Adverse Reactions : FDA

Suppress to impress

Bryan Hubbard — Fri, 25 Jan 2008 15:06:00 GMT

What shall we do with the drug companies? The year is only a few weeks old but already they've been caught out on two occasions suppressing vital data that revealed their drugs weren't working anywhere near as well as they have claimed.

In the first case - involving the cholesterol-lowerting drug Zetia (ezetimibe) - the truth about its inneffectiveness was revealed only when a Congressional hearing in the USA forced the manufacturer to release the data from its Enhance trial.

In the second, independent researchers discovered that selective reporting of data from trials into a range of antidepressants had made them seem at least 30 per cent more effective than in fact they were.

America's drug regulator, the Food and Drug Administration (FDA), has one answer. From next September, every drug trial must be registered with the agency, and ongoing reearch and findings must be revealed other than during the first, preliminary stages.

The worry is that the ruling has no teeth. Drug companies that fail to comply can be fined a whopping $10,000 (UK£5,100), which will certainly make them think twice before suppressing data on drugs that generate billions of dollars of sales every year.

Still, it's an attempt of sorts, we suppose, and we don't expect the UK's drug regulators - who pride themselves on being the fastest in the world - to come up with anything similar any time soon.

Heart patients given Avandia

Bryan Hubbard — Thu, 07 Jun 2007 14:35:00 GMT

Avandia , the diabetes drug that causes heart failure , has regularly been given to patients. . .with heart failure. The practice is so common that one medical trial even focused on 224 patients with congestive heart failure who were taking the drug....(read more)

Diabetes drug may soon be pulled

Bryan Hubbard — Tue, 22 May 2007 14:39:00 GMT

Avandia (rosiglitazone), the diabetes drug, may soon be pulled from markets around the world after a study discovered it increased the risk of heart attack by 45 per cent. America's drug regulator, the Food and Drug Administration ( FDA ), has issued...(read more)

A missed opportunity

Bryan Hubbard — Fri, 11 May 2007 11:30:00 GMT

America's senators have missed an enormous opportunity to give their citizens genuine protection against a pharmaceutical industry that is all too rarely brought to account. Instead they voted overwhelmingly in favour of moves that draw the industry and the drug regulator, the Food and Drug Administration, even closer together.

The Senate has voted 93 to 1 in favour of a 'drug safety' measure - S.1082 - which deepens the financial ties between the industry and the FDA. Drug companies will be doubling the amount of money they pay to the regulator, thus giving strength to the notion that the drug industry is becoming increasingly self-regulating in the USA.

The new measure fails to exclude foods and nutritional supplements, and so the protection enjoyed by these harmless substances that was enshrined by the DSHEA law has all but been overturned.

Worse, a novel and radical move - known as the Grassley amendment - was defeated by a single vote. This amendment, classified as S.1039, attempted to bring in genuine drug safety protection for consumers.

As it is, an industry that kills 100,000 Americans every year - and that's according to the most conservative figures available - will continue to generate enormous profits with impunity.