Healthy Skepticism Library item: 7399

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Publication type: news

Pmlive .
“Ethical Pharmaceuticals” model threatens big pharma
PMLive 2007 Jan 4
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=5076

Full text:

Two academics based in the UK have revealed a way to invent new medicines and bring them to market at a much lower cost currently charged by big pharmaceutical companies.

According to a report in UK newspaper, The Guardian, the “Ethical Pharmaceuticals” model, devised by Sunil Shaunak, professor of infectious diseases at Imperial College and based at Hammersmith hospital, works by changing the molecular structure of an existing, expensive drug, which would turn it into a new medicine no longer protected by a 20-year patent to a multinational drug company, enabling it to be made and sold cheaply.

“The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries, but also back to the UK…slashing the NHS drugs bill,” says the report.

Shaunak and his colleague from the London School of Pharmacy, Steve Brocchini, have linked up with an Indian biotech company, Shantha, based in Hyderabad, which will manufacture a hepatitis C drug, should clinical trials sponsored by the Indian government succeed.

Drug companies with a global reach put the cost of R&D of a new drug at $800 million (£408 million). Shaunak and Brocchini were reported as saying that the cost of their R&D process was only a few million pounds.

For the hepatitis C drug, Shaunak and Brocchini redesigned the drug, known as pegylated interferon, currently sold by Swiss drug company, Roche. The large sugar molecule, which made the drug last longer in the blood, was moved from the inside to the outside of the drug molecule. They then contacted Shantha, which had made the world’s first cost-effective hepatitis B vaccine and was already making the original interferon. Shantha has agreed to produce the new medicine and the Indian government will subsidise the clinical trials.

Imperial College will hold the patent on the hepatitis C drug to prevent anybody attempting to block its development. The college employs top patent lawyers who also work for some of the big pharmaceutical companies. Once the drugs have passed through clinical trials and is licensed in India, the same data could be used to obtain a European licence and then sold to the NHS.

Shaunak told The Guardian that it was time that the monopoly on drug invention and production by multinational corporations, which charge high prices to claw back the money spend on R&D and appease shareholders, was broken.

The team’s work on the hepatitis C drug has “impeccable establishment credentials”, according to the paper. It is supported by a grant from the Wellcome Trust and help and advice from the Department of Trade and Industry and the Foreign and Commonwealth Office.

Sarah Bosely, The Guardian’s health editor, said that the professors’ ethical pharmaceutical model was unlikely to find much favour with multinational pharmaceutical companies, which already employ large teams of lawyers to defend the patents. According to an industry insider, legal challenges would ensue if the new drugs were not genuinely innovative, becoming a “huge intellectual property issue”.

Bosely further revealed that Shaunak and Brocchini were working on a drug for visceral leishmaniasis, a fatal disease transmitted by the sand fly. The 70-year old drug commonly used to treat the disease kills 10% of patients. Glilead’s patented AmBisome cures patients within hours of the first injection and has few side effects, but costs $800 (£408). The drug was developed from amphotericin B, which was rendered non-toxic by inserting the molecule into a lipid. Shaunak and Brocchini have put their molecule of amphotericin B into sugar-based polymers to make the drug stable in warmer climates, but it will only cost 2-3% of the price.

Both scientists have teamed up with the Drugs for Neglected Diseases Initiative (DNDi), a non-profit organisation set up by Médicins sans Frontières, which will raise the initial funds.

Ben Hayes of the ABPI told The Guardian that the key question was if the new drug was truly innovative: “The issue is whether the researcher has developed a novel compound which is therefore not covered by the patent on any other product. Then they would have the right to patent it.”

The drug would, however, still face the challenge and expense of clinical trials before it could be licensed first in India and then in the UK. Only then could the NHS consider whether it was worth prescribing, added Hayes.