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Clare Fauke, Physicians for a National Health Program, clare@pnhp.org or 312-782-6006
The skyrocketing cost of prescription medications is one of the biggest concerns for American voters. However, in his proposal last Friday, President Donald Trump failed to offer any new policies that would expand access, reduce costs, or increase the safety and efficacy of prescriptions.
Today, a group of 21 prominent experts published a comprehensive proposal to ensure universal access to safe, innovative, and affordable medications. "Healing an ailing pharmaceutical system: prescription for reform for the U.S. and Canada," identifies seven critical areas for reform, along with both short- and long-term solutions to improve the development, approval process, affordability, and marketing of medications:
1. Access: Even insured patients face high out-of-pocket costs, leaving them unable to fill prescriptions. To achieve universal access, the proposal calls on the U.S. and Canada to establish national formularies of the safest, most effective, and least expensive medications, and provide all residents with full coverage of formulary drugs without copays or deductibles.
2. Affordability: The industry's pricing strategy is to charge whatever the market will bear, regardless of the actual cost of development. As a result, the U.S. spends about twice as much per-capita on prescriptions than any other nation. Under this proposal, public agencies would negotiate with manufacturers to make branded medications more affordable, and if negotiations fail, issue a "compulsory license" to allow generic manufacturing. The U.S. and Canadian governments also would create a publicly owned manufacturing capacity to produce needed products, along with an increase in public funding for the development of non-patented medications.
3. Preclinical development and patent protection: The current patent system encourages the development of "me-too" products that offer only trivial modifications and higher costs. Under this proposal, patents would be limited to medications that provide real innovation. While current law allows publicly funded researchers to patent and sell their discoveries to private firms, this proposal would keep publicly funded research in the public domain. The plan also calls for health agencies to fund a new public research program to develop and test new treatments outside of the patent system, prioritizing medications with high clinical value, and for conditions deemed unprofitable and ignored by the industry. Such treatments could be sold cheaply as generics as soon as they are brought to market.
4. Clinical testing: Most clinical trials are conducted by private firms, often using unsound methods and selective reporting, calling into question the objectivity of research and the usefulness and safety of new therapies. Corporate ownership of trial data can hide safety problems and obstruct further research. The proposal calls on approval agencies to increase standards for clinical trials and increase transparency by making all trial data publicly available. Experts believe that most clinical trials should be funded and supervised by public health agencies to maintain safety standards and to facilitate innovation for needed treatments.
5. Approval reform: Regulatory agencies are funded primarily by industry fees, creating conflicts of interest. Too many unsafe products are approved, and the increased use of "expedited reviews" and weaker standards of evidence threatens to bring more unsafe or ineffective products to market. This proposal would strengthen regulators' independence by funding them exclusively with public funds. Approval agencies would strictly limit expedited reviews and the use of surrogate endpoints only to treatments likely to offer genuine clinical advances.
6. Postmarketing surveillance: Due to weakening of the approval process, postmarket studies are critical to confirm the efficacy and safety of medications already in use. However, regulators fail to penalize firms that don't complete them. The proposal would require that companies promptly perform and submit safety studies after their products are on the market, increase regulators' funding for postmarketing surveillance, and give regulators the power to order safety warnings and remove unsafe therapies from the market.
7. Promotion: Pharmaceutical corporations spend more on marketing than on research and development, and promotional materials often include inaccurate or misleading claims. This proposal would improve monitoring and stiffen sanctions for misleading or off-label promotions. Companies would be prohibited from funding continuing medical education programs for providers.
"Our pharmaceutical system prioritizes industry profits over public health, but it doesn't have to be this way," said Dr. Adam Gaffney, a critical care physician and faculty member at Harvard Medical School, and co-chair of the Pharmaceutical Reform Working Group. "Through a series of commonsense reforms, we can increase the affordability, safety, and effectiveness of medicine for our patients."
Dr. Gaffney warned that combating the power of major pharmaceutical firms won't be easy, noting that the industry spent a combined $171 million on lobbying last year. "Every year we wait for reform means another spike in medication prices," he said.
"The pharmaceutical industry directly funds the regulating arm of the FDA, and paid more than $800 million in user fees in 2017," said Dr. Sidney Wolfe, founder of Public Citizen's Health Research Group. "The FDA's independence is too important to expose to the influence and money of the industry."
Dr. Wolfe added that increasing affordability of lifesaving therapies should be a national priority. "Lack of access to medicines results in preventable deaths and serious illness to hundreds of thousands of patients a year," he said.
Rep. Keith Ellison (D-Minn.) encouraged his colleagues in Congress to take action. "The outrageous cost of prescription drugs in this country is a crisis that the American people feel every day," he said. "There are real solutions we can implement that we know will lower drug prices and save lives, but what we lack right now, and what we need, is the political will from those in Congress and other elected officials to do the right thing and stand up to the greed of Big Pharma."
Physicians for a National Health Program is a single issue organization advocating a universal, comprehensive single-payer national health program. PNHP has more than 21,000 members and chapters across the United States.
One critic said Republican Gov. Kristi Noem is "stopping at nothing until every woman in South Dakota is forced to carry an unwanted pregnancy to term."
South Dakota's Republican governor and attorney general on Tuesday issued a threatening letter directed at the state's pharmacists in response to a recent move by the Biden administration to ease restrictions on dispensing abortion pills amid the GOP's nationwide assault on reproductive freedom.
Gov. Kristi Noem and AG Marty Jackley's letter begins by noting that after Dobbs v. Jackson Women's Health Organization, the U.S. Supreme Court ruling that reversed Roe v. Wade last year, abortion became illegal in South Dakota except to save the life of the pregnant person. It's one of 14 states where abortions are now largely unavailable.
The letter states that "in South Dakota, any person who administers, prescribes, or procures for any pregnant female any medicine or drug with the intent to induce an abortion is guilty of a felony."
\u201c.@KristiNoem stopping at nothing until every woman in South Dakota is forced to carry an unwanted pregnancy to term\u201d— Julie Alderman Boudreau (@Julie Alderman Boudreau) 1674590026
In a policy change long advocated by medical experts and rights campaigners, the Food and Drug Administration (FDA) earlier this month formalized a regulatory change to allow retail pharmacies in the U.S. to dispense mifepristone, one of two drugs often taken in tandem for a medication abortion.
Referencing that development, the letter says that "under South Dakota law, pharmacies, including chain drug stores, are prohibited from procuring and dispensing abortion-inducing drugs with the intent to induce an abortion, and are subject to felony prosecution under South Dakota law, despite the recent FDA ruling."
As The Associated Pressreported Tuesday:
The [FDA's] change could expand access at online pharmacies. People can get a prescription via telehealth consultation with a health professional and then receive the pills through the mail, where permitted by law.
Still, in states like South Dakota, the rule change's impact has been blunted by laws limiting abortion broadly and the pills specifically. Legal experts foresee years of court battles over access to the pills as abortion rights proponents bring test cases to challenge state restrictions.
Amanda Bacon, the director of the South Dakota Pharmacists Association, said in an email that she was not aware of any South Dakota pharmacies with plans to participate in the federal program to dispense abortion pills.
The pro-choice Guttmacher Institute, which tracks policies across the country, labels all six states that border South Dakota as restrictive of abortion access to various degrees—and South Dakota is among the dozen "most restrictive" states in the nation.
Since the Dobbs decision, states with pro-choice policies—especially those like Illinois, which is surrounded by states with abortion restrictions—have seen an influx of "healthcare refugees."
While the FDA's recent move was widely seen as a step toward alleviating some of the strain on clinics trying to serve a growing number of patients fleeing states with forced-birth policies, an ongoing legal battle over the agency's initial approval of mifepristone in 2000 could jeopardize access to the drug nationwide.
\u201cOne of the medications taken in the most common way to end a pregnancy could soon be taken off the market nationwide.\n\nNationwide.\n\nThat means medication abortion can\u2019t exist even in places that have PROTECTED abortion access.\n\nhttps://t.co/fZlZG6vBzA\u201d— Planned Parenthood Action (@Planned Parenthood Action) 1674575101
Anti-choice physicians last month asked Judge Matthew Kacsmaryk—appointed by former President Donald Trump to the U.S. District Court for the Northern District of Texas—to throw out the FDA's 2000 decision. The judge, who was previously the deputy general counsel at a conservative Christian legal advocacy group, could issue a ruling as soon as February 10.
If the Christian alliance that launched the attack on the FDA approval "wins in federal district court, the Biden administration would appeal to the 5th Circuit in New Orleans, a conservative court with 12 of its 16 active judges appointed by Republicans," CNBCpointed out Tuesday. "From there, the case could end up at the Supreme Court."
"Florida considers books to be more dangerous to students than assault rifles," noted one observer. "This is truly a dystopian state."
Teachers in at least one Florida county this week began removing or covering books in their classrooms to avoid running afoul of a new law requiring every volume to be vetted by a state-trained "media specialist"—violation of which could result in felony charges.
The Sarasota Herald-Tribune reports the Manatee County School District has directed teachers to remove all books that have not been approved by a specialist, who will ensure that all titles are "free of pornography," are "appropriate for the age level and group," and contain no "unsolicited theories that may lead to student indoctrination."
The vetting requirement comes under H.B. 1467, a Republican-sponsored bill signed into law last year by Republican Gov. Ron DeSantis, who stridently hypes Florida as the "freest state in these United States" while banning classroom discussions of systemic racism,gender identity, and even an entire course of college preparatory study.
Manatee High School history teacher Don Falls, who is involved in a lawsuit against DeSantis' Stop WOKE Act banning the teaching of critical race theory—a graduate-level discipline not taught in K-12 schools—called H.B. 1467 "not only ridiculous but a very scary attack on fundamental rights."
\u201c1. Florida teachers are being told to remove all books from their classroom libraries OR FACE FELONY PROSECUTION\n\nThe new policy is based on the premise that teachers are using books to "groom" students or indoctrinate them with leftist ideologies. \n\n\ud83e\uddf5\n\nhttps://t.co/SzHzgelT64\u201d— Judd Legum (@Judd Legum) 1674481453
Because few if any books have been screened by media specialists, many Manatee County teachers erred on the side of caution and covered their entire classroom libraries. However, teachers and students found ways of resisting the new law, even as they took action to comply with it.
"Readers Gonna Read," read one student-drawn sign taped to swaths of blue construction paper covering one middle school classroom's library. "Free the Books," demanded another. "There is no friend as loyal as a book," asserted a third sign hanging below a notice designating the room's "safe zone" in case of school shooter attack.
"A perfect picture of DeSantis' Florida," area elementary school teacher Tamara Solum wrote on Facebook.
\u201cPhoto of a classroom library at Bayshore High School in Manatee County, Florida after they banned all classroom libraries. Florida considers books to be more dangerous to students than assault rifles. This is truly a dystopian state.\u201d— Alejandra Caraballo (@Alejandra Caraballo) 1674501448
Manatee Education Association President Pat Barber told the Herald-Tribune that "it's a scary thing to have elementary teachers have to worry about being charged with a third-degree felony because of trying to help students develop a love of reading."
In a final ironic twist, it's Literacy Week in Florida schools, which according to the state's Department of Education "is designed to raise awareness about the importance of reading and to inspire Florida's students and families to make reading part of their daily routines."
"The real 'emergency' here is our declining biodiversity," said one campaigner. "It's time farmers got support for alternatives, not a green light for using toxic chemicals."
Biodiversity defenders have sounded the alarm about the United Kingdom government's Monday decision to provide another so-called "emergency" exception for the use of an outlawed neonicotinoid pesticide lethal to bees.
"Bad news again for bees as the U.K. government allows banned neonicotinoids in our fields against the advice of its own experts," Friends of the Earth campaigner Sandra Bell tweeted. "The real 'emergency' here is our declining biodiversity—it's time farmers got support for alternatives, not a green light for using toxic chemicals."
Despite U.K. guidance affirming that emergency applications should not be granted more than once, the Department for Environment, Food, and Rural Affairs (DEFRA) announced for the third straight year that it will permit the use of sugar beet seeds coated with thiamethoxam under certain conditions in England.
"If the government is serious about halting biodiversity loss by 2030, they must support farmers to explore long-term, agroecological solutions that don't threaten our endangered bee population."
Against the recommendation of an independent panel of pesticide experts, the agency approved the use of thiamethoxam just four days after the European Union's highest court ruled that providing emergency derogations for prohibited neonicotinoid-treated seeds is inconsistent with the bloc's laws. The U.K. withdrew from the E.U. in 2020.
DEFRA's emergency authorization for thiamethoxam-coated sugar beet seeds also comes one month after the U.K. government advocated for a stronger global pesticide reduction target at the United Nations COP15 biodiversity summit.
Calling the authorization "yet another shameful episode in a long list of failures to protect the U.K. environment," the British chapter of the Pesticide Action Network (PAN) said that "putting bees and other insects at risk shows just how seriously this government takes the biodiversity crisis."
\u201cFlying in the face of expert recommendation and putting #bees and other #insects at risk shows just how seriously this government takes the #biodiversity crisis. Yet another shameful episode in a long list of failures to protect the UK environment\u201d— PAN UK (@PAN UK) 1674493039
"It's incredibly brazen to allow a banned bee-harming pesticide back into U.K. fields mere weeks after the government talked up the need for global ambition on reducing pesticides at the U.N. biodiversity talks in Montreal," Bell said in a statement issued by the Pesticide Collaboration, a progressive coalition of 83 health and environmental organizations, trade unions, farmer and consumer groups, and academics.
"This is the third consecutive year that the government has gone directly against the advice of its own scientific advisers with potentially devastating consequences for bees and other vital pollinators," said Bell. "The health of us all and the planet depends on their survival. The government must fulfill its duty to protect wildlife and keep pesticides off our crops for good—that means supporting farmers to find nature-friendly ways to control pests."
University of Sussex biology professor Dave Goulson has estimated that a single teaspoon of thiamethoxam—one of three neonicotinoids produced by Bayer, the German biotech corporation that merged with agrochemical giant Monsanto in 2018—is toxic enough to wipe out 1.25 billion bees.
A Greenpeace U.K. petition imploring Thérèse Coffey, a Conservative Party lawmaker serving as secretary of state for environment, food, and rural affairs, to "enforce a total ban on bee-killing pesticides" has garnered nearly one million signatures.
\u201cBREAKING: The government just approved the use of a BANNED bee-killing pesticide AGAIN! \n\nOne teaspoon of the pesticide is enough to kill 1.25 billion bees - it should be kept away from them!\n\u2060\nWho else thinks the government should listen to the science and NOT the sugar lobby?\u201d— Greenpeace UK (@Greenpeace UK) 1674577444
Describing DEFRA's move as "a huge disappointment," the Stand By Bees campaign on Tuesday urged supporters to "continue pushing" and "write to your local MP."
\u201cThis news is a huge disappointment for us. Despite our efforts, we have been unable to prevent this outcome. We must keep up the pressure. Now more than ever, we must #StandByBees. We must continue pushing. \n\nPlease write to your local MP: https://t.co/DgpLTfutVV\u201d— StandByBees (@StandByBees) 1674580286
In 2013, the European Commission banned the use of thiamethoxam and two other hazardous neonicotinoids produced by Monsanto—clothianidin and imidacloprid—on bee-attractive crops including maize, rapeseed, and some cereals. This was followed by a prohibition on all outdoor uses in 2018, which the European Court of Justice upheld in 2021, rejecting an appeal by Bayer.
The Pesticide Collaboration warned Monday that DEFRA's latest authorization for thiamethoxam-coated sugar beet seeds "raises wider concerns over whether the government will maintain existing restrictions on neonicotinoids and other harmful pesticides, or whether they may be overturned as part of a forthcoming bonfire of regulations that protect nature, wildlife, and communities."
At issue is the Retained E.U. Law Bill, which threatens to rescind E.U.-era environmental standards and other measures enacted prior to Brexit.
\u201cOur position on the Retained EU Law Bill \u2b07\ufe0f\n\n"The Pesticide Collaboration remains extremely concerned that if this Bill becomes law, there is a chance that all the EU-derived pesticide regulation with teeth will simply fall away."\n\nhttps://t.co/jw81ZS1gOz\u201d— The Pesticide Collaboration (@The Pesticide Collaboration) 1674470782
"It is inexcusable to see England falling so far behind the E.U. on regulations in place to prevent such a detrimental impact on biodiversity," Soil Association, a U.K.-based research and advocacy group, tweeted Tuesday. "It's not credible to claim an exemption is 'temporary' or 'emergency' when it is used year after year. How many more years will it happen?"
According to Amy Heley of the Pesticide Collaboration: "In previous years, DEFRA insisted that the sugar industry must make progress in finding alternatives, but we are yet to see any outcomes of this. The Pesticide Collaboration is deeply concerned that this emergency derogation is simply another example of the government failing to follow through on their own pledges to improve the environment and protect human health."
As Joan Edwards, director of policy & public affairs at the Wildlife Trusts, noted Monday: "Just last month, the Secretary of State Thérèse Coffey committed the U.K. to halving the environmental impact of damaging pesticides by 2030. However, today she has incompatibly authorized the use of a banned neonicotinoid, one of the world's most environmentally damaging pesticides."
“Only a few days ago, the E.U.'s highest court ruled that E.U. countries should no longer be allowed temporary exemptions for banned, bee-toxic neonicotinoid pesticides," said Edwards. "Yet this government deems it acceptable to allow the use of a toxic pesticide that is extremely harmful to bees and other insects, at a time when populations of our precious pollinators are already in freefall. This is unacceptable."
The Soil Association, meanwhile, argued that "if the government is serious about halting biodiversity loss by 2030, they must support farmers to explore long-term, agroecological solutions that don't threaten our endangered bee population."
"Neonicotinoids simply have no place in a sustainable farming system," the group added.