Chinese Drug Maker Untainted By 2008 Heparin Tragedy Makes Strong Financial Debut

0 comments

Posted on 7th May 2010 by gjohnson in Uncategorized

, , ,

The world’s largest supplier of heparin products, which is also the only Chinese heparin maker accredited by the Food and Drug Administration, has become a publicly traded company. It got off to such a strong start that its founders have become “overnight” multi-billionaires.  http://www.nytimes.com/2010/05/07/business/global/07drug.html?scp=2&sq=heparin&st=Search

If you believe the claims of Shenzen Hepalink Pharmaceutical, which started trading on the Shenzen stock exchange Thursday, it is one of the few good guys, one of the few Chinese heparin makers with its hands clean, in the tragedy in 2008 when contaminated heparin imported from China was linked to the deaths of hundreds in the United States.

Shenzen Hepalink claims that it not only has accreditation from the FDA, but also from the European Directorate for the Quality of Medicines and Healthcare.

Officials at Shenzen Hepalink underpriced their initial public offering, as the company’s shares jumped 18.3 percent from the opening price. That put the drug maker’s valuation at $10 billion, and made very rich men of its founders, Li Li and his wife Tan Li.

The New York Times Friday described Shenzen Hepalink’s main product as “highly purified heparin, a substance made from the mucous membranes of pig intestines.”  Heparin is a blood thinner. 

The Times suggested that the reason Shenzen Hepalink’s shares did so well their first day on the market was because the company was guiltless, and never cited, as one of the Chinese companies that provided contaminated heparin to the states. Tainted heparin from 12 Chinese companies was sent to nearly a dozen countries, according to The Times.   

The paper also pointed out that in China, “pig intestines are often cooked in unregulated family workshops.” In 2008, a contaminant called oversulfated chondroitin sulfate was in the tainted heparin, undetected by normal testing.

The Food and Drug Administration has said that there were 149 deaths caused by allergic reactions to the contaminated heparin, according to The Times.

That’s way below our estimate. We believe that hundreds of deaths can be linked to the tainted heparin, and there are hundreds of wrongful-death suits pending in the matter. 

 Here’s a side note to this story. Another investor that did very well with Shenzhen Hepalink’s IPO was beleaguered Goldman Sachs. It paid $4.9 million for a 12.5 percent share in the heparin company back in 2007. That stake is now worth 200 times what Goldman first paid for it, according to Bloomberg News.   

    

 

      

 


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Rep. Barton Demands Answers about Heparin Contamination

0 comments

Posted on 7th May 2009 by gjohnson in Uncategorized

, , , ,

Finally someone in Washington has remembered that there are still consequences to what they called a “catastrophe” last year.

According to the Dow Jones Newswire, Rep. Joe Barton, R.-Texas, “is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn’t know what caused U.S. patients to get sick or die while taking the blood thinner last year.”

Barton is a member of the House Energy and Commerce Committee which held hearings last year. He has written a letter to the FDA demanding the agency turnover databases on the Heparin contamination. According to Dow Jones:

Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.

“We don’t seem to be any further along a year later from understanding” this issue, said an Republican staffer for the committee, who asked not to be named. “What are they doing about it? Is this an acceptable practice in China?”
It is time that the FDA went public with all it knows about the Heparin Catastrophe. Freedom of Information Requests have been pending before the agency for more than a year now. What does the FDA know? Why are they not telling the American public about the full breadth of this poisoning?


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Heparin – FDA’s SPL Inspection – No One in Charge

0 comments

Posted on 6th April 2009 by gjohnson in Uncategorized

, , , , , , ,

Today we discuss what has to be the most staggering aspect of the manufacturing situation at the Changzhou SPL plant in China, Baxter’s source of the API which made up the contaminated Heparin: No one with specialized knowledge of Heparin, was working for SPL in China.

These quotes are taken from the April 29, 2008 hearings before the House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina Brown of the FDA was questioned in those hearings by U.S. Representative, Jan Schakowsky:

Question by Schakowsky: There was no person with special knowledge of Heparin at the firm to guide decisions made by the quality unit. So Ms. Brown, I would assume that if a plant was making Heparin API, it would want to have a person with “special knowledge” of that product, in case deviations from any manufacturing process were observed, wouldn’t you agree?

Answer by Brown: They had a quality unit there, which consisted of four people, they were trying to track what was going on with the firm. The person with the special knowledge I mentioned, because when I arrived, management was aware that there were Baxter recalls, and that there were adverse drug events and deaths in the United States. It was middle of February, the general manager of the firm, Mr. Wong, was the one who described the process to me and how he thought that impure materials were removed from the crude heparin to make it into the heparin API and he said he wasn’t a heparin expert. And so, he was really the person who gave me my fullest extent of knowledge during the inspection.

Q: So, neither he nor the others had any special knowledge, he had the most knowledge?

A: I believe so, yes.
Unbelievable. SPL is manufacturing a drug that is going to be put in to the veins of our sickest people and they don’t have anyone on site with specialized knowledge as to how to make Heparin? How could Baxter have allowed this? Any superficial investigation would have determined that Changzhou SPL didn’t know what it was doing. Such a breakdown in the process of making an intravenous pharmaceutical is outrageous and is an institutional catastrophe.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Heparin – Frequently Asked Questions – How Many People?

0 comments

Posted on 24th March 2009 by gjohnson in Uncategorized

, , , , , ,

9. How many people were poisoned?

Baxter still isn’t giving a straight answer to this question, so we don’t even know how many cases to fully investigate. But we want to create a ground swell of public opinion demanding full public disclosure. We do know that millions of vials of contaminated heparin were put into the health system. How many people were poisoned? We won’t know unless each and every case in which a person died or was severely injured who was on heparin is investigated.

Contact your Congressman, demanding answers. Write the FDA demanding answers. If you were part of Barack Obama’s campaign, contact them or the Whitehouse. This is one of the most important issues impacting public health and the Federal Government must demand the same sort of answers that they are now demanding of AIG.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

30 years transform China, but not its politics

0 comments

Posted on 17th December 2008 by gjohnson in Uncategorized

, , ,

When we were arch enemies, China arguably made us stronger. As an economic ally, they may have sewn the seeds of undoing. Heparin is just the most vivid portrait of the damage they have done to us. Their undermining of our industrial base, may ultimately destroy us, as it leads them towards a vulnerability towards our capitalism that may result in another revolution, when our demand for their imports stop.

Attorney Gordon Johnson
http://heparin-law.com
http://fishtail.tv
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2008


Date: 12/17/2008 9:56 PM
By AUDRA ANG
Associated Press Writer

BEIJING (AP) — Thirty years ago this month, China’s communist leaders launched an economic revolution, opening the door to free market reforms and foreign trade — though not to political change.

The new era began with a Communist Party gathering on Dec. 18, 1978, that endorsed small-scale private farming, the first step toward abandoning the late leader Mao Zedong’s vision of communal agriculture and industry.

China’s economy has since grown into the world’s fourth-largest behind the U.S., Japan and Germany, and annual per capita income has soared to about 19,000 yuan ($2,760) last year, up from just 380 yuan in 1978.

The party marked the anniversary Thursday with a ceremony in the Great Hall of the People in central Beijing, opening with a speech from Hu Jintao, general secretary of the party and China’s president.

“The reform and opening-up policy provided the theoretic foundation for the prosperity of China’s economy,” Hu said in the nationally televised program.

Along with private enterprise and capital markets have come greater prosperity and stability than ever before.

Virtually all Chinese families now have at least one television and, in the cities, a washing machine — rare items three decades ago. Some 15 million families own private cars, and many Chinese also own their own homes.

“Nowadays, we worry instead about eating too well rather than not eating enough,” says Guo Linchun, 78, retired music teacher in Beijing. “Now, living standards have improved so much, we see not only televisions, so many people even own cars.”

But with modern industries come many other modern ills: pollution, industrial accidents and product safety scandals. And China’s heavy reliance on exports and foreign investment ensures that the uncertainties now afflicting the global economy are haunting the Chinese as well.

As economic growth slows and factories close, job losses threaten to fuel political unrest. Authorities have slashed interest rates and promised to spend more than half a trillion dollars to stimulate the economy.

The seeds of China’s tremendous transformation were planted in 1978, when then-leader Deng Xiaoping declared, “We must learn to manage the economy by economic means” — calling for pragmatism to trump communist ideology.

It was a crucial turning point between the 30 years of economic central planning that followed the founding of the People’s Republic in 1949, and the current era of catching up to the affluent, industrial West.

“To get rich is glorious,” proclaimed Deng, a fiery revolutionary hero who was twice persecuted for being a “capitalist roader” before he came to power in 1978.

Today, China’s worship of progress and wealth is evident — in the bright neon billboards of Shanghai’s waterfront Bund, in Beijing’s teeming expressways and showcase Olympic stadiums, in the vast industrial parks and luxury villas crowding farmers out of city suburbs.

In the early 1980s, just a few years after the reforms were launched, Beijing’s wide thoroughfares were empty and dark at night. A stroll down Shanghai’s Nanjing Road took a visitor past ill-lit tenements and tiny shops.

Traveling across town involved slow rides on lumbering buses, or long treks by bicycle; taxis were still unheard of. Dining out after 6 p.m. meant going hungry — most restaurants were closing by then, their meager menus finished for the day.

Shanghai’s bar streets now bustle until the wee hours; local noodle shops compete with McDonald’s for the pre-dawn crowd.

China is now a lynchpin in international trade and a powerful player in world diplomacy. Its leaders take each major anniversary as an opportunity to spotlight the Communist Party’s role in its success story.

Next year, the country marks another, darker anniversary, that of the 1989 crackdown on pro-democracy protests centered in Tiananmen Square, a military assault on unarmed demonstrators that killed hundreds, perhaps thousands.

Despite dramatic economic changes, China’s political system would remain petrified, with the Communist Party firmly in control.

“China has enjoyed remarkable economic growth and social progress, but it is least impressive in terms of political reform and cultural diversity,” says Ding Xueliang, a former Communist Party official who teaches at the Hong Kong University of Science and Technology.

Calls for greater freedoms persist. Earlier this month more than 300 lawyers, writers, scholars and artists circulated a public appeal, called the “Charter 08,” urging the party to loosen its 60-year monopoly on power and allow democratic reforms.

“Where is China headed in the 21st century?” it asks. “This is a historic moment, and our future hangs in the balance.”

China’s leaders still punish public dissent and perceived challenges to their power. One Chinese writer who signed the charter remained missing more than a week after police took him away, and more than three dozen others have reported harassment, according to the group Chinese Human Rights Defenders.

Though China has the world’s largest population of Internet users, more than 250 million, it still seeks to control what its citizens see and hear.

Despite China’s abundance of food and material wealth, it is a developing country. According to the World Bank’s most recent estimates, more than 100 million of the 1.3 billion Chinese still live on less than $1 a day. That’s way down from 800 million three decades ago, but hundreds of millions more get by on just $1 to $2 a day.

For the rural poor, the only escape from poverty is to flee farms for the cities, where many get by working in factories or construction sites, driving taxis and trucks, or gathering trash for recycling.

Taking the most dangerous, unpleasant jobs, China’s migrant workers may be the biggest victims of the country’s pell-mell industrialization. But all suffer from skies choking with auto exhaust and smog from coal-fired power plants; rivers bubbling with untreated sewage and villages festooned with plastic bags and other litter.

Simmering protests over pollution and industrial accidents have prompted authorities to pledge better enforcement of environmental, labor and safety standards.

Though its problems with product quality are nothing new — exploding beer bottles and television sets once were the main headline grabbers — thanks to its newfound role as the world’s factory floor, China now answers to global consumers outraged by unsafe food, drugs and other products.

China’s own economy remains a hodgepodge of freewheeling private enterprise and state-dominated big industries. It is only gradually easing controls on foreign investment in shares. It keeps its currency trading in a narrow band, and re-imposed price controls on food and other key commodities when inflation surged earlier this year.

But whatever the risks and frictions from globalization, even with the world financial system in chaos, Beijing remains committed to the reforms that have taken it so far from its communist revolutionary roots.

“The financial crisis in the West has definitely discouraged many in China from moving quickly on financial reforms,” says Ding. “The political and business leadership will look at things more prudently and more carefully, but I wouldn’t say they’d turn back.”

_

Associated Press writer Elaine Kurtenbach in Shanghai contributed to this report.

Copyright 2008 The Associated Press.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Reports of serious drug reactions hit record

0 comments

Posted on 22nd October 2008 by gjohnson in Uncategorized

, , , , , ,

Date: 10/22/2008 11:30 AM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ A health industry watchdog group reports that a record number of serious problems and deaths linked to medications were reported to the government in the first three months of this year.

An analysis of federal data by the nonprofit Institute for Safe Medication Practices shows that the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths. The group analyzed quarterly data going back to 2004, and yearly totals dating to the 1990s.

Two drugs accounted for a disproportionately large share of the reports early this year. One was Pfizer’s anti-smoking medication, Chantix, and the other was heparin, the tainted blood thinner from China that caused a safety scandal.

Copyright 2008 The Associated Press.
www.heparin-law.com


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Army creates team to review security at biolab

0 comments

Posted on 8th August 2008 by gjohnson in Uncategorized

, , , , , ,

We could have filled this and other blogs this week with all of the news and commentary about Anthrax. But what does that have to do with the Heparin Catastrophe. It just drives home even harder, the point we have been making on this blog since February that any firm in the pharmaceutical industry had to do the utmost to insure absolute purity of its drugs. Not only has there been on the front burner of the FDA agenda the risk of counterfeit drugs, but more seriously, the risk of intentional tampering, with malicious intent. Any company that makes drugs, must make them with such utmost security, that no opportunity to infect large numbers of people could exist.

That reality is even more important with a product like Heparin, that is designed to be taken, not only intravenously, but also given to our sickest individuals, those on kidney dialysis. Nothing less than an absolute guarantee of purity is required, and exporting the manufacture of raw materials and expecting a federal agency that has a 30 year backlog, is not the way to do it.


Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2008

Date: 8/8/2008 7:53 PM

By LOLITA C. BALDOR
Associated Press Writer

WASHINGTON (AP) _ The Army has created a team of medical and other military experts to review security measures at the research laboratory where the scientist linked to the anthrax mailings worked.

Army Secretary Pete Geren has asked at least a dozen military and civilian officials to scrutinize safety procedures, quality controls and other policies and practices at the biodefense lab at Fort Detrick, Md., Army spokesman Paul Boyce said Friday.

To date, the Army has offered no explanation for how its biosecurity system, which is set up to catch mentally troubled workers, failed to flag scientist Bruce Ivins for years. Ivins, the microbiologist accused of sending anthrax-laced letters in 2001 that killed five people, committed suicide last week as the FBI began closing in on him.

Boyce said Friday that Geren met with military officials on Thursday night, then traveled to the high-security Army Medical Research Institute of Infectious Diseases, known as USAMRIID, at Fort Detrick on Friday morning to talk with leaders there.

Boyce said the team, which is only now being formed, is not targeting individuals but instead will be reviewing documents, procedures and other safety measures to ensure security at the military biodefense lab. He added that as yet there are no deadlines for reports from the team.

The facility has come under intense public scrutiny as more details have spilled out about therapists’ concerns that in recent years Ivins had become paranoid, delusional and bent on violence.

Investigators said that between 2000 and 2006, Ivins had been prescribed antidepressants, antipsychotics and anti-anxiety drugs. By 2005, the government had matched anthrax in his lab to the strain that killed five people.

It wasn’t until November 2007, after the FBI raided his home, that Fort Detrick revoked Ivins laboratory access.

Army officials have declined to discuss any other efforts to either watch Ivins more closely or put other restriction on him prior to the November action.

Instead, they have stressed that safety procedures at the lab have included ongoing personnel evaluations, which rely largely on employee self-reporting medical or criminal problems and observations by other workers and supervisors.

Boyce said the impending review will be headed by a two-star general, and will include representatives from the medical research command, the Army’s surgeon general, and Army operations.

While the lab has strict security measures meant to weed out troubled scientists, there are lingering questions about why it took so long for supervisors to restrict Ivins access to the deadly toxins.

Ivins’ attorney, Paul F. Kemp, says the government’s evidence was too weak to trigger any action.

But members of Congress have questioned whether adequate action was taken, and they have pledged to investigate the case and lab security as a whole.

Overall, there are nearly 1,400 biological defense labs, with an estimated 14,000 scientists working with the world’s deadliest pathogens.

In 2005, the Pentagon ordered new “biosurety” safeguards requiring workers such as Ivins to be “mentally alert, mentally and emotionally stable.” The program was meant to ferret out workers with mental problems and those who attempted or threatened suicide.

Colleagues have differed in their observations of Ivins, with some saying they never say signs of mental illness, and others describing him as a “manic basket case” or saying they’d seen him openly weeping at his desk.

Ivins himself wrote in a July 2000 e-mail that he might be suffering from a paranoid disorder.

“I get incredible paranoid, delusional thoughts at times, and there’s nothing I can do until they go away, either by themselves or with drugs,” he wrote that August, in an e-mail included in government documents released Wednesday.

Copyright 2008 The Associated Press.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Heparin Disaster -FDA Inspections Weren’t Sufficient to Rely on Safety of Drug

0 comments

Posted on 17th July 2008 by gjohnson in Uncategorized

, , , ,

One of the lingering excuses for the Heparin Disaster is that it was the FDA’s responsibility, not the manufacturers, to make sure that Heparin was safe. That is like Wesley Snipes blaming overworked auditors for his tax fraud.

The risk factors of counterfeit drugs are known not only by drug companies like Baxter and SPL, but by the public at large. Every time we struggle to open a sealed package of anything we are reminded of why these seals are on these products: to avoid tampering. The risk of tampering and counterfeit are not something that can be transferred to an imperfect government auditing system, especially in light of what insiders have been saying for years about the thoroughness of FDA inspections.

In previous blogs, we have discussed the testimony before Congress: “Weaknesses Place Americans at Risk” Subcommittee on Oversight and Investigations held April 22, 2008. Click here for those hearings:http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml

During such hearings, Benjamin England, a former FDA inspector testified as to how inadequate the current FDA was to keep up with the problem of inspections.

I am founder and owner of an FDA consulting practice, FDA Imports.com, Inc., and a practicing attorney representing foreign and domestic food, drug, medical device and cosmetic companies in matters involving the U.S. Food and Drug Administration (FDA). I am a 17-year veteran of the U.S. Food and Drug Administration (FDA). From 1986 to 2003 I held the positions of Regulatory Microbiologist in FDA’s Baltimore Microbiology Laboratory, Consumer Safety Officer and Compliance Officer in FDA’s Baltimore District Office, Special Agent with FDA’s Office of Criminal Investigations in the Miami Field Office, Compliance Officer in FDA’s Miami Resident Post, and Regulatory Counsel to FDA’s Associate Commissioner for Regulatory Affairs (or ACRA) in Headquarters. I resigned my most recent FDA position as Regulatory Counsel to the ACRA in July 2003 — a position I held in FDA for over three years as a Title 42 appointee.


In his testimony, England stated:

Today we are confronted with serious adverse events involving a widely used drug product that appears to have been made using substituted active ingredients at a foreign facility that was never inspected by FDA – because of some human error in deciding whether an inspection had already been conducted or should be conducted. I believe that we are truly on the brink of a series of these events and that waiting for FDA to take some action that actually mitigates risk or encouraging the agency to act unilaterally will be an exercise in futility. As I said in the press and to your staff, Mr. Chairman, this recent case appears to be the close cousin of the same conduct discovered nearly two decades ago. At that time, it was through intensive and smart facility inspections and by the efforts of forward thinking forensic scientists and investigators the activity was discovered. Moreover, the successfully prosecuted counterfeit bulk drug case was made possible only through the intellectual connections between certain domestic inspections at U.S. facilities by a keen FDA investigator who had previously conducted the foreign inspection of the bulk supplier, coupled with follow up inspections at the foreign supplier, which were themselves targeted with knowledge of where evidence of illegal conduct was likely to be found.

It is no different today – except that we now have available to us significantly improved technological solutions that may prove useful to more precisely and efficiently identify, target, and intercept safety risks prior to their realization in the market place.
In our next blog, we will discuss England’s perspective on the FDA’s failures to use those technological advances to prevent tampering and contaminants in imported drugs.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

FDA Identifies Contaminant in Heparin

0 comments

Posted on 6th March 2008 by gjohnson in Uncategorized

, , ,

The FDA, at a press conference yesterday indicated that the FDA has identified the contaminant in the suspect Heparin injections, amid speculation that the such contamination could have been intentional.
In a news story on that Press Conference, the Chicago Tribune states:
“The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December.”
Click here for the Chicago Tribune story.
The FDA attributed this Heparin to as 19 deaths and 785 serious illnesses since Jan. 1, 2007.
According to the Tribune story the Heparin deaths and illnesses are suspected to extend further back in time than the original September of 2007 timeframe which was originally identified.
The Tribune quoted the FDA spokesman as follows:
“We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
Areas of inquiry and controversy that are now swirling around this tragedy include suspicions of a Chinese pig epidemic being passed thru to the drug, concerns about the possibility of the contaminant being used because the active ingredient was in short supply and the possibility of other wrongdoing.
As I have asked before on this blog: Why are we risking the safety of our medicines, given to our frailest of citizens, on products that come from Chinese pigs? Only greater profits, in an industry that is taxing the American economy as greatly as the oil industry, can justify not getting such product from Illinois or midwestern pork. We fight so hard to keep animal diseases out of this country, then import them into products for human medicines, because we have no effective control or accountability on the foreign suppliers of such products.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney

Heparin Purity – China Doesn’t Seem to Care

0 comments

Posted on 28th February 2008 by gjohnson in Uncategorized

, , , ,

Last summer China got some outrageous publicity, when it executed the individual responsible for the poisons that got into US Pet Food. Apparently, the Chinese government is less concerned about the health of American people. It was reported today that the Chinese government is washing its hands to the quality of the raw ingredients which make up the Heparin sold by Baxter, which has resulted in deaths and hundreds of adverse reactions here.

According to a story published by the Wall Street Journal:

“The Chinese FDA said it works with foreign regulators to monitor factories, but the ultimate responsibility for “safeguarding the legality, quality and safety of active pharmaceutical ingredients” lies with the importing nation, the WSJ’s Gordon Fairclough reports. http://blogs.wsj.com/health/2008/02/27/

So who is to blame? Clearly, Baxter, as the producer of this product, must have ultimate responsibility, as must its Wisconsin based partner, Scientific Protein Labroratories, based in Waunakee, WI, who had the joint venture with the Chinese company that imported the toxic product. But can our government continue to have bureaucratic snafus that cost American lives? Can the Bush adminstration continue to tolerate a “wash our hands” attitude from China about safety? The political controversy this week swirls around safety issues and NAFTA. But shouldn’t this issue of the Chinese government saying “whatever”, sound just as loudly?

While one can argue a synergistic growth to the North American economy from NAFTA, how can one argue that we benefit by shipping the production of essential drugs like heparin, which require the processing of pigs, to a place where we can’t practically monitor and the producers don’t prioritize safety? I do think, on the threshold, Baxter must explain why American pigs were incapable of being used to make heparin. Clearly, there is no shortage of pork within a hundred miles of Baxter’s headquarters in suburban Chicago.


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

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney