FDA warns Pfizer's antipsychotic Geodon and generic versions of the drug could cause a fatal skin reaction

As Reported by Reuters

Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday.

A new warning has been added to the drug's label to describe the condition - known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - which may start as a rash and spread all over. (1.usa.gov/1Gh2I8p)

Other symptoms include fever, swollen lymph nodes and organ inflammation.

Geodon, known generically as ziprasidone, is used to treat schizophrenia and bipolar I disorder by reducing hallucinations, delusions and other psychotic symptoms.

While no deaths have been reported, the regulator reviewed six cases in whom the signs and symptoms of D.R.E.S.S. appeared between 11 and 30 days after ziprasidone treatment was initiated.

Last year, 2.5 million prescriptions for oral formulations of ziprasidone were dispensed, the agency said.

Patients on the drug who have a fever with a rash and/or swollen lymph glands should seek urgent care, the regulator said, advising doctors to halt treatment if they suspect D.R.E.S.S.

SSRIs and Dangerous Drug combinations

As seen in this quick article, SSRIs can be dangerous when used used in certain combinations with other drugs. The article also covers other drugs, but we have selected the quote on the psychiatric use of SSRIs.

Dangerous Drug combinations are putting many people at risk, a fact few realize. As Americans take more and more medications for everything from upset stomachs to depression, drug clashes have fueled a new epidemic of unexpected, sometimes dangerous side effects and complications. One recent study suggested that at least 1.3 million Americans have prescriptions for drugs that could cause problems if taken together—and that only counts people with health insurance. Although the overall toll is unknown, it’s undoubtedly huge, experts say. And growing. Taking many medications at the same time, or large doses of a few, can result in a conflict according to Marietta Anthony, PhD, associate director of the Center for Education Research and Therapeutics at the University of Arizona. Common items like drugstore pain relievers can clash with other meds.

SSRIs (selective serotonin reuptake inhibitors can conflict with a triptan drug used to treat migraines because triptans and SSRIs both increase serotonin levels and too much serotonin can cause serotonin syndrome resulting in mania, increased heart rate, seizures, and death.

Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) can cause bleeding ulcers and other stomach troubles. Adding an SSRI increases this risk since serotonin encourages blood platelets to stick together, but because platelets soak up less serotonin when one is on an SSRI, they may have trouble clumping together to form clots and prevent excessive bleeding.

Of course, as documented elsewhere on this site, SSRIs are dangerous all by themselves, due to various other side effects.

FDA Rebukes Wyeth for Effexor XR Advertising Claims

From the News Inferno Website

Ads for Effexor XR in a medical journal are misleading, the Food & Drug Administration (FDA) says, prompting the agency to issue a warning letter to Wyeth, the maker of the widely-used antidepressant. The FDA said the wording of the ad overplays the benefits of Effexor XR and minimizes dangerous side effects.

Effexor XR is an extended version of the original Effexor. Effexor is the top selling anti-depressant in the world, according to Wyeth, and Effexor drugs reaped sales of $958 million in the third quarter of 2007 alone.

[...] both drugs are known to have dangerous side effects, including an increased risk of suicidal thoughts and behavior when used in children and adolescents, as well as hypertension and serious withdrawal symptoms. Despite such serious side effects, Effexor and Effexor XR are marketed by Wyeth as better alternatives to antidepressants like Paxil, Prozac and Zoloft.

Now, the FDA is charging that an ad which appeared in a medical journal makes “unsubstantiated superiority” claims about Effexor XR. The FDA criticized several claims in the ad, including citation of a study claiming that said Effexor XR prevented a depressive episode in 92 percent of cases, versus 55 percent for a placebo. The agency said that claim is “based on a study that is inadequate.”

The FDA also faulted Wyeth’s claim that 20 million people have been treated with the Effexor XR, a statistic the FDA said is based on suspect data. Because people may associate the number of people treated with quality, this claim “may mislead consumers and healthcare providers,” FDA wrote.

This is not the first time Wyeth has been accused of making misleading Effexor claims. Last month, Dr. Daniel Carlat recounted his experiences as a Wyeth-paid Effexor lecturer in the New York Times.

According to Dr. Carlat, the Effexor information Wyeth instructed him to convey during visits to physician offices was often incomplete, downplayed risks, and was skewered to favor Effexor over other drugs. When Dr. Carlat, uncomfortable with the Wyeth-provided script, altered it to include more complete data on hypertension, he was visited by a district manager, who expressed concern that the doctor was not exhibiting enough “enthusiasm” in his talks. Dr Carlat quit lecturing for Wyeth shortly after that episode.

The FDA has ordered Wyeth to cease running ads for Effexor XR that make misleading claims in medical journals. The company must also provide the FDA with a list of other Effexor XR marketing materials that make similar claims, as well as a detailed plan for discontinuing the use of such materials. Wyeth has until December 21 to respond to the FDA Effexor XR warning letter.

The Effexor XR ads in question are no longer running, but a spokesperson for Wyeth told Reuters that the company believes they were “responsible.”

Prozac nation: alarm at huge rise in anti-depressants’ use

From the Herald, in Scotland

Government efforts to cut the number of anti-depressants prescribed by GPs were thrown into doubt yesterday after new figures showed they had increased four-fold over the past decade.

A report by NHS Quality Improvement Scotland (QIS) found that the number of prescribed daily doses of the drugs had gone up from 19 per thousand to 85 between 1992 and 2006.

Medical experts at QIS, a health board established to oversee improvements in the NHS, said the record level of prescriptions may be due to the popularity of newer anti-depressants such as Prozac, which had fewer side effects, and patients being given more drugs over a longer period. But it was not clear whether there had been any increase in the number of people diagnosed as depressed.

Mental health charities expressed alarm at the latest figures, saying they showed an overdependence on medication to treat mental illnesses and highlighted a lack of available alternative treatments such as psychological therapy.

Faced with a rise in prescriptions, the previous Scottish Executive imposed a target of reducing the increase in anti-depressants being prescribed to zero by 2009. But while there were some signs that prescription rates were levelling out, there was scepticism over the SNP's manifesto commitment to cut them by 10% over the same period.

Dr Dorothy Muir, chair of the QIS clinical outcomes group, said that, though there were signs prescription rates were levelling, it was "probably unlikely" they could be reduced.

Dr Geraldine Bienkowski, lead clinician for psychology at NHS Education for Scotland, said there was "limited" evidence that providing alternative therapies led to a cut in prescription rates. But there was also evidence that, in some situations, increasing the provision of psychological therapies had a knock-on effect of increasing the rate of prescriptions, as it increased awareness of depression among GPs, she said.

Prescription rates for anti-depressants are strongly linked to deprivation, with Greater Glasgow having the highest rate in the country, according to QIS's figures.

Women are more likely to be diagnosed with depression and the condition was most common in the 25 to 44 age group, its figures show.

However, research undertaken by Glasgow University has found wide variations in prescribing levels between GP surgeries and that factors such as deprivation, gender, and age only account for 50% of these.

Dr Philip Wilson, a Glasgow GP involved in the research, said that different prescribing cultures within GPs surgeries may account for some of the variation. He also questioned whether simply cutting levels of prescriptions was in patients' best interests.

"There's a lot of evidence that people's depression relapses if they stop them too soon. In the case of a second or subsequent episode of depression the guidelines are now telling us we should be prescribing for a period of two years," he said.

Shona Neil, chief executive of the Scottish Association for Mental Health, said the figures betrayed a medical culture in which there was a "pill for every ill". She said: "People are being prescribed these pills for problems which are far beyond mental health issues. If you're living in poverty, are unemployed and without a good social support network, a pill isn't going to improve any of that. We have pathologised suffering to a level that isn't helpful."

Dr David Steel, chief executive of NHS QIS, defended the use of a target but conceded it was unlikely the new goal could be met. He said: "One of the great advantages of a target like that is it gets us talking about it, even if we don't meet it."

Shona Robison, Health Minister, said the Scottish Government was committed to the previous administration's goal of "levelling off" the prescription of anti-depressants and had invested £4.5m in developing alternative treatments for people with depression.

But she made no mention of the SNP's previous manifesto commitment. "We are striving to drive down the prescribing of antidepressants by offering a range of other effective interventions," she said.

Last night a Scottish Government spokeswoman denied that the manifesto commitment had been dropped saying it was "still committed to the reduction over the next two years".

Study: Antidepressants Double Stomach Bleeding Risk, Mixing With Painkillers Increases Risk Six Times

Via Fox News, yet another reason not to be misdiagnosed with one of these marketable diseases

Taking antidepressants alone is enough to double your risk of stomach bleeding, but mixing them with painkillers is even more dangerous, a new study finds.

Mixing SSRIs (drugs used in the treatment of depression) such as Prozac, Paxil and Zoloft with over-the-counter non-steroidal anti-inflammatory drugs like ibuprofen increases an individual's risk of stomach bleeding six-fold, according to research by the U.K.'s University of East Anglia.

About 10 million Americans use antidepressants. For the study, Dr. Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice, worked with colleagues at North Carolina's Wake Forest University. The results are published in the journal Alimentary Pharmacology & Therapeutics.

Currently, most SSRIs warn users of an increased risk of stomach bleeding when mixing the drugs with painkillers. However, authors of the new research claim to be the first to show that just taking the antidepressants alone is enough to raise the risk of stomach bleeding.

The findings are based on an analysis of four studies covering more than 153,000 patients, which estimate that over a period of one year, one in every 106 patients taking SSRIs together with painkillers will require hospital admission due to bleeding in the stomach.

“While the SSRIs on their own carry only a small risk of harm, this risk becomes much more serious when they are taken in combination with painkillers,” Loke said in a news release.

The researchers also looked in detail at more than 100 cases of patients who suffered bleeding in the stomach related to SSRIs and found that two-thirds of the patients were taking painkillers at the same time.

“If you have a history of stomach ulcers or indigestion, then SSRIs may not be the best choice for treating your depression,” said Loke. “There are other antidepressants which seem to be less harmful.”

Loke advised that patients on SSRIs may do better taking drugs such as Tylenol, rather than ibuprofen.

New Federal Drug Safety Bill Signed Into Law

Some details not noted below - Among the many reforms, this new law gives the FDA the authority and money to monitor, investigate, report (and take action) on adverse side effects of drugs once they are on the market. It also requires all PRINT ads (Magazines, newspapers etc) to say: "You are encouraged to report side effects of prescription medication to the FDA's medwatch call 800# or log onto www.fda....." In six months the Secretary of Health and Human Services must make a report to Congress on how they can implement this in TV ads.

As seen in this report

The Food and Drug Administration on Thursday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill President Bush signed into law.

At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of the FDA's overall budget, defraying the cost of reviewing products that need agency approval.

Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the bipartisan legislation as a vehicle to reform the FDA's handling of drug safety.

In part, the legislation shifts more of the FDA's attention from experimental drugs pending approval to those already are on the market, and gives the agency more power to act when worrisome problems emerge.

"It really represents an important addition to the FDA's authority," said FDA commissioner Dr. Andrew von Eschenbach.

It gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not yet approved drugs could be subject to the requirement later.

Still, how the Food and Drug Administration Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees.

The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them. The fine-print list of actions the FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The FDA may have to draft new regulations or guidelines - a process that can take years - to implement some of those provisions, Lutter said.

The legislation does spell out that the FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year.

"The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America.

It also requires the FDA to step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive.

"We welcome the ability to really engage in how those products perform once they are out on the market," said Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, citing the use of data-mining techniques to sift through electronic medical databases for hints of problems.

The manufacturers of certain new drugs will have to draft for each one a so-called "Risk Evaluation and Mitigation Strategy" that can include medication guides distributed with each prescription to ensure the medicine's safe use.

Under the legislation, the FDA will set up a registry to log incidents where adulterated food could pose a health risk. The agency also will have to establish pet food ingredient and processing standards - a provision born of the massive dog and cat food recalls earlier this year.

"It strengthens safety rules for the wave of new miracle drugs coming on the market that Americans count on to protect their health. It brings needed reassurance to families that the food they feed their pets is safe," said Sen. Edward Kennedy, D-Mass.

60 Minutes Report: Who Killed Rebecca Riley?

Last night 60 Minutes broadcast a report on the death of Rebecca Riley, and on the storm of controversy that has resulted when it was found out that the 4 year old died as a result of an overdose of psychiatric medication for bipolar disorder, the disease formerly known as Manic Depression.

Bipolar disorder in a 4 year? Are the psychs crazy? In my opinion, yes they are.

The full 15 minute report is available on the website, including streaming video through CBS's own Flash player and a transcript. It is too long to provide in full here. Instead, we can provide some snippets that we find interesting.

"According to the medical examiner, her heart and lungs were damaged, and this was due to prolonged abuse of these prescription drugs, rather than one incident. Prolonged abuse of these prescription drugs," Couric remarks.

"Yes. And the doctor had Rebecca on .35 milligrams, daily, for months. And I didn't know anything about dosages. How much was fatal," Riley says.

The medical examiner ruled that Rebecca died of a drug overdose from a mix of medications. And that the amount of Clonidine alone would have been fatal.

Today, awaiting trial, Carolyn Riley says she now knows more about bipolar disorder than she ever did when her daughter was alive.

Asked if she thinks Rebecca was really bipolar, Riley says, "Probably not."

"What do you think was wrong with her, now?" Couric asks.

"I don't know," she says. "Maybe she was just hyper for her age."

---

The prosecutor alleged at their arraignment in February that they were overdosing Rebecca by repeatedly giving her more medication than she was prescribed. "It was used on Rebecca, her sister and her brother for one simple purpose by these defendants: to knock them out and make them sleep," the prosecutor claimed.

But the Rileys claim that they were following doctor's orders. 60 Minutes wanted to talk to the psychiatrist, Dr. Kayoko Kifuji, but she declined. Instead 60 Minutes got a statement from her hospital: "The care we provided was appropriate and within responsible professional standards."

60 Minutes did obtain a copy of Rebecca's medical records. In them, Dr. Kifuji notes Rebecca's increased risk of mental illness because of her family history. She diagnosed Rebecca after Carolyn said her daughter was - quote - "driving me crazy" and her mood switches within a minute. She would eventually prescribe the preschooler more than ten pills a day.

Riley says she did feel that that was a lot of pills for a little girl, but she says she went ahead and gave Rebecca the prescriptions. "I trusted the doctor," she says.

Dr. Kifuji has stopped practicing, pending a ruling by the state medical board. But her lawyer has said she was just practicing mainstream psychiatry. It's now estimated that nearly one million children like Rebecca Riley have been diagnosed with bipolar disorder, or manic depression. And while some psychiatrists told 60 Minutes that early diagnosis is saving lives, a growing number of doctors say it is being over-diagnosed.

---

Dr. John McClellan [...] says the children's psychiatric hospital he runs in Washington state is filled with kids who have been misdiagnosed as bipolar. He says it has become a catchall for aggressive and troubled children.

"I think it's a problem to label kids with a major adult psychiatric disorder when they're five years old or when they're three years old," Dr. McClellan says. "Little kids are not adults. And little kids do things that if an adult did them, it would be evidence of a mental health problem."

"Having said that, if someone is bipolar and it presents later in life, doesn't it make sense that these issues exist really from birth?" Couric asks.

"No, that does make sense," McClellan says. "The problem is symptoms like irritability or recklessness or high energy when you're an eight-year-old don't necessarily predict in the long run developing bipolar disorder. Some might. Do you expose all those kids to medications to prevent the one kid that's going to get it?"

Maybe we need to ask if psychiatry kills. After all, the psychiatrist is not being investigated by law enforcement, and maybe psychiatrists should be, especially when there is a death involved. The death of a child.

Psychologists Shot Down Nine Times in 2007

Seen in this report

The National Psychologist reported in its Sept/Oct 2007 issue that prescription privileges bills to give psychologists prescription privileges in nine different U.S. states failed in each and every case. Most never left committee, reflecting the leadership’s unease of granting prescription rights to non-medical professionals.

The bills failed in Hawaii, California, Georgia, Illinois, Mississippi, Missouri, Montana, Tennessee and Oregon. It came closest to passing in Hawaii, but was vetoed by the governor when it reached her desk.

What’s at stake here?

Two powerful professional organizations — the American Psychological Association and the American Medical Association — butting heads over whether it is safe to allow psychologists, with additional medical training, to prescribe psychiatric medications.

Psychologists receive little or no formal training in medicine in their graduate studies today (as most physicians who are not psychiatrists receive little or no formal training in psychological theory and practices). If psychologists gained greater prescribing authority, they could rely less on medical doctors, such as psychiatrists, to prescribe common psychiatric medications.

Psychologists argue that there is a demand for such services in rural and areas throughout the country that currently do not have coverage by psychiatrists.

Doctors argue such privileges are already available to professionals who want them by undergoing medical school or similar training.

Psychologists believe they don’t need such intensive training because psychiatric medications are largely limited to affecting the mood, and don’t interact as much with other body systems.

As anyone who has looked into the side effects of psycho-active drugs knows, this last point is a woefully naive take on the situation. I can only imagine what additional horror stories await us if this were to go through.

The truth behind the increase in child suicides

As seen a Psychiatric Services News Report of the American Psychiatric Association

"In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling."

The CDC reports an increase in youth suicide from 2003 to 2004 and some "experts" are blaming this increase on the decline in antidepressant use among youth. However, the Black Box warning was not approved until September 2004 and, even then, it took months before the use of antidepressants among youth began to decline.

Data Courtesy of the SSRI Stories Website

End result? The experts are blaming an increase in suicides on a decrease of antidepressants that did not take place.

UPDATE (via the Furious Seasons weblog)

On September 12th the National Center For Health Statistics (a branch of the CDC) released preliminary death data for 2005 (see Table B of report here).

The suicide rate dropped from 10.9 per 100,000 in 2004 to 10.6 per 100,000 in 2005, a decrease of about 3 percent--still unacceptably high. 2005 was the first full year of the black box warning of possible suicides and suicidal ideation, which technically only applied to ages 0 to 14 at the time (it's been expanded through 24 year olds more recently). The new data won't be broken out by age groups, genders and race until next summer, so for now it isn't possible to say how the 2004 and 2005 suicide data compared.

Which confirms the national trend

Xanax Found in More DUI Stops

Hillsborough sheriff's Deputy Larry Morrell pulled over the 26-year-old woman after she crashed into an apartment gate on Brandon's Regency Avenue.

He shined a light in her eyes and asked her to track its movement. She couldn't.

"It looked like a pingpong game going on with her eyes," Morrell said.

Typically, only an extremely inebriated driver would fail the test so badly, he said.

But the woman's breath test showed a blood alcohol content of just 0.09 percent, slightly above the 0.08 level at which the state presumes impairment.

So while processing her arrest, Morrell asked her whether she had taken any drugs.

Yes, she admitted. She'd been at a party at a hotel in Brandon and had taken some Xanax, a prescription antianxiety pill.

Law enforcement officers increasingly encounter drivers impaired by dangerous combinations of alcohol and Xanax.

In Pinellas County last year, it was the most commonly detected prescription drug among those arrested for impaired driving, according to the Pinellas-Pasco Medical Examiner's Office, which tracks the statistics. The drug was found in 177 drivers suspected of driving under the influence.

That's a sharp increase from 1998, when the drug turned up in just four cases. Then, experts say, doctors were writing prescriptions much less frequently.

The drug isn't as potent as methadone, and not as well known as painkillers like OxyContin. But it is widely prescribed and reacts so strongly with alcohol that people taking Xanax become incapacitated with fewer drinks.

The drug, known generically as alprazolam , exacerbates alcohol's intoxicating effect.

"One plus one may equal three or more," said Dr. Raphael Miguel, the program director of pain medicine at the University of South Florida College of Medicine.

A drug on the rise

Xanax, also used to treat panic disorders, gives users a feeling of euphoria, said Dr. Bruce Goldberger, a toxicologist and director of forensic medicine at the University of Florida College of Medicine.

"That's why it's abused," he said.

The pills can be bought from friends who have prescriptions or illegally from an online pharmacy advertising "Anxiety Drugs with Discounts this Week!!!" But the drug is widely available legally, too.

Alprazolam is the fifth-most-commonly prescribed drug in America, according to data from IMS Health, a health care information company. In 2006, 37.5 million presprescriptions for it were dispensed, up from 29.9 million in 2002.

"People aren't any more anxious," Goldberger said. "But patients are being prescribed more and more medication in the past decade."

Miguel prescribes Xanax infrequently, but when he does, he tells patients about the drug's anesthetic effect, which can cause fuzzy memories, and warns them that the pills may make them drowsy.

"I prefer to start them on a weekend when they don't have job responsibilities, so they get a good idea of how they're going to feel on the medication," he said.

Patients starting on the drug may take doses of 0.25 or 0.5 milligrams, Miguel said.

Those doses can seem far less potent than the 80- or 160-milligram doses of OxyContin, a frequently abused painkiller, making it easy for someone to take too much of it.

"Doctors prescribe it for three times a day, but for patients with true anxiety, that's not enough, so they end up popping it four or five times a day," Miguel said. "It's easy to spill over into the next effect of oversedation."

Last year, 456 people overdosed on alprazolam, according to a report by the Florida Medical Examiners Commission, making it the fourth-most common cause of overdose, after cocaine, methadone and oxycodone, the generic name for OxyContin.

Big Headache for Big Pharma

From the NovoPress Blog Archive

For pharmaceutical giant Eli Lilly, death and injury are just a cost of doing business. When Zyprexa, Lilly’s drug to treat schizophrenia and bipolar disorder, hit the marketplace in 1996, it was hailed as an “atypical” – a “safe, gentle psychotropic,” more effective than older drugs like Thorazine and Trilafon, without the dangerous side effects. Sales skyrocketed. The hype soon gave way to reality, as Lilly faced waves of lawsuits by patients suffering from diabetes, massive weight gain, pancreatitis and cardiac problems.

Lilly responded with the cozy arrangement that worked with Prozac, another blockbuster plagued with problems: quietly settle suits out of court, with proceedings sealed and secret under a gag order. Anything embarrassing – or illegal – that Lilly is doing behind closed doors would remain hidden from public view.

Even though the payout is enormous – more than a billion dollars in settlements to tens of thousands of plaintiffs – Lilly can afford it: atypicals sell for ten times more than older drugs, and Lilly’s marketing machine made Zyprexa its biggest profit maker, with more than 20 million customers worldwide and sales topping $4 billion annually. So Lilly writes a check, buys the silence of the people harmed by its products, and then turns around and passes the cost along to the consumer at inflated drugstore prices. All perfectly legal.

What Lilly didn’t count on was a whistleblower, a lawyer and hackers taking matters into their own hands. Just as Lilly’s legal muscle was lax during Christmas holidays, one of the expert witnesses in the Zyprexa litigation contacted human rights attorney Jim Gottstein, who used a combination of clever subpoena wizardry and fast action to get hundreds of secret documents out from under the court seal. Gottstein turned the memos over to The New York Times before Lilly could plug the leak.

The memos, emails and correspondence reveal how Lilly’s marketing strategy bent and broke the law, hid unfavorable risk studies and pushed Zyprexa for unapproved use on the elderly and children. The Times ran repeated front page stories, and Lilly’s stock took a nose dive.

Claiming “trade secrets” and proprietary “merchandising techniques,” Lilly lawyers swooped down on Gottstein, seizing emails and voice mail records. They convinced the court to order an injunction forbidding further distribution of the files, but Gottstein had already sent out disks loaded with scanned copies to a dozen activists and journalists around the country. Lilly tracked the disks down, trying to halt the escalating crisis.

And this is where the hackers come in. Someone – still not identified by Lilly – got a copy, but any distribution traced back to them could lead to contempt of court and serious legal consequences. So they turned to software called Tor, set up by the Electronic Frontier Foundation. Tor is an anonymous server privacy tool EFF created to help dissidents in totalitarian regimes like China slip past state censors. It was perfect to help the whistle-blowers evade Lilly’s surveillance. The file – zyprexakills.tar.gz – found its way into cyberspace, and the court finally ruled that Lilly couldn’t block websites from hosting the file once it was freely available online. The leak finally went public.

The Zyprexa documents are a disturbing glimpse into the marketing mind of one of the biggest companies in the world, a firm with close ties to the Bush Administration (Lilly CEO Sidney Taurel sits on the Homeland Security Council). When a study showed three times the risk of diabetes over other drugs, Lilly simply hid it from the Food and Drug Administration’s scrutiny. Lilly aimed sales to dementia patients – without approval – in a campaign called “Viva Zyprexa.” They instructed product representatives to downplay drug risks, and targeted children, who Zyprexa has never been tested on. Emails discussed the strategy of indemnifying doctors who prescribe Zyprexa against any legal action: “Our experience with Prozac,” the memo said, “confirms the impact and goodwill of such an initiative.” The memos reveal callous indifference to the diabetes risk Zyprexa causes, perhaps because Lilly’s other top selling drugs include – you guessed it – diabetes medications.

Lilly now faces a snowballing scandal. The Times compared Zyprexa to Vioxx, Merck’s painkiller withdrawn from the market after leaked documents showed the company hid heart attack risks. FDA scientist Dr. David Graham, who blew the whistle on Vioxx, testified to Congress that atypicals like Zyprexa kill some 62,000 people a year in unapproved uses. A study in the Archives of General Psychiatry concluded atypicals were no more effective than older, cheaper drugs, and five state governments, with enormous budgets for atypicals, initiated investigations. And last month, four-year-old Rebecca Riley died from drugs prescribed by a psychiatrist, including an atypical, raising concerns about the approximately 30,000 children under five who take these drugs, despite no study on drug safety for children.

Lilly objected to its secret memos going public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.” Yet this gets to the heart of Lilly’s corruption. Beyond hiding drug risks and marketing illegally, Big Pharma doesn’t trust its customers to make informed decisions about their health care. Growing numbers of people are turning off the TV pill ads and exploring other ways to deal with their suffering. A New York Times article last year broke the story of the many people with a schizophrenia diagnosis who do well with non-medication treatments. Maybe the solution isn’t to be found in a pill after all?

Now that would bring down Big Pharma faster than any scandal.

Army Recruiters and Lies about Prozac

Army recruiters have been under sufficient pressure that many have been instructing their recruits to lie about taking the medication. Of course, being on the drug is reason to not recruit them to begin with, since a recruit cannot bring any medications with him to boot camp. Sometimes the cold turkey withdrawals have quite tragic results.

As seen in this investigative report. There are also concealed camera videos

A top Army official says "enough is enough."

That's his reaction to a NewsChannel 5 investigation that caught Army recruiters and their Dishonorable Deceptions.

The Army's deputy director of recruiting operations sent an e-mail Tuesday morning to top Army recruiting officials across the country. That e-mail is being forwarded to rank-and-file recruiters. (Read the e-mail.)

He says he has "no better way to communicate this" other than to let them see our hidden camera video.

He adds that "this is not the first undercover story, but it should be the last" to show recruiters engaged in such misconduct.

And what about the men and women NewsChannel 5 Investigates caught on camera?

Our chief investigative reporter Phil Williams went on a mission in search of those recruiters.

In a time of war, with American soldiers dying every day, it's tough to be an Army recruiter.

"People are afraid to even talk to us," a recruiter in Madison, Tenn., confides to our undercover producer.

But the video we captured on hidden cameras had recruiters not wanting to talk to us.

"I'll show you if you want to see it," Williams tells the station commander in Antioch, Tenn.

"No, I don't need to see it, sir," he replies, pushing down the top of a DVD player.

In Murfreesboro, Tenn., Phil confronted a recruiting sergeant that we caught on tape.

"Would you ever recommend that a recruit lie to get into the Army?" Williams asks.

"Like I say, you have to talk to...," the sergeant answers, pointing inside to his commander.

"It's simple yes or no question, sir," Williams interjects.

The sergeant still won't answer.

Sergeant: "I know but we...."

"There is no pressure that should cause you to compromise your integrity," says Lt. Col. Patrick Brewington of U.S. Army Recruiting.

That's what Brewington says is the Army's official position.

But inside its recruiting stations we discovered a different attitude.

"Bottom line is I take Zoloft," our undercover producer tells each recruiter.

He was re-enacting the real-life story of Pvt. Jay Mallard, who killed himself during basic training after -- his family says -- a recruiter urged him to lie about his long-term dependence on antidepressants.

"It ain't going to look too good if all of a sudden you like pull up your M-16 and start whacking people," the Murfreesboro recruit tells us.

While the sergeant insists that the Army has a good reason to know the truth, inside his offices, he tells his potential recruit that he'll keep the secret if the man really wants to enlist.

"There's ways around the system," he confides.

"You've probably seen TV reports and all that. More or less, me and you are the only ones that know it."

After the sergeant invited us inside to see his commander, even the commander had to stop to watch and listen to the whispered conversations in a back room of the recruiting office.

"The only thing they know about you is what you tell them," the recruiter adds.

Remember: the recruiters help fill out this medical screening form which carries a warning that there are severe penalties -- up to five years confinement -- to anyone making a false statement.

"The only thing they know about you is what you tell them," Williams repeats to the sergeant and his commander. "Is this the way the Army recruits soldiers?"

"No, sir, it is not," the commander replies.

Brewington says, "That is not how we expect our recruiters to behave. As a result, it appears they did not uphold the values and they compromised their integrity."

A recruiter in Antioch, Tenn., tells our undercover producer, "If you take this and you get to basic training and you take it with you, you can't have it in a bottle."

Over and over, the recruiters tell our potential recruit that he'll have to hide his medications or quit cold turkey.

"One thing that we do not test for when we do like a drug and alcohol test, we do not test for that," the Murfreesboro recruiter says.

But they assure him that he probably won't have to worry about the Army catching him in his lie.

"We don't go pull everybody's medical records... unless they ... actually give us a medical reason," the Madison recruiter adds.

Brewington says, "I would say that is not indicative of the over 8,000 recruiters that we have across the recruiting command."

But Congressman Jim Cooper isn't so sure.

"If you caught three, there are probably a lot more out there," he tells Williams.

Cooper, D-Tennessee, sits on the House Armed Services Committee, which has been investigating the Army's lies in the cases of Jessica Lynch and Pat Tilman.

"To encourage people to lie to the federal government about their own medications and their own health situations, that's an outrage," Cooper adds. "It's got to be stopped and it's got to be stopped now."

Despite the Army's slick recruiting ads, top brass have known for some time that, as recruiters face increasing pressure to recruit, some also feel increasing pressure to cheat.

Two years ago, the Army ordered a day-long recruiting stand-down after numerous allegations of misconduct.

And the Antioch recruiter says she's to be careful and let the recruit decide for himself about whether he's going to lie to get into the Army.

"That'll be your decision," she says, "'cause we are not gonna get you into a situation where it's bad on you, it's bad on us."

Cooper says he doesn't just blame the recruiters.

"I blame the folks up the chain of command. They are getting orders, pressure and relax standards to say fill the quota regardless of what it takes."

In fact, the Army's own figures show that 5 of every 10 recruiters who were found to have engaged in improprieties were relieved of duty five years ago.

Now, just 3 out of 10 get the harshest penalty. (See "Summary of Army Recruiting Investigations.")

"Kindly leave the office," the Antioch station commander tells Williams.

"Do you want to see what one of your recruiters was doing?" Williams asks.

He answers. "I'm going to see that probably on the news tonight, sir."

As for the recruiters we caught on tape, Cooper says what we showed him is "sufficiently grave that we need to have a full-scale nationwide investigation."

The congressman says he fears recruiters could be putting people who may be unstable out with soldiers who already have enough to worry about.

In his e-mail, the deputy director of Army recruiting said -- after watching our video -- it was obvious to him that some "soldiers just don't get it."

He says they've had recruiting stand-downs before. But now, they've got to do something about the problems and not just let them continue.

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

From the FDA Press release dated Wednesday, May 2nd, 2007

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

For more information:

Antidepressant use in children, adolescents, and adults, including the draft labeling and draft Medication Guides
www.fda.gov/cder/drug/antidepressants/default.htm

FDA's Psychopharmacologic Drugs Advisory Committee, including transcripts from the December 2006 meeting

www.fda.gov/ohrms/dockets/ac/cder06.html#Psychopharmacologic

Panel votes to extend antidepressant black box warning to children and teens

As seen on News Target

An advisory panel for the FDA recommended that warnings of suicidal thoughts and behavior in adults up to age 25 be put on antidepressant drug packaging, but a health advocate notes that few people pay attention to these warnings anyway.

Currently, antidepressant drugs such as Pfizer's Zoloft and Eli Lilly's Prozac and Cymbalta carry "black box" warnings -- the FDA's most severe warning for dangerous prescription drugs -- stating that the medications may increase suicidal thoughts or behavior in children and teens shortly after initial treatment. According to health information company IMS Health, sales of these drugs brought in $12.5 billion in 2005.

[...]

Before the recommendations were debated, family members of patients who had committed suicide while on antidepressants testified to the panel that strong warnings for the drugs should be applied to patients of all ages. Some said the first emergences of antidepressant-linked suicidal behavior should have spurred the FDA into action in the early 1990s.

"I hold you all responsible for (my husband's) death, and I always will," said Suzanne Gonzales, whose 40-year-old husband shot himself in the head soon after beginning treatment with GlaxoSmithKline's Paxil. Recently, GlaxoSmithKline has added information from a study that showed young adults on placebo were less likely to report suicidal behavior than those on antidepressants to their label.

Pfizer and Effexor maker Wyeth maintained that adult trials indicated no link between their drugs and suicidal thoughts or behavior, although Wyeth's Vice President for Neurosceince, Dr. Philip Ninan, said the company would support some type of warning about possible risks for such behavior in young adults taking any antidepressant.

"Black box warnings are health safety gimmicks that allow the FDA to avoid having to ban dangerous prescription drugs that should be banned," said Mike Adams, a consumer health advocate and critic of the overmedication of children and teens. "The warnings are all but ignored by doctors and patients alike. They serve no purpose other than allowing the FDA to disclaim responsibility for the hazardous side effects.

While the FDA usually follows recommendations from its advisory panels, Adams noted that this is not always the case. Earlier this year, the panel voted to require black box warnings on Ritalin after methylphenidate, the generic name for Ritalin, was implicated in 19 cases of sudden death. As noted in the Feb. 18 issue of New Scientist, the FDA decided to reject the recommendation.

"I have no doubt that if antidepressants were actually herbs, the FDA would declare them to be 'unsafe at any dose' and ban them from the marketplace," Adams said. "But because they are high-profit pharmaceuticals that earn billions of dollars for drug companies, the FDA keeps them on the market as long as possible, using black box warnings to excuse themselves from drug safety responsibilities."

International Coalition For Drug Awareness

International Coalition For Drug Awareness is a private, non-profit group of physicians, researchers, journalists and concerned citizens.

Our primary focus is to address the world's most pervasive and subtle drug problem—prescription drugs. We are dedicated to educating the people of the world regarding the potential harmful and life threatening short and long term effects of these drugs along with the serious problems associated with the unethical marketing techniques of pharmaceutical companies and the off-label prescribing of these drugs by many physicians. As the cause of an estimated 200,000 deaths per year in America, drug reactions are now the third leading cause of death!

The most dangerous period of time for a drug is upon market introduction. At that point physicians and their patients have information on adverse reactions present in the controlled environment of a clinical trial, but are unaware of the potential adverse reactions of these new drugs when dispensed to the general public. We feel there is a need to track and report patient reactions more carefully and more rapidly than what is presently being done, which should result in lower medical costs for the patients and doctors as well. And also might begin to bridge the gap that is beginning to form between well-meaning doctors and maltreated patients.

By keeping prescribing physicians and their patients abreast of recent adverse reaction reports and approved uses of drugs as opposed to their off-label uses, we hope to cut the number of unnecessary deaths due to drug reactions and interactions and lessen the number of malpractice suits filed against physicians as a result of those reactions. Beyond this public education process our intention is to serve as a watchdog group over the FDA and similar organizations around the world, encouraging them to remove drugs which demonstrate high numbers of dangerous adverse reactions and threaten the public safety.

Their board is composed of medical professionals. They also have a good collection of online resources

Court Allows Eli Lilly To Bury Zyprexa Documents

As seen here. Part of a much larger well documented article detailing the sordid history of Eli Lilly in this matter.

Alaskan attorney, Jim Gottstein, says that after being served with a mandatory injunction, he has returned the internal Eli Lilly documents that he obtained in litigation and provided to the New York Times to the court.

Information from the documents related to Lilly's antipsychotic drug, Zypexa, was highlighted two days in a row in front-page articles in the Times

The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.

For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.

FDA Panel Recommends Warning For Adult Antidepressant Suicide Risk

As seen in Medical News Today

An FDA advisory panel on Wednesday voted 6-2 in favor of updating black box warnings on antidepressants to state that there is an increased suicide risk for young adults up to age 25, the New York Times reports (Carey, New York Times, 12/13). According to FDA's review, for every 1,000 young adults ages 18 to 24 who are given the drugs, about four will act on suicidal thoughts who otherwise would not have done so. The review found that the drugs did not increase the risk of suicide in adults ages 25 to 65 and that they significantly lowered the risk of suicide in people older than 65. Antidepressants since 2004 have carried a black box warning about an increased risk of suicidal thoughts and actions in children and adolescents (New York Times, 12/13). FDA proposed adding new warnings about suicide risk in young adults, which the advisory panel has now endorsed. The advisory panel "also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions," the Journal reports (Wall Street Journal, 12/14).

FDA Comments
Thomas Laughren, director of FDA's division of psychiatry products, said, "We don't know" why antidepressants appear to have different effects on different age groups (Graham, Baltimore Sun, 12/14). Laughren said FDA is leaning toward expanding the black box warning to include young adults, and agency officials said they will try to write language that would encourage health care providers to prescribe the drugs carefully, not abandon them, the Washington Post reports. Robert Temple, director of FDA's Office of Medical Policy, said that regulators are in a difficult position because they are obligated to warn physicians about monitoring patients for suicidal tendencies but also are concerned that the warning might lead doctors to stop prescribing the drugs (Vedantam, Washington Post, 12/14).

Testimony
Davis Shern, president of Mental Health America, said that the current black box warning for children and adolescents has resulted in a 20% drop in antidepressant prescriptions for those age groups. At the same time, Shern noted the suicide rate for children and adolescents has increased, according to some estimates. He said, "A black box warning will scare people away from treatment and end up causing greater harm than it does good" (Baltimore Sun, 12/14). Christopher Kratochvil, a psychiatrist and spokesperson for the American Academy of Child and Adolescent Psychiatry; John Mann, a psychiatrist and spokesperson for the American Foundation for Suicide Prevention; and Donna Barnes, president of the National Organization for People of Color Against Suicide, all said that new suicide warnings might harm depression patients by making them afraid of treatment. However, British psychiatrist David Healy and Harvard University lecturer and psychiatrist Joseph Glenmullen said that FDA's review downplayed the risk of suicide from antidepressants and suggested that several suicides in industry-sponsored studies were never disclosed, the Post reports (Washington Post, 12/14).

Broadcast Coverage
Several broadcast programs reported on the FDA panel's consideration of the issue:

• ABCNews' "World News Tonight": The segment includes comments from U.S. residents who testified for and against increased labeling for antidepressants (McKenzie, "World News Tonight," ABCNews, 12/13).
  
  Related ABCNews video is available online.
  


• CBS' "Evening News": The segment includes comments from Sherri Walton, second vice president of the Mental Health Association of Arizona, and U.S. residents who testified for and against increased labeling for antidepressants (Attkisson, "Evening News," CBS, 12/13).
  
  Video of the segment is available online.
  


• NBC's "Nightly News": The segment includes comments from U.S. residents who testified for and against increased labeling for antidepressants (Snyderman, "Nightly News," NBC, 12/13).
  
  Video of the segment is available online.
  


• NPR's "All Things Considered": The segment includes comments from Joanne Silberner, health correspondent for NPR, and U.S. residents who testified for and against increased labeling for antidepressants (Norris, "All Things Considered," NPR, 12/13).
  
  Audio of the segment is available online.
  


• NPR's "Day to Day": The segment includes comments from Silberner (Chadwick, "Day to Day," NPR, 12/13).
  
  Audio of the segment is available online.

Antidepressants to get new suicide warnings

As seen here

Antidepressants can increase the risk of suicidal behaviors in people up to age 24, federal public health officials warned Wednesday as they decided to expand a drug warning label that now applies only to children and adolescents.

Users of all ages should be closely monitored, the Food and Drug Administration said after a contentious hearing on an issue that has bitterly divided psychiatrists, mental health advocates and the family members of people who have committed suicide.

After a huge federal analysis of hundreds of clinical trials, an expert federal panel recommended that agency officials tell doctors and the public of the risk but also find a way to note that the risk declines with age and that leaving depression untreated is also risky.

While the studies on the relationship between the drugs and suicide appear contradictory, the experts said one possibility is that the drugs may pose a risk early in treatment but have a protective effect in the long term.

The action taken Wednesday is unlikely to quell the debate.

"I've been out here 21 times and I'm not going to stop," said Kim Witczak, 40, of Minneapolis. She became a crusader for the warning on antidepressants in 2003 after her husband, Woody, hanged himself in their garage shortly after he began taking the antidepressant Zoloft for insomnia. She was one of dozens of people who crammed the hearing in Silver Spring, Md., and said the expanded warning does not go far enough.

"How does a drug know the difference between someone who is 25 and 35 years old?" she asked.

[...]

The FDA based its decision on a review of 372 studies on 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.[...]