Prescribing Death for Profits

The Triangle Shirtwaist Factory Fire, for The Call by John Sloan

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.

By Donald L. Barlett and James B. Steele

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.


63 Comments on “Prescribing Death for Profits”

  1. NW Luna says:

    Big Pharma spends more on advertising and marketing than they do on drug research & development. As a prescriber who simply wants to know whether a medication will work for most patients, and what the risk/benefit profile of the med is, I have no love for Big Pharma. I can read my Tarascon or ePocrates drug database info and see that generic med X is 20% of the price of brand-name med X; I’ll write the Rx for generic.

    But it is simply not true that “Clinical trials are no longer held in Western Europe, Canada, or the United States.” There are thousands of trials going on now; just check clinicaltrials.gov to see a list.

    Regarding Celebrex, a type of non-steroidal anti-inflammatory drug (NSAID), we’ve known for a few years that it’s a class effect. You’re not much or even any safer with ibuprofen. Analyses get complicated, based on dosage.

    “Results showed that NSAID use was associated with an increased risk of stroke. This increased risk ranged from about 30% with ibuprofen and naproxen to 86% with diclofenac.

    Risk of Stroke With Various Nsaids
    NSAID HR (95% CI) for risk of stroke
    Ibuprofen 1.28 (1.14–1.44)
    Diclofenac 1.86 (1.58–2.19)
    Rofecoxib 1.61 (1.14–2.29)
    Celecoxib 1.69 (1.11–2.26)
    Naproxen 1.35 (1.01–1.79)

    Gislason noted that there was also a dose-relationship found, with the increased risk of stroke reaching 90% (HR 1.90) with doses of ibuprofen over 200 mg and 100% (HR 2.0) with diclofenac doses over 100 mg. He pointed out that the results were particularly striking, given that this study was conducted in healthy individuals.

    He conceded that his results could have some confounding but noted that the data were controlled for age, gender, and socioeconomic status and the patient population did not include those with chronic diseases. “We also have to think about the degree of confounding needed to nullify risk. It would have to increase risk four- to fivefold, which is very unlikely,” he commented.”

    http://www.medscape.com/viewarticle/728205

    Another study:

    “Prescription use of the nonselective NSAID diclofenac and the selective COX-2 inhibitor rofecoxib was associated with an increased risk of cardiovascular death (odds ratio 1.91 and 1.66, respectively), with a dose-dependent increase in risk.

    Our results further strengthen the association between NSAID use and cardiovascular risk by demonstrating effects on all cardiovascular outcomes.

    There was a trend for an increased risk of fatal or nonfatal stroke associated with ibuprofen treatment (OR 1.29), but naproxen was not associated with increased cardiovascular risk (OR for cardiovascular death 0.84).

    Although rofecoxib was withdrawn in 2004, another COX-2 inhibitor, celecoxib (Celebrex, Pfizer), is still available. But Fosbøl et al say they were unable to draw any firm conclusions about the cardiovascular safety of celecoxib in this study because the analysis is based on few events, especially at higher doses. The results of the ongoing Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen and Naproxen (PRECISION) trial should shed more light on the risks and benefits of this drug, they say.

    They also showed that all NSAIDs except for celecoxib were linked to a substantial increase in risk of serious bleeding, a well-known adverse effect of NSAIDs “that needs to be kept in mind.”

    http://www.medscape.com/viewarticle/723206

    Take-home on NSAIDs is that generic naproxen (brand name Aleve) has least cardiovascular risk based on available data.

    • Branjor says:

      I believe aspirin is also an NSAID. I used to be able to take it, but now even one will cause cramps and diarrhea. I can’t take any NSAIDs anymore, I am totally allergic. And my dog Jordi died of a reaction to the veterinary NSAID rimadyl.

      • NW Luna says:

        Oh I am so sorry to hear that. Losing an animal companion is hard. What terrible bad luck for your dog to have that reaction. I’m not familiar with veterinary medicine, but the generic for rimadyl (when I did a PubMed search) has a “profen” ending so it most definitely sounds like an NSAID. The search turned up indications of gastric ulcers and even perforations in some dogs; not sure what the dosage was or how long it was taken. Catastrophic reactions to a med such as your poor dog suffered are usually very, very rare — not that it’s any consolation.

        My vet is now not using NSAIDs for chronic pain in cats and prescribed tramadol instead.

        • Branjor says:

          Thanks, Luna 😦 He took 25 mg and only for 13 days. Now the only pain killer I’ll use for my pets is tramadol.

        • Branjor says:

          It’s an NSAID all right. They call it “doggy aspirin.” It was given for his arthritis. All of a sudden, he became inappetant, had some black stool, at one point lost his balance and fell off my bed (!!!). The vet said it wasn’t the rimadyl and that he wasn’t that sick, he would recover, but he just got worse and died as I was rushing around at 5 AM to get him to a veterinary ER. Before the rimadyl, he was healthy. It was in fact the rimadyl that caused it as his reaction was classic. These reactions are supposedly rare, but you are right, it was no consolation. 😦

    • dakinikat says:

      There are still studies done here, they’re just not the of the same number or type as they used to be. This is not the preferred place to do clinical trials any more because of the law suit risk.

      • Branjor says:

        Since when do poor people in the States have money for lawsuits?

        • dakinikat says:

          If you’re injured, a personal liability lawyers will take your suit for free and collect 1/3 of the damages on the win. Class action suits make billionaires out of these guys. If you’ve got an actionable suit, they’ll fight over you.

  2. zaladonis says:

    In my opinion, Big Pharma is the most disgusting industry in America because it’s not only monumentally greedy, it kills and debilitates people while it tricks them into taking extravagantly expensive medication that may or may not treat symptoms that may or may not be as bad as the drug’s side-effects.

    When I hear those drug ads that end with a list of possible side effects that’s so long and horrible it’s unintentionally comical, often including death, I always think how do they know that? Who, and how many people, agreed to be guinea pigs and how many died or ended up with damaged hearts, etc, for Pfizer to collect that information? Figured it couldn’t be here in the US, not legally anyway. So now I know. And why am I not surprised.

    Great expose, Kat. Looking forward to your next one. It’s revolting but good to know. I stay away from pharmaceuticals as much as possible and as far as I’m concerned this just added another good reason.

    • NW Luna says:

      I dislike much about Big Pharma. However, I wouldn’t want to be without a lot of the meds that a lot of hard work and creative research and development have brought us. New meds can be researched, produced, marketed and sold without having scummy callous physicians and unscrupulous greedy CEOs behind them.

      But any big business in the last several decades has gotten so power-hungry — and there is no effective government control looking out for those small folks who merely happen to want some easing of their illnesses.

      • RalphB says:

        Big Pharma isn’t good but I’ll take them over Goldman Sucks or BofA.

        • zaladonis says:

          Goldman Sachs doesn’t do what Kat describes above. Neither do they advertise in mass media with Orwellian seduction campaigns. And some of their products and practices may be scummy but compared with what Big Pharma sells there aren’t very often side effects like stroke and death.

          Goldman is plenty shameful but IMO Big Pharma is worse.

        • dakinikat says:

          I’ve never known Goldman Sachs or BOA to do things that routinely kill babies.

          • RalphB says:

            You will if the recession turns into a depression.

            Nothing has no risk involved when it is used to treat illness. Some people will always respond negatively but, if properly used, medications can work well for most of us. As a survivor, you are well aware of risks and benefits.

          • dakinikat says:

            Well, I was fully aware of what I was doing when I got my unique chemo regimen and I had the ability to sit in the Med Center Library and read studies about oncology protocol. My Doctor even helped me. Plus I was the mother of a 5 month old, inoperable and had cancer every where but my bones. I was part of a clinical study on heparin actually after I had my C section. My gyn took me off it because it was overwhelming me at the time. (probably because of the in situ cancer that no one caught because I delivered C section. ) This is completely different than going to a hospital in a poor country and pay the doctors to search out people that can’t even sign there names to allow their healthy infants to be experimented with ….

            Also, this is a depression for the over 10% of the population that can’t find jobs and pay their bills and are approaching bankruptcy. I’ve been in both situations and I do not see this as equivalent at all. My oldest went into the chicken pox vaccine study but it was the last phase before approval. There’s different stages in clinical trials and the earliest and most risky are going to countries where the subjects can’t even read and are desperate for money. Really, I just respectfully disagree. I was fully aware of the risk. I can’t believe some one that uses a fingerprint for a signature was probably aware or fully informed of the risks.

          • bostonboomer says:

            Babies will die if they are homeless and have no access to medical care. It’s pretty hard to develop a hierarchy of evil when you are dealing with villians as bad as these. Plus, Goldman and BOA probably invest in some of these products/enterprises.

          • bostonboomer says:

            Great post, Dakinikat!

          • dakinikat says:

            Thx BB. I’m going to try to go into each of the issues that surrounded these studies and why most of them would not have take place here.

      • zaladonis says:

        NW Luna:

        It’s not going in a better direction and it’s not going to, not for now anyway. And it’s not only the fault of scummy physicians and unscrupulous CEOs. Greed and entitlement has spread and now elected representatives and government agencies and even consumers are fully part of the problem as well. It’s getting worse.

        Everybody’s free to make their own choices. My choice is to be as little a part of it as I can. And it’s not just protest – I don’t trust them. I don’t, unless I’m convinced I absolutely have to, trust pills from people who make choices, either themselves or accepting that others do in their industry, that are so disgusting. I’d rather find other ways to deal with depression and sleeplessness and anxiety and pain in my joints. That’s just me.

        • NW Luna says:

          Just catching up on posts…. Zal, I sure don’t see greed going away either. Any treatment for anything has risks/benefits, pros and cons. You didn’t refer to supplements, but the supplement industry has similar problems.

          “…people who make choices, either themselves or accepting that others do in their industry, that are so disgusting.” I may be misinterpreting, but that sounds like anyone working in healthcare these days is guilty by occupational-category association? No; just because drug company BigPig is doing unethical testing that does not mean I should find a different career. Or withhold prescribing a necessary med when the benefits outweigh the risks. I discuss everything else people can do before and instead of meds.

          And I hate direct-to-consumer advertising of meds. No way to have a real discussion about risks/benefits in 30 sec. I usually am dead-set against whatever it is someone wants if they say they saw it on TV.

  3. zaladonis says:

    Oh and by the way …

    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.

    um yeah. It’d be nice to have some hard evidence but we know darn well it does!

    • NW Luna says:

      “Follow the money; see where it goes. It leads to shrunken men, stuffed up with greed.”

      –Bruce Cockburn

      Think he was writing about bought politicians in that song, but it’ll work OK for bought media CEOs.

  4. RalphB says:

    Wonder how much money is being spent, and by whom, to spread this falsehood.

    Clinical trials are no longer held in Western Europe, Canada, or the United States

    There are a few going on locally now and there must be loads of others around the country. Who profits from that lie?

    • NW Luna says:

      Yeah, as I pointed out above just go to clinicaltrials.gov to see a nifty searchable list. The include non-drug trials, too.

    • dakinikat says:

      I probably stated that wrong … they’re are still trial/studies going on here but they are markedly different and the numbers are much lower than they used to be. It’s easier to do the trials elsewhere and the FDA doesn’t follow up on the trials in other countries much at all. I footnoted the numbers section below. The preferred place to test now is overseas. Big Pharmaceutical companies have farmed out sourcing of clinical trials to broker firms who shop for the best locale.

      • dakinikat says:

        Here’s another quote from the VF article:

        Many U.S. medical investigators who manage drug trials abroad say they prefer to work overseas, where regulations are lax and “conflict of interest” is a synonym for “business as usual.” Inside the United States, doctors who oversee trials are required to fill out forms showing any income they have received from drug companies so as to guard against financial biases in trials. This explains in part why the number of clinical-trial investigators registered with the F.D.A. fell 5.2 percent in the U.S. between 2004 and 2007 while increasing 16 percent in Eastern Europe, 12 percent in Asia, and 10 percent in Latin America. In a recent survey, 70 percent of the eligible U.S. and Western European clinical investigators interviewed said they were discouraged by the current regulatory environment, partly because they are compelled to disclose financial ties to the pharmaceutical industry. In trials conducted outside the United States, few people care.

        • NW Luna says:

          There is an increase in clinical trials run by people not in regular medical practice. Also federal funding continues to decrease, and funding by industry increases proportionately. There is also a huge increase in regulation, some of it not contributing to patient safety, similar to some of the Food Safety Bill’s requirements which are disproportionately burdensome on small farmers.

          I’ll go dig up some more info on that. I worked as a research RN in graduate school (disclaimer: non-drug trial).

      • bostonboomer says:

        My guess is that infants are not routinely given dangerous drugs in clinical trials in the U.S.–maybe it will get that bad eventually, but there are some protections here. That’s why these companies go overseas for victims.

        • RalphB says:

          That seems right. Corporations are amoral creatures of money and only go for more profits. To think otherwise is to delude oneself. It would seem to me that they should provide protections for their citizens overseas. It would make it harder to find victims.

          Here’s one reason the race is to the bottom. We are not as upset about the foreign lack of citizen protections as about corporations making money from it. Corporate culture is not going to get better so it would be better to lobby for consumer protections overseas. The same is probably true for wages. What’s missing is any leverage at all to get anything done.

          • dakinikat says:

            Surely, there is some way to make the FDA consider removing approval of drugs that have been tested in countries in unethical ways. Of course, we’d have to wrest the FDA from big Pharma. They are the prime example of a captured regulator although from my stand point here in LA., the EPA looks pretty useless too.

          • dakinikat says:

            Of course that would assume we have a president that wasn’t captured by interests too. Money doesn’t talk any more it screams.

      • Fannie says:

        I’ve had doctors who have given me free medications that are new, and where do the doctors get these new medications. I am sure they must get them from various conferences they attend, and from pharma salespeople. And who are they pharma people pushing pills on doctors?

  5. jh says:

    wow, dak, amazing article. this news would not have been well received at your previous home! thank GOD you have a place where you can explore this “hot” topic on your own. this is a profound spiritual service to humankind.

    • dakinikat says:

      The more I’m reading about this the more I just can’t believe it! I feel very freed that I can explore this and other topics in an environment where there is bound to be disagreement, but I’m certain it will take a completely different tone.

      • Minkoff Minx says:

        Kat this was magnificent. I really appreciate the work you did for this piece.

      • jh says:

        I send them love all the time, love is the only thing more powerful than hate. It’s my own eternal challenge but if I give in to anger I’m the one who gets hurt, not them. This subject is like an angry red boil on the american psyche that’s about to explode in all directions. I am simply not up for rationalizations about work that basically creates the opposite of what it claims as its mission. Your investigation will hopefully bring more attention to the whole pharma insanity.

  6. Branjor says:

    There’s so much to say about drugs. Sometimes, due to pressure to get new drugs on the market fast, they are not adequately tested before being FDA approved. My mother was on the drug Seldane, now removed from the market due to cardiac effects, when she died of a heart attack. I have had neurologically mediated muscular problems due to prescription drugs and I have already told what happened to my dog. Now we are hearing of a new dimension to the problem, clinical testing more and more being exported to poor countries with more lax regulations.

    • Minkoff Minx says:

      Branjor, My mother was on seldane as well. This is what the Drs think causes her cirrhosis. That was one bad drug…

    • dakinikat says:

      You know I think there are class actions suits out there for Seldane victims. You might google the participating lawyers and see if your mothers qualified.

    • paper doll says:

      My mom was on it as well…and here her frugalness saved her…she didn’t take as many as was prescribed…couldn’t afford to….and so just had heart issues…but her cousin, took the full dose and was dead within two years …yet all the time I see a hot new drugs on TV that are then taken off the market…how many times have we seen that over the last few years? …and the list of side effects” …“if you have or plan to have a liver in the future …so and so drug may not be for you” I love the sleep aids that may make you want to kill yourself…oh yeah let’s get that to market toot sweet .

      Thanks for this post

  7. Minkoff Minx says:

    I will say this, if Wikileaks does have the good on Big Pharma, that would be something I want to read. The thing that gets me, is the amount of commercials that are shown on TV. Can you imagine all the connections…money connections. From investors, to advertising companies, to selling time on networks, not to mention the Big Pharma lobby…insurance company back room deals. It makes me dizzy.

    • dakinikat says:

      I’m waiting for the release of that and that of BOA.

    • grayslady says:

      The Guardian (http://tinyurl.com/24ueqvw) has already published the WikiLeaks cables regarding the scandal with Pfizer and drug testing in Nigeria.

      • Minkoff Minx says:

        Thanks Grayslady! From the article:

        The world’s biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

        Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

        Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

        But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government.

        • Sima says:

          What worries and appals me even more than Dak’s excellent article is the thought of some unscrupulous company seeding a disaster, like meningitis, in order to have the environment necessary to test its drugs.

          I dunno, maybe I’m getting too tin-foily.

          But after the stuff I’ve been reading about the ‘little’ things wikileaks is revealing, I dunno. A tin foil chapeau may soon be necessary apparel.

      • TheRock says:

        Great catch grayslady!!!!!! I was going to post this same link!! FDA testing has been going on back home for years. In fact, as was seen with the swine flu epidemic, big business has been exploiting 3rd world countries for years. Most of the current unrest, located in the Delta region, is because of oil companies exploiting that region. All you really have to do is buy off a few high level politicians and you can basically get away with anything. Our current president is the first to really go after the corrupt politicians and it has put his life and his young presidency in peril.

        Dak, I can’t wait to read the upcoming posts and I look forward to the accompanying discussions…..

        Hillary 2012

      • dakinikat says:

        Thank goodness for the Guardian’s daily update on Wikileaks!!!

      • dakinikat says:

        Also, this just goes to show you that all the distraction surround Assange is taking the focus off the Wikileaks themselves. It is not for the press or the blogosphere to indict Assange or defend his attackers. That is for the courts to do.

        He and his organization are simply the vehicle that is standing to get important inside information to the day light.

        People that are focusing on Assange are falling for the oldest magician’s trick imaginable. Ignore the leaks and focus on the odd man behind the curtain.

        I’m going to follow up on this.

        • paper doll says:

          It’s all about the distraction…and if there wasn’t one, they would create it…as you say,

          It is not for the press or the blogosphere to indict Assange or defend his attackers. That is for the courts to do.

          Indeed

    • paper doll says:

      Oh I just mentioned the TV ads…really there are more ” ask your doctor” ads for drugs than there are car ads! It’s a major source of TV income !

  8. CB says:

    The Constant Gardener (book/movie) covered this very same topic. Highly recommend it if you haven’t encountered it.

    What we lack is much of an emphasis on healthy living that is not influenced by industrial trade groups for beef, cheese, dairy products. Although some of the studies in The China Study may be flawed, the overall difference between diseases in rural China …or countries that adhere to their deeply rooted cultural diets…where the diet is primarily plant based can’t be denied. Many of the diseases that afflict affluent countries can be attributed to diet, and the government and the various ag businesses (don’t believe the ones from fruits and vegetables are very powerful) make sure that the various studies that suggest otherwise always have degree of controversy (as did the tobacco industry and the climate change deniers do today).

    The solution is going to be an easy one–take a pill, or a handful of pills if you don’t want to address your diet and take up exercise. Not that everyone can, but many of the illnesses that are prevalent today have a life-style component.

  9. Boo Radly says:

    I had a rude awakening at the end of May – after almost dying in a hospital from a doctor prescribed FDA approved drug. It was a fluoroquinolone antibiotic. It was and continues to be life altering in so many ways. No one would tell me what happened to me in the hospital nor why I was crippled and in excruciating pain for months at home. I had to demand my hospital records. It was all spelled out. In my book that is unethical and I was shocked.

    Clinical studies are paid for by the drug company that manufactures it in most cases. There is not one healthcare agency that is not being paid to promote certain drugs; hospitals, nursing homes, physicians. The FQ’s medicine guides spell out some of the risks, Levaquin is black boxed now after a decade + of known problems – that happened only after Public Citizen took them to court. If I had been consulted about use of this drug I would never have taken it. I had never heard of it but would have read the Black Box warning. They gave me three other drugs along with it that was specifically stated not to be used.

    The following link is for ProPublica, Journalism in the public interest. It shows how much physicians are paid to give “talks”(reporting is now required) by seven of the big pharma companies. It actually lists the amounts paid by each drug company and names the doctors. You can look up your own doctor to see if they are listed. Some of the commenters on that article are physicians, one is a Dean, at The University of Rhode Island, College of Pharmacy. I found some of them to have frightening perspectives. It explains why not one of seven new doctors I have had to go to has ever heard a discouraging word about the FQ’s…….it’s just amazing. There are also a few physicians who do acknowledge there is a problem when doctors are paid to push, er “teach”, recommend certain drugs. And they have stories by doctors who cry foul – they are shunned.

    http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records

    ProPublica is doing a series on big Pharma and doctors interaction.(above link)

    From my perspective, it is not only the very poor – we are all guinea pigs now. “Adverse reactions” to FQ’s are not rare but they are under-reported. If you have taken one in the past and not suffered, please consider never taking it again because there are documented cases that it will get you the next time. It’s not even that effective – it’s a lose – lose situation. There are many other drugs on the market that will work without these dangerous “side effects”(it is actually a poison – it alters your dna).

    MotherJones had a bit of read on it a couple weeks ago. http://motherjones.com/mojo/2010/12/levaquin-tendon-damage-tendinitis

    Since I thought I was so informed about RX drugs(avoiding most), and since I had been inured with such statements as “always consult your physician” – “standard of care” – I wish to inform others so that they do not have to suffer. Doctors have been known to demand that their patient complete the total regiment even when devastating symptoms occur.

    Clinical studies are done at almost all the leading medical schools – a lot are artfully written. Clinical studies are done on animals as well with these drugs and it is disgusted what happens to them. The FDA is lax in the US. Dak please include our own country – there is a vast amount of info out there.

    Drugs are manufactured in India as well as outsourced clinical studies. I personally do not want to use RX manufactured there.

    Can anyone remember when prescription drugs were NOT 80% of the commercials on TV and they did not list 50 -60 fatal possible reactions? You can thank Bu$hit – he reformed the tort laws. If the FDA approves a drug, as long as you don’t die, you have little recourse. – you were warned. Oh, and your doctor will just tell you it was used as a “standard of care”, meaning that’s their protocol. One size fits all.

    Sometimes, lately, I feel overwhelmed with all the heartache, pain and suffering caused by greed for a great percentage of the world population.

    Count me among many who were waiting for the Wikileaks Pharma cables.

    • dakinikat says:

      Omigosh. This is terrible! I am so sorry!!

    • paper doll says:

      There is not one healthcare agency that is not being paid to promote certain drugs; hospitals, nursing homes, physicians.

      This is so true….I discovered by chance that my wheel chair bound mother was
      being used for trials at her “great “nursing home and it’s far better than most!….because she’s receiving subsidies to be there I couldn’t do much but bark my head off ..and that has proved effective. In this case I was told the state requires them to do such testing …I believe the state gets the $$ from the drug companies and the home needs the money from the state etc.. Calling Dr. Mengele…code blue. Everything rides on a wave of money in the health care industry. If you have family in nursing homes, they must be visited regularly even if they themselves are out to lunch. They have to be seen as having interested family around to have a chance

    • Sima says:

      Sometimes, lately, I feel overwhelmed with all the heartache, pain and suffering caused by greed for a great percentage of the world population.

      This is exactly how I’ve been feeling lately. I’m so sorry to hear you are feeling this way as well, it’s very, very depressing.

  10. Seriously says:

    God, the idea of these companies preying on the desperation of sick people and the parents of sick children to use them as guinea pigs is truly horrifying. As is how hard they’d fight to make sure they get no access to the drug if it actually proved effective. Thanks for bringing this to our attention.

  11. janicen says:

    My daughter was recently almost killed by a widely prescribed Rx drug. In her case, it was one of the generics that caused the problem. One very troubling thing I learned from the whole experience is that healthcare providers are NOT required to report serious drug side effects to the FDA. That responsibility falls to the consumers. How is that a valid way to gather data? I’m not a scientist, what is the FDA going to do with my opinion on a scientific matter? As far as getting medical personnel to back up our claim, it’s not so easy. The doctors and nurses who felt the drug was at fault either blurted their opinions out and then quickly back-peddled, or were so vague as to be useless to quote.

    If there are any defenders of generic drugs out there, please spare me the mumbo jumbo about bio-equivalency. The FDA requires bio-equivalency as far as the formulas of the generics, but the FDA has no oversight of the manufacturing of generic drugs because the manufacturing goes on all over the world and then the drugs are imported here.

    My daughter was required to take a six month course of the blood thinner Coumadin after her hospitalization. If you know anything about Coumadin, you know that managing the level of the drug in the bloodstream is crucial. The patient has to have her blood tested every couple of days initially, and then once a week for a long period of time to make sure the levels are stable. Either too much or too little in the bloodstream can be very serious. What I found most telling is that the doctors recommended that she NOT take the generic form of Coumadin because the levels of the active ingredient in the drug can vary widely in the generic forms of the medication. If that is true of Coumadin, then is it not logical that it’s true of any other generic drug? And isn’t that something people should be aware of because it might cause serious side-effects? Whenever I ask that question of doctors, I get a whole lot of mumbo jumbo again.

    • NW Luna says:

      Well first, coumadin/warfarin is a potentially deadly drug. It needs to be monitored so frequently because there is only a small safety range.

      Generics do have to meet certain criteria and have a tight range allowed for differences from the brand name drug. For that matter, brand name drugs have to meet criteria as to % difference from labeled strength. If a brand name drug is risky, the generic of it will be also.

      For coumadin or warfarin, one checks the INR and doses to the appropriate range of the INR. However, so many things interact with warfarin — eating lots of leafy green vegetables, for example. So providers need to counsel thoroughly and test frequently. I was taught to never Rx coumadin/warfarin unless the patient could be managed by an anti-coagulant clinic with the appropriate personnel and time.

      I am sorry that your daughter went through all that, janicen.

      • janicen says:

        Thank you for your kind words. I understand, from first-hand experience, all of the intricacies of taking Coumadin. I’m sure my daughter’s doctors did as well. The point I was trying to make, although perhaps I was unclear, is that the doctors (two, in fact) specifically said that the level of anti-coagulants in the pills can vary widely in the generics. They both said that Warfarin made by one generic manufacturer can have different levels of anticoagulants than Warfarin from another one, and there can be variations from one batch to another. Both doctors specifically ordered that my daughter not take the generics, and it had nothing to do with the vegetables she ate. She was very well advised by the nutritionist in the hospital about what she could eat while taking Coumadin.