The Wall Street Journal has some of the best health care reporting of any major newspaper, yet its editorial page is often filled with shrill, misleading nonsense—particularly when it comes to health care. Unfortunately, this week some of the rhetoric of the WSJ’s opinion section seems to have leaked into its reporting: on Tuesday, the paper ran a piece warning that “too much information about drug safety—disseminated through media, online alerts from consumer watchdog groups and even by the Food and Drug Administration itself—might overwhelm patients and raise undue alarm.” Essentially, the article suggests that, when it comes to prescription drugs, the less we know, the better.

The story’s author, Shirley Wang, provides little evidence that America is too concerned about drug safety. As evidence to support her argument, she offers a Pfizer survey of 300 medical professionals which “found that 89% of respondents were at least somewhat concerned that patients might stop their medications if potentially negative safety information was released to the public too early.”

I’m not entirely sure why this is news. Of course a drug company is going to release a survey that hints at the dangers of excessive regulation and oversight. And of course doctors are going to be “somewhat concerned” about the science behind drug risks; I’d wager that just as many are “somewhat concerned” about the science behind reputed drug benefits as well. Good doctors will always be concerned about the integrity of data that will affect the behavior and health of their patients. Pfizer’s survey doesn’t tell me anything I don’t already know; nor is it proof that doctors think our health care system in fact does release negative safety information too early

Unfortunately, the rest of Wang’s article is just as speculative. For example, she notes that in 2004 the FDA “required a so-called black-box warning label—the agency's toughest—on antidepressants to caution about the increased risk of suicidal thoughts and behaviors among teenage patients.” Following the re-labeling, “the number of prescriptions for the drugs decreased” and “the rate of teenage suicides went up.” This would be scary except for the fact that it “isn’t clear” whether or not “the higher suicide rate is linked to the lower number of prescriptions.”

So two contemporaneous events may or may not be related? More non-news.

Another not-quite-convincing citation is a Kaiser Family Foundation survey which found “only 27% of the public feels ‘very confident’ that prescription drugs sold in the U.S. are safe” and that “just over half feel that pharmaceutical companies do enough to test and monitor the safety of their drugs.” In the context of the article, the implication is that our lack of faith in drug safety could lead patients to forgo effective drugs out of fear of their risks. But in truth, we have good reason to be suspicious.

A paper published in the Journal of the American Medical Association (JAMA) in 2002 showed that, of 548 new drugs approved between 1975 and 2000, 10 percent had new black box warnings or were withdrawn from the market; about half of those warnings or withdrawals occurred within two years after the product had been on the market. You’ve got to wonder: how did so many risky drugs make it to market?

More recent research, published in JAMA in October of this year, is equally disturbing: fully one-quarter of biologic therapies (drugs derived from biological sources, including antibodies, enzymes and hormones) approved in the United States and Europe since 1995 have been the subject of at least one safety-regulatory action in the decade since they were approved. None were withdrawn from the market, but 11 percent, including Remicade (infliximab), used to treat Crohn's disease and rheumatoid arthritis, and Avastin (bevacizumab), used to treat cancer, have been issued a "black box" warning.

"This suggests the need for more in-depth investigation before approval and highlights the importance of vigilance in post-marketing surveillance for adverse effects," said Dr. Phil B. Fontanarosa, an editor at JAMA. "[Adverse effects] generally occurred in general disorders, like serious allergic reaction or cardiac arrest, administration site problems, infections and infestations," he added. "A lot of these drugs act on the immune system, so infections are common complications of these products."

"We've always known that because biologics were going to modulate the immune system, there would be this risk," acknowledged Lisa Saubermann, associate director of clinical pharmacy services at the University of Rochester Medical Center. "Any time we modulate the immune system, that's the problem, because we know that the immune system is preventing other things from happening, like cancers. It's alarming.”

Not all adverse events can be avoided. But it would be better if we knew more about these products before they came to market—and if the drug-industry followed through on  promises to keep the FDA apprised of what it discovers through “post-market surveillance” of its products.

But the drug industry spends more on advertising than it does on research and development, and often conceals the risks of its products or buries trials that didn’t turn out as hoped. As the Medicare Payment Advisory Commission noted in its June report, “researchers have shown that bias in industry-sponsored trials is common.”And in a March post, Maggie noted that “Both medical journals and the mainstream press have spotlighted cases where practice guidelines created by industry have been dangerous for patients.”

Drug makers also exaggerate the benefits of their products. For example, the most important data point for a given drug is a value called the “number needed to treat,” i.e. the number of patients to whom researchers give a drug before they stumble across someone who actually benefits from it. This number is often surprisingly high: drug trials for cholesterol-lowering heart drugs like statins show that at least 250 low-risk patients need to take the drugs for five years before researchers strike gold and find someone who actually benefits from the medication.

In other words, you have a one in 250 chance (.04 percent) of benefiting from the drug if you take it. Yet advertisements for drugs like Lipitor don’t mention this fact (of course). Instead, they focus on ostensibly more impressive numbers, such as how many people who took the drug  suffered heart attacks when compared to people who didn’t take it. For example, if three people in the control group suffered heart attacks, as opposed to only two in the group that took Lipitor, the advertisements trumpet the fact that Lipitor reduces the rate of heart attacks by 33 percent (because one-third fewer people suffered from them in the group that took the drug). But the odds that the drug will help you aren’t one-in-three; they’re still one-in-250.

The Journal seems unfazed by the hype.  Consider what Wang has to say about Crestor, a protein-reducing drug that set the industry abuzz in November when it “slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands of seemingly healthy people.” This isn’t as impressive as it sounds. As Maggie pointed out when the news first broke last month, Crestor is a drug for “seemingly healthy” people—who, in fact, might need it.  Or, as Stephen Colbert put it, Crestor helps you “to not have the heart attack that there’s no way of knowing that you would have had.”

Yet Wang uses Crestor as an example of a good drug that gets a bad rap from patients. She points to Elona Boykin, a 54-year old woman in Ohio whose “doctor has been ‘hounding’ her to start” Crestor. Boykin is “reluctant” because “her brother and sister have experienced side effects from a similar medicine…and she's heard that Crestor can lead to serious conditions like pancreatitis… Still, [Boykin says that if her] doctor reassures her at the next visit, she…will start taking the drug.” That’s not necessarily good news.

If an industry regularly lies about the benefits of its products, what’s to stop it from lying about the risks? In theory, the FDA should insist on clean numbers and full disclosure. But as we’ve pointed out many times in the past, the agency is a mess. It’s understaffed, underfunded, and actually receives about 30 percent of its budget directly from drug companies through its accelerated approval program, which allows drug makers to pay an extra fee to expedite review of their products.

Wang suggests we needn’t worry. After all, drug companies are self-regulating. In fact, they’re “ramping up efforts to be more open about drug safety” by “launching Web sites that go beyond traditional lists of side effects” and present clinical data for popular consumption. The fact that we’re supposed to be impressed with the fact that drug companies are no longer hiding clinical data to the degree that they once did shows just how low the we’ve set the bar when it comes to pharma accountability.

Nothing drives this point home more strongly tha
n another story in the WSJ highlighted yesterday by Gary Schwitzer on his blog. The article is titled “Drug Makers, Facing Critics, Will Stop Some Ads,” and judging from this headline, you might think that drug companies are finally getting their act together. But it turns out that their concessions to transparency are incredibly meager. Schwitzer points out that drug companies have agreed to three changes in their advertising. First, they won’t promote drugs for uses that haven’t been approved by the FDA; second, companies will stop using actors as doctors without saying so in the advertisement; and third, ads will only feature celebrity endorsers who actually take the drug that’s being advertised. So no more bending the rules and no more phony testimonials—this is what passes for progress.

Given all of this, it’s really up to the drug companies to restore their credibility. If people don’t trust drug makers to be straight-forward when it comes to identifying and understanding the risks of their products, it’s only because we have no reason to take them on good faith. In contrast, we have every reason to believe that drug companies will cut corners when it comes to drug safety—because they’re doing so with everything else.

Tuesday’s WSJ article is nothing more than speculation; a weird, pointlessly contrarian piece totally out of touch with the current environment.  At some point in the far, far future, should the regulation of prescription drugs ever become truly oppressive, Wang’s piece and its anti-regulatory, pro-industry sentiment might be relevant. But right now the consensus is that government has gone too far in the other direction. There has been too little regulation, and as a result, drug companies have been free to twist and distort information about their drugs. The Journal’s article didn’t need to be written; but it does need to be debunked.