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US senator is urging federal agencies to limit the use of a prescription version of the powerful painkiller fentanyl, going so far as to say the government may be helping to fuel the ongoing opioid epidemic by failing to more aggressively police its use.

Edward Markey, a Massachusetts Democrat, sent letters Tuesday to the heads of two federal agencies in response to a STAT article detailing the death of a 32-year-old woman who overdosed on the prescription form of fentanyl called Subsys. The drug, which is sold by Insys Therapeutics, is approved only for use in cancer patients suffering from sharp bouts of previously untreatable pain.

The woman, Sarah Fuller, who overdosed while taking Subsys, did not have cancer. She was prescribed the drug “off-label” for chronic neck and back pain stemming from two automobile accidents as well as painful fibromyalgia, according to her family. The government insurer, Medicare, paid $250,544 for a 15-month supply of Subsys prescribed to Fuller, billing records show.

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“By reimbursing prescriptions for improper off-label use of Subsys, CMS appears to be contributing to the opioid abuse epidemic, rewarding Insys for its wrongdoing, and costing taxpayers millions of dollars,” Markey wrote to Andy Slavitt, the acting administrator for the Centers for Medicare and Medicaid Services.

Medicare is paying for “tens of millions of dollars in Subsys prescriptions that may have also led to the overdose deaths of people who should never have received the drug in the first place,” Markey wrote. Medicare paid $30 million for Subsys in 2013 and then $97 million just a year later in 2014, according to Markey’s letter.

A Medicare spokesman said the agency would respond directly to the senator.

The senator said he was concerned prescription use of fentanyl may be adding to the country’s opioid problem. Much of the fentanyl abused in the United States is produced illicitly in China and then funneled into the country by Mexican drug cartels. It has quickly replaced heroin and other prescription painkillers as the leading cause of fatal opioid overdoses in some regions of the country.

“Fentanyl prescribed by physicians, and in many instances paid for by Medicare, now appears to be contributing to the epidemic,” Markey wrote.

He alleged that Insys has “aggressively and illegally pushed this off-label prescribing” of Subsys.

Insys did not return messages requesting comment.

Markey also wrote to Robert Califf, the commissioner of the Food and Drug Administration, to urge that agency to “reign in any improper and dangerous marketing and promotion of off-label use” of Subsys.

He asked the FDA to provide him with any steps it has taken in response to Insys’s off-label marketing of Subsys.

An FDA spokeswoman said the agency would respond to the senator after reviewing his letter. She added the agency is “deeply concerned about the opioid epidemic” and working on a number of steps that are part of the FDA’s opioid action plan.

Subsys, which is sprayed under the tongue, is part of a special FDA program designed to mitigate the risk of prescription fentanyl products. Doctors cannot prescribe Subsys unless they are enrolled in that program and successfully pass a test about the appropriate use of the drug and the risks of it being abused.

Markey asked Califf how the off-label use of Subsys was consistent with the agency’s program designed to limit the abuse of prescription fentanyl. He also asked Medicare to provide him with more information, including whether the agency is taking any steps to make sure it is not paying for any inappropriate prescribing of Subsys.

While doctors are allowed to prescribe drugs for off-label conditions, drug makers aren’t permitted to promote medications for these purposes. Insys, based in Chandler, Ariz., is under investigation by several state attorneys general and federal prosecutors for the marketing of Subsys, according to disclosures made by the company. An Insys sales rep in Alabama and a nurse in Connecticut have pleaded guilty to federal kickback charges related to off-label Subsys prescribing.

In the case of Fuller, her father said an Insys sales representative was present in the doctor’s office when his daughter was first prescribed Subsys.

Sarah Fuller started on the drug in January 2015. She was delivered 30-day supplies to her house by FedEx. She died on March 25. A toxicology report detected fentanyl in her blood at 15 to 20 times the therapeutic level and well above rates considered lethal.

Subsys is the only brand-name drug Insys sells. In 2011, the year before it hit the marketplace, Insys was operating at a loss with no reported revenue. Last year, company revenues were $330 million, and it reported a profit of $58.5 million.

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  • The off-label system clearly does not keep patients safe. It also makes certain medications unavailable to patients who legitmitely need them and suffer tremendously without them.

  • Good job, Kim. I wrote my piece but got a message that I was commenting too quickly. That’s very strange. I only made one comment. Nevertheless, I tried. Good to hear from you; I’ve been very ill and out of our groups for quite some time.

  • It is important to realize their are currently three analogs of fentanyl that are either street manufactured or in no way prescribed by a physician. These analogs are being blamed for many overdoses as they are being found in heroin, as well as pills designed to look like hydrocodone, Oxycontin, and Xanax. This “fentanyl” is NOT the fentanyl that comes from a legitimate medical source.

    The agencies in charge of how much pain medication chronic pain patients are being prescribed and even how much opioid medication can be produced by pharmaceutical companies, are reacting as this Congressman; limiting a source of opioids that will in no way improve the opioid “epidemic”. By continuing to restrict adequate pain treatment of chronic pain patients, the DEA, CDC, Congress, the President and even the media are driving up suicide rates of those whose pain is no longer being treated and their quality of life is next to non existent.

    The so called “opioid epidemic” is still alive and raging due to the continued attack of the wrong supply of opioids, while chronic pain patients are suffering needlessly. There is no way stopping me from being in chronic pain will keep addicted individuals from consuming elephant tranquilizer (Carfentanil), heroin or any of the street manufactured fentanyl analogs being sent by the boatload from China that are flooding the US and Canada. It’s past time to realize kicking this dead horse is not working because the entirely wrong group of people and medications are being reacted to. This has no hope whatsoever of stopping the actual problem, street drugs.

  • This is just barbaric what our government and the DEA are doing to innocent law abiding chronically ill citizens who suffer from debilitating incurable conditions that cause severe pain. The government has used propaganda BS to spread their lies about a made up opiod epidemic, There is a heroin problem but its not coming from pain pts and our drs! The DEA is continuing to restrict lifesaving pain medication from those who truly need these meds as a life neccessity!! For god sake legitimate pain pts are being forced to the streets for relief or worse suicide! There has been a huge deceease in legally prescribed opiods, as more and more pain pts are having their meds lowered to ineffective doses or abruptly stopped sending many into shock, seizures and what coukd be deadly withdrawal. What would happen if we stopped a diabetic from getting insulin!?!? Denying lifesaving pain medication to the suffering is torture and that is a crime!! The DEA and government have the blood of many on their hands, the blood of every pain pt who took their life to end the pain, Our healthcare system is a disgrace, the DEA continues to target any dr who continues to give pain meds to legitimate pain pts, leaving us nowhere to go. Our vets who fought for this country, come home wounded are being neglected and denied pain medication, senior citizens whose bodies are over ome with unbearable pain are denied pain medication, people of all walks of life who are suffering from debilitating incurable conditions are denied pain medication, going in for major surgery? Dont do it, you will only be given three days worth of postop pain medication! forcing you to suffer! If you are in pain and go to an ER, you are treated like a drug addict and told to leave, denied medical treatment and treated like a criminal, drs are turning their backs on the chronically ill in fear of the DEA. What kind of country do we live in that allows human beings to be tortured!?!! Enough with these politicians who are as corrupt as they can be, they dont feel my pain, i bet half of the corrupt politicians are on some form of medical including pain medication! But they all have their private drs and pharmacies in their back pockets, bought and paid for, no hoops for them to jump thru, no degrading, no drug tests, or surprise pill counts, I am sick and tired of paying the price with my health and overall well being because of those who choose to abuse and the witchhunt the government and DEA are continuing to do, war om drugs is a war/attack on pain pts, enough is enough!

  • To begin with, there is no opioid epidemic. The current “epidemic” is based on faulty and falsified studies — and completely ignores the chronic pain pandemic. Lies are promoted heavily through the media, equating addiction with pain management. Fewer than 2% of all chronic pain patients become addicted. If you think that reducing both manufacturering and the prescribing of opioids is going to change the addiction numbers, you’re fooling yourselves and obviously drinking the koolaid served by the DEA, CDC, FDA, the US Surgeon General, PROP and Andrew Kolodny. In doing so, you are CAUSING an escalation in overdose deaths, heroin deaths, and suicides by chronic pain patients who are being thrown under the bus by a heartless, brainless system.

    Secondly, why are you pretending to be so concerned about “off-label usage”? Every day, thousands of patients (including pregnant women!) are injected with Depo-Medrol and/or Kenalog, both with clear contraindications for use in the spine. Daily, patients are being crippled by this “safe” procedure that has resulted in arachnoiditis and other damage in thousands of patients. We’ll probably never know the true number, because arachnoiditis is usually deliberately mis-diagnosed due to its iatrogenic nature. You doctors protect yourselves, not your patients, then deny them pain relief for the incurable, degenerative condition you have set in motion.

  • I understand that in this case, yes, this was a prescribed medicine for a patient that did harm. But honestly, this is actually rare. While for some reason, there is a concern about ‘cancer pain’ versus ‘non cancer pain’ in the real world, pain is pain and it doesn’t distinguish between cancer and non cancer. Many patients are prescribed these medicines and have no adverse effects and no addiction. They take them responsibly, and don’t mix alcohol and other drugs with them. In Fuller’s case, from the little information that was released, it appeared that she overdosed from the medicine along with Xanax, and no mention if the Xanax was prescribed or not. Either way, the Fentanyl patches do have different dosing, and they are often time released. The idea that ‘off labeling’ in this case is ‘bad’ is erroneous, as pain is pain, and with most chronic pain conditions, there are limited alternative therapies. This kind of Fentanyl is different, because it’s a sublingual spray. Now Fentanyl is not necessarily a ‘bad drug’. It has to be dosed appropriately, and frankly is mostly reserved for patients that are NOT ‘opiate naive’. In that, they have taken opioid analgesics before. The patch forms of Fentanyl are safe, as they are trans dermal, and release the medicine slowly over time. Addicts who abuse these scratch off the patch and melt it and then inject. Hardly the way an actual chronic pain patient would EVER take their medicines. Going back to this sublingual form, it is a strange issue that perhaps Fuller didn’t properly administer the dose, and more than likely didn’t realize how much she was spraying. Fentanyl is designed to be potent at lower doses, hence, why there isn’t as much of a need to take very high doses because it is so potent at the lower doses. In other words, very little can still be greatly effective compared to other opioid medications. My belief is that Fuller was not properly administering the dosages and sprayed too much, not understanding that Fentanyl is administered in low doses because it’s so potent, and there’s no need to really take exceedingly higher doses. In other words, unless the Subsys has no dosing measurement tool to administer the medicine,which is unlikely, the sad reality is that the blame is squarely on her shoulders as she administered too much of the spray and ended up overdosing, and since she included the Xanax, this potentiated the CNS depression and effects on her breathing. The point to be taken from here is that, because one person did not follow directions , there is NO need to limit use of this life saving medication. For every Sarah Fuller, there are literally MILLIONS of pain patients who take these medications responsibly and do not abuse or misuse them. This continuing oppressive nature of legislators continuing to place blame on the manufacturers and these medicines instead of the people who did it to themselves continues to harm legitimate and INNOCENT pain patients who rely on these medications. They too either have cancer pain and non cancer pain which are the SAME. People have formulated strange perceptions about this, especially about treatment. As if simply doing physical therapy can take away all their pain so there’s ‘no need for those medicines!”. Which of course is also quackery and ignorance. Many pain patients, many of whom also have inoperable, and limited treatment options are already suffering due to these misunderstandings and ignorance of these medications. I understand these legislators want to ‘save the People from themselves’, but frankly, they’re not. They’re creating a culture of lack of responsibility and as much as they say these actions ‘will not affect those who use them responsibly’ that is a blatant lie. Even if they believe so, it doesn’t end up working that way. Because myself, or another person, another patient will continue to be treated as if we cannot follow directions and act responsibly…so we must endure the punishment and torture of our painful lives because sadly, one person over dosed. Do we now start to take away everyone’s Driver’s Licenses because that person over that decided to drink and drive?? Do we not allow you to buy your liquor and cigarettes because they kill people and are addicting?? No. Well then why do you follow that line of thinking with people’s MEDICINES of all things??? These are their medications, not sandwich ingredients for Pete’s sake! Get a grip , please. And learn to understand how not to make everyone else pay for the misdeeds of others. I do not want to live in an America where you all condone and accept this slippery slope.

  • There is a difference when a patient using a drug prescribed for him or her in the prescribed dosage that is monitored monthly by urine testing and examination than those that misuse the drug to escape from the problems of life. There are millions if not billions of people that are suffering due to the fact that their pain medicine has been discontinued or the dosage has been cut not for any medical reason but because the pressure by the government is so intense that doctors are now afraid to do what is right and humane. Our democracy is going away and being replaced by a dictatorship!!! Is this what we really want? Most people at some time in their lives will experience severe pain either Chronic or Acute in their lifetimes and they should not have to suffer needlessly. Who is going to support all these people that may be able to work with proper pain treatment but are now forced to retire or go on disability especially since many Americans have little or no savings due to the fact that incomes have not kept pace with the cost of living!!! What kind of deficit do we want to leave for future generations?

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