I’ve been reading a most interesting book, titled “Deadly medicines and organized crime: how big pharma has corrupted healthcare,” by Dr. Peter Gøtzsche. Dr. Gøtzsche, a specialist in internal medicine and professor at the University of Copenhagen, co-founded the Cochrane Collaboration in 1993 and established the Nordic Cochrane Centre.
The book goes into lurid (but exquisitely documented) detail about how big pharma, like big tobacco, commits massive crime and peddles death. I am alternately horrified and astounded by the revelations, coming one after the other and implicating all of the major pharma players, with frequent complicity by government agencies which are supposed to be monitoring and overseeing.
But I differ philosophically from Gøtzsche on the idea that big pharma peddles death. A dead customer cannot earn you profit (unless you’re a pathologist or work in the funeral industry). I believe, instead, that the modus operandi of these companies is based on four strategies:
- Design and sell products for real diseases, medications which partially relieve symptoms and often induce dependence. This strategy involves pharmaceutical products which cause side effects. These side effects must then be treated by more drugs, surgeries, or other interventions, adding to the business and the profits of not only big pharma, but health professionals of every description.
- Design and sell products for “treating” conditions or states which have no symptoms, where results are unmeasurable, and for which medication “must” be taken for many years. Again, side effects requiring management can generate income for all sorts of players.
- Influence how a disease is understood and explained from a biological point of view, by shifting a scientific paradigm away from a model in which individuals can influence their own disease towards one in which drugs are required. This strategy requires the participation of key opinion leaders, typically specialist physicians who are both clinicians and researchers.
- The fourth strategy is similar in that clinician-scientists are also at the core; in this case, however, diagnoses and their diagnostic criteria are shifted, again in a direction away from self-management and towards drug-requiring conditions.
All four strategies involve convincing doctors to prescribe medications which are either unnecessary, have risks which outweigh benefits, are less effective than other available treatments, or are more expensive than equally effective treatments.
Although I am a psychiatrist, it does not take a psychiatrist to understand that these four strategies have been and continue to be highly successful for big pharma in increasing profits, in large part because they play upon the emotions of the doctors who prescribe their drugs. Dr. Gøtzsche points to the self-interest of many doctors and their susceptibility to the pampering and flattery showered upon them by drug company reps. What he hasn’t talked about is how reluctant doctors are, once “conned” by the marketing ploys of big pharma, to change their opinions, even in the face of convincing evidence that they should. No one easily admits, either to oneself or to one’s peers, that they’ve been wrong about something, that they’ve been conned. It’s even more difficult to say to a patient, “You know this medication that I’ve been prescribing for you all these years? Well, it’s the wrong treatment for your condition. I’m terribly sorry that your condition hasn’t improved as much as it could have, and that you’ve had these side effects that were unnecessary”.
Can you imagine the lawsuits that would result if doctors made admissions like that to their patients?
So rather than peddling death, as Dr. Gøtzsche’s book suggests, I believe that big pharma peddles ill health, and gets away with doing so because so many other people and organizations profit.
Let’s look at each of these four strategies in a bit more detail. Examples of the first strategy, to design and sell products for real diseases which only partially relieve symptoms and may induce dependence, are second-generation antidepressants, the SSRIs and SNRIs. These medications are only slightly better than placebo for mild to moderate depression, and those research findings are based on studies funded by the pharmaceutical industry, who tend to only publish studies which make the drugs look good. Many patients, even if they get little or no benefit, have difficulty stopping these antidepressants because of what has been labelled as a “discontinuation syndrome”: the development of flu-like symptoms or disturbances in sleep, mood, cognition, sensation, or movement. While not a true withdrawal syndrome, these symptoms are often distressing enough to convince patients that they have to keep taking the medication.
The second strategy may be the real moneymaker for big pharma, if we consider the drugs used to treat hypertension or to lower cholesterol. Hypertension is not a disease; it is a finding on physical examination. Hypertension has no symptoms (except in the relatively rare condition known as malignant hypertension, where sufferers frequently experience headache). And although hypertension in middle age is known as a risk factor for stroke, angina, and heart attacks, most strokes and ischaemic heart disease events occur in persons who do not have high blood pressure. In the very elderly, higher blood pressure may even be better!
Medications which lower blood pressure appear to be effective at reducing strokes, ischaemic heart disease, and mortality, but support for the hypothesis that this effect is due to blood pressure lowering is based on estimates, not on hard evidence. Studies in this area appear to avoid reporting on associations between the amount of blood pressure lowering and changes in outcome, as if the study authors had failed to find such an association and would prefer that you not know this. Doctors are told that blood pressure lowering is beneficial, and that if one drug doesn’t lower blood pressure “enough”, then add another drug or even a third! Additionally, although guidelines suggest first line treatment should be with a thiazide diuretic costing pennies a day, drug companies spend huge amounts of money “detailing” the newest drugs to doctors, drugs which of course are expensive and generate huge profits for their manufacturers.
Overall, it may be worthwhile for doctors to identify individuals at risk for vascular disease, and put them on standard doses of one or two medications, regardless of what their initial blood pressure is and regardless of how much their blood pressure is lowered. Just think of how much money would be saved by no longer requiring patients to come in for blood pressure measurements!
I mentioned drugs used to lower cholesterol as an example of big pharma’s use of the second strategy. The statins have been among the most successful generators of profits in all of history. But while many patients take these medications, few appear to be aware that statins increase the risk of developing diabetes by 18%, cause myalgia (muscle pain) in about 10% of patients, and also increase risk of cataracts.
Let’s look at what high cholesterol means. First, it is important to know that hypercholesterolemia is not a disease, it is simply a lab result. It has no symptoms. Individuals would never know they have hypercholesterolemia if their doctor had not ordered a blood test. And there is little or no solid evidence that the limited beneficial effects of statins on mortality or cardiovascular disease are due to lowering of cholesterol.
For the third strategy, that of shifting the scientific paradigm for a condition, let’s discuss type 2 diabetes. A bit of history is in order. For many years, diabetes mellitus was considered by clinicians and researchers as one disease. Eventually, however, it was discovered that juvenile onset diabetes, now frequently referred to as type 1, was caused by a failure of the pancreas to produce insulin, whereas type 2 diabetics actually produced more insulin than normal, although not sufficient to overcome the insulin resistance that is a hallmark of this condition and also of the more recently described metabolic syndrome. When I was in medical school in the late 1970’s, we were taught that high insulin levels caused the insulin resistance characteristic of type 2 diabetes. This made sense, as in many biological receptor systems, high substrate concentrations lead to receptor downregulation. And this explanation lent itself to treatments involving diet (since dietary carbohydrates stimulate insulin secretion, reducing sugars and starches in the diet will lower insulin levels and thus improve insulin resistance) and treatment using medications such as metformin which lower insulin levels. For some individuals, dietary treatment alone was sufficient to normalize sugar levels. In other words, they no longer had diabetes!
Sometime in the 1980’s, however, this explanation got changed. Dr. Gerald Reaven published articles stating that the hyperinsulinemia in type 2 diabetes was reactive, ie was caused by, insulin resistance. A turnaround in thinking of 180 degrees. So what is causing insulin resistance in this new paradigm? Well, that’s not so clear anymore. It’s “multifactorial” with contributions from inflammation, obesity, hormones, aberrant fat cell metabolism, etc. This new paradigm led to new approaches to treatment, including medications to stimulate the pancreas to secrete more insulin, or to increase the sensitivity of insulin receptors, or to inject insulin in earlier stages of the disease. Unfortunately, these treatments often increase obesity, and they serve to maintain the diabetic condition or make it worse. Perfect for selling more medication, and of course for keeping a whole army of endocrinologists earning big salaries in treating what has now become a lifetime illness. Never mind the armies of specialists and mountains of medication that are now required to treat the kidney failures, retinopathies, vascular problems, dementias, and neuropathies that result from longstanding type 2 diabetes.
The fourth strategy used by big pharma with the collusion of scientist-clinician key opinion leaders is to shift diagnoses and diagnostic criteria. Psychiatry seems to be the area that is greatly affected, since there are essentially no lab tests or imaging studies that can help diagnose psychiatric conditions. For the past several decades, the Diagnostic and Statistical Manual (DSM; the current version is DSM-V) produced by the American Psychiatric Association has been the “bible” for North American psychiatrists, as it provides detailed lists of criteria to guide clinicians in choosing a diagnosis so that appropriate treatments can be prescribed. With successive versions, there has been a creeping tendency to turn normal conditions into pathological states requiring drug treatment. For example, following the death of a loved one, it is normal to be in mourning for a period of time. Since the symptoms of bereavement are very much like the symptoms of depression, at what point does extended mourning become depression? In DSM-IV, bereavement within the previous 2 months generally excluded a diagnosis of major depressive disorder. In DSM-V, that exclusion for bereavement was removed! So it’s now apparently OK to put someone on antidepressant medication even for symptoms due to a recent loss of a loved one.
Even more insidious, though, is the tendency to label psychosis as “schizophrenia” so that expensive newer generation antipsychotic medications can be prescribed. There is good reason to believe that many people who have been told by their doctors that they suffer from schizophrenia may actually have a bipolar affective disorder. Bipolar disorder can be effectively treated with lithium, but this would be unprofitable; or by controlling the timing of sleep, light, and social rhythms (chronotherapy) which involves the patient in their own recovery.
Unfortunately, long-term treatment with antipsychotics can cause a disfiguring, irreversible movement disorder called tardive dyskinesia. No wonder psychiatrists are reluctant to change the diagnosis from schizophrenia to bipolar disorder, even when a person has manic symptoms, a strong family history of bipolar disorder, and a good clinical response to mood stabilizer medications. Fred Frese, a “poster boy” for schizophrenia sufferers who do well in spite of their illness, is a case in point. John Nash, the Nobel prize winning mathematician who unfortunately died recently in a traffic accident, may be another example of individuals labelled with schizophrenia who likely are bipolar.
Even when making a diagnosis involves clear, objective criteria, there can be diagnostic creep. While earlier I included medication treatment for hypertension and hypercholesterolemia as examples of the second strategy, once these conditions were established as “diseases” in need of treatment, the fourth strategy was put to effective use.
In November 2017, the American Heart Association and the American College of Cardiology jointly published an update of their guidelines for managing high blood pressure. A major change was the reduction of the cutoff value for diagnosing hypertension from 140/90 mm Hg (with some exceptions, such as type 2 diabetes patients) to 130/80. In one fell swoop, the number of Americans with hypertension increased by about 40 million adults! Forty million new customers for drugs!
A similar phenomenon occurred when the same two organizations released their guidelines for treatment of cholesterol in 2014. With expanded criteria for recommending statin treatment, the revised version added more than 13 million Americans to the roster of those eligible for this extremely profitable class of drugs, compared to the 2001 version of the guidelines.
You should ask, what interest would the AHA and the ACC have in promoting increased medication prescribing? According to the Huffington Post, the AHA was receiving huge financial donations from big pharma, and 7 of the 15 authors of the cholesterol guidelines disclosed ties to industry.
Big pharma provides financial support to many other charitable organizations, such as Diabetes Canada, the Heart and Stroke Foundation, or the Kidney Foundation of Canada. These organizations, in turn, provide research funding. The research findings, when published, do not include this funding in conflict of interest declarations.
I believe there are many other examples out there of these four strategies being put to use in the service of greed. What all four have in common is that they reduce the ability of the individual to manage his or her own condition, increase dependence on drugs, prolong symptoms, and induce side effects which in turn require treatment. These are the paths to long-term excess profits, not killing off your customers.
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