Our country on drugs

One of the world’s largest pharmacy benefit managers announced more success of its drug benefit management this week. More than half of all insured Americans, children and adults, are now on prescription medications for chronic diseases — and 20% are on three or more drugs. Nearly half of all young women in their 20s and 30s are now chronically taking prescription drugs, as are nearly one in three children.

While the media has been quick to conclude this is evidence we’re more chronically diseased and unhealthy than ever, that is not what this reveals at all. Prescriptions are not a measure of health, but of marketing...

Medco Health Solutions, Inc. offers health risk assessments and pharmacy benefit management for major insurance companies, corporations, unions, health maintenance organizations, federal employees and those with Medicare* Part D. It states it is now "the nation's leading pharmacy benefit manager based on 2007 total net revenues of more than $44 billion." Its sales had first reached $1.4 billion in 2002 — meaning, it's had over a 3,143% increase in revenue in just 5 years.

According to Medco’s press release, for the first time in history, the majority of Americans have now been placed on prescription drugs for chronic conditions. People under insurance company managed care, more specifically. The greatest jump in prescription drug sales since 2001 of any group is among young women. Nearly half of all young women in their 20s, 30s and up to age 44 are taking prescription pills, with most on antidepressants — nearly one in five young women in our country is now taking antidepressants. One in three young men of similar ages are also being prescribed drugs, mostly for blood pressure and cholesterol — cholesterol drug sales among young men soared more than 80% over the past 7 years. Prescriptions for cholesterol drugs being given to women in their 40s to early 60s have doubled over those same 7 years. Nearly one out of every three children and teens is taking a drug, most for allergies/asthma, attention deficit hyperactivity disorder (ADHD) and antidepressants. And seniors are the most drugged of all, with about a quarter being given 5 or more chronic prescription drugs (28% women 22% men).

We are largely witnessing the successful marketing of “health risk factors,” that people have been misled to believe must be treated and perfectly controlled to prevent chronic diseases of aging and premature death; or to believe that the indices, themselves, are lifestyle diseases.

We are largely witnessing the success of being surrounded by nonstop scares about disease and the pervasive preoccupation with health and “wellness.” Even little kids before they’re barely old enough to read are being taught to worry about their weight, fitness, health indices and getting adult diseases of aging. It’s sad to see so many normal, healthy people, needlessly anxious and scared. Younger patients in particular are becoming ‘health obsessed', said Dr. Michael Fitzpatrick, author of The Tyranny of Health— doctors and the regulation of lifestyle.

We are largely witnessing the success of managed care by insurers and pharmacy benefit managers. PBMs are a missing piece to the puzzle as to why insurance companies, government agencies and employers are so intent on getting us to participate in wellness programs, undergo prolific health screenings and lab tests, and complete health risk assessments. Why “health risk factors” — health indices such as BMI, cholesterol, blood pressure and blood sugars — are being medicalized. And why performance measures for our healthcare providers are tying their pay to their conformity.

“Seek and ye shall find” is the principle of screenings to identify more for lifestyle and medical interventions, and prescriptions. Most health indices have been redefined with ideals set so low, that most normal healthy adults as they age, or by genetics, now find themselves “needing” treatment. Health indices are not malleable by “healthy lifestyles,” however, only prescriptions will get them down to those increasingly stringent “ideal” ranges. All toll, the quality measures in the new performance program with 74 clinical measures recently launched by the Centers for Medicare & Medicaid Services, for example, would encourage doctors to prescribe some 15 different prescriptions for adults over age 50 in order to meet the requisite health indices. How many people know if all of these pills have really been shown to improve health and longevity, or sufficiently enough that they might personally choose to accept the potential risks that go along with them?

For its health insurance provider clients, Medco Health Solutions, Inc. not only manages the prescriptions, but their health to make sure members “live life well.” It has online health risk assessments and “a tool to track and manage daily health activities,” health and wellness information specific to their conditions and to inform them of their medication needs, information on healthy lifestyles said to improve members’ health score, disease management and health alerts and reminders for screening tests and prescriptions, and medication management. Its “integrated data and predictive modeling identifies potential health risk factors” by compiling health risk assessments, lab results and pharmacy claims, then comparing their health indices against clinical rules, and then alerting healthcare providers and monitoring their performance in accordance with the health plan directives.

As was covered last fall, today’s pharmacy benefit managers (PBMs) don’t just fill prescriptions as they once did, they’ve become managed care companies. Ethical concerns come to bear when those who control the access and costs of prescription medications are also in control of our medical records, the health information we get, and the medical care we receive. According to FTC hearings on PBMs, they mandate tight management of health risk indices based on their guidelines and steer doctors to write prescriptions for drugs that they make the greatest money on through manufacturer rebates and through point spreads on each prescription between what’s billed the insurance provider and paid to the pharmacy.

The more prescriptions filled, the greater their profits.

Consumers’ compliance has been elicited by convincing them that health is under their personal control, and that obesity and chronic diseases of aging are lifestyle diseases that can be prevented by “healthy” diets and lifestyles. Their cooperation has been elicited by convincing them that “health risk factors” need regular monitoring and medications in order to prevent dire health consequences. Dr. Fitzpatrick has seen the number of healthy young people in their 20s wanting physicals and screening tests soar over recent years, “but they need nothing of the sort,” he said. Most of this preventive screening is unnecessary. “They should be enjoying themselves, not testing their cholesterol,” he said. “These companies are feeding off people's anxieties and making a vast income from something of dubious value.”

Few consumers really understand that risk factors are not actual risks for diseases, but correlations. [See The greatest myth of health risk factors.] The public rarely hears that even the biggest popularly believed risk factors don’t predict who will succumb to chronic diseases or premature death. As Dr. Prediman K. Shah, M.D., director of cardiology at Cedars-Sinai Medical Center explained: “Our traditional risk factors [BMI, blood “cholesterol,” blood sugar, blood pressure, and lifestyle factors] are very weak overall predictors of future risk.”

Virtually all heart disease occurs in those without risk factors and the clinical evidence for managing risk factors such as cholesterol levels to prevent heart disease have been “overemphasized and overmarketed,” said Dr. Donald L. Vine, M.D., a cardiologist and professor at the University of Kansas School of Medicine in Wichita, who reviewed the evidence in American Family Physician.

The public rarely hears how controversial among medical professionals the micromanagement of health indices in these moderate ranges are, as well as the evidence behind such guidelines for primary prevention. The public rarely hears how minimally cholesterol-lowering drugs increase lifespans in men, for instance, as explained Dr. Malcolm Kendrick, Medical Director of Adelphi Lifelong Learning, Cheshire, UK, and long-time cholesterol researcher. Let alone do women know that statins are absolutely pointless for them, as he said, while putting them at risk for serious side effects. Few consumers realize that cholesterol screening for young people is even more controversial and, not only have normal values not even been established and associated with cardiovascular health, but the long term safety of cholesterol-lowering drugs is unknown. Neither the American Academy of Family Physicians or the U.S. Preventive Services Task Force recommends screening for hyperlipidemia in children or teens.

As was reported here, the latest Health US 2007 report issued by the U.S. Health and Human Services Department, found that antidepressants make up the largest percentages of drugs prescribed for Americans — 35.5% of all prescriptions. Prescriptions for antidepressants have dramatically increased, more than tripling among adults just between 1988-94 and 1999-2002. Usage among women is twice that of men and rose from 3.3% to 10.6%; with nearly half (47.7%) of every prescription written for a woman in 2004-2005 was for an antidepressant. Have we all really become this unable to cope or is this another sign of our fear-driven culture?

Yet consumers may also not realize how vehemently the efficacy of antidepressants has been debated within the medical community for years. When all of the clinical trial data submitted to the FDA for licensing of the six most widely-prescribed antidepressants approved by the FDA between 1987 and 1999 for adults was examined (the only analysis to include both published and unpublished randomized, placebo-controlled clinical trials), the authors found virtually no difference in the improvement in depression scores [Hamilton Rating Scale of Depression, the 65-point scale used to evaluate severity of depression] among patients with moderate depression taking the drug versus a placebo. Effects only reached statistical significance (yet still smaller than is considered clinically meaningful), among patients with severe depression. The controversial paper was originally published in 2002 and more recently in the open public access journal, Public Library of Science Medicine. Dr. Irving Kirsch, Ph.D., of the Department of Psychology at the University of Hullin the UK and colleagues argued that with marginal clinical benefit for vast numbers of people being put on these drugs, the potential risks associated with the drugs become so much more important to weigh.

The concerns are similar to those being discussed in the medical community for other drugs, such as for weight loss and cholesterol-lowering: that adverse effects could needlessly be putting the health of millions of people at risk, in return for minimal or no benefits. For example, antidepressants, specifically various SSRIs, have been shown to be associated with increased risks for hyperglycemia and diabetes, weight gain and the metabolic syndrome, as researchers at the Einar Martens' Research Group for Biological Psychiatry, Center for Medical Genetics and Molecular Medicine in Norway reported. Dr. Gerard Ahern, Ph.D., assistant professor of Pharmacology at Georgetown, led a study in a 2006 issue of the journal Blood, suggesting that SSRIs could also play a role in auto-immune disorders or immunity. According to Dr. Daniel Hall-Flavin, M.D., Mayo Clinic psychiatrist, “weight gain is a reported side effect of nearly all antidepressant medications currently available.” Antidepressants have been reported in obesity research for over a decade as producing weight gain, unrelated to diet or activity changes, an adverse effect not widely reported. The evidence and risks for children are even more controversial and worthy of a separate future article.

Few consumers realize the enormity of the financial interests behind today's health promotion and preventive health. They don’t hear about the evidence that even intensive disease management programs through third-parties for serious conditions, which would seem intuitively beneficial, haven’t demonstrated improved health outcomes or lowered healthcare costs, let alone most preventive health and “wellness” programs with even less efficacy. Unlike the classic public health programs, such as immunizations, that have been wonderfully effective in preventing actual disease and saving lives, the diseases we die from today are the result of aging, genetics and the luck of the draw and can’t be eradicated like polio or prevented by controlling risk factors. We’ve examined the lack of evidence behind those who want us to believe that by eating “healthy” and having optimal nutrition and wellness, we can prevent chronic diseases and aging (and all be slim, too). The nonprofit Canadian Health Services Research Foundation based in Ottawa, also examined the evidence surrounding the adage “An ounce of prevention buys a pound of cure” and concluded that “the evidence is simply not there” to support the cost-savings argument for most health promotion and disease prevention measures, even the most popularly claimed initiative, physical activity. “The health and cost benefits of these programs remain largely anecdotal.” The fact is, we can spend our entire lives religiously eating some special "healthy" way (however that may be defined) and following some ideal lifestyle, and it won't prevent us from growing old or getting cancer, heart disease or some other chronic disease.

Yet the public doesn’t get all sides of these issues. They aren’t given all of the available evidence and allowed to freely make choices for their own bodies, with their own doctor free to advise them. This raises concerns about the increasingly coercive nature of care managed through a third party with its own interests.

Consumers are subjected to the most intrusive and paternalistic monitoring of their personal lifestyles by third party “wellness coaches” and case managers through insurance company and PBM-originated programs, as covered here. Their participation and compliance with meeting indices set by the PBMs and insurers, and even their doctors’ compliance with the performance measures, are being monitored and incentivized.

So, yes, most Americans are now on prescription drugs.

But, no, this is not evidence that we’ve all suddenly become so unhealthy. And, with obesity rates among young people and adults unchanged since 1999-2000, according to the CDC National Center for Health Statisitics, this spike in drugs isn’t because we’ve all suddenly become fat, either.

© 2008 Sandy Szwarc

Click on images of Medco literature to enlarge.

*Federal prosecutors charged the company with attempting to defraud Medicare and Medicaid, paying kickbacks to insurers in exchange for their business, seeking kickbacks from drug companies to promote their prescriptions, and switching prescriptions without physicians consents and not filling others and destroying patient prescriptions. It settled in October, 2006, agreeing to pay the government $137.5 million and an additional $9.5 million in civil charges.