(Subjects: Religion/Worship, Lightworkers, Food, Health, Prescription Drugs, Homeopathy, Innate (Body intelligence), New Age movement, Global Unity, ... etc.) - (Text version)

“…… Should I use Doctors and Drugs to Heal Me or Spiritual Methods?

"Dear Kryon, I have heard that you should stay natural and not use the science on the planet for healing. It does not honor God to go to a doctor. After all, don't you say that we can heal with our minds? So why should we ever go to a doctor if we can do it ourselves? Not only that, my doctor isn't enlightened, so he has no idea about my innate or my spiritual body needs. What should I do?"

First, Human Being, why do you wish to put so many things in boxes? You continue to want a yes and no answer for complex situations due to your 3D, linear outlook on almost everything. Learn to think out of the 3D box! Look at the heading of this section [above]. It asks which one should you do. It already assumes you can't do both because they seem dichotomous.

Let's use some spiritual logic: Here is a hypothetical answer, "Don't go to a doctor, for you can heal everything with your mind." So now I will ask: How many of you can do that in this room right now? How many readers can do that with efficiency right now? All of you are old souls, but are you really ready to do that? Do you know how? Do you have really good results with it? Can you rid disease and chemical imbalance with your mind right now?

I'm going to give you a truth, whether you choose to see it or not. You're not ready for that! You are not yet prepared to take on the task of full healing using your spiritual tools. Lemurians could do that, because Pleiadians taught them how! It's one of the promises of God, that there'll come a day when your DNA works that efficiently and you will be able to walk away from drug chemistry and the medical industry forever, for you'll have the creator's energy working at 100 percent, something you saw within the great masters who walked the earth.

This will be possible within the ascended earth that you are looking forward to, dear one. Have you seen the news lately? Look out the window. Is that where you are now? We are telling you that the energy is going in that direction, but you are not there yet.

Let those who feel that they can heal themselves begin the process of learning how. Many will be appreciative of the fact that you have some of the gifts for this now. Let the process begin, but don't think for a moment that you have arrived at a place where every health issue can be healed with your own power. You are students of a grand process that eventually will be yours if you wish to begin the quantum process of talking to your cells. Some will be good at this, and some will just be planting the seeds of it.

Now, I would like to tell you how Spirit works and the potentials of what's going to happen in the next few years. We're going to give the doctors of the planet new inventions and new science. These will be major discoveries about the Human body and of the quantum attributes therein.

Look at what has already happened, for some of this science has already been given to you and you are actually using it. Imagine a science that would allow the heart to be transplanted because the one you have is failing. Of course! It's an operation done many times a month on this planet. That information came from the creator, did you realize that? It didn't drop off the shelf of some dark energy library to be used in evil ways.

So, if you need a new heart, Lightworker, should you go to the doctor or create one with your mind? Until you feel comfortable that you can replace your heart with a new one by yourself, then you might consider using the God-given information that is in the hands of the surgeon. For it will save your life, and create a situation where you stay and continue to send your light to the earth! Do you see what we're saying?

You can also alter that which is medicine [drugs] and begin a process that is spectacular in its design, but not very 3D. I challenge you to begin to use what I would call the homeopathic principle with major drugs. If some of you are taking major drugs in order to alter your chemistry so that you can live better and longer, you might feel you have no choice. "Well, this is keeping me alive," you might say. "I don't yet have the ability to do this with my consciousness, so I take the drugs."

In this new energy, there is something else that you can try if you are in this category. Do the following with safety, intelligence, common sense and logic. Here is the challenge: The principle of homeopathy is that an almost invisible tincture of a substance is ingested and is seen by your innate. Innate "sees" what you are trying to do and then adjusts the body's chemistry in response. Therefore, you might say that you are sending the body a "signal for balance." The actual tincture is not large enough to affect anything chemically - yet it works!

The body [innate] sees what you're trying to do and then cooperates. In a sense, you might say the body is healing itself because you were able to give it instructions through the homeopathic substance of what to do. So, why not do it with a major drug? Start reducing the dosage and start talking to your cells, and see what happens. If you're not successful, then stop the reduction. However, to your own amazement, you may often be successful over time.

You might be able to take the dosage that you're used to and cut it to at least a quarter of what it was. It is the homeopathy principle and it allows you to keep the purpose of the drug, but reduce it to a fraction of a common 3D dosage. You're still taking it internally, but now it's also signaling in addition to working chemically. The signal is sent, the body cooperates, and you reduce the chance of side effects.

You can't put things in boxes of yes or no when it comes to the grand system of Spirit. You can instead use spiritual logic and see the things that God has given you on the planet within the inventions and processes. Have an operation, save your life, and stand and say, "Thank you, God, for this and for my being born where these things are possible." It's a complicated subject, is it not? Each of you is so different! You'll know what to do, dear one. Never stress over that decision, because your innate will tell you what is appropriate for you if you're willing to listen. ….”

Monsanto / GMO - Global Health


(Subjects: Big pharma [the drug companies of America] are going to have to change very soon or collapse. When you have an industry that keeps people sick for money, it cannot survive in the new consciousness., Global Unity, ... etc.) - (Text version)
"Recalibration of Free Choice"– Mar 3, 2012 (Kryon Channelling by Lee Caroll) - (Subjects: (Old) Souls, Midpoint on 21-12-2012, Shift of Human Consciousness, Black & White vs. Color, 1 - Spirituality (Religions) shifting, Lose a Pope “soon”, 2 - Humans will change react to drama, 3 - Civilizations/Population on Earth, 4 - Alternate energy sources (Geothermal, Tidal (Pedal wheels), Wind), 5 – Financials Institutes/concepts will change (Integrity – Ethical) , 6 - News/Media/TV to change, 7 – Big Pharmaceutical company will collapse “soon”, (Keep people sick), (Integrity – Ethical) 8 – Wars will be over on Earth, Global Unity, … etc.) - (Text version)
"The Recalibration of Awareness – Apr 20/21, 2012 (Kryon channeled by Lee Carroll) (Subjects: Old Energy, Recalibration Lectures, God / Creator, Religions/Spiritual systems (Catholic Church, Priests/Nun’s, Worship, John Paul Pope, Women in the Church otherwise church will go, Current Pope won’t do it), Middle East, Jews, Governments will change (Internet, Media, Democracies, Dictators, North Korea, Nations voted at once), Integrity (Businesses, Tobacco Companies, Bankers/ Financial Institutes, Pharmaceutical company to collapse), Illuminati (Started in Greece, Shipping, Financial markets, Stock markets, Pharmaceutical money (fund to build Africa, to develop)), Shift of Human Consciousness, (Old) Souls, Women, Masters to/already come back, Global Unity.... etc.) - (Text version)
"THE BRIDGE OF SWORDS" – Sep 29, 2012 (Kryon channeled by Lee Carroll) (Subjects: ... I'm in Canada and I know it, but I will tell those listening and reading in the American audience the following: Get ready! Because there are some institutions that are yet to fall, ones that don't have integrity and that could never be helped with a bail out. Again, we tell you the biggest one is big pharma, and we told you that before. It's inevitable. If not now, then in a decade. It's inevitable and they will fight to stay alive and they will not be crossing the bridge. For on the other side of the bridge is a new way, not just for medicine but for care. ....) - (Text Version)

Pharmaceutical Fraud / Corruption cases

Health Care

Health Care
Happy birthday to Percy Julian, a pioneer in plant-drug synthesis. His research produced steroids like cortisone. (11 April 2014)
Showing posts with label US. Show all posts
Showing posts with label US. Show all posts

Tuesday, October 6, 2026

US closely monitoring case of lab worker who ‘possibly’ died of plague in Siberia, says Rubio

The Guardian, Mon 5 Oct 2026, Pjotr Sauer and Luke Harding 

Quarantine measures in place in several hospitals in eastern Russia amid uncertainty over death of Darya Shipilova 

Darya Shipilova died on the night of 2 October at a regional hospital in
Shelekhov. Photograph: Social Media

The US secretary of state, Marco Rubio, has said the US is closely monitoring the case of a Russian laboratory worker who died last week after a reported accident at a plague research institute in Siberia.

“We’re watching and monitoring it closely,” Rubio said on Monday before leaving for a trip to Europe. “I
⁠don’t think it’s cause for alarm, but it is cause for focus and a cause just to keep an ⁠eye on it.”

Darya Shipilova, a 28-year-old employee at the anti-plague institute in the city of Irkutsk, became ill at work. She died two days later on the night of 2 October at a regional hospital in the nearby town of Shelekhov.

It remains unclear how she became unwell. Unconfirmed reports in Russian media have suggested Shipilova may have been infected after a mishap at the laboratory. Officials have not publicly confirmed that account.

Local media have reported that the institute has subsequently been locked down, with staff forced to sleep on the floor and on chairs. “They’ve been isolating everybody since Friday – more than 60 people,” one relative, Roman, told the news portal Siberia.Realities.

He said family members were allowed to drop off food at a checkpoint while tests were carried out inside the building. Similar quarantine restrictions have been placed on several other hospitals in and around the city.

Rubio, citing what ‌Russians have released about the death, said it seemed a worker in the lab became ​infected and there was concern the disease may have spread internally.

“There’s very limited travel between the US and Russia, obviously,” he said. “But like anything else, something like that gets out, it just quickly spreads.”

Senior Russian officials have added to public disquiet by sending conflicting messages. Alexey Tsydenov, the head of the Buryatia region, which neighbours Irkutsk, initially wrote that Shipilova had died of plague, before editing his post to say she had “possibly” died of the disease.

Rospotrebnadzor, Russia’s health watchdog, said Shipilova died from “pneumonia of unknown aetiology”. It insisted that tests found no micro-organisms linked to her professional work and described the “sanitary and epidemiological” situation in the area as stable.

Authorities in the nearby city of Baikalsk briefly urged residents to avoid travelling to Shelekhov and surrounding settlements after what they said was unofficial information about a possible plague infection. They later deleted the post from social media.

“There are no obvious changes to daily life on the streets, but people are worried and anxious. Locals are angry that they are not being told anything,” said Elena Trifonova, a journalist with People of Baikal, an exiled Russian media outlet specialising in Siberia.

Despite the lack of a confirmed diagnosis, precautionary measures appear to have been introduced across the region. The US-funded Radio Free Europe/Radio Liberty reported on Monday that several hospitals in Irkutsk had been placed under quarantine.

The outlet confirmed that staff from Shipilova’s workplace, the Irkutsk Anti-plague Research Institute of Siberia and the Far East, had been kept inside the institute since 2 October.

Patients at Irkutsk city clinical hospital No 1 and the Ivano-Matreninskaya children’s hospital said relatives were not being allowed to visit and people inside were not permitted to leave.

On social media, local residents described some of the precautions being introduced.

Ulyana Gavryunina, who went on Monday to one of Irkutsk’s main maternity hospitals for a routine check-up on Monday, said doctors refused to allow her mother in, citing a quarantine imposed over the suspected plague case. Gavryunina said staff member checked her for flu-like symptoms and asked her to fill out a screening form for infections, on which “plague” was listed. She posted a photograph of the form on Instagram.

Elsewhere, a mask requirement was introduced at the Irkutsk aluminium smelter in Shelekhov. The plant’s director, Artyom Fominykh, called it a preventive measure, saying: “Better safe than sorry.” Over the weekend several public events in Irkutsk were cancelled.

Shipolova’s death has prompted intervention from senior federal health officials. Anna Popova, the head of Rospotrebnadzor and the country’s chief sanitary doctor, travelled to Irkutsk on Friday.

She attended an emergency meeting of the regional sanitary and anti-epidemic commission over what officials called a suspected case of a “particularly dangerous infection”.

Igor Kobzev, the governor of the Irkutsk region, urged residents to remain calm after meeting Popova to coordinate the response. “All identified contacts have been placed under medical observation. As of today, none is showing signs of illness and laboratory tests have returned negative results,” he wrote on Telegram.

Kobzev made no reference to reports that a laboratory worker had died.

US politicians have raised concerns about the incident, which follows longstanding and unfounded allegations by the Kremlin that Ukraine has secretly carried out biological weapons research with the support of Washington.

A Republican representative, Don Bacon, a senior member of the House armed services committee, wrote on social media: “I remember hearing from anti-Ukraine voices about their so-called bio labs. It was Russian disinformation ops at their best. But in reality it is Russia with the bio labs.”

Plague remains endemic in parts of Siberia and the Russian far east, where the bacterium persists naturally among wild rodents and their fleas.
But human cases in Russia are rare. Before the suspected Irkutsk case, the country’s last recorded human infection was in 2016, when a 10-year-old boy in Siberia’s Altai Republic contracted plague after helping butcher a marmot.

“This case here seems like a rare lab accident and is unlikely to go much further,” Prof Ian Jones, a professor of virology at the University of Reading, in the UK, said. “Although it is true that pneumonic plague is directly transmissible, the contacts of the primary case are known and can be treated if they show any sign of infection.”

He added: “Plague carries a huge history and is still present in many parts of the world, including Russia, but the living conditions associated with previously spread plague are no longer generally true, antibiotics are available and its potential is therefore limited.”


The victim was working at the anti-plague institute in 
the Siberia city of Irkutsk. AFP via Getty Images.

Related Articles:

Rubio urges Russia to share more information on plague lab worker's death

WHO says it does not have ‘full picture’ from Russia following suspected plague death


Why scientists are concerned about leaks at biolabs


(>13.46 Min - Reference to the Global Coronavirus crisis)

Thursday, March 2, 2023

US drugmaker Eli Lilly says slashing insulin prices

Yahoo – AFP, John BIERS, March 1, 2023 

US pharmaceutical giant Eli Lilly announced Wednesday it would cut the cost of its insulin by 70 percent, with President Joe Biden calling on others to follow suit to tackle soaring drug prices.

 Manufacturers have ratcheted up insulin prices in recent years, hitting millions of Americans living with diabetes -- and drawing sharp political criticism. 

"Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It's flat wrong," said Biden in a statement. He hailed Eli Lilly's price cut as "huge news." 

"It's time for other manufacturers to follow," Biden added. 

Indianapolis-based Lilly announced a series of steps to rein in prices of the life-saving drug, such as capping out-of-pocket costs at $35 per month for people with insurance. 

"Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system," the drugmaker said in a statement. 

While the $35 cap takes effect immediately, other measures will be implemented in the course of 2023. 

A centerpiece is the 70 percent price drop in Humalog, Lilly's most commonly prescribed insulin. 

The incidence of diabetes in the United States in adults has doubled over the last 20 years, afflicting 37.3 million people, according to the US Centers for Disease Control and Prevention. 

Insulin prices have soared in the US, costing over eight times more than in 32 comparable high-income countries, a 2020 Rand Corporation study found. 

But much of the bounty from lofty prices do not go to pharma firms. Instead, they are passed on to health insurers in the form of rebates. As a result, the financial hit from Lilly's decision could fall hardest on insurers. 

The unaffordability of insulin -- particularly to uninsured Americans -- has become a rallying cry for pharmaceutical industry critics. 

Self-rationing insulin 

The cost of a five-pack of Humalog is currently $530.40, although the out-of-pocket price to a user varies depending on one's insurance plan. Average monthly use varies by user, Eli Lilly says on its website. 

Drug pricing in the United States is affected not only by the cost of producing and distributing the pharmaceutical, but also other players such as insurers and pharmacy benefit management companies. 

Critics such as progressive Senator Bernie Sanders have blasted the industry as emblematic of "unacceptable corporate greed." 

"At a time when Eli Lilly made over $7 billion in profits last year, public pressure forced them to reduce the price of insulin by 70%," Sanders said on Twitter after the price-cut announcement. 

"Sanofi and Novo Nordisk must do the same," he added, referring to two other companies which along with Lilly dominate the insulin market. 

Both Sanofi and Novo Nordisk released statements to AFP pointing to programs to help make insulin more affordable, including to uninsured users. But neither company commented directly on whether they would match the Lilly plan. 

A survey by nonprofit T1International showed that one in four respondents living with diabetes reported rationing their insulin because of the financial strain. 

The Inflation Reduction Act, signed into law last year by Biden, capped insulin prices for Medicare recipients at $35 per month, but people with private insurance or without insurance were left out. 

Biden, in his State of the Union Address, called on lawmakers to rein in "Big Pharma" and "finish the job this time" by instituting a national cap on insulin costs. 

In the company's statement, Eli Lilly Chief Executive David Ricks urged rival producers to join the effort. 

"We know that 7 out of 10 Americans don't use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable," said Ricks. 

The company's statement referred uninsured consumers to an insulin affordability website, saying they could "receive Lilly insulins for $35 per month." 

Lily shares were up 1.2 percent at $315.07 in afternoon trading. 

Because most of the price cut will affect rebates from Lilly to insurers rather than revenues to the drugmaker itself, Wednesday's announcement will leave "Lilly less affected than the price cuts would suggest," said Morningstar analyst Damien Conover in a note. 

The cut should not "significantly disrupt" Lilly sales, while insurers "will need to take the hit" from Washington's fixation on runaway prices, he added. 

"Addressing the pricing concerns around insulin should help Lilly maintain pricing power with new innovative drugs," said Conover.

Thursday, July 28, 2022

Israel's Teva reaches potential $4.25 bn US opioid settlement

Yahoo – AFP, 27 July 2022 

Israeli generic drug maker Teva has reached an agreement in principle to pay $4.25 billion over 13 years to settle a series of court cases over its role in the US opioid epidemic. 

If the deal is finalized, Teva would become the latest major company to reach a settlement over the crisis which caused hundreds of thousands of deaths and ravaged communities across the country. 

Teva reached the potential agreement on the terms of a "nationwide opioids settlement" with a working group of state attorneys general and lawyers for Native American tribes and other plaintiffs, the company said in its second-quarter financial results. 

"Teva will pay up to $4.25 billion (including the already settled cases) plus approximately $100 million for the tribes, spread over 13 years," it said. 

The overall figure includes up to $1.2 billion in the generic version of Narcan, which can reverse opioid overdoses. 

The deal will include "no admission of wrongdoing," but "it remains in our best interest to put these cases behind us," the company added. 

Teva has already gone through several opioid-related lawsuits and reached agreements with some states. 

The opioid crisis, which has caused more than 500,000 deaths over 20 years in the United States, has triggered a flurry of lawsuits from victims as well as cities, counties and states impacted by the fallout. 

Drugmaker Johnson & Johnson and three major distributors, McKesson, AmerisourceBergen and Cardinal Health, have agreed to pay out $24.5 billion over several years to end more than 3,000 lawsuits. 

Purdue Pharma, considered by many to be a major driver of the crisis because of its aggressive promotion of its pain killer OxyContin, filed for bankruptcy in September 2019 as it faced a flood of legal action.

Tuesday, May 17, 2022

Dutch doctor says group will keep sending abortion pills to US women

France24 – AFP, 16 May 2022

Rebecca Gomperts, the founder of abortion-rights groups Women on Waves and
Aid Access, is seen in Amsterdam in September 2020 Remko de Waal ANP/AFP/File

Washington (AFP) – Rebecca Gomperts, a 55-year-old Dutch physician, has spent years fighting for women's access to abortion around the world. 

Made famous by her "abortion boat," as recounted in the 2014 documentary "Vessel," she and her Women on Waves group have anchored the ship in international waters off the coasts of Poland, Spain, Mexico and other countries, offering medical abortions to women otherwise unable to obtain them. 

But it is in the United States that interest has been surging in her other organization, Aid Access, which since 2018 has provided abortion pills over the internet. 

Behind the fast-rising demand is what appears -- based on a rare leak from the US Supreme Court -- to be the imminent end of federal protection for abortion rights. Once the court makes its decision official, probably next month, some 20 states are poised to ban or severely restrict abortions. 

"We're already seeing a huge increase in requests," Gomperts told AFP, saying some people were "panicking." 

"It's not only when this takes place; it has already made people aware how vulnerable they are." 

Aid Access, based in Austria, has been working with physicians to fill requests in the 20 US states where abortion pills can be legally prescribed by telemedicine. 

For requests from the other states, Gompert's group has exploited a legal loophole to send the pills from abroad. 

Demand was strong even before word of the high court's intentions leaked out. In a little more than a year (from October 2020 to December 2021), Aid Access says it received more than 45,000 requests from the United States. 

Reasons for the requests vary: the high cost of other abortion services, the cost and difficulty of traveling to distant abortion clinics, or the impossibility of doing so due to job or child-care demands. 

After filling out a questionnaire, women are instructed on how to take the pills at home. The price is adjusted depending on their ability to pay, and the pills are mailed from a pharmacy in India. Aid Access checks in with the women afterward. 

The most vulnerable

The pills are easy to find elsewhere on the internet, usually for a few hundred dollars. But those websites, also based outside the United States, are purely commercial and provide no medical support. 

For Gomperts, who in 2020 was listed as one of the world's 100 most influential people by Time magazine, the fight for abortion rights is a matter of "social justice." 

"The biggest problem is that the women that are not literate, that cannot read and write, that have no access to internet -- the most impoverished group -- they will not be able to find these solutions," she said. 

Many of them would lack the resources to travel to a state where abortion remains legal. 

"These are the women that might be forced to give birth or that will take drastic measures to end their pregnancy."  

These pills -- mifepristone and misoprostol -- can be used in generally very safe
at-home abortions, experts say; this picture comes from the Plan C advocacy
group Elisa WELLS PLAN C/AFP/File

The certain result, Gomperts said, will be an increase in maternal mortality and morbidity. 

A safe method

According to a 2017 survey of several thousand women in the United States, 20 percent of those who had attempted an at-home abortion used the pills, 29 percent used other drugs, 38 percent used plant-based infusions and 20 percent tried physical methods (some used more than one method, so the total exceeds 100 percent). 

During recent demonstrations outside the Supreme Court, women protesters brandished a disturbing object, something that seemed an artifact from a long-ago era: metal clothes-hangers -- a symbol of highly risky abortions performed clandestinely. 

And yet, up to the 10th week of pregnancy, abortion pills are very safe, experts say. 

A demonstrator holds up a clothes hanger marked 'Never Again' during an abortion
rights rally May 3, 2022 outside the US Supreme Court Stefani Reynolds AFP/File

 Today they represent half of all abortions in the United States (in France, by way of comparison, the figure is 70 percent). And their use outside of any medical setting is a "very acceptable" option, according to the World Health Organization (WHO). 

Two drugs are used: first a dose of mifepristone is taken to block the hormones that support a pregnancy; then, 24 to 48 hours later, misoprostol is taken to induce contractions. 

Complications that might require medical help -- an excessive flow of blood, an infection or an allergic reaction -- are rare. 

So, beyond the medical aspect, the real risk to at-home abortions is legal complications. 

The NGO If/When/How has counted 60 cases in which women who allegedly self-managed abortions, or people who assisted them, were arrested, charged or sentenced between 2000 and 2020. 

The group, which says it envisions "a future when all people can self-determine their reproductive lives free from discrimination, coercion or violence," helps find legal representation for such women. 

It fears the trend toward criminalizing abortion will be greatly aggravated if the Supreme Court rules as expected. 

Such a ruling, said Gomperts, "instills fear in people, and especially in health-care providers -- and that is the biggest impact."

Thursday, February 3, 2022

Pharma giants to pay $590 mn to US Native Americans over opioids

Yahoo – AFP, John Biers, with Chris Stein in Washington, 1 February 2022 

Pharmaceutical companies and distributors have agreed to pay $590 million to
settle litigation related to opioid addiction in the Native American population
(AFP/Eric BARADAT) (Eric BARADAT)

A group of pharmaceutical companies and distributors agreed to pay $590 million to settle lawsuits connected to opioid addiction among Native American tribe members, according to a US court filing released Tuesday. 

The agreement is the latest amid a deluge of litigation spawned by the US opioid crisis, which has claimed more than 500,000 lives over the last 20 years and ensnared some of the largest firms in the world of American medicine. 

Pharmaceutical companies McKesson, AmerisourceBergen and Cardinal Health had already struck a separate deal with the Cherokee tribe last September for $75 million. 

According to documents filed in an Ohio federal court Tuesday by a committee of plaintiffs, the companies agreed to pay another $440 million over seven years to other Native American tribes. 

The pharmaceutical group Johnson & Johnson, for its part, agreed to pay $150 million over two years to all the tribes, of which $18 million are destined for the Cherokee. 

Native Americans have "suffered some of the worst consequences of the opioid epidemic of any population in the United States," including the highest per-capita rate of opioid overdoses compared to other racial groups, according to the filing from the Plaintiffs' Tribal Leadership Committee. 

"The burden of paying these increased costs has diverted scarce funds from other needs and has imposed severe financial burdens on the tribal plaintiffs." 

Johnson & Johnson, McKesson and the other two companies in the accord -- AmerisourceBergen and Cardinal Health -- previously agreed to a $26 billion global settlement on opioid cases. 

J&J said Tuesday the $150 million it agreed to pay in the Native American case has been deducted from what it owes in the global settlement. 

"This settlement is not an admission of any liability or wrongdoing and the company will continue to defend against any litigation that the final agreement does not resolve," the company said. 

It was unclear if the other companies would take their portion under the latest agreement from the global settlement. 

'Measure of justice' 

Robins Kaplan, a law firm negotiating on the behalf of the plaintiffs, said the agreement still must be approved by the Native American tribes. 

"This initial settlement for tribes in the national opioid litigation is a crucial first step in delivering some measure of justice to the tribes and reservation communities across the United States that have been ground zero for the opioid epidemic," Tara Sutton, an attorney at the firm, said in a statement. 

Douglas Yankton, chairman of the North Dakota-based Spirit Lake Nation, said the money from the settlement would "help fund crucial, on-reservation, culturally appropriate opioid treatment services." 

Steven Skikos, an attorney representing the tribes, told AFP the group is pursuing claims against other drugmakers. 

"This is hopefully the first two of many other settlements," he said. 

Every tribe recognized by the US government, 574 in all, will be able to participate in the agreement, even if they have not filed lawsuits. 

Many of the lawsuits regarding the opioid crisis have centered on Purdue Pharma, the manufacturer of OxyContin, a highly addictive prescription painkiller blamed for causing a spike in addiction. 

A judge in December overturned the company's bankruptcy plan because it provided some immunity for the owners of the company in exchange for a $4.5 billion payout to victims of the opioid crisis. 

The litigation wave has also swamped pharmacies owned by Walmart, Walgreens and CVS, which a jury found in November bear responsibility for the opioid crisis in two counties in Ohio.

Sunday, January 16, 2022

US judge bans Shkreli for life from pharmaceutical industry

Yahoo – AFP, Fri, January 14, 2022

A federal judge banned former pharmaceutical executive Martin Shkreli from
working in the drug industry (AFP/SPENCER PLATT)


A federal judge banned Martin Shkreli for life from the pharmaceutical industry, ruling Friday that the former drug executive could again harm society by monopolizing important medications.
 

Shkreli, who has been serving a seven-year prison sentence on securities fraud, must also pay $64.6 million in damages to victims, said US District Judge Denise Cote, ruling on a case brought by the Federal Trade Commission (FTC) and six states. 

"Banning an individual from an entire industry and limiting his future capacity to make a living in that field is a serious remedy and must be done with care and only if equity demands," Cote wrote. 

"Shkreli's egregious, deliberate, repetitive, long-running and ultimately dangerous illegal conduct warrants imposition of an injunction of this scope." 

"The risk of recurrency here is real," Cote said. "Shkreli has not expressed remorse or any awareness that his actions violated the law." 

Once dubbed "the most hated man in America," Shkreli, 38, became infamous for suddenly raising the price of the HIV drug Daraprim in 2015 by 5,000 percent -- from $13.50 a pill to $750. 

Shkreli reached exclusive supply agreements for a key ingredient for Daraprim, delaying generic competition for at least 18 months, Cote wrote in the decision, which followed a December 2021 trial. 

Shkreli's company, Turing, was renamed Vyera, and settled with the FTC and other parties shortly before the trial, agreeing to pay $40 million in ill-gotten gains. 

In a 135-page ruling, Cote said Shkreli continued to direct Vyera's policies and choose executives even from prison. 

"Whether he used a smuggled phone or the prison's authorized phones, he stayed in touch with Vyera's management and exercised his power over Vyera as its largest shareholder." 

Shkreli has been in prison since 2017 and is set to be released in October 2023, or one year earlier pending succesful completion of an early release program.

Wednesday, November 17, 2021

Pfizer strikes global licensing deal for Covid pill

Yahoo – AFP, Robin MILLARD, November 16, 2021 

Pfizer's Covid pill showed an 89 percent reduction in hospitalisation and
death in clinical trials. (AFP/Don EMMERT)

US pharmaceutical giant Pfizer on Tuesday announced a deal to make its prospective antiviral Covid-19 pill available more cheaply in the world's least wealthy countries. 

Pfizer will sub-licence production of its promising Paxlovid pill to generic drug manufacturers for supply in 95 low- and middle-income nations covering around 53 percent of the world's population. 

Under the deal struck with the global Medicines Patent Pool (MPP), Pfizer -- which also produces one of the most widely-used Covid vaccines with German lab BioNTech -- will not receive royalties from the generic manufacturers, making the treatment cheaper. 

The agreement is subject to the oral antiviral medication passing ongoing trials and regulatory approval. 

The Pfizer drug is to be taken with the HIV medicine ritonavir. 

Interim data from ongoing trials demonstrated an 89 percent reduction in the risk of Covid-19-related hospitalisation or death compared to a placebo, in non-hospitalised high-risk adults with Covid-19 within three days of symptom onset, said Pfizer. 

Similar results were seen within five days of symptom onset, it added. 

The Geneva-based MPP is a United Nations-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations. 

If approved, the pill could be on the market in "a matter of months", MPP policy chief Esteban Burrone told AFP. 

HIV drug mix

Pfizer will forego royalties on sales in all countries covered by the agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. 

Last month, the WHO maintained the highest level of alert over the spread of the SARS-CoV-2 virus that causes Covid-19. 

Paxlovid, or PF-07321332, is an investigational antiviral therapy designed to block the activity of the SARS-CoV-2-3CL protease -- an enzyme that the coronavirus needs to replicate. 

Taking it together with a low dose of ritonavir helps slow the breakdown of PF-07321332. It therefore remains active in the body for a longer period at a high concentration, to help combat the virus. 

The pill could potentially help patients avoid severe illness, which can lead to hospitalisation and death, Pfizer said. 

"We believe oral antiviral treatments can play a vital role in reducing the severity of Covid-19 infections, decreasing the strain on our healthcare systems and saving lives," said Pfizer chairman and chief executive Albert Bourla. 

While a multitude of vaccines have been rolled out in the pandemic, the hunt for treatments for those who have already caught the disease has not been as fruitful. 

Agreement follows Merck deal 

The MPP was founded by Unitaid, which works on innovations to prevent, diagnose and treat major diseases in poorer countries. 

"During a pandemic, saving time means saving lives. This agreement could help us to reach more people more quickly as soon as the medicine is approved," said Unitaid executive director Philippe Duneton. 

Potential sublicensees have until December 6 to register an expression of interest. 

The announcement comes after the MPP signed a similar voluntary licensing deal with Pfizer's US rivals Merck & Co last month for its investigational oral antiviral medicine molnupiravir. 

Subject to regulatory approval, the deal will help create broad access to molnupiravir in 105 low- and middle-income countries. 

Pills are easier to make than vaccines, do not require a cold chain for delivery and can be self-administered by the patient. 

In terms of relieving health systems by preventing hospitalisations, "it's a game changer", said Burrone. 

He said pricing for the Pfizer pill had not yet been set, but said that "in a competitive environment... the prices tend to come down" to a low level. 

Doctors Without Borders (MSF) meanwhile suggested it might cost around $700 per Pfizer treatment course, in line with molnupiravir. 

The medical charity said it was disheartened by the deal, saying restrictive voluntary licences were no substitute for guaranteed global access to Covid tools to bring the pandemic under control.

Monday, May 31, 2021

Why scientists are concerned about leaks at biolabs

Yahoo – AFP, Issam Ahmed, Lucie Aubourg and Paul Handley, May 30, 2021

This general view shows the Wuhan Institute of Virplogy in Wuhan,
in China's central Hubei province

The theory that Covid-19 might be the result of scientific experiments has thrown a spotlight on the work of the world's most secure biolabs. 

While the evidence linking SARS-CoV-2 to the Wuhan Institute of Virology in China is strictly circumstantial, a number of experts want tougher controls on such facilities over fears that accidental leaks could touch off the next pandemic. 

Here's what you should know. 

59 top facilities 

The Wuhan lab belongs to the most secure class, commonly referred to as biosafety level 4, or BSL4. 

These are built to work safely and securely with the most dangerous bacteria and viruses that can cause serious diseases for which there are no known treatment or vaccines. 

"There are HVAC filtration systems, so that the virus can't escape through exhaust; any waste water that leaves the facility is treated with either chemicals or high temperatures to make sure that there's nothing alive," Gregory Koblentz, director of the Biodefense Graduate Program at George Mason University, told AFP. 

The researchers themselves are highly trained and wear hazmat suits. 

There are 59 such facilities across the world, according to a report Koblentz co-authored that was released this week. 

"There are no binding international standards for safe, secure, and responsible work on pathogens," the report, called Mapping Maximum Biological Containment Labs Globally, said. 

Accidents do happen 

Accidents can happen, sometimes at the top tier facilities, and much more frequently at lower rung labs of which there are thousands. 

Human H1N1 virus -- the same flu that caused the 1918 pandemic -- leaked in 1977 in the Soviet Union and China and spread worldwide. 

In 2001, a mentally disturbed employee at a US biolab mailed out anthrax spores across the country, killing five people. 

Two Chinese researchers exposed to SARS in 2004 spread the disease to others, killing one. 

In 2014, a handful of smallpox vials were uncovered during an Food and Drug Administration office move. 

Lynn Klotz, a senior science fellow at the Center for Arms Control and Non-Proliferation, has been sounding the alarm for many years about the public safety threats posed by such facilities. 

"Human errors constitute over 70 percent of the errors in laboratories," he told AFP, adding that US researchers have to rely on data from Freedom of Information requests to learn of these incidents. 

'Gain of function' controversy 

There is disagreement between the US government, which funded bat coronavirus research in Wuhan, and some independent scientists, about whether this work was controversial "gain of function" (GOF) research. 

GOF research entails modifying pathogens to make them more transmissible, deadlier, or better able to evade treatment and vaccines -- all to learn how to fight them better. 

This field has long been contentious. Debate reached a fever pitch when two research teams in 2011 showed they could make bird flu transmissible between mammals. 

Harvard epidemiologist Marc Lipsitch told AFP he was concerned "that it would create a strain of virus that if it infected a laboratory worker could not just kill that laboratory worker... but also cause a pandemic." 

"The research is not required and does not contribute to the development of drugs or vaccines," added molecular biologist Richard Ebright of Rutgers University, one of the staunchest opponents of this kind of research. 

In 2014 the US government announced a pause in federal funding for such work, which gave way in 2017 to a framework that would consider each application on a case-by-case basis. 

But the process has been criticized as lacking transparency and credibility. 

As late as last year, a nonprofit received funding from the US on research to "predict spillover potential" of bat coronavirus to humans in Wuhan. 

Questioned by Congress this week, Francis Collins and Anthony Fauci of the National Institutes of Health denied this amounted to gain of function research, but Ebright said it clearly does. 

The path ahead 

None of this means that Covid-19 definitely leaked from a lab -- in fact there is no hard scientific evidence in favor of natural origin or lab accident scenario, said Ebright. 

But there are certain lines of circumstantial evidence in favor of the latter. For instance, Wuhan is around 1,000 miles north of bat caves that harbor the ancestor virus, well out of the animals' flight range. 

Scientists from Wuhan were however known to be carrying out routine trips to those caves to take samples. 

Alina Chan, a molecular biologist from the Broad Institute, said there were no signs of risky pathogen research dying down in the wake of the pandemic -- in fact "it's possibly expanded." 

Last year, Chan published research showing that, unlike SARS, SARS-CoV-2 was not evolving fast when it was first detected in humans -- another piece of circumstantial evidence that could point to lab origin. 

Chan considers herself a "fence-sitter" on the competing hypotheses, but does not favor banning risky research, fearing it would then go underground. 

One solution "might just be as simple as moving these research institutes out into extremely remote areas...where you have to quarantine for two weeks before we re-enter in human society," she said.

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(>13.46 Min - Reference to the Global Coronavirus crisis)