Millions of Patients Face Pain and Withdrawal as Opioid Prescriptions Plummet

https://www.bloomberg.com/news/articles/2017-11-21/millions-of-patients-face-pain-and-withdrawal-as-opioid-prescriptions-plummet

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.

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.” 

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.

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.

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 ?

Filed under: General Problems | 4 Comments »

https://nypost.com/2017/11/20/amazon-is-selling-sketchy-health-products-and-it-may-be-illegal/

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.

Modal Trigger

“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.”

Modal Trigger

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%.

Filed under: General Problems | 1 Comment »

GAO: CMS failed to identify thousands of Medicare beneficiaries at risk for opioid addiction

https://www.beckershospitalreview.com/opioids/gao-cms-failed-to-identify-thousands-of-medicare-beneficiaries-at-risk-for-opioid-addiction.html

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:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“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.

Filed under: General Problems | 2 Comments »

www.aei.org/publication/indias-dodgy-pharmacy/

Key Points

• 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.

Filed under: General Problems | 1 Comment »

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 ?

Remember Dr. Kevorkian ?

https://en.wikipedia.org/wiki/Jack_Kevorkian

“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 ?

Filed under: General Problems | Leave a Comment »

http://www.wcsh6.com/news/local/chronic-pain-sufferers-applaud-changes-to-opioid-limits-law/450683168

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.

Filed under: General Problems | 24 Comments »

Study: W.Va. heroin overdoses doubled after use of drug-monitoring program

https://www.ems1.com/opioids/articles/362080048-Study-W-Va-heroin-overdoses-doubled-after-use-of-drug-monitoring-program/

Researchers suggested that limiting the ability to acquire prescription painkillers can lead to more people using heroin

MORGANTOWN, W.Va. — New research suggested that drug-monitoring programs can lead to more heroin overdoses if not paired with a policy to help treat addiction.

Pacific Standard reported that after West Virginia made it a law that doctors must use the drug-monitoring database, heroin overdoses doubled in three years.

“It really underscores the need for a multi-faceted, comprehensive solution for this,” West Virginia University graduate student Sara Warfield, who led the study, said.

Other researchers have suggested that restricting access to prescription painkillers can lead to people turning to heroin if programs are not put into place to help addicts get treatment.

Warfield looked at data from a network of hospitals, and she looked at how often painkiller and heroin overdose patients were admitted between 2008 and 2015. She found that heroin overdoses spiked significantly in 2012.

“It’s extremely difficult to say anything with causality, but our findings did show that the current opioid overdoses are really being driven by heroin and not by prescription opioids,” Warfield said.

Filed under: General Problems | Leave a Comment »

www.nationalpainreport.com/a-call-to-arms-for-the-chronic-pain-community-8834850.html

Since 2012, and more recently in intervening months, weeks and days, the climate of health care for persons who require support for chronic and intractable pain has deteriorated – in part because of the politicization of health care that includes mental health, substance abuse services, care that addresses pain. The conflation of health care with other social issues, crime statistics, and the introduction of illicit drugs into the public mainstream blurs the lines across the system and creates fear at every level.

This is simply unacceptable. The continuing campaign by DEA directed at targeting small healthcare specialty providers who treat complex illness is an example of this contaminated environment. Not only is it destroying the capacity of the healthcare system to serve its sickest citizens, it is contributing to reactive legislation and regulation that cannot possible contribute to any kind of a system solution for directing resources appropriately.  It is based on lies, bad data, fear mongering, and the maintenance of structural inequities that assure the resources of the many are reserved for the few.

Terri Lewis PhD

We are feeding the bear of fear, but it’s not the bear we should be feeding.  The evidence for the feeding of hysteria is all around us. Structural deficits contribute in a large way to increasing deaths by overdose, drug poisonings, suicides even as scripts for legal prescriptions are reducing.  The volume of persons battling addiction is increasing even as communities are unable to fund appropriate services for treatment. Mental health and economic strain is directly reflected in mass gun deaths. 

Picking on sick people and the doctors who treat them is shooting at the wrong target and directing the wrong resources into these problems. We are done putting up with it.

We are done allowing anyone to make us feel afraid, invisible, powerless.

If you are a policy maker, you are accountable to us. We will have policies that serve us.

If you are a physician we will support you in the practice of your profession but only if you provide equitable services to all while seeking collaboration with your colleagues.  Our precious dollars will be focused on those who serve us.

If you are a lawmaker we expect your activities to open the door to ensuring the least among us are represented, served, and have access to participation. Our votes will be reserved for those who serve us.

If you are an educator, we expect you to arm yourself with the best science and research to groom the next generation of care givers and policy makers. We will be served by professionals with the knowledge and skills that lead effective community change.

If you are a consumer trapped in this nightmare, we will support you to develop the self-efficacy skills to work your way past this nightmare. 

But here’s what we won’t do. We won’t put up with this anymore.

We are DONE being invisible, powerless, silent.

Filed under: General Problems | Leave a Comment »

http://www.foxnews.com/us/2017/11/18/wwii-veteran-calls-for-help-and-dies-as-nurses-laugh-video-shows.html

A hidden video from 2014 showed nurses laughing as a World War II veteran repeatedly called for help and died while in their care.

The family of James Dempsey, 89, of Woodstock, Ga., hid a camera in the late veteran’s room in the Northeast Atlanta Health and Rehabilitation Center which captured the night he died.

The video showed the decorated WWII veteran repeatedly calling for help, saying he could not breathe. It also showed the nurses failing to take life-saving measures and laughing as they tried to start an oxygen machine.

Dempsey’s family sued the nursing home in 2014 following the veteran’s death. Dempsey’s family declined to comment on the video, citing a settlement with the nursing home, WXIA-TV reported.

The nursing home’s attorneys attempted to stop media news outlet WXIA-TV from getting the video but a DeKalb County Judge ruled to unseal the footage.

The nurses, including a nursing supervisor, Wanda Nuckles, told Dempsey’s family lawyers in the deposition that when she learned the veteran had stopped breathing, she rushed to his room and took over CPR, keeping it up until paramedics, WXIA-TV reported.

However, the secret video showed that nobody was doing CPR when she arrived, and she did not start immediately. After the attorneys showed Nuckles the video, she told them it was an honest mistake, based on her normal reactions.

When the attorney’s asked what Nuckles was laughing, she said she did not remember.

WXIA-TV reported the nursing home was told of the video in 2015 but did not terminate the nurses until 10 months later. Nuckles and another nurse did not surrender their licenses until this September when the Georgia Board of Nursing was sent a link to the video by the news station.

Two nurses surrendered their licenses in Sept. 2017.  (11 Alive)

Records showed the nursing home continued to have problems, including $813,000 in Medicare fines since 2015, WXIA-TV reported. It said the nursing home got a good inspection report in May, but still has Medicare’s lowest score, a one-star rating. The nursing home was currently still open.

Filed under: General Problems | 3 Comments »

www.nationalpainreport.com/figures-lie-and-liars-figure-why-the-demographics-of-the-so-called-prescription-opioid-crisis-dont-work-8834839.html

Anybody who reads a newspaper or watches evening news has heard the screaming headlines:  “60,000 Drug Overdose Deaths” (or similar numbers).  When reporters seek maximum sensationalism, we hear deaths by overdose summed over 10 years or compared to casualties in the Vietnam War.  500,000 drug deaths is a much more impressive number — even though it’s mostly hype.

Unfortunately for all of us – and for US public policy makers — such numbers misrepresent more than they illuminate [Ref 1].  Public policy concerning opioid addiction which is based on such inflated numbers will inevitably fail spectacularly, just as the “War on Drugs” did in the 1980s.

When we boil off the hype, we find that the “real” numbers of yearly deaths where a pain killer prescribed to a pain patient might have been involved is much smaller — like maybe 7,000 instead of 60,000 in 2016. About half of drug-related deaths don’t involve opioids at all (thousands of deaths from heart failure or liver toxicity are attributed to Ibuprofen or Acetaminophen).  Among the remaining 33,000 deaths last year, most involved multiple street drugs and alcohol – something we rarely hear except as a footnote. The drugs most often detected by county medical examiners in 2016 were illicit fentanyl, heroin, morphine stolen from hospital dispensaries and methadone diverted from community drug treatment programs.  So-called “prescription” drugs come in fifth – but many of those drugs weren’t actually prescribed to patients. [Ref 2-4] They were diverted to the street by theft from pharmacies and home medicine closets. Under prevailing CDC rules for mortality data collection, any death where an opioid is detected among other factors is labeled “opioid related” [Ref 5].  When Massachusetts traced opioid related deaths into their State prescription tracking database, only 8% of OD victims had a recent prescription.  When a reporter breathlessly reports deaths by “opioid overdose” without clarifying sources or types of drugs, they’re essentially committing journalistic fraud.

Richard A. Lawhern, Ph.D

We also hear tragic stories about young adults who overdose and die following a sharp descent into addiction.  Many of them, we’re told, start down this path by being prescribed opioid pain killers for a few days or weeks after a sports injury or automobile accident.  Without doubt, such stories are tragic and the families are devastated. The problem is that such stories aren’t representative or typical [Ref 4].

90% of drug addicts first begin abusing drugs and alcohol in their teens or 20s.  According to the National Survey on Drug Use and Health, “…75% of all opioid misuse starts with people using medication that wasn’t prescribed for them—obtained from a friend, family member or dealer.”  The typical new addict is a young white male with a history of family trauma, sustained unemployment, and mental health issues.  [Ref 6]

So who is the typical chronic pain patient?  According to the National Academies of Medicine, over 100 million US citizens now suffer moderate to severe pain.  Of these, an estimated 18 million are prescribed opioids during any given year, and perhaps 2.7 to 3.3 million will be managed on opioids for longer than 90 days.  [Ref 7]

Causes of long-lasting severe pain are multiple and complex.  Some chronic pain seems to emerge “of itself” for no presently understood reason, while other cases follow from injury or diseases.  It might not be helpful to imagine a “typical” pain patient, due to the multiple overlapping conditions involved.  However, broad trends are well known [Ref 8-9].

–       Back pain is the leading cause of disability in Americans under 45 years old. More than 26 million Americans between the ages of 20-64 experience back pain. Many other chronic pain conditions also affect older adults [Ref 8].
–       Women are more likely to experience pain than men (~60% vs 40%) and to experience more intense pain.  Likelihood of pain increases with age, with new cases reaching a plateau or decreasing after Age 60. [Ref 9]
–       Non-white and poor people experience more — and more severe — pain than well educated white elites.[Ref 9]
–       For certain types of painful disorders such as facial neuropathic pain, Complex Regional Pain Disorder or Fibromyalgia, the typical patient is a woman in middle age or later. [Ref 10, 11]

When the known risk factors for addiction are compared with statistics on chronic pain, it becomes clear that attribution of the US “opioid crisis” to over-prescription of opioid pain relievers is unjustified.  The great majority of addicts begin as male adolescents from troubled or disadvantaged socio-economic backgrounds – a population that is medically under-served.  Few teens will see a physician for pain severe enough to justify prescription of an opioid for longer than a few days, and most such visits involve dental surgery.  By contrast, a significant majority of chronic pain patients are women of middle age who have a very low risk of opioid addiction.

The demographics simply do not work.    

The contrasts between addicts and chronic pain patients are strongly reinforced by the few available studies of the long-term effectiveness and risks of opioid treatment for common pain conditions.  Not many of these studies have been conducted.  But one which stands out is a 2010 Cochrane Review [Ref 13].  Key results of this review are worth repeating here: “We reviewed 26 studies with 27 treatment groups that enrolled a total of 4893 participants….” “Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome….”

“Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare.” As a parenthetical note, we do not know in detail, the reasons for “discontinuance of opioid therapy due to inadequate pain relief”.  But one of those reasons seems likely to be under-treatment of people who poorly metabolize opioids. [Ref 12]

The President’s Commission on Combating Addiction and the Opioid Crisis released its report in early November 2017.  Although some aspects of the report seem positive, it is deeply flawed overall by its clinging to the false narrative that medically managed prescriptions in some way provide a “gateway” to addiction. Some of the Commission’s recommendations will almost certainly drive more physicians out of pain management practice and more patients into agony through desertion or denial of adequate medication. [Ref 14] Perhaps the only saving grace for chronic pain patients in the Commission report, is a recommendation for expansion and clarification of the 2016 CDC Guidelines on prescription of opioids to chronic pain patients.  If this project is approached honestly and led by pain management specialists instead of addiction psychiatrists, almost the entirety of the CDC guidelines must be thrown out and done over.  There is wide agreement among medical professionals that the published Guidelines are biased against opioid pain relief, scientifically unsupported and seriously incomplete [Ref 12].

Whether the US Government will permit the correction of its sorry record of distortions and mistakes in the so-called “opioid epidemic” remains to be seen.  But it is now clear that the demographics of addiction and chronic pain only marginally overlap.  Effective public policy cannot be based on the fiction that doctor-prescribed pills are the problem. Pill counting is not a viable solution [Ref 15].  Americans deserve pain management practices based on facts rather than sensationalism.

Filed under: General Problems | 2 Comments »