Tainted Pills From Puerto Rico Reach U.S.

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Tainted Pills From Puerto Rico Reach U.S.

 

SAN JUAN, Puerto Rico, Feb. 5, 2008

 

(AP) The first warning sign came when a sharp-eyed worker sorting

pills noticed that the odd blue flecks dotting the finished drug

capsules matched the paint on the factory doors.

 

After the flecks were spotted again on the capsules, a blood-pressure

medication called diltiazem, the plant began placing covers over

drugs in carts in its manufacturing areas.

 

But the factory owner, Canadian drug maker Biovail Corp., never tried

to find out whether past shipments of the drug were contaminated - or

prevent future contamination, according to U.S. regulators.

 

Thirteen of the 20 best-selling drugs in the United States come from

plants on this island. But an investigation by The Associated Press

has found dozens of examples over four years of lapses in quality

control in the Puerto Rican pharmaceutical industry, which churns out

$35 billion of drugs each year, most of it for sale as part of the

$300 billion market in the U.S.

 

An AP review of 100 pages of Food and Drug Administration reports

shows even modern drug plants here under the watch of U.S. regulators

have failed to keep laboratories sterile and have exported tainted

pills.

 

" People would be shocked to find this whole variety of

contamination, " said Dr. Sidney Wolfe of the Washington watchdog

group Public Citizen. " The common denominator of all these is there's

really poor quality control. "

 

FDA officials say the problems in Puerto Rico are proportionate with

the large number of pharmaceutical plants here and generally no worse

than those on the U.S. mainland.

 

Consumer advocates say they demonstrate the regulatory agency does

not sufficiently monitor the industry across Puerto Rico and in the

mainland.

 

The FDA issued a warning letter to Wyeth in May 2006, after consumers

reported finding machinery pins inside bottles of Effexor, a leading

depression treatment, and the heartburn drug Protonix. The letter

expressed concern that the plant was not " able to detect that the

affected equipment was missing some of its parts. " The Madison, N.J.-

based company faulted mistakes by workers who packaged the drugs.

 

In another case cited in a June 2006 FDA inspection report, a plant

owned by Teva Pharmaceutical Industries exported drugs - including

the diabetes treatment metformin - even though they were known to

contain small amounts of metal particles. The company had also

received at least six consumer complaints of dark residue inside

bottles or foreign material embedded in tablets, according to the

report.

 

Teva's quality-control unit said the presence of some metallic

material was to be expected because the manufacturing equipment is

made of metal, according to the report.

 

Teva recalled 21 different drugs as a result of the inspection,

according to FDA officials, and the Israeli drugmaker announced two

months later it was closing the plant, citing a restructuring.

 

Denise Bradley, a Teva spokeswoman, insisted the medicine from the

now-closed plant was safe and effective despite the contamination.

 

The reports obtained by AP were produced by FDA inspections from 2003

to 2007 of 13 pharmaceutical plants - roughly half the total in this

U.S. territory, a Caribbean island with one of the world's highest

concentrations of drug makers.

 

Several are closing or downsizing as the expense of updating decades-

old plants to meet regulations adds to struggles with rising energy

costs and tightening tax breaks.

 

The FDA often hesitates to crack down at the first sign of problems

because manufacturers can chalk them up to isolated mishaps, said

John Scharmann, a former FDA administrator for the Denver district

now associated with a watchdog group.

 

That appeared to be the case at the Biovail-owned factory in the San

Juan suburb of Carolina where the sharp-eyed worker noticed the

foreign specks of blue.

 

" Incident was considered an isolated event ... even when the employee

reported having observed the same particles before, " the report said.

 

David Elder, director of enforcement in FDA's regulatory affairs

office, said pharmaceutical companies generally fix problems on their

own and issue recalls if necessary once notified.

 

" They're making products that save or support lives, so it's not in

their interest to make products that are unsafe or ineffective, " he

said. " I think they're good corporate citizens by and large and want

to do right by their patients. "

 

Four of the plants described in the reports closed or announced plans

to do so after the discovery of significant quality-control problems,

but none of them cited the discoveries as a reason for closing.

 

One of those four, GlaxoSmithKline PLC, produced tablets of the

popular antidepressant Paxil CR that split apart, potentially causing

patients to take incorrect dosages.

 

When the company would not recall all the affected pills, U.S.

marshals raided the plant in March 2005 in the largest drug seizure

in FDA history and also collected tablets of the diabetes treatment

Avandamet after some were found not to have accurate doses of the

active ingredient.

 

Some plants in Puerto Rico are three decades old, built when the

territory's pharmaceutical industry took off thanks to tax incentives

aimed at developing more high-tech manufacturing.

 

The industry here has faded somewhat. Companies have shed more than

3,000 jobs in the last 18 months and closed several plants for a

variety of reasons, including the loss of federal tax breaks and cost-

cutting.

 

Still, this island turns out some top-selling drugs on the U.S.

market, including cholesterol drugs Lipitor and Zocor, the blood-

thinner Plavix, anemia drugs Aranesp and Epogen and the

antidepressant Zoloft.

 

The FDA's San Juan office has 22 inspectors who devote about a

quarter of their time to pharmaceutical plants. They typically visit

the factories once every two years, more often if there are consumer

complaints or the company has repeated infractions.

 

Factories confronted with violations often make extensive changes.

The Biovail plant invested $5 million in equipment upgrades and

addressed problems including errant metal particles from cleaning

spatulas. A follow-up FDA inspection found no problems, said Gilbert

Godin, executive vice president of the Ontario-based company.

 

Scharmann, a consulting editor for the watchdog publication

Dickinson's FDA Review, said the FDA is concerned by anything that

affects drug quality but considers the likelihood that the companies

may file legal challenges to enforcement actions.

 

" There's a fairly broad latitude that is allowed, " Scharmann said.

 

Elder contends inspections are rigorous.

 

" The folks doing this work aren't just regulators. That's our job,

but we're also consumers of these products, " he said. " It's personal

to us to make sure these products are in compliance. "

 

© MMVIII The Associated Press.