Sham Medical Devices & "All-Natural" Treatments

I recently responded to a question about NEUROVA, a copy of TENS unit that doesn't require a prescription (a HUGE red flag).

This led me to the decision to write a post about scams. Scammers are taking advantage of chronic pain patients, especially desperate pain patients, and the current climate regarding opioids.

The most common scam medical devices are "electric stimulators", which are a cross between those electric weight loss belts from the 90s that were supposed to give you abs without working out and TENS units, they bypass FDA clearance & approval by calling them "electronic massagers". These "TENS" units are not the same thing as the more expensive FDA approved TENS units that treat pain, especially neuropathy. Any legal TENS unit (the devices that can treat pain) require a prescription. Really, anything that is supposed to treat pain but isn't approved by the FDA or a similar international agency is suspect. Prescriptions are required for all legitimate longterm pain treatments with only a few exceptions (even FDA approved OTC treatments, like acetaminophen/paracetamol/Tylenol and Ibuprofen/Advil/Motrin aren't safe and effective longterm chronic pain treatments without doctor supervision (which is why the label tells you to seek medical care if you haven't improved after a few weeks). Acetaminophen/APAP is hepatotoxic and NSAIDs cause stomach irritation and bleeding.

Anyway, back on track...

When it comes to sham medical devices and "all-natural" treatments, the websites are great places to found clues, the wording frequently gives them away. Examples of Ted flags include:
* bad mouthing other treatments, especially opioids
* vague explanations of how it works
* not listing ingredients
* anything that's "proprietary" or "patented"- Remember patenting doesn't mean it works, it means they filled some paperwork. If they're advertising or bragging about the patent, they're scraping bottom for ways to con you out of your limited resources

If you want all natural, drug free treatments, research & purchase specific supplements, not "proprietary blends". You can save a fortune by purchasing these ingredients in bulk and putting them in capsules by yourself. Amazon sells everything you need, if you're interested.

Disclaimer: The links above are affiliate links, which means that if you click either link and subsequently make any Amazon purchased I, or rather my daughter's college fund, will receive up to 2% of the purchase price of eligible items.

Report Claims Drug Testing for Painkillers Motivated by Profit - National Pain Report

Report Claims Drug Testing for Painkillers Motivated by Profit - National Pain Report
http://bit.ly/1rUK2oW

"...between 2000 and 2009 the number of all Medicare laboratory services increased by about 48%, while the number of drug tests conducted in physicians’ offices increased over 3,000,000 percent ....

An estimated 116 million Americans suffer from acute and chronic pain. Many doctors who treat chronic pain patients require them to submit to random drug screens as a condition for receiving prescription pain medications. The stated rationale is to prevent misuse and possible addiction, but Collen claims there is little evidence to support the value of drug tests on people with chronic pain.

“It would be naive to say that money has not played a role in the dramatic increase in drug testing as noted in the paper,” Collen wrote in an email to American News Report. “I believe profits drove drug testing behavior and behavior drove acceptance of the procedure before there was sufficient evidence of efficacy. Now physicians may be drug testing patients because others are doing it.”

Until recently doctors could charge Medicare and private insurers up to $225 for a urine drug test that cost them a little over $20. Medicare changed its reimbursement rules after the government found evidence that some laboratories and doctors were using questionable billing practices.

Ameritox, a national laboratory that provides drug testing, agreed to pay $16.3 million in fines in 2010 to settle claims that it gave kickbacks to doctors for using its labs. A whistleblower lawsuit filed by an Ameritox sales representative alleged the company made cash payments to physicians for drug test referrals and also placed personnel in doctors’ offices to collect urine samples for drug tests that were then billed to Medicare. Ameritox says its business practices have changed since the settlement. Another testing company, Calloway Laboratories, was indicted by a Massachusetts grand jury for an “extensive” kickback scheme for doctors. Calloway has denied the charges.

Concern about a “lack of boundaries” in drug test billing led the American Academy of Pain Medicine (AAPM) to warn its members about increased government oversight. “The use of clinical drug tests in pain management has become an area ripe for the submission of fraudulent and abusive claims for reimbursement and rampant ‘overutilization’ of laboratory services,” warned Jennifer Bolden, a former federal prosecutor who is a special counsel to the AAPM."

My doctor stopped "random" drug testing on both my wife and myself, when they found out that it wasn't covered and, as Medicaid recipients, they couldn't bill either of us.

Steve M

New Harvard paper slams FDA, says agency 'cannot be trusted'

New Harvard paper slams FDA, says agency 'cannot be trusted'
http://bit.ly/1eEj15e

This link was posted on a support group and I started to reply, but that turned into a rant, which sent off-topic. Essentially, it's about the problems with the FDA, and the system as a whole specifically as it relates to pain management, opiophobia, the epidemic of undertreated pain, and how money in medicine is a conflict of interest.

Sorry for the length, but, like I said, it just spilled onto the page. Yes, this has hurt me directly, but it's really hurt me the most indirectly. I've had to sit idly by as my wife, friends, and fellow support group CP/IP sufferers suffer needlessly from crippling diseases including EDS, Fibromyalgia, CFIDS/CFS/ME, IP, cancer pain, lupus, MCTD (mixed connective tissue disease), various autoimmune diseases, CPS (Central Pain Syndrome), Rheumatoid Arthritis, RSD/CRPS (Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome) and so much more.

This is emotional and disorganized, for that I apologize (I'm too sleep deprived to correct it).

~~~~~~~~~~~~~~~~~~~~~~~~~
I've known that we can't trust the FDA since Lyrica and Cymbalta were approved for pain. Yeah, they help some people, but they're statistically irrelevant. That, and their constant denials of efficacious drugs like Xyrem/sodium oxybate for Fibromyalgia (the Fibromyalgia formulation wouldn't be called Xyrem) and several pain medications despite superior evidence than many other approved drugs.  I'll eat my hat if they ever approved Sativex.

The DEA is in charge of diversion, the FDA is not supposed to deny drugs because of abuse potential, but they do it all the time.

Don't get me started on the untested abuse deterrent OxyContin, Opana ER, etcetera.

Plus, they don't make any generic manufacturer test the extended release mechanism on anything but the lowest dose, the test are statistical estimates. The worst part is that the FDA approved monographs parade these estimates as trial results.

The problem is our system, profit is put ahead of people and that's why we all suffer. If FDA approval was based on efficacy and adverse reactions, medicine was about helping patients, and not the almighty dollar, cannabis, Sativex, sodium oxybate for FM, 90 day sufentanil implants, diacetylmorphine/diamorphine, ibogaine, countless other medications would be readily available, and many, many other medications would never have been approved. Actiq would be available for any patient that can't get relief from pills, not just well insured cancer patients (although even we cancer patients can't get prescriptions anymore because writing opioids prescriptions isn't cost effective for doctors because of poor reimbursement and excessive paperwork).

Kids sbouldn't be given $20/pill (over $60,000/yr) antipsychotics for insomnia (melatonin, zolpidem, benzodiazepines, barbiturates, Rozerem, all more effective, safer, and cheaper), behavioral issues (discipline), autism, Asperger's Syndrome (TALK to your children and work with them, you can overcome it without toxic antipsychotics, and in many cases, no drugs at all; insomnia must be treated, but many respond to melatonin).

The FDA is owned by the drug companies, their profits, not our best interests are at heart.

Occasionally, Opiophobia or similar irrational fears of abuse overcome profits, but it's extremely rare. Usually, it's profits.

Ibogaine is more effective that methadone or buprenorphine, but out only requires one treatment and can't be patented.

Methadone is $10-15/month, but it can only be used to treat addicts in expensive, inconvenient clinics. They could allow doctors to prescribe it for addiction like they do for pain management, but that's not in Suboxone's best interests. Sparse methadone clinics, daily visits, high costs, limited hours, and overall inconvenience push people from methadone to Suboxone. Many of my friends with CP/IP have faked addiction to get methadone and/or to get buprenorphine (never at the same time) when their states effectively banned effective pain management, I've researched this for many friends in Florida, Texas, Washington, Oregon, and several other opiophobic states.

AVERAGE monthly costs (excluding initial methadone/Suboxone intake fees; $150-300+)
methadone Rx $10-15
Methadone clinic $60*-600
30 day Suboxone $600-900
*$60 are state funded clinics and not really average

Legalized Cannabis is a drug company's worst nightmare, effective, safe, and NATURAL (no patent). Not only that, but people can GROW IT THEMSELVES, no need for drug companies at all. Even generics make them big money.

Methadone is a great pain drug, but terriers prescriber education. Also, when used for pain management, it only lasts 6-8 hours. They could make a once daily version, but the drug is so cheap that insurance companies aren't going to pay 20-50x more for methadone ER and drug companies aren't going to sell methadone ER for anywhere near its current price
*~Breakthrough Med Pricing~*
135 methadone 10 mg (45mg/day)<$12 (cash), ~$6 (Medicare D)
180 oxycodone 30mg (30mg 6x/day) ~$300 (cash), ~$75 (Medicaid rate)
1080 oxymorphone 10mg (20mg 6x/day) ~$11,000/90 day (cash), ~$6000/month (Medicare)
270 oxymorphone 10mg (15mg 6/day) ~$3000/month (cash), ~$1600 (Medicare)
Is it surprising that OxyContin and Opana ER are pushed by drug companies? Those are GENERIC prices. Why bother with ER methadone, especially when it's exclusivity would be much more limited than OxyContin.

*Wholesale prices per pill*
Oxymorphone 10mg $5.65
Opana 5mg $3.60
Opana 10mg $6.53
Oxymorphone ER 5mg $1.74
Oxymorphone ER 40mg $11.13
Opana ER 5mg $2.39
Opana ER 40mg $15.31

Oxycodone 30mg $0.36-1.45
OxyContin 30mg $6.93
OxyContin 80mg $16.33

Morphine 30mg $0.23
Kadian 30mg $6.37
Kadian 200mg $43.01
Avinza (morphine) 30mg  $5.77
Avinza (morphine) 120mg $19.89
MSContin 30mg $4.04
MSContin 200mg $21.39
Morphine Sulfate ER 30mg $0.82-1.70
Morphine sulfate ER 200mg $3.95-8.99

Methadone 5mg $0.0852-0.0868
Methadone 10mg $0.1410-0.1920
Methadone 40mg solutab $0.2976-0.3316 (methadone clinics only)
Dolophine 10mg $0.2026
Methadose 40mg solutab $0.3300

Fentora 0.6mg $82.24

Methadone ER isn't going to happen in our system.

Prialt/ziconotide intrathecal (cone snail neurotoxin) was only approved to discourage abuse proof intrathecal morphine. They actually put a neurotoxin closer to your spine than an epidural. It causes psychosis and death in way too many patients, including several of my friends.

Actiq was $1-2/dose and extremely effective, but the opiophobic FDA refused to approve it for over 20 indications. They shut the company up by going from moderate to severe BTP (breakthrough pain) to the incredibly narrow severe breakthrough cancer pain. This indication got it to the market and physician's wrote prescriptions off-label for desperate patients who had tried everything else. Unfortunately, the prove started to rise. Eventually, the price got high enough to cancer insurance companies to require prior authorization and limit coverage to cancer patients, effectively banning off-label use. This caused further prove increases. GENERIC OTFC (Oral Transmucosal Fentanyl Citrate) is now $20-80/lozenge and patients are limited to four lozenges (2 flares per day). My prescription was $60/dose, $240/day, $7200/month, & $21,600/90 day Rx. Thankfully covered by Medicare (they negotiated ~$6,000/month ~18,000/90 day Rx). Unfortunately, the FDA furthered the EPIDEMIC of undertreatment and underprescribing of opioids by instituting an extremely overzealous class-wide REMS on TIRF (transmucosal immediate release fentanyl; Actiq/OTFC/Fentora/Onsolis/Subsys/Lazanda/Abstral). This seems like just Opiophobia, but there is also a financial motive. While it would seem that restricting such an extensive drug would be detrimental,  a second generic manufacturer finally broke the duopoly, which would have allowed competition if demand hadn't been decimated. Also, despite fentanyl lozenges being extremely high profit thanks to fentanyl citrate being DIRT cheap, even more money can be made with interventional pain management, antipsychotics, antidepressants, anti-epileptic mood stabilizers, and overpriced NSAIDs, like the cox2 inhibitor, Celebrex.

I can take an effective dose of opioids, or I can get less relief and more side effects by taking a conservative dose of opioids plus OVER a DOZEN non-opioids.

Last, but not least, the lack of FDA approved treatment for CFIDS, despite clear evidence that Rituxan/rituximab and Ampligen are both effective. Unfortunately, they're expensive, very expensive. Antidepressants are cheap and so many people believe the CDC propaganda. CFIDS research funding has been frozen for 20 years. In order for it to have kept up with inflation alone, it should have doubled.

The US clinical trials for CFS/ME are less conclusive than they should be because the FDA requires the use of there CDC CFS criteria instead of the more specific ME criteria and too many misdiagnosed patients end up trials. The FDA uses this as an excuse to block approval. If you exclude the patients that don't resound at all, the drugs are miraculous for the remaining patients.

The real reason that that hasn't been approved is two-fold.
1) it treats CFIDS as a physical illness
2) Ampligen is owned by a tiny Philadelphia biopharma company, Hemispherx. They don't have the money to have have the FDA in their pockets and aren't rich enough to get away with bribery

Posted 12/25/2013 08:57:00 AM
Edited March 16, 2014 7:42 am
Edited March 16, 2014 6:05 pm

Neurontin ‘Snake Oil’ Lawsuit Upheld - National Pain Report

Neurontin ‘Snake Oil’ Lawsuit Upheld - National Pain Report
http://bit.ly/JfoJNd