The past year has not been very good for commercial US-China relations. We’ve witnessed the heparin contamination scandal, the tainted milk debacle, and counterfeit drugs manufactured in China. Now, it’s Chinese drywall. The problem stems from the building boom five years ago. Houses, especially in southwest Florida, were being constructed in record numbers. To cut costs, builders such as Lennar Homes and Aubuchon contracted with Chinese companies to purchase dirt cheap drywall. That’s when the old adage, “you get what you paid for” comes into play. The problem is the drywall was made with waste materials from scrubbers on coal-fired power plants. According to Dan Reid of Intuitive Environmental Solutions in Fort Myers, “Those materials leak into the air as gases and combine with the moisture on an air conditioning coil to create sulfuric acid, which appears to be dissolving solder joints and copper tubing — creating leaks, blackening the coils and even causing the system to fail.”
The problem doesn’t just involve private residences. Three Cape Coral Florida charter schools are being investigated to determine whether Chinese drywall was used in the construction of the schools. According to a News-Press article, “Cape Coral Mayor Jim Burch’s call for an investigation into the construction of all city buildings during years the drywall was imported to the U.S.”
“I have growing concern that the Chinese drywall problem could present serious economic and health challenges to Lee County,” Burch wrote in a Monday memo to City Manager Terry Stewart.
The health effects of exposure to the sulfur compound is unknown at this point.
According to the South Florida Business Journal, at least 80 Lennar Homes have been built with the controversial and potentially dangerous Chinese drywall. A spokesperson for Lennar Homes has said that the homes in question were built during the building boom in southwest Florida during 2005-06.
The drywall causes unpleasant, noxious odors, electrical problems, and potential health problems yet undetermined by health officials tasked with investigating the latest Chinese scandal.
Drug Products
Six States Join EPA in Ohio River Cleanup Study
Six states including Kentucky, Illinois,Indiana, Ohio, Pennsylvania, and West Virginia have joined forces with the Environmental Protection Agency to study bacteria and other pathogens that pollute the Ohio River.
While the task is enormous the symbolic effect of state involvement in the bacteria study is significant. A similar effort led to the restoration of healthy oxygen levels in the Middle Cuyahoga River.
The study which is scheduled to be completed next year will determine how much bacteria sewage treatment plants, factories, and other sources of pollutants can discharge into the river without exceeding the standards of safety. Presently, there are 49 cities and towns in the area which release untreated sewage directly into the river during heavy storms. An expensive upgrade is needed in order to stem the tide of bacterial flow into the river.
This is a good first step in identifying, treating, and restoring the Ohio River to its environmentally healthy place. It’s a good thing to have states cooperate with the federal government on an issue as important as environmental clean-up and restoration.
Godspeed Mr. President
As I write this, the country is marking an historic occasion tomorrow. The first African-American is to be sworn in as President of the United States of America. The first Senator in 44 years is to be elected president of the United States. Perhaps, the most important milestone revolves around the perilous times this young president embarks on leading this country in a time where we’re fighting two wars, an economic collapse the likes of which we’ve never seen, and the domestic turmoil evidenced by the chaos in the FDA. Yet, there is hope. This President is seemingly capable of rousing the American people to hope and resolve. In spite of our political differences, he has summoned our “best angels” to support him and pray for his success. At this moment in history, we need a leader, a courageous leader to show us the way. We wish him all the success. Our hopes and our fortunes ride with him.
Spine Consultant Receives $20 Million Plus in Compensation from Medtronic
A prominent University of Wisconsin spine researcher, surgeon, and perhaps most significantly, Medtronic consultant, was paid more than $20 million by Medtronic which just happens to be one of the world’s foremost manufacturers of spinal medical devices.
The revelation is creating a tsunami of conflict of interest in the industry as well as on Capitol Hill. Thomas Zdeblick, the Wisconsin surgeon, was receiving the Medtronic payments for his work in promoting and developing the spinal products. The massive payments spanning the four years from 2003-2007 went far beyond what had been initially reported to the University of Wisconsin. The school, like all other schools receiving federal funding for research, is required by law to monitor its researchers’ potential conflicts of interest.
One of the more troubling aspects of this case involves the doctor’s duplicity. In each of the last five years he has told the University of Wisconsin that Medtronic payments were approximately $20,000. That’s a far, far cry from $20,000,000!
US Senator Charles Grassley has stated that Wisconsin’s disclosure rules are insufficient and need to be reformed. Robert Golden, dean of the University of Wisconsin’s medical school, agrees with Grassley and has noted that most states have similar disclosure laws.
What is clear and transparent is that each instance that such conflictual relationship is revealed to the public, the erosion of public trust in the healthcare system grows. It needs to be fixed sooner rather than later.
Newer Antipsychotics Like Zyprexa Double Risk of Death from Heart Failure
The new, expensive drugs such as Risperdal, Zyprexa, and Seroquel were supposed to be more effective than the old treatments for schizophrenia, autism, and dementia. At least that’s how they were marketed to patients and doctors alike. Yet a new study finds these new “wonder drugs” double the risk of death due to heart failure. Furthermore, they haven’t been found to be as effective as the older anti-psychotic drugs.
The most susceptible populations to the risks of rapid weight gain and heart failure are the young and elderly. Professor Wayne Ray of Vanderbilt University authored the study and concluded that the significance of risk compelled prescribing doctors to perform thorough cardiac evaluations prior to giving the drugs to their patients.
Zyprexa, manufactured by Eli Lilly, has been the target of lawsuits ever since it was found that the drug led to rapid weight gain as well as the onset of diabetes in some cases. Besides the civil lawsuits, Eli Lilly has just agreed to pay $1.4 billion to settle criminal and civil investigations into its marketing of the drug Zyprexa. Lilly will pay $615 million to settle the criminal probe and approximately $800 million for the civil investigation. The settlement comes in the midst of the cirminal probe targeting Lilly for promoting Zyprexa for uses for which it had not been approved.
FDA Found to Be Lax on Oversight During Trials
A new study has found that the FDA does very little when it comes to monitoring doctors who may have financial conflicts with companies whose drugs and medical devices they are supposed to be testing. Perhaps the most damning finding was the revelation that agency officials didn’t believe it was “worth the effort” to try to protect patients from such conflicts of interest.
This latest study is just the latest in a myriad of bad press, resignations, and reports of mismanagement at the federal agency. This is especially bad since the courts have virtually left consumer safety in the hands of the FDA regarding the safety of medical devices.
According to the NY Times article, “Fewer than 1 percent of the doctors who helped oversee clinical trials registered with the agency and who filed the required financial disclosure forms reported that they had a significant conflict of interest. By contrast, studies have found that one-fifth to one-third of all doctors have such conflicts.”
Another Case of Contaminated Peanut Butter
We’ve been here before with salmonella tainted peanut butter. This time it’s King Nut Companies whose spokesman said in a statement that it asked customers to stop distributing all peanut butter under its King Nut and Parnell’s Pride brands with a lot code that begins with the numeral “8.”
According to the AP report, “The peanut butter was distributed only through food service providers in Ohio, Michigan, North Dakota, Minnesota, Arizona, Idaho, New Hampshire, Massachusetts and Florida. It was not sold directly to consumers.
Preliminary laboratory testing found salmonella bacteria in a 5-pound container of King Nut brand creamy peanut butter, the Minnesota Department of Health said Friday.”
The CDC said Friday that 399 cases had been confirmed nationally, with about one in five of victims hospitalized. California has reported the most cases, with 55, followed by Ohio with 53. All the illnesses began between Sept. 3 and Dec. 29, but most of the people grew sick after Oct. 1.
FDA Scientists Complain to Obama about Corruption at FDA
A group of FDA scientists have written a blunt letter to President-elect Obama’s transition team about corruption and mismanagement at the federal agency’s medical device inspection division. The letter was written on Center for Devices and Radiological Health letterhead. The division is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. Interestingly, the concerns outlined in the letter are similar to those voiced by members of the FDA’s drug review division during the Vioxx investigation.
The letter, released to the Associated Press by a Congressional official, states, “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”
With the Supreme Court’s ruling concerning pre-emption in Riegel v. Medtronic, this letter’s importance can not be overvalued. Congress will be considering a measure to overturn the Court’s decision and given the reports of problems with the FDA, the legislation appears to have a good chance at passing.
Coal Ash Dump in Tennessee Should be a Warning
Last month’s coal ash dump in Tennessee was one of the worst environmental disasters of that kind in US history. Yet, according to a report today in the NY Times, the Tennessee coal ash incident is not isolated. There are more than 1,300 similar coal ash dumps around the country and they contain hazardous chemicals such as arsenic, lead, mercury, and selenium. These toxins are a serious threat to human health and local drinking water supplies.
More importantly, none of these dumps are monitored or regulated. Without such regulation, the probability of another toxic spill like the one in Tennessee is fairly high.
The environmental problem has been growing with the increasing demand of electricity coupled with efforts in the last few decades to curb air pollutants. What once spewed through the air near coal plants has now been transformed into solid waste stored at these coal ash dumps. The dumps are not just the problem of the coal mining regions either. Coal ash dumps can be found near such unlikely cities as Tampa, St. Louis and even the Mississippi River.
According to the NY Times article, “as the E.P.A. has studied whether to regulate coal ash waste, the cases of drinking wells and surface water contaminated by leaching from the dumps or the use of the ash has swelled. In 2007, an E.P.A. report identified 63 sites in 26 states where the water was contaminated by heavy metals from such dumps, including three other Tennessee Valley Authority dumps. Environmental advocacy groups have submitted at least 17 additional cases that they say should be added to that list.”
This past week a judge approved a class-action lawsuit settlement concerning such toxic coal ash dumping against Constellation Power Generation in Maryland.
In spite of the fact that the EPA has been studying the issue for 28 years, nothing has been done to address the problem. The EPA’s inertia has led to chaos and a growing problem that threatens to seriously impact our groundwater supply and public health. States are not much better at tackling the issue in their own backyards. Alabama doesn’t regulate or monitor the situation at all. Texas deals with the problem by denying it. They don’t view coal ash as solid waste and don’t have any type of monitoring or engineering requirements for utilities that dump the ash in their state.
As with most large federal agencies, part of the problem is political. The Times article notes, “In 2000, the agency came close to designating coal ash a hazardous waste, but backpedaled in the face of an industry campaign that argued that tighter controls would cost it $5 billion a year. (In 2007, the Department of Energy estimated that it would cost $11 billion a year.)” Once again, lobbying and influence peddling in Washington puts our public health in jeopardy.
In spite of the growing public health concern and 28 years of inactivity, the director of the office of solid waste at the EPA had this to say to the NY Times, “We’re still working on coming up with those standards. We don’t have a schedule at this point.” Perhaps his firing should be scheduled.
Vermont Catholic Diocese Asks Judge to Reject Jury’s Judgment
The Catholic Diocese of Vermont or the Diocese of Burlington has asked a judge to dismiss the jury’s verdict which awarded a priest sex abuse victim $3.6 million last month. Lawyers for the plaintiff have countered that their client is willing to use the money for the Catholic education of children but that offer has been ignored by the Diocese.
This is an interesting case especially the church’s stance after the verdict. We live in a country whose civil justice system is ultimately based upon the judgment of one’s peers in the jury box. After all the legal hurdles have been overcome, a civil trial comes down to the judgment of the jury. In some instances, the judge may overrule a jury’s verdict if it is illegal or grossly unfair. However, most judges hesitate to do this because they understand the importance of the jury system. As a trial lawyer, I’ve always felt comfortable with leaving the verdict and the amount of compensation in the hands of a jury. The outcomes have not always been in my favor but the system works.
Another aspect of this post-case wrangling concerns the survivor of abuse. Is the Diocese of Burlington saying his life isn’t worth what the jury awarded? Is the Diocese saying what he suffered really wasn’t all that bad? The priest who abused the plaintiff in this case was a well-known pedophile, Fr. Edward Paquette and the Diocese of Burling knew about his sex abuse history before they brought him to work with children in Vermont.
One final thought-how can the Catholic Church in Vermont have any moral credibility when it denies responsibility for its own actions? It’s part of Catholic teaching that bad behavior has consequences. Isn’t that what the jury verdict tells us? Responsibility and accountability are important qualities in moral leadership. If Vermont’s Catholic Church shirks such, how can it claim moral leadership?



