Treatment IND News
In 1987, the FDA enacted regulations that provide increased access to experimental drugs for patients with life-threatening or seriously-debilitating diseases when no alternative treatment exists. These guidelines, commonly called Treatment IND (Investigational New Drug), provide for rapid review of new therapies even when clinical trials results proving efficacy have not yet been established. Once a drug's safety has been determined in human trials, it may be prescribed to patients that are terminally ill or suffering from diseases such as HIV/AIDS, herpes simplex encephalitis, or subarachnoid hemorrhage under the Treatment IND protocol. Typically Treatment IND applications are made for drugs that are in Phase III trials; however in rare cases the FDA approves a Treatment IND for a drug that has not yet progressed beyond Phase II. In order to stay compliant with the protocol, the drug developer must continue to collect safety and efficacy data on test subjects in order to better establish a drug's therapeutic benefit to patients. Additionally, it must continue to make a good faith effort to win final approval from the FDA; if the drug developer stops working on the product, the Treatment IND can be rescinded and patients may lose access to the drug.
Treatment Investigational New Drugs are rare. From the period of 1987-1999, only 39 such applications were granted approval. Of these 39 experimental treatments, 13 were for cancer and 11 were for HIV/AIDS. Patient advocates and healthcare activists often push for companies to apply for Treatment INDs when they think a new drug may hold some promise to cure or treat a disease. However, there are myriad problems associated with the system as it now stands. First of all, drug companies tend to eschew applying for Treatment INDs because they would rather have many of the patients who will take their drug under that protocol take part in a controlled clinical trial. Patients also become frustrated with the process because the FDA sets a high bar for granting Treatment IND approval. Finally, since most insurance companies won’t cover experimental treatments, patients are left to foot the bill for lab tests, hospitalizations, treatment for adverse side effects, and in some cases, the experimental drugs themselves.
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