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GSK’s Cervarix ad campaign promoting cervical cancer vaccine under Indian drug regulator’s scanner

Friday, December 18, 2009, 18:41 This news item was posted in Legal category and has 0 Comments so far.

Drugs Controller General of India (DCGI), the to drug regulatory authority of India, has pulled up GlaxoSmithKline Plc’s (GSK) for “unlawful” propagation of its cervical cancer vaccine Cervarix, through mass media.

GlaxoSmithKline’s promotional advertisement campaign appeared in different newspapers and television channels of late announcing the the vaccine will be effective against cervical cancer contravenes the provisions of Indian drug laws. Related story: Cervical cancer vaccine market hots up in India

Drugs and Cosmetics Act, 1940 and Drugs & Magical Remedies Act 1954, does not allow  any claim to prevent or cure diseases in Schedule J of the Act, which includes cancer.

Under the Drugs and Cosmetics Act, drugs sold under prescription cannot be advertised and this includes vaccines. India only allows advertisement of over-the-counter (OTC) drugs.

Even though GSK ads does not refer the name of the product Cervarix anywhere in the ad campaign “those ad clearly claims that vaccination can prevent cervical cancer, so it doesn’t matter that they don’t name the vaccine,” experts said.

Following this, the drug regulator has decided to issue a show-cause notice to GSK and also write to the state authorities about these ads.

“They (GSK) say the vaccine will be effective for cervical cancer. This kind of advertising is not allowed,” DCGI Surinder Singh was quoted as saying.

The ad can send a wrong message to the public also that by getting this vaccine the cancer can be prevented. And these vaccines are not cheap, he added.

However, GSK maintained that such disease awareness programmes do not contravene any of the provisions of the Drugs and Cosmetics Act. The public awareness campaign attempts to build awareness about this debilitating disease, cervical cancer.

Such awareness campaigns can only highlight to all women that cervical cancer is preventable by screening and vaccination and they encourages everyone to consult a gynaecologist/paediatrician, according to GSk.

GSK has launched the cervical cancer vaccine Cervarix in India recently. Apart from GSK, Merck Sharp and Dohme (MSD), an affiliate of Merck and Co. Inc, the the competitor in cervical cancer vaccines also launched its version Gradasil in Indian market.

Cervical cancer is a serious disease that can be life-threatening. This disease is caused by certain high-risk HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these precancerous lesions are not diagnosed early and treated, they may turn cancerous after a few years.

Every year, almost 74,000 women die due to Cervical cancer in India, which is more than one fourth of the world deaths due to Cervical cancer. Woman in India have a 2.5% life time risk to get Cervical Cancer, which is double the risk as compared to the data worldwide (1.3%).

The human papillomavirus, also called HPV, was a common pathogen predominantly affecting women. Approximately 80 per cent of women get one or more types of virus by the age of 50.

Reportedly, there are more than 100 types of HPV. Of these, about 15 high-risk types were known to cause virtually all cases of cervical cancer. “Two of these types (16 and 18) are believed to cause 70 per cent of these cases (76.7 per cent in Indian women).

Though there is no known cure for cervical cancer, the recent advances in vaccine technology have made it more or less certain that cervical cancer can be prevented in majority of cases using vaccine. The global market for cervical vaccine is estimated at more than $10 billion last year.
Cervarix is a vaccine against certain types 16 and 18, which currently cause about 70% of cervical cancer cases.

Cervarix is a preventative cervical cancer vaccine, not therapeutic. Cervarix vaccine will not block infection from cervical cancer-causing HPV strains other than HPV 16, 18, 31 and 45.

Cervarix vaccine is approved and sold in more than 60 countries, including US, Australia (for women ages 10 to 45),  Philippines and European Union, among other countries. Cervarix had sales of 125 million pounds ($182 million) last year. Cervarix has received approval by the UK government for its national programme of vaccination for teenage girls. Glaxo has also won exclusive contracts to provide Cervarix to young girls and women in the Netherlands and the U.K.

Gardasil contains recombinant virus like particle (VLPs) assembled from the L1 proteins of HPVs 6, 11, 16 and 18. Since VLPs lack the viral DNA, they cannot induce cancer. They do, however, trigger an antibody response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine.

As per available data, till February 2009, 40 million doses of Gardasil had been distributed worldwide. There is no evidence the vaccine has caused serious adverse effects. According to the Centers for Disease Control, the vaccine was tested in over 11,000 women and girls (ages 9 to 26).

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