Special Report
Drug Lobby Second to None
How the pharmaceutical industry gets its way in Washington
By M. Asif Ismail

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WASHINGTON, July 7, 2005 : The pharmaceutical and health products industry has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years, a Center for Public Integrity investigation has found. Its lobbying operation, on which it reports spending more than $675 million, is the biggest in the nation. No other industry has spent more money to sway public policy in that period. Its combined political outlays on lobbying and campaign contributions is topped only by the insurance industry.

The drug industry's huge investments in Washington - though meager compared to the profits they make - have paid off handsomely, resulting in a series of favorable laws on Capitol Hill and tens of billions of dollars in additional profits. They have also fended off measures aimed at containing prices, like allowing importation of medicines from countries that cap prescription drug prices, which would have dented their profit margins. Pfizer, the world's largest drug company, made a profit of $11.3 billion last year, out of sales of $51 billion.

The industry's multi-faceted influence campaign has also led to a more industry-friendly regulatory policy at the Food and Drug Administration, the agency that approves its products for sale and most directly oversees drug makers. (See FDA: A Shell of its Former Self).

Most of the industry's political spending paid for federal lobbying. Medicine makers hired about 3,000 lobbyists, more than a third of them former federal officials, to advance their interests before the House, the Senate, the FDA, the Department of Health and Human Services, and other executive branch offices.

In 2003 alone, the industry spent nearly $116 million lobbying the government. That was the year that Congress passed, and President George W. Bush signed, the Medicare Modernization Act of 2003, which created a taxpayer-funded prescription drug benefit for senior citizens.

That figure was not anomalous. In 2004, drug makers upped their reported expenditures on lobbyists to $123 million, a record amount for the industry. Of the 1,291 lobbyists who were listed that year as prepresenting pharmaceutical corporations and their trade groups, some 52 percent were former federal officials.

By adding the benefit to Medicare, the government program that provides health insurance to some 41 million people, the industry found a reliable purchaser for its products. Thanks to a provision in the law for which the industry lobbied, government programs like Medicare are barred from negotiating with companies for lower prices.

Critics charge that the prescription drug benefit will transfer wealth from taxpayers, who provide the funding for Medicare, to pharmaceutical firms. According to a study done in October 2003 by Boston University professors Alan Sager and Deborah Socolar, 61 percent of Medicare money spent on prescription drugs will become profit for drug companies. Drug-makers will receive $139 billion in increased profits over eight years, the study predicts. The Medicare prescription drug benefit starts in 2006.

America the lucrative
The U.S. government contributes more money to the development of new drugsin the form of tax breaks and subsidies - than any other government. Of the 20 largest pharmaceutical corporations, nine are based in the United States. Yet drugs are more expensive in the United States than in any other part of the world, and global drug companies make the bulk of their profits in the United States.

Marketing Maladies
More than a third of pharmaceutical companies' resources go into promotion and marketing.
Company Marketing costs Research and Development:

Pfizer $16.90 billion $7.68 billion
GlaxoSmithKline $12.93 billion $5.20 billion
Sanofi-Aventis $5.59 billion $9.26 billion
Johnson & Johnson $15.86 billion $5.20 billion
Merck $7.35 billion $4.01 billion
Novartis $8.87 billion $4.21 billion
AstraZeneca $7.84 billion $3.80 billion
Hoffman La Roche $7.24 billion $4.01 billion
Bristol-Myers Squibb $6.43 billion $2.50 billion
Wyeth $5.80 billion $2.46 billion
Abbott Labs $4.92 billion $1.70 billion

Annually, the industry spends nearly twice as much on marketing as it spends on research and development, although drug companies report neither total precisely. Various news reports estimate that the industry spent anywhere between $30 billion to $60 billion on marketing in 2004. The trade group PhRMA estimates its members spent $39 billion on R&D that year. As this table shows, the same year, 11 major companies reported spending close to $100 billion on marketing, along with administrative expenses not categorized separately. Those companies reported spending $50 billion on R&D.
In 2004, Pfizer spent almost $120 million for media ads for Lipitor, the world's number-one selling prescription drug, while companies promoting erectile dysfunction treatments Viagra, Levitra and Cialis spent $425 million. Direct to consumer advertisement has also grown significantly: from $791 million in 1996 to $3.8 billion in 2004.

Many blame the industry's clout in Congress and with the executive branch for the high price of drugs. While many governments worldwide have regulated drug prices, the industry has been able to block a host of measures aimed at controlling prices in the United States. In the past few years, the industry has mounted an effective, organized campaign against legalizing importation of drugs from Canada.

As the Center reported in January, the industry trade group, Pharmaceutical Research and Manufacturers of America, hired a former U.S. ambassador to Canada, Gordon Giffin, and his top aide to lobby the Canadian government on the issue. The industry's pressure may be paying off. Last week, Canadian Health Minister Ujjal Dosanjh announced that his government would ban the bulk export of prescription drugs and crack down on Internet pharmacies that sell drugs to Americans.

A spokesman for PhRMA, Jeff Trewitt, told the Center in January that price controls thwart innovation and importation of drugs pose serious health risks.

The top 20 drug corporations and the industry's two trade groups, PhRMA and the Biotechnology Industry Organization, which represents biomedicine companies, disclosed lobbying on more than 1,600 bills between 1998 and 2004. They may have lobbied on far more bills; the Center could only count bills specifically mentioned by the companies and trade groups in their filings. In many cases, lobbyists list issues, like "animal health issues," rather than specific bills. In counting the number of bills, the Center excluded those lobbied on by BIO that relate solely to biotechnology issues, such as genetically engineered foods.

Apart from Congress, the industry lobbied an array of agencies including the Department of Health and Human Services, the Food and Drug Administration and the State Department on dozens of issues. For instance, PhRMA lobbied 33 federal agencies on 39 issues separately identified under the Lobbying Disclosure Act of 1995.

As the Center reported last week, the agencies include the Office of the U.S. Trade Representative, which shapes the country's trade agreements with other nations. Since 1998, it has filed 59 lobbying reports concerning the USTR, more than any other lobby or interest.

In recent years, the industry has shown significant power in influencing U.S. trade policy. For example, current drafts of the Dominican Republic-Central American Free Trade Agreement reflect PhRMA's desire to remove price controls on drugs and provide intellectual property protection in proposed member countries. Recently, the USTR, at the behest of the pharmaceutical industry, pressured Guatemala into repealing a recently passed law permitting wider marketing of generic drugs.

Lobbying numbers since 1998
Amount spent on lobbying $675 million
Lobbyists 3,009
Former officials who registered to lobby 1,014
Former members of Congress who lobbied 75
Bills lobbied More than 1,600

The top 20 corporations and the trade groups reported spending nearly $478 million on lobbying, or nearly 70 percent of all the money the industry reported. These corporations had roughly 64 percent of the global market share, according to IMS Health, a private consulting company that studies the industry.

Congress is most frequently listed as a target of the industry's lobbying attentions; contacts with the House or Senate are listed on about 5,500 lobby disclosure reports. The Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Food and Drug Administration and the Executive Office of the President are other agencies heavily lobbied by the industry.

Like other well connected interests in Washington, pharmaceutical firms look to former insiders to carry their message to Congress and executive branch officials. In May 2003, as the battle over the Medicare legislation was climaxing, the Pharmaceutical Research and Manufactures of America, the industry trade group, hired the newly formed lobby shop of Larson Dodd, LLC to join its already formidable army of representatives swarming the hallways of Congress. The hiring of Dave Larson and Quin Dodd by PhRMA - and later by Wyeth and other drug manufactures - was in keeping with the industry's standard operating procedure: employing former officials to lobby on bills sponsored by their ex-bosses.

Larson was a health policy advisor to Senate Majority Leader Bill Frist, the chief sponsor of a Medicare bill that, six months later, would become law, with potentially tens of billions of dollars of windfall for the drug companies. Dodd is a former legislative director to Sen. Kay Bailey Hutchison, the fourth ranking Republican in the upper chamber.

A third of all lobbyists employed by the industry are former federal government employees, including more than 15 former Senators and more than 60 former members of the U.S. House of Representatives. The two trade groups, PhRMA and BIO, are headed by two influential former members of Congress. PhRMA chief Billy Tauzin and BIO president Jim Greenwood were on committees that regulated drug companies and they each sponsored several bills related to the industry.

The Center reviewed the 1,600 plus bills the top 20 drug corporations and PhRMA and BIO lobbied. Sponsors of more than 50 percent of those bills had one or more former staff members representing the industry. A few of the sponsors have gone on to become lobbyists themselves.

Political giving
In addition to hiring former members and their staffs, the industry has also helped keep lawmakers in office by making political contributions. Since the 1998 election cycle, employees of the pharmaceutical and health product industry, their family members and industry political action committees have given $133 million in campaign contributions to candidates running for federal and state offices, according to the Center for Responsive Politics. Since 2000, the top drug corporations and their employees and PhRMA gave more than $10 million to 527 organizations, tax-exempt political committees which operate in the grey area between federal and state campaign finance laws.

Nearly $87 million of the contributions went to federal politicians in campaign donations, with almost 69 percent going to Republican candidates. Top recipients of the industry's campaign money include President George W. Bush (upwards of $1.5 million) and members who sit on committees that have jurisdiction over pharmaceutical issues.

In the states, the industry gave more than $46 million to candidates since '98, according to the Institute on Money in State Politics, which tracks campaign finance at the state level.

The Center could not determine the amount drug interests spent on lobbying in states because of the lack of comparable state disclosure requirements for expenditures. But their lobbying, campaign donations and grassroots efforts have taken on an added dimension because many states are threatening the industry's high profit margins in a way the federal government and Congress have been unwilling to do.

With states running into fiscal crises, several governors and legislatures have been exploring ways to contain drug prices. Among the several options that have been considered around the country include allowing seniors and others to legally buy drugs from Canada and other countries.

Though some states have been less amenable to drug industry pressure, the drug industry hasn't given up the fight. For Washington's biggest spending lobby, it's a small investment to make for its continuing prosperity.

Victoria Kreha, Alexander Cohen, Kevin Boettcher and Emily McNeill contributed to this report.

A Timeline of Political Clout
Here's what the pharmaceutical industry has gotten on its political investment

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2005
Thirty-three of the 40 countries PhRMA requests be put on the U.S. Trade Representative's Special 301 list appear on the list. Inclusion in the Special 301 report establishes intellectual property issues - such as patents - as a priority in bilateral discussions between the United States and the designated country.

2004
American Jobs Creation Act is signed into law. The act repeals the Extraterritorial Income Act tax regime and provides for $137 billion in new corporate tax incentives over the next decade. Taking advantage of a provision in the law, Pfizer, the world's largest drug company, is expected to repatriate nearly $17 billion it earned in profits abroad.

BioShield Act passes, providing $5.6 billion over 10 years for biodefense products.

CREATE Act passes unanimously in both houses of Congress. Allows patents for inventions researched jointly by public institutions and private entrepreneurs.

Thirty-three of the 38 countries cited in a PhRMA petition to the United States Trade Representative's Office appear on the USTR watch list.

2003
The Medicare Modernization Act of 2003 provides for a prescription drug benefit for Medicare recipients but prevents price negotiations with drug companies. The act partially reverses cuts in reimbursements to pharmaceutical companies.

2002
The Best Pharmaceuticals for Children Act is signed into law. It extends "pediatric exclusivity" provision of the FDA Modernization Act of 1997 that gives prescription drug makers an additional six months of patent protection during which generic drugs cannot be sold, in exchange for the manufacturer conducting studies of the drug's effects in children. The Congressional Budget Office estimates that, in the long run, prices for prescription drugs will increase as a result of the bill.

Trade Act of 2002 (H.R.3009) passed. The Act makes intellectual property rights and the elimination of regulatory practices (such as price controls) negotiating objectives in trade agreements.

Prescription Drug Users Fee Act renewed. Included in the legislation are industry requests to speed up product reviews and use third-party advisors recommended by the companies to assess products.

Greater Access to Affordable Pharmaceuticals Act is defeated. The Act would have weakened patent restrictions on pharmaceuticals, making way for more generic drugs.

A policy is enacted that requires warning letters sent to drug companies to first be cleared by the FDA counsel's office. The number of warning letters sent by the FDA dramatically decreases.

The Department of Health and Human Services proposes new privacy regulations that could give FDA-regulated entities, including drug companies, access to medical records without notice to patients.

The FDA approves rule change allowing some drugs, such as vaccines against biowarfare agents, to be approved after testing in animals.

A provision to protect companies from lawsuits regarding thimerosal contained in their vaccines is a last-minute addition to the bill that created the Department of Homeland Security. In the face of popular outrage, the provision is repealed a few months later.

1997
FDA Modernization Act is signed into law. Allows medical device makers to hire for-profit companies to review their products and promote them to the FDA. Codifies previous reforms. Allows manufacturers to disseminate journal articles describing the results of trials for unapproved uses of drugs. Reauthorizes the Prescription Drug User Fee Act. Authorizes six-month "pediatric exclusivity" patent extensions.

The FDA eases restrictions on direct-to-consumer advertising of prescription drugs, allowing ads to refer consumers elsewhere to find risk information instead of including it in the ads themselves.

The Orphan Drug Act tax credit is made permanent.

1996
Congress reauthorizes the Orphan Drug Tax Credit for one year. The credit covers 50 percent of the cost of clinical trials for orphan drugs. Companies not yet profitable enough to pay taxes are allowed to take the tax credit at a later date.

1995
The FDA relaxes regulations, eliminating the establishment licensing application, which required a separate application to approve the manufacturing sites of new drugs. Lot-lease approvals, a continuous review of manufacturing sites after initial approval, also end.

The US Patent Office allows companies to show potential usefulness by submitting preclinical trial data rather than data from clinical trials.

The Patent Office relaxes its criteria on awarding patents for genes.

1994
After heavy lobbying by the industry, price control proposals that were part of the Clinton health care plan are abandoned.

1992
Prescription Drug User Fees Act passes. Allows companies to pay a fee to the FDA in return for a faster review period.

1991
The FDA accelerates the review of drugs for life-threatening diseases.

1987
The Prescription Drug Marketing Act passed. (Requires distribution of samples and safeguards against the sale of substandard or counterfeit drugs.)

1984
Hatch-Waxman Act (The Drug Price Competition and Patent Term Restoration Act of 1984) passes. One of the major loopholes in the act allows brand-name drug companies a 30 month patent extension on a drug by suing a generic manufacturer.

1983
Orphan Drug Act passes. The law encourages development of drugs to treat rare diseases affecting fewer than 200,000 by giving incentives to companies.

1980
Bayh-Dole Act passes. The Act promotes university-industry partnerships and allows the industry to tap research conducted at taxpayer-subsidized facilities.

Top Companies

Methodology

Drug lobby preparing a bitter pill

Bush-Backed Drug Marketing Schemes
Evelyn Pringle

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At an FDA hearing on the safety of psychotropic drugs on Feb 2, 2004, dozens of tortured parents testified that their children had committed suicide or other violent acts after being prescribed the same drugs that are being marketed in the Bush-backed pharmaceutical industry schemes aimed at recruiting the nations 52 million school children as customers.
In July 2003, the Bush appointed New Freedoms Commission on Mental Health (NFC) recommended screening all children for mental illness and designated TeenScreen as a model program to ensure that every student receives a mental health check-up before finishing high school.

The NFC also has a preferred drug program in place modeled after the Texas Medication Algorithm Project (TMAP), that lists what drugs are to be used on children found to be mentally ill.

The list contains every drug that people complained about at the FDA hearing, including Paxil, Zoloft, Celexa, Wellbutron, Zyban, Remeron, Serzone, Effexor, Buspar, Risperdal, Zyprexa, Seroqual, Geodone, Depakote, Adderall, and Prozac.

There is little if any evidence that these drugs work on children but nevertheless, an estimated 10 million children in the US are now taking these mind-altering drugs even though they have documented side-effects including suicidal ideation, mania, psychosis, and future drug dependence.

According to a May 2003 report in the New York Times, national sales of anti-psychotics reached $6.4 billion in 2002, making them the fourth highest-selling class of drugs which proves the drug companies are already making a killing by drugging our kids.

Experts Against Screening

Dr Jane Orient is an internist and executive director of the Association of American Physicians and Surgeons. She offered a few words to the wise in United Press International's "Outside View" on December 16, 2004.

In regard to TeenScreen, Orient says parents ought to be asking some very serious questions before the government experts interview the first child such as:

What are the credentials of the screeners? What are the criteria for possible abnormality? What is the scientific validation? Will you be allowed to get a second opinion? Can you see the record and enter corrections if indicated? Will the record at any point be destroyed, or will the stigma of a diagnosis such as "personality disorder" follow the child throughout life?

What will happen if your child fails the screen? What sort of treatment will be given? Who will supervise it? What if you don't approve of it?

Do drug companies expect to have a large number of new consumers of their psychoactive drugs? Who might profit from the program (perhaps discoverable by asking who lobbied for it)? Bingo, right question Dr. Who stands to profit?

In 2003, Medico Health Solutions, reports that the use of behavioral drugs for children topped all other types of drugs at 17% of total spending. In the year 2003, the market research firm, IMS Health, calculated worldwide sales of antidepressants at $19.5 billion, up 10% from the year 2002.

Phyllis Schlafly, author of "No Child Left Unmedicated," raises several valid questions. What are the rights of youth and parents to refuse or opt out of such screening? Will they face threats of removal from school, if they refuse privacy-invading interrogations or medications? How will a child remove a stigmatizing label from his records?

Psychiatrist Peter Breggin, a court-qualified medical expert, and author of books, Talking Back to Prozac and The Anti-Depressant Fact Book, warns about the life-long damage a label of mentally illness can cause.

"There is nothing worse that you can do to a human being in America today than give them a mental illness kind of label and tell them they need drugs and these children are 3,4,5,6,7,8,9 years-old being treated in this manner," Breggin reports, "I then see them coming to me as adults saying I'd like to be a doctor but how can I when I have crossed wires in my head," he warns.

In a report, Allen Jones, former investigator Penn Office of Inspector General Bureau of Special Investigations, points out that there has been a 500% increase in children being prescribed drugs during the past 6 years.

Jones says the NFC call for mandatory screening of all students, with follow-up treatment as required, translates into putting more kids on mind-altering and potentially lethal drugs.

"TeenScreen is purely and simply a marketing scam to sell psychotropic drugs," according anti-child drugging advocate, Ken Kramer, "When they use "even if we save one life" as an argument to arouse emotions in parents that truly care, they are lying," he warns.

Bush Promotes Dangerous Drugs

The truth is, with full support from Bush, the pharmaceutical industry is using TeenScreen as a vehicle to push dangerous drugs on children who in the eyes of many experts are already being overmedicated.

Despite that the fact that SSRI antidepressants are banned for use with children in the UK and despite the FDA "black box" warning label now required on all SSRIs that the drugs increase suicidal thinking and behavior in kids, the NFC not only recommends that the same drugs be prescribed to children, it promotes the very schemes that will increase the number of kids on these drugs in schools and other public institutions.

According to a report by the Florida Statewide Advocacy Council, posted on Ken Kramer's website records@psychsearch.net, an investigation in Florida found that of 1,180 kids in foster care, 652 were on one or more psychotropic drugs.

In Texas, Dr John Breeding, an Austin psychologist, has seen cases where some foster children were placed on as many as 17 drugs and says drugs are being used as chemical restraints in Texas. He wants all SSRIs and neuroleptic drugs banned from use on children "The SSRIs are extremely harmful and addictive; and can cause or exacerbate suicidal or homicidal tendencies; withdrawal is painful and dangerous," Breeding warns.

Dr Ann Blake Tracy is the Director of the International Coalition for Drug Awareness, holds a doctorate in biological psychology, and is a specialist in the adverse reactions to SSRI medications. Tracy claims the whole hypothesis of SSRIs is "backwards." She says the drugs increase serotonin while decreasing the metabolism of serotonin, especially in the 7 to 10% of the population that studies have shown don't have the proper enzyme to metabolize SSRIs in the first place, according to the Aug 22, 2004 Desert Morning News.

Dr Tracy can recite hundreds of horror stories involving violence by people taking the same drugs that TeenScreen is marketing to more children.

She told the Morning News about, - the professor on Prozac who bit her mother to death; the Stanford graduate on Paxil who stabbed herself in the kitchen while her parents slept; the mother who bludgeoned her son and then drank a can of Drano; and the 12-year-old girl who strangled herself with a bungee cord she attached to a plant hanger on the wall."

"Most of these drugs are not approved for children, but it doesn't stop doctors from prescribing them," Tracy points out.

Turning People Into Psychotic Murderers

Besides causing suicide, enough evidence now exists to prove that psychotropic drugs have played a major role in the senseless acts of violence by school-age children in this country in recent years.

Dr Breggin, is against the use of psychotropic drugs in children, and has testified in civil and criminal cases numerous times about the link between SSRIs and suicide and other acts of violence.

On April 15, 2001, 16-year-old Cory Baadsgaard took a rifle to his High School in Washington State and held 23 classmates and a teacher hostage. Cory sat in jail for 14 months before finally being released based on expert testimony by psychiatrists that his behavior was an adverse reaction to the drugs he was prescribed.

Cory has no memory of his actions at the school that day. 21 days before the event, he had been taken off Paxil and prescribed a high dose of the drug Effexor.

Cory's father Jay told Insight News, "They always talk about how the kids who do these things are the ones who get picked on by the jocks and stuff, but Cory was a jock. He was on the varsity basketball team, played football and golf, and was very popular in school.

Jay wants the media to warn people about the dangers of putting kids on these drugs, "If Cory had been on PCP the media would say 'Oh, he needs drug rehabilitation,' but because these were prescribed medications they say 'Oh, it can't be that,' but now we know it can be," he said.

"The morning that Cory went to school and did what he did, my wife and I just knew that it had to be something with the drugs," Jay reports. One of Cory's friends described the incident to Jay, "Cory was yelling and then he just stopped, looked down and saw the gun in his hand and woke up," he said.

Cory recently made an unlikely new friend in Colorado, when he met Columbine High School shooting victim, Mark Taylor, who is suing the manufacturer of the antidepressant that Eric Harris was on when he opened fire at Columbine.

Kelly Patricia OMeara interviewed Mark Taylor, and recounted his description of the shooting incident in a report for Insight on Sept 2, 2002.

Taylor told Kelly, "I was sitting on a hill outside the school eating lunch with my best friend when Eric Harris came over and started shooting me," Taylor recalled, "I was shot between seven and 13 times. No one really knows the exact number because there were so many bullet tracks. Most of the bullets just went right through me. After I was shot I just lay there, playing dead, and could see others being shot," Taylor recalled.

It has never been revealed if Dylan Klebold was on any legal drugs at the time of the shootings, but an autopsy revealed that Harris was on the psychotropic drug Luvox, a selective serotonin reuptake inhibitor (SSRI).

Taylor's attitude toward the teen who nearly killed him is surprising. He told O Meara, "I'm suing Solvay because I believe that Eric Harris did what he did because of this drug."

Taylor's suit claims the drug made Harris manic and psychotic and as a consultant in the suit, Dr Tracy agrees. "All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug," she told Insight News, "Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts," she explained.

Gary Null & Associates of New York is filming a documentary called "The Drugging of Our Children," that will feature interviews with both Cory Baadsgaard and Mark Taylor, and will chronicle the long history of tragic events that have resulted from the use of these drugs on children.

A little known fact is that a few days before the Columbine tragedy, Eric Harris had been rejected by the Marine Corps specifically because he was taking the drug Luvox.

In 2001, 18-year-old Jason Hoffman, shot five students and teachers at a California High School, while on the drugs Celexa and Effexor, and he too was rejected by the Navy one day before he went on his rampage, according to the San Diego Union-Tribune.

In a letter to his mother, Hoffman said, "I want people to know that what happened was not the real me, I was just angry, maybe my medication. It was a fluke of the moment. The person was not the true Jason Hoffman," he wrote.

On Oct 29, 2001, Jason Hoffman killed himself by hanging from a vent screen in his jail cell, the Tribune reported.

Kip Kinkel was 15 on May 21, 1998, when he murdered his parents, and then went to Thurston High School in Springfield, OR where he shot and killed 2 students and injured 22 more. Kinkel was on Ritalin and Prozac at the time of the killings even though Prozac was not approved for pediatric use.

Seven years after the senseless killings by Kinkel, on December 18, 2003, Eli Lilly sent letters to British healthcare providers, warning that Prozac was not recommended for any use in children.

14 year-old Elizabeth Bush was on antidepressants when she took a gun to school and wounded another student in Williamsport, PA in 2001.

12-year-old Christopher Pittman was on Zoloft when he shot his grandparents and set their house on fire, and says his violence was caused by the drug he was. Before Zoloft, he had been on Paxil.

According to court records, the doctor who prescribed the drug to Christopher mentioned no problems in his medical notes. A few days before the murders, the doctor wrote: "Lots of energy. No plans to harm self. Not flying off the handle."

Christopher now sits in prison.

His father, Joe Pittman, testified about the effects of the drugs on his son at the FDA Hearing and read a letter Christopher wrote that described how he felt when he committed the murders, "Through the whole thing, it was like watching your favorite TV show," he wrote, "You know what is going to happen but you can't do anything to stop it."

Dr Tracy explains how this happens. SSRIs suppress "the REM state or dream state [of sleep] ... These drugs allow a person to be awake but at any time they can slip into the REM state. This is why people often discuss how they couldn't tell the difference between the dream and reality. These drugs are horribly damaging to the entire system," she warns.

Even the people closest to Jeff Weise are at a loss to say what led to the deadly killing spree by Weise in Minnesota, where the 16-year-old shot his grandfather, his companion, and then went to the high school and shot 5 students, a teacher and a security guard before killing himself. According to school employee, Gayle Downwind, Weise was on Prozac at the time of the shootings.

Dr Tracy has consulted on many cases where children engaged in violent behavior including a 15-year-old boy on Zoloft who shot and killed a woman and is serving life in prison; a 17-year-old boy on Paxil for three months who jumped off an overpass into the path of a trailer truck; a 14-year-old girl prescribed Paxil to deal with the suicide of her father (who was on Paxil before killing himself) drank Drano in a suicide attempt; and a 16-year-old boy on Paxil who stabbed a woman over 60 times, drove his car into a cement abutment in a failed suicide attempt, and is now serving life in prison.

"In each of these cases," Tracy told Insight News, "individuals close to them were shocked at the violent and destructive behavior because it was so out of character for them."

Courts Starting to Get It

Drug companies are finally starting to be held responsible for violent behavior associated with these drugs. A jury in Cheyenne, Wyoming recently determined that Paxil, "can cause some individuals to commit suicide and/or homicide." The jury decided Paxil caused Donald Schell to shoot his wife, daughter and granddaughter before killing himself after being on the drug only two days.

The jury allocated 80% of the fault on Paxil drug maker GlaxoSmithKline and awarded the surviving family members $8 million in damages.

On June 18, 2003, GlaxSmithKline issued a warning to British physicians against the use of Paxil in children, acknowledging failure of clinical trials "to demonstrate efficacy in major depressive disorders and doubling the rate of reported adverse events - including suicidal thoughts and suicide attempts - compared to placebo."

In Bismarck, ND, 10 days after Ryan Ehlis began taking Adderall, he shot and killed his 5-week-old baby and then turned the gun on himself. He survived and was tried for the murder but was acquitted after the Judge agreed with psychiatrists who testified that the murder resulted solely from a psychotic state caused by the drug.

In February 2005, Canadian regulators ordered Adderall off the market after the drug was linked to 20 sudden deaths and a dozen strokes. Of the 20 deaths, 14 were children.

There has been a lot written about the increase in teen violence and school shootings but no one has identified a common denominator in the lives of these kids with one exception, the drugs. If we allow the Bush-backed marketing schemes to succeed in recruiting more kids as customers for these dangerous drugs, according to Tracy, we had better prepare for more of the same.

"We've got a nightmare on our hands with these drugs, an absolute nightmare," she warns, "We've got kids on these drugs that are ticking time bombs in every school in America."

"When all of this is over and we count up the dead, we're going to be in shock," she adds.

Miamisburg OH

(Evelyn Pringle is an investigative journalist focused on exposing government corruption)

TeenScreen - New York Times - Danger Signs
Evelyn Pringle

Maybe my expectations are too high. All of my life I've put a lot of stock in a story if I read it in the New York Times. In hindsight, I must admit that I found the whole saga of the planted WMD stories, that in large part helped the administration push the country into an unnecessary and senseless war in Iraq, troubling to say the least. However, to its credit the Times did give Judith Miller the boot and thus, restored my confidence in the legitimacy of the paper at least somewhat.
That said, my expectations were shattered again on December 4, 2005, when I read the article, "Danger Signs," which paints a totally inaccurate picture of a pharma-backed marketing scheme, billed as a suicide prevention tool, under the name, "TeenScreen."

This profiteering scheme was actually hatched by several front groups in concert with the industry, with the ultimate goal of getting a foot in the door of the nation's public school system to recruit the 52 millions students as life-long customers in the sale of a new generation of useless, dangerous, and expensive psychiatric drugs.

In Danger Signs, the Times talks about how in the mid-1980's, Dr David Shaffer, a psychiatrist employed by Columbia University, became concerned about an increase in teen suicide which motivated the good doctor to develop the TeenScreen survey.

The truth is that in 1987, Prozac, the first in a stream of SSRI antidepressants, hit the market which necessitated a heavy-duty plan for legal drug pushing. Pharma needed an expanded customer base, so they put their heads together and came up with the bright idea for Shaffer to develop the ridiculous survey and play on the nation's soft side when it was passed off as a prevention tool to save poor suicidal teens.

In reality, TeenScreen is one of the slickest, and sickest, marketing schemes that I've run across in my 2 years of investigating the world's most profitable drug cartel better known as the pharmaceutical industry.

It's certainly no secret that certain officials in the nation's regulatory agencies are members of the cartel so it's no wonder that I got a little suspicious when I read the comment in the Times about a CDC survey that claimed about 8% of high school students answered yes when asked if they had attempted suicide during the past year. The Times did not say 8% thought about suicide, it said 8% of the kids attempted suicide.

Now don't get me wrong, I am not insinuating that the CDC is exaggerating, or that it ginned up a survey, not at all. I'm saying that the CDC official who presented the Times with the 8% story is a liar.

If they did a survey and found 8 kids out of a 100 who actually attempted suicide in the past year, they either surveyed kids in substance abuse treatment, or a homeless shelter, which is the favorite hunting grounds of the bandits running TeenScreen when they go out trolling for potential suicide statistics to inflate their numbers.

Case on point for manipulating statistics, here is what TeenScreen's Executive Director, Laurie Flynn, wrote in a promotional article titled, Before Their Time: Preventing Teen Suicide.

"Since 1960 the suicide rates for males 15-19 years old has tripled. More alarming, suicide is increasingly claiming its victims at younger ages. From 1980-1996, suicide rates among children 10-14 years old increased 100 percent."

Imagine that, an increase of 100%. I am shocked, just shocked!

Experts find the deliberate inflation of numbers appalling. "They are pulling numbers out of thin air - falsely presuming that this crisis is about lack of access to drugs and calling for government to provide more and more of what many of us believe is the wrong kind of treatment," according to Robert Whitaker in an interview with Kelly O'Meara on May 16, 2003, published by Insight News.

The truth is, that although the class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), marketed to children via TeenScreen, have been prescribed to tens of millions of people over the past decade and they have not lowered suicide rates an iota.

A government sponsored study published in the Journal of the American Association surveyed 9708 people aged 18 to 54, and compared the suicide data from the 1990-1992 National Comorbidity Survey and the 2001-2003 National Comorbidity Survey Replication and found: "Despite a dramatic increase in treatment, no significant decrease occurred in suicidal thoughts, plans, gestures, or attempts in the United States during the 1990s," Trends in Suicide Ideation, Plans, Gestures, and Attempts in the United States, 1990-1992 to 2001-2003, JAMA. 2005;293:2487-2495

The study's authors also note that their findings are corroborated by "other information" which "argues against the possibility that the increase in treatment prevented an increase that would otherwise have occurred in suicide-related behaviors. Specifically, randomized controlled trials find only modest effects of treatment in reducing suicidality, even with optimal regimens."

Not only do SSRIs not prevent suicide, on July 21, 2004, the Journal of the American Medical Association reported that during treatment with SSRIs, there was a "significantly higher risk of suicide and suicidal thoughts ... during the first nine days of treatment" and that children first starting treatment were 4 times more likely to think about suicide, and 38 times more likely to commit suicide. Children as young as five have committed suicide while taking these drugs, the study found.

When discussing the number of child suicides, the Time's Danger Signs article says about "1,500 succeed annually, making suicide the third-leading cause of death in teenagers after accidents and homicides."

I don't know where those statistics came from, or whether they are accurate. But think about it, there are 52 million kids in the nation's public school system, not counting the kids aged 0 to 5. And according to the CDC, in 2004, there were over 4,000,000 births in the US.

A statistically low number of 1,500 suicides is hardly worth subjecting millions of kids to an intrusive mental heath screening that is going to label a third with mental health disorders, after which they will be drugged with medications that carry a black box warning against their use with children because they can cause kids to commit suicide.

There is also absolutely no evidence to support the theory that TeenScreen can prevent suicide. In fact, in March 2004, the United States Preventive Special Task Force found no evidence that screening for suicide risk reduces suicide attempts or mortality.

It also noted that there is limited evidence on the accuracy of screening tools to identify suicide risk in the primary care setting, including tools to identify those at high risk The task force also found no studies that addressed the potential harm of screening for suicide risks.

And finally, the USPSTF found insufficient evidence that treatment of those at high risk reduces suicide attempts or mortality. As a result, the task force said it could not determine the balance of benefits and harms of screening for suicide risk.

According Danger Signs, Shaffer went public with TeenScreen four years ago, offering it to schools at no charge. That assertion is another blatant misrepresentation. When TeenScreen went public in Ohio, tax payers in 3 counties were billed $15,000 each, to implement the scheme in Ohio schools.

In Tennessee, a drug company financed the first program at a Nashville High School, in which a third of the kids screened were steered to a mental health clinic.

And while testifying before Congress, Flynn, asked lawmakers to take funds earmarked for alcohol and drug abuse treatment programs and allow those tax dollars to be used to set up this drug profiteering scheme in public schools.

The Times should have done a bit of fact checking before it wrote: "It is given to students with their parents' consent." The reporter responsible for the article should ask Chelsea Rhodes and her parents in Indiana if the school had consent to test Chelsea and send her home diagnosed with 2 mental illnesses.

Telling an impressionable and vulnerable young girl that she is mentally ill is child abuse and school officials involved should be arrested. Chelsea will likely be affected by this labeling for life.

This next comment that indicates a serious deficiency in fact checkers at the Times states: "With only word-of-mouth marketing, the questionnaire has spread to 461 sites in 43 states."

Here again, the reporter might want to check and see how much money was funneled through TeenScreen to the PR firm that marketed the survey. The same firm that lists many of the major drug companies as clients on its web site.

Rabin Strategic Partners is one of the PR companies, that put together a publication called, "Catch Them Before They Fall; How to Implement Mental Health Screening Programs for Youth as Recommended by the President's New Freedom Commission on Mental Health," according to Sue Weibert, The Genesis of President Bush's New Freedom Commission on Mental Health, OpEd News, December 15, 2005.

Only word-of-mouth? According to Flynn at that 2004 AACAP Meeting, they mailed a copy of, Catch Them Before They Fall, "to people who were on key committees" in all 50 states," Weibert reports.

Also the Times might want to check out the $180,000 that was funneled through TeenScreen to Florida officials to try to sell the survey to schools that state.

The Times said TeenScreen's aim is merely to identify kids at risk, not to encourage use of antidepressants. Then I'd like to know what Shaffer meant at the February 2004, FDA hearing, after hearing all the other professionals testify about the reports and studies documenting the serious adverse reactions in children while on SSRIs, when he said:

"There have been no direct studies with frequent and careful measurement examining whether SSRIs increase, decrease, or have no effect on suicidal ideation and behavior, so that we are dependent very much on inference, but maybe that is always the case."

"I just would like to conclude with the following," Shaffer told the panel. "After increasing for years, teen suicide rates have been declining consistently in many countries. During this period, there has been a marked increase in exposure of teens to SSRI antidepressants," he claimed.

"We have nothing to do with providing recommendations for treatment," Flynn told the Times reporter, who evidently bought it hook, line and sinker.

People temped to believe that claim ought to watch TeenScreen's video-taped presentation at the annual convention of the National Association for Mental Illness, where the TeenScreen crew tells the army of NAMI members that helping TeenScreen might require them to contact a child's insurance company to check on coverage or drive a child to an appointment with a shrink.

The video also shows the TeenScreen crew passing around a pad of paper for NAMI members from all across the country to sign on as volunteers and agree to rise up against anyone who speaks out against TeenScreen when it tries to move into a new community.

In the video, the presenter also explains the importance of tricking kids into agreeing to take the survey first, by bribing them with pizza or movie coupons or other perks, because according TeenScreen, the parent won't agree to the survey so they need to win the kids over first and then send them home to talk the parents into it.

The Times reporter might want to check and see how much drug money has actually been funneled through NAMI, the nation's number-one front group of all time, to set up this marketing scheme in schools all over the country.

Its actually comical to watch Flynn change her talking points depending on the audience. On March 2, 2004, she testified at a congressional hearing and said that in the screening process, "youth complete a 10-minute self-administered questionnaire that screens for social phobia, panic disorder, generalized anxiety disorder, major depression, alcohol and drug abuse, and suicidality."

After the school tells parents that TeenScreen determined that their child has one or more of the mental health disorders she listed for Congress, what is Flynn inferring will happen to the kids, if they are not put on drugs?

I read one meaningful statement in Danger Signs which said: "Other critics worry that TeenScreen will funnel too many kids into treatment and lead to overuse of medication, with possibly dangerous results."

However, even that comment is an understatement. The concern about the overuse of drugs with children is far more than a "worry."

According to an on-going investigation of Pinellas County, Florida, by expert records researcher, Ken Kramer, a review of relevant information for 2002 and 2003, revealed that 81% of the teens who committed suicide were either on psychotropic drugs or had received psychiatric treatment.

Dedicated anti-child-drugging advocate, Doyle Mills, made a good point about teen suicide when he said, "try to find a suicide victim who has not already received some form of psychiatric treatment, usually drugs."

Shaffer and Flynn, the self-proclaimed prevention "experts," forgot to tell the reporter that the majority of kids who have committed suicide, or other violent acts, in recent years were already on the lethal SSRIs.

When discussing the issue, Flynn suggests that school violence is caused by a lack of drugs. "While national awareness of the pressures our kids face today has been raised in the wake of recent school violence," she said in NAMI E-News, July 6, 1999, Vol 00-1, "the far greater difficulties children with serious mental illnesses and their families confront each day, every year, are being overlooked. They are trapped inside a system of horrors."

The children who went on out of character killing sprees were trapped inside a system of horrors all right but not due to lack of drugs. The FDA's warning about SSRI behaviors "known to be associated with these drugs," include "anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania," according to court-certified expert on SSRIs, Dr Peter Breggin, on PBS Frontline.

"Each of these reactions," Breggin advises, "can worsen the individual's mental condition and can result in suicidality, violence, and other forms of extreme abnormal behavior."

Evidence from many sources confirms that SSRIs commonly cause or exacerbate a wide range of abnormal mental and behavioral conditions, according to Breggin, International Journal of Risk & Safety in Medicine 16 (2003/2004).

At the FDA hearings in February 2004, dozens of devastated parents testified that their children had committed suicide, or other violent acts, as a direct result of being prescribed the same drugs that TeenScreen is pushing.

A factor that stands out when reviewing the testimony is that the conduct by children on these drugs is extremely violent, regardless of whether the behavior involves homicide or suicide. A bizarre pattern emerges when listening to parents describe the acts of their children that is totally unheard of.

For instance, Sara Bostock described how her daughter, Cecily, a recent Stanford University graduate, stabbed herself to death in the chest with a kitchen knife two weeks after she was prescribed Paxil, while her mother slept in the next room.

"The only noise was a slight yelp and a thump when she fell on the floor," Sara said. "To die in this violent, unusual fashion without making a sound ... Paxil must have put her over the edge," she pointed out.

Glenn McIntosh told the panel, "I would like to introduce you to my daughter, Caitlin Elizabeth McIntosh," he said, "it is actually only a two-dimensional image of her, but it is all I have left."

"She died of suicide at age 12 years, 3 months," her father explained, "just eight weeks after being put on Paxil and then Zoloft." On January 5, 2000, Caitlin hung herself in the bathroom at school, Glenn said.

Mark and Cheryl Miller described the strange suicide method of their son Matt after he was put on Zoloft. Matt was told to take the pills for a week and then call the doctor back, but he never made it a week, he hung himself from a bedroom closet hook, barely higher than he was tall.

'To commit this unthinkable act," his father said, "he was actually able to pull his legs up off the floor and hold himself that way until he lost consciousness."

Lisa Van Syckel told how her daughter, Michelle, was placed on Paxil after being diagnosed with depression and anorexia nervosa, when as it turns out, Michelle actually had Lymes Disease.

"My daughter self-mutilated, became psychotic, became violent, attempted suicide twice," Lisa told the panel.

Her friends at school call Michelle Psycho, Lisa said, "all because she was misdiagnosed and all because everyone has withheld from the public the adverse effects of Paxil."

"Please," Lisa asked the panel, "have respect for our children, make sure that you put proper warnings on these medications."

"Our children's lives are at stake here, because not only does it cause suicide, it also causes them to become violent, very, very violent," she added.

Tom and Kathy Woodward's daughter, Julie, hung herself after being on Zoloft for a short time, even though she had no history of self-harm or suicide.

They explained that the doctor had said Zoloft was safe and had very few side effects and had never discussed the possibility of violence, self-harm, or suicidal acts and that the two and a half pages of information that came with the drug never mentioned self-harm or suicide either.

"We are here because we believe the system we have in place is flawed," Tom told the panel. "It is clear that the FDA is a political entity and its leadership has protected the economic interests of the drug industry."

Grieving mother, Shannon Baker said, "I am here today, because I am representing the love that my daughter had for life and to be her voice and the voice of all the other children who their voices have been silenced by these drugs. "

"Their deaths have been so senseless and needless," Shannon continued, "I am here speaking in front of you, hoping that you will go in the right direction and ban these drugs for children."

"There needs to be no more senseless and needless deaths because of these drugs," she added.

Christopher Pittman's father testified that 12 year-old Chris had shot his grandfather and grandmother while they slept, and then set the house on fire, and fled in the family car within a few weeks of being prescribed Zoloft, and 2 days after the dose had been doubled. Before Zoloft, Christopher had been on Paxil.

His maternal grandmother said Christopher adored the grandparents he killed and had never been violent before in his life. Chris himself describes the event as like being in a dream watching a movie where you can see what is happening but you can do nothing to stop it.

In the criminal trial, Christopher was tried as an adult and sentenced to 30 years in an adult prison.

Joyce Storey told the panel how her 17-year-old son Brian was diagnosed with depression, given Zoloft pills and told to come back in two weeks. "Five days later, my son killed a woman," Joyce said.

The psychiatrist that examined Brian, Dr. James Merkangis, testified at trial that Brian had a manic reaction to Zoloft. And similar to Christopher Pittman, Brian testified that it was just like being in a dream. Brian is now serving life without parole.

Brian's mother told the panel of another boy at Brian's school who 6 months after Brian's crimes, took an ax to both of his parents and his thee brothers and sisters while on Prozac. That child is now serving 2 life sentences, Joyce said.

"This is not a coincidence," she warned. "There is a common denominator, teenager, severely depressed, on an SSRI antidepressant."

"What is scary," Joyce said, "is that you are only hearing from a few of us that this has happened to, and there are a lot more out there."

Young Mark Taylor was shot between 6 and 13 times, by Eric Harris during the Columbine shooting spree, while Harris while on SSRIs.

When testifying Mark told the panel: "The measure of a man is not his strength or how much money he has, or how good he looks or how strong he is, or how powerful he is. The measure of the man is how noble he is."

"I want to ask you guys," he said, "are you really being noble with your choices, or are you just allowing the drug companies to squeeze by you just because they have a big pocketbook?"

"I am amazed that you guys are even standing here supporting these drug companies," he told the panel. "I mean this has never happened in the history of America," Mark said, "this is a shame and it ought to be stopped today, not next week."

Mark is right, most of the children involved in violent events in recent years have been on SSRIs. Eighteen-year-old, Jason Hoffman, was on Celexa and Effexor when he shot three students and one teacher at a California High School.

"I want people to know that what happened was not the real me," Jason wrote in a letter from his jail cell. "I was just angry, maybe my medication. It was a fluke of the moment," he said. "The person was not the true Jason Hoffman."

On Oct 29, 2001, deputies found Jason dead, hanging from a vent screen in his jail cell.

Kip Kinkel, was 15 and on Prozac, when he killed his parents and then drove to school where he shot and killed two of his classmates and injured 22 others.

Sixteen-year-old, Jeff Weise, was on Prozac when he shot his grandfather and his female companion, and then went and shot 5 students, a teacher, and a security guard at a school in Minnesota, before killing himself, according to school employee, Gayle Downwind.

What most people don't realize is that the experiences of these children don't represent unknown behaviors. The drug companies and the FDA have known about many of these side effects since before the drugs came on the market.

The British Medical Journal recently received a series of in-house Eli Lilly documents and studies concerning Prozac from an anonymous source. The BMJ forwarded the documents to other authorities, including Congressman Maurice Hinchey and the FDA.

Congressman Hinchey distributed the materials to others, including Dr Breggin, who reviewed the documents and issued the January 12, 2005, report, An Examination of Eli Lilly and Company's Contentions that the BMJ Prozac Documents were Never Missing and Have No Significance.

The first study Breggin reviewed, "Activation and Sedation in Fluoxetine Clinical Trials," dated November 8, 1988, reported a 38% rate of stimulation in the patients, even though many of the patients were sedated and even though many parameters of stimulation were not counted. This study was requested by the German regulatory agency but Lilly never gave it to the German agency or to the FDA.

The second set of documents Breggin examined related to a July 1985 in-house analysis by Lilly in which the company found a large statistically significant increase in suicide attempts for patients taking Prozac during their placebo controlled clinical trials.

Breggin discovered that there were 12 suicide attempts found in the Prozac group and only one in each of the control group and comparison drug, a tricyclic antidepressant.

According to Breggin, "even after the company winnowed out six of the suicide attempts, the remaining 6:1 ratio was alarming." Furthermore, Lilly hid many of the suicide attempts under false categories and did not turn this study over to the FDA either.

One study was conducted by the FDA concerning increased spontaneous post- marketing reports of "hostility" and "intentional injury" on Prozac and was generated shortly before the 1991 FDA meeting that evaluated antidepressant-induced suicidality.

In this study, the FDA used a comparison antidepressant, trazodone, as a control and found a 20-fold increase in reports of hostility and intentional injury per prescription of Prozac compared to trazodone.

Breggin had repeatedly attempted to obtain the FDA study through FOIA requests. The FDA finally wrote and said the documents could not be found.

The rise in Prozac reports occurred before any controversy arose concerning Prozac and violence, and the studies include graphs showing a 40-fold relative increase in reports of suicide attempts, overdose and psychotic depression with Prozac compared to trazodone.

Other documents reviewed by Breggin, included an in-house Lilly memoranda by Claude Bouchy written in November 1990, showing that the firm consciously hid Prozac-induced suicidal acts under misleading categories, such as "no drug effect," and remained undisclosed to the FDA.

"In one memo," Breggein said, "a Lilly employee expresses shame and regret about hiding this data."

According to Breggin, Lilly had completed all of the above studies by the time of the 1991 FDA hearing to evaluate the risk of antidepressant-induced suicidality.

In fact, the company continued to hide the data during the 2004 FDA hearings on suicides related to SSRIs. At the hearings, Tom Laughren of the FDA said that he knew of no data linking SSRIs to suicide or hostility.

Breggin openly contradicted Laughren and told him that suicide data did exist in regard toLilly's Prozac, but the FDA continued to act unaware of the existence of any such documents in 2004 and did not ask Breggin any details about the data.

In addition, Breggin reports that Lilly has secretly settled every lawsuit, and until now has been successful in keeping the documents sealed.

On top of the serious risks of placing kids on SSRIs, study after study has shown that they do not work. Irving Kirsch and his associates at the University of Connecticut used a FOIA request to obtain the studies submitted to the FDA for the purpose of gaining approval of SSRIs, and found that the difference between the response to a placebo verses an SSRI was statistically insignificant.

Their findings were published in Prevention and Treatment, where they explained that the miniscule difference between a placebo and medication is commonly referred to by researchers, FDA reviewers, and critics, as the "dirty little secret."

According to Robert Whitaker, author of Mad In America, a "question that has to be asked is why it has taken 15 years to find out about this data," he told Insight News. "Why are we learning about these increased suicides in clinical trials 15 years after the drugs were approved?"

The way things are going, that question might be answered at some point. The hidden studies are drawing the attention of all kinds of regulatory officials. On September 27, 2004, the Boston Globe reported that evidence showing that drug manufacturers and the FDA concealed negative clinical trial data and deceived physicians, consumers, and shareholders about failure to demonstrate the safety and effectiveness of SSRI antidepressant drugs has caught the interest of the Securities and Exchange Commission.

The FDA is as secretive as their partners in crime. "The FDA is as obstructionist as the drug companies, if not more so," says CBS reporter Sharly Attkisson, according to Judy Lieberman, in the July-August 2005, Columbia Journalism Review. "That may be the biggest scandal behind these drug stories," Attkisson said.

On another front, last summer, New York Attorney General, Eliot Spitzer, charged GlaxoSmithKline, with "repeated and persistent fraud," for failing to disclose clinical trials about Paxil, and specifically that it suppressed trials showing Paxil ineffective in treating depression in children. The lawsuit said that in 2002, over 2 million prescriptions for Paxil were written for children in the US.

According to the results of the report, Pediatric and Adolescent Antidepressant Drug Use in the US, presented at a February 18, 2004 FDA hearing by Dr. Gianna Rigoni from the Office of Drug Safety of the FDA, in 2002, Zoloft was the most commonly prescribed product, accounting for about 31% of dispensed antidepressants, followed by Paxil and then Prozac. The adolescent population accounted for approximately "8.1 million prescriptions dispensed" in 2002, Rigoni told the panel.

Dr Donald Marks, MD, Ph D, testified at the hearing as a prescribing physician, a father, and as a former director of clinical research for two multinational pharmaceutical companies.

"The seriousness and severe adverse event effects of SSRI drugs," Marks said, "makes their use hardly justified in the majority of cases because SSRIs are well known to have limited efficacy over placebo and against non-pharmacologic treatments."

"There are many studies in the peer reviewed medical literature, supporting the causal role of serotonin in disinhibition and violence," he said.

"My own prescribing experience with SSRI drugs and evaluation of numerous cases referred to me," Marks advised, "has revealed significant agitation and aggression, akathisia, activation of mania and hypomania, increased depression, serious dependency and withdrawal difficulties, suicidal ideation, and toxic interactions with other drugs."

"It is important to be aware," the doctor warned, "that these symptoms of SSRI toxicity can be mistaken for the progression of the underlying mental state being treated, leading to use of more of the same and other offending SSRI drugs rather than to withdrawal of the causative SSRI agent."

"Danger Signs," does not mention that Dr Shaffer has testified as an expert witness in civil and criminal trials, on behalf of the drug companies and against patients and families who had endured horrendous experiences caused by SSRIs.

Despite the widely publicized evidence of adverse affects, Shaffer continues to urge the use of SSRIs with children, illustrating his willingness to place drug maker profits over the proven risks of suicidal and violent behavior committed by children on these drugs.

The Time's article fails to mention his lengthily history of pushing these dangerous drugs on kids whenever a protective barrier is erected. Two years ago, the New York Times itself noted that Shaffer, at the request of a drug maker, attempted to block the recommendation to ban the drugs from use in children in the UK by sending a letter to the British regulatory agency claiming there was insufficient data to restrict the use of the drugs in adolescents, on December 11, 2003.

Dr Marks discussed the potential resistance that would arise in response to banning the use of the drugs on children in the US, when he told the panel that SSRI manufacturing and sales is "serious business with tens of millions of patients in the U.S. and a market in the tens of billions of dollars."

In his experience working for drug companies Marks warned, any attempt to decrease sales by increasing warnings will be met with severe organized resistance.

However, the pharmaceutical industry has nothing to worry about when it comes to blocking attempts to decrease the sale of SSRIs to kids. As the article in the Times indicates, the "severe organized resistance" of Shaffer, Flynn, NAMI, and TeenScreen are up to the task

Evelyn Pringle evelyn.pringle@sbcglobal.net

(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government)

Teen Boot Camps: Behavior Modification or Torture Centers?

Pharma To Republicans -- Time To Pay Up Again
Evelyn Pringle

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The generation of children injured by vaccines containing the mercury-based preservative thimerosal is now reaching puberty. Many of these children will require life-long care and support. The cost to their parents by today's standards, will reportedly exceed $2 million dollars for each child.
An ever-growing number of health care professionals point to thimerosal as the culprit behind the explosion in cases of autism and other neurological disorders. The only common thread connecting these damaged children to one another is their exposure to mercury through childhood immunizations.

Accountability from vaccine makers is something that parents of injured children have been seeking for years; but accountability appears more illusive with each year's passage. On October 27 2005, the Hartford Courant reported that "Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people."

The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S 1873), is being pushed through Congress without giving voters the chance to make their objections known to their elected officials.

Nicknamed "Bioshield Two," the bill's primary sponsor, Senator Richard Burr (R-NC), claims the Act will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."

Co-sponsored by Senators Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), the Act will in truth, eliminate current regulatory and legal safeguards applied to vaccines.

What kind of profits need protecting? A good example is GlaxoSmithKline, which predicts that some of its new vaccines will become blockbusters with projected sales of more than $1 billion a year, according to Reuters on June 30, 2005. Glaxo aims to launch five major vaccines by 2010, it said.

ADVERTISEMENT Another example, for people who believe there's no profit in vaccine making, "tell it to Wyeth, a big drug maker whose vaccine Prevnar ... costs more than $250 for the four-dose treatment given to infants," says Kristine Severyn, PhD, author of the report, Profits, Not Science, Motivate Vaccine Mandates Vaccine Policy Institute.

Despite the price, "the government has recommended that all infants get the vaccine, and insurers generally pay for it - as does the federal Vaccines for Children program for low-income families. Prevnar, with sales expected to top $1 billion this year," says Severyn.

Severyn's predictions were right on. According to Wyeth's 2005 first quarter earnings report, Prevnar achieved net revenue of $391 million, more than double the first quarter earnings in 2004.

Bush's FY2006 budget proposes to improve access to vaccines by allowing underinsured children to receive Vaccines for Children at state and local health clinics. The Department of Health and Human Services estimates that cost of the proposal will be $140 million in 2006, and $700 million over the 2006-2010 period.

How much does this sort of government protection cost? For starters, according to the Center for Public Integrity, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is the industry's trade organization and it has topped the list of pharmaceutical lobbying spending since 1998, shelling out $74 million. Its members include 16 of the industry's 20 largest companies and their subsidiaries and its current president is Billy Tauzin, is a former Republican congressman from Louisiana.

In the 2002 election cycle, PhRMA gave $3,505,052 with 95% going to Republicans. The top recipient in the Senate was none other than Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics. So far in the 2006 cycle, Gregg has received over $106,000 and Enzi has taken in $21,000 in pharma money.

Frist is a real piece of work. He has been trying to get a law passed to protect the drug companies for years. In 2002, he was behind the dead of night insertion of a provision into the Homeland Security bill that would have immunized vaccine makers from lawsuits related to thimerosal.

Frist has made millions upon millions profiting off human misery. The basis of the family fortune is the Hospital Corporation of America, the largest for-profit hospital conglomerate in the nation. However, the corporation also paid the largest health care settlement in history of more than $1.7 billion in civil and criminal penalties to settle charges of massive Medicare and Medicaid billing fraud.

Until recently, Frist and his wife owned $26 million worth of HCA stock. They are currently being investigated on charges of insider trading in the sale of HCA stock in the weeks immediately before the stock's value plummeted, and conflict of interest charges involving his ownership of HCA stock which he had previously claimed he knew nothing about because in accordance with ethics rules, it was in a "blind trust."

According to the Center for Justice and Democracy, Frist has received more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, raising more cash from health-care interests than 98% of his colleagues. In return, his legislative work in the Senate consists of almost nothing but trying to push through laws to increase profits for his number one backer.

Its worth noting that while Frist was its chairman, the pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee, doling out about $4 million, with Eli Lilly, the company that invented thimerosal, being the single biggest contributor, giving $1.6 million.

The National Vaccine Information Center (NVIC), a watchdog advocacy group, is highly critical of the pending protection legislation. According to the group's President, Barbara Loe Fisher, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades." The NVIC calls the Act "a drug company stockholder's dream and a consumer's worst nightmare."

According to NVIC, currently there are at least ten different bills pending in Congress that will contain provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.

"This proposed legislation," Fisher told UPI, "is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur."

The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single authority for the advanced research and development of drugs and vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws. In addition, the Act specifically bars citizens from challenging the Secretary's rulings in court.

BARDA will be exempt from the Freedom of Information Act and the Federal Advisory Committee Act, to ensure that no evidence related to injuries caused by vaccines classified as "countermeasures" will become public.

"It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take," Fisher told UPI, "that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."

In a November 15, 2005, letter to Senator Burr's staff director, Fisher describes S 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.

"It is exactly this type of legislation that leads to civil disobedience and many times in the extreme form," Dr Boyd Haley, a well-known expert on heavy metal toxicity, told this author, "I am very fearful of how certain segments of our society will respond to any mass vaccination program---especially if it does cause a problem like the thimerosal/autism situation," he said.

As it stands today, if the Bush administration and its puppets in Congress achieve their common goal of protecting pharma profits by shielding vaccine makers from lawsuits, tax payers will have to foot the bill for the life-long costs of caring for millions of injured children.

Tax payers are already funding their special education needs. In a January 14, 2005, letter to a Congressional Subcommittee on Human Rights, the Government Accountability Office (GAO), informed committee members that the number of children diagnosed with autism served under the IDEA has increased by more than 500% in the last decade and that "about 1.5 million Americans are currently living with some form of autism."

In a recent interview with Teri Small published in the journal, Medical Veritas 2 (2005), Dr Geier said that he believes that this may be the greatest iatrogenic epidemic in history. "The damage already done to our society is already in the trillions of dollars," he warns. "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.

"All of us alive," Dr Geier says, "will have to bear its effects both in the lifetime care of the damaged children and the loss of what they otherwise might have contributed to our society."

Evelyn Pringle
epringle05@yahoo.com
(Evelyn Pringle is a columnist for Independent Media TV and an investigative columnist focused on exposing corruption in government.)

Pharma's Poisoned Generation
Evelyn Pringle, Sierra Times

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A growing number of professionals in the health care field are reporting that a relationship exists between the epidemic in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay all across the country, and the use of thimerosal, the mercury-based preservative used in childhood vaccines.
Vaccines are the only medicines that Americans are mandated to receive as a condition for attendance in school and day care, and for some types of employment. Parents who receive federal assistance are also required to show proof that their children have been vaccinated.

While the mandate for which vaccines must be included on the vaccine schedule is a state mandate, it is the Centers for Disease Control and Prevention (CDC) and its Advisory Committee that make the recommendations to which the majority of states adhere when determining mandates. The current epidemic actually began in the late 1980s when a large number of new vaccines were added to the schedule.

The blame is at least partially attributable to the failure of government officials to keep track of the cumulative amounts of mercury as they added triple-dose-vaccines to the schedule and the amount of thimerosal was multiplied by three.

Each new vaccine contained 25 micrograms of mercury and according to Professor Lynn Adams, of Radford University, who specializes in autism, by 1999, a study determined that the average child received 33 doses of 10 different vaccines by the age 5.

Elected lawmakers first became aware of the problem in 1999, when the House Committee on Government Reform initiated an investigation into the dangers of mercury exposure. An alarm rang early about the exposure of children to thimerosal.

By October 25, 2000, Committee Chairman, Dan Burton (R-IN), was trying to get the substance out of vaccines as quickly as possible and sent a letter to the Department of Health and Human Services, asking the director to get the FDA to recall all vaccines with thimerosal.

"We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain Thimerosal," Burton wrote. "Every day that mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk," he said.

"I implore you to conduct a full recall of these products," he wrote. "If the only action ... is a gradual phase out, children will continue to be put at risk every day," Burton warned. "These vaccines will continue to be injected in children for years to come - putting our nation's most vulnerable population ... at risk for mercury poisoning," he added.

The Reform Committee soon discovered that regulatory agencies were still allowing thimerosal to be used decades after the recognition that it was harmful. The Committee was told that the Food and Drug Administration, (FDA), uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency:

"at the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. The FDA will allow a product to present more of a risk when its potential benefit is great - especially for products used to treat serious, life-threatening conditions."

The argument that the known risks of infectious diseases outweighs any potential risk of neurological damage is one that has continuously been used by officials. The FDA claims that any risk from thimerosal is theoretical because no proof of harm exists.

However, after its review of scientific literature and listening to the testimony of witnesses, the Committee found plenty of evidence to support the fact that thimerosal posed a grave risk. "The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature," the Committee said.

The Committee also discovered that regulatory agencies have never required drug companies to conduct studies on the use of thimerosal. During a June 20, 2002, hearing, Burton questioned officials from the FDA and CDC and said, "You mean to tell me that since 1929, we've been using Thimerosal and the only test that you know of is from 1929, and every one of those people had mennigitis, and they all died?"

In his opening statement at a July 18, 2000, hearing, Burton said:

"We assume that the FDA would protect our children from exposure to any level of mercury through drugs. But that hasn't been the case. Thimerosal was first marketed in 1930 and has become the most widely used preservative in vaccines. It is present in over 50 licensed vaccines."

"The FDA recently acknowledged that in the first six months of life, children get more mercury than is considered safe by the EPA," Burton noted. "The truth is that sometimes kids go to their doctor's office and get four or five vaccines at the same time," he added.

"My grandson received vaccines for nine different diseases in one day," Burton said. "He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines."

"According to his weight, the maximum safe level of mercury he should be exposed to in one day is 1.51 micrograms," Burton advised. "This is forty-one times the amount at which harm can be caused," he added.

In his opening remarks at a June 19, 2002, hearing, Burton described the devastation of witnessing the correlation between vaccines and autism.

"My only grandson became autistic right before my eyes - shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing, healthy, grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism."

People often wonder why regulatory officials would protect drug makers. In large part, because the CDC and FDA policy decisions are made through advisory panels whose members have financial relationships with the same companies they are charged to regulate.

The decisions of the 300 experts who sit on the FDA's 18 advisory committees affect billions of dollars in sales. The panel members play a crucial role in determining what drugs will be approved and participate in just about every major decision related to industry regulation.

When it comes to vaccines, the large population in the USA transforms into a lucrative customer base when our government makes vaccines mandatory and keeps adding more and more to the list. Between 2003 and 2006, it was predicted that the annual global market for vaccines would rise from $6 billion to $10 billion, by Mark Benjamin for United Press International on July 21, 2003.

Investors follow the decisions made by the advisory panels closely. A favorable vote by a committee can add hundreds of millions of dollars to a company's stock value which also means the potential for corruption in the panels is enormous.

In a July 18, 2000 hearing, Burton mentioned the problem. "We have a lot of doctors who serve on Federal advisory committees who have serious conflicts-of-interest problems. They're allowed to vote on vaccines made by companies that they get money from."

An analysis conducted by USA Today, of 159 FDA advisory committee meetings that took place between January 1, 1998, and June 30, 2000, revealed conflicts of interest were wide-spread:

At 92% of the meetings, at least one member had a financial conflict of interest.

At least one committee member had a financial stake in the topic under review at 146 of 159 advisory committee meetings.

At 55% of meetings, half or more of the FDA advisers had conflicts of interest.

At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.

Many parents are now refusing to vaccinate their children because they believe there is an on-going conspiracy by government officials and the pharmaceutical industry to boost profits by mandating unnecessary vaccines, while at the same time, denying their potential for harm. Congressman Burton addressed this issue in a June 19, 2002 hearing:

"Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well."

Burton also noted the need to get honest about the current epidemic. "As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury," he said.

In May 2003, the Reform Committee, released a report that said the "FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule."

As an example the report cited the Hepatitis B vaccine. "When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled." The report identified thimerosal as the cause of the autism and chastised the FDA:

"Thimerosal used as a preservative in vaccines is directly related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal and the sharper eyes of infant exposure to this known neurotoxin. The public health agencies failure to act is indicative of institutional malfeasance for self protection and misplaced protectionism of the pharmaceutical industry."

Many people have not yet recognized the seriousness of the epidemic, largely because the majority of people have not seen many autistic children due to the fact that parents seldom take their affected children out in public because of the difficulty in trying to control them in a strange environment.

However, the rising numbers in special education classes in the nation's public school system provides a clear measurement of how wide-spread the epidemic has become. State by state statistics for students with autism from the Department of Education for the 12-year period between 1992-93 and 2003-04, are almost unbelievable. For instance, in Ohio in 1992-93, there were only 22 cases of autism, by 2003-04 there were 5,146. In Illinois, there were only 5 cases twelve years ago and 6,005 in 2003-04. Wisconsin had 18 cases of autism in 1992-93 and the numbers rose to 3,259 in 2003-04.

The true reality of these statistics will register in the not too distant future. "With eighty percent of autistic Americans under the age of 18, the dramatic impact of this crisis will be felt by taxpayers in the coming years when these autistic children become adults," says Anne McElroy Dachel, Media Relations Coordinator for the National Autism Association.

Most vaccines on the immunization schedule now are said to be thimerosal-free but some still do contain trace amounts. "An exception is the flu shot, which the Centers for Disease Control and Prevention recommends for pregnant women and for infants 6 to 23 months old," advises Don Olmsted in United Press International on November 19, 2005.

For 6 to 23-month-old infants, the schedule calls for two flu shots that contain 12.5 micrograms of thimerosal each to be given a month apart. "That total of is the same amount that was in vaccines some parents believe triggered their child's autism," Olmsted advises. "And some of them believe in utero exposure to mercury via the pregnant mother might be the most dangerous exposure of all," he said.

When deciding whether mercury-laced flu vaccines are safe for children, parents had better think long and hard before rolling the dice.

Evelyn Pringle epringle05@yahoo.com

(Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government)

July 02, 2005
CAFTA and the Drug Lobby
CAFTA not as free trade but as intellectual property protection:

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