What's worse than breast tenderness and nausea in the female effort to prevent pregnancy? Heart attack, stroke or death. Quitting this week is going to consider the everyday erosions of our medical liberties by the political and economic culture at large.
Loss of liberty is not necessarily obvious when we flip on the television at night and pharmaceutical advertising flows over us like, well, Flomax. Happy couples in which one has and one is free from genital herpes (Valtrex). Lumbering turtles or careless hares (Chantix). Heartburn grimaces (Nexium), or virile older couples sitting astride powerful motorcycles (Viagra, Levitra, Cialis).
The government watchdog of pharmaceuticals is the Food and Drug Administration; but since it is both a political animal and under-funded, it doesn't come nicely packaged into your living room to influence your drug choices, cajole you to ask your PCP for the brand-du-jour or conduct clinical trials of questionable design.
A current crop of lawsuits against health-care giant Johnson & Johnson over the Ortho Evra birth control patch is showing how the FDA is being ushered by the Bush administration ever closer to the anti-regulatory precipice.
The story is not quite like the Chantix one — where the company in question left out the very demographic meant for the drug — but the company's own documents show that it obscured critical information on dosing, leading to increased risk of blood clotting.
Johnson & Johnson documents show their scientists cooked some numbers on their Ortho Evra birth control patch back in 2000, after the clinical trials for the drug were finished, when pesky data came to light showing the patch delivered more estrogen than was legally allowed (read: safe). This recipe, which the company called a "correction factor," was buried deep in a document sent to the FDA and comprehensible only to a mathematician. It was not part of the original study protocol, not published publicly and not part of the rationale for the 2001 FDA approval of the drug.
More than 3,000 women, or their next of kin, are suing Johnson & Johnson because they wore that patch, took in a far higher dose of estrogen than is delivered in pill form and suffered something awful as a result, life-changing awful.
And yet, in a riveting "not my problem" defense strategy, Johnson & Johnson will be arguing in the Supreme Court (friend to big business) that it cannot be sued for the ruined lives because the FDA approved the drug, despite original labeling listing the wrong amount of estrogen. They knew, they knew. They knew taking this drug could, and likely would, end up in brain bleeding, pulmonary embolisms, and clots in leg muscles. And they sold it anyway.
The legal argument is one that attorneys, pharmaceutical companies and our very own Bush administration wants to see in place. It goes like this: the FDA is the expert for overseeing drugs and it should not be subject to court judgments. If the FDA says a drug should be approved, it should be approved and all liability to the original company should be forgiven. Forever.
Never mind that the agency is of a size nowhere able to match budgets, conduct independent research or levy sanctions that actually hurt. No, the FDA is really only in a position to rubber stamp whatever information the drug companies want it to have, in order to get things to market.
The director of the FDA, Andrew C. von Eschenbach, M.D, spoke publicly on Feb. 29 to the National Press Club, where he noted that the "FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century." To his credit, he sketches out a detailed plan that might actually work — if someone funded it.
I do have an idea for a new FDA logo. Remember the seemingly fearsome abominable snowman in that Rudolph animation at Christmas? His fearsome visage became pathetic, if you recall when he opened his maw to show nothing more than gums.
Chantix antics are reaching Canada now. Back to that story next week. suzanne.danforth@gmail.com.
