Topic: Health Care & Welfare

FDA Doesn’t Want E-Cigs Marketed as Safer Than Tobacco Cigarettes

In a forthcoming article in Regulation California Polytechnic State University economics professor Michael Marlow describes the negative effects on public health of the proposed regulation of e-cigarettes. The FDA proposes to expand its authority granted under of Section 911 of the Family Smoking Prevention and Tobacco Control Act. “Section 911 bans marketing tobacco products as modified risk products without FDA approval. Moreover, manufacturers are unable to inform consumers their products do not contain tobacco.”

The prohibition on marketing e-cigarettes as safer than traditional cigarettes has not been subject to cost-benefit analysis. This is particularly significant given that the literature on e-cigarettes suggests that they help smokers quit. Even the JAMA Patient Page, published by The American Medical Association last January, highlighted a number of potential e-cigarette benefits such as their lack of tobacco and the less toxic nature of e-cigarette vapor compared to cigarette second-hand smoke.

In his back-of-the envelope calculation using quit rates from the published literature, Marlow estimates that the benefits related to e-cigarettes would be between $15.6 and $49.2 billion a year as the result of between 2.4 and 6.4 million smokers becoming former smokers every year. “Prohibiting sales to youth and requiring a clear description of product ingredients may be appropriate. But prohibiting any information regarding potential efficacy in harm reduction is hard to justify given substantial benefits reported in currently available studies.”

The Great Debate Over Hobby Lobby

The Supreme Court’s 5-4 ruling granting certain for-profit companies religious exemptions from Obamacare’s contraceptive mandate has of course generated a flurry of debates between conservatives and liberals (with libertarians siding with the right not to be forced by the government to violate your conscience). But what about within the camp that supported the decision in Hobby Lobby? Was there some conservative vs. libertarian split?

Well, as it happens, one of the icons of the libertarian legal movement, my former professor Richard Epstein, contributed an article to the most recent volume of the Cato Supreme Court Review. He concluded that Justice Samuel Alito’s majority opinion reached the right result for the wrong reason, that the Court should’ve rejected the mandate because the government didn’t have a compelling interest to advance not because it didn’t use the least-restrictive means to advance it. 

Epstein wasn’t able to attend our Constitution Day symposium, however, so Ed Whelan – president of the conservative Ethics & Public Policy Center and noted legal contributor to National Review Online – took Epstein’s place in discussing Hobby Lobby. Whelan took issue with Epstein’s approach; during the panel [see starting at 35:00] his comments about the Review article were akin to Justice Antonin Scalia’s “blistering concurrences” this term, agreeing with little other than the final judgment.

So this sounds ripe for the libertarian-versus-conservative trope, right? Maybe Epstein focused on liberty and Whelan on religion? Actually not really; (most of) their dispute is more about principle with pragmatism.

Decrying “Wishful Science” on NPR(!)

Global Science Report is a feature from the Center for the Study of Science, where we highlight one or two important new items in the scientific literature or the popular media. For broader and more technical perspectives, consult our monthly “Current Wisdom.”


First, a disclaimer. I don’t listen to NPR. “State radio” bugs me. But I have friends who do, and I was bowled over when one sent me a seemingly innocuous story about the search for a pharmaceutical treatment for Amyotrophic Lateral Sclerosis [ALS], the horrific ailment also known as Lou Gehrig’s Disease.

I knew something big was about to happen when correspondent Richard Harris led off with this zinger:

There’s a funding crunch for biomedical research in the United States—and it’s not just causing pain for scientists and universities.  It’s also creating incentives for researchers to cut corners—and that’s affecting people who are seriously ill.

Predictably, NPR, itself a federally (and privately) funded creature, said the problem was a lack of funding, even titling the piece, “Patients Vulnerable When Cash-Strapped Scientists Cut Corners.”

Allow NPR its sins, because what’s in the article is one key to a very disturbing trend, not just in biomedical science, but in “most disciplines and countries.” It seems that negative results are systematically disappearing from science. Those words appear in the title of a blockbuster 2012 article by University of Montreal’s Daniele Fanelli, more completely, “Negative Results are Disappearing from Most Disciplines and Countries.”

Memo to NPR:  Scientists  are always “cash-strapped.” Just ask one. The reason is very simple, and can be illustrated by my area, climate science.

There are actually very few people formally trained at the doctoral level in this field (yours truly being one of them).  One reason was that, prior to the specter of anthropogenerated climate change, there wasn’t very much money from the federal government. It was about a $50 million a year operation, if that much. We didn’t have enough research dough. 

Now the federal outlay is $2.3 billion. Guess what: we’re all climate scientists now. So ecologists, plant biologists, and even psychologists hitched their wagons to this gravy train. Today’s shocker: we don’t have enough research dough.

What Harris found out about ALS really does apply in a Fanelli-like fashion. It seems that drugs that work fine on mice and rats flop miserably when tested on humans. It turns out that the animal studies were all pretty shoddy.

Story Landis, director of the National Institute of Neurological Disorders and Stroke, explained why.  According to NPR, “There is no single answer, she says, but part of the explanation relates to a growing issue in biomedical science: the mad scramble for scarce research dollars.”  She went on: “The field has become hypercompetitive,” and NPR added, “Many excellent grant proposals get turned down, simply because there’s not enough money to go around. So Landis says scientists are tempted to oversell weak results.”  

“Getting a grant requires that you have an exciting story to tell, that you have preliminary data and you have published”, she says. “In the rush, to be perfectly honest, to get a wonderful story out on the street in a journal, and preferably with some publicity to match, scientists can cut corners.”

According to a research paper published earlier this year, corner-cutting turned out to be the rule, rather than the exception, in animal studies of ALS.

Stefano Bertuzzi, the executive director of the American Society for Cell Biology, says that’s because there is little incentive for scientists to take the time to go back and verify results from other labs;

“You want to be the first one to show something”, he says—not the one to verify or dispute a finding, “because you won’t get a big prize for that.”

Landis noted that “ALS is not the only example of this type of wishful science [emphasis added].”  She found similar problems with other drugs for other diseases.

It’s too bad that NPR didn’t then go to Montreal’s Fanelli, because they would have found that similar problems are infecting science everywhere, which is why Cato now has a Center for the Study of Science.

Coming up: I’ll be posting soon on what this does to science itself.  Teaser: if there’s little incentive to publish negative results, whatever reigning paradigm is operating in a given field will be very resistant to change. As the Center for the Study of Science’s Richard Lindzen has observed, there has been a remarkable lack of paradigm substitution in overall science as research budgets ballooned. Ironically, the more we spend on science, the more science can be harmed.

 

More Headaches in Obamacare Open Enrollment

Open enrollment for Obamacare’s second year begins in two months. Recent reports suggest that this year’s enrollment period will not be a smooth process.

According to Ricardo Alonso-Zaldivar of the Associated Press, individuals face many hurdles in signing up for or renewing coverage:

  • For the roughly 8 million people who signed up this year, the administration has set up automatic renewal. But consumers who go that route may regret it. They risk sticker shock by missing out on lower-premium options. And they could get stuck with an outdated and possibly incorrect government subsidy. Automatic renewal should be a last resort, consumer advocates say.
  • An additional 5 million people or so will be signing up for the first time on HealthCare.gov and state exchange websites. But the Nov. 15-Feb. 15 open enrollment season will be half as long the 2013-2014 sign-up period, and it overlaps with the holiday season.
  • Of those enrolled this year, the overwhelming majority received tax credits to help pay their premiums. Because those subsidies are tied to income, those 6.7 million consumers will have to file new forms with their 2014 tax returns to prove they got the right amount. Too much subsidy and their tax refunds will be reduced. Too little, and the government owes them.
  • Tens of millions of people who remained uninsured this year face tax penalties for the first time, unless they can secure an exemption.

These won’t be the only issues. In July, the Government Accountability Office told Congress that the HealthCare.gov website is still not complete. The back-end system that links the website to insurers and distributes the subsidies is not operational. Additionally, thousands, possibly millions, of insurance policies will be cancelled over the next several months for not including all of Obamacare’s mandates which will increase the confusion for individuals.

The Obama administration says that this year’s open enrollment period will be better than the last, but the complexity and short enrollment period will still create lots of headaches for consumers. Shockingly, overhauling a large swath of the United States economy is not easy work.

Arkansas’ Budget-Busting Medicaid Expansion

Back in February, I highlighted the fight to reauthorize Medicaid expansion under ObamaCare in Arkansas. The states’ plan not only expanded Medicaid; it did so in a more expensive way.  Supporters claimed that the concerns were hogwash. Costs would be the same or lower because Department of Health and Human Services (HHS) required “budget neutrality” for the expansion. A new report from the Government Accountability Office (GAO) confirms that AR’s expansion is a budget-buster.

Medicaid provides insurance to low-income individuals, focused on pregnant women, children, and the disabled. ObamaCare sought to expand this program adding millions of able-bodied, childless adults to the program. States that agreed to dramatically expand the entitlement program would receive a large sum of federal funding. The federal government agreed to fund 100 percent of expenditures through 2016, slowly decreasing to 90 percent in 2020 and after. Even with the large financial enticement, states, rightly, resisted. The program is expensive to operate. States also have little control over the program. The quality of insurance is poor. A 2013 study found “no significant improvements” in health outcomes for individuals joining the program.

Arkansas decided to try something different. Under the plan passed by Democrat Governor Mike Beebe and the Republican legislature, more than 200,000 individuals would join the state’s Medicaid rolls. These individuals would not join the traditional program, but instead would receive money from the state and federal government to purchase insurance on the state’s newly-created health insurance exchange. This plan was preferable, according to advocates, because it would eliminate the known health disparities between traditional Medicaid and private insurance. Better yet, the AR Department of Human Services said that the so-called private option would save the state $670 million over the next ten years and would save the federal government $600 million. Choice and competition would power the market and result in lower prices.

Supporters argued that if the state was going to dramatically expand an entitlement program; it should do it in a fiscally-conservative way saving money in the process.

However, subsidizing Medicaid expansion through private insurance is not fiscally conservative. It turns out that private insurance costs $3,000–or 50 percent more–per enrollee than traditional Medicaid coverage according to the Congressional Budget Office (CBO). Spending $3,000 per person more adds up to a huge added cost for taxpayers. This would be compounded by the Arkansas’ decision–due to federal strings–to eliminate any out-of-pocket expenses for enrollees; no co-pays, no deductibles, no cost-sharing.

Supporters of Arkansas’ expansion claimed it didn’t matter because HHS’s approval required that the plan be “budget neutral.” In other words, the federal government would not spend more than if the state pursued traditional expansion. If the state exceeded the budget cap, the state would be responsible for the additional expenses. The state would be forced to tweak the program later if costs rose.

The plan passed and costs quickly grew. The first month was overbudget. As of June, the program was $10 million overbudget.

GAO now says that HHS did not guarantee budget neutrality in the Arkansas plan suggesting that even more taxpayer money is at risk. “HHS did not ensure budget neutrality. HHS approved a spending limit that included hypothetical costs despite questionable state assumptions and limited supporting documentation…HHS officially told us they accepted the state’s projections of the increased cost of expanding Medicaid in the absence of a demonstration without requesting data to support the state’s assumptions.”

HHS just accepted what Arkansas said, and did not question the state’s assumptions. The promised federal backstop does not seem to exist. GAO estimates that the “$4.0 billion spending limit approved by HHS was about $778 million [over three years] more than what it would have been.”  That’s a 20 percent increase in costs for federal taxpayers.

Making matters worse, GAO says that AR has the authority to “adjust the approved spending limits if costs…prove higher than expected.” This sort of upward flexibility never used to be granted, but HHS recently granted it to 11 other states. AR has already acknowledged that it might need a higher spending limit.

This is not the first time that GAO has highlighted HHS’ inability to properly enforce budget neutrality. HHS’ refusal to properly set spending caps is costing federal taxpayers millions, or billions, more than it should. GAO confirms that Medicaid expansion in Arkansas is busting the budget.  

ObamaCare Exchanges Recklessly, Often Unlawfully, Throwing Taxpayer Money At Health Insurance Companies

Robert Laszewski, health policy wonk, blogger, and president of Health Policy and Strategy Associates, tells Inside Health Insurance Exchanges:

The Obama administration has no idea how many people are currently enrolled [in exchanges] but they keep cutting checks for hundreds of millions of dollars a month for insurance subsidies for people who may or may not have paid their premium, continued their insurance, or are even legal residents.

And if you think they’re doing those “enrollees” a favor, remember that if it turns out a recipient wasn’t eligible for the subsidy, he or she has to pay the money back.

Surprised? Don’t be. This is part of a deliberate, consistent strategy by the Obama administration to throw money at individual voters and key health care industry groups—lawfully or not—to buy support for this consistently unpopular law.