FDA Criticized For Role In Heparin Contamination Case

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Posted on 30th April 2010 by gjohnson in Uncategorized

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A congressional probe has faulted the Food and Drug Administration for failing to identify the companies responsible for  contaminated heparin being imported from China to the United States, where it was linked to hundreds of deaths, according to a story in The Wall Street Journal Friday. http://online.wsj.com/article/SB10001424052748703572504575214420823549694.html?mod=WSJ_hpp_sections_news

That should come as no surprise to anyone with knowledge of that nightmarish heparin disaster. It’s rather obvious that the FDA was not doing its job, and still may not be doing its job in this regard, namely properly policing imported medicines and drugs.

Rep. Joe Barton, R-Texas, and Rep. Mike Burgess, R-Texas, in a letter to the FDA this week outlined the details of their investigation into the deadly heparin case. They told the agency that it had failed to follow up on several “specific and credible leads” that could have identified who was responsible for the contaminated blood thinner, The Journal reported.

Between 2007 and 2008 the contaminated imported heparin was tied to more than 80 deaths, and to hundreds of incidents where people fell sick.

Barton, the top Republican on the House Energy and Commerce Committee, has been spearheading the probe, and a vocal critic, of  how the FDA handled the tainted heparin situation.

The letter to the FDA asserted that the federal agency hasn’t done any follow-up with the Chinese government on issues related to some Chinese companies, according to The Journal.

The investigation also found that the FDA didn’t investigation leads it received from foreign officials. For example, one November 2008 FDA memo said that a respectable foreign government agency had shared “a significant finding” that a Chinese business was manufacturing counterfeit heparin with plans to ship it to the United States under another company’s name, The Journal reported.

China is the source of much of the world’s crude heparin, as that country processes pigs intestines as an ingredient for that drug.

Back in March 2008, the FDA announced that it had identified the heparin contaminant. It was chondroitin suflate, which was mixed into the raw heparin in China “to stretch the supply,” according to The Journal.

The FDA never announced who it thought was responsible for the contamination. But there seemed to be several obvious culprits.

The letter cited the case of  Chongqing Imperial Bio-Chem in China, which supplied pharmaceutical ingredients. An FDA document from April 2008 said that some of the crude heparin that Chongqing sent to an Ohio company was tainted, The Journal reported.

The FDA in March 2009 did ban pharmaceutical ingredients from Chongqing from coming to the states. But Barton and Burgress maintained that the agency should have probed further, in terms of Chonqging’s actual name and its place in the drug supply chain, according to The Journal.   

 The congressmen’s letter also pointed out that the FDA will have to overcome legal and language hurdles to conduct probes of drugs overseas

Chinese Drywall Maker Looks To Settle With U.S. Builders

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Posted on 29th April 2010 by gjohnson in Uncategorized

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It looks like at lease one Chinese maker of drywall that’s been blamed for releasing sulfurous orders, making people ill and damaging appliances, is going to own up to its responsibilities, according to The Wall Street Journal. http://online.wsj.com/article/SB10001424052748704471204575210153577223286.html?mod=WSJ_WSJ_US_News_5

The drywall maker Knauf Plasterboard Tianjin Co., known as KPT, has been negotiating with home builders in the United States to settle their claims and complaints about the drywall, also known as gypsum board.

Those builders have been sued by homeowners who claim that the drywall imported from China used in their homes emits noxious fumes.

Some skeptics question whether companies like KPT would ever pay up and compensate U.S. builders if homeowner suits succeeded against them.

Homeowners won a victory earlier this month when seven families in Virginia won a $2.6 million judgment against another Chinese drywall maker.

The federal government has advised construction companies to remove the defective drywall from houses. In turn, the home builders have been suing Chinese drywall makers and other companies to try to get compensated for ridding homes of the faulty drywall.

The drywall was brought in from China during the period of 2004 to 2007, when there was a housing boom in states such as Florida and Arizona.

Patient-Safety Advocate Dennis Quaid Finds Staunch Supporter In Iowa Congressman Bruce Braley

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Posted on 27th April 2010 by gjohnson in Uncategorized

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Actor Dennis Quaid, a crusader for patient-safety improvements after his twins were almost killed by an accidental heparin overdose, has found an ally in U.S. Rep. Bruce Braley, D-Iowa. http://www.brucebraley.com/free_details.asp?id=1

Braley, who spent 23 years as a trial attorney before turning to politics and going to Congress, participated in the first Oversight and Government Reform hearing where Quaid testified about his newborn twins being given near-fatal heparin overdoses at Cedars-Sinai Medical Center in Los Angeles in 2007. http://www.brucebraley.com/free_details.asp?id=39

If  life-and-death issues weren’t at stake here, it would almost be amusing to watch a Federal Drug Administration official squirm as Braley grilled him at the hearing. Braley impressed Quaid so much that at the end of the proceedings, the actor thanked the Iowa lawmaker and said he wished that the lawyer was his Congressman.

During the hearing, Quaid testified that drug companies shouldn’t have “immunity from any liability” – an argument that heparin manufacturer Baxter International is making — just because the drugs they sell have been approved by the FDA. Drug companies should be laughed out of court, the nation’s highest court in fact, for trying to make that argument.

The U.S. Supreme Court has in fact decided to hear a case regarding whether the law preempts suits being filed against drug companies, since their medications have FDA approval, Quaid noted during his testimony in Washington.

Quaid has been everywhere, not only D.C. but “The Oprah Winfrey Show” and medical conferences, to talk about his near-tragic experience and plead for safeguards to reduce potentially lethal medical mistakes. His twins are 2 ½ years now, and appear to be healthy despite their touch-and-go experience at Cedars-Sinai. But the problem regarding mistakes with heparin hasn’t been solved.

In a chat not long ago with The Wall Street Journal, Quaid cited a recent and well-publicized case where a toddler died of a heparin overdose caused by an infusion-pump setting mistake in a Nebraska hospital.  http://blogs.wsj.com/health/2010/04/22/patient-safety-the-movie/tab/print/

Quaid had been scheduled to attend the recent world premiere of his documentary, “Chasing Zero: Winning the War on Healthcare Harm” at the International Forum on Quality and Safety in Health Care in Nice, France.

But then Quaid and Dr. Charles Denham, who was in charge of  production of the documentary, couldn’t get to the screening because of the disruption of air travel due to the Icelandic volcano eruption, according to The Journal. Only 500 attendees made it, out of an expected crowd of 3,000, because of the travel disaster.

The documentary, which features Quaid, aired on Discovery Channel April 24 and will be repeated Saturday, May 1. After the documentary airs on TV, Denham and Quaid’s recently merged research foundation, TMIT, will hand out copies of it free to all 5,700 U.S. hospitals to spotlight the importance of adopting the safe practices developed by the National Quality Forum, which crafts voluntary safety rules for hospitals, according to The Journal.

There are an estimated 100,000 deaths each year from medical errors and another 100,000 deaths each year from hospital infections, many of then preventable, according to Quaid and his supporters, like Rep. Braley.


The exact number of these deaths is still unknown because a lot of  states don’t have a standard or mandatory reporting system for injuries caused my medical mistakes, according to Scientific American magazine. http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10

Let’s see if Rep. Braley helps Quaid make any headway in his quest for patient safety.

 

Actor Dennis Quaid Mounts Crusade Against Hospital Errors After Heparin Scare

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Posted on 19th April 2010 by gjohnson in Uncategorized

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After his newborn twins were almost killed by an accidental overdose of heparin, actor Dennis Quaid has made promoting hospital safety his personal mission, according to several recent press reports. http://www.medicalnewstoday.com/articles/185383.php

 Quaid gave did an extensive Q&A interview with Newsweek magazine April 13, http://www.newsweek.com/id/236313

about his crusade to stop medical errors. His new documentary, “Chasing Zero: Winning the War on Healthcare Harm,” will debut this month at the global summit on patient safety in France.

 The actor got involved in the cause after his twins Zoe Grace and Thomas Boone almost died after being twice given huge doses of the blood thinner heparin that “were 1,000 times too high” at Cedars-Sinai Medical Center in Los Angeles, according to Newsweek.

 Quaid told Newsweek that he and his wife Kimberly thought about suing Cedars-Sinai for malpractice, but decided against it.

 In the wake of the near-deadly overdose to the Quaid babies, Cedars-Sinai spent millions of dollars to install bedside barcodes to eliminate prescription errors.

 “I must say Cedars has stepped up to the plate,” Quaid told Newsweek.

 And the Quaids started the Quaid Foundation, which has now combined with the Texas Medical Institute of Technology.

 

E. Coli Infections Declined Significantly, New CDC Report Says

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Posted on 16th April 2010 by gjohnson in Uncategorized

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 It looks like new food-safety rules are having an impact on E. coli,  with infections from the potentially deadly bacteria significantly declining last year, to the lowest level since 2004, according to The Wall Street Journal. http://online.wsj.com/article/SB10001424052702304628704575186380101435578.html

 But the same couldn’t be said for other types of food poisoning, whose rates remain nearly the same as they were in 2004, according to preliminary figures from a national monitoring program, FoodNet, which tracks infections in 10 states. The data was issued in a press release Thursday from the U.S. Centers for Disease Control and Prevention (CDC).

http://www.cdc.gov/media/pressrel/2010/r100415b.htm

While the 2009 rates for most of the nine illnesses tracked through FoodNet saw declines since the agency began in 1996, most have shown little change since 2004, according to the press release.

“The interventions begun in the late 1990s were successful in decreasing some of these foodborne diseases, but we haven’t seen much recent progress,” Dr. Chris Braden, acting director of CDC’s  Division of Foodborne, Waterborne, and Environmental Diseases.     “To make additional strides against these diseases and ultimately better protect the American people from foodborne illness, CDC, our federal and state partners, and the food industry will need to try new strategies.”

The CDC said that E. coli is of special concern because in 5 percent to 10 percent of its cases the infection causes kidney failure, and E. coli is especially dangerous for children and the elderly.

 ”Today’s report confirms our past success combating foodborne illness by setting an aggressive goal, designing an effective system to meet that goal, and relentlessly implementing it; it’s time to do it again,” Dr. David Goldman, assistant administrator of the  Office of Public Health Science of the U.S. Agriculture Department’s Food Safety and Inspection Service.

The full report is available online at www.cdc.gov/mmwr. 

We are a little suspect of the timing of this CDC press release, as it comes in the wake of The New York Times winning a Pulitzer Prize Monday for stories relating to lax food regulation. In one of those stories, a young woman was paralyzed for life after eating one hamburger contaminated with E. coli. We’d like to know what that New York Times reporter, Michael Moss, would have to say about Thursday’s CDC report.

 Following the 1993 outbreak of E. coli , the government declared it an adulterant, implemented Hazard Analysis and Critical Control Point (HACCP) production systems to prevent food contamination, established FoodNet and set a goal of cutting E. coli illnesses in half by 2010, the CDC said.  

“There is more work to do,” Goldman said. “Under the President’s Food Safety Working Group we are setting new goals and modernizing the system to meet those goals so that we can see renewed progress in cutting foodborne illnesses.”

FoodNet data is important to help FDA to design food safety policies and programs to reduce foodborne illness, according to Jeff Farrar, the FDA’s associate commissioner for food protection.

“FDI is pursuing a number of initiatives to strengthen the foods program, such as new preventive measure requirements during the production of shell eggs to address salmonella enteritidis,” he said in the CDC press release, “This measure will become effective this summer. FDA also is developing a proposed rule that includes risk-based safety standards for preventing illness from produce, and it is expected to be published within a year.”

The only significant decline in incidence in recent years other than for E. coli was for shingella infections. Although some shingella infections are transmitted by food, most are probably transmitted directly from one person to another, often among children in child care settings, rather than through food.

Vibrio infections increased by 85 percent compared with the first three years of surveillance. While the overall number of vibrio infections is a small percentage of all foodborne illnesses, the infection may cause severe illness or death, particularly in people with weakened immune systems. Most vibrio infections are the result of eating raw or undercooked shellfish, especially oysters.

Among the four pathogens tracked in FoodNet that have national incidence goals, Salmonella is furthest from meeting the goal, according to the CDC. That’s possibly because salmonella  is spread through a wide variety of foods, and also through non foodborne routes. Salmonella can be spread by poultry, meat, eggs, produce and processed foods, as well as by contact with animals like baby chicks, small turtles, reptiles and frogs.

For most of the infections, the rate was highest in children under the age of four years. People over 50 years old had the highest rates of hospitalizations and deaths from most foodborne illnesses, emphasizing the need for those over 50 to get diagnosed and get treatment quickly after becoming ill, the CDC said.

FoodNet is a collaborative project of CDC, 10 state health departments, the U.S. Department of Agriculture and the FDA.  Since its inception, FoodNet has grown to sites in 10 states, covering 46 million people or about 15 percent of the American population. 

Data from FoodNet is generally representative of the entire United States. The sites are the states of Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, and Tennessee, and selected counties in California, Colorado, and New York.

New York Times Wins Pulitzers For Series On Driver Distraction, And Lapses In E. Coli Testing For Beef

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Posted on 13th April 2010 by gjohnson in Uncategorized

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The New York Times earlier this week won Pulitzer Prizes for two topics that are carefully covered by the blogs, like this one, that are part of the Brain Injury Index: driver distractions and indefensible lapses in government safety regulation of food. http://www.nytimes.com/2010/04/13/business/media/13pulitzer.html

 The remarkable reporting and stories written by Matt Richel and Michael Moss are must-reading for anyone interested in those two topics. Beyond the Pulitzer, the work by these two writers achieved the highest, and hardest, goal of any journalistic undertaking: They forced change.

 In the series “Driven to Distraction,” Richel wrote on a topic that now is in the papers almost on a daily basis, namely how driver distractions like texting and conversing on cellphones are leading to deadly accidents. http://topics.nytimes.com/top/news/technology/series/driven_to_distraction/index.html?scp=2&sq=richtel&st=cse#

 Oprah Winfrey is the latest to speak out and lobby for that cause, but it was Richel who put the issue in the national spotlight and had an impact. In the wake of his stories, legislators have proposed more than 200 bills aimed at prohibiting distractions in cars. President Obama barred federal employees from texting while they were driving. And the U.S. transportation secretary has started action to enact a ban on truckers texting.

 Moss, while covering a salmonella outbreak that was traced back to tainted peanuts, heard talk about the poor, or non-existent, enforcement of federal food safety laws for beef. He wrote a series of stories on the lax testing for deadly E. coli in meat. http://topics.nytimes.com/topics/reference/timestopics/people/m/michael_moss/index.html

 And he did what every good reporter must do to drive a story home, to humanize it. He found a 22-year-old woman who had been vibrant and active, until she ate one hamburger in the fall of 2007 that had E. coli. She is now paralyzed for life. http://www.nytimes.com/2009/10/04/health/04meat.html?_r=1

 The story, headlined “The Burger That Shattered Her Life,” was so tragic, shocking and heart-wrenching that it became water-cooler talk at some offices after it was published on Page One of The Times.

 According to the Times’ house ad celebrating its Pulitzers, in the course of his reporting Moss “discovered that the Agriculture Department didn’t even require testing of ground beef for E. coli, and that some slaughterhouses refused to sell to ground beef producers unless they agreed not to test.”

 As a result of Moss’s stories, the Agricultural Department was shamed into reviewing its safety procedures, and a food retailer and major slaughterhouse agreed for the first time ever to test the ingredients that go into ground beef.

 The work by Richel and Moss deserves your time, it deserves to be read.  And it will make you think twice before answering that cellphone while you’re driving, or eating a hamburger. 

Federal Judge Grants $2.6 Million Judgment In Chinese Drywall Suit

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Posted on 9th April 2010 by gjohnson in Uncategorized

In what may be the first of many such verdicts, a federal judge in New Orleans Thursday awarded $2.6 million in damages to a half dozen families in Virginia that filed suit against a Chinese manufacturer whose drywall is suspected of being unsafe, according to The Wall Street Journal. http://online.wsj.com/article/SB10001424052702304198004575171853420327126.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsForth

Just a week ago the U.S. Consumer Product Safety Commission urged homeowners to remove Chinese-produced drywall from their homes, because it was causing health and safety problems.

It looks like it will be an ongoing situation involving many new homes in Louisiana and Florida in particular. That’s why the federal trial and verdict “has been closely watched by homeowners, home builders and insurers,” according to The Journal.

Federal Judge Eldon Fallon, who presides in federal district court in the Big Easy, in an opinion more than 100 pages long ruled in favor of seven Virginia families against Taishan Gypsum Co., a Chinese-state owned drywall maker.

Since Taishan didn’t even come to court to defend itself, it’s not known how the judgment will be collected.

Thousands of complaints have been filed by homeowners over the drywall, with the actions claiming that the material is releasing fumes that are causing respiratory problems, and even corroding the metal on electrical appliances.

Since The Journal estimated that millions of tons of this drywall, or gypsum, were sent to the United States during the 2004 to 2007 housing boom, it appeals to be a significant problem.

The consumer product commission has said that some of this Chinese drywall is releasing hydrogen sulfide, a flammable gas, at 100 times the level of non-Chinese drywall.

Judge Fallon mandated that Taishan must remove and replace the drywall, copper plumbing, ventilation systems, flooring and electrical wiring in the homes of those who had filed suit.       

There should be a ruling soon in a case, Hernandez vs. Knauf Plasterboard Tianjin, similar to the one in New Orleans. That suit is also being handled by Judge Fallon in New Orleans.    

 

Tainted Drywall The Latest Scourge From China

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Posted on 6th April 2010 by gjohnson in Uncategorized

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First, China brought us contaminated heparin. Now, it’s brought us drywall that is endangering American homeowners.

The federal government on Friday warned families with the defective drywall to take it out of their homes, because its noxious emissions are being linked to health and safety problems. http://online.wsj.com/article/SB10001424052702304871704575159971085212294.html?mod=WSJ_WSJ_US_News_5

The drywall, also called gypsum or wallboard, has been connected to electrical problems and causing respiratory problems for residents of new homes, mainly in Louisiana and Florida. http://www.nytimes.com/2010/04/03/business/03drywall.html?ref=business

Some Chinese-made drywall is emitting hydrogen sulfide at rates 100 times greater than non-Chinese drywall, according to information The Journal cited from the Consumer Product Safety Commission and Department of Housing and Urban Development.

The drywall came under federal investigation after homeowners complained about smelling rotten-egg like sulfide odors. But that’s not all. Homeowners complained that they were suddenly getting bloody noses, headaches and respiratory problems – and that some of their appliances were corroding.

More than 3,000 complaints have been filed with the Consumer Product Safety Commission from people who claim fumes from the drywall have damaged their homes, according to The Journal.

One consulting firm pegged the damage from the faulty drywall at $15 billion to $25 billion. The question now is who will foot the bill.

Some home builders are already fixing homes they built with the defective Chinese drywall. One company, Lennar Group, has budgeted $81 million to fix 600 homes it built in Florida, The Journal reported. Lennar wants to get that money back from insurers and subcontractors.

Toddler Dies After Heparin Overdose At Nebraska Hospital

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Posted on 5th April 2010 by gjohnson in Uncategorized

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In a case that mirrors the near-tragedy that happened to actor Dennis Quaid’s twins, a toddler has died from an overdose of the blood thinner heparin at an Omaha, Neb., hospital. http://www.emaxhealth.com/1506/24/texas-toddler-dies-nebraska-hospital-after-heparin-overdose.html

Almariah Duque, 23 months old, of Dallas, Texas, was at Nebraska Medical Center to receive organ transplants when was given the allegedly fatal dose of heparin. The hospital is investigating the child’s death.

An estimated 100,000 people die each year in hospitals as a result of medical mistakes, and heparin is typically high on the list of drugs involved in medication errors, according to an online story on eMaxHealth.com.

There’s a reason for that: Pediatric and adult doses of heparin used to come in bottles that had the same size and shape, with just a slight difference in their blue color. Heparin’s manufacturer, Baxter International, redesigned the bottle’s labels to try to prevent future mistakes with the medication. There is now a red caution label on the vials that must be removed before they can be opened.

But the drug maker didn’t recall the old heparin bottles.

Quaid and his wife Kimberly made preventable medical errors their cause celebre after an incident in 2007 when their twins were accidentally given 1,000 times the common dosage of heparin at Cedars-Sinai Medical Center in Los Angeles.

The babies began bleeding, and had to be given protamine sulfate to counteract the heparin’s effect. The twins were hospitalized for 12 days.

On the CBS show “60 Minutes,” Quaid said he had learned that accidental heparin overdoses often happened. He and his wife have created the Quaid Foundation to raise awareness about medical mistakes that are fatal.

Researchers Working On Better, Faster E. Coli Test

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Posted on 4th April 2010 by gjohnson in Uncategorized

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There’s been a breakthrough in the testing for the E. coli microbe, which is often the culprit in tainted beef, according to The New York Times. http://www.nytimes.com/2010/04/01/science/01obtest.html?ref=us

The actual E. coli microbe isn’t what sickens people if they eat food contaminated with it. Rather, it’s the toxins that E. coli produces that do the harm. For that reason, testing should be done for both the microbe and the toxins it produces, which typically requires two tests.

But researchers at Agricultural Research Service of the U.S. Department of Agriculture say they are making progress creating one test that will that will detect pathogenic E. coli and its toxins.

That test was talked about at a recent meeting of the American Chemical Society. The new test employs small polystyrene beads that are covered with antibodies for the proteins found on the bacteria and two of the toxins it produces, according to The Times. The beads are then put into ground beef, and then separated from it an analyzed.

The new test is quicker to perform than today’s E. coli tests, with the results coming in 24 hours rather than a week. And this test can also be used on vegetables.

But the new test is not ready yet for commercial use yet, and could take a few years to get to market.

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