"In a time of universal deceit telling the truth is a revolutionary act." -George Orwell

Posts Tagged ‘Big Pharma’

So Young and So Many Pills: Over 25% Of Kids And Teens In The U.S. Take Prescriptions Drugs On A Regular Basis

In Uncategorized on December 29, 2010 at 12:43 pm

Oldspeak:” A vastly expanded and globalized pharmaceutical industry always requires new test subjects- err.. I mean “customers” to sell their “medicine” to. And they’re getting younger and younger. 8 year olds on blood pressure meds. 4 year olds on powerful anti-psychotics. Our children are part of the largest uncontrolled experiment in history. No one really knows the long term health effects of exposing still developing brains to questionably tested drugs that alter brain chemistry. Never mind the psychological effects of socializing the use of pharmaceutical “cures” and unnatural response to illness, rather than dealing with the unseen societal conditions that cause them.”

From Anna Wilde Mathews @ The Wall Street Journal:

Gage Martindale, who is 8 years old, has been taking a blood-pressure drug since he was a toddler. “I want to be healthy, and I don’t want things in my heart to go wrong,” he says.

And, of course, his mom is always there to check Gage’s blood pressure regularly with a home monitor, and to make sure the second-grader doesn’t skip a dose of his once-a-day enalapril.



These days, the medicine cabinet is truly a family affair. More than a quarter of U.S. kids and teens are taking a medication on a chronic basis, according to Medco Health Solutions Inc., the biggest U.S. pharmacy-benefit manager with around 65 million members. Nearly 7% are on two or more such drugs, based on the company’s database figures for 2009.

Doctors and parents warn that prescribing medications to children can be problematic. There is limited research available about many drugs’ effects in kids. And health-care providers and families need to be vigilant to assess the medicines’ impact, both intended and not. Although the effects of some medications, like cholesterol-lowering statins, have been extensively researched in adults, the consequences of using such drugs for the bulk of a patient’s lifespan are little understood.

Many medications kids take on a regular basis are well known, including treatments for asthma and attention-deficit hyperactivity disorder.

But children and teens are also taking a wide variety of other medications once considered only to be for adults, from statins to diabetes pills and sleep drugs, according to figures provided to The Wall Street Journal by IMS Health, a research firm. Prescriptions for antihypertensives in people age 19 and younger could hit 5.5 million this year if the trend though September continues, according to IMS. That would be up 17% from 2007, the earliest year available.

Researchers attribute the wide usage in part to doctors and parents becoming more aware of drugs as an option for kids. Unhealthy diets and lack of exercise among children, which lead to too much weight gain and obesity, also fuel the use of some treatments, such as those for hypertension. And some conditions are likely caught and treated earlier as screening and diagnosis efforts improve.

Gage, who isn’t overweight, has been on hypertension drugs since he had surgery to fix a heart defect as a toddler, says his mother, Stefanie Martindale, a Conway, Ark., marketing-company manager.

Most medications that could be prescribed to children on a chronic basis haven’t been tested specifically in kids, says Danny Benjamin, a Duke University pediatrics professor. And older drugs rarely get examined, since pharmaceutical firms have little incentive to test medicines once they are no longer under patent protection.

Still, a growing number of studies have been done under a Food and Drug Administration program that rewards drug companies for testing medications in children. In more than a third of these studies, there have been surprising side effects, or results that suggested a smaller or larger dose was needed than had been expected, Dr. Benjamin says. Those findings underscore that children’s reactions to medicines can be very different than those of adults. Long-term effects of drugs in kids are almost never known, since pediatric studies, like those in adults, tend to be relatively short.

“We know we’re making errors in dosing and safety,” says Dr. Benjamin, who is leading a new National Institutes of Health initiative to study drugs in children. He suggests that parents should do as much research as they can to understand the evidence for the medicine, confirm the diagnosis, and identify side effects. Among the places to check: drug labels and other resources on the FDA’s website, published research at www.pubmed.gov, and clinical guidelines from groups like the American Academy of Pediatrics.

When a child psychiatrist diagnosed their then 8-year-old daughter with bipolar disorder four years ago, Ken and Joy Lewis, of Chapel Hill, N.C., sought a second opinion from another child psychiatrist.

They also worked with a psychologist. Dr. Lewis, who leads a company that does early-stage drug studies, reads all the available research on each medication suggested for the girl, now 12, who has taken antipsychotics and other psychiatric medications including Risperdal and Haldol.

“If your child has a chronic problem, then you have to invest the time as a parent,” he says.

Parents and doctors also say nondrug alternatives should be explored where possible. Tom Wells, a professor of pediatrics at the University of Arkansas for Medical Sciences who sees patients at Arkansas Children’s Hospital in Little Rock, frequently pushes diet and exercise changes before drugs for hypertensive kids. “Obesity is really the biggest cause I see for high blood pressure in adolescents,” he says. But only about 10% of families adhere to his diet and exercise recommendations, he says.

Beverly Pizzano, a psychologist who lives in Palm Harbor, Fla., spent years struggling with behavioral therapies for her son Steven, 10, who showed symptoms of ADHD at a young age. She worked with a counselor on a system of rewards for good behavior, and even had a research team watch him and suggest interventions. But she turned to medications after he struggled in kindergarten. “We tried everything before I would get to that,” she says.

After a drug is prescribed, children must be closely monitored, doctors say. They may not recognize or communicate a possible side effect, or whether their symptoms are improving. They also don’t always follow prescription instructions.

Robert Lemanske, a professor at the University of Wisconsin in Madison, says patients at his pediatric asthma clinic are checked regularly for side effects such as slowed rates of growth. He quizzes parents and young patients on details like where they keep their inhalers to make sure they’re taking their prescribed medicine.

Nichole Ramsey, a preschool teacher whose 9-year-old son Antwone is a patient at the clinic, watches her son’s basketball practices so she can head off any wheezing or other symptoms. She also makes sure she’s around when he gets his regular Advair dose. If Antwone stays at a friend’s house overnight, she asks the parents to watch that he takes steps like rinsing out his mouth to avoid a fungal infection that can be a side effect of the inhaled drug.

“You’re still the best monitor of what’s going on with them,” she says of a parent’s role.

Ms. Ramsey is particularly concerned about Advair, which has been tied to rare instances of asthma-related death, but says it works better than a previous drug he was using. Before he started the medications, Antwone was hospitalized several times for asthma attacks.

As children’s bodies change and grow, they often need different drugs or doses, says Greg Kearns, chairman of medical research at Children’s Mercy Hospital in Kansas City, Mo.

Jennifer Flory, a homemaker in Baldwin City, Kan., says that after her daughter Cassandra, now 16, started taking a higher dose of the asthma drug Singulair a few years ago, she became more moody and sad. Ms. Flory didn’t connect the change to the drug, but when she eventually mentioned it to a nurse practitioner at the girl’s asthma clinic, the nurse suggested stopping Singulair, which currently has a precaution in its label about possible psychiatric side effects. Cassandra, who continued taking Advair, became far more cheerful and didn’t have any increase in asthma symptoms, Ms. Flory says.

A spokesman for Merck & Co., which makes Singulair, said in a statement that the company is “confident in the efficacy and safety of Singulair,” which is “an important treatment option for appropriate patients.”

Write to Anna Wilde Mathews at anna.mathews@wsj.com

Over Half a Million U.S. Kids Per Year Suffer Health Reactions From Prescription Drugs

From David Gutierez @ Food Matters:

More than half a million children suffer adverse reactions every year in the United States from prescription drugs, according to a study conducted by researchers from the Children’s Hospital in Boston and published in the journal Pediatrics.

The researchers examined data on emergency room and clinic visits between the years of 1995 and 2005 by children under the age of 18. The average number of children receiving treatment for adverse prescription drug effects each year in that time period was 585,922. The number fluctuated very little from year to year.

Adverse drug events included accidental overdoses, side effects and wrong prescriptions.

Prior research has found that another half million children suffer adverse prescription drug reactions every year while in hospitals, bringing the total annual number of adverse drug effects in children up to more than one million. These numbers do not include negative reactions to over-the-counter drugs.

Researchers in the current study uncovered no reports of deaths caused by adverse drug reactions, but 5 percent of children did require hospitalization. Forty-three percent of the adverse reactions occurred in children under the age of five, with another 23 percent occurring in those between the ages of 15 and 18.

The most common causes of adverse effects in young children were prescription antibiotics. Some of the more common side effects were diarrhea, rash and stomach ache. Birth control pills were a common cause of side effects in teenagers, producing problems such as nausea, vomiting and disrupted menstrual cycles.

Drugs for depression and cancer were also significant causes of negative reactions.

According to lead author Florence Bourgeois, doctors need to inform parents of the possible side effects of any drugs children are given. Parents should watch their children especially carefully when a new drug is taken, she said, because “first-time medication exposures may reveal an allergic reaction.”


Deadly Medicine

In Uncategorized on December 20, 2010 at 11:27 am

Oldspeak: “The fruits of privatized, profit-driven medicine: Prescription drugs kill 300% more Americans than illegal drugs. Hundreds of thousands of dead Americans a year. Exported human experimentation on sick Russians, homeless Poles, slum-dwelling Chinese and desperately poor Africans, usually without their consent and lax industry created safety protocols, where the FDA has no ability to regulate. Big Pharma has become the biggest defrauder of the U.S. Gov’t. But pot is illegal. Why are prescription and far more deadly drugs subsidized, while natural ones are stigmatized, criminalized and banned?

From Donald J. Barlett & James B. Steele @ Vanity Fair:


You wouldn’t think the cities had much in common. Iaşi, with a population of 320,000, lies in the Moldavian region of Romania. Mégrine is a town of 24,000 in northern Tunisia, on the Mediterranean Sea. Tartu, Estonia, with a population of 100,000, is the oldest city in the Baltic States; it is sometimes called “the Athens on the Emajõgi.” Shenyang, in northeastern China, is a major industrial center and transportation hub with a population of 7.2 million.

These places are not on anyone’s Top 10 list of travel destinations. But the advance scouts of the pharmaceutical industry have visited all of them, and scores of similar cities and towns, large and small, in far-flung corners of the planet. They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans. It’s the next big step in globalization, and there’s good reason to wish that it weren’t.

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.

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do. They note that the prevailing diseases in other countries, such as malaria and tuberculosis, can skew the outcome of clinical trials. But from the point of view of the drug companies, it’s easy to see why moving clinical trials overseas is so appealing. For one thing, it’s cheaper to run trials in places where the local population survives on only a few dollars a day. It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment. And it’s easier to find what the industry calls “drug-naïve” patients: people who are not being treated for any disease and are not currently taking any drugs, and indeed may never have taken any—the sort of people who will almost certainly yield better test results. (For some subjects overseas, participation in a clinical trial may be their first significant exposure to a doctor.) Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. Ethical concerns are a figure of speech. Finally—a significant plus for the drug companies—the F.D.A. does so little monitoring that the companies can pretty much do and say what they want.

Consent by Thumbprint

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.

The Celebrex story does not have a happy ending. First, it was disclosed that patients taking the drug were more likely to suffer heart attacks and strokes than those who took older and cheaper painkillers. Then it was alleged that Pfizer had suppressed a study calling attention to these very problems. (The company denied that the study was undisclosed and insisted that it “acted responsibly in sharing this information in a timely manner with the F.D.A.”) Soon afterward the Journal of the Royal Society of Medicine reported an array of additional negative findings. Meanwhile, Pfizer was promoting Celebrex for use with Alzheimer’s patients, holding out the possibility that the drug would slow the progression of dementia. It didn’t. Sales of Celebrex reached $3.3 billion in 2004, and then began to quickly drop.

“Rescue Countries”

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.” Rescue countries came to the aid of Ketek, the first of a new generation of widely heralded antibiotics to treat respiratory-tract infections. Ketek was developed in the 1990s by Aventis Pharmaceuticals, now Sanofi-Aventis. In 2004—on April Fools’ Day, as it happens—the F.D.A. certified Ketek as safe and effective. The F.D.A.’s decision was based heavily on the results of studies in Hungary, Morocco, Tunisia, and Turkey.

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.

As the months ticked by, and the number of people taking the drug climbed steadily, the F.D.A. began to get reports of adverse reactions, including serious liver damage that sometimes led to death. The F.D.A.’s leadership remained steadfast in its support of the drug, but criticism by the agency’s own researchers eventually leaked out (a very rare occurrence in this close-knit, buttoned-up world). The critics were especially concerned about an ongoing trial in which 4,000 infants and children, some as young as six months, were recruited in more than a dozen countries for an experiment to assess Ketek’s effectiveness in treating ear infections and tonsillitis. The trial had been sanctioned over the objections of the F.D.A.’s own reviewers. One of them argued that the trial never should have been allowed to take place—that it was “inappropriate and unethical because it exposed children to harm without evidence of benefits.” In 2006, after inquiries from Congress, the F.D.A. asked Sanofi-Aventis to halt the trial. Less than a year later, one day before the start of a congressional hearing on the F.D.A.’s approval of the drug, the agency suddenly slapped a so-called black-box warning on the label of Ketek, restricting its use. (A black-box warning is the most serious step the F.D.A. can take short of removing a drug from the market.) By then the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths.

During the congressional hearings, lawmakers heard from former F.D.A. scientists who had criticized their agency’s oversight of the Ketek trials and the drug-approval process. One was Dr. David Ross, who had been the F.D.A.’s chief reviewer of new drugs for 10 years, and was now the national director of clinical public-health programs for the U.S. Department of Veterans Affairs. When he explained his objections, he offered a litany of reasons that could be applied to any number of other drugs: “Because F.D.A. broke its own rules and allowed Ketek on the market. Because dozens of patients have died or suffered needlessly. Because F.D.A. allowed Ketek’s maker to experiment with it on children over reviewers’ protests. Because F.D.A. ignored warnings about fraud. And because F.D.A. used data it knew were false to reassure the public about Ketek’s safety.”

Trials and Error

To have an effective regulatory system you need a clear chain of command—you need to know who is responsible to whom, all the way up and down the line. There is no effective chain of command in modern American drug testing. Around the time that drugmakers began shifting clinical trials abroad, in the 1990s, they also began to contract out all phases of development and testing, putting them in the hands of for-profit companies. It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas. They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.

What began as a mom-and-pop operation has grown into a vast army of formal “contract-research organizations” that generate annual revenue of $20 billion. They can be found conducting trials in every part of the world. By far the largest is Quintiles Transnational, based in Durham, North Carolina. It offers the services of 23,000 employees in 60 countries, and claims that it has “helped develop or commercialize all of the top 30 best-selling drugs.”

Quintiles is privately owned—its investors include two of the U.S.’s top private-equity firms. Other private contractors are public companies, their stock traded on Wall Street. Pharmaceutical Product Development (P.P.D.), a full-service medical contractor based in Wilmington, North Carolina, is a public company with 10,500 employees. It, too, has conducted clinical trials all around the world. In fact, it was involved in the clinical trials for Ketek—a P.P.D. research associate, Ann Marie Cisneros, had been assigned to monitor Dr. Anne Kirkman-Campbell’s testing in Alabama. Cisneros later told the congressional investigating committee that Kirkman-Campbell had indeed engaged in fraud. “But what the court that sentenced her did not know,” Cisneros said, was that “Aventis was not a victim of this fraud.” Cisneros said she had reported her findings of fraud to her employer, P.P.D., and also to Aventis. She told the congressional committee, “What brings me here today is my disbelief at Aventis’s statements that it did not know that fraud was being committed. Mr. Chairman, I knew it, P.P.D. knew it, and Aventis knew it.” Following her testimony the company released a statement saying it regretted the violations that occurred during the study but was not aware of the fraud until after the data was submitted to the F.D.A.

The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. (ProPublica, an independent, nonprofit news organization that is compiling an ongoing catalogue of pharmaceutical-company payments to physicians, has identified 17,000 doctors who have collected speaking and consulting fees, including nearly 400 who have received $100,000 or more since 2009.) Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.

Because of the deference shown to drug companies by the F.D.A.—and also by Congress, which has failed to impose any meaningful regulation—there is no mandatory public record of the results of drug trials conducted in foreign countries. Nor is there any mandatory public oversight of ongoing trials. If one company were to test an experimental drug that killed more patients than it helped, and kept the results secret, another company might unknowingly repeat the same experiment years later, with the same results. Data is made available to the public on a purely voluntary basis. Its accuracy is unknown. The oversight that does exist often is shot through with the kinds of ethical conflicts that Wall Street would admire. The economic incentives for doctors in poor countries to heed the wishes of the drug companies are immense. An executive at a contract-research organization told the anthropologist Adriana Petryna, author of the book When Experiments Travel: “In Russia, a doctor makes two hundred dollars a month, and he is going to make five thousand dollars per Alzheimer’s patient” that he signs up. Even when the most flagrant conflicts are disclosed, penalties are minimal. In truth, the same situation exists in the United States. There’s just more of a chance here, though not a very large one, that adverse outcomes and tainted data will become public. When the pharmaceutical industry insists that its drugs have been tested overseas in accordance with F.D.A. standards, this may be true—but should provide little assurance.

The F.D.A. gets its information on foreign trials almost entirely from the companies themselves. It conducts little or no independent research. The investigators contracted by the pharmaceutical companies to manage clinical trials are left pretty much on their own. In 2008 the F.D.A. inspected just 1.9 percent of trial sites inside the United States to ensure that they were complying with basic standards. Outside the country, it inspected even fewer trial sites—seven-tenths of 1 percent. In 2008, the F.D.A. visited only 45 of the 6,485 locations where foreign drug trials were being conducted.

The pharmaceutical industry dismisses concerns about the reliability of clinical trials conducted in developing countries, but the potential dangers were driven home to Canadian researchers in 2007. While reviewing data from a clinical trial in Iran for a new heart drug, they discovered that many of the results were fraudulent. “It was bad, so bad we thought the data was not salvageable,” Dr. Gordon Guyatt, part of the research group at McMaster University in Hamilton, told Canada’s National Post.

In addition to monitoring trials abroad, which it does not really do, the F.D.A. is responsible for inspecting drug-manufacturing plants in other countries, which it also does not really do. In 2007 and 2008, hundreds of patients taking the blood thinner heparin, which among other purposes is used to prevent blood clots during surgery and dialysis, developed serious allergic reactions as a result of a contaminant introduced at a Chinese manufacturing facility. It took months for the F.D.A., its Chinese counterpart, and Baxter International, the pharmaceutical company that distributed the drug, to track the source of contamination to Changzhou, a city of 3.5 million on the Yangtze River.

The delay was perhaps understandable, given the manufacturing process. The raw material for Baxter’s heparin comes from China’s many small pig farms. To be precise, it’s derived from the mucous membranes of the intestines of slaughtered pigs; the membranes are mixed together and cooked, often in unregulated family workplaces. By the time the source of the contaminant was pinpointed, many more patients in the United States had experienced severe reactions, and as many as 200 had died. It later turned out that the F.D.A. had indeed inspected a Chinese plant—but it was the wrong one. The federal regulators had confused the names.

The good news was that, in this instance, the F.D.A. at least knew which country the heparin had come from. The bad news is that it does not always know where clinical trials are being conducted, or even the names or types of drugs being tested, or the purpose for which they will be prescribed once approved. Companies may withhold the foreign test data until they actually submit the application to the F.D.A. for approval. By then the agency has lost the ability to see whether the trials were managed according to acceptable standards, and whether the data collected was manipulated or fabricated.

$350 per Child

If the globalization of clinical trials for adult medications has drawn little attention, foreign trials for children’s drugs have attracted even less. The Argentinean province of Santiago del Estero, with a population of nearly a million, is one of the country’s poorest. In 2008 seven babies participating in drug testing in the province suffered what the U.S. clinical-trials community refers to as “an adverse event”: they died. The deaths occurred as the children took part in a medical trial to test the safety of a new vaccine, Synflorix, to prevent pneumonia, ear infections, and other pneumococcal diseases. Developed by GlaxoSmithKline, the world’s fourth-largest pharmaceutical company in terms of global prescription-drug sales, the new vaccine was intended to compete against an existing vaccine. In all, at least 14 infants enrolled in clinical trials for the drug died during the testing. Their parents, some illiterate, had their children signed up without understanding that they were taking part in an experiment. Local doctors who persuaded parents to enroll their babies in the trial reportedly received $350 per child. The two lead investigators contracted by Glaxo were fined by the Argentinean government. So was Glaxo, though the company maintained that the mortality rate of the children “did not exceed the rate in the regions and countries participating in the study.” No independent group conducted an investigation or performed autopsies. As it happens, the brother of the lead investigator in Santiago del Estero was the Argentinean provincial health minister.

In New Delhi, 49 babies died at the All India Institute of Medical Sciences while taking part in clinical trials over a 30-month period. They were given a variety of new drugs to treat everything from high blood pressure to chronic focal encephalitis, a brain inflammation that causes epileptic seizures and other neurological problems. The blood-pressure drugs had never before been given to anyone under 18. The editor of an Indian medical journal said it was obvious that the trials were intended to extend patent life in Western countries “with no consequence or benefit for India, using Indian children as guinea pigs.” In all, 4,142 children were enrolled in the studies, two-thirds of them less than one year old. But the head of the pediatrics department at the All India Institute maintained that “none of the deaths was due to the medication or interventions used in clinical trials.”

For years, American physicians gave anti-psychotic medicines to children “off label,” meaning that they wrote prescriptions based on testing for adults, sometimes even for different conditions. That didn’t work out so well for the children, who, when it comes to medicine, really are not just little adults. To provide the pharmaceutical industry with an incentive to conduct clinical trials on children’s versions of adult drugs, Congress in 1997 enacted legislation, known as the Pediatric Exclusivity Provision, extending the patent life of certain drugs by six months. It worked so well that the industry has, in the ensuing years, been able to put younger and younger children on more and more drugs, pocketing an extra $14 billion. Between 1999 and 2007, for instance, the use of anti-psychotic medications on children between the ages of two and five more than doubled.

A study of 174 trials under the Pediatric Exclusivity Provision found that 9 percent of them did not report the location or number of sites of the clinical trials. Of those that did, two-thirds had been conducted in at least one country outside the United States, and 11 percent were conducted entirely outside the United States. Of the 79 trials with more than 100 subjects participating, 87 percent enrolled patients outside the United States. As is the case with adult studies, many children’s trials conducted abroad are neither reported nor catalogued on any publicly accessible government database. There is no public record of their existence or their results.

In the mid-90s, Glaxo conducted clinical trials on the antidepressant Paxil in the United States, Europe, and South America. Paxil is a member of a class of drugs called selective serotonin re-uptake inhibitors. The class includes Zoloft, Prozac, and Lexapro. In the United Kingdom, Paxil is sold as Seroxat. The clinical trials showed that the drug had no beneficial effect on adolescents; some of the trials indicated that the placebo was more effective than the drug itself. But Glaxo neglected to share this information with consumers; annual sales of the drug had reached $5 billion in 2003. In an internal document obtained by the Canadian Medical Association Journal, the company emphasized how important it was to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” The memo went on to warn that “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.” After the document was released a Glaxo spokesperson said that the “memo draws an inappropriate conclusion and is not consistent with the facts.”

“Smoke and Mirrors”

It may be just a coincidence, but as controversy swirls around new drugs, and as the F.D.A. continues to slap medicines with new warning labels—especially the black-box warnings that indicate the most serious potential reactions—most of the problematic drugs have all undergone testing outside the United States. Clinical-trial representatives working for GlaxoSmithKline went to Iaşi, Romania, to test Avandia, a diabetes drug, on the local population. Glaxo representatives also showed up in other cities in Romania—Bucureşti, Cluj-Napoca, Craiova, and Timişoara—as well as multiple cities in Latvia, Ukraine, Slovakia, the Russian Federation, Poland, Hungary, Lithuania, Estonia, the Czech Republic, Bulgaria, Croatia, Greece, Belgium, the Netherlands, Germany, France, and the United Kingdom. That was for the largest of the Avandia clinical trials. But there have been scores of others, all seeking to prove that the drug is safe and effective. Some took place before the drug was approved by the F.D.A. Others were “post-marketing” studies, done after the fact, as the company cast about for ways to come up with more positive results so it could expand Avandia’s use for other treatments. Based on the initial evaluations, Avandia was expected to—and did—become another Glaxo multi-billion-dollar best-seller.

While sales soared, so, too, did reports of adverse reactions—everything from macular edema to liver injury, from bone fractures to congestive heart failure. In 2009 the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit group that monitors the prescription-drug field, linked the deaths of 1,354 people to Avandia, based on reports filed with the F.D.A. Studies also concluded that people taking the drug had an increased risk of developing heart disease, one of the very conditions that doctors treating diabetics hope to forestall. The risk was so high that worried doctors inside and outside the F.D.A. sought to have the drug removed from the market, an incredibly difficult task no matter how problematic the medicine. As always, the F.D.A. was late to the party. In 2008 the American Diabetes Association and the European Association for the Study of Diabetes had warned against using Avandia. The Saudi Arabian drug-regulatory agency yanked it from the market, and the Indian government asked Glaxo to halt 19 of its Avandia trials in that country. In September 2010 the European Medicines Agency pulled Avandia from the shelves all across Europe. The F.D.A. still could not bring itself to take decisive action. This even though the F.D.A. knew that Glaxo had withheld critical safety information concerning the increased risk of heart attacks, and the F.D.A. itself had estimated that the drug had caused more than 83,000 heart attacks between 1999 and 2007. The agency settled for imposing new restrictions on the availability of the drug in the United States. Glaxo released a statement saying that it “continues to believe that Avandia is an important treatment for patients with type 2 diabetes,” but that it would “voluntarily cease promotion of Avandia in all the countries in which it operates.”

The Avandia case and others like it have prompted the U.S. Justice Department to mount an investigation under the Foreign Corrupt Practices Act. While it is legal for doctors in this country to accept money from drug companies for acting as consultants, this is not the case abroad, where doctors often are government employees, and such payments can be considered bribes. There are other legal issues. So far, Glaxo has paid out more than $1 billion to settle lawsuits arising from claims against Avandia and other drugs. The Senate Finance Committee calculates that, since May 2004, seven drug companies have paid out more than $7 billion in fines and penalties stemming from unlawful drug dealings. Pfizer paid the largest such fine in history—$2.3 billion for promoting off-label uses of the arthritis drug Bextra.

In theory, pharmaceutical companies are barred from selling a drug for any purpose other than the one that the F.D.A. has approved on the basis of clinical testing. But the reality is different. The minute a drug receives the green light from the F.D.A. for a specific treatment, the sponsoring company and its allies begin campaigns to make it available for other purposes or for other types of patients. The antidepressant Paxil was tested on adults but sold off-label to treat children. Seroquel, an anti-psychotic, was marketed as a treatment for depression. Physicians, often on retainer from pharmaceutical companies, are free to prescribe a drug for any reason if they entertain a belief that it will work. This practice turns the population at large into unwitting guinea pigs whose adverse reactions may go unreported or even unrecognized.

To secure the F.D.A.’s approval for Seroquel, which ultimately would go to treat schizophrenia, bipolar disorders, and manic episodes associated with bipolar disorder, AstraZeneca, the fifth-largest pharmaceutical company, conducted clinical trials across Asia, Europe, and the United States. Among the sites: Shenyang and more than a dozen other cities in China, and multiple cities in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Croatia, Indonesia, Malaysia, Poland, the Russian Federation, Serbia, Ukraine, and Taiwan. The F.D.A. initially approved the drug for the treatment of schizophrenia. But while schizophrenia may have opened the door, off-label sales opened the cash register. Money poured in by the billions as AstraZeneca promoted the drug for the treatment of any number of other conditions. It was prescribed for children with autism-spectrum disorders and retardation as well as for elderly Alzheimer’s patients in nursing homes. The company touted the drug for treatment of aggression, anxiety, anger-management issues, attention-deficit hyperactivity disorder, dementia, and sleeplessness. Up to 70 percent of the prescriptions for Seroquel were written for a purpose other than the one for which it had been approved, and sales rose to more than $4 billion a year.

It turned out, however, that AstraZeneca had been less than candid about the drug’s side effects. One of the most troubling: patients often gained weight and developed diabetes. This meant a new round of drugs to treat conditions caused by Seroquel. In an internal e-mail from 1997 discussing a study comparing Seroquel with an older anti-psychotic drug, Haldol, a company executive praised the work of the project physician, saying she had done a great “smoke-and-mirrors job,” which “should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.” After the e-mail was disclosed, in February 2009, the company said that the document cannot “obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed” the drug. In April, AstraZeneca reached a half-billion-dollar settlement with the federal government over its marketing of Seroquel. The U.S. attorney in Philadelphia, where the settlement was filed, declared that the company had “turned patients into guinea pigs in an unsupervised drug test.” Meanwhile, the company was facing more than 25,000 product-liability lawsuits filed by people who contended the drug had caused their diabetes.

Death Toll

The only people who seem to care about the surge of clinical trials in foreign countries are the medical ethicists—not historically a powerhouse when it comes to battling the drug companies. A team of physician-researchers from Duke University, writing last year in the New England Journal of Medicine, observed that “this phenomenon raises important questions about the economics and ethics of clinical research and the translation of trial results to clinical practice: Who benefits from the globalization of clinical trials? What is the potential for exploitation of research subjects? Are trial results accurate and valid, and can they be extrapolated to other settings?” The Duke team noted that, in some places, “financial compensation for research participation may exceed participants’ annual wages, and participation in a clinical trial may provide the only access to care” for those taking part in the trial. In 2007, residents of a homeless shelter in Grudziadz, Poland, received as little as $2 to take part in a flu-vaccine experiment. The subjects thought they were getting a regular flu shot. They were not. At least 20 of them died. The same distorting economic pressures exist for local hospitals or doctors, who may collect hundreds of dollars for every patient they enroll. In theory, a federal institutional review board is supposed to assess every clinical trial, with special concern for the welfare of the human subjects, but this work, too, has now been outsourced to private companies and is often useless. In 2009 the Government Accountability Office conducted a sting operation, winning approval for a clinical trial involving human subjects; the institutional review board failed to discover (if it even tried) that it was dealing with “a bogus company with falsified credentials” and a fake medical device. This was in Los Angeles. If that is oversight in the U.S., imagine what it’s like in Kazakhstan or Uganda. Susan Reverby, the Wellesley historian who uncovered the U.S. government’s syphilis experiments in Guatemala during the 1940s, was asked in a recent interview to cite any ongoing experimental practices that gave her pause. “Frankly,” she said, “I am mostly worried about the drug trials that get done elsewhere now, which we have little control over.”

The pharmaceutical industry, needless to say, has a different view. It argues that people participating in a clinical trial may be getting the highest quality of medical care they have ever received. That may be true in the short term. But, unfortunately, the care lasts only until the trial is completed. 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.

In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. So far, these deaths have triggered no medical crusades, no tough new regulations. After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions.

And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.

15 Dangerous Drugs Big Pharma Shoves Down Our Throats

In Uncategorized on November 30, 2010 at 2:00 pm

Oldspeak: Ambien, Lipitor, Crestor, Chantix, Yaz, Yasmin, Lyrica, Topomax, Lamictal, Humira, Prolia, Tamoxifen, Boniva, Prempro and Premarin: If you or anyone you know is on these “medicines” Rethink using them. They cause more illness than they “cure”. In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. Long studies to truly assess a drug’s risks just delay profits after all — and if problems do emerge after medication hits the market, settlements are usually less than profits. Remember, Vioxx still made money.”

From Martha Rosenberg @ Alter Net:

The following drugs are so plagued with safety problems, it is a wonder they’re on the market at all.It’s a testament to Big Pharma’s greed and our poor regulatory processes that they are.

— Lipitor and Crestor

Why is Lipitor the bestselling drug in the world? Because every adult with high LDL or fear of high LDL is on it. (And also 2.8 million children, says Consumer Reports.) No one is going to say statins don’t prevent heart attack in high-risk patients (though diet and exercise have worked in high-risk groups too). But doctors will say statins are so over-prescribed that more patients get their side effects — weakness, dizziness, pain and arthritis — than heart attack prevention. Worse, they think it’s old age!

“My older patients literally do without food so that they can buy these medicines that make them sicker, feel bad, and do nothing to improve life,” says an ophthalmologist web poster from Tennessee. “There is no scientific basis for treating older folks with $300+/month meds that have serious side-effects and largely unknown multiple drug interactions.” What kinds of side effects? All statins can cause muscle breakdown (called rhabdomyolysis) but combining them with antibiotics, protease inhibitors drugs and anti-fungals increases your risks. In fact, Crestor is so highly linked to rhabdomyolysis it is double dissed: Public Citizen calls it a Do Not Use and the FDA’s David Graham named it one of the five most dangerous drugs before Congress.

— Yaz and Yasmin

It sounded too good to be true and it was. Birth control pills that also cleared up acne, treated severe PMS (Premenstrual Dysphoric Disorder or PMDD) and avoided the water retention of traditional birth control pills.

But soon after Bayer launched Yaz in 2006 as going “beyond birth control,” 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. Fifteen-year-old Katie Ketner had her gallbladder removed. Susan Gallenos had a stroke and part of her skull removed. College student Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli from taking Yaz, says her mother Joan Cummins.

While TV ads for Yaz in 2008 were so misleading that FDA ordered Bayer to run correction ads, Yaz sales are still brisk. In fact, financial analysts attribute the third quarter slump in the Yaz “franchise” of 28.1 percent to the appearance of a Yaz generic, not to the thousands of women who have been harmed.

Why is Yaz sometimes deadly? It includes a drug that was never before marketed in the U.S. — drospirenone — and apparently causes elevated potassium, heart problems, and a change in acid balance of the blood. Who knew? But not only is Bayer still marketing it, women do not receive “test subject” compensation for using it either.

— Lyrica, Topomax and Lamictal

Why would Americans take an epilepsy seizure drug for pain? The same reason they’ll take an antipsychotic for the blues and an antidepressant for knee pain: good consumer marketing. In August FDA ordered a warning for aseptic meningitis, or brain inflammation, on Lamictal — but it is still the darling of military and civilian doctors for unapproved pain and migraine. Lamictal also has the distinction of looting $51 million from Medicaid last year despite a generic existing.

All seizure drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels. An April article in JAMA found seizure drugs linked to 26 suicides, 801 attempted suicides, and 41 violent deaths in just five years.

All three drugs can make you lose your memory and your hair, say posters on the drug rating site askapatient.com. Topamax is referred to as “Stupamax” in the military — though evidently not enough to ask, “Why am I taking this drug again?”

— Humira, Prolia and TNF Blockers

If you think pharma is producing a lot of expensive, dangerous injectables lately, you’re right. Yesterday’s blockbuster pills have been supplanted with vaccines and biologics that are more lucrative and safer…from generic competition, that is. The problem is, not only are biologics like Humira and Prolia creepy and dangerous — they’re made from genetically engineered hamster cells and suppress the actual immune system — the diseases they treat are “sold” to healthy people.

Recently, thousands of college students in Chicago found inserts in their campus newspapers hawking Humira for Crohn’s disease, rheumatoid arthritis and psoriatic arthritis. (“Hate psoriasis? Love clearer skin,” says an ad on the Humira Web site featuring a pretty woman.) And earlier this year Prolia was approved by the FDA for postmenopausal osteoporosis with a high risk of fracture. Do healthy people really want to suppress their body’stumor necrosis factor (TNF) and invite tuberculosis, serious, possibly lethal infections, melanoma, lymphoma and “unusual cancers in children and teenagers” as the Humira label warns? Nor is it clear these drugs work. TheHumira label warns against developing “new or worsening” psoriasis — a condition it is supposed to treat.

— Chantix

How unsafe is the antismoking drug Chantix? After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal acts, thoughts or behaviors and 28 suicides, the government banned pilots and air traffic controllers and interstate truck and bus drivers from taking Chantix in 2008. Four months later, some military pharmacies banned the drug, which reduces both cravings and smoking pleasure. In addition to Chantix’ neuropsychiatric effects (immortalized by New Bohemians musician Carter Albrecht, who was shot to death in 2007 in Texas by a neighbor after acting aggressively), Chantix is linked to angioedema, serious skin reactions, visual impairment, accidental injury, dizziness, muscle spasms, seizures and loss of consciousness. In defending an increasingly indefensible drug, Janet Woodcock, director of the FDA Center for Drug Evaluation said last year, “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.” True enough — but if you smoke cigarettes you can still drive an interstate truck.

— Ambien

Sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes according to the National Institutes of Health (NIH).

But Ambien has additional cachet compared to its soporific brethren: it is the drug Tiger Woods reportedly used when cavorting with his consorts; and former U.S. Rep. Patrick Kennedy was taking it when he crashed his Ford Mustang while driving to Capitol Hill in the middle of the night to “vote” in 2006.

In fact Ambien’s legendary somnambulism side effects — people walk, drive, make phone calls and even have sex while sleeping — has increased traffic accidents say law enforcement officials, with some drivers not even recognizing arresting police. Thanks to bad Ambien press, Sanofi-Aventis has had to run ads telling the public to get in bed and stay there if you are going to take Ambien. (Or you’ll break out in handcuffs, as the joke goes.) Ambien has also increased the national weight problem as dieters wake up amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twins.

— Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZenaca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? Both the original safety studies of Tamoxifen, which causes cancer, birth defects and is a chemical cousin of organochlorine pesticides, and its original marketing were riddled with scientific error. In fact, FDA objected to AstraZeneca’s marketing claim of breast cancer prevention and the casting of endometrial cancer as an “uncommon” event 10 years ago.

Yet today pharma-linked doctors still tell women to take Tamoxifen to prevent breast cancer even though an American Journal of Medicine study found the average life expectancy increase is nine days (and Public Citizen says for every case of breast cancer Tamoxifen prevents there is a life-threatening case of blood clots, stroke or endometrial cancer). A Gynecologic and Obstetric Investigation study shows an example of Tamoxifen’s downside: 57.2 percent of women on continuous Tamoxifen developed atrophy of the lining of the uterus, 35.7 coexisting hyperphasia and 8.1 percent uterine polyps. We won’t even talk about eye and memory problems — or the Tamoxifen cousin, Evista, that pharma is also pushing which has a “death from stroke” warning on its label.

 

— Boniva

Why is the bisphosphonate bone drug Boniva available in a convenient, once-monthly formulation? Could patients balk at the fact that after you take it you have to avoid lying down for at least 60 minutes to “help decrease the risk of problems in the esophagus and stomach,” wait at least 60 minutes before eating or drinking anything except water, never take it with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins, and of course, “do not chew or suck”? Nor should you take Boniva, say the warnings, “if you have difficult or painful swallowing, chest pain or continuing or severe heartburn, have low blood calcium or severe kidney disease or if severe bone, joint and/or muscle pain.”

Bone drugs like Boniva, Fosamax and Actonel are a good example of FDA approving once-unapprovable drugs by transferring risk onto the public’s shoulders with “we warned you” labels. The warnings are supposed to make people make their own safety decisions. Except that people just think FDA wouldn’t have approved it if it weren’t safe.

— Prempro and Premarin

You’d think Pfizer’s hormone drugs Prempro and the related Premarin and Provera would be history in light of their perks: 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease, double the rates of blood clots and links to deafness, urinary incontinence, cataracts, gout, joint degeneration, asthma, lupus, scleroderma, dementia, Alzheimer’s disease and lung, ovarian, breast, endometrial, gall bladder and melanoma cancers — pant pant. But you’d be wrong. Even as we speak, Pfizer-linked researchers are testing the cognitive and cardiovascular “benefits” of hormone therapy, in some cases with our tax dollars, at major universities. Even though thecancer rate in the U.S. and Canada fell when women quit hormone therapy in 2002 (as did the U.S. heart attack rate in women), pharma is rolling out HT “Light” for women who suffer from the “ism” of incredibly short memory.

 

Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.


Pfizer: The Pharmaceutical Giant That Makes Bank From “Medicine” That Can Kill You.

In Uncategorized on July 13, 2010 at 1:51 pm

Oldspeak:”To say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia. Profit is Paramount.”

From Martha Rosenberg @ Alter Net:

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the “world’s largest research-based pharmaceutical company” which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?”

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Worse, it bought Warner-Lambert in 2000, which made Neurontin, knowing the drug’s marketing practices were under criminal investigation. (And knowing its Rezulin had been withdrawn.)

And even as it entered into its 2004 CIA for Neurontin, it was off-label marketing the seizure drug Lyrica, called Son of Neurontin, and three other meds, and had to enter into a third CIA, last year’s $2.3 billion Bextra settlement which was the largest health care fraud settlement in US history.

The same day the settlement news broke, Pfizer announced it bought the drug giant Wyeth despite its thicket of Fen-Phen heart valve suits and Prempro cancer suits.

And there was more “bring ’em on” chutzpah.

After Vioxx and Pfizer’s Bextra were withdrawn from the market for cardiovascular risks, Pfizer sought FDA approval for its Celebrex, the last legal COX-2 inhibitor, also suspected of cardiovascular risks, for use in children as young as two.

And in June, days before Pfizer suspended development of the osteoarthritis drug tanezumab for worsening joints, it touted the drug as “well-tolerated.”

As a company, Pfizer, based in New York City with research headquarters in Groton, CT, looks better from the outside than the inside. Its Pac-Man like acquisition of drug companies, Warner-Lambert, Pharmacia (Searle, Upjohn), SUGEN, Vicuron, Rinat and Wyeth (also creating the world’s biggest animal drug company) has created a silo structure in which the company’s 90,000 employees in 90 countries feel unconnected to a corporate heartbeat. Loyalty is rare as employees in absorbed companies bought for their products alone fear getting pfired and 14,000 scientists bemoan that the company’s biggies like Lipitor, Celebrex, Neurontin, Zithromax, Zyrtec and now Wyeth’s Prempro weren’t created inhouse.

Despite flying doctors to Caribbean resorts to attend drug pitches (by other paid doctors) and bestowing four figure honorariums on them, and Enron moments like a Bextra sales extravaganza with acrobats, dancers and gigantic “fist” logo, Pfizer’s Midtown Manhattan offices consist of unimpressive cubes.

After becoming the world’s biggest drug company in 2000, Henry A. McKinnell, former Pfizer CEO and a Bushmate (replaced by less conservative Jeffrey B. Kindler) vowed to make Pfizer the “the world’s most valued company to patients, to customers, to business partners, to colleagues, and to communities where we work and live.” But thanks to the parade of damaging safety and ethics scandals, Esprit de corps is lacking except in some sales units.

“Pfizer is a black hole,” Peter Rost, MD, author of The Whistleblower: Confessions of a Healthcare Hitman and probably Pfizer’s most famous former employee told AlterNet. “It is nothing but a maze of cobbled together drug companies that aggressively markets drugs it didn’t create in a military-like command structure.”

Still, Pfizer’s vast product line, its $50 billion a year revenues — exceeding some states’ entire budgets — and reputation for having the best trained sales reps make it the team to beat for competing salesmen and examples of Pfizer envy dot Cafepharma, the drug industry chatroom considered pharma’s washroom wall.

“Glad they did it,” wrote a poster about last year’s Department of Justice (DOJ) Bextra settlement. “Pfizer is only sticking it to the American person when they perpitrate a fruad (sic) of this magnitude. The rest of you who sat by and said nothing are no better than a bunch of crooks. My father always said, ‘you lie, you cheat, you steal; you can’t do one without doing them all’. You must be so proud…I would take that name badge off when I walk into an office if I were you.”

“If you think that Pfizer is the only drug company that has dealt with off-label promotion issues you are sadley (sic) mistaken,” perpitrated the next poster.

“You are so right. All the other companies are doing it, so we did too. Waaah, waaah, waaaaah! (stomping my foot). It’s not fair! It made us so much money! Patients don’t matter, money does,” wrote the next poster. Characterizations about wives and mothers followed.

Patients also resent Pfizer and have sued over Chantix, Lipitor, Celebrex, Bextra, Neurontin, Lyrica, Viagra, Zoloft and other drugs. Pfizer downplayed Lipitor’s “serious and irreversible side effects” says Mark Jay Krum, an attorney representing plaintiffs in a class-action suit, and “is willing to promote the drug at any cost.” Say that.

Even the DOJ calls Pfizer incorrigible. “…illegal conduct was pervasive throughout the company and stemmed from messages created at high levels within the national marketing team,” it wrote in the Bextra sentencing memo. “Employees, including district managers, explained that they did not question their supervisors about the illegal conduct that they were being instructed to carry out, because to do so would be considered a ‘CLM’ or ‘Career Limiting Move.'”

Still the FDA needs to take some blame for waving iffy Pfizer drugs through, especially under the 1992 Prescription Drug User Fee Act (PDUFA) in which drug companies “buy” accelerated approvals.

Why did the FDA allow Pfizer to make money for ten years on the leukemia drug Mylotarg, which was given an accelerated approval, and allow people to take it as guinea pigs for ten years while “confirmatory” studies establishing its safety and efficacy were still outstanding? Patients who took Mylotarg while on chemotherapy had more deaths than those just on chemotherapy in a clear example of the lethal metrics of rushed through drugs.

Why was Pfizer’s pain drug tanezumab, an injected monoclonal antibody made from bio-engineered immune cells, even considered for knee pain except for the profits in such Frakendrugs?

Why was Pfizer allowed to continue clinical trials on children, or anyone, after the FDA found Geodon overdoses in April — and why is Geodon, rejected once by the FDA and promoted by Richard Borison MD who is in Hancock State Prison for research fraud — hello — on the market? Obama appointees Commissioner Margaret Hamburg, MD and principal deputy commissioner Joshua Sharfstein, MD come from public health backgrounds but it will be hard to turn the FDA ship around.

And speaking of dangerous drugs, what’s up with Pfizer’s anti-smoking drug Chantix?

In 2007, Texas musician Carter Albrecht, who played with Sorta and Edie Brickell & New Bohemians, became a poster boy for Chantix’ unpredictable mental effects when he was fatally shot trying to kick in a neighbor’s door. In 2008, with 988 adverse effects reported including seizures, heart trouble and suicides, the FDA banned airline pilots and air traffic controllers from taking it. Thanks for that. Last year it gave Chantix a black box warning to “highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.”

Most pharma watchers agree that financial penalties, including last year’s $2.3 billion Bextra settlement, won’t upend Pfizer whose one year budget for R & D alone is in the billions. Yet the DOJ repeatedly lets Pfizer pawn off guilty pleas to the False Claims Act (which include a ban on Medicare, Medicaid and VA eligibility) on its shell companies and keep doing business with the government. Why?

“Pfizer is the largest drug company in the world and if you include its generics unit it makes literally hundreds of different drugs. Getting tough would mean no Lipitor, no Viagra, no Bacitracin, no Cipro, no Zithromax, no Sutent, et cetera,” says Jim Edwards, a pharmaceutical reporter on Bnet and former managing editor of Adweek. “The government is not really in a position to be cutting itself off from all that medicine.”

“So many Medicaid, Medicare and VA drugs come from Pfizer, the government would never convict them,” agrees Peter Rost. “It would stop the drug flow.”

And then there’s lobby power.

Just as former Louisiana Republican representative Billy Tauzin left the House Committee on Energy and Commerce which oversees the drug industry and resurfaced as head of PhRMA, Pfizer recently hired Gregory Simon who served on Obama’s transition team and as chief domestic policy advisor to Vice President Gore to head its “global policy effort.” Its senior corporate counsel until 2008, Arnold Friede, had an FDA background and Pfizer’s former senior vice president for worldwide public affairs, Richard Bagger, has re-emerged as New Jersey Governor Christopher Christie’s chief of staff. Hey, you guys look familiar!

Even the Bextra settlement arouses cynicism since $102 million of it went to a doctor and five former Pfizer reps who served as whistleblowers on the case, one getting $51 million.

Isn’t making big money off pharma how the trouble started?

Obama’s Health Care Bill Is Enough To Make You Sick

In Uncategorized on July 12, 2010 at 12:37 pm

Oldspeak:” Until we take the profit motive out of health care we cannot live in the way we want to live. We are still a nation full of health care hostages, we live in fear of losing our health care. Millions of people have lost their health care. We fear bankruptcy. The inability to pay medical bills is the No. 1 cause of bankruptcy. We fear not being able to afford medications. Millions of people skip medications. They skip these medications to the detriment of their health. We are not free. And we won’t be free until health care is a human right, until health care is not tied to a job, because we still have an employment-based system, and until health care has nothing to do with immigration status. We don’t care if you are documented or undocumented. It should not matter what your health care status is, if you have a disease or you don’t. It should not matter how much money you have or don’t, because many of our programs are based on income eligibility rules. Until we abolish the private, for-profit health insurance industry in this county we are not free.  This legislation doesn’t do any of that. It doesn’t change those basic facts of our health care system.”

From Chris Hedges @ Truthdig:

A close reading of the new health care legislation, which will conveniently take effect in 2014 after the next presidential election, is deeply depressing. The legislation not only mocks the lofty promises made by President Barack Obama, exposing most as lies, but sadly reconfirms that our nation is hostage to unchecked corporate greed and abuse. The simple truth, that single-payer nonprofit health care for all Americans would dramatically reduce costs and save lives, that the for-profit health care system is the problem and must be destroyed, is censored out of the public debate by a media that relies on these corporations as major advertisers and sponsors, as well as a morally bankrupt Democratic Party that is as bought off by corporations as the Republicans.

The 2,000-page piece of legislation, according to figures compiled by Physicians for a National Health Plan (PNHP), will leave at least 23 million people without insurance, a figure that translates into an estimated 23,000 unnecessary deaths a year among people who cannot afford care. It will permit prices to climb so that many of us will soon be paying close to 10 percent of our annual income to buy commercial health insurance, although this coverage will only pay for about 70 percent of our medical expenses. Those who become seriously ill, lose their incomes and cannot pay skyrocketing premiums will be denied coverage. And at least $447 billion in taxpayer subsidies will now be handed to insurance firms. We will be forced by law to buy their defective products. There is no check in the new legislation to halt rising health care costs. The elderly can be charged three times the rates provided to the young. Companies with predominantly female work forces can be charged higher gender-based rates. The dizzying array of technical loopholes in the bill—written in by armies of insurance and pharmaceutical lobbyists—means that these companies, which profit off human sickness, suffering and death, can continue their grim game of trading away human life for money.

“They named this legislation the Patient Protection and Affordable Care Act, and as the tradition of this nation goes, any words they put into the name of a piece of legislation means the opposite,” said single-payer activist Dr. Margaret Flowerswhen I heard her and Helen Redmonddissect the legislation in Chicago at the Socialism 2010 Conference last month. “It neither protects patients nor leads to affordable care.”

“This legislation moves us further in the direction of the commodification of health care,” Flowers went on. “It requires people to purchase health insurance. It takes public dollars to subsidize the purchase of that private insurance. It not only forces people to purchase this private product, but uses public dollars and gives them directly to these corporations. In return, there are no caps on premiums. Insurance companies can continue to raise premiums. We estimate that because they are required to cover people with pre-existing conditions, although we will see if this happens, they will argue that they will have to raise premiums.”

The legislation included a few tiny improvements that have been used as bait to sell it to the public. The bill promises, for example, to expand community health centers and increase access to primary-care doctors. It allows children to stay on their parent’s plan until they turn 26. It will include those with pre-existing conditions in insurance plans, although Flowers warns that many technicalities and loopholes make it easy for insurance companies to drop patients. Most of the more than 30 million people currently without insurance, and the 45,000 who die each year because they lack medical care, essentially remain left out in the cold, and things will not get better for the rest of us.

“We are still a nation full of health care hostages,” Redmond said. “We live in fear of losing our health care. Millions of people have lost their health care. We fear bankruptcy. The inability to pay medical bills is the No. 1 cause of bankruptcy. We fear not being able to afford medications. Millions of people skip medications. They skip these medications to the detriment of their health. We are not free. And we won’t be free until health care is a human right, until health care is not tied to a job, because we still have an employment-based system, and until health care has nothing to do with immigration status. We don’t care if you are documented or undocumented. It should not matter what your health care status is, if you have a disease or you don’t. It should not matter how much money you have or don’t, because many of our programs are based on income eligibility rules. Until we abolish the private, for-profit health insurance industry in this county we are not free. Until we take the profit motive out of health care we cannot live in the way we want to live. This legislation doesn’t do any of that. It doesn’t change those basic facts of our health care system.”

Redmond held up a syringe.

“I take a medication that costs $1,700 every single month,” she said. “I inject this medication. It costs $425 a week for 50 milligrams of medication. I would do almost anything to get this medication because without it I don’t have much of a life. The pharmaceutical industry knows this. They price these drugs accordingly to the level of desperation that people feel. Billy Tauzin, the former CEO of [the trade organization of] Big Pharma, negotiated a secret deal with President Obama to extend the patents of biologics, this new revolutionary class of drugs, for 12 years. And Obama also promised in this deal that he would not negotiate drug prices for Medicare.”

Obama’s numerous betrayals—from his failure to implement serious environmental reform at Copenhagen, to his expansion of the current wars, to his refusal to create jobs for our desperate class of unemployed and underemployed, to his gutting of public education, to his callous disregard for the rights of workers and funneling of trillions in taxpayer money to banks—is a shameful list. Passing universal, single-payer nonprofit health care for all Americans might have delivered to Obama, who may well be a one-term president, at least one worthwhile achievement. Single-payer nonprofit health care has widespread popular support, with nearly two-thirds of the public behind it. It is backed by 59 percent of doctors. And it would have helped roll back, at least a bit, the corporate assault on the citizenry.

Medical bills lead to 62 percent of personal bankruptcies, and nearly 80 percent of these people had insurance. The U.S. spends twice as much as other industrialized nations on health care, $8,160 per capita. Private insurance bureaucracy and paperwork consume 31 percent of every health care dollar. Streamlining payment through a single nonprofit payer would save more than $400 billion per year—enough, PNHP estimates, to provide comprehensive, high-quality coverage for all Americans.

Candidate Obama promised to protect women’s rights under Roe. v. Wade, something this legislation does not do. He told voters he would create a public option and then refused to consider it. The health care reform bill, to quote a statement released by PNHP, has instead “saddled Americans with an expensive package of onerous individual mandates, new taxes on workers’ health plans, countless sweetheart deals with the insurers and Big Pharma, and a perpetuation of the fragmented, dysfunctional, and unsustainable system that is taking such a heavy toll on our health and economy today.”

“Obama said he was going to have everybody at the table,” Redmond said, “but that was a lie. Our voice was not allowed to be there. There was a blackout on our movement. We did not get media attention. We did actions all over the country but we could not get coverage. We had the ‘Mad as Hell Doctors’ go across the country in a caravan, and they had rallies and meetings. If that had been a bunch of AMA Republican doctors, Cooper Anderson would have been on the caravan reporting live. NPR would have done a series. Instead, they did not get much coverage. And neither did the sit-ins and arrests at insurance companies, although we have never seen that level of activity. They turned us into a fringe movement, although poll after poll shows that the majority of people want some kind of single-payer system.”

Our for-profit health system is driven by insurance companies whose goal is to avoid covering the elderly and the sick. These groups, most in need of medical care, diminish profits. Medicare, paid for by the government, removes responsibility for many of the old. Medicaid, also paid for by the government, removes the poor people, who have a greater tendency to have chronic health problems. Hefty premiums, which those who are seriously ill and lose their jobs often cannot pay, remove the very sick. If you are healthy and employed, which means you are less likely to need expensive or complex treatment, the insurance companies swoop down like birds of prey. These corporations need to control our perceptions of health care. Patients must be viewed as consumers. Doctors, identified as “health care providers,” must be seen as salespeople.

Insurance companies, which will soon be able to use billions in taxpayer dollars to bolster their lobbying efforts and campaign contributions, know that single-payer nonprofit insurance means their extinction. And they will employ considerable resources to make sure single-payer nonprofit coverage is denied to the public. They correctly see this as a battle for their lives. And if human beings have to die so they can survive, they are willing to make us pay this price.

The for-profit health care industry, along with the Democratic Party, consciously set out to confuse the public debate. It created Health Care for America NOW! in 2008 and provided it with tens of millions of dollars to supposedly build a public campaign for a public option. But the organization had no intention of permitting a public option. The organization was, as Dr. Flowers said, “a very clever way to distract members of the single-payer movement and co-op some of them. They told them that the public option would become single payer, that it was a back door to single payer, although there was no evidence that was true.”

Physicians for a National Health Plan attempted to fight back. It worked with a number of organizations under a coalition called the Leadership Conference for Guaranteed Health Care. The group, which included the National Nurse’s Union and Health Care Now, sought meetings with members of Congress. Flowers and other advocates asked Congress members to include them in committee debates about the health care bill. But when the first debate on the health care reform took place in the Senate Finance Committee, chaired by Sen. Max Baucus, a politician who gets over 80 percent of his campaign contributions from outside his home state of Montana, they were locked out. Baucus invited 41 people to testify. None backed single payer.

The Leadership Conference, which represents more than 20 million people, again requested that one of their members testify. Baucus again refused. When the second committee meeting took place, Flowers and seven other activists stood one by one in the room and asked why the voices of the patients and the health care providers were not being heard. The eight were arrested and removed from the committee hearing.

Single-payer advocates were eventually heard on a few of the House and Senate committees. But the hearings were a charade, part of Washington’s cynical political theater. It was the insurance and pharmaceutical lobbyists who were in charge. They dominated the public debate. They wrote the legislation. They determined who received lavish campaign contributions and who did not. And they won.

“We are talking about life and death, about the difference between living your life and dying,” Redmond said. “And once again it came down to the Democratic Party trumping the needs of the people.”