07.22.08
When Wal-Mart is better than the FDA, something’s wrong
This is amazing. Suemedha Sood reports in the Washington Independent:
Fortune Magazine has an opinion piece up blasting advocacy groups, retailers and politicians for working to get a chemical found in baby bottles and infant formula cans, called Bisphenol A (BPA), off the shelves. In the piece, Marc Gunther accuses retailers like Wal-Mart, CVS and Toys R’ Us of playing FDA by refusing to sell products containing the chemical. But retailers say their reasoning is that consumers do not want to buy them.
As we’ve reported, the National Institutes of Health and the House Energy and Commerce Committee have been investigating the chemical’s safety. A recent draft report from NIH suggests it might harm babies and young children.
Nonetheless, Gunther argues that the chemical must be safe because the FDA says it is.
“Bisphenol-A has been widely used since the 1950s,” he argues. Yeah, well, so has lead. But let’s let him finish:
The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move purely precautionary.
To be sure, other scientists worry because animal studies have linked small doses of BPA to cancer and other health problems. But scientific debate isn’t driving the baby bottle war; a hard-hitting push by activist groups, politicians and trial lawyers is.
Okay, wait a second. The non-partisan Environmental Working Group — composed of expert scientists and analysts — is at the forefront of the activist groups Gunther mentions. In addition, some of the loudest voices on this matter are independent scientists.
More importantly, Gunther seems to argue that Americans have no reason to question federal actions (or inaction) on public health. And that agencies don’t need to be held accountable. We should just assume that, hey, they’re probably doing an OK job! But then, he says this:
…[T]he FDA typically uses industry research because it doesn’t have the money to conduct independent studies of the thousands of chemicals on the market. It then reviews what industry produces.
Yet another reason that consumers are right to scrutinize the FDA. The agency judges the safety of Bisphenol A (and other chemicals) by examining reports conducted by the people who manufacture and sell Bisphenol A. Naturally, that presents a conflict of interest.
Finally, when Gunther asked Wal-Mart why it’s no longer going to sell products with BPA, spokeswoman Linda Blakley said, “We sell products our customers want to buy. Our customers are telling us they want this option.” Businesses like Wal-Mart are certainly not making a moral choice by banning BPA products — they’re doing what they do best: focusing on the bottom line. But in this case, their bottom line revolves around consumer concerns. And shouldn’t consumers have the right to demand the safest products they can get?
pantheophany said,
22 July 2008 at 11:19 am
Companies like Wal-mart, when they’re doing what they should, are beholden to customer whim. Agencies like the FDA, when they’re doing what they should, are beholden to the science. Customer whim and hysteria often have nothing to do with science, and I don’t want the FDA to swing it’s regulatory muscle every time some email rumor tells people that Fabreeze kills pets. If Wal-mart wants to pull it, fine, but we don’t need the gov’t stepping in and banning it without good reason.
No one’s goal should be “the safest products they can get.” If it were, we would have a speed limit of 2 mph, only vegetables in the market, and no over the counter medicines (all have dangers, almost none are life saving). Instead we want a reasonable trade-off of safety and utility, and even safety and pleasure. Straight razors are not the safest shaving product we can get, but I don’t want the government to step in and ban them, regardless of whether Wal-mart is willing to carry them.
I’d like to see a lot more about this NIH report before I jumped to banning something. How strong is the evidence that “it might harm babies and young children?” What is NIH actually recommending, and is FDA following, considering or ignoring that recommendation?
LeisureGuy said,
22 July 2008 at 11:38 am
I agree with what you write, but I also bemoan the current state of the FDA and the degree to which regulatory agencies in general (including the FDA) seem more interested in protecting the businesses they regulate than the public and consumers.
TYD said,
22 July 2008 at 12:47 pm
Vegetables only in the market? Really? read the news — they can kill you these days (spinach, tomatoes, jalepaneos,…)
pantheophany said,
22 July 2008 at 1:47 pm
In a properly functioning risk-management system, we should expect to see occasional lapses followed by effective corrective action if there was a systemic problem. If we see lapses often, then the system is too loose. If we never see lapses, then the system is either too tight (too risk adverse) or the lapses are being covered up. Cynically, having been a security risk assessor for years, I tend to find that the best systems are those where both sides say it’s gone too far in the “other” direction.
So what do we see at FDA? We see thousands of drugs moving through the approval process, with continual push-back from the FDA (at least from my talks with friends in the medical devices industry), and very few drugs turning out to be unsafe or ineffective in the end. In the cases that do slip through (Vioxx), we’re generally talking about useful drugs with marginal, though statistically significant, risks. We’re not talking about dangerous, useless drugs that FDA has signed off on to help out their corporate buddies. We’re seeing the expected outliers in a properly working system, and we’re seeing the kinds of process changes we’d expect when these kinds of problems come up.
If anything, the FDA has probably become too reactionary in its treatment of manufacturers. The level of documentation required, even for small changes, is staggering and wildly costly both in time and money. And quick time to market helps patients as much as it help companies. Every long-term clinical trial required pushes off much-needed cures. The FDA has to balance that fact every time they raise the bar. In order to provide perfect medical safety, you have to provide no medicine.
I admit that I tend to give folks the benefit of the doubt that they’re doing their job well until I’ve studied their job and can point to specific places they’re failing (realizing that even after I’ve studied it, my initial recommendations will likely be naive and will need correcting). Are there specific reforms that you’d like to see at FDA?
Anyway, those are my criteria for determining if a risk-management system is working correctly. What criteria would you use?
Thanks for all the links. I do find them interesting.
LeisureGuy said,
22 July 2008 at 2:01 pm
We’ve seen quite a few episodes of contaminated foods in recent years, so on that side the FDA is not doing a good job, I would say. Indeed, many imported foods escape inspection altogether. (The FDA regulates around 80 percent of the food supply, which includes food for humans and animals, except meat products, poultry products, and egg products, which are regulated by the U.S. Department of Agriculture.)
I’m sure you’re aware of the foot-dragging at the FDA (in spite of promises to fix it) for approval of things that conservative, fundamentalist Christians oppose, like the Plan B contraceptive. Indeed, the continuing delays on Plan B led to a top-level resignation. I do not think the FDA was doing a good job in that case.
pantheophany said,
22 July 2008 at 2:30 pm
Interesting. I haven’t studied contaminated food as much as I’ve studied the medical side. I’m not aware of the inspection issues around imported food. Do you have any good links around that subject?
Regarding political issues at FDA, it is a funny problem. Regulatory agencies only exist as extensions of the Executive branch. They’re not called for in the Constitution. So they exist in a bizarre little pocket of government. Should they be political entities, subject to the will of the current President, or should the be apolitical entities, above the tides of changing Administrations? The question seems obvious when asked that way, but let me rephrase it. Should regulatory agencies be directly accountable to the voters, or should they be accountable primarily to their own bureaucracies? You can’t be directly accountable to the voters and not be a political entity. The only way to protect the agencies from their boss (the President) is to entrench their bureaucracy. But we tend to hate unaccountable bureaucracy. It’s a nasty Catch-22.
It’s interesting that you blame the FDA over Plan B when Wood’s resignation was in protest over the Administration’s meddling in FDA. That sounds like an FDA that is trying to do exactly what you want, but is being actively stopped by the President. I would think you’d consider the FDA laudable in this case. What more can they do but quit if they’re forbidden from doing their jobs by the man they work for? They have no authority beyond that. In the end, they work at the pleasure of the President. Much as that might be an abused principle in recent years, it is still true.
LeisureGuy said,
22 July 2008 at 4:41 pm
How about this article, which begins:
Your take on regulatory agencies is interesting. I’ve tended to view them as the civil service, and thus protected to some extent from political manipulation, though certainly under the current Administration we’ve seen a variety of agencies, up to and including the Department of Justice, suborned to serve political ends. Certainly the science-based agencies (such as the FDA, the EPA, NASA in terms of weather and climate prediction, and the like) should be directed by science and their mission, not by political considerations. And when an industry lobbyist is put in charge of an industry regulatory agency, it seems to me that there is something mightily wrong. (Cf. Consumer Products Safety Commission.)
The FDA was not laudable in the case I referenced because Commissioner Crawford had been confirmed only upon his specific assurance that he would immediately bring forth a decision on Plan B. Once confirmed, he reneged and stalled the decision further. Moreover, it’s a bad sign when standard agency procedures are violated to arrive at (or hold up) a decision—and this pattern of overriding standard procedures has occurred repeatedly under Bush: in the FDA, the EPA, the DoJ, and others.
Of course, ultimately the voters must speak, and I am looking forward with interest to the outcomes of the Congressional, Senatorial, and Presidential elections this coming fall.
spiritwealth said,
23 July 2008 at 4:27 pm
Yes, I’ve noticed that Wal-Mart does plenty of things right too. Here are some of the good things Wal-Mart has done over the years, in my opinion.
LeisureGuy said,
23 July 2008 at 4:41 pm
Wal-Mart has incredible inventory control, but unfortunately uses it to drive down price until it has bankrupted some of its suppliers. It has absolutely wretched labor practices, including many that are found in court to be illegal. It’s hard to say whether the overall effect of the company has been positive or not, though it’s certainly made the Walton family incredibly wealthy.
spiritwealth said,
23 July 2008 at 5:00 pm
It’s true what you say LeisureGuy, but then we are a capitalistic nation. If you read why they do the things they do with prices, you will see it is because it does make profit for them in their business model. And, all the people who flip out after they go bankrupt for doing business with Wal-Mart forget to mention that initially they saw their profits go through the roof too from all the extra business. Then, Wal-Mart comes back and asks them to lower their prices to be more competitive and if they say no, they go to a competitor who can give them the deal that they want. And, all that extra business dries up. If they say yes, they lose money too. So, either way. That’s the capitalistic, dog-eat-dog system for you, and unless we can think up a better one I think it will probably continue. I’m not sure that’s Wal-Mart’s fault since that’s the epitomy of competition in a free market. They are pretty straightforward with their suppliers exactly what they intend to do and people sign anyways.
pantheophany said,
23 July 2008 at 5:55 pm
spiritwealth, you’re right that in a capitalist society, Wal-Mart should be expected (even encouraged) to pursue profit as their primary goal. But the other side of this is that profit is not simply the drive to lowest price. In a free market, customers are free to vote with their wallet, and they can vote over any issue that they like, not just price, and they’re free to encourage others to do the same. I’m not fond of how Wal-Mart operates, so I don’t shop at Wal-Mart. If enough people agree with me, then Wal-Mart will change their practices (and in some cases they have).
In my opinion the deep problem in our country isn’t so much the companies as the hypocrisy. The same people who say they oppose Wal-Mart’s practices shop at Wal-Mart because the prices are the lowest. If you do that, you’re saying that the lower price is more important than the other issues and the companies follows our lead. It should be so obvious that it doesn’t need saying, but if you don’t like how a company operates, stop giving them your money.
LeisureGuy said,
23 July 2008 at 6:29 pm
If the making of profit is the only goal, then we as taxpayers and as a society have to deal with the spillover—for example, the effects of lead used in paint and toys, the stalling on action on findings on cigarettes and global warming, the numerous toxic waste sites that must be cleaned up, the bad construction of cars that cost thousands of lives until regulations forced safety measures, and so on. Businesses will externalize costs whenever possible—i.e., leave it to taxpayers to pay the piper (Bear Sterns? Fannie Mae and Freddie Mac? Savings & loan failures?), while keeping the profits for themselves.
Fortunately, the US is not a completely laissez faire capitalist society, and we do have some agencies that are supposed to ride herd on businesses, but it’s a constant struggle.
diembe said,
23 July 2008 at 6:35 pm
Interesting and solid post, LeisureGuy.
I’m compelled to recommend the book Exposed by Mark Schapiro. It’s a pretty thorough comparison of the very different approaches to risk and how legislation springs forth from that.
The EU applies a precautionary principle: if a preponderance of data suggest a likely hazard or risk to health and safety from a particular chemical, preventative measures are taken.
In the US, by contrast, the approach is rooted in an insistence that 100% bulletproof certainly must be provided, else it’s deemed not a problem worth addressing. I own my bias in favor the EUs approach. Anyone with a smattering of understanding of how scientific process functions and what outcomes are yielded knows that unanimity is more common that the unicorn.
We in the US–particularly under the current political climate–increasingly put blind, naive faith in a private sector to increasingly police itself, while at the same time the findings of our own scientists are watered down or, worse, censored.
And who gets served? We as taxpayers and consumers get short shrift. And salmonella and ecoli in our produce. And so forth.
Appreciate your post very much.
Best,
dmb
LeisureGuy said,
23 July 2008 at 6:43 pm
Thanks. It’s time for liberals to push back.
Edward said,
23 July 2008 at 8:27 pm
I don’t see anything wrong with the actions Wal Mart or CVS, its called market forces. For a publication that has for years said we should support the will of the markets, capitalism, free trades, etc… I find it odd that they now are against it. If people won’t buy a product, you don’t sell it, simple supply and demand, when there is no demand for a product, you don’t sell it. I’m sure the writer of the article understands this so I am left to wonder what is his true motive for the complaint.
LeisureGuy said,
23 July 2008 at 8:38 pm
I agree: it’s an odd stance for Fortune to take.
spiritwealth said,
23 July 2008 at 8:39 pm
Okay, pantheophany, so then the people who refuse to buy the BPA stuff are on the right track, but Wal-Mart gets blasted for doing something the FDA refuses to do? You see the pickle they’re in? They listened to the customers who voted with their wallets and people are still upset? At what point is Wal-Mart in the right? Never? Why is that?
pantheophany said,
23 July 2008 at 9:29 pm
LeisureGuy, I agree with the issue of externalities. This is where the government must step in and ensure that the costs are born by those who are making the profits. When costs and profits go together, decisions can be made that benefit everyone.
spiritwealth, Wal-Mart is not in a pickle over what the FDA will or won’t do. Read the first comment in this thread for my position about that. It’s not up to the FDA to ban something until the science says that it’s a problem. The NIH, just a few months ago, released the first US govt study to ever say that this chemical is cause for “some concern” because “the possibility that bisphenol A may alter human development cannot be dismissed.” This is not strong language from a scientific report, but it is not to be dismissed either. It’s appropriate that the FDA reconsider BPA now based on new evidence. It is not yet appropriate to panic.
Some customers will rightly like to use this new information and avoid BPA, and I wouldn’t consider this an overreaction (though most of the rhetoric has been). Wal-Mart has responded to that, based on customer desire, not hard science. Wal-Mart isn’t getting “blasted” in the Fortune article or in LG’s original post. Note the title: “When Wal Mart is *better* than the FDA….” So to your question, I think everyone has said Wal-Mart is in the right on this action.
But I still don’t like their business practices and I still won’t shop there. That has nothing to do with what they do or don’t do with BPA. So also to your question, Wal-Mart gets to be in the right when they change the way they treat their employees, becomes better integrated into their communities, and improve their environmental impact. They’re working on these things I know. If they can create an employment culture that retains employees who actually care about helping me as a customer and keeping the shelves organized and the merchandise undamaged, I might even go back.
Billy said,
25 July 2008 at 2:05 pm
To echo what has been posted above, and to offer a slightly different angle: it is difficult to figure out a net + or net – Wal-Mart has brought to our nation. Wal-Mart presents us with low prices they acheive through their innovative supply chain and their questionable labor practices. It allows people with less to afford more. It creates some jobs but eliminates similar, higher-paying ones.