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April 2007 Big Pharma Litigation Update – Drugs – Part I

Evelyn Pringle April 5, 2007

For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.

Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.

Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.

It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.

On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.

There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report. The case was later settled for an undisclosed amount.

PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.

And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff’s attorney, Paul Rheingold, in “Fen-Phen and Redux: A Tale of Two Drugs,” says, “there is blame enough to go around.”

The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.

Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff’s heart attack and awarded $20 million in damages.

According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff’s heart attack.

A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff’s allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.

Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a “signature disease,” meaning a condition easily tied to the drug because it is rare.

The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. “We’ve uncovered about 1,000 patients in the past six to nine months alone,” he said, “so the magnitude of the problem is just starting to be recognized.”

FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA’s Office of Drug Safety.

Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, “Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people.”

The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs’ attorneys that the company is willing to cut a deal.

Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.

The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.

There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.

On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.

Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon’s painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.

Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.

In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.

In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.

Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.

He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.

According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.

The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.

More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.

To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.

On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.

All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.

Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.

Filed under: 2007, AstraZeneca, Cephalon, Eli Lilly, fen-phen, fentanyl, Fosamax, Johnson and Johnson, Merck, ONJ, Ortho, patch, PPHN, Seroquel, settlement, Vioxx, Wyeth, Zyprexa

Makers of Zyprexa Risperdal and Seroquel Under Fire

Evelyn Pringle March 9, 2007

Eli Lilly, Johnson & Johnson, and AstraZeneca, are all named defendants in a new lawsuit filed by the state of Pennsylvania on February 26, 2007, to recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.

Pennsylvania is the 5th state to sue Lilly over its illegal marketing of Zyprexa. And according to SEC filings, Lilly was served with four Canadian lawsuits in 2005, with claims “similar to those in the litigation pending in the United States.”

So far, two states have sued Johnson & Johnson over Risperdal, but Pennsylvania is the first state to file a lawsuit against Seroquel-maker AstraZeneca.

The drugs belong to a class known as “atypical” antipsychotics, FDA approved only to treat adults with schizophrenia or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world. In 2006, Zyprexa sales were $4.3 billion, Seroquel’s earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.

A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.

According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.

When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug. Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.

On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZeneca, requesting information related to the exact same charges alleged in lawsuits filed by individual states.

The letter sent to Lilly states in part, “Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa,” and requests information relevant to these allegations.

The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.

In addition, Rep Waxman wants Lilly to turn over all internal company documents that were kept under seal for years with a court order, but were provided to him by Attorney, James Gottstein, in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.

According to the New York Times, some of these documents reveal that Lilly knew about Zyprexa’s link to high blood sugar and extreme weight gain that often leads to diabetes, and others show the details of off-label marketing scheme called “Viva Zyprexa.”

Rep Waxman’s letter to AstraZeneca basically asks for the same documents requested from Lilly except that he requests more information related to the physicians and authors involved in company sponsored studies and writing the reports.

Late last year, the atypical makers also received subpoenas from the attorney general of California seeking much of the same information.

In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has hired private attorneys. According to the complaint, the defendants cost Pennsylvania millions of dollars “for non-medically accepted indications and non-medically necessary uses of Zyprexa, Seroquel and Risperdal,” as well as “significant sums of money for the care and treatment” of patients injured by the drugs.

The Pennsylvania case comes on the heels of lawsuits by two Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who say, drug companies are making a fortune from the off-label sale of drugs to patients whose care is funded by Medicaid and Medicare.

At the heart of the off-label scheme, they say, are the preferred drug lists, or medication formularies, maintained in many states. Once drugs are added to the list, they must be prescribed as a first line of treatment for all patients in state run institutions and patients in the general population who are covered by public health care programs.

In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with the Pennsylvania Department of Public Welfare, and charged with reviewing psychiatric care provided by state-funded agencies to identify waste, fraud, and abuse. He was also responsible for reviewing the deaths of individuals in state care who died under suspicious circumstances in facilities inside and outside of Pennsylvania.

Early in his investigation, Dr Kruszewski noticed that almost all of the patients under state care were on drug cocktails consisting of antipsychotics, antidepressants, and anticonvulsants. The populations he found drugged most often, he said, were children in state care, the disabled, people in state prisons, and children in the juvenile justice system.

For instance, he says, Neurontin was only approved for controlling seizures, but “was being prescribed for anxiety, social phobia, PTSD, oppositional defiant behavior, and attention deficit disorder with no evidence to support these uses.”

When he informed his superiors about the high rate of off-label prescribing and warned about the risk of liability to the state of Pennsylvania if it continued, he was told, “it is none of your business.”

In June 2003, Dr Kruszewski inspected a facility in Oklahoma that housed children from Pennsylvania after an unexpected death of a child, and found children were being overmedicated and housed in deplorable living conditions, in addition to being sexually and physically abused by staff and kept in unnecessary restraints and seclusion.

In a report, Dr Kruszewski recommended removing the children from the facility, “in order to protect other innocent individuals from morbid and mortal consequences of severe over-medication, including chemical restraints; emotional, physical and sexual abuse; seclusion; and dirty and inadequate living conditions.”

A day later, Dr Kruszewski was accused of “trying to dig up dirt,” and was subsequently fired in July 2004, because he refused to keep quiet and accept that it was none of his business, he says.

A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that patients under state care were being drugged for profit and prescribed as many as 5 psychiatric drugs at the same time, and that four children and one adult had died.

In his action, Dr Kruszewski alleged that his superiors violated his right to free speech by firing him because he made statements about the abuses in the state system, which were a matter of public concern.

Dr Kruszewski is represented by attorneys from Government Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and Mark Cohen, in Federal Court in the Middle District of Pennsylvania with Chief Judge Yvette Kane presiding.

Defendant, Christopher Gorton, is the Chief Medical Officer for DPW, who fired Dr Kruszewski. He filed a motion for summary judgment to dismiss the First Amendment claim on the basis that the law does not protect whistleblowers if they are fired for making comments they would be expected to make in the context of their employment.

In reading the Court’s March 2, 2007, Decision denying Mr Gorton’s motion, it appears that Mr Gorton tried to have it both ways. When Dr Kruszewski was employed and tried to report the harm to people under state care, he was told it was none of his business and to quit digging up dirt. Under oath in a deposition, Dr Kruszewski stated that he was told that the subjects of his statements were not part of his job duties.

However, in his motion, Mr Gorton now claims that Dr Kruszewski’s comments were made pursuant to his official employment duties. In her written opinion, Judge Kane, quoted relevant case law to describe comments that are protected:

“A public employee’s statement is protected activity when (1) in making it, the employee spoke as a citizen, (2) the statement involved a matter of public concern, and (3) the government employer did not have an adequate justification for treating the employee different from any other member of the general public as a result of the statement he made.”

“The statements in question can be categorized,” Judge Kane wrote, “as: (1) reports regarding poor quality of care, including abuse of patients by staff at treatment facilities; (2) complaints about the lack of qualifications of another private contract doctor; and (3) statements about use and costs of medications.”

In order to grant a motion for summary judgment, a judge has to find that there are no genuine disputes of material fact that would require a jury to resolve. In this case, Judge Kane found there were disputes regarding Dr Kruszewski’s job duties and whether his statements were substantial and motivating factors in his termination.

In his motion, Mr Gorton claims the statements were not protected speech, but then says, even if they were, they were not a factor in his decision to terminate Dr Kruszewski, because he was unaware of the statements when he decided to fire Dr Kruszewski.

However, Judge Kane found evidence in the record that, “if credited by a fact-finder,” she wrote, “would support Plaintiff’s claim that Gorton knew of at least some of Plaintiff’s protected statements.”

“Because there remain genuine disputes of material fact,” she states, “regarding Plaintiff’s job duties and whether Plaintiff’s statements were substantial and motivating factors in his termination, the Court cannot grant summary judgment for Defendant Gorton.”

According to Dr Kruszewski, apart from all the legal wrangling, his focus remains on trying to protect Pennsylvania citizens against unwarranted drugging, sexual and physical abuse, and unnecessary restraint and seclusion.

His original lawsuit alleges that drug companies used “political friendships, money, and other emoluments” to achieve “a level of influence with Pennsylvania’s state government” to promote “the use of their products.”

These charges echo those previously made by the other Pennsylvania whistleblower, Allen Jones, who was also a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, and was fired after he informed his superiors that drug companies were funneling money to state officials and policy makers in positions of influence over the state’s preferred drug formulary known as PennMap.

Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania, also with the assistance of the Government Accountability Project. While he did not agree to a gag order regarding his concerns, he did agree not to discuss the terms of the settlement.

During his investigation, Mr Jones found collusion between drug companies and several state officials and specifically, Steven Fiorello, Pennsylvania’s chief pharmacist, a valuable player because he monitored pharmacy operations at 9 state hospitals and served on the committee that determined which drugs would be prescribed to patients in state hospitals.

On November 21, 2006, Mr Fiorello was arraigned on two felony counts of conflict of interest and misdemeanor counts of accepting money and failing to disclose the income on his yearly financial interest statements.

A year and a half earlier, the Pennsylvania State Ethics Commission had determined that Mr Fiorello had repeatedly violated state ethic laws by using his position to earn money from drug companies. To settle the charges with the Ethics Commission, Mr Fiorello paid fines totaling $27,269, before the case was referred for criminal prosecution.

Down in Texas, another state official, Dr Steven Shon was fired from his job in October 2006, after the state’s attorney general, Greg Abbot, found J&J had improperly influenced Dr Shon to list Risperdal in a state formulary called the “Texas Medication Algorithm Project,” or TMAP, while receiving money from J&J.

In December 2006, Mr Abbott joined another whistleblower lawsuit filed by Mr Jones, against J&J, alleging in part, that the company misrepresented the safety and effectiveness of Risperdal and unduly influenced Dr Shon and others, to make it a drug of choice for persons covered by public health care programs in Texas.

TMAP required doctors to prescribe atypicals rather than the older, less expensive antipsychotics. “The plan,” Mr Jones explains, “was part of a larger scheme designed to infiltrate public institutions to influence prescribing practices in which drug companies bought the opinions of a few key doctors and state policymakers, and opened the door for spending billions of tax dollars on dangerous drugs.”

The Texas lawsuit describes exactly how the TMAP preferred drug list was developed in Texas in 1997, and according to the complaint, Dr Shon traveled around the country at J&J’s expense to convince officials in other states to adopt the TMAP model, which is now used in 17 states.

The lawsuit says, J&J promoted Risperdal by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments and that Risperdal was recommended as the drug of choice for children, even though it was not approved for use with children.

TMAP was highly successful in getting doctors to prescribe atypicals to kids. According to an investigation of psychiatric drug use by Texas children on Medicaid, ACS-Heritage, a medical consulting firm, found 19,404 teens were prescribed an antipsychotic in July or August of 2004, with nearly 98% being atypicals.

ACS also found that more than half of the doses were inappropriately high, almost half of the prescriptions did not appear to have diagnoses warranting their use, and one-third of the children were on two or more drugs.

The Texas lawsuit alleges that J&J concealed Risperdal’s link to hyperglycemia, stroke, and renal failure, to qualify for reimbursement under Medicaid, and that Texas seeks to recover money paid to purchase the drug for off-label uses and the cost of medical care for the people injured by Risperdal.

In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.

Critics say, the Governor of Pennsylvania is suing atypicals makers now to portray a hard stance against the pharmaceutical industry because he wants to run for higher office, when in reality, he has known about the PennMap off-label scheme for years.

The consensus is that Mr Rendell believes he missed a chance for national prominence by allowing the two whistleblowers to be fired and sweeping the results of their investigations under the rug. Critics point out that PennMap is still in place even though TMAP has been discredited in Texas and other states.

In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David Graham’s estimate that 62,000 Americans die each year from the off-label prescribing of atypicals. According to Mr Jones, this translates into nearly 10,000 deaths occurring in Pennsylvania during Governor Rendell’s first term.

During a congressional hearing last month, Dr Graham testified that the off-label use of atypicals to sedate people in nursing home kills roughly 15,000 people a year. Based on this estimate, Mr Jones says, about 2,400 Pennsylvania senior citizens died in the Governor’s first term.

“During this time,” Mr Jones reports, “Pennsylvania citizens, insurers and taxpayers paid in the neighborhood of one billion dollars for drugs proven to be no more effective, and far more deadly, than the older antipsychotic medications.”

Filed under: 2007, antipsychotics, AstraZeneca, Eli Lilly, Johnson and Johnson, RISPERDAL, Seroquel, settlement, Zyprexa

Certain Asthma and Allergy Drugs Get Stiffer Suicide Warning

Evelyn Pringle June 2009

The requirement for a more prominent warning regarding an increased risk of neuropsyhiatric events, including suicide, applies to Singulair (montelukast), and Accolate (zafirlukast), leukotriene receptor antagonists, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor.

The reported neuropsychiatric events “include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor,” the FDA said in a June 12, 2009, statement on its Website.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” the FDA states.

“FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling),” the agency notes.

Singulair, Accolate, and Zyflo are approved to treat asthma, and Singulair is also approved to treat allergic rhinitis and prevent exercise induced asthma.

In March 2008, the FDA announced that Singulair may be associated with suicidality and suicide, and subsequently conducted a review of neuropsychiatric events in post marketing reports and clinical trial data submitted by the drug makers.

Events were not found to be common in the clinical trials but the trials were not designed to look for neuropsychiatric events, the FDA said. “Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo,” the agency noted.

AstraZeneca markets Accolate, and Zyflo is made by Cornerstone Therapeutics. Singulair was Merck’s top selling product in 2008, and the sixth top selling drug in the US, with sales of $3.5 billion, according a March 2009 report by IMS Health.

Filed under: 2009, allergy drugs, AstraZeneca, Merck, suicide

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