by Victoria McGrane
Is libertarian rock star and Texas Republican Ron Paul going mainstream?
He’s got everyone from South Carolina Republican Sen. Jim DeMint to Minnesota moderate Democrat Collin Peterson to California liberal Barbara Boxer on his side in his audit-the-Fed crusade. He’s drawing liberal support in his push to rein in the cost of the war in Afghanistan. Senate candidates like Democratic Rep. Paul Hodes of New Hampshire are finding Dr. No’s populist economic anger to be useful in the campaign, echoing Paul’s criticism of the Federal Reserve.
Even Financial Services Committee Chairman Barney Frank (D-Mass.) is delivering backhanded compliments, taking credit for merely allowing a vote on Paul’s amendment to audit the central bank.
This convergence of odd bedfellows, and the economic angst that’s driving it all, is yet another signal that President Barack Obama is going to have more and more trouble keeping his traditional Democratic allies on his side as the economic debate continues. It seems that everyone is looking for something new to latch on to in the economic debate — even if those ideas belong to one of the more eccentric members of Congress.
“This brought people together [from] the whole political spectrum, from progressives and liberals and libertarians and conservatives. ... they all came together. That, to me, is what is really so important,” said Paul, who has been introducing his audit-the-Fed measure since the early ’80s.
After so many tries, this time Paul’s measure attracted 313 co-sponsors in the House, representing every possible point on the political spectrum. It also scored a strong vote in a key committee and has a companion in the Senate that’s supported by a bipartisan coalition of senators.
And Paul’s economic views, long dismissed by the political establishment, seem to be resonating more broadly than just the audit-the-Fed measure, both in the larger financial reform debate and the growing concern about the cost of continuing the war in Afghanistan.
To be sure, Paul’s bill to abolish the personal income tax or to end the United States’ membership in the United Nations still puts him well outside the mainstream.
But lawmakers — and, more important, the voters they represent — are starting to believe that the financial meltdown and the dramatic government rescue effort seems to have gotten Wall Street back on its feet quite nicely while leaving regular folks on the curb, analysts say.
“On financial regulation matters, most Americans sympathize with Ron Paul’s outrage,” said Cook Political Report House analyst Dave Wasserman.
Take Rep. Alan Grayson (D-Fla.), a firebrand liberal who infamously declared that the Republican health plan is for people to die instead of to use the health system. Despite being on opposite sides of the political universe from Paul on a wide range of issues, Grayson paired up with Paul to help push the amendment version of the Fed audit bill in the House Financial Services Committee.
The committee victory for the Paul-Grayson amendment came at the defeat of a weaker alternative offered by Rep. Mel Watt (D-N.C.) and backed by Frank. In normal times, the Watt amendment was just the kind of chairman-backed compromise Democrats would usually dutifully embrace. Instead the committee, including more than a dozen Democrats, opted 43-26 for the more intrusive Paul-Grayson measure.
"So far, the Federal Reserve has refused to answer questions about special loans and deals for Wall Street banks. I support an audit of the Federal Reserve to provide answers for working families and to protect New Hampshire taxpayer dollars,” said Hodes, a Democrat who is running for Senate in New Hampshire and backed the Fed measure.
Even Frank, who voted against the amendment, went out of his way during committee debate to associate himself with Paul’s effort. And a YouTube video of Frank’s remarks was quickly posted by a top pro-Paul website.
“I do want to claim credit as chairman of the committee for being the first one in 26 years who gave the gentleman from Texas the chance to [offer] this legislation,” said Frank, an expert at reading the political winds.
“I have never been a Fed worshiper,” Frank continued, before explaining his concerns that the amendment in its present form would raise inflationary expectations.
But Paul isn’t stopping with the auditing measure. He sees the other financial reform proposals throughout Congress as adding, not subtracting, from the vast Fed powers. And he has allies in the heart of the Democratic Caucus.
Democrats like Peterson and Maryland Rep. Elijah Cummings, along with liberals such as Ohio Reps. Dennis Kucinich and Marcy Kaptur echo concerns shared by Paul that the Fed gains too much power under the financial reform legislation authored by Frank and the Obama administration. Under Frank’s bill on systemic risk, the Fed would be the primary agent of a new council to regulate big, complex “too big to fail” financial firms, a position that would expand the central bank’s current oversight powers.
“Why are we even thinking about giving more power and authority to the Fed?” Peterson, a rural Democrat, asked during a hearing. “It is one of the more unaccountable parts of federal government. Its governance is influenced more on the wishes of major banks and the American people.”
And Sen. Chris Dodd, a liberal Democrat from Connecticut, surely wouldn’t credit Paul, but his sweeping financial reform draft legislation proposes stripping the Fed from bank oversight powers that the central bank has held since its creation.
Paul’s long-standing critique of American foreign policy has also earned him some new allies. Paul joined Reps. Walter Jones (R-N.C.), Jim McGovern (D-Mass.) and Steve Kagen (D-Wis.) on Nov. 18 in a series of House floor speeches to argue against committing more resources to Afghanistan and Pakistan.
The members of this bipartisan team were all signatories of a Sept. 25 letter to Obama that carried 53 other Republican and Democratic names opposing sending more troops to Afghanistan.
“I don’t think we can win the argument,” Paul recalled telling his three co-speakers as they planned the debate. “But eventually we’ll win — not because they’re going to listen to us and have another foreign policy. But we’re going to win because we don’t have any money, we’re broke and the troops will come home.”
“All empires end through a flawed foreign policy,” Paul said at another point in his interview with POLITICO.
For Paul and his vibrant grass-roots supporters, the next item on the legislative agenda is to continue pushing the Fed audit measure all the way to the president’s desk. Campaign for Liberty, a coalition of pro-Paul activists that grew out of the Texas Republican’s 2008 presidential campaign, has dropped hundreds of thousands of petitions on both sides of Capitol Hill in support of the measure. They and other online groups have been drumming up phone calls to congressional offices as well.
“The Senate’s not as close to the people as the House is, so it’s a little harder,” Paul said. “It will take some work over there; there’s no doubt about it. Believe me, the defenders of the Fed are still around, and we’ll still hear a lot from them.”
There were plenty of cowardly votes in the House last night but there was only one truly brave one. The unsung hero of the night was Ohio Representative Dennis Kucinich. Despite enormous pressure to support H.R. 3962, Rep. Kucinich did the right thing and voted 'no'. Unlike the Blue Dog votes against the bill, he did it for all the right reasons.
In a principled and practical statement, Rep. Kucinich said what a growing number of progressives have realized as we've watched real health care reform be compromised again and again.
During the debate, when the interests of insurance companies would have been effectively challenged, that challenge was turned back. The "robust public option" which would have offered a modicum of competition to a monopolistic industry was whittled down from an initial potential enrollment of 129 million Americans to 6 million. An amendment which would have protected the rights of states to pursue single-payer health care was stripped from the bill at the request of the Administration. Looking ahead, we cringe at the prospect of even greater favors for insurance companies.
Personally, I supported President Obama in the primaries and the election but do not support him on this corporate giveaway built on broken campaign promises. I voted for the Barack Obama who opposed the individual mandate, who said the negotiations would be televised on C-SPAN and who campaigned against backroom deals with PhARMA.
Conservatives have expressed outrage for months about the way the health care bill was handled. Their anti-government anger is misplaced because the lets the insurances and drug companies who really helped drive this bill off the hook. But I understand their sense that this bill was passed despite the people.
Progressives should be every bit as upset that President Obama lied to us to get his historic health bill. The citizens of this country did not have a seat at the table. Proponents of the Single Payer didn't have a seat at the table. Under the guise of health care reform, we watched as the insurance industry got a bill passed that entrenches and enriches them.
Don't let anyone fool you that this bill is a good start. It's got a poison pill "Public Option" that is designed to fail. As the brilliant RJ Eskow wrote recently about the House bill's public option,
The plan will have low enrollment and little power to negotiate, causing the CBO to state as fact what I've long considered possible: That the public option could become a dumping ground where private plans jettison sicker people, while lacking the efficiencies of scale or negotiating power to get better rates or administer itself more economically.
As a result, says the CBO, a public plan's premiums might be higher than private insurance. While the CBO's word isn't gospel, it's entirely possible that they're underestimating the cost of any "public option" we're likely to see this year. The likeliest political outcome, once the House and Senate bills are combined, is a non-robust "public option" with a state-by-state opt out. The CBO didn't consider the opt-out when it came up with its shocking (to some) estimate.
Even if it passes in its weak form, this Public Option will be the target of the GOP for years and they won't rest until it is dead. As the Public Option kicks into gear, they will find stories of 'rationing' and denial of care they can highlight, true or not. They will use the higher costs as proof of the Public Option's folly. They will grind away at the Public Option relentlessly but they will leave the Individual Mandate alone. If anything, once the Mandate is in place, the Republicans will make sure the insurance industry is 'free to compete' and unrestricted.
The corporate interests that spend millions to influence the media and both political parties want you to ignore Congressman Kucinich. Too many Democrats unwittingly help them. Don't be a patsy.
People like Dennis Kucinich, Ralph Nader and Michael Moore have been made pariahs by establishment Democrats. They have all been marginalized and made fun of...but check their records. They have been considered 'fringe' because they are telling us the truth about corporate abuses of power long before most of the rest of us catch up to the reality of what's happened.
If enough of us stand with Dennis Kucinich, maybe we'll actually get real health care reform. If we don't, maybe we don't deserve that reform.
]]>It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.
In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.
New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.
What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.
On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.
Record High Fine
For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states.
“At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004, Pfizer was itself in its other operations violating those very same laws,” Loucks, 54, says. “They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.”
The penalties Pfizer paid this year for promoting Bextra off-label were the latest chapter in the drug’s benighted history. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.
Across the U.S., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of chest infections, heart attacks, suicidal impulses or death.
$7 Billion in Penalties
Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.
In September 2007, New York-based Bristol-Myers paid $515 million -- without admitting or denying wrongdoing -- to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases.
In January 2009, Indianapolis-based Lilly, the largest U.S. psychiatric drug maker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients.
In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia -- twice the death rate for those taking a placebo. Those findings were reported in an October 2005 article in the Journal of the American Medical Association.
‘Don’t Respect the Law’
“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law,” says Jerry Avorn, a professor at Harvard Medical School in Boston and author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs” (Random House, 2004). “The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”
The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.
“It’s an unbearable cost to a system that’s going broke,” says Avorn, who heads the pharmacology economics unit of Brigham and Women’s Hospital in Boston. “We can’t even afford to pay for effective, safe therapies.”
10 Million Prescriptions
About 15 percent of all drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work, according to a study by Randall Stafford, a medical professor at Stanford University in Palo Alto, California.
He estimates that doctors write more than 10 million such prescriptions each year.
As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms’ annual revenues.
The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.
The total of $2.75 billion Pfizer has paid in off-label penalties since 2004 is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.
$36 Billion in Revenue
Lilly already had a criminal conviction for misbranding a drug when it broke the law again in promoting schizophrenia drug Zyprexa for off-label uses starting in 1999. The medication provided Lilly with $36 billion in revenue from 2000 to 2008.
That’s more than 25 times as much as the total penalties Lilly paid in January.
Companies regard the risk of multimillion-dollar penalties as just another cost of doing business, says Lon Schneider, a professor at the University of Southern California’s Keck School of Medicine in Los Angeles.
In 2006, he led a study for the National Institute of Mental Health of off-label use of drugs, including Zyprexa, for the treatment of Alzheimer’s disease.
“There’s an unwritten business plan,” he says. “They’re drivers that knowingly speed. If stopped, they pay the fine, and then they do it again.”
Shareholders Unmoved
Schneider has been paid both by Lilly as a consultant and by plaintiffs suing the company.
Big Pharma’s off-label transgressions didn’t trigger a rush for the doors by shareholders. From Jan. 26, when Pfizer announced that it would pay billions in penalties, to Oct. 12, Pfizer’s share price increased 9.3 percent, just shy of the 11.2 percent rise in the Standard & Poor’s 500 Health Care Index.
From Oct. 21, 2008, when Lilly said it would pay its penalties, to Oct. 12, the company’s stock value went up 0.6 percent; the S&P index gained 6.9 percent in that time.
In pushing off-label use of drugs, companies find ready and willing partners in physicians. Under the fragmented system of medical regulation in the U.S., it’s legal for doctors to prescribe FDA-approved drugs for any use.
The FDA has no authority over doctors, only over drug companies, regarding off-label practices. It’s up to the 50 states to oversee physicians.
“I think the physician community has to take some ownership responsibility and do their own due diligence beyond the sales and marketing person,” says Boston’s former U.S. Attorney Michael Sullivan.
Off-Label Benefits
Loucks says prosecutors realize that patients can benefit when doctors use drugs for off-label purposes based on science and not on false marketing claims.
Doctors generally don’t tell people that they’re prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments, says Peter Lurie, deputy medical director of Public Citizen, a Washington-based public interest group.
Most physicians don’t keep track of FDA-approved uses of drugs, says Lurie, a physician who has published articles in “The Lancet” and the “Journal of the American Medical Association.”
“The great majority of doctors have no idea; they don’t even understand the distinction between on- and off-labeling,” Lurie says.
Pharmaceutical companies have showered doctors with cash to persuade them to use drugs off-label, according to their guilty pleas.
‘Buying Access’
Pfizer’s marketing program offered doctors up to $1,000 a day to allow a Pfizer salesperson to spend time with the physician and his patients, according to a whistle-blower lawsuit filed by John Kopchinski, who worked as a salesman at Pfizer from 1992 to 2003.
“By ‘pairing up’ with a physician, the sales representative was able to promote over a period of many hours, without the usual problems of gaining access to prescribing physicians,” Kopchinski says. “In essence, this amounted to Pfizer buying access to physicians.”
Pfizer spokesman Chris Loder says the company stopped what it calls “mentorships” in 2005. He says Pfizer paid doctors $250 per visit.
It used to be legal for companies to promote drugs for any use in the U.S. Congress banned the practice in 1962. The catalyst was Thalidomide, a morning sickness drug taken by pregnant women outside the U.S. that caused severe birth defects.
Recouping Investments
The 1962 law required pharmaceutical companies to prove their drugs were safe and effective for specific uses. Before that, a drug company could market an approved medicine for any illness.
If the law is clear, why do drug companies keep breaking it? The answer lies in economics. Pharmaceutical companies spend about $1 billion to develop and test a new drug. To recoup their investment, the companies want doctors to prescribe their drugs as widely as possible.
Pfizer’s Neurontin is a case in point. The FDA approved the drug as a supplemental medication in treating epilepsy in 1993. Pfizer took in $2.27 billion from sales of Neurontin in 2002. A full 94 percent -- $2.12 billion -- of that revenue came from off-label use, according to the prosecutors’ 2004 Pfizer sentencing memo.
Pfizer, which bought Wyeth on Oct. 15 for $68 billion, put itself at the center of illegal off-label drug marketing with an acquisition frenzy a decade earlier. From 1995 to 2005, Pfizer purchased more than 20 companies.
Guilty Pleas
Since 2004, companies that are now Pfizer divisions have pleaded guilty to off-label marketing of two drugs. Pfizer continued off-label promotions for these medications after buying the firms, according to Pfizer’s Sept. 2 guilty plea and FDA correspondence with Pfizer.
Pfizer first stepped into an off-label scheme in 1999, when it offered to buy Morris Plains, New Jersey-based Warner-Lambert Co. Prosecutors charged that Warner-Lambert marketed Neurontin off-label between 1995 and 1999.
Warner-Lambert admitted doing so for one year in a May 2004 guilty plea for which Pfizer paid $430 million in fines and penalties.
Neurontin, which was invented by Warner-Lambert, was first tested in humans in 1987. When the FDA approved it in 1993 to be used only along with other epilepsy drugs, the agency wrote that a side effect of the drug can be that it induces depression and suicidal thoughts in patients.
Whistle-Blower
Much of what prosecutors learned about Warner-Lambert’s marketing of Neurontin comes from a former employee.
David Franklin, who holds a Ph.D. in microbiology from the University of Rhode Island, left his job as a pediatric researcher at Harvard University’s Dana-Farber Cancer Institute in 1996 to work for the Parke-Davis unit of Warner-Lambert in Boston.
He says he hoped the salary boost -- to $55,000 annually from $18,000 -- would help him pay off student loans and better support his family.
Franklin’s title at Warner-Lambert was medical liaison. He says he soon realized his new employer viewed his doctorate as a badge that would allow him to strike up conversations with physicians.
Franklin, 48, says his job involved more salesmanship than science. He told doctors that Neurontin was the best drug for a dozen off-label uses, including pain relief, bipolar disease and depression.
‘What I Did Was Wrong’
“Technically, I had responsibility for answering physician questions about all of Parke-Davis’s drugs,” Franklin says. “In practice, my real job was to promote Neurontin for off- label indications heavily -- to the exclusion of just about everything else.”
Franklin, whose wife is a lawyer, says he knew such uses of the drug had no scientific support for effectiveness and safety.
“I was actually undermining their ability to fulfill the Hippocratic oath,” Franklin says, referring to a physician’s pledge to “first, do no harm.”
Franklin says he was horrified when he learned from a doctor that a child had a behavioral outburst at school for the first time after taking Neurontin.
“Don’t we have an obligation to tell physicians about this?” Franklin says he asked his manager, Phil Magistro. His boss tried to reassure him, Franklin says.
‘Total Disregard’
“‘Don’t worry about this stuff,’” he says Magistro told him. “‘It can never get back to us.’”
Franklin was stunned.
“I realized at that moment, looking into his eyes, that there was an absolute total disregard for the patient,” he says.
Magistro, who now works at drug marketing adviser Atom Strategic Consulting LLC in Randolph, New Jersey, didn’t return calls seeking comment.
Franklin saved phone messages from Magistro to his sales team urging them to market Neurontin for off-label uses, including pain relief. During one such call, on May 23, 1996, at 5:48 p.m. in Boston, Magistro told his staff, “You’re supposed to be pushing on Neurontin,” according to a transcript of the tape filed in federal court.
“When we get out there, we want to kick some ass. We want to sell Neurontin on pain,” Magistro said. “All right?”
Quit the Job
After working for Warner-Lambert for three months, Franklin grew concerned about his own liability. He quit the job and talked with Boston attorney Thomas Greene, who helped him file a lawsuit against the company.
Franklin acted as a whistle-blower, suing on behalf of taxpayers to recover money the government paid for illegally promoted drugs. Under federal and state whistle-blower statutes, he stood to collect as much as 30 percent of any settlement the company made with the government.
Franklin had to wait four years -- until 2000 -- before the Justice Department began a criminal investigation. In November 1999, Pfizer made its public offer to buy Warner-Lambert. In January 2000, a federal grand jury in Boston issued subpoenas to Warner-Lambert employees to testify about the marketing of Neurontin.
That March, Warner-Lambert’s annual report disclosed that prosecutors were building a criminal case. Undeterred, Pfizer bought Warner-Lambert in June for $87 billion. It was the third- largest merger in U.S. history.
‘Misleading and in Violation’
A year after the acquisition, the FDA discovered that Neurontin was still being marketed off-label. In a letter to the company on June 29, 2001, the agency wrote that Pfizer’s promotion of the drug “is misleading and in violation of the Federal Food, Drug and Cosmetics Act.”
The agency asked Pfizer to stop such promotions of Neurontin. The FDA said Pfizer had distributed brochures -- known as “slim jims” because they’re small enough to put in a jacket pocket -- improperly claiming that the drug could improve energy levels and memory.
“Immediately discontinue the use of this slim jim and any other promotional material or practices with the same or similar messages,” the FDA wrote.
Pfizer marketed Neurontin off-label after receiving that letter, agency records show. For 2001, Pfizer reported revenue of $1.75 billion from Neurontin sales, making it the company’s fourth-largest-selling drug that year, ahead of impotence pill Viagra, which Neurontin topped for four years.
Marketing Violated Rules
As Neurontin sales soared to $2.27 billion in 2002, the FDA found that Pfizer was improperly claiming that the drug was useful for a broader range of brain disorders than scientific evidence had established.
The agency sent a letter dated July 1, 2002, that said the company’s marketing practices were in violation of FDA rules. It asked Pfizer to stop using misleading promotions. Pfizer reported $2.7 billion in revenue from Neurontin in 2003. Overall, the drug has provided Pfizer with $12 billion in revenue.
In a response to Bloomberg News, Pfizer spokesman Chris Loder said, “Regarding the 2001 and 2002 FDA letters, we do not believe that they were suggestive of any continuing off-label promotion.”
For blowing the whistle on his employer, Franklin collected $24.6 million under the False Claims Act.
Prosecutors Loucks and Sullivan got involved in the case after Franklin filed his suit, relying on information from Franklin and their own investigation. Before 2004, prosecutions for off-label marketing were rare.
‘Everybody Does It’
“Until a couple of these cases became public, companies were probably saying, ‘Everybody does it this way,’” Sullivan says.
Loucks had a track record in off-label prosecutions. He gave up private practice at Choate Hall & Stewart LLP in Boston in 1985 to join the U.S. Attorney’s Office.
In 1994, he negotiated a $61 million settlement with Murray Hill, New Jersey-based C.R. Bard Inc., which pleaded guilty to promoting off-label use of a heart catheter that led to patient deaths.
In 2002, he co-authored, with Carol Lam, “Prosecuting and Defending Health Care Fraud Cases” (BNA Books).
In the January 2004 settlement negotiations with Loucks, Sullivan and two other prosecutors, Pfizer’s lawyers assured the U.S. Attorney’s Office that the company wouldn’t market drugs off-label.
‘Those Promises’
“They asserted that the company understood the rules and had taken steps to assure corporate compliance with the law,” Loucks says. “We remember those promises.”
What Pfizer’s lawyers didn’t tell the prosecutors was that Pfizer was at that moment running an off-label marketing promotion using more than 100 of its salespeople. They were pitching Bextra, a Pfizer sales manager admitted when she pleaded guilty to misbranding a drug on March 30, 2009.
Jeff Kindler, who became Pfizer’s general counsel in 2002, supervised the lawyers who made the promises to prosecutors. By 2004, Kindler increased the compliance budget 12-fold. He became chief executive officer in 2006. In Pfizer’s ethics guide, he says stories about misbehaving companies and executives abound.
“Pfizer truly stands apart,” he says. “I am proud of our record.” On Oct. 1, Kindler was elected to the board of the Federal Reserve Bank of New York. Kindler declined to comment.
Peapack, New Jersey-based Pharmacia & Upjohn Inc. developed Bextra, which was approved by the FDA only for the treatment of arthritis and menstrual discomfort in 2001.
Sales Manager Pleads Guilty
P&U and Pfizer had by then already crafted a joint marketing agreement to sell the drug. In November 2001, Mary Holloway, a Pfizer regional manager for the Northeastern U.S., began illegally training and directing her sales team to market Bextra for the relief of acute pain, Holloway admitted in a March 2009 guilty plea.
On Dec. 4, 2001, Pfizer executives sent Holloway a copy of a nonpublic letter from the FDA to the company. The agency had denied Pfizer’s application to market Bextra for acute pain. Clinical trials had shown Bextra could cause heart damage and death.
Pfizer bought Pharmacia & Upjohn in April 2003. From 2001 to the end of 2003, P&U, first as an independent company and then as a unit of Pfizer, paid physicians more than $5 million in cash to lure them to resorts, where salespeople illegally pitched off-label uses for Bextra, P&U admitted in its Sept. 2 guilty plea.
‘Golf, Massages’
“Pharmacia paid targeted physicians both airfare and two to three days’ accommodations at lavish resorts in the Bahamas, Virgin Islands and across the United States and further entertained these physicians with golf, massages and other recreation activities,” according to prosecutors’ findings.
In her guilty plea, Holloway said her team had solicited hospitals to create protocols to buy Bextra for the unapproved purpose of acute pain relief. Her representatives didn’t mention the increased risk of heart attacks in their marketing.
They told doctors that side effects were no worse than those of a sugar pill, Holloway admitted in her guilty plea.
In 2003, Holloway reported her unit’s off-label promotions of Bextra up the corporate ladder at Pfizer, according to a pre- sentencing memo to the judge written by Robert Ullmann, Holloway’s attorney. Top managers didn’t attempt to halt the illegal conduct, the memo said.
“Corporate tracked this information, and at no time did it inform Ms. Holloway that any of the reported protocols were inappropriate,” he wrote. “Instead, the instruction was to get more protocols.”
Blockbuster Status
By the end of 2004, Bextra reached blockbuster status, with annual sales of $1.29 billion. Holloway promoted Bextra until the FDA asked Pfizer in April 2005 to pull it from the market for all uses, evidence in her case shows.
The agency concluded that the drug increased the risk of heart attacks, chest infections and strokes in cardiac surgery patients. In June 2009, Holloway, 47, was sentenced to two years on probation and fined $75,000. She didn’t return phone calls seeking comment.
Ronald Rainero, a Pfizer district sales manager and employee for more than 20 years, says he was responsible for promoting Bextra in New York from 2001 to 2005. In September 2007, Rainero, 47, began cooperating with federal prosecutors on the Bextra case.
Hotel Meetings
He says he met monthly with his fellow managers at a Hilton hotel in Staten Island, New York, to discuss sales methods of promoting Bextra off-label. As a whistle-blower, Rainero was awarded $9.3 million as part of the September settlement.
In the same time period that Pfizer was marketing Bextra off-label, the company’s sales force was promoting another drug, Zyvox, improperly, Pfizer admitted at the time of its September plea agreement.
Zyvox was approved in 2000 by the FDA for treating MRSA- caused pneumonia and skin infections. Raniero told federal prosecutors that Pfizer began the Zyvox campaign in 2001. The company admitted to falsely claiming that the drug was better than other medications for treating MRSA pneumonia.
Pfizer told doctors to use Zyvox rather than vancomycin, a generic antibiotic that cost $18 a day. Pfizer sold Zyvox for about $150 a day. A table on page 30 of a 35-page fact book produced by Pfizer for Zyvox says the drug is less effective than vancomycin for MRSA pneumonia.
‘Misleading Promotion’
On July 20, 2005, the FDA sent a letter to Hank McKinnell, then Pfizer’s CEO, saying, “Your misleading promotion of Zyvox, and in particular your unsubstantiated implied claims regarding its superiority to vancomycin, poses serious health and safety concerns.”
The agency ordered the company to stop the promotion. In response, Pfizer told the FDA it would stop saying Zyvox was more effective against MRSA pneumonia than vancomycin.
Despite its 2005 pledge to the FDA, Pfizer continued to tell hospitals and doctors that Zyvox would save more lives than vancomycin, the company admitted in the September settlement.
By 2007, the criminal and civil cases against Pfizer, its employees and its subsidiaries had started to mount. The tally of drugs cited by federal prosecutors for off-label promotion reached six by 2009. In April 2007, P&U pleaded guilty to a felony charge of offering a $12 million kickback to a pharmacy benefit manager.
$2.2 Billion in Penalties
Pfizer paid a criminal fine of $19.7 million. Thomas Farina, a Pfizer district sales manager, was convicted in federal court in March 2009 for destroying records during the Bextra investigation. Farina, 42, was sentenced to three years on probation, including six months of home confinement. He didn’t return calls seeking comment.
Pfizer itself was called to account on Sept. 2, when it agreed to pay the $2.2 billion in fines and penalties. P&U pleaded guilty to a felony charge of misbranding Bextra with the intent to defraud. After the settlement, Pfizer general counsel Amy Schulman said the company had learned its lesson.
“We regret certain actions we’ve taken in the past,” she said. “Corporate integrity is an absolute priority for Pfizer.”
One reason drug companies keep breaking the law may be because prosecutors and judges have been unwilling to use the ultimate sanction -- a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.
“It’s potentially a death sentence for a drug company,” prosecutor Sullivan says.
Fig Leaf
A legal fig leaf allows a parent company to continue to participate in government programs even after its subsidiary has pleaded guilty.
Pfizer maintains its good standing with such agencies because its subsidiaries, Warner-Lambert and P&U, and not the corporation itself, entered the guilty pleas to felony charges.
A felony conviction of a pharmaceutical giant could lead to disaster for shareholders, Loucks says, adding that’s a step that may have to be taken for repeat offenders.
“I think it’s something the trigger will get pulled on,” he says from his ninth-floor office in the federal courthouse, with a sweeping view of Boston Harbor. “It’s just a question of when.”
At Pfizer’s Pharmacia sentencing on Oct. 16., U.S. District Court Judge Douglas Woodlock said companies don’t appear to take the law seriously.
“It has become something of a cost of doing business for some of these corporations, to shed their skin like certain animals and leave the skin and move on,” he said.
Eli Lilly
Lilly’s rap sheet goes back to 1985. That’s when the company pleaded guilty to 25 federal misdemeanor charges related to its misbranding of Oraflex, an arthritis drug.
Lilly stopped selling the drug four months after U.S. sales began in 1982, following the company’s failure to tell the FDA about illnesses and deaths tied to the medication. Lilly paid a $25,000 fine.
Twenty years later, in 2005, Lilly paid $36 million in a guilty plea to one federal misdemeanor for off-label marketing of Evista, a drug the FDA had approved for bone strengthening.
In 1997, the agency had rejected Lilly’s application to market the drug to reduce the risk of breast cancer. Yet beginning the next year, Lilly adopted an Evista marketing plan that included a seminar with doctors designed to appeal to women’s breast cancer concerns, Lilly admitted in its 2005 guilty plea.
In 2007, the FDA approved Evista for preventing breast cancer in two limited groups.
Back in Court
In January 2009, Lilly was back in federal court. Prosecutors in Philadelphia accused the company of earning hundreds of millions of dollars by illegally promoting its schizophrenia drug Zyprexa for the unapproved treatment of dementia from 1999 to at least 2003.
In 2001, Lilly’s senior management decided not to seek FDA approval for Zyprexa to treat dementia because of what they viewed as mixed results in clinical trials and safety risks, according to admissions by Lilly in its 2009 guilty plea. In its marketing, Lilly promoted the drug as effective.
Zyprexa has been Lilly’s best-selling drug for the past decade.
“Eli Lilly undertook this illegal off-label promotion for its own financial gain despite the potential risk to patients’ health and lives,” prosecutors wrote in their sentencing memo.
Lilly Chairman and CEO John Lechleiter said after the settlement that the company was devoted to acting responsibly.
‘Deeply Regret’
“We deeply regret the past actions covered by the misdemeanor plea,” he said. “Doing the right thing is nonnegotiable at Lilly.”
In a written response to questions from Bloomberg News, Lilly said, “Lilly entered into a very narrow guilty plea. Even though the company disagrees with and does not admit to the allegations, Lilly agreed to settle the dispute.”
Lilly paid $1.42 billion for a fine and penalties in the January settlement with federal and state governments. That included the largest criminal fine in U.S. history -- until Pfizer pleaded guilty in September.
The Justice Department could have charged Lilly with a felony. Prosecutors decided that it wouldn’t be fair to innocent Lilly employees, shareholders and pensioners to potentially shut down the company, according to the sentencing memo.
‘All the Factors’
“The government considered all the factors in its decision,” prosecutors wrote. “Those factors included other persons not proven personally culpable.”
Federal regulators have detected a similar pattern of dishonesty by other pharmaceutical firms. Schering-Plough Corp. drug salesmen pitched off-label uses of a cancer drug called Temodar at the American Society of Clinical Oncology’s annual conference in San Francisco in May 2001.
Schering-Plough representatives said Temodar compared favorably to a placebo in clinical trials for the off-label uses and was approved by the FDA for first-line use in treating brain tumors.
An FDA employee attending the conference took note. The next month, the FDA accused Schering of lying.
There had been no such clinical trials and the agency had not approved Temodar as the salespeople had claimed, the FDA said in a June 28, 2001, letter to Mary Jane Nehring, Schering’s senior director of marketed products. The agency ordered the company to immediately cease illegal promotion of Temodar.
Kenilworth, New Jersey-based Schering-Plough was quick to respond. On July 12, 2001, it wrote back to the FDA, assuring regulators that the San Francisco activity was an isolated incident.
‘Certainly Inconsistent’
“It was certainly inconsistent with the direction provided by the home office,” the drug company wrote, according to prosecutor’s records.
The FDA told Schering-Plough three weeks later that it had closed its investigation.
Schering-Plough didn’t stop pitching the drug for unapproved uses. At the direction of top management, Schering ordered widespread off-label marketing of Temodar and Intron A, another cancer drug, until December 2003, the company admitted in an August 2006 guilty plea.
Schering, which agreed in March to be acquired by Merck & Co., earned a pre-tax profit of $124.2 million from the illegal sales after promising the FDA in 2001 it would stop marketing for off-label uses, the company admitted.
Schering-Plough pleaded guilty in August 2006 to conspiring to make false statements to the FDA. The company agreed to pay $435 million to settle the case.
‘Upsetting to Me’
U.S. District Court Judge Patti Saris, who had presided over the Neurontin whistle-blower case before the Pfizer probe, accepted Schering’s plea in her Boston courtroom in January 2007. She expressed dismay with the drug industry.
“It’s been upsetting to me how many of the big pharmaceutical companies have engaged in what I view as clearly illegal behavior in terms of off-label marketing,” she said. “It almost seems as if the pharmaceutical companies said ‘Yeah, yeah, yeah’ to the FDA and then went and did it anyway.”
Brent Saunders, a Schering-Plough senior vice president, said after the settlement that his company had made great progress in putting integrity at the center of its work.
“With this agreement, we are putting issues from the past behind us,” he said. Schering declined to comment further.
As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark. Doctors often choose the medications based on dishonest marketing by drug company salesmen.
‘A Morass’
“It’s a morass of undifferentiated information out there,” Public Citizen’s Lurie says. “And the doctors, let alone patients, aren’t able to distinguish the good from the bad.”
One thing all people should do, Lurie says, is ask whether their prescriptions are for FDA-approved uses, and if not, whether strong evidence supports using the drug, particularly if it can be dangerous.
Loucks says that putting an end to the criminal off-label schemes by the pharmaceutical industry is more difficult. As drugmakers repeatedly plead guilty, they’ve shown they’re willing to pay hundreds of millions of dollars in fines as a cost of generating billions in revenue.
The best hope, Loucks says, is that drug companies actually honor the promises they keep making -- and keep breaking -- to obey the law of the land.
To contact the reporter on this story: David Evans in Los Angeles at davidevans@bloomberg.net
]]>Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.
Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.
“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.
Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.
She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”
There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.
Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.
Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”
Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”
However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”
Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.
This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old “is a great big public health experiment.”
At the time, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”
“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”
When asked why she was speaking out, she said: “I want to be able to sleep with myself when I go to bed at night.”
Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.
Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.
The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: "The rate of serious adverse events is greater than the incidence rate of cervical cancer."
Ms. Robinson said she respects Dr. Harper’s candor. “I think she’s a scientist, a researcher, and she’s genuine enough a scientist to be open about the risks. I respect that in her.”
However, she failed to make the case for Gardasil. “For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”
In reality, aspartame is a drug, not an additive in the sense many people associate with that word. It interacts with other drugs, has a synergistic and additive effect with MSG, and is a chemical hyper-sensitization agent. Dr. John Olney, who founded the field of neuoscience called excitotoxicity, attempted to stop the approval of aspartame with Attorney James Turner back in 1996. The FDA's own toxicologist, Dr. Adrian Gross told Congress that without a shadow of a doubt, aspartame can cause brain tumors and brain cancer and violated the Delaney Amendment which forbids putting anything in food that is known to cause Cancer. Detailed information on this can be found in the Bressler Report (FDA report on Searle).
Dr. Olney isn't alone in attempting to reach out to the medical community and warn the American people about this drug. Dr. Ralph Walton, Professor and Chairman of the Department of Psychiatry, Northeastern Ohio Universities College of Medicine has written of the behavioral and psychiatric problems triggered by aspartame-caused depletion of serotonin.
According to the top doctors and researchers on this issue, aspartame causes headache, memory loss, seizures, vision loss, coma and cancer. It worsens or mimics the symptoms of such diseases and conditions as fibromyalgia, MS, lupus, ADD, diabetes, Alzheimer's, chronic fatigue and depression. Further dangers highlighted is that aspartame liberates free methyl alcohol. The resulting chronic methanol poisoning affects the dopamine system of the brain causing addiction. Methanol, or wood alcohol, constitutes one third of the aspartame molecule and is classified as a severe metabolic poison and narcotic.
Dr. Woodrow Monte in the peer reviewed journal, Aspartame: Methanol and the Public Health, wrote: "When diet sodas and soft drinks, sweetened with aspartame, are used to replace fluid loss during exercise and physical exertion in hot climates, the intake of methanol can exceed 250 mg/day or 32 times the Environmental Protection Agency's recommended limit of consumption for this cumulative poison."
Neurosurgeon Russell Blaylock, MD, author of "Excitotoxins: The Taste That Kills," wrote about the relationship between aspartame and macular degeneration, diabetic blindness and glaucoma (all known to result from excitotoxin accumulation in the retina).
The medical text, Aspartame Disease: An Ignored Epidemic, by Dr. H. J. Roberts is 1038 pages of symptoms and diseases triggered by this neurotoxin. The claim is made that aspartame has even caused the epidemic of obesity because it makes you crave carbohydrates so you gain weight, and the formaldehyde accumulates in the adipose tissue (fat cells) according to the Trocho Study. Further accusations are that aspartame is also responsible for the epidemic of diabetes as it not only can precipitate diabetes but simulates and aggravates diabetic retinopathy and neuropathy, can cause diabetics to go into convulsions and interacts with insulin.
The effects of aspartame are documented by the FDA's own data. In 1995 the agency was forced, under the Freedom of Information Act, to release a list of ninety-two aspartame symptoms reported by thousands of victims. It appears this is only the tip of the iceberg. H. J. Roberts, MD, published the medical text "Aspartame Disease: An Ignored Epidemic" -- 1,000 pages of symptoms and diseases triggered by this neurotoxin including the sordid history of its approval. [See Video "Sweet Misery, a Poisoned World"]
Since its discovery in 1965, controversy has raged over the health risks associated with the sugar substitute. From laboratory testing of the chemical on rats, researchers have discovered that the drug induces brain tumors. On Sept 30, 1980 the Board of Inquiry of the FDA concurred and denied the petition for approval.
In 1981, the newly appointed FDA Commissioner, Arthur Hull Hayes, ignored the negative ruling and approved aspartame for dry goods. As recorded in the Congressional Record of 1985, then CEO of Searle Laboratories Donald Rumsfeld said that he would "call in his markers" to get aspartame approved. Rumsfeld was on President Reagan's transition team and a day after taking office appointed Hayes. No FDA Commissioner in the previous sixteen years had allowed aspartame on the market.
Dr. Betty Martini has worked in the medical field for 22 years. She is the founder of Mission Possible International, working with doctors around the world in an effort to remove aspartame from food, drinks and medicine. According to Dr. Martini, aspartame has brought more complaints to the American Food and Drug Administration than any other additive and is responsible for 75% of such complaints to that agency. From 10,000 consumer complaints FDA compiled a list of 92 symptoms, including death.
The history of aspartame and its approval has a political history as well as a scientific one. According to Dr. Martini,
"When Donald Rumsfeld was CEO of Searle, that conglomerate manufactured aspartame. For 16 years the FDA refused to approve it, not only because its not safe but because they wanted the company indicted for fraud. Both U.S. Prosecutors hired on with the defense team and the statute of limitations expired. They were Sam Skinner and William Conlon. Skinner went on to become Secretary of Transportation squelching the cries of the pilots who were now having seizures on this seizure triggering drug, aspartame, and then Chief of Staff under President Bush's father. Some of these people reach high places. Even Supreme Justice Clarence Thomas is a former Monsanto attorney. (Monsanto bought Searle in 1985, and sold it a few years ago). When Ashcroft became Attorney General, Thompson from King and Spalding Attorneys (another former Monsanto attorney) became deputy under Ashcroft. (Attorneys for NutraSweet and Coke).
"However, the FDA still refused to allow NutraSweet on the market. It is a deadly neurotoxic drug masquerading as an additive. It interacts with all antidepressants, L-dopa, Coumadin, hormones, insulin, all cardiac medication, and many others. It also is a chemical hyper sensitization drug so that it interacts with vaccines, other toxins, other unsafe sweeteners like Splenda which has a chlorinated base like DDT and can cause auto immune disease. It has a synergistic and additive effect with MSG. Both being excitotoxins, the aspartic acid in aspartame, and MSG, the glutamate people were found using aspartame as the placebo for MSG studies, even before it was approved. The FDA has known this for a quarter of a century and done nothing even though its against the law. Searle went on to build a NutraSweet factory and had $9 million worth of inventory.
"Donald Rumsfeld was on President Reagan's transition team and the day after he took office he appointed an FDA Commissioner who would approve aspartame. The FDA set up a Board of Inquiry of the best scientists they had to offer who said aspartame is not safe and causes brain tumors, and the petition for approval is hereby revoked. The new FDA Commissioner, Arthur Hull Hayes, over-ruled that Board of Inquiry and then went to work for the PR Agency of the manufacturer, Burson-Marstellar, rumored at $1000.00 a day, and has refused to talk to the press ever since.
"There were three congressional hearings because of the outcry of the people being poisoned. Senator Orrin Hatch refused to allow hearings for a long time. The first hearing was in 1985, and Senator Hatch and others were paid by Monsanto. So the bill by Senator Metzenbaum never got out of committee. This bill would have put a moratorium on aspartame, and had the NIH do independent studies on the problems being seen in the population, interaction with drugs, seizures, what it does to the fetus and even behavioral problems in children. This is due to the depletion of serotonin caused by the phenylalanine in aspartame."
According to a press release put out by the National Justice League on April 26, 2004, lawsuits were filed in three separate California courts against twelve companies who either produce or use the artificial sweetener aspartame as a sugar substitute in their products: Defendants in the lawsuits include Coca-cola, PepsiCo, Bayer Corp., the Dannon Company, William Wrigley Jr. Company, Walmart, ConAgra Foods, Wyeth, Inc., The NutraSweet Company, and Altria Corp. (parent company of Kraft Foods and Philip Morris).
The suits allege that the food companies committed fraud and breach of warranty by marketing products to the public such as diet Coke, diet Pepsi, sugar free gum, Flintstone's vitamins, yogurt (including Yoplait) and children's aspirin with the full knowledge that aspartame, the sweetener in them, is neurotoxic.
Dr. Martini recommends that consumers read all labels on any food, medicine or drinks they intend to consume.
© 2004 - NewsWithViews.com - All Rights Reserved
]]>The dangers of aspartame poisoning have been a well-guarded secret since the 1980s. The research and history of aspartame is conclusive as a cause of illness and toxic reactions in the human body. Aspartame is a dangerous chemical food additive, and its use during pregnancy and by children is one of the greatest modern tragedies of all.
Why haven't you heard about this before? Partly because the diet industry is worth trillions of American dollars to corporations, and they want to protect their profits by keeping the truth behind aspartame's dangers hidden from the public. When NutraSweet® was introduced for the 'second' time in 1981, a diet craze revolutionized America's eating protocols and a well-oiled money machine was set into motion changing modern lifestyles. After more than twenty years of aspartame use, the number of its victims is rapidly piling up, and people are figuring out for themselves that aspartame is at the root of their health problems. Patients are teaching their doctors about this nutritional peril, and they are healing themselves with little to no support from traditional medicine.
Read the full story at www.sweetpoison.com
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You have probably seen your nurse insert a syringe into a large vial, extract some liquid, and then leave a substantial amount of vaccine in the original container. If you've witnessed this seemingly benign procedure, you've seen how vaccine manufacturers are saving money at the expense of public health. In order to store larger amounts of vaccine at a lower cost, companies began offering "multi-dose units" while adding preservatives to prevent contaminations. That way doctors can open and close a vaccine container, inviting germs into the once-sterile solution, while assuring the public that those contaminants are quickly killed by the preservative.
Sound familiar? It's the same story of corporate America's love affair with preservatives. It saves them money, while posing an undue risk to your health. But like many toxic preservatives found in food, a vaccine preservative kills more than just bacteria and fungi; it can lead to extensive neurological damage in your children, and has even been implicated in autism.
Thimerosal
Thimerosal is the preservative of choice for vaccine manufacturers. First introduced by Eli Lilly and Company in the late 1920s and early 1930s, the company began selling it as a preservative in vaccines in the 1940s. Thimerosal contains 49.6 percent mercury by weight and is metabolized or degraded into ethylmercury and thiosalicylate. Mercury, or more precisely, ethylmercury, is the principle agent that kills contaminants. Unfortunately, mercury also kills much more than that.
The Department of Defense classifies mercury as a hazardous material that could cause death if swallowed, inhaled or absorbed through the skin. Studies indicate that mercury tends to accumulate in the brains of primates and other animals after they are injected with vaccines. Mercury poisoning has been linked to cardiovascular disease, autism, seizures, mental retardation, hyperactivity, dyslexia and many other nervous system conditions. That's why the FDA rigorously limits exposure to mercury in foods and drugs. Some common sources of mercury include dental amalgam fillings, various vaccines and certain fish contaminated by polluted ocean waters.
The toxicity of mercury has never been in question. The real question is precisely how much mercury-laced thimerosal is toxic, and what are the possible consequences for our children at low doses?
Eli Lilly and Co. supposedly answered this question for us back in 1930. Concluding thimerosal to be of "a very low order of toxicity . . . for man," the company hired its own doctors to perform thimerosal experiments in Indianapolis City Hospital on meningitis patients during a severe outbreak in 1929. This 60-year-old evidence was still quoted on the company's brochures as recently as 1990. Andrew Waters, who is involved in a lawsuit against Eli Lilly, claims that most critical studies on the toxicity of thimerosal were suppressed by the company until now.
Banned around the world, but not in the United States
That might explain why thimerosal was eliminated in many countries 20 years ago. In 1977, a Russian study found that adults exposed to ethylmercury, the form of mercury in thimerosal, suffered brain damage years later. Studies on thimerosal poisoning also describe tubular necrosis and nervous system injury, including obtundation, coma and death. As a result of these findings, Russia banned thimerosal from children's vaccines in 1980. Denmark, Austria, Japan, Great Britain and all the Scandinavian countries have also banned the preservative.
Eli Lilly stuck to its "scientific" facts, but the truth began slipping between the cracks in 1999. After the number of immunizations rose to 12 to 15 per child, the public finally became privy to the possible dangers of thimerosal. One 1999 study revealed that some infants, due to a genetic or developmental factor, lack the ability to eliminate mercury. Trace amounts of mercury in these infants, when accumulated over several vaccines, could pose a severe health risk. Some vaccines, such as vaccines for hepatitis B, contained as much as 12.5 micrograms of mercury per dose. That's more than 100 times the EPA's upper limit standard when administered to infants.
Hepatitis B vaccines aren't the only immunizations under suspicion. According to Burton Goldberg in Alternative Medicine, scientists are finding stronger and stronger links between thimerosal and neurological damage. One report by Dr. Vijendra Singh of the Department of Pharmacology at the University of Michigan found a higher incidence of measles, mumps and rubella vaccine (MMR) antibodies in autistic children.
The National Vaccine Information Center in Vienna, Virginia, has noted a strong association between the MMR vaccine and autistic features. Reporting similar findings, the Encephalitis Support Group in England claims that children who became autistic after the MMR vaccine started showing autistic symptoms as early as 30 days after vaccination. The diphtheria, pertussis and tetanus vaccine (DPT) given at two, four and six months has triggered autistic symptoms, as well.
When the FDA finally formally released this information in 1999, the news came too little too late for some parents. The damage had already been done.
Autism affects 500,000 to 1.5 million Americans and has grown at an annual rate of 10 to 17 percent since the late 1980s. California found a 273 percent increase in autism between 1987 and 1998. Maryland reported a 513 percent increase in autism between 1993 and 1998 and several dozen other states reported similar findings. Some scientists say the estimated number of cases of autism has increased 15-fold –1,500 percent – since 1991, when the number of childhood vaccinations doubled. Whereas one in every 2,500 children was diagnosed with autism before 1991, one in 166 children now have the disease.
This increase in reported autism cases eerily parallels the increase in the number and frequency of thimerosal-containing vaccinations administered to infants. As of today, children are given as many as 21 immunizations in the first 15 months of life. After a number of scientists and concerned activists noticed the correlation, an investigation was launched to get to the heart of the matter.
In June 2000, federal officials and industry representatives were assembled by the Centers for Disease Control and Prevention to discuss the disturbing evidence. According to Tom Verstraeten, an epidemiologist who had analyzed the data on the CDC's database, thimerosal appeared to be responsible for a dramatic increase in autism and other neurological disorders. Verstraeten told those at the meeting that a number of earlier studies indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism.
Verstraeten offered no possible cause for this correlation, but held that the statistical evidence linking vaccines and neurological disorders was strong. Dr. Bill Weil, a consultant for the American Academy of Pediatrics, and Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado, presented similar concerns to the group. However, given no causal relationship, the CDC and industry representatives were quick to discredit the evidence.
Consequently, the CDC paid the Institute of Medicine (IOM) to conduct another study on thimerosal. According to Robert F. Kennedy Jr., this study was fixed in order to "whitewash" previous findings. In its 2001 report, the IOM's Immunization Safety Review Committee did conclude that the link between thimerosal and neurodevelopmental disorders was biologically plausible, though the evidence neither proved nor negated it. The Committee stated that phasing out thimerosal from vaccines was “a prudent measure in support of the public health goal to reduce mercury exposure of infants and children as much as possible.” However, these findings offered no imperative. The data presented at the 2000 meeting was withheld from publication and the link between thimerosal and autism remained "inconclusive."
But what does "inconclusive" mean? Well, that depends on who you talk to. According to the FDA, these "inconclusive" findings negate the risk of a causal relationship between thimerosal and autism. Even Tom Verstraeten, one of the presenters of epidemiological evidence at the CDC meeting, seemingly changed his tune a bit. In 2000, Verstraeten vigorously campaigned against thimerosal based upon his "inconclusive" correlation, but after he was hired by GlaxoSmithKline, the doctor changed his position. The same evidence from 2000, in Verstraeten's eyes, became "neutral" in 2003. After criticism for this apparent flip-flop, Verstaeten wrote a letter to the editor of Pediatrics in 2004 backing the CDC's actions and his own research methods.
Without an imperative to eradicate thimerosal immediately, vaccine manufacturers like Merck & Co. seemingly took their time in reducing thimerosal levels in vaccines. After a large public outcry in 1999, Merck & Co. began decreasing or eliminating the amount of thimerosal in its vaccines. In September 1999, Merck announced that its new line of vaccines were preservative-free, but still continued to distribute the remainder of thimerosal-preserved vaccines until 2001. Only after a congressional inquiry in 2002 did they stop distributing their stockpile. Rep. Dave Weldon, R-Fla., called Merck's actions "misleading."
While officials at the Center for Disease Control claim evidence is lacking to support the possible risks of thimerosal, Dr. Mark Geier, a Maryland geneticist and vaccinologist, along with his son and research partner David Geier, says the CDC has chosen to ignore the science. According to Dr. Geier, more than 5,000 articles have been published that question the safety of thimerosal in vaccines.
The Geiers analyzed the data and determined that the more thimerosal a child receives, the greater his or her chances are of being autistic. The CDC says the Geiers misused information from a CDC database that was not intended to help prove theories. Given no real causal mechanism linking thimerosal and autism, the game seems to have become one of slanting the data to suit the needs of government and industrial interests. Even Verstraeten has admitted that these "inconclusive" findings certainly don't rule out the possibility of finding a link in the future.
Given the dearth of health organizations owning up to the dangers of thimerosal, many parents followed their gut instincts and took legal action against vaccine manufacturers. More than 4,200 families have filed lawsuits claiming thimerosal caused injuries to their children. These lawsuits often have two goals: First, to seek reparations for the loss of consortium (basically meaning that an autistic child creates emotional and psychological burdens on their family life), and second, to ensure that these companies exercise more concern for public health and less concern for their own bottom line.
The lawsuits are slow in producing results. The first constraint on these lawsuits is the National Childhood Vaccine Act of 1986. This act stipulates that victims cannot seek redress in the courts without first filing a claim for recovery in the federal Vaccine Court. The statute of limitations for this is within three years of "the first symptom or manifestation of onset or of the significant aggravation of a [vaccine-related] injury."
In the cases of many thimerosal victims, the link between autism and vaccines didn't appear until six years after the first vaccine was administered. While this statute has stopped some claims against vaccine manufacturers, including such big firms as Aventis, GlaxoSmithKline, Merck and Johnson & Johnson, many judges are now allowing suits against Eli Lilly, the maker of thimerosal, to stand. While the Vaccine Act shields vaccine manufacturers, one judge reasons that the legislation does not protect the production of thimerosal because it is a "component."
The burden of proof in court is also extremely problematic for most of these suits. Given the supposed lack of scientific data, lawyers are hard-pressed to prove the link between thimerosal and autism. In what seems like an underhanded move, the CDC sold its data to a private company, ensuring that lawyers could not access it under the Freedom of Information Act.
In the past five years, Congress has also aided vaccine manufacturers, supposedly for "security" reasons. In 2002, a mysterious piggyback on the 2002 Homeland Security bill freed drug companies of liability in lawsuits regarding thimerosal. Called the "Eli Lilly Protection Act" by outraged parents and activists, the then-House Majority Leader Dick Armey told CBS News he snuck the amendment in to keep vaccine-makers from going out of business. Armey claimed it was a matter of national security. "We need their vaccines if the country is attacked with germ weapons."
Ironically, foreign biological terrorism hasn't been a big problem for American citizens, but those whose lives (and the lives of their children) have been affected if not ruined by the harmful effects of thimerisol would undoubtedly say these potentially harmful vaccines are indeed a problem. Armey's piggyback bill was repealed in 2003, but that didn't stop lawmakers from continuing to protect the vaccine industry.
Senate Majority Leader Bill Frist is no stranger to the thimerosal debate, having received $873,000 in contributions from the pharmaceutical industry and $10,000 from Eli Lilly. Frist's position allowed him to attempt to help the industry from the inside, according to Kennedy. Kennedy reports that on five occasions, Frist tried to seal the government's vaccine-related documents and shield Eli Lilly from subpoenas. Frist also introduced a provision in the 2005 Senate Bill S-3 called the "Protecting America in the War on Terror Act," that would effectively insulate the pharmaceutical industry from liability for thimerosal poisoning. Pharmaceutical manufacturers, including Merck, GlaxoSmithKline, Aventis, Weyeth and Eli Lilly, can basically get off scot-free for their actions, even as more and more evidence suggests that top company officials were aware of the possible dangers and did nothing.
A secret memo leaked to the Los Angeles Times reportedly implicates one vaccine manufacturer, Merck & Co., for knowing that thimerosal could pose serious threats to infants. Allegedly, Dr. Maurice Hilleman, one of Merck's top scientists, warned the president of Merck of a possible threat as early as 1991. Dr. Hilleman told executives that six-month-old children receiving regular immunizations frequently received mercury doses 87 times higher than guidelines for the maximum consumption of mercury. Given today's more prudent mercury standards, those thimerosal doses would be 400 times that of safe levels. Dr. Hilleman recommended in the memo that thimerosal be discontinued.
Not only do government and industry officials seem to be trying to downplay the possible harms of thimerosal; the media is also denying the issue coverage. Just recently, ABC flip-flopped on whether it will air interviews with Robert Kennedy Jr., a leading critic of thimerosal. ABC has been accused of suppressing the interviews because of its ties to the pharmaceutical industry.
Along with the enormous amount of controversy surrounding this issue, the five-year-old plea for "more research" may have finally produced some results. Burton Goldberg notes that a defect in the myelinization process (insulation of nerve fibers) could explain mercury's propensity to cause autism and neurological damage. This may also account for the frequent development of epilepsy in older autistic children.
Scientists are also working on biological links that support the strong correlations. Researchers at Northeastern University, working with scientists from the University of Nebraska, Tufts and Johns Hopkins University, may have recently found the mechanism by which thimerosal interferes with brain activity. If these researchers are right, vaccine manufacturers could do little to keep the damaging effects of thimerosal hidden.
Pharmacy professor Richard Deth and colleagues found that exposure to thimerosal potently interrupts growth factor signaling, causing adverse effects on the transfer of carbon atoms. These carbon atoms play a significant role in regulating normal DNA function and gene expression and are critical to proper neurological development. Additionally, the scientists recently obtained more insight into the mechanism by which thimerosal interferes with folate-dependent methylation. The mechanism inhibits the biosynthesis of the active form of vitamin B12 (methylcobalamin), a vitamin now being administered to autistic children.
Now all childhood vaccines have at least one mercury-free version, and I urge parents to ask for those versions if they choose to vaccinate their children. Injecting mercury into children, especially infants whose immune systems are still underdeveloped (hepatitis B shots are typically given at birth, before the immune system has developed), can be an assault to the immune system.
What Your Doctor May Not Tell You About Autoimmune Disorders by Stephen B Edelson MD, page 65
In 1999 studies began to surface showing that multi-dose vial vaccines, such as the MMR and hepatitis B vaccines, contained enough thimerosal to expose vaccinated children to 62.5 ug of mercury per visit to the pediatrician. This is one hundred times the dose considered safe by the Federal Environmental Protection Guidelines for infants! Worse yet, some infants will receive doses even higher; because thimerosal tends to settle in the vial. If it is not shaken up before being drawn, the first dose will contain low concentrations of mercury and the last dose will contain enormously high concentrations. If your baby is the unlucky one that gets the last dose, serious brain injury can result…
Health And Nutrition Secrets by Russell L Blaylock MD, page 166
Thousands of families say they can demonstrate with videotapes and photos that their children were normal prior to being vaccinated, reacted badly to the vaccines, and became autistic shortly thereafter. The number of vaccines given before age two has risen from 3 in 1940, when autism occurred in perhaps one case per 10,000 births, to 22 different vaccines given before the age of two in the year 2000.
Building Wellness with DMG by Roger V Kendall PhD, page 104
We know that certain forms of mercury, such as methylmercury and phenylmercury, are highly lipid soluble, which makes the brain especially susceptible to mercury accumulation. These forms of mercury are found in vaccines as the preservative thimerosal. Once in the brain, it tends to attach itself to protein structures, especially to the cell membrane, where it can disrupt membrane functions.23 By binding to the cell membrane, mercury changes the membrane's fluid-like quality, making it stiffer and causing the cell to age faster.24 The brain is unique in that neurons depend on special microscopic tube-like structures within the cell, appropriately called neurotubules, for their function. These neurotubules are manufactured by the cell from a substance called tubulin. We know that mercury interacts with tubulin causing it to unravel. Studies in rats have shown that doses of mercury corresponding to those seen in humans can cause a 75 percent increase in tubulin inhibition.
Health And Nutrition Secrets by Russell L Blaylock MD, page 53
In the case of the susceptible newborn infant and toddler, multiple exposures to mercury-containing and multiple antigen vaccines are highly suspect in the causation of multiple organ injury (Bernard et al. 2000). The GI tract, the liver, the pancreas, the kidneys, the immune system, and the brain are major sites of mercury absorption. Researchers have clearly shown a chronic inflammatory bowel disease due to vaccine strain measles in a subset of children with autism (Thompson et al. 1995; Wakefield et al. 1995, 1999, 2000a,b; Kawashima et al. 2000; Pardi et al. 2000; Uhlmann et al. 2002).
Disease Prevention And Treatment by Life Extension Foundation, page 153
Studies of autistic children have frequently shown very high levels of mercury, with no other source but vaccines found for the exposure. These levels are equal to those seen in adults during toxic industrial exposures. Several autism clinics have found dramatic improvements in the behavior and social interactions in children from whom the mercury was chelated. Results depended on how soon the mercury was removed following exposure, but permanent damage can be caused if the metal is not chelated soon enough. Still, even in cases of severe damage, because of the infant brain's tremendous reparative ability, improvements are possible. The problem of autism involves numerous body systems including the gastrointestinal, immune and nervous systems; as a result we see numerous infections and magnified effects of malnutrition. Intrepid workers in the shadows, that is outside the medial establishment, have worked many miracles with these children using a multidisciplinary scientific approach completely ignored by the orthodoxy. Some children have even experienced a return to complete physiological normalcy.
Health And Nutrition Secrets by Russell L Blaylock MD, page 166
Mercury and autism mercury toxicity is a suspected cause of a steep rise—a tenfold increase between 1984 and 1994—in diagnosed cases of autism in children around the world, according to some scientists. Specifically, the culprit is thimerosal, a mercury-based compound used as a preservative in vaccines commonly administered to babies and infants. thimerosal-free vaccines are available. If you have a child who will be receiving vaccinations, ask for and make sure thimerosal-free vaccines are used. Kelp, with its essential minerals (especially calcium and magnesium), helps remove unwanted metal deposits.
Prescription For Dietary Wellness by Phyllis A Balch, page 198
The pertussis vaccine (DPT) may cause 45,000 cases of autism per year in America, affecting 15 cases out of 10,000 vaccinations; also caused by the measles-mumps-rubella vaccine (MMR) that causes mental impairment, gastrointestinal damage, and increased mortality in 6-12 months from impaired immunity; 9 out of 10 cases were not breast-fed; eating dairy products caused parasites in the autistic (take Vermex; contact Dr. Nelson in Mexico for control of parasites in children with autism). There are now over 500,000 victims of autism residing in the United States, in 1994. The pertussis vaccination is not used in Sweden, which has virtually 0 cases of autism, as does Holland. This mental illness afflicts environmentally and socially non-reactive persons, ofwithdrawn personality; with inability to speak, violenttantrums, insomnia, actions such as bolting across aroad with no regard for the dire consequences. May be caused infant antibiotic use in ear infections with subsequent yeast overgrowth, by cumulative genetic Brain damage, Vitamin deficiencies, or milk and additives allergies. Immune disorders in autism include white blood cellneutrophil Myeloperoxidase enzyme deficiency for insufficient hypochlorite ions to kill yeast - genetic type from Chromosome 17 mutation or biotinidase deficiency, or acquired type from lead poisoning, Folic acid or B-l 2 deficiency, infection or leukemias…
Anti-Aging Manual by Joseph B Marion, page 450
Multiple vaccinations, especially in newborns, are another major source of childhood mercury exposure because of the mercury-containing thimerosal preservative. Over twenty-two vaccinations are now recommended for children before the age of two!
Health And Nutrition Secrets by Russell L Blaylock MD, page 64
In addition, there is some anecdotal evidence that autism may be tied to diet. One theory is that, in very rare cases, a child's immune system could be weakened by the measles-mumps-rubella vaccination (MMR), which is usually administered before a child turns 2. As a result of this weakening, the theory goes, the child's digestive system is unable to break down certain food proteins, leading to abnormal brain development. Proponents of this theory believe that putting the child on a diet that eliminates certain foods, such as wheat and dairy products, could in certain cases reverse the course of the disease. This theory remains speculative, however, and research needs to be done to determine its validity. In fact, a 2001 report issued by an Institute of Medicine committee examining studies about the health effects of the MMR vaccine in young children suggests that there is no proven link between the vaccine and autism. The committee recommends that there be no change in immunization practices that require children to be immunized during early childhood.
The Immune Advantage by Ellen Mazo and Keith Berndtson MD, page 292
Rather than calling for an all-out immediate ban on thimerosal-containing vaccines, they suggested that parents continue to have their children vaccinated with mercury-contaminated vaccines until new stocks of uncontaminated vaccine could be made available. Here are two doctors' unions that had to be beat over the head with an overwhelming amount of data that mercury-contaminated vaccines were harming children far worse than the actual diseases against which the vaccine was intended to protect them, only to have them suggest that parents continue to harm their children just to satisfy their vaccination obsession. Are you surprised to discover that recent investigations have found that several doctor-members of vaccine boards were either receiving grants from vaccine manufacturers or held stock in the companies? They were willing to sacrifice the health of millions of children just to fill their pockets with cash. These people should be looking through bars, not serving on boards.
Health And Nutrition Secrets by Russell L Blaylock MD, page 167
Vaccines may afflict 45,000 cases of autism per year in America, which afflicts 15 victims in every 10.000 births: there are now 5 00,000 of these victims in the U.S. In Sweden not using the pertussis vaccine, there is virtually no autism (and likewise in Holland).
Anti-Aging Manual by Joseph B Marion, page 600
Many symptoms of autism are similar to those of mercury poisoning. Immune dysfunction, visual disturbances, and motor dysfunction are seen in both. Treating autistic children for removal of mercury and other heavy metals has shown significant improvement in their autistic symptoms. Most autistic individuals have poor liver detoxification, low antioxidant levels, and low levels of glutathione. Vaccines are effective, but the production and use of vaccines should proceed more cautiously. Currently manufactured vaccines still contain harmful substances like mercury. The link between vaccines and autism is far stronger than the medical community is willing to admit, and more research in this area should be an urgent priority.
Building Wellness with DMG by Roger V Kendall PhD, page 105
Studies indicate that autism may be the result of adverse reactions to childhood vaccinations. Dr. Alan Cohen, an environmental physician from Connecticut, notes that high levels of autism and attention deficit disorder (ADD) did not occur until the mandatory use of childhood vaccinations, and suggests that there may be a connection between certain vaccines and the onset of these conditions.
Complete Encyclopedia Of Natural Healing by Gary Null PhD, page 46
Almost from the inception of vaccination programs, manufacturers added a mercury preservative called thimerosal to vaccines. The practice continued until recently, and was stopped only because of the outcry from thousands of concerned parents and numerous experts in the field. The American Academy of Pediatrics and the American Academy of Family Practice did not warn parents or pediatricians that the mercury was dangerous until they were forced to. That mercury was toxic to cells had been known for over sixty years, but manufacturers apparently were more worried about lawsuits…
Health And Nutrition Secrets by Russell L Blaylock MD, page 165
In fact, a 2001 report issued by an Institute of Medicine committee examining studies about the health effects of the MMR vaccine in young children suggests that there is no proven link between the vaccine and autism. The committee recommends that there be no change in immunization practices that require children to be immunized during early childhood. Another disorder affecting the brain, Alzheimer's disease, may also have an immune connection. Alzheimer's is a degenerative disease that slowly attacks nerve cells in the brain. It eventually results in the loss of all memory and mental functioning. Scientists are currently investigating the role that the immune system plays in producing an overabundance of the amino acid glutamate, a powerful nerve-cell killer. Another immune connection that researchers are investigating is the idea that Alzheimer's might be triggered, in part, by a virus.
The Immune Advantage by Ellen Mazo and Keith Berndtson MD, page 292
In the past 10 years, the number of autistic children has risen between 200 and 500 per cent in every state in the U.S. This sharp increase in autism followed the introduction of MMR vaccine in 1975. Representative Dan Burton's healthy grandson was given injections for 9 diseases in one day. These injections were followed by autism.
A Physicians Guide To Natural Health Products That Work By James Howenstine MD, page 267
"Probably 20% of American children, one in five, suffers from a "development disability'," according to Harris Coulter, Ph.D., Founder and Director of the Center for Empirical Medicine, in Washington, D.C. "This is a stupefying figure and we have inflicted it on ourselves. 'Development disabilities' are nearly always generated by encephalitis. And the primary cause of encephalitis in the U.S. and other industrialized countries is the childhood vaccination program. To be specific, a large proportion of the millions of U.S. children and adults suffering from autism, seizures, mental retardation, hyperactivity, dyslexia, and other branches of the hydra-headed entity called 'development disabilities' owe their disorders to one of the vaccines against childhood diseases."
Alternative Medicine by Burton Goldberg, page 1101
Martin noted that the increased incidence of chronic fatigue syndrome, attention deficit hyperactivity disorder, autism, and other behavior-linked illnesses "may be an inadvertent consequence of stealth virus vaccine contaminants."
AIDS And Ebola by Leonard Horowitz, page 493
Just for perspective if we go back to 1971 up to 1980, we see that California consistently added 100 to 200 new cases a year; but in the year 2002, California added 3,577 new cases. Since 1980, the documented start of California's autism epidemic, the number of new cases has steadily increased. If we break down those statistics it means that from 1994 to 1995, California only added on average 2 new autistic children a day into its system. In 2001, it was a rate of 8 new autistic children added a day; in 2002, it jumped up to 10 children a day. mercury-containing vaccines are still in use today, including the most recently recommended addition to the childhood immunization schedule, 2 shots of flu vaccine for infants, bringing the total number of vaccines up to 41 in California that a child will receive before the age of two. It will take a few years to start seeing the effect of the phasing out of the mercury-containing preservative thimerosal from childhood vaccines on this autism epidemic. Many symptoms of autism are similar to those of mercury poisoning. Immune dysfunction, visual disturbances, and motor dysfunction are seen in both. Treating autistic children for removal of mercury and other heavy metals has shown significant improvement in their autistic symptoms. Most autistic individuals have poor liver detoxification, low antioxidant levels, and low levels of glutathione.
Building Wellness with DMG by Roger V Kendall PhD, page 105
Since the 1990s, there has been a tenfold or 1000-percent increase in autism, an increase which has been linked by some researchers to the organic mercury preservative commonly found in baby vaccines. A greatly increased incidence of juvenile diabetes has been correlated to specific vaccination sequences and to the number of vaccines given. In some Australian Aboriginal communities, every second child died shortly after vaccination.
The Natural Way to Heal by Walter Last, page 309
The best current estimates are that autism occurs in 40 to 67 children per 10,000 live births. This means that the prevalence of autism has increased 1,000 percent in the last decade. According to the latest figures just released in January 2003 by the California Department of Developmental Services, California experienced an astounding 31 percent increase in the number of new children…
Building Wellness with DMG by Roger V Kendall PhD, page 104
Get the entire story at an excellent vaccination website here.
]]>
by Gary Hart
Rare is the catastrophe that does not offer some promise. The key is having the genius to discover hope within the rubble.
An argument can be made that the current financial disaster offers a future president, Obama in this case, the chance to transform the U.S. economy. A weakened Wall Street and a chastened conservative community are not now in a position to resist thoughtful and sober re-regulation of markets. The Reagan era (actually Nixon-Reagan-Bush) is over and with it the arrogance that laissez faire always presumes.
But recreation of another Rooseveltian period of 1932 to 1940, with a new set of rules for intricate financial institutions, is not enough. We must transform our economy from one of consumption to one of production, invest much more heavily in new technologies, research, and invention, and start the process of creating a post-carbon economy. The current wreckage must not simply be put back together to recreate the old economy. It must be pushed out of the way to make space for a new, 21st century economy.
The same may be said for foreign policy. Merely returning to the pre-Bush status quo will not work because the new century features a host of new realities: proliferation of weapons of mass destruction; the rise of stateless nations; the threat of pandemics; failed and failing states; mass south-north migrations; climate change; globalized economics; and the list continues. An Obama administration will have responsibility for repairing damaged traditional relations. But it will also have the opportunity to create a new round of international institution-building that includes international financial regulation and cooperation, international administration of a post-Kyoto treaty, reduction in nuclear weapons, integration of public health services, and so on. Our new foreign policy should be patterned on the immensely creative 1945 to 1948 Truman era.
And when troops and equipment are returned from Iraq and Afghanistan, our military should not merely be "re-set", the Washington code word for rebuilding the Cold War military. Our defenses in the new century must acknowledge the transformation of war and the changing nature of conflict which will require new military structures, command and control systems, and even weapons themselves.
The Wall Street disaster is a metaphor for excess and greed, but also for a time gone by. The world of the new century requires not just a new Democratic administration, but one that is prepared to transform our nation and help transform the world
]]>Columbo-tantalite, i.e. coltan, is found in three-billion-year-old soils like those in the Rift Valley region of Africa. The tantalum extracted from the coltan ore is used to make tantalum capacitors, tiny components that are essential in managing the flow of current in electronic devices. Eighty percent of the world’s coltan reserves are found in the Democratic Republic of Congo (DRC). Niobium is another high-tech mineral with a similar story.
Sprocket reports that the high-tech boom of the 1990s caused the price of coltan to skyrocket to nearly $300 per pound. In 1996 U.S.-sponsored Rwandan and Ugandan forces entered eastern DRC. By 1998 they seized control and moved into strategic mining areas. The Rwandan Army was soon making $20 million or more a month from coltan mining. Though the price of coltan has fallen, Rwanda maintains its monopoly on coltan and the coltan trade in DRC. Reports of rampant human rights abuses pour out of this mining region.
Coltan makes its way out of the mines to trading posts where foreign traders buy the mineral and ship it abroad, mostly through Rwanda. Firms with the capability turn coltan into the coveted tantalum powder, and then sell the magic powder to Nokia, Motorola, Compaq, Sony, and other manufacturers for use in cell phones and other products.
Keith Harmon Snow emphasizes that any analysis of the geopolitics in the Congo, and the reasons for why the Congolese people have suffered a virtually unending war since 1996, requires an understanding of the organized crime perpetrated through multinational businesses. The tragedy of the Congo conflict has been instituted by invested corporations, their proxy armies, and the supra-governmental bodies that support them.
The process is tied to major multinational corporations at all levels. These include U.S.-based Cabot Corp. and OM Group; HC Starck of Germany; and Nigncxia of China—corporations that have been linked by a United Nations Panel of Experts to the atrocities in DRC. Extortion, rape, massacres, and bribery are all part of the criminal networks set up and maintained by huge multinational companies. Yet as mining in the Congo by western companies proceeds at an unprecedented rate—some $6 million in raw cobalt alone exiting DRC daily—multinational mining companies rarely get mentioned in human rights reports.
Sprocket notes that Sam Bodman, CEO of Cabot during the coltan boom, was appointed in December 2004 to serve as President Bush’s Secretary of Energy. Under Bodman’s leadership from 1987 to 2000, Cabot was one of the U.S.’s largest polluters, accounting for 60,000 tons of airborne toxic emissions annually. Snow adds that Sony’s current Executive Vice President and General Counsel Nicole Seligman was a former legal adviser for Bill Clinton. Many who held positions of power in the Clinton administration moved into high positions with Sony.
The article “Behind the Numbers,” coauthored by Snow and David Barouski, details a web of U.S. corruption and conflicts of interest between mining corporations such as Barrick Gold (see Story #21) and the U.S. government under George H. W. Bush, Bill Clinton, and George W. Bush, as well as U.S. arms dealers such as Simax; U.S. defense companies such as Lockheed Martin, Halliburton, Northrop Grumman, GE, Boeing, Raytheon, and Bechtel; “humanitarian” organizations such as CARE, funded by Lockheed Martin, and International Rescue Committee, whose Board of Overseers includes Henry Kissinger; “Conservation” interests that provide the vanguard for western penetration into Central Africa; and of course, PR firms and news outlets such as the New York Times.
Sprocket closes his article by noting that it’s not surprising this information isn’t included in the literature and manuals that come with your cell phones, pagers, computers, or diamond jewelry. Perhaps, he suggests, mobile phones should be outfitted with stickers that read: “Warning! This device was created with raw materials from central Africa. These materials are rare, nonrenewable, were sold to fund a bloody war of occupation, and have caused the virtual elimination of endangered species. Have a nice day.” People need to realize, he says, that there is a direct link between the gadgets that make our lives more convenient and sophisticated—and the reality of the violence, turmoil, and destruction that plague our world.
UPDATE BY SPROCKET
There are large fortunes to be made in the manufacturing of high-tech electronics and in selling convenience and entertainment to American consumers, but at what cost?
Conflicts in Africa are often shrouded with misinformation, while U.S. and other western interests are routinely downplayed or omitted by the corporate media. The June 5, 2006, cover story of Time, entitled “Congo: The Hidden Toll of the World’s Deadliest War,” was no exception. Although the article briefly mentioned coltan and its use in cell phones and other electronic devices, no mention was made of the pivotal role this and other raw materials found in the region play in the conflict. The story painted the ongoing war as a pitiable and horrible tragedy, avoiding the corporations and foreign governments that have created the framework for the violence and those which have strong financial and political interests in the conflict’s outcome.
In an article written by Johann Hari and published by The Hamilton Spectator on May 13, 2006, the corporate media took a step toward addressing the true reason for the tremendous body count that continues to pile up in the Democratic Republic of Congo: “The only change over the decades has been the resources snatched for Western consumption — rubber under the Belgians, diamonds under Mobutu, coltan and casterite today.”
Most disturbing is that in the corporate media, the effect of this conflict on nonhuman life is totally overlooked. Even with a high-profile endangered species like the Eastern lowland gorilla hanging in the balance, almost driven to extinction through poaching and habitat loss by displaced villagers and warring factions, the environmental angle of the story is rarely considered.
The next step in understanding the exploitation and violence wrought upon the inhabitants of central Africa, fueled by the hunger for high-tech toys in the U.S., is to expose corporations like Sony and Motorola. These corporations don’t want protest movements tarnishing their reputations. Nor do they want to call attention to all of the gorillas coltan kills, and the guerrillas it feeds.
It is time for our culture to start seeing more value in living beings, whether gorillas or humans, than in our disposable high-tech gadgets such as cell phones. It is time to steal back a more compassionate existence from the corporate plutocracy that creates destructive markets and from the media system that has manufactured our consent.
It is not just a question of giving up cell phones (though that would be a great start). We must question the appropriation of our planet in the form of a resource to be consumed, rather than as a home and community to be lived in.
“High-Tech Genocide” and other articles about cell phone technology are available by contacting the author: sprocket@riseup.net.
UPDATE BY KEITH HARMON SNOW
War for the control of the Democratic Republic of Congo—what should be the richest country in the world—began in Uganda in the 1980s, when now Ugandan President Yoweri Museveni shot his way to power with the backing of Buckingham Palace, the White House, and Tel Aviv behind him.
Paul Kagame, now president of Rwanda, served as Museveni’s Director of Military Intelligence. Kagame later trained at Fort Leavenworth, Kansas, before the Rwandan Patriotic Front (RPF)—backed by Roger Winter, the U.S. Committee on Refugees, and the others above—invaded Rwanda. The RPF destabilized and then secured Rwanda. This coup d’etat is today misunderstood as the “Rwanda Genocide.” What played out in Rwanda in 1994 is now playing out in Darfur, Sudan; regime change is the goal, “genocide” is the tool of propaganda used to manipulate and disinform.
In 1996, Paul Kagame and Yoweri Museveni, with the Pentagon behind them, launched their covert war against Zaire’s Mobutu Sese Seko and his western backers. A decade later, there are 6 or 7 million dead, at the very least, and the war in Congo (Zaire) continues.
If you are reading the mainstream newspapers or listening to National Public Radio, you are contributing to your own mental illness, no matter how astute you believe yourself to be at “balancing” or “deciphering” the code.
News reports in Time Magazine (“The Deadliest War In The World,” June 6, 2006) and on CNN (“Rape, Brutality Ignored to Aid Congo Peace,” May 26, 2006) that appeared at the time of this writing are being interpreted by conscious people to be truth-telling at last. However, these are perfect examples filled with hidden deceptions and manipulations.
For accuracy and truth on Central Africa, look to people like Robin Philpot (Imperialism Dies Hard), Wayne Madsen (Genocide and Covert Operations in Africa, 1993–1999), Amos Wilson (The Falsification of Consciousness), Charles Onana (The Secrets of the Rwanda Genocide—Investigation on the Mysteries of a President), Antoine Lokongo (http://www.congopanorama.info), Phil Taylor (http://www.taylor-report.com), Christopher Black (“Racism, Murder and Lies in Rwanda”). World War 4 Report has published my reports, but they are inconsistent in their attention to accuracy, and would as quickly adopt the propaganda, and have done so at times.
It is possible to collect little fragments of truth here and there—never counting on the mainstream system for this—but one must beware the deceptions and bias. In this vein, the elite business journal Africa Confidential is often very revealing. Some facts can be gleaned from http://www.DigitalCongo.net and Africa Research Bulletin.
Professor David Gibb’s book The Political Economy of Third World Intervention: Case of the Congo Crises is an excellent backgrounder that identifies players still active today (especially Maurice Tempelsman and his diamonds interests connected to the Democratic Party). Ditto King Leopold’s Ghost by Adam Hocshchild, but—exemplifying the expedience of “interests”—remember that Hocshchild never tells you, the reader, that his father ran a mining company in Congo. Almost ALL reportage is expedient; one needs take care their propensity to be deceived.
Professor Ruth Mayer’s book Artificial Africas: Colonial Images in the Times of Globalization is a particularly poignant articulation of the means by which the “media” system distorts and manipulates all things African. And, never forget http://www.AllThingsPass.com.
Also hoping to correct the record and reveal the truth, the International Forum for Truth and Justice in the Great Lakes of Africa (http://www.veritasrwandaforum.org), based in Spain, and co-founded by Nobel Prize nominee Juan Carrero Seraleegui, is involved in a groundbreaking lawsuit charging massive crimes against humanity and acts of genocide were committed by the now government of Rwanda.
]]>The United States is directly responsible for over one million Iraqi deaths since the invasion five and half years ago. In a January 2008 report, a British polling group Opinion Research Business (ORB) reports that, “survey work confirms our earlier estimate that over 1,000,000 Iraqi citizens have died as a result of the conflict which started in 2003…. We now estimate that the death toll between March 2003 and August 2007 is likely to have been of the order of 1,033,000. If one takes into account the margin of error associated with survey data of this nature then the estimated range is between 946,000 and 1,120,000”.
The ORB report comes on the heels of two earlier studies conducted by Johns Hopkins University published in the Lancet medical journal that confirmed the continuing numbers of mass deaths in Iraq. A study done by Dr. Les Roberts from January 1, 2002 to March 18 2003 put the civilian deaths at that time at over 100,000. A second study published in the Lancet in October 2006 documented over 650,000 civilian deaths in Iraq since the start of the US invasion. The 2006 study confirms that US aerial bombing in civilian neighborhoods caused over a third of these deaths and that over half the deaths are directly attributable to US forces.
The now estimated 1.2 million dead, as of July 2008, includes children, parents, grandparents, great-grandparents, cab drivers, clerics, schoolteachers, factory workers, policemen, poets, healthcare workers, day care providers, construction workers, babysitters, musicians, bakers, restaurant workers and many more. All manner of ordinary people in Iraq have died because the United States decided to invade their country. These are deaths in excess of the normal civilian death rate under the prior government.
The magnitude of these deaths is undeniable. The continuing occupation by US forces guarantees a mass death rate in excess of 10,000 people per month with half that number dying at the hands of US forces— a carnage so severe and so concentrated at to equate it with the most heinous mass killings in world history. This act has not gone unnoticed.
Recently, Dennis Kucinich introduced a single impeachment article against George W. Bush for lying to Congress and the American people about the reasons for invading Iraq. On July 15 The House forwarded the resolution to the Judiciary Committee with a 238 to 180 vote. That Bush lied about weapons of mass destruction and Iraq’s threat to the US is now beyond doubt. Former US federal prosecutor Elizabeth De La Vega documents the lies most thoroughly in her book U.S. Vs Bush, and numerous other researchers have verified Bush’s untrue statements.
The American people are faced with a serious moral dilemma. Murder and war crimes have been conducted in our name. We have allowed the war/occupation to continue in Iraq and offered ourselves little choice within the top two presidential candidates for immediate cessation of the mass killings. McCain would undoubtedly accept the deaths of another million Iraqi civilians in order to save face for America, and Obama’s 18-month timetable for withdrawal would likely result in another 250,000 civilian deaths or more.
We owe our children and ourselves a future without the shame of mass murder on our collective conscience. The only resolution of this dilemma is the immediate withdrawal of all US troops in Iraq and the prosecution and imprisonment of those responsible. Anything less creates a permanent original sin on the soul of the nation for that we will forever suffer.
Peter Phillips is a Professor of Sociology at Sonoma State University and director of Project Censored a media research group. He is the co-editor with Dennnis Loo of the book Impeach the President: The Case Against Bush and Cheney.
What the public doesn't know, of course, is that there's much more to the story than they're reading or watching on FOX. What they also don't seem to understand is that Russia has the capability to create a massive problem for America if they re-engage with our enemies in a proactive way.
This article explains more.
]]>The good news is that factcheck.org just destroyed this rumor by doing some real, old-fashioned journalism work. They went to the Obama Chicago headquarters and saw it live and in person.
Here's the link
]]>Why Russia’s response to Georgia was right
By Sergei Lavrov
Published: August 12 2008 19:52 | Last updated: August 12 2008 19:52
For some of those witnessing the fighting in the Caucasus over the past few days, the narrative is straightforward and easy. The plucky republic of Georgia, with just a few million citizens, was attacked by its giant eastern neighbour, Russia. Add to this all the stereotypes of the cold war era, and you are presented with a truly David and Goliath interpretation – with all its accompanying connotations of good and evil. While this version of events is being written in much of the western media, the facts present a different picture.
Let me be absolutely clear. This is not a conflict of Russia’s making; this is not a conflict of Russia’s choosing. There are no winners from this conflict. Hours before the Georgian invasion, Russia had been working to secure a United Nations Security Council statement calling for a renunciation of force by both Georgia and South Ossetians. The statement that could have averted bloodshed was blocked by western countries.
Last Friday, after the world’s leaders had arrived at the Beijing Olympics, Georgian troops launched an all-out assault on the region of South Ossetia, which has enjoyed de facto independence for more than 16 years. The majority of the region’s population are Russian citizens. Under the terms of the 1992 agreement to which Georgia is a party, they are afforded protection by a small number of Russian peacekeeping soldiers. The ground and air attack resulted in the killing of peacekeepers and the death of an estimated 1,600 civilians, creating a humanitarian disaster and leading to an exodus of 30,000 refugees. The Georgian regime refused to allow a humanitarian corridor to be established and bombarded a humanitarian convoy. There is also clear evidence of atrocities having been committed – so serious and systematic that they constitute acts of genocide.
There can be little surprise, therefore, that Russia responded to this unprovoked assault on its citizens by launching a military incursion into South Ossetia. No country in the world would idly stand by as its citizens are killed and driven from their homes. Russia repeatedly warned Tbilisi that it would protect its citizens by force if necessary, and its actions are entirely consistent with international law, including article 51 of the UN charter on the right of self-defence.
Russia has been entirely proportionate in its military response to Georgia’s attack on Russian citizens and peacekeepers. Russia’s tactical objective has been to force Georgian troops out of the region, which is off limits to them under international agreements. Despite Georgia’s assertion that it had imposed a unilateral ceasefire, Russian peacekeepers and supporting troops remained under continued attack – a fact confirmed by observers and journalists in the region. Russia had no choice but to target the military infrastructure outside the region being used to sustain the Georgian offensive. Russia’s response has been targeted, proportionate and legitimate.
Russia has been accused of using the conflict to try to topple the government and impose control over the country. This is palpable nonsense. Having established the safety of the region, the president has declared an end to military operations. Russia has no intention of annexing or occupying any part of Georgia and has again affirmed its respect for its sovereignty. Over the next few days, on the condition that Georgia refrains from military activity and keeps its forces out of the region, Russia will continue to take the diplomatic steps required to consolidate this temporary cessation of hostilities.
Mikheil Saakashvili, Georgia’s president, has stated that "unless we stop Russia, unless the whole world stops it, Russian tanks will go to any European capital tomorrow", adding on a separate occasion that "it’s not about Georgia any more. It’s about America". It is clear that Georgia wants this dispute to become something more than a short if bloody conflict in the region. For decision-makers in the Nato countries of the west, it would be worth considering whether in future you want the men and women of your armed services to be answerable to Mr Saakashvili’s declarations of war in the Caucasus.
Russia is a member of the Security Council, of the Group of Eight leading industrialised nations and partner with the west on issues as varied as the Middle East, Iran and North Korea. In keeping with its responsibilities as a world power and the guarantor of stability in the Caucasus, Russia will work to ensure a peaceful and lasting resolution to the situation in the region.
The writer is minister of foreign affairs of the Russian Federation
Copyright The Financial Times Limited 2008