Furosemide wikipedia
EXCERPT:
Furosemide (INN) or frusemide (former BAN) is a loop diuretic used in the treatment of congestive heart failure and edema. It is most commonly marketed by Sanofi-Aventis under the brand name Lasix. It has also been used to prevent thoroughbred and standardbred race horses from bleeding through the nose during races.

Along with some other diuretics, Furosemide is also included on the World Anti-Doping Agency's banned drug list due to its alleged use as a masking agent for other drugs.

Sanofi aventis
EXCERPT:
Sanofi-aventis is the third largest drug maker in the world and number one in Europe. Headquartered in Paris, France, sanofi-aventis works on the development of drugs for relieving symptoms of cardiovascular problems, thrombosis, allergies, oncology, diabetes, and vaccines.

Their worldwide revenue is $31.6 billion annually and they employ almost 100,000 employees.

The sanofi-aventis Group in the US is located in Bridgewater, NJ and employs about 14,000 employees who consist of more than 8,000 sales and marketing employees. Its sales and marketing force makes up over half of its total US employee base.

Sanofi-aventis was created in 2004 when Sanofi-Synthelabo merged with Aventis Pharmeceuticals. At first, Sanofi-Synthelabo tried to acquire Aventis through a hostile takeover but later launched a friendly bid and upped the price at the spurring of the French Government, allegedly over concerns that Swiss drug maker Novartis would buy Aventis first.

In 2001, three executives of Aventis CropScience in the US were fired following a scandal in which banned genetically modified corn products were found in Taco Bell taco shells. The US had approved the corn product, called StarLink, for animal feed, but it was found to cause allergic rashes and diarrhea in humans.

Sanofi-aventis are the makers of Allegra, one of its biggest products that accounts for $1.4 billion annually in sales.

Arava – Sanofi-aventis are also the makers of Arava. Arava is an oral prescription medication designed to alleviate pain associated with rheumatoid arthritis. While rheumatoid arthritis is currently an incurable disease, Arava is designed to slow or stop the spread of pain or the disease from getting worse. Arava has also been linked to several serious side effects and birth defects in babies born to mothers taking it. Women are highly cautioned to not take Arava if they think they may become pregnant, or are already pregnant.

Heparin tainted from China
EXCERPT:
The Food & Drug Administration (FDA) has cited two Chinese manufacturers for shipping tainted heparin to the U.S. According to The Wall Street Journal, one of the firms has also been charged with lying to the FDA about its role in the contaminated heparin scandal.

In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, after being administered the products. There were similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
In March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

FDA failures contribute to spread of contaminated drugs
EXCERPT:
The Worldfocus investigation has learned that the contaminant, oversulfated chondroitin sulfate (OSCS), was invented in a laboratory by a team of University of Iowa and Japanese scientists who wanted to create synthetic heparin. They published a paper on their findings in 1998. After publication, they tested the product on mice. The mice died. Unfortunately no paper was published disclosing the alarming result of the in vivo experiment, since it was deemed to be unsuccessful and unworthy of peer review.

Not knowing that the material was lethal, Shandong University in China filed a patent for the chemical on Dec. 20, 2005, believing that it could provide a cheap substitute for heparin. “It was our material,” recalls Robert J. Linhardt, a world-renowned heparin specialist who led the Iowa team and is now a professor at the Rensselaer Polytechnic Institute. “Based on our paper, I guess they believed it could have been useful in vivo.”

Heparin in China and Changzhou SPL
EXCERPT:
SPL Statement Following Receipt Of A Warning Letter From The FDA Regarding Recent Inspection Of Facility In Changzhou, China
Article Date: 21 Apr 2008 - 13:00 PDT

The following statement was issued by Scientific Protein Laboratories (SPL) LLC and Changzhou SPL Company, Ltd. following receipt of a Warning Letter from the Food and Drug Administration regarding the recent inspection of the Changzhou SPL facility in Changzhou, China:

We regret FDA's decision to send a Warning Letter to Changzhou SPL, and we do not believe that the Warning Letter reflects Changzhou SPL's actual state of compliance with current good manufacturing practices (GMPs) in the heparin Active Pharmaceutical Ingredient (API) industry, or the positive findings in prior third-party audits of the facility. The Warning Letter repeats some of the agency's inspectional observations. Changzhou SPL already has provided a comprehensive response on these issues.

For example, the letter reiterates the observation as to the use of an unauthorized supplier, an allegation that Changzhou SPL believes already has been disproven conclusively in its 483 response. Changzhou SPL is committed to cooperating with FDA and will promptly provide a detailed response to the Warning Letter.

As FDA has previously acknowledged, there is nothing in the observations made in the Form 483 or Warning Letter that would have caused or contributed to the presence of the contaminant at issue in heparin products.

The contaminant found in certain lots of finished heparin product was not introduced in the manufacturing processes at Changzhou SPL or SPL. Based upon testing of crude heparin materials and reports from other manufacturers around the world, it is now clear that the suspect contaminant was introduced earlier in the supply chain in China and was widespread throughout the unrelated Chinese supply chains of many companies. Moreover, FDA has made clear that the contaminant in question appears to pass all prior manufacturing controls and testing requirements for heparin manufacture. SPL and Changzhou SPL continue to work actively with the FDA to identify the root cause of the contamination.

It is important to note that the Warning Letter does not relate to SPL's Waunakee, Wisconsin facility, which has maintained an exemplary inspectional record over 30 years of heparin production.

StarLink everywhere
EXCERPT:
October, 2000
"What it really indicates is that the entire food production system is
ill-equipped to deal with these genetically engineered products," insists
Rep. Dennis Kucinich, D-Ohio, a long-time critic of the industry.
Regulators have characterized the health risks from the unapproved corn as
"remote," although no one truly knows for sure. But this incident could
create a massive public relations problem for the biotech business, whose
future depends on the trust of consumers. Consumers are being given little
information with which to determine which products already on their dinner
tables may contain the adulterated corn. The Food and Drug Administration,
by its own regulations, must remain tight-lipped. While many questions
remain unanswered, this much is clear: For three years, U.S. farmers have
been growing a variety of genetically engineered corn that medical experts
fear could cause allergic reactions in humans, ranging from nausea to
shock. The corn, created by North Carolina-based Aventis CropScience and
sold under the brand name StarLink, was supposed to be restricted for use
as an animal feed or production of products such as ethanol. Aventis tried
to control distribution of the corn by relying on an honor code, of sorts,
among farmers. But that system failed.
"What it really indicates is that the entire food production system is
ill-equipped to deal with these genetically engineered products," insists
Rep. Dennis Kucinich, D-Ohio, a long-time critic of the industry.
Regulators have characterized the health risks from the unapproved corn as
"remote," although no one truly knows for sure. But this incident could
create a massive public relations problem for the biotech business, whose
future depends on the trust of consumers. Consumers are being given little
information with which to determine which products already on their dinner
tables may contain the adulterated corn. The Food and Drug Administration,
by its own regulations, must remain tight-lipped. While many questions
remain unanswered, this much is clear: For three years, U.S. farmers have
been growing a variety of genetically engineered corn that medical experts
fear could cause allergic reactions in humans, ranging from nausea to
shock. The corn, created by North Carolina-based Aventis CropScience and
sold under the brand name StarLink, was supposed to be restricted for use
as an animal feed or production of products such as ethanol. Aventis tried
to control distribution of the corn by relying on an honor code, of sorts,
among farmers. But that system failed.
"What it really indicates is that the entire food production system is
ill-equipped to deal with these genetically engineered products," insists
Rep. Dennis Kucinich, D-Ohio, a long-time critic of the industry.
Regulators have characterized the health risks from the unapproved corn as
"remote," although no one truly knows for sure. But this incident could
create a massive public relations problem for the biotech business, whose
future depends on the trust of consumers. Consumers are being given little
information with which to determine which products already on their dinner
tables may contain the adulterated corn. The Food and Drug Administration,
by its own regulations, must remain tight-lipped. While many questions
remain unanswered, this much is clear: For three years, U.S. farmers have
been growing a variety of genetically engineered corn that medical experts
fear could cause allergic reactions in humans, ranging from nausea to
shock. The corn, created by North Carolina-based Aventis CropScience and
sold under the brand name StarLink, was supposed to be restricted for use
as an animal feed or production of products such as ethanol. Aventis tried
to control distribution of the corn by relying on an honor code, of sorts,
among farmers. But that system failed.