http://www.rense.com/general89/gates.htm
By Thomas C. Mountain
Online Journal
2-26-10
ASMARA, Eritrea -- The "richest man in the world," Microsoft's Bill Gates, recently announced that he was making a $10 billion donation towards finding vaccines to prevent some of the world's worst diseases.
Malaria is the number one killer in Africa. From what I'm hearing about $1 billion of Bill Gates donation/tax write-off is for research to find a vaccine to prevent malaria.
The African country of Eritrea, where I live, has reduced malaria mortality by 85 percent in the last seven years. How? By using basic public health methods. By distributing pesticide treated mosquito nets and organizing the pesticide retreatment every three months of mosquito nets. By habitat eradication. And by community medical clinics for immediate treatment.
Malaria is a parasite-based disease noted for its variety and quick development of resistance to medication. Any "vaccine," if even a billion dollars is able to produce such, would have a limited lifetime and new, patented medications would have to be bought by Africa's poor every few years.
So "donating" a billion dollars to develop a malaria "vaccine" could turn into tens of billions of dollars in drug sales in Africa alone, and Bill Gates, through his drug company investments, will quietly pocket more African blood money.
All the while a very successful malaria mortality reduction program is operating, effectively, safely and affordably, in Eritrea.
Why isn't this being publicized internationally? Could it be that such a program is not going to put billions into the pockets of the drug lords of Western finance?
Bill Gates and other assorted financial terrorists through their control of the Western media and "aid" organizations are suppressing implementation of a successful malaria mortality program while investing in a malaria drug addiction for Africa's people.
These financial terrorists are perfectly willing to see millions die in Africa while they search for their next highly profitable "wonder drug" to cure malaria, all the while deliberately ignoring, worse, engineering a white out/cover up of what could prevent millions of deaths, let alone uncounted suffering.
And HIV/AIDS, Africa's N0.2 killer? Bill Gates is said to be providing over a billion dollars for research into developing an AIDS vaccine. AIDS, a virus based disease, has already shown to have varieties and to have developed resistance to the medications developed to treat it. Like the flu vaccine, a new AIDS vaccine would most likely have to be developed every few years to combat the latest strain of the AIDS virus; another gold mine of new, patented medications for sale to Africa's sick.
Eritrea has reduced HIV/AIDS infection rates by 40 percent, according to Physicians for Peace, and is the only country in Africa to reduce HIV/AIDS. How? By using public health education promoting condom use everywhere in the country. Over a billion for a "vaccine" that may never work while an effective program that can reduce HIV/AIDS infection by 40 percent, safely and affordably can be immediately implemented?
Remember, Western billionaires didn't get that way by being out to really help anyone. Millions die in Africa as the Western drug lords and their financial terrorist stockholders reap their billions in blood money. All the while real heroes in the Eritrean public health service struggle to save people's lives.
So don't believe that Bill Gates is up to any good when he donates $10 billion to vaccine research, just the opposite. And don't forget that as far at the USA is concerned in Africa, no good deed goes unpunished, and, once again, Eritrea is subject to UN Security Council sanctions.
Stay tuned to Online Journal for more news from Africa's Horn that the so called free press in the west refuses to cover.
Thomas C. Mountain was, in a former life, an educator, activist and alternative medicine practitioner in the USA.
Email thomascmountain at yahoo.com.
Saturday, February 27, 2010
Friday, February 26, 2010
Pharmaceutical Pillage
http://www.thepeoplesvoice.org/TPV3/Voices.php/2010/02/24/pharmaceutical-pillage
Pharmaceutical Pillage
02/24/10
Joel S. Hirschhorn
Business ethics has become an oxymoron. Wall Street bonuses were up 17 percent to over $20 billion in 2009, the year taxpayers bailed out the financial sector after its meltdown. So, everyone has many reasons to hate the banking and financial sectors that dumped our economy, and the general corruption of American politics by corporate interests. There are good reasons to detest the pharmaceutical industry. Besides raping people with onerous prices for prescription drugs, corporate greed coupled with ineffective government regulation and oversight is actually killing Americans through unsafe drugs.
Enter the newest fiasco, that sweetly named diabetes drug Avandia, so heavenly sounding, yet now revealed to be just another in a long history of drugs that get government approval but turn out to be lethal. According to Bloomberg News: “Safety reviewers at the U.S. Food and Drug Administration urged the agency to take GlaxoSmithKline Plc’s diabetes drug Avandia off the market in 2008 because they said it was causing 500 additional heart attacks per month.” A month! The drug was linked to 304 deaths during the third quarter of 2009, which implies many thousands of deaths to date.
Consider these depressing developments. In recent years, pharmaceutical companies have committed acts that forced them to pay the largest criminal fines in American history. In cases involving Pfizer, Eli Lilly, Bristol Myers Squibb and four other drug companies, these fines and penalties have totaled over $7 billion since May 2004. That is an amazing number, but in comparison to drug industry profits, merely a pittance.
In particular, Pfizer has been fined multiple times in the past 6 years for illegal off-label promotion of their drugs. In its latest plea agreement, which took place last September, Pfizer paid $2.3 billion in fines and penalties for off-label promotion of Bextra. This settlement was the largest criminal fine in US history. Clearly, this kind of corporate behavior requires diligent oversight by the Food and Drug Administration to protect Americans and to ensure the safety of American medicine. Yet this newest Avandia outrage proves, yet again, that the federal government is failing people.
The Senate Finance Committee has just released a report and a letter to the FDA. They have revealed that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. “Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” said Senator Max Baucus.
The Senate committee started their investigation after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia. Avandia entered the market in 1999 and reached annual revenue of $3 billion by 2006, including sales of a combination drug that includes Avandia. Sales plummeted to $1.2 billion in 2009, two years after that study was published which linked Avandia to a 43 percent increased risk of heart attack. Before that the drug was the company’s second best selling drug, and they did everything to protect sales, rather than users of the drug.
The Senate report provides incredible details on how the drug company pursued countless awful tactics to thwart many efforts to reveal to the public and the medical community just how unsafe Avandia is. The report notes: “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”
The company continues to fight to keep its drug in the market. You can imagine the army of lobbyists being used to safeguard the interests of drug companies. Other industries exhibit the same behavior, giving us widespread corporate pillage.
I and millions of other owners of Toyota vehicles cringe because, like so many other companies, it lost the capacity for telling the truth and protecting their consumers, and the federal government failed its oversight function. With 31 lobbyists in Washington last year, Toyota has spent nearly $25 million on federal regulatory and legislative lobbying matters in the last five years, much more than any other foreign automaker. Toyota’s registered lobbyists include at least eight former officials from Congress and the executive branch and it employs former engineers and officials from the National Highway Traffic Safety Administration, the regulatory agency that failed to detect a pattern of safety problems at Toyota.
Put aside the anti-government rhetoric of the Tea Party movement. The critical need is not for less government but for better government that really works in the public interest, especially protecting consumers from dastardly corporate powers. Until that happens it is not surprising that the recent Washington Post-ABC News poll found that two-thirds of Americans are dissatisfied or angry about the federal government. Nearly 75 percent of independents feel this way. If you think that electing either Democrats or Republicans will fix broken government, think again. Both major parties are corrupted by corporate interests.
Pharmaceutical Pillage
02/24/10
Joel S. Hirschhorn
Business ethics has become an oxymoron. Wall Street bonuses were up 17 percent to over $20 billion in 2009, the year taxpayers bailed out the financial sector after its meltdown. So, everyone has many reasons to hate the banking and financial sectors that dumped our economy, and the general corruption of American politics by corporate interests. There are good reasons to detest the pharmaceutical industry. Besides raping people with onerous prices for prescription drugs, corporate greed coupled with ineffective government regulation and oversight is actually killing Americans through unsafe drugs.
Enter the newest fiasco, that sweetly named diabetes drug Avandia, so heavenly sounding, yet now revealed to be just another in a long history of drugs that get government approval but turn out to be lethal. According to Bloomberg News: “Safety reviewers at the U.S. Food and Drug Administration urged the agency to take GlaxoSmithKline Plc’s diabetes drug Avandia off the market in 2008 because they said it was causing 500 additional heart attacks per month.” A month! The drug was linked to 304 deaths during the third quarter of 2009, which implies many thousands of deaths to date.
Consider these depressing developments. In recent years, pharmaceutical companies have committed acts that forced them to pay the largest criminal fines in American history. In cases involving Pfizer, Eli Lilly, Bristol Myers Squibb and four other drug companies, these fines and penalties have totaled over $7 billion since May 2004. That is an amazing number, but in comparison to drug industry profits, merely a pittance.
In particular, Pfizer has been fined multiple times in the past 6 years for illegal off-label promotion of their drugs. In its latest plea agreement, which took place last September, Pfizer paid $2.3 billion in fines and penalties for off-label promotion of Bextra. This settlement was the largest criminal fine in US history. Clearly, this kind of corporate behavior requires diligent oversight by the Food and Drug Administration to protect Americans and to ensure the safety of American medicine. Yet this newest Avandia outrage proves, yet again, that the federal government is failing people.
The Senate Finance Committee has just released a report and a letter to the FDA. They have revealed that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. “Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” said Senator Max Baucus.
The Senate committee started their investigation after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia. Avandia entered the market in 1999 and reached annual revenue of $3 billion by 2006, including sales of a combination drug that includes Avandia. Sales plummeted to $1.2 billion in 2009, two years after that study was published which linked Avandia to a 43 percent increased risk of heart attack. Before that the drug was the company’s second best selling drug, and they did everything to protect sales, rather than users of the drug.
The Senate report provides incredible details on how the drug company pursued countless awful tactics to thwart many efforts to reveal to the public and the medical community just how unsafe Avandia is. The report notes: “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”
The company continues to fight to keep its drug in the market. You can imagine the army of lobbyists being used to safeguard the interests of drug companies. Other industries exhibit the same behavior, giving us widespread corporate pillage.
I and millions of other owners of Toyota vehicles cringe because, like so many other companies, it lost the capacity for telling the truth and protecting their consumers, and the federal government failed its oversight function. With 31 lobbyists in Washington last year, Toyota has spent nearly $25 million on federal regulatory and legislative lobbying matters in the last five years, much more than any other foreign automaker. Toyota’s registered lobbyists include at least eight former officials from Congress and the executive branch and it employs former engineers and officials from the National Highway Traffic Safety Administration, the regulatory agency that failed to detect a pattern of safety problems at Toyota.
Put aside the anti-government rhetoric of the Tea Party movement. The critical need is not for less government but for better government that really works in the public interest, especially protecting consumers from dastardly corporate powers. Until that happens it is not surprising that the recent Washington Post-ABC News poll found that two-thirds of Americans are dissatisfied or angry about the federal government. Nearly 75 percent of independents feel this way. If you think that electing either Democrats or Republicans will fix broken government, think again. Both major parties are corrupted by corporate interests.
Saturday, February 20, 2010
Paxil Birth Defect Litigation - First Trial A Bust For Glaxo
http://www.opednews.com/articles/Paxil-Birth-Defect-Litigat-by-Evelyn-Pringle-100216-915.html
February 18, 2010
By Evelyn Pringle
Glaxo Smith Kline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.
Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.
First Trial A Bust for Glaxo.
The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The jury awarded the family $2.5 million in compensatory damages.
After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. "There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further," he said.
On October 14, 2009, the American Lawyer reported that the plaintiff's lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. "They said the fact that GSK never adequately studied their own drug was a big deal," Tracey said. "The animal testing they did showed that they had a potential problem, and they didn't follow up with adequate studies on animals or humans."
Glaxo's lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.
Over 600 Trials To Go.
A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.
"Although one might worry that this would cause a jury to blame the prescribing doctor," says Vickery, "in this case, we can show that GSK encouraged this use, by sending out over 1500 "medical information" letters touting the benefits of Paxil for migraine headaches, and by leaving "approved WLF reprint" articles with the prescribing doctors."
Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.
In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the "FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations," and advised:
"Despite this categorization," says Vickery, "in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects."
"Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia," he notes.
Case of the Dead Rats.
During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were "going to see documents in this case that have never seen the light of day before."
"You will see internal GlaxoSmith documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before," he said. "They have been under seal for over three years."
Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.
Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.
Healy explained that a teratogen is an agent that will cause birth defects and "it could be a drug or maybe a virus or maybe an illness."
In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.
The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil.
The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead.
In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4.
Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four.
Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects.
After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, "GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning."
"I would like you to note three things about the discussion in the product information about the animal studies," she said.
"First, there were no birth defects in the study," she told he jury. "That is, there were no malformations or difficulties, structural difficulties, with the animals."
"Second," she said, "the rat pups who died shortly after birth were dosed at something like ten times the normal dose."
"And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation," Varner told the jury.
"You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem," she said, "it was during the lactation period that these pups died."
While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner's claims in stating: "Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation."
He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. "Yes, they were," Healy said. "They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after."
He also told the jury that there were three major malformations in the Paxil exposed group, and "there may well have been more."
"The figures from the studies do give grounds for concern that there were, in fact more," he said, "far more."
The fact that the more Paxil they got the more they died, "indicates that the drug has played a part ... in whatever the cause of death is," Healy told the jury.
"It's clearly the drug that has caused the death," he said. "What we aren't clear from here is just what actually happened. Why they died."
In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies. In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner's claim that the rats received 10 times the normal dose.
"At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy," Baldwin wrote.
"That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed," Healy told the jury.
"That Paxil is a drug that if it comes on the market, may cause birth defects," he said. "So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated."
Which "would mean in this case," Healy said, "do not use the drug in women of childbearing years unless, for instance, they're using some form of birth control."
Another portion of Baldwin's memo stated: "On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels."
"This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects," Healy told the jury. "We need to do more work to actually before it's out, does the drug come with this risk or not."
"He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not," Healy said. "The implication being that if they haven't done it, we should."
In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. "I know they did further studies, but I don't think they did anything to address the issues that were raised by 295, 296, 297," he said. "Or if they did, they kept it well hidden it would seem."
Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, "Active Psychiatric Scandinavia," and stated: "There appeared to be no selective effect on the embryo or any signs of teratogenicity."
Baldwin "appears to be saying here that there is no evidence that the drug causes birth defects," Healy told the jury. "That appears to me to be incompatible with the data that we reviewed earlier."
Baldwin's paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.
Incriminating Data Destroyed.
During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: "It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993."
Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. "From my work on the serotonin system back in the early '80s, almost 30 years ago," he said, "I still have the raw data."
"The idea that I would destroy the data is almost inconceivable," Healy stated.
People may be concerned about a particular study and want to go back and look at the books, he said. "It's a bit like auditing a major company like Enron."
But it's "even more important actually in science," Healy told the jury. "People with a different point of view need to be able to say, look, show me the data."
They may "even suspect that I didn't do the study," he said, "so a defense for me is to be able to say here are the notebooks, here are the clinical records."
So you have to "be prepared to have all sorts of challenges," he told the jury. "But for that to happen, the notebooks, the clinical records, the lab notebooks must be there."
Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. "I believe there were efforts to try and find the microfilms, but they have not been found," he said.
Healy explained that when studies are done, there are a set of procedures called "good laboratory practice," or GLP.
"And it is hoped these days when a company brings a drug to the market," he said, "that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice."
"And part of the requirements here of good laboratory practice is that the raw data is maintained," he told the jury.
Later in Healy's testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under "maintenance of records," stated "this material will be stored," and the "material will not be discarded or released from these laboratories without the sponsor's prior consent."
Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.
During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.
A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony.
Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.
When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company "do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born," she said.
"Cross-fostering is ... taking rats from treated mothers and putting them with a control rat that didn't receive the drug," she explained to the jury. "So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born."
The FDA asked Glaxo to submit a protocol for the study, "for our concurrence," before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.
She testified that such a study "would have helped to address where the negative effects were coming from."
While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam's mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.
The label stated: "in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester."
Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label "implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester," she testified.
The label is saying "there is no evidence of teratogenic effects," she said, "that means that it's safe for the first trimester. "
"If a physician were to read this, they would be more likely to prescribe it early in pregnancy," she told the jury.
February 18, 2010
By Evelyn Pringle
Glaxo Smith Kline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.
Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.
First Trial A Bust for Glaxo.
The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The jury awarded the family $2.5 million in compensatory damages.
After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. "There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further," he said.
On October 14, 2009, the American Lawyer reported that the plaintiff's lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. "They said the fact that GSK never adequately studied their own drug was a big deal," Tracey said. "The animal testing they did showed that they had a potential problem, and they didn't follow up with adequate studies on animals or humans."
Glaxo's lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.
Over 600 Trials To Go.
A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.
"Although one might worry that this would cause a jury to blame the prescribing doctor," says Vickery, "in this case, we can show that GSK encouraged this use, by sending out over 1500 "medical information" letters touting the benefits of Paxil for migraine headaches, and by leaving "approved WLF reprint" articles with the prescribing doctors."
Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.
In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the "FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations," and advised:
"Despite this categorization," says Vickery, "in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects."
"Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia," he notes.
Case of the Dead Rats.
During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were "going to see documents in this case that have never seen the light of day before."
"You will see internal GlaxoSmith documents that the FDA hasn't seen, that the United States Congress hasn't seen, and that no jury has ever laid their eyes on before," he said. "They have been under seal for over three years."
Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.
Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.
Healy explained that a teratogen is an agent that will cause birth defects and "it could be a drug or maybe a virus or maybe an illness."
In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.
The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil.
The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead.
In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4.
Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four.
Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects.
After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, "GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning."
"I would like you to note three things about the discussion in the product information about the animal studies," she said.
"First, there were no birth defects in the study," she told he jury. "That is, there were no malformations or difficulties, structural difficulties, with the animals."
"Second," she said, "the rat pups who died shortly after birth were dosed at something like ten times the normal dose."
"And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation," Varner told the jury.
"You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem," she said, "it was during the lactation period that these pups died."
While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner's claims in stating: "Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation."
He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. "Yes, they were," Healy said. "They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after."
He also told the jury that there were three major malformations in the Paxil exposed group, and "there may well have been more."
"The figures from the studies do give grounds for concern that there were, in fact more," he said, "far more."
The fact that the more Paxil they got the more they died, "indicates that the drug has played a part ... in whatever the cause of death is," Healy told the jury.
"It's clearly the drug that has caused the death," he said. "What we aren't clear from here is just what actually happened. Why they died."
In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies. In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner's claim that the rats received 10 times the normal dose.
"At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy," Baldwin wrote.
"That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed," Healy told the jury.
"That Paxil is a drug that if it comes on the market, may cause birth defects," he said. "So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated."
Which "would mean in this case," Healy said, "do not use the drug in women of childbearing years unless, for instance, they're using some form of birth control."
Another portion of Baldwin's memo stated: "On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels."
"This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects," Healy told the jury. "We need to do more work to actually before it's out, does the drug come with this risk or not."
"He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not," Healy said. "The implication being that if they haven't done it, we should."
In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. "I know they did further studies, but I don't think they did anything to address the issues that were raised by 295, 296, 297," he said. "Or if they did, they kept it well hidden it would seem."
Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, "Active Psychiatric Scandinavia," and stated: "There appeared to be no selective effect on the embryo or any signs of teratogenicity."
Baldwin "appears to be saying here that there is no evidence that the drug causes birth defects," Healy told the jury. "That appears to me to be incompatible with the data that we reviewed earlier."
Baldwin's paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.
Incriminating Data Destroyed.
During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: "It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993."
Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. "From my work on the serotonin system back in the early '80s, almost 30 years ago," he said, "I still have the raw data."
"The idea that I would destroy the data is almost inconceivable," Healy stated.
People may be concerned about a particular study and want to go back and look at the books, he said. "It's a bit like auditing a major company like Enron."
But it's "even more important actually in science," Healy told the jury. "People with a different point of view need to be able to say, look, show me the data."
They may "even suspect that I didn't do the study," he said, "so a defense for me is to be able to say here are the notebooks, here are the clinical records."
So you have to "be prepared to have all sorts of challenges," he told the jury. "But for that to happen, the notebooks, the clinical records, the lab notebooks must be there."
Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. "I believe there were efforts to try and find the microfilms, but they have not been found," he said.
Healy explained that when studies are done, there are a set of procedures called "good laboratory practice," or GLP.
"And it is hoped these days when a company brings a drug to the market," he said, "that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice."
"And part of the requirements here of good laboratory practice is that the raw data is maintained," he told the jury.
Later in Healy's testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under "maintenance of records," stated "this material will be stored," and the "material will not be discarded or released from these laboratories without the sponsor's prior consent."
Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.
During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.
A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony.
Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.
When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company "do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born," she said.
"Cross-fostering is ... taking rats from treated mothers and putting them with a control rat that didn't receive the drug," she explained to the jury. "So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born."
The FDA asked Glaxo to submit a protocol for the study, "for our concurrence," before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.
She testified that such a study "would have helped to address where the negative effects were coming from."
While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam's mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.
The label stated: "in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester."
Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label "implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester," she testified.
The label is saying "there is no evidence of teratogenic effects," she said, "that means that it's safe for the first trimester. "
"If a physician were to read this, they would be more likely to prescribe it early in pregnancy," she told the jury.
Big Pharma Researcher Admits to Faking Dozens of Research Studies for Pfizer, Merck
THIS GUY IS A PSYCHOPATH!!!!
http://www.naturalnews.com/028194_Scott_Reuben_research_fraud.html
Mike Adams
NaturalNews
Thu, 18 Feb 2010 00:00 EST
It's being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer's speakers' bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.
Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery. There's only one problem with all this: No patients were ever enrolled in the study!
Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.
It wasn't the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.
As a result of Dr. Reuben's faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 "scientific" papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.
After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.
He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years.
Business as usual in Big Pharma
What's notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It's not the fact that so-called "scientific" medical journals published his fabricated studies. It's not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.
The real story here is that this is business as usual in the pharmaceutical industry.
Dr. Reuben's actions really aren't that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.
Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn't operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.
Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben's faked studies even though this journal claims to be a "scientific" medical journal based on peer review. Funny, isn't it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.
Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on "good science." It's all scientific and trustworthy, they claim, while accusing alternative medicine of being "woo woo" wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that's based largely on fraudulent research, bribery and corruption.
You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is "scientific" while natural medicine is "unproven." Sure it's scientific -- about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a "let's play doctor" gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.
For all those people who ignorantly claim that modern pharmaceutical science is based on "scientific evidence," just give them these three words: Doctor Scott Reuben.
Drug companies support fraudulent research
Don't forget that the drug companies openly supported Dr. Scott Reuben's research. They paid him, in fact, to keep on fabricating studies.
The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben's research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to "prove" that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). "Here's another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink)."
And before long, Dr. Reuben would magically materialize a brand new study that just happened to "prove" exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don't believe in magic, but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician's wand and chanting, "Abra cadabra... let there be RESEARCH DATA!"
Shazam! The research data materializes just like that. It all gets written up into a "scientific" paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.
I guess these people believe in magic after all, huh? Where science is lacking, a little "research magic" conveniently fills the void.
The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever "scientific evidence" they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.
What is "Evidence-Based Medicine?"
The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what's really behind "evidence-based medicine."
The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as "fact!"
When pushers of pharmaceuticals and vaccines resort to quoting "evidence-based medicine" as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on "real science," what they really mean is that it's based on fraudulent science but they've all secretly agreed to call it "real science." When they claim to have "scientific facts" supporting their position, what they really mean is that those "facts" were fabricated by criminal researchers being paid bribes by the drug companies.
"Evidence-based medicine," it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals -- without getting caught by his peers -- then what does that say about the credibility of the entire peer-review science paper publishing process?
Here's what is says: "Scientific medicine" is a total fraud.
And this fraud isn't limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 years before being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven't yet been caught in the act. Their fraudulent research papers have no doubt already been published in "scientific" medical journals. They've been quoted in the popular press. They've been relied on by FDA decision makers to approve drugs as "safe and effective" for widespread use.
And yet underneath all this, there's nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?
How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?
Keep up the great work, Dr Reuben
Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable "scientific" journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.
Keep up the good work. After paying your fine and serving a little jail time, I'm sure your services will be in high demand at all the top drug companies that need yet more "scientific" studies to be fabricated and submitted to the medical journals.
You may be a dishonest, disgusting human being to most of the world, but you're a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!
Because if there's one place that extreme dishonesty is richly rewarded, it's in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth.
http://www.naturalnews.com/028194_Scott_Reuben_research_fraud.html
Mike Adams
NaturalNews
Thu, 18 Feb 2010 00:00 EST
It's being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer's speakers' bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.
Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as "proof" that Celebrex helped reduce pain during post-surgical recovery. There's only one problem with all this: No patients were ever enrolled in the study!
Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.
It wasn't the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.
As a result of Dr. Reuben's faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 "scientific" papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.
After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.
He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years.
Business as usual in Big Pharma
What's notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It's not the fact that so-called "scientific" medical journals published his fabricated studies. It's not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.
The real story here is that this is business as usual in the pharmaceutical industry.
Dr. Reuben's actions really aren't that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.
Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn't operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.
Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben's faked studies even though this journal claims to be a "scientific" medical journal based on peer review. Funny, isn't it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.
Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on "good science." It's all scientific and trustworthy, they claim, while accusing alternative medicine of being "woo woo" wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that's based largely on fraudulent research, bribery and corruption.
You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is "scientific" while natural medicine is "unproven." Sure it's scientific -- about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a "let's play doctor" gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.
For all those people who ignorantly claim that modern pharmaceutical science is based on "scientific evidence," just give them these three words: Doctor Scott Reuben.
Drug companies support fraudulent research
Don't forget that the drug companies openly supported Dr. Scott Reuben's research. They paid him, in fact, to keep on fabricating studies.
The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben's research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to "prove" that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). "Here's another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink)."
And before long, Dr. Reuben would magically materialize a brand new study that just happened to "prove" exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don't believe in magic, but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician's wand and chanting, "Abra cadabra... let there be RESEARCH DATA!"
Shazam! The research data materializes just like that. It all gets written up into a "scientific" paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.
I guess these people believe in magic after all, huh? Where science is lacking, a little "research magic" conveniently fills the void.
The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever "scientific evidence" they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.
What is "Evidence-Based Medicine?"
The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what's really behind "evidence-based medicine."
The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as "fact!"
When pushers of pharmaceuticals and vaccines resort to quoting "evidence-based medicine" as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on "real science," what they really mean is that it's based on fraudulent science but they've all secretly agreed to call it "real science." When they claim to have "scientific facts" supporting their position, what they really mean is that those "facts" were fabricated by criminal researchers being paid bribes by the drug companies.
"Evidence-based medicine," it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals -- without getting caught by his peers -- then what does that say about the credibility of the entire peer-review science paper publishing process?
Here's what is says: "Scientific medicine" is a total fraud.
And this fraud isn't limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 years before being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven't yet been caught in the act. Their fraudulent research papers have no doubt already been published in "scientific" medical journals. They've been quoted in the popular press. They've been relied on by FDA decision makers to approve drugs as "safe and effective" for widespread use.
And yet underneath all this, there's nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?
How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?
Keep up the great work, Dr Reuben
Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable "scientific" journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.
Keep up the good work. After paying your fine and serving a little jail time, I'm sure your services will be in high demand at all the top drug companies that need yet more "scientific" studies to be fabricated and submitted to the medical journals.
You may be a dishonest, disgusting human being to most of the world, but you're a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!
Because if there's one place that extreme dishonesty is richly rewarded, it's in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth.
Corruption of physicians by Big Pharma now "limited" to $500 an hour
http://www.NaturalNews.com/z028168_Big_Pharma_corruption.html
February 16 2010
by Ethan A. Huff, staff writer
(NaturalNews) Congressional investigation over the unethical relationships between doctors and drug companies has led to a change in policy at Partners HealthCare, a Boston based hospital system affiliated with Harvard Medical School, that prohibits its physicians who sit on the boards of various biotechnology and pharmaceutical companies from receiving company stock and unlimited fees for their presence. They are now limited to only $500 an hour, or $5,000 a day, for their services which include things like attending board meetings.
The fact that about 25 vice presidents, clinical department heads, and other top executives in the system will be affected by this new rule illustrates the degree to which the medical system has been influenced by pharmaceutical interests. Physicians from top medical centers, including academic ones, often join the ranks of drug companies and are paid top dollar to push various drugs and treatments. They are even paid with company stock.
This blatant conflict of interest is not isolated to Partners, as many different organizations and academic institutions have come under fire by state regulators, Congress, and even hospitals themselves for allowing this practice to occur. Nationally, there has been a heavy push to stop the drug industry's control over doctors whether it be through perks, incentives or comfortable board positions.
The new policy at Partners prohibits doctors from touring the nation as paid drug company spokesmen, a practice commonly utilized by drug companies to promote their products. Partners will not, however, ban its physicians from working for drug companies altogether. They will still be allowed to sit on their boards and receive compensation - it will merely be "reduced" to $500 per hour.
It is virtually impossible for a physician to be both a physician and an executive for a drug company. For the drug company, he will be responsible for helping it achieve financial success, while for the hospital, he will be responsible for objectively treating patients. A physician cannot objectively treat a patient while at the same time be paid to use a company's drugs to treat that patient.
According to Dr. Dennis Auseillo, chief scientific officer at Partners and cochairman of drug-giant Pfizer's science and technology committee, all drug companies have at least a couple physicians on their boards. After being named a director of Pfizer in 2006 himself, Auseillo has received over $700,000 in company stocks and compensation. He plans to continue working for Pfizer under the new rules.
February 16 2010
by Ethan A. Huff, staff writer
(NaturalNews) Congressional investigation over the unethical relationships between doctors and drug companies has led to a change in policy at Partners HealthCare, a Boston based hospital system affiliated with Harvard Medical School, that prohibits its physicians who sit on the boards of various biotechnology and pharmaceutical companies from receiving company stock and unlimited fees for their presence. They are now limited to only $500 an hour, or $5,000 a day, for their services which include things like attending board meetings.
The fact that about 25 vice presidents, clinical department heads, and other top executives in the system will be affected by this new rule illustrates the degree to which the medical system has been influenced by pharmaceutical interests. Physicians from top medical centers, including academic ones, often join the ranks of drug companies and are paid top dollar to push various drugs and treatments. They are even paid with company stock.
This blatant conflict of interest is not isolated to Partners, as many different organizations and academic institutions have come under fire by state regulators, Congress, and even hospitals themselves for allowing this practice to occur. Nationally, there has been a heavy push to stop the drug industry's control over doctors whether it be through perks, incentives or comfortable board positions.
The new policy at Partners prohibits doctors from touring the nation as paid drug company spokesmen, a practice commonly utilized by drug companies to promote their products. Partners will not, however, ban its physicians from working for drug companies altogether. They will still be allowed to sit on their boards and receive compensation - it will merely be "reduced" to $500 per hour.
It is virtually impossible for a physician to be both a physician and an executive for a drug company. For the drug company, he will be responsible for helping it achieve financial success, while for the hospital, he will be responsible for objectively treating patients. A physician cannot objectively treat a patient while at the same time be paid to use a company's drugs to treat that patient.
According to Dr. Dennis Auseillo, chief scientific officer at Partners and cochairman of drug-giant Pfizer's science and technology committee, all drug companies have at least a couple physicians on their boards. After being named a director of Pfizer in 2006 himself, Auseillo has received over $700,000 in company stocks and compensation. He plans to continue working for Pfizer under the new rules.
Friday, February 19, 2010
Over Half a Million U.S. Kids Per Year Suffer Health Reactions From Drugs
http://www.NaturalNews.com/z028143_children_side_effects.html
February 11 2010
Over Half a Million U.S. Kids Per Year Suffer Health Reactions From Drugs
by David Gutierrez, staff writer
(NaturalNews) 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."
Sources for this story include: www.foxnews.com; healthfieldmedicare.suite101.com.
February 11 2010
Over Half a Million U.S. Kids Per Year Suffer Health Reactions From Drugs
by David Gutierrez, staff writer
(NaturalNews) 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."
Sources for this story include: www.foxnews.com; healthfieldmedicare.suite101.com.
Tuesday, February 16, 2010
Gets Cozy With Congress, Spends $100 Million in Advertising to Cash in on Health Reform
Pharma Giant Gets Cozy With Congress, Spends $100 Million in Advertising to Cash in on Health Reform
By Paul Blumenthal, Sunlight Foundation
February 16, 2010
http://www.alternet.org/story/145685/
More than a million spectators gathered before the Capitol on a frosty January afternoon to witness the inauguration of Barack Obama, who promised in his campaign to change Washington’s mercenary culture of lobbyists, special interest influence and backroom deals. But within a few months of being sworn in, the President and his top aides were sitting down with leaders from the pharmaceutical industry to hash out a deal that they thought would make health care reform possible.
Over the following months, pharmaceutical industry lobbyists and executives met with top White House aides dozens of times to hammer out a deal that would secure industry support for the administration’s health care reform agenda in exchange for the White House abandoning key elements of the president’s promises to reform the pharmaceutical industry. They flooded Congress with campaign contributions, and hired dozens of former Capitol Hill insiders to push their case. How they did it—pieced together from news accounts, disclosure forms including lobbying reports and Federal Election Commission records, White House visitor logs and the schedule Sen. Max Baucus releases voluntarily—is a testament to how ingrained the grip of special interests remains in Washington.
In the 2008 campaign, Obama declared his intention to include all stakeholders as he sought to reform the nation’s health care system, but also supported key Democratic health reform policies. Among these were several that targeted the pharmaceutical industry: Allowing re-importation of drugs from first world countries with lower drug prices and providing Medicare with negotiating authority over prescription drug prices in the recently enacted Part D program. These weren’t just promises, Obama had already voted for both of them as a senator in 2007. (Roll Call Vote 132 and Roll Call Vote 150.)
Set to carry out this agenda were two Capitol Hill veterans, schooled in the monied Washington culture, chief of staff Rahm Emanuel and deputy chief of staff Jim Messina. Emanuel was a former fundraiser, Clinton administration official, investment banker and member of the Democratic leadership in Congress. Messina was the former campaign manager and chief of staff to the powerful Senate Finance Committee chairman Max Baucus. Both were known for their unparalleled legislative abilities.
Because of Obama’s decision to develop a plan operating through the legislative process, members of Congress also played key roles. Early on, the pharmaceutical companies were told to deal directly with Senate Finance Committee chairman Max Baucus. Baucus would be the vehicle for the deal worked out behind the scenes by the White House and PhRMA.
Central to this effort was PhRMA president, CEO and top lobbyist Billy Tauzin, a longtime Democratic member of Congress who switched party affiliations after Republicans gained control of Congress in 1994. By switching parties Tauzin was able to maintain his influence and even rose to be Chairman of the House Committee on Energy & Commerce. Tauzin became the poster child of Washington’s mercenary culture. He crafted a bill to provide prescription drug access to Medicare recipients, one that provided major concessions to the pharmaceutical industry. Medicare would not be able to negotiate for lower prescription drug costs and reimportation of drugs from first world countries would not be allowed. A few months after the bill passed, Tauzin announced that he was retiring from Congress and would be taking a job helming PhRMA for a salary of $2 million.
Tauzin’s job change became fodder for a campaign ad that then presidential candidate Barack Obama ran in the spring of 2008 simply titled “Billy.” It featured the candidate, sleeves rolled up, talking to a salon of gasping Americans about the ways of Washington. “The pharmaceutical industry wrote into the prescription drug plan that Medicare could not negotiate with drug companies. And you know what, the chairman of the committee, who pushed the law through, went to work for the pharmaceutical industry making $2 million a year.” The screen fades to black to inform the viewer that, “Barack Obama is the only candidate who refuses Washington lobbyist money,” while the candidate continues his lecture, “Imagine that. That’s an example of the same old game playing in Washington. You know, I don’t want to learn how to play the game better, I want to put an end to the game playing.”
Aiding PhRMA in their outreach to Congress would be a squadron of lobbyists to push their health care reform priorities. Over the course of 2009, the drug industry trade group spent over $28 million on in house and hired lobbyists. Aside from PhRMA’s massive in-house lobbying operation, the trade group hired 48 outside lobbying firms. The total number of lobbyists working for PhRMA in 2009 reached 165. Some 137 of those 165 lobbyists representing PhRMA were former employees of either the legislative or executive branches. Of these dozens were former congressional staffers including two former chiefs of staff to Max Baucus.
According to data compiled by the Center for Responsive Politics, drug makers contributed huge sums to congressional campaign committees during the same period—from January to the end of October (4th quarter numbers are still being totaled), industry political action committees, employees and their family members flooded lawmakers with over $8 million. Those contributions tilted heavily to Democrats over Republicans by a 57 to 42 percent margin—the first time in any election cycle going back to 1990, the first year that the Center for Responsive Politics began tracking industry giving, that Democrats were so favored. Given their majorities on Capitol Hill, and the new President’s intention to reform America’s health care system, the new tilt was perhaps not surprising.
***
On March 5, the White House held a meeting with major health care industry leaders to try to bring them to the table and see what could be done to gain their support. In attendance were Billy Tauzin, president, CEO and top lobbyist for PhRMA, Pfizer CEO Jeff Kindler, America’s Health Care Plans (AHIP) Chairman Karen Ignani, Tom Donohue of the Chamber of Commerce and Robert Wood Johnson Foundations’ Risa Lavizzo-Mourey. A day before the White House meeting Tauzin appeared on CNBC touting health care reform and promising to work closely with the Obama administration. In the interview he touted it as an “optimistic plan”, acknowledging that the industry did have a few problems but was glad to have a chance to discuss these. Some were caught dumb-founded by this apparent change of heart on behalf of an industry long adverse to health care reforms.
On April 15, Jim Messina and Jon Selib, chief of staff to Senate Finance Committee chairman Max Baucus, convened a meeting at the headquarters of the Democratic Senatorial Campaign Committee (DSCC) with leaders of organized labor and health care groups, including PhRMA. At the meeting, the groups decided to form two nonprofit entities to promote reform efforts, Healthy Economy Now and Americans for Stable Quality Care, that would be almost entirely funded by PhRMA. The two groups spent $24 million on their advertising campaigns; the contract to produce and place ads went to White House Senior Advisor David Axelrod’s former firm, AKPD, which owed Axelrod $2 million.
In the next month, CEO’s from pharmaceutical companies would meet with Baucus and administration officials at least four times. These talks preceded a major public event at the White House, one critical to its strategy to promote health care reform. On May 11, PhRMA and other trade industry groups pledged cost cutting measures to the White House that would save, they claimed, upwards of $2 trillion over the next decade. President Obama announced the deal in the State Dining Room, flanked by leaders of the various trade groups; the administration followed up with a media blitz in the press and on the White House Web site.
The next day, Healthy Economy Now’s PhRMA funded ad campaign ran their first advertisement in support of the health care reform process calling for the government to finally “fix” the nation’s health care cost problems. While many elements of the $2 trillion cost cutting pledge fell apart, the drug industry remained committed to the process in the hopes that they could ultimately win out and defeat the provisions they most feared in closed-door meetings with the White House.
The first occurred on June 2. White House visitor logs show PhRMA’s top executives, including Tauzin, and industry CEOs met with Sarah Fenn from the White House Office of Health Care Reform. On the same day, the publicly available schedule of Senator Max Baucus shows Tauzin and the same industry CEOs met the Senate Finance Committee chairman. What ultimately resulted from these coordinated meetings would be revealed by Baucus on June 20.
In a press release featuring a statement by Tauzin, Baucus revealed that the pharmaceutical industry had accepted $80 billion in cost cutting measures to be included in the Senate Finance Committee version of the bill. According to news reports, Baucus initially proposed $100 billion in cost cutting measures, but the executives and lobbyists meeting on June 2 were able to win the lower figure.
The terms of the initial cost-cutting deal included $30 billion go directly towards closing the “donut hole” in Medicare prescription drug coverage. The “donut hole” is a term for the gap in coverage that occurs within the Medicare prescription drug coverage. For those purchasing prescription drugs through the Medicare program coverage cuts off at $2,700 spent and does not pick back up again until $6,154 is spent by the participant. The amount proposed in the deal, 50 percent coverage for drugs within the coverage gap, however, would not completely close the “donut hole.”
In Baucus’ press release, Tauzin is quoted as saying, “This is a once-in-a-lifetime opportunity and, working together, we can make this hope for a better tomorrow a reality today.” This “once-in-a-lifetime” opportunity also extended to the pharmaceutical industry’s ability to blunt the long-term Democratic agenda of lowering prescription drug prices through Medicare negotiations, re-importation and quicker release of generics onto the market. After making such a grand statement of support through cost cutting proposals it was time for the pharmaceutical industry to finally force the White House and Democrats to take certain chips off the table.
Baucus proceeded with a plan to convene a bipartisan group in an effort to craft the bill desired by the White House. These participants included Democrats Kent Conrad and Jeff Bingaman and Republicans Chuck Grassley, Mike Enzi and Olympia Snowe. Baucus’ decision and the need to solidify deals with groups like the pharmaceutical industry – which were reliant on Baucus producing a bill – slowed down the legislative process making it impossible for Congress to meet the White House’s announced August recess deadline for passing health care reform.
Soon after, PhRMA’s big guns and industry lobbyists paid the White House another visit on July 7 and this time met with Rahm Emanuel and Jim Messina (Baucus’ chief of staff Jon Selib is also listed in White House visitor logs for this meeting). In August, The Huffington Post’s Ryan Grim reported on an internal memo that was drafted at that meeting that outlined the policies that would not be allowed into any final version of health care reform. These included Medicare prescription drug negotiations, drug re-importation, and the lowering of prices for drugs available through Medicare Part D and Part B. The deal would be $80 billion in cost cutting and absolutely no more.
***
While the $80 billion deal was cut with Baucus’ committee, other congressional committees continued to mark-up their own versions of health care reform without the knowledge that the White House was relying on Baucus to produce the final product. In the House of Representatives, the House Energy & Commerce Committee leveled a direct threat to the $80 billion deal. Energy & Commerce Chair Henry Waxman sought to include all of the provisions that PhRMA had gotten the White House and Baucus to cut out of the reform bill. These included drug reimportation, Medicare negotiating power and speedier release of generics to the market. According to previous analysis of the measures proposed by the committee, these measures would have totaled hundreds of billions in cost cuts, far exceeding the $80 billion cap agreed to by the White House, Baucus and PhRMA.
The cost cutting measures passed in the Energy & Commerce bill spooked the board of PhRMA, which included all of the CEOs involved in the deal-cutting meetings with the White House and Baucus. The board pressured Tauzin to go public with the deal to ensure that the White House would recognize it and not renege. On August 4, the Los Angeles Times, in an exclusive report, featured quotes from Tauzin claiming that a deal between the White House and PhRMA existed and that, as Tauzin put it, “The White House blessed it.” Tom Hamburger wrote in the article, “For his part, Tauzin said he had not only received the White House pledge to forswear Medicare drug price bargaining, but also a separate promise not to pursue another proposal Obama supported during the campaign: importing cheaper drugs from Canada or Europe.”
The White House’s Jim Messina later confirmed Tauzin’s claim, stating, “The president encouraged this approach … He wanted to bring all the parties to the table to discuss health insurance reform.”
Democratic lawmakers were furious. Rep. Raul Grijalva, chairman of the Progressive Caucus, asked, “Are industry groups going to be the ones at the table who get the first big piece of the pie and we just fight over the crust?”
***
On September 7, Baucus’ bill made a private circulation on the Hill; pharmaceutical industry cost-cutting did not exceed $80 billion. Five days later, the New York Times reported that PhRMA planned to spend up to $150 million in an advertising blitz in support of Baucus’ bill. The Times noted that the ad spending “…would be a follow-up to the deal that drug makers struck in June with Mr. Baucus and the White House.” On September 16, Baucus released the full text of his legislation to the public.
The White House, PhRMA and Baucus still had to fight a few battles to keep the deal intact. The key amendment targeting the PhRMA deal in committee mark-up came from Sen. Bill Nelson from Florida, which has one of the largest Medicare participant populations in the nation. The pull of constituent needs clearly put Bill Nelson into a position to push for further cost cutting in Medicare prescription drug pricing. His target: closing the “donut hole” completely.
Nelson claimed that his amendment would generate $106 billion in revenue, or from PhRMA’s perspective increase their cost-cutting to $186 billion. That would be unacceptable to PhRMA, to Baucus, to the White House and to the pharmaceutical industry who had made the deal. Other Senate Democrats, Tom Carper and Robert Menendez voted with Republicans and Baucus on the committee to defeat the amendment. It is little surprise the Carper’s Delaware is home to AstraZeneca and Menendez’ New Jersey is home to Merck and Bristol-Myers-Squibb, all of which lobbied for the $80 billion cap.
Senate Majority Leader Harry Reid introduced the final bill, with the cap in place, on November 19. Debate began on Dec. 3, and with it come one more attempt by members to change the terms of the deal. Senator Byron Dorgan introduced an amendment that would allow for drug re-importation, but as the date for voting drew near, the Federal Drug Administration (FDA) released a letter objecting to the proposal that echoed pharmaceutical industry talking points: “…as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns.” Dorgan’s amendment was defeated with numerous Democrats previously in support of reimportation switching to “no” votes.
On Christmas Eve, the bill passed the Senate with the PhRMA deal fully intact.
***
New Year’s Eve passed with no further action on health care reform. Public opinion regarding the health care reform bill had been slipping throughout 2009. It reached a fulcrum in the special election to replace the deceased senator Ted Kennedy in Massachusetts on January 19, 2010. Newly minted senator Scott Brown campaigned that he would be the senator to provide Republicans with the votes to filibuster the final health care reform bill. Democrats ran for cover. Despite having the largest majorities of any party since the 1970s, Democrats put the brakes on their agenda, particularly health care reform.
In the end, the pharmaceutical industry’s support for health care reform would be left up in the air. After spending $100 million in advertising in support of legislation that Tauzin and key executives hoped would be a windfall for the pharmaceutical industry, the legislative process had flat-lined. In February, the board of PhRMA, split over the deal cut by Tauzin, pushed Tauzin to resign his post.
In an interview with Diane Sawyer, President Obama owed up to failures in the process of passing health care reform, “[T]he health care debate as it unfolded legitimately raised concerns not just among my opponents, but also amongst supporters that we just don’t know what’s going on … And it’s an ugly process and it looks like there are a bunch of back room deals.”
Paul Blumenthal is the Senior Writer at the Sunlight Foundation.
By Paul Blumenthal, Sunlight Foundation
February 16, 2010
http://www.alternet.org/story/145685/
More than a million spectators gathered before the Capitol on a frosty January afternoon to witness the inauguration of Barack Obama, who promised in his campaign to change Washington’s mercenary culture of lobbyists, special interest influence and backroom deals. But within a few months of being sworn in, the President and his top aides were sitting down with leaders from the pharmaceutical industry to hash out a deal that they thought would make health care reform possible.
Over the following months, pharmaceutical industry lobbyists and executives met with top White House aides dozens of times to hammer out a deal that would secure industry support for the administration’s health care reform agenda in exchange for the White House abandoning key elements of the president’s promises to reform the pharmaceutical industry. They flooded Congress with campaign contributions, and hired dozens of former Capitol Hill insiders to push their case. How they did it—pieced together from news accounts, disclosure forms including lobbying reports and Federal Election Commission records, White House visitor logs and the schedule Sen. Max Baucus releases voluntarily—is a testament to how ingrained the grip of special interests remains in Washington.
In the 2008 campaign, Obama declared his intention to include all stakeholders as he sought to reform the nation’s health care system, but also supported key Democratic health reform policies. Among these were several that targeted the pharmaceutical industry: Allowing re-importation of drugs from first world countries with lower drug prices and providing Medicare with negotiating authority over prescription drug prices in the recently enacted Part D program. These weren’t just promises, Obama had already voted for both of them as a senator in 2007. (Roll Call Vote 132 and Roll Call Vote 150.)
Set to carry out this agenda were two Capitol Hill veterans, schooled in the monied Washington culture, chief of staff Rahm Emanuel and deputy chief of staff Jim Messina. Emanuel was a former fundraiser, Clinton administration official, investment banker and member of the Democratic leadership in Congress. Messina was the former campaign manager and chief of staff to the powerful Senate Finance Committee chairman Max Baucus. Both were known for their unparalleled legislative abilities.
Because of Obama’s decision to develop a plan operating through the legislative process, members of Congress also played key roles. Early on, the pharmaceutical companies were told to deal directly with Senate Finance Committee chairman Max Baucus. Baucus would be the vehicle for the deal worked out behind the scenes by the White House and PhRMA.
Central to this effort was PhRMA president, CEO and top lobbyist Billy Tauzin, a longtime Democratic member of Congress who switched party affiliations after Republicans gained control of Congress in 1994. By switching parties Tauzin was able to maintain his influence and even rose to be Chairman of the House Committee on Energy & Commerce. Tauzin became the poster child of Washington’s mercenary culture. He crafted a bill to provide prescription drug access to Medicare recipients, one that provided major concessions to the pharmaceutical industry. Medicare would not be able to negotiate for lower prescription drug costs and reimportation of drugs from first world countries would not be allowed. A few months after the bill passed, Tauzin announced that he was retiring from Congress and would be taking a job helming PhRMA for a salary of $2 million.
Tauzin’s job change became fodder for a campaign ad that then presidential candidate Barack Obama ran in the spring of 2008 simply titled “Billy.” It featured the candidate, sleeves rolled up, talking to a salon of gasping Americans about the ways of Washington. “The pharmaceutical industry wrote into the prescription drug plan that Medicare could not negotiate with drug companies. And you know what, the chairman of the committee, who pushed the law through, went to work for the pharmaceutical industry making $2 million a year.” The screen fades to black to inform the viewer that, “Barack Obama is the only candidate who refuses Washington lobbyist money,” while the candidate continues his lecture, “Imagine that. That’s an example of the same old game playing in Washington. You know, I don’t want to learn how to play the game better, I want to put an end to the game playing.”
Aiding PhRMA in their outreach to Congress would be a squadron of lobbyists to push their health care reform priorities. Over the course of 2009, the drug industry trade group spent over $28 million on in house and hired lobbyists. Aside from PhRMA’s massive in-house lobbying operation, the trade group hired 48 outside lobbying firms. The total number of lobbyists working for PhRMA in 2009 reached 165. Some 137 of those 165 lobbyists representing PhRMA were former employees of either the legislative or executive branches. Of these dozens were former congressional staffers including two former chiefs of staff to Max Baucus.
According to data compiled by the Center for Responsive Politics, drug makers contributed huge sums to congressional campaign committees during the same period—from January to the end of October (4th quarter numbers are still being totaled), industry political action committees, employees and their family members flooded lawmakers with over $8 million. Those contributions tilted heavily to Democrats over Republicans by a 57 to 42 percent margin—the first time in any election cycle going back to 1990, the first year that the Center for Responsive Politics began tracking industry giving, that Democrats were so favored. Given their majorities on Capitol Hill, and the new President’s intention to reform America’s health care system, the new tilt was perhaps not surprising.
***
On March 5, the White House held a meeting with major health care industry leaders to try to bring them to the table and see what could be done to gain their support. In attendance were Billy Tauzin, president, CEO and top lobbyist for PhRMA, Pfizer CEO Jeff Kindler, America’s Health Care Plans (AHIP) Chairman Karen Ignani, Tom Donohue of the Chamber of Commerce and Robert Wood Johnson Foundations’ Risa Lavizzo-Mourey. A day before the White House meeting Tauzin appeared on CNBC touting health care reform and promising to work closely with the Obama administration. In the interview he touted it as an “optimistic plan”, acknowledging that the industry did have a few problems but was glad to have a chance to discuss these. Some were caught dumb-founded by this apparent change of heart on behalf of an industry long adverse to health care reforms.
On April 15, Jim Messina and Jon Selib, chief of staff to Senate Finance Committee chairman Max Baucus, convened a meeting at the headquarters of the Democratic Senatorial Campaign Committee (DSCC) with leaders of organized labor and health care groups, including PhRMA. At the meeting, the groups decided to form two nonprofit entities to promote reform efforts, Healthy Economy Now and Americans for Stable Quality Care, that would be almost entirely funded by PhRMA. The two groups spent $24 million on their advertising campaigns; the contract to produce and place ads went to White House Senior Advisor David Axelrod’s former firm, AKPD, which owed Axelrod $2 million.
In the next month, CEO’s from pharmaceutical companies would meet with Baucus and administration officials at least four times. These talks preceded a major public event at the White House, one critical to its strategy to promote health care reform. On May 11, PhRMA and other trade industry groups pledged cost cutting measures to the White House that would save, they claimed, upwards of $2 trillion over the next decade. President Obama announced the deal in the State Dining Room, flanked by leaders of the various trade groups; the administration followed up with a media blitz in the press and on the White House Web site.
The next day, Healthy Economy Now’s PhRMA funded ad campaign ran their first advertisement in support of the health care reform process calling for the government to finally “fix” the nation’s health care cost problems. While many elements of the $2 trillion cost cutting pledge fell apart, the drug industry remained committed to the process in the hopes that they could ultimately win out and defeat the provisions they most feared in closed-door meetings with the White House.
The first occurred on June 2. White House visitor logs show PhRMA’s top executives, including Tauzin, and industry CEOs met with Sarah Fenn from the White House Office of Health Care Reform. On the same day, the publicly available schedule of Senator Max Baucus shows Tauzin and the same industry CEOs met the Senate Finance Committee chairman. What ultimately resulted from these coordinated meetings would be revealed by Baucus on June 20.
In a press release featuring a statement by Tauzin, Baucus revealed that the pharmaceutical industry had accepted $80 billion in cost cutting measures to be included in the Senate Finance Committee version of the bill. According to news reports, Baucus initially proposed $100 billion in cost cutting measures, but the executives and lobbyists meeting on June 2 were able to win the lower figure.
The terms of the initial cost-cutting deal included $30 billion go directly towards closing the “donut hole” in Medicare prescription drug coverage. The “donut hole” is a term for the gap in coverage that occurs within the Medicare prescription drug coverage. For those purchasing prescription drugs through the Medicare program coverage cuts off at $2,700 spent and does not pick back up again until $6,154 is spent by the participant. The amount proposed in the deal, 50 percent coverage for drugs within the coverage gap, however, would not completely close the “donut hole.”
In Baucus’ press release, Tauzin is quoted as saying, “This is a once-in-a-lifetime opportunity and, working together, we can make this hope for a better tomorrow a reality today.” This “once-in-a-lifetime” opportunity also extended to the pharmaceutical industry’s ability to blunt the long-term Democratic agenda of lowering prescription drug prices through Medicare negotiations, re-importation and quicker release of generics onto the market. After making such a grand statement of support through cost cutting proposals it was time for the pharmaceutical industry to finally force the White House and Democrats to take certain chips off the table.
Baucus proceeded with a plan to convene a bipartisan group in an effort to craft the bill desired by the White House. These participants included Democrats Kent Conrad and Jeff Bingaman and Republicans Chuck Grassley, Mike Enzi and Olympia Snowe. Baucus’ decision and the need to solidify deals with groups like the pharmaceutical industry – which were reliant on Baucus producing a bill – slowed down the legislative process making it impossible for Congress to meet the White House’s announced August recess deadline for passing health care reform.
Soon after, PhRMA’s big guns and industry lobbyists paid the White House another visit on July 7 and this time met with Rahm Emanuel and Jim Messina (Baucus’ chief of staff Jon Selib is also listed in White House visitor logs for this meeting). In August, The Huffington Post’s Ryan Grim reported on an internal memo that was drafted at that meeting that outlined the policies that would not be allowed into any final version of health care reform. These included Medicare prescription drug negotiations, drug re-importation, and the lowering of prices for drugs available through Medicare Part D and Part B. The deal would be $80 billion in cost cutting and absolutely no more.
***
While the $80 billion deal was cut with Baucus’ committee, other congressional committees continued to mark-up their own versions of health care reform without the knowledge that the White House was relying on Baucus to produce the final product. In the House of Representatives, the House Energy & Commerce Committee leveled a direct threat to the $80 billion deal. Energy & Commerce Chair Henry Waxman sought to include all of the provisions that PhRMA had gotten the White House and Baucus to cut out of the reform bill. These included drug reimportation, Medicare negotiating power and speedier release of generics to the market. According to previous analysis of the measures proposed by the committee, these measures would have totaled hundreds of billions in cost cuts, far exceeding the $80 billion cap agreed to by the White House, Baucus and PhRMA.
The cost cutting measures passed in the Energy & Commerce bill spooked the board of PhRMA, which included all of the CEOs involved in the deal-cutting meetings with the White House and Baucus. The board pressured Tauzin to go public with the deal to ensure that the White House would recognize it and not renege. On August 4, the Los Angeles Times, in an exclusive report, featured quotes from Tauzin claiming that a deal between the White House and PhRMA existed and that, as Tauzin put it, “The White House blessed it.” Tom Hamburger wrote in the article, “For his part, Tauzin said he had not only received the White House pledge to forswear Medicare drug price bargaining, but also a separate promise not to pursue another proposal Obama supported during the campaign: importing cheaper drugs from Canada or Europe.”
The White House’s Jim Messina later confirmed Tauzin’s claim, stating, “The president encouraged this approach … He wanted to bring all the parties to the table to discuss health insurance reform.”
Democratic lawmakers were furious. Rep. Raul Grijalva, chairman of the Progressive Caucus, asked, “Are industry groups going to be the ones at the table who get the first big piece of the pie and we just fight over the crust?”
***
On September 7, Baucus’ bill made a private circulation on the Hill; pharmaceutical industry cost-cutting did not exceed $80 billion. Five days later, the New York Times reported that PhRMA planned to spend up to $150 million in an advertising blitz in support of Baucus’ bill. The Times noted that the ad spending “…would be a follow-up to the deal that drug makers struck in June with Mr. Baucus and the White House.” On September 16, Baucus released the full text of his legislation to the public.
The White House, PhRMA and Baucus still had to fight a few battles to keep the deal intact. The key amendment targeting the PhRMA deal in committee mark-up came from Sen. Bill Nelson from Florida, which has one of the largest Medicare participant populations in the nation. The pull of constituent needs clearly put Bill Nelson into a position to push for further cost cutting in Medicare prescription drug pricing. His target: closing the “donut hole” completely.
Nelson claimed that his amendment would generate $106 billion in revenue, or from PhRMA’s perspective increase their cost-cutting to $186 billion. That would be unacceptable to PhRMA, to Baucus, to the White House and to the pharmaceutical industry who had made the deal. Other Senate Democrats, Tom Carper and Robert Menendez voted with Republicans and Baucus on the committee to defeat the amendment. It is little surprise the Carper’s Delaware is home to AstraZeneca and Menendez’ New Jersey is home to Merck and Bristol-Myers-Squibb, all of which lobbied for the $80 billion cap.
Senate Majority Leader Harry Reid introduced the final bill, with the cap in place, on November 19. Debate began on Dec. 3, and with it come one more attempt by members to change the terms of the deal. Senator Byron Dorgan introduced an amendment that would allow for drug re-importation, but as the date for voting drew near, the Federal Drug Administration (FDA) released a letter objecting to the proposal that echoed pharmaceutical industry talking points: “…as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns.” Dorgan’s amendment was defeated with numerous Democrats previously in support of reimportation switching to “no” votes.
On Christmas Eve, the bill passed the Senate with the PhRMA deal fully intact.
***
New Year’s Eve passed with no further action on health care reform. Public opinion regarding the health care reform bill had been slipping throughout 2009. It reached a fulcrum in the special election to replace the deceased senator Ted Kennedy in Massachusetts on January 19, 2010. Newly minted senator Scott Brown campaigned that he would be the senator to provide Republicans with the votes to filibuster the final health care reform bill. Democrats ran for cover. Despite having the largest majorities of any party since the 1970s, Democrats put the brakes on their agenda, particularly health care reform.
In the end, the pharmaceutical industry’s support for health care reform would be left up in the air. After spending $100 million in advertising in support of legislation that Tauzin and key executives hoped would be a windfall for the pharmaceutical industry, the legislative process had flat-lined. In February, the board of PhRMA, split over the deal cut by Tauzin, pushed Tauzin to resign his post.
In an interview with Diane Sawyer, President Obama owed up to failures in the process of passing health care reform, “[T]he health care debate as it unfolded legitimately raised concerns not just among my opponents, but also amongst supporters that we just don’t know what’s going on … And it’s an ugly process and it looks like there are a bunch of back room deals.”
Paul Blumenthal is the Senior Writer at the Sunlight Foundation.
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