Health & Wellness | Toronto Caribbean Newspaper
The silent return of HIV; Why Canada can’t afford complacency
"One in eight people living with HIV today don’t know their status, and that silence spreads.”
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"One in eight people living with HIV today don’t know their status, and that silence spreads.”
The post The silent return of HIV; Why Canada can’t afford complacency first appeared on Toronto Caribbean Newspaper.
1 month 1 week ago
Health & Wellness, #communitynews, facts about HIV/AIDS, Get the facts about HIV, hiv
Cabinet Ministers to donate one month’s salary to Project Polaris fund
The Prime Minister and his Cabinet will start this process by donating one month’s salary before the end of 2025 and thereafter one month’s salary in each calendar year, until Project Polaris is commissioned
View the full post Cabinet Ministers to donate one month’s salary to Project Polaris fund on NOW Grenada.
1 month 2 weeks ago
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Opposition Leader experiences minor injuries on way to Parliament
Due to a vehicular accident in which she sustained minor injuries, Opposition Leader Emmalin Pierre was not present at Parliament for the ceremonial opening on Friday, 12 September
View the full post Opposition Leader experiences minor injuries on way to Parliament on NOW Grenada.
1 month 2 weeks ago
Health, Politics, cecile la grenade, dickon mitchell, emmalin pierre, kate lewis-peters, linda straker, parliament, throne speech
Throne Speech 2025: Delivering a better future, together
“The challenges before us are many, but so are the opportunities to build a future that is more just, prosperous, and inclusive”
View the full post Throne Speech 2025: Delivering a better future, together on NOW Grenada.
“The challenges before us are many, but so are the opportunities to build a future that is more just, prosperous, and inclusive”
View the full post Throne Speech 2025: Delivering a better future, together on NOW Grenada.
1 month 2 weeks ago
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Caribbean Healthcare leaders converge in Miami for Transformative HIV Training to Fast-Track 95-95-95 Targets
– Pan Caribbean Partnership Against HIV and AIDS (PANCAP)
GEORGETOWN, Guyana – The Pan-Caribbean Partnership Against HIV and AIDS (PANCAP), in collaboration with the University of Miami Miller School of Medicine and with support from the Pan-American Health Organization (PAHO) and The Global Fund, will host a high-impact Strengthening HIV Prevention and Treatment Services Training Programme, from September 17–19, 2025, at the University of Miami Miller School of Medicine in Miami, Florida.
Building on the groundbreaking PANCAP Learning Journey held earlier this year at Amsterdam’s renowned Public Health Service (GGD Amsterdam), this Miami training will further equip regional frontline healthcare providers with advanced skills in motivational interviewing (MI) and other cutting-edge clinical strategies. The Amsterdam session demonstrated remarkable success in enhancing providers’ ability to engage high-risk populations in PrEP programmes and re-engage people living with HIV who have fallen out of care.
The training will assemble clinical leaders from several Caribbean nations, including Antigua and Barbuda, The Bahamas, Barbados, Belize, Commonwealth of Dominica, Guyana, Jamaica, Montserrat, St Kitts and Nevis, Saint Lucia, Suriname, Trinidad and Tobago, St Vincent and the Grenadines, Anguilla, The British Virgin Islands, and the Dominican Republic. Participants will include physicians, nurses, and community health specialists representing both public health systems and civil society organisations, ensuring comprehensive knowledge transfer across all levels of care.
This intensive capacity-building initiative comes at a critical juncture as the region works assiduously to overcome persistent challenges in reaching UNAIDS’ ambitious 95-95-95 prevention targets by 2030.
“This isn’t just another training, it’s a strategic intervention to change the trajectory of HIV in our region,” emphasised Dr Wendy Telgt Emanuelson, Director of the PANCAP Coordination Unit. “By mastering motivational interviewing techniques and applying the latest evidence-based approaches, our regional clinicians will become powerful change agents in their communities, particularly in reaching marginalised populations most in need of these services.”
Dr Shanti Singh Anthony, Knowledge Management Coordinator at the PCU, underscored:
“The Amsterdam Learning Journey proved that when clinicians adopt patient-centred approaches, outcomes improve dramatically. This training on motivational interviewing will allow for a differentiated and client-centred approach to recruit, initiate and retain persons on HIV prevention and treatment services, helping us close gaps in the HIV care continuum and achieve the global targets.”
With Caribbean nations facing uneven progress toward HIV targets, this training addresses critical gaps in the regional HIV response.
The programme’s unique value lies in its “train-the-trainer” approach, ensuring participants can share their new skills with their colleagues back home. This creates sustainable capacity that will continue benefiting health systems throughout the region long after the Miami session concludes.
This training programme is a critical step toward revitalising HIV prevention and treatment efforts in the Caribbean. By empowering clinicians with evidence-based tools, PANCAP and its partners aim to reduce new infections, improve retention in care, and accelerate progress toward ending AIDS as a regional public health threat by 2030.
PANCAP graciously thanks The Global Fund, University of Miami Miller School of Medicine and PAHO for making this pivotal training experience a reality.
The post Caribbean Healthcare leaders converge in Miami for Transformative HIV Training to Fast-Track 95-95-95 Targets appeared first on Caribbean News Global.
1 month 2 weeks ago
Caribbean News, Featured, Health & Fitness, Latest News, News
STAT+: Pharmalittle: We’re reading about FDA adcomms, Kenvue lobbying RFK Jr. about Tylenol, and more
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to shop for a new tool to help us manicure the Pharmalot grounds, catch up on our reading, possibly enjoy a soiree, and of course, hold a listening party with Mrs. Pharmalot.
So far, the rotation will include this, this, this, this and this. And what about you? Summer may be nearing an end but time still remains to enjoy the great outdoors. If weather does not permit, perhaps this is an opportunity to get a head start and winterize your castle. You could also lounge about and stream a moving picture or two. Or catch up with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
U.S. Food and Drug Administration leaders are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield agency decisions from public scrutiny, KFF Health News tells us. The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research. He relayed the message Tuesday at a meeting of health care product makers and Wednesday to an FDA advocacy group. In addition to being redundant, Tidmarsh said advisory meetings on specific drugs were “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.” Tidmarsh said committees would still be consulted on general issues like how to regulate different classes of drugs. But meetings on specific drugs were mainly useful, he said, because they allowed the public to see how the FDA worked.
Novo Nordisk’s new chief executive officer Maziar Mike Doustdar is calling workers back to the office as the Ozempic maker struggles to catch up with Eli Lilly in the hyper-competitive obesity market, Bloomberg News says. Office-based employees will need to come in five days a week starting Jan. 1. The move comes a day after Doustdar announced the drugmaker, which is headquartered in Denmark, would slash its workforce by 11%. Novo did not previously have a global policy on working from home, a common perk for Danish employees. The company had prized work-life balance, with employees in its home market frequently taking much of the month of July off and leaving the office by 4 p.m. to see to personal obligations. Before this week’s layoffs announcement, Doustdar also fired newly hired employees who had not yet started their jobs — some within days of when they were scheduled to begin — cut bonuses, and began a hiring freeze. Doustdar has called for a “performance culture” to catch up with Lilly, which has taken the lead in the U.S. obesity market.
1 month 2 weeks ago
Pharma, Pharmalot, pharmalittle, STAT+
Health Archives - Barbados Today
One plus one equals trouble: The hidden math of disease risk
Disease risk factors are characteristics or behaviours that increase a person’s chance of developing a particular disease. Not everyone who has a disease risk factor will develop the disease, and there are some people who develop a specific disease without having a disease risk factor.
That said, in our population, the main diseases are the non-communicable diseases (NCDs), like heart diseases and strokes, and cancers. Indeed, in Barbados over the last decade, we average just over a heart attack a day and two strokes every three days.
Not everyone dies after having their first heart attack or stroke, but each month, at least 20 people die after having a heart attack and another 20 die after having a stroke.
The main disease risk factors for the NCDs include a family history, getting older, being overweight or obese, being inactive, unhealthy eating habits, drinking alcohol and cigarette smoking. Some of these cannot be modified or changed, such as getting older or changing your family, but, for the most part, the other disease risk factors can be modified or changed. If you have hypertension, diabetes or high cholesterol, you are perhaps many steps closer to having a full-blown heart attack or stroke, or (heaven forbid) even sudden death. Reaching this point depends largely on your eating, drinking and exercise habits.
So, for example, drinking alcohol increases your risk of having a heart attack. Similarly, being overweight or obese increases your chance of having a heart attack. In fact, the bigger you are, the greater the risk. But if you have two risk factors, such as being an alcohol drinker as well as being overweight or obese, the risk of a heart attack just doesn’t double, but jumps up significantly. Thus, one risk factor plus one risk factor does not just double the risk for a heart attack or stroke, but may increase this risk fivefold.
While normal arithmetic suggests that one plus one equals two, this does not hold for disease risk factors. One disease risk factor plus another disease risk factor may increase the risk of a disease more than two times, for example.
Someone with three risk factors, for example, may have a tenfold (or higher) risk of developing a particular disease.
Learning about your risk factors can help you make informed decisions about your health and lifestyle. It allows you to take steps to reduce your risk, such as making changes to your diet or quitting smoking. Knowing your risk factors can also help you and your family doctor monitor your health more closely and potentially prevent a disease, or catch a disease early, when it may be reversed or easily treated and controlled.
We now know that some of the ‘modifiable’ risk factors for cardiovascular disease, such as smoking, drinking alcohol, poor diet, inactivity and overweight/obesity, are also the risk factors for many (but not all) cancers. Thus, if we wish to lower our rates of cardiovascular disease and cancer, we must address the risk factor stage of many conditions before they become full-blown diseases that are often difficult to reverse.
As far as cardiovascular diseases are concerned, over the last decade, scientists have developed “Cardiovascular Risk Tables”, which allow doctors to ‘tally’ the cardiovascular risk of individuals, and calculate the chance of that individual having a major cardiovascular event (like a heart attack or stroke) in the next ten years, for example.
This then allows the doctor-patient to identify specific targets, e.g. lose 10 lbs, and lower your systolic blood pressure by 10 mmHG, to lower the chance that you would develop a major cardiovascular event.
The Pan American Health Organisation, PAHO, has introduced a cardiovascular risk calculator called Cardiocal, for specific countries in Latin America and the Caribbean, including Barbados. This was part of the Hearts in the Americas programme, aiming to promote the adoption of best practices in the prevention and control of cardiovascular diseases (CVD). Use of this calculator should give doctors and their patients targets that can eventually reduce the risk of a major cardiovascular event, lower the overload at the Accident and Emergency Department, and lower the suffering and deaths associated with these major cardiovascular events.
The latest hypertension guidelines, the first ‘upgrade’ since 2017, were endorsed by the American Heart Association (AHA) and the American College of Cardiology (ACC), released a few days ago, suggest individual treatment guidelines based on an individual’s cardiovascular risk calculated in a table called PREVENT. PREVENT, unlike Cardiocal, is not calibrated for Latin America and Caribbean use. These 2025 updates represent a more aggressive approach towards managing high blood pressure, based on the latest research. But in the Caribbean, we should still be using Cardiocal.
These are also risk factor calculators for kidney (renal) disease and a few other conditions, but at this time, these do not seem to be in widespread use, perhaps until they are calibrated for specific populations.
Thus, a ‘touch of sugar’, plus a ’touch of pressure’ and only ‘one or two drinks’ can send you on a one-way trip to the local cemetery. A little bit of laziness plus a little bit of ‘lickrishness’ add up to big trouble, as far as ‘life and death’ are concerned. Beware disease risk factors.
Dr Colin V Alert is a family physician and former researcher with the Chronic Disease Research Centre.
The post One plus one equals trouble: The hidden math of disease risk appeared first on Barbados Today.
1 month 2 weeks ago
Health, Local News
Health Archives - Barbados Today
Businesses urged to promote healthy eating among youth
Barbadian businesses must play a greater role in protecting young people from unhealthy choices within schools, says President of the Barbados Chamber of Commerce and Industry (BCCI), Paul Inniss.
Speaking during a Healthy Caribbean Coalition (HCC) webinar themed Back to School, Back to Health: Nothing at School Should Encourage Unhealthy Choices, Inniss said closer collaboration between the private sector, the Ministry of Health, and other stakeholders is needed to create effective solutions.
“I’m actually working through trying to coordinate between business, the Ministry of Health and other stakeholders… how can we pool resources and become more effective in [managing] the concerns around companies that actually pitch to our kids unhealthy foods and so forth. It is a balancing act… quite frankly, in talking to a lot of them, they actually want to be part of the solution as well. I don’t think we have figured it out,” he admitted.
Inniss noted that while companies like Sagicor have long supported schools by donating equipment or funding, there is room for businesses to go further.
“For companies like Sagicor, we started adopting schools. But no school has ever said to us, ‘Why can’t we devise a health programme?’ Maybe that is where we partner with the Heart and Stroke Foundation, HCC and others to actually be part of what is happening within the schools,” he said.
He also cautioned against fragmented approaches, stating, “Too many agencies are coming into business houses, independently, and everybody’s trying to achieve the same result, and there’s limited resources, limited capacity. You have to find a way to harness the resources and actually focus them where they are needed.”
The call comes against the backdrop of growing concern about how marketing and food environments exploit the vulnerabilities of young people.
Caribbean Vice-President of the International Association for Adolescent Health (IAAH), Dr Asha Pemberton, stressed that children and adolescents are neurologically wired to gravitate towards products that make them feel good.
“The frontal lobe… is simply not complete in maturation until age 25. So young people do things that feel good over and over… and that is exploited by all the industries. The food industry knows this because ultra-processed products taste good, they’re crunchy, they’re sweet, they’re salty [and] their dopamine drive happens. They are uniquely targeted,” she explained.
Dr Pemberton argued that it is unfair to place the responsibility solely on young people.
“The simplistic ‘just make better choices’ only goes so far. We have to recognise that these are children and adolescents. Unless our environment, through a comprehensive ban, removes these items from their most intimate environment—and their school is one—it really becomes difficult to ask a developing brain to make these choices one by one,” he said.
Dr Pemberton said it is ultimately the responsibility of adults, caregivers, policymakers and businesses to create supportive spaces: “We cannot ask them to make decisions that they don’t have the capacity to do. We have to create an environment that is best supportive of their health and development.” (SB)
The post Businesses urged to promote healthy eating among youth appeared first on Barbados Today.
1 month 2 weeks ago
Business, Health, Local News
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
Tragic: Jabalpur Army doctor dies of cardiac arrest inside parked car
Jabalpur: In an unfortunate and tragic incident, Major Dr Vijay Kumar, posted at Jabalpur Military Hospital, was found dead inside his parked car on the driver’s seat after reportedly suffering a massive cardiac arrest.
Jabalpur: In an unfortunate and tragic incident, Major Dr Vijay Kumar, posted at Jabalpur Military Hospital, was found dead inside his parked car on the driver’s seat after reportedly suffering a massive cardiac arrest.
Originally from Bengaluru, Dr Kumar had travelled to the city for some personal work when his health suddenly deteriorated. Locals passing by noticed that he had been sitting in the car with the door open for too long, and the vehicle was not moving.
On moving closer, they found him unconscious and immediately alerted the police. Upon reaching the spot, the police carried out a preliminary investigation and identified the vehicle as an army car.
Also read- Fifth Tragic Loss: Orthopaedician dies of heart attack at 45
Soon after, the army officials were informed, and Major Kumar was rushed to the Military Hospital in an ambulance, where doctors declared him dead.
According to a Free Press Journal report, the doctor’s car was parked near the Indian Coffee House in Sadar Bazaar, and the incident occurred around 11 AM.
While the police suggested the death was caused by a cardiovascular health issue, they are also reviewing CCTV footage from the area to understand how the situation unfolded.
His body was sent for post-mortem late Wednesday night, and his family arrived from Bangalore on Thursday morning. After completing the necessary formalities, the body was handed over to his family.
The doctor’s untimely demise has left the medical fraternity in shock, underscoring the urgent need to prioritise the mental and physical well-being of healthcare professionals, who often exhaust themselves while working tirelessly to serve others.
Sharing the news on 'X', a doctor said, "Another Doctor Lost to Sudden Cardiac Arrest: A Wake-Up Call for the Medical Fraternity. The medical community has once again been struck with grief. Dr. Major Vijay Kumar, posted at Jabalpur Army Hospital, Madhya Pradesh, lost his life after suffering a massive cardiac arrest. He collapsed in his car in the market area, unable to receive timely help."
He further pointed out that this tragic incident highlights a larger, ongoing concern that doctors themselves are becoming increasingly vulnerable to lifestyle-related diseases.
In recent times, there has been a worrying rise in reports of doctors dying young due to cardiac arrest and heart attacks. Long working hours, stress, and irregular lifestyles are taking a serious toll on their health, reminding us that even those who save lives are not spared from these silent killers.
Medical Dialogues reported a series of tragic incidents involving the sudden deaths of five doctors over the past two weeks. Dr Gradlin Roy, a 39-year-old consultant cardiac surgeon at Saveetha Medical College, died of a massive cardiac arrest while on duty rounds. Similarly, 40-year-old Dr. Prakash Gupta, an anaesthesia specialist at Goyal Hospitals in Jodhpur, also succumbed to cardiac arrest.
Dr Gaurav Mittal, a 39-year-old critical care specialist; Dr Devan, a 42-year-old associate professor from the cardiology department at Manakula Vinayaga Medical College, and Dr. Sangram Sabat, a 45-year-old associate professor in the Department of Orthopaedics at MKCG Medical College and Hospital, all of them passed away from massive heart attacks.
Also read- 39-year-old Cardiac Surgeon dies of cardiac arrest while on duty
1 month 2 weeks ago
State News,News,Health news,Madhya Pradesh,Doctor News,Latest Health News,Notifications,Recent Health News
Health Archives - Barbados Today
‘Not punishment’: Ministry explains nurse reassignments
The Ministry of Health has confirmed the reassignment of six nurses from the Geriatric Hospital to district facilities in St Lucy and St Philip, but insists the move was not punitive.
The Ministry of Health has confirmed the reassignment of six nurses from the Geriatric Hospital to district facilities in St Lucy and St Philip, but insists the move was not punitive.
Permanent Secretary Wayne Marshall on Thursday rejected claims of victimisation, saying the decision was driven by urgent staffing needs and a commitment to maintaining safe, high-quality care across the public health system.
Marshall was responding to concerns raised in letters from two trade unions, which suggested the transfers were linked to nurses’ complaints about patient allocation during a recent scabies outbreak at the Geriatric Hospital. He maintained that the reassignments were solely intended to address acute shortages at the district hospitals, and pointed out that staff had previously been redeployed in the opposite direction to support the Geriatric Hospital during similar circumstances.
The ministry remains focused on balancing resources across facilities, Marshall said, adding that the affected nurses were notified both verbally and in writing at least two weeks prior to the effective date.
He also addressed union concerns about the handling of the outbreak, stating that all actions taken, including patient relocations, were guided by medical and infection control professionals.
“Measures such as patient relocations were carried out to facilitate proper isolation, treatment, and sanitisation, ensuring the safety of both patients and staff,” he said.
Marshall further asserted that there was no serious threat to health or safety as a result of the ministry’s decisions.
Acknowledging an administrative oversight, the permanent secretary confirmed that incorrect legislation had been cited in letters issued to the nurses, but assured that corrected correspondence would be provided.
He emphasised that the reassignments were within his authority and did not infringe on the rights of any officer.
The ministry has already met with senior union officials and plans to convene an additional meeting in response to the most recent correspondence. Written responses will also be issued to formally outline its position.
The National Union of Public Workers, had flagged growing unrest at the Geriatric Hospital, with Acting General Secretary Wayne Walrond saying nurses were surprised by the timing and lack of formal documentation, and believed they were being penalised for raising concerns about the outbreak’s management. (EJ)
The post ‘Not punishment’: Ministry explains nurse reassignments appeared first on Barbados Today.
1 month 2 weeks ago
Health, Local News
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
No Generics for AbbVie's Rinvoq Until 2037, Analysts See Multi-Billion Dollar Boost
New Delhi: AbbVie shares rose 4% to a record high on Thursday after the U.S. drugmaker said it expected no generic competition for its blockbuster immunology drug Rinvoq until 2037, a four-year extension, according to some analysts.
Rinvoq, used for the treatment of rheumatoid arthritis and other autoimmune diseases, is AbbVie's second best-selling drug behind Skyrizi.
New Delhi: AbbVie shares rose 4% to a record high on Thursday after the U.S. drugmaker said it expected no generic competition for its blockbuster immunology drug Rinvoq until 2037, a four-year extension, according to some analysts.
Rinvoq, used for the treatment of rheumatoid arthritis and other autoimmune diseases, is AbbVie's second best-selling drug behind Skyrizi.
The company has been doubling down on the immunology treatments to counter the drop in sales of arthritis treatment Humira, its once bestselling drug that is battling competition from several cheaper biosimilars in the U.S. since 2023.
The settlement with some generic drugmakers, which is subject to certain provisions, is expected to prevent sales erosion of Rinvoq from generic competitors until April 2037.
J.P. Morgan analyst Chris Schott said the extension gives AbbVie "several more years of runway on one of its key growth drivers", providing more time to develop its experimental drugs ahead of major loss of exclusivity in the mid-2030s.
Rinvoq generated sales of $5.97 billion, or more than 10% of the company's total revenue, in 2024. Skyrizi and Rinvoq are expected to together bring in more than $31 billion in 2027, according to AbbVie.
Also Read:AbbVie to buy Gilgamesh Pharma Bretisilocin for Major Depressive Disorder
"This is clearly a positive development, supporting longer-term protection of the Rinvoq franchise," said William Blair analyst Matt Phipps, who had previously assumed a 2033 loss of exclusivity.
Phipps assumes four additional years of exclusivity could lift AbbVie's expectation to add roughly $2 billion to peak-year sales of Rinvoq with the next wave of potential approvals.
The drug is being tested for several immune-related diseases such as alopecia areata, vitiligo, hidradenitis suppurativa and systemic lupus erythematosus.
Also Read:AbbVie Emrelis gets USFDA accelerated approval for a type of lung cancer
1 month 2 weeks ago
State News,News,Delhi,Industry,Pharma News,Latest Industry News
I was just 34 and in perfect health when a massive stroke left me unable to walk or talk. All young people need to know about these easy-to-dismiss symptoms
Melissa Clayton, a public relations account director from London, was holidaying with friends in Barbados over New Year when she suddenly became unwell.
Melissa Clayton, a public relations account director from London, was holidaying with friends in Barbados over New Year when she suddenly became unwell.
1 month 2 weeks ago
When Is the Best Time to Sleep? - Outside Magazine
- When Is the Best Time to Sleep? Outside Magazine
- Warning signs your body needs more sleep The Indian Express
- How to fix your sleeping pattern – from adjusting eating times to reducing stress The Independent
- How much sleep do YOU need? Take the test to find out if you're getting enough slumber Daily Mail
- Look for these 5 clues you need more sleep The University of North Carolina at Chapel Hill
1 month 2 weeks ago
Under Trump, FDA Seeks To Abandon Expert Reviews of New Drugs
FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny.
The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research. He relayed the message Tuesday at a meeting of health care product makers and Wednesday to an FDA advocacy group.
In addition to being redundant, Tidmarsh said, advisory meetings on specific drugs were “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.”
The FDA’s advisory committees were created in their current form by a 1972 law aimed at expanding and regulating the government’s use of experts in technical decisions. They’re periodically summoned for advice, including to review evidence and vote on whether the FDA should approve drugs, vaccines, and medical devices, often when FDA officials face a difficult decision.
FDA actions have traditionally aligned with committee votes. A departure can provoke controversy and public debate, as was the case with the split 2021 decision on whether to approve the Biogen drug Aduhelm to treat Alzheimer’s disease.
The FDA approved the drug despite a “no” vote from its advisory committee, whose members felt the medicine did little to treat the disease. The conflict over Aduhelm laid bare the FDA’s struggle to reconcile pressure from industry and desperate patients with its rigorous evaluation of drug risks and benefits.
Tidmarsh said the committees would still be consulted on general issues like how to regulate different classes of drugs. But meetings on specific drugs, in which experts plow through piles of studies and hours of testimony from FDA and company officials, were mainly useful, he said, because they allowed the public to see how the FDA worked.
This month the FDA began publishing the “complete response letters” it sends to companies when it declines to approve their products. Releasing the letters, which previously required filing requests under the federal Freedom of Information Act, promotes a level of transparency akin to the advisory meetings’, Tidmarsh said.
Advisory committee meetings on individual drugs “are redundant when you have the complete review letters,” he told KFF Health News in a brief interview after appearing at the health care products conference.
Former FDA officials and academics who study the agency disagree. The meetings help FDA scientists make decisions and increase public understanding of drug regulation, and abandoning them doesn’t make sense, they said.
Tidmarsh’s reasoning is “hard to follow,” former FDA Commissioner Robert Califf told KFF Health News. “It’s extremely useful for people inside FDA to find out what other experts think before they make their final decisions. And it’s important to do that in a way that enables the public to understand the points of view.”
“Experts might ask questions of the company or FDA that neither of them thought of on their own,” said Holly Fernandez Lynch, an associate professor of bioethics and law at the University of Pennsylvania. “The public has few other opportunities to comment about FDA decisions.”
Spokespeople for FDA and the Health and Human Services Department did not respond to repeated requests for elaboration on Tidmarsh’s comments.
Califf at times disagreed with advisory committees as commissioner of the agency and once floated the idea that it might be better if they deliberated but did not vote on products. Still, while “maybe someone can come up with a better one, I always thought it was an amazing system,” he said.
The FDA is not obliged to ask the outside experts to review drugs and usually hasn’t. It calls on them mainly for important new types of medications or when a decision is especially tricky because of high demand for a product that may have limited value, Aduhelm being a classic example.
The advisory committees are “an important resource” for the FDA, said Sarah Ryan, a spokesperson for the Pharmaceutical Research and Manufacturers of America. “They can play an important part of the rigorous human drug review process we have in the U.S.”
The committees are often asked to help settle disagreements within the FDA about how to move forward on a regulatory decision, said Reshma Ramachandran, a health services researcher and clinician at the Yale School of Medicine.
She and other researchers and former FDA officials praised FDA Commissioner Marty Makary’s decision to publish the complete response letters.
But the letters don’t obviate the need for committee meetings, said Peter Lurie, a former associate FDA commissioner who heads the Center for Science in the Public Interest.
“A disclosed complete response letter tells the public that a company’s application was rejected and why,” Lurie said. “An advisory committee meeting says to outside experts and the public, ‘Here’s what we’re thinking of doing and we’d love your input before we decide.’ Plainly, those are not equivalent.”
The changes Tidmarsh described are already playing out on the ground. The FDA has held only seven advisory committee meetings since Trump reentered the White House, compared with 22 over the same time frame last year. Officials say they will now release complete response letters as they are sent, and published a batch of 89 earlier in September.
Makary has to some extent replaced the advisory committees, whose members have traditionally been vetted for expertise and biases and which are required to deliberate in public, with panels of handpicked scientists who support his views on subjects such as hormone replacement therapy and antidepressants.
Diana Zuckerman, an FDA watchdog, attended the July hormone replacement therapy panel that considered the FDA’s black-box warning listing dangers of the treatment. Makary had wanted the warning removed and packed the panel with like-minded experts.
The event was hastily called with no opportunity for the public to review discussion materials or comment on them, she said.
“All that was transparent was that they didn’t want to hear from anyone who disagreed with them,” said Zuckerman, who leads the National Center for Health Research.
Before becoming commissioner, Makary pushed for more advisory committee meetings. In early 2022, he blasted the FDA’s decision to approve covid boosters for children ages 12 to 15 without consulting its Vaccine and Related Biological Products Advisory Committee. Makary posted on the social platform X at the time, “It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board.”
But Tidmarsh seems to disagree.
Instead of asking an advisory committee to vote in favor of or against a Duchenne muscular dystrophy drug, for example, he said the FDA would be better served by a committee studying the best way to evaluate such drugs, such as which outcomes, or end points, to measure. “Is this end point correct for Duchenne muscular dystrophy? That’s an important question that cuts across many different companies,” he told KFF Health News.
FDA official Vinay Prasad canceled a planned July advisory committee meeting to discuss a Duchenne drug made by the biotech company Capricor Therapeutics. The FDA later published its rejection, or “complete response letter,” to Capricor, which then published its own letter of response to the FDA. Prasad was later pushed out and rehired with fewer powers.
An advisory committee meeting could have worked through the drug’s risks and benefits in a calmer, public, less politicized atmosphere, Ramachandran said.
The FDA usually agrees with the votes of its several dozen advisory committees. A 2023 study found that the FDA agreed with 97% of “yes” votes and 67% of “no” votes.
That’s why Tidmarsh’s comments “come as a complete surprise,” said Genevieve Kanter, an associate professor of public policy at the University of Southern California, who wrote commentary accompanying the study. The FDA has postponed a lot of meetings this year, but “everyone thought it was temporary, with the transition and all the firings.”
“Another theory is that this decision is strategic,” she said, “in terms of consolidating power in the agencies so that you are no longer accountable to outside experts or the public.”
We’d like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message KFF Health News on Signal at (415) 519-8778 or get in touch here.
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KFF Health News' 'What the Health?': Countdown to Government Shutdown
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
Oct. 1 is the start of the next fiscal year, and unless Congress reaches agreement on continued spending, big parts of the government could shut down that day. Democrats, whose votes will be needed in the Senate, would like Republicans to extend the Biden-era extra tax credits for Affordable Care Act insurance plans as part of a compromise, but so far Republicans don’t seem willing.
Meanwhile, Health and Human Services Secretary Robert F. Kennedy Jr. released his much-anticipated “Make America Healthy Again” blueprint to improve children’s health, but the report contained few specifics on how his goals would be reached.
This week’s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Sandhya Raman of CQ Roll Call, and Lauren Weber of The Washington Post.
Panelists
Anna Edney
Bloomberg News
Sandhya Raman
CQ Roll Call
Lauren Weber
The Washington Post
Among the takeaways from this week’s episode:
- Congress has less than three weeks to approve federal government spending for the new fiscal year and avert a shutdown. Democrats are pushing for the legislation to include an extension of enhanced subsidies for those covered by ACA plans, which otherwise will expire at the end of the year and contribute to an increase in premium costs. But that proposal is already getting bogged down in longtime fights over abortion funding.
- The Department of Health and Human Services is expected to cite the use of Tylenol during pregnancy in a pending report on the causes of autism — despite a lack of definitive scientific evidence. And the remade Advisory Committee on Immunization Practices is scheduled to meet next week, while some Americans are struggling to access the covid vaccine.
- The lack of teeth in the MAHA report — along with the White House’s lengthy review before publication — suggests industry officials helped shape the final product. Plus, its calls for things like healthier meals in schools and hospitals amid federal funding cuts raise an important question: Who will pay for these policy changes?
- And the Trump administration is seeking changes to federal regulations on pharmaceutical advertising that could effectively kill drug ads on television, though free-speech rights could complicate that effort.
Plus, for “extra credit” the panelists suggest health policy stories they read (or wrote) this week that they think you should read, too:
Julie Rovner: NPR’s “What Kind of Dairy Does a Body Good? Science Is Updating the Answer,” by Will Stone.
Anna Edney: Bloomberg News’ “The Implants Were Supposed to Dissolve. They Didn’t,” by Anna Edney and Tanaz Meghjani.
Sandhya Raman: The Texas Tribune’s “Texas’ New Parental Consent Law Leaves School Nurses Confused About Which Services They Can Provide to Students,” by Jaden Edison.
Lauren Weber: ProPublica’s “‘Just Let Me Die,’” by Duaa Eldeib.
Also mentioned in this week’s podcast:
- The New York Times’ “As Trump Weighs I.V.F., Republicans Back New ‘Natural’ Approach to Infertility,” by Caroline Kitchener.
click to open the transcript
Transcript: Countdown to Government Shutdown
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Sept. 11, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So, here we go.
Today we are joined via videoconference by Anna Edney of Bloomberg News.
Anna Edney: Hey, everybody.
Rovner: Lauren Weber of The Washington Post.
Lauren Weber: Hello, hello.
Rovner: And Sandhya Raman of CQ Roll Call.
Sandhya Raman: Hello, everyone.
Rovner: No interview this week, but plenty of news. So let us dive right in. As of today, we are less than three weeks away from a government shutdown if Congress can’t pass all 12 spending bills — spoiler, that is not going to happen — or pass some sort of continuing resolution to keep the government funded while lawmakers continue working on the spending bills. Now, even though Republicans control the House, Senate, and the White House, it will take Democratic votes, at least in the Senate, to make any of this happen, because appropriations bills, unlike that budget reconciliation bill that passed earlier this summer, require 60 votes to pass rather than just 51. So how’s it all going, appropriations watchers? Sandhya, you’re there on the Hill.
Raman: It’s a work in progress. You know, I think there are a lot of different options kind of being floated around right now to try to avoid a government shutdown. So something our budget reporters reported yesterday is that House Republican leaders are trying to bring a clean CR to the floor next week, so the same spending levels that we have now through late November, early December. But that would include the ACA [Affordable Care Act] subsidy extension that the Democrats want.
There’s also, in the works right now, they’re voting as we speak, kind of, in the House on advancing three of the spending bills, but not HHS [the Department of Health and Human Services] and maybe attaching a clean CR for the rest to that. And whether or not that could eventually include something else that the Democrats want is unclear. Or it’s still in play where just now Democrats were speaking about how they want a very bipartisan — they won’t come to the table unless they’re getting their voice at the table. So it’s unclear if any of these three options are going to happen, just because so much is in flux right now and we’re still a couple weeks out from their deadline. And you know how Congress can be about this.
Rovner: Yes, three whole weeks — why should they do anything? Let’s talk about those ACA subsidies for a minute. We talked about them last week. Republicans are finally realizing that if they don’t extend the Biden-era tax credits that it’s going to be a lot of their voters who are going to see these sort of eye-popping premium increases. And the Democrats would like to sort of do a deal, but so far I’ve seen Republicans saying, Nope, not going to happen. At least not as part of this, keep-the-government-open continuing resolutions. That where they still are?
Raman: I think it depends on who you talk to. When you talk to some of the more hard-line Republicans, they just don’t want this continued. It’s something that you have to offset with a lot of money, and so they’re not on board at all. There are some of the more moderate Republicans in the House that have signed onto a bill last week that would extend it for a little bit, and so others have been a little bit more wishy-washy. But where they fall, I think that complicates things. We also have a new breakdown in the House right now where the Republicans only have a two-person majority, so it just makes it even more narrow for them to get something across if not everyone is aligned on this.
Rovner: And of course, because this is the Affordable Care Act we’re talking about, we’re going to have an abortion fight with this too, right?
Raman: You know I was just saying earlier that everything old is new again, that anytime that we get into this, we get into the debate of whether or not we include some sort of Hyde Amendment kind of language to say no federal funding for abortion except in rare circumstances. And so the anti-abortion groups have signed on and said, You should not support any sort of ACA subsidy extension that doesn’t have that language. Some of the Democrats have already come out saying that that’s a no-go. In the past, generally when we’ve had funding for health care, either if it’s in the approps cycle or something separate, there has been that language, so I’m not sure where that will land if they get to an extension. Just 15 minutes or so ago, House and Senate Democrats had said they really want to get to a bipartisan deal, but they didn’t kind of draw a line in the sand that if the ACA subsidies weren’t in whatever spending deal we get in the next few weeks that that would be a deal-breaker. So it’s complicated in terms of where the cards may land in the next few weeks.
Rovner: Long way to go.
Raman: Yeah.
Rovner: Well, meanwhile, the House Appropriation Committee this week approved its version of the bill that would fund the Department of Health and Human Services along with the Departments of Labor and Education. The House committee bill cuts HHS funding, but by far less than the Trump administration had asked, but still by a lot more than the more bipartisan bill approved by the Senate Appropriations Committee just before they left for the August recess. What is the outlook for HHS funding going forward?
Raman: I don’t think that we’ll see, whenever we get to some sort of deal, something super close to what we had advanced by House appropriators today, but I also don’t think that we’re going to see something identical to what the Senate did before recess. My guess would be a little bit more aligned with what the Senate did. They’re both run by Republicans, but that one did get, in the Senate, bipartisan support, and since they do need Democrats to pass it in the Senate, I could see it being a little bit more aligned there.
The Senate one had slightly higher spending and didn’t have as many of the new riders as in the House related to abortion and trans health and things like that. But we are in kind of a weird circumstance in that, earlier this year, instead of doing new funding, they renewed funding at the same level as last year for another year. So that’s also a possibility, which is not something that happens super often, in the past, and I don’t really see we’re getting a lot happening in either chamber until we get kind of a deal, just because they don’t have an agreement on any of the other funding really, either.
Rovner: One of the things that we do see particularly appropriators complaining about with, and we’ve talked about this, is this whole pocket rescission thing, the idea that they’ve appropriated this money, they’ve gotten a deal to pass this spending, Congress is supposed to be in charge of spending, and the administration isn’t spending money that’s been appropriated. Is there some possibility of putting in some kind of You must spend this money guarantee, or at least an effort to make a guarantee, in one of these bills? Or are they just sort of tiptoeing around this?
Raman: They’ve kind of tiptoed around that. I mean, they’re supposed to spend money. If they don’t, they can have the impoundment issues that they’ve had this year where they aren’t spending the money and get told that you’re violating the Impoundment Act, but that hasn’t seemed to stop some of these cases. I think there’s also a lot of things happening in this that haven’t happened before. We’ve had Russell Vought just kind of say that appropriations should be less of a bipartisan process than it has been. So I’m not sure if even adding that kind of language would necessarily mean that that wouldn’t happen or there wouldn’t be different ways around that.
Rovner: And of course, Russell Vought, the head of OMB [the Office of Management and Budget], is just itching to take this to the Supreme Court so that they can say that the Impoundment Act is illegal and that the administration can decide whether or not it wants to spend money that Congress has appropriated, which is obviously something that we will get to at some point with the Supreme Court, but I think we’re not quite there yet.
Well, moving on, the fallout continues from efforts at the Department of Health and Human Services to translate Secretary Robert F. Kennedy Jr.’s anti-vaccine views into policy. We now know that the ousted director of the Centers for Disease Control and Prevention, Susan Monarez, is scheduled to testify before the Senate HELP [Health, Education, Labor, and Pensions] Committee next week. That’s the committee chaired by Sen. Bill Cassidy, the Republican doctor who cast the deciding vote to confirm Kennedy back in the winter. The meeting of the CDC’s advisory committee on vaccines is also scheduled for next week. Do we know if that’s going to happen? I know several officials, including Cassidy, have called on it to be postponed. Anna, are you planning for it to take place?
Edney: I think, so far, planning for it to take place, but maybe not so sure what they’re going to discuss and whether the covid vaccines will be something that they’ll vote on, at least, because that’s what a lot of people are waiting on. That’s what has caused a lot of confusion is that the FDA [Food and Drug Administration] gave its limited approval to some of these, and then we haven’t heard ACIP’s [the Advisory Committee on Immunization Practices’] vote on that, or it hasn’t been held. And so insurers are finding ways not to cover those vaccines for some people, and people are confused whether they can get them. Pharmacies in some states need prescriptions to be able to give them out. So there’s just a lot of confusion around and people — the middle of September is already late, and so people were hoping, at least people who are interested and, once the confusion cleared up, were hoping that this will come up. But no indication for sure yet.
Rovner: One of Kennedy’s most stubborn pushbacks at last week’s hearing at the Senate Finance Committee was that he has not prevented people from getting the covid vaccine. Except in the ensuing days we’ve seen story after story about people who should be eligible for covid boosters but still haven’t been able to get them or, and as you said, haven’t been able to get them covered by insurance, even in some states where governors have tried to intervene to make them more available. I had a note from a friend in Oregon whose 80-plus-year-old husband couldn’t get the vaccine. I mean, obviously over 65 and couldn’t get a prescription from his doctor to get the vaccine because — and, of course, one of those states that doesn’t have MinuteClinics where you can go and get a nurse practitioner to give you the vaccine. I mean, what are you guys hearing about people’s ability to actually get this vaccine? We’ve now been sort of conditioned to: OK. it’s September. Kids are back to school. We should go and get our flu shots and our covid boosters.
Edney: Yeah, I think that Secretary Kennedy had said everyone can get it, and maybe there’s a tiny kernel of truth in there in the sense that if you knew all the work-arounds you could do it. Maybe you could find a way to get someone to put the shot in your arm. Who would pay for it, though? I mean, we’ve heard of people postponing because they’re hoping that insurance will cover it. They’d rather not pay $200. So essentially this is causing a lot of people to gamble with their health because they’re hoping in the next few weeks they don’t get covid while they’re waiting on insurance to possibly cover it and on direction.
So it’s not true that just anyone can get it if they want to, I don’t think, or those aren’t the stories that I’m reading, that I’m seeing, or even hearing. There was a colleague, actually, she had an interesting story. Her husband had, instead of signing up on the website for a pharmacy, because you have to answer the questions if you have any preexisting conditions, a lot of people don’t if they’re under 65. He just walked in and he said: Well, the pharmacist didn’t ask me anything there. They just gave it to me. So, I mean, people are finding ways, but it doesn’t mean that everyone can do it or pay for it.
Rovner: I feel like Kennedy has sort of conflated the I didn’t ban it with the Everybody can get it. Those are two very different things. Lauren, yes.
Weber: I mean, Kennedy also has previously said that the covid vaccine is the deadliest vaccine ever made and then claimed that [President Donald] Trump should get the Nobel Peace Prize for Operation Warp Speed. So there is a lot of dissonance between the secretary’s statements and sometimes with the reality.
Rovner: And I will note, actually going back to our budget discussion, that there was a bipartisan amendment at the House Appropriations Committee to restore the money for mRNA vaccine research that Kennedy cut. Who knows whether we’ll ever see that into law, but I was interested to see that Republicans joined with Democrats to sort of push back at that.
Edney: Yeah, I think mRNA has a lot of applications beyond vaccines that even hard-line anti-vaxxers could see. Is curing cancer a good idea, or treating it? I mean, it has a lot of other things that mRNA really is meant for.
Rovner: Yeah, and also the speed with which, I mean, that was what made Operation Warp Speed work was the speed with which you can actually make vaccines using the mRNA technology. Well, now, apparently, at least according to The Wall Street Journal, HHS is planning to link Tylenol taken in pregnancy to the rise of autism. Just the story appearing on the website tanked the stock of the drugmaker that makes Tylenol last week and has prompted quite the pushback from doctors and researchers as well as drugmakers. What do we know about the links between Tylenol, acetaminophen, and autism?
Edney: I think what we know is that there are mixed results in studies out there, that no one has definitively linked it. No one has definitively, either way. I think there’s sort of confusion. But the big study that they’re using out of Harvard to kind of say that Tylenol use during pregnancy causes autism, even the study’s authors say: That’s not what we were saying. We were saying that there is an association, but that doesn’t mean causation. I think that’s something we always come back to when we’re talking about studies. And in this sense, I think it’s unfortunate that the discussion is happening without more definitive answers.
Because when you’re talking about pregnancy, and if acetaminophen is the only thing a pregnant woman can take when she has a very high fever, then high fever can cause a lot of problems as well, and you’re scaring women off from, even, it can cause birth defects if the fever is high enough. The March of Dimes actually says there is concern that a high fever during pregnancy in the first trimester is linked to autism. So you just have this circle that nobody actually has any answers, and unfortunately I don’t anticipate that the autism report is going to provide them. It might provide more fear for pregnant women.
Rovner: Lauren, you want to add something
Weber: Yeah, I mean, Robert F. Kennedy Jr. has promised to have the cause of autism by September, which, many medical experts and autism researchers have cautioned, seems like that may not be a complete report, as this is something that has been examined for many years and it seems to be multifaceted. But I think it’s worth noting that in the lead-up to this report being due, we at The Washington Post, in looking at MAHA influencers, noticed that Tylenol has been 15 times more likely to be mentioned by these influencers in August as opposed to April. So there seems to be a lot of MAHA contingent around the Tylenol hypothesis that also potentially could be driving some of this, but we’ll see what happens when we see more of the report.
Rovner: So where exactly is President Trump on this whole vaccine issue? On the one hand, he’s been pro-vaccine in some of the comments that he’s made since Kennedy’s confrontational appearance last week at the Finance Committee. But he also posted on, he the president, also posted on his social media a video pushing the long-since discredited accusation that autism is linked to the vaccine preserved with thimerosal, which hasn’t even been in most childhood vaccines for the last two decades. I feel like the president’s kind of walking this fine line waiting to see which way public opinion falls.
Weber: I think that’s right, Julie. I think also we have to go back. The president has a history of making vaccine-skeptical comments. I mean, in presidential debates he’s asked questions about vaccines being too big for a horse for children. I mean, he’s said, certainly, things that are of vaccine-skeptical rhetoric. That said, I think he and others have seen polling recently that shows that vaccines are overwhelmingly popular. The vast majority of Americans do vaccinate their children, and while he is conscious that Kennedy and the MAHA movement brought him voters, I think he’s maybe being counseled by others that he could lose voters if he goes too far. So if anything, the man has a shrewd assessment of what’s going to win him political points. So it seems to me that it’s a messaging to both sides of the fence and it’s kind of a You pick the message you want to hear so you can stay in the tent kind of vibe is how I am interpreting it.
Rovner: Yeah, that’s my impression, too. And as we know, he’s very good at being on all sides of an issue until he actually has to come down one way or the other. Well, there was a lot more from the Department of Health and Human Services this week than just vaccine news. Secretary Kennedy issued the second part of his long-awaited Make America Healthy Again strategy to improve children’s health. It didn’t mention some of the biggest threats that we know about for children’s health, like gun violence, climate change, or tobacco. It did mention things Kennedy has talked about a lot, like exposure to chemicals and ultraprocessed food, but it didn’t really lay out concrete plans for how the administration plans to address those concerns. So what does this report say? And do we think it got watered down by the White House? Do we think it might’ve been stronger at some point?
Edney: I think with what I saw with the report when I read the report is sort of a list of a lot of the things that Kennedy would like to focus on that he sees as the biggest threats to children. Although it got watered down, I think, for sure throughout this process and certainly potentially as the White House held it for about a month or so from coming out. But a lot of people have made the point that Kennedy had to work with the heads of the EPA [Environmental Protection Agency] and the Agriculture Department on this, who are in many ways more aligned with the chemical companies and the big farmers than Kennedy himself might be or had wanted to be in this.
So you kind of lost any ability to maybe go after chemicals in the food supply or things like that. And so there weren’t a lot of concrete things that it would do or ways forward, which I would expect in a large administration report like this is kind of more of the next steps, not just the list of what’s going on. And I imagine we’ll talk about it, but there was one piece in that with drug ads that it kind of simultaneously came out with the report.
Rovner: Yes, we’ll get to that next.
Edney: Yeah, so I assume we’ll talk about that. So maybe they have some plans on some things that we just don’t know about yet. But I think that that has, for me, been a struggle in covering and watching this administration is there’s been a lot of talk and it’s hard to know what the rhetoric is versus what is actually being done. And I kind of see that continuing, and even with drug ads, when we talk about that and get there.
Rovner: Yeah. Lauren, you’ve obviously been following the MAHA movement pretty closely. What was your take from this report?
Weber: Well, my takeaway from this report is I was fascinated there were no footnotes, so there could be no AI conversation like the last time we talked about this on the podcast. But no, my other takeaway was, clearly, as Anna pointed out, it seems like industry influence had watered down some of the big pushes of the MAHA movement around pesticides. And I also, my biggest takeaway is: Who’s paying for all of this? I mean, they promised healthy, nutritious foods in schools, VAs [Department of Veterans Affairs facilities], hospitals. These are things that nutritionists have wanted for a very long time. There was talk of MAHA boxes. Where’s the funding? I mean, as far as I understand, all the funding’s getting cut everywhere I turn around. So I’m curious where the funding for this transformation of America’s health care is coming from. And I also think it’s worth noting that in there there was a conversation around some pet projects among folks that are involved in the Trump administration. I’m very curious. Right now it was basically a bullet points with no action plan. So as Anna smartly pointed out: When will the rhetoric become reality? We shall see.
Raman: I was just going to agree with Lauren. That was kind of exactly my takeaway is that if you’re calling for more research and this and this and then the White House at the same time, when they put out their budget proposal, they called for a 40% decrease in NIH [National Institutes of Health] funding. It just seems counterintuitive. And even thus far in the appropriations process, the Senate didn’t even have money for MAHA in theirs. The House did. But we don’t know if that happens. And so I am very curious how they would get to do some of these things that they’re exploring, because it really did seem more like an executive order in the formatting, is like: This is early on. Explore this issue. Rather than Here are concrete things we need you to do.
Rovner: And I would just, to underscore something that Lauren said, a lot of talk about how to improve nutrition for kids and things about the SNAP [Supplemental Nutrition Assistance Program] food stamp program, then at the same time that the “Big Beautiful Bill” cut food stamps. So there is sort of right hand not recognizing what the left hand is doing. Well, Anna, as you mentioned, on the same day, the administration issued its not-so-earth-shaking MAHA report, the president signed an order that could end those annoying direct-to-consumer TV ads for pharmaceuticals, at least as we know them.
This is the moment where I get to repeat the fact that the U.S. and New Zealand are the only developed countries that allow drugmakers to advertise their products on TV. The executive order purports to return to the status quo before 1997, when drug companies basically couldn’t advertise on TV, because they were required to talk at so much length about possible side effects and contraindications. Now, I think both Republicans and Democrats in the past 28 years would’ve loved to have taken this same action. Drug ads aren’t exactly popular with the public. But there’s a First Amendment issue here, right? Something about commercial speech?
Edney: Yes. Yeah, certainly. It seems like long ago the train left the station on banning these pharmaceutical ads completely, because the free-speech protection seems to have encompassed this and it feels like no getting rid of them. There’s been no successful effort. So what the Trump administration has said that they’re going to do is change that regulation that allowed them, the drugmakers, to water down their statement in those ads on all of the awful side effects that can happen to you by taking drugs. And so right now in a drug ad, they can just say, Talk to your doctor and visit this website to see what the side effects are.
And so they want to roll that back and so be able to take it back to having to list all of them, which if you’ve looked at a drug pamphlet, a prescription drug pamphlet, I mean, that could take several minutes to get through, and so effectively possibly killing a lot of these advertisements. I think this is still a situation that where the devil’s in the details. We haven’t seen the regulation. And I feel like this happens pretty often where they say they’re going to roll back a huge thing and then it becomes a little bit different than that when the actual regulation is out. But you never know. I mean, I would love — I’m not a fan of drug ads, either, so it’s not like I need to listen to them on the—
Rovner: Yeah, could they at least get rid of the jingles?
Edney: Right. So you don’t say them all day in your head.
Rovner: Yes.
Edney: But yeah. And then they said that, the FDA commissioner said, they were going to be sending out warning letters to potentially thousands of companies, and Just to let you know, we’re going to be cracking down on this, because that’s not something the FDA has done a lot in recent years, making sure that they’re complying with regulations in their advertisements. But they made it into more of a — a warning letter’s a very strong thing that the FDA can do. What this is is more of a form letter saying, Just to let you know we’re going to, not that you specifically violated it, but we’re going to start cracking down on this. So I’ll be curious to see where this lands. They also want to go after more of the social media influencers because they don’t fall under these regulations, so bring them more in line with the idea that they need to talk about the side effects and not just how much weight they quickly lost or something along those lines.
Rovner: But certainly we would expect the drug companies, if not TV networks, to sue to protect the right to run these ads, in cases of the networks to get paid to run these ads.
Edney: Definitely. I think that there’ll be some litigation over this, and that first requires the regulation to be made, and so that also takes some time. So this could be a kind of a long haul.
Rovner: Yeah, it was actual big news. Well, last week we caught up with some but not all of the reproductive health news that happened over our break. One thing I didn’t want to leave out is that lawsuit that the Supreme Court threw out earlier this summer, challenging the FDA’s approval 25 years ago of the abortion pill, mifepristone. It is not dead yet. While the justices said the anti-abortion doctor group that sued originally did not have standing to sue, since then three states — Missouri, Kansas, and Idaho — have replaced the group as plaintiffs, and now Texas and Florida are asking to join the suit as well. Sandhya, the original suit sought to wipe away the FDA’s original approval. That’s now off the table. But the states do want the courts to effectively end the mailing of the pills and return to the FDA’s tighter rules that were enforced before the pandemic, right? Just that could have a major impact.
Raman: It really could, just, if you look at in the last few years, how much of it, abortion, is medication abortion, how much of that has been telehealth after covid, and if you look at what’s happening in some of the states right now. Texas has cracked down on it. But then there’s [Texas] Attorney General [Ken] Paxton last year had sued a doctor in New York for allegedly mailing medication abortion to Texas. And then just this week, the attorney general of New York, Letitia James, has intervened in that lawsuit. So it’s going to be a battle between two of probably the most front-and-center attorney generals, especially in these kinds of issues. So I think with those odds, it’s something that I would definitely watch to see does this go back to the Supreme Court at some point. Even if it’s not this case, this issue is rising up again.
Rovner: Yeah, that’s right. That’s what I was going to say. I mean, at some point the Supreme Court is going to have to adjudicate this question about these blue-state shield laws. Not only has Texas gone after this doctor in New York, Louisiana, I believe, has indicted this doctor in New York, has tried to charge her criminally, which Attorney General James in New York is also trying to prevent. So I mean, we’re going to see this come to the Supreme Court at some point, right?
Raman: I do think so. Just because of how front and center this within the whole movement has kind of become, and especially I think even if we look past, in the past few weeks, how much more mifepristone has come up is something that Republicans want HHS to look into. RFK Jr. has brought it up. There could even be changes on that level that spur a lawsuit, or I think that there’s a lot going on, and so even if it’s not this specifically, something else will nudge it that we see that elevate.
Rovner: Well, meanwhile, anti-abortion groups, or should I say anti-in-vitro-fertilization groups, are now promoting something called “restorative reproductive medicine” as an alternative to IVF. According to Caroline Kitchener writing in The New York Times, quote, “the concept addresses what proponents describe as the ‘root causes’ of infertility, while leaving I.V.F. as a last resort,” close quote. Groups that support IVF are not amused. The American Society of Reproductive Medicine, which represents doctors that treat infertility, calls “restorative reproductive medicine” and “ethical IVF,” quote, “misleading terms that threaten access.” Sandhya, is this yet another effort to ban reproductive technologies that have pretty broad political support by basically rebranding bans?
Raman: You know this one is interesting because it also, to me, has a tinge of kind of what we see in MAHA in that it’s kind of pointing to We’re doing this whole-person thing to elevate health care in the same way that they’ve said: It’s not that you’re having these issues because of something you need medicine for. It’s the food. It’s the chemicals and that kind of stuff. So I’m curious, A, if this gets kind of elevated more just because there’s similar thinking in both of those, but also just kind of how the messaging plays out. When we’ve had some of these IVF battles, we’ve had people walking kind of a fine line because maybe they’ve used it themselves or someone in their lives had but that they know that some of the people in their base do have some issues related to if all the embryos get used and things like that. So elevating this does seem like something that would be politically easier for certain people to message on, but I’m not sure.
Rovner: Lauren, you want to add something.
Weber: Yeah, I mean, I think we talked about Trump toeing a political line earlier in this podcast, and I see this as a similar version of that. I mean, this is the president who vowed to expand access to IVF, but some of his hard-right conservative base has issues with it. They see it as potentially interfering with life itself. And so I think offering up this alternative health care strategy, which, to be clear, there could be good things in there — treating women with endometriosis, investing in the root causes of infertility. There’s nothing inherently wrong with that. In fact, there’s a fair amount of lack of information where it becomes questionable and where I—
Rovner: There’s also, I said, there’s nothing inherently controversial about any of that.
Weber: No, I think there’s a lot of people that would be very excited about that. I think where it hits a line that’s confusing and that Caroline’s story kind of gets into is, is it at the expense of — that’s usually the entry point, which a lot of these health organizations have made clear. Those are all great things to do, but at some point there is potentially a need to hit the next step, and there is concern that this movement could replace the push for IVF. And so I think that tension point and how Trump and the administration is kind of toeing that line with both the MAHA group and the far right is really interesting.
Rovner: Yeah, I mean, I would add that IVF is expensive, involved, unpleasant. It’s not something that people turn to as a first choice anyway, so I was a little bit sort of taken. It’s like, yes, I would think that people with infertility do explore most of their other options first. But yes, what’s wrong with having more research to try and solve the problem before you actually have to resort to IVF? We will watch this one as well.
All right, that is this week’s news. Now it’s time for our extra-credit segment. That’s where we each recognize the story we read this week we think you should read, too. Don’t worry if you miss it. We will put the links in our show notes on your phone or other mobile device. Anna, why don’t you go first? You have your story, which I’m really glad you’re doing.
Edney: Thank you. Yeah, I appreciate that. So mine was from last week: “The Implants Were Supposed to Dissolve. They didn’t.” So I did an investigation into this device called BioZorb that’s made by a company called Hologic. And they have a huge women’s health division and a breast division that — so a lot of mammogram machines that they sell and things like that. But they were selling BioZorb. It was supposed to revolutionize breast cancer treatment because, at least the idea, this isn’t what they had FDA approval for, but what it was talked about as is something that could help women when they were healing, that their breasts would grow back after a tumor was taken out. Their breasts would grow back more, heal more full-looking, not have dips and maybe other deformities that can happen with a lumpectomy. And instead, these women have experienced all kinds of awful infections, and some people actually had the device poking through their breasts because it was supposed to dissolve, but it was years where some people still had it.
A woman I talked to, it shattered inside of her. So there were 24 pieces of plastic, sharp shards in her breast that were causing immense pain. A lot of people complained about pain, but the key to this is that Hologic and a company that invented the device and sold it early on, called Focal, were hiding these complaints. They were not handing them over to the FDA as they should have, and some for as long as 10 years. So nobody knew what was going on, but women were still being implanted with the devices. I think it’s just a bigger story about oversight of devices and also how devices come to market, because this device was never studied in humans, in women, despite it being implanted inside of them. And that’s actually really typical to how devices make their way through the FDA.
Rovner: Really important investigation. Thank you. Sandhya.
Raman: So my extra credit is called “Texas’ New Parental Consent Law Leaves School Nurses Confused About Which Services They Can Provide to Students,” and it’s at The Texas Tribune, by Jaden Edison. And I picked this because I thought it was something really interesting that I’d never really thought about before, but there’s a new law in Texas that you have to get parental consent before the nurse or whoever at the school can do health services for students. And they’re getting more confused about if they would also be penalized for handing out Band-Aids or ice packs or just first aid. And school districts are required by the law to discipline violations of the law, but how it’s kind of being done across the state is a little varied, and some places have been saying they’ll only even intervene if it’s life-threatening. So I think it’s interesting as part of the parental consent movement of when is this something that is debilitating and if someone doesn’t have a form signed, how that’s going to affect kids at school.
Rovner: Yeah, a lot of good discussion about thinking things all the way through. Lauren.
Weber: Mine is titled “‘Just Let Me Die,’” by ProPublica, written by Duaa Eldeib. And it is just a heartbreaking tale, one that ProPublica has been doing really well, where they examine the fact of prior authorization and what it means for patients. And it’s about a gentleman who was trying to get approved for mental health stays after several suicide attempts. It’s a gutting story. And the reviewer at the end of the appeal process, he was so appalled by what had happened that he called the wife of the man who had been trying to get these appeals. And it’s an important read, especially as Congress is weighing things on prior authorization and as [Centers for Medicare & Medicaid Services Administrator Mehmet] Oz has vowed to expand prior authorization for some things. So a lot here to be unpacked. And ProPublica, again, big props for how they’ve covered the prior auth issue in the last couple of years.
Rovner: Yeah, it’s been fodder for a lot of — really a lot of — good stories. All right. My extra credit this week is from NPR by Will Stone. It’s called “What Kind of Dairy Does a Body Good? Science Is Updating the Answer,” and it’s a really clear story about how it turns out that full-fat dairy, at least in some cases, isn’t nearly as bad for you as other high-fat animal products appear to be. It looks at this one case where science is working as it’s supposed to, with researchers continually updating and refining what they know and recommend. Bottom line seems to be that full-fat cheese and yogurt — probably not bad for you, maybe even good for you. But butter? Still not great. It’s too bad for me. I like butter. Also, what matters is what else is in your dairy products. It’s one of those really well-done pieces that it’s like: OK, this is what we know. This is what we’re trying to find out. This is what’s new. This is the kind of consumer-helpful information we should have more of.
OK. That is this week’s show. Thanks as always to our editor, Emmarie Huetteman, and our producer-engineer, Francis Ying. If you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review. That helps other people find us, too. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me on X, @jrovner, or on Bluesky, @julierovner. Where are you folks hanging these days? Sandhya.
Raman: On X and on Bluesky, @SandhyaWrites.
Rovner: Anna.
Edney: Same places, @annaedney.
Rovner: Lauren.
Weber: Same spots, @LaurenWeberHP. The HP is for “health policy.”
Rovner: We will be back in your feed next week. Until then, be healthy.
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