Chemist (Dr. Blais) Gets Fired After Calling Breast Implant Unsafe

[Guest guest]

http://www.the-scientist.com/yr1989/sep/spurgeon_p7_890904.html

The Scientist Sep. 4, 1989

Chemist Gets Fired After Calling Breast Implant Unsafe

Canadian scientist appeals his dismissal, charges the

agency that employed him with trying to stifle his

criticism of the product

By DAVID SPURGEON

OTTAWA—Research chemist J.J.B. Pierre Blais joined the

health protection branch of Canada’s Department of

National Health and Welfare in 1976 in the midst of a

productive career in the federal science bureaucracy.

He had spent seven years at the National Research

Council, and looked forward to many more satisfying

years with his new agency.

For a while it was just that. An expert in the

biocompatibility of implant materials, Blais has

worked on projects that have led to amendments in

Canada’s Medical Devices Regulations and served as

section head within the department. “He’s a brilliant

scientist who is always searching for the truth,” says

one of his superiors, Agit Das Gupta. Blais also built

a reputation as an innovative and productive

investigator, with some 180 published articles, book

chapters, patents, and monographs.

But six weeks ago Blais, at the age of 49, was fired

from his job. And he blames that same bureaucracy that

had employed him for 20 years for trying to stifle his

scientific criticism of a product that he and others

believe is unsafe.

That product is a polyurethane-coated breast implant

known as Même. Blais first became interested in it in

1979, and the more he learned about Même, the more

concerned he became about its potential harmful

effects on the women who had received it as part of

reconstructive or cosmetic surgery.

Blais is not the only scientist to hold such views.

All silicone gel-filled breast implants are unsafe,

says Teisch of the Health Research Group, a

Washington, D.C.-based consumer advisory body, and

polyurethane-covered types are “a particularly

noxious” variety. Laval University’s Guidoin,

whose laboratory of experimental surgery conducts

research on breast, heart, and cardiovascular implant

designs, believes the implant should be removed from

the Canadian market. And the U.S. Food and Drug

Administration last spring warned the parent company

of the current manufacturer of the implant that the

manufacturer has failed to report at least 11

prosthesis failures that probably caused serious

injuries.

Spokesmen for Canada’s Department of Health and

Welfare refuse to comment on any details of the Blais

case, noting that his dismissal is being appealed by

the labor union to which Blais belongs, the

Professional Institute of the Public Service. Blais

says he was persuaded by the institute to lodge the

appeal, which is not expected to be heard for several

months, “in order to protect the professional and

scientific reputation of the department.” The

department, which carries out a range of scientific,

regulatory, and social welfare functions, has some

9,000 employees and oversees expenditures of $36

billion.

Another government scientist, who is also a former

executive for the union’s scientific research group,

says that Blais “has enormous backbone, considerable

personal and technical integrity, and a conscience.”

Citing a stream of budget cuts and previous cases in

which the advice of government scientists on various

health issues was ignored, the scientist called Blais’

dismissal “another blow to the morale of the

scientific community in the Canadian public service”

and “a sign of general malaise” in the government.

The events that led to Blais’ firing go back a decade,

when he first learned about the implant. By 1985 Blais

had collected a spate of journal articles that cited

difficulties stemming from its use. The following year

other medical product manufacturers started to

complain to the health minister about the practices of

the product’s Canadian distributor, Real Laperriere

Inc., of Montreal, (The U.S. distributor is Surgitek

Medical Inc., of Racine, Wis., a subsidiary of Bristol

Myers Pharmaceuticals. Since January, the manufacturer

has been Surgitek’s Aesthetec Division of Paso Robles,

Calif.)

Soon surgeons began to ask Blais to identify material

from implants removed from patients. In November 1988,

the Canadian health minister received a letter asking

him if he would agree to have Blais appear as an

expert witness in a lawsuit involving the prosthesis.

It was at that point, Blais says, that the government

lowered the boom on him.

“I was ordered not to commumcate with anyone connected

with this type of implant,” he says. “I was given no

reason. It was the first time I had seen such a thing

happen.” Blais says that he has been told that the

department fought subpoenas from the court requesting

that he testify. “They initiated a series of

procedures that blocked or reduced the probability I

would be compelled to appear,” he says. Although the

government’s attempts failed, Blais has yet to testify

because the trial has been postponed.

By this time, Blais had written a number of memos

asking for further investigation of the implant and

calling for a voluntary halt to its sale until the

work was completed. He believes that those memos made

him a target of on-the-job harassment. At first Blais

was bewildered by the logistical roadblocks thrown in

his way, but eventually he was told that his

professional activities were being restricted for

purposes of “policy coordination.”

Finally, on July 17 Blais received a letter of

dismissal, citing his official “misconduct.” He was

accused of leaking confidential information on the

Même implant to the press, contrary to departmental

regulations, and of having failed to return all his

laboratory samples and files. Given only a few hours

to clean out his desk, he was escorted from his

office.

Weeks later, Blais is still trying to figure out why.

He admits to having become increasingly convinced that

the Même implant was unsafe, and he’s made no secret

of his views within the department. But, he declares;

I am not a whistle-blower. I have never gone public

with this type of information. I’ve always held [to]

the confidentiality of the department—in fact more so,

perhaps, than I should have in retrospect, because

many situations involve the public good. I remained

within the terms of reference given to me by the

department, but I fought tooth and nail within the

department to get this stuff off the market.”

What apparently caused the health and welfare

department to clamp down on Blais were reports earlier

this year in the Montreal Gazette that quoted his

confidential memos. Says Blais, “It was a time when

much of this information [about the implant] was

already surfacing in different ways, and because the

department is very small and there’s only a few

plastic specialists, everyone inferred that [the

person responsible for the leaks] was me. I’d

published before on this subject for the scientific

literature. I’d given lectures and so on.”

Blais says that the government is wrong in its

assumption. “The department leaks like a sieve,” he

says. And he says that he wouldn’t be surprised if the

leaks continued.

In the meantime, Blais is still reeling from the shock

of being fired. “It’s one of the most distressing

episodes in my career,”he says.

“It’s not just that I have been dismissed. I fought

within the department to have the product at least

sidetracked until we knew more about it, but they

refused to withdraw it.”

He says that many scientists have called him and the

union to express their support for his appeal. “They

feel,” he says, “that the whole integray of the

scientific arm of the public service is at stake.”

Spurgeon is a freelance science writer based in

Ottawa.

[Guest guest]

Chemist (Dr. Blais) Gets Fired After Calling Breast

Implant Unsafe

>

> http://www.the-scientist.com/yr1989/sep/spurgeon_p7_890904.html

>

> The Scientist Sep. 4, 1989

>

> Chemist Gets Fired After Calling Breast Implant Unsafe

> Canadian scientist appeals his dismissal, charges the

> agency that employed him with trying to stifle his

> criticism of the product

> By DAVID SPURGEON

>

> OTTAWA-Research chemist J.J.B. Pierre Blais joined the

> health protection branch of Canada's Department of

> National Health and Welfare in 1976 in the midst of a

> productive career in the federal science bureaucracy.

> He had spent seven years at the National Research

> Council, and looked forward to many more satisfying

> years with his new agency.

>

> For a while it was just that. An expert in the

> biocompatibility of implant materials, Blais has

> worked on projects that have led to amendments in

> Canada's Medical Devices Regulations and served as

> section head within the department. " He's a brilliant

> scientist who is always searching for the truth, " says

> one of his superiors, Agit Das Gupta. Blais also built

> a reputation as an innovative and productive

> investigator, with some 180 published articles, book

> chapters, patents, and monographs.

>

> But six weeks ago Blais, at the age of 49, was fired

> from his job. And he blames that same bureaucracy that

> had employed him for 20 years for trying to stifle his

> scientific criticism of a product that he and others

> believe is unsafe.

>

> That product is a polyurethane-coated breast implant

> known as Même. Blais first became interested in it in

> 1979, and the more he learned about Même, the more

> concerned he became about its potential harmful

> effects on the women who had received it as part of

> reconstructive or cosmetic surgery.

>

> Blais is not the only scientist to hold such views.

> All silicone gel-filled breast implants are unsafe,

> says Teisch of the Health Research Group, a

> Washington, D.C.-based consumer advisory body, and

> polyurethane-covered types are " a particularly

> noxious " variety. Laval University's Guidoin,

> whose laboratory of experimental surgery conducts

> research on breast, heart, and cardiovascular implant

> designs, believes the implant should be removed from

> the Canadian market. And the U.S. Food and Drug

> Administration last spring warned the parent company

> of the current manufacturer of the implant that the

> manufacturer has failed to report at least 11

> prosthesis failures that probably caused serious

> injuries.

>

> Spokesmen for Canada's Department of Health and

> Welfare refuse to comment on any details of the Blais

> case, noting that his dismissal is being appealed by

> the labor union to which Blais belongs, the

> Professional Institute of the Public Service. Blais

> says he was persuaded by the institute to lodge the

> appeal, which is not expected to be heard for several

> months, " in order to protect the professional and

> scientific reputation of the department. " The

> department, which carries out a range of scientific,

> regulatory, and social welfare functions, has some

> 9,000 employees and oversees expenditures of $36

> billion.

>

> Another government scientist, who is also a former

> executive for the union's scientific research group,

> says that Blais " has enormous backbone, considerable

> personal and technical integrity, and a conscience. "

> Citing a stream of budget cuts and previous cases in

> which the advice of government scientists on various

> health issues was ignored, the scientist called Blais'

> dismissal " another blow to the morale of the

> scientific community in the Canadian public service "

> and " a sign of general malaise " in the government.

>

> The events that led to Blais' firing go back a decade,

> when he first learned about the implant. By 1985 Blais

> had collected a spate of journal articles that cited

> difficulties stemming from its use. The following year

> other medical product manufacturers started to

> complain to the health minister about the practices of

> the product's Canadian distributor, Real Laperriere

> Inc., of Montreal, (The U.S. distributor is Surgitek

> Medical Inc., of Racine, Wis., a subsidiary of Bristol

> Myers Pharmaceuticals. Since January, the manufacturer

> has been Surgitek's Aesthetec Division of Paso Robles,

> Calif.)

>

> Soon surgeons began to ask Blais to identify material

> from implants removed from patients. In November 1988,

> the Canadian health minister received a letter asking

> him if he would agree to have Blais appear as an

> expert witness in a lawsuit involving the prosthesis.

> It was at that point, Blais says, that the government

> lowered the boom on him.

>

> " I was ordered not to commumcate with anyone connected

> with this type of implant, " he says. " I was given no

> reason. It was the first time I had seen such a thing

> happen. " Blais says that he has been told that the

> department fought subpoenas from the court requesting

> that he testify. " They initiated a series of

> procedures that blocked or reduced the probability I

> would be compelled to appear, " he says. Although the

> government's attempts failed, Blais has yet to testify

> because the trial has been postponed.

>

> By this time, Blais had written a number of memos

> asking for further investigation of the implant and

> calling for a voluntary halt to its sale until the

> work was completed. He believes that those memos made

> him a target of on-the-job harassment. At first Blais

> was bewildered by the logistical roadblocks thrown in

> his way, but eventually he was told that his

> professional activities were being restricted for

> purposes of " policy coordination. "

>

> Finally, on July 17 Blais received a letter of

> dismissal, citing his official " misconduct. " He was

> accused of leaking confidential information on the

> Même implant to the press, contrary to departmental

> regulations, and of having failed to return all his

> laboratory samples and files. Given only a few hours

> to clean out his desk, he was escorted from his

> office.

>

> Weeks later, Blais is still trying to figure out why.

> He admits to having become increasingly convinced that

> the Même implant was unsafe, and he's made no secret

> of his views within the department. But, he declares;

> I am not a whistle-blower. I have never gone public

> with this type of information. I've always held [to]

> the confidentiality of the department-in fact more so,

> perhaps, than I should have in retrospect, because

> many situations involve the public good. I remained

> within the terms of reference given to me by the

> department, but I fought tooth and nail within the

> department to get this stuff off the market. "

>

> What apparently caused the health and welfare

> department to clamp down on Blais were reports earlier

> this year in the Montreal Gazette that quoted his

> confidential memos. Says Blais, " It was a time when

> much of this information [about the implant] was

> already surfacing in different ways, and because the

> department is very small and there's only a few

> plastic specialists, everyone inferred that [the

> person responsible for the leaks] was me. I'd

> published before on this subject for the scientific

> literature. I'd given lectures and so on. "

>

> Blais says that the government is wrong in its

> assumption. " The department leaks like a sieve, " he

> says. And he says that he wouldn't be surprised if the

> leaks continued.

>

> In the meantime, Blais is still reeling from the shock

> of being fired. " It's one of the most distressing

> episodes in my career, " he says.

>

> " It's not just that I have been dismissed. I fought

> within the department to have the product at least

> sidetracked until we knew more about it, but they

> refused to withdraw it. "

>

> He says that many scientists have called him and the

> union to express their support for his appeal. " They

> feel, " he says, " that the whole integray of the

> scientific arm of the public service is at stake. "

>

> Spurgeon is a freelance science writer based in

> Ottawa.

>

>

>

>

>

> Opinions expressed are NOT meant to take the place of advice given by

> licensed health care professionals. Consult your physician or licensed

> health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

> Find out what the facts are, and make your own decisions about how to live

> a happy life and how to work for a better world. " - Linus ing,

> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

>