Adverse cognitive effects of antiepileptics

Here are excerpts from several articles that investigate the effects of antiepileptics, like gabapentin (Neurontin) and pregabalin (Lyrica), which are increasingly prescribed for pain simply because they are not opioids.

This is a followup from a previous post: Some antiepileptic drugs increase risk of dementia.

Adverse cognitive effect of gabapentin [Neurontin] in individuals with spinal cord injury: preliminary findings. – PubMed – NCBI – Spinal Cord Ser Cases. 2018 Jan   Continue reading


Ban of the Term “Evidence-Based Medicine”

Why Evidence-Based Medicine is Not Going Away, Despite Alleged Ban of the Term – December 20, 2017 – By Angie Drakulich

The scientific community has been incensed—as well as confused—by the past week’s [Dec 2017] alleged ban/unban of certain words by the Trump administration in connection with the US Centers for Disease Control and Prevention’s 2019 budget proposals.

Among other terms, “evidence-based” and “science-based” were called into question.

Some practitioners have scoffed at the terminology, especially after the 2016 CDC guidelines on prescribing opioids emerged, noting that the most effective way to treat a patient is through a case-by-case, personalized approach .

Individualized medicine may be especially pertinent when long-term, large population studies are lacking for certain complex, comorbid, lifelong, or rare diseases and conditions.

Practical Pain Management collected feedback from its editorial advisory board members.

This group of clinical, pharmacological, research, and academic professionals work day in and out in to assess, diagnose, and treat patients living with chronic pain conditions.

The following comments contribute to the conversation at stake.

Administrators and politicians think it [evidenc-based medicine] means physicians using diagnostic and management algorithms developed externally for the purpose of standardizing medicine and lowering its cost.

There it is: our government is trying to standardize our medical care to save money.

If it only takes a blood test and computer algorithms to process the results to determine the correct diagnosis and treatment of a patient, expensive doctors would no longer be needed for most care.

They are essentially trying to replace our primary care providers with fancy equipment and computers.

This is what I’ve also been saying all along: the practice of medicine can’t be “standardized” because the proper practice of medicine involves the examination of and determination of care for individuals, who differ greatly in their presentation and internal biological situation.

“Before I would be willing to develop a response to any attempt—political or otherwise – to sideline EBM, I would require a better understanding of the argument against EBM and the logic behind the attempt. I would also wish the opponent to better understand EBM.”

-I. Jon Russell, MD, PhD, ACR Master, Fibromyalgia Research and Consulting, Texas

“These expressions come and go. The National Science Foundation has to find homonymous expressions that relay the same meaning.

For someone like me who spent his childhood behind the Iron Curtain, this was a favorite task that people actually enjoyed doing to fight the communists. 

So Dr. Sella implies that we are living during a time in American history where scientists must find clever expressions to describe phrases, like evidence-based medicine, in politically approved language.

Rules dictating what words cannot be used in federal documents is practically the definition of censorship.

The advent of the curtailing of freedoms in our country may give some room for thought to the people who looked down at those living under the Iron Curtain.”

-Gabe Sella, MD, MPH MSc, PhD, Ohio Valley Medical Center, Wyoming

The absurdity and wrongfulness of dictating what words can be used is an insult to science and our nation. If we don’t champion evidence-based or science-based medicine, we might as well return to the age of witchcraft, blood-letting, and snake-oil salesmen.”
-Don L. Goldenberg, MD, Oregon Health Services University, Oregon

“The lack of the use of evidence-based medicine is one of the many reasons for the travesty that is the CDC Guidelines. Failure to use evidence-based or scientifically based data to create guidelines or use them to write certain medical and scientifically based literature would, many times, reduce the work to anecdotal information, or even bobe-mayse (fairy tales) for those who care.”

-Gary W. Jay, MD, Neurology, University of North Carolina

“Interestingly, the ‘PharmacoMafia’ has to find evidence of only 5% above average placebo of 35% to claim a drug is ‘effective.’

No drug is 100% effective and virtually all produce complications called side effects. The bottom line is: What does effective mean? And what does evidence- or science-based mean?”

-Norman Shealy, MD, PhD, International Institute of Holistic Medicine, Missouri

I do believe that clinicians must use common sense and not always rely exclusively on evidence-based medicine in an effort to treat the individuality of each patient

To eliminate both in discussions and official documents propagates lawlessness to government and the clinicians that care for patients.

A case in point is the recent publication ‘Safety Concerns with the Centers for Disease Control Opioid Calculator’ (Fudin et al) which explains the Wild-Wild-West mentality that was allowed in the development of the controversial 2016 CDC guidelines on opioid prescribing, and the risk to patients from their non-evidence/non-science based online opioid conversion calculator.”

Safety concerns with the Centers for Disease Control opioid calculator – Free full-text PMC article
-Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP, Remitigate, New York; Western New England University College of Pharmacy; Albany College of Pharmacy and Health Sciences

“As a scientist, of course I am evidence- and scientifically based, but as a working clinician, I am much more open to the concept of new uses for older medications.

If we do consider ourselves as the pioneers of pain management, then we ought certainly do no harm, but we also owe our patients the best efforts, within our specialties and interests. And our strong desire is to help the ones in need.”

-John Claude Krusz, MD, PhD
Anodyne Headache, PainCare & Well-Being, Texas

As scientists and policymakers pave their way through the terminology of today, the most swaying impact comes down to the patient level and what treatment will provide them with the most safe, effective, long-term outcome.

When medicine no longer pursues that goal and is controlled by government policies instead of medical knowledge and experience, we are all in deep trouble.

Original article: Why Evidence-Based Medicine is Not Going Away, Despite Alleged Ban of the Term


Argument Against Present Supply-Side Opioid Policy

New Study from American Action Forum Adds to the Argument Against Present Supply-Side Opioid Policy – April 12, 2018 – By Jeffrey A. Singer

On April 11 the Washington Post cited a new study from the American Action Forum that reinforces arguments I have made here and here, that despite a dramatic reduction in the opioid prescription rate—a 41 percent reduction in high-dose opioid prescriptions since prescriptions peaked in 2010—the overdose rate continues to climb, as nonmedical users have simply migrated to more dangerous substitutes like fentanyl and heroin while the supply of diverted prescription opioids suitable for abuse continues to come down.

four researchers working in the CDC’s Division of Unintentional Injury Prevention reported in the April 2018 American Journal of Public Health that the CDC’s method for tracking opioid overdose deaths have over-estimated the number due to prescription opioids, calling the rate “significantly inflated.”   Continue reading

Social good versus private profit

“Is curing patients a sustainable business model?” Goldman Sachs analysts ask | Ars Technica – Beth Mole – 4/12/2018, 2:45 PM

One-shot cures for diseases are not great for business—more specifically, they’re bad for longterm profits—Goldman Sachs analysts noted in an April 10 report for biotech clients, first reported by CNBC.

The investment banks’ report, titled “The Genome Revolution,” asks clients the touchy question: “Is curing patients a sustainable business model?”   Continue reading

Why would anybody volunteer for pain research?

Pain, please: Why would anybody volunteer to participate in pain research? – APRIL 6, 2018 BY BIM

As amusing as the question seemed at first, we soon realized that it was both justified and relevant to ask this question. After all, all our research is based on the assumption that our samples of volunteers represent the general population.

And yet, here we have this strange group of people, who actively volunteer to be subjected to unpleasant and painful stimuli, which most of us want to avoid if possible.

I had not thought of this before, yet I can quickly see how important it is. Pain studies will always have a skewed group of subjects self-selected by volunteering for pain research. This is not something an “average” person would do, so these people are not “average” and are not representative of the general population. Continue reading

‘Pilot studies’ of alt-medicine: unethical and harmful

‘Pilot studies’ of alternative medicine: incompetent, unethical, misleading and harmful – Apr 4 – by Edzard Ernst

During the last 25 years, my research focussed on the critical evaluation of all aspects of alternative medicine. I do not aim to promote this or that therapy or profession, my goal is to provide objective evidence and reliable information

I have noticed a proliferation of so-called pilot studies of alternative therapies.  

In today’s anti-opioid climate, any non-opioid “treatment” for pain, is accepted uncritically, even if it’s only slightly effective for a few people, is promoted as “fighting the opioid crisis” (which is actually an “addiction crisis”)   Continue reading

Patient-Focused Drug Development meeting with FDA

Patient-Focused Drug Development meeting with FDA – Twitter Conversation sent by Scott Gottlieb, the FDA Commissioner from:

Scott Gottlieb, M.D. @SGottliebFDA   
#FDA will be hosting a Patient-Focused Drug Development meeting July 9 to obtain patients’ perspectives on the impacts of chronic pain, views on treatment approaches and challenges or barriers to accessing treatments.

This sounds promising to me. It seems like big step forward for pain patients, for the FDA Commissioner to publicly acknowledge that we exist and that opioids are necessary for some of us… quite a daring move in today’s opiophobic political atmosphere. Continue reading

Bad thoughts can’t make you sick, that’s magical thinking

Bad thoughts can’t make you sick, that’s just magical thinking – Angela Kennedy | Aeon Ideas

The belief that physical illness can be psychosomatic, or caused by the mind, has long been seductive, capturing the imagination of doctors and writers alike.

Does this sound familiar? All the latest non-drug bio-psycho-social treatments of chronic pain are based on this flawed concept.

Contemporary, ad hoc resurrections of the concept of hysteria, now called conversion disorder, are commonly diagnosed by doctors and accepted by patients.  Continue reading

CDC Rx Opioid Overdoses Over-Reported by Half

CDC Opioid Overdose Death Rates Over-Reported by Half – Apr 2018 – A PPM Brief

Agency says inflated estimates were caused by blurred lines between prescription and illicit opioids.

The CDC is supposed to be an evidence and science-based agency, yet they published their opioid prescribing guidelines based on their own erroneous data.

Many laypeople and even their own authors have known for years that illicit fentanyl was causing overdoses, yet the CDC is just now starting to admit it.  

Continue reading