Prescribing Death for ProfitsPosted: December 19, 2010
An article in this month’s Vanity Fair called “Deadly Medicine” made me realize how much of the movement of various parts of corporate business functions were not only to chase the lowest wage, but to also chase the least amount of regulation. The result of this movement has been the death of many poor people in many poor countries. Yet, we hear very little of this news in this country. You can only image how much this has to do with the huge connections between Corporate Big Media and its Corporate Advertisers. I’ve had to rely on many a foreign source and watch dog blog to sniff out some of the information in this post.
You may have read a link I put in down thread to a fire in a Bangladeshi factory that killed many young women that sounded hauntingly familiar to the Triangle Shirtwaist Factory tragedy in this country in 1911. I know a lot about the Bangladeshi economy because that is where my major professor was born. Much of the country’s growth has come from the textile business. It employs young women in situations similar to what workers endured in 18th and 19 century America. We have the laws and the Ladies Garment Workers’ Union to watch for these kinds of abuses. The young women of Bangladesh have neither. This fire happened five days ago. Many of the fire exits were locked as was the case with the Triangle Shirtwaist Fire. The workers were subject to appalling conditions. At least 27 died and around 100 were seriously injured. Workers jumped to their death to avoid the flames. Bangladesh has another cottage industry that kills too. It serves as a guinea pig country for Big Pharma and the results of this relationship are frequently tragic.
Similar sad stories unfolds in parts of the old USSR, South America, and Asia as a result of the greed of Big Pharma. This industry looks for countries where it can avoid and cripple FDA regulation of their industry. I was appalled that I had not read much of this until I picked up the Vanity Fare article. After Googling the topic, I found that the media coverage at the time was limited mostly to foreign outlets. It figures. Let me give you a taste of what I’m going to write about in several installments because there is so much to tell you and it will make you weep.
Many of these clinical trials have gone to places where people give their consent with a finger print or a poorly scribbled “X”. Surely, this is questionable ‘consent’. Some of the victims of these experiments are not even capable of granting consent. My first case study for you is the example of 49 babies who died in India while undergoing experimental drug trials. In some instances, pediatricians were actually paid up to $350 a head to come up with subjects for the trials. As I share the investigative reporting on this subject, one of the things to keep in mind is that there are now companies that broker clinical trial sites and victims for Big Pharma. It’s a growth industry. These brokers act as agents who procure countries with dysfunctional laws and judicial systems and poor, desperate people for drug experimentation. There is evidently big money in prescribing death to people in the poorest nations of the word.
In August, 2008, The Sunday Times reported this story.
Forty-nine babies have died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials.
The deaths occurred over a period of 30 months at the Delhi-based All India Institute of Medical Sciences (AIIMS), an elite medical college and public hospital renowned for providing low-cost treatment to the poor. The victims were among the 4,142 infants who were used in a total of 42 clinical trials — one of the final stages of developing a new drug — at AIIMS since January 2006, many for Western companies. Of the children used in the trials, 2,728 were aged under a year old.
The mortality rate among the babies, many of whom were seriously ill before they became part of the clinical trials, was 1.2 per cent — significantly below the 4 per cent for all patients treated at the hospital. However the age of those selected for testing has shocked many in India and there are fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice.
Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, said: “The practice of using infants like guinea-pigs for drug testing must end.”
In 2006, a science Reporter for the Times asked this salient question in a headline: ‘Poor, sick, desperate. What more could Big Pharma ask in Indian drug trials?’ The article outlines steps taken by the big drugmakers to move risky trials over seans to avoid lawsuits like those resulting from products like Vioxx –a Merck product–and from Paraxel made by TeGenero. The rush to find the most vulnerable countries and people has gone largely unnoticed in this country.
And so Big Pharma has begun outsourcing its trials to India, a move that, according to bioethicists, could create a “new imperialism”. India has huge numbers of sick people glad to test drugs in return for minimal, if any, recompense. The patients rarely mind — to them, experimental healthcare is better than none at all — and they rarely complain. India also has a homegrown supply of highly educated, English-speaking doctors, who cost a fraction of their Western counterparts.
AstraZeneca has opened a drug-testing facility in Bangalore; Pfizer has done the same in Bombay. At the moment one in a hundred global clinical trials is conducted in India, but Oxygen Healthcare, a British consultancy, estimates that in five years’ time that figure will have risen to one in ten.
This makes financial sense but others are clearly worried that poor, illiterate patients are being exploited. There is certainly doubt over whether they are giving informed consent. The Indian Journal of Medical Ethics reports that patients are often unable to distinguish between trials that might benefit them and those that won’t. Another study pointed out that, of the country’s 14,000 general hospitals, fewer than 200 are equipped to carry out drug trials adequately.
Indian patients are often used to test medicines that, once marketed, they will not be able to afford.
The editors of the American Journal of Bioethics say in their blog that “pharma trials in India should be the focus of a huge amount of attention in the world of research ethics”. Even more forthright was a recent opinion piece in The Scientist. “If Gandhi were alive today, he would lead protesters to the doors of a clinical research trials facility, where the oppression of the Indian poor dwarfs that of the 1930s.” This is a reference to Gandhi’s march against the British salt tax, which made it illegal to obtain salt from anyone other than the British Government, even though it could be collected along the coast. Gandhi and his supporters marched 240 miles from western India to coastal Gujarat, gathering the mineral on the way. The march ended in a bloody confrontation at a salt factory.
The Indian Government now stands accused of colluding in this new oppression. In 2004 it stipulated that drugs tested in India should first be proved safe in their country of origin; in 2005 the law was revoked.
Believe me, I’ve been Googling up a storm on these trials in India and other places for reports in US Newspapers. I have yet to really find one. I have found one blog called PharmaGossip that discusses some of these issue and the Vanity Fare article in particular. It simply shares the article that begins with this short introduction giving you a flavor the extent and the tragedy of cases found by its authors.
Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.
The article includes examples–including the one from India above–from hamlets all over the world with exotic-sounding names. All of these countries have citizens that have died so that Big Pharma can bring wrinkle creams, erectile dysfunction drugs, and tiny twists on existing drugs to the U.S. Market. Many of these drugs are not as efficacious and have deleterious side effects compared to existing, older drugs.
If you go to the home page on PharmaGossip you’ll see more news on AstraZeneca which is one of the companies that comes up in many of these horror stories. Here’s a link to another blog called Corporate Crime Daily that tells the story of Seroquel from 2009. The article is called: AstraZeneca: Tales of a Deadly Drug Pusher. Seroquel is an anti-psychotic drug. Because the drug came to market and caused damages to U.S. citizens and wound up in court, you can find coverage by the NYT. AstraZeneca was also found guilty of defrauding Medicare in 2008. The reason I’m adding this is that when it hits our citizens and our courts, it becomes a media issue. When the trials kill Indian babies and poor Poles, the US press is mum.
The number and type of clinical trials held in Western Europe, Canada, or the United States have been reduced significantly because their judicial systems are a way to check unethical and deadly business behaviors. [Restated to avoid confusion. Yes some trials are held here but they are fewer and some types are not done here much any more.] ** As long as the FDA will approve drugs based on experimentation in vulnerable countries, we will have the blood of many on our hands. Here are some numbers from the Vanity Fare article.
Many of today’s trials still take place in developed countries, such as Britain, Italy, and Japan. But thousands are taking place in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an “X.” Bangladesh has been home to 76 clinical trials. There have been clinical trials in Malawi (61), the Russian Federation (1,513), Romania (876), Thailand (786), Ukraine (589), Kazakhstan (15), Peru (494), Iran (292), Turkey (716), and Uganda (132). Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry.The two destinations that one day will eclipse all the others, including Europe and the United States, are China (with 1,861 trials) and India (with 1,457). A few years ago, India was home to more American drug trials than China was, thanks in part to its large English-speaking population. But that has changed. English is now mandatory in China’s elementary schools, and, owing to its population edge, China now has more people who speak English than India does.
While Americans may be unfamiliar with the names of foreign cities where clinical trials have been conducted, many of the drugs being tested are staples of their medicine cabinets. One example is Celebrex, a non-steroidal anti-inflammatory drug that has been aggressively promoted in television commercials for a decade. Its manufacturer, Pfizer, the world’s largest drug company, has spent more than a billion dollars promoting its use as a pain remedy for arthritis and other conditions, including menstrual cramps. The National Institutes of Health maintains a record of most—but by no means all—drug trials inside and outside the United States. The database counts 290 studies involving Celebrex. Companies are not required to report—and do not report—all studies conducted overseas. According to the database, of the 290 trials for Celebrex, 183 took place in the United States, meaning, one would assume, that 107 took place in other countries. But an informal, country-by-country accounting by VANITY FAIR turned up no fewer than 207 Celebrex trials in at least 36 other countries. They ranged from 1 each in Estonia, Croatia, and Lithuania to 6 each in Costa Rica, Colombia, and Russia, to 8 in Mexico, 9 in China, and 10 in Brazil. But even these numbers understate the extent of the foreign trials. For example, the database lists five Celebrex trials in Ukraine, but just “one” of those trials involved studies in 11 different Ukrainian cities.
Celebrex–a PFizer product-–is one of the drugs that is a Big Pharma nightmare story. After some disclosures, it’s been found that Celebrex has many many side effects–including increased risk of heart attack–and does no better job than older, less profitable pain killers. Celebrex has even been touted as an Alzheimer’s panacea. There’s evidence that PFizer suppressed trial evidence that would have stopped the drug from going to market. Ketek–an Aventis product–appears to have similar clinical trial issues. The FDA’s decision to approve Ketek was based on clinical trials from Turkey, Tunisia, Morocco, and Hungary. These countries are called “rescue countries” in the Pharma business because they are heavily used and abused if a drug needs some last minute support by data. There are even some Ketek horror stories from Gadsden, Alabama cited in the Vanity Fare article. There are evidently go to doctors and countries that will provide what ever evidence is needed and they are either highly rewarded or have financial interests in Big Pharma. You can only imagine that if researchers found evidence in the US that what the investigative journalists found in other countries is far worse.
The approval came less than one month after a researcher in the United States was sentenced to 57 months in prison for falsifying her own Ketek data. Dr. Anne Kirkman-Campbell, of Gadsden, Alabama, seemingly never met a person she couldn’t sign up to participate in a drug trial. She enrolled more than 400 volunteers, about 1 percent of the town’s adult population, including her entire office staff. In return, she collected $400 a head from Sanofi-Aventis. It later came to light that the data from at least 91 percent of her patients was falsified. (Kirkman-Campbell was not the only troublesome Aventis researcher. Another physician, in charge of the third-largest Ketek trial site, was addicted to cocaine. The same month his data was submitted to the F.D.A. he was arrested while holding his wife hostage at gunpoint.) Nonetheless, on the basis of overseas trials, Ketek won approval.
The Ketek story unfolded in 2007-2008. Both Ketek and Celebrix are still on the market despite evidence that there are issues with both the process of approval and the drugs themselves. The drug approval process and the FDA’s complacent role–as well as its capture by Big Pharma–are subjects covered in the Vanity Fare article as well as other places. I’m going to go into this as well as some more individual issues with the drug trials in poor and developing nations in further installments. I would also like to determine if drug maker advertising has anything to do with the lack of coverage of many of these things by Big Media in the U.S. The more I read about this, the more I am horrified. Stay tuned.
Note** I wanted to clarify this since there seems to be some misunderstanding. Let me get the numbers from the Vanity Fare article.
Once upon a time, the drugs Americans took to treat chronic diseases, clear up infections, improve their state of mind, and enhance their sexual vitality were tested primarily either in the United States (the vast majority of cases) or in Europe. No longer. As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” All of this is taking place when more drugs than ever—some 2,900 different drugs for some 4,600 different conditions—are undergoing clinical testing and vying to come to market.