“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
I want to share something with you today – and that is a giant thank you from people all across the country. I’ve heard it everywhere I’ve travelled this year – “thank goodness for the ACLU.” “Thank you for fighting back.” “Thank you for standing up for people’s rights.”
People are so grateful for our work – work that you make possible.
If you have any doubt about what you helped accomplish, I hope you will take a few minutes to watch this short video – and accept sincere thanks from me and my team here at the ACLU for partnering with us in standing up to cruel policies that target the most vulnerable among us.
Tomorrow, there will be more legal appeals to file and new emergencies that will require us to show up – in court, in the legislatures and on the streets. But for right now, I hope you will take time to reflect on the powerful impact you have on the lives so many. And please accept one giant Thank You from all of us at the ACLU.
The U.S. Drug Enforcement Administration this week will grant Schedule II status to a synthetic THC drug developed by a pharmaceutical firm beset with controversy.
The DEA on Wednesday is expected to finalize the previously suggested Schedule II status for Syndros, the FDA-approved liquid dronabinol
John Kapoor and other executives were accused of providing kickbacks to doctors to prescribe the company’s Subsys fentanyl spray, a highly addictive and potentially deadly opioid painkiller. Prior to Kapoor’s arrest, Insys was party to several investigations, lawsuits and enforcement actions related to Subsys.
Syndros’ advancement, approval and scheduling have been viewed by analysts as potentially positive developments for the firm.
Insys launched Syndros in late July as a treatment to help alleviate nausea and vomiting in chemotherapy patients and to address anorexia-associated weight loss in AIDS patients. Syndros generated $700,000 in revenue during the first two months, company officials said earlier this month.
The U.S. Food and Drug Administration approved the new drug application for Syndros and, alongside the Department of Health and Human Services, provided a scheduling recommendation for the drug. DEA officials concurred, noting that the drug would have the same abuse potential as other substances classified as Schedule II, according to the preliminary, “unpublished,” filing made Tuesday in the Federal Register.
Schedule II substances include Vicodin, cocaine, oxycodone and Adderall.
In the final rule filing, the DEA noted that four comments were submitted in support of the Schedule II listing while four comments were submitted in opposition.
Of the latter, one indicated the dichotomy between Syndros garnering Schedule II status while marijuana remained in the stricter classification of Schedule I. Two commenters expressed concern that pharmaceutical firms were profiting from approved drugs containing marijuana constituents and another commenter noted that the FDA should not approve drug containing any constituents of marijuana.
“The DEA notes that FDA-approved products of oral solutions containing dronabinol have an approved medical use, whereas marijuana does not have an approved medical use and therefore remains in Schedule I,” DEA officials wrote in the filing.
Marijuana advocates have blasted Insys for its stance opposing cannabis legalization. The company donated $500,000 to the campaign against marijuana legalization in Arizona and has expressed concerns about “natural cannabis” and the legalization of marijuana in regulatory filings.
Company officials previously have told The Cannabist that synthetic drugs are highly reliable and consistent and can meet the rigorous demands of the FDA process and subsequent commercialization.
Insys officials were not immediately available early Tuesday morning to respond to The Cannabist’s before-hours request for comment.
(Reuters Health) – Policymakers and insurers have been pushing people addicted to opioids into abstinence-based detox programs, but a new study concludes that methadone and similar drug-maintenance treatments save lives and money.
If the nearly 47,000 Californians who began treatment for opioid-use disorder in 2014 had received immediate access to methadone or another opioid-agonist treatment – instead of first being forced to completely withdraw from opioids – the healthcare and criminal-justice systems would have saved $3.8 billion, researchers estimate.
Moreover, 1,262 lives would have been spared, lead researcher Emanuel Krebs, a health economist at the British Columbia Center for Excellence in HIV/AIDS in Vancouver, British Columbia, said by Skype.
“If you offer opioid-agonist treatment from the outset, people live longer, and they incur lower costs on society,” said senior author Bohdan Nosyk, a health economist and professor at Simon Fraser University in Vancouver, British Columbia.
“People may not want to stay in treatment, but it’s their best chance of staying alive,” he said in a Skype interview.
Methadone and buprenorphine, opioid agonists, bind to the brain’s opioid receptors; the correct dose will eliminate withdrawal symptoms and cravings. International addiction experts consider initial opioid-agonist treatment, or OAT, with no duration restrictions, the evidence-based standard of care for opioid-use disorder, the authors write online November 20 in Annals of Internal Medicine.
But in California, where more people have been diagnosed with opioid disorder than in any other U.S. state, publicly funded treatment programs require patients to “fail” – twice – at a three-week course of medically supervised withdrawal before they become eligible for OAT.
“My belief is that California’s persisted with this medically managed withdrawal because they think they’re saving themselves money,” Nosyk said. “You’re paying more than that in the criminal justice sector, in the healthcare section in the long run.”
Using state data, Nosyk, Krebs and colleagues created a computer model to examine the impact immediate access to OAT would have had on Californians treated for opioid-use disorder in 2014.
It would have saved as much as $850 million over five years, not including savings to the criminal-justice system, and more than $2 billion, including the cost of arrests and prosecutions, the study found.
Over 10 years, the total savings would rise to $2.87 billion, the model showed.
“We have to prevent new cases of addiction,” said Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University’s Heller School for Social Policy and Management in Boston. “But for the millions who are addicted, the study authors nailed it – the effective treatment, the opioid-agonist treatment, needs to be very easy to access.”
“It’s very hard to recover with an abstinence-based approach. Most people can’t do it, yet that’s been the first-line treatment. That’s why we’re failing,” he said in a phone interview.
Opioids killed more than 33,000 people in the U.S. in 2015, according to the U.S. Centers for Disease Control and Prevention. Prescription painkillers are fueling the epidemic.
“If we want to see overdose deaths come down, we need to make sure people who have opioid addiction are able to access effective treatment more easily than they can access heroin, fentanyl or pain pills,” said Kolodny, who was not involved with the study.
An editorial accompanying the study says it adds to decades of data on the efficacy of opioid agonists and should lead policymakers to spend fewer healthcare resources on medically supervised withdrawal and more on opioid-agonist treatment.
The editorial writers, Dr. Jeanette Tetrault and Dr. David Fiellin of Yale University School of Medicine in New Haven, Connecticut, likened treating opioid disorder with medically assisted withdrawal to treating diabetic ketoacidosis, a life-threatening complication of diabetes, without addressing diabetes.
Dr. Anna Lembke, a professor at the Stanford University School of Medicine in Stanford, California, sees opioid-use disorder as a life-threatening disease.
“A person injecting heroin is the equivalent from a medical perspective of a person having a heart attack,” said Lembke, who treats opioid addicts with buprenorphine and was not involved with the new study. “Lifesaving treatment can’t wait.”
California’s guidelines should be changed to allow patients immediate access to opioid agonists, she said by email.
“We need a model whereby patients can get immediate access to opioid-agonist treatment, a lifesaving intervention, without obstacles,” she said.
Some patients are forced to wait months for treatment, she said, and in the meantime most of them will relapse, and many will die.
“Among experts in the field of addiction, we already know that detox doesn’t work, that they’re going to relapse and when they relapse, they’re going to be at great risk for an overdose, that they’ll be at great risk for hepatitis,” Kolodny said. “Opioid addiction is a life-threatening illness.”
Long Island, NY – November 21, 2017 – U.S. Reps. John Katko (NY-24) and Tom Suozzi (NY-3) today announced that they have introduced bipartisan legislation geared towards reducing opioid addiction and drug abuse in New York and nationwide.
The legislation, introduced in the Senate by Sens. John McCain (R-AZ) and Kirsten Gillibrand (D-NY), would limit the initial supply of opioid prescription for acute pain to seven days. When a person is treated for acute pain, such as a broken bone or wisdom teeth extraction, an over-prescription of a painkiller can pave the way to addiction and abuse. This legislation is modeled after current New York State law.
Rep. John Katko said, “The opioid drug epidemic has devastated families in Central New York and communities nationwide. This bipartisan bill would target one of the root causes of drug overdoses in the United States, which is the over-prescription of highly addictive opioids. Our legislation limits the supply of an initial opioid prescription for acute pain to seven days. Doing so will reduce over-prescription of painkillers and help reduce the risk of opioid dependency.”
“The opioid epidemic is tearing apart families and friends while infecting whole communities on Long Island, Queens and throughout the nation,” said Rep. Suozzi. “Our bipartisan legislation takes a big step toward preventing people from being over-prescribed and beginning a downward spiral towards dependency on opioids.”
This legislation would require medical professionals to certify, as part of their DEA registration, that they will not prescribe an opioid as an initial treatment for acute pain in an amount that exceeds a seven-day supply, and may not provide a refill. This limit does not apply to the treatment of chronic pain, pain treated as part of cancer care, hospice or other end of life care, or pain treated as part of palliative care.
Those who suffer from drug addiction or know someone who is addicted are encouraged to call the Substance Abuse and Mental Health Services Administration Helpline: 1-800-622-HELP (4357) for assistance.
Reps. Katko and Suozzi released a video message following introduction of this bill, available here.
The suicide note Doug Hale left before killing himself.
Source: Tammi Hale
Six months after surgery to repair a damaged urinary tract in 1998, computer technician Doug Hale woke one morning with excruciating, burning pain. Hale’s suffering persisted for years, despite all sorts of treatments. Finally, in 2006, he was prescribed strong doses of opioids.
Fast-forward 10 years. Still on his pain killers, Hale was popping so many of the highly addictive pills that he regularly ran out of his prescription early. His doctor cut off his supply and urged Hale to enter a detox program. That didn’t work. Hale, still in agonizing pain and now suffering from intense withdrawal symptoms, returned to his doctor and pleaded to get back on his opioid regime. The doctor refused. The next day, Hale put the barrel of a small-gauge gun in his mouth and pulled the trigger.
It would be tempting to view Hale’s death, at 53, as one more sad entry in the never-ending national tragedy of opioid deaths. In fact, it’s much more than that. Hale’s story is a window into the country’s silent majority of opioid sufferers. These are the millions of painkiller-dependent users inhabiting a vast gray zone somewhere between medical patient and drug addict, who are finding themselves suddenly abandoned in droves by the medical system. Under threat of lawsuits and government and insurance industry crackdowns, doctors have been cutting off the supply of painkillers, forcing many of their patients to quit cold turkey after years or even decades of dependence, sometimes with catastrophic consequences. Worst of all, those left suddenly without their meds often have nowhere to turn for help.
“These are victims of our era of aggressive prescribing,” said Andrew Kolodny, co-director of opioid policy research at Brandeis University’s Heller School for Social Policy and Management. “These patients become hot potatoes that no one wants.”
Roughly 8 million Americans are on long-term opioid therapy for chronic pain, and as many as a million are taking dangerously high doses, said Michael Von Korff, a senior researcher at the Kaiser Permanente Washington Health Research Institute. In the Medicare program alone, 500,000 patients were on high opioid doses in 2016, according to a 2017 report from the U.S. Department of Health and Human Services.
Many health professionals, fearing sanctions or even the loss of their licenses following government cases against a handful of doctors, have been caught up in a broader crackdown sweeping the pharma industry. In 2016, the Centers for Disease Control and Prevention issued guidelines for treating chronic pain, warning doctors to avoid prescribing high opioid doses when possible. Doctors have been heeding the message. Since peaking in 2010, prescriptions for more dangerous, higher-dose opioids dropped 41 percent from 2010 to 2015, according to a CDC analysis.
Meanwhile, more than a dozen states and about 100 counties and cities have already sued Purdue Pharma LP, other opioid makers and drug distributors, in a strategy echoing the litigation that led to the 1998 $246 billion settlement with Big Tobacco. Purdue is proposing a global settlement in an attempt to end state investigations and lawsuits, Bloomberg News reported on Nov. 17. And last month, President Donald Trump declared widespread opioid abuse a public health emergency.
Purdue Pharma, the maker of OxyContin, said it is “deeply troubled” by the national opioid crisis and is distributing the CDC’s treatment guidelines to doctors. Johnson & Johnson, maker of the fentanyl-containing Duragesic patch, said it is “committed to working with federal, state and local officials to help find meaningful solutions” to the opioid problem. Teva Pharmaceutical Industries Ltd., which sells generic opioid pain killers, declined to comment but in the past has denied wrongdoing.
In the battle to wean patients off opioids, dosage has emerged as a critical issue. Chronic pain sufferers on high doses aren’t necessarily addicts, at least not the sort who would resort to buying drugs on the street, experts say. Some may indeed benefit from the drugs and function well on them. Yet many aren’t getting better or going back to work and still report high levels of pain, despite big doses. Even patients taking high doses prescribed by their doctors run the risk of overdosing, recent studies showed. As many as 25 percent of pain patients may exhibit some level of misuse of the drugs, studies have found.
How America’s Opioid Crisis Spiraled Out of Control
With most medical and government resources focused on treatment for more obvious drug abusers, few formal programs exist to help patients dependent on opioids. And there is little guidance for doctors, who are more accustomed to prescribing than un-prescribing drugs. A few hospitals such as the Mayo Clinic and the Cleveland Clinic have intensive outpatient pain-rehab programs, but they are pricy. The Mayo Clinic’s costs roughly $30,000 to $40,000, though most insurance companies cover at least part of the program, which offers help to specifically taper patients off opioids. The three-week intensive program consists of counseling and alternative treatments such as physical and occupational therapy.
Experts who have studied opioid dependence say that, in some cases, it’s too risky to reduce doses until complex psychological problems are under control. But that message isn’t always getting through to doctors. “We have created this monster, and we think we can stop this by just stopping opioids,” said Ajay Manhapra, a Yale University lecturer and addiction medicine specialist who treats patients at the Hampton VA Medical Center in Hampton, Virginia. Researchers who think drug doses can be brought down quickly “are very naive.”
Clare Rhodes, a 63 year old San Jose resident, took OxyContin for more than a decade following a 2001 back operation — first prescribed by a surgeon who promised it wasn’t addictive. She was cut off in 2012, after her doctor was arrested for prescribing opioids to addicts. Even though she had never misused her meds, other pain doctors covered by her workers’ compensation policy refused to take her case, so she was forced to go cold turkey. The withdrawal symptoms lasted a year and were worse than the side effects she got from breast cancer chemotherapy treatment. Rhodes was constantly agitated, suffered diarrhea, broke out in cold sweats and was unable to sleep more than an hour at a time.
Now Rhodes runs a private Facebook group for chronic pain patients. Few patients are being eased off the drug gradually, she said. Many are forced off their meds after their doctors retire or move to another clinic. So many patients on the discussion group expressed suicidal thoughts that she tried to find a psychiatrist or psychologist to offer guidance, but no one was willing to take on that responsibility. “It is an insane situation,” said Rhodes. “They are simply being cut off. It is unconscionable that doctors are doing this to their patients.”
Some have seized on medical opioid addiction as a business opportunity. Breaking Benzo, a telemedicine startup in Palo Alto, California, offers online psychiatry appointments and round-the-clock access to health coaches to help people quit opioids or anti-anxiety drugs called benzodiazepines. The service, available in California, costs $349 a month, doesn’t currently take insurance and plans to expand to at least 10 other states by next year, including hard-hit states Ohio, West Virginia and Kentucky. It is in the process of getting certified for insurance coverage.
The medical system didn’t quite know how to handle the case of Doug Hale.
A paralegal and computer technician, Hale once enjoyed an active life that included scuba diving, softball and hiking. That was before a progression of medical problems forced him to go on disability. In 1998, he needed major surgery from an obstructed urinary tract. Months later, he developed a painful and mysterious bladder inflammation.
Over the next five years, Hale tried and failed a long list of non-narcotic treatments, including behavioral therapy, nerve blocks and nerve stimulators before doctors started him on opioids in 2004, according to his wife.
A family photo of Hale with his daughter Niki Elnicki and his wife Tammi.
Source: Tammi Hale
He progressed through a laundry list of opioids, including Dilaudid, hydrocodone, oxycodone and fentanyl, before ending up on high doses of methadone, a long-acting opioid painkiller that is better known for its use in treating heroin addiction. Complicating his care was a cerebral hemorrhage in 2006 that left him with short-term memory loss, migraines and seizures.
The final years of Hale’s life were a blur of doctor visits for chronic pain, seizures and other medical problems. Most of his treatment was through his primary care doctor, Stephen Kornbluth, and other doctors at Castleton Family Health Center near Hale’s home in Rutland, Vermont. He also traveled to New Hampshire to see a neurologist and a pain doctor and twice checked into a detox center at a psychiatric hospital for week-long treatments. Nothing worked.
By April 2016, Hale was taking 16 methadone pills a day, a huge dose. His daily intake was many times the level the CDC says can significantly increase overdose risk. It still wasn’t enough to ease Hale’s pain. He started taking two or three additional pills a day and ran out a week early. His wife says he was having problems absorbing his medications as a result of weight loss surgery.
Hale and his wife sought additional methadone at an April 9 appointment. The doctor who saw him that day warned that his misuse was “exceedingly dangerous” and could put Hale “at risk for death,” according to the doctor’s notes from the encounter. But worried about severe withdrawal symptoms, she renewed the prescription for a week, until Hale’s next regularly scheduled visit with Kornbluth, who also opted to extend prescribing the drug at a lower dose.
But after Hale ran out early again in May, Kornbluth finally lowered the hammer. He told Hale and his wife, Tammi, that he wasn’t comfortable continuing the drugs beyond a month, and offered to send him yet again to a detox clinic. “Too many times she and he have messed up, though I am not convinced that there is abuse consciously,” Kornbluth wrote in medical records that Tammi Hale later received from the clinic. Hale’s wife says Kornbluth gave the couple a different reason for the discontinuation. “‘I don’t want to risk my license for you any more,’ those were his exact words,” said Tammi Hale. “We felt we had been dumped and abandoned.”
“I remember saying to the wife that I can’t prescribe because there was very inconsistent use, and I couldn’t in good conscience write for that,” said Kornbluth in response. “She kept saying she was very comfortable with that, she understood.” He said he made clear he was not opposed to Hale trying to get opioids from a pain specialist. Far from being abandoned, Hale had numerous consultations with specialists, Kornbluth said.
By mid-July, after his second stay at the detox clinic, Hale had hardly slept in two weeks. Though now entirely off opioids, he had constant tremors and shaking. He broke down crying at a visit with Kornbluth. In September, the Hale couple applied for a last ditch option: a methadone clinic for addicts. But the clinic turned him down on the basis that he wasn’t truly an addict.
On Monday, Oct. 10, Hale and his wife saw Kornbluth. The doctor refused their entreaties to restart the opioids. That day, Kornbluth was still working on finding a program that would take Hale, who, the doctor later wrote in his records, fell through “the cracks” between medical providers.
The next day, Hale was dead. “Can’t take the chronic pain anymore,” he wrote in a wobbly penned suicide note. “No one except my wife has helped me.”
Here we have Kolodny claiming that these suicides are a consequence of pt’s chronic pain being readily treated and that they are now “hot potatoes ” …mostly due to the CDC guidelines that he helped to create..
How much longer before Kolodny is recognized as the charlatan he REALLY IS ?
Nothing like someone placing blame on the system that they help to create and put in place.
Could Hale’s chronic pain be a direct/indirect results of a botched surgery on his urinary tract ? One of the estimated 250,000 – 400,000 deaths caused by medical errors ?
Amazon is hawking dubious health products, including some that have been criticized by regulators and may even be illegal.
Current health offerings, replete with literal “snake oil,”a term that refers to fake medical products, could stymie the online retailer’s reported plans to disrupt the neighborhood pharmacy.
These products include dietary supplements claiming to help with opiate withdrawal and relieve pain, although it’s illegal to market supplements as treatments or cures. And, until recently, Amazon sold at least one medical device without Food and Drug Administration oversight and products the FDA has explicitly warned against.
Amazon may have plans to expand into more-regulated areas of health care, such as pharmaceutical drugs, medical devices and medical supplies. But without a major change, Amazon could encounter regulatory scrutiny or risk having a credibility problem, experts told MarketWatch.
“Honestly, if Amazon wants to get into this business they should clean up their own house first,” said Nicodemo Fiorentino, a pharmaceutical and medical device regulatory expert, adding that consumers “do not understand the complexities of drugs and devices” and could be misled by offerings.
Concerns about “dangerously misleading” health products being sold on Amazon have been raised before, including in a report from the U.K. newspaper the Sun last year that charged the online retailer was “peddling bogus miracle cancer cures.” A subsequent report by Vox found that those products were also available in the U.S. — and many are still available to this day.
Amazon also sold — until MarketWatch brought it to the company’s attention — at least one medical device that didn’t appear to be registered with the FDA, a transcutaneous electrical nerve stimulation unit, which is used to relieve pain, and ear candles, which the FDA has warned about.
In some cases, devices sold by Amazon improperly include the FDA logo or falsely claim to have FDA approval.
On its website, Amazon says “all listings and products must comply with all laws and regulations” and states that sellers not authorized to sell regulated medical products can’t sell them. Amazon policy also says that supplements can’t be sold “that claim to cure, mitigate, treat or prevent diseases in humans.”
But it’s unclear what Amazon, which removed certain listings after MarketWatch brought them to its attention, is doing to enforce that.
In fact, “ear candles” — which Amazon explicitly lists as prohibited on its website — can be easily found on the retailer’s website. (Ear candles are touted as a way to clear ear wax buildup and relieve various symptoms, but the FDA has warned they can cause serious injuries and that no scientific evidence supports their claims.) It is important to diagnose and treat the hearing disorder accordingly. Check out https://www.tinnitusaz.com/scottsdale.html for medical center where you can receive individualized care for your ears and hearing.
While the ear candle listing sent to Amazon by MarketWatch was taken down, other examples remain on Amazon’s website. Other listings, including of several supplements claiming to help with opiate withdrawal, have also been taken down since Friday.
“Sellers are required to comply with all laws and regulations, as well as Amazon’s policies, and may lose their selling privileges if they fail to do so,” Amazon said in a statement. “We monitor the products sold on our website for product safety concerns and, when appropriate, we remove products, reach out to sellers, manufacturers and government agencies for additional information or take other actions.
“If customers have concerns about items they’ve purchased, we encourage them to contact our Customer Service directly so we can investigate and take appropriate action.”
Amazon’s current offerings pose a clear problem for consumers, who may believe that Amazon’s health products are appropriately vetted.
But it also opens Amazon up to risks, including possible action by the FDA, which regulates medical devices and can remove dietary supplements from the market.
The FDA said in a statement that it is “aware that online shopping sites may be selling medical devices that are unapproved or not cleared by the FDA, and we investigate violations and pursue appropriate action with the firms involved.”
“As part of our mission to protect public health, the FDA has an active surveillance program to monitor for the marketing and sale of unapproved medical devices,” the statement said. “Many of these online shopping sites have implemented procedures to prohibit such activity, but we have a policy of not commenting on specific cases under investigation.”
Disciplinary actions or health care fraud could prevent the licensing and accreditation needed for a potential expansion, “unless that’s all been resolved,” said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. The NABP represents state government agencies that regulate pharmaceutical drugs and medical devices and accredits organizations that want to sell them.
Could, for example, selling products not cleared by the FDA qualify?
Yes, Catizone said, “and that could factor into getting a license or registration.”
The government has stepped in before in a similar area. In 2011, Google reached a $500 million settlement with the Department of Justice over ads placed by online Canadian pharmacies to target U.S. consumers.
“The Department of Justice will continue to hold accountable companies who in their bid for profits violate federal law and put at risk the health and safety of American consumers,” then-Deputy Attorney General James Cole said at the time.
There are also many examples of the FDA and the Federal Trade Commission cracking down on nutritional supplements that make grandiose claims, including FDA warning letters and actions brought by the FTC against manufacturers claiming their products alleviate opiate withdrawal, ensure weight loss, relieve joint pain and reverse grey hair.
According to the FTC, when making a complaint it considers what parties are most responsible for deceptive advertising. The FTC says that when it comes to nutritional supplements, it can’t recall making a complaint against a platform through which a manufacturer is selling. Moreover, a section of the Communications Decency Act exempts websites when content is posted by a third party.
That defense — that Amazon is merely a platform — could also shield it from other scrutiny. But there are numerous instances in which Amazon fulfills questionable products offered by third parties. An ad for a supplement that claims to help with opiate withdrawal is the first response to a search for “opiate” on Amazon.
Amazon “has not had the cleanest supply chain so far,” said Darshan Kulkarni, a pharmacist and attorney at the Kulkarni Law Firm. But a dirty supply chain “gets very quickly eviscerated when you’re dealing with regulated products like drugs and devices.”
Kicking products off Amazon’s website could affect its product margins, because customers may no longer see it as a one-stop shop, said Kulkarni, who noted he holds Amazon stock.
But if Amazon expands into medical devices, pharmaceutical drugs or medical supplies, “they’re going to go from serving customers, which they’re very good at, to serving agencies… and that may end up impacting how they do business,” he said. “When you’re serving two masters, one is probably going to end up being unhappy.”
Amazon shares have gained 50% in 2017, while the S&P 500 has gained 15% and the Dow Jones Industrial Average has gained about 19%.
The U.S. Government Accountability Office called on CMS last week to improve its oversight of opioid use among Medicare Part D beneficiaries after identifying flaws in the agency’s monitoring of opioid prescriptions.
CMS estimated 33,223 Medicare recipients were at risk of opioid overutilization based upon its recently revised prescribing guidelines. However, the GAO believes CMS guidelines, which rely on prescription monitoring information from private organizations that implement Medicare drug plans, miss many Medicare patients at-risk for addiction and misuse. The GAO determined more than 727,000 enrollees in Medicare’s prescription drug program in 2015 were at risk of opioid addiction or misuse due to opioid prescriptions not aligned with CDC prescribing guidelines, according to a GOA report released on Nov. 6.
“CMS oversees the prescribing of drugs at high risk of abuse through a variety of projects, but does not analyze data specifically on opioids,” wrote the authors of the GAO report. “However, GAO found that CMS does not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and does not require plan sponsors to report actions they take when they identify such providers. As a result, CMS is lacking information that it could use to assess how opioid prescribing patterns are changing over time, and whether its efforts to reduce harm are effective.”
To improve CMS’ opioid oversight, the GAO recommended the agency gather information on beneficiaries receiving high doses of opioids, identify providers who write high amounts of opioid prescriptions and require plan sponsors to report potentially inappropriate provider prescribing practices.
In 2016, providers prescribed more than 14 million Medicare Part D beneficiaries opioids.
Imagine that, 48 million people on Medicare (40 million 65+ & 8 million disabled) and 14 million Medicare folks got at least one prescription for a opiate.. that is about 30% of the Medicare population. Since it is claimed that there are some 100 + million chronic pain pts.. and we have a population of 320 million – that is 31%.
According to the GAO 727,000 Medicare folks are “at risk” of opiate use disorder which is abt 1.5% of the Medicare population… which is not that much different that the per-cent of the overall adult population that could be defined as having a “opiate abuse disorder”
It would also seem like CMS has “adopted” the CDC “guidelines”… that was NEVER SUPPOSE TO CARRY THE WEIGHT OF LAW… so much for that.
Here is four quotes from the CDC opiates guidelines:
“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”
“Clinicians should consider the circumstances and unique needs of each patient when providing care.”
“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”
“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”
Since there is nothing in the CDC guidelines to take into consideration of CYP-450 opiate enzyme deficiencies to account for higher/more frequent dosing…
So apparently the definition of “high doses” is going to be by some fairly rigid “cookie cutter formula” and what the individual needs of the pt will not be a consideration.
The quality of medicine today is much less reliable due to several factors: Western regulators have difficulty overseeing foreign plants, domestic regulators lack the interest to oversee these plants, and generic companies are unable to differentiate their products except by price. This is not limited to a single group, company, or country. However, in this paper I primarily address India.
The rapid rise of India’s pharma industry has not been matched by quality production. The Indian government protects its industry at all costs, and corruption is widespread.
Change is required in both India, which must update its laws and improve its regulator, and the US, which must better identify and punish quality infractions. Additionally, the biggest lie in the pharmaceutical market, that all generics are the same quality, must end.Executive Summary
Thirty years ago, most medicines consumed in rich nations were made there. Today most of the ingredients and nearly half the finished products come from India and China. India and China have low costs, which have driven the three-decade change. Both nations have capable chemists and businesses that can make high-quality products, but they also have a lot of slipshod producers (not unlike the West of the mid-20th century).
Western regulators’ difficulties in overseeing these plants, domestic regulators’ lack of interest in overseeing them, and generic companies being unable to differentiate their products (due to prescribing practices, limits on advertising, and so forth), amid the fiction that all generics are equal, mean that quality, which should be more assured, is more hit-and-miss today than before. This is not a problem limited to a single group, company, or country. However, in this paper I primarily address India.
A pharmacologist works inside the bio safety room at Natco Research Centre in the southern Indian city of Hyderabad. Reuters.
The rapid rise of India’s pharma industry has not been matched by a sufficient capacity to regulate legal medicine production. India is far from unique in exhibiting this problem, but it is the worst protected of the major exporting nations. Like other nations, policing medicine counterfeiting is at least attempted in principle, but unfortunately in India it is almost nonexistent in practice. Additionally, widespread corruption enables all sorts of bad actors to endanger patients by exposing them to a wide variety of inferior-quality medicines. Most worrying is increasing evidence that not all, or even the majority, of legal Indian manufacturers are operating to acceptable standards.
Any manufacturer, even well-known Western companies, makes mistakes. But in countries with robust rule of law and effectual regulation, infractions are noticed and remedies made, either by the federal government or through the threat of private litigation. Manufacturers know that repeated negligence will lead to plant closures, massive fines, civil damages, and even bankruptcy, and so they happen rarely.
This was certainly not the case historically. For much of the 20th century, manufacturers in the US and Europe operated with little oversight, and in response, reputable companies differentiated their brands by ensuring quality or purity, which nurtured trust, reputation, and brand loyalty. Rigorous regulation slowly followed, and an iterative process of quality production and stricter regulation has evolved. Undoubtedly this process has improved quality in the West.
India is, in many ways, in a similar situation to the West of 60 to 70 years ago. India currently lacks regulatory oversight and exhibits legal weaknesses that encourage substandard drug producers to flourish, often crowding out better producers, which cannot compete on price with those cutting corners. While Europe and America faced this problem in the mid-20th century, at that time it was easier to differentiate products based on branding and advertising, whereas today, all “generic” products are assumed to be interchangeable, and advertising is often illegal. This means companies can often distinguish themselves only on lower price and reliable delivery.
Additionally, the plethora of substandard products is worsened by the Indian government’s price-control policy, which drives low prices for government contracts to supply pharmaceuticals—prices so low, some manufacturers simply cannot make good-quality medicines and cover costs.
Furthermore, some Indian producers seem to be consistently and intentionally making poorer-quality products for certain domestic and foreign markets where quality control and consumer discernment are perceived to be weak. But companies sometimes send poor-quality medicines to markets with good oversight, too, and occasionally get caught as a result. Increasingly, Western regulatory agencies are identifying failing Indian companies and sanctioning them—most infamously, the pharmaceutical company Ranbaxy paid a $500 million settlement in 2013, as the company admitted to fraud and supplying substandard medicines. Since then, dozens of other Indian companies have been reprimanded or fined by the US Food and Drug Association (FDA) or limited in their ability to export their products to the US. But the Indian government continues to deny it has a problem, to the chagrin of foreign regulators and drug producers and of increasing concern to some American physicians and patients. Perhaps most striking, India’s regulators never even bothered to investigate Ranbaxy following the US case.
As a result, Indian regulators are increasingly isolated from the rest of the world. Indian producers may also be isolated in the future; US congressional committees are investigating drug quality, and President Donald Trump is pushing for more production in the US. But at the same time, the president wants cheaper drugs, and no producers can beat India on price.
We may be approaching a crossroads for Indian medicines. If India does not shape up, resulting in tragedy to US patients, a US boycott of Indian drugs could devastate India’s pharmaceutical industry—the good with the bad. It may also double the price of medicines in the US and lead to shortages. It is in nearly everyone’s interest that India sort out its medicine business.
This paper explains the problems with Indian medicines, while acknowledging the vital role they play, and then discusses some of the methods by which quality can be improved, using a mixture of carrots and sticks.
Several options are available to fix the lack of consistent quality. The simplest is to be open about quality differences and allow the market to adapt. Allowing generic manufacturers with spotless records to advertise this fact, pointing out how their products are more reliable than their competitors, would probably drive demand by patients for those products and drive drug wholesalers and pharmacists to deliver demanded products based on such differentiation. The knock-on effects would be significant: If Indian or Chinese companies are exposed as making shoddy products, they would lose business, and some, maybe most, would change practices as a result.
A more likely political approach would be for the US to enact legislation that prevents all Indian and Chinese products from being imported, unless they are certified to the highest standards. This means not just passing an initial FDA inspection, but passing ongoing private-sector audit requirements, with stringent penalties such as marketing prohibition if a producer fails in these audits.
Price increases and shortages would be an inevitable result of such an approach, but whatever path is taken, there are only imperfect real-world policies with trade-offs that affect patients and entrenched interests. It is ironic that an overreliance on the cheapest sources of chemicals and finished products is caused by the near impossibility of differentiating products based on quality.
Introduction
The pharmaceutical industry is one of the most heavily regulated in the world, yet medicine manufacturing is often opaque, even to the very regulators charged with protecting consumers from ineffective and potentially dangerous products. Furthermore, patients and even physicians are often ignorant of the products they take or prescribe every day.
Regulation is slow to change, often for good reasons, since business dislikes uncertainty and invests more when the rules of the game are set. But as industry has changed, its practices, notably its procurement practices, have changed so radically in the past three decades that the regulatory environment is no longer capable of overseeing consistent product quality. With no effective regulations and with opaqueness from most of the supply and distribution system, quality problems were almost inevitably going to arise.
A key change has been geographic. India has developed a reputation of producing cheap generic drugs, making it the pharmacy to the world. It is a well-deserved reputation since Indian drugs dominate pharmacy sales in every part of the developing world and increasingly in the West.
This paper is split into three sections. The first discusses publicly available data and stories about Indian drug-quality flaws and provides a brief analysis of legal institutions and organizations charged with addressing quality problems. The second section addresses my own efforts to assess the problem from a decade of drug procurement of Indian medicines. The third section deals with actual and potential policy responses to the problems identified in the first two sections.
I would like to be included in this lawsuit. After more than 15 years of continuous prescription pain medication use for daily intolerable pain I am currently going through forced unsupervised withdrawal. With no warning
my insurance company CVS Caremark
is denying me access to my meds pending a “prior authorization”. Its now been several days and not only am I dealing with my pain, but physical symptoms of wthdrawl. This kind of treatment is not only not what we pay our insurance fees for, buts its inhumane.
If this pt ends up committing SUICIDE… you can’t convict/jail the CVS Corporation… they might get fined… I wonder if their MEDICAL DIRECTOR or those on the committee who came up with these policies and procedures could be charged with ASSISTING SUICIDE ?
“In 1999, Kevorkian was arrested and tried for his direct role in a case of voluntary euthanasia. He was convicted of second-degree murder and served eight years of a 10-to-25-year prison sentence. He was released on parole on June 1, 2007, on condition he would not offer advice nor participate nor be present in the act of any type of suicide involving euthanasia to any other person; as well as neither promote nor talk about the procedure of assisted suicide”
Chronic pain pts have TWICE THE SUICIDE RATE of the general population… will such policies and procedures of companies like CVS/CAREMARK just enough of a NUDGE to cause how many chronic pain pts to take steps to CEASE THEIR SUFFERING FOR GOOD ?
There is already 5 states that have passed laws legalizing “death with dignity law ” and another 30 states have it on their legislative agenda this year.. Are we headed down the path of “covert genocide” ?
We already have abt 50,000 mental health pt commit suicide each year with another one million attempts… is anyone going to pay attention to the increased suicides… or has the system already been put in place that those chronic pain pts taking opiates… when a opiate shows up in their toxicology.. their death will be classified as just a “opiate related death” and not be counted as a SUICIDE ?
AUGUSTA, Maine (NEWS CENTER) — People taking opioid painkillers for chronic pain are breathing a little easier. A new state law that went into effect Friday is clearing up confusion about how much a patient can legally take.
The law used to require people taking opioids to taper down their daily doses to no more than 100 morphine milligram equivalents, with exceptions only for those under hospice or palliative care in connection with a serious illness.
Doctors knew they could prescribe more for patients treated for cancer or hospice care, but many didn’t think they could go over that limit for patients with chronic pain. This new law makes it clear that people with chronic pain can be exempt.
Brian Rocket, a midcoast lobster wholesaler was one of those patients who was told by his doctor several months ago that he had to taper down his opioid dose to meet a new state law. He suffers from chronic pain from prior injuries and was worried he wouldn’t be able to run his business.
With the new law in effect, he says his doctor’s now confident that Brian is exempt from that 100-milligram limit and can accept a higher dose.
“I’ve certainly been reclassified under the palliative care back to where I was on medicine and I can function,” he said. “I can live to fight another day.”
Eric Wass, a roofing contractor, who for 20 years has been taking opioids to manage chronic pain, was also forced to taper down and is also now allowed a higher dose. He said it’s made all the difference.
“I can work all day and I have a vegetable garden over there now,” he said, “so it’s giving me my life back because it was being taken away from me.”
Both men went so far as to hire a lawyer to sue the state and then testified at public hearings about the need to change the law.
Lawmakers heard those pleas and passed a bill the governor signed — offering relief for those who found themselves dependent on painkillers after having them legally prescribed by their doctors.
“It’s not much fun,” Wass said. “I’m not proud of it. I don’t like it, but I don’t have much choice.”
Maine DHHS expressed concerns about adding too many exemptions to the law, saying that excessive overprescribing of opioid painkillers is what led to this epidemic that Maine and the nation are now facing.
Reps. Suozzi and Katko Introduce Bipartisan Legislation to Combat Opioid Addiction
Remember Dr. Kevorkian ?