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Experimental Treatments? Unapproved But Not Always Unavailable

Beyond Clinical Trials

In 1987, FDA created a regulatory mechanism (first proposed in 1982) to permit expanded access to investigational drugs outside of controlled clinical trials. The "treatment IND" allows people with serious and life-threatening illnesses to take investigational drugs while the products are being tested in a clinical trial. Typically, however, drugs allowed under treatment INDs already have shown promise and proven safety. In addition to the benefit to individual patients, treatment INDs generate useful information about how the drug affects larger segments of the patient population than might otherwise receive it in a clinical study.

For example, the AIDS drug Videx (ddI) was made available to people with AIDS outside the clinical trial at a time when the choices for AIDS therapy were few and many people had already exhausted the then available options. Although patients seeking treatment with ddI were told that it was still under study and that there were risks, more than 20,000 decided to take ddI anyway. This not only gave them a better chance to survive but also gave researchers more information about the drug's safety than would have been possible from the some 4,000 patients involved in the clinical studies.

Since the final treatment IND rule was published more than a decade ago, FDA has made more than 40 drug or biologic investigational products available to patients early and has approved 36. Of these, nearly a dozen were for cancer and another dozen for AIDS or AIDS-related conditions.

Single-Patient INDs

As with a clinical trial, there may not be an appropriate treatment IND for an individual patient's condition, but there may be a new drug still working its way through development. If enough is known about the drug's safety, and there is some clinical evidence of effectiveness, FDA may allow a patient to become his or her own study. This so-called single-patient IND, or compassionate use IND, virtually ensures that any patient can get access to any investigational new drug.

Although FDA's requirements for a single-patient IND are relatively simple, setting up this kind of access for an individual patient is not. First of all, the company must be willing to provide the new drug to the patient. This can be expensive and time consuming for the company since, in addition to providing the drug, the company needs to track shipments of the drug, create special instructions for its use, and create a way of collecting safety data and a mechanism for tracking outcomes for each patient. Second, the patient must give informed consent, understanding that the drug is not approved and may cause side effects from mild to fatal. Third, the patient's physician must be willing to take responsibility for treating the patient and agree to collect information about the effects of the drug.

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