“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
New Hampshire’s chief medical examiner recently leased the state’s latest opioid overdose death totals for 2018. As in most of the country, prescription opioids are not propelling the death rate in New Hampshire. For the last several years, more and more non-medical users have been dying from heroin and fentanyl, with fentanyl accounting for more than 83 percent of overdose deaths in the Granite State.
But you won’t hear about the Fentanyl crisis, because all anyone seems to talk about is the opioid crisis. It’s a false narrative which holds that the serious number of overdoses nationwide is the result of greedy drug makers manipulating gullible doctors into overtreating patients in pain and hooking them on drugs.
And even then, it’s not Fentanyl that’s at the root of our nation’s overdose problems. The real source of our woes is drug prohibition.
The fact is, the overdose crisis has always been primarily the result of non-medical users accessing drugs in the dangerous black market that results from prohibition. As the supply of prescription opioids diverted to the underground gets harder to come by, the efficient black market fills the void with other, more dangerous drugs. Lately, the synthetic opioid fentanyl has emerged as the number one killer. The DEA reports that the overwhelming majority of seized fentanyl is “illicit fentanyl” — fentanyl made in a powdered form (unlike prescription grade fentanyl) in underground labs in Asia and Mexico and smuggled in often by mail, Fedex, or United Parcel Service. This drug is 50 times more potent than heroin. Some fentanyl analogs designed by inventive drug dealers are even more powerful than that.
Drug prohibition fuels this lucrative enterprise. Prescription surveillance boards and government-mandated prescribing limits have pushed prescribing down dramatically. High-dose prescriptions were down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year. But the overdose rate continues to climb. Estimates place the 2017 overdose rate related to opioids at 49,000 deaths.
Moreover, the black market for drugs is full of dangerous uncertainty. Dealers with pill presses turn the powder into counterfeit prescription pills and sell them to unsuspecting users—sometimes to desperate patients who’ve been cut off from their pain meds by doctors terrorized by surveillance boards—causing them to asphyxiate from an overdose. That’s what happened to Prince. He liked to use Vicodin (hydrocodone) to get high. Records show he never went to a doctor for a prescription. His dealer scored him some counterfeit Vicodin that turned out to be fentanyl. Prohibition killed Prince, not prescription opioids.
There is a stark difference between the U.S., with its strict prohibition, and other countries which have liberalized drug policy. Portugal, in 2001, recognized that prohibition was driving the death rate. At the time it had the highest overdose rate in Western Europe. It decriminalized all drugs and redirected efforts towards treatment and harm reduction. Portugal saw its population of heroin addicts drop 75 percent, and now has the lowest overdose rate in Europe. It has been so successful that Norway is about to take the same route.
If the political will is not yet there to consider decriminalization, then at a minimum policymakers in the U.S. should turn to harm reduction. They should expand syringe exchange and supervised injection facilities, lighten the regulatory burden on health care practitioners wishing to treat addicts with medication-assisted treatments such as methadone and buprenorphine, and reschedule the overdose antidote naloxone to a truly over-the-counter drug.
It’s time to stop calling it an “opioid crisis.” The term is misleading. One particular opioid, fentanyl, is the primary killer. But even calling it a “fentanyl crisis” would be inaccurate. The real killer is prohibition.
We have reported on the causes and effects of the opioid epidemic for several years — interviewing government whistleblowers, doctors, and Americans who’ve grown dependent on the powerful pain pills. We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and its federal regulator, the Food and Drug Administration, which he says opened the floodgates on the crisis with a few little changes to a label.
Ed Thompson: The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.
Bill Whitaker: The FDA ignited this opioid crisis?
Ed Thompson: Without question, they start the fire.
Ed Thompson speaks with correspondent Bill Whitaker
Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used “short-term.” But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.
Ed Thompson: So this is what a package insert looks like.
Bill Whitaker: Wow
The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for “daily, around-the-clock, long-term… treatment.” And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.
Ed Thompson: A drug’s label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.
Bill Whitaker: How so?
Ed Thompson: Because it allows you to then promote the drug based on the labeling.
Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It’s made him a rich man. But now he’s putting his livelihood at risk. He’s doing what no other drug maker has ever done, he’s suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.
“There are no studies on the safety or efficacy of opioids for long-term use.”
Thompson is challenging the FDA to start with his newest opioid. It’s Thompson’s creative way to sabotage the system. He may lose money rolling out his new drug, but if he is successful, it would set a precedent. Other manufacturers would be forced to change their labels and limit their marketing.
Bill Whitaker: A decision going in your direction could pull down a multi-billion-dollar industry.
Ed Thompson: Correct. Probably somewhere between $7 and $10 billion a year would come off the market. We made a decision to stop selling snake oil to U.S. citizens in 1962.
Bill Whitaker: Snake oil?
Ed Thompson: Yes, sir. You’re using high-dose, long-duration opioids when they’ve never been designed to do that. There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.
Brandeis professor Dr. Andrew Kolodny is one of the country’s most-recognized addiction specialists and has been an expert witness in litigation against Big Pharma, including Purdue, the maker of Oxycontin. He has been trying to get the FDA label changed since 2011 to make clear opioids are not for everyone.
Dr. Andrew Kolodny
Dr. Andrew Kolodny: These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you’re taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect. In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.
Bill Whitaker: That sounds exactly like heroin addiction.
Dr. Andrew Kolodny: It’s essentially the same drug.
To understand how this began we traveled to this small courthouse in Welch, West Virginia, where we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state’s lawsuit against Purdue for deceitful marketing.
60 Minutes got a court order to obtain these documents. They reveal it was at those secret meetings the FDA bowed to Purdue Pharma’s demands to ignore the lack of scientific data, and changed the label to, “around the clock…for an extended period of time.”
Ed Thompson: I can’t think of anything more harmful taking place that took place then. It opened the floodgates. It was the decision of no return for the FDA.
Purdue told us Oxycontin always was approved for long-term use. But an internal document shows the company was jubilant about the labeling change. Quote: “The action by the FDA…has created enormous opportunities” to expand the market. The drug company’s ads soon extolled the virtues of Oxycontin’s effectiveness and sales tripled.
Dr. David Kessler: It was a marketing tsunami. And the agency didn’t catch it.
60 Minutes has called on former FDA commissioner David Kessler many times for his expertise on drug safety issues. He ran the FDA in the 1990s when Oxycontin was first approved, but he left before the labeling change. Today, he’s been retained by cities and counties suing Big Pharma for the opioid crisis. After reviewing the documents we obtained, and checking on his own, he says changing the label to long-term use was a mistake.
Dr. David Kessler: There are no studies on the safety or efficacy of opioids for long-term use.
Bill Whitaker: But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.
Dr. David Kessler: That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.
The label change was a blank check – one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.
Bill Whitaker: Let me remind you of some of the words that you have used to describe the pharmaceutical industry, your industry.
Ed Thompson: Yeah?
Bill Whitaker: Corrupt.
Ed Thompson: Yeah.
Bill Whitaker: Immoral?
Ed Thompson: Yes.
Bill Whitaker: Depraved?
Ed Thompson: Yes. They’re appropriate for the behavior that’s taken place.
Bill Whitaker: You are a drug executive. You manufacture drugs.
Ed Thompson: Many drugs.
Bill Whitaker: Are you at fault in this epidemic in any way?
Ed Thompson: I wish I was smart enough to have seen this epidemic before– before I got three or four years into it. Absolutely. But once you find out that it’s not correct, you have to do the right thing. Is there anything more important?
Emily Walden: My son wanted to fight for his country. His country failed him.
If there is one victim who confirmed for Ed Thompson that turning on his industry was the right thing to do, it was Emily Walden, who would become an unlikely ally. Thompson manufactured an opioid oxymorphone. The same drug that took the life of Walden’s son TJ, a private in the Kentucky National Guard.
Emily Walden: He was getting ready to be deployed to Africa and a few weeks prior to that he went on a camping trip with a group of friends and a police officer knocked on my door the next morning telling me that he had passed away.
Tj had grown addicted to the drug and was easily able to get it without a prescription. Walden went to Washington, D.C. to ask the FDA why her community was being flooded with pain pills. It was there she met Ed Rhompson.
Bill Whitaker: What did you say to him?
Emily Walden: “You manufactured the drug that killed my son.”
Bill Whitaker: He is now on your side.
Emily Walden: Yes.
Bill Whitaker: That just seems like an odd connection.
Emily Walden: It is. But Ed might be my only hope in getting this fixed. The FDA’s responsibility is public health and the safety of drugs, and they’re not doing their job. They haven’t been doing their job for 20 years.
Dr. Andrew Kolodny agrees. The Brandeis addiction specialist began his own investigation into why the FDA would approve the long-term use of opioids when there was no credible science to back it up.
Bill Whitaker: What did you find?
Dr. Andrew Kolodny: We found out that a group of experts and FDA and pharmaceutical companies were having private meetings and at these meetings, changing the rules for how opioids get approved.
He filed Freedom of Information Act Requests. In email after email between the FDA, Big Pharma and consultants, he learned of closed-door meetings at luxury hotels, like this Four Seasons in Washington, DC, where for $35,000 a piece, drug makers paid consultants to, “sit at a small table with the FDA,” “hobnobbing with the regulators.” Emails show one participant worrying it might be seen as “pay to play.”
Dr. Andrew Kolodny: They had drugs in their pipeline, pain medicines that they wanted approved. And through these meetings, they were able to get those products on the market.
Bill Whitaker: That sounds unethical.
Dr. Andrew Kolodny: It is unethical.
Bill Whitaker: If not illegal
Dr. Andrew Kolodny: If it’s not illegal, it should be illegal.
Equally suspicious but legal, the large number of key FDA regulators who went through the revolving door to jobs with drug manufacturers. The two medical officers, who originally approved Oxycontin, Curtis Wright and Douglas Kramer, went to work for the opioid maker, Purdue Pharma, not long after leaving the FDA.
Dr. Andrew Kolodny: The culture at FDA continues to be much too cozy with the industry it’s supposed to be regulating.
The agency bills drug companies more than $800 million a year in fees and depends on that industry money to pay the salaries of staffers who not only changed the opioid label, but also review new drugs like Dsuvia, the most powerful opioid pill ever approved.
Dr. David Kessler
Bill Whitaker: Just a few weeks ago the FDA approved a new opioid that is 1,000 times more powerful than morphine. And this is in the middle of this opioid epidemic. How is that possible?
Dr. David Kessler: I don’t get it. I get your question; I don’t get the agency’s action.
Bill Whitaker: Isn’t the FDA supposed to be our watchdogs to protect us?
Dr. David Kessler: How many people do you think were working in a division that oversaw promotion or when this epidemic started to occur?
Bill Whitaker: I have no idea.
Dr. David Kessler: Five.
Bill Whitaker: When I’m looking at the carnage in American towns and cities, that just doesn’t seem like a good excuse to me.
Dr. David Kessler: It’s not an excuse. It’s the reality. You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it.
Current FDA commissioner Dr. Scott Gottlieb declined our request for an interview but, in a statement said, “the FDA has taken aggressive steps to confront the crisis,” but he admitted “many mistakes were made along the way… While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those who should have acted sooner.”
Bill Whitaker: You say they have to do things to fix the label. The label has been in place since 2001. I– I’m not a scientist, but that doesn’t seem like that’s that hard to do.
Dr. David Kessler: And it needs to be done.
Ed Thompson: We got a real problem here.
Ed Thompson isn’t waiting. He has now joined a growing movement of doctors, lawyers, and patient activists who want Big Pharma to kick its addiction to opioid profits. That’s why he made the decision to take on his industry and the FDA.
Bill Whitaker: If you succeed, you could pull down a multibillion-dollar industry.
Ed Thompson: And if I fail, you’re gonna have ever-increasing deaths every day as well. It’s a pretty good decision, isn’t it?
Hi. Just want to let you know that patients of Dr Lesly Pompy have started suing the DEA over their medical records being illegally obtained during the raid on Dr Pompy’s office on 9/26/16. Unable to find a lawyer to take the case, the patients are representing themselves. A hearing was just held and the cases were consolidated and the case moves forward. More people are filing. Should be up to 23 filing by next week. Not sure if you want to do a story on this or follow what is happening with the case. Thank you for your time,
According to this pt, no attorney wants to DEAL WITH THE DEA… it is almost like they have DIPLOMATIC IMMUNITY… maybe it is because the legal profession is just one BIG LEGAL FRATERNITY and you don’t attack a fraternity brother ?
It is claimed that about 40% of Congress are ATTORNEYS… does that explain a lot about how no one can get their attention about illegal imported Fentanyl being the primary reason behind OD’s. More “fraternal protection” ?
It has been only in the last couple of years … now that more and more cops are wearing body cameras that a few cops have actually been charged/convicted for some of their actions where a private citizen …. ends up dead or seriously injured.
It would appear that those 100 million chronic pain pts in this country are on their own and no part of our bureaucratic system is going to help/protect you. It looks like Robert Rose (https://sickofsuffering.com/ ) and this group of pts are moving in a direction that all chronic pain pts who are being abuse are going to have to take.
Start filing complaints with the appropriate agencies (Board of Pharmacy, Board of Medicine, state ADA .. etc…etc) and this is one of those situations where SIZE MATTERS… a few complaints will be discarded/ignored because they will presume that it is some substance abuser that is unhappy because they couldn’t get their next fix/high… Start filing complaints in the courts. How many more pts have to end up being bed/chair/house confined because their meds have been cut or pushed to suicide as the only solution they have to end their unrelenting intractable chronic pain.
LAS VEGAS – Despite their influence and stature, Nevada physicians are not overtly political, but it looks like doctors are planning to make their presence known at the Nevada Legislature this year.
Monday is designated as doctor day at the legislature, where physicians and medical organizations hope to make an impression on lawmakers.
One issue at the top of their list of concerns is the regulation of pain management, which doctors say has become burdensome for them and deadly for their patients.
Hours after being released from a month-long hospital stay, Theresa Hatter told the I-Team about the moment she was first diagnosed with arachnoiditis.
“I couldn’t see. It was the worst pain I ever had. If you were saying pain on a scale of 1 to 10, I was at a 15,” Hatter said.
For 16 years, she was a model patient in pain management. Opioid medication was her only relief. Then out of the blue, her doctor told her goodbye and good luck.
Reporter George Knapp: “With pain medication you had a life?”
Theresa Hatter: “I had a life.”
Reporter George Knapp: “And now you don’t?”
Theresa Hatter: “I’m in bed.”
In the 90s, Tracy Davis was shot in the back. The bullet ripped through his stomach and lung and is still inside, until recently his insurance paid for pain medication. But then the culinary union plan ordered his doctor to cut the meds in half.
Reporter George Knapp: “Someone decided you don’t need it?”
Tracy Davis: “Yes. They never even ran a test on me.”
Across the country, the great opioid crackdown continues. Doctors have been pressured into cutting or eliminating pain medications against their own medical judgements. Insurance companies have cut or eliminated coverage. Pharmacy chains have imposed their own — often severe — limitations or requirements.
Doctors like Maurice Gregory are squeezed by regulators, lawmakers, insurance executives, and pharmacists, none of whom have examined the actual patients.
“This anti-opiate has gotten to the extreme of sacrificing people’s lives,” said Dr Maurice Gregory, Las Vegas physician. “We are already sacrificing people’s quality of life.”
Opioid prescriptions are now at their lowest point in 15 years, but overdose deaths are at their highest in that same time. Cutting medications for legitimate pain patients has had no effect on addicts’ overdosing.
What it has done is to create suffering for millions of people whose mistake was they got sick or injured and are now expected to live the rest of their lives in pain.
“You can live 30, 40, 50 years with these diseases. The only thing you can do for them is control the pain. There’s no reason, why would we not want to do that,” said Terry Murphy, public policy consultant. “And yet we are taking medication away from them and forcing them to live in torture in America in 2019. Why?”
Murphy has had multiple surgeries and was a pain patient herself. Now, she is helping Nevada doctors to mobilize. Murphy and others including medical associations are gearing up to make their presence known at the Nevada Legislature. Among the goals is to get a handle on changes imposed two years ago which give pharmacists the ability to deny or alter prescriptions or to make excessive demands for patient information or new tests.
“These decisions need to be made between a doctor and a patient and what is happening is between a doctor, a pharmacy benefit manager, a pharmacist, an insurer, and the patient gets lost in that equation and the doctor who really wants to help the patient is frustrated,” Murphy said.
While doctors here feel under the gun, Murphy says Nevada is already less draconian than some states. She thinks that pending legislation could make Nevada into a model for the rest of the country, with appropriate safeguards, but also something missing from the system — compassion.
It sounds like from this report the Nevada state legislature has turned the Medical Licensing Board into a PAPER TIGER. The legislature has apparently granted about anyone that has something to do with the healthcare system in Nevada the legal right to practice medicine. Don’t have to have a medical degree, don’t have to do a in person physical exam/evaluation… just create some personal or corporate “cookie cutter policies” that can be applied to EVERYONE.
I guess that the DEA could care less that controlled meds are being started, changed, stopped without the person – or corporation – doing it has done a in person exam/evaluation – as required by the Controlled Substance Act 1970.
The vast majority of the people who have a legal medical necessity for controlled meds are covered by the Americans with Disability Act.. so where are the civil rights attorneys or organizations. Nevada has 3 + million people so average stats would suggest that there are abt 300,000 intractable chronic pain pts in the state and another 700,000 or so dealing with some sort of chronic pain and at least on occasions have the need to have a opiate to get their pain under control.
Are these legislators believing the FACTOIDS that are being thrown around they are meaningful ? Are these FACTOIDS drowning out the REAL FACTS that have no relationship to those FACTOIDS ?
TOMS RIVER — An admitted drug dealer who was caught with about 4,150 doses of heroin worth $25,000 was sentenced to just six months of rehab and five years of probation.
Gary Fox, 30, of Toms River, who has a criminal record that includes previous drug convictions, avoided prison by being accepted by Drug Court and pleading guilty to two counts of third-degree possession with intent to distribute and a count of possession.
Fox, however, does face an alternate prison sentence of 10 years in prison with 3 1/2 years of parole ineligibility if he fails to complete the Drug Court program, according to a spokesman for the Ocean County Prosecutor’s Office, who added Wednesday that the sentence was not a result of a plea deal with prosecutors.
The Drug Courts, part of Gov. Chris Christie’s reform efforts in the wake of a massive heroin addiction epidemic gripping the state, are meant to provide drug users with rehabilitation instead of placing them behind bars. Drug Courts, however, are not for violent or hardened criminals.
The courts found Fox eligible for the program and he began rehab in November, remaining in custody until his guilty plea in January, prosecutors said. Court records show he spent 168 days in county jail.
Toms River police arrested Fox in May, saying he had 80 wax folds of heroin and $740 in cash. A search of his storage unit found an additional 83 bricks of heroin, which amounted to 4,150 doses and a cash value of close to $25,000, police said at the time.
A month later, police at his Old Street home found another 40 wax folds of heroin, more than 1.5 pounds of marijuana, $2,000 in cash, prescription medications, a scale and packaging materials.
Fox was initially charged with possession of heroin, possession of heroin with intent to distribute, possession of over 50 grams of marijuana, possession of marijuana with intent to distribute, possession of Alprazolam and Suboxone, and possession of drug paraphernalia.
He plead guilty to two counts of third-degree possession with intent to distribute and one count of possession.
Police on Tuesday said they could not provide more details about the investigation.
This is not the first time Fox has been sentenced to rehab as a result of drug charges.
In 2009, he received the same sentence from a different judge in Ocean County for arrests in 2006 and 2007 on charges of possession of cocaine and Percocet.
Fox was represented by the Public Defender’s Office.
