PharmedOut 2015

PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing, and educates healthcare professionals about pharmaceutical marketing practices. Founded in January, 2007, it is an Internet-based alternative for doctors seeking Continuing Medical Education (CME) courses, not sponsored by the pharmaceutical industry.

Inasmuch as the industry derives its greatest profits from new proprietary drugs, it has a built-in tendency to tout them, even though newer is not always better. One example, cited at the time of PharmedOut’s founding, came from Georgetown Ob-Gyn doctor Anthony Scialli: “Take oral contraceptives. Over the years they have increased in number, but there haven’t really been any major advances since the 1970s. The newer ones are more expensive. Why do doctors prescribe them? Because of promotion and educational activities funded by the manufacturers.”

Starting in 2010, PharmedOut has organized annual conferences. The theme of this year’s conference (June 11-12) was “The Real Risks of Rx Drugs.” Over the two days, there were 16 presentations. Let’s take a look at three of them…

The endangered normal: Does anyone escape a diagnosis?—-given by Georgetown’s Dr. Adriane Fugh-Berman, a founder of PharmedOut. As she puts it, “the medicalization of daily life has become endemic.” Whether it is a shy kid with “social anxiety disorder”; a young woman who is less horny than her partner with “hypoactive sexual desire disorder”; or someone who urinates more than four times per day with “overactive bladder syndrome,” people with these common–and likely harmless–conditions create a potentially huge, if unjustified market.

Given TV drug advertising, patients are probably more susceptible to this sort of fearmongering, but doctors are not immune. To be sure, Big Pharma uses financial and non-financial inducements to influence those who prescribe. In an earlier article, Fugh-Berman noted that “Physicians fail to recognize their vulnerability to commercial influences due to self-serving bias, rationalization, and cognitive dissonance.” She added that “Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias.”

 

Researchers behaving badly: Misconduct in clinical trials —-given by Charles Seife, journalism professor at NYU, with a math background. In exposing wrongdoing at the FDA, Seife engaged his investigative reporting class to discover shocking examples of FDA burying evidence of research misconduct. Even though the form 483s (Establishment Inspection Reports) can be heavily redacted, if one takes the time to cross reference these with clinical trial data, it is possible in certain cases to pierce the veil of secrecy. And, pierce it they did.

Among other examples, they discuss the appalling case of “RECORD 4” (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism and Pulmonary Embolism). In this study, the new drug rivaroxaban (Xarelto) was being compared to the non-proprietary enoxaparin. At half of the sites that drew FDA scrutiny there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out.

Too bad that the official report, published in The Lancet, proclaiming the superiority of rivaroxaban, makes no mention of these issues. As the lawsuits against Xarelto are counted up, the FDA may change its tune, but don’t hold your breath.

 

Hyperglycemia, sedentary obesity, and complications of type 2 diabetes—-given by Thomas Finucane, MD of Johns Hopkins. It would be safe to say that Finucane is unconvinced regarding the merits of tight glycemic control. The final sentence of the abstract for his presentation makes that pretty clear: “The massive enterprise of setting and using drugs to achieve glycemic targets is unsupported by data, biologically implausible, and massively profitable to several interests.”

Finucane covered much of this ground in his August, 2012 paper, published in Journal of the American Geriatrics Society, with the legendary title “Tight Control in Geriatrics: The Emperor Wears a Thong.” He goes after the diabetes industry, which ceaselessly proclaims the benefits of aggressive glycemic control–especially in light of the ad agency developed Aim-Achieve-Believe: Diabetes A1c Initiative, launched on World Diabetes Day, 2002.

Finucane comes close to joining the Type 2 Deniers Club (current members include Ernest Curtis, MD and yours truly) by shredding several highly touted studies which proclaim the gospel of glycemic control. Even better, he publicizes a relatively obscure metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. One of the findings was that the risk of a cardiovascular event rose exponentially starting at a fasting blood sugar of 75 mg/dL. Apparently, virtually all of us are doomed!

In the 2012 paper, Finucane states: “The timidity of performance-measurement initiatives, disease-focused charities, professional societies, and academics in confronting the discrepancy between the data and the public relations enterprise is a matter for serious consideration.”

But does the paper’s sardonic title betray his reluctance to unequivocally condemn the type 2 memes? Indeed, why does the emperor even wear a thong, and is not simply naked?

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7 responses to “PharmedOut 2015

  1. The overactive bladder nonsense was insulting. So was the “dry eye disease”. Most frightening was the reintroduction of the IUD. It’s plastic now, so that makes it safe and fine? No way.

    I’m curious why you are so obsessed with Type 2 diabetes. There are hundreds of bad medical choices out there, but you keep coming back to this one.

    Actually, some doctors do recognize “tight control” as a myth and often undesirable. However, I would suspect they don’t tell patients this because they are afraid the patients will use this to just ignore trying to control at all. Both my GP and eye doctor have told me tight control is not going to happen in most cases and the eye doctor admitted tight control can actually make some problems worse.

    I admit I am horrified at the lengths I have read diabetics go to to achieve a normal A1c. Some will even pass out. I doubt they tell their doctor this, so perhaps some reading of blogs and forums would help.

    • @Reality–
      “Obsessed” because it is the most facile and dangerous “diagnosis” that exists today.

      1.    Simple and irreversible criterion

      2.    Simple home test (that can be massively inaccurate, BTW)

      3.    Many, many available proprietary drugs—-some with horrific side effects, including simply making the condition even worse.

      4.    Cynically conflates real diabetes with idiopathic hyperglycemia to create huge industry.

  2. There are Type 1, Type 2, gestational, type 1.5 (LADA), and type 3 (tentative type believed by some to cause Alzheimers) diabetes. It is insane the number of “types” there are and all are so different. I wish they had other names that made clear these are very different diseases.

    Which home test are you referring to–meter testing or the home A1C? (The A1C is one of those tests with varying scales on the results and possible confounding variables, so I am thinking maybe that’s it? Then again, meters have a 20% variability or greater…)

    I know people who are Type 2 who had serious complications because of late diagnosis. I also know people with the diagnosis that probably should not have been given the label and certainly not medicated. (She fit the idiopathic hyperglycemia category.) Some of the Type 2 medications are scary. As noted in my previous comment, so are the unrealistic goals for A1C’s that are used to sell those drugs.

    I understand much of your frustration. I am Type 1 who does not get A1C’s done (doctors are horrified by this, of course). I do my best and my best is very brittle at times. Fortunately, I read a lot and have no problem standing up to doctors. Realistically, there’s only so much one can do. No matter what type of diabetes, no medication is ever going to work like your own system did and it’s wrong to believe it can.

  3. @Reality–
    Just this AM, I took a glucose reading on one finger, which seemed high. I took another on the other hand less than 2 minutes later, and it was 32 points lower.

    Best as I can tell, the chemistry is affected by all sorts of residuals on the skin–including soap. The test strip people do not reveal any of this to the public, however. Never mind that readings can vary a lot just based on cortisol levels, etc.

    That’s why they tell you to never repeat a reading.

    A few years ago, I was “diagnosed” but am skinny, take no drugs. At that time went low carb–and stayed low carb. Still, my readings can go over 150, which I think is not such a big deal.

  4. Yes, that is a serious problem with glucose meters. My meter company was so happy when my readings were within 20% of the hospital’s readings. I thought that was really bad, though admittedly better than testape for urine sugars, which is what I started with. I wasn’t impressed and my meter is supposed to be one of the most accurate. Worse were the original meters that were basically colorimeters that were miles off if not regularly calibrated, and few were. I use visual comparison for years before going to an actual meter.

    Meter companies ask if you washed your hands, etc. Yes, I did. The hospital used alcohol and didn’t wait for it to dry. If you ask the meter companies, they will tell you this. I don’t know of any instructions not to repeat a reading–in fact my meter says to repeat the test if the result does not match how you are feeling. There’s also the problem that meters and A1C’s don’t match and really aren’t supposed to. Few discuss that. And different meters give different readings, side by side, 2 seconds apart. You learn to ignore a lot of things that make no sense whatsoever.

    I would agree that readings over 150 are not cause for panic. Even with the best of care, Type 1s go over 150 a lot. I’m happy to stay under 300 and my doctor is okay with an average of 200 to 210. I’ve been diabetic for over 43 years and it’s been this way for the entire time. Meters are a help, but we just do not have the technology to achieve control like doctors want, even with pumps (which are not just like your pancrease, no matter how many times someone says so). If only patients understood that an ideal is not really achievable but one keeps trying to do the best one can.

    I bought a book years ago on diabetes complications—a huge statistical book because percentages don’t really give the true story. An increased risk of 50% for heart disease isn’t as helpful as 1 to 2 diabetics per 100 have heart problems. It was a far more realistic look at the disease.

  5. If you check the pkg instructions with Life Scan:/OneTouch, they admonish you not to repeat, as do the phone CSRs. Why? Because then you would see how non-reproducible the readings are.

    Yeah, yeah, I know, they use bacterial enzymes, and it is not super analytical, except people are not taught from the outset that plus or minus 20% is as good as it gets.

    For you being a “brittle one” sounds like you’re doing great, and know well not to micromanage the damned thing. I personally know of two guys who croaked doing just that.

    As far as PharmedOut, Seife’s clinical trial presentation is *devastating* Really.

  6. Guess the meter companies would be unhappy if they found out how many of us do compare meters, recheck results, etc!

    My physician actually told me hospitals and doctors are learning that overmanaging diabetes makes it worse. Maybe there’s hope yet.

    I agree that drug testing and approval leaves much to be desired. Too much bureaucracy, not enough science, and too much at stake.

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