Paxil And Babies

Good news. Here’s what Bloomberg had to say about the verdict yesterday against GSK over the dangers of Paxil for pregnant mothers and their babies. We are gratified that Bloomberg also mentioned the Cheyenne, Wyoming trial in which we were privileged to serve as trial counsel. Now there have been two verdicts against GSK, the one in Cheyenne and yesterday’s.

“GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial.

Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.

It’s the first time a jury has considered claims that Glaxo, the U.K.’s largest drugmaker, knew Paxil caused birth defects and hid the risk to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, or 2.1 percent of Glaxo’s total revenue”.

In the Kilker case, the jury found that Glaxo officials “negligently failed to warn” the doctor treating Lyam’s mother about Paxil’s risks and concluded the medicine was a “factual cause” of the child’s heart defects.

Juror Joe Mellon, who voted for Kilker, said Glaxo didn’t 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,” Mellon said after the verdict was announced.”
“Glaxo is also fighting suits in the U.S., Canada and the U.K. over claims that Paxil, whose generic name is paroxetine, causes homicidal and suicidal behavior. The company settled some suicide claims, under undisclosed terms.”
“In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Glaxo’s Mr. Colgan.”

On July 24, 2009, an Arkansas federal judge granted access to evidence of ìghostwriting.î The United States District Courtís decision allows public access to evidence that Wyeth Pharmaceuticals www.wyeth.com fudged articles about the hormone therapy drug Prempro. Recently, a national study found Prempro to increase risk of stroke, heart attack, blood clots, cardiovascular disease and cancer in women.

Twenty six documents written by ìghostwritersî have emerged after the Arkansas courtís decision. These twenty six new documents are scientific papers backing the use of a drug produced by Wyeth. According to an article in the New York Times www.nytimes.com,
ìthe level of hidden industry influence on medical literature is broader than previously known.î This is true with SSRI medication and others used by pregnant women, babies and other people.

What is ghostwriting? It happens with articles written about medications when the motivation for the opinions doesnít come from straight information, but instead comes from incentives given by the company. For example, a hypothetical pharmaceutical company might pay a communications firm to draft papers stating positives about a drug that the hypothetical company produces. Typically these phony scientific papers are review articles. The papers consider a body of ìevidenceî and offer information on a particular medication or aliment designed to say ìour medication is the bestî or ìsafeî when that is not necessarily so.

Often, medical journals publish ghosted articles because it can be difficult to tell the difference between the legitimate and the fakes. While it is difficult for journal editors to tell the difference between a ghostwritten article and a legitimate article, it is even more difficult for a practicing doctor who relies on journals to keep up with new developments.

Why is ghostwriting a negative thing? Doctors rely heavily on medical literature for information about treatment methods and which medications to use. A doctor might select or change a treatment method based on medical literature. If that literature is not accurate, it can be harmful for patients.

In the United States, postpartum depression is common among women. It ís so common in fact that Congress is considering legislation to increase medical treatment. What about depression during pregnancy?

Some commentators question whether antidepressant use during pregnancy or afterward is really necessary for some patients. We leave that to the good judgment of doctors and their patients. The common rationale for antidepressant use during pregnancy is that while some medications may present risks, depression is more risky. While people will argue that the research does not support this rationale, this much cannot be disputed: women who are pregnant or who may become pregnant or have had a baby are all entitled to all of the facts about their medications. So are their doctors.

Unfortunately, as the Paxil birth-defect trial proceeds, it has become clear that Paxilís maker, GlaxoSmithKline, is not above withholding negative information about its drugs. It is also clear that Glaxo is trying to shift the focus in court to the question of whether Paxil is beneficial or not, when it is clear it is safe for some patients and not for others. The focus really should be: aren’t patients and their doctors entitled to all the information about Paxil, negative or positive, before they use it? That way, with proper disclosure, they can advise and decide with full and fair information.

Why would Glaxo decide not to warn of the dangers of pregnant women using Paxil? Profits, thatís why. Issuing a warning could hurt sales.

Sales are really what the Paxil baby case now on trial in Philadelphia is all about. Paxil is hugely profitable for Glaxo. If it had warned women of childbearing age about the risks to the fetus of using Paxil, it would have lost some sales. But arenít people entitled to know the risks?

Of course, Paxil helps a lot of people. Thatís what I told the jury in our successful Wyoming trial. But for some, it is dangerous. So everyone needs a warning about the risks, so they can decide if the risks outweigh the benefits. The reason the jury found in our favor is that Glaxo did not warn users of the dangers, although it knew them.
Pregnant women can be among those for whom Paxil can be dangerous. Glaxo scientists reportedly said they were “almost certain” that Paxil had caused problems for an unborn child after a woman reported that she had been taking Paxil and had terminated her pregnancy because of damage to her baby. Nevertheless, GSK did not tell the woman or the FDA about the link.

Interestingly, one of the witnesses in the trial in Cheyenne has popped up again in Philadelphia. Her name is Bonnie Rossello. At the time of the trial in Cheyenne, she was a Vice-President of Glaxo, and heavily involved in marketing. Glaxo spends millions and millions on marketing to boost its sales of Paxil.

In our trial, she did not appear in person, and we could not make her come to trial. That’s because all federal courts have geographic limits on their subpoena power. She was outside our courtís geographic limits.

So my co-counsel took her deposition. Whatís that? Itís testimony under oath before the trial. Then that testimony can be read to the jury, or shown if it was videotaped. The testimony is still subject to objections and court rulings.

When you consider the consequences of a warning to Glaxo, which hurts sales, that shows why it would be loath to put out such a warning.

So what about Bonnie Rossello? In the opening statement for the family in the case now on trial, counsel pointed out that Rossello described in a 1997 memo what the company would do if forced to conduct animal studies on Paxil. She told her company it could bury negative studies linking its antidepressant drug to dangers: ìIf neg. results can bury.î It will be interesting to see if she shows up in person this time so she can be cross-examined.

Parents of damaged babies are getting their day in court as the first Paxil birth defect trial is ongoing in Philadelphia. We represent several families whose babies were damaged. The mothers took Paxil during pregancy. GlaxoSmithKline’s own documents show a link between ingestion of its SSRI antidepressant, Paxil, and birth defects.

Pregnant women sometimes get depressed, just as other people do. When they visit their doctors and discuss their depression, of course the doctors want to help. Some doctors turned to Paxil, promoted by Glaxo’s field representatives as safe for pregnant women. That is not so, as we hope will be proven in the courtroom. Some of these baby cases involve heart defects and other problems.

Glaxo, for all its wealth, resources and law firms, can be beaten. We know that from our trial in the United States District Court, where a jury found in our favor in a death case.

There have been two major studies concerning the health of babies whose mothers were and were not treated with antidepressants. A study published in the American Journal of Psychiatry ajp.psychiatryonline.org found the preterm birth rate of newborns exposed to antidepressants to be 14.3 percent greater then the preterm birth rate of newborns who had not been exposed to antidepressants. The study also found that newborns who had been exposed to antidepressants were two times as likely to be admitted to the special care nursery. Similar results were reported by a study published in the Archives of General Psychiatry archpsyc.ama-assn.org.

A study published in the American Journal of Obstetrics and Gynecology www.ajog.org found antidepressant use in pregnancy had quadrupled from 1996 to 2005. The study focused on pregnant women treated at seven health maintenance organizations (HMOs), and found that almost 8 percent of them were treated with antidepressants in 2005. A second study published in this journal found similar results. It looked at the medical records of 105,335 pregnant women enrolled in Tennessee Medicaid from 1999 to 2003. The study found that antidepressant use had increased from 5.7 percent in 1999 to 13.4 percent in 2003.

One of the commonly prescribed anti-depressants is Paxil. While its use can be effective in treating depression, there are downsides to it. Any woman thinking of using it will want to discuss the side-effects with her doctor, including the potential for harm to her unborn, developing baby.

According to an article in the New York Times www.nytimes.com, GlaxoSmithKline www.gsk.com increased its 2009 second quarter earnings by 11 percent. Glaxo was not alone in increasing earnings, as two other drug manufacturers Eli Lilly www.lilly.com and Pfizer www.pfizer.com also reported higher second quarter earnings and improved their profit outlooks. We have cases pending against GSK and Lilly centered on adverse effects of anti-depressants.

We certainly hope the upcoming Paxil baby trials succeed so that Glaxo can spend some of that money taking care of babies with cardiac problems. Mothers who took Paxil while pregnant have delivered babies with heart malformations.

For many years, drug company representatives have provided physicians with information concerning medications. However, in recent years, their usefulness as an information resource has become questionable. In todayís climate, it is possible to research medication information with a few strokes of the keyboard. Why then, do drug companies still send out drug reps to provide information about medications? In the end, drug reps are promoting medications and sometimes withholding the details about them. For example, these company representatives did not disclose risks to unborn babies whose mothers took Paxil during pregnancy.

Drug companies hire representatives on two criteria, attractiveness and charisma. Scientific education is not even a consideration. So why then do highly educated doctors choose to listen to information provided to them by drug reps who do not necessarily have any scientific education? The answer is the same reason that drug companies hire drug reps who meet the criteria: charisma and attraction.

Patientís interests are not top priority for drug reps. An article by Dr. Adriane Fugh-Berman http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18473146 states that drug companies compile information regarding prescriptions so they can evaluate ways to sell more of their medications. The only place the patient fits into this equation is what is located in their wallets.

It is very easy to research medications now with the Internet. Two good sites to check medication information are www.fda.gov and http://www.toxnet.nlm.nih.gov. Both sites provide useful information. However, those are only two examples of many reputable Internet resources that can provide invaluable information about medications. Now ask yourself, if you (most likely a non-medical professional) can research in depth information about medications for free, why is there a need for another handsome or pretty face to tell your doctor about medications on the market? In the famous words of Steve Martin, “It’s a profit deal.”

What is the importance of knowing about the gifts doctors are receiving from drug manufacturers?

According to Dr. Christopher McCoy, a member of the National Physicians Alliance http://npalliance.org, gifts, grants and vacations given to physicians by drug companies are causing physicians to prescribe more expensive medications when a better fit might be available. In other words, doctors who receive gifts, grants and vacations from drug companies feel a loyalty to the companies and prescribe their medications more often. In our last post, we talked about an organization called No Free Lunch www.nofreelunch.org. According to this group, even small promotional gifts such as pens and notepads can create the feeling of loyalty.

The problem with gifts of any kind originates from the fact that pharmaceutical marketing is more about sales than science. Gift registries are an attempt to reveal gifts doctors receive from pharmaceutical companies by making the information available for free on the Internet. Once patients can see what kind and amount of gifts a particular doctor is receiving, the patient can understand the motives behind prescribing a particular medication.

How does this relate to Paxil use during pregnancy? A pharmaceutical company that influences sales and research about a particular medication can sometimes cause a problem to be hidden. In the case of Paxil, GlaxoSmithKline www.gsk.com was aware of the potential risks of Paxil use during pregnancy. However, as is evident in the recent scandals involving Emory University researchers who shaded their work, Glaxo goes to great lengths to influence the amount and kind of information available about its medications. A registry might be a step in the right direction to eliminate these conflicts of interest.