Overdosed America (38 page)

But even this does not capture the depth of the problem.
PhRMA was successful
in helping to defeat an amendment to the Medicare prescription drug bill that would have funded research to determine the comparative effectiveness and value of the drugs senior citizens are struggling to afford. A quick look at the 15 most frequently prescribed drugs for seniors in 2003 shows that, before coming up with a very expensive plan to provide access to these drugs, it would be wise to determine which drugs actually provide effective and efficient treatment for senior citizens.

Celebrex 200 mg was the sixth most frequently prescribed drug for American seniors in 2003. As we saw in
Chapter 3
, when the results from the second half of the manufacturer-sponsored study (not included in the article published in JAMA) are taken into account, as FDA reviewers deemed appropriate, Celebrex offers no significant advantage over much less expensive anti-inflammatory drugs, and
may actually cause more GI problems
when taken for longer than six months.

The second and tenth most frequently prescribed drugs for seniors are
Norvasc 5 mg and 10 mg
for blood pressure control, costing $549 and $749 per year, respectively. Evidence shows, however, that, for most people, neither is as effective at preventing the complications of high blood pressure as a
diuretic that costs only $29 per year
, hydrochlorothiazide—the forty-second most frequently prescribed drug.

Three of the top fifteen drugs for seniors are cholesterol-lowering statins. We don’t know how many of those are being prescribed to prevent recurring heart attacks, the situation in which statins are most effective. We do know, however, from the
PROSPER study
that high-risk elderly patients with no previous history of heart disease have no fewer heart attacks when they are treated with a statin for three years. But they do develop significantly more cancer. Furthermore, the first statin introduced to the market, Mevacor, is now available as a generic drug, lovastatin, which costs less than half as much as the brand-name drugs and has never been shown to be any less effective at preventing heart attacks in people over the age of 65. (In the Prove It study, the people over the age of 65 derived no greater benefit from Lipitor than from Pravachol, one of the earlier statins.) Lovastatin, however, did not make the top 50 list.

Vioxx made the top 15 as well, despite a little-known fact buried in data from the manufacturer’s own study: treating 100
patients over the age of 65
with Vioxx instead of naproxen will lead to 2.5 additional serious cardiovascular complications each year. To put the risk of Vioxx in perspective, treating
patients over the age of 65
with Vioxx instead of naproxen is about
four times more likely to
cause
a cardiovascular complication
than a statin is likely to prevent one, even in patients who have already had a heart attack.

Two of the top 15 drugs are
stomach acid–blocking drugs
costing about $4.60 a day. One of these, Prilosec, is now available without a prescription for about $0.62 a day—and even this price will soon come down with generic competition. I found that most patients with symptoms of heartburn could be started on the more powerful acid-blocking drugs, then switched to less strong medication, such as ranitidine (brand name Zantac) once their symptoms were under control. If symptoms recurred, patients could easily be switched back to one of the more powerful drugs.

The third most frequently prescribed drug for seniors is Fosamax for osteoporosis. One wonders how many of the women taking this drug actually benefit, since, as we have seen, it does not reduce fractures when
used to prevent osteoporosis
. And for women over 70—even those with severe osteoporosis—Fosamax’s cousin, Actonel, significantly reduces the risk of hip fractures only in women who have already had spine fractures. Meanwhile, how many women taking these drugs are aware of the research showing the significant benefits of exercise in preventing fractures and, more important, improving overall health and longevity?

Those are 10 of the 15 best-selling drugs for seniors. If the government’s real goal were to increase senior citizens’ access to the most effective medications, its first step would have been to determine the best care based on the best scientific evidence available, helping patients and doctors to make informed decisions. Instead, the Medicare prescription drug bill simply opens the public coffers to pay full price for expensive brand-name drugs. One might conclude that the purpose of this drug bill was to transfer wealth from the taxpayers to the drug companies rather than to ensure senior citizens access to the most effective drugs at the lowest possible cost to themselves and to the federal government. As an unnamed drug lobbyist told the
New York Times
when this legislation was being debated, “Having both houses of Congress Republican-controlled was great. Like in Monopoly,
when you get to add hotels
.”

As if that weren’t bad enough,
Congress was not even allowed to see
Medicare’s own estimate of the real cost of the prescription drug bill before it voted (this estimate was $100–$200 billion higher than the projected cost that the Bush administration was presenting to Congress). Medicare’s chief actuary, Richard S. Foster, told the
New York Times
that he had been ordered not to provide this information to Congress and ordered not to respond directly to Congressional requests for data. Foster said that his understanding was that Medicare officials “would try and fire me” for doing so. The
Times
reported that the director of Medicare, Thomas A. Scully, denied having threatened to fire Foster, but did acknowledge having instructed Foster to “withhold certain information from Congress.”

Just six weeks after the president signed the bill, the price tag was publicly acknowledged to be fully one-third higher than the $400 billion Congress had been promised. How did this happen?
Thomas Scully had received an ethics waiver
in May of 2003 that allowed him to continue to work on the drug bill while he was seeking employment in the private sector. One month after receiving the waiver, he changed the long-standing practice of allowing Medicare actuaries to report requested information directly to Congress. Under the new rules, actuarial information had to go through Mr. Scully (reminiscent of the change at the FDA that required all letters to drug companies about marketing violations to be reviewed by the office of the chief counsel). At least some of Medicare’s estimates of the cost of the drug bill were sent to the White House; but they weren’t sent to Congress. According to the
Wall Street Journal,
within weeks of the final vote on the bill, Scully told Foster,
“We can’t let that [estimate] get out.”
In March 2004, Foster told the
New York Times,
“There was a pattern of withholding information for what I perceived to be political purposes, which I thought was inappropriate.”

One month after the Medicare prescription drug bill was passed, Mr. Scully announced that he had accepted a position with a law firm that, according to the
Times,
represents many companies in the health care industry affected by the new prescription drug bill, and is a registered lobbyist for Johnson and Johnson and the National Association for Home Care.

An article published in
Health Affairs
in February 2004 shows that once coverage for prescription drugs for Medicare patients becomes effective, prescription drug costs are
likely to increase even more than predicted
. The study found that use of Celebrex and Vioxx more than doubles when senior citizens have insurance that covers at least 75 percent of the cost of prescription drugs. (The Medicare prescription drug bill will provide 75 percent coverage.) The authors conclude that health policymakers should “be concerned with potential overuse of drug therapy by Medicare beneficiaries once the benefit is implemented.” Surely the use of expensive drugs by senior citizens will skyrocket—regardless of their proven value—unless measures are taken to base prescription drug use on the real scientific evidence.

If the crisis in American medicine were simply due to the rising cost of ever more effective care, there would be no choice but to cobble together the least noxious combination of increased spending and rationing. But the bad news about American medicine—and, paradoxically, the good news as well—is that the primary problem is not the escalating cost but the low quality of medical care that results when those with health insurance receive too much of the wrong kind of care and those without health insurance receive too little of the care that is necessary.
Dr. Donald Berwick
, one of the nation’s leading crusaders for improving quality in medicine and an author of the Institute of Medicine’s report “Crossing the Quality Chasm,” states the problem succinctly: “Hundreds of billions of dollars are being flushed away because care isn’t related closely to need.”

Commercial interests are so successful in appearing to represent the public’s interest that doctors, health policy experts, and the public are unable to discern the commercial distortions of the medical knowledge upon which they rely. “Quality of care” is now defined largely in ways that best serve the financial interests of drug and other medical industries rather than the health needs of the American people.

In this context, the most urgent challenge facing American medicine is not how to guarantee adequate access, but first to determine “access to what?” Nor is it even how to ensure quality of care, because this presumes that the available scientific evidence is adequate to make that determination. The most important health care issue in the United States today is whether our current method of creating medical knowledge realizes the full potential of medical science to improve our health, and whether this knowledge is then best applied to clinical practice and communicated effectively to the public. By these standards, American medicine is clearly failing to fulfill its promise.

The first step in reorienting American medicine toward the effectiveness the American people have a right to expect and are more than paying for would be to relieve the foxes of their responsibility for guarding the henhouse. How absurd to have
more than half the budget
of the FDA division that approves new drugs (the Center for Drug Evaluation and Research, CDER) paid directly by the drug companies’ user fees because the federal government is unwilling to provide adequate funding. Completely invisible to the public, officials at the National Institutes of Health are allowed to participate in lucrative consulting contracts with the drug companies. Experts with financial ties to the drug companies dominate the FDA’s Advisory Committees and the panels that write the clinical guidelines that define the standards of care for practicing doctors. The medical industry even funds the majority of doctors’ continuing education.

The production and implementation of medical knowledge in the United States is by now so riddled with conflict of interest at virtually every level and every stage that nothing less than a new
independent national public body
is needed to protect the public’s interest in medical science. Such a body must have the independence and expertise of the Institute of Medicine (part of the National Academies of Science), which would be well suited to accept responsibility for evaluating the scientific evidence. Lessons from the past show that this public body would require maximum insulation from political and commercial influence, on the model of the Federal Reserve Board—long and staggered terms, no financial ties to industry, and secure funding from Congress—to avoid evisceration when its findings were not to the liking of powerful interest groups. Surely the health of the American people and almost $2 trillion in annual expenditures are important enough to warrant such rigorous oversight.

This new independent board would have a threefold mission. First, it would ensure that medical research was designed, conducted, analyzed, and disseminated with the primary purpose of improving health and in accordance with accepted scientific standards. Second, it would provide oversight in developing clinical guidelines for the prevention, diagnosis, and treatment of specific medical problems and overall health through independent analysis of all the available scientific evidence.
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Third, it would identify, fund, and oversee research when important scientific evidence was lacking. For example, the absence of evidence from randomized controlled trials precludes informed recommendations about whether routine bone mineral density testing for postmenopausal women has any clinical benefit, or whether drug therapy, lifestyle modification, or both will best prevent hip fractures in women with osteoporosis. Although clinical trials to study these two issues might not be advantageous to the companies that make bone density testing equipment or drugs for osteoporosis (and therefore would be unlikely to be funded by them), such trials would certainly be beneficial to American women.

To accomplish this threefold mission, the new body would need authority to require that all clinical trials were registered at the outset, with a clearly identified research design (“protocol”), including the duration of the study, the outcomes, and adverse effects to be measured. This would put an end to the current “Heads, I win. Tails, you lose” situation in which studies that support their sponsors’ interests are published quickly while unfavorable results are published slowly or not at all and therefore never become part of our medical knowledge. Although registration of all clinical studies may seem like a simple and obvious way to improve the benefit that society derives from medical research, the drug companies, through their trade organization PhRMA, have stated: “
Sponsors [of clinical research]
do not commit to publish the results of every exploratory study performed, or to make the designs of clinical trial protocols available publicly at inception, as in a clinical trial registry.”