The federal government thwarted a promising cancer treatment. The Food and Drug Administration (FDA) put Dr. Stanislaw Burzynski on trial twice, saying “it did not matter” whether his “unconventional cancer treatments saved people’s lives,” only “that he had failed to get the FDA’s permission first.” But as Reason’s Jacob Sullum notes, the Phase II clinical trials that the FDA belatedly carried out “under congressional pressure have supported what the teary testimonials of patients and their families suggested: Although Burzynski’s antineoplastons are far from a cure-all, they seem to be more effective, and are certainly much less devastating in their side effects, than radiation and chemotherapy for certain deadly, intractable cancers.”

The government is also thwarting the production of life-saving drugs, causing critical shortages of key medicines. The supply of an essential cancer drug may run out within weeks: “A crucial medicine to treat childhood leukemia is in such short supply that hospitals across the country may exhaust their stores within the next two weeks, leaving hundreds and perhaps thousands of children at risk of dying from a largely curable disease, federal officials and cancer doctors say.” As a commenter quoted by law professor Glenn Reynolds points out, this is the result of government price controls: “So price controls are imposed on injectable drugs and lo and behold a shortage arises. Who would have thunk it?” As a doctor notes, this drug shortage is far from unique: “these shortages are very real… one center I work at has trouble getting propofol for anesthesia and another cannot get zofran (ondansetron), one of the most effective anti-nausea drugs on the market.” As another commentator notes, the “government has distorted the market and removed incentives for the production of life-saving drugs.”

The Obama administration has also sought to sharply restrict the market for bone-marrow transplants, potentially costing thousands of lives. It recently asked a federal appeals court to extend the reach of the National Organ Transplant Act beyond its text, in order to ban compensation for the collection of peripheral blood stem cells needed by many transplant recipients.  By doing so, it hopes to prevent organ transplants from being affected by “market forces.”

The federal DEA recently caused shortages of the drug Adderall, which is needed by people suffering from narcolepsy. Earlier, government regulations caused cancer and burn victims in the Third World to die in agony without any pain relief.  More links on the federal government’s role in causing shortages of hospital drugs can be found here.

Have a listen here.

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.

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.

Since 2006, SEIU collected nearly $6 million a year and $28 million total (and counting) in union dues from Medicaid payments to homecare providers. The Mackinac Center broke the news and filed suit to stop the forced unionization and dues payments of homecare workers.

Once Michigan lawmakers became aware of SEIU’s exploitation, they took action to stop it. Gov. Rick Snyder eliminated MQC3 funding in the FY 2012 budget and planned to close the program on September 30, 2011. State Rep. Paul Opsommer (R) introduced H.B. 4003, banning stealth unionization of private contractors and forced union dues payments of homecare workers, which passed House.

Apparently, laws that protect low-income individuals with health problems are unpopular in Michigan. Union-friendly state lawmakers worked behind the scenes to stall H.B. 4003 in the Senate and to maintain union funding from MQC3. Their efforts included State Senator Roger Kahn (R) conducting a meeting with SEIU officials to preserve their forced dues collection. Sen. Kahn’s first notes of the meeting read. “SEIU is concerned re: moving forward w/ funding QC3. Gent. Agreement to find $.”

Sadly, SEIU’s collective bargaining power made their political influence superfluous. The binding powers of CBAs allow SEIU to continue collecting union dues until the contract expires on November 15, 2012.

Mackinac Center Legal Foundation Director Patrick Wright explains the devastating effects of union political influence combined with government collective bargaining power, “The amazing resilience of MQC3 indicates that legislation is going to be required to ultimately end the government employee unions’ practice of diverting money from the state’s most needy citizens to fill their own coffers.”

All attempts to protect those in need and taxpayers (by way of lawsuits, reform, and defunding) from corruption have failed. Big Labor’s ability to convince legislators to set up dummy agencies enabling unions to steal from taxpayers is so strong that repealing government union collective bargaining power is the only way to end all such heinous behavior.

However, one legal maneuver may be left to stop illegal forced-dues payments and to recover taxpayer funds in Michigan. Medicaid receives funding from federal and state governments, opening the door for filing “false claims” charges in both state and federal courts to recover taxpayer funds. False claims are taxpayers’ most powerful tool to recover stolen government funds.

On the federal level, the False Claims Act, 31 U.S.C. §§ 3729-3733, allows taxpayers to recoup losses from any person or entity that “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.”

In Michigan, the Medicaid False Claims Act, Act 72 of 1977, directs the state “to prohibit fraud in the obtaining of benefits or payments in connection with the medical assistance program; to prohibit kickbacks or bribes in connection with the program.” Violations of the Medicaid False Claims Act involve “making a claim or causing a claim to be made under the social welfare act that contains a statement of fact or that fails to reveal a fact, which statement or failure leads the department to believe the represented or suggested state of affair to be other than it actually is.”

The creation of MQC3 was fraudulent, exposed as political payback from e-mails obtained by the Mackinac Center. Additionally, proposals creating MQC3 failed to reveal the fact that union dues would be taken out of Medicaid payments.

Government union collective bargaining power allows Big Labor to steal from the needy and increase the costs of providing public services. Removing collective bargaining power from government unions would diminish their political influence and reduce false claims and fraud.

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.

According to a July 2010 investigation by the Los Angeles Times, one organization that represents scientific whistleblowers has been “getting complaints from government scientists now at the same rate [it was] during the Bush administration.” And because the Obama administration routinely ignores public disclosure requirements and Freedom Of Information Act requests, who knows how many more cases of politicization have not yet been revealed?

I would rather like to see the President explain how to square this behavior with his public boasting. So, here’s a challenge. Obama should take the opportunity at this State of the Union Address to own up to his presidency’s failings on scientific integrity, and re-commit his administration to reject the politicization of science. And this time, let us all hope he means it.

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.”

Earlier, John Stossel of Fox News reported on how Obamacare is stopping businesses from hiring, and interviewed affected business owners on his TV show.

Obamacare will reduce the number of people employed in the U.S. by around 800,000, according to the Congressional Budget Office.

Obamacare will raise the cost of insurance by a massive 55-85 percent in Ohio, according to one study.  It will harm life-saving medical innovation, concluded the Harvard Medical School Dean and others. It taxes medical devices and cosmetic surgery, and raises taxes starting in 2013 on investors. Obamacare also breaks many campaign promises, and increases state budget deficits.  Even liberal businessmen are increasingly worried about the growing cost of big government and expanding bureaucratic red tape: Democratic businessman Steve Wynn called Obama “the greatest wet blanket to business and progress and job creation in my lifetime.”

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.

Last month, CEI submitted comments on a joint Food and Drug Administration-U.S. Department of Agriculture query about the effectiveness of various approaches to reducing sodium consumption. We argued that:

Public health analysts who continue to advocate for mandatory sodium reductions have selectively highlighted only those research results that suggest a clear and direct link between sodium consumption and higher blood pressure. They have ignored or attempted to explain away contrary findings. In some cases, analysts even appear to have cherry-picked individual observations from within studies that reveal both positive and negative associations between salt consumption and blood pressure in order to bolster arguments that the link is definitive.

In some ways, this type of behavior is unsurprising. It is well-established that researchers often exhibit what is sometimes known as “White Hat Bias,” the propensity to give preferential treatment to studies or data that confirm a widely held “politically correct” view on scientific issues. A study of White Hat Bias published last year in the International Journal of Obesity found that, when referring to the results of previously published research, authors frequently cite data incorrectly and cite only findings that confirm the commonly accepted or politically correct view. An accompanying editorial explained further that “negative results may be ignored and secondarily positive analyses are cited as the conclusions of the study.”

Of course, some people do unequivocally benefit from reducing their sodium intake: many individuals with high blood pressure, for example, as well as African Americans (who tend to have higher blood pressure). But reducing salt consumption does not lower every individual’s blood pressure, even those with hypertension. A Cochrane Collaboration review published this year, examined 167 studies in the peer reviewed literature and found that reducing salt consumption lowered average systolic blood pressure in healthy individuals by just 1 millimeter of mercury (mmHg), and reduced systolic blood pressure among hypertensives by 3.5 mmHg. That’s not a heck of a lot.

More importantly, lowering blood pressure by reducing salt intake does not clearly improve overall health (see here and here, for example). Lowering blood pressure substantially does appear to be associated with a reduction in heart disease, particularly among hypertensives. However, the blood pressure-reducing effect of eating less salt is so small that it does not appear to be associated with morbidity or mortality benefits. Another of the major studies published this year, in the Journal of the American Medical Association, found that, while higher sodium consumption was associated with slightly higher blood pressure, this “association did not translate into a higher risk of hypertension or [cardio-vascular disease] complications.” More surprising, however, the authors found that lower sodium consumption was associated with higher cardiovascular disease (CVD) mortality. The third of study subjects who consumed the least salt had three times the mortality as the third who consumed the most salt.

None of this suggests that those with average sodium consumption should switch to a high-salt diet. And again, some consumers should indeed try to cut back. But the overwhelming weight of scientific evidence does suggest that we have a lot less to worry about than the public health nannies would like us to believe.

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.”

Unfortunately, this is not a case of benign neglect. On April 2, 2009, FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued 14 Notices of Violation to drug manufacturers for their use of sponsored links on Web search engines that included the name of a drug and a brief statement about the disease it treats, while directing users to a separate website that contained complete benefit and risk information. Essentially, FDA decided to apply its its existing rules for conventional print ads, which stipulate that, if an ad contains the name of a drug or device and any affirmative statement about the product or the disease it treats, then all of the mandatory risk information must also appear in the ad. According to DDMAC, that means that a sponsored link or other Web ad may not read something like, “Learn How Spiriva May Help You Manage Your COPD” or “Online Resource for Women with Breast Cancer. www.Femara.com,” unless the full risk disclosure also appears in the sponsored link. Having the risk disclosure “one click” away via the hyperlink is not enough.

Since sponsored links resulting from key word searches are generally limited to a around 100 individual characters, give or take, (See here, for an example), this policy effectively precludes the use of sponsored link drug ads. But the policy has far broader implications for other Internet and social media fora. Is it legal for a drug manufacturer to host a Facebook page or Web discussion group in which patients and doctors discuss medicines they’re taking or prescribing if every single page view does not also include the complete risk disclosure? What about user generated tweets aggregated in a Twitter stream that’s embedded on a company-sponsored website? No one really knows for sure how the FDA would treat those scenarios. And that’s a problem.

Again, Silverman points out that, “With the advent of patient-centered ‘participatory medicine’ poised to become one of the century’s great trends in health care, it’s more vital than ever that consumers have access [to] well-vetted health information, available via where they live, online. The biopharma industry has recognized this, which is why so many companies have opted to take the risk to push ahead despite the lack of guidance.”

As attorney Arnold Friede and I discussed in a short paper two years ago, “The FDA’s approach to hyperlinked disclosures is particularly frustrating in light of the Federal Trade Commission’s (FTC) more nuanced approach for advertising in other industries. The FTC does not categorically reject hyperlinked disclosures in determining whether an advertisement is misleading or not. Instead, when considering the adequacy of a required information disclosure, it examines the conspicuousness of the hyperlink, whether it signals the availability of risk information, and other contextual factors. Rather than ticking off arbitrary boxes, the FTC looks at an entire presentation and considers the ‘net impression’ that a ‘reasonable man’ would form when viewing the information aggregated on linked web pages.”

Until April 2009, the pharmaceutical industry had assumed FDA would apply this so-called “one click” rule for its own purposes. After all, the whole point of a sponsored link is to drive traffic to the Web page where the reader can learn more information. But the agency seems to have rejected that common sense approach — at least so far. Once the agency does settle on a formal policy for Internet and social media advertising, however, adopting the one click rule or some other policy that recognizes the unique limitations and added functionality of the Internet would not be unprecedented. After all, the FDA did something similar with television advertising.

In its “major statement” guidance for risk disclosures in television advertising, FDA acknowledges the inability of TV to carry contemporaneous and instantaneous disclosure of all risk information. Because TV ads are limited to just 30 or 60 seconds, the agency permits drug manufacturers to include just a brief description of the product’s “most important risk information,” while providing the full risk disclosure through alternative means, such as a toll-free telephone number, in print advertisements that appear concurrently in publications reaching the same audience likely to see the TV ad, or on the Internet.

What’s that again?

It’s an important point, so let me repeat it:  FDA’s television advertising policy allows viewers of a TV ad to be directed to a drug or device’s full risk disclosure on a website not intrinsically connected to the commercial. However, under its current interpretation of the statute, drug and device manufacturers cannot direct readers of an Internet ad to another, hyperlinked, Web page to see the full risk disclosure. That’s absurd! It is long past time for the FDA to set out a rational Internet and social media policy that recognizes the ease with which Internet users can navigate from one Web page to another, and to access information linked directly from the one they’re currently reading.

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.

The use of antibiotics in animals is only one factor (and a small one at that) in the emergence of antibiotic-resistant pathogens, and it contributes far less to the development of resistance than does misuse among human patients. More importantly, though, the use of antimicrobial drugs in food-producing animals delivers substantial benefits for both animal and human health. Even the often criticized sub-therapeutic uses of these drugs contribute to reduced pathogen loads in animal-derived foods and have a positive impact on human safety. The question that few have even bothered to ask, and that the scientific community has not yet answered is whether, on balance, forbidding sub-therapeutic use of antibiotics in livestock would do more good than harm. There is good, though by no means conclusive, reason to believe the answer is no.

Generally, even when antibiotic-resistant bacteria are present in livestock, the likelihood of human exposure is remote, in part because risk management strategies to minimize and contain resistant pathogens have been implemented throughout the food chain. But, even when human consumers are exposed to resistant bacteria, the effect of the drug-resistance is typically inconsequential. General intestinal enteritis caused by Salmonella, for example, is rarely treated with antibiotics, leaving little opportunity for a therapeutic failure. And, in other cases where antibiotic treatment is indicated, bacteria that are resistant to one or more antibiotics remain sensitive to others. While not zero, the risk of a treatment failure in human patients arising from the development of antibiotic-resistant pathogens in food animals is quite low (See here, here, here, and here).

But is it worth tolerating even a small risk merely for the benefit of cheaper food? Some would argue “no.” The New York Times, for example, editorialized that rejecting the petitions was “a bad decision that runs counter to the F.D.A.’s own research.” And “The drugs make the animals grow faster, but their overuse increases the likelihood of antibiotic-resistant pathogens.” But posing the question that way ignores other important benefits.

Consumers benefit from lower prices, to be sure. But humans also derive health benefits from the presence of safer and healthier livestock animals. Sub-therapeutic antibiotics use helps to control and reduce the spread of a number of zoonotic diseases, and it is associated with a generalized reduction in health problems in the animals in which they are used. Carcasses from slaughtered animals not treated with antibiotics are more likely to be contaminated with human pathogenic microorganisms than those from treated animals (See here and here). And, because sub-therapeutic antibiotics use increases feed conversion efficiency, it lets farmers produce more food with fewer animals and less feed, which has significant environmental benefits — including, but not limited to, a need for less land in raising livestock and animal feed crops, and less waste from the animals.

Furthermore, experience in foreign countries that have banned or heavily restricted sub-therapeutic use is decidedly mixed. So, it is not clear whether a ban in the U.S. would result in less resistant bacteria or improved human health outcomes. Denmark, for example, began restricting sub-therapeutic uses in 1995. But over the following decade, while resistance to some antibiotics decreased among some pathogens in some livestock animal species, resistance among other pathogens to other antibiotics in other animals rose (See here and here). And there is little evidence that the occurrence of antibiotic-resistant pathogens in humans was affected at all.

Similar results were seen following the European Union-wide restriction on sub-therapeutic uses. “The expected decrease in the incidence of resistant human pathogens did not occur. Instead, prevalence of many resistant human pathogens increased, in some cases up to 49 percent of the pre-ban incidence.”

There is no doubt that the rise in antibiotic resistant bacteria is a serious problem. And it may even be wise to ban the use of new antibiotic classes — or existing classes that are considered antibiotics of last resort — in livestock, or at least to postpone their use for a period of years following their introduction. But it’s not remotely clear that consumers would experience net positive benefits from a ban on essentially all sub-therapeutic uses.

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.”

I don’t have access to the scientific research that the FDA considered in making its decision, so I can’t comment on the wisdom of either choice. And no one should be so naïve to think that potentially controversial decisions by scientific agencies, including the FDA, have not been subject to political pressures for as long as agencies have been making such decisions. After all, back in 2003, an FDA advisory panel recommended changing Plan B’s status from prescription only to over-the-counter. And it was widely believed that the decision was being held up by the White House, which only relented three years later when faced with Senate opposition to the administration’s new FDA Commissioner nominee. Only then, in 2006, did the FDA finally allow OTC sales to women 18 and older.

What I find so striking is that the Obama administration would be so brazen about it after taking such a holier than thou attitude on scientific integrity. After all, this is believed to be the first time that an HHS Secretary has publicly overruled a decision of the FDA, which is part of that department. The administration clearly wanted us to know that it was overruling the FDA.

The entire affair reminds me of an episode from season three of the television show “The West Wing.” For those who are unfamiliar with it, that program was a weekly serial that dramatized events in the day-to-day lives of White House staffers for the fictional President Josiah “Jed” Bartlet — an attractive, thoughtful, passionate, articulate, liberal former college professor cum politician. Sound familiar?

By season three, President Bartlet was preparing for what was expected to be a tough re-election campaign when the White House staff was informed that the FDA was about to announce its approval of the controversial RU-486 — the so-called “abortion pill.” When Deputy Chief of Staff Josh Lyman suggests asking the FDA to postpone the approval, President Bartlet and the rest of the White House staff are indignant. “We could never interfere with an FDA decision,” they say, or words to that effect. “It’s an independent agency.” I recall screaming at my TV: No! Damn it! FDA is part of HHS. (Such is the life of a policy wonk.)

Oh, those were the days. When thoughtful liberal Democrats insisted that politicizing such an important decision just couldn’t be done — even behind closed doors, and even in the name of securing a much needed campaign advantage. Well, that was then, and this is now.

So, let’s hear it boys and girls:  Can a White House devoted to scientific integrity and its political henchmen over-ride a decision by the Food and Drug Administration?

Yes We They Can!