Drug Products

Raytheon Tests Wells as Plume Concern Grows in St. Pete Neighborhood

Raytheon has inspected wells in the Azalea neighborhood and plans to do more testing in the wake of class action lawsuits and a report due to the Florida Department of Environmental Protection on May 31. In spite of Raytheon’s continued insistence that there is no danger to human health as a result of the toxic plume, the DEP has contacted six residents in the Azalea neighborhood and advised them against using their irrigation wells until after the DEP reviews Raytheon’s findings at the end of the month.
In the meantime, our class action lawsuit investigation into Raytheon’s toxic spill and subsequent neglect will continue. Besides the obvious health concern, many residents affected by the Raytheon groundwater contamination are worried about plummeting property values and the stigma associated with living in or next to toxic waste caused by Raytheon.

Celebrex and Bextra Manufacturer to Settle Lawsuits

According to the Wall St. Journal, Pfizer is starting to settle lawsuits against its painkilling drugs Celebrex and Bextra. While the numbers are not yet official, one attorney told the Journal that he was offered $200,000 per client for his Bextra clients while he was offered $40-50,000 per client for his Celebrex cases.
Pfizer appears to be handling their cases differently than Merck whose product Vioxx is in the same class of painkilling drugs. All are classified as Cox-2 inhibitors which have come under intense scrutiny because they’ve been linked to an increased risk of heart attack and stroke.

Merck Warned About Plant Issues

Merck & Co. has received a warning letter from the FDA concerning issues with manufacturing standards at its West Point Pennsylvania facility. The facility in question manufactures vaccines and was cited by the FDA for numerous deviations in its laboratory procedures. The FDA noted that Merck’s lab procedures were not scientifically sound when it came to assessing the “strength, quality and purity” of products manufactured at the West Point, Pa. facility. Merck has failed to evaluate the stability of certain vaccines such as measles, mumps, and rubella over a number of years.
Merck’s latest issues comes in the wake of Congressional testimony slamming the FDA and fellow pharmaceutical giant Baxter for its failure to safeguard its heparin supply. The tainted heparin, imported from China, has been linked to 81 deaths in the USA.
Recently, the FDA has come under increasing fire from Congress as the safety and quality of pharmaceuticals has been criticized.

Raytheon Has Contaminated Ground Water Before

The recent discovery of a toxic plume of pollution in the ground water at the Raytheon Plant in the Azalea neighborhood of St. Petersburg, Florida is not the first time Raytheon has been a bad neighbor. In 1986 the Raytheon plant in Mountainview, California was the subject of an EPA order to clean up contaminated ground water around that plant. The contamination of the ground water at the Mountainview site was believed to be from leaking underground chemical storage tanks. In that case Raytheon installed three wells to pump and treat ground water to contain the contaminated plume.
Raytheon certainly had the knowledge about these types of chemical leaks over twenty years ago based upon this California case. Apparently, Raytheon chose not to spend the money in St. Petersburg to pump and treat the polluted water but rather decided that “natural attenuation” was the best choice and cheapest choice for them. By doing this Raytheon has caused substantial damage to the real estate values and likely the health of the residents in the Azalea neighborhood of St. Petersburg.
I have heard from three real estate agents in the last week who have called me to report sales contracts on homes in the Azalea area that have fallen through because the buyers backed out for fear of the pollution of the ground water. The class action lawsuits that have been filed in Pinellas County are seeking damages for the residents for their loss of the value of their homes.

Heparin Contamination May Have Been Deliberate

In what has only been mentioned in whispers has now come into the light of day during Congressional testimony-the heparin that led to 81 deaths in the United States may have been contaminated deliberately. The FDA has been considering this possibility for months but now the whispers have become public in testimony given to to the House Subcommittee on Oversight and Investigations.
David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied contaminated heparin material to Baxter International, which manufactured and distributed the finished drug, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities

Raytheon Contamination Identified in 6 Wells

A firm hired by Raytheon Corporation has found that at least six wells in the Azalea neighborhood have been contaminated by high level contaminants coming from the Raytheon plant in St. Petersburg. The tainted wells are scattered to the south as far as Eighth Avenue and to the east of the Raytheon site on 72nd Street. The results have prompted the following response from the DEP, “We are asking them until further notice to not use their irrigation wells and to please use municipal water for irrigation purposes until further notice.” This is a far cry from the initial response by DEP and Raytheon when both stated that there was no danger to the health of pets or humans. The investigation will continue and evidence will be gathered in the case. One thing is certain-Raytheon has not been a good neighbor to the residents of the Azalea neighbohood who knew nothing of this contaminaiton until the media uncovered the problem a few weeks ago.

Raytheon Groundwater Contamination Cleanup Likely to be Lengthy and Expensive

In an article published in today’s St. Petersburg Times, the cost and length of the cleanup of Raytheon groundwater contamination will likely be lengthy and expensive. According to the article, environmental consultants determine that the process offici won’t even begin the process until it is first determined the extent and nature of the plume. This obviously increases the burden and suffering of Azalea residents who are left to worry and wonder what will become of their health and their property values.
As we know, the original problem began in 1991 when the plant that caused the spill was owned by E Systems. However, Raytheon inherited the problem as well as the responsibility for it after it merged with E Systems in April 1995. While Raytheon and the DEP continue to insist the chemicals trichloroethylene (TCE), vinyl chloride, 1,4-dioxane are not hazardous to human health, other environmental experts disagree. According to the Times, “a DEP document shows that wells tested in March 2007 at Azalea Park, 72nd Street N, the Brandywine Apartments, 70th Street N and Stone’s Throw Condominiums show levels of trichloroethylene (TCE), vinyl chloride, 1,4-dioxane and other toxic chemicals well above levels considered potentially hazardous to human health.”
No matter how you look at it this is a tragic situation for the good people of the Azalea neighborhood of St. Petersburg. It also demonstrates the consequences of corporate bad behavior.

Sanofi-Aventis’ Heparin Injection Lovenox Tainted

French pharmaceutical company Sanofi-Aventis has announced that its blood thinning injection drug Lovenox has been found to be slightly tainted with the same contaminant that was linked to 81 US deaths-over-sulfated chondroitin sulfate. However, Sanofi-s contaminated heparin has not been linked to any adverse health reactions and probably will not cause any since the size of the contaminant is relatively small.
Sanofi’s revelation comes in the wake of Baxter’s heparin problem which was linked to contaminated heparin from Chinese plants. The furor over the contamination has caused problems between China and US and has led to Congressional inquiries over the safety of Chinese imports. Regulators inspecting the Chinese plants faulted them for quality control issues as well as plant safety problems.

Heparin Recall Update

The heparin recall that was linked to China has now spread to 11 countries and has been definitively linked to the serious health effects of numerous people as well as 81 deaths in the United States.
A high ranking Chinese embassy official has disputed the findings and is pushing for inspections of US plants where the finished heparin product was manufactured. The news belies a growing tension between the two countries regarding the safety and quality of Chinese exports including toys, drugs, and raw materials.
The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese plant identified as the source of contaminated heparin made by Baxter International in the United States. It warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.
Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.
The F.D.A. has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Deborah Autor, director of compliance at the F.D.A.’s drug center, said the agency did not know the original source of all the contamination or the points in the supply chain at which it was added.

Raytheon’s Groundwater Contamination and the Azalea Neighborhood

I spent the weekend talking with the concerned residents of the Azalea neighborhood in St. Petersburg. These are hard working, good people whose lives have been turned upside down by the reckless and careless disregard of their corporate neighbor Raytheon. Raytheon never bothered to tell Azalea residents about a toxic plume spilling from their plant in St. Petersburg that has contaminated the local groundwater.
The decrease in property values is not their only concern. The Azalea residents spoke to me about concern for their children’s health and welfare. They had questions about their pets who may have been exposed to the toxic chemicals Raytheon let seep into the groundater. This is a very difficult time for these good people who wake up every morning what the future holds in store for them.
Unfortunately, it’s too early to tell if there will be any long term health consequences linked to this contamination. We also don’t know when the contamination will be cleaned up or if property values will return to previous valuations. The anxiety and worry caused by the bad behavior of Raytheon has wrecked havoc in the daily lives of these residents.