medication

What If We Are Wrong? Medication, Medical Science and Infallibility

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What if we are wrong? Such a simple question, but one that seems all but absent in modern medicine. Patients, particularly women, routinely present with chronic, treatment refractory, undiagnosed or misdiagnosed conditions. More often than not, the persistence of the symptoms is disregarded as being somehow caused by the patient herself. If the tests come back negative and the symptoms persist, then it is not the tests that are insensitive or incorrect but the patient. If the medication prescribed does not work or elicits ill-understood side effects, then somehow the patient is at fault. If the patient stops taking the medication because of said side-effects, then they are labeled non-compliant and difficult. The patient is always at fault. It is never the test, the disease model, or the treatment.

What if we are wrong? What if the tests to diagnose a particular condition are based on incorrect or incomplete disease models? What if a medication universally prescribed for a given condition doesn’t work or creates adverse reactions in certain populations of people? What if the side-effects listed are incomplete? Is it so difficult to admit that gold standards evolve or that medical science is fluid? Certainly, if a patient is presenting with a constellation of symptoms that create suffering and those symptoms do not remit with a given medication or medications and/or do not appear on the available diagnostic tests, why is it so difficult to consider that either the medication doesn’t work, the diagnostic was insufficient, or the diagnosis itself was incorrect? Why is it that we assume it must be a mental health issue or somehow the patient is causing the symptoms herself?

Here, one doctor tells how he learned that he was wrong about diabetes and metabolic disorder. He gleaned this not from a book or from his training and not from listening to his patients, but when he, a previously healthy young man, developed a metabolic syndrome that led to obesity and type 2 diabetes. It was by his own personal crisis that he began to question the model of diabetes and its relationship with obesity. Dr. Peter Attia asks:

What if we are wrong?

What if we are wrong, indeed. There are so many areas of medicine where we may be wrong; where we are likely wrong, but where no one is asking the question.

We congratulate Dr. Attia for his discovery, but why does it take a personal crisis for a physician to question the status quo? Why is there such fealty to particular disease classifications or disease models even when there is evidence to the contrary? Is it the nature of modern medicine to lay down guidelines and be done or is it simply human nature to resist the notion that we can be wrong? Maybe a combination of both; I don’t know the answer, but I do know that if one is certain of everything there can be no room for learning or discovery.

On the other hand, if we begin with the notion that humans, and thus, the structures humans create are fallible – that we do not know or understand everything – and if we add to that humility a dose empathy, perhaps then we can begin healing patients rather than managing them.

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This post was published originally on Hormones Matter in July 2013.

Over-The-Counter Painkillers: Use Medications with Caution

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The over-the-counter (OTC) medications acetaminophen (Tylenol) and ibuprofen (Advil, Motrin) are used by millions of people every day, for common conditions such as headaches, fever, muscle pain, chronic pain conditions, and arthritis. Yet how many people are aware that they can cause serious side effects, and in the most severe cases, death? Because these medications are available over the counter in drugstores and are taken by many people without any discussion with a doctor or pharmacist, the risks may not be well understood.

Medications with Acetaminophen

Acetaminophen is the leading cause of acute liver failure in the U.S., a serious and sometimes fatal condition which in some cases can necessitate liver transplant. Many cases of acute liver failure are caused by acetaminophen overdose; however, half of overdose cases are unintentional. In many cases of unintentional overdose, patients took more than one medication containing acetaminophen without realizing that both medications contained it. Acetaminophen is present in many medications, both prescription and non-prescription. Combination products that have acetaminophen as an ingredient include:

  • Prescription painkillers such as Darvocet, Percocet, Lortab,  Ultracet, and Tramacet
  • OTC cold and flu medications such as Actifed, Dayquil, Dristan, Nyquil, Sudafed, and Theraflu
  • Headache medications such as Excedrin

There is also some concern about the safety of acetaminophen at label-recommended doses, especially in patients at higher risk of liver injury from alcohol consumption. Acetaminophen at therapeutic doses may exacerbate the effects of liver injury from other causes. Individuals who are at higher risk of liver injury, such as those who consume more than three drinks of alcohol daily, are severely malnourished, or who take medications that induce liver enzymes, need to be aware of the potential risk of taking acetaminophen.

FDA and the Acetaminophen Medications

Because of these facts, in January 2011, the FDA announced new measures to reduce the risk of severe liver injury with acetaminophen-containing medications. Manufacturers are required, by 2014, to reduce the amount of acetaminophen in any combination product to 325 mg, in order to reduce the risk of accidental overdose when multiple acetaminophen-containing products are taken together. The FDA also requires a boxed warning on the package inserts of acetaminophen products highlighting the risks of liver injury, and the fact that concurrent alcohol consumption has been identified as a risk factor. Further, pharmaceutical manufacturers in the U.S. have lowered the recommended daily maximum dose on the labels of OTC acetaminophen products from 4000 mg to 3000 mg.

In addition to the liver injury risks, acetaminophen is also associated with rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Reactions can occur with the first use of acetaminophen, or any time it is being taken. The FDA has issued a warning to consumers about these reactions, and will require that a warning be added to the labels of prescription acetaminophen-containing products.

Medications with Ibuprofen

Ibuprofen is another common OTC medication that can have serious side effects. Ibuprofen is a type of non-steroidal anti-inflammatory (NSAID): medications of this type are very commonly used for chronic pain syndromes and arthritis, with more than 70 million prescriptions and 30 billion OTC tablets sold annually in the U.S.  Prescription NSAIDs include celecoxib, diclofenac, indomethacin, mefenamic acid, meloxicam,  and naproxen (Celebrex, Voltaren, Indocin, Ponstel, Mobic, and Anaprox), and OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve).

NSAIDs as a group (prescription and OTC) are generally well tolerated, but their use can increase the chance of a heart attack or stroke that can lead to death. Individual NSAIDs have different cardiovascular risk profiles. The highest risk is with the newer class of NSAIDs called COX-2 inhibitors, which include celecoxib, rofecoxib, and valdecoxib (Celebrex, Vioxx, and Bextra). In fact, rofecoxib and valdecoxib were taken off the market due to concerns over their cardiovascular safety: clinical studies had shown an increase in the risk of heart attack and death. The traditional NSAID diclofenac also has an increased risk of cardiovascular morbidity and death, similar to the COX-2 inhibitors. The safest alternatives with respect to cardiovascular risk are ibuprofen in OTC doses (less than 1200 mg per day total) and naproxen. The risk of cardiovascular morbidity increases with increasing dose and duration of use.

In addition, NSAIDs can cause adverse gastrointestinal events such as ulcers, and bleeding in the stomach and intestines, which can occur at any time during treatment. Gastrointestinal complications can range from mild, such as indigestion, to severe, such as ulcer-related perforation, obstruction, or hemorrhage. Mild gastrointestinal adverse events such as nausea, heartburn, dyspepsia, and abdominal pain are extremely common and may occur in up to 40% patients taking NSAIDs regularly. Serious complications, although much more rare, are still too common, and their incidence has not changed in the last decade. For example, in patients taking NSAIDs for arthritis, the annual number of hospitalizations for serious gastrointestinal complications is estimated to be about 100,000, with over 16,000 deaths.

Almost 75 percent of patients who used NSAIDs regularly were either unaware or unconcerned about possible gastrointestinal complications, and two-thirds of patients stated that they expected warning signs before developing serious complications. However, only a minority of patients with serious gastrointestinal complications due to NSAIDs had gastrointestinal complaints prior to the serious complication.  Risk factors for adverse gastrointestinal events include advanced age, higher doses of NSAIDs, a history of gastroduodenal ulcer or gastrointestinal bleeding, concomitant use of corticosteroids or anticoagulants, and serious coexisting conditions.

Although risks of ibuprofen at OTC doses have not been as well studied as prescription NSAIDs, or NSAIDs as a group, the same risks are definitely present when taking OTC ibuprofen. The risk of an adverse event increases with increasing dose of ibuprofen, and for heart disease, the risk also increases with longer duration of use. Many users of ibuprofen may exceed the label-recommended dose in an attempt at better pain relief, or combine ibuprofen with other NSAIDs, both of which would increase the risk of adverse events. The label-recommended dose of OTC ibuprofen is 400 mg per dose, up to 1200 mg per day. However, in my own experience I have been advised by multiple doctors to take 600 to 800 mg per dose, up to 3200 mg per day, without any discussion of the potential for adverse events. Not surprisingly, I have NSAID-related gastritis. I have also talked to many chronic pain patients who routinely exceed the label-recommended doses of both ibuprofen and acetaminophen, and combine these medications with other prescription pain medications containing NSAIDs or acetaminophen. Although this might be acceptable for some patients, in some circumstances, it should definitely not be done without a physician’s recommendation and discussion of possible side effects.

Bottom Line with OTC Painkillers

The bottom line is that although acetaminophen and ibuprofen are generally well-tolerated at OTC dosages, especially for short durations of use, the potential for serious side effects exists. Just because a medication is available without a prescription doesn’t mean it is safe to use in all circumstances. Patients should be aware of the potential risks of these medications, and discuss their use, both in duration, and dosage, with their physicians. In addition, individual patients may have relevant medical history or concomitant medication use that puts them at higher risk of an adverse event, even with OTC medications, another reason to discuss their use with a physician.

Adventures in Prescription Medications – Woman to Woman

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How’d you like to bypass years of countless doctor visits, cornucopias of medications with names beginning with every letter from the alphabet, take-one-a-days, with- meals, mixtures, combinations, co-pays, micrograms and tears?

The answer might be simpler than you think:

Just eliminate one or two real assholes from your life!

And the only known side effect you’ll “suffer”: New found, authentic happiness – organically produced by your formerly abused spirit… the one that always seemed ready and willing to absorb total blame and negativity for what was wrong in your life!

Woman, this is a deep, dark secret the big pharmaceutical companies DON’T want you to know: that all too often, the truth about your misery and “depression” can’t be found at the bottom of a pill bottle, but lies on the other side of your bed. The root of your problem? The jerk lying with his manipulative little head on the opposite pillow, snoring like a revved up chainsaw, not some “chemical imbalance” roiling in your brain. And woman, just boot him out of your bed, and you’ll step into your fresh, drug-free future!

Can it really be that easy? Well, yes and no.

Remember how Alice in Lewis Carroll’s classic Alice’s Adventures in Wonderland only had to choose which side of the mushroom to bite to “right size” her enlightenment? We real-world women let ourselves endure strenuous drug trials and errors much more dangerous than Alice’s mushroom. Why? Because in typical womanly fashion, we’re so prone to look in the mirror and accuse the face we see there, rather than look outward and objectively scrutinize the fingerprints of asshole’s thumbs we’re stuck under.

Sister, if I had a dollar for every woman I’ve heard say, “I quit antidepressants cold turkey because I realized they did absolutely nothing for me,” I could buy as many shoes as Imelda Marcos. And needless to say, you’d never see me twice in the same pair of stilettos.

Women, we can only find our salvation by making serious changes in ourselves and our surroundings – starting with understanding how and why we think, feel and react to negative and self-lacerating “triggers,” and then learning to dance with these shadows rather than fear them. We can find true healing in all sorts of crazy ways: places, faiths, interests and communities too large and lively to fit into any capsule. Sometimes even complete solitude can be our alternative to prescriptions.

While suffering my own deepest depression about five years ago, I remember feeling envious of people who claimed antidepressants at least made them feel like zombies. The pills never got me near feeling no pain, and the grass certainly did seem greener on the other side, ‘cause my side of life seemed to be a daily skate on thin ice. At any moment, I dreaded a crack might start in the ice, through which everything in my world would slip, never to be seen again.

But then I took the “great risk”: I removed the asshole from my world. I didn’t go crazy off the pills, I not only regained my sanity and my life, I realized how terribly sad that pill-driven desire was – to feel nothing, to want my days to roll over like fog mist. Now I know every day is too precious, too fragile…too full to waste. Me, I was truly better off letting those medications slip down the trash bag rather than into my blood stream. My life’s still filled with challenges. I still cry. I still worry. But I’m no longer afraid of the “edges” of experience. They’re there, and I’m here. I accept the love and support of people who honestly love, benefit and respect me. Anyone else, I show the door.

I know that for many women the issue of whether or not to take antidepressants is no question at all; it’s necessary to avoid the insistent beckoning call of the edge. Taking a pill never makes you inferior, and you shouldn’t feel ashamed to take one if you have a true, measurable chemical imbalance. But never forget: You’re not the pill; you’re a woman, aware and alive enough to value and cherish the air in your lungs. And that pill might be keeping you from being that inspiration to others you could be.

Many of us stand in the space between poor, suffering lab rats and the Big Pharma company fat cats. We struggle to decipher what extra help we might need to lead vital and healthy lives and whether to cut out the magic bullets that weren’t magical after all. Here is where we indeed have something in common with Alice: Even she had to deal with a conniving Cheshire Cat.  Are we willing to consider that some manipulative “cat” has driven us to Dr. Feelgood and the pill bottle?

The old “Serenity Prayer” still applies when it comes to deciding which pills to swallow and which ones to ditch. God grant me the serenity to know when I’m able to remove myself from trying chemical paths to health, even the courage to disregard a doctor’s orders when my gut instinct says, “Hell no!” to still another prescription. And the wisdom to know the vast differences between these very grey areas. Amen.

Oh, and P.S.: God grant me the gumption to toss out every asshole in my life once and for all, even if I don’t toss all the pills out with them, too!