FDA rejects OTC statins

An FDA advisory committee has again rejected Merck's and Johnson & Johnson's bid to sell a non-prescription, low-dose version of a statin. The panel voted 20 to 3 against over-the-counter (OTC) sales of a 20-mg dose of lovastatin (Mevacor) because of concerns that it could not be used safely without physician guidance. Although panel members did not doubt the efficacy of the statin, some said that Merck's 'actual use' study, which simulates pharmacies selling OTC Mevacor, failed to show that consumers could properly decide whether to take the treatment. The FDA rejected earlier proposals for non-prescription statins from Merck and others, most recently in 2000, but UK authorities approved the use of OTC statins in 2004. Despite the setback, Bristol-Myers Squibb said it still plans to seek FDA clearance to sell an OTC version of pravastatin (Pravachol).

Pharmacogenomics chip approved

Roche has received approval from the FDA to market its first microarray-based test. The AmpliChip CYP450 identifies cytochrome P4502D6 genotype variations to predict drug metabolism. The test was launched in Europe in 2004, but the FDA had delayed its decision, questioning whether the test needed a pre-market application, because it is a complicated device with specific directions that, if misused, has the potential to harm patients through misdiagnoses. Sales of the AmpliChip CYP450 could reach US $100 million a year, according to Roche, compared with average peak annual sales of US $10–20 million for other diagnostics.

Bayer buys back rights to impotence drug

Bayer has agreed to pay €208 million (US $272 million) to GlaxoSmithKline to regain sole marketing rights outside of the United States for the impotence drug vardenafil (Levitra). Bayer hopes that the move will help lift earnings. Analysts say that the move fits in with Bayer's moves to focus on Europe and fields in which it has successful products, but reflects the weak sales performance of Levitra in comparison to its competitors. Pfizer's sildenafil (Viagra) still dominates the field, with more than 70% of the market share in the USA, whereas Lilly's tadalafil (Cialis) controls about 19%.

New initiatives to provide greater access to drug data

The International Federation of Pharmaceutical Manufacturers and Associations, along with three other industry associations covering Europe, the United States and Japan, said they will be creating a freely accessible online registry of current and completed drug trials. The registry will publish detailed information about all clinical trials, other than exploratory Phase I studies. Participation is voluntary, but the scheme already has backing from GlaxoSmithKline, Pfizer, AstraZeneca, Merck, Novartis and Sanofi-Aventis. Also, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) will open up its drug safety monitoring system. Patients will in future be able to view anonymous data on suspected adverse drug reactions on the MHRA Web site.

Arguments over missing Prozac documents

Eli Lilly is defending itself against what it says are inaccurate statements made about the company and its antidepressant fluoxetine (Prozac) in the British Medical Journal. According to a news story in the 1 January issue, the BMJ received documents from an anonymous source suggesting a link between Prozac and suicide attempts and violence, which had gone missing during a 1994 lawsuit. The case against Lilly was on behalf of victims of a workplace shooting in Louisville, Kentucky, by Joseph Wesbecker, who was prescribed Prozac a month before the shootings. Lilly's lawyers have notified the BMJ that the article is “inaccurate and defamatory”, and said that all their relevant data had been previously submitted to the FDA. The BMJ said it had validated its information and forwarded the documents on to the FDA, but it will address Lilly's concerns after reviewing them.

Risks of HIV drug withheld

Nevirapine (Viramune; Boehringer-Ingelheim), used to block HIV transmission between mothers and babies in Africa, is at the centre of controversy over its safety. Viramune reduces the chances of HIV transmission by up to 50%, but can also promote drug-resistant forms of the virus and has been linked to potentially fatal liver toxicity. According to documents obtained by the Associated Press, US officials knew about the problems as early as January 2002 from trial data, but did not tell President Bush before he authorized shipping the drug to Africa as part of a US $500-million initiative. The FDA has now issued a warning that Viramune could cause liver damage, but the World Health Organisation said that it would continue recommending use of the drug, as the benefits outweigh the toxicity problems.