Bureaucrats trying to get FDA to remove some/many/all opiates from the market ?

Senator Manchin has tried a number of times to get a FEDERAL TAX ON PHARMA OPIATES and each time he has FAILED and WV just reached a settlement with the major drug wholesalers for 400 million dollars https://www.foxbusiness.com/economy/west-virginia-reaches-400-million-settlement-opioid-distributors

It is pathetic how they use the English Language…  they talk about less opiate Rxs and then in the next sentence they talk about DEATHS TIED TO THE MEDICATIONS – they didn’t say “deaths tied to opiate medications” and then they get to the next sentence with the statement that “STUDIES SUGGEST “.   I would bet that a study could be done that would SUGGEST that people that die in motorcycle accidents started out riding bicycles.

Should our government make decision that could affect the lives and quality of life of tens of millions of our citizens based on a study that SUGGESTS a particular outcome.  The CDC, has stated that there is an estimated 15,000/yr deaths from the use/abuse of NSAIDS…  Each year 100,000 die from the use/abuse of the drug alcohol and 450,000 die from the use/abuse of Nicotine and neither of these meds have a valid medicinal use. Maybe because there is a very healthy tax revenue stream attached to those two “drugs”.. is the reason that – as a society – we accept all those deaths ?

Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year. And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.

‘We still have a really huge problem’: FDA’s promised ‘sweeping’ opioid review faces skeptics in Congress and among patient advocates

https://www.marketwatch.com/story/we-still-have-a-really-huge-problem-fdas-promised-sweeping-opioid-review-faces-skeptics-in-congress-and-among-patient-advocates-01659135675

Senate Democrat Joe Manchin of West Virginia says he requested an update in April on the FDA’s progress toward policy recommendations but didn’t receive a response

As U.S. opioid deaths mounted in 2016, the then-incoming head of the Food and Drug Administration promised a “sweeping review” of prescription painkillers in hopes of reversing the worst overdose epidemic in American history.

Dr. Robert Califf even personally commissioned a report from the nation’s top medical advisers that recommended reforms, including potentially removing some drugs from the market. But six years later, opioids are claiming more lives than ever, and the FDA has not pulled a single drug from pharmacy shelves since the report’s publication. In fact, the agency continues putting new painkillers on the market — six in the last five years.

Now Califf is back in charge at the FDA, and he faces skepticism from lawmakers, patient advocates and others about his long-promised reckoning for drugs such as OxyContin and Vicodin, which are largely blamed for sparking a two-decade rise in opioid deaths.

“All the concerns that we had at the time on opioids are still there. We still have a really huge problem,” said Richard Bonnie, a University of Virginia public health expert who chaired the committee that wrote the report.

Bonnie and his co-authors say the FDA seems to have incorporated several of their recommendations into recent decisions, including a broader consideration of a drug’s public health risks. But they say there is more to be done.

In an interview with the Associated Press, Califf said a new internal review of opioids has been underway for months and that the public will soon “be hearing a lot more about this.” While the review will look at past FDA decisions, Califf suggested the focus will be on future policy.

“It seems like people love sort of looking back and fault-finding, but I’m much more interested in learning so we can go forward and make the best decisions for what we need to do today,” said Califf, who split his time between Duke University and working for Google after leaving the FDA in 2017 following President Donald Trump’s election.

The 453-page report issued five years ago this month by the National Academies of Sciences laid out a strategy for reducing overprescribing and misuse of opioids, with particular focus on the FDA.

From the archives (June 2017): Opioid addiction diagnoses rose nearly 500% in the last seven years

At the center of the recommendations was a proposal for the FDA to reassess the dozens of opioids being sold to determine whether their overall benefits in treating pain outweigh their risks of addiction and overdose. Those that don’t should be removed from the market, the group said.

The lack of swift action underscores the glacial pace of federal regulation and the legal obstacles to clawing back drugs previously deemed safe and effective.
“It’s really hard for the agency to get a drug taken off the market once it’s been approved,” said Margaret Riley, a University of Virginia food and drug law professor who consulted on the report.

Last year, U.S. overdose deaths soared to a record of 107,000, driven overwhelmingly by fentanyl and other illegal opioids.

‘The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs.’

— Margaret Riley, University of Virginia

Opioid prescriptions have fallen about 40% in the last decade amid restrictions by hospitals, insurers and state officials. But deaths tied to the medications remain at 13,000 to 14,000 per year. And studies suggest people who become addicted to opioids continue to start with prescription opioids, before switching to cheaper heroin and illegally made fentanyl.

Dr. Robert Califf gathers his documents at the adjournment of a committee hearing on his nomination as commissioner of the Food and Drug Administration. AP/Manuel Balce Ceneta/File

“If Dr. Califf is serious about addressing the drug epidemic, the FDA should immediately implement” the report’s recommendations, Sen. Joe Manchin of West Virginia said in a statement.

Manchin told the AP that he requested an update in April on the FDA’s progress on the recommendations but didn’t receive a response. He was one of five Democrats from hard-hit opioid states who voted against Califf’s confirmation in February.

In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some which predated the report. The agency said it has acted on “nearly all” of the recommendations, by enhancing prescriber education and labeling, convening meetings and improving data collection.

“I think what you’ve seen is the agency grabbing at some of the low-hanging fruit and only to a certain level,” Riley said.

Despite heightened scrutiny, the FDA continues putting new painkillers on the market. Many of the drugs have formulations designed to make them harder to misuse, such as hard-to-crush coatings that discourage snorting or injecting.

Califf has said the FDA is bound by its regulations: Companies need only show that their drugs work better than a placebo, and the agency can’t require new opioids to be safer or more effective than ones already on the market. He told Senate lawmakers in April that doing so might require legislation from Congress.

One of the report authors disagreed. “I think the FDA has a lot of flexibility at this point to say, ‘Look, given these circumstances we don’t think that a placebo-controlled trial would be adequate,’ ” said Dr. Aaron Kesselheim, a lawyer and professor of medicine at Harvard Medical School.

As for older opioids like OxyContin, Califf says that as the agency gets more evidence on opioids’ risks, it will “aggressively look at relabeling.”

But delays in getting that evidence illustrate just how slowly the FDA process moves. It’s been nearly 10 years since the agency required makers of long-acting opioids to conduct a dozen studies of their drugs’ risks and effectiveness.

The main clinical trial looking at opioids for chronic pain has been delayed since 2019, due to repeated changes to its design. And results from seven other studies released in 2020 don’t give a clear picture of whether the drugs are truly safe and effective for long-term use.

“We’ve got to have the data, and we can’t accept excuses that it’s hard to do,” Califf said. “That’s not going to be acceptable.”

Riley said the data the FDA is seeking will be critical to providing the evidence needed to remove opioids from the market, which would likely face years of industry pushback.

“The question to me is whether the agency will actually have the gumption to use those tools to start pulling drugs,” Riley said. “Do they have the will to do it?”

6 Responses

  1. I Aam so sick of this.By the prescription mointering programs they have found most people do not start by getting a opiate medication from a doctor or if they did that first prescription was not a problem. Addiction has little to do with the substance being abused, as longs as it provides the escape that addicts longs for. Most peole when they go to treatment will lie and say they started on perocet but that does not mean that is what it really was or that it came from a doctor. The bottom line is few people rarely just abuse one prescription drug and most people who die from prescription opiates also drank alcohol from it. Meanwhile we need to understanding in a free world that mean peole have to take some responsibility for their own actions. No one forced these people to buy these drugs or to even take them. Also even if a doctor does prescribe that is still your choice to take it and in today world there is no excuse to say well I did not know it was addictive. Well if it is being abused by you, than it is addictive for you, and what people get addicted to is not going to be the same for all. Meanwhile they could have done much better than what they did with better publoc education. For example telling seniors to always lock up there meds, even when the grandkids are over. Never combine alcohol or certain other drug unless in very small amounts. Like no more than 1 glass or wine or beer a day. I find it interesting about these studies but when you find out how to qualify for one they are very selected. They would never take someone like myself who has never had a issue on opiates for over 30 years. Do not have any organ damage, nothing. One month of NSIDs almost killed me by bleeding ulcers and with gabapentin I gain 30 pounds in 4 month with no change in diet and only got at the most a 15% decrease in pain. I was in the hospital for a horrible infection that almost killed me and they refused to give me any opiates. I was in bed for 6 weeks. As soon as my pain got treated by getting on just my normal opiate medication I was able to walk down to the nurse station and back by myself. Pain kills. These doctors need to open there eyes Also those patient who are considered legally disabled should not be required to these insane limits. Meanwhile pain kills and what a great way to kill people off by making them have stokes and heart attacks from chronic daily pain.I do not know why the Democratic party even allows Machin to run under their party name, since he said he would have no reason to vote for women right to their own bodies. Well if Kansas tells use anything, it states that this country does not want to pretend we are a Christian country when it fact we never have been and the fake facade of pretending the 1950 was some perfect time needs to stop. The reason why the 1950s seemed so great was because we spent the 20 years before in hell with the depression and WW2.

  2. They are having a problem separating illegal/from legal. Yes, illicit fentanyl keeps claiming people but not legal/prescribed prescriptions. PROP get your names straightened up and you will be able to track everything very well. Illicit fentanyl- deaths, prescribed and properly dispensed- not so much. Lack of prescribed pain killers= dangerously high blood pressure, heart problems, up to and including death.

    • Talking about heart,I couldn’t even finish a simple MRA,, to look at all the blood vessels in my body.A simple deep breath part of the test,,threw my heart into a tizzies svt,vt,atril fib etc.Since they did the forced reduction on me,,,started about 2 years ago,,my heart muscle has been fighting back in a bad way.They did a complete cardiac work-up ,just before they cut my meds,,I had 16 cardiac ablation from undiagbnose pancreatits,in 2006,,they wanted to re-check,point being,,MY HEART MUSCLE WAS FINE,,, on my 100 mg a day of pain meds,,now forced down to 30,,my heart is not happy.If they have thrown this heart into heart failure,,i will be screaming it from the billboards,,as that is a severe side effect from FORCED physical pain,
      ..I’ve contacted soooo many people to help us,and yes my senatores,,, I JUST DON’T KNOW WHO’S LEFT?I guess we are just going to have to keep pounding this drum,and maybe try again,the International communty??If u notice…MOST,,,I SAY MOST OF EUROPE is not doing this to there people,,yea their tryen to get into Britian, but they all have been warned about KOLODNY and his tactics and the damage kolodny policed public policies have done.I personally wish we could get under 1 banner,,,, NO DENIAL OF ANY ESSENTIAL MEDICINE OPIATES IF YOU HAVE A PHYSICALLY PAINFUL MEDICAL CONDITION,,,,,,,however,,their are some,,even here,,who think they tooo have the right to decide who forcible suffers in physical pain,,,even though that is no-one rite to decide,who forcible suffers in physical pain from a medical conditions,,as some here,,actually think they have that rite,,,jmo,maryw ,

  3. It’s unbelievably disgusting that these politicians are so ate up with political posturing that they would throw MILLIONS OF AMERICANS under the political grandstanding bus. I don’t care what side of the political aisle you affiliate with because at this point it’s coming from both sides. They’re all complicit in fighting to ensure that we will never again be properly and adequately treated. Not a single one stands up for us. It’s time to look past the divides and unite over the common goal. If we don’t do something soon, I’ve little doubt that we will lose even bigger than we have up until this point. I may not know what it is exactly that needs to be done but I am all about pledging my own help. Reading this just tells me that they’re not going to stop nor even slow down, unless and until we can find a way to make sure that we are heard. Until we can tell our side of the events in such a way that they can’t ignore us. If we can’t come up with a way to do that, we might as well plan for the worst. Believe me, I’m racking my poor little pained brain every day. I’ve got a couple of ideas so far but I am in the research phase, trying to determine whether those ideas could even possibly come to fruition. I feel a little more urgency every day that goes by. We can’t afford to sleep on this because they certainly don’t. It’s safe to say that they’re always plotting and planning. It seems like every day is something new. All I know is that we have to try to do something and sooner, rather than later.

    • Well MN and CA got their laws changed under Democrats. But things do not change by people just whining facebook. IN MN a group of use met at one of the pain rallies and some were able to work together and talk and call there representatives. I had all my friend call there representatives just to call ask for them to place vote for the bill. The bill won by a large majority. The biggest problem is that you have people accusing doctors who know nothing how to treat pain and think just because a doctor prescribes so many pills he is running a pill mill. Well when you are the only doctor who helps those in chronic pain of course you stand out for it. The best thing we can do as a society is if we are ever on a trial for some bogus thing like this is just not convict. If the courts cannot get doctor convicted than they will stop this. No doctor does a exams every time they prescribe a medication or dose change. However this is how the DEA get most doctors. They have agents come in with fake records and try to get the doctor to prescribe. If the doctor does, by going by the record in front of him and his exam than the doctor is a dealer. They will usually have something that will not quite match so that if the doctor studied the record he might catch it and may see the records as being wrong. However most health records are full of errors so seeing someone height be 6″ taller may not catch anyone attention. Well how can any doctor provide care if you have to have a trial everytime you need help because you need to prove that you have pain. This has totally ruined doctor patient relationship to the point patient do not trust doctors and doctor do not believe patients. That is not good care. Meanwhile maybe if w Virginia spend more money on education and new business and jobs opportunities people would have better things to do than using drugs all day. Meanwhile KY is underwater and not a peep out of Sen McConnell or Sen Paul. But thatvis OK as long as you get no pills and continue to suffer.

      • I was referring to on a federal level. No one says a word about pain sufferers when it comes to proposals like NOPAIN or the relevant items in this article. We don’t have any reps fighting for us, they all act as if addiction is the only issue that exists. It’s great that a couple of states have changed their laws but if we see someone push through a federal bill to totally halt opioid pain medications, it won’t matter what state you live in. I am well aware of what the problems are and the fact that the wheels aren’t moving much but I can’t exactly fault anyone for that when I haven’t brought any big ideas to the table myself. I do my share of complaining too. FB is the only place I can do that where other people actually understand. Still, we have had plenty try reaching out to representatives and we all seem to get the same canned answers, no matter what political party the rep belongs to. Bottom line is if Manchin pushes hard enough, I have no doubt he would have all of the bipartisan support he would require to see at least certain opioids gone for good. Which isn’t a step in the right direction, seeing as how some people can only take certain ones due to med sensitivity or outright allergy. Then, there’s always the chance he’ll go for the slam dunk. And again if that happens, there won’t be any pain meds to pass state laws over. Its not matter of whether they CAN do that or not, its matter of whether they will. I guess we will find out.

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