Miscalculating Public Health: A Response on Statins and More

In a previous post, The Politics of Measurement: Miscalculating Public Health , I wrote of the risk that drug companies will convince us that we are at risk for everything, so that we take many expensive meds to ward off disease. The money that is spent on drugs might do more for our health, I argued, if spent elsewhere (even on public transportation). Along the way, I cited health journalist Shannon Brownlee’s doubts about  whether statins should be prescribed for people who have no symptoms of heart disease, and I wondered whether the drug was being expensively over-prescribed in Israel.

Gary Ginsburg, a world-class health economist (and South Jerusualemite), wrote me the following response, which I’m happy to present:

When I studied public health in Chapel Hill, North Carolina, I visited the old bus station and saw the separate doors with their “whites only” and “blacks only” notices written in large red letters. But very few things in life (except for fascism and cigarette smoking) can be viewed in terms of black and white.

My epidemiology teacher, David Kleinbaum, always told us that the answer to every question was “it depends.” Should you care for the elderly and mentally ill in the community? Answer: “It depends” on the level of their functional ability.

Should we vaccinate against the Human Papilloma Virus (HPV), which causes cervical cancer? We could prevent around 63% of the cases in Israel by vaccination. Answer: “It depends” on the price. Currently three shots cost over $400, and I have opposed vaccinating in an internationally published article, in Vaccine . Obviously it drew flack from the vested interests of the pharmaceutical companies. The feminist lobby (probably paid for by the drug company) also attacked the “chauvinist decision makers” who are not willing to publicly fund the HPV vaccination. The truth is that $400 per person can be used to save ten times as many women (and children and men!) if invested elsewhere in the health system. When the price comes down to a reasonable (non mega-profit ) level, I will be the first to support the introduction of the vaccine. So I suggest the feminists turn their wrath on the drug companies.

Again one has to acknowledge that the pharmaceutical companies do spend vast amounts of money producing new drugs that are good for humanity (not too many new drugs were produced under Soviet rule) and should be able to cover their costs and make “reasonable” profits. Of course, in this era of transparency in decision making, no drug company reveals its real production and development costs for scrutiny.

So: Should one give statins? The answer is “it depends” on the person’s risk of having an Acute Myocardial Infarction (AMI) during the next 10 years. To go one step further: My field is health economics, which integrates epidemiology with economics and uses as its gold standard the cost per QALY (Quality Adjusted Life Year saved). So regarding statins the answer is now “it depends on the risk of an AMI and the cost of the drug (including side effects).”

I recently built a model that calculates the costs per QALY for various statins that incorporates many elements including the decreased risk of AMI, stroke, and peripheral vascular disease that can be attributed to statins, as well as the costs of prescribing and monitoring them and caring for any side

effects. In contrast to Shannon Brownlee’s statement I found many trials showing the positive effect of statins on general populations – I guess one can say that everyone is at risk of heart disease, it’s just a question of to what extent.

But for people with a low risk of AMI, statins (which are relatively cheap) are definitely not a cost-effective intervention. Any money spent on them could be put to better use saving more people via other interventions. For these people, the health services could supply cost-effective interventions to reduce the risk factors of stress, lack of physical exercise, obesity (preventing weight loss), and smoking (smoking cessation programs including nicotine replacement therapy).

On the other hand, for people with a high to medium risk of AMI, statins are an effective, indeed even a cost-effective intervention. Again, first-line interventions to reduce the major risk factors should be tried. Only if they fail, then one should resort to prescription drugs.

A combination of a lack of available prevention programs and overworked general practicioners who find it easier just to prescribe a drug to receptive patients, who find popping a pill easier than eating less and working out, leads to an over-prescription of statins, be it to low-, medium- or high-risk groups.

So statins are OK, in medium to high risk populations, after  other preventive measures have been tried.

My evaluation also included an adjunct drug to statins, Ezetimibe, that could double the reduction of bad cholesterol levels (LDL-C) achieved under statins. Seemingly, Ezetimibe is a wonder drug. But in January this year, the manufacturers disclosed a report that under Ezetimibe there was no improvement in the width of the arterial vessels that lead to the heart. What this means is that despite the huge drop in LDL-C levels, something else is going on, and it is likely that there will be absolutely no decrease in AMIs in persons taking Ezetimibe. Trial data for Ezetimibe on the real hard end point (a euphemism for deaths) will not be available until 2010. In the meantime, it looks like Ezetimibe is a loser.

The classical case of pharmaceutical companies pushing things in Israel is the case of Avastin, a drug that prolongs the misery of patients with color-rectal cancer for a few more weeks (not much quality of life) at a very high price. So opposite the Knesset there were demonstrations of people stress and lack of physical exercise for Avastin. Cost per QALY for Avastin is in excess of $250,000.

There is a viable preventive alternative, a procedure known as colonoscopy. During the 20-minute colonoscopy the physician looks for and removes potentially carcinogenic polyps from the patients colon and rectum. Providing this procedure in persons over the age of 50 every 10 years can reduce the incidence of colorectal cancer by more than 50% at a cost per QALY of around $1,500. But of course no one nowhere goes out to demonstrate for preventive procedures.

Needless to say in the land of Chelm, political pressures triumphed, and the citizens of Israel can get Avastin from the public system, but not colonoscopies (unless they have a medical indication – family history or a symptom).

So in ten years time there will be 100 people demonstrating outside the Knesset for Super-Avastin for their colorectal cancer. If colonoscopies had been provided, then there would have been less than 50 demonstrators and money would have been freed up to treat other diseases.

Put another way, it’s as if you went into a corner grocery and saw bananas priced 1.50 shekels a kilo and a similar bunch at 250 shekels a kilo, and you decided to buy the ones for 250 shekels a kilo bunch. As I said, Chelm!

2 thoughts on “Miscalculating Public Health: A Response on Statins and More”

  1. In the U.S., the recommendation is that everyone should get a colonoscopy at age 50 and every 10 years thereafter. Yes, it’s an expensive procedure, but consider the cost of colorectal cancer. I think that it’s pretty standard for U.S. health insurance to pay for colonoscopies, on this very ground. I’m surprised that the same is not true in Israel.

  2. wondering what studies you read that led you to the conclusion that stains are helpful to so many individuals –your statement “I found many trials showing the positive effect of statins on general populations” makes it obvious you did not utilize the NNT (number needed to treat) in making your judgment. and what about the adverse effects from statin use? no risk there you can discern? visit Dr. Duane Graveline’s web site to read a few thousand reports of adverse effects attributed to statins such as ALS, Parkinson’s, Transient global amnesia, peripheral neuropathy, severe cognitive decline, mypoathies, etc. you could also read Dr. Ralph Edwards’ statistical analyses concerning the association btn statins and ALS, or Dr. Xuemei Huang MD’s studies that found decreased LDL in individuals with Parkinson’s disease. and subsequently proposed a clinical trial to determine if statins trigger parkinson’s.
    Please cite the articles that effectively prove statins decrease mortality, esp in women and the aged.

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