A school for developmentally disabled students in Massachusetts has won a controversial appeal to use electric shock therapy on self-harming pupils.
In March of last year the Food and Drug Administration (FDA) banned the use of electric shock devices as treatment for individuals engaging in self-injuring or aggressive behaviors.
The Judge Rotenberg Educational Center in Canton, Massachusetts, which is the only place in the country to use electric shock therapy for this purpose, petitioned the ban with the support of parents and guardians of patients who receive the treatment.
This week a federal appeals court overturned the ban, stating that it was a regulation of the practice of medicine, which is outside the FDA’s area of authority.
According to the court filing, The Judge Rotenberg Educational Center treats patients with the most severe mental disabilities that other facilities could not successfully treat.
It describes common self-injurious behaviors among the center’s patients, including head-banging and self-biting, which have at times been severe enough to cause self-inflicted brain trauma, broken bones, and even blindness.
The center manufactures its own electric shock devices, which work by administering brief shocks through electrodes attached to the skin of patients. If they engage in self-harm a shock is remotely administered to try and discourage it. Approximately 20% of the center’s patients are being treated with them at any given time.
In a statement following the ruling, the school said it was pleased to be able to continue to use the “life-saving treatment of last resort”.
“With the treatment, these residents can continue to participate in enriching experiences, enjoy visits with their families and, most importantly, live in safety and freedom from self-injurious and aggressive behaviors,” it said.
The Judge Rotenberg Educational Center has been highly criticized by disability rights activists and even the United Nations, which has previously said the center’s use of electric shock therapy amounted to “torture”.
The president of Disability Rights International, Laurie Ahern, previously told The Guardian, “The idea of using electric shocks to torture children has been recognized as unconscionable around the world – the US government has got to respond to this and put a stop to it.”
Court documents stated that while the FDA had found little evidence for the device’s long-term effectiveness in stopping self-harming, it did not have the legal authority to ban an otherwise legal device from a particular use.
The Judge Rotenberg Educational Center treats over 300 individuals, 55 of which are approved for electric shock therapy, according to Massachusetts News.
Pfizer announced Thursday that it plans to seek authorization for a booster shot next month. But in a joint statement later the same day, the Food and Drug Administration and Centers for Disease Control and Prevention said Americans don’t need boosters right away.
Pfizer anticipates that a third dose of its existing coronavirus vaccine could be given six to eight months after the first two, the company’s research head, Mikael Dolsten, told Bloomberg.
But research so far indicates that coronavirus vaccine protection lasts for the better part of a year, and likely many months beyond that.
Still, the spread of the Delta variant – the most transmissible version of the virus to date – has raised concerns about the degree to which vaccine protection holds up, and whether it could fade more quickly. Preliminary data from Israel’s health ministry found that Pfizer’s vaccine was 64% protective against coronavirus infections from June to July, when the Delta variant was spreading widely in the country. The vaccine was 94% effective the prior month, before Delta infections surged.
Dolsten told Bloomberg that these findings indicate antibody levels may have faded among vaccinated people in Israel. That could result in more mild breakthrough cases – the term for COVID-19 diagnoses at least two weeks after someone is fully vaccinated.
But many disease experts say that the goal of vaccines has always been to prevent severe disease and death, which the shots still do in the face of Delta. The Israeli data, along with several other studies, show that Pfizer’s vaccine largely prevents hospitalization. Two doses were 93% effective at keeping people in Israel out of the hospital from June to July, and 98% the month prior.
“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” the CDC and FDA wrote. The statement added that “virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.”
Preventing mild cases could still curb the virus’ spread
There are benefits to preventing mild coronavirus cases, of course. Nobody wants to get sick, and scientists still don’t know whether mild breakthrough cases can leave people with long-lasting symptoms the way some natural infections do.
Experts don’t even know for sure yet whether vaccines are significantly less effective in the face of Delta. A recent study found that 95% of blood samples from vaccinated people developed neutralizing antibodies against Delta after two doses of Pfizer’s vaccine – a sign that those people would be protected from a symptomatic infection.
A UK analysis, too, found that Pfizer’s vaccine was 88% effective against symptomatic COVID-19 caused by Delta. And a Canadian study similarly found that Pfizer’s vaccine was 87% effective against symptomatic Delta infections.
Drug companies’ approach: ‘Better safe than sorry’
Insider recently spoke with nine experts about booster shots, and several predicted that follow-up doses wouldn’t be necessary for another one to five years. Others questioned whether the general public would ever need another round of shots.
But for the most part, pharmaceutical companies have adopted a “better safe than sorry” approach.
“I think for next fall, we, as a community, should rather be two months too early boosting than two months too late,” Moderna CEO Stéphane Bancel said at a Goldman Sachs investor conference in June.
Pfizer’s early data does seem to suggest that boosters could offer additional immune protection: A third shot appears to increase neutralizing antibody levels five-to-10-fold compared to the original vaccine.
But US health agencies are looking for a more holistic picture of how vaccine protection holds up over time, based on laboratory, clinical-trial, and real-world data. Studies from pharmaceutical companies are just one part of that, the CDC and FDA said on Thursday.
Ultimately, the decision to roll out boosters will depend on the level of vaccine efficacy that health authorities are willing to accept – a threshold that hasn’t been determined yet. Research might also still reveal that antibody responses only dip in certain groups of people, such as the elderly, people with preexisting health conditions, or those who never caught the disease. So boosters could wind up being recommended for just a limited group.
“We are prepared for booster doses if and when the science demonstrates that they are needed,” the CDC and FDA said.
Janet Woodcock, acting commissioner of the FDA, published a letter Friday asking the federal government’s top inspector to investigate if FDA staff worked inappropriately with biotech company Biogen to approve the new drug.
“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General, in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” she wrote in the open letter.
The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency’s scientific advisors resigned following the decision.
The interactions pre-dated Woodcock, who became interim commissioner in January when the Biden Administration took office. She has been with the FDA for more than two decades and is one of the top contenders to permanently take the role, according to biotech analysts.
After the FDA approved Aduhelm, Biogen set its price at about $56,000 a year. Analysts estimate the US Medicare program could pay anywhere from $6 billion to $29 billion per year for Aduhelm, according to a recent New York Times analysis.
Biogen’s stock, which surged when the FDA approved Aduhelm, declined 3.2% to $357.09 a share on Friday afternoon.
Novavax shares climbed as much as 9% on Monday after the company said a late-stage study of its experimental COVID-19 vaccine showed efficacy of more than 90% in nearly 30,000 people. The results move the company closer to seeking authorization for its use in the US.
The company said it plans on filing for regulatory approval of NVX-CoV2373 with the Food and Drug Administration in the third quarter and upon receiving clearance it would remain on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter. It also foresees hitting manufacturing capacity of 150 million doses per month by the end of the fourth quarter.
Novavax traded 2% higher as of 9:55 a.m. in New York, and has now gained more than 90% year-to-date.
Novavax’s phase 3 study of 29,960 participants in 119 sites in the US and Mexico overall efficacy of 90.4% after observing 77 COVID-19 cases among the participants, with 63 in the placebo group and 14 in the vaccine group. It said the potential vaccine demonstrated 100% protection against moderate and severe disease.
The vaccine is administered in two doses and preliminary safety data from the Prevent-19 study showed the potential product to be generally well-tolerated.
“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus,” said Gregory Glenn, M.D., president of Research and Development at Novavax, in a statement.
The company said further analyses of the trial are ongoing and that data will be submitted to peer-review journals for publication. It also said the placebo-controlled portion of its study of 2,248 adolescents ranging from 12 years to less than 18 years of age continues.
In May, the company’s shares slid to the $121 range after Novavax said it was delaying seeking approval for its COVID-19 vaccine from three regulators, including the Food and Drug Administration, because of manufacturing issues.
A third member of a Food and Drug Administration expert panel has resigned over the approval of a controversial new Alzheimer’s drug.
In a resignation letter obtained by CNBC, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, “was probably the worst drug approval decision in recent US history.”
Kesselheim joins two other former members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, who resigned from their positions earlier this week, as the backlash against the agency’s accelerated approval process continues to mount.
Aduhelm, formerly known as aducanumab, was approved by the FDA on Monday, despite the prestigious advisory committee voting against the approval of the treatment in November. Though the FDA isn’t required to follow the panel’s recommendation, it typically does so.
The drug has been a point of debate in the scientific community for years, because it failed one of its late-stage clinical trials, and another trial failed to produce conclusive evidence that Aduhelm helped patients with memory and cognition issues.
But facing ongoing pressure from Alzheimer’s patients’ friends and family, the FDA decided to approve the drug under accelerated approval, a special mechanism that allows authorization on the condition that Biogen runs a follow-up trial to confirm the drug works. The method is usually used for cancer medications, according to CNBC.
In his resignation letter, Kesselheim said the FDA switched its review to the accelerated pathway “at the last minute” based on a “debatable premise” about the drug’s effectiveness, CNBC reported. He also said it was clear to him that the agency is not “presently capable of adequately integrating the committee’s scientific recommendations into its approval decisions.”
“This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system,” Kesselheim wrote.
The FDA did not immediately respond to Insider’s request for comment.
Dr. David Knopman, a neurologist at the Mayo Clinic whose resignation from the central nervous system panel was first reported by Insider’s Allison DeAngelis, said he was baffled by the FDA’s decision and felt the advisory committee had been “mistreated.”
“The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That’s what their press release said in so many words,” he told Insider. “That seems illogical to me.”
“I don’t want to be a part of that in the future,” Knopman added.
Neurologist Dr. Joel Perlmutter of Washington University in St. Louis also resigned from the panel on Monday.
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Yesterday, the FDA approved Biogen’s aducanumab, the first drug to treat the underlying cause of Alzheimer’s (sticky brain plaques) and potentially slow the disease’s progression in early stage patients. Although far from a cure, aducanumab could mark a new era in treating the leading cause of dementia and the sixth leading cause of death in the US.
Not all doctors are ready to prescribe
Biogen had shelved the drug in early 2019, then surprised the medical community by breaking it back out that October. Last November, an expert panel advised the FDA not to approve aducanumab after a pair of studies showed conflicting results about its effectiveness.
But the agency fast-tracked it, arguing that the benefits of slowing Alzheimer’s outweigh the risks. Since aducanumab’s clinical effectiveness isn’t certain, Biogen still has to conduct post-approval trials, but some health experts worry the FDA made the wrong decision.
Big picture: It’s easier to crack the TikTok algorithm than it is to treat Alzheimer’s. A string of failures led many pharma companies to give up, though some analysts think Biogen’s breakthrough could renew interest, Reuters reports. There’s certainly money to be made: Biogen says the treatment, which will be sold under the name “Aduhelm,” will cost $56,000 a year.
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Dozens of workers at Houston Methodist Hospital have sued their employer over a policy requiring them to get vaccinated against COVID-19.
The lawsuit, filed Friday, includes the names of more than 100 staffers and alleged that the hospital was “forcing its employees to be human ‘guinea pigs’ as a condition for continued employment.”
Houston Methodist made national headlines earlier this year when it announced it would require its 26,000 employees to be fully vaccinated against the coronavirus by June 7.
“Those who are not vaccinated by that date face suspension and eventual termination,” the hospital said in a FAQ page published in April. The hospital’s policy also contained exemptions for workers with sincerely held religious beliefs, and certain medical conditions, including pregnancy.
The lawsuit called the COVID-19 vaccines “experimental,” and noted that none have been granted full approval by the US Food and Drug Administration. Instead, the FDA has granted “emergency use authorization” to the three major vaccines: Pfizer-BioNTech, Moderna, and Johnson & Johnson.
Each of the vaccines have undergone rigorous clinical trials involving tens of thousands of participants. Pfizer and BioNTech have already applied for full approval of their vaccine and Moderna has announced plans to apply soon.
The workers allege the hospital is violating the Nuremberg Code against human experimentation
The lawsuit against Houston Methodist cited the Nuremberg Code of 1947, regarding medical ethics around consent and experimentation, saying workers had a “right to avoid the imposition of human experimentation.”
“Shockingly, [Houston Methodist’s] policy memo fails to recognize, appreciate, or identify that the ‘mandatory immunization’ and ‘vaccination program’ requires the employee to be injected with an experimental vaccine that has not been approved by the FDA.” the lawsuit said.
A Houston Methodist spokesperson told Insider in a statement that 99% of the network’s employees have already been fully vaccinated and that the hospital is “extremely proud of our employees for doing the right thing and protecting our patients from this deadly virus.”
The statement also noted that there’s precedent for a mandatory vaccination policy at the hospital.
“It is unfortunate that the few remaining employees who refuse to get vaccinated and put our patients first are responding in this way,” the statement said. “It is legal for health care institutions to mandate vaccines, as we have done with the flu vaccine since 2009. The COVID-19 vaccines have proven through rigorous trials to be very safe and very effective and are not experimental.”
The US Equal Employment Opportunity Commission on Friday released updated guidance on vaccine mandates, noting that federal laws allow employers to require COVID-19 vaccines for workers who are physically present at the workplace – so long as the employers also include accommodations such as religious and medical exemptions.
The lawsuit against Houston Methodist alleged that the hospital has “arbitrarily denied” some employees’ requests for religious and medical exemptions.
The lawsuit requested that a judge order a temporary injunction to prevent the hospital from taking action against non-compliant employees while the case is litigated.
The firing last month of Justin Zhu from the top job at marketing startup Iterable thrust the issue of workplace drug-use back into the conversation, highlighting an ongoing tension between individual performance-hacking and traditional corporate norms.
According to Zhu, the reason the board cut him loose from the company he co-founded was because he took a “microdose” of the psychedelic drug LSD before a company meeting in 2019, in the hopes of improving his focus.
While Zhu was by no means the first – or the highest-profile – tech industry leader to experiment with psychoactive substances to boost their professional performance, the company said it had a policy barring drug use among employees.
“Like it or not, this is an illegal activity,” said Matthew Johnson, a professor of psychiatry at Johns Hopkins and the associate director of the university’s Center for Psychedelic and Consciousness Research, which was the first research group in the country to receive regulatory approval to study psychedelics with healthy volunteers.
“Microdosing has become such a fad, and particularly talked about in the tech industry, but these are Schedule I drugs,” he said, referring to the US Drug Enforcement Administration’s classification of substances with high risk for abuse.
With microdosing, users take fractional doses of what might ordinarily be considered a recreational substance like LSD, ecstasy, or magic mushrooms, attempting to stay below the hallucinogenic effects the drugs are known for. In many cases, these low doses are repeated at regular intervals to achieve a cumulative effect over time.
As to whether it works, “my jury is still firmly out on that one,” said Jamie Wheal, a researcher and writer on the neurophysiology of human performance, and the founder and executive director of the Flow Genome Project, which consults with high-growth startups and Fortune 500 companies like Google and Cisco.
“The biohacker bro is a relatively new version,” he said. “I first noticed it probably a decade ago with some Google engineers and other places where some folks were beginning to see microdosing as a brain-hack optimization thing.”
This ad-hoc experimentation is an extension of the academic research pioneered in the 1960’s and 70’s by psychologists like James Fadiman that was effectively shunted out of the mainstream in favor of the development of less potent alternatives.
“We could have had the Age of Aquarius – instead, we got Prozac nation,” Wheal said.
“LSD shows you that there’s another side to the coin, and you can’t remember it when it wears off, but you know it. It reinforced my sense of what was important,” Jobs said.
Indeed, research by Johnson and others has shown that heroic doses of psychedelics have been shown to have a host of benefits in clinical trials, but they also effectively incapacitate the user and require the close supervision of a trained professional to guide a person safely through the experience.
In other words, you wouldn’t be able to lead a meeting – or do much of anything for that matter – when on the recreational or higher amounts of psychedelics required to experience the reported therapeutic benefits.
But the current findings indicate those benefits don’t seem to transfer down the scale very well. Although some users claim to see attentional or creative benefits from microdosing, Johnson says the science just doesn’t support the specific claims of heightened creativity and focus.
If anything, Johnson says “tinkering with the serotonin system” could have an ongoing benefit for mood, but that raises other medical concerns for cardiac health.
“If there is something there, I think the the antidepressant effects seem the most credible, and if it works, the most important,” he said. “But psychedelics wouldn’t be the on the top of my list to investigate to enhance focus.”
Indeed, a recent study published in the journal eLife found that microdosing’s reported benefits were largely attributable to the placebo effect. Considering the health, legal, and professional risks of a wrong dose, Johnson suggested revisiting a more familiar cognitive boost: caffeine.
“If you’re not taking it every day, 200 milligrams of caffeine has some real performance and cognitive enhancing effects,” he said.
Every company has its own culture and norms, but Johnson said he would see no contradiction if one of the several psychedelic startups looking to cash in on developing an FDA-approved therapy were to prohibit the sort of self-experimentation that got Zhu into trouble with Iterable’s board.
“We’ve got safeguards in our research, and anything that sends to the FDA pathway, they’re going to have safeguard the safeguards in place,” he said.
When it comes to psychedelics, contrary to the Silicon Valley ethos of “move fast and break things,” experts say it’s better to go slow and follow the rules.
The US regulator who oversaw the approval of the highly-addictive opioid OxyContin got a six-figure gig at the drug’s manufacturer a year later, a new book claims.
Curtis Wright, once a director at the US Food and Drug Administration who oversaw evaluation for pain medication, got a position with a first-year compensation package of $400,000 at Purdue Pharma a year after he led the approval of OxyContin, according to the book “Empire of Pain: The Secret History of the Sackler Dynasty” by Patrick Radden Keefe.
Purdue Pharma’s sale of OxyContin, a formulation of the narcotic oxycodone that was said to slow down the release of the strong painkiller when taken as prescribed, has been associated with the rise of the opioid crisis, according to a trillion-dollar lawsuit filed by nearly all US states.
OxyContin was the “most prescribed brand name narcotic medication” for treating moderate to severe pain by 2001, according to a report by the US Government Accountability Office. Deaths from prescription opioid overdose quadrupled between 1999 to 2019, and the Centers for Disease Control and Prevention recorded 247,000 deaths from prescription opioid overdose over the last two decades.
Keefe’s book explores the lives of the billionaire Sackler family who founded Purdue Pharma and profited off of the sale of OxyContin. Forbes estimates the Sackler family’s net worth at $10.8 billion, as of December 2020.
“This author has refused to correct errors in his past reporting and also blatantly violated journalistic ethics by refusing to meet with representatives for the Sackler family during the reporting of his book,” Daniel S. Connolly, an attorney for the Raymond Sackler family, said in a statement to Insider. “Documents being released in Purdue’s bankruptcy now demonstrate that Sackler family members who served on Purdue’s board of directors acted ethically and lawfully.”
The FDA approved OxyContin in December 1995, originally believing the controlled-release formulation of OxyContin would result in “less abuse potential,” according to the agency’s website. The agency amended the label in 2001, giving OxyContin a “black box” warning it adds on drug with the highest possible abuse potential, per the FDA website.
Keefe wrote Wright had confessed in a sworn deposition that he “might” have written the portion of the FDA package insert that said OxyContin was “believed to reduce the abuse liability of the drug.” Keefe added that Wright would instruct Purdue Pharma to mail him documents at his home office, and conducted reviews of clinical study reports regarding the safety of OxyContin with the help of Purdue Pharma employees.
After Wright left the FDA he spent a year at another company before joining Purdue, according to the book.
“That was sufficient as a cooling-off period, apparently, to allay any concerns that Richard Sackler might have had about the appearance of a conflict of interest,” Keefe wrote.
Purdue Pharma did not have additional comment to add. The FDA declined to comment.
The US Food and Drug Administration is planning to ban menthol cigarettes and all flavors of cigars, saying the measure will help people quit smoking and keep young people from starting.
In a statement Thursday, the agency said the move “will help save lives,” though it did not specify when the ban would begin.
Acting FDA Commissioner Janet Woodcock said the ban would help current smokers to quit the habit, keep young people from starting, and decrease health disparities in communities of color, low-income populations, and LGBTQ+ individuals, all of whom are more likely to use the tobacco products.
“We believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.,” Woodcock said in the release.
Menthol flavoring covers up the harshness of tobacco products and makes them more appealing to young people, the FDA said.
In a briefing following the announcement, Woodcock said the idea to lower nicotine levels in all cigarettes was “still under consideration.”
“It’s on the table but we have not finished deliberations on that matter,” she said on the call.
Woodcock also said President Joe Biden has been fully supportive of the move to ban menthol cigarettes and all flavors of cigars.
Health and Human Services Secretary Xavier Becerra also hailed the move.
“This science-based decision reflects the Biden Administration’s commitment to improve the health of all Americans and to tackle health disparities in our most marginalized communities. Tobacco-related death and disease must become a part of America’s past. These public health measures will save lives,” Becerra said in a statement.
Altria, the parent company of Philip Morris, which makes several kinds of menthol cigarettes, told Insider in a statement: “We share the common goal of moving adult smokers from cigarettes to potentially less harmful alternatives, but prohibition does not work. Criminalizing menthol will lead to serious unintended consequences.”
“Youth smoking rates, including menthol cigarettes, are at historical lows, and science and evidence does not support such a ban. We will review FDA’s announcement and continue to engage in this multi-year process with a focus on the science and evidence,” the statement said.
British American Tobacco did not immediately respond to Insider’s request for comment on the matter. Shares of both tobacco companies fell Thursday, according to Markets Insider data.
Of those numbers, about 230,000 African Americans would quit smoking and another 237,000 African American deaths would be averted, the studies showed.
“For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally.”