When Chantix, Pfizer’s so-called smoking cessation drug, was brought onto the market, it was touted as a good method to quit the habit. However, Pfizer’s pre-marketing trials didn’t include 44% of the smoking population-those with diagnosed mental disorders such as schizophrenics and alcoholics. This month, the FDA has reported 34 suicides among Chantix users. Increased suicides have not been reported with other smoking cessation drugs such as nicotine-replacement therapies like gum, lozenges or patches, or with bupropion, marketed by GlaxoSmithKline PLC as Zyban or Wellbutrin.
It turns out that the FDA did inspect a Chinese drug manufacturing plant after all. It just wasn’t the plant manufacturing the active ingredient in heparin. If you haven’t been following this story, the plant where the active ingredient in heparin was manufactured has a similar name as the one the FDA inspected. Oh well, we could say mistakes happen, especially when you factor into the equation an overworked, understaffed FDA and a plant inspection that took place in China. However, people died as a result of the mistake and hundreds of others had adverse reactions to the heparin.
It’s scary to think that the FDA isn’t required by law to inspect such Chinese plants. The task would be impractical anyway. Yet, we don’t even know the number of foreign plants shipping pharmaceuticals into this country. How could we possibly inspect them or monitor them. It seems to me that this issue has risen to the level of a serious threat to the US. If our pharmaceutical supply can not be monitored for safety, how can we guarantee consumer safety and a decent quality of life?
The judge in charge of the Kugel Mesh hernia patch lawsuits has allowed for the expansion of claims against the manufacturer Davol, Inc. Essentially, the judge has ruled that legal claims may include hernia patches that did not contain an internal ring, but were made of a special bi-layered material similar to the Kugel Mesh patches. This means that if you have experienced abdominal pain, bowel adhesions, bowel obstructions or bowel perforations and have a hernia patch that was not recalled you may have a legal claim. The recall had only involved the Kugel Mesh hernia patch because its internal ring did not function properly.
The US Department of Agriculture has just announced the largest beef recall in the nation’s history. 143 million pounds of frozen beef has been recalled. The beef recall stems from beef manufactured at Chino, a California-based Westland/Hallmark Meat Co. The recall affects all beef dating back to February 1, 2006. The California company has provided beef to school lunch programs. According to the USDA, the company violated health regulations when it failed to contact veterinarians when cattle became non-ambulatory after passing inspection.
Westland has been under investigation for animal abuse after a Human Society video captured employees kicking, shoving, and shocking cattle too sick or crippled to enter the slaughterhouse. While Westland has not faced charges yet an investigation is ongoing. Two former employees were charged Friday. Five felony counts of animal cruelty and three misdemeanors were filed against a pen manager. Three misdemeanor counts — illegal movement of a non-ambulatory animal — were filed against an employee who worked under that manager. Both were fired.
Officials at the USDA estimate that 37 million pounds of beef have been transported to schools.
Sick or non-ambulatory cattle are deemed not appropriate for human consumption because they are more susceptible to mad cow, salmonella, and E. coli since the sick cattle tend to wallow in fecal matter.
One of the things that I neglected to mention in yesterday’s blog post about priest sexual abuse of minors is the disturbing aspect of the abuse in the Diocese of Pensacola-Tallahassee. Fr. Vijay Godugunuru, a visiting priest from India, was charged and convicted of a sexual offense against a minor. He was ordered deported from the US, his passport was confiscated, but Indian authorities were not notified. In other words, who’s protecting children from this sexual abuser back in India? As far as I know, no one knows about Fr. Vijay and his molestation of a minor in the United States. Children in India should be afforded the same protection as those in the US.
I just completed a three day road trip during which I filed three lawsuits against the Dioceses of Pensacola-‘Tallahassee, St. Augustine, and Orlando. While the venues were dissimilar, the circumstances of each abuse tale were somewhat similar. A priest had ingratiated himself into the lives of devout Catholic families, targeted an unsuspecting minor, and attacked when the child was most vulnerable. One of the tragic cases occurred two years ago while another happened over fifty years ago. The one constant between these two cases remains that lives were shattered, faith lost, and justice was not served.
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If the FDA is allowed to publish new guidelines for the marketing of off-label drug use, it would be a drug company’s dream come true. Presently, doctors may determine the proper method of prescribing a drug for off label use. However, the pharmaceutical company may not market or promote in any fashion that off-label use. However, the FDA wants to give the drug companies some room to do just that. Luckily, Congressman Henry Waxman (D-CA) doesn’t think that’s such a good idea. Drugs can be dangerous enough without allowing the greedy, hyped-up marketing machine of big-pharma in on the act. Waxman warned the FDA that such approval would “allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns.” This is a very bad idea. If approved, consumer safety will be at an even greater risk.
Heparin deaths and allergic reactions appear to extend beyond the nine lots disclosed by Baxter a week ago according to a Wall Street Journal Report on Thursday February 14,2008. Heparin is used for a wide variety of medical procedures to prevent clotting such as kidney dialysis and open heart surgery. Baxter did not suspend sales of heparin because it markets about 50% of the heparin on the market and suspension of sales would cause a shortage. This decision was made in consultation with the U.S. Food and Drug Administration. Baxter confirmed to the Wall Street Journal that it gets the active pharmaceutical ingredient for heparin from a Chinese factory that had not been inspected. Our firm is investigating these cases and I expect that we will discover that again the FDA is understaffed and underfunded to protect the public from the danger of poor manufacturing practices in China.
Baxter Healthcare has announced the recall of its blood thinner Heparin. The recall involves 9 lots of the blood thinning drug. The lots involved in the recall are 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111.
The drugs were manufactured in a Chinese factory that eluded an FDA inspection. The factory was supposed to have had an inspection but, due to human error, the inspection never took place.
Once again, it seems to be the Chinese involved in a consumer product recall. This time, it’s Baxter Healthcare’s Heparin, a blood thinner widely used by patients in this country. The FDA has admitted that the plant should have been inspected, in fact, it was scheduled to be inspected, but it was not inspected. The FDA attributes the non-inspection to human error. This past Monday, the company announced it was suspending production of Heparin because of 350 reactions (including 4 deaths) linked to the drug. 40% of the reactions were considered serious by the FDA. Symptoms include stomach pain, vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.
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