There are two news items of interest this morning that concern how pharmaceutical companies’ marketing efforts are dangerous to consumer safety.
First, the FDA has moved to restrict and more closely regulate the prescribing of certain narcotic drugs including Oxycontin, the powerful and popular painkiller. In announcing the new restrictions, the FDA noted that doctors are sometimes too cavalier in the manner in which they dole out the powerful pain drugs. Interestingly, the governmental agency commented that the real culprit was the manner in which the drug companies themselves market these drugs as cure-alls while downplaying their dangerous side effects and the potentially life-threatening effects of misuse and overuse. For years now, I watched as pharmaceutical companies market their products as if they were candy. Finally, the FDA is moving to do something about this problem.
Secondly, Bayer, the manufacturer of YAZ, a popular birth control drug, will limit the way it markets the product. This comes on the heels of Bayer’s settlement with 27 states over Bayer’s marketing claims that YAZ can treat symptoms such as PMS for which it was never approved. As a result of the settlement, Bayer must implement a $20 million marketing campaign to remedy its misstatements in previous marketing campaigns.
Pharmaceutical companies have tons of money to throw at marketing campaigns. The more aggressive the marketing campaign, the more doctors and consumers will demand the drug. If there are no federal regulations concerning their marketing campaigns, drug companies can continue to put consumer safety at risk.

It’s been almost 12 years since the FDA asked to have fen-phen, the popular diet drug, to be removed from the diet drug. Fen-phen, a mixture of fenfluramine and phentermine, was causing valvular heart disease as well as pulmonary hypertension. Years of litigation and destroyed lives later, the FDA is now going after another set of diet drugs. This time the problem concerns the unknown or “hidden” ingredients in diet drugs that are marketed as natural. In spot inspections, the FDA has cited 69 weight loss supplements such as StarCaps, Sliminate, Superslim, ans SlimUp to name a few. The problem with these products is that the FDA has no real regulatory authority over their approval prior to their entering the marketplace. The FDA can step in and do spot checks which they are doing on a limited basis but the proverbial barn door is already open. The NY Times quoted Michael Levy as saying, “A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all,” said Michael Levy, the director of the F.D.A.’s division of New Drugs and Labeling Compliance. “We don’t think consumers should be using these products.”
This could be a more dangerous consumer product safety issue than fen-phen. At least with fen-phen, those who used the product knew what was actually in the drug. Now, with the prevalence of these new supplements, the consumer has no real idea what they are ingesting into their system. Furthermore, if something happens to the person using such supplements, a doctor will have trouble diagnosing the issue correctly because he or she will be in the dark as to what’s in the supplement. The federal government needs to change the law concerning these supplements and ensure some sort of regulatory approval process PRIOR to these products entering the marketplace. Right now, if you take these so-called natural supplements you’re playing Russian roulette with your health and quite possibly your life.

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
According to a January 15, 2009 GAO (Government Accountability Office) report, the FDA’s process for reviewing and approving the sales of medical devices is severely flawed. In reviewing potential medical devices for market here in the US, the FDA uses an antiquated process that dates back to 1976, which categorized medical devices into three groups or tiers depending upon their risk level to consumers.
Between 2003 and 2007 228 medical devices were found to have passed through an insufficient medical review process including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, according to the government report.
In spite of the flawed FDA system, the Supreme Court denied consumers the right to sue medical device manufacturers for faulty and dangerous medical devices, arguing that if the device received FDA approval, the device company was immune from product liability lawsuits in state courts.
Wyeth Pharmaceuticals, one of the country’s largest manufacturers of prescription and over-the-counter drugs, has brought suit in order to extend this same legal protection for drug manufacturers. Last November, the case was brought before the Supreme Court. If the Court extends this benefit to drug companies, it will prove to be another loss for consumers.

In the last few weeks we’ve witnessed some extraordinary events in the long, tragic saga that is the Catholic Church’s priest abuse scandal. Thomas O’Brien, the US Attorney in Los Angeles is undertaking a federal probe of the Archdiocese of Los Angeles’ actions and lack thereof regarding its handling of priest abusers. Just this past week, the deceased founder of the Legionaries of Christ, Rev. Marcial Maciel, is reported to have fathered a child. The child, now in her early 20’s wants to write a book about her infamous father and her mother’s relationship with him. Even the Legionaries have stopped disputing the allegation as spurious.
Yet, we still have bishops attacking the media for reporting on the scandals. Bishop Jenky of Peoria Illinois claims that the media’s intense hatred for Catholics is fueling the stories. Jenky is distributing a letter to all parishes of the diocese this weekend complaining about the church’s unfair treatment in the courts and in the press. An excerpt of the letter reads as follows: ““Amid all the tensions of our nation’s culture wars and in the face of the media’s intense hatred for our Catholic faith, I am increasingly concerned that our Church in effect no longer enjoys equal justice under the law.” In his tirade, Jenky did not spare lawyers either.
“Attorneys representing some claimants and some “victims groups” obviously have a significant financial stake in trying to overturn our Diocesan policies.”
Jenky claims, abundant evidence to the contrary, that these “attacks” are an attack on the faith and not a matter of justice, truth, or protecting victims (whose credibility he questions by putting the words in quotation marks).
This defensive, reactive posture will not resolve the scandal nor will it restore credibility to the Church whose own members have suffered as a result of these scandals.

It’s still not known how many homes in southwest Florida contain the defective and toxic Chinese drywall. One thing we do know at this point-Lt. Governor Jeff Kottkamp’s house is one of those homes containing the cheap, defective drywall. Kottkamp’s home was built by Aubuchon Homes owned by Gary Aubuchon who, ironically replaced Kottkamp in the State Legislature when Governor Crist named Kottkamp as his lieutenant governor.
The problem with the Chinese drywall is under investigation. We do know that the drywall emits sulfur compounds that could pose a health risk. Kottkamp who lives in North Ft. Myers, has called for the state Health Department to conduct tests on the home.
The potential area of affected Chinese drywall homes spans quite a large area on the west coast of Florida from St. Petersburg to Naples. There have already been lawsuits, including two class action suits, filed against manufacturers, suppliers, and builders who used the Chinese dry wall.

It’s ubiquitous in the public square. We’re seeing it with our new President and his Cabinet appointments. We’ve witnessed it in the Catholic Church for a number of years now. It’s the irony of one’s words and statements when matched up against actions. Presently, the most poignant example of it is Cardinal Mahony of Los Angeles who for years was a staunch defender of the church’s moral positions. He’s even publicly criticized past Administrations on such moral issues as war, poverty, disease, and immigration. Yet, his actions belie another reality. This is a public leader, a Cardinal in the Catholic Church who’s been dogged by the priest abuse scandal. While the epicenter of the scandal in the east was Cardinal Law of Boston, few would argue that that distinction belongs to Cardinal Mahony of Los Angeles. He is now faced with a federal investigation, that unlike other inquiries, which should prove to challenge even Mahony’s formidable skills of evasion and covering-up. However, we have to sound a word of caution here. The man hasn’t been known as Roger the Dodger for nothing. He’s survived this scandal pretty much unscathed. He’s had to make some financial payments to abuse survivors but he kept himself out of the courtroom. Thus far, he’s been able to escape the fate of others who haven’t escaped the irony of real politick.

Lennar Corporation, a major builder in southwest Florida, has filed a lawsuit against manufacturers, installers, and suppliers of a toxic drywall that has affected numerous Florida homes.
The Chinese drywall emits gas that corrodes the walls of the homes, according to the complaint filed in Miami-Dade Circuit Court. Two class action lawsuits have been filed separately as a result of the defective Chinese drywall. The class action lawsuits allege that the defective drywall has adversely affected the health of those residing in the homes containing the Chinese drywall. The companies being sued for using the drywall dispute those claims. One target of the class action lawsuit is Knauf Plasterboard Tianjin Co. Ltd., a Chinese subsidiary of German-based manufacturer Knauf. Another company that will have to answer the suit is Knauf Tianjin and its German parent, along with a second manufacturer, Taishan Gypsum.
According to a published report in the Sarasota Herald Tribune, the companies have shipped millions of pounds of the defective Chinese drywall into Florida since 2006.

US Attorney Thomas P. O’Brien is looking into whether Roger Cardinal Mahony of Los Angeles can be charged with honest services fraud in connection with the priest sexual abuse cases in the Archdiocese. However, O’Brien has declined comment and has refused to acknowledge such an investigation exists.
The “honest services” fraud charge concerns parishioners and others who relied on such Catholic leaders as Mahony to keep their children safe from predatory priests who abused numerous children in the Archdiocese for many, many years.
Allegations of mishandling and covering-up sexual abuse matters have dogged Cardinal Mahony for years. A few years ago, Mahony and the Archdiocese of Los Angeles setted more than 500 claims by paying $660 million.

Los Alamos National Laboratory has warned that as many as 2,000 employees and visitors to the lab may have been exposed to beryllium. According to OSHA, exposure to beryllium by inhalation of beryllium dust or fumes can cause serious damage to the lungs, lung cancer, and may be fatal.
Berylliums is a natural metal found in beryl and bertrandite rock. It is very lightweight and hard. It serves as a good conductor of electricity and heat.
According to OSHA, “Chronic beryllium disease (CBD) primarily affects the lungs. CBD may occur among people who are exposed to the dust or fumes from beryllium metal, metal oxides, alloys, ceramics or salts. It occurs when people inhale beryllium in these forms. CBD usually has a very slow onset, and even very small amounts of exposure to beryllium can cause the disease in some people. In some cases, CBD develops while workers are still on the job, but in others it may not develop until many years after a person has stopped working in the beryllium industry, or has been transferred to a job that does not involve beryllium exposure. The amount or length of exposure to beryllium necessary to cause a specific individual to develop CBD is not known, but recent information suggests that exposure below OSHA’s 2 micrograms/m3 TWA PEL over a very short time (weeks or months) can lead to CBD in some workers.”
Symptoms may include: unexplained cough, shortness of breath, especially with activity; fatigue, weight loss or loss of appetite, fever, or night sweats. The disease may develop slowly over a period of years and many of those affected may be carrying it without their knowledge.
The Los Alamos beryllium exposure concern first surfaced in November when a box containing beryllium was delivered to the Los Alamos plant. The box appeared damaged so officials at the lab tested the area for contamination. The area was found to have beryllium contamination but the source of the contamination was not the box. The lab had not been tested for beryllium exposure since 2001 so Los Alamos officials have sent warning letters to anyone who worked there since or visited the lab since 2001.

“We reject as false the choice between our safety and our ideals.” Those words you very well may recognize as delivered by President Barack Obama on the day of his Inauguration. However, they are equally appropriate in response to an article in the Contra Costa Times this morning which bemoaned a federal law scheduled to take effect in a few weeks. The law is called Consumer Product Safety Improvement Act. The news article is entitled, “Product Safety Law Casts Gloom Over Businesses” hardly an unbiased title. The premise of the article is that businesses will be hurt by this overly restrictive law. Very little mention is made of those whom it is designed to protect-our children. The law is targeting lead in products used by those 12 years of age and under. Lead is a known as a potent neurotoxin. The law is also regulating and for the most part eliminating phthalates from children’s products and toys. Phthalates, used to make hard plastics, is particularly dangerous to reproductive systems.
Any bill designed to protect children, especially when the offending agents are known and proven to be dangerous, is a good consumer protection. I’m surprised the Contra Costa Times or any media outlet would side with big business over and above consumer product safety.