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.
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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.
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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.”
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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.
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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.”
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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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According to Bloomberg News, North Carolina Democratic Senator Kay Hagan is set to introduce a bill that would create new “progressive” and “exceptional” approval processes for new drugs to treat unmet needs. These would be similar to the FDA’s existing “accelerated approval” process, open primarily to AIDS and cancer drugs, which permits the agency to grant a conditional approval once intermediate clinical trials demonstrate improvement in a so-called “surrogate end-point” such as tumor shrinkage. Once granted accelerated approval, these drugs must still complete more rigorous Phase III clinical trials to demonstrate improvement in the ultimate clinical end-point of patient survival, or the agency may revoke the conditional approval.
Details of the bill are not yet available, but I understand that “progressive approval” would function essentially like accelerated approval does now, but that the pathway would be open to any drug that would be the first approved treatment for a given disease or condition, or for an identifiable sub-population with the disease or condition. “Exceptional approval” would be available in cases where standard controlled clinical trials would be unfeasible to conduct, such as when the patient population is so small that enrolling a large clinical trial of thousands of patients would be nearly impossible. It would also be open to cases in which it would be unethical to conduct a standard placebo-controlled trials because that entails some patients getting no active treatment.
The accelerated approval process has been somewhat controversial, inasmuch as it can result in the withdrawal of an approved drug that has benefited some, but not all, patients taking it. That’s what happened with the breast cancer indication for the drug Avastin, which I wrote about earlier this year. It also becomes difficult for manufacturers to enroll clinical trials once a product may be legally sold to any patient whose doctor prescribes it. There’s a critical discussion of accelerated approval here.
The process is by no means perfect. But to the extent that it helps get needed drugs to market sooner, accelerated approval has been a tremendous boon for patient health. So, I look forward to seeing Sen. Hagan’s bill, and I applaud her efforts to help expedite the availability of new treatment options.
Twenty-nine years ago tomorrow, the U.S. Food and Drug Administration approved Eli Lilly’s and Genentech’s Humulin, making it the first ever fully approved product of recombinant DNA, or what we now call modern molecular biotechnology. Humulin was the first biosynthetic human insulin, produced by splicing the human gene that codes for insulin production into a harmless microbe. Previously, diabetics who needed supplemental insulin used bovine or porcine insulin that was purified from the pancreases of cows and pigs. They worked reasonably well, but were not perfect analogues of human insulin. With the introduction of Humulin they could now take actual human insulin, which improved the treatment’s safety and efficacy.
According to The New York Times, my friend and colleague “Dr. Henry Miller, the medical officer in charge of Humulin at the F.D.A., said the development was a major step forward in the ”scientific and commercial viability of’” recombinant DNA techniques. ”We have now come of age,” Dr. Miller said.”
Since 1982, biotechnology has revolutionized the practice of medicine and the pharmaceutical industry. Over the past 29 years, some 200 or so biotech medicines have been approved in the United States, with roughly 900 more now being developed to treat more than 100 diseases ranging from cancers and infectious diseases to autoimmune disorders and cardiovascular diseases.
Unfortunately, while food biotechnology has the same potential, it has not fared nearly as well. A broad scientific consensus has concluded that rDNA technology (known variously as gene splicing, genetic engineering, and genetic modification) is merely an extension, or refinement, of less-precise breeding techniques that scientists have long used for similar purposes, but it’s use has been hobbled by vast over-regulation in the U.S. and around the world — a phenomenon I have written about at length elsewhere. So, let’s celebrate the tremendous success of the medical biotechnology industry, but let us not forget how government has nearly strangled food biotechnology in its crib.
Every five years, Congress must reauthorize a piece of legislation called the Prescription Drug User Fee Act (PDUFA), which gives the Food and Drug Administration authority to charge pharmaceutical companies substantial fees for regulating their products. Every time a manufacturer submits an approval application for a new medicine, a new use for an already approved medicine, a generic copy of an already approved medicine, or any number of other things, it has to pay a “user fee” that ranges roughly from $100 thousand to $2 million dollars, depending on the particular application.
These fees now account for about a quarter of FDA’s total budget, and close to two-thirds of the drug and biologics regulation budget, which means that Congress views reauthorization as a “must pass” bill. So, every five years since PDUFA was first enacted in 1992, Congress has seen reauthorization as an opportunity to force through certain other FDA regulatory measures that may or may not be able to pass on their own.
Usually, Congress just lards on loads of additional regulatory hurdles. But, sometimes, such as in 1997′s FDA Modernization Act, some of these changes are actually moderately positive. With the House of Representatives now under Republican control, there has been discussion of using the 2012 PDUFA reauthorization to make some positive regulatory reforms. But reforming the FDA drug and medical device approval process doesn’t sit well with FDA’s career staff, who would rather prefer to be left to their own devices. At a public meeting on rare diseases two weeks ago, Director of the FDA’s Center for Drug Evaluation and Research Janet Woodcock warned against Republican reform efforts.
“It’s not that I’m against legislation. … I’m not sure in this political environment, and I’ve said this repeatedly, that there’s enough rationale (sic) deliberation that could result in the kind of legislation that we need if we plan to change the legislative framework. I’m afraid people are in a blowing up mood and often beware of what you ask for because you may get it.”
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A couple of days ago, Talking Points Memo’s Jim Kozubek reported that the Food and Drug Administration had finally decided to approve AquaBounty’s genetically engineered salmon for human consumption, and that the “evaluation is now under review at the White House’s Office of Management and Budget.” I’d seen the TPM article, but didn’t write about it at the time because premature reports of FDA being on the brink of approval have been filtering out through the media for several years now. (I filmed a TV interview for Fox News’s “Your World With Neil Cavuto” way back in 2005, when it looked like an approval was right around the corner, for example. And I talked about it again on John Stossel’s show last year.) But a friend of mine asked today why an FDA approval decision would have to get a second look from the White House, so I thought that would be worth discussing.
As the TPM article mentions, the AquaBounty salmon has been hugely controversial. Wild Atlantic salmon grow to full adult size in about three years, in part because they only grow six or seven months per year. As water temperatures decline in the late autumn months, a genetic switch turns turns off the gene that produces growth hormone, so the salmon can conserve energy through the winter. Energy conservation isn’t as big a problem for farmed fish, though, because they have easy access to food all year and little exposure to predators. So, AquaBounty engineered Atlantic salmon with a promoter (the genetic switch) from an Arctic fish called the ocean pout, attached to the growth hormone gene from Pacific Chinook salmon. And, voila! The engineered salmon grows year round and reaches normal adult size in about 18 months, lowering the cost of raising them and lowering the price of fish in grocery stores. Here’s the packet of scientific information FDA prepared for its scientific advisory committee last year.
Environmentalists don’t like it, of course. In part because ocean pen-raised farmed fish are known to occasionally escape into the wild, meaning the AquaBounty salmon could theoretically interbreed with wild salmon, with potential impacts on the wild gene pool. And in part because they just don’t like biotechnology. To address the arguably legitimate concerns, the AquaBounty salmon will only be raised in contained, inland pools, not open water pens, and they”ll be farmed only in Panama, where, if they do escape, the ambient water temperatures will be too high for them to survive. AquaBounty also uses two other breeding techniques that, with a 98 percent degree of certainty, produces only female fish that have been rendered infertile. So, even if they were to escape and survive, nearly all of them would be incapable of successfully mating with wild fish. Also, because the AquaBounty fish will be searching for food during the early spring months when wild Atlantic salmon are breeding, it turns out that the engineered fish have an extraordinarily low mating instinct. (Insert ribald, ex-wife joke here.)
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