January 18, 2012 4:00 PM
Sick people, like those suffering from narcolepsy, are suffering from a manufacturing shortage of Adderall. That shortage was caused by the Drug Enforcement Agency, which controls and limits the supply of Adderall’s ingredients.
Denying the obvious, the DEA falsely claims that there is no shortage, and that if there is one, it's because manufacturers don't want to make more of the drug, despite the fact that there is plenty of market for the drug:
To manage controlled substances that can potentially be abused, the DEA sets manufacturing quotas for drug ingredients each year to control supplies like Adderall. But Adderall drug manufacturers . . . say they cannot meet the growing demand for the product without looser limits from the DEA. The DEA questions whether there is actually a shortage of generic supplies, which are at an especially low supply . . . Despite the growing demand, Special Agent Gary Boggs of the DEA’s office of diversion control told the New York Times, "We believe there is plenty of supply.” Barbara Carreno, a DEA spokeswoman, told Reuters that . . .“Any shortage of these products is therefore a result of decisions made by industry regarding manufacturing or distribution,” Carreno told Reuters. But a Teva spokesperson told Reuters, "Our production facilities are currently running at maximum capacity for Adderall utilizing all available API (the drug’s active pharmaceutical ingredient). The catalyst for the problem is the quota system, not the business.”
January 12, 2012 12:21 PM
Greece is rapidly degenerating into third-world status. The UK's Daily Mail reports:
Youngsters are being dumped by their parents who are struggling to make ends meet in what is fast becoming the most tragic human consequence of the Euro crisis. It comes as pharmacists revealed the country had almost run out of aspirin, as multi-billion euro austerity measures filter their way through society.
If you only read this much of the article, you would assume that the country’s “austerity measures" are responsible for the medicine shortage, but if you’ve ever opened an economics textbook, you’d know this can’t be the case. Shortages occur when prices aren’t able to readjust to higher demand. Why aren’t prices able to adjust? Keep reading.
Further evidence of Greeks feeling the pinch of austerity measures is the lack of aspirin and other medicines now available in the country.
Actually, that’s more inaccurate information. Keep reading further.
Pharmacists are struggling to stock their shelves as the Greek government, which sets the prices for drugs, keeps them artificially low. This means that firms are turning to sell the drugs outside of the country for a higher price - leading to stock depletion for Greeks. Mina Mavrou, who runs one of the country's 12,000 pharmacies, said she spent hours each day pleading with drug makers, wholesalers and colleagues to hunt down medicines for clients. And she said that even when drugs were available, pharmacists often must foot the bill up front, or patients simply do without.
January 3, 2012 6:50 PM
A year from now, the federal government will start collecting a new tax on medical devices from tongue depressors to imaging machines, thanks to the sweeping health-care overhaul that Democrats enacted in the spring of 2010. People in the industry say it’s already having an effect.
In November, citing the new tax, Stryker Corp. (SYK), whose products include artificial hips and knees, announced that it would let go about 1,000 of its workers. Earlier last year, Covidien Plc (COV), maker of surgical instruments, said it would lay off 200 workers in the U.S. and move production to Costa Rica and Mexico. It, too, cited the tax.
Other companies in the field have announced similar measures -- or plans to expand production overseas but not in the U.S. -- without mentioning the tax. The sluggish economy is clearly part of the explanation, but the medical-devices industry had been a relative bright spot within U.S. manufacturing, losing only 1.1 percent of its employees during 2007-2008 while manufacturing as a whole lost 4.8 percent. A study done for AdvaMed, a trade association for the industry, claims the tax could ultimately cost more than 45,000 jobs.
Medical-device companies employ more than 400,000 Americans. Their wages are higher than the national average. The U.S. is a net exporter of medical devices.
The tax will change these numbers for the worse. It will be levied at 2.3 percent of sales; on average, profits make up less than 4 percent of sales in the industry. The AdvaMed study concludes, “The new 2.3 percent excise tax will roughly double their total tax bill and raise the average effective corporate income tax rate to one of the highest effective tax rates faced by any industry in the world.” . . .Richard S. Foster, the Medicare chief actuary, has estimated that if the tax is passed on to consumers it will raise national-health costs by $18.2 billion in 2018.
December 28, 2011 2:17 PM
At Bloomberg News, Andrew Puzder, CEO of CKE Restaurants, Inc., explains how the 2010 healthcare law is preventing jobs from being created and resulting in layoffs.
For example, Puzder notes, CKE Restaurants, which operates Hardee's and Carl's Jr. restaurants, “will have to cut spending on new restaurant construction," in order to “offset higher health-care expenses," even though "building new restaurants is how" the company creates jobs. Puzder argues that the increase in the company's healthcare costs will “more than consume" the amount it "spent on new restaurant construction last year, leaving nothing for growth." It “will also need to reduce" its "capital spending," even though such spending creates jobs and enables the restaurant company to improve its infrastructure and maintain its business. Thus, its “ability to create new jobs could vanish."
Puzder also points to the similar situation of "Grady Payne, chief executive officer of Connor Industries Inc., a supplier of cut lumber and assembled wood products" with 450 employees, who has laid out the unpleasant options facing "his company under the health-care law, each of which would cost $1 million or more," which is "'more than the company makes.' [Payne] concluded that his company’s goals have turned “from ‘hire-and-grow’ to ‘cut-and- survive.’”
Puzder also documents the complaints of Victoria Braden, the president and CEO of Braden Benefits Strategies Inc., "a corporate employee-benefits adviser":
"[Braden] said adoption of the law led to immediate job cuts at her company as she scaled back an expansion into a new line of business. Obamacare 'is devastating to my business, expensive for me and my clients to administer, and works against our goals of helping businesses to expand, and putting people back to work,' she said."
December 23, 2011 11:48 AM
Journalist John Stossel describes how "three successful businessmen came on" his TV show last week "to explain how Obamacare is a reason that unemployment stays high. Its length and complexity make businessmen wary of expanding." "An owner of 12 IHOPS told me that he can’t expand his business because he can’t afford the burden of Obamacare." Others complained that even experts admit they "can't tell you" how much Obamacare will cost them. "Brad Anderson, CEO of Best Buy, added that Obamacare makes it impossible to achieve even basic certainty about future personnel costs."
Stossel agrees with Robert Higgs of the Independent Institute, who says that "if you wonder why businesspeople are not investing and reviving the economy, the answer lies in all the question marks that Obamacare and other new regulations confront them with." Higgs calls this “regime uncertainty." As Stossel notes, "it’s also what prolonged the Great Depression." Obamacare also contains work disincentives that the Congressional Budget Office says will shrink the size of the economy and the workforce.
December 16, 2011 9:39 AM
Way back in September 2009, the Food and Drug Administration announced that it would begin using the social media site Twitter to share news and other information about drug safety and regulation. "Messages on Twitter provide consumers, healthcare professionals, the pharmaceutical industry, and others with timely information on new drug approvals, safety alerts, compliance actions, and consumer information," the announcement said.
It was curious that FDA mentioned the pharmaceutical industry. You see, drug and device companies have been feeling their way around the Internet and other new media, including Twitter, for several years without substantive guidance from the FDA. That's important because, under the Food, Drug and Cosmetic Act, there's a lot that's not permitted, but nobody's quite sure what is and what isn't. And if the industry guesses wrong, they could subject themselves to some pretty harsh civil and criminal penalties.
As Ed Silverman at Pharmalot explained in an op-ed posted yesterday, the agency has been promising for years that it would develop of a formal policy on the matter. As early as 1996, the FDA held a public meeting (see reference at the bottom of this document) to discuss issues related to the advertising and promotion of medical products on the Internet. Then, in November 2009, the agency held another public meeting, with the promise that it would soon thereafter develop guidance or other policies that addressed Internet promotion and social media. But, as Silverman notes:
"the guidelines didn't appear in the wake of the meeting. And they didn't appear by the end of 2010, despite an unofficial FDA deadline to push something out by New Year's Day. And then the agency missed another deadline, this one on March 31. By mid-year, FDA officials said they would stop setting deadlines."
December 8, 2011 1:35 PM
Back in March 2009, President Obama issued a memorandum on scientific integrity to the heads of executive branch agencies and departments. It announced that “[s]cience and the scientific process must inform and guide decisions of [his] Administration on a wide range of issues.” And in a statement to the press, Obama insisted that “Our government has forced what I believe is a false choice between sound science and moral values.” Previous administrations (and one in particular -- nudge nudge, wink wink … Know what I mean?) had let politics interfere with what should have been purely science-driven decisions by expert agencies. But that just wasn’t going to happen in the Obama administration.
I guess Kathleen Sebelius didn’t get the memo.
Yesterday, HHS Secretary Sebelius publicly overruled a decision by the Food and Drug Administration to make the Plan B emergency contraceptive available to girls under age 18 without a prescription. According to The New York Times, “Dr. Margaret Hamburg, the F.D.A.’s commissioner, issued a lengthy statement saying it was safe to sell Plan B over the counter, while Ms. Sebelius countered that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B.” Commissioner Hamburg's public letter on the decision explains that:
“Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. [FDA’s Center for Drug Evaluation and Research] experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.”
December 7, 2011 5:21 PM
By now, there's been plenty of news highlighting last week's decision by the Ninth Circuit Court of Appeals that the National Organ Transplant Act of 1984 (NOTA) does not forbid compensation for the majority of bone marrow donors. That's great news for patients needing marrow transplants. And the non-profit Institute for Justice deserves a tremendous amount of applause for arguing the case. Unfortunately, the decision is far narrower in scope than it has been portrayed by some news outlets. And, although there is plenty here to celebrate, it neither "deregulates the bone marrow market" nor paves the way for compensating organ donation more broadly.
AEI's Sally Satel had a good piece in yesterday's Wall Street Journal discussing some of the nuances of the issue. Unfortunately, the headline on Dr. Satel's op-ed misrepresents the nature of the ruling. (For the record, neither the author nor the primary editor of most newspaper articles has any control over the headlines.) So, here's a bit more context.
Until recently, bone marrow donations could only be performed by having a large, thick, and very very painful needle pierced through your pelvic bone in order to suck out the liquid marrow. Today, however, the majority of marrow donations are not actually donations of marrow at all. Instead, peripheral blood stem cells are isolated from circulating blood, and those stem cells develop into bone marrow in the new patient. That means that most "marrow" donations can be as simple (more or less) as giving blood at your office's annual blood drive. (It's a slightly more extensive process than that. But you get the point.) That's been a tremendous boon to patients needing marrow transplants, since the process is now far less invasive, less painful, and less risky in the majority of cases.
December 7, 2011 1:24 PM
Point of Law has an interesting debate over whether medical-malpractice noneconomic damage caps hurt consumers, between Ted Frank and Shirley Svorny. As Frank notes, "medical malpractice awards are" often "haphazard," failing to distinguish between negligent and non-negligent physicians (jurors are, after all, not experts in medicine, and may be unable to understand scientific concepts that undergird some malpractice lawsuits). As Svorny notes, however, malpractice verdicts are not purely random, and thus provide some disincentive for negligence.
In a rational world, we would have specialized health courts to decide malpractice disputes, the way many other civilized countries do, since such tribunals are better able to see through unfounded malpractice claims and detect genuine negligence by doctors than are uninformed juries of laypeople. But state constitutional rights to jury trials often exist in state courts, and in federal courts, the Seventh Amendment right to jury trial applies, making it impossible to totally abolish such trials in malpractice cases despite their often erroneous results. (By contrast, in most states, legislators could toughen up limits on junk science in malpractice cases, although liberal activist judiciaries in a few states have thwarted legislative attempts to do so.) Perhaps legislators could impose stringent caps on malpractice cases tried in regular court, while giving specialized administrative tribunals more leeway to award damages. That way, people who have genuinely suffered lots of damages due to doctors' negligence could do so before a tribunal of experts that has the expertise to distinguish between meritorious and meritless claims, while people with weak claims who wish to play litigation lottery would remain free to seek lesser amounts of damages in regular court before a jury of their (often uneducated) peers.
December 6, 2011 4:15 PM
Kidney sales should be legal, explains kidney donor Alexander Berger in The New York Times. Berger is a research analyst for GiveWell, a nonprofit that helps charitable donors decide where to give. As Berger notes, allowing kidney donors to be compensated would save countless lives by providing people with an incentive to donate their kidneys. Right now, you have to be unusually altruistic to donate a kidney, since you have to spend several days in the hospital to donate one, take off a lot of time from work, and run a tiny, tiny risk of death from surgery. Most people just aren't that altruistic. Allowing kidney sales would also help the poor, who currently often unable to obtain kidneys: as Berger notes, people unable to get kidney transplants now are "disproportionately African-American and poor."
If kidney sales were legal, the taxpayers would save money, too, since the government would be able to give kidneys to poor people and elderly people who need them, with the increased number of kidneys that would become available due to kidney sales, rather than paying for incredibly costly and debilitating dialysis treatment, which has consumed billions of tax dollars over the years. It would be much cheaper for the government to buy a kidney for a poor or elderly person rather than paying for years and years of dialysis. As Berger notes, paying for kidneys would likely "save the government money; taxpayers already foot the bill for dialysis for many patients through Medicare, and research has shown that transplants save more than $100,000 per patient, relative to dialysis."