organization:f.d.a.

  • The Terrifying Potential of the 5G Network | The New Yorker
    https://www.newyorker.com/news/annals-of-communications/the-terrifying-potential-of-the-5g-network

    Two words explain the difference between our current wireless networks and 5G: speed and latency. 5G—if you believe the hype—is expected to be up to a hundred times faster. (A two-hour movie could be downloaded in less than four seconds.) That speed will reduce, and possibly eliminate, the delay—the latency—between instructing a computer to perform a command and its execution. This, again, if you believe the hype, will lead to a whole new Internet of Things, where everything from toasters to dog collars to dialysis pumps to running shoes will be connected. Remote robotic surgery will be routine, the military will develop hypersonic weapons, and autonomous vehicles will cruise safely along smart highways. The claims are extravagant, and the stakes are high. One estimate projects that 5G will pump twelve trillion dollars into the global economy by 2035, and add twenty-two million new jobs in the United States alone. This 5G world, we are told, will usher in a fourth industrial revolution.

    A totally connected world will also be especially susceptible to cyberattacks. Even before the introduction of 5G networks, hackers have breached the control center of a municipal dam system, stopped an Internet-connected car as it travelled down an interstate, and sabotaged home appliances. Ransomware, malware, crypto-jacking, identity theft, and data breaches have become so common that more Americans are afraid of cybercrime than they are of becoming a victim of violent crime. Adding more devices to the online universe is destined to create more opportunities for disruption. “5G is not just for refrigerators,” Spalding said. “It’s farm implements, it’s airplanes, it’s all kinds of different things that can actually kill people or that allow someone to reach into the network and direct those things to do what they want them to do. It’s a completely different threat that we’ve never experienced before.”

    Spalding’s solution, he told me, was to build the 5G network from scratch, incorporating cyber defenses into its design.

    There are very good reasons to keep a company that appears to be beholden to a government with a documented history of industrial cyber espionage, international data theft, and domestic spying out of global digital networks. But banning Huawei hardware will not secure those networks. Even in the absence of Huawei equipment, systems still may rely on software developed in China, and software can be reprogrammed remotely by malicious actors. And every device connected to the fifth-generation Internet will likely remain susceptible to hacking. According to James Baker, the former F.B.I. general counsel who runs the national-security program at the R Street Institute, “There’s a concern that those devices that are connected to the 5G network are not going to be very secure from a cyber perspective. That presents a huge vulnerability for the system, because those devices can be turned into bots, for example, and you can have a massive botnet that can be used to attack different parts of the network.”

    This past January, Tom Wheeler, who was the F.C.C. chairman during the Obama Administration, published an Op-Ed in the New York Times titled “If 5G Is So Important, Why Isn’t It Secure?” The Trump Administration had walked away from security efforts begun during Wheeler’s tenure at the F.C.C.; most notably, in recent negotiations over international standards, the U.S. eliminated a requirement that the technical specifications of 5G include cyber defense. “For the first time in history,” Wheeler wrote, “cybersecurity was being required as a forethought in the design of a new network standard—until the Trump F.C.C. repealed it.” The agency also rejected the notion that companies building and running American digital networks were responsible for overseeing their security. This might have been expected, but the current F.C.C. does not consider cybersecurity to be a part of its domain, either. “I certainly did when we were in office,” Wheeler told me. “But the Republicans who were on the commission at that point in time, and are still there, one being the chairman, opposed those activities as being overly regulatory.”

    Opening up new spectrum is crucial to achieving the super-fast speeds promised by 5G. Most American carriers are planning to migrate their services to a higher part of the spectrum, where the bands are big and broad and allow for colossal rivers of data to flow through them. (Some carriers are also working with lower-spectrum frequencies, where the speeds will not be as fast but likely more reliable.) Until recently, these high-frequency bands, which are called millimetre waves, were not available for Internet transmission, but advances in antenna technology have made it possible, at least in theory. In practice, millimetre waves are finicky: they can only travel short distances—about a thousand feet—and are impeded by walls, foliage, human bodies, and, apparently, rain.

    Deploying millions of wireless relays so close to one another and, therefore, to our bodies has elicited its own concerns. Two years ago, a hundred and eighty scientists and doctors from thirty-six countries appealed to the European Union for a moratorium on 5G adoption until the effects of the expected increase in low-level radiation were studied. In February, Senator Richard Blumenthal, a Democrat from Connecticut, took both the F.C.C. and F.D.A. to task for pushing ahead with 5G without assessing its health risks. “We’re kind of flying blind here,” he concluded. A system built on millions of cell relays, antennas, and sensors also offers previously unthinkable surveillance potential. Telecom companies already sell location data to marketers, and law enforcement has used similar data to track protesters. 5G will catalogue exactly where someone has come from, where they are going, and what they are doing. “To give one made-up example,” Steve Bellovin, a computer-science professor at Columbia University, told the Wall Street Journal, “might a pollution sensor detect cigarette smoke or vaping, while a Bluetooth receiver picks up the identities of nearby phones? Insurance companies might be interested.” Paired with facial recognition and artificial intelligence, the data streams and location capabilities of 5G will make anonymity a historical artifact.

    To accommodate these limitations, 5G cellular relays will have to be installed inside buildings and on every city block, at least. Cell relays mounted on thirteen million utility poles, for example, will deliver 5G speeds to just over half of the American population, and cost around four hundred billion dollars to install. Rural communities will be out of luck—too many trees, too few people—despite the F.C.C.’s recently announced Rural Digital Opportunity Fund.

    Deploying millions of wireless relays so close to one another and, therefore, to our bodies has elicited its own concerns. Two years ago, a hundred and eighty scientists and doctors from thirty-six countries appealed to the European Union for a moratorium on 5G adoption until the effects of the expected increase in low-level radiation were studied. In February, Senator Richard Blumenthal, a Democrat from Connecticut, took both the F.C.C. and F.D.A. to task for pushing ahead with 5G without assessing its health risks. “We’re kind of flying blind here,” he concluded. A system built on millions of cell relays, antennas, and sensors also offers previously unthinkable surveillance potential. Telecom companies already sell location data to marketers, and law enforcement has used similar data to track protesters. 5G will catalogue exactly where someone has come from, where they are going, and what they are doing. “To give one made-up example,” Steve Bellovin, a computer-science professor at Columbia University, told the Wall Street Journal, “might a pollution sensor detect cigarette smoke or vaping, while a Bluetooth receiver picks up the identities of nearby phones? Insurance companies might be interested.” Paired with facial recognition and artificial intelligence, the data streams and location capabilities of 5G will make anonymity a historical artifact.

    #Surveillance #Santé #5G #Cybersécurité

  • #F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women - The New York Times
    https://www.nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html

    It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.

    The agency issued the decision against the two companies, Boston Scientific and Coloplast, at a time when multimillion-dollar verdicts against manufacturers of the devices continue to be awarded or upheld on appeal.

    Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.

  • The Challenge of Going Off Psychiatric Drugs | The New Yorker
    https://www.newyorker.com/magazine/2019/04/08/the-challenge-of-going-off-psychiatric-drugs

    Laura had always assumed that depression was caused by a precisely defined chemical imbalance, which her medications were designed to recalibrate. She began reading about the history of psychiatry and realized that this theory, promoted heavily by pharmaceutical companies, is not clearly supported by evidence. Genetics plays a role in mental disorder, as do environmental influences, but the drugs do not have the specificity to target the causes of an illness. Wayne Goodman, a former chair of the F.D.A.’s Psychopharmacologic Drugs Advisory Committee, has called the idea that pills fix chemical imbalances a “useful metaphor” that he would never use with his patients. Ronald Pies, a former editor of Psychiatric Times, has said, “My impression is that most psychiatrists who use this expression”—that the pills fix chemical imbalances—“feel uncomfortable and a little embarrassed when they do so. It’s kind of a bumper-sticker phrase that saves time.”

    Dorian Deshauer, a psychiatrist and historian at the University of Toronto, has written that the chemical-imbalance theory, popularized in the eighties and nineties, “created the perception that the long term, even life-long use of psychiatric drugs made sense as a logical step.” But psychiatric drugs are brought to market in clinical trials that typically last less than twelve weeks. Few studies follow patients who take the medications for more than a year. Allen Frances, an emeritus professor of psychiatry at Duke, who chaired the task force for the fourth edition of the DSM, in 1994, told me that the field has neglected questions about how to take patients off drugs—a practice known as “de-prescribing.” He said that “de-prescribing requires a great deal more skill, time, commitment, and knowledge of the patient than prescribing does.” He emphasizes what he called a “cruel paradox: there’s a large population on the severe end of the spectrum who really need the medicine” and either don’t have access to treatment or avoid it because it is stigmatized in their community. At the same time, many others are “being overprescribed and then stay on the medications for years.” There are almost no studies on how or when to go off psychiatric medications, a situation that has created what he calls a “national public-health experiment.”

    Roland Kuhn, a Swiss psychiatrist credited with discovering one of the first antidepressants, imipramine, in 1956, later warned that many doctors would be incapable of using antidepressants properly, “because they largely or entirely neglect the patient’s own experiences.” The drugs could only work, he wrote, if a doctor is “fully aware of the fact that he is not dealing with a self-contained, rigid object, but with an individual who is involved in constant movement and change.”

    A decade after the invention of antidepressants, randomized clinical studies emerged as the most trusted form of medical knowledge, supplanting the authority of individual case studies. By necessity, clinical studies cannot capture fluctuations in mood that may be meaningful to the patient but do not fit into the study’s categories. This methodology has led to a far more reliable body of evidence, but it also subtly changed our conception of mental health, which has become synonymous with the absence of symptoms, rather than with a return to a patient’s baseline of functioning, her mood or personality before and between episodes of illness.

    Antidepressants are now taken by roughly one in eight adults and adolescents in the U.S., and a quarter of them have been doing so for more than ten years. Industry money often determines the questions posed by pharmacological studies, and research about stopping drugs has never been a priority.

    Barbiturates, a class of sedatives that helped hundreds of thousands of people to feel calmer, were among the first popular psychiatric drugs. Although leading medical journals asserted that barbiturate addiction was rare, within a few years it was evident that people withdrawing from barbiturates could become more anxious than they were before they began taking the drugs. (They could also hallucinate, have convulsions, and even die.)

    Valium and other benzodiazepines were introduced in the early sixties, as a safer option. By the seventies, one in ten Americans was taking Valium. The chief of clinical pharmacology at Massachusetts General Hospital declared, in 1976, “I have never seen a case of benzodiazepine dependence” and described it as “an astonishingly unusual event.” Later, though, the F.D.A. acknowledged that people can become dependent on benzodiazepines, experiencing intense agitation when they stop taking them.

    In the fifth edition of the DSM, published in 2013, the editors added an entry for “antidepressant discontinuation syndrome”—a condition also mentioned on drug labels—but the description is vague and speculative, noting that “longitudinal studies are lacking” and that little is known about the course of the syndrome. “Symptoms appear to abate over time,” the manual explains, while noting that “some individuals may prefer to resume medication indefinitely.”

    Audrey Bahrick, a psychologist at the University of Iowa Counseling Service, who has published papers on the way that S.S.R.I.s affect sexuality, told me that, a decade ago, after someone close to her lost sexual function on S.S.R.I.s, “I became pretty obsessive about researching the issue, but the actual qualitative experience of patients was never documented. There was this assumption that the symptoms would resolve once you stop the medication. I just kept thinking, Where is the data? Where is the data?” In her role as a counsellor, Bahrick sees hundreds of college students each year, many of whom have been taking S.S.R.I.s since adolescence. She told me, “I seem to have the expectation that young people would be quite distressed about the sexual side effects, but my observation clinically is that these young people don’t yet know what sexuality really means, or why it is such a driving force.”

    #Psychiatrie #Big_Pharma #Addiction #Anti_depresseurs #Valium

    • Le problème, c’est que les psychiatres ont surtout le temps pour prescrire, pas pour creuser. Et que le temps de guérison entre frontalement en conflit avec le temps de productivité.

      Le temps de guérir est un luxe pour les gens bien entourés et avec assez de moyens financiers.

      Et il manque toujours la question de base : qu’est-ce qui déclenche ses réponses psychiques violentes ?

      J’aurais tendance à dire : un mode de vie #normatif et étroit qui force certaines personnes à adopter un mode de vie particulièrement éloigné de ce qu’elles sont, de ce qu’elles veulent. Notre société est terriblement irrespectueuse et violente pour tous ceux qui ne se conforme nt pas au #modèle unique de la personne sociale, dynamique et surtout, bien productive !

      #dépression

  • Lawsuits Lay Bare Sackler Family’s Role in Opioid Crisis - The New York Times
    https://www.nytimes.com/2019/04/01/health/sacklers-oxycontin-lawsuits.html

    The Sacklers had a new plan.

    It was 2014, and the company the family had controlled for two generations, Purdue Pharma, had been hit with years of investigations and lawsuits over its marketing of the highly addictive opioid painkiller OxyContin, at one point pleading guilty to a federal felony and paying more than $600 million in criminal and civil penalties.

    But as the country’s addiction crisis worsened, the Sacklers spied another business opportunity. They could increase their profits by selling treatments for the very problem their company had helped to create: addiction to opioids.

    The filings cite numerous records, emails and other documents showing that members of the family continued to push aggressively to expand the market for OxyContin and other opioids for years after the company admitted in a 2007 plea deal that it had misrepresented the drug’s addictive qualities and potential for abuse.

    In addition to New York and Massachusetts, Connecticut, Rhode Island and Utah have filed suit against members of the family. Last month, a coalition of more than 500 counties, cities and Native American tribes named the Sacklers in a case in the Southern District of New York, bringing the family into a bundle of 1,600 opioids cases being overseen by a federal court judge in Cleveland.

    In 2009, two years after the federal guilty plea, Mortimer D.A. Sackler, a board member, demanded to know why the company wasn’t selling more opioids, email traffic cited by Massachusetts prosecutors showed.

    In 2011, as states looked for ways to curb opioid prescriptions, family members peppered the sales staff with questions about how to expand the market for the drugs. Mortimer asked if they could sell a generic version of OxyContin in order to “capture more cost sensitive patients,” according to one email. Kathe, his half sister, suggested studying patients who had switched to OxyContin to see if they could find patterns that could help them win new customers, according to court filings in Massachusetts.

    The lawsuits brought by the attorneys general of New York and Massachusetts, Letitia James and Maura Healey, named eight Sackler family members: Kathe, Mortimer, Richard, Jonathan and Ilene Sackler Lefcourt — children of either Mortimer or Raymond Sackler — along with Theresa Sackler, the elder Mortimer’s widow; Beverly Sackler, Raymond’s widow; and David Sackler, a grandson of Raymond.

    Purdue’s business was fundamentally changed after the F.D.A. approved OxyContin in 1995. The company marketed the drug as a long-acting painkiller that was less addictive than shorter-acting rivals like Percocet and Vicodin, a strategy aimed at reducing the stigma attached to opioids among doctors.

    While the Sacklers “have reduced Purdue’s operations and size, Rhodes continues to grow and sell opioids for the benefit of the Sackler families,” the New York suit contends.

    By 2016, Rhodes, though little known to the public, had a greater share of the American prescription opioid market than Purdue, according to a Financial Times analysis. Together, the companies ranked seventh in terms of the market share of opioids.

    Purdue temporarily abandoned plans to pursue Project Tango in 2014, but revived the idea two years later, this time pursuing a plan to sell naloxone, an overdose-reversing drug, according to the Massachusetts filing. A few months later, in December 2016, Richard, Jonathan and Mortimer Sackler discussed buying a company that used implantable drug pumps to treat opioid addiction.

    In recent years, the Sacklers and their companies have been developing products for opioid and overdose treatment on various tracks. Last year, Richard Sackler was awarded a patent for a version of buprenorphine, a drug that blocks opioid receptors, administered by mouth in a thin film. In March, the F.D.A. fast tracked the company’s application for an injectable drug for emergency treatment of overdoses.

    Fait très rare, cet article comporte de nombreuses photos des membres de la famille Sackler

    #Opioides #Sackler #Procès

  • The Unlikely Politics of a Digital Contraceptive | The New Yorker
    https://www.newyorker.com/tech/annals-of-technology/the-unlikely-politics-of-a-digital-contraceptive

    In August, the F.D.A. announced that it had allowed a new form of contraception on the market: a mobile app called Natural Cycles. The app, which was designed by a Swedish particle physicist, asks its users to record their temperature with a Natural Cycles-branded thermometer each morning, and to log when they have their periods. Using a proprietary algorithm, the app informs its users which days they are infertile (green days—as in, go ahead, have fun) and which they are fertile (red days—proceed with caution), so that they can either abstain or use a backup method of birth control. In clearing the app as a medical device, the F.D.A. inaugurated “software application for contraception” as a new category of birth control under which similar products can now apply to be classified. The F.D.A.’s press release quotes Terri Cornelison, a doctor in its Center for Devices and Radiological Health, who said, “Consumers are increasingly using digital health technologies to inform their everyday health decisions and this new app can provide an effective method of contraception if it’s used carefully and correctly.”

    On touche vraiment au grand Ogin’importe quoi.

    In January, a single hospital in Stockholm alerted authorities that thirty-seven women who had sought abortions in a four-month period had all become pregnant while using Natural Cycles as their primary form of contraception. The Swedish Medical Products Agency agreed to investigate. Three weeks ago, that agency concluded that the number of unwanted pregnancies was consistent with the “typical use” failure rate of the app, which they found to be 6.9 per cent. During the six-month investigation, six hundred and seventy-six additional Natural Cycle users in Sweden reported unintended pregnancies, a number that only includes the unwanted pregnancies disclosed directly to the company.

    Berglund’s story—a perfect combination of technology, ease, and self-discovery, peppered with the frisson of good fortune and reliance on what’s natural—has helped convince more than nine hundred thousand people worldwide to register an account with Natural Cycles. But the idea of determining fertile days by tracking ovulation, known as a fertility-awareness-based method of birth control, is anything but new. Fertility awareness is also sometimes called natural family planning, in reference to the Catholic precept that prohibits direct interventions in procreation. The most familiar form of fertility awareness is known as the rhythm method. First designated in the nineteen-thirties, the rhythm or calendar method was based on research by two physicians, one Austrian and one Japanese. If a woman counted the number of days in her cycle, she could make a statistical estimate of when she was most likely to get pregnant. Those methods evolved over the years: in 1935, a German priest named Wilhelm Hillebrand observed that body temperature goes up during ovulation. He recommended that women take their temperature daily to determine their fertile period.

    Plenty of doctors remain unconvinced about Natural Cycles. “It’s as if we’re asking women to go back to the Middle Ages,” Aimee Eyvazzadeh, a fertility specialist in San Francisco, said. Technology, she warned, “is only as reliable as the human being behind it.” Forman, from Columbia, said that “one of the benefits of contraception was being able to dissociate intercourse from procreation.” By taking a pill or inserting a device into an arm or uterus, a woman could enjoy her sexuality without thinking constantly about what day of the month it was. With fertility awareness, Forman said, “it’s in the opposite direction. It’s tying it back together again. You’re having to change your life potentially based on your menstrual cycle. Whereas one of the nice benefits of contraception is that it liberated women from that.”

    #Médecine #Hubris_technologique #Contraception #Comportements

  • The Opioid that Made a Fortune for Its Maker — and for Its Prescribers - The New York Times
    https://www.nytimes.com/interactive/2018/05/02/magazine/100000005878055.app.html

    For Insys, Chun was just the right kind of doctor to pursue. In the late 1990s, sales of prescription opioids began a steep climb. But by the time Subsys came to market in 2012, mounting regulatory scrutiny and changing medical opinion were thinning the ranks of prolific opioid prescribers. Chun was one of the holdouts, a true believer in treating pain with narcotics. He operated a busy practice, and 95 percent of the Medicare patients he saw in 2015 had at least one opioid script filled. Chun was also a top prescriber of a small class of painkillers whose active ingredient is fentanyl, which is 50 to 100 times as powerful as morphine. Burlakoff’s product was a new entry to that class. On a “target list,” derived from industry data that circulated internally at Insys, Chun was placed at No. 3. The word inside the company for a doctor like Chun was a “whale.”

    In the few months since Subsys was introduced, demand was not meeting expectations. Some of the sales staff had already been fired. If Burlakoff and Krane could persuade Chun to become a Subsys loyalist, it would be a coup for them and for the entire company. The drug was so expensive that a single clinic, led by a motivated doctor, could generate millions of dollars in revenue.

    Speaker programs are a widely used marketing tool in the pharmaceutical business. Drug makers enlist doctors to give paid talks about the benefits of a product to other potential prescribers, at a clinic or over dinner in a private room at a restaurant. But Krane and some fellow rookie reps were already getting a clear message from Burlakoff, she said, that his idea of a speaker program was something else, and they were concerned: It sounded a lot like a bribery scheme.

    But the new reps were right to be worried. The Insys speaker program was central to Insys’ rapid rise as a Wall Street darling, and it was also central to the onslaught of legal troubles that now surround the company. Most notable, seven former top executives, including Burlakoff and the billionaire founder of Insys, John Kapoor, now await trial on racketeering charges in federal court in Boston. The company itself, remarkably, is still operating.

    The reporting for this article involved interviews with, among other sources, seven former Insys employees, among them sales managers, sales reps and an insurance-authorization employee, some of whom have testified before a grand jury about what they witnessed. This account also draws on filings from a galaxy of Insys-related litigation: civil suits filed by state attorneys general, whistle-blower and shareholder suits and federal criminal cases. Some are pending, while others have led to settlements, plea deals and guilty verdicts.

    The opioid crisis, now the deadliest drug epidemic in American history, has evolved significantly over the course of the last two decades. What began as a sharp rise in prescription-drug overdoses has been eclipsed by a terrifying spike in deaths driven primarily by illicitly manufactured synthetic opioids and heroin, with overall opioid deaths climbing to 42,249 in 2016 from 33,091 in 2015. But prescription drugs and the marketing programs that fuel their sales remain an important contributor to the larger crisis. Heroin accounted for roughly 15,000 of the opioid deaths in 2016, for instance, but as many as four out of five heroin users started out by misusing prescription opioids.

    By the time Subsys arrived in 2012, the pharmaceutical industry had been battling authorities for years over its role in promoting the spread of addictive painkillers. The authorities were trying to confine opioids to a select population of pain patients who desperately needed them, but manufacturers were pushing legal boundaries — sometimes to the breaking point — to get their products out to a wider market.

    Even as legal penalties accrued, the industry thrived. In 2007, three senior executives of Purdue Pharma pleaded guilty in connection with a marketing effort that relied on misrepresenting the dangers of OxyContin, and the company agreed to pay a $600 million settlement. But Purdue continued booking more than $1 billion in annual sales on the drug. In 2008, Cephalon likewise entered a criminal plea and agreed to pay $425 million for promoting an opioid called Actiq and two other drugs “off-label” — that is, for unapproved uses. That did not stop Cephalon from being acquired three years later, for $6.8 billion.

    Subsys and Actiq belong to a class of fentanyl products called TIRF drugs. They are approved exclusively for the treatment of “breakthrough” cancer pain — flares of pain that break through the effects of the longer-acting opioids the cancer patient is already taking around the clock. TIRFs are niche products, but the niche can be lucrative because the drugs command such a high price. A single patient can produce six figures of revenue.

    Fentanyl is extremely powerful — illicitly manufactured variations, often spiked into heroin or pressed into counterfeit pills, have become the leading killers in the opioid crisis — and regulators have made special efforts to restrict prescription fentanyl products. In 2008, for instance, the F.D.A. rebuffed Cephalon’s application to expand the approved use for a TIRF called Fentora; in the company’s clinical trials, the subjects who did not have cancer demonstrated much more addictive behavior and propensity to substance abuse, which are “rarely seen in clinical trials,” F.D.A. officials concluded. An F.D.A. advisory committee reported that, during the trials, some of the Fentora was stolen. The agency later developed a special protocol for all TIRF drugs that required practitioners to undergo online training and certify that they understood the narrow approved use and the risks.

    Despite these government efforts, TIRF drugs were being widely prescribed to patients without cancer. Pain doctors, not oncologists, were the dominant players. This was common knowledge in the industry. Although it is illegal for a manufacturer to promote drugs for off-label use, it is perfectly legal for doctors to prescribe any drug off-label, on their own judgment. This allows drug makers like Insys to use a narrow F.D.A. approval as a “crowbar,” as a former employee put it, to reach a much broader group of people.

    That points to a major vulnerability in policing the opioid crisis: Doctors have a great deal of power. The F.D.A. regulates drug makers but not practitioners, who enjoy a wide latitude in prescribing that pharmaceutical companies can easily exploit. A respected doctor who advocates eloquently for wider prescribing can quickly become a “key opinion leader”; invited out on the lucrative lecture circuit. And any doctor who exercises a free hand with opioids can attract a flood of pain patients and income. Fellow doctors rarely blow the whistle, and some state medical boards exercise timid oversight, allowing unethical doctors to continue to operate. An assistant district attorney coping with opioids in upstate New York told me that it’s easy to identify a pill-mill doctor, but “it can take five years to get to that guy.” In the meantime, drug manufacturers are still seeing revenue, and that doctor is still seeing patients, one after another, day after day.

    Kapoor believed that he had the best product in its class. All the TIRF drugs — for transmucosal immediate-release fentanyl — deliver fentanyl through the mucous membranes lining the mouth or nose, but the specific method differs from product to product. Actiq, the first TIRF drug, is a lozenge on a stick. Cephalon’s follow-up, Fentora — the branded market leader when Subsys arrived — is a tablet meant to be held in the cheek as it dissolves. Subsys is a spray that the patient applies under the tongue. Spraying a fine mist at the permeable mouth floor makes for a rapid onset of action, trials showed.

    Once the F.D.A. gave final approval to Subsys in early 2012, the fate of Insys Therapeutics rested on selling it in the field. The industry still relies heavily on the old-fashioned way of making sales; drug manufacturers blanket the country with representatives who call on prescribers face to face, often coming to develop personal relationships with them over time.

    The speaker events themselves were often a sham, as top prescribers and reps have admitted in court. Frequently, they consisted of a nice dinner with the sales rep and perhaps the doctor’s support staff and friends, but no other licensed prescriber in attendance to learn about the drug. One doctor did cocaine in the bathroom of a New York City restaurant at his own event, according to a federal indictment. Some prescribers were paid four figures to “speak” to an audience of zero.

    One star rep in Florida, later promoted to upper management, told another rep that when she went in search of potential speakers, she didn’t restrict herself to the top names, because, after all, any doctor can write scripts, and “the company does not give a [expletive] where they come from.” (Some dentists and podiatrists prescribed Subsys.) She looked for people, she said, “that are just going through divorce, or doctors opening up a new clinic, doctors who are procedure-heavy. All those guys are money hungry.” If you float the idea of becoming a paid speaker “and there is a light in their eyes that goes off, you know that’s your guy,” she said. (These remarks, recorded by the rep on the other end of the line, emerged in a later investigation.)

    As a result of Insys’s approach to targeting doctors, its potent opioid was prescribed to patients it was never approved to treat — not occasionally, but tens of thousands of times. It is impossible to determine how many Subsys patients, under Kapoor, actually suffered from breakthrough cancer pain, but most estimates in court filings have put the number at roughly 20 percent. According to Iqvia data through September 2016, only 4 percent of all Subsys prescriptions were written by oncologists.

    Insys became the year’s best-performing initial public offering, on a gain of over 400 percent. That December, the company disclosed that it had received a subpoena from the Office of the Inspector General at Health and Human Services, an ominous sign. But a CNBC interviewer made no mention of it when he interviewed Babich a few weeks later. Instead he said, “Tell us what it is about Insys that has investors so excited.”

    In 2014, the doctors each averaged one prescription for a controlled substance roughly every four minutes, figuring on a 40-hour week. A typical pill mill makes its money from patients paying in cash for their appointments, but Ruan and Couch had a different model: A majority of their scripts were filled at a pharmacy adjacent to their clinic called C&R — for Couch and Ruan — where they took home most of the profits. The pharmacy sold more than $570,000 of Subsys in a single month, according to Perhacs’s criminal plea. Together the two men amassed a collection of 23 luxury cars.

    Over dinner, according to the Boston indictment, Kapoor and Babich struck a remarkable agreement with the pharmacists and the doctors, who were operating a clinic rife with opioid addiction among the staff: Insys would ship Subsys directly to C&R Pharmacy. An arrangement like this is “highly unusual” and a “red flag,” according to testimony from a D.E.A. investigator in a related trial. As part of the terms of the deal, the pharmacy would make more money on selling the drug, with no distributor in the loop. And there would be another anticipated benefit for all involved: Everyone could sell more Subsys without triggering an alert to the D.E.A.

    The local medical community felt the impact of the raid. Because refills are generally not allowed on controlled substances, patients typically visited the clinic every month. For days, dozens of them lined up outside in the morning, fruitlessly trying to get prescriptions from the remaining staff or at least retrieve their medical records to take elsewhere. But other providers were either booked up or would not take these patients. “Nobody was willing to give the amount of drugs they were on,” a nurse in the city said. Melissa Costello, who heads the emergency room at Mobile Infirmary, said her staff saw a surge of patients from the clinic in the ensuing weeks, at least a hundred, who were going through agonizing withdrawal.

    Two months after the raid in Mobile, Insys’ stock reached an all-time high.

    Insys itself is still producing Subsys, though sales have fallen considerably. (Overall demand for TIRFs has declined industrywide.) The company is now marketing what it calls the “first and only F.D.A.-approved liquid dronabinol,” a synthetic cannabinoid, and is developing several other new drugs. Some analysts like the look of the company’s pipeline of new drugs and rate the stock a “buy.” In a statement, the company said its new management team consists of “responsible and ethical business leaders” committed to effective compliance. Most of its more than 300 employees are new to the company since 2015, and its sales force is focused on physicians “whose prescribing patterns support our products’ approved indications,” the company said. Insys has ended its speaker program for Subsys.

    #Opioides #Pharmacie #Bande_de_salopards

  • This Man’s Immune System Got a Cancer-killing Update - Facts So Romantic
    http://nautil.us/blog/this-mans-immune-system-got-a-cancer_killing-update

    William Ludwig was almost dead when he became Patient Number One in a radical new cancer treatment, one that’s just won the endorsement of F.D.A. advisors.Photograph by sebastianosecondi / ShutterstockWilliam Ludwig was a 64-year-old retired corrections officer living in Bridgeton, New Jersey, in 2010, when he received a near-hopeless cancer prognosis. The Abramson Cancer Center at the University of Pennsylvania had run out of chemotherapeutic options, and Ludwig was disqualified from most clinical trials since he had three cancers at once—leukemia, lymphoma, and squamous cell skin cancer. In a later interview, the scientist Carl June described Ludwig’s condition as “Almost dead.” Alison Loren, an oncologist at Penn, had been taking care of Ludwig for five painful years. If chemotherapy is (...)

  • Their Hair Fell Out. Should the F.D.A. Have the Power to Act ? - The New York Times
    http://www.nytimes.com/2016/08/16/us/politics/cosmetics-industry-congress-regulation-wen.html?_r=0

    Le régulateur doit-il réguler (sic) ? En fait non seulement le soit-disant régulateur ne peut réguler puisque business run politics, mais de plus en plus business run le régulateur (voir affaire vioxx par exemple).

    “If you are in business and are not involved in politics, then politics will run your business,” explained a presentation prepared by Mary Kay last summer for sales representatives and obtained by The New York Times.

  • Questions for President Obama’s Nominee to lead the F.D.A.
    http://mobile.nytimes.com/2015/11/16/opinion/questions-for-president-obamas-nominee-to-lead-the-fda.html

    #Obama nomme un homme étroitement lié à l’industrie pharmaceutique à la tête de la #FDA, qui n’en a pourtant guère besoin.

    In recent years, the F.D.A. has approved two diet drugs that European regulators have deemed too risky, leaving the impression that it gives in to industry demands over safety. A new commissioner must be strong enough to protect the agency against such pressure from industry and from members of Congress who believe the approval process for drugs and devices should allow faster approvals with less scientific evidence.

    #Santé #conflit_d'intérêt #Etats-Unis #pharma

  • Study Warns of Diet #Supplement Dangers Kept Quiet by F.D.A. - NYTimes.com
    http://well.blogs.nytimes.com/2015/04/07/study-warns-of-diet-supplement-dangers-kept-quiet-by-f-d-a/?ref=health&_r=1

    ...public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and #lobbying group.

    #conflit_d’intérêt #porte_tournante #FDA #pharma #désespérant #santé #BMPEA #Etats-Unis

  • F.D.A. Restricts Antibiotics Use for Livestock
    http://www.nytimes.com/2013/12/12/health/fda-to-phase-out-use-of-some-antibiotics-in-animals-raised-for-meat.html

    The Food and Drug Administration on Wednesday put in place a major new policy to phase out the indiscriminate use of antibiotics in cows, pigs and chickens raised for meat, a practice that experts say has endangered human health by fueling the growing epidemic of antibiotic resistance.

  • Doctor’s Doubts Imperil Lucrative Diabetes Drugs - NYTimes.com
    http://www.nytimes.com/2013/05/31/business/a-doctor-raises-questions-about-a-diabetes-drug.html?pagewanted=1

    Sur le Dr. Butler, le chercheur dont les travaux (le premier- et dernier bien entendu- commandité par Merk en 2008) mettent en évidence un risque pancréatique pour les antidiabétiques oraux de la famille des incrétines http://www.theheart.org/fr/article/1523409.do (sans que leur commercialisation ne soit suspendue)

    He said that studies done by the drug companies that led to the drugs’ approval by the F.D.A. tended to use young healthy animals that would not be expected to get pancreatic cancer.

  • In Vast Effort, F.D.A. Spied on E-Mails of Its Own Scientists
    http://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html

    A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.

    #privacy #whistleblowers