There’s an unusual bit of good news out of the U.S. Food and Drug Administration. In March 2010 and again last November, the FDA rejected approval for a new medical device designed to help doctors detect cancerous skin lesions caused by melanoma, even though the agency’s scientific advisory board voted in favor of approval both times. But yesterday, the manufacturer, Mela Sciences, announced that the FDA had reversed course and agreed that the device is in fact approvable — pending agreement on labeling and the compilation of an appropriate user manual for physicians.
That’s good news. About 70,000 people are diagnosed with melanoma in the U.S. every year, and nearly 9,000 die from it. But it is nearly 100 percent curable if detected early. The question remains, however, what caused FDA to change course?
Unfortunately, it’s difficult for doctors to distinguish between skin lesions that are cancerous and those that are benign, so the detection process usually involves doctors making a judgement call about which lesions to biopsy based on their appearance. Highly experienced dermatologists are fairly accurate, but less experienced ones and general practitioners aren’t nearly as good. That, unfortunately, leads to a lot of false positives (unnecessary biopsies that are expensive and at times painful and disfiguring) and false negatives (lesions not biopsied that are actually cancerous). The MelaFind device aids in detection by digitally scanning a lesion using light from multiple wavelengths, including infrared, and then analyzing its appearance with an algorithm that factors in all the relevant characteristics. As an output, it essentially provides the doctor with a second opinion about whether any individual lesion should be biopsied. It can’t replace a doctor’s educated judgment, but it does provide a pretty good backstop against possible mistakes.
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Last week, D.C.’s Capital Bikeshare program celebrated its millionth trip and one-year anniversary. U.S. Secretary of Transportation Ray LaHood celebrated the milestone with a blog post, calling the government-subsidized bicycle system “remarkable.” Capital Bikeshare is supposedly revolutionizing transportation in the District, reducing nasty polluting and obesity-causing auto use. I will now explain why this is not the case with some back-of-the-envelope arithmetic, and why Capital Bikeshare should be panned rather than praised.
Let’s look at some data. From January 2011 to July 2011 (the most recent complete data available), Capital Bikeshare averaged 3.35 trips per in-service bike per day in Washington, D.C. (This is overestimated given that DDOT/Capital Bikeshare do not break down their active fleet by municipality as they do for ridership, but I’m feeling charitable today.) According to the most recent National Household Travel Survey (2009), Washington, D.C., averages 1.92 million person trips per day. This can be broken down into modes: 44.3 percent of trips were made by personal automobile, 18.4 percent by transit (rail and bus), 1.9 percent by taxi, 1.6 percent by bike, and 27.9 percent by walking. This means that a few years ago, Washingtonians made 11.5 million trips annually by bicycle.
Let me again be charitable and assume that not only did Capital Bikeshare add 1 million trips (bringing annual bicycle trips to 12.5 million), D.C. cyclists using their own vehicles (myself included) added another 1.3 million additional bicycle trips — bringing annual cycling trips to 13.8 million — while holding total trips constant. We’ve now increased cycling’s share of person trips by 20 percent from the 2009 NHTS. Even given these very optimistic assumptions, cycling would only represent a little over 1.9 percent of all trips taken in Washington, D.C. (Capital Bikeshare’s mode-share in this scenario: 0.14 percent of all trips.) It would take a pretty twisted view of reality to herald this figure as somehow revolutionizing urban mobility.
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The United States Postal Service has lost over $8 billion in the past two years and going for a third year in the red. Labor — wages and benefits — accounts for 80 percent of USPS costs. Annual mail volume has dropped from a peak of 213 billion pieces of mail to a projected 170 billion in 2010.
In the words of Anthony Vegliante, executive vice president of USPS, “If the Postal Service was a private sector business, it would have filed for bankruptcy and utilized the reorganization process to restructure its labor agreements to reflect the new financial reality.” Given the USPS’s quasi-government agency status, reorganization is out of the question. Congress would prefer the taxpayer foot the bill.
Elected officials on both sides of the aisle, along with Postmaster General Thomas Donahue, are asking for reform of USPS. In general, they want to provide flexibility enabling USPS to react to market conditions.
This has been tried. The bipartisan Postal Accountability and Enhancement Act of 2006 was supposed to bring about greater flexibility and cost saving. Annual billion-dollar deficits prove the Act has failed.
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OPINION
SIMON JOHNSON – “Who Will Eclipse the U.S.?”
“According to Voltaire, the Roman Empire fell ‘because all things fall’. It is hard to argue with this as a general statement about decline: nothing lasts forever. But it is also not very useful. In thinking, for example, about American predominance in the world today, it would be nice to know when it will decline, and whether the United States can do anything to postpone the inevitable.”
NOAM COHEN – “Dealing With an Identity Hijacked on the Online Highway”
“Despite his prominent position as a Republican candidate for president, Rick Santorum has lost control of his online identity. And for all the snickering online about it, his predicament stands as a chilling example of what it means to be at the mercy of the Google algorithm.”
MEGAN MCARDLE – “Solyndra Was Just a Bad Bet From the Beginning”
“Solyndra didn’t invent the photovoltaic cell; they had a solar panel technology that didn’t use silicon and was (by the company’s account, anyway) supposed to be easier to install on the roofs of big box stores. However, this design was tricky and very expensive to manufacture, apparently: my reading indicates that Solyndra was able to make a product for $6 that sold for $2-3 (before the market collapsed, anyway). I take it that the idea was that Solyndra would somehow ease this disparity by getting up to scale, but the product was apparently extremely difficult to manufacture, and they never got their assembly line working properly.”
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Recently and for different reasons, two high-profile players from different parts of the financial sector – JPMorganChase CEO Jamie Dimon and respected banking analyst Christopher Whalen – have called for the U.S. top pull out of the Basel III bank solvency agreement. I agree, and it’s good that at long last these international agreements are finally getting the scrutiny they deserve. They have contributed to the very problems they claim to solve — bad risk management and moral hazard.
The international agreements to ensure the financial stability of banks, Basel I, II, and now the emerging III — claimed to strengthen banks by ensuring that the assets included in banking reserves were well selected. Risk-based capital was the goal — encouraging banks to place greater emphasis on assets that were more secure, less on those more likely to default. But, of course, governments tend to trust governments; thus, sovereign debt (specifically that of “developed” nations and government-sponsored enterprises (GSEs)) received a higher rating and thus, a higher weighting. One unit of sovereign debt was the equivalent of more than four units of ordinary commercial loans. Not surprisingly, banks shifted toward the former.
Much of the risks that they now face were the result. Was a Greek bond really four times less risky than a loan to ExxonMobil? And should a Greek bond be viewed as having the same risk as one from Germany or Texas? Government ratings are crude instruments in a highly differentiated and complex world.
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The Obama administration is attacking religious freedom in court, even as Obama depicts his policies as ordained by God. At a Congressional Black Caucus rally Saturday, he implied that God supported his policies, “likening” the “black voters who ‘keep the faith’ by supporting him and his policies” to “Biblical prophets who had faith in God — and so refused to worship an idol.” “Obama then explained how he had ‘kept the faith’ through various acts as president — by responding to the economic crisis with the Dodd-Frank Wall Street regulations bill, through certain tax credits he had passed and through Obamacare. He finished with a plug for the American Jobs Act.”
(Obama’s suggestion that the Dodd-Frank Act was God’s will may come as a surprise to the thousands of Americans whose jobs will be wiped out or outsourced due to the Dodd-Frank Act, just as his belief that the healthcare law was divinely-ordained may baffle people whose insurance premiums have gone up due to Obamacare. Experts have given Obama’s so-called American Jobs Act a thumbs down, and if it were enacted, it would drive up the national debt without creating jobs.)
Meanwhile, Obama Justice Department appointees took aim at a longstanding protection for religious freedom. The Establishment Clause and Free Exercise Clause of the Constitution generally forbid government “entanglement” with religion. One such forbidden entanglement is government meddling in who churches, synagogues, and religious organizations hire to act as “voices of the church,” such as ministers, rabbis, theology professors, and instructors of religion. To prevent such entanglement, every federal appeals court has recognized a “ministerial exception” to federal and state labor and employment laws dictating who employers must hire. A long line of court rulings recognizes this principle, such as EEOC v. Catholic University and Young v. Northern Illinois Conference of United Methodist Church. Thus, the Catholic Church cannot be forced to hire a female priest, and a synagogue cannot be forced to hire a Christian or Muslim as a rabbi. But Justice Department lawyers recently called for this limit on government interference to be rejected. In Hosanna-Tabor Evangelical Lutheran Church and School v. EEOC, the Justice Department intervened to attack religious freedom, and its “brief disputes the general existence of the ministerial exception.” The Justice Department thus seeks to apply to religious institutions the requirements that historically applied only to secular employers, like the Title VII requirement of not having policies that either intentionally or unintentionally discriminate against any group.
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The Charleston Daily Mail’s Don Surber points to a recent study “that shows that 790,000 Ohioans will lose their private health insurance and premiums will rise 55%-85% when Obamacare takes full effect in 2014.” The study was commissioned by the Ohio Department of Insurance.
Obamacare also harms medical advances, patients, and employers. And it contains racial discrimination and racial preferences that were criticized by the U.S. Commission on Civil Rights.
It’s not living up to its backers’ promises. As Dr. Milton R. Wolf, a cousin of President Obama, noted,
“President Obama, former House Speaker Nancy Pelosi, and Senate Majority Leader Harry Reid, Democrats all, in their rush to take over America’s health care system, made all sorts of outlandish, unkeepable promises. Among the most egregious: Obamacare would allow you to keep your current health insurance and your doctor. Mr. Obama’s own Medicare chief actuary now acknowledges that Obamacare may cause up to 20 million Americans to lose their current health insurance policies, and doctors are increasingly leaving Medicare, Medicaid and the practice of medicine altogether. Good luck keeping them. Another unkeepable promise: Obamacare ‘will create 4 million jobs, 400,000 jobs almost immediately.’ The Congressional Budget Office’s budget director estimates the law actually will destroy 800,000 jobs.”
CEI filed an amicus brief on behalf of Minnesota and North Carolina legislators explaining why Obamacare unconstitutionally exceeds Congress’s powers under the Commerce and Spending Clauses and violates principles of federalism. The brief was filed in Florida v. HHS, which declared Obamacare’s individual mandate unconstitutional for being beyond Congress’s commerce-clause powers.
Our Constitution created a pro-property rights, pro-contract rule of law — a system promoting entrepreneurial growth. On this 224th Anniversary of the creation of the Constitution, the business community should recognize its value and act to defend it.
The Founders sought a balance between the need for a strong government (Madison’s observation that because men aren’t angels, governments are necessary) and George Washington’s warning that government, like fire, is a dangerous servant and a powerful master. Our Founders sought to restrain the fire of government to its proper sphere. The Constitution created firewalls: separation of powers; clearly enumerated and limited powers to the national government; and set forth basic rights of the people. That document — supported both culturally and legally — restrained Leviathan for almost a century.
The highpoint of judicial respect for economic liberty came in the early 1900s. In the famous 1905 Lochner case, the Court struck down an anti-competitive state restriction about the number of hours bakery employees might work. Similarly, in Buchanan v. Warley (1917), the Court struck down a local racial residence restriction as a violation of property rights.
But the Progressive movement soon eroded these restraints. Progressives, the secular priests of America’s emerging intellectual class, believed that if America freed itself from the archaic restraints created by the Constitution, it could become Heaven on Earth.
That belief led Progressives to disdain all restrictions on Leviathan. They discredited the Constitutional understanding that many things simply shouldn’t be done by the federal government, no matter how popular. Their successes breached the Constitutional firewall, allowing government intervention to consume our liberties. The bright-line restraints of the Constitution were gradually replaced by a “majority is always right” concept (at least, regarding economic liberties).
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Over at National Review today, I have a lengthy but necessary rebuttal of a misbegotten post at The Corner by Rory Cooper of the Heritage Foundation which mistakenly castigates NASA for the sins of Congress. As I say there:
Senators Hutchison (who is retiring next year) and Nelson (who is likely to be defeated next year) are the rocket scientists behind the design of the Senate Launch System. They insisted that NASA spend three billion on it and Orion just this year alone, making it in effect the biggest earmark in the budget for a business case that won’t close (think of it as “Shuttlyndra”). NASA didn’t “inflate the cost estimates” — they came up with an estimate to accelerate the schedule so it might have meaningful capability sometime in this decade. When Congress screamed about it, they went back to the more sedate one. Booz Allen Hamilton came out with an independent cost assessment that indicated NASA’s cost estimates in the out years were optimistic. But Senators Hutchison and Nelson (and Hatch and Shelby and others with pigs in the fight) insisted on a bipartisan basis that NASA move forward with their rocket to nowhere, because all they care about is jobs in their states this election cycle. And the rest of Congress doesn’t care at all, because space policy isn’t very important in the context of trillion-dollar deficits, a stagnant economy, and a meltdown of the Eurozone.
Meanwhile, the most near-term solution to eliminating our dependence on the Russians is to accelerate the Commercial Crew activities, for which the administration requested $850M for 2012. For a few billion (as opposed to the tens of billions that the SLS will cost), we could have multiple competitive commercial providers of access to and from the ISS and low-earth orbit within three years. These would include Boeing and the United Launch Alliance with their reliable Atlas and Delta rockets, and actually spawn a useful new industry with competition to drive down costs, enabling innovative and affordable means of serious space exploration in the next decade through which America could once again lead the world. But the House appropriated only about $300M for it, and while the Senate version of the bill appropriates $500M, it holds $200M of it hostage to progress on the SLS. Yesterday, the relevant House authorization committee had a show hearing featuring the first man and last man to walk on the moon, for no apparent purpose. All of which indicates that for all their noise about losing leadership and risks to our national security, the legislative branch continues to be profoundly unserious about our future in space.
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Here’s another batch of regulatory bloopers:
- In Seattle, Washington, the maximum length allowed for concealed weapons is 6 feet.
- The federal government has a Shell Egg Surveillance Program.
- In Pocatello, Idaho, “The carrying of concealed weapons is forbidden, unless same are exhibited to public view.”
- In Memphis, Tennessee, it is against the law for frogs to croak after 11:00pm.
- In Oregon, it is illegal to wipe your dishes with a cloth or towel to dry them. They must drip-dry.
- In Norfolk, Virginia, it is illegal for hens to lay eggs outside the hours of 8am-4pm.
- In Jamestown, New York, dentists can be fined $250 for hypnotizing their patients.
- In Utah, birds always have right of way on all state highways.
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