I spent the day yesterday with my wife as she went for a baseline heart assessment. She worries because her father and mother as well as her brother all had significant heart disease diagnosed in their late fifties. She is in her early sixties with some risk factors for heart disease so her goal was to establish a baseline as a way to measure changes in her risk for heart disease. That is all well and good. I am a firm believer in understanding risks and probabilities, I play poker after all. What I am most worried about is the desire of physicians, especially cardiologists in my experience, to treat risk factors in the absence of actual disease. When I was in graduate school we were encouraged to ask two questions as we began to investivate research reports. First, who funded the research; is there a funding agent that has a significant dog in the fight because if there is the results of the research are significantly less valuable than if the research was conducted objectively. Secondly, we were encouraged to ask just who actually benefits from the results of the research; understanding the relationship between beneficiaries of research and those upon whom the research is actually intended to benefit along with the divergency in ultimate beneficiaries is important in evaluating the results of the research itself.
Take Lipitor, as an example. According to Wikipedia, “Atorvastatin [Lipitor] was first synthesized in 1985 by Bruce Roth of Parke-Davis Warner-Lambert Company (now Pfizer). The best selling drug in pharmaceutical history, sales of Lipitor since it was approved in 1996 exceed US$125 billion, and the drug has topped the list of best-selling branded pharmaceuticals in the world for nearly a decade.When Pfizer’s patent on Lipitor expired on November 30, 2011,generic atorvastatin became available in the United States.” (emphasis added) While I am not looking at specific studies, I can imagine a reasonable scenario in which the vast majority of research done on Lipitor was funded by Pfizer or their predecessor company, studies that showed the benefits of Lipitor in preventing fatal heart disease. I immediately am skeptical of research that is funded by the company that benefits in terms of manufacture and sales when the drug goes on the market. In the case of Lipitor, the drug was the best selling pharmaceutical for over ten years; a patented drug the profits from which flowed into the coffers of Pfizer’s treasury. Clearly, Pfizer was a major beneficiary of the drug Lipitor.
The question of patient benefits are a bit more sketchy. Side effects from Lipitor (and other statin drugs) are many and some are even deadly. Again according to Wikipedia:
As stated earlier, myopathy with elevation of creatinine kinase (CK)] and rhabdomyolysis are the most serious side effects, although rare at <1%. Headache is the most common side effect, occurring in more than 10% of patients. Side effects that occur in 1–10% of patients taking atorvastatin include:
- Insomnia and dizziness
- Chest pain and peripheral edema
- Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea
- Urinary tract infection
- Arthralgia, myalgia, back pain, arthritis
- Sinusitis, pharyngitis, bronchitis, rhinitis
- Infection, flu-like syndrome, allergic reaction
Atorvastatin and other statins are associated with anecdotal reports of memory loss by consumers, which have been seen in clinical practice in a tiny percentage of users, particularly women. Evidence is conflicting with anecdotal reports contrasting with a well-established association of high cholesterol with dementia. However, it is known that cholesterol synthesis is necessary for normal neuron functioning. According to Pfizer, the manufacturer of Lipitor, clinical trials “do not establish a causal link between Lipitor and memory loss.”
High-dose atorvastatin had also been associated with worsening glycemic control in the Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy.
Side effects occur in up to 10 percent of all patients taking Lipitor, or now generic Atorvastatin; one in nine people will experience some side effect from this drug. What is even more interesting is the list of side effects does not include potential damage to one’s liver, neuropathy, or other conditions that may occur when using Lipitor. What is even more unsettling is that the drug is designed to treat “Secondary prevention in people with coronary heart disease and multiple risk factors for myocardial infarction, stroke, unstable angina, and revascularization.” The first part of this sentence shows a use for treating disease while the second half of the sentence specifically treats risk factors for, or the probability of being affected by, something that has not yet occurred. I wonder just how much profit Pfizer made from treating risk and not treating actual disease? My guess it that it amounted to over 75% of all profits earned from the sale of this drug.
Risk factors are just that, factors that may or may not contribute to an individual’s chances for developing a particular disease. With regular doctor’s visits, a solid program of reasonable weight control, exercise and a baseline from which to assess risk, clearly one need not spend untold thousands of dollars popping pills. A personal example, from the time that Prostate Specific Antigin (PSA) testing was available I had mine checked at least once a year. I had significant risks for prostate disease, especially prostate cancer so establishing a baseline that was particular to me, not to some generality of statistical risk, became a guide post for my own awareness of the changing risk factors. When my PSA suddenly spiked to 23 the time had come to actively pursue treatment options. Until that time, however, taking prevention pills was not a personal option. Treating risks is something like carrying an umbrella on a sunny day thinking that there is a potential for rain albeit an unlikely chance that rain will occur at all. When there are potentially deadly side effects in taking a drug aimed at prevention, when the drug is known to destroy one’s liver, the risks of taking the drug are perhaps greater than the risk of disease itself.
I am ranting here because my wife was prescribed Lipitor by a new cardiologist, had to undergo a stress-echo test in which her skin was sandpapered raw, and she was told that she could only eat chicken, fish, veggies, and fruit and she had to eat all this food without seasoning the food. Seriously? If it were me, I’d simply run the other way. I avoid doctors that prescribe medication on a first visit and surgeons who do not offer non-surgical treatment before they recommend surgery. I am disturbed by the practice of medicine that throws the patient under the bus in order to benefit pharmaceutical purveyors and themselves first and the patient second. I am not sure what she intends to do but I will do all within my power to encourage a second opinion, one from a cardiologist who doesn’t reach for the prescription pad first and alternatives second. For me it is a matter of medical ethics and holistic treatment of a patient and not a risk factor.