The Indiana House of Representatives and Senate have unanimously passed so-called "Right to Try" legislation, which would grant terminally ill patients access to drugs that have only made it through the first of three phases in the federal Food and Drug Administration's approval process. The bill will now head to the governor for final approval.

Laura McLinn has been advocating for "Right to Try" legislation on behalf of her 5-year-old son, Jordan, who has Duchenne Muscular Dystrophy, a 100 percent fatal disease.

"I'm trying to find every way that I can to save my son's life," McLinn says. "What ‘Right to Try' says is if something has passed phase I, you have the right to try it."

A drug that could potentially increase Jordan's life expectancy from 20-something years to anywhere between 50 and 80 years will enter phase I clinical trials this summer. Jordan likely won't qualify for the clinical trial because he won't meet the age requirement, but if the drug passes through the first phase, he could have access to it much sooner.

Phase I of the FDA's approval process tests a drug's safety, but not its effectiveness.

However, the drug that could possibly help Jordan has the same chemical backbone as a drug that has made it to the third phase of the FDA's approval process, meaning it has been proven safe and effective. McLinn says she's pretty sure the drug will work and "Right to Try" would grant Jordan access to it.

Dr. Bert O'Neil, Phase I Director of the Indiana University Simon Cancer Center, oversees Phase I clinical trials for all areas of cancer treatment. He says bills like Indiana's "Right to Try" have come out of frustration with the process of getting access to early experimental drugs.

"That, for all of us, is understandable," O'Neil says. "We've all had to face patients and tell them we just don't have any other treatments to offer or there's a drug that could potentially be helpful for you, but it's only available in a clinical trial somewhere far away that patients may not want to go. So the idea of having this is very understandable, but some of the specifics of this particular bill can cause some serious problems."

The bill allows terminally ill patients to use experimental drugs as long as they meet three criteria:

• The drug poses no risk of danger, which is determined in phase I of the FDA's approval process.
• The individual has a terminal disease with no comparable treatment options.
• The risk to the individual is no greater than the probable risk from the individual's disease or condition.

The bill also states drug manufacturers can either provide it to the patient for free or require the patient to pay. It doesn't require a manufacturer to make available any investigational drug, biological product or device and medical professionals prescribing the drugs will not be liable for potential negative side effects.

O'Neil says it's difficult to determine whether a drug is potentially effective if it has only gone through one phase of the process. He questions who would decide what could be the best drug for a patient because physicians may not have enough information about a drug in its early stages.

He also says that, because the legislation doesn't specify who is responsible for the costs, he expects it to fall onto the patients.

"It really has the potential to be unfair because patients with more money may get more access to these drugs than patients with less money," O'Neil says.

McLinn says if the legislation benefits even just one person, it will be worth it.

"All the people we're talking about have a terminal condition; that's not fair," McLinn says. "But by helping one person or hopefully many, it's not putting any more hurt on the people that are in the situation that they're already in."

Dr. Chris Daugherty's research for the University of Chicago Medicine's MacLean Center for Clinical Medical Ethics focuses on ethical issues involved in cancer treatment. He says the cost involved in gaining access to experimental drugs is a serious concern because patients have difficulties paying for even considerably routine medical care. A relatively new FDA approved drug in cancer treatment costs patients between $10,000 and $12,000 per month, so most patients cannot use it.

Daugherty also says that as long and cumbersome as the standards within the regulatory process are, they're in place for a reason.

"They come as a result of an inability to provide and to develop agents safely and to really meaningfully identify which agents are going to be useful," Daugherty says.

Daugherty says there is still a large potential for the experimental drugs to cause more harm than good.

But McLinn says that's what the legislation is all about - giving patients the right to say if they want to pursue a potentially life-saving drug or product.

"They absolutely have that right to say it," Daugherty says. "The question is whether or not they have the right to say it in such a way that other individuals, organizations, institutions are going to have an obligation to make that happen."