Gardasil was fast-tracked

In 2006 when the HPV vaccine Gardasil was licensed and marketed to young girls and women 9-26 years of age, the phase 3 clinical trials had not been completed. This meant that the benefits of the vaccine and any safety issues arising from it were not known. The time period from clinical trial to recommending the vaccine was only 4 years. According to Dr Diane Harper, one of  Merck’s HPV researchers “most vaccines take 3 years to develop and then 5 to 10 more for universal acceptance.” “Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”

Gardasil was fast-tracked by the US Food and Drug Administration (FDA) due to industry lobbying from the manufacturer Merck who in December 2005 submitted an application to the FDA for fast track approval. Shortly after in February 2006 Merck announced that the FDA had given the go-ahead and that Gardasil was to be given a ‘priority review’. Such an accelerated review is reserved for vaccines and other products that are urgent and for conditions where other treatment does not exist. Did Gardasil fulfill this unmet need? No it did not. Cervical cancer is a rare outcome of HPV infection and in countries with cervical cancer screening programs, cases of the disease and fatalities have more than halved and if a cancer is found early and treatment given, the 5 year survival rate is 72%. But in spite of these facts the FDA review date was scheduled for June 8 , 2006 whereupon the first HPV vaccine was approved and recommended for all women aged between 9-26 years even though it had not been tested for the prevention of precursor lesions in females younger than 15 years of age.

In Too Fast or Not Too Fast: The FDA’s Approval of Merck’s HPV Vaccine Gardasil, Canadian researchers Lucija Tomljenovic and Christopher A. Shaw state that ‘Merck’s HPV vaccine Gardasil failed (and continues to fail) to meet a single one of the four criteria required by the FDA for Fast Track approval’.
According to Tomljenovic and Shaw,
In order to gain approval, a Fast Track drug must demonstrate the following:
1. Show superior effectiveness to existing treatments (if such are available)
2. Avoid serious side effects of an available treatment
3. Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
4. Decrease a clinically significant toxicity of an accepted treatment
Even so Gardasil continues to be marketed and promoted to young girls and now boys for prevention against a disease they are most unlikely to ever get.
Read more about how this Fast-Tracked and Flawed vaccine was licensed and marketed in Gardasil: Fast-Tracked and Flawed

 

 

 

 

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