Reference:

A letter, with attachments, that i received from Willi Nolan. The information presented here warrants careful attention: we can extrapolate from this specific case a number of more general issues that we are facing with MAI and similar attempts at corporate empire building.

From: Willi Nolan <willi@biobiz.com>
[...]

FYI, Canada Gazette. Part 1 "Medical Devices Regulations" refers to a Mutual Recognition Agreement for marketing clearance for medical devices (I've learned this from my work selling tampons, which are classed as medical devices by Health Canada)

A "Mutual Recognition Agreement" intends to harmonize marketing approval for medical devices, negating the need for each country (under the agreement) to separately approve the sale and marketing of medical devices for products sold in their countries.

At the end of this letter, you'll find a copy of my recent submission to Health Canada, as comments on the proposed changes to Medical Devices Regulations. You will note the pointed comments to government reliance on industry-sponsored research, and the inherent and actual dangers. I'm sending this to you as a concrete example of how the MAI will compromise Canadians. Feel free to post my letter in it's entirety, making sure to quote its source.

Your comments are welcome.

IN health,

Willi Nolan

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May 3, 1997

Hi there!

This message is an action alert for those of you who've indicated an interest in knowing more about tampon safety, women's and environmental health issues and the "Politics."

If you have received this message in error, please accept our apologies.

Governments across the world are introducing new laws for the sale of medical devices (tampons are classed as medical devices). Under the "Mutual Recognition Agreement," if a product is found to be safe for sale in one country, other countries under the agreement will have to allow the product to be sold in their country WITHOUT BEING EVALUATED by the receiving country's health authorities.

There's a letter at the end of this message, that I've sent to Health Canada, so that they will *properly* investigate problems I've found with the sale of tampons. I'm kind of proud of it, because I get to write from the perspective of a tampon company, as well as a concerned woman and mother. The letter also lists MORE tampon health risks (yes, there are MORE health risks from tampons!) and the roles of government & industry to date.

Industry has had lots of time to comment on the proposed medical device regulations from their "greed" perspective. In my opinion, the new regulations WILL BRING MORE UNSAFE PRODUCTS TO STORES. I believe that the new regulations will force governments to rely even more on information from tampon manufacturers, and less on dangers to women's health.

New Canadian regulations may become adopted on August 1, 1997; please check with the F.D.A. for U.S. regulations (or your federal bureau of health if you are from another country).

The letter below is meant to be passed along to any people who could lend a hand to demand safer tampons (women, doctors, politicians, public health, church groups, etc.). Also, you are free to use my letter as a draft, to edit it as you please, and to demand answers to protect women's health!

Thanks again for the support, and thanks for listening. I'm really looking forward to your comments! Be well.

In health,

Willi Nolan

P.S. [CANADIAN women: Please note the list of cc-s to ministers. It would be really appropriate for people to confront them (and ALL candidates) about this, given there's a federal election under way! AND there have been some rumblings about M.P. Maria Minna introducing our own "Women's Health Act!" The proposed Canadian regulations can be found in the Canada Gazette, Part I, February 15, 1997,"Medical Devices Regulations."]

[AMERICAN women: The "Women's Health & Dioxin Act," Bill H.R.3796, introduced by Rep. Carolyn Maloney, has already been presented to Congress. Please use the information to demand that U.S. politicians and women's groups support the Bill. More information about the bill can be found at our web site: www.biobiz.com/terrafemme/uspoltam.htm]

;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-) ;-)

Via Fax & Mail: (613) 941-4726 5 pages

Mr. David F. Clapin General and Restorative Devices, Medical Devices Bureau Device Evaluation Division, Health Canada Room 1605, Statistics Canada Main Building Tunney's Pasture Ottawa, Ontario K1A 0L2

Dear Mr. Clapin:

Regarding the comment period for Medical Device regulations, I submit the following information.

I believe that harmonizing the pre-market approval regulations for Medical Devices under the Mutual Recognition Agreement would be premature at this time, and could undermine the intent of legislation behind the development of health regulation and policy to protect public health. I offer my experiences as a marketer of menstrual tampons as a case in point:

1. According to the information that I have received from Health Canada and the United States Food and Drug Administration (F.D.A.), much of the research which is used for the development of pre-market approval regulations for tampons, and for the development of public health promotion materials, has been research sponsored by tampon companies. A significant body of independent research is available, and yet guidelines and regulations appear, on the whole, to be based upon research funded by tampon companies. "Independent" tampon research has been repeatedly refuted, dismissed and disregarded by scientists whose research has been "sponsored" by tampon companies. Therefore, the reliance of health authorities upon "sponsored" research is, in my opinion, questionable.

Further, I understand that this research is based solely upon epidemiological studies. We are unaware of the completion of clinical studies related tampon use (other than Swedish studies, which, I understand, were disregarded by the European medical community), although we have made numerous contacts with individual medical practitioners who have diagnosed "mild" and severe cases of tampon-related Toxic Shock Syndrome (TSS).

With respect to the strict case definition for an "official diagnosis" of TSS, i.e., a number of 'lesser' symptoms, along with the involvement of 3 or more organ systems, little attention has been given to "mild" cases of TSS. Given that exposure to the TSST-1 toxin for women who do not have antibodies to the toxin are at increased risk for TSS, it would appear prudent to initiate clinical studies of tampon-related disorders prior to adapting a global policy for the marketing of this medical device.

2. Most recently, I have been questioning the position of F.D.A. regarding the advertising of the safety of the use of tampons overnight "up to 8 hours."

Health Canada's current "Issues" paper regarding the safe use of menstrual tampons (as received from Health Canada Health Protection Branch in Toronto on February 27, 1997), which is distributed to the Canadian public, suggests that, in order to minimize the incidence of tampon-related Toxic Shock Syndrome, tampons should be used for only 4 to 6 hours, and that external protection should be used overnight.

Our research has indicated a general decrease in the incidence of TSS over the last 10 years or so, as attributable to the following:

- more women are aware of tampons as a factor in the development of the disease, are alert to the symptoms and steps that need to be taken to prevent TSS, and seek medical care at the first signs of TSS; - women are more careful to wash their hands before and after using a tampon; - less synthetic ingredients are used in the manufacture of tampons, e.g. 3 of 4 synthetic fibres have been removed from tampon production; carboxymethylcellulose, polyester foam and polyacrylate rayon. - compared to the 1980s, tampons in the 1990s have decreased in absorbency by approximately 50%; - women are using fewer tampons during their menstrual period, and alternate their use with menstrual pads, especially on light days; - many women do not use tampons at all; - women tend to use tampons with an absorbency appropriate for their flow; - more women use external protection overnight.

It is reasonable to suggest that despite F.D.A. guidelines, permitting the encouragement of the overnight use of tampons "up to 8 hours" in advertising, would create increased incidence of TSS.

During our telephone conversation in the week of March 3, 1997, I requested clarification of Health Canada's position on the use of tampons overnight. You stated that tampons should be used no longer than 4 to 6 hours, and recommended the use of external protection overnight, consistent with the public information contained in the "Issues" paper. I requested copies of published and unpublished research to support these positions, which you agreed to forward to me within a week. After a week, I was still awaiting copies of those materials, and on March 11, 1997, I called you to inquire about the materials, which I had not received, and still await.

You made the following statements to me on March 11, 1997:

- you had difficulty in locating material in support of the information contained in the "Issues" paper; - the "Issues" paper was "incorrect on several points," and that you had new information regarding the frequency of changing tampons as a factor in the development of TSS, because of the association between oxygen in the tampon or vagina, and the amplification of the TSS toxin. - you stated that the information that you had suggested that leaving a tampon in for either too long or too short a period of time could raise the risk of the development of TSS, and that there was an "optimal range" of time that a tampon should be used. - you stated that you were awaiting a FedEx delivery of "other research," information related to the overnight use of tampons. This information was related to a study of the sleeping patterns of young women, which "contradicted" the basis of the original public health recommendations, because young women sleeping longer than 8 hours was disproved in "a study." - We discussed my submission of comments to the discussion of proposed revisions to the Medical Devices Regulations, as released in the February 15, 1997 issue of the Canada Gazette, as regulations regarding the sale of menstrual tampons are open for public comment. You indicated the direction of the revisions as being toward newly developed warnings for tampon-related TSS and recommendations for the proper hygiene while using tampons.

You stated that you would send the supporting research and journal information to me, along with a copy of the relevant section of the Canada Gazette. I have received a copy of the Canada Gazette, and still await the research and journal information, along with the other materials listed in my fax message to you dated March 19, 1997. I would appreciate your sending this material at your earliest convenience.

3. It is my understanding that all major brands of tampons contain synthetic fibres and compounds. We are not aware of any study that provides a clear statement as to the cause of tampon-related TSS. However, virtually all of the TSS-related research which we have reviewed points to tampon composition as a factor in the development of TSS. Most of the research available to us suggests the need for continued attention to the factors believed to be contributors to the development of the disease; design, absorbency, fibres and other constituents.

I direct you here to the comments contained in "Toxic Shock Syndrome: An Epilogue," prepared in 1994 by Drs. Philip M. Tierno and Bruce A. Hanna of New York University School of Medicine: " Before 1976, tampons were made from unaltered cotton or blends of cotton and rayon. Post 1976 tampons have contained increasing amounts of high absorbency synthetic fibers such as carboxymethylcellulose, polyester, polyacrylate, and viscose rayon ... the propensity of different fibers and other substances to amplify TSST-1 production, as well as a comparative analysis of the underlying mechanisms, are essential to our understanding of TSS."

I am of the understanding that the studies performed by Drs. Tierno and Hanna over the last 17 years is independent, i.e., has not been sponsored by tampon companies. I am also aware that all major tampon companies have been successfully litigated against in tampon-TSS related lawsuits, and that Dr. Tierno's testimony was a key factor in the litigation against Proctor and Gamble, manufacturers of the 'Rely' tampon, which was subsequently removed from the market. Notably, a class action lawsuit was launched in 1994 against the manufacturers of Tampax and Playtex tampons, the plaintiffs alleging that the manufacturers sold these products knowing that the viscose rayon contained in these tampons could amplify the production of the TSST-1 toxin, and thereby cause the injury and death of tampon users. Viscose rayon continues to be used in the manufacture of tampons sold in North America.

To my knowledge, neither F.D.A. nor Health Canada have independently investigated TSS risk as related to tampon composition, nor have TSS risks related to tampon composition been outlined in tampon safety information presented to the public.

I am keenly aware of fiscal restraint as having presented a burden to health authorities in both countries. One should expect that industry will provide reliable research in order to assist overburdened health departments to develop informed policy decisions and regulations. However, my experiences as a women's advocate and a responsible marketer of tampons compel me to strongly suggest that health authorities re-examine the wisdom of such an expectation.

Further, my contact with women who use tampons over the last five years has made me acutely aware that publicly available information about the many health risks associated with tampon use has been understated. Besides our day-today contact with women who use tampons, in 1995, we undertook an 18-month survey of 3,500 women which gathered information on women's knowledge and experiences with tampons. Since initiating this study, our company has become seriously concerned about a number of issues, including, a large percentage of respondents who reported experiencing symptoms of TSS while using tampons; a lack of awareness among women of many of the symptoms of TSS (especially young women); a high incidence of reports of other female reproductive disorders among tampon users, including endometriosis and cervical dysplasia; a significantly greater-than-officially-reported incidence of actual diagnosis of tampon-related TSS.

4. It is my understanding that all major brands of tampons contain fibres treated with chlorine compounds, and that the use of chlorine compounds results in the production of dioxin, a known human carcinogen (International Agency for Research on Cancer, Feb. 14, 1997). My research has discovered that manufacturers of menstrual products, as well as suppliers of chlorine compound-treated raw materials for their production, have admitted to finding dioxin in their products.

As you are aware, a bill currently before the U.S. Congress (H.R. 3796) seeks to require the National Institutes of Health (NIH) to determine health risks related to the use of menstrual products, including cervical, ovarian and breast cancer, endometriosis and Toxic Shock Syndrome. The bill refers specifically to dioxin in menstrual products as a health hazard.

One important reason that dioxin in tampons is dangerous, is because it articulates with the vaginal mucosa, and as such, any amount of dioxin can be absorbed into women's bodies, as opposed to contact with a dioxin outside the body, e.g. from paper products, menstrual pads, diapers, and so on.

Members of the Canadian government are currently investigating H.R. 3796, as well as the introduction of similar legislation for Canada.

5. Information gathered from the U.S. Centers For Disease Control outlines injuries caused by tampon applicators, known to lacerate vaginal tissue and in some instances, to cause arterial laceration. Fragments of tampon fibres (along with any additives that they may contain) and applicators can become imbedded in vaginal tissue, causing ulceration and prolonged exposure to the stated and 'proprietary' ingredients in various brands. I am unaware of any current or proposed requirement by any health authority to warn women about these potentialities, and would recommend that a public statement be made available to consumers.

6. Regarding labeling requirements for the absorbency of tampons, it has come to my attention that these issues have been a subject of discussion among European tampon manufacturers. I understand tampon design as a factor in determining the 'actual' absorbency of various tampons, as well as concerns around the accuracy of the syngyna method of absorbency testing as compared to 'in vivo' testing. I am not aware of any similar discussion among either health authourities or tampon manufacturers in North America.

However, since relative absorbency has been strongly identified as a risk factor in tampon-related TSS by both F.D.A. and Health Canada, it would be reasonable to expect that an investigation of these issues by both authorities would be of assistance in informing the revision of regulations for the sale of tampons.

7. Since Canadian doctors are not required to report the incidence of tampon-related Toxic Shock Syndrome, we have no basis, other than that provided by other countries, on which to develop medical device guidelines, policy or regulation for Canadian women.

8. We have become aware of other health risks associated with the use of tampons. For example, we were contacted by the husband of a woman who was seeking information after his wife had sustained life-threatening injuries after a tampon became lodged in her uterus while she was water-skiing. The man reported that it was necessary for the tampon to be surgically removed from his wife's body. We then followed up this report with a medical professional, who informed us that women should not use tampons while participating in a number of sports, especially water sports.

I have used tampons for over 25 years, and have been dedicated to gathering information about health risks related to the use of tampons for over five years, since becoming involved in their manufacture and sale. This is the first information about the risks of the use of tampons during sports activities of which I have become aware during this time. As a woman, I consider myself fortunate to have this information. As a marketer of tampons, I am compelled to disseminate this information with dispatch, and to expand my research in this area.

In summary, I believe that it would be unwise to proceed with a harmonization of Medical Device Regulations under the Mutual Recognition Agreement until the satisfactory completion of comprehensive investigations into 'under-reported' health risks associated with the use of Medical Devices. Given my experiences with one product, it is also reasonable to assume that health authority reliance upon risk-related product information provided by manufacturers may have provided incomplete information for the purposes of health promotion.

I request that my comments be directed to those responsible for the development of revised Medical Device Regulations, and to those responsible for investigating and prioritizing Medical Devices Problem Reporting. Please forward copies of correspondence with the departments and individuals regarding these issues to my attention.

Please do not hesitate to contact me if I may be of assistance to your department. Thank you for your attention.

Yours Sincerely,

Wilhelmina Nolan President Bio Business International Inc.

enclosure: Toxic Shock Syndrome: An Epilogue, Philip M. Tierno, Ph.D., Bruce A. Hanna, Ph.D.

cc.
Hon. David Dingwall
Hon. Maria Minna
Hon. Charles Caccia
Hon. Sergio Marchi
Senator Anne Cools
Rep. Carolyn Maloney
Terra Femme web site and email list, Bio Business International
Robb Cribb, CBC Marketplace
Michelle Landsberg, Toronto Star
Colette Bouchez, New York Daily News
Corporate Watch
Public Interest Research Group
Reach for Unbleached!
Women's Network on Health and the Environment
Coalition for a Green Economic Recovery
Anishnawbe Health
Hassle Free Clinic
Native Women's Resource Centre
Ida Bianchi
National Association of Women and the Law
Canadian Environmental Law Association
National Organization of Women
Columbia University School of Public Health
Women's College Hospital
Dr. Philip M. Tierno

"Never doubt that a group of thoughtful, committed citizens can change the world: indeed its the only thing that ever has." Margaret Mead

Terra Femme web site favorites: "The Politics of Tampons" <http://www.biobiz.com/terrafemme/uspoltam.htm>

Health Info & References: <http://www.biobiz.com/terrafemme/health.htm>

Ordering: <http://www.biobiz.com/terrafemme/ordering.htm>

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