More Sleaze from Big Pharma

Health Tips / More Sleaze from Big Pharma

I can appreciate you might be fatigued with this topic, but let’s face it: for virtually everyone, health care today means going to the doctor and coming home with a prescription.

In your heart of hearts, you know your prescription is made up of a chemical and carries a boatload of potential side effects you hope won’t kill you. Take a full bottle of the stuff, all the pills at once, and you might die on the spot. Oh, I’m sorry, aren’t those bottles generally labeled “Poison”? So, fingers crossed, you swallow a pellet of whatever chemical’s been prescribed and hope for the best.

When the FDA was created in the 1920s to protect us from snake oil salesmen, who would have ever guessed that snake oil–now known to be high in both antioxidants and omega 3s–is actually better for you than most prescription drugs?

The reality is that some of us will die as a result of prescription drugs. As an occasional prescription-writing physician, imagine my perpetual discomfiture scribbling what might later appear on your death certificate. You could be part of this shocking statistic: correctly taken prescription drugs are the fourth leading cause of death in the US.

Since I keep my own prescription-writing to a minimum I don’t lie awake at night stewing about this. Ironically, though, if I neglect to write certain prescriptions I can be sued for failing to abide by the professional standards of good medical practice. So the system does get you both coming and going.

Fortunately, instead of actually dying from these chemicals, we get side effects. Listen to them all in every TV drug ad, spoken so quickly that death–the ultimate side effect–comes out “dith,” like a little spritz of the announcer’s saliva. Thus with every prescription, we hope we’re spared weight gain, vomiting, skin rashes, or the humilities of a marshmallow penis. Nobody wants their sex drive or ability to have an orgasm to become a remote memory.

We just want to feel better.

So whenever I see an article by Marcia Angell, MD, former editor of the New England Journal of Medicine (who resigned because she so disliked the influence of Big Pharma on her journal) and now in the medical ethics department at Harvard, I always get a sinking feeling. That’s because she’s also the author of The Truth About Drug Companies: How They Deceive Us and What We Can Do About It.

“What piece of feel-bad information will Dr. Angell tell me today,” I muse. “How, yet again, has my profession botched up everything?”

The latest from Dr Angell

Her two-part article reviewing three recently published books highly critical of the entire psychiatry profession and its coziness with Big Pharma appears in the last two issues of the New York Review of Books. I summarize Dr Angell’s not-for-the-beach summer reading and my own gut-wrenching moments in these bullet points:

  • All psychiatry now owes its existence to the pharmaceutical industry. Talk therapy? Freud? Analysis? History! (Though this I already knew.)
  • Virtually all classes of psychiatric drugs were given FDA approval on evidence that would trigger an ironic chuckle out of any 6th grader working on her science fair project. For a typical antidepressant, your average pharmaceutical company submits approximately eight double-blind placebo-controlled trials (meaning neither patient nor doctor allegedly knows which was medicine and which was dummy pill). For most of these drugs under review, six of the eight studies showed the drug was not superior to the placebo, but the company was allowed to suppress these six tests and publish only the two favorable ones. To gain access to the suppressed studies, you need to invoke your rights under the Freedom of Information Act.
  • Practicing physicians will see only the two favorable studies, published in “reputable” journals that receive millions in advertising from Big Pharma. As a reader of these journal articles myself, I am led to believe the drug really works.
  • The guinea-pig patients who volunteer for these studies receive nice financial rewards for their effort. They make themselves available for multiple trials, which is why they’re called “recyclable volunteers.” Not surprisingly, although they’re not supposed to know if they’re taking actual drug or placebo, they do know within a few days…because the drug gives them side effects and the placebo none. To please the investigator and get re-hired for the next clinical trial, they’re skilled at reporting what the investigator wants to hear. “I feel better” when taking the drug, “I feel nothing” when not.
  • When a group of researchers was actually studying just the placebo effect–not in relation to any particular drug–they tried changing the rules slightly by giving patients a placebo that also contained a harmless chemical to deliberately induce side effects—called an “active” placebo. When the researchers pitted this “active” placebo against a typical antidepressant, the two pills produced exactly equal results. Both the antidepressant and the active placebo relieved depression.
  • Physician investigators (virtually always department heads at prestigious university hospitals) conducting the trials for drug companies seeking FDA approval are paid obscene amounts of money to run these trials. Since psychiatric results are extremely subjective (as opposed to a medicine for high blood pressure, which either lowers blood pressure or doesn’t), the data obtained in these studies can be cleverly manipulated to slide the results through the FDA-approval process.
  • The DSM (Diagnostic and Statistical Manual of Mental Disorders), a huge manual published by the American Psychiatric Association, codifies psychiatric diagnoses. It can only be described as “loosey-goosey” in its standards. In a recent survey of randomly selected adults, a full 46% of them met the DSM criteria for having at least one, and often multiple, forms of mental illness. Every single time the standards are loosened (like adding “Prone to temper tantrums” to the criteria for childhood bipolar disorder) or a new syndrome is created (like “Social Anxiety Disorder” or “Shift Workers Sleep Disorder”), the eyes of some Big Pharma CEO light up at the thought of owning the patent on the drug for it. For example, just as Abilify was about to go generic, the FDA approved a smaller dose for a different condition (depression instead of schizophrenia), allowing the company a patent extension and the right to sell it for $17 a tablet.
  • All this leads to a lot of pill swallowing. Right now 10% of all Americans over age six are taking an antidepressant. And there are more Americans taking antipsychotics than cholesterol-lowering meds. Woe betide if you are a wise-ass 11-year-old mouthing off to your teacher—you stand a good chance of being quickly labeled as having bipolar or “oppositional defiance” disorder and for the rest of your incarnation your doctor will be adjusting your drug cocktail. Plus, you’ll probably die young, since the side effects of the meds include obesity, high cholesterol, and diabetes.

Oh, wait. We have drugs for those too.

Despite these grim revelations, every physician (and I certainly include myself) has seen remarkably beneficial effects when depressed or anxious patients take an SSRI antidepressant. So after reading articles like this, we doctors scratch our heads. What can this mean?

Dr. Angell, and the authors of the three books she reviews in this article, suggests these possibilities:

For most people, depression and anxiety are temporary, and were I without your knowledge to deliberately prescribe you a placebo–especially an “active” placebo with side effects–the pill would give the appearance of doing something. Believing you were taking an antidepressant, you’d have just as much chance at feeling better as you would with an actual one. The success rate of the two is the same.

“Getting well,” especially from a mood disorder like depression or anxiety, is highly complex. If a patient is really motivated (“I’ve got to get over the panic attacks or I’ll lose my job”) and has limited choices for treatment (“I can’t afford talk therapy”), then her whole mindset is geared toward that pill working for her. Receiving her own supply of the same pill those smiling people in the TV ads are using successfully could be just the trigger to switch her brain into a more positive mood. This effect is enhanced if she trusts her doctor and he or she has told her that the medicine has worked for many other patients. In other words, the whole healing process is far more complex than just chemicals in a pill.

In reality, surveys show that at least two thirds of patients prescribed antidepressants go off them, reporting “I didn’t feel anything except side effects.” Many never bother to fill the prescription at all and simply tough it out. Doctors don’t know about this two-thirds group and end up giving the meds much more credit than they deserve.

To say that all this is blindingly frustrating to a primary care physician like me is an understatement. Despite this news, I will continue to carefully write prescriptions for antidepressants (though my own preference is for the virtually side-effect-free herbal antidepressant St John’s wort) because despite my limited toolbox of prescription drugs, patients need help and antidepressants do help some patients.

I’ll also continue to rely on JAMA, New England Journal of Medicine, and a dozen other journals to keep me abreast of research in my field.

But with Dr. Angell’s revelations, I will look at the newly released antidepressant Viibryd (supposedly both clinically effective and free of side effects) and wonder, “Is there anyone I can trust?”

Be well,

David Edelberg, MD