The Health Daily

When cold medicine containing a poison made in China killed nearly 120 Panamanians in 2006 and early 2007, Americans could take some comfort in the belief that a similar epidemic could never happen here, not with one of the best drug regulatory systems in the world.

Then last spring, hundreds if not thousands of pets died or were sickened in the United States by a Chinese pet food ingredient that contained lethal levels of melamine, an industrial product used to artificially boost protein levels. That was followed quickly by the discovery that Americans were brushing their teeth with Chinese toothpaste containing a poisonous chemical used in antifreeze.

Still, no Americans died from the chemical.

And then came heparin.

A hugely popular blood thinner used in surgery and dialysis, heparin turned out in some cases to contain a mystery substance that sophisticated lab tests earlier this month determined to be a chemically modified substance that mimics the real drug. The United States Food and Drug Administration has linked it to 19 deaths and hundreds of severe allergic reactions, though the agency is still investigating whether the contaminant was the actual cause.

What a difference a year makes.

After many near misses and warning signs, the heparin scare has eliminated any doubt that, here and abroad, regulatory agencies overseeing the safety of medicine are overwhelmed in a global economy where supply chains are long and opaque, and often involve many manufacturers.

“In the 1990s governments were all about trying to maximize the volume of international trade,” said Moisés Naím, editor in chief of Foreign Policy magazine and author of “Illicit: How Smugglers, Traffickers and Copycats Are Hijacking the Global Economy.” “I’m all for that, but I believe this decade is going to be about maximizing the quality of that trade, not quantity.”

Mr. Naím said the heparin scare is already having a “huge” impact, fueling worldwide anxiety over imported medicine and a growing demand for consumer protection.

Congressional Democrats are talking about authorizing more money so the F.D.A. can do more overseas inspections, particularly in China, where more and more drug ingredients are made. The agency is also completing a plan to permanently station employees in China for the first time.

“Just focusing on the borders of the United States does not work,” said Dr. Murray Lumpkin, a deputy commissioner at the F.D.A. “In order for us to do our job better domestically, we have to work better internationally.”

Chinese drug regulators have also begun to take small steps toward plugging some of the country’s gaping regulatory holes, particularly with the thousands of chemical companies that sell pharmaceutical ingredients without a drug license. Regulators have much to do and many obstacles to overcome in trying to adapt to changes brought on by globalization.

The way heparin is made and distributed illustrates the challenges they face. The drug’s raw material comes from mucous membranes in the intestines of slaughtered pigs. Those membranes are mixed together and cooked, a process that in China often takes place in unregulated family workshops.

It is then transported to middlemen, called consolidators, who direct the product to plants in China that manufacture heparin’s active ingredient for shipment to either another trader or the finished dose manufacturer. In the United States, the tainted ingredients ended up at Baxter International, which later had to recall the blood thinner.

Since the outbreak in the United States, Japan and several countries in Europe have recalled certain heparin products made with Chinese ingredients. In some instances, European traders buy and sell the heparin to companies in other countries, extending the supply chain even more.

Anti-counterfeiting experts say that the longer the chain, the greater the opportunity for counterfeiters to adulterate the product. In fact, F.D.A. investigators have yet to figure out where in the multistage manufacturing process the chemical that mimics heparin was added.

“Advanced technology and global manufacturing outlets have made fake drugs a big and illicit business that is literally poisoning patients,” said Alan C. Drewsen, executive director of the International Trademark Association.

And since supply chains often pass through more than one country, there is no government agency with the power to police all of it. The World Health Organization runs a program that helps track counterfeit medicine, but it has no regulatory authority.

Manufacturers also need to do a better job of testing imported ingredients, drug experts say.

For example, tests failed to detect the heparin-like contaminant because it was so similar to the real thing. And that worries Dr. Roger L. Williams, chief executive of the United States Pharmacopeia, which sets quality standards for medicine and supplements.

“What you are seeing here is the tip of the iceberg,” Dr. Williams said. “How do we know what else has gone wrong?”

He said, for example, that melamine was missed because “we have a bad test for protein.” Other tests should also be improved, he said. To help companies identify diethylene glycol, the inexpensive poison that ended up in Panamanian cold medicine and in Chinese toothpaste, USP recently came up with a better way of determining if that poison is present.

Some leading members of Congress don’t want to rely so heavily on manufacturers to protect the public, particularly afterreports said poor management and scientific inadequacies have weakened the F.D.A.

More than 500 plants in China export drug ingredients to the United States but the agency inspected only 13 of them last year.

One of the plants not inspected was the one that made the contaminated heparin ingredient. That plant, Changzhou SPL, blames someone else further upstream in the supply chain for selling tainted raw materials.

The F.D.A. is continuing to investigate.

“We can blame the Chinese for this stuff as much as we want, but the truth of the matter is we are the people who are buying,” said Joseph G. Acker, president of a chemical trade association.

And Mr. Acker points a finger at the F.D.A., adding, “I think that organization needs a total overhaul.”

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Father’s invention tells NICU doctors, visitors when they are being too loud

INDIANAPOLIS - Warning lights hover over the snoozing patients in Riley Hospital for Children’s neonatal intensive care unit, ready to flash whenever sound levels creep beyond normal conversation.

As decibels rise, the colors change from green to yellow to red, hushing chatty parents or doctors so the babies get the rest they need to develop.

Noise louder than roughly the level of conversation can cause premature or sick babies’ hearts to beat too fast or too slowly, said Dr. William Engle, a neonatologist at Riley. And interfering with babies’ vital signs or sleep can slow development and healing because their bodies do most of that work while they sleep.

“The function of babies is to grow and develop, and in between they eat,” he said.

Preemies also need quiet so they can learn their mother’s voice and their brains can figure out how to process sound, things that normally happen in the last trimester before birth.

“It’s definitely a great idea,” Dr. Bob White, a neonatologist at South Bend’s Memorial Hospital, said of the sound monitoring system in Riley’s neonatal intensive care unit, or NICU.

White, who is not involved in creating or distributing the system, helped write national noise standards for NICUs that have been adopted by the American Institute of Architects and are used in most hospital design.

A father’s mission
Inventor Chris Smith hopes doctors around the country agree with White. He has sold his Sonicu system to several Indiana hospitals and wants to expand nationally.

Smith, 43, had no training as a sound engineer and no plans to become an entrepreneur when his son Sean was born five weeks premature in 2000. But he noticed Sean flinch in response to bright light in the NICU of St. Vincent Indianapolis Hospital, and he wound up designing a system to soften the unit’s lighting.

Then the nurses asked him what he could do about sound.

“That’s really when I realized that there was no good way out there to measure sound, other than your standard, hand-held meter,” he said.

Babies born too soon lose the muffling effect of the womb before their ears can filter sound, White said.

“The sounds … come from all different directions and all different sources, and they’re often associated with unpleasant sensations for the baby,” White said.

NICUs are rife with noise pollution created by employees, equipment and excited family members.

“There’s no good way for the nurses or doctors to walk up to a parent, tap them on the shoulder and say, ’You’re being too loud,”’ Smith said. “That’s confrontational.”

The former car mechanic filled hours of spare time in the evenings and on weekends researching sound standards and building a system.

Smith, who tinkered in radio and TV electronics in high school, hired an acoustical engineer to help. They created a ceiling-mounted system of microphones that picked up sound and funneled data back to a large control panel.

“There was a lot of wiring, a lot of labor, a lot of programming,” he said.

St. Vincent paid around $100,000 for the system, which it installed about five years ago. Smith had no interest in shopping his invention to other hospitals because the work took so much time.

Then Riley Hospital, also in Indianapolis, called a few months later.

“They basically said, ’I want that,”’ he said.

New version can mimic rising, setting sun
The latest version of Sonicu can feed a stream of both sound and light data digitally to a computer. It offers the cone-shaped warning lights and can quickly dim the lighting in a room that gets too noisy. It also can make lighting mimic the sun by brightening toward noon and then fading, which also helps babies sleep well.

White, the neonatologist who helped write the national standards, said he knows of no other NICU monitoring system that sophisticated.

Smith has sold systems to a handful of Indiana hospitals, so far to good reviews. He said the systems can cost anywhere from $40,000 to $400,000, depending on each hospital’s needs.

The monitors have taught hospital staff to limit the number of groups making rounds at the same time because having more than one group in a room raises noise levels dramatically.

Most NICUs are filled with noise that can’t be helped, White said. Fans in the heating and ventilation system have to operate almost constantly, and the monitors need to beep.

The Sonicu system reins in the main noise maker that can be controlled.

“People think, ’Oh gosh, I didn’t realize, I’ll go over here so I won’t have to talk so loud,”’ White said. “It really is something that addresses the human factors that we do have some control over.”

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