As for drugs and treatments before they are "ready for prime time"

It is not a situation that any of us could want. What if you had a terminal illness such as cancer or ALS (Lou Gehrig's disease), a rare and debilitating disease, and I knew there was a treatment that could help you, but not FDA approved? Fortunately there is a way to get access to experimental treatments or medications. Your doctor may use through programs "expanded access" FDA or "compassionate use".

However, some patients and physicians seeking treatment for these programs have felt the process was too long. And when time is short, the delays are intolerable. Since 2014, 21 states have passed laws to help accelerate this process. These laws, laws called "right to try", allow patients to avoid the cumbersome process of FDA and allow doctors to request certain medications (which have already been tested by the FDA for safety, but are not still in the market) directly from the drug companies that make them.

This may sound good in theory, but getting the drugs before they are available to everyone is at risk - even for those with drugs that have not been rigorously tested can cause side effects that erase any profit potential so that beautiful "nothing to lose". time for these people much more unhappy than necessary. And physicians who want to weigh the risks and benefits of these treatments are effective in the dark; They have no way to access information to help them counsel patients.

These laws have also raised general ethical issues. Ask your doctor for a prescription for a drug that is still in development requires knowing this is even possible. It is likely that these applications already significant inequalities in health care perpetuate and encourage those who have access, resources and money.

There are also concerns about going unwanted, by the usual process of the consequences of the FDA. If you give a drug to a very small number of people who interfere with the usual test of a promising drug, so the benefits outweigh the needs of the few.

In an effort to answer some of these questions, a pharmaceutical company is working with the New York School of Medicine University of Medical Ethics Division to meet the demands of patients for drugs. A committee consisting of medical experts, bioethicists, and patient representatives met to consider each request for medication. The objective is to examine each request thoughtfully, fairly and consistently.

The rapid emergence of legislation on the right to try to open the door to wider options for patients, but are not actually ensure that the patient requests will be granted. These laws do not require pharmaceutical companies to provide experimental medications or health insurance companies to pay them. In fact, for example, try Colorado right laws explicitly allow insurance companies to refuse coverage - not only for the experimental drug - Patients who use drugs in research. Thus, the laws of right to be treated can actually do little to improve access.

The inadequacy of the law of the right to trial discouraged. However, in February this year, the FDA proposed a "faster" revised and expand access to treatment research process. This can be a way to deal with two powerful competing needs: to get help quickly to those whose time is short and ensure that the medicines we offer are distributed fairly and safely.
By: Amy Ship, MD.