A Plea to the FDA

Protesters crash the BIO conference to protest the delayed approval of a breast cancer drug.

By | June 21, 2012

Flickr, AslanMedia


Protesters outside the Boston Convention & Exhibition Center, where the Biotechnology Industry Organization’s convention is being held this week, are protesting the US Food and Drug Administration’s (FDA) slow approval of T-DM1, a potential breast cancer therapy that has met success in clinical trials. T-DMI is a combination of Herceptin, which has already been approved for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+), and a new drug made by Immunogen Inc.

In 2010, after successful Phase II clinical trials of the drug, the FDA refused to grant T-DMI accelerated approval, forcing the makers of the drug to go into phase III trials, which are currently ongoing.

“I have been taking this drug for 19 months, with no side effects, and I have no cancer,” an anonymous protester told the Boston Business Journal.

The FDA is currently moving toward changing its drug review process to make it more streamlined and open, but still the agency draws criticism from the industry for being too slow.

“Do not believe it when the FDA says it is reforming its process,” another protester yelled at the demonstration. “They are moving slower than ever.”

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Avatar of: Redshirt1


Posts: 3

June 21, 2012

It boils down to whether the people who take the drug are willing to forego legal "compensation" when a result of taking an experimental or rapidly approved drug is not what they envisioned as the outcome of their treatment.  If you are willing to accept the risk of adverse outcomes then the FDA should be willing to use you as a human experimental subject.  If you are not willing to accept the risk (independent free will decision) then I would suggest that you not complain so much.  Getting well and living happily ever after is not always the resulant of drug therapy experimentation.

Avatar of: Aajaxx


Posts: 3

June 21, 2012

Non-experts do not know how to assess risk of treatments. They should be very careful what they demand if they do not want to be responsible for a tragedy. 

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