Merck Frosst responds to Maclean's


    MONTREAL, Aug. 20 /CNW Telbec/ - A response based on scientific facts to
the article on the front page of the August 27 issue of Maclean's was
published, Friday August 17, on the Merck Frosst Web site. To view the
complete response, please visit:
    "We are greatly troubled by the apparently biased journalism of
Maclean's. To gamble with the health of millions of Canadian women by raising
unfounded fears and exaggerating safety concerns about one of the most
extensively tested vaccines is, in my mind, irresponsible," said Dawn Graham,
President of Merck Frosst Canada Ltd. "There is no question that HPV affects
many Canadian lives and the tolerability profile of Gardasil(R) is excellent."

    Impact of HPV in Canada

    Three in four (75 per cent) sexually active Canadians will have at least
one HPV infection episode in their lifetime.(1) HPV infections annually lead
to approximately 400,000 abnormal Pap smear results(2), 85,000 consultations
due to genital warts and 36,000 new cases of genital warts(3), as well as
1,400 cervical cancer diagnoses and 400 cervical cancer deaths.(4)
    HPV is also linked to other cancers in both men and women, such as cancer
of the penis, anus, vagina and vulva, as well as loss of female fertility and
premature ovarian failure.(5) According to the Society of Obstetricians and
Gynaecologists of Canada, the incidence of cervical cancer is on the rise in

    Comprehensive clinical research program

    Gardasil(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18)
Recombinant Vaccine) clinical data is supported by one of the most extensive
research programs for a vaccine in terms of number of subjects studied and
length of evaluation. The vaccine has been studied for over five years in
clinical trials involving close to 25,000 people in 33 different countries. So
far 80 countries, including Canada, have approved Gardasil(R) on the merits of
the scientific data.
    In clinical trials the vaccine was shown to be 96 to 100 per cent
effective at preventing infections from the HPV types that cause the most
clinical diseases: HPV 6, 11, 16 and 18. These HPV types account for more than
90 per cent of genital warts, approximately 70 per cent of cervical and
anogenital cancers and high-grade pre-cancers, 35 to 50 per cent of low-grade
cervical, vaginal and vulvar lesions, and all four types cause abnormal Pap
test results.(7)
    The clinical trials found no increased number of serious adverse events
in vaccinated subjects compared to placebo. Given that over ten million doses
of Gardasil(R) have been distributed in the US, many of the reported adverse
events in that country likely occurred coincidentally following vaccination.
In particular, the often mentioned Guillain-Barre Syndrome (GBS) is a
naturally occurring event which can lead to paralysis and occurs in
approximately 3 of every 100,000 people each year in the US.(8) To date, the
rate of GBS reported among people who received the vaccine is consistent with
what you would expect to see in the population.

    Approved, recommended and endorsed

    Gardasil(R) has been approved by Health Canada and recommended by the
National Advisory Committee on Immunization, a Canadian committee of
recognized experts in the fields of pediatrics, infectious diseases,
immunology, medical microbiology, internal medicine and public health. The
vaccine has also been endorsed by the Society of Obstetricians and
Gynaecologists of Canada, the Society of Gynecologic Oncologists of Canada and
the Society of Canadian Colposcopists.
    Canada's Chief Public Health Officer, Dr. David Butler-Jones, recently
acknowledged that "...unfortunately, we tend to only have this debate when we
are considering prevention measures, despite the fact that history has
repeatedly demonstrated that public health efforts designed to prevent illness
and death are consistently safer, more effective and less costly than

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company. Merck Frosst discovers, develops and
markets a broad range of innovative medicines to improve human health. Merck
Frosst is one of the top 20 R&D investors in Canada, with an investment of
$114 million in 2006. The Company is committed to fostering partnerships to
deliver the most valuable health outcomes for Canadian patients. More
information about Merck Frosst is available at

    Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the cautionary statements in Item 1
of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by

    (1) Health Canada, It's Your Health HPV Web site. (Accessed at
    (2) Statement by the Society of Obstetricians and Gynaecologists of
        Canada (SOGC) on CMAJ Commentary, "Human papillomavirus, vaccines and
        women's health: questions and cautions". (Accessed on August 14, 2007
    (3) Brisson, M et al. The health and economic burden of HPV infection,
        genital warts, cervical dysplasia and cervical cancer in Canada.
        Presented at the 7th Canadian Immunization Conference (CIC) on
        December 3, 2006 in Winnipeg.
    (4) Public Health Agency of Canada, Cervical Cancer Screening in Canada:
        1998 Surveillance Report, Executive Summary. (Accessed at
    (5) Statement by the Society of Obstetricians and Gynaecologists of
        Canada (SOGC) on CMAJ Commentary, "Human papillomavirus, vaccines and
        women's health: questions and cautions". (Accessed on August 14, 2007
    (6) Statement by the Society of Obstetricians and Gynaecologists of
        Canada (SOGC) on CMAJ Commentary, "Human papillomavirus, vaccines and
        women's health: questions and cautions". (Accessed on August 14, 2007
    (7) Efficacy of a Prophylactic Quadrivalent Human Papillomavirus (HPV)
        (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine for
        Prevention of Cervical Dysplasia and External Genital Lesions (EGL).
        Presented by C. Sattler at the 45th Annual Interscience Conference on
        Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC.
    (8) J Infect Dis., Prevots DR, et al, " Assessment of Guillain-Barre
        syndrome mortality and morbidity in the United States: implications
        for acute flaccid paralysis surveillance."
        1997 Feb;175 Suppl 1:S151-5
    (9) Canada's Chief Public Health Officer refutes Maclean's article on HPV
        vaccine. Public Health Agency of Canada. (Accessed on August 19, 2007

For further information:

For further information: Sheila Murphy, Manager, Public Affairs Merck
Frosst Canada Ltd., (514) 428-2748; Daniel Brennan, NATIONAL PharmaCom, (514)

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