Baxter

FDA finds 'final link' in heparin case

Tracy Staton — Thu, 31 Jul 2008 09:44:34 -0400

For the first time, the FDA has conclusively tied patients' deaths to the contaminant found in Baxter's heparin blood thinner. Of 10 deaths reported from anaphylactic shock, three of them were traced to lot numbers of the drug that tested positive for oversulfated chondroitin sulfate. (The lot numbers of the other seven weren't known.) "We have what looks like cause and effect in some patients," Dr. Janet Woodcock, CDER chief, told the Chicago Tribune. "This is one of the final links in the chain."

As you know, Baxter recalled its heparin products in February after a spike in severe allergic reactions to the drug. The investigation led to suppliers in China, which, some officials said, may have contaminated raw heparin deliberately to save money. In the process, the probe raised questions about just how close an eye drugmakers keep on their foreign supply chains; Baxter admitted that it didn't know much about the ultimate source of the ingredient it bought from Scientific Protein Laboratories, which operated a plant in China. All told, FDA counted more than reports of more than 90 deaths and 1,000 adverse reactions to heparin.

- read the story in the Tribune

IMS: Pace of outsourcing accelerating

Tracy Staton — Tue, 27 May 2008 09:39:45 -0400

Drugmakers are pulling out of manufacturing at an unprecedented rate, according to a new report from IMS Health. Four of the top 10 pharma players announced big new outsourcing programs last year. That's evidence that pharma execs are thinking in vastly different ways from their predecessors, who believed R&D and manufacturing had to work hand-in-glove, and that the skills required to make drugs couldn't be found in emerging markets.

This shift toward contract manufacturing has risks, IMS concludes. First, there are safety concerns. Just think of Baxter's heparin supplier Scientific Protein, which made crude heparin in partnership with a Chinese manufacturer whose plant was riddled with problems when the FDA finally inspected it after millions of doses of the blood thinner had to be recalled. Then there's Sanofi-Aventis, whose contract manufacturer went bankrupt, leaving Sanofi to deal with its manufacturing breaches. Secondly, in other industries, contract manufacturers have found ways to enter the market as competitors. Finally, there's economic implications of shipping work to emerging markets. Europe, for instance, counts 640,000 pharma jobs. If they are perceived to be under threat from outsourcing, politicians might intervene.

- read the story at Outsourcing Pharma

Baxter's Robert Parkinson - CEO Pay

Tracy Staton — Mon, 19 May 2008 14:46:21 -0400

Baxter - Robert Parkinson

Total Compensation: $17.6M

2007 Revenue: $11.3B
2006 Revenue: $10.4B
Change: 8.6%

Details: Parkinson's $17.6 million haul was driven primarily by strong company and individual performance in 2007 and 2006. According to the company's proxy statement, Parkinson's compensation "reflects the role he has played in the turnaround of the company since his arrival in 2004." Parkinson gained $1.29M in base salary, $3.75M in stock option awards, and $2.28 in additional pension.

Baxter News:
Baxter: Fake heparin predated API
Baxter recalls heparin on adverse events

GSK nabs EU approval for pandemic shot

Tracy Staton — Mon, 19 May 2008 10:42:52 -0400

Put GlaxoSmithKline at the head of the list of vaccine-makers able to profit from a potential flu pandemic. The company just got EU go-ahead to market its H5N1 vaccine, Prepandrix, becoming the first pharma to get a Euro-license for a pre-pandemic vaccine. Prepandrix gives some protection against several currently circulating strains of avian flu. If a pandemic broke out, it would be administered to health workers and others most at risk as a sort of stop-gap measure, while drugmakers worked to develop another vaccine precisely targeted to the pandemic strain.

Countries such as Switzerland and Finland had already placed orders for the shots, anticipating approval, while others are in talks with GSK. As in the case of Roche's Tamiflu antiviral med--and to a lesser extent GSK's antiflu Relenza--countries are looking to stockpile Prepandrix to prep for the possibility of an H5N1 outbreak. Sanofi-Aventis, Novartis, and Baxter all are developing pandemic vaccines, too, but GSK obviously will have the first-to-market advantage.

- see the story in the Wall Street Journal
- check out the coverage in The Times

Leavitt: We'll bar subs-par exporters

Fri, 16 May 2008 06:59:56 -0400

U.S. Health and Human Services honcho Mike Leavitt is baring his teeth at Chinese exporters that don't meet certification standards. Saying that regulators simply can't inspect all imported goods--some $2 trillion this year--companies that don't meet FDA standards won't be allowed to sell their products in the United States.

Leavitt's comments came during a trip to China to follow up on an agreement reached with Chinese regulators in December. Then, officials agreed to boost certification and regulation of exporters and to close some loopholes that have allowed Chinese companies to ship off unsafe food and drugs. Exporters are now required to register with the Chinese government, which will certify that they meet FDA standards.

Among the loopholes left to close: One that allowed chemical companies to produce drug ingredients without being inspected by drug regulators. That, of course, is one of the reasons why heparin tainted with oversulfated chondroitin made its way from Chinese suppliers to the U.S., where it was eventually recalled--but only after being linked to hundreds of severe allergic reactions, including up to 81 deaths.

- see the story in the Wall Street Journal

Leavitt: We'll bar subs-par exporters

Fri, 16 May 2008 06:59:56 -0400

- see the story in the Wall Street Journal

Quaid: Preemption unfair to patients

Thu, 15 May 2008 06:59:54 -0400

Dennis Quaid added some star power--and colorful language--to a dry legal debate yesterday. Testifying before Congress, Quaid backed people's right to sue drugmakers, saying that FDA approval shouldn't automatically negate patient lawsuits. "If preemption of lawsuits is allowed to prevail, it will make all of us--the public--uninformed and uncompensated lab rats," he said.

You'll recall that Quaid and his wife sued Baxter after their twin infants were given an enormous overdose of heparin. The lawsuit alleges Baxter knew other babies had died as a result of improper labeling of the drug, had started making heparin with new labels, but failed to recall the older vials mistakenly given to the Quaid twins. Among Baxter's defenses is the FDA's approval of its product.

The Bush administration has been pushing preemption, saying that approval by FDA, a federal agency, should supersede any state-level claims. This fall the Supreme Court will consider the idea when it hears a case pitting a patient against Wyeth. A Congressional committee met yesterday to hear testimony about preemption; presumably, Congress could circumvent a Supreme Court ruling in favor of it by enacting a law specifically allowing the lawsuits.

- read the Los Angeles Times story
- see the article in the Wall Street Journal

ALSO: Currently the sole supplier of heparin for the U.S. market, APP Pharmaceuticals is increasing its prices because of tightening Chinese stocks of the drug's raw ingredient. Several suppliers there have been shut down in the wake of an investigation of contaminated lots of the drug. Report

SPOTLIGHT: Heparin prices double since recalls

Fri, 09 May 2008 06:59:52 -0400

Since Baxter recalled virtually all its heparin products on reports of severe reactions and deaths, the price for the blood thinner has doubled. The sole U.S. supplier, APP Pharmaceuticals, says costs for crude Chinese heparin have risen fivefold since last year and recent price increases don't cover all its higher expenses. Report

Blaming Baxter, China denies heparin guilt

Tue, 06 May 2008 06:59:57 -0400

Point fingers at us, we'll point back at you. That's what China appears to be saying about the heparin scandal, claiming that it wasn't the "heparin-like substance" found in batches of the blood thinner that caused hundreds of severe reactions and up to 81 deaths.

Chinese officials are also blaming Baxter, which recalled millions of doses and stopped heparin production; they say the drugmaker won't cooperate with their investigation. The company destroyed some drug samples and production records that China considered important to their probe, one official said. A company spokeswoman denied the allegation, saying Baxter has cooperated "with all parties."

Admittedly, the FDA says it can't prove that the oversulfated chondroitin found in the offending batches actually caused the reactions. But China can't prove its theory that the culprit was actually introduced in the U.S., rather than overseas. Nor will China say where the heparin-like substance came from or how it got into the blood thinner. Until proof is on the table, the blame game will likely continue.

- check out the story in the International Herald Tribune
- see the Pharmalot item

ALSO: Analysts are bullish on Baxter's prospects despite the heparin recall and attending fallout. Report

Impurities found in Sanofi heparin product

Fri, 25 Apr 2008 06:59:55 -0400

While heparin maker Baxter mulls whether to re-enter the market for that blood thinner, Sanofi-Aventis is announcing that small amounts of an impurity have been found in batches of its heparin injection Lovenox. Batches of contaminated Lovenox have been found in the U.K. and in Sweden, where it is sold under the name Clexane. European regulators said that there's no evidence of any risk to patients, but Sweden has withdrawn the product anyway as a precaution.

Back in Chicago, Baxter CEO is saying that the company is leaving its heparin options open. You'll recall that Baxter recall virtually all its heparin products after the med was linked to severe allergic reactions and deaths; since then, investigators found a contaminant in the problem batches and have said they suspect it was introduced somewhere along the med's Chinese supply chain.

Before deciding whether to sell heparin vials again, CEO Robert Parkinson told analysts, the company needs to understand how the product was contaminated in the first place. "We need to ensure that that supply chain is controlled as effectively as possible," he said.

- check out the Sanofi story in the Wall Street Journal
- see the piece on Baxter in the Chicago Tribune