SUBSCRIBE TO OUR FREE NEWSLETTER
Daily news & progressive opinion—funded by the people, not the corporations—delivered straight to your inbox.
5
#000000
#FFFFFF
5
#000000
#FFFFFF
health and human services
Marijuana Should Be Descheduled—Not Rescheduled
Reclassifying cannabis from Schedule I to a lower classification (like II or III) won’t bridge the widening gap between state and federal marijuana laws.
Sep 08, 2023
Nearly a year ago, the Biden administration asked the Department of Health and Human Services to reconsider how marijuana is scheduled under federal law.
Under the Controlled Substances Act (CSA) of 1970, different drugs are regulated or prohibited according to their placement in five different “schedules.”
The federal government currently puts marijuana in Schedule 1 — the most restrictive level, which it shares with heroin, ecstasy, and other drugs. By definition, substances in this category must possess “no currently accepted medical use” or “accepted safety for use… under medical supervision.”
After a long internal process, the Department of Health and Human Services now recommends removing the drug from Schedule 1. While the explicit details of the recommendation aren’t public, Bloomberg reports that the agency is suggesting moving marijuana to Schedule III.
The HHS recommendation now goes to the Drug Enforcement Administration (DEA), which will conduct its own scientific review. In the past, most recently in 2016, the agency has categorically refused to reschedule the drug. We likely won’t know how the DEA will respond for some time.
In the meantime, some observers have lauded the proposed change as a giant step forward. But my own reaction is more restrained.
That’s because reclassifying cannabis from Schedule I to a lower classification (like II or III) won’t bridge the widening gap between state and federal marijuana laws. Simply put, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as they see fit, free from federal interference.
To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and recreational use of marijuana for adults. All of these state laws are in conflict with federal marijuana laws — and they will remain in conflict even if the drug is rescheduled.
That’s because Schedule III substances — which include ketamine, anabolic steroids, testosterone, and others — are uniformly regulated by the federal government. Legal access to these substances is limited to those with a prescription from a licensed physician and who obtain the product from a licensed pharmacy.
Currently, no states regulate cannabis this way — nor are they likely to reconstruct their existing laws and regulations to do so. That means citizens and state-licensed operators following the law in legal states will still be violating federal law. And the DEA will still have the same authority it has now to crack down.
A far more productive outcome of the current scheduling review would be to deschedule cannabis — to remove it from the Controlled Substances Act altogether and give states greater discretion to establish their own distinct marijuana policies. That would put cannabis in line with how we treat alcohol and tobacco, two far deadlier substances.
There’s recent precedent for this. In 2018, Congress completely removed hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them, from the federal scheduling system.
By contrast, rescheduling fails to provide any federal legal recognition for either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.
Descheduling cannabis would remove federal intrusion from state marijuana programs and respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”
Keep ReadingShow Less
Biden Admin Scientific Integrity Policy Falls Short, Warn Watchdogs
"Nothing about this proposed policy would prevent a return to the reign of 'alternative facts' should Trump be reelected," said one critic.
Sep 05, 2023
A coalition of public health and science advocacy groups on Tuesday called on the Biden administration to strengthen its proposed scientific integrity policy, warning that the proposal does little to solve the problem of the political interference that was rampant in the federal government under former Republican President Donald Trump.
Shortly after taking office, President Joe Biden signed an executive order pledging to "protect scientists from political interference and ensure they can think, research, and speak freely to provide valuable information and insights to the American people," followed by a requirement for federal agencies to review how such interference can be avoided through policy changes.
More than two years later, the White House Office of Science and Data Policy joined the U.S. Department of Health and Human Services (HHS) in releasing a draft policy which, if finalized, would cover all scientists working within the department and could serve as a template for other federal agencies.
But without provisions for independent investigations into alleged misconduct, legal protections for scientists doing certain types of work, and with "few safeguards against scientific work being altered or suppressed," the coalition said the draft "leaves a lot to be desired."
"Scientific integrity problems at HHS have ranged from unwarranted age restrictions on emergency contraception during the Obama administration to halting important research and interfering with Covid-19 guidance during the Trump administration."
Groups including Public Employees for Environmental Responsibility (PEER), the Government Accountability Project, and the Center for Reproductive Rights wrote to the administration to warn that both Democratic and Republican administrations have stood in the way of scientific integrity, calling for vigilance from the Biden White House.
"Scientific integrity problems at HHS have ranged from unwarranted age restrictions on emergency contraception during the Obama administration to halting important research and interfering with Covid-19 guidance during the Trump administration," wrote the groups in their public comments on the policy. "HHS should design its scientific integrity policy to provide protections against such meddling and effective avenues for correction when interference occurs. HHS should also consider the possibility of individuals acting in bad faith using the policy to harass scientists who are doing their jobs, and HHS should erect barriers to such bad-faith attempts."
The groups listed a number of areas in which they believe the new draft policy is lacking, including:
- Protections and accountability for grantees;
- Specifics that delineate scientists' ability to communicate with the media and public about their areas of expertise, without leaving scientists vulnerable to bad-faith attacks;
- Specific protections from retaliation for those engaged in certain scientific activities; and
- Penalties sufficient to deter wrongdoing and hold accountable all violators of scientific integrity, including political appointees.
PEER pointed out that the lack of specific guidance for grantees is a "major gap" in the policy, as much of the scientific work at agencies such as the National Institutes of Health is completed by scientists who receive grants.
The group's comments notes that the right-wing Trump administration canceled teen pregnancy prevention grants and terminated federally funded research using fetal tissue, yet the policy draft does not include "specific protections against early termination of both research and service grants for political reasons."
The policy's "'Protecting Scientific Processes' section could include a prohibition against terminating intramural or extramural research funding for reasons other than breach of contract, abusive behavior, or gross mismanagement," the groups said.
"Nothing about this proposed policy would prevent a return to the reign of 'alternative facts' should Trump be reelected," said Pacific PEER director Jeff Ruch. "Under this proposed policy, every aspect of enforcing scientific integrity principles would remain a captive of the political process inside the agencies."
The policy also includes "the extremely broad statement that HHS scientists 'shall refrain from making or publishing statements that could be construed as being judgments of, or recommendations on, HHS or any other federal government policy,'" reads the letter. "A bad-faith actor seeking to harass a scientist whose work they find distasteful could claim to have 'construed' virtually any statement as a judgment of government policy."
"For instance," the groups added, "a scientist who makes a factual statement about the effect of a policy—for instance, explaining how a Trump administration directive to stop procuring fetal tissue halted work on an HIV study—could be accused of criticizing that policy decision. We recommend that HHS remove this text from its scientific integrity policy to avoid creating a weapon for bad-faith actors."
The watchdogs applauded the administration for taking steps to protect government scientists from retaliation, "rather than relying on existing whistleblower protections alone."
But the policy, they said, should include language assuring scientists that they can work "free from reprisal or concern for reprisal" and should "specifically provide protections against blocklisting/blacklisting and retaliatory investigations and offer an affirmative defense to whistleblowers who are subjected to civil or criminal lawsuits."
When Biden announced an overhaul of scientific integrity policies to protect scientists in 2021, groups including PEER said the move was a "welcome change from the Trump administration."
On Tuesday, however, Ruch warned that "little about this proposed policy would restore public faith in the credibility of government science."
Keep ReadingShow Less
Sanders to Biden: Don't Let Big Pharma Bankrupt Medicare With 'Unconscionable' Price of Alzheimer's Drug
"We must substantially lower the price that Medicare pays for prescription drugs like Leqembi," said the Vermont Independent, "and HHS has the power to do just that."
Jun 07, 2023
U.S. Sen. Bernie Sanders on Wednesday urged the Biden administration to use the "full extent" of its executive authority to lower the "outrageously high" price of a new Alzheimer's treatment being reviewed by federal regulators.
"Alzheimer's is a horrible disease," Sanders (I-Vt.), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, wrote in a
letter to Xavier Becerra, secretary of the U.S. Department of Health and Human Services (HHS). "We must do everything possible to find a cure for the millions of people who suffer from it. But we cannot allow pharmaceutical companies to bankrupt Medicare and our federal government in the process."
At issue is Leqembi, a drug developed by Eisai, a Japanese pharmaceutical corporation, and Biogen, a U.S. company that previously sought to charge $56,000 for an annual supply of a different Alzheimer's treatment called Aduhelm. Following a pressure campaign led by Sanders and other drug affordability advocates, Biogen reduced the price of Aduhelm—whose efficacy and safety have been questioned by doctors—to $28,200 per year.
"A prescription drug is not effective if a patient who needs that drug cannot afford to take it."
"Despite concerns among the scientific community about the clinical benefit of Leqembi, its manufacturers... plan to charge $26,500 per year for this drug even though the Institute for Clinical and Economic Review, an independent non-profit organization, has estimated that this drug should be sold for as little as $8,900 per year based on its effectiveness," Sanders wrote.
"If just 10% of the 6.7 million older adults with Alzheimer's disease take Leqembi, the Kaiser Family Foundation has estimated that it would cost $17.8 billion—or nearly half of what Medicare Part B spent on all drugs in 2021," noted the Vermont Independent. "And this is just for one drug. As you know, many of the new drugs coming onto the market are even more expensive. This is not sustainable."
Moreover, "the introduction of Leqembi at this unconscionable price would be grossly unfair to seniors suffering from Alzheimer's disease who simply could not afford to pay the 20% co-payment of more than $5,000 a year for this drug," the progressive lawmaker continued. "With a median income of about $30,000 a year for seniors on Medicare the purchase of this one drug would amount to over one-sixth of their limited income."
"People with Alzheimer's disease deserve a drug that is safe, effective, and affordable," he added. "A prescription drug is not effective if a patient who needs that drug cannot afford to take it."
\u201cAlzheimer\u2019s is a horrible disease and we must find a cure. But we cannot allow pharmaceutical companies to bankrupt Medicare in the process. We must substantially lower the price that Medicare pays for prescription drugs like Leqembi, and HHS has the power to do just that.\u201d— Bernie Sanders (@Bernie Sanders) 1686152167
Sanders pointed out that the U.S. Food and Drug Administration (FDA) plans to convene an advisory meeting on Leqembi this week.
"As it considers whether to grant full approval of this drug, FDA has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency's review" of Aduhelm, wrote Sanders, alluding to evidence that the pharmaceutical firm and those tasked with regulating it collaborated before the medicine received a green light.
If the FDA approves Leqembi, HHS "must protect patients and substantially reduce the price," Sanders stressed.
The senator went on the remind Becerra—who routinely expressed support for invoking executive authority to rein in soaring drug prices before he joined the White House—of the powers at his disposal:
Under current law, Medicare has the responsibility to determine whether Leqembi is "reasonable and necessary" for the treatment of Alzheimer's. In my view, charging an outrageously high price for this drug is not reasonable. It will prevent seniors who need this drug from receiving treatment. It will undermine the finances of Medicare. And it will increase the premiums of over 60 million seniors who receive Medicare whether they need to take this drug or not.
If Biogen and Eisai refuse to lower the price of this drug, HHS has the authority (under 28 U.S.C. Section 1498) to break the patent monopoly on Leqembi. Further, HHS can direct the Center for Medicare and Medicaid Innovation to launch a new demonstration project that would limit payment for Leqembi to reflect the drug's actual benefit.
Sanders told Becerra that he and other HELP committee members "look forward to discussing this important issue with you as soon as possible." The panel "would like to know how Biogen and Eisai came up with a cost of $26,500 and what the cost of this drug will mean to the finances of Medicare," Sanders wrote. It "would also like your estimate as to how much Medicare premiums will go up for all seniors if Biogen and Eisai are allowed to charge $26,500 for Leqembi, as well as how many seniors who need this drug would not be able to afford to pay a 20% co-payment for it."
Sanders' letter comes one day after the pharmaceutical giant Merck sued the Biden administration over an Inflation Reduction Act provision that empowers Medicare to directly negotiate the prices of a small number of ultra-expensive prescription medicines with drugmakers.
It also comes less than a month after Sanders condemned Big Pharma CEOs for years of deadly price gouging and reiterated the need to make all prescription drugs affordable at a HELP committee hearing.
"I know that our guests from the drug companies will tell us how much it costs to develop a new drug and how often the research for new cures is not successful," Sanders said in May. "I get that. But what they are going to have to explain to us is why, over the past decade, 14 major pharmaceutical companies... spent $747 billion on stock buybacks and dividends."
"They will also have to explain how as an entire industry pharma spent $8.5 billion on lobbying and over $745 million on campaign contributions over the past 25 years to get Congress to do its bidding," Sanders continued. "Unbelievably, last year, drug companies hired over 1,700 lobbyists including the former congressional leaders of both major political parties—that's over three pharmaceutical industry lobbyists for every member of Congress."
As Sanders put it, "That could well explain why we pay the highest prices for prescription drugs in the world and why today drug companies can set the price of new drugs at any level they wish."
"While Americans pay outrageously high prices for prescription drugs, the pharmaceutical industry and the [pharmacy benefit managers] make enormous profits," the lawmaker lamented. "In 2021, 10 major pharmaceutical companies in America made over $100 billion in profits—a 137% increase from the previous year. The 50 top executives in these companies received over $1.9 billion in total compensation in 2021 and are in line to receive billions more in golden parachutes once they leave their companies."
"In other words, Americans die, get sicker than they should, and go bankrupt because they cannot afford the outrageous cost of prescription drugs, while the drug companies and the PBMs make huge profits," he added. "That has got to change and this committee is going to do everything possible to bring about that change."
Keep ReadingShow Less
Most Popular