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 All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.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.

Wyeth’s Off-Label Promotion of Prempro Leads to 5,200 Lawsuits

Evelyn Pringle March 30, 2007

For many years, Wyeth led women to believe that taking Prempro, with the combined hormones of estrogen and progestin, would not only relieve hot flashes, vaginal dryness, night sweats, and moodiness, but it would also prevent heart disease, osteoporosis, and mental deterioration.

Very little of that advice now appears to be true. The latest FDA approved labeling for Prempro states in part:

“Do not use estrogens and progestins to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens and progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older.”

Prempro was approved as a hormone replacement therapy to treat menopause and prevent osteoporosis only. The wide-spread over-prescribing of the drug for other conditions was a result of Wyeth promoting the drug for off-label uses.

Off-label refers to the practice of physicians prescribing an FDA approved medication for uses other than the indications listed on the drug’s label. While this practice may be justified in exceptional cases, critics say, HRT illustrates the damage that can occur when off-label prescribing becomes routine.

The widespread myths about the cures of hormone therapy began in 1965, when Dr Robert Wilson, published the book, “Feminine Forever,” without revealing that he was a consultant to Wyeth, the maker of the hormone drug Premarin.

By the mid-1970’s, a clinical trial showed that Premarin increased the risk of endometrial cancer, and a scientific panel had rejected virtually all of its benefits except for hot flashes and vaginal dryness. When Premarin sales fell, Wyeth added progestin to the pill, and created HRT.

The vast popularity of HRT, was in large part due to Wyeth’s successful efforts to promote the off-label use of Prempro through the media by providing information which overstated its benefits and downplayed the cancer risks.

For instance, a May 25, 1992, Newsweek article, entitled, “Every Woman for Herself,” stated in part, estrogen replacement therapy: “almost always zaps hot flashes, soothes vaginal dryness, improves bladder problems, evens out mood swings, and clears up short-term memory loss. It also combats the more serious effects of estrogen deficiency: osteoporosis and an elevated risk of heart attacks. The hormone retards bone loss and cuts death from heart attacks in half.”

An article in the October 1997, Ladies Home Journal, stated: “A woman’s chance of dying from heart disease is more than five times greater than dying from breast cancer, and HRT lowers that risk.”

A story in the September 1998, Better Homes and Gardens, told women, “talk to your doctor about taking estrogen or hormone replacement therapy.”

“Research has shown,” the article stated, “that estrogen and HRT may reduce the risk of heart attack after menopause by as much as 50 percent.”

As part of a Wyeth-sponsored American Heart Association campaign in 1998, the media received a pamphlet entitled, “Take Charge! A Woman’s Guide to Fighting Heart Disease.”

It listed loss of estrogen first under risk factors for heart disease, and stated: “Estrogen replacement helps protect against coronary heart disease risk.”

What critics say is most disturbing, is that the media continued to publish articles with similar statements even after the 1998 Heart and Estrogen/Progestin Replacement Study, which found that women who used HRT actually had a higher rate of heart disease during the first year of therapy.

It got to the point where the National Institute of Health decided that the use of hormones for disease prevention had to be studied precisely because doctors were prescribing the drugs off-label to so many women, even though long-term safety and efficacy had not been established.

In 2002, millions of women quit taking hormone pills, after an 8-year study was halted by the NIH after five years. The study by the Women’s Health Initiative included 16,000 women and found that women who received HRT had significant increases in breast cancer, heart attacks, strokes, and blood clots.

The principal investigators of the study reported that further trials to test other estrogen and progestin formulations would be unethical and a waste of tax dollars because there was no reason to believe any other formulations would render a different result.

Similarly, they said, there would be no reason to test HRT for the prevention of heart disease in women 50 to 59-years-old, because one third of the WHI’s volunteers were in their 50’s, and they had the highest increased risk of stroke.

Within 3 months after the study was released, Wyeth’s stock had fallen more than 55%, eroding its $48 billion in market value, according to TradingMarkets.com on February 28, 2007.

Critics of the study claim that it was the type of hormones, the dose, and the method of use which increased the health risks. The study tested HRT with estrogen made from the urine of pregnant horses, and some experts believe that estrogen from plant sources is better suited for treating menopause because it is closer to what the human body produces.

The most common risks associated with HRT, are blood clots, which can cut off the blood supply to vital organs and, in the most serious cases, a pulmonary embolism can occur if a clot travels to the lungs from another area of the body.

A recent study by French researchers in the journal Circulation, compared 271 women who suffered blood clots to 610 women without clots and found that women taking hormone pills orally were over 4 times more likely to develop clots than women who did not take hormones or who received them from patches, gels or creams.

Hormones delivered through the skin cause fewer blood clots, doctors say, because they enter the bloodstream directly, similar to natural hormones. When taken in pill form, the drugs must be metabolized by the liver triggering some of the unwanted side effects before entering the blood stream.

Since the release of the 2002 study, Wyeth’s massive off-label promotion of HRT has come back to haunt the drug giant. According to SEC filings, as of December 31, 2006, there were approximately 5,200 lawsuits pending against the company filed on behalf of approximately 8,400 women for injuries related to its HRT, with about 60% of the cases filed in federal courts and 40% in state courts.

The latest lawsuit was filed by Nancey Land, a retired South Carolina teacher, who blames her breast cancer on Prempro, according to The State on March 2, 2007.

Ms Land’s attorney, Ken Suggs, won a case against Wyeth in February 2007, when a Philadelphia jury returned a $3 million verdict for a 67-year-old Dayton, Ohio, woman who said Prempro caused her breast cancer which resulted in a double mastectomy, chemotherapy, and radiation.

The woman initially won $1.5 million in October 2006, but a mistrial was later declared after a juror was found to be ineligible, Mr Suggs told The State.

During the retrial, the jury was told that Wyeth knew for decades that HRT could cause breast cancer but failed to warn patients.

In January 2007, Mr Suggs’ law firm also handled a trial where the jury awarded $1.5 million to an Arkansas woman.

So far, Wyeth has won two cases in federal court.

No End in Sight for Fen-Phen Lawsuits

Evelyn Pringle January 29, 2007

On December 5, 2006, five women with ages ranging from 53 to 71, who took the appetite suppressants drugs known as fen-phen in 1996 and 1997, filed lawsuits against Wyeth Pharmaceuticals after being diagnosed with a life-threatening lung disorder.

These lawsuits demonstrate that the harm caused by fen-phen can surface many years after a person stops taking the drugs. For instance, plaintiff, Renee Tedesco, 53, of New Jersey, took fen-phen 10 years ago but was not diagnosed with primary pulmonary hypertension (PPH), until April 2006. She has undergone a double lung transplant to save her life.

In addition, studies released in November 2001, indicate that PPH in fen-phen users may be 7 times higher than originally predicted in 1997.

Fen-phen refers to a combination of the drug phentermine and the diet drugs Redux (dexfenfluramine) or Pondimin (fenfluramine). According to the FDA, these drugs were approved as appetite suppressants to be used separately in the treatment of obesity for short periods of time.

The fen-phen combination was never FDA approved for any indication so all prescriptions were written for off-label uses. Drug companies are prohibited from promoting drugs for off-label use but doctors may prescribe a drug that has been approved for one indication for any condition they deem appropriate. In recent years numerous drug makers have come under fire for illegally promoting their drugs for off-label uses.

Prescriptions written off-label for fen-phen were massive. Patients were able to get fen-phen over the internet, and Jenny Craig and Nutri-System set up weight loss programs where doctors would prescribe the drugs to patients.

Doctors prescribed fen-phen without doing a thorough examination, and in many cases without any exam at all. Most doctors prescribing the drugs had little or no training in obesity, according to One Half-Phen In the Morning/One Fen Before Dinner: A Proposal For FDA Regulation of Off-Label Uses of Drugs, by Maime Wilsker (1998).

One Illinois patient said that she obtained fen-phen from a weight-loss clinic without ever seeing a doctor and that a nurse gave her the prescriptions.

An estimated 6 million people have taken fen-phen and more than 18 million prescriptions were written for the combination in 1996 alone. From 1992 to 1997, new prescriptions for fen-phen increased by 442% for phentermine and 6390% for fenfluramine, according to a report in the March 24, 1997, Archives of Internal Medicine.

However, the run-away-train prescribing about came to a screeching halt on July 8, 1997, when the FDA issued a Public Health Advisory to 700,000 health care professionals and institutions warning that researchers at the Mayo Clinic had reported 24 cases of heart valve disease in previously healthy women who took fen-phen on average for 12 months.

Of the 24 women identified who had valve disease, eight also had moderate or severe pulmonary hypertension, which had not been previously identified.

The Advisory also noted that the agency had received additional reports of the same nature, and advised health care professionals to report any similar cases to the FDA through MedWatch. Subsequently, the FDA received 66 more reports of valve disease.

The lesions that formed on the heart valves of fen-phen users cause blood to flow backwards instead of forwards, which is called regurgitation. The Mayo Clinic study was reported in the August 28, 1997, New England Journal of Medicine and concluded by stating: “significant de-novo left-sided regurgitant valvular heart disease in a population less than 50 years old is rare. Thus, the association of valvular regurgitation with fenfluramine-phentermine is not likely due to chance.”

The researchers said that fen-phen users “should be informed about serious potential adverse effects, including pulmonary hypertension and valvular heart disease.”

Cardiologist, Dr Heidi Connolly led the study and was interviewed on PBS on August 27, 1997. At that time, she reported that five of the women in the study had required open heart surgery to repair or replace damaged heart valves.

Pulmonologist, Dr Lewis Rubin was also interviewed on the PBS program as part a member of the research team that linked PPH to fen-phen. Dr Rubin’s research found that people who took fen-phen for 3 months had a 9-fold increased risk for PPH, and 6-month users had a 23-fold increased risk of developing PPH.

After the Mayo Clinic report was published, the FDA conducted a study in five areas of the country, including Florida, Minnesota, Wisconsin, Indiana, and Pennsylvania and found a 32.8% presence of lesions causing valvular regurgitation, significantly higher than would be expected amongst the general population.

In addition to the FDA data supporting the link, Dr Mehmood Kahn performed a study in Minneapolis shortly after the July, 1997 announcement about valvular disease and found that approximately 25% of the 226 fen-phen users in his study had aortal regurgitation of mild or greater severity, compared with 1% in the 81 patients who did not take the drugs.

On August 27, 1997, acting FDA Commissioner, Dr Michael Friedman was interviewed on PBS and basically blamed the problems on the off-label prescribing explaining that “when these drugs are used in accordance with the labeled instructions, the number of side effects from pulmonary hypertension or from the valve abnormality are extremely rare.”

“When these medications are used outside of those labeled indications,” he advised, “at a higher dosage, for a longer period of time, or in combination with one another, then these side effects are seen more frequently.”

“But we’ve had very few, if any, valve abnormalities in patients who have used the products in an appropriately-labeled fashion,” Dr Friedman said in the interview.

He explained that the label indication “says to use these medications only for a short period of time, some few weeks, and in conjunction with dietary restrictions.”

On September 15, 1997, the FDA called for the removal Pondimin and Redux from the market, based on findings from patients evaluated with echocardiograms to test heart valve functioning. “These findings,” the FDA stated, “indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms.”

The injuries resulting from the fen-phen debacle are reportedly one of the largest number of adverse drug reactions that the FDA has ever dealt with.

Since American Home Products Corporation, which became Wyeth in 2002, withdrew the drugs from the market, a massive number of lawsuits have been filed against the company alleging injuries of valvular heart disease and PPH caused by the drugs.

Heart valve damage is an extremely serious medical condition that is life-threatening. Experts note that there are no medications that can reverse valve damage and valve replacement surgery is often the only option available.

In a healthy heart the valves fit tightly when closed, preventing blood from flowing backwards. But in the hearts of the patients studied at the Mayo Clinic, a waxy substance prevented the valves from closing completely.

Valvular insufficiency occurs when the valves do not close properly, which forces the heart to work harder to circulate the blood and can lead to serious problems such as heart attack or heart failure, according to WebMD.

Valve replacement requires open heart surgery, according to the Texas Heart Institute. The 2 kinds of valves used are mechanical valves made of metal or plastic, and biological valves made from animal tissue or human tissue from a donated heart.

Mechanical valves are stronger but because blood tends to stick to them and create blood clots, patients need to take blood-thinning drugs for the rest of their lives. And because these drugs increase the risk of bleeding, patients must wear a medical alert bracelet so that medical professionals will know they are taking a blood-thinning drug.

Patients with biological valves usually do not have to take blood-thinning medications but because the valves are not as strong as mechanical valves, they may need to be replaced every 10 years.

PPH is also an extremely serious condition that may require a heart-lung transplant. In its simplest form, PPH means high blood pressure in the lungs and the constriction of the vessels makes it harder for the heart to pump blood through the lungs. According to the FDA, PPH “results in death in about 40% of affected individuals within 4 years.”

On November 22, 1999, the Philadelphia Inquirer interviewed a woman who was almost entirely housebound and on a waiting list for a double lung transplant. She was connected to oxygen tubes 24 hours a day and had an IV line connected to a pump to deliver drugs into her heart with her at all times. The woman said that as soon as she starts to move she gets weak and likened living with PPH to living on Mount Everest without oxygen.

Redux was FDA approved in April, 1996, even though there were already concerns about PPH. Reports of PPH with the drug had appeared in European literature in the 1980’s and 1990’s.

Two months after its approval, the International Primary Pulmonary Hypertension Study reported that the appetite suppressants (anorectic agents) increased the risk of PPH to between 23 and 46 cases per million, compared to the usual 1-2 cases per million. Redux and Pondimin represented 90% of the anorexigens in the study.

The IPPHS found that “the use of any anorexigen within the previous year was associated with a ten-fold risk of developing PPH, and the risk increased to more than 20-fold with use for longer than three months.”

There have also been reports of neuropsychological damage in fen-phen users that can include memory loss, behavioral changes, depression, psychotic breakdowns, and mood swings. A study reported in the September 1997, Journal of the American Medical Association, indicated that Redux and Pondimin can reduce the production of a key brain-signaling chemical and adversely affect memory, cognition and moods.

Critics say this too was a known risk at the time that Redux was FDA approved. In fact, after its approval, a group of neuroscientists sent a letter to the FDA criticizing the agency for ignoring animal tests that suggested that prolonged use of Redux damaged brain tissue.

In litigation, some plaintiffs are going after the doctors for their off-label prescribing. In a Philadelphia PPH jury trial, a doctor was held liable for half of the $8 million verdict for prescribing fen-phen for the plaintiff between 1995 and 1997.

The woman’s attorney stated that “the claim against [the prescribing doctor] was that he not only prescribed the drug beyond the two weeks recommended by the manufacturer, but he prescribed it for years . . . and he prescribed it until she [the plaintiff] called him and said that she had heard on CNN when she was in Italy touring that there were side effects,” according to Lori Litchman, in the February 24, 2000, Legal Intelligencer.

On the other hand, the drug maker can hardly argue that it was unaware of the widespread off-label use of fen-phen with record profits pouring in from the drugs.

According to one plaintiff’s attorney, Paul Rheingold, in Fen-Phen and Redux: A Tale of Two Drugs, “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 said, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.

A national class action settlement has been reached involving claims for valvular heart disease, but the settlement did not include claims for PPH or neurological damage. Lawsuits with those claims are being tried individually.

Wyeth has reportedly allocated $21 billion to cover the costs and damages of fen-phen litigation.

Fen-Phen May Cause Rummage Sale of Wyeth Assets

Evelyn Pringle August 23, 2006

On August 18, 2006, Bloomberg News reported that Wyeth has faced more than 175,000 claims since fen-phen was removed from the market, and that over the past 9 years, the company has settled many claims without forcing fen-phen users to file a lawsuit.

All total, the company has set aside more than $21 billion to cover legal costs and settlements since the diet drugs were withdrawn, according to Reuters News on May 24, 2006. As for how long Wyeth can stay afloat under the tidal wave of fen-phen lawsuits, financial experts say the answer could boil down to insurance coverage.

If this is true, the future looks bleak for Wyeth shareholders because according to, “The $22 Billion Gold Rush,” by Robert Lenzner & Michael Maiello, on Forbes.com on April 10, 2006:

“Insurance covered only $400 million of the damage costs, forcing Wyeth to fund the rest by selling $8 billion in assets and giving up a merger with Warner-Lambert to get a $2 billion kill fee; it warns it may have to sell more assets to fund still more claims.”

Well then maybe its time for Wyeth to put up signs for a rummage sale because on August 10, 2006, in the most recent fen-phen trial, a jury in a Philadelphia returned a $300,000 verdict in favor of 41-year-old, Jodi Wier, after deliberating only 6 hours. Ms Wier took fen-phen for about three months starting in October 1996, and was diagnosed with primary pulmonary hypertension 5 years later.

“She has an incurable disease and has to be treated for the rest of her life,” her attorney, Edward Freidberg, told the jury in closing arguments.

The lawsuit was filed in 2004 by attorney, Theodore Holt, of the California firm of Hackard & Holt, and was the first fen-phen-related PPH case to go to trial in Philadelphia. In a July 27, 2006, press release at the onset of the trial, Mr Holt, stated that “PPH is a serious incurable disease that can take years to develop.”

“We suspect,” he said, “there are still many undiagnosed victims and that PPH litigation will continue well into the future.”

In the fall of 1997, American Home Products Corporation (renamed Wyeth in 2002), withdrew the diet drugs Pondimin and Redux, which in many cases were being prescribed together with phentermine, in the combination commonly referred to as “fen-phen.”

“Fen” is short for fenfluramine, marketed as Pondimin, since it gained FDA approval in 1973, and its chemical cousin, dexfenfluramine, marketed as Redux, since it was approved in 1996.

“Phen” is short for phentermine, which is marketed under various trade names such as Ionamin and Fastin, as well as several generic forms.

According to the FDA, phentermine and fenfluramine were approved to be used as separate appetite suppressants for short periods of time of a few weeks in the management of obesity.

Nonetheless, doctors prescribed the drugs together and for extended periods of time in what the FDA referred to as “off label” use because there have been no studies submitted to the FDA to demonstrate the effectiveness or safety of the drugs taken together or for longer than a few weeks.

It is estimated that more than 6 million people took fen-phen and Pondimin and Redux became two of the most widely prescribed drugs in the US. In 1996 alone, their sales totaled over 20 million prescriptions.

Things began to head downhill for Wyeth in July 1997, when researchers at the Mayo Clinic reported 24 cases of a rare valvular disease in women who took fen-phen. On July 8, 1997, the FDA issued a Public Health Advisory describing the Mayo findings.

The FDA also revealed that it had received additional reports of the same kind, and requested that all health care professionals report any similar cases through MedWatch or the respective drug makers. Subsequently, the FDA received 66 additional reports.

The findings of the Mayo Clinic were also reported in the August 28, 1997, New England Journal of Medicine, along with an FDA letter to the editor describing additional known cases of valve disease.

At that point, the FDA asked Wyeth to stress the risk to the heart in the drugs’ labeling and package inserts. But on September 15, 1997, citing new evidence about significant side-effects, the FDA asked the company to remove both Pondimin and Redux, from the market. The action, it said, was based on findings by doctors who had evaluated patients taking the drugs with echocardiograms, a procedure that can test the functioning of heart valves.

“These findings,” the FDA stated, “indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms.”

“The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine,” the agency warned, “present an unacceptable risk at this time to patients who take them.”

These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA’s two earlier warnings concerning fen-phen, the agency advised.

The reports of cases of heart valve disease in patients taking Pondimin or Redux alone prompted the FDA to advise patients using either of the drugs to stop taking them and contact their doctors to discuss treatment.

“These findings call for prompt action,” said Michael Friedman, MD, the Lead Deputy Commissioner of the FDA at the time.

However, internal FDA documents have since surfaced in litigation that shows the FDA could have acted much sooner. As it turns out, a doctor from Fargo, North Dakota sent the FDA reports of valve damage associated with the diet drugs in February and March of 1997, and when he got no response, the doctor called the FDA in May of 1997, and had his assistant fax 25 reports to the official he spoke with.

But the official who received the information, did not alert her superiors and in fact, did nothing about the situation for a month, until she mentioned in a routine report that there was a doctor in Fargo who discovered problems with the drugs that should be tracked.

In describing valvular disease, the FDA’s web site states: “There are four major valves controlling the flow of blood into, out of, and between the four chambers of the heart.”

“Several disease processes,” it explains, “including infection and toxicity, may damage the valves, causing them to malfunction, and may produce severe heart and/or lung disease.”

Symptoms of the condition can include shortness of breath, swelling in the legs, chest pain and heart palpitations.

In some cases, the FDA says, medication can control heart failure associated with valvular damage but in others, surgery may be necessary to replace the valves with artificial valves.

Mass litigation followed the removal of the drugs from the market and continued as more studies confirmed their association with valve damage. By 1999, Wyeth faced nearly 20,000 personal injury lawsuits in state and federal courts, and more than 100 putative class actions, with some moving quickly toward certification.

The injuries alleged by plaintiffs included: heart valve regurgitation, valvular heart disease, or an increased risk of developing these conditions.

The plaintiffs claimed that Wyeth not only failed to do the testing that would have revealed the dangers of the drugs but that the company was fully aware that the fen-phen cocktail was being prescribed and sought to profit from the pairing of the two drugs. One complaint states:

“As a result of Defendants’ promotions, there was an enormous increase in sales revenues and profits for Defendants, their affiliates, and other commercial entities involved in the manufacturing and distribution chains of these anorectic pharmaceuticals.”

The complaint also alleges that Wyeth’s gross sales of Pondimin in the US increased from $3.7 million in 1993 to $150 million in 1996.

The lawsuit charges that the defendants knew that there were at least 41 reports of PPH associated with fenfluramine by the spring of 1994, and knew that the drug’s label describing only four cases of PPH was false and misleading and that they intentionally concealed information, “in order to maximize sales and profits of Pondimin.”

By 1996, the complaint says, defendants knew of at least 71 cases of PPH, including twelve deaths, while the Pondimin PDR entry continued to falsely state that there had been only four PPH cases, and only one case was fatal.

The complaint also alleges that the defendants deliberately decided not to submit proposed labeling changes to the FDA about the risk of PPH with Pondimin, to avoid any negative impact on the New Drug Application for Redux, pending before the FDA in 1995-96.

Defendants knew, it says, that PPH risks associated with Pondimin were relevant to the FDA’s consideration of Redux because both drugs had the same active ingredient.

On December 10, 1997, the Judicial Panel on Multidistrict Litigation transferred all federal fen-phen lawsuits to the US District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings before the Honorable Louis Bechtle, Chief Judge Emeritus, and upon his retirement, on June 29, 2001, the litigation was reassigned to Judge Harvey Bartle III.

The first two fen-phen cases to go to trial turned out to be a disasters for Wyeth. One settled after several plaintiffs in Mississippi won over $100 million in compensatory damages and a Texas case resulted in a verdict that included high punitive damages.

On August 7, 1999, a Texas jury awarded 36-year-old Debbie Stone Lovett, $23 million. Legal experts said the verdict was significant being Wyeth tried the case believing that the facts were their favor. The case was reportedly settled during an appeal for $2.2 million.

In another 1999 trial in Oregon, Wyeth lost a $29.2 million verdict that eventually was settled for $15.5 million. In this case, Mary Linnen, took fen-phen for just 23 days before developing PPH.

A few months after she was diagnosed, Ms Linnen had to undergo surgery to insert a tube in her heart, so that she could inject a medication into her heart several times a day. Less than 3 months later she died and her family filed the first fen-phen wrongful death lawsuit against the company.

Legal experts say Wyeth was so alarmed over the large punitive damage awards that it was desperate to find a way to set a limit on what fen-phen litigation would cost the company.

Wyeth believed that a class action could alleviate the threat of enormous punitive damage awards providing that only a small number of patients decided to opt out of the class. Under the rules, people who rejected the class action outright could sue for punitive damages, but victims who did not opt out at the first stage, would be barred from seeking punitive damages if they later decided to sue Wyeth.

The company offered the plaintiffs a good reason to remain in the class by conceding causation so that class members who stayed would not have to prove that Pondimin or Redux caused their heart valve damage, only that they had valve damage after taking the drugs.

Wyeth also offered generous compensation to class members. At the high end of the payment schedule, plaintiffs with valve damage so severe that they had strokes, heart transplants or died could receive upwards of $1.3 million.

The low end of the schedule was about $7,500 for claimants whose medical testing showed evidence of significant valve damage but no other indication of serious heart disease.

To cover its end of the deal, Wyeth agreed to ante up $2.55 billion for claimants who qualified for the larger payments, and another $1 billion for the smaller cash benefits and medical services for people with less severe heart damage.

On May 2, 2000, the US District Court in Pennsylvania held a hearing to determine whether the proposed Settlement Agreement was fair, adequate, and reasonable and held another hearing on August 10, 2000, to hear evidence on the fairness of changes contained in the Agreement.

On August 28, 2000, Judge Bechtle issued Memorandum and Pretrial Order approving the Agreement and the four amendments. A Settlement Trust was established on September 1, 2000, to administer the provisions of the Agreement, and to process the claims of class members.

In the end, Wyeth put up $3.75 billion to manage the litigation and was forced to add another $1.3 billion to the pot in 2004.

However, before the ink even had a chance to dry on the class action agreement, a new nightmare began for Wyeth when about 50,000 victims decided to opt out. The prospect of 50,000 punitive damage awards was an extremely frightening thought for Wyeth, given the results of the jury trials in 1999.

Legal experts say this looming threat prompted Wyeth to attempt settle the opt out cases as quickly as possible for whatever amount necessary and when the word got out, the whole mess quickly turned into a feeding frenzy for litigants.

Experts say news about previous large settlements may have prompted many victims to opt out. For instance, on July 22, 1999, the Dallas Morning News reported a case where the company paid more than $3 million to settle a lawsuit with a 70-year-old Texas woman. The agreement, the newspaper said, was at least the 12th settlement involving former fen-phen users, but was the first in a Dallas County court case.

A month before the $3 million settlement was reported, the article said, the company agreed to pay between $6 and $7 million to settle a case in Harris County, Texas that linked a woman’s death to fen-phen.

Adding to the risk of trying cases before a jury, is the fact that more documents keep surfacing that prove useful in court. For instance, an internal FDA e-mail dated about a year before the agency issued the fen-phen advisory, written by former FDA reviewer, Leo Lutwak, to a colleague says the serious side effects linked to fen phen and the drugs’ marginal benefits “should be brought out.”

“The company has gotten away with much manipulation these past 3 years, of the public, of the press, of the FDA,” Mr Lutwak wrote. “I started getting upset about this drug in ’93 or ’94 and was running into a lot of blocks from the FDA and from the drug company,” he said.

Although other injuries associated with fen-phen include PPH and neuropsychological damage, only persons with heart valve damage are allowed to participate in a national class action settlement.

Persons suffering from neuropsychological damage that can include depression, mood swings, memory loss, behavioral changes, and psychotic breakdowns, must sue separately.

According to the FDA, PPH has been reported to occur in about 1 in 25,000 people using the appetite suppressants for more than 3 months. Close to half of all PPH cases result in death. The Pulmonary Hypertension Association defines the condition as:

“Pulmonary hypertension (“PH”) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening.

“Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting.

“When pulmonary hypertension occurs in the absence of a known cause, it is referred to as primary pulmonary hypertension (PPH). This term should not be construed to mean that because it has a single name it is a single disease. There are likely many unknown causes of PPH. PPH is extremely rare, occurring in about two persons per million population per year.”

“This disorder,” the FDA web site says, “results in death in about 40% of affected individuals within 4 years.”

Studies released in November 2001 suggest that the occurrence of PPH may be 7 times higher than anticipated in 1997, when the diet drug were removed from the market.

According to the FDA, the disorder can also occur in association with valvular heart disease, but the class action settlement still does not apply even in those cases. However, this ruling may turn out to be the nail in the coffin for Wyeth.

On April 27, 2004, a Texas jury awarded over $1 billion to the family members of a woman who died of PPH after taking fen-phen for about two years. The verdict included $113.4 million in compensatory damages, and $900 million in punitive damages, according to Wyeth’s 2005 Annual Report filed with the SEC. The case was later settled for an undisclosed amount.

As of July 24, 2006, Wyeth told shareholders in its latest SEC filing, the company is listed as a defendant in 103 lawsuits that allege a claim of PPH, alone or with other injuries, and in approximately two additional lawsuits pleaded as valvular regurgitation cases, the plaintiff’s attorneys have advised the company that the plaintiffs will allege a claim of PPH.

Back in February 2006, at the Merrill Lynch health-care conference in New York, Kenneth Martin, chief financial officer of Wyeth, said he was hopeful that the remaining lawsuits may be “wrapped up” within 12 to 24 months.

However, according to Fen-Phen e-Resource, Natexis Bleichroeder analyst, Jon LeCroy, said Wyeth may be able to eliminate “the bulk” of the cases within the next 24 months, but predicted it will take at least 4 more years to eliminate cases involving serious heart-valve damage and cases involving fen-phen users who developed PPH.

“So we are assuming Wyeth will need to take another $4 billion in fen-phen charges through 2010,” Mr LeCroy said.

Jury selection for the next state court trial is set to begin on September 1, 2006, in a PPH case brought by Beverly “Kim” Tilmon of Palestine, Texas, seeking a combined total of $180 million in compensatory and punitive damages, according to the June 15, 2006 Palestine Herald.

Ms Tilmon alleges she developed PPH, after taking fen-phen for four months in 1997. This case ended in a mistrial on January 31, 2006, when Texas Judge, Jim Parsons, ruled that defense attorneys “exceeded the boundaries” during opening statements.

Flu Vaccinated Kids More Likely to be Hospitalized

Evelyn Pringle May 26, 2009

On May 19, 2009, researchers presented a study that found children who received the trivalent inactivated influenza vaccine [TIV] had a three times greater risk of hospitalization for the flu than kids who were not vaccinated at the International Conference of the American Thoracic Society in San Diego.

To determine whether the vaccine was effective in reducing the number of hospitalizations over consecutive flu seasons for 8 years, the researchers conducted a study of 263 children between the ages of 6 months and 18, evaluated at the Mayo Clinic between 1996 and 2006, with laboratory-confirmed influenza and reviewed records to determine which kids had received a flu shot before the illness and hospitalization.

The CDC currently recommends that “all children aged 6 months up to their 19th birthday get a flu vaccine,” on its website.

However, according to the study above, not only did the vaccine not prevent the flu, the kids who received it got sicker than those who did not. Which means that for the 8 year period studied, health insurance companies, government programs and parents were bilked for the cost of useless vaccines, doctors office calls and three times more flu-related hospitalizations, with the children following the expert’s advice suffering the most.

The American Academy of Pediatrics, an organization that claims to represent “60,000” pediatricians, also recommends that children be required to receive a flu shot annually, along with a host of other useless and harmful, but highly profitable vaccines throughout childhood.

Last July, CBS News reported that the vaccine industry gives millions to the Academy for conferences, grants, medical education classes and even helped build their headquarters. Totals were secret, but documents cited by CBS revealed the following:

A $342,000 payment from Wyeth, maker of the pneumococcal vaccine – which makes $2 billion a year in sales.
 
$433,000 from Merck, the same year the academy endorsed Merck’s Gardasil HPV vaccine – which made $1.5 billion a year in sales.
 
Another top donor: Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot added to the childhood vaccine schedule in June 2008.

In April 2009, the AAP even went so far as to file an amicus brief (friend of the court) with the US Supreme Court in support of a petition for a writ of certiorari from vaccine makers Wyeth and GlaxoSmithKline to overturn a unanimous ruling by the Georgia Supreme Court that decided a civil lawsuit filed by Marcelo and Carolyn Ferrari on behalf of their autistic son was not barred (preempted) by the National Childhood Vaccine Injury Compensation Act.

The Georgia decision noted that recognizing presumptive preemption would “have the perverse effect of granting complete tort immunity from design defect liability to an entire industry.”

The Farrari family alleges that the vaccine makers could and should have manufactured safer childhood vaccines without the mercury-based preservative, thimerosal, that caused their son’s autism. The Georgia court’s ruling would allow a jury to decide the case.

“The AAP can be counted to be the strongest supporters of the vaccine industry,” says Ann Dachel, the mother of an autistic son and the media editor for “Age of Autism.”

“And why not?” she points out, “What would a well-baby check be like without the lineup of shots every time a visit is scheduled?”

It should be noted that roughly four million new customers in need of well-baby checks are born every year, according to CDC stats. Some vaccines given to children, such as flu and tenanus, still contain thimerosal.

Other organizations that signed on to the AAP brief to help vaccine makers defeat the lone family include: “American Academy of Family Physicians, AAP Section on Infectious Diseases, American College of Osteopathic Pediatricians, American Medical Association, American Public Health Association, Every Child By Two, Immunization Action Coalition, Infectious Disease Society of America, Pediatric Infectious Disease Society, and the Vaccine Education Center at The Children’s Hospital of Philadelphia,” according to an April 9, 2009 AAP press release.

Last summer, in addition to listing the vaccine maker funding of the AAP, CBS News reported on pediatrician, Dr Paul Offit, described as “perhaps the most widely-quoted defender of vaccine safety.”

Offit has went so far as to claim babies can tolerate “10,000 vaccines at once.” In responding to the CBS report, Offit reportedly told the Orange County Register, “what I actually have said is at least 10,000. It’s probably closer to 100,000.”

According to CBS, this is how Offit described himself in a previous interview: “I’m the chief of infectious disease at Children’s Hospital of Philadelphia and a professor of pediatrics at Penn’s medical school.”

But Offit also holds a $1.5 million dollar research chair at Children’s Hospital, funded by Merck, CBS found. And he holds the patent on Rotateq, an anti-diarrhea vaccine he developed with Merck.

At the time of the report, future royalties for the vaccine were just sold for $182 million cash. “Dr. Offit’s share of vaccine profits? Unknown,” CBS New noted on July 25, 2008.

Offit also wrote the book, “Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure.” According to a summary on the Amazon site in September 2008:

“In this book, Paul A. Offit, …. challenges the modern-day false prophets who have so egregiously misled the public and exposes the opportunism of the lawyers, journalists, celebrities, and politicians who support them. Offit recounts the history of autism research and the exploitation of this tragic condition by advocates and zealots. He considers the manipulation of science in the popular media and the courtroom, and he explores why society is susceptible to the bad science and risky therapies put forward by many antivaccination activists.”

In a February 24, 2009 article in the Huffington Post, Robert F Kennedy, Jr, most appropriately pointed out that: “it’s worth recalling that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families.”

“Big tobacco prevailed for six decades even without the help of supportive government agencies deliberately suppressing real science and research,” Kennedy says. “In that sense vaccine victims must leap a much higher hurdle.”

In 1982, American children were given only three vaccines: a live oral polio vaccine; the MMR; and the DPT vaccine, according to the National Vaccine Information Center. By 2007, children were being told by government health officials and pediatricians to get 48 doses of 14 vaccines by age six and 53-56 doses of 15 or 16 vaccines by age 12.

On April 7, 2008, Kalorama Information issued a press release on a market research study and reforecast of the vaccine market titled, “Vaccines 2008: World Market Analysis, Key Players, and Critical Trends in a Fast-Changing Industry,” and reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck’s Gardasil, had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”

According to the report, “new products approved in recent years, in particular Gardasil, but also RotaTeq, Pentacel, Zostavax and FluMist, are now having an impact on the market,” the release says. “These new products, combined with a continued emphasis on flu vaccines in the U.S. healthcare system, have created a healthy environment for vaccine products.”

Kalorama “expects vaccine sales to more than double in five years,” the release notes.

What the Media Doesn’t Say about Antidepressants & Pregnancy

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Unlike Vogue Magazine or TIME, for some reason ABC has decided to promote more misinformation that will no doubt prove deadly for far too many babies, and possibly mothers too. Read on to find out more…

You may have read a couple of posts I recently wrote (see: here – AMA Review: Antidepressants Pose Significant Risk of Serious Harm to Babies and here – ABC Story on ACOG Release Refers Readers to momsandmeds.com and CHAADA) after I was contacted for a possible story on TV by an ABC producer regarding the ACOG / APA guidelines on antidepressants and pregnancy.

As I wrote in those articles, I had sent numerous emails to the producer with various studies and analyses including not only the conflicts of interest (the conflicts document was so extensive that it took up about 20 pages or so in Word and I didn’t even look up all the names) among the researchers either writing or cited in the report, but also a comparison of the difference between the ABC article they published, and the actual report issued by the ACOG and APA.

I don’t expect that I’ll be hearing much back from them, but the reason I am writing this is not because I really wanted to be on TV (far from it) but because it just makes me horrified that the media can take something that says there is evidence of harm to babies (to quote the ACOG release, “[T]he use of antidepressant medications during pregnancy have been associated with negative consequences for the newborn…some studies have linked fetal malformations, cardiac defects, pulmonary hypertension, and reduced birth weight to antidepressant use during pregnancy.”) and twist it around by quoting “experts” with fancy titles who are willing to say that “the jury is still out” on whether antidepressants can hurt babies. The proposition is that it’s the depression that causes the birth defects, not the drugs.

The ACOG report clearly says that there is evidence of harm – but unfortunately when you watch the videos put out or read the articles on the ABCnews.com website you won’t know that unless you look further.

Just think about cases in which mothers who lose babies to antidepressants or have babies with severe birth defects linked to antidepressants go on to have more children off of antidepressants, without further problems in the babies. Julie Edgington is one example (out of 5 children, only one baby had problems and it was the one exposed to Paxil, Manie, her 4th), Kelly S., who lost her baby to a Paxil heart defect, is another. I was myself told that I shouldn’t have more kids because I would risk severe PPD. I had nothing of the sort. Toby is one of the healthiest kids I’ve seen. I know I am not the best example because I wasn’t actually depressed during pregnancy (was never depressed except for when I was taking Zoloft while nursing), but it just goes to show that there is no conscience regarding the harm coming to babies from these drugs. I was told to stay on Zoloft if I ever did want to have another baby. I am so thankful that Toby is drug-free and healthy.

I honestly do not know how these people can live with themselves.

A great example of what the public sees if they are not up on the latest information, but just passively receiving news bytes, is the ABC piece that just came out which covers Heather Armstrong’s story and states that there is no convincing proof that antidepressants cause harm to the baby. In it Heather tells ABC that she went off her meds during her last pregnancy but experienced panic attacks, and then later, suicidal thoughts after her baby was born, so she decided to stay on it during this recent pregnancy.

1) Of course when you go off antidepressants you can experience panic attacks or even suicidal thoughts – it’s called withdrawal. Been there, done that. For me the withdrawal was way worse than being on the drug at a stable dose, but once I got off of the drug and had time for it to clear out of my system I felt so much better.

Even if you were suicidally depressed before ever taking antidepressants, that does not mean that antidepressants will cure the suicidal thoughts, nor does it mean that you cannot find safe and effective alternatives (link to postpartum nutrition / orthomolecular medicine article). (See also: Preventing & Treating Emotional Problems and a post about counseling and self help.)

Perhaps Prozac really helped Heather feel better mentally but that does not justify what could have happened to the baby. During her last pregnancy she says that she had panic attacks. I think I’ll take panic attacks over my baby dying. It wasn’t even until after her baby was born that she says she had suicidal thoughts. So, were those a result of a drug withdrawal, or did she have a hormonal imbalance after birth of estrogen or thyroid that so many women have? I can’t claim to know what caused Heather Armstrong’s depression after her birth of her first child, but I can guarantee that it was not a Prozac deficiency and that there are safe treatments available. However it still makes no sense to me why having PPD would lead someone to consciously decide to take drugs during a subsequent pregnancy. If you had PPD before, then by all means if you are going to take drugs for PPD, do so after the baby is born and don’t do it while nursing. The time it takes you to get your placebo effect should be well worth it considering the peace of mind and increased safety for the baby.

In my opinion the reason women do this sort of thing stems from the misinformation fed to them by their doctors or other people in the public doing the off label marketing spin. Off-label marketing, or promoting psychiatric drugs to pregnant women (no psychiatric drug is FDA approved for pregnancy), by the way, is currently illegal, but the drug companies usually find ways to get others to do it for them. That’s more than I can say for Pfizer’s criminal behavior with the illegal marketing of Geodon and Lyrica.

2) Just because Heather Armstrong’s baby was born without complications (and she had an unmedicated birth if I am not mistaken) does not mean that the drugs are safe. Nor does it mean that whatever drug she is feeding her daughter in her breast milk is safe for the baby. I am so thankful that her daughter is ok so far, because no baby deserves to suffer from these drugs and I truly hope that she continues to be ok.

But this does not excuse pushing drugs on the entire country with misleading information from conflicted “researchers.”

Here is what you will probably not see on ABC any time soon:

(I hope ABC will prove me wrong, but so far no such luck)

Craniosynostosis caused by Antidepressant Exposure
Craniosynostosis before / after surgery (caused by antidepressant exposure)
Omphalocele caused by antidepressant exposure
Omphalocele caused by antidepressant exposure
Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal
Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal

Look at these devastating photos and ask yourself if it is really worth it to expose your baby to something that can cause a birth defect like this, when there is no taking back the exposure. I lived through suicidal and homicidal thoughts for four months because of Zoloft and I would not want to live through that again, but I would rather go through it (drug-induced or not) a hundred more times rather than have to live through losing a baby or having a baby born with a severe birth defect.

Everyone is bound to go through sad times, depression, grief and despair at some point in their lives but that does not mean that the entire human population suffers from serotonin deficiencies (when in reality serotonin excess is what leads to problems in the first place) or “chemical imbalances.”

I enjoy occasionally drinking wine or mixed drinks, but that doesn’t mean that because I feel relaxed while drinking alcohol, that I should drink when pregnant or that I suffer from an alcohol imbalance.

Women deserve to know the truth about what can happen with these drugs. They deserve to get the truth about what is causing their emotional problems (not some sales tactic like attributing it to an unproven, unprovable chemical imbalance) and how to safely deal with them with “alternative” medicine, orthomolecular medicine, proven hormone therapy, counseling, etc. They deserve support and understanding and compassion. They do not deserve to be fed deadly lies. But mostly, their babies deserve for the mothers to know.

ABC quotes doctors who say you cannot separate the health of the child from the health of the pregnant mother. This is an illogical catch phrase that they use in order to try and make us feel guilty for insisting on drug free options because some women obviously already take antidepressants and find it impossible to stop (again, this is caused by horrific withdrawal and the drug companies seem fine with that). Try and think about what this really means. They are saying that the mother’s mental health cannot be ignored during pregnancy because doing so hurts the baby. They are saying depression is more dangerous than drugs to the baby. Aside from the fact that this is clearly untrue, and that antidepressants do not reduce birth defects, but rather, increase them, think about whether you have ever been sad during pregnancy. Does feeling sad during pregnancy or being depressed cause PPHN, cardiac defects, the lack of a forebrain, and stillbirth? Or do toxic drugs with mystery chemicals that dangerously elevate serotonin and affect the organ development of babies cause these problems?

Something most people don’t know is that Fen-phen which was taken off the market for heart and lung-related deaths is actually a serotonergic drug which was a chemical mirror image of an SSRI. As I have said repeatedly and will say again, when you have drugs leading to heart problems and PPH in adults, how could they possibly not hurt babies the same way or worse?

Even after considering the fact that antidepressants actually cause depression and suicide, and work about as well as a placebo, this catch phrase makes about as much sense to me as saying that a mom who is addicted to crack, or drinks 5 coffees a day, or smokes, or is an alcoholic, should be told to keep doing those things if it eases her anxiety or fatigue while pregnant. Or about as much sense as telling women to go take Thalidomide because we’re not really sure that Thalidomide causes problems and it was probably actually the morning sickness causing the birth defects and not the Thalidomide. The jury is still out on whether swallowing RAID or drinking bleach while pregnant is bad for your baby. Perhaps working in a nuclear plant or handling plutonium should be considered safe for pregnant women too.

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Stop lying to women about what are confirmed, known risks.

If the jury were still out, the FDA would not be issuing warnings like:

“Infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

See: PPHN Paxil baby Sarah Hart here. Sarah survived, but Matthew did not.
Face to Face:
http://www.flickr.com/groups/madnapfacetoface/

See more FDA MedWatch Data here: http://www.cchrint.org/psychdrugdangers/MothersAct.html

I can only hope that every person responsible for off-label marketing will be held accountable in some way. I am no expert in FDA  or criminal law, but when you essentially have money laundering taking place – drug companies giving donations to organizations, who then promote drugs through their own organizations via blogs, press releases, and speeches, it would seem that either the drug companies, or the individuals doing the marketing should be held to account for the off label promotions.


Warnings/Studies Showing Risks Associated with Antidepressants and Pregnant Women or New Mothers:

There is ample evidence to support the risks associated with placing pregnant women or new mothers on antidepressant drugs:

  • September 7, 2005: The Australian Therapeutic Goods Administration issued an information sheet to health professionals warning that SSRI antidepressant use—especially Paxil—in early pregnancy could cause congenital [defect at birth] heart abnormalities in newborns.[i]
  • September 27, 2005: The FDA and GlaxoSmithKline issued a warning that pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy, placed their newborns at increased risk of major congenital and cardiovascular [heart] malformations at birth.[ii]
  • February 9, 2006: The New England Journal of Medicine found that mothers who took SSRI antidepressants in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN). The condition occurs when a newborn’s circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal. Between 10% and 20% of infants with PPHN would die even if they receive treatment.[iii]
  • March 10, 2006: Based on the New England Journal of Medicine study, Health Canada issued a warning that SSRI antidepressants and other newer antidepressants when taken by pregnant women placed newborns at risk of developing the rare lung condition; persistent pulmonary hypertension or PPHN.[iv]
  • April 7, 2006: A Canadian study from the University of Ottawa published by the American Journal of Obstetrics and Gynecology, found pregnant women who used SSRI antidepressants were more likely to have premature and low birth weight babies.[v]
  • June 2006: An Archives of General Psychiatry study found women who take antidepressants during pregnancy at risk of giving birth to children with respiratory problems.[vi]
  • July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels.[vii]
  • November 2006: The journal Epidemiology published a study entitled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations.” Researchers did the study from Aarhus University. It found that pregnant women who take SSRI antidepressants are more likely to have babies with birth defects than mothers who don’t take these drugs.[viii]
  • August 2007: The American Journal of Psychiatry published a study that determined that antidepressant use during pregnancy was associated with premature births.[ix]
  • September 18, 2007: A study published in the Annals of Internal Medicine of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy.
  • Moreover, experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.[x]
  • The Physicians’ Desk Reference (PDR) states: “Like many other drugs, paroxetine [chemical name for the antidepressant Paxil] is secreted in human milk, and caution should be exercised when Paxil…is administered to a nursing woman.”

Selected SSRI Antidepressant Studies/Warnings on Suicide Since 2001:

  • March 22, 2004: The FDA warned that SSRIs could cause “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement] and mania [psychosis characterized by exalted feelings, delusions of grandeur].”
  • February 18, 2005: A study conducted at the Ottawa Health Research Institute and published in the British Medical Journal determined that adults taking SSRI antidepressants were more than twice as likely to attempt suicide as patients given placebo.[xi]
  • June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications,” that there could be an increased risk of suicidal behavior in adults taking antidepressants. It recommended that physicians monitor adults who took antidepressants for suicidal tendencies.[xii]
  • August 4, 2005: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting evidence supporting an association between SSRI use and “new onset of suicidality” in adults.[xiii]

[i] “Information for health professionals concerning the use of SSRI antidepressants in pregnant women,” Australian Therapeutic Goods Administration,” 7 Sept. 2005.[ii] “Important Prescribing Information,” Letter to healthcare professionals by GlaxoSmithKline, Sept. 2005; Miranda Hitti, “New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants,” WebMD Medical News, 27 Sept. 2005.[iii] Christina D. Chambers, Ph.D., M.P.H., Sonia Hernandez-Diaz, M.D., Dr.P.H., Linda J. Van Marter, M.D., M.P.H., Martha M. Werler, Sc.D., Carol Louik, Sc.D., Kenneth Lyons Jones, M.D., and Allen A. Mitchell, M.D., “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn,” New England Journal of Medicine, Vol. 354, 2006, pp. 579-587.

 

[iv] Health Canada Advisory, “Newer antidepressants linked to serious lung disorder in newborns,” 10 Mar. 2006.

[v] Andre Pickard, “Prozac-type drugs increase birth risks, study finds,” Globe and Mail, 4 June 2006.

[vi] Tim F. Oberlander, M.D., FRCPC; William Warburton, Ph.D.; Shaila Misri, M.D., FRCPC; Jaafar Aghajanian, B.Sc.; Clyde Hertzman, M.Sc., M.D., FRCPC, “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data, Archives of General Psychiatry, Vol. 63, 2006, pp. 898-906.

[vii] “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006.

[viii] Wogelius, Pia, Nørgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et.al. “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, Nov. 2006.

[ix] Rita Suri, M.D., Lori Altshuler, M.D., Gerhard Hellemann, Ph.D., Vivien K. Burt, M.D., Ph.D., Ana Aquino, B.S., Jim Mintz, Ph.D., “Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Risk of Preterm Birth,” American Journal of Psychiatry, Vol. 164, Aug. 2007, pp. 1206-1213.

[x] Evelyn Pringle, “Women not warned about SSRI-related lung birth defect,” Countercurrents.org, 2 October 2007.

[xi] “Drugs Raise Risk of Suicide; Analysis of Data Adds to Concerns on Antidepressants,” The Washington Post, 18 Feb. 2005.

[xii] “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, 30 June 2004.

[xiii] “Suicidality with SSRIs: adults and children,” The Australian Therapeutic Goods Administration (TGA) Adverse Drug Reactions Bulletin, Vol 24, No. 4, Aug. 2005, p. 14.