Spotlight on Drug Regulators

Drug regulators are protecting drug companies profits over patients' lives by withholding unpublished trial data, argue researchers.

They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.

Weight Loss Drugs (Diet Pills)
Diet pills are medicines that help control or reduce weight. Diet pills are otherwise know as weight loss drugs or anti-obesity medications.

Despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter G'tzsche and Dr Anders J'rgensen from the Nordic Cochrane Centre in Denmark.

Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s.

This must be remedied, they say, and they describe a three-year struggle to access unpublished trial reports for two anti-obesity drugs, submitted by the manufacturers to the European Medicines Agency (EMA) for marketing approval in the European Union.

UK Drug Regulators Approve Botox for Migraine Treatment
The Medicines and Healthcare Products Regulatory Agency has approved the use of botox for the treatment of chronic migraine.

"The information was important for patients because anti-obesity pills are controversial," say the authors. "People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been de-registered for safety reasons."

But the EMA refused access, arguing that this would undermine commercial interests and that there was no overriding public interest in disclosure. They also cited the administrative burden involved and the worthlessness of the data after they had edited them.

Anti-obesity Drugs Provide Short-term Health Benefits
Researchers have pointed out, anti-obesity drugs fall short of providing long lasting health benefits.

The authors appealed to the European ombudsman, who criticised the EMA's refusal to grant access. But only after the ombudsman accused EMA of maladministration, did it agree to widen public access to documents.

"There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients," say G'tzsche and J'rgensen.

Anti-obesity Drugs Inhibits Pleasure in Eating
Anti obesity drugs could make all the lovely, yummy food look much less yummy, say scientists at the University of Cambridge.

Source-Eurekalert