"Ethical pharmaceuticals" - Scientists find way to slash cost of drugs

[Al-khiyal]

Indian-backed approach could aid poor nations and cut NHS bills:

Two UK-based academics have devised a way to invent new medicines and get them to market at a fraction of the cost charged by big drug companies, enabling millions in poor countries to be cured of infectious diseases and potentially slashing the NHS drugs bill.

Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can 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 back to the UK.

Professor Shaunak and his colleague from the London School of Pharmacy, Steve Brocchini, have linked up with an Indian biotech company which will manufacture the first drug - for hepatitis C - if clinical trials in India, sponsored by the Indian government, are successful. Hepatitis C affects 170 million people worldwide and at least 200,000 in the UK.

Multinational drug companies put the cost of the research and development of a new drug at $800m (£408m). Professors Shaunak and Brocchini say the cost of theirs will be only a few million pounds.

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 have been licensed in India, the same data could be used to obtain a European licence so that they could be sold to the NHS as well.

Professor Shaunak says it is time that the monopoly on drug invention and production by multinational corporations - which charge high prices because they need to make big profits for their shareholders - was broken.

"The pharmaceutical industry has convinced us that we have to spend billions of pounds to invent each drug," he said. "We have spent a few millions. Yes, it will be a threat to the monopoly that there is.

"I'm not only an inventor of medicines - I'm an end user. We have become so completely dependent on the big pharmaceutical industry to provide all the medicines we use.

"Why should we be completely dependent on them when we do all the creative stuff in the universities? Maybe the time has come to say why can't somebody else do it? What we have been struck by is that once we have started to do it, it is not so difficult."

The team's work on the hepatitis C drug has impeccable establishment credentials, supported by a grant from the Wellcome Trust and help and advice from the Department for Trade and Industry and the Foreign and Commonwealth Office.

But the professors' ethical pharmaceutical model is unlikely to find much favour with the multinational pharmaceutical companies, which already employ large teams of lawyers to defend the patents which they describe as the lifeblood of the industry.

One industry insider envisaged legal challenges if the new drugs were not genuinely innovative. It could become "a huge intellectual property issue", he said.

Scientists find way to slash cost of drugs

[NinaGucci]

If what i understand is right, these professors suggest to do clinical trials in third world countries (in this case India) to bring the cost down...
well, industrialists have suggested even manufacturing drugs in India (outsourcing the manufacturing plants, or even building their manufacturing facilities in those countries)
to be honnest, clinical trials are not the ones which constitute the major production costs, it's mainly the drug development (both scientifique development including creating the actual molecules and the manufacturing process development), also the manufacture for those clinical trials (especially phase I and II)+ manufacturing for the commercial stage, and finally, all the validation and registration work which follows.
Also, when u want to launch a pharmaceutical product in any country, u will have to do clinical trials in that country again. for the moment, only Europe has a semi unified clinical system, as through the EMEA, u can file for registration in different countries (and even with this, u ll still need to provide extra data for some countries such as the UK and France). in other words, if u sell a drug in Europe for 10 years and u wanna start selling it in the US for example, u will still need to do clinical trials in the US and present the data to the FDA, even if u had a bluckbuster drug.
from those points, i deduct that it will not be possible to do clinical trials in India and expect the drug to be sold later on in the UK (about this hepatitis C drug)...so the professors will have a bad surprise as clinical trials are regulated by individual governements. u might also be surprised to know that western countries care much more about their patients than about the rest of the world. they want clinical trials on their own people as they re of different races and have different health conditions and therefore, they might react differently to drugs...although i do not share this opinion, we re all humans and i dont see them more fragile than Indians for example, but this is the reality.
as for outsourcing MANUFACTURING, indeed, that is very feasable, and it is already beeing applied by some of the big pharmaceuticals such as GSK who is not manufacturing some of its drugs in Bombay and selling them in Europe. even with this, there are still some problems with the validation of those processes as the EMEA has to accept validation works on those manufacturing processes before giving authorisation for commercialisation. the validation may have some issues as the companies might bring the same machines they use in Europe or America, but they can not use the same water...air...etc, and the manufacturing will not be 100% in the same environement as it would have been in if it was in western countries. these are only very basic complications u might have.
i thought that we may be able to apply such business models in Algeria...if anybody is in the pharmaceutical industry, it would be nice to get ur company to consider opening manufacturing branches in Algeria, it s a huge market, and it s extremelly cheap to produce there....very broad matter i guess, u r welcome to tell me what u think

[amalgamate]

Under the Influence?
Drug companies, medical journals, and money.
By Kent Sepkowitz
Posted Monday, Sept. 10, 2007, at 1:21 PM ET

Scientific fraud comes in several varieties. Data can be fabricated, ideas swiped, experiments gamed. One dramatic version is the too-late revelation that an investigator was drinking at the watering hole of a pharmaceutical company when he or she published an article about the wonders of a certain drug, produced by the watering hole's operators.

To prevent such embarrassments, medical journals now run authors through the wringer to potentially illuminate their often-cozy relationships with pharmaceutical companies. We writers complete an extensive conflict-of-interest form describing any payments received for lectures or advice, research grants, and personal or family financial interests. This information is then included at the end of the published article, allowing the reader to judge whether an author might have been working under the influence.

Although onerous to coordinate (and annoying to complete), this approach is an important first step in preventing unseemly trysts between doctors and the pharmaceutical industry. But it does not go far enough because it ignores an even more conspicuous denizen of the watering hole, the medical journal itself.

Just as pharmaceuticals fund studies and pay doctors to give lectures, so too do they buy journal ads and reprints of favorable articles—lots of them. Often a drug company may find one of its products featured in a scientific article while another of its products is dolled up in a high-gloss ad a few pages later. Yet the journals keep quiet about these financial arrangements. When an article is published that shows a specific drug at great advantage, the reader may learn plenty about the author while nothing—absolutely nothing—is disclosed about the medical journal itself.

The public deserves to know about the extent to which every medical journal relies on pharmaceutical advertising revenue to run its business. In 2003, drug companies spent almost half a billion dollars on advertising in medical journals. The two lead general medical journals in the United States—the New England Journal of Medicine and JAMA, the Journal of the American Medical Association—receive about $18 million and $27 million each year, respectively, for display advertisements (as opposed to classified ads placed by individuals seeking jobs or institutions seeking qualified candidates). The display ads represent 10 percent to 21 percent of the journals' overall revenue, according to one study.

And display advertising is only one of the ways that dollars can move from a drug company to a medical journal. Many journals publish "supplements," typically a one-topic, free-standing volume that shares font and layout with the parent magazine—but not serious peer review. In other words, it looks and sounds like your favorite medical journal, but it's not quite the real thing. These supplements have sponsors (guess who?) that front the production and publication costs sometimes with a Producers-like overpayment.

Another trick is the sale of reprints of a specific article. Say a group of researchers has published a favorable article about a drug. Well, the pharmaceutical company can show its love by snapping up thousands and thousands of reprints to sprinkle around in the good name of education—and in the process, pay the journal tens of thousands of dollars. As Richard Smith, former editor of the British medical journal BMJ and a leader in trying to protect editorial integrity, once wrote about the effect of reprints: An editor in chief must "publish a trial that will bring US $100,000 of profit [in reprints] or meet the end-of-year budget by firing an editor."

The consequence of the pharma-journal relationship is far from abstract. A few years ago, Dialysis & Transplantation, a leading journal for kidney specialists, received an editorial that argued against a double dose of a pharmaceutical product, Epogen, which can ameliorate the anemia common in dialysis. The author claimed the big dose was twice as expensive (about $10,000 to $12,000 per patient annually, versus the typical $5,000 to $6,000) but no better than the regular dose—and perhaps less safe.

The piece was accepted through the standard peer-review process. And then the reviewing scientists were overruled by the marketing department. As the journal's editor explained when the situation came to light, the author's opinion that a lower dose was preferable "apparently went beyond what our marketing department is willing to accommodate." Though the journal eventually restored its original decision and decided to publish the article, the damage to its reputation had been done (and the author declined the invitation). Earlier this year, the FDA determined that the higher dose indeed was less safe than the standard dose because of an increase in the rate of stroke, blood clots, and heart attack.

How often do questionable episodes like this one take place? We don't know. But the examples that are known about, and the possibility that medical observations are influenced by anything other than cold hard facts, are sufficiently sobering to warrant additional disclosure. And so I have a modest suggestion: In addition to requiring authors to post conflict-of-interest statements when they publish an article, medical journals should tell readers how much revenue they themselves have received in the previous year from the company producing the drug or device under discussion. The total sum should include not just advertising pages purchased, but also the other ways that industry money can slip into journal pockets, by buying reprints and journal supplements. Show us the actual dollar (or euro or pounds sterling) amount. And if a professional society sponsors the journal, tell us about its financial dealings with the drug companies as well.

Such disclosures would take work, annoy scads of people (most of them honorable), and be completed under protest. But they're worth it, to help assure the integrity of medical literature. Just as compromised relationships are unusual among researchers, they are likely, in the end, to be unusual among medical journals. But it is naive to think that only authors are influenced by who is writing the checks.