COVER

ANATOMY OF A NIGHTMARE

DOW CORNING FIGHTS A PUBLIC OUTCRY

PATRICIA CHISHOLM March 9 1992
COVER

ANATOMY OF A NIGHTMARE

DOW CORNING FIGHTS A PUBLIC OUTCRY

PATRICIA CHISHOLM March 9 1992

ANATOMY OF A NIGHTMARE

DOW CORNING FIGHTS A PUBLIC OUTCRY

Keith McKennon seems like an unlikely savior. A chemist and inventor, McKennon sprinkles his speech with such terms as “gee” and “folks” and claims that one of the principal accomplishments of his 35-year career at Dow Chemical Co. has been to “bask in obscurity.” No more. Last month, McKennon was plucked from the executive ranks at Dow Chemical and installed as the troubleshooting new chief executive of Dow Corning Corp., one of the world’s largest manufacturers of silicone-gel breast implants. Although the corporate shuffle places him squarely at the centre of the bitter debate over implants, McKennon already appears to have defused some of the fury of the attack. On the same day that his appointment was announced, he supervised the public release of sensitive Dow Corning documents dealing with the safety of the devices. Then, he floated a proposal to pay for the removal of implants for low-income women. And while McKennon defends the past

efforts of the Midland, Mich.-based company to ensure the safety of the implants, he is also the first top executive to acknowledge that it made mistakes. Declared McKennon: “Dow Coming must say, ‘Gee, we didn’t do everything perfect, and if we were able to do it over, we would perhaps do it differently.’ ”

Damaging: That conciliatory tone is a sharp reversal for Dow Coming, which has been widely criticized for failing to show concern for thousands of women who have reported serious health problems with its product. Under former chief executive officer Lawrence Reed, the company—one of four U.S. breast-implant makers—repeatedly assured such women and their doctors that the implants were safe. And until McKennon’s appointment on Feb. 10, the company kept guard over hundreds of internal memos that suggest that some of Dow Corning’s own employees have long been dissatisfied with the scientific data on implants. But the damaging release of some of those documents

from a San Francisco court in December— followed in January by a surprise U.S. Food and Drug Administration (FDA) moratorium on the sale of implants—has turned the controversy into a public-relations nightmare for Dow Corning. “Until the appointment of Keith McKennon, this was a textbook case of crisis mismanagement,” said Michigan crisis-management consultant Gerald Meyers. “The company had been playing a hardball defence all the way, and that is a surefire formula for failure.”

But even McKennon’s reputation as a diplomat may not be enough to silence the storm over Dow Coming, a joint venture between Dow Chemical of Midland and Coming Inc., a New York state manufacturer of glass, chemicals and fibre optics. For many angry women, Dow Coming’s reluctance to tell what it knows—and does not know—about the devices is almost as painful as the health problems, such as lupus and arthritis, that they say their implants have caused. Last December, a federal district court jury in San Francisco awarded $8.6 million to a California woman who claimed that she suffered an autoimmune disease because of implants. In a stunning blow to the company, the jury also found that Dow Coming acted with fraud, malice and oppression, because of its failure to disclose information about the implant’s hazards. Company executives reacted to the ruling with outrage and blamed the finding on “sensationalist” media reports.

But the real damage was still to come. Soon afterward, hundreds of pages of internal Dow

Corning documents used in the case were released, despite the company’s efforts to prevent their general publication with a secrecy order. In the past, Dow Coming has used similar socalled protection orders to prevent the disclosure of sensitive documents used in other breast-implant cases. Reports about the contents of the San Francisco documents shocked many women, who learned that some Dow Corning employees suspected as early as 1971 that it lacked sufficient scientific data to guarantee the safety of the implants. In one 1983 memo, lab technician William Boley stated: “Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.” In 1985,

Boley warned that unless the company did more testing, “I think we have excessive personal and corporate liability exposure.”

Hotline: Meanwhile, Dow Corning stepped up an ad campaign that it had started in the fall of 1991. In newspapers across the country, it urged women with questions about implants to call a company hotline. The ads said that instead of “half-truths,” callers would receive information based on “30 years of valid scientific research.”

But when some women called, they were told that the implants were “100 per cent safe.” Shortly afterwards, the FDA warned Dow Corning that some of the information on its hotline was “false or used in a confusing or misleading context.” FDA staff members are now running their own information hotline.

In fact, the federal agency has been running to catch up ever since the resolution of the San Francisco lawsuit. In November, the FDA decided to permit implants to remain on the market,

largely because it found that there was insufficient scientific evidence linking the devices to health problems. But after receiving the San Francisco documents, the agency demanded more information from Dow Coming. On Jan. 6, it issued an unexpected moratorium on the use of implants. By Feb. 20, an FDA advisory panel had recommended that use of the implants be restricted to clinical studies and patients requiring breast reconstruction. How-

ever, the panel stopped short of concluding that there is a link between leaks from implants and health problems, such as autoimmune disease. More research is needed before such a conclusion can be made, the panel said. The FDA stated that it will issue a final decision before the end of April.

Reputation: But Dow Coming will likely be fighting the issue for years to come. At least three class actions have already been launched in the United States, as well as hundreds of other suits by individuals. But the biggest loss may be the decline of Dow Corning’s reputation in the minds of consumers. “Dow Coming has actively covered this issue up,” said Dr. Sidney Wolfe, director of the Public Citizen Health Research Group in Washington. “They are reckless and they have a reckless attitude about women.”

If McKennon does succeed in defusing the incendiary publicity surrounding implants, it will be an accomplishment that crowns a long career of peacemaking. At 58, he is one of Dow’s elder statesmen, a scientist with a reputation for mediation. In the early 1980s, he helped steer Dow Chemical out of similar crises over the use of the chemical dioxin and the herbicide 2,4,5-T, also known as Agent Orange. Said McKennon: “If there is a silver lining to this, I believe it’s that everybody at Dow Coming will have a different perception of how important the outside world is.” For women who claim that their breast implants have caused serious health problems, the issue is why the company did not learn that lesson a long time ago.

PATRICIA CHISHOLM