Non-English speakers not told of Vioxx dangers by Merck
In a recent study completed by K.B. Forbes of Consejo de Latinos Unidos, a nonprofit organization which educates and assists Latinos and others in the areas of health care, has found that in Puerto Rico, Merck failed to adequately warn Vioxx patients and doctors about the risks of the drug since the information was available in English only. While this study was focused entirely on Puerto Rico, it is fair to assume that other speakers of other languages worldwide may not have received correct information about the risks of Vioxx. (Related article: Vioxx recall cases outside the USA)
Some of the key findings of the report are:
- As aggressive as Merck was in marketing Vioxx, Merck appears not to have adequately informed the public or medical community in Puerto Rico about the cardiovascular dangers of Vioxx, even after the FDA called on them to do so in late 2001. (Related article: Why Merck did not recall Vioxx earlier?)
- Merck appears to have failed to circulate information of the cardiovascular dangers in Spanish to the public or medical community in Puerto Rico between 2002 and 2004, time period after they had modified Vioxx warning labels (known as patient package inserts) and before the drug was pulled.
- Puerto Rico residents who used Vioxx and suffered cardiovascular problems feel they were used as “guinea pigs” and that the company should have informed them and their doctors of the associated risks. In one case, a victim knew about the dangers of using Vioxx with her kidney problems, but was never informed of the cardiovascular dangers. “The only thing I can say is that I was told that [Vioxx] would damage my kidneys. This is why I did not take them daily.” She ended up having two heart attacks.
But why did patients fail to be informed?
As Consejo de Latinos Unidos investigated the problems in Puerto Rico, they were astounded to find that literature and documents from Merck were distributed to physicians and patients in English. English is not spoken by all Puerto Ricans. "Using English-only materials was a disservice and could have been responsible for many of the deaths and injuries suffered by the individuals and families that contacted the Consejo," says K.B. Forbes. (Related article: Doctors lose trust in FDA after Vioxx recall mess)
The study concludes that, "This oversight, this possible negligence, may have also impacted other Hispanic households in the United States." The organization spoke to Vioxx victims in Puerto Rico and is suggesting a series of changes so that Vioxx-type tragedies do not happen again: (Related article: 140,000 Americans hurt after taking Vioxx)
- Merck and other leading pharmaceutical companies should institute a campaign in Spanish to educate the Puerto Rican community about the risks associated with their pharmaceutical products that is equal to the campaigns to promote their product.
- Merck and other leading pharmaceutical companies should publish all warning labels (patient package inserts) in Spanish and heavily distribute them with their representatives in Hispanic areas of the United States and in Puerto Rico.
- Merck should resolve these legal challenges by injured Vioxx patients fairly and equitably.
Related article: Vioxx lawsuits by non-US residents
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