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  • Eff the FDA

    Posted by Shannon Love on March 4th, 2011 (All posts by )

    A few years ago I blew a gasket in my abdomen and after emergency surgery woke up in intensive care. The hospital was part of a local chain owned and managed by an order of physically tiny but frightfully efficient Catholic nuns. So, the first thing that catches my eye after I claw my way up to semi-consciousness is an old school Catholic crucifix up on the wall. We’re not talking a dry, Protestant two-pieces-of-crossed wood here but an anatomically detailed Jesus in agony nailed in place complete with a tiny crown of thorns.

    As I blinked in disorientation at the cross, Jesus began dancing his torso from side-to-side in time with Monty Python’s Always Look at the Bright Side of Life which began playing loudly in my head. For my entire time in intensive care, I couldn’t understand anything anyone said to me because I couldn’t hear them over the endlessly looping song. Every time I looked at the crucifix, Jesus started dancing.

    A couple of days later, after I had been moved to an ordinary room, I woke up from a fitful sleep and attempted to escape the hospital. I dragged myself out of bed trailing leads and IVs, screaming in pain and losing my gown in the process. It was quite a shock for the nurses. I even attempted to operate my cell phone and call 911. Why did I do that?

    Simple: I thought I was a small Cajun piglet escaping the laboratory of a mad Nazi scientist operating out of a bordello in the French Quarter of New Orleans. True story.

    Anyhow, long story short, that is how I began to suspect that morphine and I didn’t get along.

    Less humorously, towards the end of my hospitalization, I experienced a crushing depression combined with extreme agitation. I recognized that as a false emotion but I had to constantly struggle not to simultaneously weep and scream at the staff. It was a very unpleasant couple of days. I still have nightmares about it. Not about anything else related to the surgery, just that horrible sense of despair combined with an angry compulsion to do something about it.

    All the strangeness ended when they took me off morphine, and when I went back in for my follow up surgery they gave me Demerol instead and that worked fine. Since then I’ve refused morphine and pretty much explained to care givers that I would rather crawl across broken glass than ever take morphine again.

    Now, I have an unrelated chronic condition that causes joint and muscle pain, hypotension and disturbed sleep. I did a sleep study and they found I had restless-leg syndrome. I tried some of the meds for the condition but one of the side effects of all of them is orthostatic hypotension. Since I already had hypotension, when I tried to treat my restless leg syndrome, I often found myself at random suddenly on the floor.

    So, in the end, I resorted to using hydrocodone to control the pain so I could sleep and just had to live with the restless-leg syndrome. I usually took just one at bedtime, but at times the pain grew so bad I had to take a couple overnight and a couple more during the day. After about three days of this, I began to experience depression combined with agitation.

    After an embarrassingly long time, I eventually put two and two together and realized that, since morphine and hydrocodone are chemically similar, that I probably had the same negative reaction to both.

    I did some research and in September of 2010 went to my doctor and requested Darvocet which is an old-school pain killer that belongs to another branch of the opiate chemical family tree.

    It worked wonders! I could take a dose every four hours if needed without any mental or physical side effects. My mood improved and I began to suspect that even the low doses of hydrocodone had been having a depressing effect.

    I began to sleep surprisingly well, even better than I did when I had no pain. I went back to my research and found that Darvocet has shown success in treating restless-leg syndrome. By chance, I had found probably the only existing drug I could take for restless-leg syndrome that wouldn’t cause random fainting!

    My life got a lot better. I was largely pain free, I could sleep soundly and I stopped kicking my dogs. Everything was great!

    …for about 3 months and then the explicative-deleted FDA banned Darvocet!

    Son-of-a-…..!  Turns out after 50 years of use they suddenly decided that Darvocet was too dangerous! Seems it can cause heart problems (mostly in the elderly) and (anecdotally)  suicide.

    Now obviously, the incidence of these problems must be very low. Darvocet came on the market in 1957. It was one of the half-dozen drugs that JFK was hopped up on during the Cuban Missile Crisis. Even though the FDA is a government agency, I don’t think even they could miss serious problems with a drug for 50 years.

    No, it turned out the problem with Darvocet wasn’t major, in fact, that was why it had never been noticed before. Only new, computerized, data-mining epidemiology studies were able to find the small numbers of people who had cardiac problems while taking the drug.

    The reasoning of the FDA seems to have been that there are alternative pain killers to Darvocet so even though the risk is small, it is unnecessary because safer alternative exist. You know, the old if-it-saves-just-one-life excuse.

    In my bitter imagination, I see the committee  members sitting around the meeting table and chuckling, “After all, how many people out there can there be who don’t tolerate other pain killers and who also have hypotension and therefore can’t take other treatments for restless-leg syndrome?”

    Well, there’s at least one, you f*ckheads!

    This is why one-size-fits-all government regulation is bad for the individual. Perhaps the ban will statistically save lives, but if it does it will do so by making people like myself worse off.

    I’m not going to die or anything but I haven’t had a really good night’s sleep since the FDA banned Darvocet back in November.  Not sleeping well causes a serious decrease in the quality of life. I’m more irritable, have a harder time concentrating and statistically, years of poor sleep will shorten my lifespan. Owing to the emotional side effects, I refuse to take more than two hydrocodone a day and only at night. If I hurt during the day, I just tough it out.

    My case is trivial compared to that of the “super-responders” to the breast cancer drug Avastin. Because cancers are so closely tied to genetics and the specific mutations that cause each subtype of cancer, a cancer drug can work wonders for some people while doing little for everyone else.

    However, by its very nature as a government agency, the FDA must average the good and bad of every drug it regulates across the entire affected population which can include hundreds of millions of people. If the average harm is larger than the average benefit, the drug is banned.

    There is no role for individualism at the FDA. The FDA thinks of us as if we were soldiers. If some of us must suffer and die for the greater good, so be it. I can’t have the one pain-killer/restless-leg-syndrome drug that works for me and Avastin super-responders can’t have Avastin because in both cases the FDA has judged the greater good demands we suffer. Our unit has been ordered to make the suicidal charge up the hill and that’s that.

    We need to change the role of the FDA. If, in the past, the practicalities of disseminating information about drugs and drug risk necessitated a one-size-fits-all, statistical approach to regulation, we can safely say such a practical need no longer exist in the Internet age. Today, individuals and doctors can easily find information detailing the risks and benefits of any particular drug for any particular set of circumstances.

    The only legitimate role left to the FDA is one of being a (theoretically) honest monitor of drug research. Instead of banning drugs, the FDA should confine itself to issuing Internet accessible summations of a drugs benefits and risks. The decision of what risk to take for what benefits, should always be the individual’s.

    Of course, the real problem today is socialized medicine. With 47% of the US population dependent in whole or in part on government health care and with the micro-regulation of insurance industry by the states, the dictates of the FDA decide what treatments people will get and what treatments they won’t. The FDA is increasingly being pushed into the role of controlling cost for the government and not providing the best care for the individual (even if it really ever had that role in the first place.)

    We need a radical overall of how we manage and pay for health care in America. For historical reasons, we will probably need to still have the government pay for the medical care for a lot of people but we need to move the decision of tradeoffs in medical decisions out of the hands of a small number of “experts” and into the hands of the individual citizen where it belongs.

    I don’t want the FDA to decide that it’s in the best interest of society that I someday be drugged into running around stark naked while believing I am a Cajun piglet chased by a dancing Jesus on a crucifix.

    And trust me, you don’t either.

     

    18 Responses to “Eff the FDA”

    1. c. sheen Says:

      say, if you aren’t going to use that morphine, mind if i have your share?

    2. Kathy Hall Says:

      http://www.medicalnewstoday.com/articles/173193.php

      above is just one article on magnesium deficiency and restless leg syndrome.

      Just google it and you’ll find many articles and studies. I’ve helped many friends with this land it works.

    3. Bill Waddell Says:

      I agree with C. Sheen. I have spent a lifetime avoiding drugs of all kinds, but that dancing Jesus stuff sounds like I may have to rethink my philosophy.

    4. Michael Kennedy Says:

      You haven’t seen the half of it. I review cases for workers compensation insurance companies and, more recently, the company I work for has begun to get cases from HMOs and PPOs. Yesterday, I got a call from the medical director, an old friend. I got a nonsensical request from Blue Cross the other day and, trying to be helpful, mentioned that their rules didn’t make sense. Well, I probably won’t have to deal with them anymore as they seem to have fired us. The essence of the matter is that Blue Cross would rather a patient have a breast biopsy than a breast MRI.

      Today, I had a nice discussion with a surgeon in northern California who had requested an MRI of the neck on a patient he had been treating for 12 years. He has operated on her five times and she is no better. I suggested the possibility that his diagnosis was wrong and she had what is called “thoracic outlet syndrome.” It can be difficult to diagnose. When we finished our conversation, he was going to go right back to the office and send her to UCSF, which has an excellent department for that condition. We knew a bunch of people in common and had a nice chat. I know he is a nice guy because he said I certainly didn’t sound like I was 73.

      Had I made that suggestion in my report to the insurance company, I would be in deep trouble.

      A year ago, my son’s mother-in-law had a mysterious illness that her internists had been mismanaging for months. Finally, she developed signs of a bowel obstruction. I called the son of my former partner, who now runs the practice that used to be his dad’s and mine, and told him that she had a carcinoma of the small bowel. Sure enough. He later told her that I had made the diagnosis on the telephone.

      There is one advantage to being 73 and having been in medicine since 1962 (1958 if you count my time as an Air Force medic). There is very little you haven’t seen.

      One phenomenon that I am seeing more and more is that the older of us are getting out of medicine. Now, doctors are considered rather old at 60 and the HMOs and PPOs don’t want them. Too set in our ways. Of course, we know too much, too.

      The trend predated Obama but it has been given a big shot of steroids by Obamacare. Fortunately, I won’t be here to see the worst of it.

    5. zenpundit Says:

      Great post!

      There needs to be some formal way to force the FDA to count the adverse impact of non-approval on everyone for who drugs would be beneficial and then have an independent body review the risk and move drugs of proven effectiveness to a schedule considered “informed consent to risk” that waives liability for doctors and manufacturers so that ppl can have access

    6. Dan from Madison Says:

      Michael Kennedy – interesting story. I don’t want to hijack the thread, but this is the main reason that I am so hell bent on trying to eat right and exercise regularly. I know it doesn’t mean I will never get sick or have a problem, but I simply don’t trust doctors/insurance companies enough right now and am trying to do everything I can to stay healthy, along with making my family do the same.

    7. TMLutas Says:

      You should be aware that this drug is still available in Australia and you may be able to arrange for its availability for your personal use.
      http://en.wikipedia.org/wiki/Dextropropoxyphene
      An australian pharmacy that has the stuff can be found here:
      http://www.epharmacy.com.au/

      I am not a lawyer. You probably need a lawyer to make sure that this is done with the minimum risk possible. Go talk to one and don’t cut legal corners.

    8. Shannon Love Says:

      Bill Waddell,

      I have spent a lifetime avoiding drugs of all kinds, but that dancing Jesus stuff sounds like I may have to rethink my philosophy.

      I wouldn’t bother. Between you, me and the internet, Jesus doesn’t have very good rhythm.

    9. Dr Ulf Jonasson Says:

      Dear Sirs,

      We want to add to this text that we have studied the painkilling substance propoxyphene (DXP) since 1993. Now FDA says that ONE NEW STUDY made them stop Darvon. We have informed FDA about our research since 1999-2000, they know about our 8 scientific articles about the substance, we also wrote two doctorial dissertations (2000 and 2001) in Sweden.

      We are actually the Whistleblowers about the painkilling substance Propoxyphene in the whole world and informed Public Citizen in 2002 and 2003. I personally met with Dr Larry Sasich at Public Citizen i Washington DC and informed them about our research. I have also visited the FDA twice, 2004 and 2007.

      Our research was behind the decision in UK, Sweden and The European Union (EU) to stop the drug. Go to this link,

      http://qjmed.oxfordjournals.org/content/98/3/159.2.full

      Our references are nrs 21-26

      Ulf Jonasson, Doctor of Public Health
      Birgitta Jonasson, PhD

      Search Jonasson+Propoxyphene for more information about us

      Go to YouTube, Darvon, Distalgeic and Co-Proxamol. The worst drugs ever
      http://www.youtube.com/watch?v=q92lL4kM-JE

      Some Twitters:

      We have worked since 1993 to stop the painkiller Darvon – containing propoxyphene – in US. Now it is done. http://bit.ly/9r5VOU

      Who were responsible for the Darvon disaster during 45 years? Of course it was Eli Lilly. Go to http://bit.ly/exdSOn

      “Darvon and Darvocet trials will be bigger than Vioxx”, predicts Dr Ulf Jonasson – http://bit.ly/i7hnIB

      Are we actually the Whistleblowers about banning Darvon) Judge for yourselves. http://bit.ly/exdSOn

      Eli Lilly has the moral responsibility for 100 000 deaths caused by Darvon since 1957. Time to pay http://bit.ly/i7hnIB

      We are just two Davids against the Goliaths, “Big Pharma” is the enemy and we are winning the battle. http://bit.ly/9r5VOU

    10. TMLutas Says:

      The preceding comment is a cut and paste monstrosity that’s been spammed over the Internet over 15k times according to Google. It’s mindless, unthinking, and does not address the issues in the article. It’s a sophisticated form of comment spam.

    11. Shannon Love Says:

      TMLutus,

      Yeah, I just got it in an email too. Clearly, they never read my post or they might have been more leery in sending me their name and address after I just complain how much worse they made my life. I mean, a plane ticket to Norway isn’t that much and I understand Norwegian prisons are quite comfortable.

      I looking into their research claims right now. So far, they are risible.

      One has to wonder if the good doctor will be a highly paid expert witness at the trials which will be “bigger than Vioxx”.

      Oh, hey, he sent me his picture as well. My, my. It’s like a trail of bread crumbs.

      *Sigh* This isn’t the kind of thing one can actually get bloody revenge over, especially on some old dude, but I can hope there really is such a thing as karma.

    12. Michael Kennedy Says:

      I suspect there is more money in expert witness work than pharma research. The “100,000 deaths” sound like they have been transmuted from Iraq.

    13. Michael Kennedy Says:

      An excellent sentence from the link:

      “To put it into a nutshell, Darvon affects your heart muscles and you forget to breathe, so people die,” Jonasson explains.”

      Sir William Harvey is turning over in his grave as his discovery that the heart is not the organ that “breathes” is sacrificed in the interests of trial lawyers world wide.

    14. ExExZonie Says:

      You said, “We need to change the role of the FDA.”

      The FDA is a captive of the pharmaceuticals (to reduce competition) and the trial lawyers. Further, I believe their plan to ban Avastin is a trial balloon to set the stage for the massive cutbacks to medical care needed to provide the “savings” that the Obamacare bill promised.

      Wait until the FDA decides that dialysis for folks over 55 is no longer justified. At that time, there will be horror stories about its costs (anywhere from $50,000 to $150,000 per patient per year, most of which is borne by Medicare, even for patients under 65) for the elderly. The party line will then be that dialysis “does more harm than good” for older Americans, based on studies for elderly patients who are deemed to be close to death and in very bad health.

      Dialysis will extend the life of a patient for the last weeks of life even if she already suffers high blood pressure, diabetes, metabolic syndrome, and other deadly conditions. But it will be argued that “younger patients” need the chair that she is occupying and the Medicare dollars she is consuming. The media will calculate it for their readers: about $600 per session x three times a week = $1800 per week, which they will extrapolate for a year’s time under the hypothesis “costs could be as high as $50,000”. This will be compared to other patients’ conditions that are going begging.

      I have seen people on dialysis who are incapacitated to the point that they do not know where they are. But the people who advocate the “courageous” decision to pull the plug on those they deem vegetables – would they have the guts to go to the clinic and literally rip out the bloodlines themselves?

      No – it’s much easier to do it through bureaucratic edict from on high. This is the legacy of Terri Schiavo.

    15. bill Says:

      I can’t say that I support taxpayers doling out $100,000 a year to care for an obese Medicaid patient that doesn’t exercise or care about diet (to use a hypothetical) … or even $100,000 to extend the pain and suffering for an illegal immigrant (or anyone that is not “paying their own way”) on dialysis. For those that depend on the “kindness” and judgment of strangers, I might actually support those “death panels”.

      I had one uncle that refused dialysis, even though he could afford it. People can make their own choice, but can they choose to spend a million of other people’s money? (and it comes down to money, which can be translated into “life” at some level)

      I’ve been part of a few uncles’ end of life decisions/thoughts, and now am the caregiver for my Mom 24/7. Hospital experiences indicate they are a for profit organization. A recent UTI adventure for a four day visit went through five doctors of differing opinions. (her “regular” doctor never came by, even though his office is attached to the hospital). The last two docs were pretty new, and when I talked of her recovery, they shook heads no … she would not come back, long talks … hospice the only reasonable course (they directed). Two earlier docs thought the UTI was culprit, and it was acute not chronic. But it was luck of the draw for these important decisions.

      They were dead wrong … I’m fortunate to have a nephew doc to consult with, but the hospital put me through the palliative and hospice paces, even as I said I was pretty confident she’d recover. She did get a heel x-ray though, when a tech misread a note that said “heal lift”, not “heel left”. More important fluids and meals were missed, but they got that heel x-ray in there. (and their big heel lift boots actually caused an additional sore, after they removed my sheepskin booties). They wouldn’t do a swallow test for fear they’d be liable if she aspirated, so I got her to swallow and then she passed with flying colors. Till then their course of action was hospice … no liability if they get me to sign on with that I guess. I think the nurses were happy when she was asking for ice water, I hope the doctors were chagrined.

      Now she is better than in quite a while, and I think the reluctance to give antibiotics and “let her go” delayed treatment in the first place. Doctor and nurse put me off when I suggested a UTI might be an issue … some get prophylactic antibiotic care, others get none. The hospice people were rather happy to inform me her doctor also happens to head up the hospice care, so we were lucky.

      The driving forces are profit, as I see it. There is a ton of waste, along with major bureaucratic inefficiencies. But the bills (congressional I meant, but also the ones we pay) are still written by the drug companies, insurers, hospitals, trial lawyers and equipment suppliers. More online resources would help individuals … but the wrong people seem to make all the big decisions.

      Why does the FDA get to take away a drug (Darvon) that has been proven to relieve pain? It makes as much sense as the hospital’s unwillingness to “risk” aspiration in a swallow test, safer to go with starvation and hospice care.

    16. tehag Says:

      I’m sure everyone here at every opportunity voted against the parties that, once in office, would appoint new FDA commissioners, and instead supported with words, money, and votes the party that would abolish the FDA.

    17. Shannon Love Says:

      Bill,

      The driving forces are profit, as I see it.

      As opposed to what, political power? Medical care is very expensive and the system will implode almost immediately if someone isn’t playing the adult and watching the bottom line. Hospitals don’t make money when their patients die or get shipped off to another facility.

      You really can’t create a large system in which people work for the good of others at their own expense. It’s a mythology that some people cultivate about themselves but in the end, everyone is motivated by selfish motives, even unconsciously.

      A medical system dominated by “higher” motive than profit would have its own built in distortions that would endager medical care. Look at the military, notionally a service profession, which has to constantly fight to maintain its integrity and often fails. Look at the history of monastic orders and how quickly doctrines of obedience, humility and good works degenerated into cynicism, arrogance, greed and indifference.

      The real problem is that you and your mother are not actually paying the bills. You are not actually the medical customer. The government or the insurance companies are. Both follow their own self-interest. It’s not that they are bad people, it’s just that their incentives to balance care versus cost always comes down on cost.

      There never was a time when medical care wasn’t about money and there won’t ever be a time when it isn’t. You only get to choose whether profit motive is the only distortion or whether politics is an ADDED distortion. That’s it.

    18. bill Says:

      It’s not that they are bad people, it’s just that their incentives to balance care versus cost always comes down on cost.

      Being the actual payer would make a difference in decision making for sure. And I was not very clear. But I think protocols and the incentive for income overrides care consistently. An X-ray is good income … that gets done pronto on just a misread note.

      A need to do a swallow test is skipped because of the fear of liability from aspiration. A more dangerous (but more profitable) “PEG” is discussed, which is surgery. There was still no evidence she couldn’t swallow or had aspirated at all, they were just afraid to try.

      I guess this is why it seemed like your Darvocet story … their “one size fits all” protocol was to not do the swallow test except with a certain level of responsiveness. But in my Mom’s case, their alternative was to let her starve or risk a surgery. Even the nurse said it was fear of liability that was the problem. Even the doctor didn’t want me to let her try, but was discussing the surgical procedure. I got her to drink anyway … with a rough voice from the feeding tube she said “give me ice water”. Good grief. Her throat finally healed up.

      But you hit on a key point … Medicare is the payer (and the insurance that picks up the other 20%) and the hospital knows what they can collect for. THAT is the major determinant in what procedures are done, and how long a patient stays.

      Many years ago I clearly remember my uncle sitting alone in his hospital room, waiting to go home. I asked the nurse how much longer, and she knew … it was the date his 30 days of Medicare allowance ran out. Nothing to do with his condition. My Mom had the same thing with her knee surgery, and they really hate to let them go “early”. She felt she was “in prison”.

      “Politics” shouldn’t have to be an added distortion, government should provide oversight, if they are the payer. But they are distorted by lobbyists. It seems like corruption is the problem … if that was mostly overcome, a few distortions would be bearable.

      The day may come when they try to actually CUT costs, but so far I mostly see they want to use up every dollar they can get out of Medicare (or the insurance).