CytoDyn, Inc. (Pink Sheets:CYDY) has sent the FDA what the Company believes is a complete response to the agency’s preliminary comments on Cytolin®, a monoclonal antibody designed to restore immune function in those afflicted with HIV/AIDS.
As one example of how this process works, the FDA asked CytoDyn to conduct a laboratory experiment to quantify the effect of Cytolin® on HIV. In its response, the Company explained that an immune modulator cannot have a direct effect on a virus making what the FDA requested a scientific impossibility. Rather, the reduction in HIV levels consistently observed in patients treated with Cytolin® is due to improved functioning of the immune system, as confirmed by a restored ability of patients treated with Cytolin® to recognize five germs to which most adults have been previously exposed. This effect is studied by injecting a small quantity of dead germs just under the skin and is referred to as a resolution (cure) of cutaneous (skin related) anergy (lack of immunologic activity). It was first observed in the earliest human study of Cytolin®, a small pilot study conducted by AIDS reSEARCH ALLIANCE in 1995 and subsequently reported in the peer-review literature.
As another example, the FDA expressed a concern that Cytolin® ―which reduces HIV levels indirectly by strengthening the immune system, might suppress the immune system and exacerbate infections. Precisely because this concern is nonsensical, it underscores the impact of the criticism that was directed at the FDA after the approval of Raptiva®, an antibody designed to be the opposite of Cytolin® and to suppress the immune system as a treatment for moderate to severe plaque psoriasis, a disease caused by a hyperactive immune system and characterized by rash, fever, chills, and severe itching. Raptiva® is the registered trademark of Genentech (NYSE:DNA). In other words, it is as if the FDA had been criticized for allowing a company to pour water on a fire that was out of control after some patients alleged this had left them susceptible to infections. The FDA is now concerned that pouring gasoline on a fire weakened by HIV will do the same thing as water because the agency lacks the expertise to distinguish between two very different fluids.
Section 117 (C)(3) of the Food and Drug Administration Modernization Act of 1997 requires the FDA to act within 30 days of receipt of a complete response to its preliminary comments. However, it is common knowledge that the FDA is seriously underfunded and understaffed. Consequently, the FDA may not be capable of complying with this provision of the law even if it agrees that CytoDyn’s response was complete. The inadequate staffing of the FDA, and the resulting impairment of that agency, was cited by Public Citizen in support of the recent ruling by the U.S. Supreme Court rejecting the policy of the Bush Administration, which precluded patients from suing for damages allegedly caused by FDA-approved drugs. In other words, the impairment of the FDA due to inadequate funding has been cited as one reason why FDA approval should not be deemed to imply drug safety. The counter argument asks why the drug companies should be compelled to spend billions of dollars for FDA approval, thereby increasing the already staggering costs of health care, if that approval does not provide assurances of drug safety.