as the virus continues to spread in other countries, USDA said.
The USDA is also testing bird flu vaccines, Reuters reported in April.
THANKS TO: https://childrenshealthdefense.org/defender/bp-son-died-us-courts-protect-big-pharma/?utm_source=luminate&utm_medium=email&utm_campaign=defender&utm_id=20230626
A Son Died, His Parents Tried to Sue. How U.S. Courts Protect Big Pharma + More
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.
By
The Defender Staff
Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
A Son Died, His Parents Tried to Sue. How U.S. Courts Protect Big Pharma
Reuters reported:Nicholas England, a healthy 22-year-old from Virginia, shot himself in the head in 2017, less than two weeks after he started taking an allergy medicine that had been linked for years to episodes of depression and suicidal thinking.
His parents soon started exploring a lawsuit against Merck, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. Nicholas had no history of mental health problems, they said.
The Englands were shocked to learn from legal advisers that they had no case. Like countless other potential plaintiffs, they had run into one of Corporate America’s most effective liability shields: the legal doctrine of preemption, the principle that federal law supersedes state law.
These legal dynamics left the England family with no legal remedy at all. A pair of U.S. Supreme Court rulings, in 2011 and 2013, essentially barred lawsuits against generic drugmakers based on state laws that enabled claims over design defects or a failure to warn consumers of potential dangers. The court’s reasoning: Such claims were preempted by federal regulations preventing generic drugmakers, when copying name-brand drugs, from changing the formulation or the warning label.
That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair.
Pfizer to End Development of Experimental Obesity Pill Due to Elevated Liver Enzymes
CNBC reported:Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, [url=https://www.pfizer.com/sites/default/files/plsr-studies/C3991002 Plain Language Study Results Summary %28PLSRS%29 Phase 1 PK Primary Endpoint.pdf]lotiglipron[/url], due to elevated liver enzymes in patients who took the drug once a day in mid-stage clinical studies.
Those elevated enzymes often indicate damage to cells in the liver, but the pharmaceutical giant said no patients experienced liver-related symptoms or side effects.
New York-based Pfizer said it will instead focus on its other oral obesity drug, danuglipron, which is in a fully enrolled phase two clinical trial.
The company expects to finalize plans for the phase three clinical trial program on danuglipron by the end of 2023. Pfizer added that it is also developing a version of danuglipron that patients take once a day instead of twice.
The Next Big Advance in Cancer Treatment Could Be a Vaccine
Associated Press reported:The next big advance in cancer treatment could be a vaccine. After decades of limited success, scientists say research has reached a turning point, with many predicting more vaccines will be out in five years.
These aren’t traditional vaccines that prevent disease, but shots to shrink tumors and stop cancer from coming back. Targets for these experimental treatments include breast and lung cancer, with gains reported this year for deadly skin cancer melanoma and pancreatic cancer. More than ever, scientists understand how cancer hides from the body’s immune system.
Cancer vaccines, like other immunotherapies, boost the immune system to find and kill cancer cells. And some new ones use mRNA, which was developed for cancer but first used for COVID-19 vaccines.
Drugmakers Moderna and Merck are jointly developing a personalized mRNA vaccine for patients with melanoma, with a large study to begin this year. The vaccines are customized to each patient, based on the numerous mutations in their cancer tissue. A vaccine personalized in this way can train the immune system to hunt for cancer’s mutation fingerprint and kill those cells. But such vaccines will be expensive.
ACIP Endorses 20-Valent Pneumococcal Vaccine for Kids — New High-Risk Conditions Added as Well, Including Chronic Kidney Disease and Asthma
MedPage Today reported:The CDC‘s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children.
“Pneumococcal vaccines at the moment are messy, and we’re trying to make them a little bit coordinated with what’s already out there,” ACIP member Sarah Long, MD, of St. Christopher’s Hospital for Children in Philadelphia, explained prior to the voting.
Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and chair of ACIP’s work group on pneumococcal vaccines, expressed concern over the lack of clinical data for the new vaccines: “I think it’s very important to remind everybody that all we have is immunogenicity data,” she said. “We have no effectiveness and no efficacy data on either PCV15 or PCV20.”
ACIP chair Grace Lee, MD, MPH, of Stanford University School of Medicine in California, said the multiple vaccine options were important, given the lack of data available on efficacy, particularly in children.
Ozempic as a Pill: Drug Makers Race for Cheaper Weight Loss Drugs (Without the Shots)
Forbes reported:Novo Nordisk, Eli Lilly and Pfizer have all entered the race for FDA approval of a first-in-class oral weight loss and diabetes drug, and because pills are cheaper to manufacture, these oral weight loss drugs may signal a more affordable (and easier) alternative to drugs — like Ozempic, Wegovy and Mounjaro — that require injections.
The heightened popularity of weight loss medications has caused an increase in investor interest in the weight loss treatment market, which is estimated to reach $100 billion by the end of the decade.
On Sunday, Novo Nordisk presented findings from a new phase three trial that focused on oral semaglutide tablets. The study, published in the Lancet, lasted 68 weeks and followed 667 participants. 85% of the participants who took the semaglutide tablet lost at least 5% of their body weight compared to just 26% of those who took the placebo. On average, participants who took semaglutide saw a loss of about 15% of their body weight, around six times more than the placebo.
U.S. to Spend $502 Million on Future Bird Flu Response
Reuters reported:The U.S. Department of Agriculture will spend $502 million to ensure its rapid response to any future bird flu cases as the country’s worst-ever outbreak of the virus levels off, the agency said Friday.
Bird flu has killed 58.7 million chickens, turkeys, and other birds across 47 states since January 2022, a record number in the U.S., according to June 7 data from the Centers for Disease Control and Prevention.
The new funding will allow USDA’s Animal and Plant Health Inspection Service (APHIS) to prepare for the possibility of future outbreaks as the virus continues to spread in other countries, USDA said.
The USDA is also testing bird flu vaccines, Reuters reported in April.
THANKS TO: https://childrenshealthdefense.org/defender/bp-son-died-us-courts-protect-big-pharma/?utm_source=luminate&utm_medium=email&utm_campaign=defender&utm_id=20230626
