Paxil And Babies: Paxil News

Off-Label Prescription Uses Grow

Jim Fitzgerald — Tue, 13 Nov 2007 20:19:34 GMT

Consumers can find information on off-label uses for many drugs if they know where to look. Here’s one link: http://books.google.com/books?id=fhEFkBxEtH8C&pg=PA118&lpg=PA118&dq=%22off+l

In a previous blog, we noted that 1 out of 7 prescriptions is written off-label. Now prescription drugs have become so popular that 1 out of every 4 prescriptions written is off-label. That's a whopping 115 million off-label prescriptions a year.

Typical off-label conditions for which doctors prescribe common anti-depressants include Wellbutrin to treat chronic lower back pain, and Prozac and Zoloft to relieve the symptoms of menopause.

Off-label prescriptions are completely legal and your doctor will tell you, accurately, that they are a vital alternative for optimal patient care. However, there are still risks of side-effects with these medications - no matter what the reason is that they might be prescribed. So consumers need to actively engage in open discussion with their physicians regarding side effects of any medication they might be given.

Echocardiograms for the Newborn

Jim Fitzgerald — Fri, 19 Oct 2007 16:36:00 GMT

A recent article shows that 15% or approximately 1 in 7 expectant mothers will experience depression at some level during their pregnancies. http://www.medicinenet.com/script/main/art.asp?articlekey=84213

For mild to moderate depression, treatments such as cognitive therapy may be effective, according to the article. The severity of the depression determines whether a doctor will prescribe anti-depressant medication such as an SSRI. The use of SSRIs in treating depression is common but certain ones such as Paxil have been found to have serious potential risks to the fetus, especially if the mother takes Paxil in the first trimester.

Paxil was more likely to be prescribed for conditions such as anxiety or panic than other SSRIs. Interestingly, babies whose mothers used an SSRI had a much higher rate of echocardiograms in the first year of life when compared to babies whose mothers took nothing.

How Do SSRI Medications Work?

Jim Fitzgerald — Wed, 03 Oct 2007 20:59:56 GMT

Selective Serotonin Reuptake Inhibitors are a class of antidepressants used to treat depression, anxiety disorders and some personality disorders. The brain has neurotransmitters, chemicals that act as messengers. These neurotransmitters are made of serotonin, also known as 5-Hydroxytryptamine or 5-HT, chemicals that naturally occur in the human brain.

Two specific areas of the brain have serotonin concentrations, the midbrain and the hypothalamus. These areas regulate mood, hunger, sleep and aggression. The neurotransmitters are released at one point and absorb at another. This is how the chemical message is emitted and received in the body.

Chemical imbalances of serotonin in these areas cause a variety of mood disorders, particularly depression. SSRI medications prolong or inhibit the process by which serotonin is taken up by neurons, thereby maintaining chemical balance in brain. http://psychcentral.com/lib/2006/choosing-the-best-ssri Inhibiting means stopping or retarding a chemical reaction. SSRI medications treat depression by inhibiting the uptake of serotonin, thus making more available for better brain function. www.answers.com/topic/inhibitor?cat=health

Unfortunately, these medications have side effects. www.holisticonline.com/Remedies/Depression/dep_antidepressant-SSRI.htm Side effects can be perilous for an unborn baby by, for example, damaging the fetal heart.

Babies and Risks of Paxil

Jim Fitzgerald — Wed, 26 Sep 2007 19:11:35 GMT

Taking an antidepressant like Paxil may increase a pregnant woman’s risk of having a baby with a birth defect. Although some researchers suggest that the chances appear remote and confined to a few so-called “rare” defects, those defects can be substantial.

The findings appeared in The New England Journal of Medicine. www.nejm.org GlaxoSmithKline www.gsk.com claims that antidepressants are not a major cause of serious physical problems in newborns.

Here’s the problem with these studies: they didn’t include enough cases to adequately assess risks and they didn’t include information on how long women were taking antidepressants or at what doses.

“These are important papers, but they don’t close the questions of whether there are major effects” of these drugs on developing babies. That’s what Dr. Timothy Oberlander said. He’s a developmental pediatrician at the University of British Columbia www.ubc.ca who was not involved in the studies. “There are many more chapters in this story yet to be told.”

In both studies, researchers interviewed mothers of numerous infants with birth defects, including heart valve problems. They found that mothers who remembered being on antidepressants like Paxil while pregnant were at no higher risk for “most” defects than a control group of women who said they had not taken antidepressants. But they are at higher risk for some birth defects.

For example, the study led by Carol Louik of Boston University www.bu.edu found that use of Paxil was associated with an increased risk of a heart defect in a newborn.

Heart Surgery for a Baby

Jim Fitzgerald — Wed, 19 Sep 2007 19:26:04 GMT

Well, we haven’t posted for awhile due to our trial schedule but now we have some time. Here’s the latest.

Consumers need to be actively involved in decision making when their doctors prescribe medications for them. Don't be afraid to ask questions and challenge decisions made by your doctor. If the decisions are good ones, they will stand up to scrutiny.

A case in point is Lisa Collins. Her general practitioner prescribed Paxil for her six months before she became pregnant because she had irritable bowel syndrome and at times felt claustrophobic. This proved to be a catastrophic choice for her son Chase who was born with a serious heart defect, which required open-heart surgery. http://www.houstonpress.com/2006-09-14/news/baby-blues/ As noted in this article, Collins did not suffer from severe depression or any mental illness - yet her doctor chose Paxil as a suitable choice to treat her symptoms.

GlaxoSmithKline's expert witness in our Tobin trial in Cheyenne testified that general practitioners have insufficient training to take the detailed history required before prescribing Paxil. Consumers need to be alert for problems that the prescribing doctor does not heed.

Gifts to Doctors-Damages to babies?

Jim Fitzgerald — Fri, 22 Jun 2007 21:04:24 GMT

A Harvard Medical School professor, Dr. Blumenthal, revealed the likelihood of a physician using a particular drug company’s brand of medicine in exchange for free gifts. Those gifts could lead doctors to prescribe brand-name drugs, when less expensive generic versions may be just as effective. Should these gifts influence doctors who prescribe medications, especially those to pregant women?

Here are some examples of how the gift system works. A medical student walked into the office of a medical practice and found food, trinkets, pens and coffee mugs being handed out to the whole office staff, courtesy of Merck & Co. The physician who was the number one prescriber of Vioxx in his entire region that year, was ‘awarded’ a pair of Philadelphia Eagles season tickets. Vioxx’s party ended with the painkiller getting yanked from the market because it could cause heart problems. Investigations revealed that Merck marketers had misled physicians, wrongly suggesting that Vioxx was better for the heart than other pain relievers, even after research suggested possible dangers. See Stephen Cha’s article, These Gifts Are Bad for Our Health http://www.washingtonpost.com/wp-dyn/content/article/2005/07/22/AR2005072202220.html

A professor of social medicine, David J. Rothman, at Columbia University Medical Center opines that $13,000 per physician is spent annually by drug companies in their effective marketing tactics aimed at getting physicians to do what each drug company wants - to prescribe their product. See the article by Ceci Connolly, Distance sought Between Doctors and Drug Industry http://www.biopsychiatry.com/bigpharma/doctors-drugcompanies.html

From Medals to Troubles - The FDA's Path

Jim Fitzgerald — Tue, 12 Jun 2007 22:05:27 GMT

A United States Senator, Charles E. Grassley of Iowa www.senate.gov, recently said the treatment of certain doctors at the United States Food and Drug Administration www.fda.gov reveals a pattern showing that the FDA needs to be reformed. The latest doctor the FDA abused is Dr. Rosemary Johann-Liang. She left the FDA last Friday after rough treatment for rubbing some people the wrong way over the FDA’s handling of Avandia. www.nytimes.com She wanted the FDA to require a Black Box warning more than a year ago.

As you know, this blog now focuses on newly discovered issues about Paxil, pregnancy and related heart problems in babies. However, we recall the 2003 treatment of Dr. Andrew Mossholder. This doctor discovered that SSRI antidepressants caused suicidal ideation in some children.

The FDA started a criminal investigation after Dr. Mossholder’s findings leaked to a reporter. The agency then wouldn’t let him speak to an advisory committee about his findings. It hired a team of researchers from Columbia University to reanalyze Dr. Mossholder’s data. But guess what? That esteemed team concluded that Dr. Mosholder was right. Part of this sad story is that the re-analysis took a year. Before then, we proved at trial in the United States District Court in Cheyenne, Wyoming, that Paxil could cause death. But what happens to doctors who question the FDA?

Let’s contrast Dr. Johann-Liang’s treatment with another brave FDA doctor, Dr. Frances Kelsey. John Fitzgerald Kennedy presented her with the President's Award for Distinguished Federal Civilian Service in 1962. http://www.lib.umich.edu/govdocs/jfkeo/eo/10979.htm And for what? She was an FDA inspector who demanded evidence of the safety of thalidomide. Nowadays, the FDA is overruling doctors who stand up to big business and ask for evidence of safety – by punishing the doctors and pushing them out of the agency.

Big Pharma Paying Convicted Doctors To Test Drugs For Mothers?

Jim Fitzgerald — Fri, 08 Jun 2007 22:26:45 GMT

What would you like to know about the doctors who are studying the SSRI anti-depressant drugs being prescribed during pregnancy? Would you want to know if any of them had criminal fraud convictions?

Doctors in private practices study drugs for Big Pharma. Their backgrounds are important to pregnant women and babies throughout America. But there is no national database that makes background records on them publicly available. You cannot get them, except in one state, Minnesota. See http://www.state.mn.us/portal/mn/jsp/home.do?agency=BMP if you’re interested.

In Minnesota alone, the drug industry has paid more than 100 doctors to study drugs who have been disciplined or criticized by the state medical board. At least two of them have criminal fraud convictions.

One of the doctors that Minnesota disciplined, Dr. Faruk Abuzzahab, is a Minneapolis psychiatrist. He says the drug makers were aware of his record but have hired him anyway. He says he helped study Paxil, for instance.

He is still overseeing drug testing on patients and pharmaceutical companies are still paying him. Up to twelve drug companies have paid him for research or marketing since he was disciplined. And would you like to know what he was disciplined for?

Ten years ago, Minnesota’s Board of Medical Practice accused him of a “reckless, if not willful, disregard” for the welfare of 46 patients. Of those, 5 died while under his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that. But that hasn’t kept the drug industry from paying him to study drugs. We wonder how many more like this doctor are on the payroll of Big Pharma.

Source Of Information - Effects of SSRI Medications During Pregnancy

Jim Fitzgerald — Fri, 01 Jun 2007 22:23:09 GMT

Here's a quick note on a Friday afternoon. An excellent source of information about pregnant women who want to know about the effects of Paxil on babies is www.babycenter.com That website dicusses topics related to birth defects and antidpressant medication that we have covered in this blog. Go to www.babycenter.com/expert/pregnancy/prenatalhealth/2343.html for a good article in Q&A format.

Doctors Ignoring Drug Risk Warnings?

Jim Fitzgerald — Wed, 30 May 2007 20:45:51 GMT

Considering Paxil's apparent link to heart problems in babies, what can be done to spread the word to doctors. We hope information about this link gets more attention. In light of a recent Canadian report showing that drug regulatory agencies’ warnings of the heightened risk of suicides linked to some antidepressants like Paxil were nearly all ignored by doctors who prescribed these medications, it may be that pregnant mothers may have to do their own homework.

Dr. Paul A. Kurdyak, from the Centre for Addiction and Mental Health in Toronto, and colleagues performed a time-series analysis of new antidepressant prescriptions in Ontario between 1998 and 2005. The American Journal of Public Health published the report online. www.ajph.org

Earlier, the UK Committee on Safety of Medicine released a report cautioning doctors against prescribing Paxil to patients under the age 18, thus bringing attention to the antidepressant suicide risks. Then, the U.S. Food and Drug Administration www.fda.gov issued a similar drug advisory of selective serotonin reuptake inhibitors (SSRIs)—a particular class of antidepressants—in young patients. In September 2005, the FDA expanded the warnings to include the risks to an unborn fetus if the mother takes Paxil.

Kurdyak's team examined computerized prescription records of the Ontario Drug Benefit program. Investigators performed a time-series analysis of new antidepressant drugs to find trends in antidepressant prescription coverage that would indicate whether or not agency advisories were being taken seriously.

Kurdyak’s team found that of all five advisories of the increased risk of suicidal thoughts and behaviors linked to antidepressants, only the first warning resulted in change—new Paxil prescriptions for patients under 20 years of age dropped by 54 percent. Otherwise, prescription patterns did not change for any other individual or class of antidepressants in any age group. http://www.nlm.nih.gov/medlineplus/news/fullstory_45944.html No other antidepressant prescription patterns altered, indicating that physicians overlooked the risks.

The fact that the warnings are not necessarily persuading doctors is a serious cause for concern. Both the FDA and American College of Obstetricians and Gynecologists www.acog.org recommend that public should sit with doctors to talk about the risk of taking antidepressants like Paxil.

Pharma’s Gifts: Doctor’s gain? Patient’s pain?

Jim Fitzgerald — Thu, 24 May 2007 18:00:44 GMT

The easiest route for a pill to take from the manufacturer to the patient may be through gifts and sample medicines that doctors receive from pharmaceutical companies. A New England Journal of Medicine www.nejm.org study http://freeinternetpress.com/story.php?sid=11542 revealed some types of relationships between the doctors and the drug industry from the 94% of the physicians who responded to the survey.

Physicians admitted to getting meals from company representatives (83%), free drug samples (78%), reimbursements for the costs of attending educational conferences hosted by drug companies (35%), fees for consulting, speaking engagements and enrolling patients in clinical trials (28%), tickets to cultural and sporting events (7%), and so on. You can read Joseph Pereira's article, Gifts to Doctors Are Widespread at www.wsj.com.

Paxil’s maker, GlaxoSmithKline, has been one of the pharmaceutical companies promoting its place with depression patients. Would you expect a doctor having close ties with drug manufacturers to be sensitive toward side effects and to look into them before prescribing? Of course, you would, and you would hope for objectivity. But did you know that the pharmaceutical industry itself estimates that it spends about five billion, seven hundred million dollars ($5,700,000,000.00) every year on marketing directly to physicians? That an average of $6,000 to $7,000 per doctor, so you know some are getting much more. www.washingtonpost.com/wp-dyn/content/article/2005/07/22/AR2005072202220.html

What about your doctor? Almost all doctors are of course conscientious and have your best interests at heart. But you should know about the role marketing may play in your health care provider’s choice of medications to treat you. They may have side effects that a pregnant woman, for example, would want to know about before they affected her baby.

More Effects of Paxil on the Unborn

Jim Fitzgerald — Mon, 14 May 2007 15:57:29 GMT

Past posts to this blog show evidence that a baby born to a mother who tool Paxil during pregnancy are at risk for heart defects. In addition, a Canadian study has found that a number of women who took Paxil during the last trimester of their pregnancies gave birth to babies that went through withdrawal symptoms. http://citypages.com/databank/23/1141/article10788.asp.

A study investigating the prenatal effects of SSRIs on neurobehavior of newborns found prenatally exposed infants to be hyperactive, tremulous and with behavioral state abnormalities., http://pediatrics.aappublications.org/cgi/reprint/113/2/368 (Zeskind, P. S., & Stephens, L. E. (2004), Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior).

Eduard Bercovici’s research indicated that children prenatally exposed to SSRIs scored lower on psychomotor (Bayley Scales of Infant Development test) and lower on the motor quality factors (Bayley Behavioral Rating Scale). You can download the article at www.oadd.org/publications/journal/issues/vol11no2/download/bercovici.pdf (Eduard Bercovici, Prenatal and Perinatal Effects of Psychotropic Drugs on Neuro-cognitive Development in the Fetus, Journal On Developmental Disabilities)

Why So Many Scripts?

Jim Fitzgerald — Wed, 09 May 2007 21:39:23 GMT

GlaxoSmithKline’s (GSK’s) steady addition to the list of disorders Paxil is supposed to treat and an energetic campaign for its use have lead to an astounding increase in the number of users. There are an estimated 3,000 to 5,000 new users every day. In 2001, doctors wrote about 25 million new prescriptions for Paxil. Some of those were for pregnant women. However, GSK did not tell them or their doctors about the risks of defects, including heart defects, in unborn babies. How does this happen?

Drug companies are really good at getting doctors’ attention. Here are some ways they do it. There’s a new study by a team of researchers from Harvard www.harvard.edu, Yale www.yale.edu and the University of Melbourne www.unimelb.edu.au. This study polled doctors across the United States by sending questionnaires to 3,167 physicians. Responses came in from 1,662 physicians. And what did they show?

Almost all the doctors (94%) acknowledged that they had accepted some form of gifts or money from pharmaceutical and medical-device manufacturing firms. What kinds of gifts and money? 83% allowed company representatives to treat them to meals; 78% took free drug samples; 35% accepted reimbursements for the costs of attending educational conferences hosted by drug companies -- in some cases including travel, food and lodging. www.wsj.com. Here is what we’d like to know: Over dinner, or when handing samples to the doctors, were the doctors told about any risks of the drugs, so they could inform their patients?

Paxil in the 2d Trimester – Newborn PPH

Jim Fitzgerald — Wed, 02 May 2007 21:52:53 GMT

Here is some updated information on the topic of Persistent Pulmonary Hypertension in the newborn baby. Not only must pregnant women be concerned with possible heart defects in the baby, but also we are learning that PPHN is a potentially fatal lung condition. It occurs shortly after birth. A baby with PPHN cannot take enough oxygen into the bloodstream because high pressure in the blood vessels of the lungs blocks it. While many of ours posts are related to the first trimester of pregnancy, there is now information about the risks in taking Paxil in the second trimester and it relates to PPHN. As you know from a past post, the New England Journal of Medicine published a study (Feb 9, 2006), that found that taking SSRI antidepressants, including Paxil, after 20 weeks of pregnancy increases the risk of the baby being born with Persistent Pulmonary Hypertension (PPHN). The direct link is http://content.nejm.org/cgi/content/abstract/354/6/579

It is good that this second-trimester concern about PPHN is drawing attention. Previously, there were reports that late-term exposure to SSRIs can result in withdrawal symptoms such as irritability, difficulty feeding, and difficulty breathing for the mothers of the infants. http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm As you know, we recommend seeking additional information about possible PPHN in newborn babies of mothers who took SSRI antidepressants during pregnancy.

Risks of Birth Defects vs. Treatment of Depression

Jim Fitzgerald — Thu, 26 Apr 2007 11:52:12 GMT

Pregnancy has historically been viewed as a time when depression lifts. Women of reproductive age have the highest prevalence of major depressive disorders, with the American College of Obstetricians and Gynecologists www.acog.org experts estimating that about 1 in 10 will experience a bout of major or minor depression sometime during pregnancy or the postpartum period. Some women choose to keep taking antidepressants like Paxil throughout pregnancy.

The FDA www.fda.gov has strengthened its warnings about possible birth defects in babies born to women taking Paxil during pregnancy. www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html. The question then is “Is it safe for women to stop taking Paxil?” The answer may be “No”.

Those who stopped taking antidepressants or altered their doses were more likely to have a relapse of major depression during pregnancy. www.fda.gov/bbs/topics/NEWS/2005/NEW01270.htmlwww.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm. A study published in the Journal of the American Medical Association (JAMA, February 2006) found that discontinuing the medication had an impact on the risk of a relapse. Lee Cohen, MD and colleagues studied 201 pregnant women whose depression had been lifted by antidepressant drugs for at least three months before their last menstrual period. About six in 10 women who stopped taking antidepressants or lowered their doses due to their pregnancy started taking antidepressants again while still pregnant. They still reported more depression than those who never quit taking antidepressants, the study showed. ACOG, in the news release, while stating that women who are pregnant or planning on becoming pregnant should avoid the use of Paxil when possible because of the high risk of birth defects, including PPHN, also acknowledged that the potential heightened risk for birth defects must be weighed against the risk of relapsing into depression for pregnant women who discontinue their antidepressant medication. "Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications," the statement said. www.forbes.com/forbeslife/health/feeds/hscout/2006/11/29/hscout536339.html

The risk of relapsing into depression is also a serious cause for concern, leaving expectant mothers to decide whether the benefits of Paxil outweigh the risks associated with it. Unfortunately, one of the risks that has been identified is damage to the unborn baby. GlaxoSmithKline should warn women who are pregnant or may become pregnant of these risks so that they can seek informed health care.

Women, Depression, Babies & Off-Label Prescriptions

Jim Fitzgerald — Tue, 17 Apr 2007 18:46:53 GMT

One of every seven prescriptions for common drugs are for off-label uses lacking scientific support suggests a study. See www.fool.com/investing/dividends-income/2006/12/22/is-offlabel-offbase.aspx

Paxil is not approved for use in children, but doctors can prescribe drugs as they see fit and routinely recommend antidepressants for children suffering from depression and other psychological disorders.

Dr. Gleason, 53, is a Maryland psychiatrist. He was arrested and charged in connection with promoting a drug for purposes other than those approved by the federal government. At hundreds of speeches and seminars, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. www.nytimes.com/2006/07/22/business/22drugdoc.html?ex=1311220800&en=eeafd3a0752f4924&ei=5088&partner=rssnyt&emc=rss

Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug. A 2005 study showed major birth defects in babies born to women who took this antidepressant during the first three months they were pregnant. An article at www.nytimes.com discussed the study showing twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often evade the rules by funding seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.

Lawsuits Against Big Pharma

Jim Fitzgerald — Tue, 10 Apr 2007 16:42:25 GMT

More than 6,000 lawsuits have been filed in recent years against drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin. These lawsuits raise questions about whether drug makers and the FDA pay enough attention to patient safety. Added to the list is Paxil.

Paxil is manufactured by Pharma giant Glaxo SmithKline. Paxil is approved for the treatment of depression, generalized anxiety disorder, social anxiety disorder, panic disorder, obsessive compulsive disorder, and posttraumatic stress disorder in adults.

A 2005 study showed major birth defects in babies born to women who took this antidepressant during the first three months they were pregnant. An article at www.nytimes.com discussed the study showing twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

Paxil is an antidepressant drug belonging to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). Paxil is believed to be very addictive, and many users report severe withdrawal symptoms after discontinuing use. Some experts (and a jury in Cheyenne, Wyoming) have linked Paxil to an increased suicide risk.

Glaxo SmithKline Corporation, the manufacturer of Paxil, has been accused of misleading the public and the medical profession by downplaying side effects of the drug. In response, many victims have banded together and filed lawsuits against Glaxo SmithKline Corporation.

Persistent Pulmonary Hypertension of the Newborn (PPHN)

Jim Fitzgerald — Tue, 03 Apr 2007 23:35:56 GMT

The initial warning of the FDA was not to prescribe Paxil to women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate. www.fda.gov/cder/drug/advisory/paroxetine200512.htm However, the New England Journal of Medicine (Feb 9, 2006), based on a retrospective case-control study, found that taking antidepressants, including Paxil, after 20 weeks of pregnancy, i.e., in the second trimester of pregnancy, increases the risk of the baby being born with Persistent Pulmonary Hypertension (PPHN). PPHN is a potentially fatal lung condition that occurs shortly after birth. Babies with PPHN are not able to get enough oxygen in their bloodstream because of high pressure in their lung blood vessels.

More specifically, according to the authors of this study, the risk of PPHN is six times greater in women who take an SSRI antidepressant after the 20th week pregnancy. In women who do not take SSRIs, the rate of PPHN is one or two per 1000 live births. A statement on the FDA's website states, "Neonatal PPHN is associated with significant morbidity and mortality." This concern about PPHN is in addition to previous reports that late-term exposure to SSRIs can result in withdrawal symptoms such as irritability, difficulty feeding, and difficulty breathing for the mothers of the infants.

We recommend seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy.

Pregnant Women, the FDA and Warnings

Jim Fitzgerald — Mon, 15 Jan 2007 13:54:32 GMT

Word is getting out about the risks to an unborn fetus if the mother takes Paxil. The wheels sure grind slowly, though. The initial FDA www.fda.gov warning for women expecting a baby was in September 2005. The FDA based its warning on two studies, the first of which found double the risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared to the risk in the general population.

Three months later, the FDA ordered GlaxoSmithKline www.gsk.com to reclassify Paxil from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women demonstrated this risk to the unborn baby. The most common defects were cardiovascular, or heart problems.

It took another year for the American College of Obstetricians and Gynecologists (ACOG) www.acog.org to get around to issuing its own warning. Finally, the ACOG Committee on Obstetric Practice recommended that paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible, due to these risks. You can see the warning at www.acog.org/from_home/publications/press_releases/nr12-01-06-1.cfm.

Why do doctors prescribe Paxil to pregnant women?

Jim Fitzgerald — Mon, 08 Jan 2007 15:02:27 GMT

A past post talked about reports about how Paxil may be linked to baby heart defects. Why are expectant mothers prescribed Paxil? For one thing, advertising influences medical choices, leading some pregnant women to ask for Paxil by name. Since 1997, when the FDA www.fda.gov changed the advertising rules, ads for depression medications have moved on from the respected medical journals to television and magazines. When the drug industry knows that 800,000 women per year suffer some form of depression during pregnancy, that’s a huge market to tap. But what about telling pregnant mothers taking Paxil about the risks of birth injuries and congenital heart malformations in their babies.

Public Citizen www.citizen.org is a non-profit consumer advocacy group. Its Dr. Peter Lowry has testified that direct-to-consumer ads are a problem. He described how the drug industry got the power to advertise without disclosing all the side effects: “It was made to seem as if it was some ordinary regulatory step but in fact, it just totally opened up the flood gates and television has never been the same.”

These kinds of ads came under scrutiny during hearings in the U.S. House of Representatives. www.house.gov Dr. Janet Woodcock, the FDA's Deputy Commissioner for Operations, testified http://www.latimes.com that "A lot has happened in the last decade with direct-to-consumer advertising, and we believe it's time to receive additional input.” "It's critical, from a public health standpoint, that the advertisements are truthful and balanced."

But do the ads tell the whole truth? They don’t tell the risks when they can avoid it, and that happens all the time. Through lawyers and public relations firms, Big Pharma’s got quite a lobbying effort going. http://www.sourcewatch.org/index.php?title=Pharmaceutical_Research_and_Manufacturers_of_America Dr. Paul Anthony is Chief Medical Officer at the Pharmaceutical Research and Manufacturers of America. www.phrma.org He says, “Drug consumer advertising is a powerful force that can educate patients and it gets them to go in and have an informed discussion with their physician about their health conditions and treatment options.” When women intend to give birth, they need to know about the risks to their babies if they take Paxil.

The Television Viewer and the Depressed Mom

Jim Fitzgerald — Sat, 23 Dec 2006 14:36:32 GMT

Patients without enough information about a drug’s side effects sometimes ask for it by name. Commercials for prescription drugs fill the airwaves.

The New York Times www.nytimes.com published a report on fliers who need help overcoming their fear of flying. One traveler, a computer systems analyst at a bank in Columbus, Ohio, faced psychological hurdles while boarding a plane. This flier choked at the gate at the Columbus airport just when about to board a flight to Dallas. “I was at the gate and I could not walk down the jetway. So I went home.” The would-be passenger saw a doctor, who prescribed Paxil, “a drug often prescribed for acute anxiety disorders,” according to the Times.

How does an anti-depressant wind up being an anxiety drug? How does it wind up in the list of medications a doctor might prescribe to an expectant mother? Why not advertise that taking Paxil while pregnant may cause a woman to give birth to a baby with heart defects? The drug companies owe the public more information.

Ad dollars and damaged babies

Jim Fitzgerald — Fri, 15 Dec 2006 13:41:59 GMT

We wish drug companies had to fully disclose all the side effects of drugs as prominently in their ads and public relations campaigns that tout the benefits. Drugs that a well-meaning doctor prescribes for one disorder may cause other, unintended results. Our goal is to make products safer, and that includes promoting better warnings. The Paxil verdict we were privileged to obtain was based on lack of warnings about side effects. Drugs can do a world of good, but patients need to know all the risks. Pregnant mothers suffering from depression or anxiety might be interested to know that funding on drug ads skyrocketed from $791 million in 1996 to more than $4 billion in 2004. Commentary about risks to unborn children, and about drug company advertising comes from broadcasts like Marketplace www.marketplace.org on National Public Radio. www.npr.org “Direct to consumer advertising” started in 1997 when the FDA changed its regulations: prescription drug ads no longer had to include complete details of potential side effects. The drug companies could leave out details in their ads if a web site or the Physician’s Desk Reference www.pdrhealth.com talked about them. But a pregnant woman does not get the information she needs from ads, and may not know what is on a web site or in a book her doctor may or may not have read. Expectant mothers may be influenced by advertisements, without knowing about studies that point to a link between taking Paxil during the first trimester of pregnancy and heart problems in their newborn babies. The side effects don’t make it into the ads.

Scientific publications reveal side effects. For example, they suggest the possibility of increased risk for suicidal behavior in adults taking antidepressant medications. www.fda.gov/cder/drug/advisory/SSRI200507.htm The Food and Drug Administration www.fda.gov issued public warning that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start the pills or change a dose. www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2005/07/01/national/w081559D78.DTL But not enough information about the potential dangers of Paxil to a growing fetus has gotten out to the public. Expectant mothers and women who may become pregnant are advised to check with their doctors and find out all the side effects before taking Paxil. We recommend checking the side effects of all advertised drugs.

Another Warning for Pregnant Women

Jim Fitzgerald — Fri, 01 Dec 2006 11:46:51 GMT

Today's New York Times www.nytimes.com published another warning that alerts every woman to risks of Paxil if they are expecting a baby or may become pregnant. The Times reported that the American College of Obstetricians and Gynecologists www.acog.org has warned that women who are pregnant, or plan to be, should avoid taking Paxil because of a risk of birth defects. ACOG published its alert in the December issue of Obstetrics & Gynecology, its important journal.

It has been almost a year since the Food and Drug Administration www.fda.gov and GlaxoSmithKline www.gsk.com issued warnings about an increased risk of birth defects in babies born to mothers taking Paxil.

Alarmingly, two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies suffer heart defects at a rate as much as twice what is normal, the FDA said about one year ago. Now the American College of Obstetricians and Gynecologists has discussed treatment of pregnant women with SSRIs, a class of antidepressants that includes Prozac, Zoloft and Lexapro as well as Paxil. Today's publicity will help, we hope, get the word out to expectant mothers about the risks of Paxil to their unborn babies.

Pregnancy, Paxil and a “Dear Doctor” letter

Jim Fitzgerald — Sun, 19 Nov 2006 18:31:35 GMT

In a recent post, we reviewed the results of a study that linked Paxil to injury in babies in utero. www.nytimes.com After that study, the Federal Drug Administration www.fda.gov started warning doctors and consumers that Paxil may be related to birth defects in the hearts of newborns: "Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said in a news release.

You can also review this development related to heart malformations at www.webmd.com and the journal called Psychology Today www.psychologytoday.com although you do not want to stop your inquiry there.

At www.npr.org/templates/story/story.php?storyId=4945096&ft=1&f=2 you can download a “Dear Doctor” letter notifying health care providers of the potential risks of pregnant mothers using a drug such as Paxil during pregnancy. Pregnant women might want to click under Web Resources where it says “GlaxoSmithKline Warning Letter Sent To Health Care Providers.”

Paxil’s maker, GlaxoSmithKline www.gsk.com, and the FDA expanded the uses of Paxil. First, Glaxo marketed it for treating depression. Over the years, the FDA approved it for panic disorder, OCD and social anxiety disorder. Now we are learning that if a mother took Paxil,the drug may have caused birth defects, specifically a heart defect, in babies.

Babies Damaged by Paxil - What's Next?

Jim Fitzgerald — Wed, 08 Nov 2006 13:15:32 GMT

As a result of ongoing research following our verdict (the only one in history against Paxil’s maker), we have identified two kinds of damage reportedly caused to babies by this drug. Yes, we’re lawyers, and we follow the medical literature about Paxil. The first kind of damage is bad, and the second is worse.

About 800,000 women in the United States each year suffer from depression with moderate to severe symptom during pregnancy. Some of them take SSRI antidepressants. http://www.nytimes.com/2006/02/21/health/21brod.html?pagewanted=2&ei=5070&en=68d2646a31820fa7&ex=1146024000 Some of those take paroxetine hydrochloride, marketed as Paxil. GlaxoSmithKline www.gsk.com markets Paxil.

Babies whose mothers took Paxil during the late stages of pregnancy sometimes suffered a form of withdrawal after birth. While this might not be considered a birth injury, it is nevertheless distressing. http://www.healthyplace.com/Communities/depression/treatment/antidepressants/articles/004.asp

The second kind of damage came to light last fall when the Food and Drug Administration http://www.fda.gov issued a warning after reviewing the results of a study that linked Paxil to birth defects. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html The FDA reviewed studies about Paxil’s “risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.” http://www.fda.gov/cder/drug/InfoSheets/patient/paroxetinePT.htm The preliminary figures http://www.nami.org showed twice as many birth defects of the baby heart in babies born to mothers who took Paxil in the first three months of pregnancy. http://pregnancy.about.com/od/antidepressants/a/paxilinpreg.htm We get calls and email nearly every day about Paxil and, alarmingly, some of those contacts are about babies, so we started our research. There’s more to follow in future posts.

Pregnant and Taking Paxil?

Jim Fitzgerald — Mon, 24 Apr 2006 17:33:45 GMT

At first, our concern for newborns was that if their mothers took Paxil during the late stages of pregnancy, the newborns themselves could suffer a form of withdrawal, causing health problems in these babies. http://www.healthyplace.com/Communities/depression/treatment/antidepressants/articles/004.asp

Then in late 2005, the Food and Drug Administration www.fda.gov issued a warning after reviewing the results of a study that linked Paxil to birth defects. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html. The FDA determined that exposure to Paxil (generic name: paroxetine) in the first trimester of pregnancy may increase the risk for cardiac malformations. A number of women taking Paxil during the first trimester of pregnancy, compared with women using other antidepressants, reportedly had babies who were born with heart problems. http://www.fda.gov/cder/drug/InfoSheets/patient/paroxetinePT.htm. The FDA advised that preliminary data revealed double the rate of birth defects, specifically heart defects, in babies born to mothers who took Paxil in the first three months of pregnancy. http://pregnancy.about.com/od/antidepressants/a/paxilinpreg.htm

Since December, the FDA has presumably been gathering additional data on the problems caused newborns when their mothers have taken Paxil. www.nami.org Meanwhile, concerned parents of newborn with heart problems have been contacting us.

We maintain this blog in an effort to spread useful information to the 800,000 women in the United States each year who suffer moderate to severe depression during pregnancy, and who may take SSRI antidepressants www.nytimes.com/2006/02/21/health/21brod.html?pagewanted=2&ei=5070&en=68d2646a31820fa7&ex=1146024000. Paxil (paroxetine hydrochloride) is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). With too little serotonin, people can become depressed. SSRIs like Paxil prevent the re-uptake of serotonin, so that it circulates in the body longer and help cut down on the symptoms of clinical depression.

In addition, women who suffer from other illnesses may be taking Paxil. Doctors prescribe it for generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder, as well as depression. GlaxoSmithKline PLC, the maker of Paxil, applied to the Food & Drug Administration for permission to market Paxil as an effective treatment for acute social phobia, an extreme form of shyness. For whatever reason you or a loved one may be taking Paxil, be sure to review the side effects with your physician, especially if you are going to have a baby.

Paxil and Your Baby

Jim Fitzgerald — Tue, 28 Mar 2006 18:04:43 GMT

Last fall, the FDA www.fda.gov started warning doctors and consumers that Paxil may be related to birth defects. "Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said in a news release.

As you know from past posts, we took on Paxil in court - in the only successful trial ever against Paxil's maker - and proved it causes some people to commit suicide. Now there is evidence it causes problems for the most innocent in our society, babies.

You can find more information about this at www.webmd.com Journals in the health care professions like Psychology Today www.psychologytoday.com are joining the effort to get the word out to parents. Most common are heart malformations, or holes between the baby heart's two main pumping chambers.

You can download the “Dear Doctor” letter notifying health care providers of the potential risks of using a drug such as Paxil during pregnancy at http://www.npr.org/templates/story/story.php?storyId=4945096&ft=1&f=2 by clicking under Web Resources where it says “GlaxoSmithKline Warning Letter Sent To Health Care Providers.”

Prescription: Suicide? - Truth and Power on Film

Jim Fitzgerald — Fri, 18 Nov 2005 23:02:21 GMT

For anyone who’s ever loved someone on anti-depressants, this film, Prescription:Suicide? tells your story.

It was my privilege to be invited to view it at the International Film Festival in Florida last week. It captures the pain – and the devotion – of families devastated by SSRI medications.

The film itself captured a top award at the festival. It was well-deserved.

This film dispenses justice in a way the pharmaceutical companies never have. You can learn more about it and get information about the next showing at www.prescriptionsuicide.com.

What about those warnings, Doctor?

Jim Fitzgerald — Wed, 16 Nov 2005 18:42:00 GMT

How effective are warnings about side effects of SSRI medication? We're concerned that doctors are still not telling their patients enough about Paxil. On November 15th, the New York Times reported “Moreover, drugs widely billed as nonaddictive, like Paxil or Effexor, can cause withdrawal symptoms, which some patients say they only learned of from their friends or fellow sufferers.” www.nytimes.com Doctors should be telling their patients this.

More important, they need to tell their patients about the risk of suicide. It looks like the long-fought-for “Black Box” warnings are inadequate. Perhaps the doctors are telling their patients about suicide risks but not withdrawal problems, but we doubt it. If people have to learn about symptoms from “their friends or fellow sufferers,” there's something wrong with the way the drug makers are educating doctors.

We call on SSRI anti-depressant makers to re-double their efforts to educate doctors about the risks of suicide with antidepressants. Maybe they are afraid it will cost them profits if their drug reps sit down with doctors and really talk about the risks. But shouldn't all patients and their families get solid, strong warnings about what to watch for?

Paxil at the International Film Festival

Jim Fitzgerald — Tue, 15 Nov 2005 00:25:32 GMT

Some producers invited me to the International Film Festival in Florida last week for a showing of their film "Prescription: Suicide?" I'll be posting a lot more about this important documentary in the coming days. For now, I say: "You need to see this film." It's about six families affected by anti-depressants their children took. Some of the children lived to tell about it - some didn't.

Stay tuned. I'll be back with more.

Dangers and Drug Company Ads

Jim Fitzgerald — Fri, 04 Nov 2005 21:59:33 GMT

Commercials for prescription drugs show up on TV all the time. The side effects are not so prominent. Several recent scientific publications suggest the possibility of increased risk for suicidal behavior in adults who are being treated with antidepressant medications. www.fda.gov/cder/drug/advisory/SSRI200507.htm

The Food and Drug Administration www.fda.gov recently issued another public warning that adults who use antidepressants should be closely monitored for warning signs of suicide, especially when they first start the pills or change a dose. www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2005/07/01/national/w081559D78.DTL

Why do the ads promoting these medications directly to consumers even exist?

The profit motive is paramount. Funding on drug ads skyrocketed from $791 million in 1996 to more than $4 billion last year and critics say the ads work too well, as reported on Marketplace www.marketplace.org on National Public Radio. www.npr.org

It’s called “direct to consumer advertising” and it didn't even exist ten years ago. Then in 1997, the FDA changed its regulations: prescription drug ads no longer had to include complete details of potential side effects. The FDA said the details could be omitted if that information was available somewhere else, such as a web site or in the Physician’s Desk Reference. www.pdrhealth.com

Dr. Peter Lowry is with Public Citizen www.citizen.org, a non profit consumer advocacy group. He says direct to consumer ads are a problem. “It was made to seem as if it was some ordinary regulatory step but in fact, it just totally opened up the flood gates and television has never been the same.”

But the FDA is taking another look. This week, there was a new round of hearings on Capitol Hill. www.house.gov Dr. Lowry says the ads encourage patients to ask their doctors for these advertised drugs. The ads make it harder for doctors to refuse patients who seek specific drugs.

"A lot has happened in the last decade with direct-to-consumer advertising, and we believe it's time to receive additional input," said Dr. Janet Woodcock, the FDA's Deputy Commissioner for Operations. "It's critical, from a public health standpoint, that the advertisements are truthful and balanced." www.latimes.com

Marketplace reported on a case like many we see in our office. A husband started a stressful job. He couldn't sleep. He went to the doctor who gave him Zoloft and he immediately suffered a rare side effect not advertised. It is called akathesia, a medical term for extreme internal agitation, or being jumpy, all shook up, very nervous. We see cases where these symptoms came before death.

The man’s wife told Marketplace how her husband came home one day and sat on the floor with his hands around his head “like a vise,” sitting in the fetal position, crying out that he did not know what was happening to him. This sort of behavior shows up in SSRI anti-depressant cases.

Ten days later, the husband killed himself. The man didn't start out with depression. He sought the medication for his stress-related insomnia. The ads motivate people to seek these potent medications like Zoloft and Paxil. Some die by suicide.

Since 1997, when the FDA relaxed the rules on marketing, prescription medicines for depression have moved from medical journals to television networks and consumer magazines. These ads creatively describe the benefits of a more cheerful mood, but in fairness, we’d like to see more said about the side effects.

One study shows that the drug ads lead to doctors writing five times as many unnecessary prescriptions. But Big Pharma responds that the study also concluded that people who might have otherwise gone untreated for embarrassing conditions seek help because of the ads. Dr. Paul Anthony is Chief Medical Officer at the Pharmaceutical Research and Manufacturers of America. www.phrma.org He says, “Drug consumer advertising is a powerful force that can educate patients and it gets them to go in and have an informed discussion with their physician about their health conditions and treatment options.”

Yes, that’s true. But is it right? How about educating the prescribing doctors better about how to warn families about side effects? And cut back on the direct to consumer ads that push people into dangerous drugs.

You might want to balance a visit to the Big Pharma web site with one to www.sourcewatch.org/index.php?title=Pharmaceutical_Research_and_Manufacturers_of_America where you can learn about its silk-stocking lawyers and lobbyists.

Don’t misunderstand us; we’ve got nothing against the profit motive here. But if Big Parma’s members are going to profit by not fully advertising side effects, we’d like to change that.

GSK sends "Dear Doctor" Letter About Paxil and Pregnancy

Jim Fitzgerald — Thu, 27 Oct 2005 17:50:34 GMT

A dear doctor letter is prepared by a drug company when wants to notify health care providers of the potential risks of using a drug, such as Paxil. Notification is compelled by various circumstances, which usually include a push by the FDA www.fda.gov. This time, the dear doctor letter is five pages long and discusses Paxil and pregnancy.

You can download the “Dear Doctor” letter at http://www.npr.org/templates/story/story.php?storyId=4945096&ft=1&f=2 by clicking under Web Resources where it says “GlaxoSmithKline Warning Letter Sent To Health Care Providers.” You can also listen to the news about Paxil and pregnancy at that site.

At the bottom of the third page of the “Dear Doctor” letter, GSK states that it “conducted a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. A preliminary analysis has recently been conducted, which yielded adjusted odds ratios of 2.20 (95 % confidence interval [CI]: 1.24-3.63) for congenital malformations as a whole, and 2.08 (CI: 1.03-4.23) for cardiovascular malformations alone, for paroxatine, as compared to the other antidepressants in the database. The prevalence of congenital malformations as a whole and cardiovascular malformations alone were approximately 4% and 2%, respectively. Of the cardiovascular malformations reported in infants whose mothers were dispensed paroxatine, the majority were ventricular septal defects.”

Confidence intervals? You can roam around the internet and learn about statistics at web sites like www.angelfire.com/biz/rumsby/ASTUDY.html or we can simplify the “Dear Doctor” letter here.

When you cut through all of the statistical language about confidence intervals and the numbers, what it means is that twice as many babies born to pregnant women who had been on Paxil in the first trimester were born with major birth defects than were babies of mothers who were on other antidepressants. So it is important to check to see if one were on Paxil during that first trimester of pregnancy. That's when this study shows that one's chances of having a child born with a birth defect were twice as great than if the patient had been on some other antidepressant. This blog is not for medical advice. See a doctor for that.

We write this blog because we proved in a court of law that Paxil can be dangerous, and consumers need to know that. Paxil does a lot of good for a lot of people. However, some people are at risk on Paxil.

Paxil Profits Expand, But At Babies' Expense?

Jim Fitzgerald — Tue, 18 Oct 2005 18:16:16 GMT

It seems that Glaxo and the FDA www.fda.gov do quite a job of expanding profitable uses of Paxil but not of heading off problem uses. Paxil got approval for treating depression, then over time, the FDA approved it for panic disorder, obsessive-compulsive disorder and social anxiety disorder. But now the FDA is saying Paxil may cause birth defects.

What about all those babies whose mothers took Paxil for any of those conditions? Babies with birth defects whose mothers took Paxil during the first three months of pregancy showed up in a recent study that linked Paxil to birth defects. www.nytimes.com The study showed twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

How is it that Glaxo can expand the list of conditions Paxil will treat, long before it finds out that it apparently causes birth defects. Paxil has been advertised for a long time for conditions other than depression. Did Glaxo know nothing about its link to birth defects in all that time? If not, why not?

Were all those other conditions, like obsessive-compulsive disorder, panic disorder and social anxiety disorder, clear enough that Glaxo was allowed to profit on them, while Glaxo just couldn't see a link between Paxil use and damaged babies? How is it that the profitable uses get right out to the public but problems for babies don't get studied until much later?

Now, Babies and Paxil

Jim Fitzgerald — Fri, 30 Sep 2005 22:19:58 GMT

When will it end? We took on Paxil in court and proved it causes some people to commit suicide. Now the FDA www.fda.gov is warning doctors and consumers that Paxil may be related to birth defects.

A new study reveals major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy. www.webmd.com Broadly disseminated journals like Psychology Today www.psychologytoday.com are joining in to get the word out to parents.

"Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA says in a news release.

GlaxoSmithKline recently conducted a study of more than 3,500 pregnant women and found twice as many major birth defects among women on Paxil, as on other antidepressants. This happened in infants born to women who took antidepressants (including Paxil) during the first trimester of pregnancy.

Glaxo has made changes to the labeling information on pregnancy precautions that goes out with Paxil, says the FDA. Ok, but now we have to ask the same question we asked in the Paxil trial in court: How long did Glaxo know about this?

The study was a retrospective, or backward-looking epidemiological study. That means it looked at this large group of women in hindsight. So when did Glaxo know about this potential, heart-threatening problem for babies?

Most of the birth defects revealed by the study were heart related, most commonly heart malformations, or holes between the heart's two main pumping chambers.

Paxil's web site talks about the study this way: "Tell your doctor if you are pregnant or plan to become pregnant as there is a potential risk to the fetus with [Paxil]. Some studies of [Paxil] in pregnant women have suggested a possible increased risk of malformations, while others have not shown such a risk."

The Paxil web site also says: "Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.”

"Like many antidepressants, Paxil can be present in breast milk so tell your doctor if you are nursing."

Now you tell them. When did Glaxo know, and what did it know? My goodness, even babies may be at risk from Paxil?

Nauseating Drug Pricing Practices

Jim Fitzgerald — Thu, 22 Sep 2005 17:55:15 GMT

Remember when we told you how Ven-A-Care blew the whistle on Glaxo for a drug pricing scheme? California's Attorney General took action against Glaxo for allegedly defrauding California through a drug pricing method. The California action was prompted by a whistleblower lawsuit filed by a pharmacy company, Ven-A-Care, alleging that Glaxo provided false and misleading drug pricing information that the Medi-Cal program relied upon to establish its drug payment rates. Ven-A-Care also prompted the Florida Attorney General to file a similar case. www.sptimes.com/2005/07/21/State/State_files_drug_pric.shtml

Now the United States Department of Justice www.usdoj.gov has announced that Glaxo has agreed to pay more than $150 million to settle fraud accusations over the pricing and marketing of two drugs for nausea. www.nytimes.com

The Justice Department said Glaxo charged health care providers less for the drugs, knowing that the providers would be able to pocket the difference. GlaxoSmithKline, based in London but with American offices in Philadelphia, denied wrongdoing. Its spokeswoman claimed, "We believe that our price reporting was lawful and was done in good faith, but we've agreed to this settlement to avoid the delay, expense and uncertainty of litigation." Well, no one pays $150,000,000.00 for nothing.

The United States Department of Justice started its investigation into this drug pricing deal after - you guessed it - the pharmacy company Ven-A-Care filed a whistle-blower lawsuit. So the efforts of Ven-A-Care prompted not only California and Florida to go after Glaxo, but also the United States.

Paxil, Norway and The Constant Gardener

Jim Fitzgerald — Sun, 11 Sep 2005 19:36:01 GMT

The Norwegians are the latest to determine Paxil can cause some people to commit suicide. A study in Norway found that patients taking Paxil attempted suicide seven times, compared to one patient who attempted suicide while on fake medication, called a placebo. www.medpagetoday.com

The Norwegian scientists reported on 16 studies conducted with 916 patients on Paxil and 550 on placebo. Of course, GlaxoSmithKline criticized the study as "misleading" and based on outdated and "incorrectly selected" data. Talk’s cheap. In a court of law, Glaxo had to contend with the facts, and the jury found Paxil caused death by suicide.

Is it any wonder that a new film, The Constant Gardener www.theconstantgardener.com includes the line, "Big pharmaceuticals, they're right up there with the arms dealers"? That’s how low the drug makers’ reputations have sunk, in the wake of the Paxil verdict www.fitzgeraldlaw.com and others.

As to this new study, Glaxo said it “serves only to cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor,) such as paroxetine, for treatment of depression." Let me tell you that the jury in the Paxil trial in court – where Glaxo had outstanding lawyers, and a lot of them - found unanimously and unequivocally “by a preponderance of the evidence that Paxil can cause some individuals to commit suicide.”

After the Paxil verdict drew world-wide attention with reports in the New York Times www.nytimes.com, The L.A. Times www.latimes.com, The Today Show www.nbc.com, The Early Show www.cbsnews.com and all over the radio waves, the United States Food and Drug Administration www.fda.gov required all antidepressants to carry warnings about the increased risk of suicide to children and teenagers. Last year, the FDA said it is reviewing data to determine whether there is an increased risk of suicidal thinking in adults who take antidepressants. We already know Paxil does. Just read the verdict.

The FDA expects to take at least a year to complete its review. We wish it would move faster.

The Norwegian scientists who did the Paxil study suggested that adults be included in regulatory warnings. How much more does the FDA need. Science and the court result show that adults should be warned.

"We also conclude that the recommendation of restrictions on the use of paroxetine for children and adolescents recently conveyed by regulatory agencies should be extended to include usage by adults," read the report.

Drug companies’ reputations have taken a “huge plunge," observes Fran Hawthorne, author of "Inside the FDA." "The teenagers using antidepressants and all those stories about kids committing suicide, and then the Vioxx withdrawal." Although "http://www.gmp1st.com/FDA.htm" is not a website about Fran’s book, that site is kind of interesting.

The Paxil trial was no miscarriage of justice – Wyoming jurors are conservative. Since they spoke their verdict, there has been a lot of news about Paxil and children. “Children and teenagers already taking Paxil should not suddenly stop the pills,” the FDA has said. “Some doctors may feel the drug is helping enough to keep a particular patient on the drug, which the FDA warning doesn't forbid. www.usatoday.com Of course not. Here's what we ask: that all parents get warnings, so they can know what to look for if someone on Paxil is becoming suicidal. That’s the point of warnings. Shouldn’t all pediatric and adult patients get the same warnings?

A Billion Here . . . .

Jim Fitzgerald — Fri, 09 Sep 2005 22:12:59 GMT

A United States Senator from Illinois famously quipped, "A billion here, a billion there. Pretty soon it adds up to real money."

Glaxo's been on the acquisition trail lately, and it's spending billions. The latest news is an agreement to buy a Canadian vaccine maker for about $1.4 billion. www.nytimes.com

That's one thousand four hundred million dollars, if you want to look at it that way. Glaxo is only the world's second-largest drug maker. Pfizer is number one, with more billions.

Recently, another drug company, Novartis AG, bid $4.5 billion to acquire the 58% of a drug maker Chiron that it doesn't already own. www.wsj.com

Some commentators suggested Novartis wasn't paying enough, compared to what Glaxo bid for ID Biomedical of Canada. An analyst at Sanford C. Bernstein & Company www.bernstein.com predicted that the relatively higher price Glaxo offered for ID would pressure Novartis to raise its offer for Chiron.

Wow, a billion here, a billion there, and as the Senator said, we're talking about real money.

Glaxo Paid $88 Million in Penalties

Jim Fitzgerald — Mon, 05 Sep 2005 20:12:55 GMT

GlaxoSmithKline has paid $88 Million in penalties to settle allegations of pricing fraud for Flonase and Paxil. The Wall Street Journal www.wsj.com said "the cases are part of an expanding industrywide investigation of drug pricing."

This investigation shows that the federal government is putting drug makers under the microscope to look at their pricing practices. This is good, especially considering that next January, there will be a huge increase in spending for prescription drugs.

The head of the civil-fraud unit of the United States Justice Department said that "the most frequent defendant in fraud cases today is in health care." He also noted that Justice Department has focused on pharmaceutical companies over the past years. A spokesman for the non-profit advocacy group Taxpayers Against Fraud www.taf.org said the cases against Glaxo and other drug companies had so far revealed only the “tip of the iceberg.”

Cases arise under the Federal False Claims Act, a legal remedy revived in recent years. The Act, also known Qui Tam, was passed during the Civil War to help the federal government catch fraud upon military forces. In those days, someone could collect a bounty by blowing the whistle on sellers who cheated the government.

The Act still works in modern times, in cases where drug companies, for example, are supplying the government. If a drug company defrauds Medicaid, as alleged in the case against Glaxo, and someone calls that to the attention of the Justice Department, the government can take the case, collect what's owed, and pay a bounty.

The person who blows the whistle is called a relator. One whistleblower named Couto was a former marketing executive at Bayer. The government nailed Bayer for more than $257 Million for allegedly defrauding Medicaid. The relator's share of the Bayer portion of the settlement is $34 million. That's a lot, and that kind of incentive is needed to root out fraud.

Warnings and Debates-What You Need to Know about Paxil and Your Doctor.

Jim Fitzgerald — Mon, 29 Aug 2005 17:22:59 GMT

The debate continues about whether warnings are causing physicians and patients to use medications less often. Some people say that detailed warnings are bad for patients and their doctors because they are less willing to use the meds.

But when companies like Glaxo put direct-to-consumer ads on television, we think it’s best if the warnings are thorough and explicit. Drug makers advertise directly to consumers and tell them to ask their doctors about such and such a medication. OK, it’s a capitalist country. But it’s also a good idea to require the warnings, to counter-balance the marketing campaigns.

After all, even good web sites like www.webmd.com say things like: “Can antidepressants contribute to suicidal tendencies? The jury is still out . . . .” Well, if you’ve been following this blog, you know that the jury is not out on Paxil. A real jury found that Paxil can cause some people to commit suicide. So let’s just say that www.webmd.com was using a figure of speech.

The site went on to say “but concern is high enough that the FDA issued a public health advisory, warning that certain antidepressants might worsen depression and cause agitation, anxiety, and hostility in some patients.” The site brought a psychologist, Patricia Farrell, Ph.D., to talk about warnings.

As www.webmd.com reminds us, “if you have questions about your health, you should consult your personal physician. This event is meant for informational purposes only.” Webmd.com made a prophetic statement about the FDA action, that “it's sure to create a lot of confusion.” The FDA didn’t really cause the confusion. As Dr. Farrell replied, “The patient must be aware of the potential side effects and a qualified physician must be monitoring their use of it.”

So what’s a qualified physician? As you know from our past posts, one of SmithKlineBeecham’s expert witnesses testified in our trial that only a psychiatrist is qualified to take a detailed psychiatric history. The warnings can’t turn every doctor into a psychiatrist, but guess what, the warnings can make doctors think twice about the side effects. After all, Dr. Farrell said, “The FDA advisory is really just a prudent reminder that people who are depressed may become suicidal.”

The site answered a question from one of its members who asked why the FDA has to intervene in this “issue that would seemingly be left in the hands of the ‘experts?’ Have the doctors dropped the ball on this issue?”

Dr. Farrell answered that it was wise for the FDA to require better warnings. First, anti-depressants are used for a lot of symptoms, not just depression. More to our point, she said, “many physicians prescribing these medications are not psychiatrists. This . . . is of great concern, because general practitioners do not usually receive specialized training in recognizing and treating psychiatric illnesses.” Dr. Farrell, you are so right.

Dr. Farrell concluded that it “seems wise, therefore, that the FDA advises everyone about its concerns.” Yes, Dr. Farrell, we agree, and our jury agreed. The jury took to heart the defendant drug company’s own expert witness, who told the truth about non-psychiatrists’ limitations in dealing with psychiatric patients: such patients require the taking of a good psychiatric history and non-psychiatrists are not qualified to take one.

As long as the medical community is going to allow non-psychiatrists to prescribe anti-depressants, detailed warnings to them and their patients are essential. We’re dealing with life and death here.

Tales of Two Drug Makers

Jim Fitzgerald — Fri, 26 Aug 2005 23:46:14 GMT

I don’t know what’s more interesting today, the new California lawsuit against GlaxoSmithKline, the maker of Paxil. Or the reports that Merck is finally going to settle Vioxx cases.

Merck’s top lawyer revealed plans to settle Vioxx cases where patients had a heart attack and had taken Vioxx for a sufficient time, if they had few other risk factors for heart disease. The New York Times www.nytimes.com reported that the comments of Merck’s chief counsel “appear to represent a subtle but important shift in strategy for Merck.” Subtle? Merck had always declared that it would never, ever settle Vioxx cases, that it would fight every one of them in court. That was just bluster, intended to persuade patients that Merck had a scorched-earth policy. Merck was trying to scare patients and their families out of taking on the giant drug manufacturer, and its highly paid lawyers and jury consultants. Well, Merck has changed its mind, with some persuasion by ordinary citizens sitting on a jury.

Kind of makes you wonder, doesn’t it? Here’s Merck changing its strategy after one trial. That tells me Merck knows darned well that the jury was right.

As to Glaxo, California’s Attorney General took action against it and other pharmaceutical companies for allegedly defrauding California through a drug pricing scheme. The suit alleges that drug makers forced the state’s Medi-Cal program to pay artificially inflated rates, resulting in a loss of potentially hundreds of millions of dollars.

In California, health care providers are reimbursed for drugs dispensed to Medi-Cal patients. The reimbursement rates are based on pricing data supplied by drug manufacturers. Imagine that. The suit alleges that the drug makers manipulated the prices, resulting in inflated costs.

The California action was prompted by a whistleblower lawsuit filed by a pharmacy, Ven-A-Care, alleging that pharmaceutical manufacturers provided false and misleading drug pricing information that the Medi-Cal program relied upon to establish its drug payment rates.

Turns out that Ven-A-Care blew the whistle on drug makers in other places, too. In Florida, Ven-A-Care prompted the Attorney General to file a similar case. You can read more about it at www.sptimes.com/2005/07/21/State/State_files_drug_pric.shtml

You can see the suit papers on the California Attorney General’s website at www.ag.ca.gov.

Vioxx and Paxil - Twin Defenses

Jim Fitzgerald — Wed, 24 Aug 2005 23:09:04 GMT

Now that the dust has begun to settle after the Vioxx verdict last week, I want to give you my take on it. Whenever a drug company asks a jury to believe unbelievable things, a jury will straighten it out. Merck tried to tell the jury that it did not have enough evidence that Vioxx was causing health problems. Those are "bad facts," so-called by the New York Times www.nytimes.com. The Times reported that the jurors came to the conclusion that Merck was "long aware of Vioxx's potential heart risks but his those risks from patients." Merck hid the risks from doctors, too, by training its drug reps to play "Dodgeball" and deflect doctors concerns away from Vioxx's risks.

The same think happened when SmithKlineBeecham (now GlaxoSmithKline) tried to tell our jury that there weren't problems with Paxil. But the evidence was overwhelming that there were risks. And the defendant knew the risks of Paxil. But it didn't tell doctors or their patients. So the jury told SmithKlineBeecham it was wrong. I argued to the jury that SKB "should have put more information in the product instructions, the blue book that all practicing physicians have in their office about drugs and their side effects." www.fitzgeraldlaw.com

Ask your doctor. He or she will tell you they have the PDR. A new volume comes out yearly. It lists just what I said, side effects. SKB knew a lot about side effects that it wasn't telling.

So just like the Vioxx jury, the Paxil jury told the drug manufacturer that it was wrong, and it had to pay up - that's justice. You're not going to get it from the government. You get justice from 12 fellow citizens. And by the way, 11 out of 12 of the Vioxx jurors were Republicans. The Paxil trial jurors were salt of the earth citizens, and you can't fool them - They won't buy fudging.

There's No "Might" about Paxil.

Jim Fitzgerald — Fri, 19 Aug 2005 23:14:50 GMT

In the past, according the New York Times www.nytimes.com, the FDA www.fda.gov didn’t issue warnings about drugs unless studies showed the certainty of risks. Agency officials claimed that they worried that requiring warnings about suspected problems would lead to patients not taking drugs they need.

According to the Times episodes involving antidepressants and suicide risk now have made the agency more cautious.

The paper of record, as it is known, went on to say “instead of waiting for proof, the agency has promised to issue public health alerts about drug risks even when problems are only suspected.”

“Only suspected”? We’ve proven Paxil can cause a vulnerable subpopulation of patients to become suicidal.

The Times noted that over the last year, the FDA required pharmaceutical companies to add “tough” warnings for antidepressant drugs because they “might lead a small number of teenagers to become suicidal.”

Whoa, there, New York Times. It’s not just teenagers. We proved Paxil caused a man in his sixties to commit suicide. That verdict came from the evidence, brought forth in a trial in a United States Courthouse, with a conscientious United States Judge running the trial.

For some reason, the Times said “according to disclosures at open hearings, the agency has acted with little or no evidence that the risks are real.” Whose “disclosures”? There’s no better evidence than evidence that passes muster in a United States Courthouse. Paxil can cause some people to commit suicide. Don’t take my word for it. See the verdict for yourself at www.fitzgeraldlaw.com. We want doctors to have proper information so they can warn patients and their families about what signs to look for that would tell them their loved one is vulnerable.

Doctor Says Stop!

Jim Fitzgerald — Thu, 18 Aug 2005 03:41:00 GMT

"I recently decided to stop seeing drug-company sales reps." So begins the declaration of one Dr. Benjamin Brewer, a family practice doctor in Forrest, Illinois. His saga about pharmaceutical-company salespeople appeared recently in the Wall Street Journal www.wsj.com (you’ll need to go to the online Journal @ online.wsj.com/home/health) and it's flabbergasting.

The good doctor says that these company reps' sales pitches "cast a drug in the most favorable light." Right in line with our beliefs, Dr. Brewer says that items the drug makers sales force hands out are shown by research to "affect doctor's prescribing habits enough that companies continue to offer them."

We've talked before in this blog about how these attractive sales people spin their companies' products. Indeed, Dr. Brewer describes them as "likable, almost universally friendly and highly trained to detail the purported benefits of their products." In fact, they used to be called ‘detail men.’

Now here's some blockbuster news: Dr. Brewer informs us that these reps know how much of their company's drug he prescribes compared with similar products. He notes, “Federal privacy laws prevent me from disclosing any health information about a patient.” So how do the reps know? We can hardly believe this: pharmacies and pharmaceutical-benefit managers sell doctors’ prescribing data to the drug companies.

Here’s another shocker. Dr. Brewer says, “For a short while I used a free software program on my PDA to prescribe medications and wirelessly print them out. It was handy, and worked really well, but I later learned it was tracking every move I made and allowed the company to sell real-time data to the pharmaceutical industry.”

Can you imagine this? Drugs are supposed to be health aids – what we’ve now learned is how far drug companies will go to turn drugs into profit centers.

Dr. Brewer wanted to get to the bottom of all this. So he did a test. He stopped writing prescriptions for a popular brand of antibiotic he had prescribed a lot. For about three months I held off to see what would happen. Dr. Brewer found that “the sales calls increased while the drug's sales rep became increasingly strident at each visit.”

After that, the doctor moved to a new system, but writes that drug companies “can still buy my prescribing information from pharmacies.”

Here’s another alarm. Apparently drug companies have cut back on giving out free samples. That’s too bad because good people like Dr. Brewer were able to help a patient in need with some free samples. Now the drug companies have come up with a more sophisticate, and alarming, marketing tool. A doctor now may have to issue a voucher to get free pills to a patient. There’s a catch – you may have to call the drug company to activate the voucher. When you do, they may collect information from you.

How did Dr. Brewer figure this one out? He must have done very well in school because he’s one smart person. In July 2005, he gave “one or two vouchers” for sample medication. Guess what! It wasn’t long until the drug company rep told the doctor that she was glad he was using them. In his own words, Dr. Brewer wrote, “The company had used the vouchers to more closely track my prescribing habits and direct their sales tactics.”

Now here’s a good part. Dr. Brewer has had enough. He’s not letting the drug reps into his office any more. He says, “The financial goal of the drug industry is increasing profits by getting doctors to prescribe newer drugs with fatter margins through increasingly personalized and sophisticated marketing tactics. This is contrary to the needs of my patients.” Way to go, Doctor. What a refreshing approach.

Now we have to hope that Dr. Brewer’s principled decision will light the path for other doctors. Prescribing decisions need to be based on the good judgment of doctors uninfluenced by the sleek marketing tools of the drug industry.

If You Don't Have A Drug Company, Get One.

Jim Fitzgerald — Mon, 15 Aug 2005 17:43:06 GMT

There's a cynical saying about oil and money: "If you don't have an oil well, get one." We suppose the same might be said about the drug industry.

We've already told you how much money SmithKlineBeecham (now GlaxoSmithKline) made every day on Paxil. At the time of the verdict against SKB in Cheyenne for Paxil-induced deaths, this drug manufacturer was making $6.4 Million a day on Paxil alone. We mention this because - although the jury did not know that figure - the judgment precisely matched it: $6,400.000.00.

Now we've learned more about how profitable the drug industry is. Based on a report at www.footnoted.org, we find out that since the former Chairman/Chief Executive Officer of Guilford Pharmaceuticals stepped down last December, he has done well financially. On July 21st, MGI Pharma announced that it was going to buy Guilford Pharmaceuticals for $178 Million. The result: Guilford stock went up by half again its value that very day. The Chairman/CEO did even better. He enjoyed the stock gain – he owns or has the option to buy about a million shares of Guilford.

More than that, the acquiring company, MGI, agreed to take over the contract for the Chairman/CEO's consulting and severance package. That contract pays him $560,000.00 a year for the next three years. It is not totally clear what the CEO/Chairman is expected to provide or how much time he is required to spend at MGI.

Another director at Guilford is going to benefit from the result of this merger with MGI. He will earn $22,500.00 per month, based upon a contract that will continue and that has already been paying him for the last ten years.

Guilford's new CEO now will get almost $2,000,000.00 in payments due to certain agreements he signed when he joined Guilford. That's for less than a year on the job. As the cynic would say, if you don't have a drug company, get one.

Deaths: Almost Twice As Many on Vioxx

Jim Fitzgerald — Thu, 11 Aug 2005 16:01:57 GMT

Vioxx went through a study Merck called, of all things, "Approve." Merck followed 1,299 patients who took placebos, pills with no drugs in them. This drug company also followed Vioxx patients, 1,287 of them. How many of the 1,299 who took the placebos had heart attack or strokes? 25. How many of the 1,287 who took Vioxx had heart attacks or strokes? 45.

Want to know what Merck Chairman of the Board/Chief Executive Officer at the time had to say? This chieftain of drug makers said the result that Vioxx increased the risks of heart attack and strokes was "totally unexpected." www.wsj.com

Well, yes, the patients and their families expected Merck to make a safe drug, not one that would kill. No doubt Merck's profits were not "totally unexpected" - Merck made a ton of money, and left a ton of heartache behind. We expect more from drug manufacturers. They should have to be more than money makers.

Five Times As Many Black Box Warnings

Jim Fitzgerald — Wed, 10 Aug 2005 22:07:50 GMT

The FDA www.fda.gov has started requiring a lot more drug-safety warnings. Compared to last year, the Federal Food and Drug Administration has doubled the number of public advisories about drug risks. There are now five times as many black box warnings on drug labels.

In preparation for the Paxil trial in Cheyenne, Wyoming, Glaxo's lawyers challenged a doctor who was testifying for the family to write a better warning. He did. Now the FDA is requiring warnings.

"Drug makers say the warnings are scaring patients and reducing sales," according the the New York Times www.nytimes.com. But consumers do need to be alerted - better warnings give them a chance to get better medical care. When the drug companies have to put more into black box warnings, then patients and their doctors can make better choices. Presribing medicines should not be easy - it should require time and thought. Decisions can have life and death consequences - what we asked is that GSK be required to tell doctors to tell their patients about the side effects, and to warn families about what to do if their loved one shows side effects. The side effects could include agitation, or depersonalization, not feeling like oneself, for example. We argued that Paxil's maker should have to tell doctors all the side effects, so the doctors could warn their patients and the patients' families. Better warnings lead to better care - inadequate warnings can lead to suicide. We're for better warnings. The FDA agrees.

Quite a Day in New York

Jim Fitzgerald — Mon, 08 Aug 2005 20:09:12 GMT

Jim Fitzerald is the editor of this blog. He had quite a day today - met with Senator Clinton www.senate.gov/general/contact_information/senators_cfm.cfm in New York City at breakfast, then lunch with Eliot Spitzer, The Attorney General for the State of New York www.oag.state.ny.us.

Jim gets around but, being from Wyoming where people quickly see right through phonies like they were three-dollar bills, he isn't generally impressed with luminaries. However, he said these two were especially powerful in person. Senator Clinton and General Spitzer are "for the little person," Jim noted. It was "refreshing" to hear from the Senator and the General. Both meetings were "off the record."

Jim spends a lot of time fighting for "checks and balaces" on corporate America. A goal of the Fitzgerald Law Firm www.fitzgeraldlaw.com is to protect consumers and families from the excesses of drug companies. They have sometimes failed to give adequate warnings about their products for consumer protection.

The Attorney General has targeted, among others, the pharmaceutical industry: he sued GlaxoSmithKline for allegedly hiding information about the antidepressant Paxil. Merck met the same fate at his hands for withholding information about Vioxx. "It's good to hear from a brother who fights for justice," Jim said after that meeting.

Is the FDA a Watchdog or not?

Jim Fitzgerald — Sat, 06 Aug 2005 17:33:01 GMT

Sen. Charles Grassley, a powerful Republican from Iowa who serves in the U.S. Senate www.senate.gov, has challenged the FDA's handling of SSRI issues. Just after a major FDA hearing, Grassley launched an investigation of the agency for allegedly concealing risks associated with the drugs.

Dr. David Healy (see our past posts about this heroic doctor) volunteered some details about the matter when he gave testimony for an investigation in the United Kingdom. Ten days before the FDA hearing, he said, three noted psychiatrists - who authored most of the trial literature on SSRIs - declared that the drugs were "safe and effective and well-tolerated by children," even though they had never seen the raw data on which their findings were supposedly based. But despite this "pre-emptive strike," Healy noted, the FDA www.fda.gov did go on to demand stronger warning labels for childhood use of the drugs.

By then, however, use of the drugs had already soared. A government study published last year showed that children who visited the doctor for depression symptoms were nearly three times as likely to wind up on prescription drugs (usually the newer SSRIs) than they were a decade ago. Adults - including 13% of women aged 45 to 64 – were also being prescribed such drugs, according to www.TheStreet.com.

Healy has pointed to drugmakers, which spend far more promoting their products than they do developing them, as the drivers behind that trend. "Corporations work out what they have to sell and then prepare the market so that we will want those products," he warned years ago. "It works for cars, oil and everything else. Why would it not work for psychiatry?"

Danger To The Public: U.S.House Puts its Thumb on the Scales of Justice

Jim Fitzgerald — Thu, 04 Aug 2005 23:22:56 GMT

If you've been following this blog, you know that we were privlieged to go to trial for a family wrecked by Paxil. The Grandfather was on Paxil for a short time, then shot his beloved Granddaughter, his daughter that he loved with all his heart, his devoted wife of many years and, finally, he killed himself. He had always been a peaceful man. The Paxil made him do it.

After that verdict against SmithKlineBeecham, now known as GlaxoSmithKline, there was a lot of publicity including artices in the New York Times www.nytimes.com, the Los Angeles Times www.latimes.com, and appearances on The Early Show, www.cbsnews.com and The Today Show, www.nbc.com, among many other news outlets. Ultimately, the verdict and all the publicity lead to hearings by the Federal Drug Administration www.fda.gov which then required better warnings. That was the goal of the lawsuit - the family we reresented wanted to keep other families from suffering the same fate, so they were gratified that their case sparked renewed interest in better warnings.

Now we are all concerned about legislative efforts to keep families from making a difference with their lawsuits. The House of Representatives has passed a bill that must not pass the Senate. If the bill had been law at the time of the Paxil case, we could never have taken it to court; the costs would have been probitive. No family ever has the money to pay lawyers by the hour to take on a giant like GSK or any other drug maker. No family has the huge amount of cash it takes to find experts with the knowledge and guts to go up against big drug companies. The House bill described below would make it even harder.

Hidden in the bill that is being falsely advertised as malpractice insurance relief for doctors are sweet product liability protections for the drug industry: sweeping immunities that will make it impossible for people injured or killed by unsafe drugs—like Paxil and Vioxx—to hold drug manufacturers accountable. Here's what the Association of Trial Lawyers of America www.atla.org states about the bill:

Specifically, the Bill Protects Drug Makers By:

Capping damages for any injury, or even death, at $250,000

* No matter how serious the injury it causes, and no matter how negligent its misconduct, a drug company like Merck will never have to pay more than $250,000 in compensation for noneconomic loss to patients and families who are injured or killed by defective drugs. Noneconomic damages are the only compensation for the injury itself, as opposed to reimbursement of out of pocket expenses.

* Non-economic damages compensate people for devastating injury or loss, such as having to live the rest of one's life in a wheelchair, or for the loss of fertility, or for excruciating and chronic pain.

* For people with low incomes, like stay-at-home moms, children, and seniors, noneconomic damages are often the only way to be fairly compensated for devastating injury.

Under H.R. 5, drug companies will keep their profits while injured people are denied justice.

Shielding pharmaceuticals from punitive damages

* Punitive damages are intended to punish companies when they put Americans at risk by marketing a product they know to be unsafe.

* This bill ensures that except in rare instances, drug companies will never be subject to punitive damages because the bill requires an injured person to prove that a defendant intended to harm that particular person, an impossible standard to prove against a drug company that sells to millions of consumers.

* It also specifically prohibits punitive damages for FDA-approved products. Amazingly, it doesn't stop there. It also gives immunity to drug makers for many drugs and devices that are not FDA-approved!

* Under H.R. 5, the only way to recover punitive damages against a drug company is to prove that it knowingly lied to the F.D.A. and even then, a plaintiff would also have to meet a heightened standard of proof. Even in the very rare case in which a patient meets this huge burden, the bill still caps punitive damages at $250,000 or two times the amount of economic damages- no matter how egregious the misconduct.

H.R. 5 removes all incentives for safety, eliminates punishment for misconduct and leaves the public's welfare in the hands of the drug industry.

What This Means for Consumers:

* Without the threat of full liability—especially liability for punitive damages—there are no financial disincentives for keeping profitable but dangerous, even deadly drugs and medical devices off the market.

* H.R. 5 forces consumers to accept a Washington-knows-best, one-size-fits-all limit on the compensation a jury would be allowed to provide for an injury caused by a defective drug or device.

House of Representatives Gives Up Your Rights

Jim Fitzgerald — Wed, 03 Aug 2005 00:03:03 GMT

The U.S. House of Representatives www.house.gov has passed a medical malpractice bill. (Bills in the House are known a "H.R" plus a number - this one is H.R. 5.)

It doesn't help doctors with high insurance rates - it just gives sweeping immunity to drug companies that knowingly market deadly drugs. The bill puts GSK's Paxil and Merck's Vioxx effectively beyond the reach of the civil justice system.

"The Congress showed once again where its true priorities lie with the big insurance and pharmaceutical companies and their well-heeled CEOs," said the President of the Association of Trial Lawyers of America, www.atla.org after the bill passed.

H.R. 5 provides immunity to the pharmaceutical industry. It put public health in danger by putting all of us in the position where we cannot enforce drug safety through the civil justice system. The House acted in the face of evidence that Merck may have knowingly marketed a dangerous and deadly drug. Not only would the drug companies get virtual immunity from punitive damages under this bill, their total liability for serious injury or wrongful death is capped at $250,000.

"The protection this bill gives the prescription drug industry is absolutely ridiculous, especially when these companies have proven they don't give a hoot about people's safety," according to a Democratic House member. He ought to know - he's also a pharmacist.

"All this legislation does is take responsibility away from the business community and allow dangerous prescription drug companies to make money like gangbusters. It mystifies me that people could vote for a bill that puts their own family in harms way," he continued.

"As Vioxx has shown, these big drug companies will not police themselves — we need the civil justice system to ensure that they are held accountable if they endanger the public's health," noted the ATLA President.

H.R. 5 does nothing to stop insurance industry price-gouging. But our direct concern here is how much influence the drug industry has over the House leadership: even H.R. 5's supporters in the House could not defend the bill. The House leadership refused to hold a hearing, limited floor debate, and refused to allow any amendments or substitutes.