Letter from the US

Have you developed diabetes for the first time, or has your existing diabetes worsened, or have you suffered from pancreatitis or ketoacidosis since you began taking this or that drug?

Commercials from 1-800 lawyers hurl alarming questions like this from the television set; legal advertisements naming lethal, Victorian-sounding side-effects triggered by use of familiar brand drugs, plaster the bowels of subway cars and walls of telephone booths.

A thriving tort law business in America explains some of the hysteria but not all of it, as Merck demonstrated early this month when it abruptly pulled its blockbuster painkiller Vioxx off the market.

Merck withdrew Vioxx, generically known as rofecoxib, after clinical trials revealed it doubled the risk of heart attacks in people using Vioxx for more than a year. About two million Vioxx users around the world, who mainly took it for arthritic pain and inflammation, were told immediately to discontinue their prescriptions.

The news sent the company's stock down 27% on the day and wiped $25bn off its market value. Vioxx generates $2.5bn in revenues per year and represented 11% of the company's revenue last year. The recall even depressed the Dow Jones industrial average, which closed down by 0.6% on the day.

Merck discovered the dangers during an unrelated study it was using to try to prove that Vioxx could help treat colon polyps. It discovered that 15 out of 1,000 patients using Vioxx over one year developed blood clots, heart failure or stroke. Even more frightening was that the Merck trial did not include anyone with known heart disease.

It was the company then, and not its watchdog, that sounded the alarm. Worse still, it later emerged that the Food and Drugs Administration had its reservations about the painkiller back in 1999 before it approved Vioxx. Documents show that, in May of that year, Dr Maria Lourdes Villalba said there was insufficient evidence to say 'with complete certainty whether the risk of cardiovascular and thromboembolic events is increased in patients on rofecoxib [Vioxx]'.

In August, the FDA even tried - unsuccessfully - to play down the concerns of one of its researchers whose study drew a parallel between high doses of Vioxx and heart attacks.

'Instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert,' said Senate Finance Committee chairman, Charles Grassley, after reviewing e-mail exchanges over the matter.

Senator Grassley of Iowa is among several lawmakers investigating the FDA.

There are currently two investigations underway into FDA decision-making in the Senate and House of Representatives into why the FDA blocked one of its researchers from presenting evidence he had gathered that showed anti-depressants could harm children.

The FDA has since released the results of its own study that clarify a link between antidepressants and suicidal tendencies in children.

Lacking oversight

The debacle demonstrates long-held concerns in the medical profession that the agency lacks oversight in the pharmaceuticals industry and has been too pro-business under the current administration.

After President Bush's inauguration in January 2001, the FDA remained leaderless as politicians fought over an appropriate commissioner. Back then, the Senate Health, Education, Labor, and Pensions Committee, the body that oversees the confirmation of that candidate, was chaired by a Democrat, Senator Edward Kennedy, who barred any suggestions that he deemed too pro-business.

By May 2002, the powerful Biotechnology Industry Organization (BIO) was getting frustrated. It sent its second letter that year to President Bush. The letter, signed by dozens of industry executives, demanded a new commissioner, arguing that the agency desperately needed a spokesperson to lobby for more funds and expressing irritation about what it held as protracted approval times for new drugs.

Following the November mid-term elections, the matter was taken out of Democratic hands. A Republican was appointed chairman of the committee and Dr Mark McClellan was made commissioner. McClellan dutifully pushed through a new process to speed up drug approval. Since Dr McClellan's departure in February 2002, his deputy, Dr Lester Crawford, has done his best to keep up the pace.

It is not just the FDA that is being strong-armed by the pharmaceuticals industry. The vast majority of research is funded by pharmaceutical industry money, creating an obvious conflict of interest when it comes to publishing the results.

Medical experts have warned that other drugs in the same class as Vioxx could, at least in theory, carry similar risks to those posed by Vioxx.

The Vioxx debacle gives a whole new meaning to the US corporate scandal. It is bad enough for Ma and Pa America to see their life savings wiped out, while greedy executives lavish stolen money on ridiculous umbrella stands. When the FDA, as opposed to the SEC, falls asleep at the switch, it is people and not just money that get hurt.

Abigail Rayner is New York correspondent for The Times (of London).