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Twists in Chain of Supplies for Blood Drug
Multidose Vial Heparin Linked to Severe Allergic Reactions
• February 28, 2008 |
| More Information: Heparin Sodium Flush
RUGAO, China — With reports of more than 400 patients in the United States suffering serious complications after receiving the blood-thinner heparin, American investigators are trying to determine whether the raw material for the drug, made from pig intestines, became contaminated on the journey that begins in the slaughterhouses of China.
The investigators are examining the records of a factory an hour from here that supplies much of the active ingredient in heparin for Baxter International, which earlier this month halted sales of multidose vials of heparin after reports of injuries and four deaths.
The owner of the factory, which is known as Changzhou SPL, says its supply chain is safe. It buys raw material from only two reputable wholesalers, it says, and audits their 10 to 12 suppliers.
“We have a collection chain in place, and we stick with that,” said David Strunce, the president of Scientific Protein Laboratories, an American company that owns a majority of Changzhou SPL. He declined repeated requests from The New York Times to identify those smaller suppliers, saying it was proprietary information.
But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain. The picture that emerges is of a chain more complex, and less orderly, than the one Mr. Strunce laid out.
The Chinese heparin market has become increasingly unsettled over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. Traders and industry experts say even big companies have been turning more often to the small village workshops, which are unregulated and often unsanitary.
One of the wholesalers named by Scientific Protein Laboratories, Ruihua Biochemical in Hangzhou, said it provided a mix of crude heparin that it manufactured and some that it bought “from small factories nearby in several villages.” The owner, Hua Ruihua, said he never inspected the small factories. “We are not the government,” he said in a telephone interview. “We have no right to inspect their pigs or intestines or facilities.”
The owner of one of those workshops, Fan Yinan, said, “I sold to Ruihua several times before, but since last September I have had no intestines.” He confirmed that “no one from Ruihua inspected my pigs or intestines.”
Asked about Ruihua Biochemical, the S.P.L. chief, Mr. Strunce, said, “We have no information to suggest that your information is true.”
This week, a spokeswoman for Baxter said the number of reports of adverse reactions to heparin had surpassed 400. A spokeswoman for the Food and Drug Administration in the United States said the agency was reviewing the new reports and did not yet have a revised count.
The authorities have not determined that problems with the heparin supply chain led to the deaths and adverse reactions, first reported last month in Missouri. Nor have investigators determined that heparin from China was the culprit. Baxter also gets some of its ingredients from a plant in Wisconsin. Neither S.P.L. nor Baxter has been accused of doing anything wrong.
Even so, the problems involving heparin have again focused attention on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. S.P.L.’s plant in Changzhou was certified by American officials to export to the United States even though neither government had inspected it. The plant has been exporting heparin to Baxter since 2004.
Like many chemical companies in China that make pharmaceutical ingredients for export, S.P.L. fell into a regulatory void. A spokesman for China’s State Food and Drug Administration, Shen Chen, said his agency had not inspected the S.P.L. factory because “as far as we know, it is not a drug manufacturer; it is a producer of chemical ingredients.” Mr. Shen said his agency was helping American investigators as part of a recent agreement with American regulators.
The process of making heparin begins with the intestines of slaughtered pigs, from which mucous membrane is collected and cooked, eventually producing a dry substance known as crude heparin. Major heparin producers like S.P.L. take that substance, refine it and sell it to companies like Baxter that make the final product, which is widely used in cardiovascular surgery and dialysis.
Some experts say as much as 70 percent of China’s crude heparin — for domestic use and for export — comes from small factories in poor villages. One of the biggest areas for these workshops is here in coastal Jiangsu Province, north of Shanghai, where entire villages have become heparin production centers.
In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.
The floors had large puddles and drainage channels; the workshops were dilapidated and unheated; and steam from the production process fogged up the windows and soaked the walls. There were large ovens to cook ingredients and halls lined with barrels to store enzymes, resins, intestines and wastewater.
“This is our family-style workshop,” said Zhu Jinlan, the owner of one heparin operation, who stopped sorting pig intestines and invited visitors to a back room, where she lives with her husband and child. “We’ve been doing this about 10 years.”
Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.
“If you don’t control the incoming source, it’s very hard to get rid of the contaminants,” says Liu Jian, a heparin expert at the University of North Carolina.
Mr. Strunce of S.P.L. says his company never buys directly from the crude-heparin producers, only through its wholesalers, which he called “consolidators” — Changzhou Techpool, its Chinese joint venture partner, and Ruihua. His company, he said, has records documenting all the transactions.
But here in Rugao, producers of crude heparin tell a somewhat different story. A sales manager for a major supplier, Nantong Koulong, said he sells directly to S.P.L. without going through either of the two wholesalers. “We provided crude heparin to Changzhou SPL,” said the sales manager, Chen Jianjun. Some of Koulong’s stock comes from the unregulated workshops, he said.
The owner of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to S.P.L. two years ago. She also sells to Koulong. “We are really a traditional family-style plant,” she said. “We have no certificate.”
S.P.L. said it never bought directly or indirectly from Koulong.
To the south, in Zhejiang Province, two officials of Zhejiang Willing Animal Byproducts Processing said they, too, sold to S.P.L. “We supply heparin to Changzhou SPL,” said Fang Weicai, the general manager, although he said later that he sold it privately and not under the auspices of his company.
After an outbreak of blue ear pig disease swept through 25 of China’s 31 provinces and regions last year, prices soared, and many drug suppliers had to look to the small workshops. The epidemic, said Cui Huifei, a heparin expert at the Shandong University School of Medicine, “made those biotech companies inevitably purchase from the family-style plants, for cheaper prices.”
A sales manager for another large slaughterhouse in Shandong Province, north of Jiangsu, said he was approached late last year by a buyer for S.P.L. offering what he described as rock-bottom prices for crude heparin.
“It was impossible,” said the sales manager, Wang Shengfu, who works for Shandong Jinluo Group, a major producer of crude heparin. “Only small factory-style farms could accept that low price.”
The deal was never consummated.
Mr. Strunce said S.P.L. responded to the disease outbreak by buying less raw material in China. “We were not out looking for additional heparin because we made do with what we already have,” he said, adding that the company “pays more than many people for heparin over there because we require a higher standard of heparin.”
Food & Drug Administration announces Johnson & Johnson, Actavis pain patch recalls.
• February 19, 2008 | injuredus.com
February 13th and February 18th the Food & Drug Administration announced recalls for Fentanyl-containing pain patches. It has become a concern that the patches may leak and expose the person to dangerous levels of Fentanyl which considered a class II substance by the Drug Enforcement Administration (DEA). Fentanyl is an opiate that is 80 times more potent than morphine, which means that it is potential for abuse and a risk for fatal overdose.
Food & Drug Administration announces a nation wide recall for contaminated syringes.
• January 25, 2008 |
| More Information: Syringe Contamination
The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.
Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.
The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.
Recent study showed it wasn't any better then a generic medication
• January 25, 2008 |
| More Information: Vytorin
U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc’s and Schering-Plough Corp’s popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.
The Food and Drug Administration said it had not yet received a final report on the study, called Enhance. The agency’s review of Vytorin will take about six months after final results are received, the FDA said.
In the meantime, patients with questions about the Enhance study should talk with their doctors, the FDA advised.
“At this time, it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone,” an FDA statement said.
Simvastatin is the generic name for Zocor. Vytorin combines Zocor with a newer cholesterol-fighting pill called Zetia.
The FDA review puts an even bigger spotlight on a debate over Vytorin’s value in the wake of the Enhance results early last week and concern over a long delay in releasing the data.
Decline in Vytorin prescriptions
Major medical groups, prominent cardiologists and U.S. lawmakers have weighed in, while prescriptions for the drug have slipped.
“The FDA is attempting to buy time so noise can be filtered out and cooler heads can look at the Vytorin data, but it is unlikely even the FDA will be able to draw clear conclusions,” said Viren Mehta, principal at Mehta Partners, which provides investment advice to the global pharmaceutical and biotechnology industries.
“For a clear picture, we will need to wait for outcomes data (data on heart attack and stroke risk) from larger Vytorin trials” due by 2010 or 2011, Mehta said.
Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion.
The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels. Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but it did a better job of reducing “bad” LDL cholesterol.
Beyond Vytorin, the FDA said it also would review “whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.” High LDL is commonly believed to be a major risk factor for heart disease.
FDA officials cautioned the public not to overreact to the Enhance study by turning away from cholesterol-lowering drugs.
Drugs that cut LDL are among the largest selling drugs in the world, and also include Pfizer Inc’s Lipitor and AstraZeneca Plc’s Crestor. Shares of Pfizer and AstraZeneca were also lower after the FDA announcement.
Lipitor, Zocor and other drugs in the same statin class have consistently shown the ability to reduce heart attacks and strokes by up to 30 percent.
Drugmakers criticized for delay
The drugmakers have been criticized by doctors, industry analysts and lawmakers for delaying presentation of results from the trial, which was concluded in 2006, until last week.
“The delay has made everyone uncomfortable,” Mehta said. ”We don’t know why they didn’t come out earlier and just say ... the trial was not showing any possible benefit” in cutting plaque.
Deborah Cohn, a professor of marketing at Touro College Graduate School of Business in New York, said the delay in releasing the results had caused an understandable backlash.
“Consumers feel like there may be something else they’re not telling us,” Cohn said. “Nobody likes feeling like they’re being lied to and that’s how everybody’s reacting.”
Merck spokesman Christopher Garland said the company ”welcomes today’s statement from the FDA as it appropriately communicates information about the Enhance trial as well as information about Vytorin and Zetia.”
A Schering-Plough spokesman could not immediately be reached after the FDA announcement.
Chantix drug maker Pfizer will strengthen warning label to reflect recent study.
• January 19, 2008 |
| More Information: Chantix
The drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.
You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “a preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion and behavior within days to weeks of taking Chantix.”
And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.
A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.
The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.
