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So the monthly list price of your insulin has gone from $391 in 2014 to $594 in 2018, THAT’S UNACCEPTABLE!! But who’s to blame??

It must be the drug manufacturer, right?? NO!! When you look at what the drug manufacturer keeps, it actually lowered from $147 in 2014 to $135 in $2018. They are getting less!
It must be the pharmacy jacking up the price to make a huge profit, right??? NOPE!! The pharmacies are down to making $7 for the months Rx in 2018, when they need to average $11 to stay in business. That is why Pharmacies are closing at a record pace!!
Then Who??? IT’S THE MIDDLEMEN!! You know, the ones that have no work, time, money, college education, student loans, business investment or business loans involved!! No research and development, no cost of employing brilliant scientists that develop and bring life savings drugs to market!
IT’S the THIEVING PBM MIDDLEMEN taking $432 from the middle for doing a $1 job !!

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm582031.htm

Chairman Walden and Ranking Member Pallone, thank you for the opportunity to testify today before the full committee.

The epidemic of opioid addiction that’s devastating our nation is the biggest crisis facing public health officials, FDA included.

As this crisis grew, many of us didn’t recognize the consequence of this threat. We missed opportunities to stem its spread. So we find ourselves at a tragic crossroad.

We have a crisis of such massive proportion that the actions we need to take are going to be hard.

We’ll need to touch clinical practice in ways that may make certain parties uncomfortable. This may include such steps as restrictions on prescribing, or mandatory education on providers. Long ago, we ran out of straightforward options.

At FDA, we’re working across the full scope of our regulatory obligations to impact this crisis.

That means updating and extending the risk management plans and educational requirements that we impose on sponsors as a condition of a product’s approval.

It means doubling our efforts to promote the development of new, less addictive pain remedies; as well as opioids that are harder to manipulate and abuse.

It means updating our risk-benefit framework to take measure of the risks associated with misuse and abuse of opioids; and using this information to inform our decisions — including recommending that products be withdrawn from the market.

These steps and others are needed to prevent new addiction.

But given the scale of the epidemic, with millions of Americans already affected, prevention is not enough.

We must also help those who are suffering from addiction by expanding access to lifesaving treatment.

I’d like to announce three new steps towards this goal today.

First, FDA will issue guidance for product developers as a way to promote the development of new addiction treatments.

As part of this guidance, we’ll clearly lay out our interest in the development and use of novel, non-abstinence-based endpoints as part of product development. We’ll also aim to make it easier to develop new products that address a fuller range of the symptoms of addiction such as craving.

Second, FDA will take steps promote the more widespread use of existing, safe and effective, FDA approved therapies to help combat addiction. There are several FDA approved treatments. All of these treatments work in combination with counseling and psychosocial support. Everyone who seeks treatment deserves the opportunity to be offered all three options as a way to allow patients and providers to select the treatment best suited to the needs of each individual patient.

How do we know that medications work?

To start, the FDA approval process requires that all products demonstrate that they are safe and effective prior to approval.

The evidence base then grows significantly after approval.

Unfortunately, far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications. In part, this is because insurance coverage for treatment with medications is often inadequate.

To tackle the treatment gap, FDA is planning to convene experts and stakeholders to discuss the evidence of treatment benefits at the population level – such as studies that show community wide reductions in overdose following expansion of access to therapy. We will also discuss the potential for further research to assess the value of these medications in the context of today’s overdose epidemic.

There’s a wealth of information supporting the use of these medications. We’re focusing on the data in the drug labeling that can help drive broader and appropriate prescribing. So one concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA. We believe that granting such an indication in labeling can help promote more widespread use of, and coverage for these treatments.

Why is it important to promote the value of these treatments at the population level? Here’s an example. Recently, the Commonwealth of Massachusetts found a greater than 50 percent reduction in the risk of death from overdose among individuals treated with methadone or buprenorphine after a nonfatal overdose. These kinds of data have immense implications for insurers and policymakers in deciding how to adopt these treatments.

A common question that arises with treatment is the proper duration of medication therapy. Clinical evidence shows that people may need treatment with medications for long periods of time to achieve a sustained recovery. Some may even need a lifetime of treatment. Recognizing this, the FDA is revising the labels of these medical products to reflect this fact.

Now I know this may make some people uncomfortable. That’s why the third step I’m announcing today is that FDA will join efforts to break the stigma associated with medications used for addiction treatment. This means taking a more active role in speaking out about the proper use of these drugs.

It’s part of our existing public health mandate to promote the appropriate use of medicine. Misunderstanding around the profile of these products enables stigma to attach to their use.

This stigma serves to keep many Americans who are seeking a life of sobriety from reaching their goal. In this case, in the setting of a public health crisis, we need to take a more active role in challenging these conventions around medical therapy.

The stigma reflects a view some have; that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness.

This attitude reveals a flawed interpretation of science. It stems from a key misunderstanding many of us have of the difference between a physical dependence and an addiction.

Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication.

That’s very different than being addicted.

Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence.

Someone who neglects his family, has trouble holding a job, or commits crimes to obtain opioids has an addiction.

But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving more or harming themselves or others is not addicted.

The same principle applies to medications used to treat opioid addiction. Someone who requires long-term treatment for opioid addiction with medications – including those that cause a physical dependence — is not addicted to those medications.

Here’s the bottom line:

We should not consider people who hold jobs, re-engage with their families, and regain control over their lives through treatment that uses medications to be addicted.

Rather, we should consider them to be role models in the fight against the opioid epidemic.

Committee members, we need to embrace long-term treatment with proven therapies to address this crisis. At FDA, we will step up our efforts to do our part to promote these goals.

I look forward to discussing these issues with the committee. And I’m grateful for the opportunity to be here.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The administration “failed to conduct a comprehensive legal analysis” of three NSA-style bulk data collection programs, according to the Justice Department Inspector General.

https://www.nextgov.com/analytics-data/2019/03/dea-never-checked-if-its-massive-surveillance-operations-are-legal-watchdog-says/155907/

The Drug Enforcement Administration skirted numerous legal checks on a trio of bulk data collection programs dating back to the early 1990s, according to an internal watchdog.

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Another Lawmaker Overlooks Pain Management in Bill to Fight Opioid Crisis

www.rewire.news/article/2019/03/28/another-lawmaker-overlooks-pain-management-in-bill-to-fight-opioid-crisis/

“Dependence isn’t addiction, and that is continually left out of the discussion and the policies being made,” said disability advocate Maelee Johnson.

Hardly a day goes by when the discussion of opioids and their misuse is not on the front page of local or national newspapers. However, the flipside of the issue, pain management, is barely, if ever, centered in the conversation.

This came up most recently with Republican Sen. Rob Portman of Ohio, who seeks to advance a bill he previously introduced called the Comprehensive Addiction and Recovery Act 2.0, which would, among other things, establish a three-day limit for opioid prescriptions.

This lack of focus on disabled and chronically ill patients has inadvertently pitted doctors against their own patients, who are framed as going down the rabbit hole of dependency following a sprained ankle or routine dental surgery. But this overly simplistic framing erases people with long-term disabilities and chronic health conditions who are struggling to live their lives while being punished for using the best tools we have available to enable their full participation in society.

The Centers for Disease Control and Prevention (CDC) in 2016 offered strategies to taper patients off opioids, but left doctors and patients with their decision-making authority, as it should. However, while the CDC clearly intended the guidelines to be just that—recommendations—that’s not how they’ve been interpreted.

As of last fall, 33 states have put policies in place that limit a person’s access to pain medication, in some cases to three to seven days of medication with no available refills. In some states, this means that patients are forced to go back to the doctor, enduring the burdens of medically unnecessary appointments just to get a new prescription, in order to get the medication they need every seven days.

These are people for whom opioids allow them to go to school, work a job, and manage their home life. In the words of Maelee Johnson, a disability advocate, in an interview for this piece: “Dependence isn’t addiction, and that is continually left out of the discussion and the policies being made.”

This costs lives, Johnson added. “Since the opioid crisis became a political issue, I’ve lost access to all my medication, and I dread having to convince doctors that I need these meds to survive again. The consequences of this are very far reaching.”

It’s not a legislator’s job to diagnose a patient’s ailment or prescribe relief. That responsibility falls to clinicians, who go to school for years for this specialty. And yet, time after time, lawmakers in Congress think they are equipped to address the complex needs of millions of individual patients with their policymaking. In the case of Sen. Portman’s bill, this is especially concerning in light of data pointing to the disastrous impact of arbitrary day-centered limits on pain treatment.

While this bill and similar efforts—including one by Democratic Sen. Kirsten Gillibrand of New York, whose recent policy announcement ended in her pledging to work more closely with the disability and chronic health communities to fix her bill—have an exemption for “people with chronic pain,” this approach fails to take into account what that will mean in practice for actual patients.

Research shows that even when there are exemptions, the patients’ needs are overridden as physicians fear being punished for over-prescribing medication. “Despite exemptions for [chronic pain] patients in the CDC Guideline and Tennessee state law, [a nurse practitioner at Vanderbilt University’s hematology department] had seen a major push from state regulators and insurers to get [sickle cell disease] patients down to lower doses,” noted a 2018 report from Human Rights Watch.

The report showed that legislative interventions such as these do have an impact on the quality of care doctors can provide to their patients who live with chronic pain. Doctors are interpreting the CDC guidelines and congressional action as broad, iron-clad requirements, and patients and people with chronic illnesses are the ones struggling.

Every person experiences pain differently, and legislation addressing this issue needs to take that into account.

Evidence shows that policies inserting the government into the doctor-patient relationship don’t work. For one thing, the majority of people with addiction issues tied to opioids do not receive them from a medical professional. Rather, they receive them from a friend, colleague, or they purchase them on the black market, according to data from the Substance Abuse and Mental Health Services Administration. Furthermore, the U.S. Department of Veterans Affairs, when working on limiting access to opioids among its community, issued a report in 2018 that clearly showed how restrictions did not result in fewer veterans overdosing. It resulted in more veterans dying by suicide, according to the research.

If you enact a policy and it results in constituents dying, it’s a bad policy.

This is what happens time and time again when policymakers craft legislation based on “good intentions” versus tapping into the deep expertise and “lived experience” of the disability community.

Inconsistent enforcement by the Drug Enforcement Administration has also led physicians to be concerned about the prescriptions they’re writing for patients. But it isn’t just the DEA pressuring and arresting physicians; when government intervention is not successful, insurance companies may meddle in complex patient care decisions. The America’s Health Insurance Plans (AHIP) has announced it will begin to track how physicians are complying with these new policies. Though this surveillance data will not be released to the public initially, there is little doubt it will be used to track the preponderance of opioid prescriptions.

This will compound the pressure already on doctors to not diagnose people with chronic pain and will lead to a decrease in access to pain management.

Additionally, there is a concern we will see an expanded list of drugs under restriction; we have already seen anti-seizure and anti-anxiety drugs like gabapentin included in recent state regulations. Broadening what drugs are included will undoubtedly expand who is affected. As we saw when allergy medications became restricted due to their use in manufacturing crystal meth, many times a medication that could be used to combat one symptom could be used for a nefarious purpose.

Instead of trying to force a flawed, one-size-fits-all policy onto hundreds of millions of people in the United States, legislators in Congress should support the dissemination of unbiased, science-based information about appropriate opioid use. Part of the current challenge is that so much of that information is produced by the pharmaceutical industry.

The marketing of OxyContin by Purdue Pharma is a great example of how this can be a conflict of interest. Purdue flew doctors on all-expenses-paid trips to resorts around the country to “educate” them about the merits of the drug. At the same time, the Food and Drug Administration was concluding that OxyContin was not any more effective than any other drug on the market. In 2007, the manufacturer pled guilty to misrepresenting how addictive the drug was and received a significant fine.

Rather than letting pharmaceutical companies run roughshod over clinicians, doctors need education about impacts of over-prescribing, and continuing medical education (CME) requirements should focus on responsible and careful pain management and the consequences of over-prescribing opioids.

Arbitrary limits on the days of medicine a person can receive is not good policy. Nor does it help people. And isn’t that gist of the Hippocratic oath?

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