Published: Thu, 27 Oct 2016 00:00:00 -0400
Last Build Date: Thu, 27 Oct 2016 14:03:12 -0400
Thu, 13 Oct 2016 08:30:00 -0400The Drug Enforcement Administration's decision to withdraw its ban on kratom, a pain-relieving leaf from Southeast Asia, underlines the arbitrariness of the federal government's pharmacological taboos, which are based on undefined terms subjectively interpreted by bureaucrats with broad discretion to decide which substances Americans may ingest. The DEA's backtracking was prompted by complaints from kratom consumers, the companies that serve them, researchers who study the drug, and members of Congress. But despite the agency's newfound interest in public input on the question of kratom's legal status, it seems likely that we will end up with the same prohibitory result after a somewhat more elaborate process of post hoc rationalization. When the DEA announced at the end of August that it was temporarily placing kratom's main active ingredients in Schedule I, the most restrictive category under the Controlled Substances Act (CSA), it declared that a ban was "necessary to avoid an imminent hazard to the public safety." When the ban did not take effect on September 30 as expected, DEA spokesman Russell Baer assured Washington Post drug policy blogger Christopher Ingraham that "it's not a matter of if—it's simply a matter of when, in terms of DEA publishing the final order to temporarily schedule kratom." Since Acting DEA Administrator Chuck Rosenberg "has determined that kratom represents an imminent hazard to public safety," Baer said, "I have a sense that publishing our final order will be sooner as opposed to later." Rosenberg's determination was based on an unpersuasive, weakly supported analysis that dismissed kratom's benefits and exaggerated its hazards. Critics pointed out that the DEA's emergency scheduling authority, which Congress approved in 1984 at the agency's behest, was aimed at dangerous new synthetic drugs that might cause many injuries and deaths during the time required by the standard scheduling process. Here is how then-DEA Administrator Francis Mullen explained his understanding of "imminent hazard to the public safety" in a letter to legislators: The "imminent hazard" implies a need for immediate response to a drug trafficking and abuse situation that has occurred with such rapidity and with insufficient warning that normal control mechanisms would result in a large number of deaths and injuries or the continuance of an uncontrolled trafficking situation....The burden would be on the Government to prove that such an urgency exists and that the public safety would be jeopardized during the period that a drug would remain uncontrolled during routine scheduling action. As examples of substances that would be covered by the new provision, Mullen cited "newly synthesized drugs or uncontrolled analogs of existing drugs such as PCP and fentanyl," which "can cause widespread deaths and injuries in a very short period of time following their synthesis." Kratom, a "minimally toxic" natural substance that humans have used for centuries with little evidence of serious harm except in exreme cases, hardly fits that description. "The use of this emergency authority for a natural substance is unprecedented," noted Sen. Orrin Hatch (R-Utah) in a September 29 letter to Rosenberg. Whatever legislators may have had in mind when they created this prohibition shortcut, they did not define "imminent hazard to the public safety." The CSA says only that the attorney general (who has delegated his scheduling authority to the DEA) should consider a substance's "history and current pattern of abuse," "the scope, duration, and significance of abuse," and "what, if any, risk there is to the public health." That formulation leaves bureaucrats like Rosenberg free to describe any uncontrolled psychoactive substance, no matter how favorable its risk-to-benefit ratio, as "an imminent hazard to the public safety." The unscientific nature of that determination is clear from the fact that the DEA has reconsidered it in response to political pressure, as opposed to new evidence. Suddenly Rosenberg's contrived kratom crisis no longer [...]
Wed, 05 Oct 2016 12:08:00 -0400
How best to memorialize deceased loved ones is a question all families must ask themselves. For the most part, the answer is a conventional tombstone or urn. Now however those left behind have a new way to remember relatives in the form of DNA preservation.
DNA Memorial is a Canadian company that offers its customers a unique opportunity to save the genetic information of their dearly departed through their own special DNA preservation process.
How it works is quite simple: A customer, generally through a funeral home, will collect a DNA sample from the saliva or hair of the deceased on a cotton swab. That sample is then shipped to DNA Memorial, where the DNA is extracted, purified and then bound in a special chemical process to a silica-based substrate. The end result is a white powder of the deceased's genetic information that can be safely stored in the home at room temperature, preserving their unique genetic blueprint indefinitely.
Though this might sound strange to those more accustomed to burial or cremation, DNA preservation serves a number of unique purposes for relatives of the deceased.
Neal Esau, the company's co-founder and operations manager, tells Reason that many of their initial customers were interested in preserving DNA in order to trace their ancestry, for which having the exact genetic blueprint of one's immediate predecessor is quite useful. For a few this interest was more than just historical; the company has apparently performed a number of post-mortem paternity tests.
Those more interested in the sentimental side of things have themselves been drawn to DNA Memorial's line of jewelry and glassware, which is crafted with the DNA of whoever is to be memorialized
Great as these uses are, says Esau, the real benefits of DNA preservation come from its medical applications. Being able to provide a more a complete picture of a patient's genetic background enables his or her doctor to better test for and treat genetic diseases. And as the field of genetic science develops, it is hoped that the uses of DNA preservation will develop along with it, allowing medical professionals to more precisely trace mutations in populations or to create individually designed medical treatments tailored to one's specific genetic background.
Despite this being a new idea in an admittedly conservative field, Esau says DNA Memorial's services are proving quite popular. Having only started in 2014, the company now works with hundreds of funeral homes all across the U.S., U.K., and Canada, as well as with a single location in Israel.
And as the practice gains more mainstream exposure, the folks at DNA Memorial envision a number of new potential services, from launching DNA vials into space to storing it in ink for tattoos. That last one could give the classic mom-heart design some added significance.
Update 10/10: The spelling of Mr. Esau's name as been corrected.
Wed, 05 Oct 2016 00:01:00 -0400After the Drug Enforcement Administration (DEA) announced an "emergency" ban on kratom at the end of August, a spokesman for the agency said "our goal is to make sure this is available." The spokesman, Melvin Patterson, also told The Washington Post kratom does not belong in Schedule I of the Controlled Substances Act, the law's most restrictive category, even though that is where the DEA had just put it. Patterson added that kratom, which the DEA says has "no currently accepted medical use," is "at a point where it needs to be recognized as medicine." Confused? You're not alone. The DEA's ban on kratom, a pain-relieving leaf from Southeast Asia, shows how blithely and arbitrarily the government interferes with our freedom to control our own brains and bloodstreams. Kratom, which acts as a stimulant or a sedative, depending on the dose, has been used for centuries in countries such as Thailand, Malaysia, and Indonesia to ease pain, boost work performance, and wean people from opiate addiction. In recent years the drug has gained a following in the United States, sold by online merchants and head shops as an herbal medicine, dietary supplement, or legal high. That situation offended the DEA, which noted in the explanation of its ban that kratom had never been approved by the government for any use. If a psychoactive substance is not explicitly permitted, the DEA figures, it should be prohibited. The agency apparently was surprised by the backlash against its kratom ban, which included angry phone calls to Capitol Hill, a demonstration near the White House, and letters from members of Congress. The DEA still intends to finalize the ban, although it did not take effect last Friday as expected. Patterson, the DEA spokesman, said the reaction to the ban "was eye-opening for me personally." He added that "I want the kratom community to know that the DEA does hear them." That attitude is quite a contrast to the deaf arrogance the DEA displayed when it announced that it was temporarily placing kratom in Schedule I, a classification that lasts at least two years and could become permanent. Declaring that a ban was necessary "to avoid an imminent hazard to public safety," the DEA summarily dismissed kratom's benefits while exaggerating its dangers. The DEA describes all kratom use as "abuse." It was therefore easy for the agency to conclude that the plant has "a high potential for abuse," one of the criteria for Schedule I. Since the DEA assumed there was no rational, morally acceptable reason to use kratom, it did not need to muster much evidence that the drug is intolerably dangerous. It claimed there have been "numerous deaths associated with kratom," by which it meant 30. In the whole world. Ever. According to the U.S. Centers for Disease Control and Prevention, alcohol causes about 88,000 deaths a year in this country, while 28,000 deaths were attributed to heroin and opioid painkillers in 2014. Kratom looks pretty benign by comparison. Another point to keep in mind: "Deaths associated with kratom" are not necessarily caused by kratom. "Kratom is considered minimally toxic," noted a 2015 literature review in the International Journal of Legal Medicine. "Although death has been attributed to kratom use, there is no solid evidence that kratom was the sole contributor to an individual's death." As further proof of kratom's dangers, the DEA noted that "U.S. poison centers received 660 calls related to kratom exposure" from 2010 through 2015, an average of 110 a year. By comparison, exposures involving analgesics accounted for nearly 300,000 calls in 2014, while antidepressants and antihistamines each accounted for more than 100,000. As the DEA's contrived kratom crisis shows, there is little rhyme or reason to the government's pharmacological taboos, which are driven by unreasoning prejudice rather than science. The one overriding theme is that people cannot be trusted to weigh the risks and benefits of drugs for themselves. © Copyright 2016 by Creators Syndicate Inc.[...]
Tue, 27 Sep 2016 19:48:00 -0400
Arizona's Goldwater Institute has been the national leader in promoting "right to try" legislation, which allows terminally-ill Americans to legally try medications that have passed just Phase I of the Food and Drug Administration's (FDA) approval process but are not as yet legally available via doctors. Passing Phase I means that the agency is at least satisfied that the medicine can be used safely.
Today the Institute announces that, with a bill signed into law by California Gov. Jerry Brown, that state becomes the 32nd state to pass a version of that law. Brown had vetoed a similar law last year. The Institute's press release notes that "Right To Try is limited to patients with a terminal disease that have exhausted all approved treatment options and cannot enroll in a clinical trial. All medications available under the law must have successfully completed basic safety testing and be part of the FDA's on-going approval process."
KPCC radio's website has more details on the California politics:
Patients must meet a number of requirements to qualify for the program, including that they have only a matter of months to live and that two doctors recommend they try the experimental drug.
The passage of the measure caps a two-year effort by Calderon. Last year, Brown vetoed similar legislation Calderon authored. The governor said he did so because he first wanted to see whether changes in the FDA's Compassionate Use program reduced the minimum 30-day wait for experimental drugs.
And while the feds did streamline some parts of that program, patient wait times remained the same, the bill's supporters say.
Alex Manning's Reason TV video on the right-to-try movement:
src="https://www.youtube.com/embed/nerWf9Vydn4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">
Mon, 26 Sep 2016 06:30:00 -0400Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products. A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications. Kim et al. collected data from the Fatality Analysis Reporting System (FARS) for 1999 through 2013, focusing on 18 states that drug-tested at least 80% of drivers who died in crashes. They found that drivers between the ages of 21 and 40 were half as likely to test positive for opioids in states that had implemented medical marijuana laws (MMLs) as in states that had not. "Among 21-to-40-year-old deceased drivers, crashing in states with an operational MML was associated with lower odds of testing positive for opioids than crashing in MML states before these laws were operational," the researchers write. "Although we found a significant association only among drivers aged 21 to 40 years, the age specificity of this finding coheres with what we know about MMLs: a minimum age requirement restricts access to medical marijuana for most patients younger than 21 years, and most surveyed medical marijuana patients are younger than 45 years." The fact that a driver tested positive for opioids does not necessarily mean the painkillers he took contributed to the crash, so it is not safe to draw any conclusions about medical marijuana's impact on traffic safety from this study. But the FARS data are an indirect way of measuring the extent of opioid consumption in a given state. Kim et al. note that "severe or chronic pain is among the most common indications cited by medical marijuana patients." It therefore makes sense that opioid use would decline (or rise less) in states that recognize cannabis as a medicine. The FARS numbers reinforce the results of another recent study, published last July in the journal Health Affairs, that looked at prescriptions covered by Medicare from 2010 through 2013. Ashley Bradford, a graduate student in public policy at the University of Georgia, and her father, W. David Bradford, an economist at the same school, found that "the use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly once a medical marijuana law was implemented." The most dramatic decline was in painkiller prescriptions, which fell by 3,645 daily doses per physician after medical marijuana laws were implemented. There were also statistically significant drops in prescriptions for drugs used to treat seizures (down 1,370 daily doses per doctor), depression (1,280), psychosis (1,123), anxiety (1,106), nausea (1,028), and sleep disorders (615). Meanwhile, Bradford and Bradford "found no changes after implementation of a medical marijuana law in the number of daily doses filled in condition categories with no medical marijuana indication," which "provides strong evidence that the observed shifts in prescribing patterns were in fact due to the passage of the medical marijuana laws." Med[...]
Fri, 23 Sep 2016 06:30:00 -0400
(image) While sounding the alarm about an "opioid epidemic" that included a record number of painkiller-related deaths in 2014, the federal government insists marijuana has "no currently accepted medical use." As I explain in my latest Forbes column, that dogmatism may be deadly:
Insys Therapeutics, the Arizona-based pharmaceutical company that recently became the biggest financial supporter of the campaign against marijuana legalization in that state, makes an oral spray that delivers the opioid painkiller fentanyl and plans to market another one that contains dronabinol, a synthetic version of THC. Insys says it gave $500,000 to the main group opposing Arizona's legalization initiative because the measure "fails to protect the safety of Arizona's citizens, and particularly its children." But one needn't be terribly cynical to surmise that Insys also worries about the impact that legalization might have on its bottom line, since marijuana could compete with its products.
A new study suggests Insys has good reason to worry. In an article published last week by the American Journal of Public Health, Columbia University epidemiologist June Kim and her colleagues report that fatally injured drivers are less likely to test positive for opioids in states that allow medical use of marijuana. That finding, together with the results of earlier studies, indicates that making marijuana legally available to patients saves lives by reducing their consumption of more dangerous medications.
Wed, 21 Sep 2016 04:00:00 -0400
(image) Lia Sommer says that as soon as she bit into the sandwich she bought in the cafeteria at John Hersey High School in Illinois she knew she'd been exposed to peanuts. Sommer, who has a potentially deadly peanut allergy, says she was already starting to feel the effects as she rushed to the school nurse. But instead of administering an EpiPen and calling 911 as called for in the medical plan the school had on file for Sommer, the nurse tried to convince her to just take some Benadryl. Sommer had to call her mother and get her to talk to the nurse before the nurse would administer the EpiPen and call for an ambulance.
Fri, 16 Sep 2016 07:30:00 -0400Officials at the Drug Enforcement Administration (DEA) seem to have been surprised by the negative reaction to the agency's "temporary" ban on kratom, which it implausibly claimed was necessary "to avoid an imminent hazard to public safety." That ban, which will last at least two years, can be extended for another year, and during that time the DEA is supposed to go through the motions of justifying the decision it has already made. But according to DEA spokesman Melvin Patterson, the agency may decide not to keep kratom in Schedule I, the most restrictive category under the Controlled Substances Act (CSA). "I don't see it being Schedule II [or higher] because that would be a drug that's highly addictive," Patterson tells Washington Post drug policy blogger Christopher Ingraham. "Kratom's at a point where it needs to be recognized as medicine. I think that we are going to find out that probably it does [qualify as a medicine]." Patterson makes it sound as if the DEA had no idea Americans were using kratom for medical purposes, even though it discusses those uses in its explanation of the ban. The storm of protest from medical users of kratom, which included a demonstration near the White House on Tuesday, "was eye-opening for me personally," Patterson says. "I want the kratom community to know that the DEA does hear them. Our goal is to make sure this is available to all of them." And what better way to do that than banning all kratom products? Patterson's comments are surprising, not least because they contradict conclusions the DEA already has reached about kratom, a pain-relieving leaf from Southeast Asia that recently gained a following in the United States as a home remedy and recreational intoxicant. Explaining why it decided to ban kratom, the DEA says "available information indicates that [mitragynine and 7-hydroxymitragynine, kratom's main active ingredients] have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision." Those are the criteria for Schedule I, which Patterson now says is not appropriate for kratom. Although the DEA does not have to demonstrate that kratom meets the criteria for Schedule I to put it there temporarily, it goes to great lengths to show that kratom has "a high potential for abuse," mainly by classifying everything people do with it as abuse. Under the CSA, drugs in the top two schedules are all supposed to have a "high potential for abuse," while drugs in lower schedules (III through V) are supposed to have progressively less abuse potential. Patterson suggests a drug cannot have a high potential for abuse unless it is "highly addictive," which kratom is not. Yet neither are many other substances in Schedule I, including marijuana, qat, LSD, psilocybin, mescaline, MDMA, and dimethyltryptamine, assuming addictiveness is measured by the percentage of people who become heavy users after trying a drug. Evidently a drug need not be highly addictive to be placed in Schedule I. Nor does the DEA define abuse potential based on the hazards a drug poses. Chuck Rosenberg, the agency's acting administrator, notes that "Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous (including marijuana, which is less dangerous than some substances in other schedules)." Emphasis mine, because people tend to assume that Schedule I is a list of what the DEA considers to be the world's most dangerous drugs. The DEA does not see it that way. "It is best not to think of drug scheduling as an escalating 'danger' scale," Rosenberg says. If "high potential for abuse" does not refer to addictiveness or to danger, what does it signify? Nothing more than the DEA's (or Congress's) arbitrary preferences. "High potential for abuse" is a political concept, not a medical or scientifi[...]
Sun, 04 Sep 2016 12:24:00 -0400In 2015, about 3.5 million people were prescribed an EpiPen, an injection device with a pre-measured dose of epinephrine used to treat potentially fatal allergic reactions. Controversy over the fast-rising costs of the device has been used to indict the American health-care system as a playground for corporate greed. Over the past five years or so, the list price of a two-pack of EpiPends has increased about 400 percent, to $600. (Of course, what any customer might pay out-of-pocket is dependent on many factors such as insurance company, income level, and more.) Well, there's no question that the maker of the EpiPen, Mylan, is in business to make money. The CEO of the company, which is the largest maker of generic drugs in the country, says, "I am a for-profit business. I am not hiding from that." It's actually kind of great to hear a CEO unapologetically say so. But as Scott Shackford recently noted at Reason.com, the main problem is that Mylan has been granted a de facto monopoly over the market for epinephrine injectors. That isn't because it built a better mousetrap but because the Food & Drug Administration (FDA) has shot down virtually every alternative device for one reason or another. As I write in a new Daily Beast column, Mylan's path to monopoly pricing in EpiPens has everything to do with politics and nothing to with laissez-faire economics. The approval process isn't just long and expensive, it also opens things up to politics. That's one of the reasons why Mylan, which bought the rights to EpiPen in 2007, spent more than $2 million lobbying Washington in 2015. The company's PAC has spent about $80,000 so far in the 2016 election cycle. Maybe it's just coincidence, but Mylan, one of the largest generic drug companies on the planet, faces little competition from other companies that want to make devices similar to the EpiPen. As the pseudonymous doctor Scott Alexander documents at Slate Star Codex, the amount of epinephrine in an EpiPen's pre-measured dose costs about 10 cents a shot. But every time a new company tries to bring a rival product to market, the Food and Drug Administration (FDA) finds a reason to just say no. Sandoz, Teva Pharmaceuticals, Sanofi, and Adamis have all tried and failed. That seems more than a little fishy given the relative simplicity of the basic drug and delivery system involved. We're not talking brain surgery here—we're talking about a pre-loaded, single-use syringe. Let's be clear: The basic protocols that the FDA uses to approve drugs and devices are outdated and make new products far more limited and far more expensive than they need to be. Indeed, as medical researchers push forward into an era of hyper-personalized "molecular medicine" that is based on individual genomic differences among patients, the FDA insists on clinical trials that are based on average experiences. Some drugs work for some patients but not others, notes researcher Peter Huber of the Manhattan Institute. It costs somewhere between $1 billion and $5.8 billion and between 10 years and 15 years to bring new drugs to market (where maybe 20 percent become blockbusters). Yet for politicians on both sides of the aisle, the fix to the EpiPen is to threaten price controls. Here's an excerpt from a letter released by Hillary Clinton, in which she avers that the EpiPen price hike is just the latest troubling example of a company taking advantage of its consumers. I believe that our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them. "That's why I've put forward a plan to address exorbitant drug price hikes like these. As part of my plan, I've made clear that pharmaceutical [...]
Tue, 30 Aug 2016 08:50:00 -0400
The Burning Man festival, that week long experiment in temporary art-centered community in Nevada's difficult Black Rock desert, is in full swing as of yesterday. (And my book about the event's history and culture, in a conveniently updated 10th anniversary e-book edition, is for sale for $4.99 for your Kindle.)
A series of documents made public recently document a grim incident from the event last year that spotlights the crummy things that can happen when medical care is mixed with law enforcement.
In a letter in my possession sent in May by the state's Division of Public and Behavioral Health, a medic who worked the event last year was put on warning for, as the letter stated, administering ketamine (a powerful tranquilizer that is also sometimes used recreationally) unasked for to a Burning Man attendee "as necessary for the overall safety of law enforcement officials who were in contact with the attendee." (The state later rescinded the warning, on the stated grounds that their investigation had happened too late after the actual event being investigated, though the letter rescinding the warning said nothing to suggest the event she was originally warned for had not happened.)
In a letter sent earlier this month from Harley Dubois, a member of Burning Man's board of directors, to Mel Hummel, president of the board of trustees of Humboldt General Hospital who supplied the medic in question, she noted the woman shot with the ketamine was 110 pounds, had been drinking alcohol, and as a result of the ketamine injection the woman "went into respiratory failure—twice—and nearly died."
The Reno Gazette-Journal reported on the incident in the context of wranglings between Burning Man, Humboldt General Hospital, and law enforcement last week over how to set and obey protocols for medical issues at Burning Man moving forward. The medic injected the ketamine "while serving as a special reserve deputy under Pershing County Sheriff's Office, according to contracts with the Pershing County Sheriff's Office," reported the Gazette-Journal.
Like ketamine and alcohol, medical care and police work can be a very dangerous combination. See my previous reporting on hospitals who decide to conduct unasked for anal probes to help cops search for drugs, and then bill the unwilling "patient"/victim.
My 2000 Reason cover story on the event's fractious relationship with government authorities. My reporting from last year on the fruitless and aggravating practice of the Bureau of Land Management law enforcement running mail sent to Burning Man by drug dogs.
Thu, 25 Aug 2016 11:50:00 -0400Angry lawmakers and Democratic presidential candidate Hillary Clinton are going to want us to see them as heroes for their efforts to shame pharmaceutical company Mylan into lowering the cost of an allergy treatment for some people. EpiPens, used to provide injections of epinephrine in cases of severe, potentially life-threatening allergy attacks, have been creeping up in price from $100 to $600 per dose since 2009. This has become a political issue right now (at the height of an election cycle—go figure) partly because of attention by Sen. Amy Klobuchar (D-Minn.), whose daughter uses them. Clinton has waded into the debate and called the price hikes "outrageous, and just the latest example of a company taking advantage of its consumers." It would be more accurate to say that the company is taking advantage of the fact that the federal government's own regulatory scheme has given them a medical monopoly. Clinton wants to cast herself and the government as the cure for this problem. It's actually the cause in any number of ways. The Wall Street Journal detailed extensively as Clinton threw herself into the conflict that the Food and Drug Administration (FDA) has made it very difficult for competitors to enter the marketplace and push prices downward. Epinephrine is cheap and EpiPens have been around for decades. Their prices should be trending downward not upward. But the FDA's complicated (and ambiguous) process of approving other drug delivery systems has kept competitors off the market. And to be clear, there are other companies trying to participate and demonstrate they can provide safe alternatives: But no company has been able to do so to the FDA's satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety. Then in February the FDA rejected Teva's generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival. Mylan's CEO, Heather Bresch, is the daughter of Democratic West Virginia Sen. Joe Manchin, by the way. Bresch is pointing the finger (accurately) toward the many different folks who have their hands in the till when it comes to drug sales. Part of the company's solution will be to allow people to order EpiPens directly from Mylan because "more than half the amount paid by the health care system for EpiPens goes to pharmacy benefit managers, insurers, wholesalers and pharmacy retailers, not to the company itself." Yet, even as it's clear that both a lack of competition and the contributions of heavy regulation and bureaucracy play big roles in driving up drug prices, some people still want to lay the blame on capitalism. It shouldn't come as a surprise if the ultimate outcome of the fight is some mild reduction of price so that lawmakers (and Clinton) can claim that they've fought the drug companies and won. Few will consider that approving those other delivery systems the Wall Street Journal mentioned might actually drive the costs to consumers down even further. Nobody's going to win votes that way.[...]
Wed, 24 Aug 2016 12:24:00 -0400src="https://www.youtube.com/embed/uumPxbe5B0g" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0"> What would you do to save a loved one, asks the short film "Everything." Produced by the Institute for Justice, "Everything" dramatizes the difficulty of a family struggling to find a bone-marrow donor for a child. The movie makes a powerful case for an obvious solution that we at Reason have advanced for decades: Compensate donors who provide organs, body tissue, and other substances. Waiting lists and deaths attributable to chronic shortages would shrink overnight. But such an obvious, common-sense solution is blocked at every turn by defenders of a status quo that serves everyone's interest but the patient's. While donors can be compensated for certain substances (blood plasma, sperm), federal law prohibits the sale of organs, body tissue, and a variety of other substances. Sometimes the argument against compensation is rooted in religious objections and sometimes it's masked in the language of "medical ethics." What never gets addressed is a death toll that will continue to climb as more and more people need transplants and are denied by a supply chain that doesn't come close to meeting demand. Here's the original writeup about "Everything." Go here for more information about the movie and larger cause. Every year, nearly 3,000 Americans die because they cannot find a matching bone marrow donor. Common sense suggests that offering modest incentives to attract more bone marrow donors would be worth pursuing, but federal law made that a felony punishable by up to five years in prison. That is why in 2009, adults with deadly blood diseases, the parents of sick children, a California nonprofit and a world-renowned medical doctor who specializes in bone marrow research joined with the Institute for Justice to launch a legal fight against the U.S. Attorney General to put an end to a ban on offering compensation for bone marrow donors. The National Organ Transplant Act (NOTA) of 1984 treats compensation for marrow donors as though it were black-market organ sales. Under NOTA, giving a college student a scholarship or a new homeowner a mortgage payment for donating marrow would land everyone—doctors, nurses, donors and patients—in federal prison for up to five years. NOTA's criminal ban violated equal protection because it arbitrarily treats renewable bone marrow like nonrenewable solid organs instead of like other renewable or inexhaustible cells—such as blood—for which compensated donation is legal. That makes no sense because bone marrow, unlike organs such as kidneys, replenishes itself in just a few weeks after it is donated, leaving the donor whole once again. In 2011, the 9th U.S. Circuit Court of Appeals ruled in favor of the cancer patients and their attorneys from the Institute for Justice, holding that the National Organ Transplant Act's ban on donor compensation does not apply to the most common method for donating marrow. The U.S. Attorney General sought to have that ruling overturned by the full 9th Circuit, but was unsuccessful. The Institute for Justice's legal victory became final in June 2012, and a new tool in the fight against deadly diseases became available, when the Attorney General declined to appeal its loss to the U.S. Supreme Court. But no sooner was that legal victory established than the U.S. Department of Health & Human Services proposed a new rule that would negate the legal victory and block model research programs designed to examine the effectiveness of compensation. Nearly 500 people—including Nobel Laureates—wrote to HHS discouraging them from adopting the rule. But for nearly 3 years now, HHS has remained silent blocking such research and costing American ca[...]
Wed, 24 Aug 2016 06:30:00 -0400
(image) Rick Doblin, who as head of the Multidisciplinary Association for Psychedelic Studies (MAPS) has been trying for years to jump through the hoops required to get marijuana approved as a medicine, says the Drug Enforcement Administration's new willingness to license more than one producer of cannabis for research will finally make it at least theoretically possible to complete that process.
The National Institute on Drug Abuse (NIDA) has long had exclusive control over the legal supply of marijuana, which is grown by a single contractor at the University of Mississippi. In a legal battle that lasted more than a decade, MAPS tried to break that monopoly, which was a crucial barrier to meeting the Food and Drug Administration's requirements for approving a new medicine. The problem was not just the quality and variety of marijuana available from NIDA, or the agency's lack of enthusiasm for studies aimed at demonstrating the drug's benefits rather than its hazards. It was also the fact that NIDA's marijuana is available only for research, not for sale to patients following FDA approval.
"The FDA requires the Phase III studies be conducted with the exact same drug that the sponsor of the research is trying to market," Doblin explained in a recent interview on the Pacifica drug policy show Century of Lies. "So as long as the NIDA monopoly was in existence, FDA would never accept its marijuana for use in Phase III, and we could never get data that was necessary to reschedule."
MAPS is about to start a Phase II study of marijuana as a treatment for post-traumatic stress disorder in veterans, for example, but it has to use marijuana from NIDA. Since federally approved researchers are not allowed to buy marijuana from state-licensed suppliers in Colorado or Washington, NIDA is the only legal source. One problem with that is MAPS could not get all the strains it wanted: It asked for one with 12 percent THC and 12 percent cannabidiol (CBD), which NIDA did not have. But even if NIDA had a bigger variety, its marijuana would not be suitable for Phase III studies should the Phase II results look promising.
Now that the DEA has agreed to authorize other growers, research sponsors like MAPS can apply for licenses or contract with new licensees, which will make it possible to ensure that the marijuana used in their studies is the same as the marijuana they plan to make available as a medicine. "What's been so frustrating [is] that, on the one hand, the federal government has said there's not enough evidence to reschedule marijuana," Doblin said, "but on the other hand, they've blocked the ability to get the evidence. And so now that DEA has said that they'll end the NIDA monopoly, that evidence can be gathered....It's going to take four to six years, it could be $15 to $25 million, to gather it. But at least it's possible now, whereas before it was not possible."
Fri, 19 Aug 2016 00:01:00 -0400So a giant, rent-seeking insurance company is accused of having threatened to leave Obamacare's health insurance "marketplace" if the government didn't approve its giant merger. If true, this would be the least surprising development in the past six years of Obamacare fiascos. Any giant regulatory scheme bringing together big business and big government inevitably leads to cronyism and corruption. Not long after the Justice Department blocked Aetna's merger with Humana, the company announced it would be scaling back participation in Affordable Care Act (ACA) exchanges. Now, Obamacare consumers in 11 states won't be able to keep their insurance, even though, one imagines, they like their plans. But choices are getting scarcer by the year. Aetna is now one of about a dozen major insurance providers that have dropped completely out or scaled back participation in exchanges. A recent Kaiser Family Foundation study estimates that 664 counties will only feature one single insurer on Obamacare exchanges in 2017. In 2016, it was 225. Four entire states will have only one Obamacare insurer. In one Arizona county, there may be none. Since Obamacare, in effect, solidified in-state insurance cartels, the exchanges are starting to look very much the same. But opening markets up across state (and national) lines is a silly idea, I bet. At first, Aetna denied that its move was connected to the Justice Department's merger decision. Even in the most generous reading, this turns out not to be exactly true. At The Huffington Post, Jonathan Cohn and Jeffery Young have gotten their hands on a letter from Aetna's CEO that critics seem to believe catches Aetna threatening the administration. The correspondence has gotten Democrats very agitated, even though their policies are creating the problem. Even before the letter was uncovered, Sen. Elizabeth Warren (D-Mass.) and others lamented the rise of corporate power rather than the convoluted regulatory environment that fosters an unhealthy relationship between business interests and government power. Warren said, "The health of the American people should not be used as bargaining chips to force the government to bend to one giant company's will." To be honest, although I have little doubt Aetna was hoping its position on the exchanges would help with the merger, the letter sounds less like extortion and more like a sensible decision that any accountable executives would make when their company is facing losses. The real outrage isn't that insurers like Aetna are abandoning Obamacare, but that companies like Aetna likely participated in Obamacare for cronyistic reasons to begin with. The ACA has inhibited competition, which has only benefited big companies. Still, insurers are losing billions in the exchanges, and at some point it's too expensive to be in bed with Obama. Why would UnitedHealth, the nation's largest insurer, participate in a program that expects almost $1 billion in losses between this year and last? Aetna lost more than $430 million since January 2014, and it was expected to lose $300 million this year. Merger or no merger, Aetna would almost certainly stay in the exchanges if it made fiscal sense. Democrats will face increasing pressure to make this social experiment work. For instance, according to The Huffington Post, the Justice Department asked Aetna CEO Mark Bertolini how the merger would affect his company's participation in exchanges. So it's not like Aetna collaged a ransom note together and mailed it to the president. The Justice Department was curious about how the merger might impact the administration's struggling health care policy — which is a political consideration. Moving forward, would a company be looked upon [...]
Mon, 15 Aug 2016 19:20:00 -0400I'm pleased as punch today to play a very small role in the launch of media site Freethink. If that media outlet name sounds familiar, it may be from one of two things (or both!): Freethink's Honor Flight Veterans Day documentary that we've highlighted here at Reason; or from Freethink Media partner Kmele Foster, formerly of The Independents and currently participating in "The Fifth Column" podcast with Matt Welch. Today they've rolled out the first of a series of "shows," video segments about innovation in tech, policy, and culture, with some additional useful contextual articles. Here's Freethink's stated mission: Each week, we release a new video featuring passionate innovators who are solving humanity's biggest challenges by thinking differently. From aerospace engineers in the Mojave Desert to entrepreneurs in South America's biggest slum, our videos give you an intimate look at not only what they're doing but also why they're doing it, the obstacles they face, and what motivates them to keep driving forward. We're betting that after you watch these stories, you'll come away with insights and inspiration you can use to make a difference in your own way. Today's release is titled "Superhuman," a package about the scientific, medical, and engineering innovations that are helping cure diseases once thought incurable, replace body parts, and otherwise improve and prolong human life. My own contribution is a short background piece explaining how AIDS activism in the late 1980s and early 1990s served as the spiritual precursor to the current "right to try" movement. That's the increasingly successful effort to grant citizens with life-threatening conditions to right to try to get access to potentially helpful drugs before the full government testing process has been completed. Here's an excerpt: In the late 1980s, Americans were dying by the thousands from the opportunistic infections that came from full-blown AIDS. There was a single drug approved by the Food and Drug Administration permitted to help prolong the lives of people with AIDS. This first drug, azidothymidine—or AZT—was approved for use in AIDS patients in what was a remarkably fast process for the FDA at the time: 25 months. But AZT had some very serious side effects that caused other health threats, and not all AIDS patients could endure the treatment. The lack of "officially" approved treatment options gave rise to a large black market to provide access to non-permitted and foreign medicines in order to bypass the FDA. This black market was most famously highlighted in the 2013 Academy Award-winning film "Dallas Buyers Club," based on real-life drug smuggler (and AIDS patient) Ron Woodroof. Woodroof was not unique. There were groups of people across the country working to bring drugs into the United States from Mexico, Europe, and elsewhere, regardless of the FDA's approval process. Read my full piece here. And watch and read the other components of "Superhuman" at Freethink here. Some additional pieces are contributed by a name many Reasoners may find familiar: former Reason Associate Editor Mike Riggs.[...]