Unproven, dangerous cancer medicine got go-ahead from FDA

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Walking the beaches around Los Angeles where she lives was one of life’s pleasures for Susan Preston-Martin, a retired university professor and breast cancer patient.

That pleasure was interrupted when she began taking Afinitor (everolimus) to treat her breast cancer.

Just getting out of bed and taking a shower in the morning was difficult. Walks along the shore were impossible. She felt so bad she gave her pills, which cost $450 each, back to the pharmacy.

She didn’t know that the FDA approved everolimus without proof that it extended life.

Indeed, despite that lack of proof, the drug has come before the FDA five times in the last six years, and each time won approval for a new indication. Everolimus is now used to treat advanced breast and kidney cancer, a rare type of pancreatic cancer, and two types of nonmalignant tumors.

But in the desperate world of cancer medicine, toxic and expensive drugs that aren’t proven to extend life can quickly achieve blockbuster status.

For everolimus, each FDA approval for a new condition increased the pool of potential patients — and potential sales — for the drug, sometimes substantially.

Among cancer drugs, everolimus stands out for its repeated approvals despite what independent doctors say are serious concerns — particularly for breast cancer patients.

Read full, original post: Slippery Slope: A Targeted Therapy That Misses The Mark?

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