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Published: Sun, 22 Apr 2018 00:00:00 -0400

Last Build Date: Sun, 22 Apr 2018 16:16:22 -0400


New Medicare Rule Promises Needless Suffering for Pain Patients

Wed, 28 Mar 2018 14:20:00 -0400

The CDC's controversial but officially optional opioid prescription guidelines, which encourage doctors to be as stingy as possible with pain medication, seem to be getting more mandatory every day. The recommendations, which were published in March 2016, already have been imposed on veterans, incorporated into state laws, and adopted as a guide to proper medical practice by regulators, insurers, and doctors. Now the Trump administration plans to impose them on the 44 million Americans enrolled in Medicare, against the advice of critics who say that move will lead to needless suffering. Those critics include doctors who helped produce the guidelines. For patients suffering from severe chronic pain, the most problematic aspect of the guidelines is the recommendation that doctors "should avoid increasing dosage" above 90 morphine milligram equivalents (MME) per day, or at least "carefully justify a decision to titrate dosage" above that level. Critics say that threshold, which many doctors have interpreted as a hard cap, is arbitrary because patients vary widely in the way they metabolize and respond to opioids, especially if they have developed tolerance after taking pain medication for years. Thanks to the CDC's advice, patients across the country have seen their doses dramatically reduced, even when they had been responding well to opioids for years. Lynn Webster, a former president of the American Academy of Pain Medicine (AAPM), hears from such patients almost every day. He says opioids enabled them to "have a reasonable life...maybe for a decade or more," but "many of them are now bedridden, because they're being forced to take a dose far less than what has been necessary to keep them functional." The Trump administration seems determined to replicate that pattern among Medicare recipients. Under a proposed rule that is expected to take effect in January, Medicare will not cover pain medication amounting to 90 MME or more a day for more than a week, except for cancer and hospice patients. According to the Centers for Medicare and Medicaid Services (CMS), 1.6 million patients currently exceed that cap. That means many patients with severe chronic pain will have to choose between agony and paying thousands of dollars more every year for their medication, assuming they can afford it. "While a strong case can be made for consensual, supported opioid dose reductions for voluntary patients, no data support nonconsensual/forcible dose reductions or curtailment in otherwise stable patients that have become common as prescribers react to regulations, mandates, insurers and fear for professional security," say 150 physicians in a letter to CMS criticizing the new policy. "The CMS plan risks accelerating a chaotic pattern of churn, abandonment and medical harm to patients who receive opioids as physicians flee an increasingly risk-laden and cumbersome decision matrix that may not advance patient safety." Stefan Kertesz, the University of Alabama at Birmingham pain and addiction specialist who spearheaded that letter, notes that several experts who worked on the CDC's guidelines have expressed concerns about the proposed CMS limits. One of those CDC advisers, University of Minnesota internist Erin Krebs, told The New York Times she worries about "aggressive tapering or immediate discontinuation," which "could harm people, even if opioids have no benefit for their pain." Krebs emphasized that "we can't walk away from patients who have been treated with opioids for years or even decades now." Another doctor who worked on the guidelines, Lewis Nelson, chairman of emergency medicine at Rutgers New Jersey Medical School and University Hospital, told the Times: "We didn't take a specific position on people who were already on high doses. We did say that established, high-dose patients might consider dosage reduction to be anxiety-provoking, but that these patients should be offered counseling to re-evaluate." He added that "there is a difference between a CDC guideline for doctors and a CMS hard stop for insurers and pharmacists." Deb[...]

Does That JAMA Study Really Show That Advil Is Just As Effective As Opioids?

Fri, 09 Mar 2018 14:45:00 -0500

According to Vox, a JAMA study published this week "finally" provides "proof" that "opioids are no better than other medications for some chronic pain." The results of the study are "devastating," Vox says. To whom or what is not exactly clear, but the author of the article, Julia Belluz, seems to see the study as conclusive evidence against the notion that "opioids help patients with chronic pain in the long run" or that "they are worth all that risk" of "addiction and death." Similarly, NBC News declares that the "jury's in," and its verdict is that "opioids are not better than other medicines for chronic pain." Mother Jones likewise says "a new study shows that opioids are no better than other meds for chronic pain," while Newser agrees that Tylenol and Advil "work just as well as opioids." The JAMA study—the work of a team led by internist Erin Krebs, a researcher with the Minneapolis Veterans Affairs Health Care System—did not actually demonstrate any of that. But it did highlight journalists' eagerness to believe that no one really needs narcotics for pain relief, which reflects the widespread desire for a simple solution to the "opioid epidemic." If opioids have no advantage over other analgesics, why prescribe them at all? Why risk "addiction and death" when over-the-counter pain relievers are just as effective? Even if we ignore the fact that the risks for pain patients are actually pretty small (and the fact that opioid-related deaths primarily involve illegally produced drugs), this study does not show what the headlines claim. Krebs and her colleagues recruited 240 patients with moderate to severe chronic back pain or hip or knee osteoarthritis from V.A. primary care clinics and randomly assigned them to opioid or nonopioid treatment. The opioid group initially received immediate-release morphine, oxycodone, or hydrocodone plus acetaminophen. If those medications proved inadequate, subjects were treated with sustained-action morphine or oxycodone, followed by fentanyl patches if necessary. The nonopioid group initially received acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, followed if necessary by various other medications, including nortriptyline, amitriptyline, gabapentin, topical analgesics, pregabalin, duloxetine, and tramadol. The main outcome measures were pain-related function (measured by a questionnaire, with higher scores indicating a bigger burden from pain) and pain intensity (also self-reported, on a scale of 0 to 10). After 12 months, both groups were significantly better off by those two measures. The mean pain-related function score fell from 5.4 to 3.4 in the opioid group and from 5.5 to 3.3 in the nonopioid group. Mean pain intensity fell from 5.4 to 4 in the opioid group and from 5.4 to 3.5 in the nonopioid group. The difference between the two groups was statistically significant only for pain intensity, and the researchers note that "the clinical importance of this finding is unclear," since "the magnitude was small." In short, both groups fared about the same. "Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months," Krebs et al. conclude. "Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain." People in pain vary widely in how they respond to medication, so the fact that opioids did not have an advantage, on average, for this particular sample with these particular types of pain does not mean they are not a better choice for some patients. The study sample was 87 percent male, and it was drawn from V.A. clinics, which may not be representative of the general patient population. The conditions were limited to chronic back pain and chronic hip or knee pain caused by osteoarthritis, so the study does not speak to opioid treatment for other kinds of pain. The initial pain intensities were middling, so the study may not reflect the experiences of patients with more severe pai[...]

The First Amendment Applies to the FDA Too

Tue, 06 Mar 2018 08:00:00 -0500

If you use a beta-blocker called Corgard to prevent migraine headaches, you are taking advantage of an important if obscure element of modern medicine: physicians' ability to prescribe approved medicines for purposes not explicitly sanctioned by the Food and Drug Administration (FDA). Corgard is approved for angina and high blood pressure only, yet migraine sufferers and their physicians know that it has other useful properties as well. These so-called "off-label" uses of drugs are perfectly legal, yet regulators make it all but impossible for manufacturers to inform doctors about such uses. No law or regulation explicitly forbids it, but the FDA treats it as misbranding or fraud. The government has prosecuted numerous drug makers for off-label promotion, with penalties and settlements in the billions of dollars. But that could change soon. In the last few years, the agency has lost several cases in which federal courts have held that giving doctors truthful information about off-label uses is protected by the U.S. Constitution's First Amendment. And while prosecutors have continued to drag drug makers to court, new leadership at the FDA has finally signaled some willingness to obey the Constitution. In the waning days of President Barack Obama's administration, the agency issued a rule that reinforced its speech restrictions, but regulators are now reconsidering that position. Before a drug can be sold in the United States, it must be certified by the FDA as safe and effective for a specific "on-label" use—to treat high blood pressure or a certain kind of leukemia, for example. But once a drug has been approved, physicians may legally prescribe it for any other purpose. There is typically a long lag between clinical research findings and FDA approval of a new use; journal articles and presentations at scientific conferences far outpace the agency's process. So off-label prescribing makes it possible for patients to benefit from the most up-to-date medical knowledge. Off-label prescribing is ubiquitous in a number of medical specialties and, by some estimates, at least 20 percent of all prescriptions are written for off-label uses. A 2013 study, for example, found that about 30 percent of the prescriptions for oncology drugs were for off-label uses. Needless to say, off-label prescribing must be done judiciously. "Guesses" about possible uses of drugs may have deleterious results, as illustrated by a 2011 safety review of the heart drug Multaq. The approved, on-label use of the drug is to treat people with transient atrial fibrillation (an abnormal heart rhythm). However, according to the FDA, the drug increases the risk of serious cardiovascular events, including death, when used by patients with permanent atrial fibrillation. Prescribing Multaq for the latter condition because it is safe and effective for the former would put patients at grave risk. So doctors know they must continuously educate themselves about the risks and benefits of all the medicines they prescribe, for both on- and off-label uses. And drug manufacturers have a legal obligation to monitor the safety of their products long after they've been approved; whether they're promoting approved uses or off-label ones, the FDA has the authority to prosecute companies when they distribute false or misleading information. Similarly, drug companies can (and routinely are) sued by patients who believe some aspect of information is incorrect or misleading. Those are compelling reasons for manufacturers to continue to test their drugs long after approval, despite this rhetorical question posed by a former FDA official in the Washington Post, "If your drug is approved for X, why would you ever commit millions [of dollars] in additional testing to get approved for Y, when it's already legal to use it for Y?" If the threat of agency action or private litigation weren't enough, there is yet another reason why drug companies continue to test the safety and effectiveness of their products for both on- and off-labe[...]

Even in Health Care, Immigrants Do Jobs Americans Won't

Fri, 23 Feb 2018 16:16:00 -0500

The debate over American health care tends to focus on how we pay for services, rather than why we pay so much more than any other developed country. In a new working paper, Jeffrey S. Flier and Jared M. Rhoads of the Mercatus Institute suggest that we could lower costs by allowing more people to practice medicine. In a comparison of 11 industrialized nations, they write, the U.S. has the second lowest number of physicians per capita: "2.5 physicians per 1,000 population, compared to a mean of 3.1 for the group and high of 4.2 for Norway." The Association of American Medical Colleges anticipates a shortage of 40,800 to 104,900 physicians by 2030, particularly in the fields of pediatrics, primary care, family medicine, and internal medicine. (Not coincidentally, these are four of the lowest-paying medical specialties.) The association wants to address that shortage by securing more federal funding for physician training, but with no concessions on tuition, which averages $55,000 per year in the United States. Flier and Rhoads have some other suggestions: expanding the number of accredited U.S. medical schools, shortening the length of medical school, granting more independence to nurse practitioners and physicians assistants, and reforming state licensing boards so that medical doctors can no longer use their clout to suppress competition. We could also, they add, make it easier for foreign-born, foreign-trained doctors to migrate to and practice in the U.S. Indeed, there are roughly 60,000 foreign medical doctors already living in the U.S. who aren't licensed to practice. Foreign-born medical doctors who trained outside the U.S. already play a crucial role in providing care in America. These physicians "are substantially more likely to practice in rural and poorer communities and are overrepresented in primary care specialties, including family medicine and pediatrics," write Flier and Rhoads. A 2015 study found that international medical graduates (a group that includes Americans who train outside the U.S. and foreign citizens who train outside the U.S.) are filling a crucial care gap: IMGs are more likely to practice in specialties in which a physician shortage would otherwise go unfilled. For example, a higher proportion of IMGs than other graduates serve socioeconomically disadvantaged populations across the United States. They also tend to fill the gaps in workforce demands in rural areas depending on the particular state. One study reported that 19.3% of IMGs, compared with 10.4% of osteopathic physicians, are practicing in rural areas. An ambulatory care survey published in 2009 found that most office-based IMG primary care physicians are in areas with physician shortages where Medicare and Medicaid patients are overrepresented. Compared with US medical graduates, a higher percentage of IMGs are also in solo practice. Overall, IMGs have been taking up opportunities to practice within patient populations that are facing difficulties caused by uneven distribution of the physician workforce. It's possible that foreign doctors have lower debt loads and can thus pursue lower-paying specialties, or, because the American residency system prefers American born-and-trained physicians, that IMGs fill less desirable roles in order to practice in the U.S. at all. Either way, they're often willing to go to areas many American-trained physicians are not. Like Nebraska. Every year, the National Residency Match Program publishes data showing what types of doctors matched to what kind of medical residency in each state (a medical residency of at least a year is required in order to receive a medical license in the U.S.). Here's what the numbers look like for Nebraska, which had a total of 93 open positions for family medicine and internal medicine in 2017: Across the top of that chart are the various applicant types. "US sr" are fourth-year medical students attending allopathic medical schools in the U.S.; they will be M.D.s upon graduation, and 9[...]

Jeff Sessions' Advice to Pain Patients: 'Take Some Aspirin' and 'Tough It Out'

Thu, 08 Feb 2018 18:14:00 -0500

Attorney General Jeff Sessions is a well-known admirer of Nancy Reagan's recommendation that kids "just say no" to drugs. It turns out he applies that advice not only to curious teenagers but also to people suffering from severe pain. "I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech at the U.S. Attorney's Office in Tampa yesterday. "I mean, people need to take some aspirin sometimes and tough it out a little. That's what Gen. Kelly—you know, he's a Marine—[he] had surgery on his hands, painful surgery. [He said,] 'I'm not taking any drugs!' It did hurt, though. It did hurt. A lot of people—you can get through these things." While I'm sure we are all impressed by the White House chief of staff's stoicism, his personal preferences have no bearing whatsoever on whether doctors should prescribe pain medication to people recovering from surgery or whether those people should take that medication rather than "tough[ing] it out." Balancing the benefits of pain relief against the tiny risks of addiction or overdose, I think this is an easy call. But I am not a Marine, and I see no moral or practical value in suffering pain that can be relieved safely and easily. To this day, I resent the fact that I was given nothing but acetaminophen after an appendectomy when I was 10. I vividly remember the postsurgical pain (although it was not quite as bad as the presurgical pain). At the time, I did not realize that more effective treatment was possible, but in retrospect it pisses me off that none was offered, presumably because someone was worried about turning a fifth-grader into a heroin addict. That kind of irrational stinginess is pretty common, notwithstanding Jeff Sessions' confidence that "the country prescribes too many opioids." If we extend the attorney general's medical advice to people who suffer from severe chronic pain—people who need opioids to get out of bed in the morning and have something like a normal life, people who may be driven to suicide when they are denied adequate medication—his attitude is not merely cruel but downright barbaric. As a college student with Ehlers-Danlos syndrome told me when I interviewed him for an upcoming Reason feature story about opioids, the right kind of pain medication can be "the difference between wanting to put a bullet in your brain and enjoying life." Sessions' "tough it out" recommendation is similar to remarks he made after a speech on Tuesday night at the Heritage Foundation. "Sometimes you just need to take two Bufferin or something and go to bed," he said. Bob Twillman, executive director of the Academy of Integrative Pain Management, says Sessions' comments show he has no idea what he is talking about. "That remark reflects a failure to recognize the severity of pain of some patients," Twillman told the Tampa Bay Times. "It's an unconscionable remark. It further illustrates how out of touch parts of the administration are with opioids and pain management."[...]

Legal Limits on Opioid Prescriptions May Increase the Number of Pills Dispensed

Wed, 07 Feb 2018 13:30:00 -0500

Last month Arizona became the 15th state since 2016 to impose a statutory limit on the length of initial opioid prescriptions for acute pain. The rationale for such laws is that shorter prescriptions will mean fewer pills in circulation and less potential for abuse and diversion. But recent research suggests the opposite may be true, because patients tend to get refills when the initial prescription is too short. According to guidelines published by the U.S. Centers for Disease Control and Prevention in March 2016, "three days or less will often be sufficient" when doctors prescribe opioids for acute pain, and "more than seven days will rarely be needed." State legislators seem to have taken that recommendation to heart. In 2016 and 2017, according to a tally by the National Conference of State Legislatures (NCSL), 14 states enacted limits on such prescriptions, ranging from three days (Kentucky) to two weeks (Nevada), with seven days the most common. Arizona picked five days. One obvious problem with such arbitrary limits is that some patients recovering from surgery or injuries will need more than three, five, or seven days of pain medication. That is a problem for those patients, but it is also a problem for politicians trying to prevent nonmedical use. A study published last month by JAMA Surgery found that prescription lengths similar to those mandated by most of these state laws were associated with a higher likelihood of refills for some types of surgery. "While government restrictions often limit the dispensing of opioid prescriptions to 7 days or less," MedPage Today noted, this study suggests that "longer initial opioid prescription lengths following certain surgical procedures may, in fact, limit the need for refills and decrease total opioid use." Harvard surgeon Rebecca Scully and her collaborators looked at prescription data for more than 200,000 patients who took pain medication after surgery, 19 percent of whom received at least one refill. The prescription length associated with the lowest probability of a refill was nine days for general surgery, 13 days for women's health procedures, and 15 days for musculoskeletal procedures. "In practice," Scully et al. conclude, "the optimal length of opioid prescriptions lies between the observed median prescription length and the early nadir," i.e., the point where a refill was least likely. That rule of thumb would make the optimal prescription length four to nine days for general surgery procedures, four to 13 days for women's health procedures, and six to 15 days for musculoskeletal procedures. "Although 7 days appears to be more than adequate for many patients undergoing common general surgery and gynecologic procedures," Scully et al. write, "prescription lengths likely should be extended to 10 days, particularly after common neurosurgical and musculoskeletal procedures, recognizing that as many as 40% of patients may still require 1 refill at a 7-day limit." Some states with prescription limits (including Arizona) make exceptions for postsurgical pain, but the NCSL summary indicates that most do not. A legal limit of seven or fewer days not only interferes with proper patient care; it may increase rather than reduce the number of pills ultimately dispensed.[...]

Study of Postsurgical Patients Shows Addiction to Pain Pills Is Rare

Mon, 22 Jan 2018 13:15:00 -0500

(image) A new BMJ study of patients who received opioid analgesics after surgery, touted as evidence of how risky such prescriptions are, actually shows how rarely people become addicted in the course of treatment for acute pain. Tracking 568,612 opioid-naive patients who took prescription pain medication following surgery, Boston surgeon Gabriel Brat and his colleagues found that 5,906, or 1 percent, showed signs of "opioid misuse" during the course of the study, which included data from 2008 through 2016.

The outcome measure that Brat et al. used, "opioid dependence, abuse, or overdose," is a broad category that includes patterns of use falling short of what most people would recognize as addiction. That means the actual addiction rate in this study was less than 1 percent, although it's not clear how much less. The researchers note that "overall rates of misuse were low" but do not play up that angle. Instead they emphasize that the risk of misuse increased with the duration of the prescription.

"Each refill and week of opioid prescription is associated with a large increase in opioid misuse among opioid naive patients," Brat et al. write. For instance, "the rate of misuse more than doubled among those with one refill...versus those with no refills." But if you take a low number and double it, the number is still pretty low. The researchers say the incidence of opioid misuse rose from 145 cases per 100,000 person-years (roughly 0.15 percent annually) for patients with no refills to 293 cases per 100,000 person-years (0.29 percent annually) for patients who had one refill. The corresponding addiction rates would be substantially lower.

"Our study is highly suggestive of the conclusion that getting a refill increases your chances of opioid addiction," Brat told MedPage Today. "For surgical patients, it may be that we should focus less on the dose of opioids immediately after discharge and more on the length of time a patient is exposed to opioids."

Maybe, although the causality behind the correlation identified in this study may not go in the direction Brat suggests. It seems plausible that patients who like the psychoactive effects of opioids would be more inclined to ask for refills, in which case patients who are predisposed to addiction would be overrepresented in the group that received them. In other words, getting a refill may be a result rather than a cause of a higher addiction risk.

Either way, the overall results of this study should be reassuring, rather than alarming, for anyone who worries about getting hooked on pain pills after surgery. You would not get that impression from the MedPage Today story. "Each postsurgical opioid refill was associated with a 44% increase in misuse among opioid-naïve patients," reporter Judy George says in the second paragraph. "Likewise, each additional week of prescriptions bumped the risk of opioid misuse up nearly 20%, and misuse rates escalated when patients received more than 9 weeks of drugs."

A dozen paragraphs later, we learn that "overall rates of misuse were low" and get some sense of what that means in terms of rates. George is so keen to play up the risk of addiction that she says "the risk was nonzero even [when] prescription durations were shorter than 2 weeks." Nonzero is what science reporters say they think negligible is not scary enough.

D.C. Deregulates Birth Control...and Dooms It With Obamacare Add-Ons

Wed, 10 Jan 2018 12:45:00 -0500


The District of Columbia Council gave the green light Tuesday to a bill allowing birth control pills to be purchased with a pharmacist's prescription.

The measure stops short of allowing over-the-counter contraceptive sales, which would run afoul of Food and Drug Administration policy. But it would allow for women to obtain birth control pills without regular visits to a doctor. The D.C. Board of Pharmacy would figure out how to implement the change.

The change would put D.C. in line with a rapidly increasing number of states allowing pharmacist-prescribed oral contraceptives. Following Oregon and California's lead, Colorado, Hawaii, Maryland, Missouri, New Mexico and Ohio passed similar legislation last year. Several others (including Iowa, Illinois, Massachusetts, Maine, South Carolina, Texas, and Tennessee) considered it.

The D.C. bill isn't all deregulatory goodness: it would also enshrine parts of the Affordable Care Act (ACA) into local law, including the requirement that insurance companies cover contraception and other preventative health services at no out-of-pocket cost to the insured. The idea is to ensure their continued "free" coverage even if all or part of the ACA is repealed.

The bill now heads to D.C. Mayor Muriel Browser. If she signs it, the measure will then (like all D.C. legislation) be subject to congressional review—which could be tricky considering the current climate with regard to contraception mandates and Obamacare in general.

"No other state or local jurisdiction in the country has to worry that a random congressman is going to try and meddle with a locally-passed law," lamented D.C. council member and author of the bill, Charles Allen, in a statement.

True—but decreasing the barriers to accessing contraception might have a better chance if not yoked to a currently pointless policy backing up an already existing (and controversial) federal law.

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[...]

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 9 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 v[...]

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[...]

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 [...]

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:

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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 [...]