Aaron E. Carroll's Blog, page 116

Healthcare Triage News: Last Chance for Exchange Plans, No CHIP Funding, AND a Tax Bill

There’s a lot going on this week, and also a lot that’s NOT happening. The ACA’s health insurance exchanges are wrapping up the open enrollment window this week. If you need insurance, or want to shop around GO NOW and look for insurance. Also, the Children’s Health Insurance Program still isn’t funded, so time to panic about that. AND the Senate passed their tax bill, which includes a rollback of Obamacare’s individual mandate. 2017 isn’t over yet, y’all.



@aaronecarroll

The tax bill destroys an important part of Obamacare. The states can save it.

That’s the headline of my latest piece at Vox.

Adopting mandates at the state level would help stabilize insurance markets, thereby keeping premiums in check and forestalling coverage losses. It would also provide a welcome source of revenue: Some people will still prefer to pay a penalty than buy insurance. Plus, the states don’t need to stick with the precise terms of the federal mandate, which has been reviled (from different quarters) both for heavy-handedness and its ineffectuality. Stiffer state-level penalties would still be unpopular, but at least they’d work better.

States with an income tax could enforce the mandate by way of a tax, as the feds now do. But states without an income tax have options, too. Their state health departments could impose the penalty as a standard-issue fine — something like a parking ticket — and enforce the fine through liens, civil penalties, and the like. Getting a driver’s license or renewing an occupational license could be made contingent on compliance with the mandate. (Alternatively, residents could demonstrate financial hardship.)

I had to leave some of the piece on the cutting-room floor, including the following point:

The more blue states do to preserve their markets, the more they protect the ACA from congressional attack. We’re witnessing that dynamic play out now. President Trump’s abrupt termination of the cost-sharing subsidies was a brazen effort to sabotage the ACA. But a canny move by state regulators—known as “silver loading”—has largely shielded consumers from price hikes associated with the loss of that funding stream. Indeed, because of the complex financial machinery of the ACA, stopping the payments means that most people in most states will pay less for coverage. Only the federal taxpayer loses.

Moderate Republicans, Senator Alexander in particular, have offered to restore the cost-sharing payments in exchange for Democratic concessions, including some that could undermine the ACA. But Senate Minority Leader Chuck Schumer has ruled out cooperating with Republicans if they torch the mandate, and the threat is credible: because of the silver switcheroo, Democrats have less to gain than is commonly understood from cutting a deal. Republicans are stuck. Other blue-state patches will similarly drain support from congressional efforts to tamper with the ACA.

If you’re curious, I’ve got a draft of model state legislation that would straight-up replace the federal mandate. David Anderson has also drafted state legislation that takes a somewhat different approach.

@nicholas_bagley

Birth Control and Breast Cancer: Putting the Risk in Perspective

The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

I have a severe intestinal condition known as ulcerative colitis. For some time, I’ve taken an immunosuppressant to control the flare-ups. Like all drugs, this one comes with side effects. While I’m on it, I have an increased risk of developing myelosuppression, a condition in which my bone marrow might stop producing blood cells and platelets. I also have an increased risk of developing skin cancer.

I know all of this, and I take the drug every day. Why? Because the benefits still outweigh the harms. I’ve been in remission from the colitis for years, which lowers my risk for colon cancer. And I don’t worry that I’m going to lose control of my bowels at any moment the way I used to.

Yes, the risks of my medication involve serious diseases like cancer. But you can’t look only at one side of the equation. You can’t look at individual harms alone and make good health decisions.

I bring all of this up because this past week there were big headlines about a new study that linked contraceptive pills and other hormonal birth control to an increased risk of breast cancer. Some news articles stressed the risk of a commonly used medication. Others, like the one by Roni Caryn Rabin in The New York Times, carefully placed the numbers in context to explain that the absolute risk is very small. (Relative risk is the percentage change in one’s absolute risk as a result of some change in behavior.)

I would go even further. This was a prospective cohort study, meaning it was an observational study that followed women over time and saw what happened to them naturally. The data set didn’t allow for adjusting for some factors that could also be associated with breast cancer, like age at first menstruation; whether women breast-fed; whether they consumed alcohol and how much; whether they were physically active; and more. The study found only an association, and not causal proof you might obtain from a randomized controlled trial.

Even if we accept the findings in full, we might expect an additional 13 cases of breast cancer for every 100,000 person years of use. Another way to say that is for every 7,690 women who use hormonal contraception for one year, one extra might get breast cancer. The rest would not be affected.

That’s a very small risk. Moreover, it’s for women over all. The risk is different for women of different ages. For women younger than 35, there were only two additional cases for every 100,000 person years of use. That means only one extra case of breast cancer for every 50,000 women 35 or younger who use hormonal contraception each year.

This cancer risk isn’t even a new side effect. We’ve known about the link for years. It was hoped that newer formulations might have reduced it, but that doesn’t appear to be the case. The study further established that this increased risk also holds for the hormone progestin, which is also used in pills and intrauterine devices.

Additionally, women have to make sure not to view the breast cancer risk in a vacuum. As I’ve written before, other cancers also matter. Besides breast cancer, there’s evidence that hormonal birth control is associated with higher risks of liver cancer. But it’s also associated with lower risks of ovarian, endometrial and colorectal cancer.

If we look at all cancers together, the benefits seem to outweigh the harms. In other words, a woman who uses hormonal birth control might be less likely to develop cancer, in general, than a woman who doesn’t.

It’s important to note that these statistics assume an average risk of any one cancer or another. Should women have family histories or genetics putting them at higher or lower risks for a particular cancer, the calculus might change.

And let’s not forget that there are many noncancer-related benefits to birth control use. They can be helpful for women who have painful or very heavy periods. They can also be invaluable in family planning. Long-acting reversible contraception, praised for its convenience because it works for an extended time frame without needing any action, can save thousands of dollars over five years compared with other methods.

Every woman should discuss both the positives and the negatives of birth control with her health care provider. The risks include not only those discussed here, but also blood clots and stroke in women who smoke. They also include potential mood changes.

But there are also significant benefits, and for many women these will be greater than the harms. Any discussion that focuses only on one side, or just one aspect of one side, does women a disservice.

 @aaronecarroll

Healthcare Triage: Kids and Elmo and the Difficulty of Research

Nutrition research can be difficult, especially when kids, and Elmo, and careless research techniques ruin the outcome of the study. A study on kids’ nutritional choices was recently retracted because there were problems with the data collection. This happens a lot, and it isn’t doing science any favors.

@aaronecarroll

People Don’t Take Their Pills. Only One Thing Seems to Help.

The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

For all that Americans spend on prescription drugs — $425 billion last year — you’d think we’d actually take our medicine.

But one of the frustrating truths about American health care is that half or more of prescribed medication is never taken.

It’s called medication nonadherence, and it’s a well-documented and longstanding problem, particularly for patients with chronic conditions. The drugs they’re prescribed are intended to prevent costly complications, reduce hospitalization, even keep them alive. But even when the stakes are high, many patients don’t take their meds.

This seems like a problem we ought to be able to solve. It motivates high tech approaches, like digital pills that can automatically communicate to doctors that they’ve been taken.

Maybe people forget to take their meds — about 60 percent of people say as much — so we just need to remind them. Maybe people don’t understand the value of what they’re prescribed, so we just need to educate them. Maybe drug regimens are too complex, so we just need to simplify dosing.

All these methods have been tried. It’s not so clear any of them work very well.

Only one approach has repeatedly been shown to be effective: reducing the cost of medications.

First, let’s look at the research on the other methods. So-called reminder packaging — pill packaging or containers that organize drugs by single dose or day of the week — is a relatively simple idea intended to help people remember to take their prescribed dose.

A systematic review by the Cochrane Collaboration found that it was helpful in doing so, but only modestly. Surveying 12 randomized controlled trials, the authors concluded that reminder packaging increased the number of pills taken by patients by 11 percentage points. But they also found that most of the studies had significant methodological flaws, casting doubt on the findings. Other systematic reviews of reminder packaging studies also found problems with the research, like small sample sizes and short follow-up periods.

Perhaps reminder packaging is too passive, and patients need something like an alarm to alert them when they’ve missed a dose. Electronic pill monitors can do that. Some just remind patients to take their medication. More sophisticated ones alert doctors when they don’t. In 2014, a team of researchers from the Brigham and Women’s Hospital and Harvard Medical School published a systematic review of such devices in the Journal of the American Medical Association. Here, too, the results are disappointing. Most studies of such devices do not detect improvement in adherence.

A recent randomized trial not included in these systematic reviews tested three dose reminder approaches for people with a chronic health condition or depression: a pill bottle with toggles for each day of the week that can be changed after each daily dose; a pill bottle cap with a digital timerdisplaying the time elapsed since the medication was last taken; and a pill organizer with a compartment for every day of the week. Over 50,000 subjects were assigned randomly to one of these approaches or to none, as a control.

None of the devices performed better than the control in getting patients to take their medications. One possible explanation is that forgetfulness may not be why patients don’t take their medications as prescribed. Drug costs, a wish to avoid side effects, and a desire to be less reliant on drugs are some of the other reasons patients don’t take them.

“It is also possible that for reminder devices to be effective, they need to be coupled with other adherence-improvement strategies,” said Niteesh Choudhry, lead author of the study and a physician with Brigham and Women’s Hospital and Harvard Medical School.

That’s why augmenting electronic monitoring with other information or assistance delivered to patients may be more successful, if more expensive. For example, one study found that the adherence of hypertensive patients increased when digital display containers were combined with a blood pressure cuff and a card for recording blood pressure. This suggests that when patients receive feedback that signals how well they are controlling their condition, they may be more willing to take their medication.

Still, it isn’t hard to find studies that show that even with considerable support, getting patients to take medications can be challenging. A Cochrane review examined randomized controlled trials of interventions — across many dimensions — to increase medication adherence. Reminder packaging and alarms were just some of the methods assessed, with approaches including patient and family education about the value of medication, and mail or telephone follow-up.

Of the 182 randomized trials reviewed, four stood out as the most methodologically sound. Among those, two increased adherence but two did not. Over all, the authors concluded that there was a lack of convincing evidence that even complex and costly interventions significantly increased patients’ compliance with drug regimens.

“A cure for nonadherence is nowhere to be seen,” they wrote. A more recent study not included in the Cochrane review found that not even providing patients with financial incentives and social support, along with pill bottles that signal when a dose should be taken, was enough to boost adherence among heart attack survivors.

So why is price so important?

When drugs cost them less, patients are more likely to fill prescriptions. Even if people have already purchased drugs, they may skip doses — or split the pills — because of concerns that they won’t be able to afford future refills. Free drugs don’t get everyone to take them, but many more do so than if they have to pay for them.

For those with certain chronic conditions, extra help in affording medications can reduce adverse events and hospitalizations — a big increase in quality of life, as well as a potential benefit to the wider health care system and the economy.

Lowering prescription drug costs has been a longstanding pursuit for many politicians, and Medicare Part D and the Affordable Care Act helped (although most Americans still say costs are too high). President Trump said drug companies “have been getting away with murder,” but lower drug costs have not yet been a top priority of this White House.

@afrakt

 

Why a lot of important research is not being done

The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

We have a dispiriting shortage of high-quality health research for many reasons, including the fact that it’s expensive, difficult and time-intensive. But one reason is more insidious: Sometimes groups seek to intimidate and threaten scientists, scaring them off promising work.

By the time I wrote about the health effects of lead almost two years ago, few were questioning the science on this issue. But that has not always been the case. In the 1980s, various interests tried to suppress the work of Dr. Herbert Needleman and his colleagues on the effects of lead exposure. Not happy with Dr. Needleman’s findings, the lead industry got both the federal Office for Scientific Integrity and the University of Pittsburgh to conduct intrusive investigations into his work and character. He was eventually vindicated — and his discoveries would go on to improve the lives of children all over the country — but it was a terrible experience for him.

I often complain about a lack of solid evidence on guns’ relationship to public health. There’s a reason for that deficiency. In the 1990s, when health services researchers produced work on the dangers posed by firearms, those who disagreed with the results tried to have the National Center for Injury Prevention and Control shut down. They failed, but getting such work funded became nearly impossible after that.

I have also discussed the too-slowly changing approach to back pain. There’s a reason for that, too. When research was published, also in the early 1990s, arguing that the proper treatment of back pain was nonsurgical, some with a financial interest in surgical intervention tried to have the Agency for Health Care Policy and Research (now known as A.H.R.Q.) defunded. They failed, too, but left researchers skittish about focusing on this topic.

The area I complain about most, though, concerns nutrition, including supplements. That domain allows us to focus on another type of intimidation: lawsuits.

In 2013, scientists at the Food and Drug Administration published a study in The Journal of Pharmaceutical and Biomedical Analysis showing that nine brands of dietary supplements sold in the United States contained a synthetic analogue of amphetamine. The authors noted that the efficacy and safety of this stimulant, β-methylphenylethylamine (BMPEA), had never been studied in humans.

A year later, Canadian health authorities recalled supplements containing the stimulant, noting the potential for “serious cardiovascular complications.” The F.D.A., inexplicably, remained silent. The agency did not warn the public, recall products or warn manufacturers.

Dr. Pieter Cohen, an associate professor of Medicine at Harvard Medical School, replicated aspects of the 2013 study and came to the same conclusion as the F.D.A. experts: The stimulant was available in multiple brands of supplements, and a comprehensive review of the biomedical and chemistry literature found not a single scientific study of the stimulant’s efficacy or safety in humans. These results were published in Drug Testing and Analysis in 2015 and widely disseminated by national and international media outlets. Two weeks after that, the F.D.A. alerted consumers that the stimulant was potentially dangerous and warned manufacturers to remove it from their products.

One of the companies that received an F.D.A. warning letter, in turn, sued Dr. Cohen for $200 million in damages for libel, alleging that statements in the peer review article, and subsequent interviews with the media, were false. The company asserted, without supporting scientific evidence, that while the article said the stimulant was not “natural,” it had extracted it from a Mexican shrub. Company officials also claimed they had evidence of the stimulant’s efficacy and safety in humans. The lawsuit, initially filed in Georgia, was dismissed because of lack of jurisdiction there, then refiled in federal court in Massachusetts.

During the lawsuit’s discovery phase, the supplement company demanded and received access to emails related to the study, including those with co-authors, journal editors, the F.D.A., outside experts and the news media. The company also demanded and received all revisions of the manuscript, as well as peer reviewers’ comments and the authors’ responses. Despite the absence of evidence of wrongdoing, the judge allowed the case to go to trial.

Dr. Cohen got entangled in what legal scholars call a strategic lawsuit against public participation, or Slapp. Anti-Slapp laws are intended to prevent people from using courts, and even the threat of a lawsuit, to intimidate people who are exercising their First Amendment rights. But in Dr. Cohen’s case, the court refused to give full weight to Massachusetts’ anti-Slapp statute on the ground that dismissing the case would undermine the supplement company’s constitutional right to a jury trial.

Although the jury eventually found for the defense, the experience was extremely unsettling. “Preparation for the trial included a six-hour deposition, a mock trial and a review of more than 4,000 pages of studies, emails, correspondences, drafts and depositions,” Dr. Cohen told me. “The trial itself lasted seven days, and put my family through the wringer.” He was fortunate to have the full support of his university in defending his work.

Dr. Cohen and I, along with Nicholas Bagley, a law professor at the University of Michigan, recently wrote in JAMA Internal Medicine about the damage such suits inflict on scientific inquiry. We pointed out that the peer-review process already provides a way to question a study’s conclusions before publication, and that less formal peer review continues afterward in the form of letters to the editor and editorials.

If errors or mistakes are believed to be fraud, mechanisms for review exist in university systems. Only if evidence of fraud surfaces does it make sense for courts to be brought into play.

“Courts aren’t equipped to referee scientific disputes,” Mr. Bagley said. “And they have an obligation to prevent unscrupulous plaintiffs from abusing the machinery of justice to stifle science.”

Lawsuits like these are too common in health research. Mr. Bagley did a fairly comprehensive search of the reported opinions over the past 40 years. He found two cases in the 1980s and two in the 1990s. Since 2000, however, there have been 10. These numbers greatly understate the number of filed cases, however, since the vast majority are settled.

The manufacturer of a hip protector sued a researcher in 2008 over a study published in JAMA that showed the device didn’t prevent fractures. The C.E.O. of a pharmaceutical company sued a researcher who led his data monitoring committee when the researcher published a 2011 article in Annals of Internal Medicine disputing the way the C.E.O. had described a study’s results.

Lawsuits like these aren’t necessarily bound by ideology or partisan politics. Mark Z. Jacobson, an energy systems engineer at Stanford University, is suing the National Academy of Sciences and the authors of a recent paper published in the academy’s journal, PNAS. The paper criticized Mr. Jacobson’s analyses that the United States could fully power itself with wind, water and solar energy. Many, including some identified as environmentalists, have criticized the lawsuit.

For his part, Dr. Cohen remains undeterred. Last month he published a new paper finding that experimental stimulants continue to be placed in sports and weight-loss supplements. That’s what research is supposed to do: give us more data, so that we can make better decisions about our health.

@aaronecarroll

Why a CVS-Aetna Merger Could Benefit Consumers

The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

There are reasons for consumers to be optimistic about CVS’s reported purchase of Aetna for $69 billion on Sunday.

It’s one of the largest health care mergers in history, and in general, consolidation in health care has not been good for Americans.

But by disrupting the pharmacy benefits management market, and by more closely aligning management of drug benefits and other types of benefits in one organization, CVS could be acting in ways that ultimately benefit consumers.

You probably know CVS as a retail pharmacy chain — it runs nearly 10,000drugstores. But over the years, it has diversified. It now runs walk-in clinics, including in Target stores. And it runs one of the largest specialty pharmacies, dispensing high-priced drugs that require special handling.

In a big move a decade ago that set the stage for more recent developments, CVS purchased a majority of shares of Caremark for nearly $27 billion to enter the pharmacy benefits management business.

Pharmacy benefits managers are companies that help insurers devise and run their drug benefits, including serving as middlemen in negotiating prices between insurers and drug manufacturers.

Many health industry experts believe that pharmacy benefits managers effectively increase prescription drug prices to raise their own profits. This is because they make money through opaque rebates that are tied to drug prices (so their profits rise as those prices do). Competition among pharmacy benefits management companies could push these profits down, but it is a highly concentrated market dominated by a few firms, CVS among the largest.

But CVS’s recent moves may shake up an already changing pharmacy benefits landscape. In October, the insurer Anthem announced its intentions to part ways with the pharmacy benefits management firm Express Scripts. Instead, it will partner with CVS to develop its own pharmacy management business.

Anthem would not be the first insurer to forgo external pharmacy benefits management and take on the role internally. The insurer UnitedHealth Group also runs a leading pharmacy benefit management business, OptumRx. And CVS’s purchase of Aetna would also remove it as a middleman acting between that insurer and drug companies.

“While it’s still early, the moves by Anthem and Aetna have the feeling of the beginning of the end of the stand-alone pharmacy benefits manager business,” said Craig Garthwaite, a health economist with Northwestern University’s Kellogg School of Management. These insurers, and UnitedHealth Group, have concluded that outsourcing pharmacy benefits management may not serve their interests.

This removal of profit-taking middlemen could be good for consumers in the short run if it leads to lower drug prices. “In the long run, it might be harder for new insurers to enter the market because they won’t be able to negotiate lower drug prices than the larger firms,” Mr. Garthwaite said. “This could result in further concentration in the health insurance market.” That could harm future consumers, though not in ways we can predict today.

The CVS-Aetna deal would be just another of the many recent mergers across business lines in health care. Insurers are buying or partnering with health care providers. Health systems are offering insurance. Hospitals are employing physicians. Even Amazon is jumping into the pharmacy business in some states. This may be part of the motivation for CVS to buy Aetna — defensive jockeying to maintain access to a large customer base that might otherwise begin to fill drug prescriptions online.

Typically, mergers in the sector have led to higher prices and no better outcomes. But a CVS-Aetna merger might be different because their business lines complement each other. The most significant overlap is in the management of Medicare drug benefits: Both companies offer stand-alone Medicare prescription drug plans.

But there is a lot of competition in the Medicare drug plan market, so this overlap may not be a leading area of concern.

The CVS-Aetna merger is primarily about a supplier and its customer joining forces, what economists call a vertical merger. This type of merger can enhance a firm’s ability to coordinate across interlocking lines of business.

In this case, CVS-Aetna might more effectively manage certain patients with chronic conditions (those insured by Aetna), reducing costs. Let’s imagine that Aetna could leverage CVS’s pharmacies and clinics to help patients — who require medications to avoid hospitalizations — stay on their drug regimen. That could save the merged organization money. It could also translate into both better care and lower premiums, though there’s no guarantee at this stage of either.

One source of optimism: Research shows that coordinating pharmacy and health benefits has value because it removes perverse incentives that arise when drug and nondrug benefits are split across organizations. When pharmacy benefits are managed by a company that’s not on the hook for the cost of other care, like hospitalization, it doesn’t have as strong an incentive for increasing access to drugs that reduce other types of health care use. That could end up costing more over all.

So there’s reason to believe that a combined CVS-Aetna might find ways to reduce costs — and represent an instance when consumers actually come out ahead after health care consolidation.

@afrakt

Healthcare Triage: Innovation in a Changing US Health System

The US healthcare system has a lot of issues, but one thing it’s got going for it is innovation. More clinical trials originate in the United States, and more Nobel Physiology and Medicine Laureates are from here than from any other country. The key: the huge US health care market. We spend a LOT on health, which means there’s lots of money to be made. That doesn’t, however, mean that we couldn’t innovate better.



This episode was adapted from a column Austin and I wrote for the Upshot. Links to further reading and sources can be found there.

@aaronecarroll

Upshot extra: The advantage of combining drug and non-drug benefits

I have a piece on The Upshot today about the CVS-Aetna merger. With my concurrence, the editors cut a rhetorically unnecessary paragraph. Not wanting anything to go to waste, here it is:

Traditional Medicare enrollees in that program can sign up for stand-alone prescription drug plans, which are not liable for non-drug spending. A study by economists Amanda Starc, of Northwestern’s Kellogg School of Management, and Robert Town of the University of Texas, found that Medicare’s stand-alone drug plans cover drugs less generously that they otherwise would if they accounted for non-drug health care spending. In doing so, they end up costing traditional Medicare over $400 million per year. Another study by Ms. Starc and Kellogg School colleagues David Dranove and Christopher Ody, found that when states shift provision of Medicaid drug benefits to private organizations responsible for managing non-drug benefits too, program spending goes down.

@afrakt

The Threat that Lawsuits Pose to Science: Radio Edition

Yesterday, the NPR affiliate in San Diego aired an interview about my recent paper with Aaron and Pieter Cohen on the risks that lawsuits can pose to science. The jumping-off point for the interview is a recent lawsuit filed by Professor Mark Jacobson against a group of researchers who called into question his conclusion that the country could shift entirely to renewable energy by 2050.

Jacobson sued Clack [a former researchers at the University of Boulder] and the National Academy of Sciences, which published the paper, in late September. He said Clack’s work defamed him by calling his work into question even after Jacobson pointed out supposed errors in Clack’s interpretations. He also claimed the National Academy of Sciences improperly published the critique as a research paper, instead of as a letter, which are shorter and less detailed. Jacobson is seeking at least $10 million in damages.

Clack responded in a court filing Monday, saying that the dispute should continue to play out in academic journals under peer-review, a system designed to ferret out inaccurate or misleading work.

I’m on Team Clack. You can listen to the interview here!

@nicholas_bagley