China arrests 6 for role in contaminating milk

How many points in this story make no sense?...the over-under is 4...

BEIJING – China arrested three people Thursday for allegedly adding a toxic chemical to fresh milk to mask the fact that it was watered down and three others for selling the chemical.

The practice of adding melamine, a nitrogen-rich substance used in making plastics and fertilizers, to milk supplies is blamed for killing four babies in China and sickening tens of thousands.

The babies were sickened by powdered infant formula that authorities believe was made from tainted fresh milk. Melamine has also been found in other Chinese dairy products, including yogurt, candy and cream cookies.

More than 3,654 Chinese children remain hospitalized for kidney stones or other symptoms caused by ingesting melamine, the Health Ministry said Thursday. Three were in serious condition.

The official Xinhua News Agency said all six suspects arrested Thursday worked in Inner Mongolia, a region of sprawling grasslands that has become China's dairy heartland. Countless small dairy farms dot the grasslands, with milk collected at stations and then sold to large dairy companies.

One suspect, identified by Xinhua only by his surname Cui, ran a collection station and allegedly confessed to mixing about 25 gallons of water to 544 gallons of fresh milk. He then added 21 ounces — about three or four cups — of fake protein, which contained melamine, to hide the fact that it was diluted.

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Chinese government summons major dairy companies

to buy up the plants of the company that produced contaminated milk...somehow these facilties have "great value"???...

BEIJING – China summoned five of its major dairy companies to a meeting Friday over the fate of Sanlu Group Co., the company at the center of a tainted milk scandal that has sickened thousands and led to the deaths of four children, state media reported.

The five companies were brought to Beijing to discuss the purchase of the company, the 21st Century Business Herald, a major business daily, reported Friday.

The government is trying to revive its dairy industry and contain the fallout after baby formula contaminated with melamine was blamed for the deaths of four infants and the sickening of about 54,000 other children in China.

The Health Ministry said Wednesday that 5,800 children were still hospitalized — six of them in serious condition. In Hong Kong, the Department of Health said Friday two more children have developed kidney stones after drinking melamine-laced milk, bringing to 10 the total number of children with milk-related kidney stones.

Sanlu, a majority state-owned company whose products were the most heavily tainted, is now largely defunct, with companies looking to scoop up its assets.

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China orders more testing for liquid milk, powder

BEIJING - China is ordering all liquid and powdered milk manufactured before Sept. 14 to be taken off the shelves for melamine testing, a news report said Tuesday, the first time Beijing has issued a blanket recall of products since the tainted dairy scandal broke last month.

It is the latest in a series of measures China has taken to allay worries over the quality of Chinese products and restore consumer confidence since four babies died and tens of thousands of children were sickened after drinking tainted milk.

Authorities have blamed dairy suppliers for the crisis, saying they added the industrial chemical melamine to watered-down milk to fool quality control tests and make the product appear rich in protein.

Melamine can cause kidney stones as the body tries to eliminate it and, in extreme cases, lead to life-threatening kidney failure.

Citing a notice jointly approved by six government ministries and administrations, the official Xinhua News Agency said Tuesday that all milk powder and liquid milk produced before Sept. 14 must be subject to testing nationwide by manufacturers.

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China's food safety chief quits over tainted milk

Four children dead, over 50,000 sick...this helps how?

BEIJING - The head of the Chinese agency that monitors food and product safety has resigned, state media announced Monday, pushed out by a scandal over tainted baby formula that killed four babies and sickened nearly 53,000.

Beijing authorities also said that China's biggest producer of powdered milk had known for months that its baby formula was tainted with the industrial chemical melamine. There were complaints about infant formula sold by the Sanlu Group Co. as early as December, 2007, China Central Television reported, citing an investigation by the State Council, China's Cabinet.

"During these eight months, the company did not inform the government and did not take proper measures, therefore making the situation worse," CCTV said.

Melamine, which can cause kidney stones and kidney failure in babies, has since been found in infant formula and other milk products from 22 of China's dairy companies.

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China makes first arrests in tainted milk probe

Update

China finds more tainted dairy products

Probe finds 20 percent of China milk companies in scandal


Baby Milk? Baby Milk?

Apparently, this was a deliberate act...

When will we come to realize that these people have NO scuples whatsoever...

China launches nationwide baby formula probe

China makes first arrests in tainted milk probe

Producing heparin without the heartache

or without the Chinese deliberatley substtituing chemical contamination in lieu of actually producing the product they were paid to produce...but, hey, who's quiblling over details...

US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.


The breakthrough was presented at the ACS (American Chemical Society) National Meeting and Exposition in Philadelphia, US, earlier this week and described how Escherichia coli (E. coli) bacteria could be harnessed to synthesise the widely-used anticoagulant that has global annual sales of around $4bn (€2.7bn).

Heparin is produced by extraction from pig intestines and contaminated batches of the drug have been linked by the US FDA (Food and Drug Administration) to more than 80 deaths and hundreds of allergic reactions among patients treated with the drug during heart surgery and kidney dialysis.

The contaminated heparin was traced by the FDA to various batches imported from small, family-run workshops in China which supply about 70 per cent of the world’s supply.

While regulators called for greater cooperation and joint inspections of overseas active pharmaceutical ingredient (API) manufacturing plants, Professor Robert Linhardt of the Rensselaer Polytechnic Institute, US, and Associate Professor Jian Liu of the University of North Carolina, US, to search for an alternative method of production.

Prof. Linhardt was part of the team that identified the suspected contaminant as a structurally similar carbohydrate called oversulfated chondroitin sulfate.

"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," said Prof. Linhardt.

Researchers have been trying for years to develop a synthetic production method for the drug, however the first total synthesis described in 2003 by researchers from the Massachusetts Institute of Technology (MIT), US, produced only minute batches at a time and could not be economically scaled-up for commercial production.

The synthesis developed by Prof. Linhardt’s team uses a patented biosynthesis that uses enzymes expressed in E. coli bacteria to replicate the normal biosynthesis of natural heparin.

While the team has only used the technique to create the drug on a laboratory scale, scaling the process up should prove no more difficult than scaling-up the production of any other biological drug.

The group plans to begin the necessary preclinical and clinical trials needed to bring the synthetic heparin to market. If successful, the new heparin could be on the market in two to five years.

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Microbix Chinese vaccine plant boosts global capacity by 20%

Now all we need to do is make a product without contaminations...

Canada-based Microbix has pulled off a coup in sealing a deal with the Chinese government for construction of a facility that will increase the world's vaccine supply by 20 per cent.

Construction of the $198m plant is to be jointly funded by Microbix and the Hunan provincial government, with the site due to become operational in 2013.

A more unusual aspect of the deal will see Microbix construct a replica of the childhood home of Dr Norman Bethune, a Canadian physician who is revered in China for his medical work assisting Chinese communists in resisting the Japanese in the late 1930s.

William Gastle, CEO of Microbix, said: "We've been working for a number of years to bring our technology to market, so today we're delighted to be partnering with the Province of Hunan in building and ultimately operating the most modern and efficient flu vaccine manufacturing facility on the planet.

"This will make China a leader in the production of flu vaccines, and Virusmax the technology of choice in helping other manufacturers in other countries expand their capacity to meet the needs of their populations."

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Chinese SFDA crackdown to get house in order

The Chinese State Food and Drug Administration (SFDA) has revealed plans to tighten the drug registration review process as it attempts to improve standards in the nation.

At the regulatory body's monthly press conference a SFDA spokesman spelt out the policy which will only allow drug companies one opportunity to file their application documents.

By adopting a hard line stance the SFDA is sending out a strong message to its critics both at home and abroad who have cast aspersions on the integrity of the registration process.

SFDA spokesperson Yan Jiangying said: "In cases where a company's application does not satisfactorily prove the safety and efficacy of its product, the SFDA will no longer ask for further information, unlike in the past, but will simply reject the application outright."

This shift in policy is the result of an in-depth review of documents submitted to the SFDA between January and April this year to verify all information in the applications through pharmacological, toxicological and clinical trial analysis.

From this the SFDA discovered that some of the drug application documents were quite similar, which it believes is likely to signify that the company has fabricated the data.

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and Here We Go...

The Chinese start the "active evasion" portion of this tragedy...asking if people who were taking a drug used in dialysis had kidney disease...

China accuses US of shoddy probe into tainted heparin

BEIJING - China's drug safety agency accused the United States on Tuesday of blocking Beijing's inquiry into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about production.

Two Chinese experts who attended a conference on the drug, heparin, in suburban Washington, D.C., last month said the U.S. determined a contaminant was likely to blame without considering other possible factors.

"We need to resolve this in a scientific matter, not just by blaming a contaminant," said Jin Shaohong, a member of the drug evaluation committee of China's Food and Drug Administration. "I think it is too early to say that."

Besides the deaths, hundreds of patients have suffered severe allergic reactions to large doses of heparin, which is used in dialysis and other treatments.

The U.S. Food and Drug Administration said it suspects the problems stem from a contaminant the agency discovered in supplies of raw heparin coming from China — a compound derived from animal cartilage that so closely mimics heparin that routine tests can't detect it.

The Chinese experts said U.S. officials and Baxter International refused to give them information to probe the possibility that drug interactions, patients' medical histories or safety issues after the raw material left China may have played a role.

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Heparin Recall Update

The Chinese delegation visited the Baxter site in Cherry Hill last week...and there hasn't been much follow-up in the press...

It was heard that that the Chinese requested samples of the product in question in order that they can do their own testing in China...and that these samples were provided to them...

Anybody want to guess what the Chinese will report?

At an embassy news conference in Washington, Chinese officials said the problems
linked to heparin could have occurred in the United States, or that chronic
conditions in some patients led to severe reactions.

This is not the statement of a scientific team focussed on identifying the root cause of an adverse event...which is a demanding, difficult task which requires good research, scientific judgement and caution...these things need to be right...

No, this is the type of waffling statement made by organizations trying to duck out on their responsibility...they will say anything in order to shift the blame or to avoid being held accountable...exactly the sort of behavior that can not possibly result in identifying and correcting the current problem...

FDA suspects heparin contamination due to fraud

The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.

FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials.

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Beijing smog may affect athletes

They claim they can regulate smog...

too bad, drug manufacturing must be a little trickier...

But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

Beijing's heavy pollution may hurt the performances of athletes in this summer's Olympic Games, although it will not endanger their health, International Olympic Committee President Jacques Rogge said Saturday.

The IOC in recent months has acknowledged the possibility that athletes' performances may be affected by China's pollution. But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

"The health of the athletes is absolutely not in any danger," Rogge said Saturday. "It might be that some will have to have a slightly reduced performance, but nothing will harm the health of the athletes. The IOC will take care of that."

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US and Chinese pharmacopoeias expand working relationship

I would like to think that this will help...here's hoping...

The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries.

To that end, the US Pharmacopoeial Convention and the Chinese Pharmacopoeia Commission have signed a memorandum of understanding (MoU), to tighten up the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries.

The deal is in response to the globalization of the pharmaceutical market, with drug firms increasingly sourcing ingredients from a wide range of territories.

Such a climate has created the need for greater cross-border collaboration on monitoring and standards. This was highlighted by recent problems with ingredients sourced in China that saw unscrupulous suppliers substitute the excipient glycerin for the toxic compound diethylene glycol (DEG). Since the case emerged, the USP has been working with the Food and Drug Administration's Pharmaceutical Ingredient Safety Taskforce to modify the identification test for glycerine, and to move DEG-specific testing from the impurity analysis section of the monograph to become part of the identity test.

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More on the Heparin Saga

Chinese quality stinks!!! Chinese drug regulation stinks!!!

"urging"...

"issued a plea"...

"safeguarding the legality, quality and safety of active pharmaceutical
ingredients (APIs)" is ultimately the responsibility of the importing
country."

These people are unbelievable...

China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality.

The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards.

In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market.

Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware".

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The Heparin Saga expands...

B. Braun Medical issues recall of heparin

B. Braun Medical Inc. recalled heparin blood thinner in the U.S. and Canada after learning that it contained a "heparin-like contaminant" from a supplier linked to deaths and allergic reactions in another company's product.

The contaminant was supplied by Scientific Protein Laboratories, Irvine-based B. Braun Medical said Friday. Scientific Protein also supplied Baxter International Inc. with heparin containing a cheaper ingredient from China.

Baxter's heparin has been linked to serious allergic reactions and 19 U.S. deaths. The heparin recalled by Braun is sold to hospitals as a premixed solution in intravenous drip bags, a Food and Drug Administration spokeswoman said.

Neither Braun nor the FDA was aware of anyone sickened by the recalled heparin.

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Contaminant found in heparin

WASHINGTON - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."

The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

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The Baxter Heparin Saga...pick your spin...

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...

Baxter unaware plant not inspected

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

"It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Deerfield-based Baxter's troubles with heparin highlight the concerns many U.S. companies and consumers have about their vulnerability to errors by suppliers from China and other less-developed countries. Problems with tainted toys, toothpaste, tires and pet food from China in the last year preceded Baxter's issues with heparin, made from an active ingredient imported from China.

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FDA Says It Approved The Wrong Drug Plant

and things go from bad to worse...

sometimes the last thing you want to do is find out what is really going on...'cause it might be scary to contemplate...

Heparin Probe Sends Inspectors to China

The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.

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Congressman: FDA chief should resign

Now that Congress has solved the "steriods in baseball issue", they can move on to bigger and better things...

politicizing the FDA!!!...

The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. As Baxter analyzes product samples for impurities that might have caused 350 adverse reactions, including four deaths, Congress and other critics are pointing fingers at the watchdog agency. And the FDA itself admits that yes, it violated its own procedures in approving the drug for sale without inspecting the Chinese plant where its active ingredient was made. One key Congressional critic is even asking FDA chief Andrew von Eschenbach to step down.

Baxter, of course, isn't getting off scot free. Its internal investigation is squarely under the media spotlight. So far, the company has found some differences between problem heparin vials and controls, and some of the differing samples did come from China. But so far, said a company spokeswoman, "[I]t's unclear what the impact of these differences is."

Baxter also ID'd the supplier in question, which it had refused to do before. The API maker is Scientific Protein Laboratories, a Wisconsin company that makes bulk heparin at a Chinese factory and at another at HQ. SPL says both plants adhere to the same industry and FDA safeguards. The agency is prepping an inspection team to check out the Chinese plant, and Baxter plans to send its own investigators. But plant personnel know inspectors are coming. "We'll fully cooperate," said a quality-control manager at the Chinese plant.

The big question posed by lawmakers and consumer advocates alike: With most bulk drug ingredients made overseas now--and only 7 percent of foreign plants inspected a year--what else is falling though the cracks? Some even want lawmakers to bar Chinese-made pharma ingredients. "China is fundamentally incapable of safeguarding...safety and efficacy," one business ethicist told Pharmalot.

link to full article from fiercepharma