May 6, 2011 / 7:07 AM / 8 years ago

SPECIAL REPORT-Big Pharma's global guinea pigs

THROWING IN THE TOWEL

April’s annual meeting of the American College of Cardiology (ACC) in New Orleans was the usual frenetic mix of world-class science, networking and lobbying by the $850 billion-a-year pharmaceutical industry, seeking to promote its wares to key opinion leaders. The commercial razzmatazz of the convention centre’s giant trade stands, advertising big brand drugs and medical devices, painted a bright picture for medical science.

Under the surface, however, a growing number of doctors are worried about the tectonic changes in drug research. They resent the export of clinical trial work, which they blame not only on industry’s endless pursuit of lower costs but also on the increasing red tape surrounding trial procedures at home.

“Many of my colleagues have just thrown in the towel and say ‘I’m not going to do clinical research anymore’,” says Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at University of California-San Francisco, one of the top medical schools in the United States.

“It’s pervasive. They’ve just quit clinical trial work. It’s just too difficult and the expenses are so high you end up being in the red when you do a study.”

That’s in stark contrast to the experience of doctors in Hungary, many on a monthly salary of around 500 euros ($740), for whom working on a clinical study can double their pay. For medics in places like India — now also a major hotspot of clinical research — the salary boost can be even greater.

But Crawford says he does not want data from these places. He wants to see how a new medicine performs in his own country.

“I don’t have any way of assessing the quality of research in an Eastern European country. It may be wonderful, but I don’t have any way of assessing that. I know if a study is conducted in the United States and Canada, it’s done according to certain standards,” he says.

Dr. David Holmes, president of the ACC and professor of medicine at the Mayo Clinic in Minnesota, is more circumspect but also believes the Brilinta case raises important issues: “We can’t abrogate the responsibility of conducting clinical trials in the U.S. on people that live in the United States.”

The EMA’s Sweeney says there is no evidence that clinical trials conducted in developing economies are any worse than those done in the West. However, lack of evidence is not the same as positive proof and his team needs more resources to guarantee everything is squeaky clean on the front-line. Between 2005 and 2009, the European watchdog dealt with data linked to pivotal studies from 44,034 clinical trial sites, but it carried out only 44 good clinical practice inspections outside Europe and North America. The U.S. FDA, meanwhile, inspected 0.7 percent of foreign clinical trial sites in 2008, against 1.9 percent of domestic sites.

CHINA RISING

For now, the world’s emerging economies still play second fiddle to the United States when it comes to testing drugs. Clinicaltrials.org, a website run by the U.S. National Institutes of Health, currently lists more than 106,000 trials around the world, of which just over 50 percent are in the United States. But the balance is shifting, particularly when it comes to the big late-stage trials that really matter in deciding whether a drug is approved for sale. U.S. centres account for only 43 percent of the nearly 19,000 trials in final Phase III testing.

As in so many other areas of life, the rising star is China, which already has a total of more than 2,700 clinical trials and is experiencing exponential growth.

Less than two hours by high-speed train from Shanghai, Dr. Zhang Chenyu’s modern laboratory at Nanjing University’s School of Biological Science shows how Chinese medical research has vaulted up the global league table. After nine years working as a research assistant professor at Harvard Medical School, Zhang returned to China in 2004, where he is dean of the Nanjing school, and these days he finds the world’s top drugmakers beating a path to his door.

Zhang is a bit special because he and colleagues have discovered how certain molecules, or biomarkers, in blood can signal the presence of cancer as early as 33 months before conventional clinical diagnosis. As a result, his team is testing hundreds of U.S. blood samples in a lung cancer project with Johnson & Johnson (JNJ.N), which is interested in developing a new diagnostic test using the biomarker. But Zhang is also convinced the wider Chinese research community has arrived firmly on the global clinical research scene, thanks to its relatively low cost base, its expertise, its modern facilities and — crucially — the huge potential market for Western medicine in the country.

China has already leapfrogged the likes of Germany and France to become the world’s third largest market for pharmaceuticals, and by 2015 it is set to overtake Japan as the second-biggest, behind only the United States, according to pharmaceutical market information company IMS Health.

“Drug companies will surely vie for such a market,” says Zhang. “Now, more Chinese can afford to buy Western-made drugs. So instead of performing a trial in China only after completing trials in Europe or the U.S., why not conduct them all at the same time?”

Independent expert Dr. Rory Collins, a professor of medicine at the University of Oxford and co-director of its Clinical Trial Service Unit, is a big fan of the power that Chinese clinical research can bring to medicine and is deeply impressed by how far the country has come in two decades.

“I remember 20 years ago giving lectures on randomised trials in China and the idea that you would randomly allocate people to get treatment, or not, was viewed as completely alien. The response was: ‘We know which treatment works, we just ask the professor.’ Today, China is a very organised place and all the structures are there,” he says.

Indeed, the results of Chinese drug research are already bearing fruit — and not just for patients in China.

Six years ago, Collins’s Oxford team led a huge 46,000-patient study in China — the biggest ever seen in the country — to test the blood thinner Plavix and a beta-blocker in the emergency treatment of heart attacks. They found that adding Plavix to aspirin produced further benefit, while the beta-blocker metoprolol did not. That important discovery has since gone on to influence medical practice around the world.

“That study would never have been done if we couldn’t have run this very streamlined trial in China at very low cost,” says Collins, who is currently working on another pivotal heart drug study for Merck that contains no U.S. patients. “My preference would be not to do any trial in North America because it is so inefficient and so costly.”

Western Europe may be a bit better but Collins and many other researchers are highly critical of the bureaucratic obstacles there as well, following the introduction of the European Union’s 2004 clinical trials directive, which has led to a mountain of extra paperwork for each trial.

The aim of the EU directive is to harmonise standards and protect subjects.

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