The New Health Dialogue

Conflict of interest is back in the news this week, with a new story in the Washington Monthly by medical journalist Jeanne Lenzer and Keith Epstein. The story, also reported on by the Wall Street Journal and co-published with BMJ, reports that three decisive votes on a recent FDA safety evaluation panel had financial relationships with Bayer--maker of the drugs in question.

Yaz, Yasmin, Beyaz, and Safyral are Bayer's birth control drugs that contain the hormone drospirenone. Such drugs have come under heavy fire in recent years for being unsafe. Consumers and researchers have argued that the drugs increase the likelihood of fatal blood clots, deep vein thrombosis, and other serious adverse events.

In light of those allegations, the FDA convened a panel to assess the evidence. Five or six members of that panel had financial relationships with Bayer; in what appears to be a violation or misapplication of the FDA's conflict of interest rules, they were still allowed to vote. That undermines the intent of conflict of interest rules, which should aim to protect public confidence in the FDA and avoid even the appearance of impropriety. In the end, all conflicted panelists voted that the drug was safe enough to stay on the market; if the their votes had switched, it would have reversed the 15-11 vote.

The truly absurd part of this story is the member the FDA chose to exclude from voting: consumer advocare Sidney Wolfe.  Wolfe had previously made statements critical of the drugs, and so the FDA deemed that he had an "intellectual conflict of interest." Such a charge is inane; if he was conflicted, surely any clinician who had ever prescribed (or declined to prescribe) one of the drugs would be similarly unable to vote! FDA panelists are responsible for doing exactly what Wolfe does: evaluating the evidence and coming to a conclusion. Making familiarity with the evidence a disqualifying factor is patently ridiculous and contrary to the purpose of the board.

Various groups, including the Attorneys General of twenty-six states, the National Federation of Independent Businesses, and several individuals, have sued the federal government over parts of the Affordable Care Act. Specifically, they've alleged that the mandate requiring individuals to purchase health insurance is unconstitutional -- it overreaches the enumerated powers of the federal government. The case was recently accepted by the Supreme Court, with oral argument scheduled for March and a decision likely by the end of June. If the Court accepts the plaintiffs' arguments, they could strike down the individual mandate (which could create huge moral hazard problems and be catastrophic for the insurance industry) or strike down the law in its entirety.

As the excitement builds for the coming arguments, Meghan McCarthy of the National Journal issued a call for opinions and predictions on the final fate of the individual mandate. Here's our take:

The final ruling on the individual mandate is tough to forecast, but we're fairly confident that the Court will not strike it down. The challenge is based on whether Congress's power to regulate interstate commerce extends far enough to allow the federal government to require all citizens to purchase health insurance or pay a penalty.

The ruling will depend in part upon how the Court sees uninsurance: is it an active choice for an individual to go bare, in effect to self-insure, or is it due to inaction? The precise definition of action and inaction is a bit murky, but here’s how the argument goes. If going without health insurance is inaction, the Court has to deal with the messy question of whether Congress can regulate inaction when it affects interstate commerce. (Throughout the case, opponents of the Commerce Clause justification for the individual mandate have asked the government just how far Congress's power stretches. Their favorite example has been the purchase of broccoli: can Congress require everyone in the country to buy broccoli? So far, the government has not said "no" -- after all, choosing to buy, or not buy broccoli affects a whole series of interstate markets for leafy green commodities. We won't weigh in on the validity of that argument, but we agree with the Cato Institute's Ilya Shapiro that the government's inability to establish a limiting principle for the Commerce Clause may prove problematic when this argument reaches the Supreme Court.

We actually don't think the case needs to address the issue of action versus inaction at all. In the case of health care and health insurance, there simply is no inactive choice. Going without health insurance is inherently different from going without broccoli, because everyone has some interaction with the health care system at some point. Even if you choose not to buy health insurance, there is a good chance that you will need health care at some point. You are in a car accident, you get brain cancer, you fall down your stairs and break your leg. Since virtually everyone will, at some point, need  health care (and must therefore have a way to pay for it), choosing to go without private or public insurance is, in fact, choosing to self-insure. Since choosing self-insurance is an action that affects interstate commerce, it's clearly within Congress's power to regulate.

Alternatively, the Court might just accept the notion that the mandate is a tax (since its only enforcement mechanism is a penalty), in which case it is unambiguously within Congressional power. That might be more palatable to Justices uncomfortable with striking down the law, but who also don't believe in the expansive Commerce Clause power that the government's position implies.

This is a guest post from independent medical investigative journalist Jeanne Lenzer. She is a former Knight Science Journalism Fellow and a frequent contributor to BMJ, and has published works in  The Atlantic, The New York Times Magazine, Discover, The New Republic, and other outlets.

When doctors recommend tests, drugs or surgeries to prevent bad outcomes (think cholesterol-lowering agents to prevent strokes or cardiac stents to prevent heart attacks) they tap into our deepest sense of what constitutes commonsense: An ounce of prevention. Catch it early. A stitch in time.

It can’t be a bad thing to catch problems early, can it?

Unfortunately, one of the toughest things to explain is why detecting some illnesses at their earliest stages can cause more harm than good. Take this example: Since elevated cholesterol is associated with a higher risk of cardiovascular disease, doctors often prescribe drugs known as statins to people with elevated cholesterol levels in the hopes of reducing their risk of a heart attack or stroke.

Here comes the part that’s tough to explain – because it is so counterintuitive: Statins only help individuals who already have had a heart attack or stroke (with a few exceptions, and more on that later).

Of course, this makes no sense to most people. Isn’t the whole point of taking cholesterol-lowering agents to prevent a heart attack? Why should anyone wait until after a heart attack or stroke to begin taking a drug designed to prevent a heart attack or stroke?

The answer rests with disease creep and the simple statistical quirks that come with it. In the past, doctors treated diseases that caused symptoms. But now we have tests and imaging machines that can detect risk factors and illnesses in their earliest stages. Like cholesterol. Elevated cholesterol is not a disease. It doesn’t cause symptoms. It is a risk factor. People with high cholesterol levels are somewhat more likely to develop a heart attack or stroke, but they are at far less risk than individuals who already have cardiovascular disease. This is the definition of disease creep: when pre-conditions or risk factors are treated as if they are the same as the actual disease state.

Here’s a thought experiment (with purposefully exaggerated numbers) to help understand this puzzle: Imagine a group of people who have the rare but awful Disease A, which is so terrible that all of its victims will die. Now imagine the discovery of Wonder Drug X, which cures half of the patients with Disease A. Unfortunately, Wonder Drug X does have a pretty bad side effect profile – it’s a very powerful drug, after all – and 10 percent of people who take it will die from liver failure. Despite this worrisome side effect, Wonder Drug X is truly an advance for patients with Disease A: For every 200 patients with the disease who are treated, 100 will now survive and only 10 of the 100 survivors will die of the drug’s side effects. That means 90 more people out of 200 will survive thanks to Wonder Drug X.

But now imagine a different group of 200 people, who don’t actually have disease A, but instead have a genetic marker which “is associated with” Disease A. In this scenario only 1 in a million people in the general population will get disease A. If you have the genetic marker, the risk is much higher, such that 2 of these 200 people will develop the disease at some time in the future. The genetic test gets highly promoted – “find out your risk early, because we now have a treatment that works, and the sooner you’re treated, the better!” There is a tiny grain of truth to this – of the 2 people identified by the genetic test, 1 (50%) will now be saved by Wonder Drug A.   This might sound just as good as before; here’s a group of people with 10,000 times (!) the risk of the general population to develop a uniformly fatal disease. Surely it’s worth taking a drug that can cure that disease in half the cases, isn’t it?

But it really isn’t the same. Because saving that one life isn’t remotely worth the harm caused by Wonder Drug X in these 200 people. For while each individual is at a 10,000 fold risk of the disease, only 2 are destined to die from it. On the other hand, if they take Wonder Drug X, roughly 20 (10 percent of the 199 survivors) will die unnecessarily of liver failure.

Ever read a credit card agreement?

Yeah, I haven’t either.

We all know it’s important to understand the terms and conditions attached to these all-important pieces of our financial lives, but credit card agreements are long, boring and full of unintelligible boilerplate legal language. Even if we did read them, whether we'd learn anything is far from certain.

That’s why the Consumer Financial Protection Bureau (the new financial regulator born of the Dodd-Frank Act) has created a new, simplified version of a credit card agreement that is designed to provide consumers with something they can actually read before signing up for the card. The hope is that the documents will become useful tools for comparing different card offers, rather than being the thing you dig through to find out what went wrong when your rate suddenly goes up.

The Creative Commons project has used a similar system very effectively for dealing with its copyright licenses. Each CC license (there are several, allowing different levels and types of usage) is a complete contract, full of legalese and probably incomprehensible to most people. In addition, though, the contracts have “human-readable” summaries that lay out the important differences between licenses, and clearly state what people may and may not do with copyrighted material. The summary states that it isn’t the full license—it’s not a legal document -- and it doesn't lay out all the specific details that might be relevant in some cases, but for most people it's good enough.

Anyone who's ever had surgery, or even a colonoscopy, knows that the legal paperwork in medicine is just as dense as it is in banking--and the stakes are much higher. Given that, it seems like there should be a huge movement in the medical community toward creating human-readable paperwork for patients. The current system is clearly failing: people sign the documents, but the ideal of informed consent is being left behind. In too many cases, patients give consent--but they aren't informed. 

The real goal of the new credit card agreement is not only to disclose the terms of use, but to help customers make active choices among their credit options. Patient decision aids (which we've written about before) are a crucial tool for doing that in a medical setting. There's a huge opportunity to make patients much better off by giving them information that they can use to make decisions. Here's hoping  health care agencies will follow the CFPB's lead, and push hard for patients to have understandable and comparable information about their treatment (and non-treatment) options.