How Parasite Corporations Like Pfizer are Chucking U.S. Citizenship to Escape from Taxes

AlterNet / By Lynn Stuart Parramore
May 11, 2014 |


Let’s say you’re a giant American corporation like Pfizer, founded in Brooklyn way back in 1849. The fact that you exist and make a profit is largely due to the generous support of U.S. taxpayers. It’s the taxpayers, after all, who pony up for the National Institutes of Health, which does the basic research you rely on to develop drugs on which you make gigantic sums. And it’s the taxpayers who shell out large amounts of money to protect your patents, broker trade treaties in your favor, and protect your interests around the world in international negotiations. The same ones who pay for the public education of your employees and the costly infrastructure—the highways, airports, etc.—needed to move your products. The very folks who pay the billions in federal contracts you receive.

So what do you do? Do you pay your share of taxes to return some of this largesse?

Oh, no. You vigorously lobby for lower taxes and leave no loophole unexploited. You are not satisfied to have received $2.2 billion in federal tax refunds from 2010-2012 while raking in $43 billion worldwide even though 40 percent of your sales are in America. You’re not ashamed in the least that in 2012, you stashed $73 billion in profits offshore on which you paid zilch in U.S. income taxes.

Your greed and irresponsibility demand still more. So you decide to get out of paying a single nickel to the country that feeds you. You rig up an overseas purchase so you can “officially” relocate to a place with a lower tax rate and in doing so deliver a giant middle finger to your fellow Americans.

Last week, New York-based drugmaker Pfizer finally admitted why it wants to buy British drugmaker AstraZeneca, which is based in London. Sure, it will get some experimental drugs out of the deal, but that’s not what it’s really after. What Pfizer wants is to cheat American taxpayers.
Ian Read, CEO Hall of Shame

Pfizer is willing to shell out $100 billion for AstraZeneca so it can get a new tax home and lower its tax rate from the roughly 27 percent it paid last year, to the UK tax rate, which is now 21 percent and will drop down to 20 percent in 2015.

Let’s pause for a moment to consider the CEO of Pfizer, Ian Read, who is orchestrating this move. According to Forbes , he is a poster boy for grossly overblown executive salaries, hauling in almost $19 million bucks last year. Read looted the company for this obscene amount of money, despite the fact that under his leadership, profits actually declined in 2013. So instead of trying to make money by doing productive things, like, for example, investing in research and development for new products, Read is looking for shortcuts that are less about doing anything useful for society and more about plain destroying it.

Fiduciary Duty to Cheat?

Right on cue, Read trotted out the predictable nonsense that he has a fiduciary responsibility to maximize value for Pfizer shareholders, and therefore must make the tax-dodging move.

Actually, that is baloney, as economist William Lazonick has repeatedly pointed out.

Shareholder value ideology is merely an absurdity that has been spread through American business schools since the go-go 1980s — a specious justification that allows executives to turn corporations into predatory extraction machines at the expense of stakeholders like workers and taxpayers. The fiduciary-duty-to-shareholders argument would be laughed out of court in nearly all circumstances (such as the exceptional case when a company is going to be sold). The reason for this is simple. Any idiot can figure out that sometimes a company must take short-term profit hits in order to do things that are in the long-term interest of the company.

Shareholder value ideology is only about boosting stock prices in the short-term, which often depends on moves that decrease the company’s value over the longer time horizon,as Lazonick has tirelessly pointed out. So Read is utterly full of it. But things have gotten so out of hand in corporate America that executives now actually believe, as hedge fund legend Jim Chanos has observed, that they have a fiduciary duty to cheat .

There was a time when an American CEO would not dare to officially state the kind of complete disregard for the public that Read is expressing. We shouldn't underestimate the importance of shaming such anti-social CEOs for daring to do so now. Social norms matter for things like executive compensation and the consideration of stakeholders rather than just shareholders (people who own stock). Read should be made to feel that there is nothing normal, or acceptable, about his twisted logic.

A Modest Proposal

Read said that Pfizer would keep its corporate headquarters in the U.S. (a very swanky affair on 42nd Street in Manhattan) and keep its listing on the New York Stock Exchange. Which essentially means that his company will still be located in the place where it will not be paying any taxes. Which would make Pfizer a giant, blood-sucking parasite.

Of course, part of the problem is that mega-companies in other industries, like Boeing, actually pay no taxes at all, and that makes the Pfizers very upset. If other multinationals get off scott-free, why can’t they?

H. David Rosenbloom, an attorney at Caplin & Drysdale in Washington and director of the international tax program at New York University's law school, explained his view of Pfizer’s plans to Bloomberg: "This is basically an opportunity to go outside the U.S. and still sell in the U.S. and strip the tax base…If we ever had a legislature in the United States, we could do something about this, but I don't expect to live that long."

Which brings us to the question of what can be done about this looting. Some Democrats, like Sen. Carl Levin, are making noises about curbing offshore tax moves in the wake of Pfizer’s announcement. Will anything happen? Doubtful. Passing any meaningful legislation on international tax policy, as Rosenbloom points out, is all but impossible in a deadlocked Congress.

Since countries around the world are basically in a race to the bottom to lower corporate tax rates, causing companies to shift their tax burden by pretending to set up shop in places like Ireland, Switzerland and Bermuda, it may be that trying to collect corporate taxes is going to be a futile exercise in the future. Perhaps a better way, as Thomas Piketty suggests in his recent book, Capital in the 21st Century, is simply to tax individual income and wealth. We could start with Ian Read ( and don’t tell me he’s Scottish)— he’s living in the U.S. and doing his business here, so he should be paying taxes.

Here’s another idea, just for the heck of it: How about if the citizens simply occupy Pfizer’s headquarters in New York? Let us not forget that in 2010, after receiving millions of tax breaks to create jobs in New York City, Pfizer turned around and pinkslipped hundreds of employees . If Pfizer doesn’t want to pay any taxes in the U.S., then let's reclaim all the stuff we paid for, and consider Pfizer headquarters to be stolen goods. The fancy artwork in the company gallery would fetch a nice price at auction, and the office space could rent at a premium. An effort to pay back companies like Pfizer in their own coin might remind them that they can’t simply go on looting indefinitely. At some point, the looters may get looted.

Tamoxifen Makes Women Live Longer (Says Pfizer, AstraZeneca)

 The medical establishment, guided by the corrupt profiteering of Big Pharma, makes sick people sicker and kills more people than the diseases they "attempt" (profit from) to cure.--jef

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Pfizer’s Elixir of Youth?
by MARTHA ROSENBERG


It was a great moment in Pharma funded physician “education.” At a symposium at the American Psychiatric Association’s 2010 meeting called “Mood, Memory and Myths: What Really Happens at Menopause,” two Wyeth/Pfizer funded speakers tried to resurrect the benefits of cancer-linked hormone therapy. But the mostly-female audience was having none of it: what can we do about our “tamoxifen brain” from the cancer we already have, they wanted to know.

Women are to be forgiven if they are cynical about this week’s news about the cancer drug tamoxifen saving lives. Since the 1940s women were told they needed to be on hormone replacement therapy (HRT) for the rest of their lives only to find in 2002 it was causing breast cancer, heart disease, strokes and blood clots. Studies that looked as solid as this week’s tamoxifen study assured women that lifelong HRT would prevent heart disease, dementia and other blights –when it turned out to be just the opposite.

The harm from HRT, recommended by the medical mainstream for decades, was so dramatic, when women quit HRT in 2002, the incidence of US breast cancer fell 15 percent among women with estrogen-fed cancer. Fourteen thousand women who were expected to get breast cancer didn’t because they eliminated the source, said news reports. Rather than a “cure” for breast cancer, this was a literal “cause.” Unfortunately, women, their clinicians and the medical press have already forgotten this man-made cause of cancer and HRT is making a comeback.

Why should women be cynical about this week’s study in the Lancet that finds women who stay on the blockerbuster cancer drug Nolvadex/tamoxifen for 10 years instead of the usual five years are less likely to die and have cancer recur? (Inspiring some to already suggest women should stay on tamoxifen, “for life.”)

The first reason is because the study was partially funded by AstraZeneca who makes Nolvadex or tamoxifen. AstraZeneca, formerly Zeneca, co-founded National Breast Cancer Awareness Month as a “public relations scam” says the Center for Media and Democracy’s SourceWatch, even as its parent company, ICI Pharmaceuticals/Imperial Chemicals Industries, manufactured pesticides and organophosphates linked to breast cancer. Some accused the drug giant of literally playing both sides of the street, especially since tamoxifen shares some chemical properties with endocrine disrupting pesticides.

The second reason for cynicism is: tamoxifen carries its own risks which are not such a great trade off (unless you are Big Pharma). “Treatment with 5 years of tamoxifen can cause side-effects such as endometrial cancer and thromboembolic disease and continuing tamoxifen for an additional 5 years is likely to increase these side-effects,” says the Lancet article. 3.1 percent of women undergoing the extra 5 years of tamoxifen therapy got endometrial cancer in the study versus 1.6 percent who did have extra years of the drug.

There is an increasing backlash among women breast cancer survivors against tamoxifen and such trade-offs. “My cancer had a one percent chance or recurring and I was told tamoxifen would cut my chances in half,” says Kay, a Chicago fitness instructor who underwent surgery and radiation for ductal carcinoma in situ (DCIS) at the age of 50. “That means if I exposed myself to the risks and side effects of tamoxifen, my chance of recurrence would be .5 percent. No thinking women would agree to that.”

And there is a another source of cynicism for women beyond the downside of tamoxifen and the external causes of cancer, including prescribed hormones, being ignored. In November the New England Journal of Medicine published a study estimating that mammograms have caused more than a million American women to be diagnosed with early stage breast cancers, in the last three decades, that would not have proved fatal if left undetected and untreated. The millions, perhaps billions, spent in health care dollars because of such overdiagnosis and overtreatment and the suffering of women have yet to be fully quantified.

“There is more money in treating breast cancer than preventing it,” declares Kay who says she studied profiteering on the disease or what she calls “Breast Cancer Inc” since her own diagnosis. “That is why they call DCIS which is stage 0, precancer–’cancer.‘ There is more money in treating it.”

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)

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.

Dangerous Drugs Big Pharma Shoves Down Our Throats

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. And the public suffers. 

By Martha Rosenberg, AlterNet
November 19, 2010

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. Long studies to truly assess a drug's risks just delay profits after all -- and if problems do emerge after medication hits the market, settlements are usually less than profits. Remember, Vioxx still made money.

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

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

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


-- Yaz and Yasmin

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

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

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

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

-- Lyrica, Topomax and Lamictal

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

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

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

-- Humira, Prolia and TNF Blockers

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

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


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

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

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

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

-- Tamoxifen

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

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

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

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


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

Misdiagnosed anti-psychotic drug suspected of killing stressed veterans

By The Associated Press | Monday, August 30th, 2010

Traumatized vets take potent drug to help them sleep, but questions loom about potential risks

Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department's top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug's risks. They want Congress to investigate.

On April 27, the Associated Press reported, "The federal government on Tuesday reached a $520 million settlement with pharmaceutical manufacturer AstraZeneca over Seroquel."

At a news conference, Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius made the case a centerpiece of the federal government's crackdown on health-care fraud.

AstraZeneca allegedly marketed Seroquel for off-label uses - those not approved by federal drug regulators - including insomnia and psychiatric conditions other than schizophrenia and bipolar disorder.

U.S. Attorney Michael Levy of Philadelphia, where the settlement was filed, said that the company had "turned patients into guinea pigs in an unsupervised drug test."

In White's case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

"He was told if he had trouble sleeping he could take another (Seroquel) pill," said his father, Stan White, a retired high school principal.

An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the "standard of care" for his condition.

It's unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.

Spending for Seroquel by the government's military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as "off-label" prescribing.

But the drug's potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.

Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.

The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel's unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.

AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.

According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.

Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.

The military medical examiner attributed the death to "multiple drug toxicity," indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.

After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.

"Right now, I'm so angry, and I believe someone needs to be held accountable," said Julie Oligschlaeger, of Austin, Texas. "The protocol absolutely has to change."

The Defense Department's deputy director for force health protection, Dr. Michael Kilpatrick, said the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Physicians interviewed by the AP said they began prescribing Seroquel because it was the only drug that offered relief from the nightmares and anxiety of PTSD.

"By accident, some people were giving them Seroquel for anxiety or depression, and the veterans said, 'This is the first time I have slept six or seven hours straight all night. Please give me more of that.' And the word spread," said Dr. Henry Nasrallah of the University of Cincinnati, who has treated PTSD patients for more than 25 years.

Most of the soldiers and veterans seeking treatment for PTSD do so at hospitals run by the VA or the Defense Department.

The VA's spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent.

Seroquel has been the VA's second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001.

Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records.

Nasrallah and others said they use drugs like Seroquel off-label because so few treatments are approved for PTSD. The FDA has only cleared two drugs for the condition, the antidepressants Paxil and Zoloft, and they do not always work.

The only published study on use of Seroquel for PTSD-related insomnia involved just 20 patients who were followed for six weeks at a VA medical center in South Carolina. The study, which showed moderate improvement in sleep, was funded by AstraZeneca at the request of VA psychiatrist Dr. Mark Hamner, who has studied the use of Seroquel for PTSD.

In his written conclusion, published in 2003, Hamner urged caution in interpreting the results because of the study's small size and short duration.

Hamner is working on larger, federally funded studies of Seroquel. For now, he acknowledges, there is little published research on the use of the drug for PTSD.

"Clinical judgment is really the best we can use at this time because there isn't really a good database to facilitate decision-making," said Hamner, who works at the Ralph H. Johnson Medical Center in Charleston, S.C.

He stressed that VA guidelines require doctors to monitor patients for dangerous side effects with drugs like Seroquel.

The drug, approved in 1997, is AstraZeneca's second-best-selling product, with U.S. sales of $4.2 billion last year. But that success has been marred by allegations that the company illegally marketed the drug and minimized its risks. AstraZeneca agreed to pay $520 million in April to settle federal allegations that its salespeople pitched Seroquel for numerous off-label uses, including insomnia.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses. AstraZeneca also faces an estimated 10,000 product liability lawsuits, most alleging that Seroquel caused diabetes.

Since White died, his family has been searching for an explanation — and for a way to prevent other deaths.

"We trusted the knowledge of the physicians, that they weren't going to do any harm," White's father said. "And we also trusted the drug companies because that's who provides the research for the physicians. That's what our battle is now: trying to get changes made."