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F.D.A. Tobacco Science Official Takes Job at Philip Morris

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F.D.A. Tobacco Science Official Takes Job at Philip Morris

A Meals and Drug Administration official with appreciable energy over authorization choices for e-cigarettes and merchandise geared toward curbing smoking resigned on Tuesday to work for Philip Morris Worldwide, the worldwide tobacco conglomerate and maker of Marlboros.

The official, Matt Holman, was chief of the workplace of science within the company’s Heart for Tobacco Merchandise. In a memo to the employees on Tuesday, Brian King, the middle’s director, wrote that Dr. Holman had introduced that he can be leaving — efficient instantly — to hitch Philip Morris. The memo mentioned Dr. Holman had been on depart and, in keeping with company ethics insurance policies, had recused himself from all tobacco middle work “whereas exploring profession alternatives outdoors of presidency.”

Mr. King lauded Dr. Holman’s 20 years of labor on the F.D.A., the place he has lately been “making ready for and overseeing overview” of promoting functions for e-cigarettes and different nicotine-delivery merchandise. Dr. Holman mentioned in an interview on Wednesday that his actual position at Philip Morris had thus far been broadly outlined however added that he would work on tobacco harm-reduction efforts and supply some enter on regulatory submissions to the company.

His resignation provides additional turmoil to the company’s tobacco management division, which is present process a overview ordered by Dr. Robert Califf, the company’s commissioner. The division additionally misplaced its longtime director, Mitch Zeller, who retired in April.

To critics, Dr. Holman’s transfer is a very regarding instance of the “revolving door” between federal officers and the industries they regulate; on this case, one which has garnered a excessive diploma of public mistrust. It has additionally raised questions on company approvals, together with that of Philip Morris’s IQOS, a “heat-not-burn” tobacco gadget, which some researchers have discovered troubling. IQOS is just not offered on the U.S. market now due to patent litigation, but when that had been resolved, the gadget may face recent F.D.A. evaluations.

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Federal guidelines governing “revolving door” profession strikes don’t stop an official from overseeing regulatory issues one week and becoming a member of a company with merchandise underneath overview the following.

“That is authorized. That’s the underside line,” mentioned Dr. Michael Carome, director of the Public Citizen well being analysis group. “It’s such a revolving door transfer that actually undermines public confidence within the company.”

The federal guidelines do ban Dr. Holman from showing earlier than the F.D.A. on issues through which he “participated personally and considerably throughout authorities service.”

Credit score…U.S. Meals and Drug Administration

Dr. Holman mentioned that he consulted with company ethics attorneys earlier than beginning job discussions earlier this month. He mentioned he was drawn to Philip Morris as a result of he considered the corporate as being dedicated to the objective of shifting cigarette people who smoke to noncombustible and fewer dangerous merchandise.

“They’re taking the actions that I believe would align with such a objective,” Dr. Holman mentioned. “And that’s what actually drew my consideration to P.M.I. I’m going there to not assist them promote extra cigarettes, however the reverse.”

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He dismissed “revolving door” criticisms, saying that if that had been his motivation, he may have left the company for business a few years in the past. However lawmakers and a few public well being specialists criticized Dr. Holman’s alternative and its impact on the F.D.A.’s decision-making.

“It’s embarrassing for the F.D.A., which sees itself as a public well being company, to have its staff go to an organization that may be a main producer of loss of life,” mentioned Micah Berman, an affiliate professor of public well being and regulation at Ohio State College.

Consultant Raja Krishnamoorthi, a Democrat of Illinois, was equally crucial. “The revolving door between F.D.A. and the industries it’s tasked with regulating is extraordinarily disturbing,” he mentioned in an announcement. “Whereas some, together with P.M.I., might argue that their rent is proof of P.M.I.’s alleged dedication to taking the well being impacts of its merchandise extra critically, I gained’t maintain my breath.”

As head of the F.D.A. science workplace, Dr. Holman performed a key position in approvals of digital cigarettes and comparable gadgets, which producers have needed to submit for overview to remain available on the market lately.

IQOS, the Philip Morris product that Altria has a license to distribute in america, was one of many authorized merchandise. It’s offered in Korea, Japan and different international locations. An organization spokesman mentioned U.S. gross sales had been anticipated to renew subsequent yr, however it may need to endure one other overview earlier than that.

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Critics of the IQOS approval embrace Stanton Glantz, a retired professor of drugs, and his colleagues on the College of California, San Francisco, who revealed a examine saying the gadget contained toxins, some probably carcinogenic and a few at increased ranges than in flamable cigarettes. The company’s approval “disregarded legitimate scientific proof and misapplied the general public well being commonplace mandated by regulation,” the examine within the journal Tobacco Management concluded.

Dr. Glantz mentioned on Wednesday that Dr. Holman ignored one other main examine exhibiting that e-cigarette use — outdoors of managed research of quitting efforts — was not related to lowered charges of smoking. He mentioned approvals have completed little to take care of the issue of dual-use, or utilizing cigarettes and e-cigarettes, which is worse for total well being. Of Dr. Holman’s departure, Dr. Glantz mentioned, “good riddance.”

“He’s the one who signed off on these approvals,” he mentioned. “They take care of all of those points by ignoring it, by counting on out-of-date research.”

Among the many F.D.A.’s latest controversies was the choice in June to disclaim advertising and marketing authorization to Juul Labs’ e-cigarettes. Since then, the company has relented, asserting a overview of its resolution.

In a court docket submitting, Juul cited the authorization granted to Philip Morris as a cause it might seemingly prevail, saying IQOS was authorized though a dozen chemical substances in IQOS aerosols had been “‘probably genotoxic and/or carcinogenic’ and had been ‘current in increased focus[s]’ than in flamable cigarette smoke.”

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Dr. Holman mentioned many company choices have their critics, however he believed IQOS authorization was warranted on a full overview of the information.

Philip Morris mentioned in an announcement that Dr. Holman “is dedicated to serving to current grownup people who smoke entry scientifically substantiated smoke-free alternate options whereas defending youth. We’re trying ahead to him becoming a member of our crew as we proceed to pursue a smoke free future.”

The corporate additionally lately employed Keagan Lenihan, a former F.D.A. chief of employees, as a vice chairman of presidency affairs.

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally

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How The Great British Bake Off Host Alison Hammond Lost 150 Lbs Naturally


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Alison Hammond’s Weight Loss: How She Shed 150 Lbs | Woman’s World




















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One state leads country in human bird flu with nearly 40 confirmed cases

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One state leads country in human bird flu with nearly 40 confirmed cases

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health (SFDPH).

As of Dec. 23, there had been 36 confirmed human cases of bird flu in the state, according to the California Department of Public Health (CDPH).

This represents more than half of the human cases in the country.

LOUISIANA REPORTS FIRST BIRD FLU-RELATED HUMAN DEATH IN US

The latest pediatric patient, who lives in San Francisco, experienced fever and conjunctivitis (pink eye) as a result of the infection.

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The unnamed patient was not hospitalized and has fully recovered, according to the SFDPH.

A child in California is presumed to have H5N1 bird flu, according to the San Francisco Department of Public Health. (iStock)

The child tested positive for bird flu at the SFDPH Public Health Laboratory. The U.S. Centers for Disease Control and Prevention (CDC) will perform additional tests to confirm the result.

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It is not yet known how the child was exposed to the virus and an investigation is ongoing.

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“I want to assure everyone in our city that the risk to the general public is low, and there is no current evidence that the virus can be transmitted between people,” said Dr. Grant Colfax, director of health, in the press release. 

BIRD FLU PATIENT HAD VIRUS MUTATIONS, SPARKING CONCERN ABOUT HUMAN SPREAD

“We will continue to investigate this presumptive case, and I am urging all San Franciscans to avoid direct contact with sick or dead birds, especially wild birds and poultry. Also, please avoid unpasteurized dairy products.” 

Samuel Scarpino, director of AI and life sciences and professor of health sciences at Northeastern University in Boston, is calling for “decisive action” to protect individuals who may be in contact with infected livestock and also to alert the public about the risks associated with wild birds and infected backyard flocks. 

Chick bird flu test

An infectious diseases expert called for “decisive action” to alert the public about the risks associated with wild birds and infected backyard flocks.  (iStock)

“While I agree that the risk to the broader public remains low, we continue to see signs of escalating risk associated with this outbreak,” he told Fox News Digital.

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Experts have warned that the possibility of mutations in the virus could enable person-to-person transmission.

     

“While the H5N1 virus is currently thought to only transmit from animals to humans, multiple mutations that can enhance human-to-human transmission have been observed in the severely sick American,” Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, told Fox News Digital.

Split image of cows and bird flu vial

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture. (iStock)

“This highlights the requirement for vigilance and preparation in the event that additional mutations create a human-transmissible pandemic strain.”

As of Jan. 10, there have been a total of 707 infected cattle in California, per reports from the California Department of Food and Agriculture (CDFA).

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In the last 30 days alone, the virus has been confirmed in 84 dairy farms in the state.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

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Chronic Pain Afflicts Billions of People. It’s Time for a Revolution.

“In the beginning, everyone thought they were going to find this one breakthrough pain drug that would replace opioids,” Gereau said. Increasingly, though, it’s looking like chronic pain, like cancer, could end up having a range of genetic and cellular drivers that vary both by condition and by the particular makeup of the person experiencing it. “What we’re learning is that pain is not just one thing,” Gereau added. “It’s a thousand different things, all called ‘pain.’”

For patients, too, the landscape of chronic pain is wildly varied. Some people endure a miserable year of low-back pain, only to have it vanish for no clear reason. Others aren’t so lucky. A friend of a friend spent five years with extreme pain in his arm and face after roughhousing with his son. He had to stop working, couldn’t drive, couldn’t even ride in a car without a neck brace. His doctors prescribed endless medications: the maximum dose of gabapentin, plus duloxetine and others. At one point, he admitted himself to a psychiatric ward, because his pain was so bad that he’d become suicidal. There, he met other people who also became suicidal after years of living with terrible pain day in and day out.

The thing that makes chronic pain so awful is that it’s chronic: a grinding distress that never ends. For those with extreme pain, that’s easy to understand. But even less severe cases can be miserable. A pain rating of 3 or 4 out of 10 sounds mild, but having it almost all the time is grueling — and limiting. Unlike a broken arm, which gets better, or tendinitis, which hurts mostly in response to overuse, chronic pain makes your whole world shrink. It’s harder to work, and to exercise, and even to do the many smaller things that make life rewarding and rich.

It’s also lonely. When my arms first went crazy, I could barely function. But even after the worst had passed, I saw friends rarely; I still couldn’t drive more than a few minutes, or sit comfortably in a chair, and I felt guilty inviting people over when there wasn’t anything to do. As Christin Veasley, director and co-founder of the Chronic Pain Research Alliance, puts it: “With acute pain, medications, if you take them, they get you over a hump, and you go on your way. What people don’t realize is that when you have chronic pain, even if you’re also taking meds, you rarely feel like you were before. At best, they can reduce your pain, but usually don’t eliminate it.”

A cruel Catch-22 around chronic pain is that it often leads to anxiety and depression, both of which can make pain worse. That’s partly because focusing on a thing can reinforce it, but also because emotional states have physical effects. Both anxiety and depression are known to increase inflammation, which can also worsen pain. As a result, pain management often includes cognitive behavioral therapy, meditation practice or other coping skills. But while those tools are vital, it’s notoriously hard to reprogram our reactions. Our minds and bodies have evolved both to anticipate pain and to remember it, making it hard not to worry. And because chronic pain is so uncomfortable and isolating, it’s also depressing.

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