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All Reason.com articles with the "Medicine" tag.



Published: Tue, 12 Dec 2017 00:00:00 -0500

Last Build Date: Tue, 12 Dec 2017 08:56:57 -0500

 



When Good-Faith Medicine Raises ‘Red Flags’

Wed, 22 Nov 2017 00:01:00 -0500

Forest Tennant, who has been treating and researching pain at his clinic in West Covina, California, since 1975, is well-known as an expert in the field, having published more than 200 articles in medical journals and given more than 130 presentations at professional conferences. According to the Drug Enforcement Administration (DEA), all of that was an elaborate cover for drug trafficking. Or so you would have to surmise from the affidavit supporting the search warrant that the DEA served on Tennant's offices and home last week, which describes "invalid prescriptions," "red flags of diversion and fraud," and "combinations of drugs that are consistent with 'pill mill' prescribing practices." The allegations and insinuations show how the DEA has tried to criminalize differences of opinion about pain treatment, encouraging doctors to think about their legal exposure first and their patients second. Tennant says the "red flags" perceived by the DEA are consistent with a practice like his, which specializes in treating severe, intractable pain caused by conditions such as arachnoiditis, Ehlers-Danlos syndrome, reflex sympathetic dystrophy, and post-viral neuropathy. "We only take people who have failed the standard treatments," he says. Tennant's willingness to take hard cases explains why some of his patients live in other states, a fact the DEA considers suspicious. "We only see them in conjunction with their local doctors," he says. In addition to severe pain, Tennant's patients often have metabolic abnormalities that make them less sensitive to opioids and have developed tolerance after years of pain treatment. Those factors explain the doses that struck the DEA as suspiciously high and the drug combinations it deemed reckless. By the time Tennant starts treating them, his patients are already taking large doses of opioids, often in combination with muscle relaxants and benzodiazepines. "We didn't start anybody on high dosages," Tennant says. "We took them to study them to figure out how to get them off of high dosages, and that has remained our goal." In nine out of 10 cases, Tennant says, he has been able to reduce patients' opioid doses substantially, by as much as 80 percent. At the same time, he defends the use of high doses for patients who need them, a stance that bothers the DEA. The search warrant affidavit cites a 2009 article in which Tennant and two other doctors defended the prescription of "ultra-high opioid doses" for certain patients with severe chronic pain. The affidavit also notes that Tennant championed the California Pain Patient's Bill of Rights, a 1997 law affirming that "opiates can be an accepted treatment" for "severe intractable pain." The DEA seems to be arguing that Tennant's sincere medical opinions and advocacy on behalf of pain patients should be considered evidence of criminal activity. The DEA suggests that speaking fees Tennant received from Insys, which makes the oral fentanyl spray Subsys, amounted to kickbacks. The DEA also implies that it's improper to prescribe Subsys for anything other than cancer pain, the application for which it was approved by the Food and Drug Administration. Tennant notes that it's common practice for doctors who have experience with a drug to get paid for training colleagues to use it. He says Subsys "turned out to be somewhat disappointing," but he prescribes it for half a dozen patients who find it useful for breakthrough pain, including a few who do not have cancer—"off-label" uses that are perfectly legal. Tennant, who has testified against "pill mills," says his clinic looks quite different: It has a six-hour intake process, sees a maximum of 10 people a day, and has "big thick charts" for its patients, who come with their families and tend to be middle-aged. He adds that his practice, which treats about 150 patients, has never had any overdoses, suicides, or diversion problems. "I invite anybody to come in and see what we do, talk to our patients, see our financial records, talk to me," Tennant says. "My clinic is wide open." © Copyright 2017 by Cr[...]



N.H. Can’t Monitor This Elderly Doc’s Painkiller Prescriptions, and Now They’re Shutting Her Down

Mon, 06 Nov 2017 13:55:00 -0500

New London, New Hampshire, a community of 4,400 is not bursting at the seams with doctors. Nevertheless, there may soon be one fewer, thanks to state regulators. The state's Board of Medicine has taken away 85-year-old Anna Konopka's medical license, and they're resisting her efforts to get it back. Konopka's problems started with an accusation earlier in the year that she wasn't properly treating a 7-year-old with asthma. She says the child's mother wasn't following her instructions, but the Board of Medicine reprimanded her. Since then, four additional complaints have been filed against Konopka, but the details have not been disclosed. When the board began disciplinary procedures, she agreed to voluntarily surrender her license, but said she was essentially forced to do so or the board would have shut her down immediately. The "voluntary" surrender allowed her to practice to the end of October. She's gone to a judge to ask to get her license back. It may well be those complaints are serious, but a significant detail in the matter may have been overlooked: Konopka is mostly computer illiterate. She has no computers in her office, keeps patient records in filing cabinets, and says she doesn't have the time to learn how computers work. This has made it impossible for her to comply with reporting guidelines put in place in New Hampshire in 2014 to "fight" the opioid overdose crisis, according to the Associated Press. Doctors who prescribe opioids are supposed to participate in this reporting program and check a patient's drug history in the register before prescribing them. Also worth noting: Konopka often takes care of the medical needs of people without insurance who feel like they don't have many choices or treatment alternatives. From the Associated Press: She often attracts patients who have run out of options, many with complicated conditions, such as chronic pain. She also draws patients who have no insurance and little means to pay. She takes anyone willing to pay her $50 in cash. "I'm interested in helping people. I didn't go to medicine for money, and I didn't make money," she said, noting she works alone and can't afford things like and administrative assistant or even a nurse. So Konopka's inability to participate in the opioid reporting program would be a terrible reason to revoke her license. In fact, in the hearing with the judge Friday, several of her patients came to speak on her behalf, and one claimed that she helped him get off oxycontin and use other remedies. He said that his previous doctor was responsible for overprescribing medications. We're well along in the mistaken belief that prescription-based pain treatment is the source of our opioid overdose crisis, and the Trump administration is buying into it. Jacob Sullum explained just last week that this narrative is misguided and that the risk of overdose among patients seeking a doctor's assistance for fighting chronic pain is relatively low. In fact, it's government crackdowns and interventions in pain management that are sending patients to the much more dangerous black market. Poor New Hampshire residents may have one fewer treatment option because the state decided a doctor wasn't keeping records the way the state wants her to. And those demands are, in part, guided by a mistaken grasp of the opioid crisis.[...]



Opioid Commission Mistakenly Blames Pain Treatment for Drug Deaths

Thu, 02 Nov 2017 17:00:00 -0400

In the report it published yesterday, the President's Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey Gov. Chris Christie, endorses what has become the standard explanation for the rise in opioid-related deaths during the last decade and a half. "A widely held and supportable view is that the modern opioid crisis originated within the healthcare system," the report says. The problem began, it explains, with "a growing compulsion to detect and treat pain." According to this narrative, doctors in the late 1990s began to underestimate the risk of addiction and overdose among patients prescribed narcotics for pain. Responding to ill-informed advocacy on behalf of pain patients and deceptive marketing by drug companies, they lost their entirely appropriate fear of opioids and began prescribing them left and right. The surge in prescriptions led to a surge in "iatrogenic addiction" (i.e., addiction caused by treatment) and overdose deaths. To correct that disastrous mistake, the Christie commission says, doctors need to worry less about the suffering caused by untreated pain and more about the dangers posed by painkillers. That response is fundamentally misguided because the narrative endorsed by the commission is wrong in several crucial ways. Doctors did not mistakenly believe that the dangers posed by opioids had been greatly exaggerated. They correctly believed that the dangers posed by opioids had been greatly exaggerated, and they were right to think that excessive fear of opioids had led to inadequate pain treatment. Contrary to the impression left by a lot of the press coverage, opioid addiction and opioid-related deaths rarely involve drug-naive patients who accidentally get hooked while being treated for pain. They typically involve polydrug users with histories of substance abuse and psychological problems. Attempts to prevent overdoses by closing off access to legally produced narcotics make matters worse for both groups, depriving pain patients of the analgesics they need to make their lives livable while driving nonmedical users into a black market where the drugs are more variable and therefore more dangerous. "The catalyst of the opioid crisis was a denial of [these drugs'] addictive potential," the Christie commission says. The report does not try to quantify that potential, but survey data and studies of patients help to put it into perspective. According to the National Survey on Drug Use and Health (NSDUH), 98 million Americans used prescription analgesics in 2015, including both legal and illegal use. About 2 million of them qualified for a diagnosis of "substance use disorder" (SUD) at some point during the previous year. SUD is a catchall category that subsumes what used to be known as "substance abuse" and the more severe "substance dependence." The Substance Abuse and Mental Health Services Administration, which oversees the survey, does not report the breakdown between mild, moderate, and severe SUD. But based on this survey, it looks like somewhere between 1 and 2 percent of prescription opioid users experience addiction in a given year. By comparison, NSDUH data indicate that about 5 percent of past-year drinkers had an alcohol use disorder in 2015. That group was about evenly divided between "abuse" and "dependence." The NSDUH numbers provide a one-year snapshot. Some studies of patients who take opioids for extended periods of time find higher addiction rates, but they are still generally modest. A 2010 review found that less than 1 percent of patients taking opioids for chronic pain experienced addiction. A 2012 review likewise concluded that "opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence." A 2015 review noted addiction rates in various studies ranging from 3 percent to 26 percent in primary care settings and from 2 percent to 14 percent in pain clinic settings. The risk of fatal overdose among patients is very low. The CDC cites "a recent study[...]



Legal Marijuana Is Becoming the Norm

Sun, 22 Oct 2017 00:00:00 -0400

The war on drugs has been going on since 1971, and we have a winner: marijuana. Back then, possession of pot carried heavy penalties in many states—even life imprisonment. Today, 29 states sanction medical use of cannabis, and eight allow recreational use. Legal weed has become about as controversial as Powerball. One sign of the shift came in Wednesday's debate among the Democrats running for governor of Illinois. The state didn't get its first medical marijuana dispensary until 2015, and it decriminalized possession of small amounts of pot only last year. But most of the candidates endorsed legalization of recreational weed, and one supported "full decriminalization." Those positions are not politically risky, in Illinois or in most places. They're mainstream. In 2016, Gallup Poll found that 60 percent of Americans supported full legalization—up from 36 percent in 2005. Given the choice, voters generally favor it. Nine states had cannabis initiatives on the ballot last year. Medical marijuana won in four states, and recreational pot won in another four. Only Arizona's recreational pot measure failed. Next year should further erode pot prohibition. "Campaigns are underway in at least five states to legalize either medical or recreational cannabis," reports Marijuana Business Daily. It also notes that New Jersey, Rhode Island and Vermont could get recreational cannabis through legislative action. All this progress has occurred even though federal law bars possession and use—impeding normal commerce in states that permit dispensaries. Under President Barack Obama, the Justice Department chose to defer to states that allowed cannabis. But banks generally are leery of doing business with pot dispensaries, forcing many to operate on cash alone. As a candidate, Donald Trump indicated he would follow more or less the same course as Obama. Attorney General Jeff Sessions, however, has been an implacable opponent of liberalization. He once joked—well, I assume he was joking—that he had no problem with the Ku Klux Klan until he "found out they smoked pot." He appointed a task force on crime, hoping it would confirm his preposterous claim that Obama's laissez-faire policy was to blame for rising violence. But the panel report, which has not been made public, recommended sticking with that approach. The case for full legalization becomes stronger all the time. One reason is that the disproportionate impact on African-Americans has gained more attention. Blacks are nearly four times likelier to be arrested for pot possession than whites even though there is no racial difference in usage. Drug enforcement has been a major motive for stop-and-frisk tactics that have fostered resentment of cops among black men. Treating cannabis like beer or cigarettes would greatly curtail such encounters. For years, opponents said legalization would lead to disaster. But as Supreme Court Justice Oliver Wendell Holmes Jr. noted, "A page of history is worth a volume of logic." We no longer have to rely on ominous forecasts. We now have actual experience in states that have taken the leap, and the results refute the fears. Studies show that after Colorado permitted recreational pot, there was no increase in adolescent use or traffic fatalities. In Washington, which voted for legalization in 2012, crime rates proceeded to decline. California found that when medical dispensaries closed, neighborhood crime didn't fall; it rose. This year, the National Academies of Sciences, Engineering and Medicine found "substantial evidence that cannabis is an effective treatment for chronic pain in adults." That helps explains why states that allow cannabis have far lower rates of opioid overdoses. The simple reality is that marijuana eases suffering and saves lives. States with fiscal problems—Illinois being a prominent example—also stand to gain from allowing recreational pot. First, they don't have to spend so much money arresting, trying, and incarcerating users and seller[...]



On Health Care, Private Sector May Show Congress the Way

Mon, 14 Aug 2017 16:15:00 -0400

Just because Congress can't fix health care doesn't mean it can't be done. That's the message from the Health Transformation Alliance, 41 big American companies that have banded together to try to save money and lives on their own, without waiting for Congress to pass a new law. The Alliance's chief executive, Robert Andrews, himself a former Democratic congressman from New Jersey, had a recent New York Times op-ed reporting on three steps being taken by the companies, which spend about $25 billion a year on covering about 6 million employees and retirees. One is using "big data" analysis to find patterns on which providers are delivering the best results. Another involves negotiating better deals with the medicine middlemen known as pharmacy benefit managers. A third will be setting up new medical networks in Dallas/Ft. Worth, Phoenix, and Chicago to treat back pain and diabetes and to provide knee and hip replacements. Andrews writes that the drug reforms alone "are projected to save participating companies, their workers and, in some cases, retirees at least $600 million over three years—while achieving the same or better results." Which raises one big question that he doesn't get into in the Times op-ed: if these savings are such a great idea and so easily achievable, why isn't the federal government doing these things? After all, government spends more than $1 trillion a year on Medicare and Medicaid. State budgets pick up some of the Medicaid costs, in ways that are threatening to crowd out other expenditures; in Massachusetts, for example, MassHealth consumes 40 percent of the state budget. In New York, Medicaid is one third of the state budget. At the federal level, Medicare, the health care program for the elderly, is about 15 percent of the total federal budget, about the same as what gets spent on defense. True, Medicaid reimbursement rates to doctors are already rock-bottom compared to private insurance. Some states are trying to save more money on the program. In Rhode Island, for example, where about 30 percent of the state budget is devoted to Medicaid, Governor Gina Raimondo, a Democrat, says she saved $75 million on Medicaid in 2016 and $120 million in 2017 "by reducing waste and increasing program efficiency and effectiveness." Even so, the private sector's leadership here highlights some structural differences between government and business that may help explain why progress by Congress has been so slow by comparison. One big difference is that what the private sector hails as "savings," in the public sector gets demagogued as "cuts." This is a bipartisan problem. Republican presidential candidate Mitt Romney repeatedly attacked Barack Obama and ObamaCare for having supposedly having "cut Medicare for current Medicare recipients." Romney described ObamaCare as a "Medicare-cutting monster." When President Trump proposed reductions in the rate of growth of health care spending, Hillary Clinton denounced Republicans as "the death party." Another big difference is the influence of interest groups, and their effect on incentives. If a CEO wants to save shareholders money by wringing better value from health care vendors, he or she is likely to be thanked with a bonus for increasing profits. Or the CEO's stock options will be worth more. When a politician tries to save taxpayers money by doing the same thing, big and powerful campaign donors and constituents and potential future employers—drug companies, doctors, their lobbyists, hospital board members, health care worker unions, medical device manufacturers, nursing home proprietors—push back hard in the other direction. The politician may decide the potential savings aren't worth the aggravation. What does that mean for health care cost and quality? A system in which government is the only buyer is likely to be more expensive. A system in which companies or groups of individuals are buyers may have more success in controlling costs without s[...]



Will All Seriously Ill Americans Be Granted the ‘Right to Try’ Experimental Meds?

Fri, 04 Aug 2017 13:01:00 -0400

(image) A state-level movement to allow Americans who are seriously and potentially terminally ill to access medication earlier in the approval process may successfully be going national.

The U.S. Senate has approved—by unanimous consent—Senate Bill 204, sponsored by Sen. Ron Johnson (R-Wisconsin) and pushed by the libertarian Arizona-based Goldwater Institute. It mimics legislation in 37 states that allows for people with life-threatening illnesses earlier access to medication being evaluated through the very lengthy Food and Drug Administration (FDA) approval process.

To be clear, this "right to try" legislation does not create a free-for-all when it comes to access to experimental medicine. The bill requires that a person have a life-threatening illness or disease and that the drug in question has already completed the first phase of clinical trials for the FDA.

Furthermore it does not require drug manufacturers or dispensers to provide access if they don't want to, and they cannot be held liable if they refuse (and they can't be held liable if the drug causes harm except in cases of misconduct or negligence). And as a compromise for critics worried about the ethics of letting people access drugs early, drug manufactures who do provide medicine as part of this process will need to report to the government any adverse effects.

The bill now heads to the House of Representatives, where two Republican congressmen have already introduced companion legislation. In a release praising the passage of Johnson's bill, the Goldwater Institute notes how state-level right-to-try laws actually help:

Right to Try is saving lives already. In Texas alone, Dr. Ebrahim Delpassand has helped nearly 100 patients under his state law, providing a treatment that has completed clinical trials but is not yet fully approved for advanced stage neuroendocrine cancer. Many of these patients were told they had only months to live but are still alive a year later, thanks to Right to Try.

Reason has been covering the "Right to Try" movement for years now. Below, watch a ReasonTV explanation video from 2015 about the efforts:

src="https://www.youtube.com/embed/nerWf9Vydn4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">




Tired of High Health Care Costs? Look at Misbehaving Dentists and the Licenses That Enable Them

Tue, 18 Jul 2017 00:01:00 -0400

With memories of a certain scene from Marathon Man fading, it's likely that most Americans have a pretty positive view of dentists. They keep our choppers in decent working order despite a wide range of neglect and abuse of the pearly whites. But there is a darker side of the profession, which has developed a reputation for playing hardball in protecting its licensed practitioners from potential competition. It's an object lesson in the dangers of occupational licensing—a demonstration that letting any industry coopt the coercive power of government does little to help consumers, while protecting the paychecks and prerogatives of the licensed few. "Lawmakers from Maine to Alaska see a different side of dentists and their lobby, the American Dental Association, describing a political force so unified, so relentless and so thoroughly woven into American communities that its clout rivals that of the gun lobby," the Washington Post reported earlier this month. You know reporters are troubled by bad behavior when they compare it to "the gun lobby"—culturally parochial modern journalists' equivalent of invoking the devil. But what they report is truly troubling. The Post adds, "Critics say the ADA has worked to scuttle competition that could improve access to dental care in underserved areas and make routine checkups and fillings more affordable." The article goes on to detail efforts by organized dentists to intimidate lawmakers who consider allowing competition by dental therapists—non-dentist practitioners who can offer basic dental care at lower cost than dentists. It also discusses battles waged by the Federal Trade Commission against state dental boards—regulatory bodies run, as is the case with most licensing bodies, by and for the benefit of existing practitioners in the industry they oversee. "The Federal Trade Commission today announced a consent order settling charges brought in September 2003 that the South Carolina State Board of Dentistry unlawfully restrained competition in violation of Section 5 of the FTC Act by adopting a rule that required a dentist to examine every child before a dental hygienist could provide preventive care—such as cleanings—in schools," the FTC announced in 2007. "Today, the Supreme Court affirmed the Federal Trade Commission's position in recognizing that a state may not give private market participants unsupervised authority to suppress competition even if they act through a formally designated 'state agency'," the FTC reported in 2015. Yes, the scare quotes around "state agency" are original to the FTC press release—perhaps an acknowledgment by a federal regulatory body of the regulatory capture of the state body by the people it regulates, and its operation on their behalf (whether there's an implied lesson in there about all regulatory bodies I leave to readers' imaginations). So it's clear that dental licensing bodies function to protect dentists from competition, to the point that they've even had their hands slapped by the U.S. Supreme Court for their behavior. Is there any counter-balancing benefit to be had from licensing dentists? Not really, was the conclusion of a study performed by Morris M. Kleiner and Robert T. Kudrle, of the University of Minnesota and published in 1997. They compared regulatory regimes across the United States, from highly restrictive to permissive, and concluded that "increased licensing restrictiveness did not improve dental health, but did raise the prices of basic dental services." There's a lesson in here about creeping regulation over time, since "a state that changed from a low level of restrictiveness to one that was in the most restrictive grouping could expect to see an increase in the price of dental services of 14 to 16 percent." Those raised prices resulted not just in less accessible care, but also in a roughly 10 percent income boost for dentists in more highly re[...]



Brickbat: The Waiting Is the Hardest Part

Wed, 12 Jul 2017 04:00:00 -0400

(image) The United Kingdom's National Health Service reports that 20 percent of those trying to schedule an appointment with a general practitioner cannot get one within seven days and 11.3 percent cannot get an appointment at all. Meanwhile, 27.8 percent said they had difficulty just reaching a doctor's office on the phone.




Meet the Doctor Who Refuses to Stop Prescribing Opioids to Pain Patients: New at Reason

Fri, 07 Jul 2017 12:45:00 -0400

src="https://www.youtube.com/embed/cR0QJxt5sI4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0"> Pain patients from across the country are flocking to a boundary-pushing pain specialist in West Covina, California because they can't get the treatment they need in their home states. A growing "opioid epidemic" in the U.S. has led law enforcement agencies to crack down on so-called pill mills, leading to the arrest of several physicians. Last year, the Drug Enforcement Agency (DEA) clamped down on painkillers, reducing the allowed production of opioid medications by about 25 percent. Some states have filed lawsuits against pharmaceutical manufacturers, and, earlier this year, the Center for Disease Control (CDC) issued guidelines advising physicians against prescribing high doses of these drugs, which can be particularly lethal when combined with alcohol or anti-anxiety medications. Many doctors will only prescribe opioids as a last resort. Dr. Forest Tennant, 76, says this regulatory backlash is preventing chronic pain sufferers from getting the drugs they need to alleviate their conditions, and he refuses to go along. Critics have denounced his unapologetic style and unorthodox methods, but his patients depict him as one of the only physicians in America to put the needs of his patients first. "[Tennant was] the first doctor to say, 'our goal is to relieve your pain,'" says Kristen Ogden, whose husband Louis Ogden has suffered from chronic pain for decades. They travel to Dr. Tennant's office from Virginia for treatment every three months. "Every other doctor had said, 'our goal is to get you off any opioid medications.'" Many physicians have even begun to adjust the way that they think about pain. In a New England Journal of Medicine article, one of the pain specialists advising the CDC recommended that pain patients "use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity." That opioids are never an effective chronic pain treatment is quickly becoming conventional wisdom, and the American Medical Association (AMA) has even begun to advise physicians to abandon the pain rating scale when assessing patients. "I take the Hippocratic oath seriously, that my job is to relieve pain and suffering," says Dr. Tennant. "So when I see the AMA decide that they're not going to assess pain, I'm not with them." Tennant has run a pain clinic since the 1970s when he mostly treated patients with pain resulting from cancer and polio. He's never shied away from the public spotlight. In addition to serving as mayor of his city, he ran some of Los Angeles County's earliest methadone clinics to treat heroin addicts and in the late '80s served as a drug adviser for the NFL, NASCAR, and the Los Angeles Dodgers. Controversy swirled around him in many of these roles. He angered the NFL when he publicly disclosed plans to monitor several New England Patriots players for drug use. One NASCAR racer even accused him of colluding to falsify drug tests to target him. Tennant simply told the New York Times that "[n]o mistakes were ever made." Tennant says it's true that opioids were overprescribed in the past and should generally be a last resort for pain treatment. But he believes the media and government have now gone too far in demonizing them, and it's legitimate pain patients who are paying the price. Produced by Zach Weissmueller. Music by Kai Engel and Blue Dot Sessions. Subscribe to our YouTube channel. Like us on Facebook. Follow us on Twitter. Subscribe to our podcast at iTunes.[...]



Meet the Doctor Who Refuses to Stop Prescribing Opioids to Pain Patients

Fri, 07 Jul 2017 12:30:00 -0400

Pain patients from across the country are flocking to a boundary-pushing pain specialist in West Covina, California because they can't get the treatment they need in their home states. A growing "opioid epidemic" in the U.S. has led law enforcement agencies to crack down on so-called pill mills, leading to the arrest of several physicians. Last year, the Drug Enforcement Agency (DEA) clamped down on painkillers, reducing the allowed production of opioid medications by about 25 percent. Some states have filed lawsuits against pharmaceutical manufacturers, and, earlier this year, the Center for Disease Control (CDC) issued guidelines advising physicians against prescribing high doses of these drugs, which can be particularly lethal when combined with alcohol or anti-anxiety medications. Many doctors will only prescribe opioids as a last resort. Dr. Forest Tennant, 76, says this regulatory backlash is preventing chronic pain sufferers from getting the drugs they need to alleviate their conditions, and he refuses to go along. Critics have denounced his unapologetic style and unorthodox methods, but his patients depict him as one of the only physicians in America to put the needs of his patients first. "[Tennant was] the first doctor to say, 'our goal is to relieve your pain,'" says Kristen Ogden, whose husband Louis Ogden has suffered from chronic pain for decades. They travel to Dr. Tennant's office from Virginia for treatment every three months. "Every other doctor had said, 'our goal is to get you off any opioid medications.'" Many physicians have even begun to adjust the way that they think about pain. In a New England Journal of Medicine article, one of the pain specialists advising the CDC recommended that pain patients "use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity." That opioids are never an effective chronic pain treatment is quickly becoming conventional wisdom, and the American Medical Association (AMA) has even begun to advise physicians to abandon the pain rating scale when assessing patients. "I take the Hippocratic oath seriously, that my job is to relieve pain and suffering," says Dr. Tennant. "So when I see the AMA decide that they're not going to assess pain, I'm not with them." Tennant has run a pain clinic since the 1970s when he mostly treated patients with pain resulting from cancer and polio. He's never shied away from the public spotlight. In addition to serving as mayor of his city, he ran some of Los Angeles County's earliest methadone clinics to treat heroin addicts and in the late '80s served as a drug adviser for the NFL, NASCAR, and the Los Angeles Dodgers. Controversy swirled around him in many of these roles. He angered the NFL when he publicly disclosed plans to monitor several New England Patriots players for drug use. One NASCAR racer even accused him of colluding to falsify drug tests to target him. Tennant simply told the New York Times that "[n]o mistakes were ever made." Tennant says it's true that opioids were overprescribed in the past and should generally be a last resort for pain treatment. But he believes the media and government have now gone too far in demonizing them, and it's legitimate pain patients who are paying the price. Produced by Zach Weissmueller. Music by Kai Engel and Blue Dot Sessions. Subscribe to our YouTube channel. Like us on Facebook. Follow us on Twitter. Subscribe to our podcast at iTunes.[...]



Charlie Gard’s Case Shows Why Government Should Stay Out of End-of-Life Choices

Mon, 03 Jul 2017 14:30:00 -0400

In California, the government is documenting what happens when citizens can turn to medicine to end their own lives. In the United Kingdom, the government is forcing parents' hands in the case of an infant with a life-ending medical condition. Two news stories about the government's role in end-of-life issues highlight the potential slippery slope where a recognition of individual liberty transforms into a manifestation of official authority and control. California lawmakers passed right-to-die legislation in 2015. It permits doctors to prescribe life-ending medication to adults with terminal illnesses and likely less than six months to live. Now that the law is in place, the state is keeping track of who actually decides to end their own lives this way. Its first report, covering June to December of 2016, determined that 111 people committed assisted suicide in this fashion. The vast majority were over the age of 60 and receiving hospice care. In the United Kingdom, the government is deciding for itself when to pull the plug in a case sparking international news coverage and horrified responses. Charlie Gard, an infant with a serious and rare genetic condition and significant brain damage, is terminally ill. His parents would like to pursue an experimental treatment in the United States. Doctors, granted authority by the British government and their socialized medical system, have told them no. They are ordering that Gard's life support be shut down. The parents turned to the European Court of Human Rights for support and were rebuffed. Note that this is not a matter where the British government is being asked to bankroll Gard's experimental treatment. The parents themselves have raised the money to bring him to the United States. Rather, doctors and the British government are overruling the parents and deciding that they have the authority to an end the child's life and what they believe to be the child's suffering. While it seems unlikely that the treatment in the United States would change Gard's tragic fate, this case should nevertheless be seen as a dangerous assertion of authority disguised as mercy. For libertarians or anybody who supports an individual's right to end his or her own suffering, what's happening in the United Kingdom is an important and useful reminder of why some conservatives are wary about allowing this right. There is a slippery slope here: An individual's right to decide can transform into a government's insistence on making that call for those who aren't in a position to assert themselves. Western governments use their authority to override parents' decision-making in many areas, from schooling to vaccinations. But what's supposed to be a mechanism to shield children (who have little agency) from parental abuse becomes a method for paternalistic intervention. After all, what Gard's parents are doing is essentially the opposite of what should trigger government intervention. They are not abusing the child. They are doing what parents are supposed to do: everything they can to save him. And they should have the liberty to do so. It should not be difficult to avoid the slippery slope that transforms voluntary euthanasia into government-sanctioned termination. It's a matter of respecting the choice of the individual or those who are responsible for making those choices. Government intervention should be limited to situations where it can be shown that the private responsible parties are abusing or neglecting the patient, or where there are no private responsible parties. One other issue worth examining in the Gard case: The authorities have been quick to dismiss this experimental treatment because it probably won't work. They are probably right. But that's not where medicine and science ends. The development of treatment for an[...]



The GOP Health-Care Reform Plans Are Worse Than Useless: Nick Gillespie on Kennedy

Fri, 30 Jun 2017 14:05:00 -0400

(image)

I was on Fox Business' Kennedy to talk about the Senate Republicans' now-on-hold plans to reform Obamacare. The eponymous host started out by talking about an excellent letter from Sen. Rand Paul outlining the Kentucky Republican's opposition to his own colleagues' plan. Among other things, Paul objected to the plan's refundable tax credits, which he convincingly argues create a new entitlement. What is wrong with politicians that they will do anything but talk seriously about bring market forces and price signals into health care?

Watch above for our discussion. And click below to learn why the reforms being pushed by House and Senate Republicans represent not just a failure of nerve but a failure of vision about how best to actually "repeal and replace" Obamacare. The GOP currently runs the House, the Senate, and the White House. If they're not up to the task of creating a system that increases the quantity and quality of health care now, they never will be.

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Read Reason's coverage of health-care reform here.




Scott Gottlieb Confirmed as New FDA Commissioner

Tue, 09 May 2017 18:05:00 -0400

(image) Physician, venture investor, and drug industry consultant Scott Gottlieb has been confirmed by the Senate as the new Commissioner of the Food and Drug Administration. Gottlieb takes the helm of the agency that regulates products accounting for about 20 cents of every dollar of annual spending by U.S. consumers, that is, about $2.4 trillion in annual consumption that includes medical products, food and tobacco. The agency regulates medicines, diagnostic tests, medical devices, food safety including those made from modern biotech crops and livestock, food labeling, and tobacco and nicotine products. What the agency's bureaucrats decide has signifcant impact on U.S. economic growth and the livelihoods of Americans.

Gottlieb has long been a critic of the FDA's slow and protracted drug and medical device approval processes. Researchers at the Tufts University Center for the Study of Drug Development have estimated that in 1991 it cost $412 million (2013 dollars) to develop and obtain approval for a new pharmaceutical. Last year, they calculated that it now takes more than $2.5 billion, a six-fold increase.

In an email, Union of Concerned Scientists spokesperson Seth Michaels warned that Gottlieb's confirmation is "yet another example of an appointee whose record raises questions about whether they'll respect science and the public interest." On the other hand, Paul Howard, Senior Fellow and Director, Health Policy at the market-friendly Manhattan Institute issued a statement applauding the appointment. "At a time of both unprecedented scientific opportunity and rapidly evolving public health challenges, Dr. Gottlieb provides the FDA with principled and pragmatic leadership," declared Howard. "His experience as a regulator, practicing physician, cancer survivor, and innovator will help the agency navigate the scientific challenges surrounding drug and medical device development and approval without losing sight of the real-world implications of the agency's decisions for patients struggling with potentially life threatening conditions."

I earlier noted, "While not a radical reformer, Gottlieb clearly has a good understanding of how over-regulation has been slowing down innovation in medicines and foods." Good luck to him as he tries to reform the agency's excessively cautious regulatory culture.




CRISPR and the Dawn of the New Biotech Revolution

Wed, 03 May 2017 12:15:00 -0400

(image) CRISPR genome editing will transform biotechnology and our lives in the next decade making possible (and cheap*) all kinds of new cures, new crops, new livestock, new industrial processes, and new ways to manage the environmental commons. Just two years ago, Science hailed CRISPR as the scientific breakthrough of 2015 noting, "It's only slightly hyperbolic to say that if scientists can dream of a genetic manipulation, CRISPR can now make it happen." Researchers have tweaked CRISPR so that it can find and cut and, if desired, replace essentially any DNA sequence in an organism's set of genes, including those in human beings.

With regard to new cures, researchers at the Lewis Katz School of Medicine at Temple University and the University of Pittsburgh have just published results in which they used CRISPR to almost entirely eliminate HIV, the virus that causes AIDS, from living experimental animals. Basically, the researchers targeted segments of HIV genes using CRISPR loaded into a viral delivery system that inactivated the HIV genes. Temple University researcher Kamel Khalili said, "Our eventual goal is a clinical trial in human patients."

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Another group of researchers announced last week that they are developing a pill that would use CRISPR to target specific microbial pathogens. The idea is that a CRISPR antibiotic pill would instruct harmful bacteria to shred their own genes to bits. The researchers have engineered CRISPR to contain bits of genomic DNA of Clostridium difficile into bacteria-killing viruses called bacteriophages. The next step is to package the engineered phages into Lactobacillus bacteria. Found in yogurt, Lactobacillus would survive passage through the human digestive tract while shedding CRISPR phages that infect and then destroy the targeted pathogens. Unlike current antibiotics, CRISPR pills would kill only the targeted pathogens, leaving benign microorganisms alone.

*Cheap, if the Food and Drug Administration regulators don't stand in the way. The initial signs are not good.




Should You Be Compensated for Your Medical Waste?

Fri, 21 Apr 2017 16:00:00 -0400

The right answer is: No. Why bring this issue up? HBO will be showing a movie based on the 2010 bestseller The Immortal Life of Henrietta Lacks tomorrow starring Oprah Winfrey. In 1951, black Baltimorean Henrietta Lacks had surgery to remove a cervical cancer tumor. Her physician took some cells from the tumor which he turned into the first immortal line human cell line. The HeLa cell line has been subsequently used in thousands of biomedical research projects. Lacks died later that year of her cancer, and her family was not told about the HeLa cell line. One of the central themes of the book was whether or not Lacks' physician should have asked for consent and provided compensation for the use of her cells. Spurred by the controversy engendered by the book, the U.S. Department of Health and Human Services proposed revisions to the Common Rule that protects people who volunteer for federally funded research studies. The proposed revisions would have substantially increased the burden on researchers with regard to obtaining consent from patients for the subsequent use of their medical wastes, uh, biospecimens. I am happy to report that in their op/ed, "Science Needs Your Cells," in today's New York Times two bioethicists agree with me that such requirements are largely useless and would substantially slow down medical progress. From the op/ed: First, no one is taking biospecimens from patients' bodies without their permission. Patients have consented to the clinical procedure as important to their medical care. What harm could come from using leftover materials, which would otherwise be thrown away, for research? Perhaps we should be concerned about risks to a patient's privacy, but that is why we remove the identifying information. Although researchers have shown that it is possible to "de-anonymize" specimens — using clues to link them back to individuals — there have been no reports of anyone doing this for nefarious reasons. And even if there were, the answer would be to sanction the culprit through fines or criminal charges, not to make it harder for researchers to get these samples in the first place. What is left, then, is our claim to autonomy: Many of us intuitively feel we should be able to control how biospecimens derived from our bodies are used. But leftover biospecimens are just medical waste to most of us, as we lack the expertise to imbue them with scientific value. Nor have we done anything to make them valuable, other than being born with a particular genetic variant or afflicted with a particular malignancy. This is why calls to pay patients are misplaced. In addition, unlike HeLa, in which one patient's biospecimens led to dramatic advancements, most developments come from studying materials from many patients — each biospecimen contributes only marginally to the result. These relatively weak claims to control and compensation do not justify the demands more restrictions would place on biospecimen research. Hindering this research is worrisome because its benefits are so great. Among many examples, they include the identification of mutations in tumors (lung, skin and others) that can be targeted with drugs that markedly improve quality of life and survival. Requiring consent might not seem like a big deal. But it is. Consent might require tracking patients down later, whenever a study is proposed, which can be difficult or impossible. Alternately, it might involve asking patients to agree generally to any future research at the time blood is drawn or a biopsy is taken. Either way, it can be a costly, bureaucratic headache. Which patients said yes, which said no, and to what, exactly? They are correct. And the good new[...]