Washington PostBy Peter WhoriskeyOctober 6, 2013
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request. The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort”…
Milwaukee·Wisconsin Journal SentinelBy John FauberOctober 6, 2013
Federal health industry regulators and executives of companies that make pain drugs have held private meetings at expensive hotels at least once a year since 2002 through an organization funded by the drug companies, according to emails obtained through public records requests and provided to the Journal Sentinel/MedPage Today. Each year a handful of drug companies have paid up to $35,000 each to send a representative to meetings of IMMPACT, where they could discuss clinical trial testing procedures with officials from the U.S. Food and Drug Administration and other government agencies. IMMPACT’s stated goal is to improve the design of clinical trials conducted to develop new pain treatments. The emails raise concerns about a pay-for-play arrangement in which drug companies were able to buy access to invitation-only meetings where they could meet with FDA officials and affect FDA pain drug policy, said Michael Carome, director of health research for the watchdog group Public Citizen…
The mission of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT] is to develop consensus reviews and recommendations for improving the design, execution, and interpretation of clinical trials of treatments for pain. The first IMMPACT meeting was held in November 2002, and there have been a total of sixteen consensus meetings on clinical trials of treatments for pain – fourteen on trials for chronic pain in adults, one on trials for acute pain in adults, and one on trials for pediatric acute and chronic pain. Invited participants come from academia, regulatory agencies [US Food and Drug Administration, European Medicines Agency], US National Institutes of Health, US Veterans Administration, consumer support and advocacy groups, and industry. The disciplines represented at meetings varies but has included anesthesiology, clinical pharmacology, internal medicine, law, neurology, nursing, oncology, outcomes research, psychology, rheumatology, and surgery. For all IMMPACT meetings, an attempt is made to include broad representation while limiting the size of the meeting to promote vigorous and frank discussion and debate…
These stories are so common that it’s easy to become inured to hearing them and let them just drift away:
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in·ure [in(y)oor]
verb
1. accustom [someone] to something, esp. something unpleasant…
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Well, here’s a little something that might help make this one stick in your mind:
from the Journal Sentinel"The whole picture is a troubling one and it warrants an independent investigation," said Carome, who has seen the emails. Carome pointed to an initiative that sprang from the IMMPACT meetings — a new FDA policy on how to conduct clinical trials of drugs. The new method, known as enriched enrollment, allows drugs companies to weed out people who don’t respond well to a drug or who can’t tolerate taking it before the actual clinical trial begins. Experts say that approach makes it much more likely a drug will prove effective and possibly win FDA approval. It’s also cheaper for drug companies to conduct such trials.
However, the approach has drawn criticism because it essentially stacks the deck in favor of the drug. More importantly, experts say, drugs tested that way are not likely to reflect what will happen when a drug gets on the market and is prescribed for large numbers of people. "It’s in fact cheating," said Patrick McGrath, a pediatric pain expert at the Dalhousie University in Halifax, Nova Scotia.
On its website, the FDA says enriched enrollment is a potentially powerful strategy for the pharmaceutical industry because, when used appropriately, it can result in smaller studies, shortened drug development time and lower development costs. "While enrichment won’t save a drug that doesn’t work, it will help find one that will," Bob Temple, the agency’s deputy director for clinical science, wrote in a piece posted on the FDA’s website last December…
Here’s that article from the FDA about enrichment enrollment. The examples given make perfect sense, and make no mention of the fact that the idea comes from IMMPACT or that it might be used in trials of pain medications. But perhaps there’s a hint in the title "More successful Drug Trials" rather than "More Effective Drugs":
FDA VoiceBy Bob Temple, M.D.FDA Deputy Director for Clinical ScienceDecember 17, 2012
Today FDA is issuing a draft guidance that spells out how drug developers can use such strategies, known as clinical trial enrichment, to greatly increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective. These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs.
Abuse of prescription pain medications is a major public health problem in the US – rampant here in the southern wild. Volunteering in a free charity clinic, I had so many people hitting me up for pain medications that I modified my DEA certification to eliminate my ability to even prescribe them. There’s no reason for a psychiatrist to prescribe those drugs anyway. In other instances, I’m still enough of an Internist to refill our patients’ medical drugs when I see them to provide relief to our overworked primary care docs, but not "pain meds". I can now honestly say, "Can’t do it," because "Won’t do it" just lead to arguments and fights. Life is too short for such things. The notion that we need to grease the wheels of Clinical Trials to get more pain meds on the market is genuinely irrational. It’s an area where we’re doing just fine [since the dawn of time]. Reading Dr. Temples’ FDA write up, it sounds like an area where pain meds should be banned from enriched enrollment rather than the program’s bedrock.
Another reason this story ought to stick in your mind is that it involves Academia, the government’s FDA, and PHARMA, and it has been going since 2002 without anyone making any noise. The potential for Conflict of Interest jumps off the page in these articles, yet silence has prevailed for over a decade. Why hasn’t there been a whistleblower? Why indeed!…
This is so important since it seems doctors believe adverse effects are revealed in clinical trials rather than post-marketing experiences.
Pharma is doing everything it can to weed out reports of adverse events even during these time-limited clinical trials.
Pain meds are a large issue for our elderly population. I have known a number of elderly people whose pain medications would knock down a horse; in speaking with pharmacist friends they confirmed my observation.
One elderly friend had access to several strong pain medications and while I thought her speech and lack of focus was due to her diabetes, which I could not figure out due to low numbers, was due to her over use of pain medications.
The elderly have learned that a pain complaint will result in a prescription that will easily leave them in an altered state. Pain medications also allow them to continue behaviors that they may not wish to stop, but would be intolerable without medication.
We have created an entire population that craves pain meds while regulating those who need those same medications into second class citizens forcing them to deal with their cancer or other pain in some undefined manner.
Steve Lucas
Gee, and you wonder what the IPAB with PPACA will do with this type of influence? And who will be liable WHEN consequences happen with standards of care set by profit margins.
Absurd and deadly.
I managed to significantly reduce the pain of MS with a recliner I purchased with a dual motor that allows the head and foot rest to be moved independently. Changing positions frequently is a very important tactic for dealing with nerve pain. Another motor tips the chair up should the day come that I need it in order to get out of the chair and onto a walker or into a wheelchair. It’s a well made, very cushiony chair; it’s a luxury I could afford though it was the biggest purchase of my life. I can fall asleep in more than one position now. I can sleep on my back for the first time in five years in which I could only sleep sprawled on my stomach with no limbs touching other limbs because it was painful when they did. Haven’t slept in that miserable position since I got this chair; and I don’t expect anyone to pay as much as I did for a really fine and comfy piece of furniture, but surely there are options less clinical than gravity chairs for people who might benefit significantly from therapeutic options that aren’t limited to what you can get from a medical supply company.
Still I take 150 mg of amitriptyline and 20 mg of oxycontin at night for pain and 100 mg of trazadone to help knock me out. It’s difficult to fall asleep when you’re in pain. My neurologist’s supervisor wants to help me cut down the number of meds I take, which is great, but her first attempt— prescribing nortriptyline instead of amitriptyline, ended up with me in the emergency room with an allergic reaction. I surmise that one day I’ll have to start rotating opioid therapy when one loses its effectiveness. It’s risky, but unrelieved pain can make life not worth living. I don’t get what people get out of taking oxycontin illicitly and like every other vet I’ve discussed morphine with, I hate it, but it’s immoral to deny people relief from chronic, debilitating pain because others abuse these drugs.
There are all kinds of pain, and all kinds of approaches, and inescapable risks with opioids. For a lot of people, physical therapy would be more effective and far less risky, but many insurers would pay for back surgery before they paid for long term therapy. It takes time to treat pain, and a lot of trial and error to find solutions. Monitoring over prescribers should be a priority over monitoring individual patients. Also, medical professionals and organizations should lobby for treatments instead of and in addition to addictive drugs.
Yikes, wiley.
I was misdiagnosed with MS when i was younger. I was taking an antidepressent (Lexapro, for 2 years) and suffered partial paralysis of the left side of my face, word block, progressive deterioration of motor skills, memory impairments, and a bunch of other things. I also had very severe pains in my joints of my legs that spontniously came and went thoughout the day. I had a very difficult time sleeping on lexapro. On top of all that, it not even work.
All these things went away went I got off the antidepressent, but the withdrawal syndrome was pretty severe. I lost 35lbs, my job, and was in a state of continous terror for months. I wound up being prescribed Xanex to treat the severe persistent anxiety, only to then wind up strung out on xanex because it had worse physical dependence then lexapro, and i couldn’t afford to lose my job again.
Worth noting, the drug dependence and withdrawal sydrome for xanex was somewhat similiar years later. The withdrawal sydrome was worse though.
Amitriptyline is only indicated for depression, using it for pain management is an off-label prescription. Something pain management is notorious for. I’m not suprised you ended up in the ER attempting to switch one type of antidepressent to another, given my experiance just discontinuing one. i would be hesitant to take the risk of taking that thing long term. I imagine that’s why your neurologist wanted you off it. Aparently they thought you were taking it for depression so they prescribed you an old Tricyclic antidepressent as a replacement. I really have no idea what the rational for that was, it doesn’t really make any any sense.
Chronic pain really sucks, It can be very difficult to manage. Just remember, pain management (depending on the provider) is an APA board certified subspecialty of psychiatry. It has all the same crazy prescription problems as psychiatry does. Off label drug uses for pain are just as heavily ilegally marketed as anything else.
Tips for tapering amitriptyline http://survivingantidepressants.org/index.php?/topic/1099-tips-for-tapering-off-amitriptyline/
Thanks for the tips, guys, but the amitriptyline was prescribed for pain and as a sleep aid, and it works for both while having no significant impact on my mood aside from me not being more grouchy from more pain and being able to get adequate sleep most nights (as long as I take them four hours before bedtime).
I had fatigue and brain fog for two years, knew it wasn’t depression and was taking no psyche meds during that time. I found out I had MS after I was not able to stand with a cane, much less walk. I have classic Dawson’s fingers in my brain and lesions on my spine. Gabapentin made the pain much worse— only took it once— and would prefer to cut the trazodone very carefully.
A cyberbuddy keeps trying to convince me that what I really have is some venous obstruction that restricts blood flow to my brain, but I trust that my neurologist is not part of a cabal that is keeping the cure secret, especially since the cure he suggests is neurosurgery. Since I’ve been walking unaided since six weeks after I found myself in a wheelchair, I’m feeling pretty lucky.Life is a crap shoot sometimes.
My main concern is that the medical establishment not go on the warpath to the detriment of people with chronic pain— especially for people who are terminal and want to die in peace, with the presence of mind to say their goodbyes and to get their things in order before they die. It seems like our culture is hooked on 180 degree rebounds driven by emotionalism or special interest groups and lobbyists. It’s a crying shame when fields from nutrition to psychiatry to general practice in medicine are more influenced by fashion and sensationalism than evidence gleaned from sound studies and analyses.