Health

By Dietrich Knauth
New Delhi: A Johnson & Johnson subsidiary filed for bankruptcy for a third time on Friday as the healthcare giant seeks to advance an approximately $10 billion proposed settlement that would end tens of thousands of lawsuits alleging that the company’s baby powder and other talc products caused cancer.

J&J faces lawsuits from more than 62,000 claimants who alleged that its baby powder and other talc products were contaminated with asbestos and caused ovarian and other cancers. To stop those lawsuits, J&J subsidiary Red River Talc filed for bankruptcy protection in a federal bankruptcy court in Houston.

The company has denied the allegations and has called its products safe.

Erik Haas, J&J’s worldwide vice president of litigation, said on Friday that the settlement is “fair and equitable to all parties” and that 83% of current talc claimants voted for it.

The settlement proposal has divided attorneys who represent cancer victims. Opponents of the deal said they will quickly ask the court to dismiss the bankruptcy or transfer it to New Jersey, where courts have twice rebuffed J&J’s attempts to end the litigation in a so-called “Texas two-step” bankruptcy.

Andy Birchfield, an attorney opposed to the deal, said that J&J is gaming the bankruptcy system in an attempt to underpay tens of thousands of cancer victims.

“We view this so-called vote as another fraudulent effort by J&J to manipulate the bankruptcy process and minimize the legitimate claims of ovarian cancer victims,” Birchfield said.

Other attorneys spoke in support of the deal, including Allen Smith, a lawyer who had previously represented 11,000 claimants in partnership with Birchfield’s law firm.

Smith said the settlement offer “finally provides my clients reasonable and fair compensation. It’s now time to go to work and get them compensated as soon as possible.”

The “two-step” maneuver employed by J&J involves offloading liabilities onto a newly created subsidiary that then declares Chapter 11, a type of bankruptcy that involves a reorganization of assets and debts under court supervision. The goal is to use the proceeding to force all plaintiffs into one settlement, without requiring J&J itself to file for bankruptcy.

Bankruptcy judges can enforce global settlements that permanently halt all related lawsuits and forbid new ones.

Outside of bankruptcy, any settlement J&J reached with some claimants would still leave holdouts or future plaintiffs with the right to sue – and leave the company exposed to potential multibillion-dollar verdicts that encouraged it to use a two-step in the first place.

To improve its chances in a third bankruptcy effort, J&J asked plaintiffs to vote on its proposed deal ahead of time to ensure that it has enough support for its plan to succeed. J&J needed more than 75% to back the plan for a bankruptcy judge to impose the deal on all plaintiffs.

GYNECOLOGICAL CANCER CLAIMS

J&J’s third attempt at a bankruptcy settlement also differs from its previous efforts in part because it focuses only on ovarian and other gynecological cancer claims, building on J&J’s previous settlements with state attorneys general and people who had sued after developing mesothelioma, a rare form of cancer linked to asbestos exposure.

J&J’s proposed settlement would pay talc claimants about $10 billion over 25 years. The present value of the settlement is roughly $8 billion after J&J recently agreed to kick in an additional $1.1 billion to the settlement fund and pay $650 million in legal fees to attorneys that had previously opposed the settlement offer.

The company has been engaged in a bitter fight with lawyers opposing its third attempt to settle the litigation in bankruptcy.

J&J’s bankruptcy strategy still faces legal hurdles. These include a June U.S. Supreme Court decision involving Purdue Pharma’s bankruptcy, court orders dismissing its previous efforts and proposed federal legislation aimed at preventing financially healthy companies like J&J from benefiting from bankruptcy protection.

(Reporting by Dietrich Knauth and Mike Spector in New York; Additional reporting by Bhanvi Satija in Bengaluru; Editing by Will Dunham, Leigh Jones, Sandra Maler, Shounak Dasgupta and Alexia Garamfalvi)

New York: When researchers discovered enough proof that a medication used to treat bone marrow cancer and Kaposi sarcoma is safe and effective in treating hereditary hemorrhagic telangiectasia (HHT), a rare bleeding disorder that affects 1 in 5,000 people worldwide, they decided to terminate an early clinical trial funded by the National Institutes of Health (NIH).

The New England Journal of Medicine published the trial results, which show that patients with HHT who were administered the medication, pomalidomide, had a significant decrease in the intensity of nosebleeds, required fewer blood transfusions and iron infusions than HHT frequently requires, and had a better quality of life.

“Finding a therapeutic agent that works in a rare disorder is highly uncommon, so this is a real success story,” said Andrei Kindzelski, M.D., Ph.D., of NIH’s National Heart, Lung, and Blood Institute. “Before our trial, there was no reliable therapeutic to treat people with HHT. This discovery will give people who suffer with this disease a positive outlook and better quality of life.”

HHT, also known as Osler-Weber-Rendu Syndrome, is characterized by serious defects in the way the body’s blood vessels form. Instead of growing linearly, they become unusually tangled and twisted. The disordered blood vessels are fragile and prone to leaking, which causes excessive nosebleeds or bleeding along the gastrointestinal tract and other mucosal surfaces. These bleeding episodes, which worsen with age, can result in anemia and reduced quality of life. In severe cases, they can be life-threatening.

Current options to treat HHT involve closing off the malformed blood vessels in the nose and gastrointestinal tract or prescribing off-label medications that temporarily stabilize blood clotting at sites of bleeding vessels, which in turn reduces bleeding. There are currently no Food and Drug Administration-approved medications for long-term management of HHT.

Researchers speculated that pomalidomide worked by blocking the growth of abnormal blood vessels. It may cause the blood vessels to have a more normal structure or thicker walls so they are less fragile. However, the research team, led by Keith McCrae, M.D., professor of molecular medicine at the Cleveland Clinic, says further study will be needed.

Researchers enrolled 144 adults with HHT at 11 U.S. medical centers between Nov. 5, 2019, and June 27, 2023. All participants had moderate to severe nosebleeds requiring iron infusions or blood transfusions. Researchers gave 95 of the participants 4 mg of pomalidomide daily, though the dosage was reduced to 3 mg or 2 mg daily in patients with adverse reactions – mostly constipation, rashes, and lower than average white blood cell counts. The remaining 49 patients received a daily sugar pill designed to look exactly like the pomalidomide pill, in addition to their usual care.

At the start of the trial, researchers used a validated HHT-specific bleeding assessment tool to score each patient’s nosebleed severity. To establish a baseline in other areas, participants self-reported other data throughout the trial, particularly the severity of their nosebleeds and the effect of their HHT symptoms on everyday activities using a special scoring system. The number of units of red blood cells transfused or iron infused was also recorded.

In June 2023, 43 months into the scheduled four-year trial, an interim analysis found pomalidomide had met a prespecified threshold for efficacy, and the trial was closed to further enrollment.

“These findings have broader implications for people with more severe forms of HHT,” said Kindzelski. “In those cases, malformed blood vessels can develop in organs such as the lung, liver, and brain, which can lead to hemorrhagic stroke, bleeding in the lungs, or heart failure. A treatment like this could be lifesaving for such patients.”

Though researchers did not follow participants after the trial ended, McCrae noted that some of his patients from the study have gone four to six months without a recurrence of nosebleeds, even though they had stopped the medication. This suggests that the drug may have promise as a long-term or intermittent treatment. (ANI)

London: Bavarian Nordic said on Thursday its mpox vaccine was approved by the EU’s drug regulator for use in adolescents, bolstering the case for using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa.

Mpox has been declared a global public health emergency by the World Health Organization (WHO), with children and adolescents being particularly vulnerable to the disease.

Bavarian’s JYNNEOS has also been approved by the U.S. Food and Drug Administration (FDA) but only for adults 18 years and older, although it granted an Emergency Use Authorization for its use in adolescents during the mpox outbreak of 2022.

Its approval by the Committee for Medicinal Products for Human Use (CHMP), draws on data submitted by the Danish biotech firm to the European Medicines Agency (EMA) last month.

“We applaud EMA for their expedited review and decision to recommend approval,” said Bavarian CEO Paul Chaplin.

While the WHO says the vaccine can be used “off-label” for people below 18, it has only backed its use in adults.

WHO approval can guide domestic choices, as well as allowing international aid groups to buy and distribute a vaccine.

Democratic Republic of Congo (DRC), worst-hit by the current outbreak, is not planning to vaccinate under-18 year olds in its first wave of immunisations with the Bavarian vaccine.

Another mpox vaccine, made by the Japan’s KM Biologics, can already be given to children, according to the Japanese regulator, although it requires a special kind of needle.

While the EMA decision does not officially guide countries outside Europe, Congo referred to its evaluation of Bavarian’s vaccine in its June emergency use approval of the shot domestically. It also mentioned the FDA approval.

Since this outbreak began in January, there have been nearly 25,100 cases and more than 720 deaths in Africa, where the country reporting the most cases is the DRC, the WHO says. (Reporting by Maggie Fick, editing by Terje Solsvik and Alexander Smith)

Bengaluru: Vanda Pharmaceuticals said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.

Shares of the company fell about 14 per cent to $4.26 in premarket trading.

Vanda was seeking the health regulator’s nod for the drug, tradipitant, to treat symptoms of gastroparesis, a condition characterized by delayed gastric emptying.

The disease is associated with symptoms such as severe nausea, vomiting, and difficulty finishing a normal meal.

The decision comes as another setback for Vanda after the FDA declined to expand the approval of its drug Hetlioz to treat insomnia earlier this year.

In response to FDA’s rejection, the company said the additional studies required by the FDA had a design that was “inconsistent with the advice of key experts in the field”, adding that it will continue to pursue the drug’s approval.

Vanda has repeatedly requested the FDA to convene a panel meeting of experts to review the drug, but the regulator has refused to do so, it said.

Tradipitant, which Vanda licensed from Eli Lilly, failed to meet the main goal of change in the severity of nausea, compared to placebo, at 12 weeks in a late-stage trial.

Vanda still needs to meet the FDA’s request for additional animal studies and long-term safety data, raising the question if the drug can be prescribed for chronic use, Jefferies analyst Andrew Tsai said.

The FDA had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks due to safety concerns.

It is also studying the drug to prevent vomiting during motion sickness and plans to submit a separate application for it later this year. (Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan and Leroy Leo)

New Delhi, Torrent Pharmaceuticals on Friday said the US health regulator has issued a Form 483 with one observation after inspecting its Pithampur-based manufacturing facility. The US Food & Drug Administration (USFDA) conducted a routine GMP inspection of the company’s formulation manufacturing plant at Pithampur, Madhya Pradesh from September 16-20, the drug maker said in a regulatory filing.

“At the end of the inspection, the agency issued a Form FDA 483 with one observation which is procedural in nature,” it added.

The drug maker will respond to the USFDA within the prescribed timeframe and will work in close collaboration with it to address the observation at the earliest possible time, the company said.

As per the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Torrent Pharma shares were trading 2.97 per cent higher at Rs 3,450 apiece on BSE.

People who are pregnant or trying to get pregnant are advised by their health-care providers to stay away from alcohol because of the potential risks to their baby.

But what are these risks as U.S. data suggests a small increase in recent years in the number of people drinking during pregnancy and amid Fetal Alcohol Spectrum Disorder Awareness Month?

According to the CDC, 13.5 per cent of pregnant adults in the U.S. reported current drinking between 2018 and 2020, and 5.2 per cent reported binge drinking. These measures were up by 2 percentage points compared to the 2015-17 period.

In Canada, it is estimated that 10 to 15 per cent of pregnant women use alcohol during pregnancy.

“We know that there is no safe amount of alcohol that should be consumed during pregnancy, and as a result, the impact of alcohol consumption in pregnancy can vary depending on the exposure,” Dr. Naana Jumah, an obstetrician-gynecologist in Thunder Bay, Ont., said in an interview with Global News.

The Society of Obstetricians and Gynecologists of Canada (SOGC) also states that “abstaining from alcohol during pregnancy is the safest option.”

Jumah said it doesn’t matter which trimester a person is in; the no-alcohol guidance applies throughout pregnancy.

“We can’t say that there’s a certain amount that won’t result in having any problems at all. So really, the safest thing is to not consume alcohol in pregnancy, and that will prevent these issues with growth and development for the child.”

For people who are not pregnant, the latest national guidance in Canada that was released last year recommends limiting alcohol consumption to two drinks or less per week.

2:03
Health Matters: COVID-19’s impact on drinking and FASD

One of the known risks of drinking during pregnancy is fetal alcohol spectrum disorder (FASD), which is estimated to impact approximately four per cent of the Canadian population.

FASD is a life-long but preventable disability that affects the brain and body of someone who was exposed to alcohol in their mother’s womb, according to Health Canada.

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Jocelyn Cook, chief scientific officer of SOGC, said FASD is a “constellation of effects” of prenatal alcohol exposure during pregnancy and these impact different people differently.

“When an individual has FASD, they meet criteria for brain effects, neurodevelopmental disabilities and issues with learning and development,” said Cook, who is also the senior research lead for the Canada FASD Research Network (CanFASD).

A diagnosis can sometimes be made as early as when the baby is still in the womb through an ultrasound, Jumah said. But oftentimes this is something that is picked up after a baby is born, she said.

In newborns, there are three facial features strongly associated with prenatal alcohol exposure that doctors look for, Cook said.

These include small eye openings, a thin upper lip and a little dent between the nose and upper lip.

If a baby is not gaining weight as well as they should or rolling over, this could also point to FASD, Jumah said.

0:33
Doctors should make alcohol screening routine, clinical guideline suggests

However, most of the diagnosis is made later in school-aged children.

Neurobehavioral clues that signal FASD include having trouble sitting and paying attention in class, lagging behind academically, difficulty in learning language or reading, as well as issues with social interactions, experts say.

According to CanFASD, this disorder impacts more people in Canada than autism, cerebral palsy and Down syndrome combined.

September marks FASD Awareness Month – and experts say drawing attention to this disorder is key to preventing it and supporting those who suffer from it.

The only way to prevent FASD is to not consume alcohol during pregnancy.

“It’s really a simple intervention, but for some people it can be quite difficult, especially people who have issues with alcohol use and it’s really important to support those individuals to limit their consumption during pregnancy and to help them to make better choices,” Jumah said.

Cook said individuals with FASD have many strengths and they can be very successful, but they do need “some patience and understanding and that comes from awareness and education.”

A Senate bill by an independent senator is calling to develop a national framework on FASD that would set out standards for prevention, diagnosis and support measures for those who are impacted by it.

2:53
New Canadian guidelines suggest limiting alcohol consumption to 2 drinks per week

Besides the potential risks to the baby, alcohol may also have negative health implications for the expectant mother.

Cook said alcohol is “an empty source of nutrition,” so it replaces calories from other healthy options that can fuel both mom and baby.

Physiologically speaking, alcohol is “ubiquitous” as it affects different cells and organs and that can put “chemical stress” on the developing body, she said.

Binge-like alcohol exposure late in pregnancy is also associated with preterm birth and small for gestational age (SGA) babies.

Preterm birth is when the baby is born before 37 weeks of pregnancy.

SGA birth is when the baby is born with a birth weight below the 10th percentile among an infant population of the same sex and gestational age.

&copy 2024 Global News, a division of Corus Entertainment Inc.

Health Canada is warning about a recall of some tattoo inks that may pose a risk of skin infection.

Two types of water-based tattoo pigments by the brand Bloodline were recalled on Wednesday, namely All Purpose Black and Carolina Blue, due to “potential microbial contamination.”

“The recalled products may be contaminated with certain microorganisms that may present a health concern to consumers,” Health Canada said.

The agency said that using contaminated tattoo ink “can pose a risk of skin infection.”

Approximately 120 units of the affected products were sold in Canada until August.

The recalled inks were manufactured in the United States last year by Nevada-based company Sierra Stain LLC and were due to expire on July 1, 2026.

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Health Canada urged consumers to “immediately stop using the recalled product” and dispose of them according to municipal hazardous waste guidelines.

The recall is not limited to Canada, as three water-based tattoo pigments by Bloodline were also recalled in the U.S. last month.

No injuries or incidents have been reported in Canada or the U.S. related to these affected inks, as of Sept. 4.

The FDA noted that Bloodline inks and its company Sierra Stain LLC “are no longer in business and not manufacturing tattoo ink products.”

Some common symptoms of infections associated with tattoo ink include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink was applied, according to Health Canada.

Permanent scarring could also happen in some tattoo infections, the FDA said.

&copy 2024 Global News, a division of Corus Entertainment Inc.