Tag: research
Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

By appointing Dr. Vinay Prasad to run the Center for Biologics Evaluation and Research, the Trump regime has installed another prominent opponent of Covid-era public health policies to a key position at the Food and Drug Administration.

CBER is responsible for ensuring the safety and efficacy of vaccines, biologic drugs, gene therapies and the blood supply. When FDA Commissioner Martin Makary announced Prasad’s appointment yesterday, he noted the 42-year-old oncologist-epidemiologist has published hundreds of articles in the medical literature. I read their titles this morning. Only a few shed light on how he views the arenas he will soon oversee.

On the other hand, his recent writings on X (formerly Twitter), the substack Sensible Medicine, and his own substack Observations and Thoughts have plenty to say about school closures (“the great domestic policy failure of the last 25 years”); kids wearing masks outdoors (“whoever made the policy is an idiot”); and the annual Covid booster shot (“a public health disaster the likes of which we’ve never seen before”).

On the day after Trump’s election last November, he gave failing grades to the FDA and National Institutes of Health. He called for the elimination of 10,000 jobs at the Centers for Disease Control and Prevention, which he rated as an “abject failure.”

The rhetoric sounds more Trump/Muskian than even-handed or scientific. It is typical of his recent writings, which have taken on an increasingly strident tone since the pandemic. He has repeatedly attacked officials like Anthony Fauci and those at the CDC for ignoring alternative strategies and censoring proponents of herd immunity like Jay Bhattacharya, who now runs NIH.

One of Prasad’s recent posts called for large-scale, randomized clinical trials for the annual booster shots for COVID vaccines. That was in line with Makary’s order late last month that Novavax conduct a new clinical trial to test the annual update of its traditional Covid vaccine, which is the only alternative to the mRNA vaccines sold by Pfizer and Moderna. This new requirement may also be applied to the annual flu vaccines, which will cost the vaccine makers money (who cares?), but more importantly, will take much more time (something we should all care about).

“The FDA is a failure,” Prasad wrote last fall. “It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”

Right turn

This rightward turn in Prasad’s public posture is a relatively recent phenomenon. He began his academic career by studying conflicts of interest in medicine (my own field when working at the Center for Science in the Public Interest). In 2017, he published a study in JAMA Internal Medicine that challenged the ridiculously high sum big drug companies claimed it cost to develop a new drug. (Full disclosure: I was invited to write the accompanying editorial, which was headlined “A Much-Needed Corrective on Drug Development Costs”).

To this day, the insidious role money plays in medicine remains central to how he views the relationship between the drug industry and government. “This is the core rot in American regulation. The revolving door politics. I find this behavior abhorrent, and it should be criminal,” he has written.

He has called for ending all conflicts of interest on FDA advisory committees and wants to set up a “new Phase IV safety detection system” for monitoring adverse vaccine events. “I think vaccine makers should face litigation, as drug makers do,” he has written. He’s also skeptical of using surrogate endpoints and accelerated approvals, which led the FDA to “rubber stamp dozens of drugs with no evidence they help Americans.”

So here we are again. A top Trump regime appointee is championing many positions held by left wing and progressive critics of weak government oversight. Indeed, Prasad has written he once considered himself a progressive Democrat. No wonder biotech stocks temporarily tanked on news of Prasad’s appointment to run CBER.

However, as I’ve said many times in writing about these appointments, let’s watch what they do, not what they say, past or present. Will the Makary/Prasad team slow or even stop vaccine approvals to please their boss, Robert F. Kennedy Jr., the secretary of Health and Human Services? Will Trump order the new team to back off from policies and decisions that tank the stock market (vaccines on their own could never do that; they’re too small a revenue item)?

If I were a gambling man, I’d bet the answer will be ‘yes’ to both those questions.

Reprinted with permission from Gooz News.

New Technology Is Keeping The Air We Breathe Under An Unprecedented Level Of Scrutiny

New Technology Is Keeping The Air We Breathe Under An Unprecedented Level Of Scrutiny

By William Yardley, Los Angeles Times (TNS)

LOS ANGELES – Measure twice, cut once, they say. Unless you are trying to save the planet.

In that case, measure and cut constantly. Rising calls to create cleaner air and limit climate change are driving a surge in new technology for measuring air emissions and other pollutants – a data revolution that is opening new windows into the micro-mechanics of environmental damage.

The momentum for new monitoring tools is rooted in increasingly stringent regulations, including California’s cap-and-trade program for greenhouse gas emissions, and newly tightened federal standards and programs to monitor drought and soil contamination.

A variety of clean-tech companies have arisen to help industries meet the new requirements, but the new tools and data are also being created by academics, tinkerers and concerned citizens – just ask Volkswagen, whose deceptive efforts to skirt emissions-testing standards were discovered with the help of a small university lab in West Virginia.

Taking it all into account, the Earth is coming under an unprecedented new level of scrutiny.

For more than a year, satellites launched by NASA’s Jet Propulsion Laboratory have been orbiting Earth to track the global flow of carbon emissions. In Colorado, workers are using infrared cameras to find methane leaking from natural gas wells. In Boston, researchers using new measuring devices have detected “fugitive emissions” in hundreds of places across the city, including the Massachusetts State House.

Los Gatos Research in Silicon Valley now makes portable equipment for measuring greenhouse gases and other pollution that has been used on airplanes and in national forests. Piccaro, another California company, makes the machines that have been used to measure methane leaks in Boston and other cities. Other startups have created software that collects existing air quality data into apps that can advise asthmatics on areas to avoid and steer cyclists toward the least-polluted paths to work.

“There are a lot of companies picking up on this, but who is interested in the data – to me, that’s also fascinating,” said Colette Heald, an atmospheric chemist at the Massachusetts Institute of Technology. “We’re in this moment of a huge growth in curiosity – of people trying to understand their environment. That coincides with the technology to do something more.”

The push is not limited to measuring air and emissions. Tools to sample soil, test seismic regions, monitor water quality, test ocean acidity and improve weather forecasting are all on the rise. Drought has prompted new efforts to map groundwater and stream flows across the West. In space, NASA recently began a global precipitation measurement program intended, in part, to more accurately predict extreme weather events and the availability of water.

The Obama administration has rolled out a series of regulatory changes intended either to reduce pollutants in the air people breathe or limit greenhouse gases – and sometimes both. This month, the Environmental Protection Agency finalized new rules to reduce ozone and, for the first time, required so-called fenceline testing near oil refineries to track pollutants such as benzene that may be escaping – a task that requires sensitive monitoring equipment.

Industry groups often oppose new rules because complying costs money, but these rules can also drive technological development and new industries. While older emissions-monitoring devices may occupy the footprint of a living room, equipment is being developed that is portable and more sophisticated.

“Fifteen years ago we were talking about percent – fenceline testing the percentage of a particular species in a gas,” said Chris Anthony, who oversees analytical products for the ABB Group, which has expanded its investments in air and gas monitoring in recent years, including buying Los Gatos Research in 2013. “Five years ago, 10 years ago, we started talking about parts per million. In many areas now, we’re measuring parts per billion, which is very, very low levels of trace gas in exhaust.”

Chet Wayland, the director of the air quality assessment division within the EPA’s office of air quality planning and standards, recalled a research conference the agency hosted a few years ago where he met a graduate student who showed him a hand-held, homemade device that measured air pollution. The parts appeared to cost about $50.

“It wasn’t great but it was not bad,” Wayland recalled. “I’m sitting there going, ‘Oh, my gosh.’ I’m used to working in the world where these devices are $30,000 and they’re highly sophisticated, and here’s somebody who built this in a lab basically by himself. That’s when I realized that the world was changing.”

Wayland and one of his colleagues, Dan Costa, who works on air and climate issues in the EPA’s Office of Research and Development, said that as more companies and individuals make affordable equipment, they need to demonstrate that their products are accurate and reliable.

“That’s one of the key issues we at the EPA are trying to focus on,” Wayland said. “When the technology is out there and everyone starts using it, the question is, how good is the data? If the data’s not high enough quality, then we’re not going to make regulatory decisions based on that.”

He added, “Where is this data going to reside in 10 years, when all these sensors are out there, and who’s going to (manage) that information? Right now it’s kind of organic so there’s no centralized place where all of this information is going.”

Two years ago, Heald, the professor at MIT, helped lead a group of students who created a campus air quality monitoring network. They launched a website where people can track gases such as ozone and carbon monoxide.

But the site also includes a disclaimer, warning that the numbers were not necessarily “regulatory grade” measurements. Costa said the EPA’s long-term vision is “this harmonization, a synthesis of the gold standard monitoring network (run by government) with the evolving sensor technology” used by citizen groups and individuals.

(c)2015 Los Angeles Times. Distributed by Tribune Content Agency, LLC.

Photo: Kevin Dooley via Flickr

Doorstep Visits Change Attitudes On Gay Marriage

Doorstep Visits Change Attitudes On Gay Marriage

By Monte Morin, Los Angeles Times (TNS)

LOS ANGELES — A single conversation with a gay or lesbian door-to-door canvasser had the ability to change attitudes on same-sex marriage in neighborhoods that overwhelmingly opposed such unions, according to new research.

In a study conducted in Los Angeles County and published Thursday in the journal Science, researchers found that when openly gay canvassers lobbied a household resident about same-sex marriage, the resident was more likely to form a lasting and favorable opinion of gay marriage than if the canvasser was heterosexual.

The doorstep conversations also had a measurable “spillover effect,” in which some household residents who did not speak with the gay canvasser also formed a positive opinion of gay marriage, researchers said.

The experiment was modeled after public outreach campaigns conducted by the Los Angeles LGBT Center in voting precincts that overwhelmingly supported Proposition 8, the 2008 state ballot measure that repealed same-sex marriage.

The finding is unusual in that many previous studies have found that active canvassing or political advertising do little to alter firmly held opinions. In fact, researchers were so skeptical of their results the first time that they re-ran the experiment and duplicated their initial results.

“I was totally surprised that it worked at all,” said lead author Michael LaCour, a UCLA doctoral candidate in political science.

“A lot of time we find in social science that most things don’t work, they don’t change people’s minds. But we found that a single conversation was able to change voters’ minds up to a year later.”

LaCour conducted the study with Donald Green, a political science professor at Columbia University.

In all, 9,507 residences were involved in the experiment. Of the 41 canvassers, 22 were gay and 19 were straight.

Residents were randomly assigned to one of three different groups: a treatment group, in which they were lobbied on same-sex marriage; a placebo group, in which recycling was discussed instead of gay marriage; and a control group where nobody was canvassed.

The face-to-face meetings lasted roughly 20 minutes, according to researchers. Gay marriage canvassers would follow a specific script in which they asked residents to name the benefits of marriage. If the canvasser was gay, they would then inform the resident and say they wanted to experience the same benefits. Straight canvassers on the other hand said they were hoping that a close relative who was gay could enjoy the benefits of marriage.

Researchers said that immediately after the canvassing experiment, follow-up surveys showed an 8 percent increase in favorable opinions of same-sex marriage — up from an initial acceptance rate of 38 percent.

The researchers followed up a year later to find out whether the positive opinions had gained ground or diminished.

LaCour said that in cases where the canvasser was gay or lesbian, positive opinions on same-sex marriage had increased a total of 14 percent above baseline. In comparison, the positive opinion rate among the control and placebo groups had fallen to 3 percent above the baseline rate.

The researchers also noted that some of the residents’ housemates also expressed favorable opinions even though they had not spoken with the canvasser. Researchers said this suggested a spillover effect, in which they were influenced by second-hand exposure to the lobbying visit.

“It’s interesting that the effects had the same initial impact whether its a gay or straight person, but that the effect is lasting when its a gay person,” LaCour said. “You forget the message but you remember the messenger.”

The field experiment was conducted in 2013, during the month leading up to a U.S. Supreme Court decision that effectively overturned Proposition 8.

LaCour said that there was no difference in effect when researchers accounted for race or gender. However he said there was a slightly more positive effect when a gay canvasser was initially perceived as being straight.

“There seems to be something powerful about a counter-stereotypical person advocating,” LaCour said.

AFP Photo/George Frey

Japan Plans To Resume Whaling Next Year

Japan Plans To Resume Whaling Next Year

By Carol J. Williams, Los Angeles Times (TNS)

Japan informed the International Whaling Commission on Tuesday that it intended to resume hunting whales for scientific research next year, a move that conservationists called a defiance of the International Court of Justice ruling that Japan’s whale kills are illegal.

Since the commission invoked a moratorium on commercial whaling in 1986, Japan had been claiming an exception to the ban that allows whaling for scientific purposes and had set quotas of 1,035 kills in each of the last few years.

The International Court of Justice ruled in March that Japan’s failure to publish results from its purported research demonstrated that its claim of science-related whaling was a cover for banned commercial hunting and ordered a halt.

In the revised program submitted to the commission on Tuesday, the Ministry of Agriculture, Forestry, and Fisheries cut its catch quota to 333 minke whales and said it would no longer hunt the more limited pods of fin and humpback whales.

Joji Morishita, Japan’s whaling commissioner, said research findings would be published in the future to comply with the terms of the moratorium exceptions.

“All these activities, as we have been arguing, are perfectly in line with international law, a scientific basis, as well as ICJ judgment language,” he told the whaling commission, asserting that Japan’s new program to start in late 2015 will be responsive to the court order.

The challenge to Japan’s whaling program was brought in 2010 by Australia. The international court, in the Netherlands, ruled that there was no scientific basis for Japan’s quotas, nor was there sufficient published findings of its research to justify the size of the projected annual catch.

Conservationists said nothing has changed with the plan submitted by Tokyo on Tuesday.

“Japan’s new whaling proposal for the southern ocean sanctuary is neither new nor improved,” said Kitty Block, vice president of Humane Society International. “Despite the ICJ decision condemning the nation’s so-called scientific program, Japan is still trying to explain the inexplicable and defend the indefensible. The hunt is for commercial purposes — not science.”

Although Japan set catch quotas of 935 minke whales and 50 each of fin and humpbacks, its annual captures have been significantly lower in recent years due to declining demand for whale meat and increasing intervention by protesters such as the Sea Shepherd group. In 2012, Japan caught 103 minke whales and last year its catch was 251, the Japan Times reported.

Japanese whalers were ordered to suspend operations after the court order, although they plan a nonlethal hunt in spring.

Tokyo doesn’t require approval by the International Whaling Commission to resume its lethal hunt, and it was unclear whether Australia would make any legal challenge. Australian Prime Minister Tony Abbott, who was elected last year, has drawn fire for weakening his country’s environmental commitments with expanded mining and logging.

Photo via WikiCommons

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