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Colorado: First state allowing experimental life-saving drugs to dying patients

War on the FDA approval process versus unapproved life-saving drugs
War on the FDA approval process versus unapproved life-saving drugs
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The number of deaths that occur per year due to terminal illnesses have not yet been calculated, but it is reported that there are well over 500,000 Americans per year that die from cancer alone. As several potentially life-saving drugs stagger to make it through the daunting FDA approval process - which on average costs over $1billion dollars to process and takes over a decade to get approval on - many patients die knowing that there’s a possible cure out there that could have saved their lives.

Currently, only 3 percent of “the sickest patients” are eligible to participate in clinical trials. However, it was just announced yesterday that Colorado may be the first state to sign the “Right to Try Act,” which would allow patients to try drugs not yet approved by the FDA.

The drugs that are made available to patients in the Right to Try act have passed the first stage of the FDA approval phase, which essentially measures whether or not the drugs are safe to use. While Colorado may be the first to sign this law, which will be signed by Governor John Hickenlooper (D) this Saturday, similar bills are also nearing approval in both Louisiana and Missouri — and getting voted on in Arizona this November.

In a poll conducted by Goldwater Institute (a non profit public advocacy organization), More than 80 percent of Americans support a “Right to Try” legislation, including huge majorities of lawmakers from both Democratic and Republican parties.

In 2003, a petition was circulated requesting that the FDA amend certain regulations to allow patients the right to access experimental drugs that intend to treat life-threatening illnesses (after they’ve passed the first stage of safety testing), but the FDA denied the petition. When the FDA was sued regarding the denial of the petition, the court over ruled stating that:

“There are no other FDA-approved treatment options, a terminally ill patient has a constitutionally-protected “fundamental right” to access investigational drugs”

ScienceBasedMedicine.org released an article earlier this year discussing the "illusions" of the act. The article states that “several things” could go wrong as many sick people look for a 'get-well-quick' promise for a drug that may in-turn actually be more costly.

Concerns from other outlets say that the law, even if enacted, sits on murky grounds when being performed. Hospitals still have to adhere with the federal law and uphold to maximal safety procedures to protect their patients. If a lawsuit were to occur from an experimental drug gone wrong, can the hospital still be at fault?