Paxil Birth Defect Litigation - Battle of the Decade

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By Evelyn Pringle (about the author) Page 3 of 6 page(s)

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Infant Lung Disorders

In July 2006, the FDA issued a Public Health Advisory on the latest type of birth defect believed to be associated with SSRIs, based on a study in the February 2006, New England Journal of Medicine. The study found an increased risk of a live-threatening lung disorder in infants exposed to SSRIs during pregnancy, stating:

"A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy."

Infants with PPHN have difficulty making the transition from breathing inside the womb to normal breathing upon delivery causing respiratory failure that often requires mechanical ventilation. Even with treatment, between 10% to 20% of PPHN babies do not survive.

Although all the latest research clearly shows that the benefits of SSRI use by pregnant women could never outweigh the risks, the July 2006, FDA advisory titled "Treatment Challenges of Depression in Pregnancy," almost appears to be encouraging women to keep taking SSRIs, citing a study that warns that pregnant women who stop taking the drugs might relapse into depression.

Are Drug Manufacturers Selling Sickness?

In the research paper cited, the authors predicted that their findings would prompt some women to stay on antidepressants throughout pregnancy. However, the study ended up making frontpage news on July 11, 2006, after an investigation by the Wall Street Journal discovered that 9 of the 13 authors had undisclosed financial ties to the SSRI makers.

Which raises the question of whether SSRI makers are "selling sickness," using these so-called "experts" to convince doctors to keep prescribing drugs that are known to harm the fetus to increase profits.

By now, the industry's habit of planting bogus studies in medical journals and the media to promote drugs has become widely recognized. In the paper, "Selling sickness: the pharmaceutical industry and disease mongering," published in 2002, in the British Medical Journal, the authors describe how alliances of drug companies, doctors, and patient advocacy groups, use the media to portray conditions as being severe and widespread.

The paper notes that "in many cases the formula is the same: groups and/or campaigns are orchestrated, funded, and facilitated by corporate interests, often via their public relations and marketing infrastructure."

The authors could be discussing the study cited in the FDA advisory when they say: "A key strategy of the alliances is to target the news media with stories designed to create fears about the condition or disease and draw attention to the latest treatment."

The paper goes on to list the different components of this marketing technique. "Company sponsored advisory boards supply the "independent experts" for these stories, consumer groups provide the "victims," and public relations companies provide media outlets with the positive spin about the latest "breakthrough" medications.

Members of the medical profession are critical of medical journals that publish these "studies" and help make a mockery of "evidence-based medicine" with false claims about the safety and value of drugs whose lethal side effects are concealed from readers--i.e., physicians, health care policy officials, the judiciary, and the public at large, in "Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?", by Dr. John Abramson, of Harvard, and Dr. Barbara Starfeld, a professor at Johns Hopkins, in the October 2005, Journal of the American Board of Family Practice.

According to Dr Abramson and Dr Starfeld: "Although one can make a case that the purpose of an industry is to make a profit and not necessarily to serve the public good, it is difficult to accept this as a justification for the behavior of medical scientists and regulatory agencies."

15-Year History of SSRI Litigation

Unbeknownst to most people, hundreds of SSRI suicide lawsuits have been ongoing behind the scenes for more than 15 years and Baum Hedlund has been involved from the start. The drug makers have done everything in their power to keep these cases from going to trial.

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