Evelyn Pringle: Paxil Birth Defect Litigation – First Trial A Bust For Glaxo

Paxil Birth Defect Litigation – First Trial A Bust For Glaxo
By Evelyn Pringle

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Glaxo’s lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.

Over 600 Trials To Go

A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first.  The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.

“Although one might worry that this would cause a jury to blame the prescribing doctor,” says Vickery,  “in this case, we can show that GSK encouraged this use, by sending out over 1500 “medical information” letters touting the benefits of Paxil for migraine headaches, and by leaving “approved WLF reprint” articles with the prescribing doctors.”

Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.

In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised:

“Despite this categorization,” says Vickery, “in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects.”

“Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia,” he notes.

Case of the Dead Rats

During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were “going to see documents in this case that have never seen the light of day before.”

“You will see internal GlaxoSmith documents that the FDA hasn’t seen, that the United States Congress hasn’t seen, and that no jury has ever laid their eyes on before,” he said. “They have been under seal for over three years.”

Many of the sealed documents related to the Paxil studies conducted on rats and rabbits.  The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.

Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.

Healy explained that a teratogen is an agent that will cause birth defects and “it could be a drug or maybe a virus or maybe an illness.”

In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.

The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil.

The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead.

In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4.

Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four.

Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects.

After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, “GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning.”

“I would like you to note three things about the discussion in the product information about the animal studies,” she said.

“First, there were no birth defects in the study,” she told he jury. “That is, there were no malformations or difficulties, structural difficulties, with the animals.”

“Second,” she said, “the rat pups who died shortly after birth were dosed at something like ten times the normal dose.”

“And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation,” Varner told the jury.

“You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem,” she said, “it was during the lactation period that these pups died.”

While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner’s claims in stating: “Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation.”

He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. “Yes, they were,” Healy said. “They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after.”

He also told the jury that there were three major malformations in the Paxil exposed group, and “there may well have been more.”

“The figures from the studies do give grounds for concern that there were, in fact more,” he said, “far more.”

The fact that the more Paxil they got the more they died, “indicates that the drug has played a part … in whatever the cause of death is,” Healy told the jury.

“It’s clearly the drug that has caused the death,” he said. “What we aren’t clear from here is just what actually happened. Why they died.”

In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies.  In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner’s claim that the rats received 10 times the normal dose.

“At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy,” Baldwin wrote.

“That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed,” Healy told the jury.

“That Paxil is a drug that if it comes on the market, may cause birth defects,” he said. “So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated.”

Which “would mean in this case,” Healy said, “do not use the drug in women of childbearing years unless, for instance, they’re using some form of birth control.”

Another portion of Baldwin’s memo stated: “On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels.”

“This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects,” Healy told the jury. “We need to do more work to actually before it’s out, does the drug come with this risk or not.”

“He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not,” Healy said. “The implication being that if they haven’t done it, we should.”

In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. “I know they did further studies, but I don’t think they did anything to address the issues that were raised by 295, 296, 297,” he said. “Or if they did, they kept it well hidden it would seem.”

Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, “Active Psychiatric Scandinavia,” and stated: “There appeared to be no selective effect on the embryo or any signs of teratogenicity.”

Baldwin “appears to be saying here that there is no evidence that the drug causes birth defects,” Healy told the jury. “That appears to me to be incompatible with the data that we reviewed earlier.”

Baldwin’s paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.

Incriminating Data Destroyed

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: “It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993.”

Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. “From my work on the serotonin system back in the early ’80s, almost 30 years ago,” he said, “I still have the raw data.”

“The idea that I would destroy the data is almost inconceivable,” Healy stated.

People may be concerned about a particular study and want to go back and look at the books, he said. “It’s a bit like auditing a major company like Enron.”

But it’s “even more important actually in science,” Healy told the jury. “People with a different point of view need to be able to say, look, show me the data.”

They may “even suspect that I didn’t do the study,” he said, “so a defense for me is to be able to say here are the notebooks, here are the clinical records.”

So you have to “be prepared to have all sorts of challenges,” he told the jury. “But for that to happen, the notebooks, the clinical records, the lab notebooks must be there.”

Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. “I believe there were efforts to try and find the microfilms, but they have not been found,” he said.

Healy explained that when studies are done, there are a set of procedures called “good laboratory practice,” or GLP.

“And it is hoped these days when a company brings a drug to the market,” he said, “that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice.”

“And part of the requirements here of good laboratory practice is that the raw data is maintained,” he told the jury.

Later in Healy’s testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under “maintenance of records,” stated “this material will be stored,” and the “material will not be discarded or released from these laboratories without the sponsor’s prior consent.”

Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.

During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.

A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs.  Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her  testimony.

Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.

When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company “do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born,” she said.

“Cross-fostering is … taking rats from treated mothers and putting them with a control rat that didn’t receive the drug,” she explained to the jury. “So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born.”

The FDA asked Glaxo to submit a protocol for the study, “for our concurrence,” before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.

She testified that such a study “would have helped to address where the negative effects were coming from.”

While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam’s mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.

The label stated: “in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester.”

Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label “implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester,” she testified.

The label is saying “there is no evidence of teratogenic effects,” she said, “that means that it’s safe for the first trimester. “

“If a physician were to read this, they would be more likely to prescribe it early in pregnancy,” she told the jury.

Evelyn Pringle

epringle05@yahoo.com

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at www.justiceseekers.com )

Filed under: antidepressants, bigpharmavictim, Birth Defects, birth defects caused by antidepressant, birth defects lawsuits, glaxosmithkline, GSK, Paxil, paxil birth defects, Paxil birth defects trial, Paxil in pregnancy, Pregnancy, Birth Defects, drug exposure during pregnancy, Evelyn Pringle, Glaxo Smith Kline, GSK, infant deaths, Kilker v. Glaxo Smith Kline, Litigation, Paxil, Paxil Birth Defect Litigation - First Trial A Bust For Glaxo, Pregnancy

Kilker v. GSK Documents Available for Download

Sadly I have not had the chance to read all of these yet so I can’t tell you what’s in them but according to Fiddy it’s some pretty amazing stuff. I encourage you to download and read the documents in the Kilker v. GSK trial in which the jury found GSK guilty and ordered a $2.5 million verdict for the heart defect they caused that poor little boy.

Download here.

Filed under: antidepressants, drug "safety", mothers act, Paxil in pregnancy, Pregnancy, Birth Defects, guilty, heart defects, Kilker v. Glaxo Smith Kline, Kilker v. GSK, lawsuits

Antidepressants Once Seen as Miracle Drugs: Now Risks are Becoming Evident

Antidepressants Once Seen as Miracle Drugs: Now Risks are Becoming Evident

Since the horror of the Thalidomide scandal in the 1960s, pharmaceutical companies and medicines regulators have been acutely aware of the dangers drugs may pose to the unborn child.  Establishing what the effect of a drug may be on a foetus, however, is no simple task. Companies must rely on animal studies in the early stages of research and hope that the drug will behave in humans in the same way. Trials on pregnant women are rarely carried out, for obvious reasons.

Depression and anxiety became big business for the pharmaceutical industry in the 1990s as doctors became better at diagnosing the problems, exposing a population of over-achieving, highly-stressed, worried-well.

Women, always more willing to see a doctor than men, were a large proportion of those diagnosed and put on SSRIs (selective serotonin reuptake inhibitors) such as Prozac and the British drug Seroxat, known as Paxil in the US. For a while, these seemed to be the new miracle drugs. They were safer than older antidepressants because the severely depressed could not overdose on them.

But in court cases about to begin in the US, it will be argued that insufficient attention was paid to the possible dangers for young women who were pregnant or might become pregnant and more particularly, for their babies.

Twenty years ago, when serotonin, a chemical which sends messages to the brain, was under investigation, it was recognised that it was likely to have an effect on the developing foetus, according to David Healy, professor of psychiatry in Bangor, Wales, and an expert witness in the legal action against GlaxoSmithKline. It was not just a neurotransmitter, but played a role in organ development in the embryo.

Animal tests appear not to have been reassuring, he says. By 1991, a study by Shuey and Lauder had shown that all SSRIs were potentially teratogenic – could cause birth defects – in animals, albeit in small numbers. GSK denies this. “The animal and human studies did not show teratogenicity, and were made available to regulatory agencies as part of the approvals,” said a spokesman. But based on Lauder’s work, Pfizer which made a rival drug, Zoloft, recommended that women on their drug “should employ an adequate method of contraception”.

Datasheets

GSK launched Seroxat in 1992. It was recognised that insufficient work had been done to establish the safety of any of the SSRIs during pregnancy, and as a result, throughout the 1990s, the standard statement on the drug datasheets which go to doctors was that they “should not be used during pregnancy or by nursing mothers unless the potential benefit outweighs the potential risk”.

But pregnant women become depressed too. “I think depression is generally underestimated in pregnancy,” said Dr Tim Kendall, joint director of the National Collaborating Centre for Mental Health in the UK. “It is much more common than people think. It used to be thought you gave birth and you are suddenly depressed – the withdrawal of all those oestrogens. But in fact people who have postnatal depression are quite commonly depressed before the birth.”

GSK began to market Seroxat as the SSRI of choice for women who were depressed and pregnant, or might become pregnant, says Healy. GSK says marketing to women of childbearing age was valid, as women make up a high proportion of those diagnosed with depression and anxiety and most would be of childbearing age.

Seroxat was positioned as the best SSRI in cases where the benefits of treating depression outweighed any risk. It was found in only low concentrations in breast milk, the company said, which meant that breastfeeding would not be a problem. It pointed to studies which showed children born to mothers on Seroxat had no mental or behavioural problems.

GSK also argued that depression itself could harm the baby because an untreated mother is more likely to smoke, drink and take drugs and maybe even to harm herself. Healy says there is no evidence relating to women with depression during pregnancy – only to those who were diagnosed with postnatal depression.

From 2000, GSK in the US was running a targeted promotional campaign to increase sales of Paxil to pregnant women and women of reproductive age. The Mother Knows Best Campaign had three main objectives: to raise awareness of its greater claims for safety than other antidepressants, such as the low Paxil levels in breastmilk, to educate doctors and consumers generally on the benefits of the drug for women of childbearing age and to encourage women with depression to ask specifically for Paxil.

Influential psychiatrists, called in the business “key opinion leaders” were recruited to give talks and author articles on Paxil’s safety for mothers to be.

But in February 2005, the Lancet published an analysis of almost 100 cases from the World Health Organisation’s adverse drug effects monitoring centre in Sweden of babies who suffered from convulsions and other withdrawal symptoms after birth because their mother had been taking an SSRI for depression during her pregnancy.

The effects were most marked on Seroxat, it said, and recommended that all SSRIs “should be cautiously managed in the treatment of pregnant women with a psychiatric disorder”.

Malformations

In 2003, the Food and Drug Administration (FDA) which regulates medicines in the United States had asked GSK to look at the incidence of birth defects on Seroxat, or Paxil. In 2005, the company handed over a retrospective epidemiological study which found an increased risk of major congenital malformations in the babies of women who took it in the first three months of pregnancy.

GSK pointed out that data from other places did not show up a problem. Nonetheless, the FDA changed the pregnancy warning from category C, meaning not enough research has been done to be sure of safety, to category D, meaning there are signs it may not be safe.

“FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the foetus,” it said.

A later advisory notice from the FDA drew attention to a raised risk of a life-threatening lung condition called persistent pulmonary hypertension in babies whose mothers took Paxil later in pregnancy – up sixfold from the usual level of one or two per 1,000 babies born in the US. But at the same time it pointed to a study in the Journal of the American Medical Association showing women who stopped taking antidepressants while pregnant were five times more likely to relapse.

GSK insists that their drug has only ever been promoted for those who need it – in the case of pregnant women, those in whom the dangers of depression are greater than any possible risk from the drug. “GSK appropriately marketed paroxetine for use by the patients for whom it was indicated and who could benefit from it,” said the company in a statement.

Filed under: antidepressants, mothers act, PPD, Pregnancy, antidepressants, Birth Defects, Glaxo, GSK, SSRIs

Antidepressants For Women of Childbearing Age (What Big Pharma Wants)

Antidepressants For Women of Childbearing Age
(What Big Pharma Wants)

Fred A. Baughman Jr., MD
Director of the National Foundation, March of Dimes, West Michigan Birth Defects Clinic, 1965-1975
Author: The ADHD Fraud
http://www.Trafford.com

(1193 words)

In the Women Speak blog from Obstetrician-Gynecologist, Dr. Tameeka Law of the Medical University of South Carolina, (MUSC), addresses the question: ‘Can I Continue to Take Antidepressants in Pregnancy?’ http://tinyurl.com/mlyjqc

Dr. Law’s first obligation, like that of every prescribing physician involved in the care of women-of-reproductive-age is to the physical-medical health and well-being of possibly-pregnant, pregnant, or just-delivered women, whether nursing or not, as well as to the embyo, fetus or baby in the equation.

And yet we find Dr. Law espousing views about psychiatry and psychiatric drugs not consistent with her Hippocratic obligation to assure the physical-medical well-being of the patient or patients—mother and embryo, fetus or child.

Consider at the start that Dr. Law and I, and all physicians, regardless of what specialty we enter—go to medical school for 4 years, study all thing normal (biological chemistry, anatomy and physiology) all things abnormal (pathology, diseases) and, in their clinic years, how to tell those who are normal, disease-free, from those who are abnormal—diseased. The other thing we learn going through medical school is that there are no physical abnormalities-diseases in psychology and psychiatry. There is no such thing as a mental, psychological, psychiatric ‘disease.’ But this is not the impression one gets today as the almighty pharmaceutical industry (big pharma) with its bought-and paid for control over psychiatry, the entire medical profession and its medical schools and faculties insists, commands that all things emotional, behavioral, psychologic and psychiatric be called diseases or chemical imbalances so the public will see no logic but to forego “strength of character,” ‘pulling oneself up by the bootstraps,” love, talk therapy, etc, and commit to the drugs, pills, and ‘chemical balancers’ for ‘chemical imbalances’ of the brain they are, drum-beat, told they have (by virtually all of their physicians, joining the making “patients” of normals) and have come to believe they have.

And now, back to Dr. Law and the pregnant mother’s question “Can I continue to take Antidepressants in Pregnancy?”

Having said “depression affects 10 to 15% of pregnant women (how many million in this ‘epidemic’?) Dr. Law admits depression’s symptoms are “difficult to differentiate from normal changes of pregnancy.” In fact depression is a blue, dark, or melancholy mood to which all human beings are subject, from which virtually all emerge. Appropriately, Dr. Law lists the psycho-social factors that can lead to depression but claims that depression alone, as if a disease, “is associated with an increase in such negative physical outcomes of pregnancy as prematurity, low birth weight, and poor fetal growth.” Has Dr. Law been ‘bought,’ influenced? Has her department? Medical school? Is she stacking the deck in favor of antidepressants, in favor of the psychiatry-big pharma cartel—the biggest drug cartel of all time?

Next, ignoring the well-known physical-medical reproductive risks of SSRI antidepressants, Dr. Law says “overall antidepressants are safe to use during pregnancy” (for mother, developing embryo, or fetus) or while breastfeeding (for mother and nursing infant) and their use has not been shown to cause birth defects” Quite a blanket exoneration—this.

As if a salesman, Dr. Law continues to minimize the well-established, well-known risks of SSRI antidepressants for all women of child-bearing age. She continues: “… approximately 1 in 10 women will have major or minor depression sometime during pregnancy and the postpartum period.” Again, a target population of millions as is the well-worn strategy of “biological” psychiatry.

Contrary to glowing assessment of Dr. Law, numerous studies have shown that exposure to SSRIs late in pregnancy has been associated with complications in newborns that include jitteriness, seizures, respiratory distress, rapid respirations, weak cry, poor muscle tone, and an increased rate admission to the neonatal intensive care unit (meaning, in essence that their life is in the balance). Further, the use of Paxil (paroxetine-Prozac like) during the first trimester of pregnancy has been associated with an increased risk of congenital heart malformations leading the Food and Drug Administration (FDA) to issue a public health advisory and require the manufacturer to change its pregnancy category from “C” to “D” meaning the drug has been found to be harmful to human fetuses (refers to the unborn from weeks 7-9 of pregnancy to delivery)

We begin to get a different picture than that painted Dr. Law for the pregnant women of South Carolina. The mother’s symptoms from SSRIs antidepressants can include insomnia, rashes, headaches, joint and muscle pain, stomach upset, nausea, diarrhea; reduced blood clotting increasing the risk for stomach or uterine bleeding; diminished sexual interest, desire, performance, and satisfaction, and, finally, the increased risk that antidepressants will incite violent or self-destructive actions (toward any and all present–family members, the embryo, fetus or newborn). When compared with a sugar pill, a.k.a. placebo, all antidepressants, including SSRIs, seem to double the risk of suicidal thinking, from 1%–2% to 2%–4%, in both children and adults.

And what of this? With all these side effects, SSRI antidepressants are no more effective that the sugar pill-placebo in curing depression.

In December, 2006, pro-psycho-pharmaceutical drugging statement, the American College of Obstetricians and Gynecologists said to the women of child-bearing age of America that decisions about depression treatment should involve the obstetrician and the mental health clinician (MFCC? Psychologist? Social Worker?) along with the patient, ideally prior to pregnancy. However, the ACOG recognized the inconvenient truth that “because approximately 50% of pregnancies are unplanned, preconception planning for women with depression will not always be feasible, and treatment decisions about SSRIs will undoubtedly occur during pregnancy,” i.e., after mother and the already-conceived, embryo, fetus, child-to-be has been intoxicated, poisoned by the antidepressant which is not known to target a defined abnormality/disease, not in anyone.

Given the facts above, we have every reason to believe nothing would be better than to return to the un-perverted medical science and ethics of the 1960s and 1970s, which would dictate that there being no such thing as a psychiatric disease, there is no such thing as an essential psychiatric drug, especially not for women who are pregnant or could possibly be.

There is no group or classification of psychiatric drugs proved to be without physical-medical risk, short-term or long, to the embryo, fetus, newborn, nursing newborn, nursing infant, or nursing toddler and, for that matter there is no group or classification of psychiatric drugs known to be without physical-medical risk, short-term or long- for their mother or father or for any member of the human race. Look at the rates of Sudden Cardiac deaths with antidepressants (Whang, et al, 2009), Ritalin and all ADHD psychostimulants (Gould et al, 2009), and antipsychotics (Ray et al, 2009). After all they are exogenous compounds, foreign to the body, with no abnormality to make normal, no abnormality to make less abnormal. They are, like all drugs—poisons.

What’s more all physicians, especially those at the American College of Obstetricians and Gynecologists know this. But knowing this their industry economic ties are such that they, like Dr. Law, can no longer speak the truth, not even to their patients: mothers who will give birth to children—healthy and whole or defective, deformed, subnormal, who–whichever they are–that parent will have to care for all of their life.

To restore both the scientific basis of its medical practice and its conscience the American College of Obstetricians and Gynecologists should immediately acknowledge there is no such thing as a psychiatric ‘disease’ or an essential psychiatric drugs and immediately re-write its ACOG’s Committee Opinion #354, “Treatment with Selective Serotonin Reuptake Inhibitors During Pregnancy,” published in the December 2006 issue of Obstetrics & Gynecology, to read “the best possible, psycho-social-familial management should be assured in every case, eschewing all non-essential (including all psychotropic medications) medications.

Filed under: antidepressants, Birth Defects, child endangerment, Christian Delahunty, Christiane Schultz, Collusion, experimentation, mothers act, Pregnancy, Birth Defects, Fred Baughman, March of Dimes, MUSC, Pregnancy, SSRIs, Tameeka Law MD, Women Speak

Grassley Seeks More Info on Conflict of Interest Policies at Medical Schools

June 25, 2009
by Evelyn Pringle

In a June 24, 2009 letter, Senator Chuck Grassley asked 23 medical schools for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the pharmaceutical industry.

“I recently learned from an American Medical Student Association report, AMSA PharmFree Scorecard 2009, that your institution either had “no response” or “declined to submit policies” when asked to supply conflicts of interest policies,” he said in the letter.

Grassley asked the Universities to respond by no later than July 15, 2009.

Of the 149 schools asked, 126 provided information to the AMSA. The Scorecard 2009 was released on June 16, 2009. Thirty-five schools, or 23%, received an F. Seventeen got a D, 18 received a C, 36 were graded B, and only 9 schools received an A.

“There’s a lot of skepticism about financial relationships between doctors and drug companies,” Grassley said in a press release. “Disclosure of those ties would help to build confidence that there’s nothing to hide.”

“Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine,” he added.

Grassley has been working to achieve uniform and universal disclosure of the money that pharmaceutical, medical device and biologic companies give to physicians. He has conducted extensive oversight of financial relationships, especially among doctors who conduct research with the $24 billion awarded annually in federal grants by the National Institutes of Health, the press release explains.

Institutions receiving federal money dollars are required to track financial relationships, “but Grassley has found enforcement of those requirements often to be either lax or in violation,” it said.

“Beginning last summer,” Grassley wrote in the letter, “I began releasing information that made the point that universities are not managing their professors’ financial conflicts of interest and that change is needed at the NIH.” He listed a few examples as:

• Chairman of psychiatry at Emory failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of Inspector General (HHS OIG) is now investigating. [That would be Charles Nemeroff].
• Chairman of psychiatry at Stanford received an NIH grant to study a drug, while partially owning a company that was seeking Food and Drug Administration (FDA) approval of that drug. He was later removed from the grant. [The name here is Alan Schatzberg].
• Three professors at Harvard failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard plans to release a report and is working to update their conflict of interest policies. [These professors are Joseph Biederman, Timothy Wilens, and Thomas Spencer].
• Host of a show that ran on the National Public Radio (NPR) satellite station received over a million dollars from pharmaceutical companies to give promotional talks. The show had received funding from the NIH and has been cancelled. [That would be Fredrick Goodwin]
• Chair of orthopedic surgery at the University of Wisconsin reported taking more than $20,000 from a company every year, for five years. The actual amount was around $19 million. The University of Wisconsin is revising its rules. [The name here is Thomas Zdeblick].
• Professor at the University of Texas received an NIH grant to study Paxil in kids, while also giving dozens of promotional talks on Paxil. This matter has been referred to Health and Human Services, Office of the Inspector General. [This professor is Karen Wagner]
• Professor at the University of Washington in St. Louis who was formerly at Walter Reed Army Hospital failed to report hundreds of thousands of dollars he had received from a device company to develop their products. [That would be Timothy Kuklo].

“To bring some greater transparency to this issue, Senator Kohl and I introduced the Physician Payments Sunshine Act (Act),” Grassley said in the letter the Universities. “This Act will require drug, medical device, and biologics companies to report publicly any payments that they make to doctors, within certain parameters.”

The latest addition to the Grassley list is Emory University’s Zachary Stowe, for not disclosing money he received from drug makers at the same time that he was conducting federally funded research on the use of antidepressants, such as Paxil, by pregnant and nursing mothers.

Stowe has been the primary investigator of an NIH grant since 2004 to study children delivered by women who may also be taking antidepressants. From 2003 to July of 2008, he was the primary investigator of another grant that looked at fetal exposure to medications consumed by pregnant mothers. In 2008, Stowe was the primary investigator of another NIH grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to a June 2, 2009, letter from Grassley to Emory University.

In 2007 and 2008 alone, Stowe received about a quarter of a million dollars from Paxil-maker, GlaxoSmithKline, mostly for giving promotional talks, the letter shows.

Grassley was especially disturbed by an email between Glaxo employees and a public relations firm Glaxo hired, titled “For your review/Paxil Breast Milk Press Release” which states:

“[P]lease review the attached press release and forward me any comments/edits. As you may know, Dr. Stowe is on board for publicity efforts and NAME REDACTED and I are coordinating time to meet with him next week to arm him with the key messages for this announcement, which is slated for early February. We are sending the release for your review at the same time in efforts to secure distribution on Emory letterhead (as you know, would provide further credibility to data for the media).”

During a 2008 deposition in a birth defects lawsuit against Glaxo, Stowe confirmed that the press release was written by the PR firm and concerned his research on Paxil, and explained that placing the press release on Emory letterhead would make the data more credible to the public, as opposed to Glaxo letter head, Grassley said.

Stories on the internet show the Emory name was apparently used to add credibility to Paxil studies. For instance, citing a February 2, 2000, press release by Emory University School of Medicine, titled “New Study Shows Paxil Not Found in Breast-Fed Infants of Depressed Mothers,” on March 13, 2000, the StorkNet website featured an article with the headline: “Study Results Show Paxil Safe for Use by Breastfeeding Mothers With Depression.”

The story included the following paragraph with Emory specifically mentioned and Stowe’s comments:

“Due to the increased occurrence of mood and anxiety disorders during child-bearing years, it is imperative that we continue to research and make treatment options such as Paxil available for mothers who want the opportunity and benefit of breastfeeding their children,” said study leader Dr. Zachary N. Stowe, director of Emory University School of Medicine’s Pregnancy and Postpartum Mood Disorders Program.

“This study provides compelling data that Paxil is a viable treatment option for mothers who would like to continue breastfeeding.”

In the deposition, Stowe said he had been on Glaxo’s speaker’s bureau since 1999 and claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for drug companies.

On June 10, 2009, on the “Carlat Psychiatry Blog,” Dr Daniel Carlat noted that, “Stowe appears to have been deceptive during a recent deposition, when he claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for pharmaceutical companies.”

If he made $154,400 from GSK alone in 2007, “by my calculation this is already 66% more salary than he got from Emory,” Carlat said. “And Stowe did work for lots of other companies as well.”

Here is his disclosure from a Medscape CME gig he did in March 2007: “he has received grants for clinical research, grants for educational activities, and has served as an advisor or consultant to GlaxoSmithKline, Wyeth, and Pfizer. … he has served as an advisor or consultant for Bristol-Myers Squibb. … he has served on the speaker’s bureau for GlaxoSmithKline, Wyeth, Pfizer, and Eli Lilly.”

“Who knows how much money he was also getting from Wyeth, Pfizer, Bristol-Myers Squibb and Eli Lilly?” Carlat wrote. “He may very well have doubled his Emory salary, or more.”

“Furthermore,” he explained, “the $154,400 disclosed by GSK does not include all the cash they paid Stowe through laundered CME money.”

“For example, here is a CME program Stowe did for Medscape that was funded by GSK,” Carlat said, and wrote:

“The program is entitled “Long-term health risks of antiepileptic drugs in women” and is essentially a commercial for using Lamictal in pregnant women with bipolar disorder.”

“In it, Stowe begins by saying nasty things about Lamictal’s competitors, Depakote and Tegretol, and then minimizes a large study showing that Lamictal causes cleft palate.”

“I’m sure he got paid a lot for this, and that he did plenty of other similar CME programs that are scattered somewhere throughout the internet.”

“The bottom line is that Stowe has run into the same ethical problem as his boss Dr. Nemeroff-he was taking public NIH money to conduct research, while at the same time giving dozens of promotional talks for a company that stood to benefit from the results of that research,” Carlat pointed out.

On June 10, 2009, the Wall Street Journal health blog reported that, “Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women.”

The university said its medical school dean issued a letter of reprimand on April 30 to psychiatrist Zachary Stowe related to his “external relationships,” the WSJ wrote.

Emory has reprimanded Stowe, “who was instructed to immediately eliminate conflicts related to current federal grants,” the health blog noted.

Also, “the National Institute of Mental Health said it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the Atlanta Journal-Constitution reported on June 11, 2009.

http://www.lawyersandsettlements.com/blog/grassley-seeks-more-info-on-conflict-of-interest-policies-at-medical-schools.html

Filed under: antidepressants, Congress, mothers act, PPD, Pregnancy, antidepressants, Birth Defects, breast, conflicts of interest, depression, Emory, Grassley, GSK, milk, NIH, nursing, Paxil, pharma, Pregnancy, SIDS, speaker fees, Stowe, sudden infant death, Zachary

“Stress Testing The MOTHERS Act” by Kelly O’Meara

Via NaturalNews http://www.naturalnews.com/026229.html:

The Mothers Act is due to be voted on soon by the U.S. Senate. Investigative journalist Kelly Patricia O’Meara has authored an important op-ed piece on the dangers of the Mothers Act, and I’m publishing it here, with her permission, to share this with NaturalNews readers. Those wanting to stay up to date on the battle against psych drugs may also be interested in following CCHR on Twitter: http://www.twitter.com/CCHRINT

Stress Testing the MOTHERS Act

by Kelly Patricia O’Meara

It seems these days that everything is a test. Yes, the powers that be have decided that taxpayer benevolence now is contingent upon passing a stress test. But much to the dismay of those being tested, the results may reveal, for example, that the nation’s financial wizards and auto giants are actually bankrupt midgets and unworthy of America’s support.

Given that officialdom has embraced the stress test as a barometer of future viability and success and a determinant for public financing, it seems reasonable to request that other important issues that very personally impact the health and welfare of the American people be subjected to similar stress tests. There is none more deserving of stress testing than the proposed MOTHERS Act.

On the surface, the MOTHERS Act reflects its sponsors’ overwhelming compassion and empathy for women suffering from alleged mental health disorders resulting from childbirth – often referred to as Postpartum Depression. But when one conducts a brief stress test on important sections of the legislation, taxpayers may find that this costly and sweeping mental health legislation actually fails women of America, but goes a long way in inflating the balance sheets of one of the most lucrative industries in the nation – big Pharma.

For instance, the MOTHERS Act legislation that currently is pending in the U.S. Senate states that the Secretary of Health and Human Services may “make grants to eligible entities…” to deliver essential services to individuals with a postpartum condition. What the legislation doesn’t delineate is who and what entities may receive these grants. Are these “entities” funded by pharmaceutical companies? Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing.

Furthermore, no research guidelines have been provided for public disclosure. This is no small issue, given that the Senate Finance Committee recently exposed the conflicts of interest of the top ten psychiatric researchers in the U.S. who had received millions of dollars in pharmaceutical funding. Where is the guarantee that the “entities” are not pharmaceutical front-men?

The legislation also allows for the “expansion and intensification of activities” into the research of Postpartum conditions and “evaluation of new treatments.” This is a humdinger. Despite ever-increasing published data and clinical studies challenging the safety of antidepressants and other antipsychotic drugs, there is no guidance provided by lawmakers to mandate that the public be made aware of the avalanche of scientific data that not only questions the efficacy of the drugs available to mothers suffering from these conditions, but also warning of the dangers associated with currently available “treatments.”

The section of the legislation dealing with expanding the research into the causes of Postpartum conditions is wholly void of any guidelines that insure the validity of the research conducted, and provides nothing in the way of public disclosure or peer-review of research before it is launched in education campaigns. In the real world, research is conducted and submitted for peer review. In this instance, it appears that Congress has learned nothing from the ongoing banking debacle and naively believes that the researchers will be on their best behavior – self-policing themselves. This is a dangerous omission in the legislation, especially since the Senate Finance Committee has exposed the serious conflicts of interest that exist between researchers and pharmaceutical companies.

Making matters worse, much of the legislation revolves around funding national education campaigns about Postpartum Depression, including Public Service Announcements and television and radio advertisements. Based on the current language of the legislation, research will be conducted without peer review – no checks and balances; no one to validate the integrity of the research which then will be used to determine a woman’s mental health status. Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse. Congress apparently didn’t think integrity of the research is important and there are no provisions to protect women from pharmaceutical driven research.

Taxpayers may also expect that such important legislation would make provisions for some kind of oversight; some government entity that could provide feedback on the success or failure of this mental health campaign. One avenue that may help lawmakers’ determine if these new programs are working is the Food and Drug Administration’s MedWatch Adverse Event Reports. MedWatch collects information about people who have experienced adverse reactions to drugs overseen by the FDA. With the increased drugging that most certainly will occur with the increase in diagnosing, it seems logical that lawmakers would insert provisions in the legislation to annually review Adverse Event Reports collected by MedWatch, especially those relating to drugs prescribed in the treatment of Postpartum Depression. Unfortunately, because the nation’s lawmakers have provided no provisions for oversight, countless numbers of women may be harmed by the “treatments” but will be none the wiser because no protections were provided in the legislation.

There also is the very basic question of why the government is endorsing this sweeping mental health legislation and sanctioning a national advertising campaign about Postpartum Depression when there is no definitive data about the cause of the condition or that it is an objective confirmable abnormality – the scientific standard for disease. Given that there are so many unknowns in this legislation, it seems irresponsible to go forward without reasonable protections in place.

Congress must insure that all research and screening tests proposed and endorsed by this legislation be disclosed for peer-review and consumer input before implementing any screening tests and approving any research to be used in the national education campaign, including Public Service Announcements and radio and television advertising.

Given the documented risks related to the current modes of treatments, including antidepressant and antipsychotics, which are commonly prescribed for Postpartum Depression and documented to cause birth defects and host of other issues in pregnant and nursing mothers, Congress must include mandatory reviews of published research and clinical data on the drugs prescribed for the treatment of Postpartum Depression.

Finally, Congress must protect the integrity of the research by providing strict guidelines to insure that there are no conflicts of interest between the researcher and the pharmaceutical industry.

Without these safeguards, the MOTHERS Act cannot today, or ever, pass a stress test of viability and mothers and their children certainly will be on the losing end of this mental health campaign. Sometimes it’s in the best interest of the people for Congress NOT to act, and until our lawmakers are confident that all legislative precautions have been taken to insure optimum results, this is one of those times.

About the author:

Kelly Patricia O’Meara is an award-winning investigative journalist who authored more than two dozen articles examining the psychiatric pharmaceutical industry during her tenure at the Washington Times’ Insight Magazine. Her articles resulted in record sales of the issues in which they appeared and among the national and international press that have featured her articles are Fox News, the O’Reilly Factor, CBS News, BBC, ABC’s 20/20 and Hannity and Colmes. She is also the author of Psyched Out: How Psychiatry Sells Sickness and Pushes Pills that Kill. Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill and was the lead investigator in several Congressional investigations. She holds a B.S. in Political Science from the University of Maryland.

Filed under: Indiana, mothers act, #postpartum, antidepressants, babies, Birth Defects, Breastfeeding, Coalition Against The Dangerous And Invasive MOTHERS Act, Kelly O'Meara, nursing, nursing mothers, Pregnancy, psychotropic drugs, Stop The MOTHERS Act, stress testing the mothers act