Drug safety policies often driven by disasters

How Tragedy Changed the FDA

By Sara Talpos

For decades, the U.S. Food and Drug Administration has served as a gatekeeper, tasked with preventing dangerous, ineffective, and under-studied pharmaceuticals from being placed on the market. 

If you take Wegovy to help treat obesity, Lipitor to manage high cholesterol, or Xanax to quell anxiety, you’re taking a medication that the agency has decided provides more benefits, on net, than harms. Where does its authority come from — and why was it granted?

Mikkael A. Sekeres, a clinical scientist and author, explored these questions in his 2022 book, “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust.” Although Sekeres drew on his experiences as a member of a government advisory committee in 2011, the themes in his book continue to be timely today, particularly the question of how much evidence — and what kind — the government should require for a medicine to be prescribed to patients.

An FDA advisory committee met to weigh whether specialized pharmacies should be allowed to dispense seven unapproved peptides and approved them. These substances, with robot-like names such as MOTs-C and BPC-157, have not completed the rigorous testing required for drug approval. Still, they are relatively easy to obtain on the gray market, and they’re popular among the public and key figures in the Make America Healthy Again movement.

Against that backdrop, Sekeres, who is chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, spoke with Undark about the history and nuances of FDA oversight, including its process for screening advisory committee members for conflicts of interest. The interview was conducted by Zoom and edited for length and clarity.

How to do your own online health research like a scientist

A scientist offers her advice

Lucy McGowan, Wake Forest University

The instinct to “do your own research” when it comes to your health is a good one. The challenge often is not lack of information, but the opposite.

People are surrounded by studies, headlines, forums, family and friends, often all speaking at once in different directions and with different levels of reliability. How do you move through this abundance of information without getting lost in it?

I am a biostatistician by training. In my work, I study how medical evidence is generated and interpreted. 

I have been on the other side of that process, trying to make sense of medical information that could affect my health or the health of my loved ones.

Over time, I’ve found myself returning to the same road map when doing my own research to answer personal health questions. 

By sharing how I approach this process as a scientist, I’m hoping this method can help others sift through medical information carefully.

AG DINO candidate aligns with League of RI Businesses shabby electoral practices

Joseph Solomon Jr. is asking Republicans to disaffiliate and vote for him in the Democratic Primary for Attorney General

Steve Ahlquist

Here's how Charlestown DINO and sex crimes
defense lawyer Leah Boisclair hopes
to win the Sept 9 Democratic Primary: Get Republicans
to change party registration so they can sneak her in.
Incidentally, if you drive down Route 2, most
Boisclair signs now have Joe Solomon signs
right next to them.  - Will Collette

State Representative Joseph Solomon Jr. is one of the four people running in the Democratic Primary to be the next Rhode Island Attorney General. [The other candidates in the race are Kimberly Ahern, Keith Hoffmann, and Jason Knight.] 

Solomon is a conservative Democrat who voted against the codification of Roe v. Wade into Rhode Island State Law and against the assault weapons ban that went into effect on July 1. 

At the Southside Justice and Policy Debate, Representative Solomon took some hits from other candidates:

Jason Knight: I voted to put Roe v Wade into state law so that Rhode Island women were protected when the Dobbs decision came down and stripped that right away from everyone else in the rest of the country if the state hadn’t covered abortion services. Joe Solomon voted against that bill. That’s a lukewarm response from one of the candidates up here on an issue that is so critical to all of us in Rhode Island, certainly all the people that I care about.

Joseph Solomon Jr.: Let’s get this straight: I am committed to protecting a woman’s right to choose. You hear me say it now, and you’re going to hear me say it forever. I voted for the SHIELD Act, which would protect women and their doctors from out-of-state enforcement. I voted for the Equity in Abortion Coverage Act, which would provide Medicaid coverage for those who couldn’t afford it. And I’m committed to fighting the Trump Administration to protect a woman’s right to choose. My vote from years ago [2019] was before the Dobbs decision.

Once the Dobbs decision came down, it changed the entire landscape. And now I am committed. Hear me now, hear me later: I’m committed to protecting a woman’s right to choose.

Later:

Keith Hoffmann: I support a high-capacity magazine ban and an assault weapons ban because I have two children and I worry about their safety every single day, and so do you. Everybody in this community deserves to be safe from illegal firearms that should not be on our streets. Those laws need to be aggressively enforced by the next attorney general and me, and that is a difference between Mr. Solomon and me as well.

Joseph Solomon Jr.: As a bail commissioner, I need to go after the illegal guns all the time. Over and over, I see the same repeat offenders with stolen guns and with guns with serial numbers shaved off. We need to go after those violent offenders, the ones causing the crimes. We need to be careful not to go after the person who might be a lawful gun owner, because sometimes the laws that are passed, even though they have fancy names and whatnot, if you look at the details, they encompass people just like you and me, who may potentially be committing a crime because of how it was written. It is so important that we look at the details. [italics added]

It should be noted that Representative Jason Knight championed the Assault Weapons Ban bill in the House.

I thought Representative Solomon’s statements about the assault weapons ban were interesting, so I watched his appearance on the July 27, 2026 episode of the Cumberland Unfiltered podcast, hosted by Caleb Minson, Brad Dean, Jason Dean, and Andrew Bacon. Jason Dean and Andrew Bacon are members of the Cumberland School Committee. 

The guests on the show are extremely conservative. They’ve featured Mike Stenhouse, founder and CEO of the Rhode Island Center for Freedom and Prosperity, a right-wing public policy think tank; Moms for Liberty; and anti-trans Christian Nationalist Robert Chiaradio.

Here’s the video with Joseph Solomon Jr. and a transcript edited for clarity: Joe Solomon - Rhode Island Attorney General Candidate

And behind him is a communist

Here's what Trump's "evidence" of 2020 election "fraud" actually showed

Trump and Bobby Jr. continue relentless attack on life-saving vaccines.

Trump signs executive order to break up measles, mumps, rubella vaccine

Sarah Boden and Chris Dall, MA

Donald Trump is calling to "break up" the measles, mumps, and rubella (MMR) vaccine, which would require more visits and shots, instead of using a two-dose regimen to deliver the three immunizations. 

Separating out the MMR vaccine is among the recommendations in an executive order signed by the president today that urges all childhood vaccines be administered at separate visits.

“For example, at one year, you should have five separate visits for vaccines rather than getting them all in the same day," President Trump said at the signing.

There are no data to show that spacing out the MMR immunizations—or other childhood immunizations—is beneficial, but doing so could increase the risk of infection or lead to kids missing doses. And it adds to vaccination costs.

Also, breaking up the MMR vaccine could be difficult, at least in the short term, as this would require buy-in from pharmaceutical manufacturers to make three separate vaccines. And the proposed three separate vaccines are not currently licensed in the United States nor approved by the Food and Drug Administration, which would take some time.

‘None of this is reality-based’

The executive order makes no mention of autism. Yet, at today's signing, Trump and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. repeated a long-debunked falsehood that vaccinations are possibly associated with the neurodevelopmental condition. There is no link.

The executive order will do nothing to support families of children with autism or advance understanding of it, said a statement from Andrew D. Racine, MD, PhD, president of the American Academy of Pediatrics (AAP).*

Racine added that pediatricians recommend that children receive certain vaccines at specific ages based on when children's immune systems will respond best and when they are most vulnerable to certain diseases. 

Tonight, Charlestown Town Council Considers Banning Data Centers, Battery Storage Facilities

Prevention is better than damage control

By Rob Smith / ecoRI News staff

Town officials are poised this month to make Charlestown the second municipality in the state to ban data center projects, as well as utility-scale battery storage facilities.

On Aug. 11 the Town Council is scheduled to hold a public hearing and potential vote on an ordinance that would prohibit both types of projects from being proposed and built in Charlestown. The ordinance was unanimously recommended for adoption by the town planning commission in July.

Data centers, even in little Rhode Island, have made waves and stirred controversy. Smithfield made headlines earlier this year when Revity Energy, a renewable energy developer based in Warwick, showed interest in potentially building a data center on the site of Hanton City, an abandoned Colonial-era village that to this day is still relatively untouched forestland.

Smithfield banned data center developments in early May, but the Hanton City development could still squeak through, since Revity Energy filed its application for it the day before the Town Council approved the ban.

“We have a lot of concerns about what’s going on in other towns,” said Deborah Carney, Charlestown’s council president, in a phone interview with ecoRI News. “We’d rather, and I’ll be blunt, nip it in the bud.”

Carney said the town is a poor choice for a data center. The massive computer facilities require huge amounts of electricity and large amounts of water to cool the systems. Charlestown, said Carney, relies mostly on septic systems and private wells.

“We have no public water, no public sewer, it would be a massive drain on local resources, the environment, the noise, the increase in utility bills, all the stuff that comes along with these data centers,” Carney said.

Included in the ordinance scheduled for consideration Tuesday is an additional prohibition on utility-scale battery storage systems. Battery storage, to date, is a little-used technology at utility scale in Rhode Island. The state only has a single 3-megawatt (MW) facility operating in Johnston, and state regulators have only recently begun drawing up regulations and tariffs to make the projects economical.

Like data centers, battery storage has found itself at the center of public controversy. It works by drawing power from the grid when people use less electricity, like at night, and discharges power back into the grid at peak times, like in the afternoon and early evening.

Earlier this year, Green Development LLC, a Cranston-based developer of ground-mounted solar arrays, proposed building a lithium-ion phosphate battery facility that could store up to 208 MW of power in North Kingstown.

The project was proposed on 10 acres on Callahan Road in the Quonset Business Park, a commercial and industrial development area operated by the Quonset Development Corporation (QDC), where state officials often exercise more control and authority than local officials.

Residents of North Kingstown have expressed repeated concerns over developments in Quonset, including an active asphalt plant that began operations last year. Residents also expressed concerns about the battery-storage facility and the possibility of fires from the lithium-ion batteries themselves.

Carney had originally floated the idea of banning battery storage systems back in May, after a resident sent her some information on the systems, and after another council member suggested the data center ban, the town solicitor merged the two bans into a single ordinance.

“After reading it, I said yeah this is something we should look at prohibiting in Charlestown,” Carney said.

The ordinance excludes batteries used by consumer products, electric vehicle batteries, and the battery packs that often come along with rooftop solar panel installations. If passed, it would be the first-of-its-kind ban for battery storage in Rhode Island.

The Town Council is scheduled to meet Tuesday at 7 p.m. at Town Hall.

RFK Jr.’s Cooking Show Continues Long Line of Trump’s Obsession With Reality TV

Here's an idea: let Bobby do this full-time and pick a new HHS director who isn't crazy

By Chris Walker

This article was originally published by Truthout

Robert F. Kennedy Jr., the current Secretary of the Department of Health and Human Services (HHS), has launched a new food show that focuses on the questionable dietary guidelines he issued earlier this year.

“The Real Food Show,” which can be watched on the HHS website, debuted last week. The meals presented on the program fall in line with Kennedy’s so-called “upside-down” food pyramid, which emphasizes eating meats, dairy products, and fatty foods. 

When that dietary guideline was launched in January, many critics noted that its focus on those foods could be harmful to many groups of people, as they are drivers of cardiovascular disease, diabetes, obesity, and other health issues. 

Despite these concerns, Kennedy — who has neither a medical nor professional dietary-related background — stood by his version of the food pyramid.

Yet another example of the comeback of an
ancient disease on Bobby Jr.'s watch

“When we published the dietary guidelines, there was immediately sort of a good reaction, but also a little trepidation from the public and from critics saying that this food is a lot more expensive than the ultra-processed food that we’ve been eating. And that’s not true,” Kennedy said ahead of his first show.

Notably, food prices overall have increased under the Trump administration over the past year, with the most recent Consumer Price Index Report (CPI) indicating that costs overall have gone up by 3 percent — including an increase in milk by 6.6 percent and ground beef by 12.4 percent, two staples that are featured in Kennedy’s upside-down pyramid. 

Kennedy’s focus on an HHS-based reality TV show comes as the U.S. is dealing with a nationwide cyclospora outbreak, which the Centers for Disease Control (CDC) stopped monitoring last year under his watch (the diarrhea-inducing parasitic endemic has spread to 45 states). 

It also comes as Kennedy has failed to address the rapid increase in measles cases over the past two years — after being deemed virtually eliminated since 2000 (with only 285 cases being identified in 2024), last year, there were 2,286 measles cases identified. So far, as of July this year, the U.S. has already surpassed the total number of cases seen in 2025. 

Six Supremes Put Elections up for Bid

They put their thumb on the scale for the 2026 election

By Gerald E. Scorse

Statistics suggest that our current Supreme Court justices have some of the highest IQs in America. It seems fair to conclude, then, that six of them knew exactly what they were doing when they effectively put for-sale signs on the executive and legislative branches of the U.S. government—on the presidency, on the Senate, on the House of Representatives.

The deciding six were Chief Justice Roberts and Justices Alito, Barrett, Gorsuch, Kavanaugh and Thomas. Definitely and positively, all six realized the message they were sending to candidates and their big-money organizational contributors: You can do whatever you want; the campaign spending limits of the past 55 years have become past history.

Their decision came on the last day of the Court’s term, in the case National Republican Senatorial Committee v. Federal Election Commission. The ruling strikes down 1971 and 2001 decisions that limited how much money political parties could spend in coordination with candidates. The justices ruled that any cap on such spending violated the First Amendment’s free-speech rights.

Justice Kagan’s dissent underlined the decision’s gift to candidates. The ruling, she argued, “ushers in the same opportunities for quid pro quo corruption that the [prior] contribution limits were meant to check.”

“As a result,” she wrote, “a donor will be able to give a party as much as half a million dollars (as compared to the $7,000 he can give directly to the candidate) to cover the candidate’s bills. And the candidate can seek just such a donation.”

The public was all in for Kagan. By huge margins, Democrats and Republicans alike opposed the decision. Only 25 percent of GOPers approved, compared to 22 percent of Democrats. On every other decision this term, the approval difference between the major parties was over 30 percent.

An ecstatic Donald Trump responded in his over-the-top Truth Social style: “The Supreme Court just took restrictions off political spending! A BIG WIN FOR REPUBLICANS and…the First Amendment!”

It absolutely was a major win for Republicans. While individual Democrats are out-raising their GOP rivals heading into the midterms, the Republicans have a $600 million advantage for the kind of campaign financing just greenlighted by the Court.

As for Trump’s First Amendment “WIN,” here’s a sharply different view from Michael Waldman, president and CEO at the Brennan Center for Justice at NYU Law: “[The] campaign finance ruling is part of the Roberts Court’s 16-year drive to destroy anti-corruption laws. From Citizens United forward, these justices have ushered in an era of massive money in politics.” The court not only overrode Congress, it went “against the wishes of the vast majority.”

Lawyer and former Congressman Colin Allred was even more scornful: “The Supreme Court term that just ended was, in my considered legal opinion, one of the worst in modern history.”

Let’s finish up by circling back to the beginning, when six injudicious justices ignored an eternal political truth. That truth was glaringly obvious to two major figures from America’s past, Thomas Paine and George Washington.

Paine made tax proposals that would have limited income to the equivalent of about $27 million in today’s dollars. He saw the limit as a necessary guardrail; for him, extreme wealth gave the rich an “overgrown influence” and was “one of the principal sources of corruption at elections.” For Paine, money and politics made for a toxic mix.

It wasn’t big money that worried George Washington, it was anything at all. Washington “was always very reluctant to accept any kind of gift because he was afraid people might interpret it as a bribe.”

Conclusion: Six smart Supremes made a supremely stupid decision.

This article first appeared at www.nydailynews.com. Gerald E. Scorse helped pass the bill requiring basis reporting for capital gains. He writes on taxes. His articles have appeared often in Progressive Charlestown.

Solutions to US military's ammunition shortage

Charlestown blood drive on Aug. 13

Westerly Demo on Aug. 12

Why so many of us can’t let go of our old electronics, and what we can do about it

Lost in your junk drawer

Eric Williams, Rochester Institute of Technology; Payam Saeedi, Rochester Institute of Technology, and Stacey Watson, University of Waterloo

Think about the last smartphone, tablet or smartwatch you stopped using. Odds are it is not in a recycling bin or a new owner’s hands; it is sitting in a drawer.

From our survey of 4,000 American consumers, we found the single most common thing people did with a device they were finished with was nothing at all: 39% simply stored it. Recycling and reselling, outcomes better for the environment, each accounted for only about 1 in 10 devices. Throwing devices in the trash claimed another 9%.

Funded by the National Science Foundation, our multidisciplinary team blended our expertise in causal inference, sustainability and cybersecurity, to work on the tangled question of what people do with their consumer electronics when they’re done using them. We used statistical models to connect what people say – that is, their stated knowledge and attitudes – to what they actually did.

Why the drawer wins

Two main forces keep devices in the drawer. The first is anxiety about data. People who worried that recycling or reselling a device would compromise their data were 14% and 9% more likely to store it instead.

The second force is simply not knowing how to. People who did not know where to recycle were 10% more likely to hold onto a device, and many also kept old gadgets as a perceived data backup.

Recycling and reselling electronics are a lot easier than a lot of people think. In the U.S., the national chain Best Buy accepts devices for recycling; reselling online is convenient with vendors such as Back Market and Gazelle.

The Cyclospora outbreak was, and still is, a communications failure

Not to mention corruption

Jess Steier, DrPh

The response to the current large outbreak of food-related illnesses caused by a microscopic parasite is a communications failure, not a failure of the investigation. 

A few characteristics of Cyclospora make it tricky to chase down. Because it will not grow in culture, the standard playbook doesn't apply. With most foodborne bacteria, a lab grows the organism, sequences it, and uploads the genetic fingerprint to PulseNet, the national network that flags when a case in one state matches a case in another. 

The US Centers for Disease Control and Prevention (CDC) has instead been working from partial genotyping, because Cyclospora's genome is complicated enough to defeat the sequencing methods that work for bacteria. 

Cyclospora contamination on produce is often sparse and unevenly distributed, and it tends to sit close to the limit of what a test can detect, which is how contaminated lettuce ends up testing clean. Investigators were left with the oldest tools in the kit: interviews and shipping records.

Important early clues widely missed

Dr. Mike Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy (which, of course, publishes my CIDRAP Op-Eds), taught me that when cases start rolling in, the demographics of who is getting sick can hand you an important early clue. 

These cases skewed heavily toward adults, with the CDC putting the median age at 44 across a range from 1 to 89 years, and the relative absence of young children pointed toward something green rather than something fruit. 

If you have young kids you know exactly why. They are devoted fruit eaters. (I used to joke that my daughter was going to turn into a strawberry.) But more spotty toward veggies.

That narrows things, but the hunt continues. There are other important factors, too, like understanding how a growing region is organized into blocks, when each produce item was cut and by whom, how product from different fields gets combined at a processor, how long it takes to move from a field in central Mexico to a restaurant in Michigan, and how fast a perishable product cycles off the shelf. 

RI Bug Alert: More West Nile, new detection of Jamestown Canyon virus