Pharmageddon by David Healy

book jacketPharmageddon by David Healy (c 2012)

About 20 years ago, I began having trouble eating. I wan’t even particularly hungry, so that made it hard. I began losing weight, which was okay by me (seems my weight has been a constant seesaw and not in a good way, usually always something bad causes it). The doctors said “stress” and maybe “ulcer” from stress. Watchful waiting was the course of action they opted for, and that, I think, is code for your health insurance won’t pay for any tests and we haven’t a clue without doing an endoscopy or something, and you’re not dying (because no one dies from an ulcer – usually not anyway), so it will be fine. About 30 or 40 pounds later, I continued to express concern that something was seriously wrong. Still, no one seemed concerned; maybe because everyone wants to lose weight?

Looking back now, I cannot decide to laugh or cry. Doctors were telling me stress was causing me to become sick and my employer at the time ended up fighting my sexual harassment claim based on their opinion that stress did not make me sick — because, they claimed, stress does not make you sick.

It was common knowledge at the time, and for many decades before that, that stress does, in fact, make you sick. However it turned out that it does not cause ULCERS, the single most common diagnosis for ulcers was, for many years, stress.

Now we know that a germ causes ulcers, H. pylori, and it can be detected with a blood test, and cured with antibiotics. Before this germ was discovered in 1982, surgeons actually went in and cut away parts of stomachs to eliminate ulcers. Beyond stupid, but once surgery was developed, as they say, the solution to everything became a scalpel. Even when other treatments were effective enough or less consequential, doctors, consistently have failed to believe new findings. For example, longtime denial of the germ theory of disease meant that surgeons and doctors did not wash their hands or their instruments or the patient before cutting them open, or between one contagious diseased patient and the next. It is amazing that ANYONE survived surgery or early “dentistry” not to mention pre-novocain days for the sheer suffering people lived with from dental hygiene problems. Yuck.

The real tragedy, one experienced by poor women most of all of course, was (as The Dirty History of Doctor’s Hands describes) maternal deaths:

In these pre-Louis Pasteur days, the medical establishment didn’t yet know about bacteria. The main preoccupation of the time was with humours and miasmas, and ‘treatment’ for childbed fever involved inducing vomiting, bloodletting, blistering agents applied to the women’s inner thighs, enemas, and liberal use of leeches with the aim of purging the fever heat from the body.

His friend’s death [after being cut by a student’s autopsy scalpel]—so similar to the deaths in the medical student clinic—led Semmelweis to hypothesize that the trainee doctors were exposed to ‘cadaverous particles’ in the course of the autopsies they conducted, which they then transferred to the new mothers. The midwives in the neighboring clinic, who concerned themselves only with births, weren’t exposed to these cadaverous vapors. Semmelweis proposed, for the first time in medical history, a connection between touching cadavers and a risk of infection.

He instituted a policy for both the medical students clinic (that practiced on poor people for free medical care) and the midwives clinic, that all should wash their hands with soap and water, but it proved not enough to get the stench of death off hands so he added another cleanser to the protocol. The rate of maternal death went from 1 in 10 [the medical students’ stats !!!!; the midwives did better at 1 in 25] to 1 in 100. The article linked above does not specify if that was for both clinics or either.

It is astonishing to me in this day in age, though it does not truly surprise me, that poor women dying in childbirth at a rate of 1 in 10 was not the cause of massive investigation. Because I had previously read about the subsequent adoption, or lack thereof, of the germ theory by the medical community (evidence and statistics notwithstanding), it was no surprise to me when I read further in the article and discovered that instead of embracing something as simple as WASHING THEIR FUCKING HANDS, the medical community rejected the evidence and let women continue to die in childbirth  and other people in other circumstances because of their “beliefs” — much like we experience in so many areas of the actual lived experiences of today regarding climate change, medical care (or lack), extraordinary methods (for the rich), and don’t get me started on mental illness treatments.

Unfortunately, things did not end well for Dr. Semmelweis who desperately sought to persuade the medical profession to at least try washing their hands. They scoffed and derided him, making him even more desperate to get them to at least try washing their hands. His opposition bitched about his failure to do “scientific” studies to PROVE washing hands worked and that patients (women) DIED without it. Please note, they cared more for the “proof” first — even if it meant women dying — because of their love of the abstract. They could have just tried washing their hands since the outcomes certainly wouldn’t have been worse! But human beings seem to be particularly prone to say “no” first — “how can something be invisible and lurk under fingernails that can kill a person” thinking instead of saying, “yes, what the hell, people die a lot, so anything to stop death by something so cheap and accessible would be good.” But I guess there weren’t many malpractice suits back in the day, and since poor people were principally involved, the doctors did not care. And without evidence of germs, doctors could not be held liable for causing the death of a patient due to failure to wash hands rather than the disease or injury attempting to be cured.

Okay, I have digressed from the book a lot, but that is half the fun of reading and writing because when I have questions, like when did doctors start washing hands, the Internet is there and proves to be full of fascinating information. So to conclude the sad tale of this deeply committed (no pun intended) doctor to saving the lives of mothers and children, he was judged by his peers to have lost his mind and was involuntarily committed to an insane asylum.

Under this [facility tour] pretext, the 47-year old Semmelweis was driven straight to a large, public asylum. He was severely beaten by the guards and died—of an infection—two weeks later.

In honor of Semmelweis’s legacy to medicine, several medical schools, hospitals, womens’ clinics, and museums now stand proudly bearing his name. But, perhaps most appropriately, his name graces the so-called “Semmelweis reflex”: the kneejerk reflex to reject new evidence contradicting established norms.

It is a really good article, worth the 5 minutes to read. One stat mentioned was that even today, knowing and accepting the germ theory (thanks Louis Pasteur et al), the article cites that 100,000 deaths A YEAR in hospitals can be attributed to germs. Back in Dr. Semmelweis’s day, women knew better than to go to a maternity ward, choosing instead to give birth in the fields or streets. But today, since the doctors (male) drove out midwives (females) and became the heroic figures that they are (cough cough, they still call it “practicing” medicine) and yet studies have proven that they (male) still DO NOT WASH THEIR HANDS as they should. WTF is wrong with these people. Nurses (female dominated profession) do a better job of washing their hands.

The rush to the knife still plays out with the Ceasarean section becoming popular instead of only an emergency, and the subsequent necessity of additional C-sections, and BIG SURPRISE increased potential for INFECTIONS.

This leads me to the next sequence of the inevitable events: antibiotic resistant germs. This book has a good index and includes references to specific drugs, like Cipro. I mention this particular one because I learned somethings about pharmaceuticals that I did not know before: having taken this, and another drug for which there was no better alternative. (No alternative for two reasons: not FDA approved and not not allowed to be imported i.e. ordered from a Canadian (or Europe or Ireland) pharmacy where another drug is available and instead of permanent neurological damage, the worse adverse effect is SUDDEN DEATH. The drug I am talking about is for gastroparesis, the one allowed in this country is called metoclopramidetrade name Reglan). Believe me, not being able to stop vomiting makes the risk of sudden death look good, better than permanent neurological damage, but I never did get the odds for each calculated since the other drug was literally not allowed in the country (but probably made here!), I don’t recall the name now though.

Cipro is an antibiotic that is very effective for some germs in urinary tract infections, which, left untreated can kill you. It is what the industry calls a “black box” drug, meaning it has adverse effects so severe that I guess death is possible or severe consequences (black as in funeral black). In the case of Cipro that potentially impacted me, it had spontaneous torn tendons as a possible side effect. I don’t know for sure if the damage done to my wrist ligaments was related to the tendon events, but doctors I consulted about it decided it was better to not risk using it. I spent months in wrist supports in terrible pain when I moved my wrists. They did get better naturally so I am not going to take it again.

Cipro is mentioned in the index and only has one brief, damning reference on page 236.

A second reason things are different now is that unlike other industrial processes, many of which have led to tangible benefits, the logic of healthcare MARKETING may block real benefits. Companies initially attempted to PLAY DOWN THE EVIDENCE THAT ULCERS WERE LINKED TO A BACTERIUM  that could be eliminated, because THIS INFORMATION WASN’T GOOD FOR BUSINESS. They have similarly been extraordinarily successful REPLACING OLDER GENERATIONS OF ANTIBIOTICS, psychotropic drugs, and anti-inflammatories with LESS EFFECTIVE and MORE HAZARDOUS AGENTS such as Celebrex, Prozac, and Cipro. As a result some of us are now dying earlier than we should, and many more are suffering needlessly.

This time the “healthcare industry” wanted to wish away the loss of many pharmacological LIFETIME treatments for ulcers FOR PROFIT. But I guess they came around when they figured they could make lots of money off the complex triple onslaught of various drugs to kill H. Pylori when it first became standard practice.

The author, a Professor of Psychiatry, spends most of the book discussing antidepressants and related drugs, and there is plenty of chicanery in that cesspool of profiteering. The best parts of interest to me involved the way the for profit “healthcare”industry” perverts the entire practice of medical care. For one thing, they are all in it for PROFIT which is counter to being in it as a PUBLIC GOOD. It means that, according to a meme I saw somewhere, cancer drugs used to cost $10,000 a YEAR and now cost $10,000 a MONTH. My own personal pharmacological regime is appallingly costly because multiple sclerosis, Sjogren’s, and arthritis, and torn ligaments, multiple surgeries and more certainly mean I may have topped out the former (pre-Obamacare) MILLION dollar lifetime cap by insurance companies. I’m not good at arithmetic and don’t really want to know, but maybe the million was per insurance company and since not many of us spend our entire lives working for one company anymore (not necessarily willingly either), I haven’t worried about it, but post-2016 election, I am starting to be really concerned (I am on Medicare).

The pharmaceutical companies, as many cynics have noted, need sick people, not cured people. There is no profit in cures. Does anyone seriously believe that their corruption does not extend to deliberately withholding or not pursuing drugs that could cure diseases cheaply in favor of symptomatic, expensive alternatives? In a world where corporations like Exxon have lied about climate change for decades EVEN THOUGH IT MEANS THE END OF THE WORLD, do you really think they want to find a cure for cancer? They are looking for the next “blockbuster” drug that will make them billions and cost them pennies. Hence all the work to “cure” a problem that didn’t really need solving, erectile dysfunction. Think of the resources spent on this one non-life-threatening “medical” problem when the industry refuses to make “orphan” drugs available (drugs that will save the life of only a few people with rare diseases) without government compensation, or pursue variations of branded drugs that are about to go off patent so that they can vary it just enough (filler or similar irrelevant component) to allow them to obtain a new patent or they collude with generic manufacturers to buy them off for a few more years of patent brand level pricing and profit.

In the quote from p. 236 above, I relay the second reason for our problem with healthcare today. The first reason also on that page is that these drugs “physically act on stuff of which we are made and may reconfigure us quite dramatically in ways we are not told about.” (For example side effects, adverse effects, long term consequences.)

Unlike short courses of antibiotics, which do not substantially change us, chronic courses of treatments aimed at managing risk factors do change us. Whether it be a cholesterol-lowering statin, an anti-inflammatory such as Celebrex, a treatment for osteoporosis such as Actonel, or a psychotropic cocktail, these drugs do not just have the action we are told about but often have much greater effects throughout the body than the one the company markets, potentially leading to an increased risk of dementia in the case of Vioxx and Celebrex, and enduring susceptibility to heart attacks in the case of Fosamax and Actonel, or changes in our ability to make love in the case of Paxil, Cymbalta, or Zoloft. Beyond these specific problems, the indiscriminate actions of man of these drugs on our physical constitution quite probably alter both our susceptibility to various diseases and our personalities too in subtle ways.

In my case, one of my concerns is that there can be no definitive drug interaction testing of all the various things I take in order to be able to function (walk, stay awake, not vomit, not have MS exacerbations, sleep, whatever). But I still take them because without them I would be much much worse. But I have the luxury, so far, of having Medicare for insurance plus the infamous non-negotiable price fixing by industry lobbyists Plan D. I will be on exactly NONE if this insurance is eliminated by the deadly Randian’s in control of the future. While one of the drugs to prevent or reduce exacerbations costs MSers thousands of dollars a month FOR COPAYs (my quote two days ago was $2,000 + for ONE MONTH (3 shots x 4 weeks, so 12 doses). Then there is the $2,500 “donut hole” of zero coverage, so take that right off your net income. The cost of the same exact drug in Europe and Canada is about 30% of the US retail price.

The truly tragic failure of our representatives and leadership to provide single payer healthcare and deny the exploitation of people for profit continues. The current system “now produce as many perverse outcomes as they do in part because of some mechanisms we have put in place that stem from our recognition of how central health is to everything that counts for us.” The author continues (p. 237):

Given this centrality, it seemed important to Senator Estes Kefauver [D-TN] to control the pharmaceutical industry, and he, on our behalf, attempted to do so by making new drugs available by prescription only and then only letting them on the market once they had been through controlled trials. These safeguards, which were designed to bolster the role of doctors and CONTAIN industry, have in industry’s hand been turned to do just the OPPPOSITE. Increasingly alienated, doctors are not the force they once were and it is very difficult to view them as a body likely to RISE UP and demand change.

Talk about understatement! The money being paid via “educational seminars” in the Caribbean or other fancy resorts plus goody bags, and other perks — or punishments — keep the doctors’ self-interests aligned with Big Pharma, not patients. The reason they can collude like this is because PATIENTS ARE DELIBERATELY KEPT UNINFORMED or are not given the ability to judge for themselves what risks and benefits warrant a particular choice. Disinformation about the quality of generics versus brands, marketing direct to consumers so they ask for brand names and are completely unaware of other options, options which may not provide any benefit to the doctors so provides a disincentive for them to argue a patient out of a requested drug. Though some insurance requires the use of generics instead of brand names and dangle the carrot of a lower copay to patients, there are billions of dollars at stake so I am not sure that this is effective. Plus the games Big Pharma plays with fake lawsuits by generic wanna be makers getting paid off in the guise of a lawsuit settled out-of-court, cuts off the creation of a generic option before creation.

Reforms in these area will require wisdom — having good intentions is not sufficient.

[Reforms he mentions include removing clinical trials from the hands of industry, availability of RX without prescription (though that raises the specter of over-the-counter not being covered by insurance for no damn good reason), and the CURRENT PATENTING arrangements for drugs; no shit!]

Social arrangements have a great capacity to deliver exactly the opposite outcomes to those their proponents intended, as perhaps Kefauver’s 1962 Act demonstrates better than anything else. But our intentions are also important. There must be some attempt to answer just what it is we want or need in order to determine whether our arrangement are likely to facilitate this or not. (p. 239)

The development of the reform of the sixties to reduce pharmaceutical marketing by developing the concept of clinical trials was coopted by the industry in the nineties.

. . . this medical turn to controlled trials evolved into a commitment to what came to be called evidence-based medicine[EBT]. Far from resisting these moves that were meant to constrain it, industry embraced them, and from the 1990s has proselytized for evidence-based medicine. Few seem to have noticed the irony, and among those who do there is bewilderment as to how to manage this Hydra who grows new heads no matter what efforts are made to prune it back.

Medicine today has to be based on evidence — but what is evidence? Industry has masterfully exploited ambiguities in the word, and especially, a gap that lies between the data — what actually happens to a patient — and the later construction of “evidence” as to what a drug does. Where doctors are faced with the word “evidence” they for the most part believe they are dealing with data-based medicine, and as long as they think this way industry can vigorously promote their version of what happened when drugs are given under the banner of “evidence”-based medicine.

There are several ways in which the data that should be at the heart of medical evidence are hidden by the pharmaceutical industry. First, there is a drug company’s outright hiding of the data that is collected so no one gets to see it. Second, the remaining data is disguised through certain kinds of statistical models and what comes out the far end is presented as “evidence,” while the injustices that happen to you and me are degraded to the status of an anecdote. And finally companies have created a culture of data neglect, in which doctors have become blind to what is happening to the person in front of their eyes.

The issue of hiding data is not the scandal it should be in part because of the common perception is that drugs are made in company laboratories. This view misses something fundamental: companies make chemicals, but we are the laboratories in which modern drugs are made. Drugs are chemicals used for a social purpose — to treat conditions that we define as diseases. Drugs cannot come into being useless we as healthy volunteers and later as patients in clinical trials agree to take them to see what happens. Without participation, there is no drug.

Our willingness to participate in these studies was borne out of a sense of civic duty in the 1950s. We participated on the understanding that taking risks might injure us but would benefit a community that included our friends, relatives, and children. We did it FOR FREE — in perhaps the greatest ever example of how a system geared around people rather than products can make much more economic sense. The system worked and extended the compass of human freedom from the many epidemics and other scourges to which our forefathers [sic] had been subject for millennia.

But the research in which we once participated has morphed from scientific studies whose data has been sequestered. There are all sorts of protections now built into trials that weren’t there in the 1950s — centering on informed consent about the possible benefits and side effects of treatment and suitable safeguards of anonymity. But we are never informed about and asked to consent to the sequestration of our data in company trials. We assume we are participating in science and that the data arising from the risks we take are available to scientists more generally, as they once were. (p. 240-241)

More detailed discussion of drug company trials statistics and what they actually mean and how they were derived makes me question the validity of any of it, apart from the conflict of interests inherent in giving Big Pharma free research for conducting the trials and granting them lengthy exclusive patent rights without ever expecting them to comply with the original statute requirements for some quid pro quo return. He relays a perfect example of how, like in the demand for scientific proof before doctors agreed to wash their hands (theoretically), the actions in bygone days like Dr. Semmelweis who just started to make everyone wash their hands were effective compared to the study it for decades while people are dying method his doctor colleagues advocated before they would be willing to wash their hands. In this example, he refers to the infamous pump in London and the cholera outbreak in 1856:

When John Snow, investigating the outbreak of cholera in London in 1856, found a cluster of deaths from the disease on Broad Street, he was not inhibited by CONSIDERATIONS OF STATISTICAL SIGNIFICANCE because this concept hadn’t been invented. He was free to recognize a cluster. Clinical prudence dictated a course of action — remove the handle of the pump. Science mandates efforts to GO BEHIND THE DATA in an attempt to establish what has given rise to the cluster. But if companies had controlled the pump and took an Ian Hudson approach, they would not countenance the removal of the handles or any investigation of what the mechanisms giving rise to the cluster might be — unless the findings were statistically significant, which in all likelihood at Broad Street THEY WEREN’T. (p. 244)

Sadly, like the recent discussion about the Wall Street Journal editor who will not call Trump lies LIES, medical journals do not even feel compelled to do due diligence, like ask for the raw data for journal articles submitted for publication. He cites the editor of a prestigious journal that published a highly cherry picked study (“539”) and was then used by the marketing department to use the fact it was published as validation for their drug (Paxil). However, it turned out that they LIED. The drug was not sage for children, placeboes were more effective and had fewer side effects, like SUICIDE. The editor was interviewed and asked if she regretted publishing the fake/lying/killer of children article. She did not. Not her job she said, to validate author submissions, “not to tell people what to do.” And regarding salesmen, “we certainly have no control over how they use something, and “I can’t control the authors. No, I don’t have regrets. . . . If someone misuses our journal we really have very little control over that. . . .” Plus the damn report was GHOSTWRITTEN. “I can’t speak to what those authors, to the extent, how much they saw the data. Someone can write something and you may or may not agree with it. The fact that someone puts the words together may be a good thing or a bad thing depending on what the word are. . . .” (p. 246)

OMG sounds just like The Donald’s word salads, “I use the very best words.” They are all lies, but the words are good ones. Ha ha ha. (Weeping now.) The author was clearly appalled too:

In contrast to what one imagines the position of the editor of the New York Times might be had they published Study 329, Mina Dulcan seems completely unfazed by her role in the publication of one of the most notorious studies of all time. At some point it is going to take a gutsy academic editor to risk being shut down by industry or the rest of us to consider whether we would be safer if publication of clinical trials happened in the New York Times and academic journals were reclassified as periodicals and academic meetings as trade fairs. (p. 246)

The fix of prescription drugs in the sixties was to let the doctors, who gave a damn about their patients, to control the access to the drugs, rather than just let the FDA decide because they are not directly concerned with patients. Rather they are mostly about label accuracy. The author notes that the AMA actually used to run an “independent program of drug assessments.”

I did not know that prescription-only drugs was a relatively new development.

The initial prescription-only arrangements introduced in 1914 were a POLICE FUNCTION aimed at controlling the use of substances like heroin and cocaine. This seemed incompatible with the practice of medicine to many. We have since lost any perspective we once had that giving a doctor exclusive control over access to something as important as life-saving remedies might CORRUPT THE DOCTOR. . . .

Rather than a bulwark against industry, prescription-only privileges have become a bulwark for physicians against competitors in the health domain, like homeopaths, psychologists, nurses, and others — a “precise” just like the Right of Power in Lord of the Rings to be guarded jealously. A ring that puts physicians directly in the gun sights of the most sophisticated marketing on the planet. (p. 248)

Basically, the system, like so many American systems is broken. Deliberately corrupted by everyone to make another nickel regardless of consequences. Capitalism is not a good economic system for the public health. Great for profits for corporations since the choice is BUY or DIE.

So good book, basically. Fascinating tidbits on the history of how the system came to be. This could be expanded into a whole book of its own, especially given the REPEAL gang who have no apparent replacement plan in the works. If I catch up on my overdue books, I may spend some dedicated time doing more investigation of how Medicare works because I have not been able to find sources for so many things, like the mandate that you cannot bring your own prescriptions to take while in the hospital but must buy from their pharmacy, which is always, I was told by an insurance representative, considered out of network even if you walked in and bought from the pharmacy it would be in network. The problem is that the hospital charges PER PILL DELIVERY OVERHEAD. So the pill might cost $1 but to get it ordered, filled, and delivered costs $24.00 or so. They have lots of dubious reasons for this rule but cannot point me to an authoritative source. It is just like how the sky is blue, it just worked out this way. Pfft.

Oh, and in case you were stilling wondering, my problem was not stress induced ulcer, it was gallbladder disease and I had to have emergency surgery and had it removed. I had some choice words for the doctors who let me suffer for months claiming it was stress or basically not believing me.

 

 

 

 

 

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