The selling of Gardasil

Bryan Hubbard — Tue, 18 Nov 2008 15:48:00 GMT

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.

Not quite human

Lynne McTaggart — Thu, 08 Nov 2007 16:50:00 GMT

Last month, the US Food and Drug Administration (FDA) took the unprecedented step of requesting that pharmaceutical companies take a list of cold remedies for children off the market. Rarely has such a sweeping and categorical ban ever occurred, but the evidence surfacing regarding deaths related to these drugs has become difficult to ignore, even for an agency as fond of Big Pharma as the FDA. We can only hazard a guess as to the damning nature of the evidence that would prompt so sanguine a federal body as the FDA to take such action. But it’s long overdue. As the Special Report in our latest issue reveals, many of the types of drugs routinely given to adults—antibiotics, asthma drugs, painkillers, cold and cough medicines—are highly dangerous to children and, more shockingly, have never ever been tested in any basic way to ensure that they are either safe or effective for this age group.

How could such a situation arise, considering all the regulatory bodies in the US and Europe? The answer lies in the medical model of children. Until recently, doctors operated under the assumption that a fetus, a baby, even a young child, wasn’t yet human—not in the fully formed sense of the word. In this view, as babies and young children don’t develop certain nerve receptors until age seven, they don’t, for instance, feel pain. We now know that idea to be completely fallacious—a fetus is as exquisitely sensitive as you or me. However, that mindset—that a child isn’t yet a proper human being—has enabled medicine to deny children the most basic regulatory protection.

Besides assuming that children don’t suffer as much pain or even side-effects as adults, medicine also assumes that children have ‘paradoxical’ effects with drugs, so that a drug with adverse effects in adults (such as amphetamines) can actually ‘improve’ children.

Astonishingly, doctors often don’t consider the basic fact of scale. Because a child may not, in their view, react to a drug in the same way an adult would, they often administer a drug dosage appropriate for a full-sized adult to a person one-third that size. Years ago, we reported on the shocking death of nine-year-old Lexie McConnell, who was given steroids at a dosage even higher than would be administered to adults (WDDTY vol 4 no 8).

As adverse drug effects aren’t tested in children, doctors operate with impunity. A hospital can insist on administering these drugs to children without having to ask for their parents’ permission, and many parents who resist emergency drug treatments risk losing custody of their children on a temporary basis. And because doctors haven’t the slightest idea what a drug can do in children, if it all goes wrong, they look elsewhere—usually at the parents.

Dr Mohammed Al-Bayati, a Los Angeles pathologist and toxicologist, is often called upon as an expert witness for the defence when parents are accused of killing their children. In virtually all the cases he’s handled, babies and children have died as a result of some cocktail of drugs: vaccines, antibiotics, steroids and even over-the-counter preparations.

For instance, Ezbjörn Hahne was convicted of killing his 40-day-old daughter Nadine, based on evidence that she died from old and new intracranial bleeding. However, Al-Bayati’s investigation discovered that the intercranial bleeding was likely to have been caused by the three doses of antibiotics prescribed by the hospital doctors.

At the moment, because no one considers deaths in children to be drug-related, we have no idea of the scale of the problem. But the FDA’s move is the most important first step in recognizing that current paediatric medicine is nothing but a house of cards.

Lynne McTaggart - What Doctors Don't Tell You : FDA

The selling of Gardasil

Not quite human