6 Nov (OMSJ) – Last week, OMSJ responded to reports that scientists at Imperial College in London had developed a new HIV test that is “10 times more sensitive and a fraction of the cost of current methods.” Shortly after we published our report, Quest Diagnostics demanded a correction:
Quest Diagnostics has a highly comprehensive HIV testing menu that includes FDA-cleared tests. Your coverage seems to suggest that we have been involved in fraud allegations for HIV testing — this is not the case — and that our tests are somehow not appropriately regulated. In fact, the U.S. diagnostic industry is highly regulated, and we offer a menu of tests that are covered under and comply with pertinent federal and state regulations. We are proud of our HIV leadership and introduction of important diagnostic innovations that may help physicians better diagnose, treat and monitor people infected with HIV. Please immediately correct your story.
Quest’s concerns appear to stem from OMSJ’s claim that:
According to test package inserts, a sample testing positive on both ELISA and Western Blot (WB) tests can only be “presumed to be positive for antibody to HIV-1.” The inserts warn clinicians: “Do not use this kit as the sole basis of diagnosis of HIV-1 infection” and emphasize that for all persons testing positive on both ELISA and WB that “Clinical correlation is indicated … to decide whether a diagnosis of HIV infection is accurate.” (Bio-Rad, Epitope/Organon, OraSure, Cambridge)
“Clinical correlation” means that doctors must conduct a physical examination and correlate symptoms with test results, not unlike the way policemen diagnose intoxicated drivers: But while drunk drivers kill and injure far more Americans than HIV every year, no one expects policemen to arrest asymptomatic (sober) drivers or accept kickbacks when an uncorrelated test says they’re drunk.
Manufacturers emphasize that “clinical implications of antibodies to HIV-1 in an asymptomatic person are not known.” (Cambridge, Bio-Rad) Nevertheless, diagnostic labs and clinicians routinely use these tests to convince healthy asymptomatic patients that they are infected with HIV, generating billions of dollars in HIV drug sales and millions of dollars in illegal kickbacks and bribes to clinicians.
Last year, Quest paid $241 million so settle allegations that they defrauded taxpayers by paying illegal kickbacks to doctors, hospitals and clinics that directed patients to them. As part of the settlement agreement, they admitted no guilt.
So while OMSJ does not specifically allege that Quest Diagnostics and LabCorp have “been involved in fraud allegations for HIV testing,” the multi-billion dollar corruption that permeates the healthcare and pharmaceutical industries today could not occur without the passive acquiescence of Quest Diagnostics and America’s industry-controlled regulators.
UPDATE 6 Nov 2012 1415 – A representative from QUEST DIAGNOSTICS wrote:
Your post is not accurate. You have this statement in it: Last year, Quest paid $241 million so settle allegations that they defrauded taxpayers by paying illegal kickbacks to doctors, hospitals and clinics that directed patients to them. We admitted no liability for any of the allegations made, and we continue to deny any wrongdoing. Please read the statement we issued at that time below. See click the link:
Since that time, the ambiguous billing regulation was replaced by legislation that applies to all laboratories in California and sets forth a process aimed at clarifying the Medicaid billing rules in that state.