Commentary on ex-NIH Director Bernadine Healy, the FDA, and the "morning-after" pill

Irving News Comments
copyright January 24, 2004
Reproduced with Permission
US News: Science & Society 1/19/04
By Bernadine Healy, M.D.

"What 'girls' should know.

Blame and regret. We can blame the sexual revolution, women's lib, the Internet, or a society that grooves on Sex and the City for creating women's morning-after dilemma. But that will not help the individual woman waking up to a broken condom, a missed birth control pill, or a totally unplanned sexual encounter. Even abstinence has its contraceptive failures. But Mother Nature offers a time-sensitive reprieve -- pregnancy does not occur overnight. Medically, it requires implantation. It takes almost six days for an egg to find its way to the uterus and no less to establish a pregnancy should it meet a sperm along the way. A pulse of high-dose progestin (that's what the morning-after pill is) will in a matter of hours slow sperm down, suppress ovulation, and make the uterus hostile to egg implantation. An existing pregnancy is not harmed; a possible pregnancy is intercepted, in the nick of time. Thus the imperative for placing these pills over the counter, right next to the condoms. Not a bad idea, since pills don't prevent sexually transmitted diseases and condoms do."

If this glowing - if not pathetic - support for the "morning-after" pill by always controversial Doctor Bernadine Healy is any indication, the FDA will again by-pass genuine scientific evidence (see Irving submission to the FDA, and at, and rule that these dangerous pills may be sold over-the-counter. Citing heady stories of (her) heroes like Planned Parenthood's Margaret Sanger, Healy negligently delivers appalling "medical" advice to naive "young girls", all along manufacturing fake science that she uses to rally them around her. When are our public service "heroes" ever going to be called to legal account for their unprofessional public dissemination of fake science used for purely political personal gain, and for the horrific damage caused by it to the unsuspecting public? The politicization of science has truly hit epidemic proportions.

Healy's antics, however, should come as no surprise. As a member of the 1988 NIH Human Fetal Tissue Transplant Research Committee, Healy voted in favor of this research. (; see Irving discussion of this NIH conference at ( Voted as one of Washingtonian's 100 Most Powerful Women ( No stranger to health and research politics, Healy has held related positions as Deputy Director of the Office of Science and Technology Policy at the White House, Director of the National Institutes of Health, and as the dean of the College of Medicine at Ohio State University (

Forced out as CEO of the American Red Cross amidst controversy (; see especially, Healy is now an adviser on weapons of mass destruction preparedness and bioterrorism for the White House (, and a noted speaker for the World Information Technology and Services Alliance (WITSA), founded in 1978 as a consortium of 41 IT industry associations from economies around the world. (

Healy describes herself as, "a pre-women's-lib woman" who is being "portrayed as a monster because I'm tough." ( As a member of the Board of Directors for Medtronics (a silicone device manufacturer), Healy lashed out at the rash of law suits being filed by patients damaged by the devices ( In December 1992 Dr. Bernadine Healy, then Director of the NIH, approved a compassionate use exemption from the regular review process, to allow a critically ill patient to receive extremely controversial gene therapy. This circumvention of the regular approval process proved very explosive. In October 1999 the death of Jesse Gelsinger, the first fatality in a gene therapy experiment, was reported in Nature. Subsequent investigations revealed that the deaths of six gene therapy patients had not received the usual public disclosure that has characterized gene therapy research. Gelsinger's death also raised questions about researcher entrepreneurial activities and conflict-of-interest, and about government oversight procedures. ( This is the same gene therapy trial supported by bioethicist Art Caplan, who was subsequently sued (and then excused), along with Univ. of Penn. scientists. (

"Doctor" Healy's professionally disgraceful and negligent article is copied below in full. For more information on Dr. Healy, see "bios" copied below.
From US News:
Science & Society 1/19/04
By Bernadine Healy, M.D.

What 'girls' should know

Our National Pledge Of "Liberty and justice for all" has a habit of going wobbly when it comes to women's reproductive rights. Just look at the current firestorm over the "morning-after pill." Next month, the Food and Drug Administration is expected to rule on whether women can have over-the-counter access to this emergency contraceptive. Its scientific review committee has advised that they should; the drug has already been deemed safe and effective. But the outcome at the FDA is by no means clear.

It should be an easy call. After all, we're talking about simply a higher dose of a birth control pill taken as soon as possible after intercourse. It has been used worldwide since the 1970s. Though something of a medical secret in this country, many doctors have for years offered this option discreetly to women in the know, and it's routinely given to rape victims. Some 46 million abortions occur each year (close to 1 million in the United States), and the hope is that wider access and responsible use of this option will reduce those numbers significantly.

Blame and regret. We can blame the sexual revolution, women's lib, the Internet, or a society that grooves on Sex and the City for creating women's morning-after dilemma. But that will not help the individual woman waking up to a broken condom, a missed birth control pill, or a totally unplanned sexual encounter. Even abstinence has its contraceptive failures. But Mother Nature offers a time-sensitive reprieve -- pregnancy does not occur overnight.

Medically, it requires implantation. It takes almost six days for an egg to find its way to the uterus and no less to establish a pregnancy should it meet a sperm along the way. A pulse of high-dose progestin (that's what the morning-after pill is) will in a matter of hours slow sperm down, suppress ovulation, and make the uterus hostile to egg implantation. An existing pregnancy is not harmed; a possible pregnancy is intercepted, in the nick of time. Thus the imperative for placing these pills over the counter, right next to the condoms. Not a bad idea, since pills don't prevent sexually transmitted diseases and condoms do.

Right-to-life critics holler, "Whoa, not so fast." They insist that it's in essence an abortion drug because a fertilized egg would find an unwelcome womb. That's an assertion made about other contraceptives, including IUDs and Norplant. Opponents also argue that making female contraceptives as accessible as aspirin or hair spray will promote promiscuity. Any drug can be misused, but the categorical statement smacks of our Victorian past, in which fear of pregnancy was seen as a needed deterrent to women's loose living.

In the good old days of the early 20th century, women's reproductive liberty was often misconstrued as libertine. Pure women were kept ignorant, pregnant, and under control. Indeed, Margaret Sanger, the founder of Planned Parenthood, bitterly watched her Irish Catholic mother die young, after 11 children. Later, as an obstetrical nurse, she saw the horrors of botched abortions, an epidemic of infant and maternal death, and the nasty secrets of syphilis and gonorrhea.

Condoms were widely available back then, thanks to Goodyear's fine expensive vulcanized rubber, but to men only. They were dispensed mainly as prophylactics against venereal disease for those who dallied with fallen women. Women suffered under the yoke of the anti-obscenity Comstock laws, which outlawed distribution of diaphragms -- or even instruction in birth control. Sanger became the nemesis of Anthony Comstock, the public obscenity censor, as she openly flaunted gag rules, dispensed pessaries, and distributed her books -- including What Every Girl Should KnowÑabout venereal disease. For this, she happily bore ridicule, threats, legal indictments, and time in jail.

If long life is sweet revenge, Sanger had it. The last vestiges of the Comstock laws were overturned by the Supreme Court in 1965, one year before she died at age 87. Even sweeter, by then her dream of a magic pill as easy to take as aspirin had been realized: oral contraceptives, containing the same synthetic progestin at issue today. The morning-after pill is an old medical secret for today's women in today's world. It's an option that every "girl" should have, if you only imagine that you are in her shoes.

Bernadine Healy is a cardiologist and health administrator who was the first woman to head the National Institutes of Health (NIH) from 1991 to 1993. She spent the early part of her career at Johns Hopkins University. She served as deputy science advisor to President Ronald Reagan from 1984-1985. In 1985 she was appointed Head of the Research Institute of the Cleveland Clinic Foundation where she remained until her appointment as director of the NIH in 1991. Healy was also president of the American Heart Association from 1988-1989 and has served on numerous national advisory committees.

Healy attended Hunter College High School, a prestigious public school in Manhattan and graduated first in her class. At Vassar College she majored in chemistry and minored in philosophy, graduating summa cum laude in 1965. One of ten women in a class of 120 at Harvard Medical School, she received her M.D. cum laude in 1970.

Healy completed her internship and residency at Johns Hopkins Hospital in Baltimore and spent two years at the National Heart, Lung, and Blood Institute at NIH before returning to Johns Hopkins and working her way up the academic ranks to professor of medicine. During these years, she also served as director of the coronary care unit (1977-1984) and assistant dean for post-doctoral programs and faculty development (1979-1984). From there, Healy served the Reagan Administration as deputy director of the White House Office of Science and Technology Policy. President George Bush nominated her for director of NIH in September 1990 and she was later confirmed by the U.S. Senate. Her tenure with NIH ended when incoming President Clinton appointed a new director in 1993. Healy has been married to cardiologist Floyd D. Loop since 1985. ... [She was previously married] to surgeon George Bulkley, whom she divorced in 1981.

At the time that Healy was appointed director of the National Institutes of Health in 1991, ... Scientists were leaving in record numbers because of non-competitive salaries, politicization of scientific agendas ... In addition, because she had been a member of a panel that advised continuation of fetal-tissue research, her appointment was also seen as a move away from politicized science. ...the head of OSI accused Healy of mishandling a scientific misconduct case at the Cleveland Clinic Foundation. The allegations led to a hearing in 1991 in which Healy vigorously defended herself, as well as the changes that she had implemented at OSI.

Another controversy involved gene patenting. Despite the objections of Nobel laureate James Watson, head of NIH's human genome project, Healy approved patent applications for 347 genes. .... . Attempting to negotiate a political compromise on another issue, she lobbied against overturning the Bush administration's ban on fetal tissue research, despite her previous support for such research.

Healy has described herself as a life-long Republican and a feminist. ...She retired from the Red Cross on Decmeber 31, 2002.
The New York Times Sunday Magazine
December 23, 2001

Who Brought Bernadine Healy Down?


[T]he vast, empty foyer of the American Red Cross's stately headquarters in Washington seemed as remote from ground zero as white marble from rubble. That was my inescapable, if facile, thought as I glided up the Tara-like central staircase one morning in early November. The holy hush was misleading, though. It gave no hint of the passionate, even viperous intrigue that was playing out behind closed doors. At a moment when the Red Cross was supposed to be absorbed with ministering to a nation in crisis, it was confronting an internal crisis of its own making.

It had been just over a week since Dr. Bernadine Healy, 57, had announced her resignation under pressure as Red Cross president. I sat waiting for her in the president's office wing, which was still her domain but increasingly provided her little sanctuary. Healy, baldly showcasing her impatience toward Red Cross sanctities about tradition, had long displayed a saying attributed to Clara Barton above the mantle: "It irritates me to be told how things have always been done. . . . I defy the tyranny of precedent."

Sweeping into the room, Healy sank into a cranberry-colored chair and exhaled. Healy is a fine-boned, exquisitely tailored woman who, with her crisp blond coif and colorful blazers, looked more like the Republican senator she once aspired to be than a cardiologist who ran a humanitarian organization. That day, she was showing the jittery strain of the previous two months, in which she first commanded a huge disaster-relief effort and then suffered the humiliation of rejection by the Red Cross's 50-member board of governors. Under her severance agreement, Healy was supposed to stay on through year's end while the general counsel, Harold J. Decker, took over as acting C.E.O. But it was already getting pretty uncomfortable.

"I can't believe it," she said, a great sigh collapsing her small frame. "They've just fired my chief of staff. Poor Kate. They gave her a few hours to pack up and be gone. They want to get rid of us that badly?" Over the next couple of hours, there were many knocks at the door and sniffles outside it as Healy's assistants were reassigned, a first step toward their eventual firing. Healy, who had spent the previous day at a grueling Congressional subcommittee hearing, was agitated. She believed that the Red Cross might be seeking to deflect criticism -- and avoid self-criticism -- by scapegoating her. She could feel it coming, she said. The board was going to reverse course and blame unpopular decisions on her. Healy decided that day to pack up her office and return to her Ohio home as soon as possible.

It was a terribly intimate moment to observe, and Healy later said that she regretted I had been there. Her eyes watery, Healy had stared at a portrait of Barton, her heroine, who founded the American Red Cross in 1881. "You know Clara Barton was fired, too," she said, coughing up a dry laugh. "The difference is, she lasted 20 some years and I only lasted two. They got her on a trumped-up charge that she used lumber left over from a disaster recovery program in her home. It tarnished her reputation, although history ultimately redeemed her." Healy paused, hearing herself. "Not that I'm Clara Barton." She shook her head and rolled her eyes. "Far from it."

The Red Cross has come a long way since Barton established it "to afford ready succor and assistance to sufferers in time of national or widespread calamities." It now generates about $3 billion in revenues a year as a quasi-governmental bureaucracy with a split personality. On the one hand, it is what Barton intended, a nonprofit disaster-relief organization, and that chapter-based service side gives the Red Cross its identity as an icon of volunteerism. But the Red Cross is also a blood business, which after a history of indebtedness and regulatory troubles has come to operate like a centralized corporation. Tensions between the two sides are echoed in other turf battles: between the 1,034 local chapters and the national headquarters, between veterans who believe their "mission" is good deeds and newcomers who believe theirs is good management and between the president and a board so big that Decker said his first impression was "politburo."

In a confidential memo to the board in late October, Healy bitterly described how the organization's internecine dynamic was summed up for her by another executive when she arrived in September 1999: "Red Crossers will give you the shirt off their back, but will as easily put a knife in your back."

All this makes the Red Cross a difficult, unwieldy institution to head. Since 1989, there have been three leaders and four interim leaders, counting Decker. Healy succeeded Elizabeth Dole, the first female president since Clara Barton. Dole spent much of the 1990's at the helm, taking a year off when her husband ran for president, then returning and eventually leaving to prepare her own presidential bid. The Red Cross board chairman, David T. McLaughlin, said that Dole's departure was "not terribly dissimilar" from Healy's. Dole "got out ahead of the game and stepped down," he said, "but she, too, left under some pressure," the result of combustible internal politics. Unlike Dole, McLaughlin said, Healy "more than brought on" her own departure, but both women were "fighting a culture, a culture that had grown up over a long period of time."

In two years on the job, the biggest disasters under Healy's watch as Red Cross president were Hurricane Floyd and Tropical Storm Allison. On Sept. 11, she stood outside on the headquarters' marble steps as snipers positioned themselves on the White House roof and, in the distance, smoke rose in blankets from the Pentagon. She knew in her gut that the day would have serious consequences for the organization that she commanded and for her personally.

McLaughlin would say later that Healy, the first physician-president of the organization, went at the initial Sept. 11 response "very clinically, and I have to say not emotionally. She was totally in action, on point." That intensity of focus, however, was not a quality of Healy's that was roundly admired within the Red Cross. Some thought her too driven and steely for an organization that they considered an affair of the heart. The previous Red Cross president, they say, had more of a politician's human touch. "Elizabeth Dole would notice the pin you were wearing, and Dr. Healy would notice the stain on your jacket," the director of one chapter said. "Dr. Healy was not people-oriented, and the Red Cross is all about people."

That day, however, the Red Cross had to be all about performance. And Healy found what she considered a serious wrinkle in an operation otherwise shifting into high gear efficiently. At noon, Healy's office received a call from the Pentagon: "Where the hell are you guys? Where's the Red Cross?" The Pentagon requested "water, food and other things we typically provide," according to an internal memo. Charles DeVita, the organization's security chief, placed a puzzled call of inquiry on Healy's behalf to the Disaster Operations Center, a corporate-style bunker known as the DOC, which is the Virginia-based command center for all disasters. The DOC was run by two women with 60 years of experience between them. They resented DeVita's phone call, a colleague of theirs told me: DeVita was a former assistant Secret Service director whom Healy had recruited just last year. What did the two of them know about activating the DOC?

That evening, Healy, believing the problem resolved, took a police escort to the site. She arrived at a scene of breathtaking devastation, with an army of firefighters "doing everything possible" to battle the blazing building. She saw "the Sallies," as the Salvation Army is called in charity circles, out in full force. But, to echo the caller from the Pentagon, where the hell was the Red Cross?

Healy expected to find the specialized teams usually dispatched by the DOC after plane crashes. Instead she found only four volunteers from the small, local Arlington County chapter -- bless their hearts" -- earnestly trying to provide assistance to hundreds of emergency workers. There was no E.R.V., or emergency response vehicle, because Arlington's was in the shop. They didn't have any cots, so some firefighters were stretched out on the ground. Stunned, Healy punched out the phone number of a senior administrator who oversaw the two women at the DOC. She suggested the administrator report immediately to the scene, "get down on his knees and pray to God for forgiveness that we're not here."

Over the next week, Healy also stumbled on other serious problems that originated in the DOC -- a failure to dispatch chaplains to the Pennsylvania crash site and a failure to realize that a confidential database of hospitalized victims existed. And by the professional standards of Healy and her executive team, the problems demanded a swift, sure response: the two women had to go. Although it was not Healy who actually fired the women, she was held responsible by many for what was seen as a coldhearted, ill-timed attack on two women who meant well. Adding a touch of melodrama, one of the women collapsed after she was dismissed and ended up in an intensive-care unit. All told, the incidents served to accelerate opposition to Healy.

Some of the reaction was anxiety. "We're all afraid for our jobs," one senior official at the DOC wrote in an e-mail message that ended up circulating widely through the Red Cross's quite gossipy e-mail system. Some of it was resentment. "We have been silent up to now, but the deeply disturbing news of Dr. Healy firing two of our top people in Disaster Services is just too much," one couple, former co-chairpeople of the volunteer system, wrote in another e-mail message. Referring to themselves as previous victims of Healy's, they asked: "Why isn't the board of governors doing something about her?"

Well before Sept. 11, some Red Cross governors were growing uncomfortable with what they told Healy in her July evaluation was her hard-charging style. She had been encountering mounting resistance from the chapters too. The chapters had always operated pretty autonomously. They did not like it when Healy, who was aghast to learn how much of their financial reporting to headquarters was voluntary, sought to oversee them more closely. Although the Red Cross is effectively a public trust, it has never been a particularly transparent organization, not even internally.

Some chapter directors opposed her oversight for philosophical reasons; they feared that it represented the first steps toward centralization in an organization that should belong to the grass roots. Others didn't want Big Brother peering into their affairs. Or streamlining the chapter system in a way that would reduce their power or cut jobs. And then there were those with something to hide, like the administrator in Jersey City.

Healy thinks that her downfall probably began, improbably, right there in Jersey City when all these tensions exploded. An audit of the small, poor Hudson County, N.J., chapter had uncovered irregularities, suggesting embezzlement by the director; he was a longtime Red Crosser who apparently had treated his fief as a personal charity ward. Healy was horrified, suspended the man and his bookkeeper without pay and hired an outside firm to do a forensic audit. The auditors found what appeared to be significant theft, and the Red Cross turned the matter over to the local prosecutor's office. In mid-December, a grand jury handed up indictments of Joseph Lecowich, the director, and Catalina Escoto, the bookkeeper, on charges of stealing $1 million in Red Cross funds.

The fact that Healy's suspicions were proved right in the end did not matter. Several board members and veteran administrators thought that she should have suspended the employees with pay, and they objected to involving external auditors. During her July evaluation, some members criticized her for being "too fast and too tough" in Jersey City. She asked them, "What should I have been, too soft and too slow?" And they said, "See, you're too defensive."

When the Red Cross board hired Healy, a Harvard Medical School graduate and mother of two daughters, ages 15 and 22, it understood exactly whom it was getting. From her stints as the first female director of the National Institutes of Health and as dean of the Ohio State University medical school, she had an established track record. A blunt-talking New Yorker born and bred in working-class Queens, she was not known as a diplomat. Rather, she was known as a driven professional who ruffled feathers but made things happen.

Dimon R. McFerson, then the C.E.O. of Nationwide, was the Red Cross governor who oversaw the 1999 search. He said that Healy was selected because she was the best candidate and that he would make the same choice again now. The board was unconcerned about Healy's "head-on style," he said, although in retrospect it seems inevitable that the board and Healy would end up on a collision course. "We hired a change agent for a culture resistant to change," one board member said.

Under the Red Cross's Congressionally established charter, seven of its 50 board members are senior government officials, like cabinet secretaries, who almost never participate. Another 12 are corporate, business and academic leaders who are not Red Cross lifers. Neither is McLaughlin; he is a former chairman of CBS, president of Dartmouth College and president of the Aspen Institute who, like his predecessors, was appointed Red Cross chairman by the president of the United States.

The remaining 30 governors, who are selected by local Red Cross chapters through a competitive nomination process, really control the organization. They tend to be lifelong Red Crossers who have worked their way up from local to national prominence within the organization; they also tend to be protective of traditions -- and of veteran employees with whom they have longstanding relationships. Not all of them, McLaughlin said, straining to be diplomatic, "possess strong governmental or financial or programmatic experience on top of their incredible loyalty to the Red Cross." But because they are willing to give so much of their time, many of them end up presiding over the board's internal committees -- for as long as six years -- and those committee chairmen dominate the executive committee whose decisions tend to be rubber-stamped by the full board.

During the year that Dole took a sabbatical, the executive committee started playing a more hands-on role, and quickly took to it. When Dole returned, according to many Red Crossers, she did not exercise the same strong leadership she had previously. (Dole did not return several calls to her Washington office.) Then, during the year between Dole and Healy, there was another interim president. And so by the time Healy arrived, the board was acting like a hydra-headed C.E.O., "overstepping its role and authority," McLaughlin, who took over last May, said.

"I tried to pull them back," he added. "I tried to help her."

The board hired Healy at the hefty salary of $400,000, twice what Dole made, because that was Healy's value in the marketplace. According to McFerson, the board was attracted to Healy's medical background and the fact that she "knew blood," since "blood was the area that needed the most attention." The board's sole concern was that Healy was coming off "a medical challenge," as McFerson put it. She had just recovered from a brain tumor.

When the tumor was diagnosed, Healy told me, she had, in true medical-drama style, been given three months to live. Her unexpected recovery played a role in her decision to take the Red Cross job. In her grateful, post-illness state of mind, she was drawn to the chance to "do good." And in a way, some Red Cross veterans were a bit taken aback by Healy's insta-passion about the Red Cross itself. She was an outsider with the zeal of an insider; she came on so strong and fast with designs for the organization's "greatness" that some grew suspicious that Healy, who had waged a failed campaign for the United States Senate in Ohio, was motivated more by personal ambition.

It wasn't long after Healy moved to Washington from her home in Ohio, where her husband, Dr. Floyd Loop, runs the Cleveland Clinic Foundation, that she realized she would be butting heads with the board.

"She was an entrepreneur, and entrepreneurs don't like boards or controls," McLaughlin said. "She kept getting out ahead of the board, and the board was chasing after her. In hindsight, her decisions were right. But her personal style was uneven."

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