person:scott gottlieb

  • FDA takes fresh look at whether opioids are effective for chronic pain - The Washington Post
    https://www.washingtonpost.com/national/health-science/fda-takes-fresh-look-at-whether-opioids-are-effective-for-chronic-pain/2019/02/25/227a5fe6-3917-11e9-a06c-3ec8ed509d15_story.html

    The Food and Drug Administration will require drug companies to study whether prescription opioids are effective in quelling chronic pain — another step in the government’s efforts to rein in use of the narcotics that spawned the drug epidemic.

    Some studies already indicate that opioids are ineffective for pain beyond 12 weeks and many experts say long-term use can cause addiction, by prompting patients to build up tolerance to the drugs and seek higher doses. But conclusive, controlled research is scarce.

    A finding of ineffectiveness in more rigorous studies supervised by the FDA could allow the agency to change the labeling on some opioids, impose special rules for prescribing, dispensing and taking them, and even prohibit their use in some cases, according to FDA Commissioner Scott Gottlieb.

    But at least one longtime critic of the FDA’s response to the opioid crisis expressed frustration with the move. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA already has all the research it needs — and authority under existing law — to tighten restrictions on the use of opioids for chronic pain by changing instructions for how they should be prescribed.

    “Here we go again,” Kolodny said in an interview. “That’s exactly what the FDA said to us in 2013. . . . Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.’ ”

    In 2013, after Kolodny’s group complained that opioids should be labeled unsafe and ineffective for chronic pain, the FDA ordered similar research, including an attempt to determine whether painkillers cause hyperalgesia. Gottlieb said those studies were difficult to carry out because, at the time, the FDA had authority only to require post-market studies of safety, rather than effectiveness.

    On Sunday, the CBS program “60 Minutes” explored the FDA’s decision in 2001 to allow long-term use of OxyContin despite the lack of research showing it was safe and effective. Gottlieb conceded that “it’s regrettable we didn’t do this many years ago.”

    The vast majority of opioid prescriptions written in 2017 were for generic versions of the drugs. The research would be required only of companies that produce brand-name narcotics; generic producers would be required to adopt the same changes.

    #Opioides #USA #FDA #Efficacité

  • Is Marijuana as Safe as We Think ? | The New Yorker
    https://www.newyorker.com/magazine/2019/01/14/is-marijuana-as-safe-as-we-think

    A few years ago, the National Academy of Medicine convened a panel of sixteen leading medical experts to analyze the scientific literature on cannabis. The report they prepared, which came out in January of 2017, runs to four hundred and sixty-eight pages. It contains no bombshells or surprises, which perhaps explains why it went largely unnoticed. It simply stated, over and over again, that a drug North Americans have become enthusiastic about remains a mystery.

    For example, smoking pot is widely supposed to diminish the nausea associated with chemotherapy. But, the panel pointed out, “there are no good-quality randomized trials investigating this option.” We have evidence for marijuana as a treatment for pain, but “very little is known about the efficacy, dose, routes of administration, or side effects of commonly used and commercially available cannabis products in the United States.” The caveats continue. Is it good for epilepsy? “Insufficient evidence.” Tourette’s syndrome? Limited evidence. A.L.S., Huntington’s, and Parkinson’s? Insufficient evidence. Irritable-bowel syndrome? Insufficient evidence. Dementia and glaucoma? Probably not. Anxiety? Maybe. Depression? Probably not.

    Then come Chapters 5 through 13, the heart of the report, which concern marijuana’s potential risks. The haze of uncertainty continues. Does the use of cannabis increase the likelihood of fatal car accidents? Yes. By how much? Unclear. Does it affect motivation and cognition? Hard to say, but probably. Does it affect employment prospects? Probably. Will it impair academic achievement? Limited evidence. This goes on for pages.

    We need proper studies, the panel concluded, on the health effects of cannabis on children and teen-agers and pregnant women and breast-feeding mothers and “older populations” and “heavy cannabis users”; in other words, on everyone except the college student who smokes a joint once a month. The panel also called for investigation into “the pharmacokinetic and pharmacodynamic properties of cannabis, modes of delivery, different concentrations, in various populations, including the dose-response relationships of cannabis and THC or other cannabinoids.”

    Not surprisingly, the data we have are messy. Berenson, in his role as devil’s advocate, emphasizes the research that sees cannabis as opening the door to opioid use. For example, two studies of identical twins—in the Netherlands and in Australia—show that, in cases where one twin used cannabis before the age of seventeen and the other didn’t, the cannabis user was several times more likely to develop an addiction to opioids. Berenson also enlists a statistician at N.Y.U. to help him sort through state-level overdose data, and what he finds is not encouraging: “States where more people used cannabis tended to have more overdoses.”

    The National Academy panel is more judicious. Its conclusion is that we simply don’t know enough, because there haven’t been any “systematic” studies. But the panel’s uncertainty is scarcely more reassuring than Berenson’s alarmism. Seventy-two thousand Americans died in 2017 of drug overdoses. Should you embark on a pro-cannabis crusade without knowing whether it will add to or subtract from that number?

    Drug policy is always clearest at the fringes. Illegal opioids are at one end. They are dangerous. Manufacturers and distributors belong in prison, and users belong in drug-treatment programs. The cannabis industry would have us believe that its product, like coffee, belongs at the other end of the continuum. “Flow Kana partners with independent multi-generational farmers who cultivate under full sun, sustainably, and in small batches,” the promotional literature for one California cannabis brand reads. “Using only organic methods, these stewards of the land have spent their lives balancing a unique and harmonious relationship between the farm, the genetics and the terroir.” But cannabis is not coffee. It’s somewhere in the middle. The experience of most users is relatively benign and predictable; the experience of a few, at the margins, is not.

    The National Academy panel is more judicious. Its conclusion is that we simply don’t know enough, because there haven’t been any “systematic” studies. But the panel’s uncertainty is scarcely more reassuring than Berenson’s alarmism. Seventy-two thousand Americans died in 2017 of drug overdoses. Should you embark on a pro-cannabis crusade without knowing whether it will add to or subtract from that number?

    Drug policy is always clearest at the fringes. Illegal opioids are at one end. They are dangerous. Manufacturers and distributors belong in prison, and users belong in drug-treatment programs. The cannabis industry would have us believe that its product, like coffee, belongs at the other end of the continuum. “Flow Kana partners with independent multi-generational farmers who cultivate under full sun, sustainably, and in small batches,” the promotional literature for one California cannabis brand reads. “Using only organic methods, these stewards of the land have spent their lives balancing a unique and harmonious relationship between the farm, the genetics and the terroir.” But cannabis is not coffee. It’s somewhere in the middle. The experience of most users is relatively benign and predictable; the experience of a few, at the margins, is not.

    Late last year, the commissioner of the Food and Drug Administration, Scott Gottlieb, announced a federal crackdown on e-cigarettes. He had seen the data on soaring use among teen-agers, and, he said, “it shocked my conscience.” He announced that the F.D.A. would ban many kinds of flavored e-cigarettes, which are especially popular with teens, and would restrict the retail outlets where e-cigarettes were available.

    In the dozen years since e-cigarettes were introduced into the marketplace, they have attracted an enormous amount of attention. There are scores of studies and papers on the subject in the medical and legal literature, grappling with the questions raised by the new technology. Vaping is clearly popular among kids. Is it a gateway to traditional tobacco use? Some public-health experts worry that we’re grooming a younger generation for a lifetime of dangerous addiction. Yet other people see e-cigarettes as a much safer alternative for adult smokers looking to satisfy their nicotine addiction. That’s the British perspective. Last year, a Parliamentary committee recommended cutting taxes on e-cigarettes and allowing vaping in areas where it had previously been banned. Since e-cigarettes are as much as ninety-five per cent less harmful than regular cigarettes, the committee argued, why not promote them? Gottlieb said that he was splitting the difference between the two positions—giving adults “opportunities to transition to non-combustible products,” while upholding the F.D.A.’s “solemn mandate to make nicotine products less accessible and less appealing to children.” He was immediately criticized.

    “Somehow, we have completely lost all sense of public-health perspective,” Michael Siegel, a public-health researcher at Boston University, wrote after the F.D.A. announcement:

    #Santé_publique #Marijuana

  • FDA Seizes Documents From E-Cigarette Maker Amid Crackdown On Flavored Vapes : NPR
    https://www.npr.org/2018/10/03/653891923/fda-seizes-documents-from-e-cigarette-maker-amid-crackdown-on-vaping-flavors

    JUULs are trendy, USB-shaped vaporizers that provide a quick dose of nicotine to users. Introduced in 2015, the vapes are marketed as an alternative to tobacco cigarettes for adult users, but some critics say that flavors such as mango and creme appeal primarily to teenagers and children. One study suggests that 81 percent of children who ever use tobacco start with a flavored tobacco product.

    “The popularity of JUUL among kids threatens our progress in reducing youth e-cigarette use,” said Dr. Robert Redfield, director of CDC, in a press release. “We are alarmed that these new high nicotine content e-cigarettes, marketed and sold in kid-friendly flavors, are so appealing to our nation’s young people.”

    The seizure was the latest in a series of FDA crackdowns on the e-cigarette market. In September, the agency announced it had issued more than 1,300 warning letters and fines to convenience stores, gas stations and other stores over the summer for selling e-cigarettes to minors — its largest such action to date.

    “It is abundantly clear that tobacco companies are developing and marketing e-cigarette flavors that appeal to, and addict, children,” the senators wrote in a letter.

    Durban and Murkowski recently introduced legislation that would ban the use of flavoring in cigars — not e-cigarettes — and give tobacco companies one year to prove that “their e-cigarette flavors actually help adults quit smoking cigarettes” and “do no cause children to start smoking.” Currently, there is no legislation regulating the flavors of e-cigarette products.

    FDA Commissioner Scott Gottlieb called youth e-cigarette use an “epidemic” last month, saying the practice “shows no signs of abating.”

    “The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine,” he continued.

    #Tabac #Salopards #Addiction

  • Opioid crisis spurs sometimes-deadly abuse of popular diarrhea medicine - ABC News
    https://abcnews.go.com/Health/News/opioid-crisis-spurs-deadly-abuse-popular-diarrhea-medicine/story?id=55118564

    The opioid crisis has taken what the FDA calls “many new and troubling turns,” and and this is one of them. Opioid addicts are buying a popular diarrhea medicine, loperamide, sold under the brand name Imodium — to get high or as a way to taper off off opioids.

    The FDA is taking steps to change the packaging of loperamide to help deter abuse of this drug. It’s safe at approved doses but when taken at 100 times the recommended amount, as some addicts do, it can be deadly, FDA Commissioner Scott Gottlieb said in a recent article for the agency.

    "The drug acts locally, inside the gut, to treat the symptoms of diarrhea. But when loperamide is abused and taken at extremely high doses, some of it can cross the gut lining, giving users an opioid like ‘high,’” Gottlieb said.

    PHOTO: A package of Imodium Instants diarrhea tablets are pictured in this undated file photo.Martin Lee/REX/Shutterstock
    A package of Imodium Instants diarrhea tablets are pictured in this undated file photo.

    Some opioid addicts are also taking large amounts of loperamide as a bridge to help them gradually withdraw from opioids or to treat symptoms of withdrawal, which include diarrhea. The medicine has been dubbed the “poor man’s methadone.”

    #Opioides

  • Goldman asks: ’Is curing patients a sustainable business model?’
    https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html

    “Is curing patients a sustainable business model?” analysts ask in an April 10 report entitled “The Genome Revolution.”

    “The potential to deliver ’one shot cures’ is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies,” analyst Salveen Richter wrote in the note to clients Tuesday. “While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.”

    (…) “GILD is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients,” the analyst wrote. “In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise.”

    #économie #recherche #pharma #biens_publics #merci @archiloque

  • F.D.A. Official Under Bush Is Trump’s Choice to Lead Agency - The New York Times
    https://www.nytimes.com/2017/03/10/health/fda-scott-gottlieb.html

    President Trump said Friday that he intended to nominate Scott Gottlieb, a partner at a venture capital fund with longstanding ties to the pharmaceutical and biotech industries, to lead the Food and Drug Administration.
    […]
    Mr. Trump has made no secret about his desire to overhaul the F.D.A., telling a group of pharmaceutical executives in January that he planned to slash regulations and speed up drug approvals at the agency.
    […]
    Indeed, Dr. Gottlieb was the clear choice of the pharmaceutical industry — when the Wall Street firm Mizuho Securities surveyed 53 drug companies in February, nearly three-quarters said they preferred him.