How much of pharmacy theory is really based on science?

Dennis MillerThe long and sometimes peculiar history of the pharmacy profession has included salves, potions, powders, tinctures, and elixirs of doubtful safety and effectiveness. Has our profession effectively disassociated itself from the days of unproven and unsafe remedies? Some critics believe that many of the products on pharmacy shelves today are nothing more than modern versions of snake oil.

I would argue that much of pharmacy today resembles a religion far more than a science, in that religious belief requires a suspension of critical thinking and the reliance on doctrine, tradition, and authority. 

See also: What I wish I had learned in pharmacy school

Where our definitions come from

Pharmacy students are told from day 1 that pharmacy is based on science, with the double-blind placebo-controlled trial being the gold standard for determining what is true. But what if large pharmaceutical manufacturing concerns routinely massage data derived from controlled trials?

Do you believe that all the products on our shelves are indeed “safe” and “effective” as required by law? Or do you believe that the terms “safe” and “effective” are relative?

Do you believe that the FDA’s definition of “safe” and “effective” is the same as the laymen’s definition?

Mechanism of action

When reading the pharmacology section in the official prescribing information, one is struck by how often the precise mechanism of action for so many drugs is unknown or is described in terms of speculation and conjecture. So much is unknown about drug action at the molecular and cellular levels, yet it is at those levels that drugs are active.

Take the commonly prescribed drug Xanax. The official labeling for Xanax states, “CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown.”

This vast reservoir of uncertainty about cell biology and drug action doesn’t seem to discourage the pharmaceuticals industry from persistently promoting its products.

In my opinion, in light of the fact that various pharmaceutical concerns have too often suppressed and manipulated data about potential drug risks, a pharmacist is well-served by a healthy dose of on-the-job skepticism. Yet, in my experience, many pharmacists become angry when pharmaceutical products are criticized. It is almost as if someone is criticizing their religion.

See also: Drugs or lifestyle changes? Are pharmacists pill-happy?

Where’s the debate?

If pharmacists were true scientists, lively debate about the pros and cons of pharmaceuticals would be encouraged. I don’t see astronomers, physicists, and biologists getting angry when long-held assumptions in their fields are challenged, but I do often see pharmacists angered when the safety and/or effectiveness of certain popular drugs are challenged.

Pharmacy school as I remember it too often resembled a seminary in which the primary focus was molecules, cells, and chemistry, rather than health. The prevailing view was that the human body is a rickety old contraption, prone to breakdown and in need of constant shoring up with potent pharmaceuticals.

We were force-fed plenty of chemistry in pharmacy school. So when was the last time you used your extensive knowledge of chemistry in filling a prescription or in answering a question from a physician or customer?

See also: Why I wrote "Pharmacy Exposed"

An intentional mystery?

Consider this: Has there been a deliberate effort to create a mystery around the handwritten prescription?

In my opinion, an illegible prescription is part of the mystique that physicians have intentionally cultivated for themselves for centuries.

Several years ago, the FDA magazine FDA Consumer published an article stating that prescriptions were originally made up of all kinds of symbols and Latin usages to create a sense of mystery. The article stated that, in an effort to keep the knowledge of medicine and pharmacy from the general public, physicians used strange alchemic symbols to designate the materials and processes to be used in compounding medications.

The article went on to state: “The effect on the appearance of the prescription may be readily imagined,” one medical historian has written, “and it is evident that the physician succeeded perfectly in making his preparation a mystery to the patient.” Keeping the patient in the dark and creating an aura of mystery and magic are precisely the reasons given by medical historians to explain the use of Latin in prescription writing as late as 1900.

Ask any pharmacist whether he/she believes this desire to surround the prescription in mystery ended in 1900. Latin abbreviations are in common use today, even though, in most cases, an English abbreviation could be written just as quickly.

Forbidden to share information

According to another issue of FDA Consumer (March 1979, p. 12), as long as 400 years ago, English physicians were forbidden to teach their patients about medicines: “Back in 1555 England’s Royal College of Physicians advised the profession thus: ‘Let no physician teach the public about medicines or even tell them the names of medicines.’”

Admittedly, this attitude may not be confined to the professions of medicine and pharmacy. Jesse Vivian, a pharmacist, attorney, and professor at Wayne State University College of Pharmacy, has written: “Practitioners of any vocation in any sector of the universe have communication shortcuts, abbreviations, and foreign phrases or languages that are known only to those inside the occupation. In fact, there is a notion that professionals intentionally use words or phrases that are unknown to the general populace as a mechanism of keeping lay people from getting to know too much about any given profession.” (“In Pari Delicto,” U.S. Pharmacist, January 2007, p. 88)

DTC advertising

Has this time-worn practice of concealing elements of the truth from consumers continued to the present day?

Consider direct-to-consumer advertisements for prescription drugs, a practice permitted only in the United States and New Zealand.

Do you feel that prescription drug ads on TV are deceptive? It is not by coincidence that these ads often consist of images of attractive people having fun on sunny days with friends, family, and pets, while the announcer rapidly reads through a long list of scary possible side effects that can even include death.

Do you believe that these advertisements encourage the unnecessary use of prescription drugs and contribute to the overmedication of Americans?

See also: The pharmacist as author

Pathologizing human experience

The term “disorder” is appended to common human behaviors to lend legitimacy to what is, in fact, the pathologization and medicalization of the human condition. For example:

Social anxiety disorder is a $10-dollar word for shyness.

Generalized anxiety disorder is a fancy term for a broader form of shyness.

Seasonal affective disorder is a fancy term for the winterblues.

Attention-deficit hyperactivity disorder pathologizes poor school performance and/or the inability to sit still and pay attention.

Obsessive compulsive disorder now characterizes relatively common behaviors such as excessive handwashing.

Shift work sleep disorder (SWSD) refers to a circadian rhythm sleep disorder characterized by the insomnia and excessive sleepiness that affect people whose work hours overlap with the typical sleep period. Working the overnight shift would predictably have adverse consequences on one’s health, but the term shift work sleep disorder makes it sound like a medical disorder, rather than an expected consequence of abnormal sleep patterns and disruption of circadian rhythms.

Expect to hear more in the future about obsessive shopping disorder, obsessive gambling disorder, temper dysregulation disorder, and oppositional defiant disorder.

Are industry marketers so insecure about the validity of all these “diagnoses” that they feel compelled to label them “disorders” to legitimate them in the public mind?

“Brain-chemical imbalances”

Do you know that the concept of a “chemical imbalance in the brain” has never been proven? From where I sit, it looks like pure speculation, yet it is used to justify the massive prescribing of antidepressants.

Do you believe that depressed people are dealing with some depressing life circumstance (marriage problems, problems with the kids, stressful jobs, inadequate income, etc.)? Or do you believe they have a chemical imbalance in their brain?

How much of the effectiveness of antidepressants is due to the placebo effect?

Indeed, how much of the benefit from a wide range of medical treatments is due to the placebo effect?

The war on stomach acid

Do you agree with the massive war on stomach acid being conducted with H2 antagonists and proton pump inhibitors?

For hundreds of thousands of years of human evolution, stomach acid served the purpose of aiding in the digestion of foods and killing noxious organisms. Today, stomach acid is seen as pathological and an error in human physiology. Yet use of the PPIs deployed against stomach acid has been linked to a higher risk of hip fracture, pneumonia, C. diff infection, and malabsorption of magnesium, iron, or vitamin B₁₂.

It is also worth noting that acid suppression can increase susceptibility to community-acquired pneumonia, possibly because reduction of gastric acid secretion enhances colonization of the upper gastrointestinal tract with oral bacteria.

Pathological menopause

Here’s another example of the lack of respect that modern medicine often shows Mother Nature and the long course of human evolution.

The physiology of some primates is programmed for a large decrease in estrogen production at the menopause, yet modern medicine views it as pathological. The chronicle of the massive prescribing of estrogen at menopause has not seen a happy ending. Hormone replacement therapy has led to an increase in cardiovascular disease and some cancers in many of the women who were prescribed estrogen.

Endless pills for diseases of modern civilization

Modern medicine routinely prescribes potent drugs to treat such diseases of modern civilization as hypertension, type 2 diabetes, elevated cholesterol, etc.

The Merck Manual (16th edition, p. 984) says that most cases of hypertension and type 2 diabetes are preventable: “Thus weight reduction will lower the BP [blood pressure] of most hypertensives, often to normal levels, and will allow 75% of type 2 diabetics to discontinue medication.” Ninety percent of diabetics have diagnoses that fall under the heading of type 2.

Modern medicine prefers to use pills to treat obesity rather than provide lifestyle education about the importance of pushing oneself away from the kitchen table.

In your observation, how effective have obesity pills been in enabling patients to keep weight off long-term?

Cancer treatment vs. cancer prevention

Our environment is filled with synthetic chemicals never seen on the face of the earth before the last few generations.

Do you believe that most cancers could be prevented if we focused on our exposure to these agents? Or are you completely happy with modern medicine’s focus on chemotherapy rather than on prevention?

The Merck Manual (17th edition, pp. 2591-2592) essentially states that up to 90% of cancer is preventable: “Environmental or nutritional factors probably account for up to 90% of human cancers. These factors include smoking; diet; and exposure to sunlight, chemicals, and drugs. Genetic, viral, and radiation factors may cause the rest.”

Are Americans grossly overmedicated?

Modern medicine has a pill for every ill, despite the fact that many of those pills don’t do much to improve those ills.

How effective do you consider drugs that treat osteoporosis, psychosis, and Alzheimer’s?

Are you troubled by the very common diagnoses of ADHD and depression in kids?

Are you troubled by the widespread use of antibiotics for conditions like the common cold?

Are you troubled by the routine pharmaceutical treatment of mild-to-moderate fever, despite strong evidence that fever fights off invading organisms?

In my opinion, modern medicine and pharmacy are often spellbound by certain wildly popular therapies that are destined to come crashing back to reality. For example, hormone replacement therapy flew high in the sky for several decades before ignominiously falling back to earth.

Are we in a similar hype-induced bubble with the massive prescribing of statins? Cholesterol is needed for the proper functioning of every cell in the human body, yet modern medicine views cholesterol as yet another pathology.

Drugs vs. lifestyle changes

What would happen if drug studies routinely compared drugs to lifestyle changes?

Do you trust the results of studies of drug safety and effectiveness sponsored manufacturers of pharmaceuticals?

Drug studies are carried out in subjects (often paid volunteers or prison inmates) who are usually much healthier and younger than the target population for these drugs in the real world.

In drug trials, concomitant diseases are viewed as complicating factors, whereas in the real world, the people who are prescribed these drugs very often have multiple conditions.

Drug studies routinely compare Drug A to placebo. Why not compare Drug A to Drug B? Why not compare Drug A to lifestyle changes? Why not compare Drug A to dietary changes? Why not compare Drug A to exercise? Why not compare Drug A to weight loss?

Louisville cardiologist John Mandrola, MD, thinks statins are prescribed too readily and that lifestyle approaches would be more effective. He says cardiologists get inferior results compared to those seen by physical trainers and nutritionists. In an article titled “Heart Disease and Lifestyle: Why Are Doctors in Denial?” (Medscape, Jan 12, 2015), Dr. Mandrola wrote:

In a randomized controlled trial of primary prevention, no cardiologist would want to be compared against a good physical trainer or nutritionist. We would get trounced. …The study would be terminated early due to obvious superiority of lifestyle coaching over doctoring….

It's the same story at medical meetings: Sessions on drugs and procedures draw the crowds. Late-breaking studies rarely involve the role of exercise or eating well. Exercise, diet, and going to bed on time have no corporate backing.

…I believe the collective denial of lifestyle disease is the reason cardiology is in an innovation rut.

…This is how I see modern cardiology. Our tricks can no longer overcome eating too much and moving too little.

…In fact, a reasonable person could make an argument that our pills and procedures might be making patients sicker.

Think about it

In summary, do you feel that pharmacy is primarily based on science?

Or do you feel that we are still very much in an era of unproven and unscientific therapies, manipulated studies, wishful thinking, and pure hype?

There are fewer pharmacy superstars (insulin, antibiotics, morphine, thyroid hormone, etc.) than the public assumes.

What are your candidates for the most effective - and least effective - drugs in the pharmacy?

Which drugs are you most proud to dispense? Which ones would you never take yourself?

Which drugs are you embarrassed to see sitting on pharmacy shelves in the 21^st century?

Recommended reading:

1. James LeFanu, MD, The Rise and Fall of Modern Medicine (New York: Carroll & Graf Publishers, Inc., 1999)

2. Marcia Angell, MD, The Truth About the Drug Companies (New York: Random House, 2004)

3. John Abramson, MD, Overdosed America (New York: HarperCollins Publishers Inc., 2004)

4. Stephen Fried, Bitter Pills (New York: Bantam Books, 1998)

5. Thomas J Moore, Prescription for Disaster (New York: Simon & Schuster, 1998)

6. Armon Neel, PharmD, Are Your Prescriptions Killing You? (New York: Atria Books-Simon & Schuster, 2012)

7. Melody Petersen, Our Daily Meds (New York: Sarah Crichton Books-Farrar, Straus & Giroux, 2008)

8. Jerry Avorn, MD, Powerful Medicines (New York: Alfred A. Knopf, 2004)

9. Greg Critser, Generation Rx (Boston: Houghton Mifflin Company, 2005)

Dennis Miller is a retired pharmacist living in Delray Beach, Fla. He is the author of two books (Pharmacy Exposed and Chain Drug Stores Are Dangerous), both available at Amazon.com. He welcomes feedback at dmiller1952@aol.com.