Hemispherx BioPharma (HEB)

[NickPar]

WSJ reported "Drug Chief at the FDA Is Accused Of Conflict"

By ALICIA MUNDY AUGUST 12, 2009
WASHINGTON -- The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.

The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

http://online.wsj.com/article/SB125003545637224263.html

In the varied comments - two stood out concerning Ampligen:

Vince Capp wrote:

On the same subject...My question is ..”Why is the FDA and the Obama Administration failing to recognize safe products such as Ampligen as an adjuvant? Extensive research has been completed, from both an efficacy and pure biological perspective of products such as Ampligen. According to the Department of Pathology, National Institute of Infectious Diseases in Japan, their studies have concluded that the mucosal adjuvant, poly I:poly C12U Ampligen, a Toll-like receptor 3 agonist was proven to be safe in a Phase III human trial. As an effective adjuvant for H5N1 influenza vaccination these studies showed that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone and also considered “most promising”. For years, the United States regulatory entities including the HHS, FDA and CDC have known about this product and watched Asian and European countries make significant progress using it as a toll like receptor for treatment and research of debilitating diseases such as the bird flu, Aids research and Chronic Fatigue Syndrome (CFS). Although the CDC has several times in documented forums have confirmed the existence of CFS, a sister to the more commonly known “Fibromyalgia”, the FDA has failed to address Ampligen’s approval. In addition, for reasons that the FDA claims is “due to staffing issues”, the approval of this landmark product, which the FDA is late by over 3 months, remains in NDA limbo. It is troubling that Americans who can benefit from its availability outside the spectrum of an experimental status are held hostage to regulatory bureaucracy. Its leads many to be inquire if these regulatory agencies are only catering to “Big Pharma” and possibly focusing more on the depth of purse. For over 5 years the FDA has known of findings related to Ampligen and in my estimation should have fast tracked its studies and approvals accordingly. Ref: this article and meeting notes - http://www.hhs.gov/advcomcfs/sept2004_meeting_min.html .

Ampligen may and should be considered as an adjuvant in combination with seasonal trivalent inactivated influenza vaccine thereby providing cross-protective mucosal immunity against Noval H1N1 as it has been viewed in many tests performed for avian H5N1 viruses. Hemispherx and researchers in Asia and Europe consider that Ampligen as beening "generally well tolerated", with a "low incidence of clinical toxicity", particularly when compared to the toxicity of the diseases it is used to treat. "No serious safety issues have resulted from the administration of ~75,000 doses IV (most commonly 400 mg) twice weekly for up to one year periods or greater. Animal toxicity studies support this observation in humans with primates demonstrating the greatest margin of safety.”
Its time for the United States to once again take a lead in innovation or we will see our Homeland Bio-Pharma industries go the way our auto and electronics manufacturers experienced in the past three decades….” Outsourced and Dependent”. I invite my opinions to be copied by whoever wishes to submit to other blogs and article comments sections, as we must demand the transparency of these regulatory agencies that all Americans deserve.

Robert J. Sobel, M.D. wrote:

Again I ask the question of why we need to spend time worrying about copy-cats. There are many competitors to Lovenox; they are all expensive. How about getting the brand-generic warfare out of the way. Then we can focus on all the new avenues (like the toll receptor referenced above). The FDA would have an easier job if the playing field were less duplicative and the long-term was not destabilized by the drug life cycle roulette.

Regulated Royalties would eliminate the brand-generic dichotomy and extend indefinite exclusivity in exchange for a fee schedule arrangement in Medicare. This would allow new drugs and technologies to have their income prorated over time, proportionate to how long they last in the market. Billion dollar babies are killing health care. The FDA could be at the forefront if it did not have to police the unethical practices of brand-generic cycling.

As a physician affected daily by pharmacy benefit company harassment and insurance/pharmacy pettiness, I implore everyone to pay attention to the Hatch-Waxman Act. Let's achieve real reform and rewrite some bad laws. I need a steady playing field. I can only integrate new into the care of patients if it is introduced without the marketing insanity of the "billion dollar baby" syndrome. Introductory pricing would allow us to use cautiously early without bankrupting the system. Health care pricing is not like the rest of the world. It is not to be commoditized.

The FDA is essential and efforts to improve it are appreciated. I would argue that eliminating the brand-generic distraction would allow us to focus on true innovation, without short-changing implementation. Rewarding the long-term would even the playing field, so physicians and services could be reimbursed at rates that don't need to be incessantly squeezed.

The health care bubble is largely explained by the lack of price controls on new technology and pharmaceuticals and the failure of behavior modification (i.e., the managed care fallacy) to save money (savings offeset by administrative tangles). Financial coercion is currently working but is unethical (it disincentives doing the right things as well). Regulated Royalties on a modified Baucus and you've got health care reform that will work.