New Drugs Hit the Market, but Promised Trials Go Undone
By GARDINER HARRIS
Published: March 4, 2006
The agency often compromises by approving a drug quickly and then insisting that its maker prove after approval that the drug actually works. This strategy, as the numbers released Friday show, has been only marginally successful.
As of Sept. 30, of the 1,231 promised drug trials, 797, or 65 percent, had not begun or were "pending," according to the F.D.A. Another 231 were considered "ongoing" and 28 were "delayed." In the 2005 fiscal year, drug makers completed and submitted the results of 172 trials, the agency reported.
[What they don't tell us is the total number of new drugs that were approved that year.]
Dr. Scott Gottlieb, the deputy F.D.A. commissioner for medical and scientific affairs, said last month that the agency would ask an outside group to evaluate the problem, a process that could take a year.
Dr. Steven E. Nissen, chairman of the cardiology department at the Cleveland Clinic Foundation, said, "I think it's very disappointing that we're not seeing the studies that are promised being done."
Companies complete trials rapidly when the F.D.A. demands the results as a condition for approval, Dr. Nissen said...
Although the controversy about these numbers has raged for years, the ratio of uncompleted trials has remained largely unchanged. In 2002, the first year that the F.D.A. began closely monitoring the issue, 820 of 1,339 promised trials, or 61 percent, were "pending."
How does the Company's Pharmaceutical division propose to get around this? After all, Big Time and Poppy want to live forever, and even Dear Leader wants to know how all that Cialis he takes to keep up with his hotmilitarystuds4hire is gonna effect his "love" life.
How to get the data in a corporate-friendly manner? Outsource it!
The consulting firm McKinsey calculates that the market in India for outsourced trials will hit $1.5 billion by 2010. ...
Like high-tech call centers and software farms, which were meant to transform India's computer industry by creating skilled workers and a stockpile of modern equipment, drug trial outsourcing is seen as the fast route to economic and scientific growth.... With this in mind, the government is working to advertise India's most pharmacologically appealing qualities, notably its doctors (English-speaking and educated abroad) and its vast number of ailing patients — 32 million diabetics alone....
Last year, the government took a more controversial step, amending a long-standing law that limited the kind of trials that foreign pharmaceutical companies could conduct. In January, the government threw out that constraint. India, the brilliant hub of outsourced labor, was positioning itself in a newly lucrative role: guinea pig to the world.
More here, from Jennifer Kahn's orignal post:
...the number of patients willing to sign up for clinical trials is abysmally low. Just 3 percent of cancer patients opt to join trials, and the number of US patients who sign up for cardiac trials has plunged by half over the past five years.
Such reticence has created a problem for the pharmaceutical industry. Modern drug design may be a sophisticated enterprise, harnessing technology that didn't even exist a decade ago, but one part of the process remains the same: The only way to tell how well a medication really works is to feed it to a sick person. This process, the human clinical trial, is the largest and creakiest part of the drugmaking machine - a mammoth lab experiment that succeeds by brute statistical force. To make it run, companies have to round up a large number of ailing people and then convince them to swallow an unproven remedy with uncertain side effects.
The experiment unfolds in three stages: Phase I, when a compound is safety-tested on a few dozen healthy people; Phase II, conducted on a slightly larger group of mildly ill subjects; and Phase III, which is the most extensive. Involving thousands of subjects and taking up to seven years to complete, Phase III trials are the make-or-break point for new medicines and, because of their size, the hardest to fill with patients. Exacerbating the problem is the fact that discoveries of rare side effects (including lethal ones, like strokes and heart attacks caused by the arthritis drug Vioxx) have pushed companies to conduct ever larger studies. In the 1980s, a new drug typically was tested on 1,300 volunteers in a total of 30 trials. By the mid-1990s, those numbers had swelled to 4,200 patients and 68 trials.
"Twenty years ago, drugs were dropping the cardiac mortality rate from 20 percent to 15 percent," says Dhiraj Narula, medical director of Quintiles ECG, a contract-research firm that organizes trials for major multinationals. "Today we're looking at drugs that will take you from 6 percent mortality to 5 percent. To prove an effect that subtle, in a way that's statistically robust, you need a lot of patients in your sample." One cardiac drug study was conducted on a whopping 41,000 subjects.
The result is a bottleneck that Narula argues is impeding the arrival of important cures. Herceptin - an exceptionally effective breast cancer drug - languished in trials for years because its maker, Genentech, reportedly couldn't recruit enough patients to test it.
Like many in the pharmaceutical industry, Narula believes that the solution to the slow pace of drug trials lies in outsourcing. As many as half of all clinical trials are already conducted in locations far from the pharmaceutical companies' home base, in countries like India, China, and Brazil. And many industry analysts expect the market to skyrocket, particularly as expanding libraries of genetic information increase the number of drugs coming out of the lab. The consulting firm McKinsey calculates that the market in India for outsourced trials will hit $1.5 billion by 2010.
Enticed by numbers like these, developing countries have been scrambling to catch Big Pharma's eye - India most aggressively of all. Like high tech call centers and software farms, which were meant to transform India's computer industry by creating skilled workers and a stockpile of modern equipment, drug trial outsourcing is seen as the fast route to economic and scientific growth - a money train that the country can't afford to miss. With this in mind, the government is working to advertise India's most pharmacologically appealing qualities, notably its doctors (English-speaking and educated abroad) and its vast number of ailing patients - 32 million diabetics alone. Many of these patients are also, in the delicate parlance of the drug world, "treatment naive," meaning they've never taken any medication for their illnesses. This is a perk for trial managers, because it lowers the risk of unforeseen drug interactions and avoids the troublesome process of weaning patients off one medication and onto another...
...Kalantri is uneasy about his clinical success. "Patients here are very passive," he reflects. "They will almost never question their doctor." Indeed, one woman who joined the trial six months ago sits patiently for more than an hour while Kalantri translates my questions, before revealing that she is suffering from aches and fever that are likely malaria. Such deference is hard to imagine in US patients - a querulous lot - and it makes Kalantri's position tricky. "Nine out of 10 times," he says, "the patient will just ask me to make the decision about the trial for him. So what role do I play? Am I a physician, concentrating on what's best for the patient? Or am I a researcher interested in recruiting patients? I try to balance the two sides, but ..." He shrugs. "It's a dichotomy."
Kalantri began worrying about such matters not long after he started recruiting patients for Boehringer Ingelheim. The previous year, he had overseen a trial for Reviparin, an anticlotting drug that improves the health of one out of 65 cardiac patients within 30 days of a heart attack. The trial was enormous: Nearly 16,000 patients participated, half of them from India. When the trial ended, however, Kalantri wondered whether he had served his patients well by enrolling them. At 800 rupees a day, the drug they had taken was too expensive for any of them to afford. Plus, even when it worked, it showed results for just a month. Such a minute and costly improvement might make sense in the US, Kalantri felt, but was it really the kind of medication that poor Indians should be testing? "The biggest problems around here are snakebite and insecticide poisoning," he points out. "We could really use a trial for one of those."
Good luck with that.
The nice thing about the Company's model for free-range slavery is that the property has to fend for itself.
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