How Chemical/Pharmaceutical Industry Money Corrupts Health Organizations

[Guest guest]

Hot Flash, Cold Cash

How a once-respected women's group went through The Change--with the help of drug industry money.

By Mundy

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Last April, several hundred black-tie and couture-clad worthies crowded into the ornate ballroom of the Washington Ritz-Carlton for one more dinner on the spring charity circuit. This one seemed especially well-suited for the usual crowd of congressmen's wives and old-school hostesses. Themed " Coming of Age, " the entire evening was a salute to the vibrancy of middle-aged women--from the appearance by Cheryl Ladd of " Charlie's Angels " fame, glittering and trim at 51; through a special photography exhibit titled " A Celebration of Women in Midlife and Beyond " ; to a performance by 38-year-old country singer Trisha Yearwood.

Ostensibly, " Coming of Age " was thrown for the benefit of a group that enjoys, or enjoyed, a sterling reputation and pursued an unexceptionable purpose: the Society for Women's Health Research, a 12-year-old Beltway nonprofit whose " sole mission is to improve the health of women through research, " according to its brochure. But there was something different about this evening's charity ball. The whole event had been underwritten by the pharmaceutical company Wyeth, which also happens to manufacture Prempro, the drug most widely used in hormone-replacement therapy (HRT) for post-menopausal women. That evening, after a brief speech by Wyeth's CEO Essner, the celebrities joined menopause maven Gail Sheehy to read literary selections celebrating what the society called " advances in the quality and duration of a woman's life. " Sheehy read from her own book The Silent Passage, noting how women were enjoying better lives because of " lifesaving preventative measures " including " hormone-replacement therapy. "

Some participants were taken aback. " Without mentioning Wyeth, " says one, " It was like they were doing an ad for Wyeth. " The whole evening was, she recalls, " a perfect way to ensure you'll keep one of your biggest benefactors happy: a dinner theme tied to one of their biggest selling products. " A week later, Wyeth presented the society with a $250,000 check at a special event celebrating the 60th anniversary of Premarin, the company's other HRT drug.

All nonprofits, of course, must occasionally confront the tension between what's good for their stated mission and what's good for their funders. But the Society for Women's Health Research has clearly decided to bend to the latter. For decades, middle-aged women in America had been encouraged to take medications to replace the estrogen which the body ceases to produce adequately after menopause; last year, doctors wrote a total of 67 million prescriptions for such drugs, including 22 million for Prempro (which contains estrogen compounded with progestin). The medications were once considered postmenopausal wonder drugs--relieving hot flashes and insomnia, preserving mental acuity and bone strength, and, most importantly, staving off heart disease.

But as researchers examined the drugs more closely in the 1990s, they began to have second thoughts. Women on such drugs as Prempro were suffering fewer bone fractures and developing illnesses like colon cancer less often, but they were showing an increased susceptibility to strokes and blood clots. Indeed, during the two years before the society's gala, women taking Prempro had received two well-publicized letters from the directors of a major National Institutes of Health study of HRT warning them of possible heart problems connected to the drug. Months before the gala, several respected medical journals published studies suggesting links between breast cancer and the use of some types of estrogen.

These problems were to some extent well known within the women's health community the night of the gala. But the biggest bombshell burst three months later, when NIH officials halted the HRT study, and concluded, five years into the planned eight-year trial, that the verdict was clear: Although Prempro did some good when taken for shorter periods of time (i.e. during menopause), long-term use of the drug--as advocated by its makers--significantly increased the risk of heart attacks, stroke, blood clots, and last, but not least, breast cancer. Sales of Prempro plummeted about 50 percent.

In the weeks following the announcement, many nonprofit women's advocacy groups warned women about the dangers of overusing hormone-replacement therapy. The Society for Women's Health Research, however, did the opposite, attacking the study, its authors, and its conclusions on chat shows and in newspaper articles. Instead of taking the side of its constituents, the society seemingly took the side of its donors--and of Wyeth, in particular, which manufactures 70 percent of the HRT drugs on the world market.

The society's curious behavior represents the latest innovation in the art of Washington influence peddling. For years, business interests have created and bankrolled think tanks and " Astroturf " advocacy groups to generate pro-business policy thinking and political momentum in Washington. But these institutions' effectiveness is usually limited by their obvious agenda: Reporters, Hill staffers, and consumer advocacy groups can soon enough tell a front from a philanthropy, and treat them accordingly. In their dealings with the society, however, the pharmaceutical industry has figured out a new tactic. Why start a new group when generosity no more expensive than an ordinary public relations campaign can enable corporations to all but take over an already existing and respected nonprofit, and use its credibility to advance their own interests? The tactic is so clever, it's a wonder other industries didn't think of it--though many will surely copy it.

No Ladies' Room

The Society for Women's Health Research was launched in 1990 by Florence Haseltine and Blumenthal, who in the previous decade were almost the only two tenured physicians at the NIH. Like other women there, Haseltine and Blumenthal had become increasingly concerned with the way the institutes' studies of such conditions as heart disease and various cancers used male subjects almost exclusively. (Legend has it that an NIH study on aging held in one hospital ward was limited to male patients because there were no women's restrooms on that floor.) Haseltine and Blumenthal began pushing NIH to expand their studies among women; it was important, they would point out, that the nation's top medical institute track heart attacks, cancers, diabetes, mental illness, and glaucoma in both halves of the population.

But officials resisted. So Haseltine and Blumenthal, along with a few feminist groups and sympathetic congresswomen, began making their case to reporters and on the Hill. In 1990, Congress' General Accounting Office issued a study strongly critical of the NIH's lack of research on female patients. Soon after, Haseltine and Blumenthal launched the society. Haseltine became its president and Blumenthal the vice-president and scientific director. They quickly linked up with publisher Ann Liebert, jointly sponsoring a new publication, the Journal of Women's Health, and started the Congress on Women's Health, an annual event attracting politicians, scientists, and consumer advocates. Operating on a tiny budget and with no staff, Haseltine and Blumenthal recruited P.R. mavens Marie Bass and Joanne Howes, who worked for peanuts to put the issue on the map. Their efforts had an effect: In 1991, the Bush administration ordered NIH to begin funding several medical studies using women. The society's conferences became a major draw on the Hill, its galas picking up sponsorship from the well-connected wives of Reps. Henry Waxman, Dingell, and Dan Glickman.

In 1993, Blumenthal brought Phyllis Greenberger, then a lobbyist for the American Psychiatric Association, to the society. Greenberger, as executive director, was a hard worker and tireless promoter of the organization. When Blumenthal left in 1994 to take the newly created position of deputy assistant secretary for women's health at the Department of Health and Human Services, Greenberger took over completely, Haseltine falling into the background. By this time, Blumenthal and Haseltine had been wondering whether the society had finally achieved most of what it set out to do; Congress had heard them and acted, and funding for women-focused medicine was growing by leaps and bounds. U.S. health agencies were spending $100 million on relevant research (a figure up to about $4 billion per year today). They could have declared victory and gone home.

But Greenberger had other ideas--big ideas that required much more money than could be mustered by a boutique advocacy group like the society, which up until then had relied largely on funding from nonprofit health foundations. In addition to operating in-house research and science seminars, as had Haseltine and Blumenthal, Greenberger began to push the society into participating in many corporate-sponsored seminars and conventions, where those funding the event tended to control the agenda and choose the speakers. She fired Bass and Howes, replacing them with a full complement of hand-picked in-house staff. Her title changed from director to president and CEO. The group expanded its portfolio, becoming involved in such issues as the impact of television on women and families. It also began taking stands friendly to corporate interests. In 1995, for example, Greenberger testified before Congress against product liability lawsuits on the grounds that too many such suits stifle drug companies' research on women's products.

Greenberger also began to participate in or host seminars with pharmaceutical companies. As Hillary Macht, formerly the health editor of McCall's, notes, drug companies use such gatherings to " create a demand and a market " in advance of a drug's launch, in part by getting women's magazines and the media to report on a given disease--and, of course, the newly available remedy. In one instance, Greenberger participated in a September 1999 Glaxo-sponsored panel, " Ending the Silence, " about irritable bowel syndrome. At the time, Glaxo had convinced the FDA to put its drug Lotronex on a " fast-track " approval process, stressing how many women needed a remedy. The drug was approved in February 2000, only to be withdrawn in November, after it was linked to five deaths and several colostomies. (Lotronex was allowed to return to market in November under much tighter FDA restrictions.)

Meanwhile, the society's gala, which previously could have fit in a coat closet, made The New York Times in 2001, when honoree Supreme Court Justice Ruth Bader Ginsburg spoke for the first time about her colorectal cancer. Greenberger herself achieved a new prominence, becoming a regular guest on the chat-show circuit and a go-to source for women's magazines like Health and Shape (on whose boards she sits). In March 2002, the society was one of the several co-sponsors of a town hall meeting on menopause, operated jointly with the Office of Women's Health at HHS and funded by Eli Lilly, Aventis, and Wyeth. Most importantly, the society began to rake in millions of dollars in donations, which it poured into issue advocacy and P.R. and to sponsor " lobby days " on Capitol Hill.

But who, exactly, has been paying for all this? The society's development director, Jo Parrish, first told me: " government grants, a direct mail campaign, foundations. " When I asked her if the society received business money, Parrish said, " Yes, we get corporate funding and grants, " but wouldn't be more specific. When I received a copy of the group's 2001 official nonprofit tax form, which lists sources of income, the group had not included the names of major contributors (that is, those who give more than $80,000). When I called Parrish for more information, she left a message on my voicemail explaining that " Our attorney says it is confidential information that we don't distribute. " Neither she nor Greenberger would disclose the percentage of the group's income derived from corporations, although Greenberger, in a letter to The Washington Monthly, wrote that the society's corporate sponsors are " all disclosed. "

We do know the companies that sit on the society's 40-member " corporate advisory board, " created since Greenberger took over. They include Eli Lilly, & , Merck, Pfizer, and Wyeth--all of which market popular women's drugs. Many of the same names graced the list of sponsors for this year's society gala, as did the drug industry lobbying group, PhRMA. So did Wyeth's own lobbying firm, Heidepriem and Mager. Another group that sponsored the gala, perhaps in appreciation of Greenberger's testimony against product lawsuits, was the American Tort Reform Association.

Not everyone is happy with the way Greenberger has expanded the organization. Blumenthal, who as a federal official was barred from serving on the society's board and had no say over the group's transformation, told friends that she was nervous over where the money was coming from. She and Greenberger, once friends, began to grow apart. Blumenthal's other collaborator, Anne Liebert, also felt that corporate largesse was corrupting the institution; in 2000, her Journal of Women's Health and Congress on Women's Health severed their relationships with the society. " I wanted to ensure independence in choosing articles and speakers, " says Liebert. " Phyllis and I did not see eye to eye on some issues. I felt it is too hard to ignore sponsors when they are so generous. I needed to produce an independent forum. " (Greenberger says the split came because the Journal wasn't as focused on gender differences and science as the society still is.) Downey, the wife of former Rep. Tom Downey, a prominent Washington child health advocate, and a long-time supporter of the society, recently cut her ties to the group, citing the society's dependence on Wyeth. " This is clearly a case, " Downey told me, " where an institution's desire for self-preservation has far outlived its sense of purpose and mission. "

Pearson, who heads the National Women's Health Network, says that the society has been too out front in promoting the joys of " better menopause through better drugs. " Her organization doesn't take pharmaceutical money, she says, " because we believe that industry funding, at a minimum, raises questions about the credibility of advocacy groups, and in the worst cases, results in advocacy groups promoting an agenda that benefits their funders. "

When I spoke to Greenberger in November, she waved aside the criticisms. " I just don't see a problem, " she says of the growing perception that the society has become a lobbying vehicle for the drug companies, complaining that corporate donors that reliably support women's health groups " all want to give to breast cancer. " Regarding this year's benefit, Greenberger observes that Wyeth has " been good to us, underwriting our gala for years. This year we decided to let Essner mention Premarin. I don't recall what he said, " she continues, " but we did that because it was the anniversary of Premarin . . . and there was only one line about hormone replacement. " Later she said, " Maybe we shouldn't have given [Essner] a pass, but it was difficult to turn them down on Premarin's anniversary. "

Raging Hormones

When the HRT study ground to a halt, the society did more than just give Wyeth a pass. Even as the new scientific consensus on HRT--that the risks of long-term use significantly outweighed the benefits--was still coalescing, Greenberger and the society went to work attempting to undermine it. " Totally overblown " was how Greenberger described the study in a Milwaukee Journal-Sentinel article in late July. " The results were presented in a way that scared women unnecessarily. " Greenberger was quoted to similar effect in several other papers; she penned op-eds or letters to the editor for at least 10 other papers around the country, including the Chicago Tribune, in which she described the release of the study as " poorly managed, causing a media frenzy and subsequent panic among women and their doctors. " Greenberger also hit the airwaves. One station, the ABC affiliate in Washington, WJLA, learned of Greenberger's ties to the drug industry only after she appeared on a broadcast last May. When the NIH study came out in July, the society swamped WJLA with press releases suggesting Greenberger as a guest, but the station declined. Similarly, Greenberger went on the " Charlie Rose Show " without disclosing the society's relationship with Wyeth ( " Nobody asked me about it, " she explained. " What difference does it make? " ) A producer of the " Charlie Rose Show " said she was " dismayed " to learn of the society's financial support. " The policy of our show . . . is that all guests are expected to make full disclosure of who funds their organizations. "

Greenberger's defense of long-term hormone replacement therapy--especially her accusation that NIH researchers overstated their findings and released the study too abruptly, unnecessarily scaring the millions of healthy women taking HRT--doesn't hold up well under scrutiny. The study, costing some $600 million and involving 16,000 women, was perhaps the largest clinical trial in history. " This was an exceptionally well-designed and implemented study, " says Zuckerman, President of the National Center for Policy Research, a group that advocates for drug safety, FDA improvement, and women's health matters. " It's as solid as it gets. The data clearly show that the long-term risks substantially outweigh the long-term benefits. " Moreover, the warning signs had been clear for months in studies published in top medical journals, such as the Journal of the American Medical Association and the New England Journal of Medicine. If the society " was shocked by the findings, " says Zuckerman, " then they were not doing their job. "

Yet Greenberger persisted. At a conference in October of last year, scientists and journalists gathered at the NIH to hear more about the study. When a Wyeth doctor insisted that the drugs help against other menopause problems and that the risks of taking them were minimal, Greenberger echoed Wyeth's line, questioning the results and arguing that their allegedly ill-timed release had caused female subjects to drop out of medical studies. Yet one of the study's investigators, Dr. Marcia Stefanick of Stanford University, says there's no actual evidence of women dropping out. (When I asked Greenberger, she said that a doctor at NIH has told her that he was worried that such drop-outs might happen down the road.) " They can't fight the science, " says Dr. Stefanick, " so they are complaining that we gave out the news without warning. " Another doctor reviewing the study, Deborah Grady of the University of California at San Francisco, says, " The people complaining want to say this is only one drug, and only one group of people. But all the other drugs are just versions of this one--it's estrogen. The company and its defenders have to be thinking about what it means for women's health in the long term. "

In her letter to The Washington Monthly, Greenberg wrote that " the society rejects any implication that it is influenced or biased in any way by its contributors. " But it's clear that her closeness to Wyeth has already begun to alienate many of the group's original supporters. Over time, as word gets out over the Washington grapevine, the society may be likely to attract fewer and fewer women's advocates. Congressional wives may stop going to its annual gala (unless their husbands are looking for drug-company campaign donations). Reporters and liberal Hill staffers may get wise to what the society has become, and its effectiveness as a stealth lobbying arm of the industry will diminish. But by then, of course, companies like Wyeth that have supported the charitable organization will already have gotten far more than their money's worth.

Mundy, author of Dispensing With the Truth, a book about the battle over Fen-Phen, is a senior editor at Cableworld.

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