Oh, Pioids...Part II
So if you happened to read the last post you're aware of three things regarding opioids: 1) that overdose deaths and addicition due to both legal and illegal opioid drug use is skyrocketing in the U.S.; 2) that pharmaceutical companies which manufacture or distribute opiates or narcotics are making record profits and have spent little to none of those profits on education or treatment for both doctors and patients or users; and 3) as awareness among both physicians and states grows in the United States (many cities and states have filed their own lawsuits due to inaction by the federal government), many of the pharmaceutical companies are targeting other markets overseas, primarily those in Asia, Latin America, and the Middle East. And on a note of clarification, the administration's declaration of a "health" emergency in October of last year, falls short of a "national" emergency which would have meant access to federal funds; thus, no real emergency declaration means no funds or new guidelines. So all of this begs the question, how are they, the pharmaceutical companies and distributors, doing it? For that, we have to turn to India, which ironically will be one of the main areas these opiates will next hit.
In a piece that appeared in Bloomberg Businessweek, the story of "fake news" showed up once again only this time it was regarding a company that seems to specialize in generating medical and drug news headed to the doors of physicians and hospitals, one of several such companies. Studies and peer-reviewed drug and medical articles appear in their publications but are just slightly different from the more respected, traditional and vetted journals, all of which leaves physicians and hospitals to sort through the real and the fake. The particular company written about is called Omics, now with over 2000 employees and one which cites editorial addresses with UK and US signatures but are all actually routing from the desks of India. Add to Omics' publications a host of medical and drug conferences (3000 annually, according to the article), and you have a confusing world of flashy advertising and rather official-appearing pitchmen & women taunting the latest effectiveness of a new drug...but even the Federal Trade Commission has said that Omics is using "deceptive academic publishing practices." Omics response? The FTC allegation is based on "fake news." Termed predatory publishing, Omics allegedly does little background checking or research, instead charging the author a fee to publish the piece (or sometimes using a respected author's data without permission to add validity to the piece). Said the article: In response to the rapid proliferation of sketchy journals, academics around the world have performed a series of stings. In 2014, Peter Vamplew, a computer scientist from Australia, submitted a 10-page paper consisting solely of the words “Get me off your f---ing mailing list” repeated more than 800 times. The International Journal of Advanced Computer Technology, deemed predatory by Beall,* accepted it and requested a publishing fee of $150. Last year, Christoph Bartneck, a professor at New Zealand’s University of Canterbury, submitted to an Omics conference a nonsensical paper he’d written using the autocomplete function on his iPhone. Opening sentence: “Atomic Physics and I shall not have the same problem with a separate section for a very long long way.” Accepted within three hours, the piece was only slightly more absurd than articles that have popped up in Omics titles that weren’t part of a sting, such as one by an author claiming to have deciphered a code proving the existence of aliens. Take the respected journal Preventative Medicine (which does background and research checks before publishing)...Omics publishes Journal of Preventative Medicine. One would think that lawsuits would be through the roof only there's one problem...Omics has many pharmaceutical companies both publishing and appearing at their conferences. Says the piece, Omics and other such publishing companies: … provide a venue for (pharmaceutical) companies to publish studies that aren’t sufficiently groundbreaking for the lead journals, or those they’d prefer not be subject to rigorous vetting -- either to get them out sooner or to avoid scrutiny. A Pfizer paper on the financial burden of chronic lower-back pain published in 2014 in Omics’s Journal of Pain & Relief suggests the pharmaceutical company may have had an interest in skipping the traditional journals’ review processes.
On one hand, the U.S. has indeed imposed stricter rules on the use of painkillers since the U.S. now consumes 80% of the world's opioids; much of the base material for the production of narcotics such as oxycodone comes from poppy straw (vs. the sap of the unopened poppy head which is used in the production of heroin). And the source of all of this global supply which emerges from poppies? Would you believe...Tasmania. And as with any group of farmers, the legal poppy growers of Tasmania and other Australian states (which account for 80% of the legal raw material) have reduced their area of production but have increased yields. In a piece that appeared in Bloomberg Businessweek, Tasmania is facing more competition these days as India's largest drugmaker just bought out the operation of the GlaxoSmithKline Plc operation there, with Johnson & Johnson selling its production unit as well. And although demand appears to be down, there is optimism among poppy farmers with one producer saying "Ninety percent of the world's population doesn't get access to the cheapest pain relief product, which is morphine." Morphine is also derived from the unopened seed pod of the poppy and is quite similar --if weaker-- than heroin; because it is also an opiate/narcotic, morphine is medically used legally but has to prescribed.
But let's say that you don't care about all that. The fact is, you're addicted; you've had a major surgery or your back just continues to hurt and now, perhaps unintentionally, you're unabashedly hooked. MAT or Medically Assisted Treatment mimics the effects of opioids with drugs such as buprenorphine and methadone and is something currently covered by the Affordable Care Act...but the Trump administration is looking to take that coverage and payment away. And the administration is not alone for while praising itself for getting rid of regulations, it would appear that Congress is making it more difficult for doctors who would want to prescribe such treatments, imposing additional training and requirements for physicians wishing to explore such treatments for getting their patients off of their addiction. Said a piece in TIME: Doctors argue that such stringent regulations already deter many from becoming eligible to prescribe MAT and that fewer physicians will be available to dispense the potentially lifesaving addiction treatments, leading to more overdoses and deaths. The pharmaceutical industry's lobby is the largest in the U.S. and has spent the most money in Congress compared to other industries.
But let's say that you've lucked out and have now gotten access to treatment; you may find that the drugs needed to relieve your addiction has gone up in price...substantially. Demand has jumped to "21 times as large as expected" said another piece in TIME: Naloxone is a good drug. People should have access to it. But the companies that make it have also made huge profits off increased demand resulting from the opioid crisis...Three of the main companies that make naloxone products raised the prices on their drugs as demand increased. From 2005 to 2014, Hospira, which was purchased by Pfizer in 2015, increased the list price of its 10-milliliter injectable naloxone pack by 2,300%, from $9 to $220, according to data from Truven Health Analytics. (By the end of 2014, the price came down to $158.) From 2001 to 2014, the list price for Amphastar’s 20-milliliter naloxone pack jumped 175%, from $120 to $330. Kaléo raised the price of Evzio, its naloxone auto-injector, by 550%. When it was first introduced in 2014, it cost $575. In 2016, it was $3,750...drugmakers and their investors have marketed a whole new class of follow-on pills, because they know a growth industry when they see one. In 2016, the pharmaceutical companies that make opioid painkillers raked in $8.6 billion in sales for 336 million opioid prescriptions, according to the data firm QuintilesIMS. That’s enough to give pain pills to 9 out of every 10 American adults...If you become addicted to painkillers, there are pills to help you stop taking the pills. If you take too many pills, there's a pill for that too. Said a piece in Scientific American: The president also claimed that the opioid crisis “is a worldwide problem.” It isn't. Throughout Europe and other regions where opioids are readily available, people are not dying at comparable rates as those in the U.S., largely because addiction is treated not as a crime but as a public health problem. It is certainly possible to die from an overdose of an opioid alone, but this accounts for a minority of the thousands of opioid-related deaths. Many are caused when people combine an opioid with another sedative (such as alcohol), an antihistamine (such as promethazine) or a benzodiazepine (such as Xanax or Klonopin). People are not dying because of opioids; they are dying because of ignorance.
If it sounds a bit like an unwinnable battle, there's a new army of hope arriving with almost all of it outside the government and the big companies. Naloxone which was mentioned earlier, is currently only allowed to be administered via injection. Opiant Pharmaceuticals (started by a surgeon who saw a need for new treatments for overdoses) developed Narcan as a nasal spray (approved by the FDA in 2015) and is currently working on a heroin vaccine that would "trick" the body into thinking heroin is a disease and fight it off with its own immune system. Said Bloomberg Businessweek about founder Roger Crystal's ambitions: In the past, it’s been difficult to secure funding for clinical trials of a drug that would most benefit people who tend to be incarcerated or uninsured and likely unable to afford expensive treatment. With the income from Narcan to bolster it, Crystal thinks Opiant can be a critical bridge between scientists and the world of retail medicine. “You have the most brilliant minds, who are restricted by being in a government or academic setting,” he says. “Then you have our company: We’re that transition zone out of clinical development.” Another promising alternative is Exparel, a non-opioid slow-release pain reliever that is injected by surgeons at the site of the actual area being operated on; said Fast Company: Exparel has so far been used in more than 2.5 million patients (the U.S. military is one of the biggest customers by volume). The same magazine also told of start-up Antheia which is working on a less addictive opioid made of yeast. But they're not alone; INC listed an array of start-ups trying to help wean people off of their addictions including apps, patches, and even monitors placed under manhole covers in the streets (what??...the monitors actually check sewer water levels to see if certain communities are experiencing addiction issues).
One such group is Appriss, a software that accesses to databases and thus the monitoring of opioid prescriptions, which doesn't sound like much but without it addicts could jump across state borders and fulfill more prescriptions (the software also flags doctors who may be doling out excessive amounts of opioid prescriptions). Said an article, again in Bloomberg Businessweek: Appriss is filling a gap left by Washington. No federal agency synthesizes data from America's 51 monitoring programs, which so far have been left to state-level governments (D.C., Guam, and every state except Missouri)...The company's software accounted for 84 of U.S. doctors' 130 million opioid-related queries to state prescription-drug-monitoring programs last year according to data collected by the American Medical Association. That includes sharing data across state lines. "Our vision was that we want every opiate record looked at every time a doctor considers a prescription and every time a pharmacist dispenses," says Chief Executive Officer, Mike Davis...It probably won't reassure privacy advocates that Davis says he'd like to combine Appriss' siloed prescription information with data on hospital treatments for ODs and heroin use. He's hoping to identify people at risk of addiction before they're ever prescribed an opioid.
The rise of and treatment of addiction is indeed a crisis, one that The New Yorker says in an editorial that is now catching the attention of the administration perhaps only due to its effects on the economy (the piece cites figures from Goldman Sachs): If Trump were running the U.S. government like a business, as he often claims to be doing, then he would have made tackling an inefficiency of such scale a priority. “The number of people who lose their lives from prescription opioids is larger than the number who’ve lost lives to motor-vehicle accidents,” Jena (Anupam Jena, a health economist and physician at Harvard Medical School) told me. “Think of all the things that we do to make sure people don’t die from motor-vehicle accidents. We have air bags, speed limits, cops giving out tickets for speed violations. There are a lot of things we do to reduce deaths from motor vehicles. The deaths coming from prescription opioids is exceeding that now.” But for those facing pain daily, hourly, constantly, little of this matters. While the rest of the world might be waiting for a solution to stop the rate of addiction and it societal and criminal costs, those in pain just want a solution to their pain. And at the pace our government and the pharmaceutical companies are moving, it would appear that those solutions might be finally coming...but only come from outside the system.
*Jeffrey Beall, a librarian at the University of Colorado at Denver who noticed a mounting barrage of error-laden emails from open-access journals from companies that would seemingly publish anything with little to no peer review: "Writing about them on his personal blog" says the article, "Over six years, the list exploded from 18 publishers to 1,155."
In a piece that appeared in Bloomberg Businessweek, the story of "fake news" showed up once again only this time it was regarding a company that seems to specialize in generating medical and drug news headed to the doors of physicians and hospitals, one of several such companies. Studies and peer-reviewed drug and medical articles appear in their publications but are just slightly different from the more respected, traditional and vetted journals, all of which leaves physicians and hospitals to sort through the real and the fake. The particular company written about is called Omics, now with over 2000 employees and one which cites editorial addresses with UK and US signatures but are all actually routing from the desks of India. Add to Omics' publications a host of medical and drug conferences (3000 annually, according to the article), and you have a confusing world of flashy advertising and rather official-appearing pitchmen & women taunting the latest effectiveness of a new drug...but even the Federal Trade Commission has said that Omics is using "deceptive academic publishing practices." Omics response? The FTC allegation is based on "fake news." Termed predatory publishing, Omics allegedly does little background checking or research, instead charging the author a fee to publish the piece (or sometimes using a respected author's data without permission to add validity to the piece). Said the article: In response to the rapid proliferation of sketchy journals, academics around the world have performed a series of stings. In 2014, Peter Vamplew, a computer scientist from Australia, submitted a 10-page paper consisting solely of the words “Get me off your f---ing mailing list” repeated more than 800 times. The International Journal of Advanced Computer Technology, deemed predatory by Beall,* accepted it and requested a publishing fee of $150. Last year, Christoph Bartneck, a professor at New Zealand’s University of Canterbury, submitted to an Omics conference a nonsensical paper he’d written using the autocomplete function on his iPhone. Opening sentence: “Atomic Physics and I shall not have the same problem with a separate section for a very long long way.” Accepted within three hours, the piece was only slightly more absurd than articles that have popped up in Omics titles that weren’t part of a sting, such as one by an author claiming to have deciphered a code proving the existence of aliens. Take the respected journal Preventative Medicine (which does background and research checks before publishing)...Omics publishes Journal of Preventative Medicine. One would think that lawsuits would be through the roof only there's one problem...Omics has many pharmaceutical companies both publishing and appearing at their conferences. Says the piece, Omics and other such publishing companies: … provide a venue for (pharmaceutical) companies to publish studies that aren’t sufficiently groundbreaking for the lead journals, or those they’d prefer not be subject to rigorous vetting -- either to get them out sooner or to avoid scrutiny. A Pfizer paper on the financial burden of chronic lower-back pain published in 2014 in Omics’s Journal of Pain & Relief suggests the pharmaceutical company may have had an interest in skipping the traditional journals’ review processes.
On one hand, the U.S. has indeed imposed stricter rules on the use of painkillers since the U.S. now consumes 80% of the world's opioids; much of the base material for the production of narcotics such as oxycodone comes from poppy straw (vs. the sap of the unopened poppy head which is used in the production of heroin). And the source of all of this global supply which emerges from poppies? Would you believe...Tasmania. And as with any group of farmers, the legal poppy growers of Tasmania and other Australian states (which account for 80% of the legal raw material) have reduced their area of production but have increased yields. In a piece that appeared in Bloomberg Businessweek, Tasmania is facing more competition these days as India's largest drugmaker just bought out the operation of the GlaxoSmithKline Plc operation there, with Johnson & Johnson selling its production unit as well. And although demand appears to be down, there is optimism among poppy farmers with one producer saying "Ninety percent of the world's population doesn't get access to the cheapest pain relief product, which is morphine." Morphine is also derived from the unopened seed pod of the poppy and is quite similar --if weaker-- than heroin; because it is also an opiate/narcotic, morphine is medically used legally but has to prescribed.
But let's say that you don't care about all that. The fact is, you're addicted; you've had a major surgery or your back just continues to hurt and now, perhaps unintentionally, you're unabashedly hooked. MAT or Medically Assisted Treatment mimics the effects of opioids with drugs such as buprenorphine and methadone and is something currently covered by the Affordable Care Act...but the Trump administration is looking to take that coverage and payment away. And the administration is not alone for while praising itself for getting rid of regulations, it would appear that Congress is making it more difficult for doctors who would want to prescribe such treatments, imposing additional training and requirements for physicians wishing to explore such treatments for getting their patients off of their addiction. Said a piece in TIME: Doctors argue that such stringent regulations already deter many from becoming eligible to prescribe MAT and that fewer physicians will be available to dispense the potentially lifesaving addiction treatments, leading to more overdoses and deaths. The pharmaceutical industry's lobby is the largest in the U.S. and has spent the most money in Congress compared to other industries.
But let's say that you've lucked out and have now gotten access to treatment; you may find that the drugs needed to relieve your addiction has gone up in price...substantially. Demand has jumped to "21 times as large as expected" said another piece in TIME: Naloxone is a good drug. People should have access to it. But the companies that make it have also made huge profits off increased demand resulting from the opioid crisis...Three of the main companies that make naloxone products raised the prices on their drugs as demand increased. From 2005 to 2014, Hospira, which was purchased by Pfizer in 2015, increased the list price of its 10-milliliter injectable naloxone pack by 2,300%, from $9 to $220, according to data from Truven Health Analytics. (By the end of 2014, the price came down to $158.) From 2001 to 2014, the list price for Amphastar’s 20-milliliter naloxone pack jumped 175%, from $120 to $330. Kaléo raised the price of Evzio, its naloxone auto-injector, by 550%. When it was first introduced in 2014, it cost $575. In 2016, it was $3,750...drugmakers and their investors have marketed a whole new class of follow-on pills, because they know a growth industry when they see one. In 2016, the pharmaceutical companies that make opioid painkillers raked in $8.6 billion in sales for 336 million opioid prescriptions, according to the data firm QuintilesIMS. That’s enough to give pain pills to 9 out of every 10 American adults...If you become addicted to painkillers, there are pills to help you stop taking the pills. If you take too many pills, there's a pill for that too. Said a piece in Scientific American: The president also claimed that the opioid crisis “is a worldwide problem.” It isn't. Throughout Europe and other regions where opioids are readily available, people are not dying at comparable rates as those in the U.S., largely because addiction is treated not as a crime but as a public health problem. It is certainly possible to die from an overdose of an opioid alone, but this accounts for a minority of the thousands of opioid-related deaths. Many are caused when people combine an opioid with another sedative (such as alcohol), an antihistamine (such as promethazine) or a benzodiazepine (such as Xanax or Klonopin). People are not dying because of opioids; they are dying because of ignorance.
If it sounds a bit like an unwinnable battle, there's a new army of hope arriving with almost all of it outside the government and the big companies. Naloxone which was mentioned earlier, is currently only allowed to be administered via injection. Opiant Pharmaceuticals (started by a surgeon who saw a need for new treatments for overdoses) developed Narcan as a nasal spray (approved by the FDA in 2015) and is currently working on a heroin vaccine that would "trick" the body into thinking heroin is a disease and fight it off with its own immune system. Said Bloomberg Businessweek about founder Roger Crystal's ambitions: In the past, it’s been difficult to secure funding for clinical trials of a drug that would most benefit people who tend to be incarcerated or uninsured and likely unable to afford expensive treatment. With the income from Narcan to bolster it, Crystal thinks Opiant can be a critical bridge between scientists and the world of retail medicine. “You have the most brilliant minds, who are restricted by being in a government or academic setting,” he says. “Then you have our company: We’re that transition zone out of clinical development.” Another promising alternative is Exparel, a non-opioid slow-release pain reliever that is injected by surgeons at the site of the actual area being operated on; said Fast Company: Exparel has so far been used in more than 2.5 million patients (the U.S. military is one of the biggest customers by volume). The same magazine also told of start-up Antheia which is working on a less addictive opioid made of yeast. But they're not alone; INC listed an array of start-ups trying to help wean people off of their addictions including apps, patches, and even monitors placed under manhole covers in the streets (what??...the monitors actually check sewer water levels to see if certain communities are experiencing addiction issues).
One such group is Appriss, a software that accesses to databases and thus the monitoring of opioid prescriptions, which doesn't sound like much but without it addicts could jump across state borders and fulfill more prescriptions (the software also flags doctors who may be doling out excessive amounts of opioid prescriptions). Said an article, again in Bloomberg Businessweek: Appriss is filling a gap left by Washington. No federal agency synthesizes data from America's 51 monitoring programs, which so far have been left to state-level governments (D.C., Guam, and every state except Missouri)...The company's software accounted for 84 of U.S. doctors' 130 million opioid-related queries to state prescription-drug-monitoring programs last year according to data collected by the American Medical Association. That includes sharing data across state lines. "Our vision was that we want every opiate record looked at every time a doctor considers a prescription and every time a pharmacist dispenses," says Chief Executive Officer, Mike Davis...It probably won't reassure privacy advocates that Davis says he'd like to combine Appriss' siloed prescription information with data on hospital treatments for ODs and heroin use. He's hoping to identify people at risk of addiction before they're ever prescribed an opioid.
The rise of and treatment of addiction is indeed a crisis, one that The New Yorker says in an editorial that is now catching the attention of the administration perhaps only due to its effects on the economy (the piece cites figures from Goldman Sachs): If Trump were running the U.S. government like a business, as he often claims to be doing, then he would have made tackling an inefficiency of such scale a priority. “The number of people who lose their lives from prescription opioids is larger than the number who’ve lost lives to motor-vehicle accidents,” Jena (Anupam Jena, a health economist and physician at Harvard Medical School) told me. “Think of all the things that we do to make sure people don’t die from motor-vehicle accidents. We have air bags, speed limits, cops giving out tickets for speed violations. There are a lot of things we do to reduce deaths from motor vehicles. The deaths coming from prescription opioids is exceeding that now.” But for those facing pain daily, hourly, constantly, little of this matters. While the rest of the world might be waiting for a solution to stop the rate of addiction and it societal and criminal costs, those in pain just want a solution to their pain. And at the pace our government and the pharmaceutical companies are moving, it would appear that those solutions might be finally coming...but only come from outside the system.
*Jeffrey Beall, a librarian at the University of Colorado at Denver who noticed a mounting barrage of error-laden emails from open-access journals from companies that would seemingly publish anything with little to no peer review: "Writing about them on his personal blog" says the article, "Over six years, the list exploded from 18 publishers to 1,155."
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