Ives Health Using Disavowed WHO Study to Market Drug (Correct)
By David Evans
Claremore, Okla., March 5 (Bloomberg) -- Ives Health Co., a small vitamin company, last month began marketing a drug called T- Factor that it says can halt the progress of HIV for a fraction of the cost of drugs that are widely used to treat the virus.
The company started selling T-Factor on the Internet last month and expects it to help boost Ives' sales from under $1 million last year to more than $30 million in 2001.
``This is a product that can keep HIV in check in the majority of people that take it,'' said Michael Harrison, chief executive of Ives.
The claims for the drug, which isn't approved by the U.S. Food & Drug Administration, are attracting criticism. Federal regulators and HIV experts say they are concerned the high cost and sometimes unpleasant side effects of federally endorsed HIV treatments have encouraged companies like Ives to sell unproven remedies. Ives says that while FDA-approved drugs cost more than $25,000 a year, an annual supply of T-Factor sells for $600.
The company says T-Factor was proven effective in a study by inventor Robert Slayton-Bedeen and the World Health Organization. The WHO, a United Nations agency, said it has no record of the study. Ives Health fired Slayton-Bedeen in 1999, saying it wanted to ``distance'' itself after discovering he used aliases and two social security numbers to conduct business.
Federal agencies have previously sued over allegedly false claims by developers of HIV treatments. In 1999, the Securities and Exchange Commission accused Uniprime Capital Acceptance Inc., an auto dealer, of defrauding investors by claiming a subsidiary had discovered a ``major breakthrough'' in treating HIV. It based its claim on a bogus clinical study. The developer of Uniprime's treatment, Alfred Flores, later pleaded guilty to federal criminal charges of securities fraud and now awaits sentencing.
Shares of Ives, a nine-year-old company whose stock is traded on the OTC Bulletin Board, soared from 5.5 cents in December to a high of 74 cents on Feb. 16, as the company issued press releases about T-Factor. There are about 35 million shares outstanding. The stock closed at 25 cents on Friday.
False Economy Feared
``The quacks who sell this stuff are despicable,'' said Marty Algaze, director of communications for the Gay Men's Health Center of New York, the largest HIV support organization in the U.S. ``It would be tragic if someone died because they took an unproven drug like T-Factor to save money, when we know more expensive, FDA- approved drugs are keeping people with HIV alive.''
T-Factor is made from the thymus, pituitary, spleen and lymph glands of freshly slaughtered calves. Ives sells a less potent formulation from the same ingredients, called Immune 2000, in drug and grocery stores, including Albertson's Inc. and Winn-Dixie Stores Inc. locations.
``We have a very, very high confidence that it's going to render the medicinal benefit that we're claiming,'' said Keith Ives, 42, founder and president of Ives Health, in a telephone interview from his home in Claremore, Oklahoma, near Tulsa.
On Feb. 26, NBC television's Las Vegas affiliate, KVBC, described T-Factor in a news program as an ``AIDS treatment breakthrough.'' The station features a link to the company's Internet site on its Web site.
Not FDA Approved
FDA spokeswoman Laura Bradbard said the agency is concerned about unapproved HIV treatments sold over the Internet. She wouldn't say, as a matter of policy, whether or not the agency is investigating Ives or its marketing of T-Factor.
``This product is not approved by FDA for the treatment of HIV/AIDS or any other disease indication,'' said Bradbard. ``FDA does not have any information on the safety and effectiveness of the product.''
Dr. Robert Schooley, head of the infectious diseases department at the University of Colorado Health Sciences Center in Denver, has reviewed the company's claims about the ability of T- Factor to halt the progression of HIV in patients.
``From what I know about immunology, it would seem extremely unlikely,'' said Schooley.
The Java Project
There are other causes for concern about T-Factor.
Ives says the drug was proven effective in a 1993 World Health Organization clinical study of 186 HIV patients, called ``The Java Project.'' The study, conducted in Jakarta, Indonesia by Slayton-Bedeen, shows significant decreases in the patient's viral loads and increases in their white blood cell counts, the company says.
The results were never published, duplicated or peer-reviewed by other HIV researchers, said Ives, which licensed the rights to T-Factor from Slayton-Bedeen.
``Through civil unrest in Feb., 1993, Dr. Bedeen and his staff were forced to leave most of their stuff behind and flee Jakarta,'' said the company founder, explaining why a peer review study was never conducted.
The World Health Organization is unaware of the study.
``We're concerned that our name is being used without our approval in connection with this product,'' said Gregory Hartl, WHO spokesman at its headquarters in Geneva.
``We realize there may be some concerns,'' said Ives. ``We feel that through the people we've contacted, that those (Java Project) tests were real.'' He said officials of the WHO in Geneva provided the verification.
Slayton-Bedeen couldn't be reached for comment.
Proctor & Gamble
Ives says the study was partially sponsored by a $250,000 grant from Procter & Gamble Co., which Ives says is Slayton- Bedeen's former employer. Ives says P&G lost interest when they learned of his interest in natural therapies.
Slayton-Bedeen never worked for Procter & Gamble, according to its personnel archives, said company spokeswoman Marlene Feder.
``We also have no record of grant money being spent for this project,'' she said.
``I really am quite skeptical as to that response,'' said Ives. He said Slayton-Bedeen has a master's degree in pharmacy from the University of Oklahoma and a Ph.D in immunology from Case Western Reserve.
Neither the University of Oklahoma nor Case Western Reserve has any record of Slayton-Bedeen ever attending their schools, according to spokespersons for their registrar's offices.
Ives said his company verified Slatyon-Bedeen's degrees with both schools.
Slayton-Bedeen licensed the formula for making T-Factor to Ives for $25,000 in August, 1998, according to regulatory filings. In July, 1999, the company paid the inventor an additional $10,000 to cover future royalties. Three months later, Slayton-Bedeen, then living in Claremore, Oklahoma, filed under Chapter 7 for personal bankruptcy protection.
His $50,000 Toyota Land Cruiser was repossessed after his bankruptcy filing, which listed assets of $66,590 and debts of $126,861.
Slayton-Bedeen's bankruptcy petition lists his occupation as ``research and development specialist'' and his current source of income as a monthly Social Security disability payment of $1,176.
Fired in 1999
Federal bankruptcy court records also showed Slayton-Bedeen used the aliases Robert Badeen and Robert Bedeen, as well as two social security numbers. He used the different identifications to obtain a bank loan, among other things.
Ives said he knew that Slayton-Bedeen used aliases.
``We became quite aware of most of this information in 1998,'' said Ives. ``It was one of the reasons that we felt it was in the best interest of ours for us to disassociate our relationship.''
Ives says Slayton-Bedeen ran The Java Project in Indonesia in 1992. The bankruptcy filing says otherwise: In a copy of his 1992 federal income tax return, Slayton-Bedeen said he lived ``in the U.S.'' throughout the year.
``I have it on good sources that he was in fact in Indonesia from Jan., 1991 through February of 1993, '' said Ives. ``Now what he did on his income taxes and what he reported to the IRS, is a different story.''
Ives said Slayton-Bedeen was fired in March, 1999. ``We escorted him from the building,'' said Ives.
Confidence Unshaken
That doesn't shake his confidence in the Java Project.
``Ives Health Co. has done a significant amount of due diligence work to authenticate and verify through reputable sources that this test was done, has merit, and we have every reason to believe the testing results are accurate,'' said Ives.
Where is Slayton-Bedeen now?
``He's been inaccessible to us over the last several months,'' said Ives' CEO Harrison.
``The last we heard, that we can verify and substantiate, is that he was in India doing a relief effort in January and February for the earthquake victims,'' said Ives. ``I look forward to distancing myself from Dr. Bedeen.'' |
