Part II: Background Voices
|The grimmest dictatorship is the dictatorship of the prevailing orthodoxy.
What is the scientific support and therefore the rationale for lowering cutoff points for defining normal serum cholesterol, obesity, hypertension and diabetes? By placing untold millions of people on potent drugs and exposing large numbers of the population to years of worry, let alone unnecessary medication with its cost and complications, could we be doing more harm than good?
Do New Cutoff Points Add Years to Life?
The medical literature is awash in “clinical drug trials”; a Google search using this term yielded 10.4 million hits. The vast majority of these studies have marginal value, are misleading, or suffer from numerous biases, including but not limited to industry sponsoring. The difficult question remains how to avoid one’s own biases in choosing the most reliable reports out of this data-drenched arena. According to an old adage, “where one sits depends on where one stands.” Still, by carefully choosing large trials from reliable centers with sufficient follow-up and robust statistics, I believe it possible to achieve some level of objectivity.
In a recent review of cholesterol lowering drug treatment in women published in the JAMA the authors concluded that “for women without cardiovascular disease, lipid lowering does not affect total or (coronary disease) mortality” and for women with known cardiovascular disease “treatment of hyperlipidemia…does not affect total mortality.” In the recent PROSPER study, the only large scale trial of cholesterol-lowering statin drugs that included old people exclusively, total mortality was unchanged, (22 fewer deaths from heart disease and stroke but 24 more cancer deaths). In short, for women and for men without a history of heart problems, taking a statin may alter what is written on a death certificate, but it will probably not change the date.
Randomized clinical trials of blood pressure-lowering (antihypertensive) drugs without placebo comparison and not sponsored by drug manufacturers have shown negligible benefit except in patients with significantly elevated blood pressure. There have been nineteen major trials comparing active antihypertensive drugs to placebo. At the end of all trials a grand total of 150 extra life years were gained from 67,768 life years of treatment. We may infer from the results of these antihypertensive trials that if you take a blood pressure lowering tablet for thirty years, you may expect to live for 24 more days.
The cutoff changes for diabetes and for being overweight are not based on any trials but solely on extrapolations from the experience of patients with more advanced disease (e.g., patients with overt diabetes or morbid obesity). There are numerous reasons such studies are unlikely ever to be undertaken, including the problems of competing priorities. Moreover, there are the unintended consequences of distracting physicians from treating and following established cases of obvious disease since it is known that a large reservoir of undiagnosed disease already exists. Should we focus on finding and treating new patients with blood sugars of 120 rather than treating millions with blood sugars of 180 who are already in our offices?
An excellent editorial on the implications of lowered thresholds for normal cholesterol and blood pressure appeared in the British Medical Journal. This issue also includes numerous letters to the editor with a variety of interesting comments from physicians.
A Few Players in the Medicalizing Movement?
The World Health Organization,WHO, established by the United Nations in 1948 and based in Geneva, built its outstanding reputation on funding research and programs to fight communicable diseases. Today, WHO, with its 192 member nations, continues to coordinate and sponsor international efforts directed at treatment and control of worldwide health problems, such as AIDS, influenza, tuberculosis, malaria and a host of other diseases.
In the 1980’s, however, the organization expanded its attention to noncommunicable disease, although it was limited by a budget frozen at $450 million. Today, the international agency now takes in more than $500 million a year, more than it gets from all its member nations. This money comes primarily from drug companies whose fortunes are intimately connected to its donations to WHO.
Although spokesmen deny WHO is influenced by the pharmaceutical industry, the drug companies’ internal documents give another perspective. According to the Seattle Times Daphne Fresle, a former top official in the WHO office that monitors worldwide pharmaceutical use, resigned in protest in 2002, complaining of the agency’s relationships with drug makers. Unpublished documents of WHO reports first obtained by The Guardian newspaper in 2003 describe “undue influence” on guideline panels dealing with diets and food additives
Another egregious example of drug company influence is the WHO hypertension guideline, virtually a case study in itself. In 1998, the WHO set out to advise doctors worldwide on how to treat high blood pressure. The agency turned for advice to experts at the World Heart Federation. Together, the two groups named Dr. Alberto Zanchetti, a cardiologist and Professor of Medicine at the University of Milan, to examine and update guidelines for hypertension. Zanchetti, a scientific director for a 500 bed hospital doing studies funded by Bayer, AstraZeneca, GlaxoSmithKline and Bristol-Myers Squibb, appointed the other 17 members of the committee. All but one member of the group had close financial ties to drug firms.
According to the Seattle Times this guidelines committee met behind closed doors in Fukuoka, Japan, in October 1998. From the start, according to other members of the group, Drs, Zanchetti, Hansson and Mancia insisted on lower blood-pressure targets and made sweeping statements endorsing the safety of newer drugs.
For decades doctors have accepted a blood pressure of 120/80 as normal. In May 2003, however, American physicians received a shock when they received new advice from the NIH medical panel, the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7). The Committee declared systolic pressure as low as 120 could be unsafe, and established a new condition, called “prehypertension,” systolic pressure from 120 to 139, (see previous newsletter) and recommended broader use of hypertension drugs to lower blood pressures. Guidelines were also issued regarding management of blood lipids, including cholesterol, and obesity. Nine of the 11 authors of the guidelines had ties to the drug companies.
Doctors, slavishly following new guidelines from JNC 7 for hypertension began prescribing more expensive, new classes of antihypertensive drugs for ever larger groups of patients. This, despite the publication of a previous study in 2002 from a different group of experts, also funded by the Government, known as ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). This landmark study of over 44,000 patients, the largest antihypertensive trial ever, concluded that the newer blood-pressure drugs are less safe, usually no more effective and far more expensive than decades-old drugs such as Diuril© “Because of the superiority of thiazide-type diuretics in preventing one or more major forms of cardiovascular disease and their lower cost, they should be the drugs of choice for first-step antihypertensive therapy.”
The result: in 2004, patients and insurance companies spent over $16 billion for antihypertensive drugs, up 20% since 1999. Are the days of getting unbiased information over? As the drug industry welcomed the new treatment guidelines, annual spending on direct-to-consumer advertising for prescription drugs tripled between 1996 and 2000, when it reached nearly $2.5 billion. Despite this increase, such advertising accounts for only 15 percent of the money spent on drug promotion. According to just about everyone except Big Pharma, we are approaching an economic black hole in spending for health care. What to do next?
For a superb discussion see Dr. Paul Rosch’s following article and interview with Dr. John Laragh: Why Has the Treatment of Hypertension Become Such a Fiasco?.