Thursday, January 02, 2014

CHILD HEALTH - Industry Cost Concerns Hampers Drug Safety Devices

"The Fix Isn’t In:  Why a Safety Device That Can Stop Overdoses by Kids Isn’t Widely Used" by T. Christian Miller and Jeff Gerth, ProPublica 12.30/2013

See, your child's life is not worth the cost of safety to the drug industry.  Greed before people.


Starting in 2007, Dr. Daniel Budnitz, a scientist at the Centers for Disease Control and Prevention’s Medication Safety Program, began tracking an obscure but unsettling statistic about children’s health.

Each year, more and more kids were being rushed to emergency rooms after swallowing potentially toxic doses of medication.  By 2011, federal estimates put the figure at about 74,000, eclipsing the number of kids under 6 sent to ERs from car crashes.

In most cases, children experienced no lasting harm from accidentally ingesting pills or liquids from the family medicine cabinet, but about 1 in 5 had to be hospitalized for further evaluation.  About 20 children died each year from such accidents, CDC data showed.

As an epidemiologist and the father of two kids, including one who had a penchant for putting things in his mouth, Budnitz became fixated on reducing drug overdoses.

In particular, he saw an easy solution for the roughly 10,000 emergency room visits a year involving liquids, such as over-the-counter pain relievers and prescription cough syrups.

It was a type of safety valve called a flow restrictor.  The small plastic device fits into the neck of a medicine bottle and slows the release of fluid, providing a backup if caregivers leave child-resistant caps unfastened or kids pry them off.

In 2008, Budnitz persuaded drug makers, federal regulators and poison experts to come together on an initiative to add flow restrictors, which cost pennies apiece, to medicine bottles.

Today, however, that promise to make medicine safer for kids remains largely unfulfilled, hindered by industry cost concerns and inaction by federal regulators, an examination by ProPublica found.

Honoring a pledge made in 2011, drug makers have added restrictors to infants’ and children’s acetaminophen, the active ingredient in Tylenol.  That year, roughly one-quarter of kids’ ER visits for drug accidents involved pediatric or adult formulations of acetaminophen.

But the industry has neither promised nor delivered such protection on other medicines, which account for more than half of kids’ ER visits stemming from drug accidents, including antihistamines, ibuprofen, and cough and cold preparations.  ProPublica purchased more than 50 pediatric versions of these products marketed by nine different brands at outlets in California, New York and Washington, D.C., this month.  None of the products we bought had flow restrictors.

In some instances, companies that have placed flow restrictors on acetaminophen-only kids’ products have not put them on bottles of pediatric cough and cold syrup that contain the same amount of acetaminophen.

"If flow restrictors work, they should be placed on all liquid products," said Dr. G. Randall Bond, a pediatrician and poison expert who has consulted with drug makers.  “We need a technological change to get us to the next level of safety.”

Industry officials said that they were waiting for better data to quantify the extent to which restrictors mitigate kids’ risk from drug accidents before deciding whether to add the devices to more medicines.

“We will continue to evaluate whether other initiatives or interventions make sense,” said Barbara Kochanowski, the vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association, an industry trade group for over-the-counter drug companies.

Industry leader McNeil Consumer Healthcare, the Johnson & Johnson unit that makes Tylenol, said it was committed to child safety, but said flow restrictors were only one part of the solution.

“We believe the first line of defense against accidental unsupervised ingestion is secure storage and immediately returning medicines to a high and out-of-sight location following each and every time the product is used,” the company said in a statement.

Makers of liquid acetaminophen started to add flow restrictors in 2011 and, in the absence of any government or industry standards, companies rolled out a variety of designs.

To gauge their effectiveness, Consumer Reports – an independent, nonprofit testing organization – tested the devices found on 31 different products, duplicating the ways a child was most likely to squeeze, shake or suck medicine from the bottle.  The results, which were shared with ProPublica, confirmed that all models of flow restrictor reduced the amount of liquid that escaped under these conditions – an outcome Consumer Reports lauded.

This is critical with acetaminophen.  While generally safe if taken as recommended, the drug can cause liver damage and death if taken in larger amounts.  As ProPublica has reported, about 150 Americans die each year after accidentally overdosing on acetaminophen, and tens of thousands more are hospitalized, the vast majority of them adults.

But some of the restrictors used on bottles of liquid acetaminophen work better than others, Consumer Reports found. Bottles with so-called closed restrictors – covers with small holes that open when punctured by a syringe then reseal when it’s removed – outperformed those with open restrictors, hard plastic discs with holes that do not reseal.

PediaCare and store-brand acetaminophen from Safeway, Dollar General and Family Dollar used the better-performing restrictor, tests showed.  Many other store brands did not.  Consumer Reports also found that McNeil, a company that has long promoted the safety of its products, does not use the “more effective” design.  None of McNeil’s products were placed in the “preferred safety feature” category.

Consumer Reports and ProPublica contacted McNeil with questions about the test results.  The company would not directly address why it has chosen a less effective flow restrictor.  McNeil pointed to a recent study that showed 94 percent of kids tested were unable to empty an uncapped bottle within 10 minutes if it used any design of flow restrictor.

“The issue of accidental ingestion of medicine by young children is one we take very seriously,” said the company, which provided information on its product specifications for the study.  “Each manufacturer makes its own decisions about safety designs that work best with its bottles and existing manufacturing process.”

The U.S. Consumer Product Safety Commission has the power to set standards for flow restriction but, by law, must start by working toward voluntary guidelines.  Though commission officials have participated in Budnitz’s initiative for years, the agency never instigated the standard-making process.

Instead, Budnitz did so.  In early 2013, he contacted ASTM International, a leading standard-setting body.

“It is an active process that’s moving in a positive direction,” said Scott Wolfson, a spokesman for the CPSC.  (Commission officials serve on the ASTM committee that is considering flow-restrictor standards.)

Officials with the U.S. Food and Drug Administration, which oversees drug safety, have long voiced support for flow restrictors, publicly urging companies to use them.

“Tens of thousands of children still overdose each year, and yet the technology used to prevent accidental ingestion has hardly changed for decades,” FDA Commissioner Margaret Hamburg told pharmaceutical company executives at an over-the-counter drug conference in Florida in 2010.  “New tools—such as single-dose packs and flow restrictors—must be explored for their potential to prevent unnecessary suffering.”

But the FDA has not moved to require the devices; agency officials have offered differing opinions as to whether it has the power to do so.  In a statement to ProPublica, the FDA said it “encourages companies to continuously improve the safety of their products and encourages discussions with manufacturers on measures that will help in this regard.”

The hands-off approach of the FDA and CPSC has left it largely to Budnitz to continue the campaign for flow restrictors.  Trim and balding, with an abhorrence of confrontation, he has doggedly pressed forward, even though his own agency, the CDC, has no funding for his initiative and no regulatory authority over the products he is determined to make safer.

“This could be a win for everyone,” he said.  “No one wants kids to be harmed.”

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