Tuesday, Nov 24th, 2009
Two doctors from the Dartmouth Institute for Health Policy and Clinical Practice recently reported that many prescription drug labels do not contain accurate information about all side effects and the true severity of listed side effects, and they fail to mention that certain medicines are not truly effective.
A long standing problem, drug companies are in charge of writing their own drug information which is then presented to the Food and Drug Administration (FDA) for final approval. Though tasked with negotiating accurate and sensible wording, the FDA often lets slide inadequate information that is both misleading and outright deceptive.
Lunesta, a prescription sleeping drug created by Sepracor Inc., is touted on its information label as being superior to placebo in alleviating insomnia and inducing restful sleep. Test results from the most comprehensive study performed on the drug revealed that the drug did not reduce insomnia and that there were no meaningful improvements in next-day functioning and alertness as drug advertisements claimed.
Even though the study’s findings were provided to the FDA for further review, the FDA allowed misleading information to be published on Lunesta’s information sheet anyway. In response to allegations that the company is misleading the public about Lunesta, Sepracor retorted that information above and beyond what is required by the FDA is always available to those who request it.
Rozerem, another insomnia drug produced by Takeda Pharmaceutical Co., omitted similar information from its drug information sheet. Though no empirical sleeping improvements occurred in test patients who received treatment with Rozerem, the company did not disclose this fact on the product label. Takeda continues to market the product untruthfully.
Other examples of drug label deception include Novartis’ Zometa bone cancer drug. The drug’s information label states that ingesting the 8-milligram dose poses a greater risk of kidney damage with no explanation about how great a risk. Truth be told, 33 percent of patients in a test study died when taking the 8-milligram dose of Zometa.
As disturbing as all of this is, it illustrates the grave failure of the FDA in performing its job. Drug companies seemingly run the show from start to finish, researching, manufacturing, and self-regulating their own products. The FDA time and time again has caved at the behest of corporate pressure.
The FDA must be held responsible for its utter failure to function as it should. In direct opposition to its own mission statement which summates its purpose as defender of public health, the FDA operates as a corporate lapdog to pharmaceutical interests. It is time that the people demand the dismantling of this corrupt organization and the formation of a new one.
“When the people find they can vote themselves money, that will herald the end of the republic.” – Fall Of The Republic – Buy the DVD here
This article was posted: Tuesday, November 24, 2009 at 5:03 am