Recently in Birth Defects Category

If you're feeling down, or if you're a woman with difficult menstrual cycles, or if you can't concentrate, Paxil will help you feel better and focus more clearly. That's the marketing message for the highly prescribed and hugely profitable SSRI (selective serotonin reuptake inhibitor) from GlaxoSmithKline.

What the marketing hype tries to hide is that Paxil poses dangers for people of all ages, including children in the womb. Studies have linked Paxil to a 100% higher incidence of birth defects in children whose mothers used Paxil in the first trimester of their pregnancies than in children whose mothers did not use the drug.  One of the common birth defects is a condition called persistent pulmonary hypertension (PPHN). Babies with PPHN have difficulty breathing, and many of them require significant medical care.

Other problems for children born to women who have taken Paxil in their first trimester include heart malformations and cranial defects which result in an abnormally shaped skull.

Despite the marketing claims, evidence that Paxil actually does what the manufacturer promises is extremely sketchy, while evidence that Paxil causes harmful and potentially deadly side effects is strong. And, people trying to quit the drug often find themselves painfully addicted.

Recently, Paxil was the subject of one of the most damning reports imaginable. In Paxil Study 329, researchers reached this amazing conclusion:

"There was no significant efficacy difference between paroxetine (Paxil) and placebo on the two primary outcomes or six secondary outcomes in the original protocol. At least 19 additional outcomes were tested. Study 329 was positive on 4 of 27 known outcomes (15%). There was a significantly higher rate of SAEs with paroxetine than with placebo. Consequently, study 329 was negative for efficacy and positive for harm.

Paxil's effects have been so bad for so many people that an online support group has developed.  The site even offers a free E-book called Paxil Withdrawal Guide.

In a 1999 case Paxil was implicated in causing a manic-depressive to become psychotic and to murder his wife.  

With all the harm that Paxil does, it's logical to ask why it's still on the market, and the easy answer is money. Paxil makes a lot of it for GSK, and the profit margin is absolutely staggering.

In 2005, a study found that the cost of the generic active ingredient for 100 tablets of Paxil was $7.60, while the price to the consumer was $220.27.

Businesses will make plenty of donations to powerful people to protect a profit margin like that.

A more insightful answer to Paxil's continued existence is that the FDA, which is supposed to protect consumers against dangerous drugs, is more interested in protecting the profits of drug makers. One reason for that obvious betrayal of the public trust is that drug manufacturers provide at least half of the FDA's funding.

So, despite the lawsuits, the damaged babies, and the citizens groups, GSK is free to market Paxil aggressively as an elixir for just about anything that ails you. You can even go to GSK's Paxil website and self-diagnose yourself for Social Anxiety Disorder (and, of course, a trip to your doctor for a Paxil prescription).

GSK, and other drug manufacturers, make such massive profits that they're able to consider a $6.4 million lawsuit against them just another cost of doing business, like labor and raw materials. With their billions in profits, they can pay $6.4 million out of Petty Cash.

Drug companies must like lawsuits, or they wouldn't willfully endanger the consumers who support them. So don't be afraid to stand up for your rights if Paxil has harmed you or your baby.

Onward,

Richard Alexander

While an embryo may die due to a chemical exposure and result in a miscarriage, a developing fetus will survive but can suffer altered DNA that results in malformations, deformities, retardation and birth defects - lifetime serious personal injuries that can and should have been avoided. 

It is not as if scientists haven't known that dangerous chemicals cause birth defects or only learned that fact recently.

Chemical manufacturers for decades did not report all known risks of chemical exposure, relying on the weakest reports assuring safety, to avoid loss of sales.

The same chemical suppliers that find themselves defendants in cancer cases are also defendants in birth defect cases because chemicals that cause mutations upset DNA.  Mutagens are carcinogens and teratogens.  The same chemicals that cause cancer are also responsible for birth defects.

Manufacturers are held responsible for birth defects becaus of failing to warn, but they have successfully provided themselves with a handmaiden in their defense known as the American Conference of Industrial Hygienists.  It is largely a chemical industry dominated organization that has set exposure levels for workers to prevent acute, i.e. immediate adverse physical reactions.  Unfortunately OSHA has adopted these weak standards. The result is that when chemical companies are sued for birth defects their chief defense is "we have done all that we are required to do" and the pregnant mother's exposures were within the levels allowed by law. 

But it doesn't end there. 

Proposition 65 was adopted by California voters demanding a healthy and clean environment.  As a result the State of California sets health-based environmental exposure limits for specific chemicals in air and water. 

The maximum concentrations are not allowed to cause more than one additional cancer per million people exposed to the chemical over their lifetime. 

California has very stringent public health standards. 

OSHA, on the other hand, allows manufacturers and employers to expose workers to levels of chemicals that are thousands of times higher than the health levels set by Cal EPA.

Methylene chloride, benzene, epichlorohydrin, trichloroethylene and perchloroethylene have been used in industry for years. Toxicologists confirm that these chemicals are known carcinogens.

The difference in how these chemicals are regulated by environmental and health laws and OSHA is astounding.

Under environmental regulations, the maximum concentration of methylene chloride that can be discharged to the air, if converted to what is known in industry as an "8 hour time weighted average," is .001 parts per million [ppm].

Under OSHA rules the "allowable" level of exposure for methylene chloride is 25 ppm, which is 25,000 times greater than the health standard.

For benzene, the OSHA level is 1 ppm, even though the health standard is 1 part per billion [ppb]. The OSHA standard is 1,000 times greater.

Health regulations allow exposures to epichlorohydrin of 0.001 ppm, while OSHA allows 2 ppm, which is 2,000 times greater.

The maximum concentration of trichloroethylene under health standards is 0.007 ppm or 7 ppb. But the OSHA level for TCE is 25 ppm. That's 3,571 times higher.

OSHA levels for perchloroethylene are 25 ppm, but under health regulations the allowable limit is 0.003 ppm. The OSHA limit is 8,333 times greater.

On a day-to-day basis, workers have been exposed to high levels of dangerous chemicals, which have been thousands of times stronger than levels allowed by public health laws.  As outrageous as it is, it is legal.

Employers don't worry because they cannot be sued.  Workers are relegated to filing claims with the Workers' Compensation Appeals Board for "benefits" [an oxymoron] that are extremely limited.

Unborn children exposed to chemicals during pregnancy are not forced into the WCAB system because they are not employees.  Children are entitled to full constitutional protections against a parent's employer for the injuries suffered in the womb.  

In most states the time limit on bringing suit does not start to run until a person becomes an adult on their 18th birthday.  Usually two years is allowed or before the 20^th birthday, except for Tennessee that has a one-year time limit.

Most states recognize "delayed discovery." This discovery rule provides that the statute of limitations period starts to run when an injured person has, or should reasonably have, knowledge s/he has suffered injury. 

Not all claims of delayed discovery are successful.  So, filing before an injured person's 20^th birthday stops a chemical company from raising a statute of limitations defense or attacking a delayed discovery claim.

As a practical matter because it is necessary to identify the manufacturers of chemicals causing injury and to prove the level of exposure, mothers who worked with chemicals during pregnancy should promptly take action before valuable co-workers can no longer be found to testify in their support.

Onward,

Richard Alexander