FDA Recall Heparin | Heparin Deaths

FDA Soon To Issue Guides On Tracking/Tracing Drugs

Posted on 13th March 2010 by gjohnson in Uncategorized

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It may have taken three years since the heparin-contamination tragedy, but the Food and Drug Administration is apparently close to issuing its guidance for the tracking and tracing of medicines. http://www.securingpharma.com/40/articles/403.php

Joshua Sharfstein, FDA deputy commissioner, said Thursday that the guidance will set “a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits.”

He made his remarks before a House Energy and Commerce health subcommittee meeting, which was called “Drug Safety: An Update From The FDA.”

Coming up with a better system of tracking drugs is crucial, especially when about 80 percent of all active pharmaceutical ingredients used by U.S. drug makers come from overseas, according to a 1998 U.S. General Accounting Office study.

During his testimony, Sharfstein claimed that the FDA has made great progress beefing up the oversight of foreign-made drug ingredients that are coming into the United States, For example, it has opened offices in several countries and now has information-sharing deals with foreign regulatory agencies.

Sharfstein also cited the calamity involving Chinese-made heparin, which he said caused the deaths at least 80 Americans, during his comments to the subcommittee.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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Group Produces Guide Aimed To Prevent Incidents Like The Heparin Contamination Tragedy

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Posted on 3rd March 2010 by gjohnson in Uncategorized

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It’s too bad this wasn’t around in 2008, when Americans were dying after getting tainted heparin from China: a guide that helps drug makers and their suppliers identify risk in the supply chain.
http://www.securingpharma.com/40/articles/395.php

The Pharmaceutical Quality Group (PQG) has put together the guide, which says that globalization and cost-consciousness has made the pharmaceutical supply chain very complex. And that can “reduce both the knowledge and understanding of the exposure to risk.”

The story on the guide notes that it is being published “in the wake of serious incidents in which the integrity of the pharmaceutical supply chain has been compromised to allow substandard and adulterated ingredients to find their way into medicines.”

The example cited: the contamination of the blood thinner heparin made in China in 2007 and 2008, which lead to the deaths of more than 200 people around the world.

The “how-to” guide goes into detail about techniques for managing supply chain risk, and illustrates how these can be applied in the pharma industry, including in instances like the heparin incident.

German Heparin Maker Sees 19 Percent Earnings Gains in 2009

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Posted on 26th February 2010 by gjohnson in Uncategorized

anaphylactic heparin reaction, FDA recall heparin, Fresenius Medical Care Dialyzers, heparin, heparin attorney

The German pharmaceutical giant Fresenius, which had a temporary monopoly for the blood thinner heparin when the drug was recalled in 2008, reported earnings growth of 19 percent for last year on Wednesday.

http://www.reuters.com/article/idUSLDE61L20X20100224?type=marketsNews

Fresenius’s financial results got a lift from its unit APP, which it acquired for $3.7 billion in 2008 as it sought to expand into the U.S. generic infusion drug market. APP’s competitors in that market are Hospira and Pfizer.

For a short period APP had a lock on the market for heparin, a dialysis drug, in the United States when Baxter International had to recall its heparin in 2008 because it was contaminated, causing many deaths.

But last August Hospira got regulatory approval for its heparin products, and it has taken much market share from APP, according to Reuters.

Inside Look at How Much Drug Makers Pay Doctors To Promote Their Meds

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Posted on 22nd February 2010 by gjohnson in Uncategorized

Cephalon marketing methods, corruption in drug industry, FDA incompetency, FDA problems, FDA recall heparin

The entire pharmaceutical industry needs to be changed. The way Big Pharma tests drugs, the way it makes drugs and the way it markets drugs all are more about profits than health. The FDA is supposed to protect us. Guess again. If the FDA didn’t learn hard enough lessons from the heparin debacle, maybe more and more investigations like this one about Cephalon, will suddenly shake the foundations of the relationship between the regulator and who it is supposed to regulate.

Doctors getting paid to tout drugs is nothing new, but some inside light was shed on the issue recently by the pharmaceutical maker Cephalon, as chronicled in The Philadelphia Daily News Friday.

http://www.philly.com/dailynews/local/84770832.html

In a settlement Cephalon had to pay $425 million in 2008 to settle a case where it illegally marketed three drugs. As part of that settlement, it had to disclose how much it had forked over to physicians to tout its medications.

On its Web site Cephalon, based in Frazer, Pa., said that it paid 936 health-care professionals, mainly doctors, more than $9.1 million last year for consulting and speaking fees. Those payments ranged from $63 to $149,900.

Cephalon had been charged with getting doctors to promote drugs for uses that don’t have Food and Drug Administration approval. That includes Actiq, a cancer pain treatment promoted to treat migraines; Gabitril, an epilepsy drug promoted for anxiety and pain; and Provigil, a medication for sleep disorders that was promoted to treat adult attention deficit disorder, depression and multiple sclerosis.

Sen. Grassley Asks FDA For Update On Foreign Drug Inspection Improvements Since Heparin-Contamination Deaths

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Posted on 17th February 2010 by gjohnson in Uncategorized

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At least one lawmaker hasn’t forgotten the 2008 heparin-contamination tragedy, which resulted in untold numbers of people dying. Sen. Chuck Grassley (R-Iowa) has renewed his quest to hold the U.S. Food and Drug Administration accountable for improving foreign drug inspections so deadly incidents like the blood-thinner debacle doesn’t happen again.

Earlier this week Grassley, who since 2007 has twice filed legislation seeking to “beef up” the FDA’s foreign inspection operation, sent a letter to the federal agency seeking a progress report on improvements to inspections.

Here is the senator’s press release on the matter, and the full text of his letter.
http://www.iowapolitics.com/index.iml?Article=185684

In seeking a follow-up, Grassley is essentially trying to hold the FDA’s feet to the fire for commitments it made when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.

“My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn’t have a system to check the quality of upstream providers of the drug components,” Grassley said in statement. “In fact, pharmaceutical companies aren’t required to have those checks in place.”

That is terrifying information for anyone who takes medication in this country.

“I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets,” Grassley said.

His proposed legislation calls for the enhanced enforcement for quality and safety violations. But the bills, which Grassley had introduced with the late Sen. Ted Kennedy (D-Mass), hasn’t been passed by Congress.

As many of our readers will know, Grassley is one of the chief Republican obstacles to the passage of health care reform. The irony of that contrasted against his outrage with Heparin is a bit much.

Grassley’s press release noted that China is one of the largest exporters of pharmaceutical products to the United States. Following questions raised by him others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.

Dow Jones wrote a story on Grassley’s call for answers and an update from the FDA.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201002161801dowjonesdjonline000426&title;=sengrassley-asks-fda-about-monitoring-of-drugs-made-abroad

That article says that 80 deaths were blamed on contaminated heparin, a blood thinner, from China. Based on the number of wrongful death claims that have been filed against Baxter, that number may be seriously understated. The contaminant, oversulfated chondroitin sulfate, OSCS, was in the heparin that Baxter received from is supplier Chanzghou SPL. Chanzghou SPL is a subsidiary of a Wisconsin company, SPL.

Grassley wants the FDA to answer his letter by March 2.

Don’t expect too much. While Grassley’s position is laudable, more should be done by Congress to get a full accounting of just how many people Baxter and SPL killed.

Congress should be publicly asking these questions of all of the heparin players, not just the FDA:

How many wrongful death claims has Baxter received?
How many doses of the contaminated heparin were actually given to people?
Why didn’t Baxter react more quickly when it learned of the deaths?
Why didn’t Baxter have some type of tracking system on its products so that when it learned of the contamination, it could quickly pull all of the tainted product from its shelf?
Why wasn’t the FDA and Baxter more concerned about the risk of counterfeiting drugs?

Traceability And The Recalls of Deadly Heparin and Peanuts

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Posted on 11th February 2010 by gjohnson in Uncategorized

FDA recall heparin, heparin, heparin adverse reactions, heparin attorney, heparin lawyer, heparin traceability

Traceability, the ability of a manufacturer to track where it secured raw materials and where it shipped product, is a key issue in lawsuits regarding heparin, the tainted blood thinner that was recalled and is being blamed for causing countless U.S. deaths in 2007 and 2008. http://heparin-law.com

InTech Home, from the International Society of Automation, has a detailed analysis of the issue of traceability and suggests requirements for traceability systems. http://www.isa.org/InTechTemplate.cfm?Section=General_Information2&template;=/ContentManagement/ContentDisplay.cfm&ContentID;=81071

The article cites a number of pharmaceutical and food product recalls where traceability has been an issue, including heparin that came from China and had a deadly contaminant in it, allegedly killing people. The story also mentions two salmonella outbreaks: One caused by jalapeno peppers from Mexico, which sickened 1,442 people, in 2008; and the eight deaths, and sickening of more than 600 people, from foods containing tainted peanuts that same year.

“While the current U.S. Bioterrorism Act requires traceability known as ‘one up and one down,’ recent food scares such as contaminated peanuts and peppers have demonstrated true recalls and safety announcements multiple supplier cooperation,” the story says.

The article says traceability has to do with determining what lots went into a product, and that such “lot assignments are the norm in drug manufacturing.” Lawyers have a lot of questions for heparin makers about traceability and lots during litigation stemming from the deaths two years ago.

As for traceability standards, the story makes six suggestions for food products.

The story’s first recommendation for the food industry is to first create a system that identifies “all source component ingredients” of a product within seconds. The second is to enable tracing of any ingredient “to identify all associated products within seconds,” Third is to quickly implement the recommended practices. Fourth is to address public concerns about tracing products. Fifth is to create a low-cost, low-burden traceability system. Sixth is to support other industry safety initiatives.

Finally, the article calls for standard lot identification of food products, suggesting “a new universal 16-character code as a consistent method of identification.”

America Exporting our Well Being to China – From Heparin to Green Tech

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Posted on 6th October 2009 by gjohnson in Uncategorized

Baxter recall of heparin, China Going Green, FDA censure of Changzhou SPL Company, FDA recall heparin, heparin, heparin attorney

China exports what American’s want. Not because they do it better, but because they do it cheaper. Baxter’s Heparin debacle is the perfect example. Anyone who lives in the Midwest knows that we grow all the corn necessary to domestically raise all the pigs we need. The raw material for Heparin comes from the small intestines of pigs.

Yet Baxter and its supplier SPL went off to China to get Heparin. The reason of course was to save pennies on each dose. Somehow, someone at Baxter decided that maintaining manufacturing and quality control over this most dangerous of products wasn’t as important as those pennies per dose.

The problem for American society is that China, despite its communist political system, always seems to be motivated by the “green” in greed equation. The irony of that now is that even though China is seen as the world’s worst polluter, they appear to be poised to receive the green, for Going Green.

On Point, the NPR program/podcast did an excellent piece on China’s Going Green, “Green China & the Clean-Tech Race”. To get the Podcast from September 30th go to http://www.onpointradio.org/2009/09/green-china-and-the-clean-tech-race

The program listing begins with this teaser:

“On Capitol Hill today, the Senate introduces a bill meant to slow global warming. Meanwhile, back on the wind farm, American entrepreneurs are taking the problem seriously — as an environmental threat but also as the next great economic prize.

“In China, the government says it’s determined to become a green superpower — or risk drowning in its own pollution.

“Some say the next great global race is on — the clean-tech race — and that China’s entry is a “Sputnik moment.”

“Has America heard the wake-up call? Is there a clean-energy race to be won or lost? This hour, On Point: China, the U.S., and the clean-energy future.”

One of the guests in this podcast is Michael Splinter, whose American based firm, Applied Materials, is about to open the world’s largest privately funded solar research facility — in Xian, China. For more on Splinter and his company go to http://www.appliedmaterials.com/about/bio_michael_splinter.html

The Heparin Catastrophe is not just a crisis about the safety of American pharmaceuticals. It is also a crisis about American jobs, technology and economic growth. If the greed equation results in the U.S. corporations exporting the manufacturer and development of this next tech explosion to China, our prosperity made be forever compromised.

FDA Announces Weaker Heparin – Weaker than What?

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Posted on 2nd October 2009 by gjohnson in Uncategorized

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Suddenly the FDA and the manufacturer’s of heparin are worried that perhaps the quantity of active ingredients in the heparin they sell might be a bit diluted. How ironic. See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm

Throughout what Congress called the “heparin catastrophe” millions of dosages of heparin weren’t diluted by 10%, but as much as 20%, not by harmless diluters, but by dangerous ingredients such as OSCS. See also the U.S. News story at http://health.usnews.com/articles/health/healthday/2009/10/01/us-health-officials-announce-new-heparin-formula.html

According to the U.S. News story:

The correct dosing of heparin has always been highly individualized and requires intense monitoring, which is a protocol that will remain in effect, officials said.

“The use of heparin is closely tied into monitoring and doses adjusted based on that,” said Dr. Dwaine Rieves, director of CDER’s Division of Medical Imaging and Hematology Products. “That procedure will not change.”

Now the FDA tells us that the correct dosing of heparin has always been highly individualized and requires intense monitoring? How could doctors have monitored heparin dosages when no one was monitoring how much active ingredient was in the product?

The litigation around heparin has swirled around a specific contaminant OSCS. Yet, there have been thousands of additional adverse reactions outside the recall time period, continuing up to this day.

Now it begins to become clear. If the manufacturer had no way to establish how pure the product was, how could “intense monitoring” have occurred? I believe the ultimate death toll from this drug will not just include OSCS poisoning, but complications because thousands more individuals didn’t and couldn’t get the right “intense monitoring” by their doctors.

Oversulfated chondroitin sulfate (OSCS) in Heparin Kills

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Posted on 12th September 2009 by gjohnson in Uncategorized

FDA censure of Changzhou SPL Company, FDA recall heparin, heparin and punitive damages, heparin attorney, Heparin deaths, OSCS

What is OSCS? Frankly, it is poison. It politely is called a “contaminant.” It is part of what was in the Heparin (that Baxter and Scientific Protein Labs distributed) that killed people. Almost all of the controversy in the Heparin litigation has swirled around OSCS. OSCS is oversulfated chondroitin sulfate. Here is some of what the FDA has said about OSCS at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm112606.htm:

13. What is the contaminant? (new question and answer added 6/18/2008)
Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.

14. Where is the contaminant found? (new question and answer added 6/18/2008)
The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.

15. Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin? (new question and answer added 6/18/2008)

The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate. The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .

For a catastrophe the potential magnitude of the swine flu, that is pretty polite language. What the FDA doesn’t say about OSCS above is that OSCS got in Heparin by the intentional actions of some Chinese individuals trying to make an extra profit by cutting Heparin, like a street drug might be cut with sugar. OSCS was used to cut the drug because it chemically looked enough like Heparin that it would pass the crude testing that Baxter and SPL were doing to determine the purity of this drug.

What the FDA also doesn’t say is that OSCS got into Heparin because some American corporate executives also were motivated by greed. More on that tomorrow.

Wyeth shareholders vote to be acquired by Pfizer

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Posted on 20th July 2009 by gjohnson in Uncategorized

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Any lingering doubt that the drug companies are among the worst of Wallstreet’s culprits gets set aside when one large company gets swallowed up a enormous company. They may still have American sounding names, but the reality this is big business, looking out only for profits, with not even a passing glance at the American consumer and the American worker. If the FDA doesn’t get back in front of these companies soon, the drug industry might ultimately collapse because we won’t be able to trust these products enough to put them in our bodies.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/20/2009 10:15 AM

MADISON, N.J. (AP) — Shareholders of drugmaker Wyeth have voted overwhelmingly to be acquired by industry giant Pfizer Inc.

More than 98 percent of Wyeth stockholders voted to approve the $68 billion acquisition. The deal will solidify Pfizer’s position as the top-selling drug maker in the world.

For Pfizer, it transforms the company overnight from being primarily a maker of the blockbuster pills to a one-stop shop for medical treatments. That’s because Wyeth brings multibillion-dollar products and substantial expertise in researching and manufacturing biologic drugs, vaccines, nonprescription medicines and animal health products.

Wyeth’s shareholders cast their votes while gathered at their annual meeting at the company headquarters in Madison, N.J.

Copyright 2009 The Associated Press.

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FDA Soon To Issue Guides On Tracking/Tracing Drugs

Group Produces Guide Aimed To Prevent Incidents Like The Heparin Contamination Tragedy

German Heparin Maker Sees 19 Percent Earnings Gains in 2009

Inside Look at How Much Drug Makers Pay Doctors To Promote Their Meds

Sen. Grassley Asks FDA For Update On Foreign Drug Inspection Improvements Since Heparin-Contamination Deaths

Traceability And The Recalls of Deadly Heparin and Peanuts

America Exporting our Well Being to China – From Heparin to Green Tech

FDA Announces Weaker Heparin – Weaker than What?

Oversulfated chondroitin sulfate (OSCS) in Heparin Kills

Wyeth shareholders vote to be acquired by Pfizer

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