In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that “change we can believe in” was real, having forgotten that the Tooth Fairy wasn’t.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

The Tradition of Politics at the FDA

Before we delve into the specific discussion of Plan B, let’s look at the context of the politicization of the FDA, under the recent Bush administration in particular, which led to the characterization of the “broken FDA.” During that period access to healthcare information, health services, and medical research became limited by two growing trends: the infusion of increasingly restrictive religious doctrines and the implementation of ideology-driven—rather than scientific, evidence-based—public policies. Initially, access to science-based information was limited through censorship and even distortion in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This neither helped reduce the teen birthrate nor STDs. They used the same misinformation tactic with the now discredited breast cancer-abortion link.

Ideologic shifts were also demonstrated by resource allocations. For example, HIV prevention programs at the CDC were reduced by $4 million while funding for abstinence-only programs rose from $20 million to $167 million, despite the lack of evidence of effectiveness, in contrast to the previous peer-review, scientific-merit-based process of NIH grant funding. No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

The trend away from evidence-based medicine affects healthcare practitioners in numerous areas, ranging from patient education and disturbingly eroding standards of medical care to selection of research topics, grant writing, and the research funding process. Upon her dismissal from the President’s Council on Bioethics in 2004 for disagreeing with the administration’s stance on stem cell research, Dr. Elizabeth Blackburn, a prominent cancer researcher and one of only three full-time biomedical researchers on the council, wrote, “When prominent scientists must fear that descriptions of their research will be misrepresented and misused by their government to advance political ends, something is deeply wrong.” Among her many honors, incidentally, is the 2009 Nobel Prize in Medicine.

A brief history of the FDA commissioners and other key persons over the past 20 years illustrates politics at work in the FDA.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

Jane Henney (commissioner, 1998–2001), also appointed by Clinton, authorized FDA approval of RU-486. She was, not surprisingly, ousted when George W. Bush took office. She also tried to change business as usual by filling positions with career appointees rather than political ones, actively demonstrating her goal of “leading policy and making enforcement decisions based on science, not on political whims.”

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Lester Crawford (commissioner, July–September 2005) was a veterinarian also appointed by George W. Bush. His term is perhaps best remembered for three features: the audacity of a veterinarian making decisions about women’s health and reproduction, his vehement opposition to Plan B’s approval, and the criminal charges against him for false reporting about holdings relevant to his appointment (that he and his wife owned stocks in food, beverage, and medical device companies that he was in charge of regulating). He got off with probation and a fine.

Susan F. Wood was another casualty of Crawford’s brief and divisive tenure at the FDA. As noted, she resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

The FDA’s ability to function and its reputation have been seriously hurt in the past decade. In a 2006 survey of FDA scientists, about 18 percent responded that they had been asked to exclude or alter information or their report’s conclusions for nonscientific reasons. A further 60 percent were aware of cases where industry “inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” One-fifth (20 percent) said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” Lest you think this survey was markedly biased, even Senator Chuck Grassley, a staunch Republican, commented on the survey report, “The responses of these scientists reinforce the findings of the independent Government Accountability Office, which said the process for reviewing drugs on the market is deeply flawed.”

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA's integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

Even the digital world seems to be biased, as now even Siri is getting into the act. Siri conveniently can direct you where to buy Viagra, but feigns ignorance when asked to direct to a reproductive health center offering abortion counseling or services.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency? “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit. (insert pic)

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

And Plan B’s got it right, too, in their ad: “I chose a condom but it broke. Now I Have A Second Chance.”

Why don’t the politicians get it?


Images: Morning After The Morning's Trash, from waltarrrrr on Flickr; pictures of condom bouqets and t-shirt by the author; Mechai Viravaidya holding a t-shirt, from Gates Foundation on Flickr;

Previously in this series:

Molecules to Medicine: Clinical Trials for Beginners

Molecules to Medicine: From Test-Tube to Medicine Chest

Lilly’s Shocker, or the Post-Marketing Blues

Molecules to Medicine: Pharma Trumps HIPAA?

Molecules to Medicine: Should pepper spray be put on (clinical) trial?

Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be