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).
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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
