Warning: Anti-Depressants Causing Birth Defects, Miscarriages

Friday, November 2, 2012

Lisa Garber | Activist Post

Pharmaceutical companies regularly embellish the benefits and downplay the dangers of anti-depressants, and all medications for that matter—but this time, their profits could be inadvertently endangering and even killing unborn infants. Senior doctors know it and are finally raising their voices.

Tufts University School of Medicine’s Dr. Adam Urato decries the practice of prescribing SSRIs to pregnant women. “Study after study shows increased rates of newborn complications in those babies who were exposed to SSRIs in-utero,” he says. These complications include greater risk of autism, lung and bowel diseases, and more.

Doctors Failing to Properly Warn of Risks

Selective serotonin reuptake inhibitors (SSRIs) are the most common form of anti-depressants, many of which are prescribed to pregnant mothers by “general practitioners, not psychiatrists,” according to Dr. Alice Domar of Harvard Medical School. “You come in and you say I’m not feeling very well, I’m feeling lethargic so the physician writes a prescription.”

Urato says that although not proven, the outcomes of over 40 studies linking SSRIs to the endangerment of an unborn child are troubling enough to warrant further research. Family doctors must also properly caution pregnant women about the risks involved in taking SSRIs during pregnancy. (Many doctors prescribe them anyway because, if the SSRI works to improve the mother’s mood, it would lead to “a better pregnancy result.”)

Urato says “there really is not a shred of evidence” supporting the benefits of anti-depressants for pregnant women.

Big Pharma Just Wants to Get Paid

Urato unapologetically points to Big Pharma. “It is a fact that these antidepressants have been very lucrative for the pharmaceutical industry…. It stands to reason to me that the drug makers would rather that the risks of these agents in pregnancy not receive widespread attention as that would be a reason for many women to not take the drugs in the first place or to stop taking them—both of which are not good for sales of the product.”

Downplaying the risks of drugs is hardly a new game for Big Pharma. In the name of profit, GlaxoSmithKline paid celebrity doctors—like Dr. Drew—to push and make off-label claims of drugs. It’s also been found that 70 percent of advisors to the newest edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) have financial ties to pharmaceutical companies.

Not even the government is immune to funding. Although the Food and Drug Administration admits that antidepressants can worsen depression and increase risk of suicide, the public and private sectors alike push ineffective and harmful antidepressants on patients. This will likely continue despite an increasing number of studies linking SSRIs to pulmonary hypertension and cardiovascular malformations in newborns.

Be wary of taking medication during pregnancy, especially anti-depressants. “If you add up all the potential risks,” Domar says, “a lot of people would say they are unacceptable.”

Additional Sources:
The Telegraph
PubMed

Why Corporate Compliance is a Joke

An Interview With Patrick Burns

by RUSSELL MOKHIBER

 

Patrick Burns says what others know and refuse to acknowledge. Compliance is a joke. Burns is the communications director at Taxpayers Against Fraud.

“What do companies do to people who threaten their profit center – even and maybe especially if the profit center is one based on fraud? They move to isolate, to humiliate and to terminate,” Burns said last week. “And they do it every single time.”

“When I speak to compliance officers, I always ask one question right at the beginning. I raise my hand and say – any companies here ever made a whistleblower employee of the year?”

“Invariably, the room bursts out laughing. It’s treated as the opening of a comedy act when I ask that question.”

“And these are the compliance officers. Then I turn it around on them.”

“I ask them, at the end of this session, to go into their car and turn off the radio and not start the engine. And think for thirty seconds about this question – why was I hired at this company?”

“Was I hired because I am a fierce, tough, brave compliance officer?”

“Or was I hired because they sensed a weakness in me and they thought that I would be a compliant officer? An officer who would be useful to them to ferret out and finger anybody in the company who was actually going to blow the whistle, internally or externally, on massive fraud within the company.”

Does anybody object when you say that?

“They can’t.”

Because what you’re saying is that compliance is a joke?

“I have to say that it really is most of the time.”

Have you come across exceptions?

“No,” Burns said. “The compliance officers are great for the little stealing.”

“The compliance officer at Wal-Mart is there to stop employee theft. It’s to stop someone from bundling up a bunch of frozen meat in the trash bag and throwing it into the trash and then pulling it out thirty minutes later.”

“But some massive bribery scheme in Mexico, importing goods from China that have a made in America label sewed on to them – they won’t pay attention to that.”

“Not paying taxes on what they’re selling, none of that stuff, none of that is going to happen.”

“That is not what a compliance officer is supposed to do. The compliance officer is about twenty levels down within a company. He’s above the rent-a-cop in the lobby, but he’s not much higher than that most of the time.”

“And they are not able to challenge the people in the top executive suites. The never even meet those people most of the time.”

“This idea that a compliance officer is somehow a combination of the Fantastic Four meets the X-men – it’s just not true. It’s a lot closer to Barney Fife with his one bullet.”

And Burns has no illusions about the Justice Department’s war on fraud.

“If you go out to a farm field and you see 2000 pounds bulls standing behind a single strand of hot electric wire,” Burns said. “Those bulls have touched the wire once or twice. And after they touched that wire once or twice and got an immediate serious shock, they never touched it again.”

“That is not the way the Department of Justice works. The Department of Justice will take two, three, five, ten years to work a case.”

“Let me be explicit in what I’m saying here. The GlaxoSmithKline case was settled yesterday for three billion dollars. It’s the largest healthcare fraud case in US history.”

“Whistleblowers went to the company internally. The company did an internal investigation. The compliance officers in the company said – “yes we are indeed doing this fraud.”

“GlaxoSmithKline ran the numbers and decided that doing the fraud and delaying with its interaction with the Department of Justice was a better business plan than fessing up and paying up.”

“So they lawyered up and delayed.”

At the end of eleven years, they paid the three billion dollar fine. But during that time, they’ve collected billions and billions of dollars in profits.”

“Now here’s the perverse part of all of this. During that ten year period, people at GlaxoSmithKline were promoted, they were paid, they got bonuses and they got stock options based on this extravagant fraud scheme that involved nine different drugs, and was a virtual clown car of fraud.”

“All of the profits from this fraud were privatized. Private beach houses were bought. Private careers were made. Private bonuses were cashed. People sent their kids to private schools based on these frauds – this poisoning for profit.”

Burns doesn’t think jailing top corporate executives is likely. He says we need to exclude them from the industries in which they work.

“Putting people in jail we don’t think is very likely,” Burns said.

“The truth of the matter is a criminal prosecution requires a standard of evidence that is beyond a reasonable doubt. Companies will fund a full push back against the Department and there’s a very good chance that they will prevail.”

“The good thing about exclusion is that it can be done administratively.”

“Let me make it as simple as possible here. When you go to a dry cleaner and you put in a shirt or a tie and it comes back stained or ripped, you may get a little miffed. But you’ll talk to them about it, and maybe they’ll promise to never do it again.”

“But the next time you bring in a shirt or a tie and it comes back stained or ripped, you don’t say anything.”

”You just walk away and you never do business with them again.”

“We can do that. The US government is just like you. It is a consumer of goods and services. It can say – we’re done with you. If you continue to hire this person to run this dry cleaner, we will never go to this dry cleaner again.”

“We are not calling for more fines. We want America’s stolen money to be recovered, sure. But we need to disenthrall ourselves from the notion that money alone will change corporate behavior.”

“We also need to disenthrall ourselves that there is a single silver bullet solution. We need to recover America’s stolen billions, but at the same time, we need to make the pain personal within the fraudster companies.”

“That means that people who design frauds, who wink at these frauds, who operationalize these frauds, need to be made unemployed and unemployable.”

“Right now that penalty is only vested upon the whistleblower, the truth teller, the person who stands up to power for the good of all.”

“Being unemployed and unemployable is not something we do to the big fraudsters. We do not send them to jail.”

“We are not going to exclude big companies like Pfizer and Schering Plough and GlaxoSmithKline and McDonnell Douglas.”

“They employ too many people and they’re too central to healthcare and defense in this nation.”

“But if a company is too big to fail, and that may be true, there is no executive that is too big to jail. And certainly there is not an executive too big not to make unemployed and unemployable.”

Token Fine for GlaxoSmithKline Won't Stop BigPharma's Bad Behavior: Watchdog

Tuesday, July 3, 2012 by Common Dreams

Pharmaceutical mammoth GlaxoSmithKline (GSK) has been ordered to pay $3 billion fine in what is described as the largest case of healthcare fraud in U.S. history. But critics say it is just as a slap on the wrist as the amount "pales in comparison" to the profits pharmaceutical companies earn and does nothing to preclude such further behavior from big pharma.

GSK, which had $44 billion in sales and a net profit of nearly $9 billion in 2011, faces the fine for marketing its antidepressants Paxil and Wellbutrin for non-FDA-approved purposes, including marketing them to children, and for withholding from the FDA safety information for its diabetes drug Avandia.

Deputy U.S. Attorney General James Cole said, "At every level, we are determined to stop practices that jeopardize patients' health; harm taxpayers; and violate the public trust — and this historic action is a clear warning to any company that chooses to break the law," he said.

But Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, states that this is in no way a "clear warning."

"The fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity. The industry is therefore tacitly encouraged to continue its illegal activity," Wolfe said in a statement.

"Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients’ lives in danger," added Wolfe.

Economist Dean Baker notes that GSK's lying about its drugs' safety and uses was incentivized by the monopolies drug companies are allowed to have. "This is the incentive that we give to drug companies when the government grants patent monopolies that allow them to sell drugs for hundreds or even thousands of times the cost of production."

GlaxoSmithKline settles healthcare fraud case for $3 billion

By David Ingram - Reuters

WASHINGTON (Reuters) – GlaxoSmithKline Plc agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare fraud in U.S. history.

The agreement, which still needs court approval, would resolve allegations that the British drugmaker broke U.S. laws in the marketing and development of pharmaceuticals.

GSK targeted the antidepressant Paxil to patients under age 18 when it was approved for adults only, and it pushed the drug Wellbutrin for uses it was not approved for, including weight loss and treatment of sexual dysfunction (one of its side effects is sexual dysfunction), according to an investigation led by the U.S. Justice Department.

The company went to extreme lengths to promote the drugs, such as distributing a misleading medical journal article and providing doctors with meals and spa treatments that amounted to illegal kickbacks, prosecutors said.

In a third instance, GSK failed to give the U.S. Food and Drug Administration safety data about its diabetes drug Avandia, in violation of U.S. law, prosecutors said.

The misconduct continued for years beginning in the late 1990s and continued, in the case of Avandia’s safety data, through 2007. GSK agreed to plead guilty to three misdemeanor criminal counts, one each related to the three drugs.

Guilty pleas in cases of alleged corporate misconduct are exceedingly rare, making GSK’s agreement especially unusual.

The agreement to settle the charges “is unprecedented in both size and scope,” said James Cole, the No. 2 official at the U.S. Justice Department. He called the action “historic” and “a clear warning to any company that chooses to break the law.”

The settlement includes $1 billion in criminal fines and $2 billion in civil fines.

GSK said in a statement it would pay the fines through existing cash resources. The company announced a $3 billion charge in November related to legal claims [ID:nL5E7M315A].

NEW ‘ERA’ AT GSK

Chief Executive Officer Andrew Witty said the misconduct originated “in a different era for the company” and will not be tolerated. “I want to express our regret and reiterate that we have learnt from the mistakes that were made,” he said in a written statement.

The GSK settlement surpasses what had been the largest criminal case involving a drugmaker in U.S. history. In 2009, Pfizer Inc agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs.

The cases follow a trend of U.S. authorities cracking down on how pharmaceuticals are sold, in part because of the rising cost of providing drugs through government programs.

Part of civil fines address allegations that, from 1994 to 2003, GSK underpaid money owed to Medicaid, the healthcare program for the poor run jointly by states and the federal government. The company had an obligation to tell the government its “best prices” but failed to do so, prosecutors said, and $300 million of the settlement will go to states and other public health authorities.

A portion of the $2 billion in civil fines may go to a group of whistleblowers who contributed to the government’s investigation and who are eligible to share in the recovery under the False Claims Act. Cole said the amount has not been determined.

‘INTEGRITY’ PLAN

As part of the settlement, GlaxoSmithKline agreed to new restrictions by the U.S. government to prevent the use of kickbacks or other prohibited practices. The inspector general of the U.S. Department of Health and Human Services will oversee the “Corporate Integrity Agreement” for five years.

The company will not be able to compensate its salesmen based on sales goals for territories. It was also required to change its executive compensation program to allow the company to “claw back” certain pay for those engaged in misconduct.

Witty said GSK’s U.S. unit has “fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.”

Prosecutors have not brought criminal charges against any individuals in connection with the GSK case, although the settlement expressly leaves open that possibility. Cole declined to comment on the possibility of future charges.

Almost exactly a year ago GSK agreed to pay nearly $41 million to 37 states and the District of Columbia in an unrelated case about substandard manufacturing processes at a Puerto Rico factory.

In 2010, the company took a $2.4 billion charge in connection with Avandia to settle claims from patients.

GSK’s shares were positive on the New York Stock Exchange on Monday, up 1.6 percent to $46.29 at 1400 EDT.

The case is U.S. v. GlaxoSmithKline LLC, U.S. District Court for the District of Massachusetts, No. 12-cr-10206.

Outsourcing the Drug Industry

As "Blockbuster Drug" Bubble Bursts, Big Pharma Takes Jobs Overseas

by MARTHA ROSENBERG

It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed.

A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joyride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.

In Europe, governments are no longer willing to pay the high prices for drugs that they once did say published reports and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine.

Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. 

In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators–yet “new” is conveyed as “better than any drug to date” in advertising.  Some clinicians say Haldol, an inexpensive antipsychotic and lithium, a similar affordable bipolar drug are better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000′s bubble.

Before the Vioxx scandal and major settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).

But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported ZS Associates.

Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer) announced it was eliminating 1, 200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.

As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.

Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010, 10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a Union Carbide pesticide plant.

Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports FiercePharma.

Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of bone fractures by 30 percent.

In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that Forbes calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”

Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a Wall Street Journal oped, and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now? (Insane!--jef)

The Creepy Ways Big Pharma Peddles its Drugs

Big Pharma uses ads that sow hypochondria, raise health fears and sell diseases to adults and their children. 

By Martha Rosenberg, AlterNet
Posted on January 9, 2012

(Editor's Note: You can view the ads throughout the story and can click on the ad to enlarge it.)

It's no secret that advertising works. Big Pharma wouldn't spend over $4 billion a year on direct-to-consumer advertising if it didn't mean massive profits.

What is more unknown is why drug ads that sow hypochondria, raise health fears and "sell" diseases are often the most common--and effective--even when the drugs themselves are of questionable safety.

The nation's fourth most frequent drug ads in 2009 for were Cymbalta, making Eli Lilly $3.1 billion in one year, despite the antidepressant's links to liver problems and suicide. Pfizer spent $157 million advertising Lyrica for fibromyalgia in 2009, despite the seizure pill's links to life-threatening allergic reactions. The same year, it spent $107 million advertising the antidepressant Pristiq, even though it also had links to liver problems.

So, how does Pharma dupe us into using unsafe drugs? Today's drug ads, targeted directly to consumers since 1999, seem like they sell diseases and often cast women, children, the elderly and mentally ill in a bad light. But a quick look at ads before direct-to-consumer advertising (DTC) in medical journals shows that drug ads have always done so. It's just that patients didn't used to see them.

Here are some of Pharma's most offensive ad campaigns, then and now.

1. You're Sicker Than You Think

When psychiatric drugs first became popular for use in the general population, in the late 1960s, everyday personality problems became imbued with psychiatric labels. "Lady, your anxiety is showing (over a coexisting depression)," says a 1970 ad, showing an older, wrinkly woman in a bouffant wig with gigantic sunglasses and garish jewelry. "On the visible level, this middle-aged patient dresses to look too young, exhibits a tense, continuous smile and may have bitten nails or overplucked eyebrows," says the ad copy. "What doesn't show as clearly is the coexisting depression."

The ad, both sexist and ageist, suggests the woman needs the antidepressant and tranquillizer Triavil.

Another ad from 1968 shows a bored, upper-middle-class couple whose hauteur is also said to really be depression. "Do you have patients who try to hide frustration behind conformity?" says the ad for the antidepressant Aventyl HCl.

You'd think such demeaning ads would vanish with DTC advertising because people would be offended. But You're Sicker-Than-You-Think ads are alive and well since DTC advertising and even flowering.

A three-page consumer ad in the late 2000s similarly conveys that everyday psychological traits could actually be dire mental problems that require medication. If you are "talking too fast," "spending out of control," "sleeping less," "flying off the handle" and "buying things you don't need," you could be suffering from bipolar disorder said the ads, which appeared in magazines like People. And here you thought it was the coffee. Accompanying photos of a woman screaming into a phone and contorting her face are so extreme they could come out of the movie Halloween Part II, if the woman were holding a knife.

Psychiatric drugs are not just advertised for everyday personality problems. Pharma is pushing them for everyday pain conditions. Eli Lilly's original depression campaign for the antidepressant Cymbalta, "Depression Hurts," seems to anticipate its subsequent approval for pain conditions including back problems. Now ads tout Cymbalta as a "non-narcotic, once daily analgesic FDA approved for three indications across four different chronic pain conditions," as if it does not have severe controversial psychiatric risks including the suicide of volunteers who tested it.

And seizure and epilepsy drugs, known for major allergic and psychiatric reactions, are also becoming pain franchises. "What's causing your chronic widespread muscle pain?" asks an ad for the seizure and epilepsy drug Lyrica. "The answer may be overactive nerves," says the ad, even though "widespread muscle pain" and "over-active nerves," are not mentioned in the approved labeling for Lyrica, says pharmaceutical reporter John Mack. The military spent $35 million on seizure and epilepsy drugs in 2009 alone, including for migraines, headaches and pain.

And speaking of overkill, ads for genetically engineered injected drugs like Humira, approved to treat serious diseases like Crohn's disease, psoriatic arthritis and chronic plaque psoriasis look like they are designed to sell beer or beauty treatments, not immune suppressing drugs that invite cancers and lethal infections.

DTC ads don't just escalate everyday problems into psychiatric problems, they also escalate real psychiatric problems into irresponsible, sensationalistic stereotypes. Ads for the best-selling antipsychotic Risperdal, widely used in children, and in soldiers with PTSD, suggest that people with mental illness have hallucinatory fears about "boiling rain" and "dog women." The "dog woman" ad, showing a half-dog, half-woman crouched on her elbows, her eyes blackened, furthers the sensationalizing of mental illness with the tagline, "Because relapses are a living nightmare."

2. Your Kid Is Sick 

DTC ads don't just convince people they're in need of new drugs, but also that their kids may be, too. And it's been going on for decades.

Long before Pharma convinced parents, teachers and clinicians that millions of US kids had attention deficit hyperactivity disorder (ADHD), kids were said to suffer from "minimal brain dysfunction" (MBD) and "hyperkinesis," two conditions that were essentially the same as ADHD. In fact, so many kids had MBD by 1976 that an ad for the drug Cylert hailed the "Importance of single daily dose to the child, the parents and the teacher," because kids wouldn't have to be singled out anymore at pill time at school. (ADHD has been so huckstered, a YMCA ad spoofs it with the headline, "Before video games, before Facebook, before Ritalin, there was basketball.")

Yet neither Cylert--whose approval the FDA withdrew in 2005 because of liver failure and deaths--or the current ADHD drugs are safe. In 2009, researchers reported that kids are more likely to die sudden deaths while taking them and the American Heart Association recommends electrocardiograms (ECGs) before kids take them. And yet, combined sales of ADHD drugs continue to grow from $4.05 billion to $7.42 billion in 2010.

Thirty years ago, it certainly looked like kids were being overmedicated. They were given the antipsychotic Thorazine for their "hyperactivity," "hostility," sleep problems and even for vomiting. Picky eaters and kids who wet the bed were given tranquillizers. Kids with tics, stuttering and school phobia were given the tranquillizer Miltown.  

But today, ads promoting drugs for kids continue, and now they are aimed at parents. Sometimes, it's hard to tell the difference between ads for drugs or ads for sugary cereals! Pharma tells moms to give their kids the bubble gum-flavored ADHD med, LiquADD and the grape-flavored ADHD med, Methylin. The latter campaign, to parents, is "Give 'em the GRAPE!"

DTC advertising has also convinced parents their kids suffer from GERD (gastroesophageal reflux disease) otherwise known as acid reflux disease, which was barely a disease in adults much less kids, before consumer advertising. "GERD Can Be a Big Problem for Little Kids," say award-winning ads for Prevacid, which won a "RX Club" Silver award in 2004. In Europe, kids are treated for another "adult disease" and given chewable Liptitor to lower their cholesterol.

Some of Pharma's most aggressive advertising has been designed to convince parents their children's minor sniffles or wheezing are imminent asthma and require immediate and expensive drugs. To make the asthma drug Singulair (which also comes in a yummy chewable), the seventh most popular drug in 2010, Merck inked partnerships with the American Academy of Pediatrics and Scholastic, both of which parents consider neutral organizations and not Pharma mouthpieces. Merck also partnered with Olympic gold-medalist swimmer Peter Vanderkaay and NBA kid clubs to sell the asthma drug.

"A kid who's got what your kid's got is out doing what your kid's not," says one Singulair ad campaign. "Find out how you can help your child breathe a little easier."

If Singulair were not harmful, the huckstering would simply be a case of wasting money and overmedicating kids. But Singulair has been linked to both pediatric suicide and to emotional, behavioral and ADHD-like symptoms in kids, the latter likely inspiring parents to give their kids "the grape."

Of course, another kid-targeted campaign is for the vaccine against the sexually transmitted Papillomavirus or HPV, immortalized by Gov. Rick Perry and Rep. Michele Bachmann in hot exchanges this fall. Many object to the sexualizing of 9-year-olds, to government lining Pharma's pockets by promoting the vaccine (including overseas) and to the risks of the vaccines themselves. But the ads for Gardasil and Cervarix are also offensive.

Last spring, poster-sized ads for Gardasil on Chicago's commuter trains pretended to sell real estate in sought-after neighborhoods. A closer look revealed descriptions of women in those neighborhoods who thought they didn't need the HPV vaccine but did, positioning HPV not only as a general risk to the population, like flu, rather than an STD but as "hip."

HPV vaccine ads got even cooler when GSK rolled out Cervarix extravaganza TV ads and its "armed against cervical cancer" campaign with an Angelina Jolie-like model displaying a skinny arm with a Cervarix tattoo.

3. Be Like Me, and Can Your Beer Do This?

Prescription drugs may affect health, but they are still consumer products sold with the same marketing principles as toothpaste or beer. In fact, the wacky, "Can Your Beer Do This?" Miller Lite campaign of the 1990s, came back to life to sell the antidepressant Wellbutrin XR. In a glossy, color magazine ad, a young man rows his girlfriend on a scenic lake and lists the benefits of his Wellbutrin XR. "Can your medicine do all that?" he asks.

What does it say about the success of DTC advertising that people are assumed to have an antidepressant?

Experiential ads also sell prescription drugs like vintage ads for the "Kodak Moment," "Maalox Moment" and the old cigarette ads for the "L&M Moment" did. "Lunesta Sleep. Have You Tried it?" asks a 2007 ad in Parade magazine, elevating the experience to something akin to "designer sleep."

And just as celebrities move other consumer products, they have been deployed to sell prescription drugs. TV personality Joan Lunden and former baseball star Mike Piazza stumped for the allergy pill Claritin, ice skater Dorothy Hamill and track star Bruce Jenner for the pain pill Vioxx, and Sen. Bob Dole for Viagra. NASCAR figure Bobby Labonte also endorsed the antidepressant Wellbutrin XL in 2004. Yes, his medicine could "do all that."

But there has been a problem with celebrity drug endorsements, unlike product endorsements in which a celebrity like Tiger Woods or Martha Stewart could taint a product, a prescription drug can taint a celebrity! Did Dorothy Hamill know that Vioxx doubled the risk of heart attacks in users when she stumped for it? Did the model Lauren Hutton know that hormone replacement therapy causes a 26 percent higher incidence of breast cancer, a 29 percent increase in heart attacks, a 41 percent increase in strokes, and a doubling of the rate of blood clots when she shilled for it? Does actress Sally Field know that bone drugs like Boniva are linked to esophageal cancer, jaw bone death and the very fractures they are supposed to prevent as she pushes them?

Of course, good product marketing includes public relations. When Pharma sells a disease with no mention of the drug it is really selling, it's called "unbranded" advertising. Since DTC advertising, Pharma has invaded public service announcements (PSAs) that TV and radio stations confer for free, pretending their take-a-drug messages serve the public good, like messages to change smoke detector batteries or put kids in car seats.

One such "educational" "awareness" campaign called "Depression Is Real" saturated the radio air waves in 2011, funded by the National Alliance on Mental Illness, which was investigated by Congress for its Pharma funding from Wyeth, part of Pfizer, and other groups. The high-budget ads, running for free, compare depression to diabetes because it doesn't go away and to cancer because it can be fatal.

4. One Kind of Ad You Won't See Anymore

Animal research at drug companies and the National Institutes of Health is a great scientific iceberg of which people only see a tip. In drug development, millions of animals die to prove a drug's "safety." At academic and medical centers, animal study grants from NIH provide millions to researchers and labs.

As sentiment grows against animal experiments and the government's gigantic National Primate Research Centers (new rules will limit the use of chimpanzees), the research is downplayed and even hidden. But there was a time when Pharma actually flaunted animal research.

"More than a decade of animal research on various animal species has suggested that Librium (chlordiazepozxide HCI) exerts its principal effects on certain key areas of the limbic system," says an ad from the 1970s, showing three monkeys crouching and dangling in cages as assorted experiments are conducted.

An ad for the diet pill Pre-Sate is even worse. It says, "one of the most sophisticated comparative animal studies ever conducted demonstrates direct action on the satiety centers," and shows five photos of cats in experiments. One shows a life-size white cat looking at the camera with a chain around its neck and invasive instrumentation embedded in its skull.

Today's consumers, it seems, wouldn't tolerate ads like these. (Or the experiments behind them.) Why do they tolerate derisive ads about "dog women" and ploys to market pharmaceuticals to kids as if it were candy?

Hidden Dangers In HPV Vaccines

By Dr. Ilya Sandra Perlingieri
December 2, 2010
Hidden Dangers In HPV Vaccines (Dec. 2, 2010)

"The fantasy that there are shortcuts that come in syringes or bottles remains, for now just that: a fantasy." --Peter B. Bach, MD(1)

On June 8, 2006, the US Food and Drug Administration (FDA) approved a new cervical cancer vaccine, called Gardasil, manufactured by Merck [the company that also made the pain-killer Vioxx that was removed from the market due to the potential doubling of heart attacks and strokes]. Girls 11-26 were targeted for a three-shot regimen, given over six months. The cost is about $400. This vaccine is also approved for girls as young as nine years old. By February of 2007, "at least 20 states [were] considering making its use mandatory for schoolgirls."(2)

Serious side effects from Gardasil were already being reported within the first year. "Between June 8, 2006, and Dec. 31, 2008, 11,916 adverse reactions to the vaccine and the death[s] of 32 young women and girls" were reported.(3) By the Summer of 2009, vaccine-related injuries had climbed to 15,000. On March 30 of this year, the reported unexplained deaths following Gardasil injections had increased to 49.(4) More information is available at the National Vaccine Information Center: www.nivc.org

In February 2009, Spain recalled "76,000 doses of Gardasil Following Seizures in Two Young Girls."(5) At the time, Erin Brockovich noted that in the US: "We've had more than two girls [became] sick, and to my knowledge NO doses of the vaccine were ever recalled here. The issue is that two girls got sick and Spain responded immediately. Think of the human cost of rushing to market."(6)

In that regard, Dr. Mercola has written:

"Merck has convinced millions of girls [and their parents] to get vaccinated with Gardasil by instilling in them a fear of the sexually transmitted disease HPV [and] this fear mongering is only revealing a select assortment of facts. Merck would like you to hear that 6 million women contract HPV annually ­but they do not tell you that most of these cases are harmless. Your body can clear up HPV on its own, and does so more than 90 percent of the time."(7)

There has been no long-term research done for this vaccine. An article in the New England Journal of Medicine has urged "caution."(8) The author of this article, Dr. Haug, has written:

"there has been [financial?] pressure on policy makers worldwide to introduce the HPV vaccine in national or statewide vaccination programs. How can policy makers make rational choices about the introduction of medical interventions that might do good in the future, but for which evidence is insufficient, especially since we will not know for many years whether the intervention will work ­or in the worst case­ do harm?"(9)

This HPV vaccine is supposed to target two strains of an oncogenic [cancer producing], sexually transmitted virus known as Human Papillomavirus (HPV). The vaccine does not provide any protection for anyone who already has HPV. The speed with which this vaccine was rushed to market, without adequate independent research, is similar to last year's incredible fast-tracking of the poorly tested (and some of it untested) and dangerous H1N1 flu vaccines. After the World Health Organization (WHO) declared a spurious Level 6 "pandemic" on June 11, 2009, the US government was already mandating that all Americans over the age of six months be vaccinated.

There were no long-term, independent safety trial studies done for any of the 2009 H1N1 flu vaccines. Several hospital researchers involved in the Summer 2009 trials commented on the big "rush" to get these vaccines out. Some of that short-term testing did not even use the same vaccines that were going to be mandated later in the Fall. How then could accurate results be compared with different vaccine ingredients? WHO wasn't even tracking the actual number of confirmed laboratory H1N1 cases.(10) Precaution was not part of vaccine manufacture or governmental plans.

In an article written by Michel Chossudovsky last year, he noted: "There was no uniform system for collecting data on suspected swine flu [H1N1] victims in the US, which led to confusion in the absence of accurate statistics. The CDC [Centers for Disease Control] acknowledge that the figures being collected on 'confirmed and probable cases' in the US contained not separation between 'confirmed' and 'probable.'

In fact, only a small percentage of the reported cases were 'confirmed' by laboratory tests. This faulty data and much more like it from around the globe was given to the WHO, who in turn used the numbers to justify a pandemic. Sadly, the CDC is not protecting humanity because it is too busy expanding the bottom line of the pharmaceutical industry."(11)

This article, subsequently, was hailed by Project Censored as one of its top stories for 2009.

In the event of injuries and/or deaths resulting from these H1N1 vaccines, the US government indemnified the pharmaceutical companies: GlaxoSmithKline, Baxter, and Novartis. Deaths and injuries did occur. In one instance of which I know personally: the one-year-old grandson of a friend was taken by his mother for his "one-year-old check-up" to his pediatrician. Without the mother's permission, a staff nurse took the child out his mother's arms, and was given a H1N1 vaccine shot. The nurse told the mother: "Oh, it's no big deal." The child died three days later. The family remains devastated. To this date, the mother has not had any legal recourse.

It appears that the priority was corporate greed. Following the money trail, who profited? Billions of dollars were involved: GSK received $250-million to supply the US with "pandemic products"; Novartis received $346-million for antigen and $348-million for adjuvant (plus orders from 30 other countries). The total for US vaccine orders amounted to $7 billion. From where did this money come, given that the US is actually bankrupt? Further, in a post-script to the 2009 H1N1 scare, the millions of doses of unused vaccines will now be added to this year's flu vaccines.

Independent and long-term research MUST be part of any planned and truly safe vaccine program. Thirty years ago, most Americans only had three or four vaccinations. Today, the average teen-ager already has had more than 40 vaccinations. With poorly tested vaccines (often with dangerous ingredients), how has this compromised the immune systems of a generation of children? Since the Salk polio vaccine was developed 55 years ago (and even before then), there were serious concerns about the safety of vaccinating an entire country's population. Precaution would have eliminated possibly hundreds of thousands of cases of cancer that were later linked to the Salk polio vaccine. Long-term research has confirmed the link between the use of African green monkey virus, used in the Salk polio vaccine, and increased cancers. This virus is transmitted from one species to another: monkey to human. Unconscionably, this same African green monkey virus was used again last year in some of the H1N1 vaccines.(12)

The following is a list of some of the vaccine ingredients in Gardasil:

• Polysorbate 80 (also known as Tween-80): It is also used in some brands of ibuprofen concentrated oral suspensions and as an emulsifier in cosmetics. It is known to cause infertility/sterility, grand mal convulsions, spontaneous abortions, and life-threatening anaphylactic shock.

• Amorphous aluminum hydroxiphosphate sulfate: This is an adjuvant. These are included in all vaccines to make dispersal faster and easier in the body (but not more safely). It affects the "action of the drug's active ingredient." It also then requires less adjuvant, so the product can then be expanded to cover many more vaccinations with less vaccine. This also means a faster production of vaccines, and more money for the drug companies with less production output of vaccine. Dr. Mercola calls this a "turbo charge" to the body's immune system. It can "induce both behavioral and motor deficits and the loss of motor neurons [and can cause] neuronal apoptosis [cell death] in the primary motor cortex."(13) Adjuvants are linked to Gulf War Syndrome.  Aluminum (part of the composition of this adjuvant) is also known to cause cognitive dysfunction and brain damage. It is found in many products we use daily [from deodorants to baking soda]; and it is linked [along with mercury] to the staggering increases of dementia.(14)

• Sodium borate: Insecticide. Poison. This is the main ingredient in boric acid, used as a roach killer. Repeated use causes poisoning. Side effects of sodium borate toxicity include: blue-green vomiting, diarrhea, skin rashes, blisters, drowsiness, fever, low blood pressure, decreased urine output, coma, convulsions, and twitching of muscles in face, arms, legs, and feet.

According to the public interest group Judicial Watch, between May 2009 and September 2010, there were "records of 3,589 adverse reactions to Gardasil," including "213 cases resulting in permanent disability, and 16 new deaths (including four suicides)." This report also includes permanent disability from Guillain Barre Syndrome (GBS).(15) GBS is an inflammatory brain disorder that is already known to be associated with last year's hyped H1N1 flu vaccines ­put on the market worldwide without adequate clinical trial tests. However, on July 26, 2009, the UK's Health Protection Agency sent a secret letter to 600 senior neurologists to be alert for an increase in [the] brain disorder, Guillain Barre Syndrome."(16) GBS also was linked to the dangerous side effects of the 1976 swine flu outbreak; and more than 80,000 people were [then] affected by this condition, that, in essence, could be called 'flu vaccine syndrome.'"(17)

Tom Finton, president of Judicial Watch, is on record as saying:

"To say Gardasil has a suspect safety record is a big understatement. These reports are troubling and show that the FDA and other public health authorities may be asleep at the switch. In the meantime, the public relations push for Gardasil by Merck and politicians on Capitol Hill continues. No one should require this vaccine for young children."(18)

A second HPV vaccine, Cervarix, is manufactured by GlaxoSmithKline. It has been licensed in the UK, Australia, and the European Union. In the US, it was approved by the FDA on October 16, 2009. According to London's The Guardian, "Britain is the only country to have opted to use Cervarix, rather than a rival brand Gardasil." The Guardian reported one death, in this same article, of a 14 year-old girl who died shortly after receiving this vaccine injection.(19)

Cervarix is given in three doses over a six-month period. The adjuvant, ASO4 is one of the ingredients. This is the company's propriety squalene adjuvant. Squalene is a natural oil found in sharks [mostly in their livers] and humans. The American Journal of Pathology (2000) reported that rats injected with squalene triggered "chronic, immune mediated joint-specific inflammation." i.e., rheumatoid arthritis. How will this vaccine affect people who already have any immune inflammation; or, will it cause untold new cases (lupus or chronic fatigue)? Squalene adjuvant is linked to the thousands of military who have contracted Gulf War Syndrome and have suffered irreparable auto-immune damage, including lupis, multiple sclerosis, fibromyalgia, and ADD.(20)

Cervarix side effects include: headache, pain and swelling at injection site; fever; diarrhea; itching and skin rashes; joint pain; nausea and vomiting; dizziness; respiratory tract infection.(21)

As practiced today, Western medicine is based on pharmaceutical solutions, due to its enormous corporate ties. These ties also include organizations (public and private) and agencies (such as World Health Organization, Food and Drug Administration, and Environmental Protection Agency) that once were supposed to protect public health; but now, behind closed doors and secret meetings, they do the bidding of the corporations. There is very little independent research being conducted, while most research is funded by the drug companies. They have a vested interest in not reporting adverse reactions. Citizens do not fit into any of this, except as consumers.

Cures, though very important, are only one part of the answers we urgently need. We also need doctors who are well informed, better educated about environmental links to illness and disease, and actually read and research drug ingredients before prescribing pharmaceuticals to uniformed patients ­who rely on and trust their doctors. We no longer can take for granted that doctors are either well informed about the enormous environmental links to illnesses, or that they have the sorely needed medical and environmental training with which they can make correct diagnoses. This is especially true now, with illnesses being manufactured in bioweapons labs or geo-engineered toxic chemicals being sprayed from planes and let lose on unsuspecting citizens.

The major issues rarely addressed, but essential to our well being and safety, are PREVENTION and PRECAUTION.(22) We also need to hold the polluters accountable. Over the last 10 years, more than 30 years of US environmental laws have been gutted, while corporations are getting huge tax breaks. This has made it increasingly easy for corporations to poison our air, soil, and water. The staggering rates of cancers (even for small children), auto-immune, cardiac and pulmonary diseases, and now often multiple illnesses affect millions of people.

With more than 100,000 chemicals on the market, mostly untested for human safety, and a horrific legacy of invisible but highly dangerous environmental hazards surrounding our every move, corporate accountability is way overdue. This no longer is an issue to be resolved by Congress or any other governmental agency [often with no legal or Constitutional authority, where officials have been appointed to their positions, not voted into office.

With a constant revolving door between industry and government jobs, plus corporate legal "personhood," there is no longer protection for citizens. The criminality of the Gulf of Mexico oil catastrophe is just the latest heart-breaking crisis showing the power corporations have to destroy an entire ecosystem (human and all other living creatures) without any accountability.

We need massive and peaceful grassroots movements to make our planet ­our only home­ habitable and safe for all living creatures. The seminal works of Rachel Carson (written almost 50 years ago) and Dr. Theo Colburn et al.'s book, on hormone disruption, Our Stolen Future, are ignored. Not by us; but by the corporate, multi-national juggernaut.

Without really safe and precautionary corporate practices, our collective health will keep deteriorating, while out-of-control corporate greed and profits continue unabated. Our well being and safety are not part of any corporate ethos. We are all expendable for the corporate bottom line: profit. For the third quarter of 2010, Forbes magazine reported that Merck, one of the world's largest drug companies, "posted a net income of $342 million."(23) There was no mention in this article of any possible deaths and/or injuries from their Gardasil vaccine.

A recent online article suggested that this HPV Gardasil vaccine might prevent 13,000 American women from getting cervical cancer. (In the UK, the figure is about 1,000.) The article made no mention of any dangerous side effects or deaths.(24)

In my own 15 years of independent research for my book, The Uterine Crisis, there are numerous references cited regarding the extreme dangers (including a long history of our being used as uninformed, experimental lab subjects) posed by the relationships among the pharmaceutical corporations, governmental agencies, and medicine.

Parental rights are very important. The Precautionary Principle, rarely mentioned in any US media or put into corporate practice, is vital with untested and/or poorly tested vaccines with toxic ingredients. The Pap Smear and other tests are available to screen for cervical cancer. In a 2009 article, epidemiologist and physician, Dr. Peter B. Bach, wrote:

"[t]he Pap Smear, which has been around for more than 70 years, is a better prevention approach than Gardasil will ever be. Because of it, cervical caner death rates in the US fell by 74% between 1955 and 1992, and continue to fall by about 4% each year."(25) 

But the larger issues are never addressed. This would put the pharmaceutical corporations and many university research programs out of business.

It is, therefore, of the utmost importance that patients (i.e., today's medical consumers) become well educated and informed before they proceed with any vaccinations, injections, surgery, or other medical procedures. We can no longer continue on automatic pilot with crucial medical decisions left to doctors and other medical professionals who are uninformed. Caveat emptor.

Dr. Ilya Sandra Perlingieri

NOTES:
1. Peter B. Bach, MD. "A Shot in the Arm for the Pap Smear." Forbes Magazine. Oct. 20, 2009:
www.forbes.com/2009/10/20/health-care-gardasil-vaccine-cancer-opinions-contributors-peter-b-bach.html

2. Andrew Pollack and Stephanie Saul. "Merck to Halt Lobbying for Vaccine for Girls." New York Times. Feb. 21, 2007:
www.nytimes.com/2007/02/21/business/21merck.html

3. Ken Adachi. "Florida State Study Promotes Gardasil 'Benefits' Despite 32 US Deaths to Date." June 3, 2009: http://educate-yourself.org/cn/hpvshotmennotconvicnced03jun09.shtml

4. These deaths were reported to the CDC. Barbara Hollingsworth.
"Toyota 52 Deaths, Gardasil 49." Washington Examiner. March 30, 2010:
http://vactruth.com/2010/03/31/toyota-52-deaths-gardasil-49-toyota-recalled

5. See Note 3 above.

6.See Note 3 above.

7. "Dr. Mercola on Gardasil."
www.offtheradar.co.nz/vaccines/83-dr-mercola-on-gardasil.html

8. Charlotte J. Haug, MD, Ph.D. "Human Papillomavirus Vaccination ­ Reasons for Caution." New Eng. J. Med. Aug. 21, 2008: vol. 359: 861-862.

9. See Note 8 above.

10. Dr. Ilya Sandra Perlingieri. "Danger in the Shots ­ Components of H1N1 Vaccines. They are considered biodefense agents." Part 1. Aug. 8, 2009:http://www.rense.com/general86/dngers.htm

11. Michel Chossudovsky. "The H1N1 Swine Flu Pandemic: Manipulating the Data to Justify a Worldwide Public Health Emergency." Global Research. Aug. 25, 2009: http://www.globalresearch.ca/index.php?context=va&aid=14901

12. Dr. Ilya Sandra Perlingieri. "Danger in the Shots." Part 2. August 19, 2009: http://www.rense.com/general87/dangers.htm

13. Roman Bystrianck. "Study clearly demonstrates that aluminum found in vaccines can cause neurologic damage." Health Sentinal. Sept. 21, 2009: www.healthsentinel.com/joomla/index.php?option=com_content&view=article&id=
2598:study-clearly-demonstrates-that-aluminum-found-in-vaccines-can-cause-
neurologic-damage&catid=5:original&Itemid=24

14. Dr. Ilya Sandra Perlingieri. "Chemtrails: The Consequences of Toxic Metals and Chemical Aerosols on Human Health." Part 1. May 12, 2010:
http://www.globalresearch.ca/index.php?context=va&aid=19047

15. Judicial Watch. Sept. 28, 2010:
http://www.judicialwatch.org/news/2010/sep/judicial-watch-uncovers-fda-records-detailing-16-new-deaths-tied-gardasil

16. See Note 12 above.

17. See Note 12 above.

18. Judicial Watch. Nov. 23, 2010: http://www.judicialwatch.org/gardasil

19. Jo Adetunji. "School girl dies after cervical cancer vaccination." The Guardian. Sept. 29, 2009:
http://www.guardian.co.uk/uk/2009/sep/28/hpv-cervical-cancer-vaccine-death

20. See Robert F. Kennedy's 2005 article, "Deadly Immunity"
http://educate-yourself.org/vcd/kennedydeadlyimmmunity26jul09.shtml

21. See: http://www.medicines.org.uk/guides/cervarix/Vaccinations%20%28all%29/ (all)

22. Dr. Ilya Sandra Perlingieri. "The Worldwide Environmental Crisis. Gone Missing: The Precautionary Principle." Feb. 11, 2009:
http://www.globalresearch.ca/index.php?context=va&aid=12268

23. Augostino Fontevecchia. "Merck's Earnings Slump on Cost of Digesting Schering." Forbes. Oct. 29, 2010:
http://business.newsplurk.com/2010/10/merck-earnings-slump-on-cost-of.html

24. Sherwood Ross. "Cervical Cancer can be Prevented. Yet 13,000 women in the US get it." Global Research. Nov. 19, 2010:
http://www.globalresearch.ca/index.php?context=va&aid=21991

25. See Note 1 above.

Drug Industry Fraud

The Whistle Has Been Blown, But Where's the Enforcement?
By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says "the lack of criminal prosecution that would result in jailing of company executives." is key. Moreover, the report notes that "a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues."

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: ".unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

Dirty Big Pharma Tricks That Rip You Off and Risk Your Health for Profit

Even during a recession, pharma is still the nation's third most profitable sector. Here are some of the dirty tricks it employs to stay on top.
By Martha Rosenberg, AlterNet
Posted on December 22, 2010


Even during a two-year recession with people losing their homes and jobs, pharma is still the nation's third most profitable sector. How does it do that? In part by cheating the government, misrepresenting science, bribing doctors, patients and pharmacies, and squeezing the FDA. Other than that, the industry plays completely fair. Pharma has often been criticized for lack of creativity in developing new drugs. But these dirty tricks show its creativity is alive and well when it comes to putting the public at risk just to turn a profit.

1. Astroturf Patients?

Pharma promotes fake patient advocacy groups to lobby for its interests.

These front groups often push the FDA to approve an expensive drug that has acceptable, cheaper alternatives. Or, they'll try to prevent Medicaid from switching to the less pricey drug. One of the largest faux groups, the "grassroots" National Alliance on Mental Illness (NAMI), was investigated by Sen. Charles Grassley for undisclosed pharma links. He found the 10 top NAMI state chapters received $3.84 million from pharma in less than five years, the biggest largesse from Eli Lilly, AstraZeneca and Bristol-Myers Squibb.

How else can you tell an astroturf group? Their Web sites look just like the pharma companies that fund them.

2. Cheating the Government

Pharma is now a top defrauder of the federal government. “Desperate to maintain their high margin of profit in the face of a dwindling number of important new drugs,” pharma illegally promotes unapproved uses of drugs and deliberately overcharges Medicare and Medicaid, says Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. Pharmaceutical companies have been hit with $14.8 billion in wrongdoing settlements in the last five years. But that's still cheaper for Big Pharma than going about things the old-fashioned, legal way. So the fraud continues.

3. Trials and Fibulations

Presiding over clinical trials can make a doctor thousands per patient. But they wouldn't compromise patient safety just to make a buck, would they? Medical College of Georgia psychiatrist Richard Borison and his colleague Bruce Diamond did 13 years ago when they tested Zyprexa, Risperdal and 20 other drugs and ended up in jail. So did Baystate Medical Center's Scott Reuben, who went to prison earlier this year for fraudulent Celebrex, Neurontin and Lyrica trials. And a Tucson facility testing asthma drugs Symbicort, Advair and Singulair doctored data and risked patients' health to net as much as $10,000 per patient, according to a whistleblower and government and court documents. How many other drugs were tested for such fiscal outcomes? Not counting recalled ones, of course.

4. More Trials and Fibulations

Even without fraud, pharma-sponsored studies can deceive. Trials that only determine that a drug is "not worse" than another one or impute safety before real data are available -- as in the case of Vioxx and Avandia's threat of heart attacks -- can skew results. And some research is not meant to be accurate to begin with. The Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital was founded to "move forward the commercial goals of J.& J." according to unsealed court documents. Its head, Harvard's Joseph Biederman, promised J.& J. a proposed drug trial "will support the safety and effectiveness of risperidone [Risperdal] in this age group," before it was ever conducted. Why leave things up to science?

5. Overseas Adventurism

As pharma increasingly eyes poorer countries for new markets and cheaper manufacturing it also eyes them for cheaper clinical trials. In 1996, 11 Nigerian children died in trials testing Pfizer's not-yet-approved antibiotic Trovan. While Pfizer paid the Nigerian government and state of Kano millions in a settlement, documents released by Wikileaks show that Pfizer tried to extort Nigeria's former attorney general to drop the lawsuits. Trovan was withdrawn from U.S. markets in 2001 for liver toxicity, though "safety signals" may have appeared sooner.

6. Clueless Institutional Review Boards

Institutional review boards, charged with overseeing clinical trials, should catch the unsafe drugs and shady trials. But a Congress and General Accountability Office sting conducted last year on a Colorado review board raises serious doubts. When asked to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery, Coast Independent Review Board said...when do we start? Even though the product did not exist -- nor did its developer or lead researcher!

7. 'Previous Government Experience Desirable'

In the fight against medical fraud, the Justice Department is beginning to file criminal, not just civil, charges against pharma. More employees also are turning whistleblower thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlements, in some cases. But the other side has a big advantage. As long as politicians like former Louisiana Rep. Billy Tauzin, who left government to head the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to commit a career's worth of knowledge, judgment and relationships to sell product, the government is fighting itself.

8. Double Dealing at the Pharmacy

The best thing that ever happened to pharma (after direct-to-consumer advertising) is Pharmacy Benefit Managers (PBMs). Their job is to negotiate the best drugs for their clients, which are heath and pension plans. But they seem far more adept at taking money to push pharma’s top branded drugs, regardless of the cost.

Recently CVS' pharmacy benefit manager, AdvancePCS, sent letters to doctors extolling the benefits of the expensive drug Zyprexa on behalf of drug giant Eli Lilly. Had a generic drug been prescribed over Zyprexa, savings would have been huge.

9. FDA Foreplay

A sneaky way pharma tries to get FDA to approve a drug -- even when the science isn’t there -- is to float the drug to the public. That's where directed marketing comes in. When “patients” (these are often astroturf groups), really want a drug approved, it puts huge pressure on the FDA to be sensitive to the public’s wishes. This tactic famously flopped for Boehringer-Ingelheim this year when it tried to sell a medication for "hypoactive sexual desire disorder" (HSDD) in women (first it had to sell the disease itself). Even though BI debuted its pink Viagra at a medical conference last year and rolled out its elaborate "Sex Brain Body: Make the Connection" Web site with TV personality Lisa Rinna soon after, FDA said no. Seems even though Boehringer-Ingelheim was effective in "raising awareness" about female sexual dysfunction, something else wasn't effective: the drug. And when it came to foreplay, the FDA had a headache.

10. Pharma Service Announcements

Public service announcements are messages for your own good, like, "Do You Know the Seven Warning Signs of Cancer?" But a lot of the awareness messages and warning signs you hear now are not from the government or medical groups, but pharma.

“Voices of Meningitis” ads on mom sites and online TV, for example, look like they are raising awareness of meningitis, but they were actually funded by maker Sanofi Pasteur, which makes a meningitis vaccine.

"Unbranded" advertising appears to have legit origins, like the National Association of School Nurses, which sponsors the Sanofi Pasteur’s meningitis ads. But when TV, radio and web messages push "awareness" of diseases like ADHD, irritable bowel syndrome (IBS), restless legs syndrome (RLS) or excessive sleepiness (ES), be suspicious. Real diseases aren't given initials for quick recall and easy reference. Nor do they come with snappy self-quizzes and pretty patient models. Unbranded messages also pimp the PSA (public service announcement) money that media outlets have for actual public issues.

11. National 'Interests' of Health

The National Institutes of Health are supposed to fund research for the public health with the public's tax dollars. But recently, a researcher who was stripped of his own NIH grant because of his huge financial links to pharma, is ruling on other researchers' grants on NIH committees, reports the Chronicle of Higher Education. The researcher, psychiatrist Charles Nemeroff, was also allowed to keep NIH funds when he moved to the University of Miami after being disqualified from them at Emory University. Clearly, when it comes to conflicts of interest at the top of level of government research, the fox is guarding the henhouse (or pork house).

12. Big Pharma Sends Schools Doctors

Continuing Medical Education (CME) are courses that doctors are required to take to keep their state licenses and stay up-to-date with current practice and treatment guidelines. But many are created by pharma, which covers the cost of the course for the doctor in exchange for unvarnished sales pitches. Worse, many are embarrassingly dumbed down.

A recent "course" offered by Medscape was titled "Quadrivalent HPV Vaccine May Be Effective in Women 24 to 45 Years Old." Participants were told that after taking the course, they would be able to "specify the currently recommended age range" for the vaccine (especially if they could read the title!). Another course manipulates participants to "lobby your legislators" for pharma-related Medicare funding. Congress recently investigated the billion-dollar continuing education industry for illegal marketing -- too bad Congress couldn’t investigate for stupidity.

13. Ghostwriting

Ghostwriting -- papers written by medical marketing writers, with doctors only posing as the authors -- was rampant until 2008 Congressional investigations. But even though it's now prohibited, few journals have retracted ghostwritten articles that sold Vioxx, Fen Phen, Prempro and probably Avandia. Asked about the papers ghostwritten "by" Lila Nachtigall, a professor in the Department of Obstetrics and Gynecology, Deborah Bohren, vice president for public affairs at New York University's Langone Medical Center said, "If we had received a complaint, we would have investigated."

A Congressional investigation doesn't qualify as a complaint?

14. Crooked Books and Slanted Messages

Pharma is often accused of ghostwriting articles that end up in medical journals under doctors' names who had nothing to do with the writing or research. But this month an entire textbook was accused of being funded and approved by pharma. The 1999 textbook, written to help primary care doctors diagnose psychiatric conditions, was funded entirely by GlaxoSmithKline (GSK) -- which makes pills for... psychiatric conditions! Nor were its authors, two prominent psychiatrists, strangers to GSK. Alan Schatzberg is on GSK's speakers bureau and Charles Nemeroff was investigated by Congress for undeclared GSK income. Did the authors write the book themselves or was it ghostwritten by pharma or its marketing company? Does it matter?

15. May I Take Your Order?

Have you ever waited in a doctor's office with a 102-degree fever, only to have pharma reps swinging Vytorin totes see the doctor first, just because they brought free samples or lunch and are dressed for a music video (pharma tends to employ attractive people to hawk their wares)? Until Congressional investigations brought about the Physician Payments Sunshine Act, some doctors in medical centers say they never paid for a meal. Nor did pharma largesse end there. One doctor told AlterNet her entire group was jetted to a Caribbean island courtesy of her Paxil rep. Even medical students were schmoozed until the 62,000-member American Medical Student Association (AMSA) sought to end the pharma practice of gifts and free meals. Now pharma must report what it spends on doctors.