Fellow in Consumer Policy Studies Michelle Minton breaks down the FDA’s behind-the-scenes push to regulate dietary supplements nearly as strictly as prescription drugs.
Health and Illness
Proponents of government collective bargaining view it as a fundamental human right. The shameful actions of SEIU in Michigan, however, undermine this claim.
In 2005, Michigan lawmakers signed off to create the Michigan Quality Community Care Council (MQC3). MQC3 maintains a registry of homecare providers to assist Medicaid recipients looking for a caregiver. In reality, the primary function of MQC3 was to make 45,000 private homecare providers government employees and dues-paying union members.
In 2006, SEIU took advantage of Michigan law deeming homecare providers government employees. To gain exclusive representation SEIU organized a covert union campaign. The stealth-organizing tactic led to 20 percent voter turnout and SEIU won a landslide victory.
Soon thereafter, SEIU obtained a collective bargaining agreement (CBA) with the state. The events following the CBA expose the dangers of government union political influence and permanence of CBAs.
MQC3, acting as a “dummy” employer for homecare workers, created a mechanism for union dues to be siphoned off Medicaid checks. Not only is it illegal to unionize homecare workers who are private contractors, homecare workers already have employers: their Medicaid beneficiaries. Worse, the scheme wholly rejects the purpose of Medicaid by diverting funds from individuals who cannot afford medical care to Big Labor.
With the State of the Union coming up, I’ve been wondering whether, or how, President Obama might address the Plan B fiasco I blogged about here. After all, Obama has addressed science issues in his previous State of the Union addresses. And, in his inaugural address, he pledged to “restore science to its rightful place.” More importantly, he entered office promising the most transparent administration in history and vowing that, unlike previous administrations, he and his appointees would “not suppress or alter scientific or technological findings and conclusions” for political gain. But those promises were forgotten or ignored as soon as they were made.
From Obama’s March 2009 decision to fund only politically favorable types of human embryo research to his administration’s Plan B birth control decision last month, he has shown that he is every bit as willing to politicize science when it’s expedient as earlier presidents have been. The highly politicized December 7 decision by Secretary of Health and Human Services Kathleen Sebelius to over-ride a decision by Food and Drug Administration scientists to approve the Plan B emergency contraceptive for over-the-counter use has gotten plenty of attention. But for science policy experts, that case of politicized science came as no surprise given the administration’s willingness to subvert the advice of scientific experts on any number of critical issues.
Just to give a couple of examples: White House Energy Czar Carol Browner improperly altered a scientific report on oil spill remediation in order to support a ban on off-shore drilling. Then there was the administration’s rejection of Yucca Mountain as a nuclear waste depository as Nuclear Regulatory Commission scientists accused senior administration officials of politicizing their work. And there are scores of other cases — ranging from the significant to the petty — in which the Obama Administration has chosen to subvert scientific integrity for political gain.
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.”
So as Rob Port notes, “the DEA is limiting the supply of ingredients for a perfectly legal drug (when prescribed properly) which treats and alleviates a lot of suffering among Americans in order to fight the war on drugs.”
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.”
With holiday cooking on most of our minds this week, it’s worth celebrating some good news about one of the most beleaguered food ingredients: table salt. For years, consumers and food producers have been bombarded with demands to reduce sodium consumption by nanny state regulators hoping to improve public health, even though the evidence linking high sodium diets and serious health concerns has always been ambiguous at best. But this year alone, several major scientific studies have cast that link in even further doubt.
The folks over at the Salt Institute — the trade association representing salt producers and commercial users — are touting these results as “The Biggest Health & Nutrition Story of 2011.” ”In 2011, half a dozen medical studies quantified the health benefits of salt or revealed the significant risks of low-sodium diets, making it a year of vindication for this essential nutrient and the people who love it. … The latest data should raise fresh questions about the federal government’s effort to put all Americans on a low-salt diet that could do far more harm than good.”
This wasn’t surprising to us. For years, we at CEI have been pointing out that the belief that sodium consumption in the United States has reached extreme and unhealthy levels is mistaken. And, as more and more high-quality research has been conducted on this subject during the past 40 years, the link between high-sodium diets and negative health effects has become more tenuous, not more certain.
The Institute of Medicine (IOM) has recommended a Tolerable Upper Intake Level of just 2,300 mg of sodium per day and an Adequate Intake of just 1,500 mg per day. And regulators are concerned that average sodium intake per person in the U.S. is approximately 3,300 mg per day. Yet decades of scaremongering have had little effect on consumer behavior, as sodium consumption has remained essentially flat since the 1950s. As my colleague Dan Compton wrote nearly two years ago, U.S. sodium consumption isn’t particularly high by global standards. And efforts to reduce the salt content in foods is typically frustrated by consumers who adjust their dietary intake by seeking out foods with more salt — even when they’re not aware that the salt content of the foods they’ve been eating has been reduced.
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.”
I didn’t have a chance to write about it then, but a few weeks back the Food and Drug Administration denied a citizen petition submitted by environmental activists asking the agency to forbid the “sub-therapeutic” use of certain antibiotics in food animals. The petition — initially filed in 2005, and fundamentally identical to one submitted in 1999 and rejected in 2001 — argued that using antibiotics for growth promotion, rather than to treat infected animals, contributes to the development of antibiotic-resistant bacteria that threaten human health.
The issue is a complicated one, with serious implications for medical treatment and consumer well-being more broadly. We know that development by human pathogens of resistance to medically important antibiotics poses serious public health concerns. And, although a clear link between animal antibiotics use and human disease has not been proven, there are good theoretical reasons to believe, and some real world evidence suggesting, that it does — or at least could — occur.
Nevertheless, I would still argue that FDA made the right call, but for an incomplete reason. In response to both the 1999 and 2005 petitions, the agency essentially said that going through the formal legal process to revoke the approvals for a drug is intensive, time consuming, and a poor use of FDA resources. And because the agency already monitors the development of resistance and has both nominally voluntary and explicitly mandatory programs in place to restrict uses that may pose realistic threats to human health, FDA argued that beginning the revocation process isn’t worth it.
I would further argue, though, that the agency simply does not have sufficient information on which to base a decision to revoke the approvals in question, but that it should begin a less formal investigation to shed some light on the matter. The agency has never before compared the risks that arise from animal antibiotics uses to those that would arise from restricting them. But doing so should be mandatory before any bans or further restrictions are put in place.
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.”
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.
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