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I thought the pandemic would be over by now. And I’m not alone; there were sophisticated models predicting a dramatic drop in the number of infections by the summer. And while there was understandable worry about the second wave, re-infection, and the coming flu season, there was good reason to believe we’d have the worst of the first wave well behind us.
Now, that all seems like wishful thinking. Here we are, over nine months into the pandemic, with more than 224,000 deaths and more than 70,000 new cases and 800 deaths every day in this country as of late October. There are new hot spots popping up in the US and all over the world. Herd immunity, whether due to infection or vaccination, is still many months or even years away — if it happens at all. Despite these challenges, we do have some good news.
It’s easy to miss some positive developments about how the fight against this pandemic is going, given all the gloomy news. Here’s my perspective on five important ones.
For a virus that was unknown less than a year ago, all of these things happened quickly because of the dedication and cooperation of scientists and public health officials around the world. Imagine how things would be right now if we still did not know the cause of this terrible disease, and had no idea where it was spreading.
Although recommendations to wear masks or other face coverings and to maintain physical distance were first made many months ago, a compelling scientific case to support these recommendations has been published only recently. Studies of the effectiveness of these measures (such as this, this, and this) make it difficult to justify not following these recommendations.
Recognizing that there are formidable challenges and barriers to widespread implementation of these measures, we’ve seen better containment in places where testing and contact tracing are routine (such as New Zealand, South Korea, Singapore). And it seems likely that at some point we’ll have new and better tests with improved accuracy, more widespread availability (including home testing), and faster turnaround times.
This may account for reports of lower rates of death among the sickest people with COVID-19. Increased testing, detection of more asymptomatic cases, and more patients in younger age groups may also be contributing to improving numbers. Still, supportive care (such as “proning” patients), certain medications (such as dexamethasone and the recently approved remdesivir), and more experience with this infection have likely improved outcomes overall. Importantly, we have also identified ineffective treatments (such as hydroxychloroquine — see here, here, and here for studies), so that we can avoid those that are unnecessary and potentially harmful.
Again, this has happened at unprecedented speed. Multiple companies are working on different vaccine candidates. Manufacturing of some leading candidates is already happening, and officials are making plans to distribute millions of vaccine doses in the coming months. While there is no guarantee that any of the vaccines in the pipeline will be successful, these developments increase the chances that we’ll have an effective vaccine sooner than later.
It’s worth emphasizing that there are major concerns about the safety of moving so fast, a lack of transparency about trial data, and the possibility of politics influencing the process, all of which could promote a reluctance to be vaccinated. Still, it seems better that this effort is under way, rather than having to wait years for a potential vaccine to be approved.
Plenty about how our country has responded to the pandemic could — and should — have gone better. But things would be even worse if not for the items on this list.
If we all do our part in the fight against COVID-19, good news should become easier to find. Maybe that’s already happening: some places have been able to contain or nearly eliminate COVID-19, at least temporarily. And toilet paper is back on the store shelves.
Follow me on Twitter @RobShmerling
For more information on COVID-19, see the Harvard Health Coronavirus Resource Center.
The post It’s still true: Not all the news about COVID-19 is bad appeared first on Harvard Health Blog.
In March 2019, facing an estimated 2,600 lawsuits1,2 relating to its role in creating the opioid epidemic, Purdue Pharma — the maker of OxyContin — announced the company was considering filing for bankruptcy protection.
Around that same time, New York expanded its lawsuit against the company to include allegations that company funds had been fraudulently transferred into trusts and offshore accounts owned by members of the Sackler family in an effort to shield assets from litigation.3,4 In all, court documents reveal the Sacklers transferred more than $10 billion of the company's funds into family trusts.5
How this does not fall under the fraudulent conveyance statutes, which is attempting to avoid a debt by moving assets to another person or legal entity, boggles my mind. It appears the only reason they got away with this is they found the loophole of transferring their assets offshore.
The New York complaint also charged Purdue with secretly setting up a new company, Rhodes Pharma, in 2007 while the company was being investigated by federal prosecutors, as a way to protect the Sacklers from the mounting OxyContin crisis and continue their profit scheme.6 Rhodes Pharma makes generic opioids, allowing the Sacklers to benefit from the opioid epidemic both in terms of brand name sales and generic sales.7
Rhodes Pharma and Richard Sackler also hold the patent to a new, faster-dissolving form of buprenorphine, a mild opioid drug used in the treatment of opioid addiction,8 allowing the Sacklers to further profit from the addiction crisis they helped instigate, the economic burden of which is costing the U.S. an estimated $504 billion a year.9
Indeed, according to a lawsuit filed in Massachusetts,10 Purdue Pharma and the Sacklers sought to increase opioid prescriptions while simultaneously developing overdose treatment to boost its profits.
Purdue finally filed for Chapter 11 bankruptcy in September 2019.11 At the end of October 2020, Purdue Pharma agreed to plead guilty to three federal criminal charges relating to its role in the opioid crisis, including violating a federal anti-kickback law, conspiracy to defraud the U.S. government and violating the Food, Drug and Cosmetic Act.12,13
To settle the charges, Purdue is supposed to pay $8.3 billion in fines, forfeiture of past profits and civil liability payments.14 However, the company doesn't have enough cash to cover the payments so, instead, Purdue Pharma will be dissolved, and its assets used to erect a "public benefit company," in other words, a government-owned and controlled drug company.
This new company will reportedly be controlled by a trust that will "balance the trust's interests against those of the American public and public health."15 Future earnings from this public benefit company will be used to pay off the $8.3 billion penalty, which in turn is supposed to be used to combat the opioid crisis.
This is a remarkable development, and one wonders just how functional this setup is going to be. In essence, the government will now be in the business of making and selling opioids, the profits from which will then be used to combat opioid addiction. It seems like a circular and rather illogical setup. According to CNN:16
"Deputy Attorney General Jeffrey Rosen, who announced the settlement, defended the plans for the new company to continue to sell that drug, saying there are legitimate uses for painkillers such as OxyContin."
The Sackler family, meanwhile, have reached a separate settlement in which they will pay $225 million in civil liability for causing false claims about OxyContin to be made to Medicare and other government health care programs.17
While the agreement does not release the Sacklers from potential criminal liability, it seems the family will walk away scot-free. And, considering they already transferred some $10 billion into their family trusts, the $225 million fine is a very small fraction, so they won't end up wanting financially either.
Proving they have no remorse, Sackler family members, in a recent statement, shifted blame for the company's illegal activities on its managers, saying they "relied on management assertions the company acted lawfully."18 This, even though several Sackler family members sat on the company board and were intimately familiar with the company's marketing strategy.
It's unclear whether this DOJ agreement affects or includes the Sacklers' other opioid company, Rhodes Pharmaceuticals. If not, it falls short in that respect too, since they would then be able to continue their opioid business. Between 2009 and 2016, Rhodes' market share of opioid sales actually exceeded that of Purdue itself.19
Aside from Purdue and Rhodes, the Sacklers have also profited from Napp Pharmaceuticals, a Cambridge-based drug company that manufactures — you guessed it — opioids.20 In 2018, seven family members resigned from their directors' posts at Napp following a string of bad publicity relating to alleged tax evasion schemes.
Mortimer Sackler, since deceased, was found to have avoided paying income tax, capital gains tax and inheritance taxes in the U.K. by falsely claiming non-domiciled status. The family was also accused of using a Bermuda-based company to avoid paying corporate taxes for Napp Pharmaceuticals.21
Even though $8.3 billion is a record-breaking settlement, states have filed claims exceeding $2 trillion in Purdue's bankruptcy case, and according to a November 2017 report22 by the White House Council on Economic Advisers, the estimated financial cost of opioid addiction and death in the U.S. was $504 billion in 2015.
In addition to health care costs, criminal justice costs and lost productivity due to addiction or incarceration, this figure also takes into account projected lost earnings and the value of statistical life for people who died prematurely.
In response to the Justice Department's settlement with Purdue Pharma, 25 state attorneys general sent a letter23 to U.S. Attorney General William Barr, in which they object to the settlement and argue against the government getting involved in the opioid business. The letter, dated October 14, 2020, reads in part:24
"We write to ask you to revise a proposed DOJ settlement agreement that reportedly would wrongly mandate that Purdue Pharma's infamous OxyContin business be preserved as a public trust.
A business that killed thousands of Americans should not be associated with government. Instead, the business should be sold to private owners, so the government can enforce the law against it with the same impartiality as for any other company …
The role of government in any OxyContin business should be to enforce the law, just as against any other company. The public deserves assurance that no opioid business is given the special protection of being placed under a public umbrella.
Although it may take time to find a private sector buyer, the public should be confident that public officials are seeking to avoid having special ties to an opioid company, conflicts of interest, or mixed motives in an industry that caused a national crisis."
Connecticut Attorney General William Tong also told CNN:25
"This settlement provides a mere mirage of justice for the victims of Purdue's callous misconduct. The federal government had the power here to put the Sacklers in jail, and they didn't. Instead, they took fines and penalties that Purdue likely will never fully pay.
Every dollar paid here is one dollar less for states like Connecticut trying to maximize money from Purdue and the Sacklers to abate the opioid epidemic. Preserving Purdue's ability to continue selling opioids as a public benefit corporation is simply unacceptable."
In previous articles, I've discussed the role false advertising played in the creation of the opioid crisis.26 To recap, a single paragraph in a 1980 letter to the editor27,28 (not a study) in The New England Journal of Medicine — which stated that narcotic addiction in patients with no history of addiction was very rare — became the basis of a drug marketing campaign that has since led to the death of hundreds of thousands of people.
Purdue Pharma used this letter to the editor as the basis for its claim that opioid addiction affects less than 1% of patients treated with the drugs. In reality, opioids have a very high rate of addiction and have not been proven effective for long-term use.29
Research30 published in 2018 also shows opioids (including morphine, Vicodin, oxycodone and fentanyl) fail to control moderate to severe pain any better than over-the-counter drugs such as acetaminophen, ibuprofen and naproxen.
Various court cases have demonstrated how Purdue systematically misled doctors about OxyContin's addictiveness to drive up sales. The inevitable result of Purdue Pharma's ruthless and immoral marketing campaign has been skyrocketing opioid addiction, which killed 46,802 Americans in 2018 alone.31
Adding insult to injury, when it became clear that people were dying in droves from opioid overdoses, Purdue launched an extensive damage-control operation that included the suggestion that those dying from opioids were already addicts, and that this wouldn't happen to patients who were not already addicted to drugs. The company also sought to cash in on the rising addiction trend twice by getting into the business of creating overdose treatments.
Perhaps most egregious of all has been the reckless prescribing of opioids to young people. Here, dentists have been a major part of the problem, as opioids are frequently prescribed when extracting wisdom teeth.
Insurance claims data from 2016 and 2017 reveal 60% of children between the ages of 1 and 18 with private insurance filled one or more opioid prescriptions after surgical tonsil removal,32,33 and dentists wrote a staggering 18.1 million prescriptions for opioids in 2017.34
As noted by Ronnie Cohen in a March 2019 article35 in The Washington Post, "until recently, dentists seemed to have had no idea they may have been helping to feed an epidemic that resulted in a record 70,237 U.S. drug overdose deaths in 2017."36
But contribute they have, and according to data37 from the University of Michigan, 31.8%, or just over 1 in 3 people who misused opioids during their high school years ended up using heroin by age 35. Data from the National Institute on Drug Abuse also confirms that prescription opioid use is a significant risk factor for subsequent heroin use:38
Regardless of the brand of opioid, it's important to realize they are extremely addictive drugs and not meant for long-term use for nonfatal conditions. Chemically, opioids are similar to heroin, so if you wouldn't consider shooting up heroin for a toothache or backache, seriously reconsider taking an opioid to relieve this type of pain.
The misconception that opioids are harmless pain relievers has killed hundreds of thousands, and destroyed the lives of countless more. In many cases, you'll be able to control pain without using medications.
In my previous article, "Billionaire Opioid Executive Stands to Make Millions More on Patent for Addiction Treatment," I discuss several approaches — including nondrug remedies, dietary changes and bodywork interventions — that can be used separately or in combination to control pain, both acute and chronic.
If you've been on an opioid for more than two months, or if you find yourself taking a higher dosage or taking the drug more often than you initially did, you may already be addicted. Resources where you can find help include the following.
You can also learn more in "How to Wean Off Opioids." I also recommend keeping an eye out for my upcoming article about how low dose naltrexone (LDN), an opioid antagonist, is being used at ultra-low micro doses of 1 microgram to successfully treat opioid addiction.
Since long before the first settlers arrived in North America until the mid-1950s, there were billions of American chestnut trees (Castanea dentata) blanketing the forests from Maine to Florida.1 The deciduous trees could grow more than 100 feet tall and span 9 feet around. In fact, a lone chestnut estimated at 100 years old, was discovered in Maine in 2015, measuring out to a towering 115 feet tall.2
Although majestic to see, the trees also produced edible nuts that could be ground into flour, stewed into puddings or roasted and eaten out of the shell. Early Native Americans used the leaves for medicinal treatments and the wood was the first choice for pioneer log cabins.
Many times, the first 50 feet of the trunk was clean, without branches or knots, making it a builder's dream.3 The trees grow fast and did not rot, so were a good choice for telephone poles and railroad ties.
The New York Times reports that in 1915, one author estimated it was the "single-most-cut tree" in America. As North America was settled, the American chestnut trees were the basis of Appalachian subsistence farming. New York Times reports that in 2005, historian Donald Davis wrote:4
“With the death of the chestnut, an entire world did die, eliminating subsistence practices that had been viable in the Appalachian Mountains for more than four centuries.”
The American chestnut tree also provided food for animals in the forest, including deer, squirrels and bears.5 Unlike oak trees with irregular acorn cycles,6 chestnut trees produce every year. Local farmers would send their hogs and cattle to forage on the chestnuts that had ripened and fallen to the ground in the late fall.7
Near the turn of the 20th century, a fungus that has all but eradicated the mature American chestnut trees was introduced into the U.S. through infected, imported nursery stock from China.8,9 The U.S. Department of Agriculture National Invasive Species Information Center reports the blight was identified for the first time on dying chestnut trees in the Bronx Zoo.
The fungus was named Cryphonectria parasitica and may have arrived as early as 1893.10 It wasn't long afterward that states began reporting dying American chestnut trees.11 Currently, the trees are so rare that discovery of an American chestnut tree in the wild rates a report in the national press.
However, as The American Chestnut Foundation reports, the tree has not gone completely extinct but, rather, is considered “functionally extinct” since the fungus does not affect the root system.12 The American chestnut is highly susceptible to the fungus as is the European chestnut. But the Chinese chestnut tree has some resistance to the infection as it causes only a small canker in the bark.13
The fungus is an ascomycete,14 also known as sac fungi since it has a sac-like structure with four to eight ascospores in the sexual stage. Some of the largest and more commonly known ascomycetes are morel mushrooms and truffles. Other pathogens in the same group include those that cause Dutch elm disease and apple scab.15
The fungus can infect a tree through small injuries to the bark, some as small as those created by insects.16 The fungus then grows under the bark and produces yellow-brown blisters. The infection eventually makes its way around the trunk, cutting off nutrients and water.17
The infection is called a blight, potentially because the branches die quickly. However, the fungus can infect branches, stems and a trunk of any size. It grows rapidly and continues to grow after the tree has died.18
Since the disease does not affect the roots of the tree, the species continues to survive by sending up sprouts through the stump. Inevitably, however, they succumb to the disease. Yet, a USDA Forest Service survey found there may be 60 million of these sprouts growing in the forests of New York state.19
Although the U.S. has lost other plants and animals to extinction, the American chestnut tree appears to have an emotional hook that has driven some to produce a genetic modification in the hope of bringing back large stands of the trees. The New York Times reports this may have started in 1989 when Herb Darling received a call telling him of an American chestnut tree on his property.20
The tree was five stories high and about two feet wide, but also was dying from the fungal disease. Unable to save the tree, he decided to save the seeds. But since the tree wasn't making any, he went about finding a male tree to fertilize the flowers in the spring.
After one failed attempt to fertilize the flowers, the tree produced about 100 nuts. He planted some and sent the others to Charles Maynard and William Powell, tree geneticists from State University of New York College of Environmental Science and Forestry. Thus began the movement to engineer a new American chestnut tree that might be resistant to the blight.
Although the intent may be rooted in the desire to see these trees begin to repopulate the forests, ultimately the results may be disastrous. Initially, Darling looked for support from The American Chestnut Foundation, but the group was wary of genetic engineering.
The first attempt at inserting an antimicrobial compound into the tree genes originated from frogs. After several years, this was abandoned when the team feared the public would have problems with a tree containing amphibian genetics. The next step was to look for a single resistance gene in the Chinese chestnut tree that didn't have trouble with the fungus.
However, as the scientists discovered, the Chinese chestnut tree is a complex organism that uses multiple genes to protect against the blight.21 In 1997, Powell found a scientific paper describing how the insertion of one gene from wheat expressed oxalate oxidase that protected a plant against oxalate-producing fungus, which the chestnut fungus produced.
In 2013, the team announced their success in creating a version of the American chestnut tree that could defend against Cryphonectria parasitica.22 Each successive iteration of the tree has been named after Darling. This one is the Darling 58.
In 2018, Powell spoke at a chapter meeting of The American Chestnut Foundation to talk about his three-decadeslong research project. He warned the attendees that as many of the technical obstacles of producing a transgenic tree resistant to Chestnut blight had been overcome, they now face their biggest challenge: approval to plant a transgenic tree in the wild.
The approval process began with a 3,000-page report to the branch at the USDA responsible for regulating genetically engineered plants. The team also plans to file petitions so the FDA can examine the food safety of the nuts and with the EPA to review the impact the tree may have under Federal pesticide law. The New York Times reported a conversation during the meeting:23
“‘This is more complicated than science!’ someone in the audience said. ‘It is,’ Powell agreed. ‘Science is fun. This is frustrating.’ (‘Being regulated by three different agencies is kind of overkill,’ he told me later. ‘That really stifles innovation in environmental conservation.’)”
It is crucial to remember that releasing genetically engineered organisms into the wild comes with a risk. While researchers may be frustrated by the regulations, without at least the minimal oversight now in effect, the food supply could be sorely impacted.
As it is, there is a significant percentage of the foods you purchase at the grocery store that contain some form of genetically engineered ingredients. The Center for Food Safety lists potential unexpected health risks that may be posed by genetically altering human and animal food. These include:24
However, while the scientists told The New York Times they plan to submit a report to the FDA for judgment about food safety of the chestnuts, Gary Ruskin, co-director of US Right to Know, writes that the FDA has repeatedly made it clear that they do not test whether genetically engineered foods are safe.25
“As Jason Dietz, a policy analyst at FDA explains about genetically engineered food: ‘It’s the manufacturer’s responsibility to insure that the product is safe.’ Or, as FDA spokesperson Theresa Eisenman said, ‘it is the manufacturer’s responsibility to ensure that the [GMO] food products it offers for sale are safe …’”
In a white paper produced by The Campaign to STOP GE Trees, Biofuelwatch and Global Justice Ecology Project, they propose the GE American chestnut tree is a test case to determine if the public will “support biotechnology for forest conservation,” paving the way for more GE trees. They quote geneticist David Suzuki, who says:26
“We’re still at the very beginning of understanding what we’re doing. The rush to apply these [genetic engineering] ideas is absolutely dangerous, because we don’t have a clue what the long-term impacts of our manipulations are going to be.”
As Powell and Maynard push forward with the current support of The American Chestnut Foundation and others interested in populating the forest with genetically engineered trees, The Campaign to STOP GE Trees brings to light many of the questions regarding safety and the future of the environment that have not been addressed.27
“Locating and monitoring the progress of all the GE AC trees and their progeny will be near impossible, especially over a long period of time. There has been some discussion of planting the GE trees slowly, in stages, to improve the potential for monitoring. However, common sense and past experience with genetically engineered crops suggests that monitoring is not feasible.
A release of GE AC trees into natural forests raises some important questions and concerns about potential risks. For example: Will the nuts from GE AC be safe to eat? Will GE AC be safe for soils, waterways, fungi, pollinators, and other animal and plant species in the forest ecosystems where they grow?
Will inhaling pollen from GE chestnut be harmful? Will introducing GE AC present risks to the few remaining native AC trees, or those in hybrid backcross breeding program orchards?
Bees, butterflies, squirrels, birds and humans can carry away tree nuts and pollen, and pollen can also be blown on the wind. Once the engineered trees are released into forests, the GE AC ‘experiment’ will be irreversible. There is no way to prevent the trees from spreading, including across cultural or jurisdictional boundaries.
Before we can evaluate the risks, we must first ask: do we have the tools, information, time and wisdom to conduct adequate risk assessments? Only then can we determine whether the risks are worth taking.”
Anne Petermann wrote in the Scranton Times-Tribune that planting these genetically altered trees opens the door for other risky genetically engineered plants. The fact is a wild tree cannot be replaced by a genetically altered facsimile. Peterman says this is “not restoration, but an uncontrolled experiment with our forests.”28
It is impossible to have the American chestnut trees in numbers that were living in the early 1900s. However, there are other areas of research currently underway to help the species recover. The first is breeding for resistance. Researchers have experimented with crossbreeding Chinese chestnut trees with the American chestnut.29
However, the Chinese chestnut is much shorter and spreads wide instead of going tall and straight. While the process has been slow, The American Chestnut Foundation has had some success in developing a hybrid that is 15/16 American chestnut with selection for resistance and form. They are boosting seed production of a line of trees that appear to be blight-resistant to plant at test sites.
Another line of research has been aimed at lowering the virulence of the fungi. Experiments with infected European chestnut trees show the fungi had developed hypovirulence or had become less toxic to the trees. Researchers found double-stranded RNA within the fungi they later discovered was a virus. The virus caused the fungus to become less virulent.
This treatment has shown some promise in Europe and Michigan. Unfortunately, it has not had the same success along the eastern shores of North America. Researchers have been able to therapeutically treat individual infections, but using this strategy at a population level depends on nature. Petermann believes the genetically altered trees threaten to derail the reintroduction of natural trees.30
“Because the GE chestnuts were developed in a lab in a way that could never occur in nature (forcing genes from unrelated wheat plants into the DNA of trees), there is no way to know how they will respond in nature.
In fact, the researchers who promote these trees have done no long-term risk assessments to determine how these trees will interact in a natural forest over time, or how they will impact human health.”
The petition to deregulate the Darling 58 American Chestnut tree was submitted to the USDA January 17, 2020.31 The Campaign to STOP GE Trees developed several talking point samples to be used when the Animal and Plant Health Inspection Service was accepting comments.32 The deadline for public comments was October 19, 2020. At this time the USDA is reviewing the comments before making their ruling.