An advertising blitz to promote a vaccine for cervical cancer says little about the efficacy or side-effects of the drug.

FRONTLINE

Volume 27 – Issue 03 :: Jan. 30-Feb. 12, 2010
INDIA’S NATIONAL MAGAZINE
from the publishers of THE HINDU

FOR almost a fortnight in December 2009, leading newspapers and private television and radio channels kept warning the public about the dangers of ignoring cervical cancer. The advertisements in the newspapers, targeted at young girls and their mothers, highlighted the need to get vaccinated against cervical cancer but did not mention the name of the vaccine. “It’s true! Vaccination can now protect your daughter from cervical cancer,” screamed a headline, with the sub-head saying that 200 women died in India every day from cervical cancer, a bigger cause of death than breast cancer.

The advertisements, which showed a mother and daughter in a loving clasp, were issued by a multinational pharmaceutical company in the form of a public awareness initiative. They advised readers to “act today” and contact their gynaecologist or paediatrician for vaccination. They clearly hinted that it was young women who were at the highest risk of contracting the infection that “might lead to cervical cancer”.

In the advertisement, it was explained that “for the best response, the vaccine should be taken by adolescent girls as early as possible”. But nowhere did the advertisements mention anything about the possible side-effects of the unnamed vaccine.

Ministry’s silence

Predictably, the advertisement blitz caught the attention of women and health groups. They felt that the studied silence of the Ministry of Health and Family Welfare over the advertisements was grossly misleading. The advertisements were brought to the notice of the Drugs Controller General of India (DCGI), whose office pulled up the pharma major for its unlawful propagation of the vaccine Cervarix.

The Drugs and Cosmetics Act, 1940, and the Drugs and Magic Remedies Act, 1954, do not allow any claim to prevent or cure diseases that include cancer. And drugs sold under prescription, which include vaccines, cannot be advertised. Even though Cervarix’s maker had not mentioned it by name, it still fell foul of the existing legislation. The advertisements soon stopped appearing.

Apart from Cervarix, which secured approval from the United States Food and Drug Administration in October 2009 (the advertisements in India started soon after), Gardasil, a version of the vaccine, was launched by another pharmaceutical major in the Indian market.

It was in December 2005 that Gardasil’s manufacturer and the Union Ministry of Health and Family Welfare, through the Indian Council of Medical Research (ICMR), announced their collaboration to assess the use of Gardasil. Under the agreement, the manufacturer would supply Gardasil for the study.

The manufacturer’s press release includes forward-looking statements, which are about product development, product potential or financial performance. These statements are defined in the Private Securities Litigation Reform Act, 1995. The press release, issued in 2005, cautioned that “no forward-looking statement can be guaranteed and actual results may differ materially from those projected”. This essentially means that Gardasil’s maker has no obligation to update publicly any forward-looking statement, whether as a result of new information or future events, or for other reasons.

MORE…

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.