FDA oversight of drugs fails to protect many patients

<br>WASHINGTON (AP) _ Darlene Alber traces the painful, ugly boils she has had for the past five years to an injection of an alternative medicine that was contaminated with bacteria. <br><br>This year,

Wednesday, May 23rd 2001, 12:00 am

By: News On 6

WASHINGTON (AP) _ Darlene Alber traces the painful, ugly boils she has had for the past five years to an injection of an alternative medicine that was contaminated with bacteria.

This year, the Atlanta woman learned that the company which supplied her injection, Phyne Pharmaceuticals Inc., had distributed a second batch of defective products that left two people hospitalized in Pennsylvania.

Phyne's victims say the company's ability to operate for more than two decades, despite repeated brushes with the law, shows lax oversight by the Food and Drug Administration of drug makers that supply the growing alternative medicine market.

``Consumers are facing the same kind of environment that their great-grandparents did a hundred years ago when snake oil was being sold on every corner,'' said Larry D. Sasich, a pharmacist with the Public Citizen Health Research Group.

But Phyne's president, Donna Critchlow, said the FDA has been too harsh. She took over the Scottsdale, Ariz., company last year after her husband, James Critchlow, pleaded guilty in the bacteria contamination case.

``It's been a manhunt,'' she said. ``It's a bad situation.''

Government investigators have faulted the FDA in recent years for taking too long to notify drug companies of manufacturing problems and not making sure those problems are corrected.

The FDA has just one inspector for every 14 prescription drug makers in the U.S. Sasich says the FDA doesn't have enough resources to catch problems before people get hurt. Lawyers for some of Phyne's victims contend the agency often fails to enforce sanctions against troubled companies.

FDA officials say their agency is understaffed but vigilant in getting unsafe and unapproved drugs off the market. Funds for oversight of drug makers have declined since 1980, but President Bush has proposed a 21 percent increase, to $58 million.

Some examples of problems with prescription drugs:

_Thomas Ronald Theodore was convicted in March for selling a bogus alternative cancer remedy. Prosecutors said Theodore's company made the product in an unregistered, unsanitary Massachusetts lab. The FDA did not inspect the plant until four months after a manager halted production in 1995.

_The FDA halted sales of a clot-busting drug in 1998 and 1999 because of viral contamination problems at its manufacturer, Abbott Laboratories. But the FDA did not recall doses doctors already had, despite warning that the drug should be used only in emergencies.

_Since 1999, drug maker Schering-Plough has faced repeated FDA warnings and recalls because of manufacturing problems. Consumer groups contend the FDA has not taken strong enough action against Schering-Plough and has not ensured that the company fix its problems quickly.

Agency officials say two recalls and a string of court actions against Phyne _ and a current investigation into its latest troubles _ show the system is working.

The case ``is a good example of why we need a strong FDA,'' said David Horowitz, head of the FDA's compliance office. He said the FDA tries to get companies to correct problems informally, ``but if that doesn't work, the agency will take whatever action is necessary to achieve compliance.''

Phyne distributed the latest batch of problem products _ a gout medicine called colchicine _ despite a 1983 court order to stop selling unapproved drugs, a guilty plea in May 2000 to three felonies, and lawsuits from Alber and a dozen other victims.

Phyne's colchicine supplier, Amram Inc., made it in a rural Idaho home with no state license or FDA inspection. Two Philadelphia-area women were hospitalized with overdoses in December because the colchicine they took was 10 times stronger than its label indicated.

``Once we realized there was an adverse event, we made it a priority to inspect their manufacturing conditions,'' said John Taylor, director of the FDA's enforcement office.

The FDA shut down Amram's lab after finding it was inadequate and unsanitary.

Phyne's troubles with federal authorities date to its founding in 1979 by James Critchlow in Florida. Authorities sued the Critchlows and Phyne that year for selling unapproved drugs.

The Critchlows settled the case in 1983 by agreeing to stop selling unapproved drugs. But they later moved the company to Arizona and began selling an unapproved drug called adrenal cortex extract, which infected Alber and at least 54 others in 1995 and 1996.

Days after Alber injected the extract into her veins, she developed a severe infection that caused boils all over her hands, feet, arms, legs and buttocks. She was hospitalized for three months and had as many as 13 antibiotics constantly pumped into her body for two years.

At 67, Alber still has outbreaks of boils. She won a $500,000 settlement in her lawsuit against Phyne and the Alabama pharmacy that sold her the extract.

``This is worse than taking a gun and shooting someone,'' Alber said of the damage the contaminated extract did to her.

Phyne recalled the contaminated extract in 1996 after the Centers for Disease Control and Prevention reported an outbreak linked to a Denver weight-loss doctor.

Phyne and James Critchlow pleaded guilty last year to three federal felonies in connection with adrenal cortex extract sales. A federal judge fined Phyne more than $11,000 and ordered the company never to sell the extract or any other unapproved drug.

Despite that ban, Edith Crawford, Amram's former owner, said she made adrenal cortex extract for Phyne until last fall, several months after the court order.

Phyne lawyer Holly Gieszl denied that Phyne sold the extract in violation of its probation. But FDA investigators found vials of the extract in Alaska while investigating the gout drug case.