Eighteen months ago and amid enormous fanfare, pharmaceutical giant Merck announced that it had produced the first vaccine against cancer. Gardasil would fight against the human papillomavirus that caused cervical cancer and the target would be *** girls, who would be protected before they have sex.
The launch of Gardasil has been so successful that one in four teenagers in America has already been given the jab, and countrywide vaccination programmes have been launched in the UK, Canada, Australia and other countries. The US Centers for Disease Control and Prevention has recommended that 30 million American girls and women aged 11–26 be vaccinated.
Yet, hardly had the vaccine programme begun when the US government began receiving reports of thousands of girls suffering from serious side-effects, including paralysis, heart attack and death.
The selling of Gardasil represents a new low in pharmaceutical tactics to market their wares to an uneducated and trusting public. As WDDTY’s special investigation in its current issue (November 2008) reveals, this vaccine arrived on the market with not a single long-term test demonstrating its safety or effectiveness.
Although the drug was licensed for use in the States in June 2006, the first trials of
the vaccine with clinically relevant endpoints—evidence that it does actually prevent something—only appeared a year later, in The New England Journal of Medicine and The Lancet (N Engl J Med, 2008; 359: 861–2; Lancet, 2007; 369: 2161–70).
And small wonder. The two large-scale studies (both sponsored by Merck) showed only modest benefit (20 per cent or less) in preventing early cervical lesions, the vast majority of which revert to normal on their own (N Engl J Med, 2007; 356: 1991–3).
Furthermore, the vaccine has never been tested for effectiveness among the population targeted to receive the drug. The only test among *** girls simply demonstrates an immune response—it raises antibodies in the blood.
Products and books don’t become best-sellers by accident. Well before the vaccine’s launch date, Merck engaged the services of some of the world’s top advertising brains to heighten fear in the public mind about cervical cancer. The admen then unleashed its most potent weapon: a direct-to-*** ad campaign that made it cool to be vaccinated.
How did Merck manage to finesse their new product and direct-to-girls advertising through the regulatory process? To answer that, it’s important to examine what has happened to the drugs regulatory process in the US, which has undergone deregulation not dissimilar to that of the US and UK financial systems.
In the early 1990s, the US Food and Drug Administration (FDA) drastically downsized its network of independent drugs-safety experts, and began hiring more people simply to ‘rubberstamp’ drugs.
Presently, drug companies pay ‘user fees’ to fund the majority of the FDA’s drugs review process. These fees and how they’re spent are renegotiated every five years, with Big Pharma having a big say as to which drugs are fast-tracked. At this time, the industry continually presses for faster drug approval as well as approval of direct-to-consumer ads.
This leaves the FDA’s regulatory budget and priorities open to control by the very industry they are paid to oversee.
Now that we are all involved in tightening up the economic free-for-all that resulted from a totally deregulated financial industry, it’s also time to crack down on authorities like the FDA which, at the moment, are less a watchdog than a drug company’s dearest friend.