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NuvaRing manufacturer fought for no risk warning on labels

In 2002, the Dutch drug manufacturer, Organon, released NuvaRing, one of the most popular contraceptive drugs in history. The multi-billion dollar product, NuvaRing, was marketed as the first hormonal contraceptive ring in the entire world. Banking on convenience, it was allowed women to refrain from taking the pill and was hailed as the greatest advancement in birth control technology since the sixties.

However, before NuvaRing could be sold in the United States, it had to meet federal Food and Drug Administration guidelines. Needless to say, the FDA voiced some concerns, but the product went to market anyway, despite several notable risks. 

It was known during preliminary testing the hormonal contraceptives carried a heightened risk of blood clotting. This risk was compounded in women who were over the age of thirty-five or who smoked, however, some tests showed healthy women in their twenties developing blood clots and most experts agreed that this was likely in part due to the use of the NuvaRing.

As a result of these finding, the FDA did not disapprove the product, but did advise Organon to include a written statement in NuvaRing's packaging, warning them and their physicians of the possible risk of blood clots. Administrative executives from Organon, which is now a subsidiary of the giant drug conglomerate Merck & Company, opposed these written warnings as they assumed it would be a huge hit to their potential billions in profits. "We should…try to get it out of the text" wrote one administrator in an email to a coworker in 2000.

The give-and-take between the FDA and drug manufacturers and what they are supposed to have on their labels and in their packaging is skewed in favor of drug companies, many argue. The FDA relies heavily on the manufacturers to provide the clinical trial results and other reliable data. In fact, 70% of the money for FDA reviews comes directly from the drug industry. As a result, when a company puts as much stock into a drug or product like NuvaRing, public safety can often be foregone in the shadow of what a company stands to make from sales of a product.

As the FDA and NuvaRing makers went back and forth, the battle eventually wore itself out and the FDA conceded that NuvaRing's users' increased chances of blood clots was "unknown." Even after Organon basically got its way, providing minimal risk warnings to the package of NuvaRing, there director of marketing told colleagues "I am still unhappy…What are the chances that this section can be removed altogether?"

Thirteen years later, many women have fallen victim to the adverse side effects of the NuvaRing and some have even died from using the product. 

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