Fw: A cure worse than the disease

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From: " Kathi " <pureheart@...>

Sent: Wednesday, September 11, 2002 5:33 PM

Subject: A cure worse than the disease

> US NEWS & WORLD REPORT

>

> http://www.usnews.com/usnews/issue/020916/health/16fda.htm

>

> Health & Medicine 9/16/02 A cure worse than the disease When FDA

> oversight falters, tissue implants can do more harm than good

>

> BY STACEY SCHULTZ

>

> Five years ago, Warren King, a sports physician, reconstructed the right

> knee of a patient using a tendon sent to him by CryoLife, a

> Georgia-based company. The patient quickly developed an infection so

> serious the implant had to be removed. Tests showed the implant,

> obtained from a cadaver, had caused the infection. But CryoLife, one of

> many so-called tissue banks, denied it. " They denied it even when the

> evidence was overwhelming, " King says. The logical step would have been

> for King to go to the authorities, but he wasn't sure who that would be.

> " I didn't know the Food and Drug Administration was involved in

> regulating tissue banks, " he says.

>

> Well, the FDA is involved-sort of. Last month the FDA asserted its

> authority by shutting down most of CryoLife's human-tissue business. And

> since then, CryoLife has faced ever increasing troubles. Patients who

> received implants have sued. The Securities and Exchange Commission

> began investigating the company for possible accounting and

> insider-trading irregularities, following lawsuits by shareholders who

> claim that CryoLife misstated the extent of its problems. Company stock

> has plummeted from a high of $45 a share to as low as $1.40. At week's

> end, CryoLife said it had been allowed to resume shipment of some tissue

> products. Still, the company laid off 105 workers, and those who are

> left are scared of losing their jobs. " It has devastated everybody, " one

> employee says.

>

> But for some patients, the FDA's action is too little, too late. Alan

> Minvielle of Santa Cruz, Calif., had knee surgery in April 2001 with a

> CryoLife implant. He developed an infection that ate away so much of his

> knee, he recently had to have the whole joint replaced. And it wasn't

> soon enough to save 23-year-old Lykins of St. Cloud, Minn., who

> died last November after the infection from his knee surgery caused

> heart failure. " Is the FDA late? " King asks. " There's no question about

> it. "

>

> Unexamined. In fact, a closer look by U.S. News shows that despite FDA

> oversight, the fast-growing tissue-bank industry has largely gone

> unscrutinized. The FDA often does not know when companies distribute

> contaminated tissue. It doesn't approve facilities before companies

> begin selling products, and it hasn't set requirements on how to treat

> tissue implants before transplantation. Until recently, it didn't even

> know the names of all the tissue banks in operation in the United

> States. Indeed, an industry-sponsored organization-not the FDA-has set

> the standards for how tissue banks manage their day-to-day operations.

>

> Moreover, although infections pose the greatest risk when a patient

> receives a tissue implant, the FDA does not require companies to report

> when they occur. Lacking a centralized database, it is difficult for

> health officials to spot a cluster of infections coming from one company

> and thus stop the company from releasing contaminated tissue. It took

> the FDA at least five months, for instance, to learn that tissue from

> the South Texas Blood and Tissue Center in San , which

> distributed tissue in Texas and California, had infected a patient in

> late 2000 with E. coli. The agency also realized that the company had

> taken some of the tissue from the infected donor off the market, but not

> all of it. The FDA demanded that the tissue bank withdraw the rest of

> the tissue.

>

> Ironically, it was fear about transmission of infectious diseases that

> initially got the FDA interested in the tissue-bank industry. In the

> early 1990s, HIV was spread through organ and tissue donations to

> transplant recipients. FDA inspectors also found that tissue from

> foreign countries that had not been screened for diseases was being sold

> to U.S. suppliers. In response, the agency required that tissue banks

> test and screen donors for HIV and hepatitis B and C. The rules allowed

> the FDA to inspect tissue banks and to recall and destroy tissue that

> didn't meet the hepatitis and HIV standards.

>

> But the industry was growing rapidly. By last year, as many as 200

> organizations-some for profit, others nonprofit-were recovering,

> processing, and distributing tissue products to hospitals across the

> country. The FDA left it to the American Association of Tissue Banks, an

> industry group, to ensure practices that would avoid tissue

> contamination. The AATB set up a strict accreditation program that

> involves on-site inspections and a detailed review of operating

> procedures. The organization hired ex-FDA officials, including one

> former head of compliance at the FDA's Center for Biologics Evaluation

> and Review, to conduct inspections and application reviews. Currently,

> 74 tissue banks are accredited by the AATB.

>

> But participation in the program is voluntary (and costly), and many

> companies opt not to join in. And the AATB cannot close down tissue

> banks for selling contaminated products. So, when circumstances appear

> dire enough, or when cases like Lykins's come to light, the agency

> invokes its authority to prevent infectious disease. For instance,

> AlloSource of Centennial, Colo., fully accredited by the AATB, received

> a lengthy letter from the FDA on July 2 warning of numerous processing

> deficiencies and record-keeping problems. AlloSource has spent $1

> million trying to address the FDA's concerns, a spokesperson said.

>

> Action plan. Back in 1998, the FDA proposed new regulations that would

> greatly increase its authority over the tissue-bank industry. The

> " tissue action plan " has three key components: One requires tissue banks

> to register with the FDA. Another says donors must be screened for

> disease. The third, and perhaps the most needed, would establish " good

> tissue practices, " akin to the high standards set for the manufacturing

> of pharmaceuticals. Only the first of these has been put into effect.

> The others are still open for public comment.

>

> This has irked Sen. no end. " The FDA's action against

> CryoLife does not solve the underlying problem of a lack of regulation

> of this entire industry, " says the Maine Republican. Since last

> December, has sent two letters to the FDA urging the agency to

> set a deadline for putting the new rules into effect. She was told the

> FDA could not provide a date. " I am extremely frustrated, " she says. " It

> is a case of bureaucratic inertia at its worst. " Sen. Durbin, an

> Illinois Democrat, wrote to the FDA in January 2001, asking the agency

> to outline the financial resources it would need from congressional

> appropriators to implement the expanded authority. He has received no

> response. Says Philip Noguchi, acting director of the FDA's new Office

> of Cellular Tissue and Gene Therapies, " We recognize that we need to

> finish this. It's a top priority in the next fiscal year. "

>

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