Monthly Archives: January 2010

Drug Marketing Campaigns Still a Problem

The Wall St. Journal has been tracking the fines levied by the US Justice Department and the FDA for quite some time now. The names of drug company offenders includes the biggest drug companies in the United States and reads like a veritable Who’s Who of big pharma. The list includes Johnson & Johnson, Merck, Pfizer, Eli Lilly, Novartis, and Astra Zeneca, to name a few. In spite of the multi-million dollar fines, pharmaceutical companies continue to skirt the law and illegally promote their drug products. The simple answer is the marketing strategy is financially beneficial. While the fines are stiff in overall terms, they are comparatively cheap relative to pharmaceutical company profits. When drug companies are raking in sales up to $300 billion a year, a multi-million dollar fine is negligible and ineffective at curbing the practice.
According to the Wall St. Journal article, “Improper marketing often occurs when drug companies are promoting therapies that are similar to others on the market, says Patrick Burns, director of communications at Taxpayers Against Fraud, a watchdog group in Washington, D.C. “In that kind of marketplace, the business isn’t about the drug. It’s about the kickback and it’s about market expansion through illegal promotion,” he said.
One of the most common illegal tactics companies use is “off-label” marketing, when sales reps encourage doctors to prescribe drugs for uses for which they aren’t approved by the Food and Drug Administration. Doctors themselves are allowed to prescribe drugs any way they see fit, but the law says companies can’t promote them for unapproved uses.
The government has also accused companies of making payments to doctors to get them to prescribe certain drugs, both on and off-label. These payments can take several forms that are often legitimate, including consulting fees and research grants. Corporate whistleblowers often draw the government’s attention to alleged wrongdoing, sparking federal investigations.”

Irish Priests Who Abused in the US

In the wake of the Irish abuse report published earlier this year, it’s now known that at least 70 Irish-born priests have been accused publicly of abuse here in the United States. Even before the report was published, we suspected that the depth of the Irish abuse in the United States had been significantly understated. For the better part of the 19th and 20th centuries, Catholic parishes were staffed by Irish missionary priests. The dearth of US vocations and the number of Irish priests led many US bishops, some of whom were Irish themselves, to visit and recruit priests from Ireland. In most instances, there was no background check performed on these priests. In instances where an Irish priest was considered problematic in Ireland, the Irish bishop was all to happy to send him off to a foreign land where he was free to abuse others. The culture of secrecy as well as the desire to protection the institution of the church at all costs further fed this tragedy of abuse.
The situation in Ireland mirrored the situation in the US concerning how the church handled reports of abuse. Mary Raftery, who produced the documentary “States of Fear,” and wrote a book on the same subject, “Suffer The Little Children,” discussed the state of the Irish church in terms of dealing with the abuse scandal,
“The approach of the religious orders was described by the commission in 2003 as “adversarial and legalistic.” The Department of Education, whose duty it was to inspect and regulate the bulk of the institutions, was refusing at that time to cooperate fully with the commission’s demands for documents.”
This is why the civil justice system had to intervene. Years of obfuscation provide the evidence necessary to conclude the church isn’t willing and simply can’t police itself.

Chondrolysis May Be Linked to Pain Pumps

Surgical pain pumps became popular among orthopedic surgeons in the 1990’s as an alternative to longer hospital stays and prescription narcotics. The pain pumps, a post surgical medical device that delivers local anesthetics to the area through a plastic tube, were used to alleviate pain after joint surgery, particularly shoulder surgery. However, some of the patients who received pain pumps have developed an ailment known as chondrolysis where the cartilage in the joint dies, leaving joint bones to grind on each other.
According to an article in the NY Times, some studies have linked chondrolysis to the insertion of these pain pumps. In spite of their popularity, the pain pumps were never authorized by the FDA for such use. Those who are critical of the pain pumps note that by exposing cartilage to local anesthetics for up to 72 hours, the medications used to soothe pain turn toxic and lead to the deterioration of the cartilage. Last November, the FDA issued a warning about the pain pumps so as to discourage doctors from using them in joints.
The NY Times article stated, “In late 2006, after a handful of studies indicated that the pain pumps might be causing chondrolysis, the I-Flow Corporation, the largest pump manufacturer, changed its directions in package inserts to advise doctors to avoid placing the pump catheters in joints. In 2007, I-Flow posted a bulletin on its Web site notifying physicians of the risk.
The first lawsuits against pain pump companies were filed about two years ago. It is difficult to know the exact number of suits, but I-Flow reported in November that it was a defendant in 191 chondrolysis cases involving 412 patients. Of those, the company said, 80 suits were dismissed. Kay Jackson, a spokeswoman for the Kimberly-Clark Corporation, which purchased I-Flow last year, declined to comment, citing the pending litigation.
AstraZeneca, which until 2006 sold a local anesthetic that was used in the pumps, is a defendant in 68 active cases, said Tony Jewell, a company spokesman. AstraZeneca did not promote the drug, bupivacaine, for use in pain pumps inserted in the joint, nor did it seek approval for such a use, he said.

Radiation Overdoses on the Rise

In Sunday’s edition of the NY Times, highlighted the growing problem of radiation overdoses in the United States. Radiation therapy has become increasingly popular, especially in the treatment of cancer. Since 1980, the lifetime dose of radiation a person receives has increased seven fold. However, radiation is not without its risks and potential for serious injury. Dr. John J. Feldmeier, a radiation oncologist at the University of Toledo estimates that 1 in 20 patients will be injured by radiation therapy. As part of its investigation, the NY Times researched the issue in NY state hospitals from 2001 to 2008 and found 621 radiation mistakes including radiation applied to the wrong area of the body.
One particularly gruesome example highlighted in the Times article concerned a 43 year old man who received radiation to treat tongue cancer. In this case, the hospital failed to detect an equipment error which directed radiation at his brain stem and neck rather than the intended area. He died in excruciating pain, unable to see, hear, and unable to swallow. The man died in 2007.
Because such medical errors are not disclosed to the public in NY state, prospective radiation patients aren’t able to know which hospital has had radiation errors in the past. This lack of accountability leaves patients in the uncomfortable situation of having to place blind trust in hospitals or institutions that may have committed serious radiation errors in the past. It also doesn’t force such hospitals to correct errors or prevent them from occurring in the future.

First Federal Hearing on Chinese Drywall Set For Friday

The first federal court hearing on the Chinese Drywall lawsuits will be heard by US District Judge Eldon Fallon. The hearing is crucial because it involves remediation procedures as well as how much such remediation measures will cost. Most likely, the discrepancy concerning the cost of remediation will be large. The hearing will also set standards for federal Chinese drywall cases beginning in March.
Chinese drywall has damaged homes across the country but has had the most severe impact on southern states such as Florida, Virginia, and Alabama. The contaminated drywall has been associated with the corrosion of electrical equipment and has filled homes with a strong sulfur-like odor. One defendant, Taishan Gypsum Co. Ltd., has already been found in default for failing to respond to lawsuits naming the company as a defendant in the Chinese drywall lawsuits. Taishan Gypsum is controlled by the Chinese government.
The Consumer Products Safety Commission has received 2,800 complaints about Chinese drywall. The Chinese drywall was imported due to a shortage of drywall following the 2004-05 hurricanes. It’s estimated that 500 million pounds of the contaminated drywall was imported during the housing boom, perhaps affecting 100,000 US homeowners.

Meridia Gets New Warning Label From FDA

Meridia, the diet drug marketed by Abbott Laboraties, Inc, will receive a warning label for an increased risk of heart attacks and strokes in patients who’ve had prior cardiac history, including cardiac failure, hypertension, and irregular heart beats.
The FDA originally approved Meridia as a weight loss drug to be used in conjunction with regular diet and exercise. Meridia is related to the amphetamine family of stimulants.
On the same day that the FDA added the warning label to Meridia, the FDA counterpart in Europe has called for an outright ban of the substance sibutramine – sold in Europe under several names, including Reductil, Reduxade and Zelium. The European ban suggestion came in the wake of a study of 10,000 patients who had shown an increased risk for heart disease after taking a form of sibutramine.
The FDA plans to study the SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) report after it’s received from Abbott. The federal agency will most likely issue their own findings in a new report concerning Meridia sometime in March.

New Stryker Lawsuit Involved Pain Pump

Stryker had been in the news the last few years over lawsuits filed against the medical company for its defective artificial hips. Now, Stryker faces lawsuits concerning its pain pump medical device. One such lawsuit filed in federal court in Las Vegas alleges that Stryker officials have been marketing the pain pump for uses other than those approved by the FDA.
Stryker pain pumps are inserted into the joint space of the shoulder and have been associated with damage to the surrounding cartilage. The lawsuit filed in Nevada alleges, “Stryker knew or should have known that its pain pumps, when used with aesthetic medications in the joint space, could be toxic to shoulder cartilage.”

Johnson & Johnson’s Bad Week

Federal prosecutors have charged Johnson & Johnson in a huge kickback scheme and the FDA has been critical of the pharmaceutical company for its slow response in recalling some of its most popular drugs. Both are serious public relations set backs for a company that had been considered the gold standard for responding to crises. Since the company’s handling of the Tylenol recall in 1982, Johnson & Johnson has fallen from its lofty perch.
The latest recall involves Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph. The recall has been expanded and involves a moldy odor that appears to have been caused by a chemical that’s used to treat wood pallets used to store and transport the OTC drugs. Those affected by the pills have reported nausea and stomach problems. However, none of the reports have mentioned serious health concerns.
According to the American Chemical Society, “The chemical 2,4,6 tribromoanisole (TBA) is closely related to 2,4,6-trichloroanisole (TCA), the culprit behind wine’s Cork Taint. 2,4,6 tribromoanisole is the reason for the McNeil Health nationwide recall of all lots of Tylenol Arthritis with the red EZ OPEN CAP. This chemical is responsible for a musty odor, as well as gastrointestinal distress.”

Muscle Inc Issues Product Recall

Muscle Master has issued a voluntary recall of 17 of its body building supplements after the FDA informed the company that these products contain steroids. The products that contain ingredients the FDA believes have steroids include “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” Acute liver injury has been associated with products containing steroids. Symptoms of such injury include shrinkage of the testes and male infertility; masculinization of women; breast enlargement in males; short stature in children; a higher predilection to misuse other drugs and alcohol; adverse effects on blood lipid levels; and increased risk of heart attack, stroke, and death.
The recalled products are as follows:
• Advanced Muscle Science Dienedrone, 60 caps
• Advanced Muscle Science Liquidrone, 60 ml
• Anabolic Formulation M1, 4AD, 60 caps
• Anabolic Formulations 1, 4 AD, 60 caps
• Anabolic Xtreme Hyperdrol X2
• Anabolic Xtreme 3-AD, 90 caps
• BCS Labs Testra-Flex, 90 caps
• Competitive Edge Labs M-Drol, 90 Caps
• Competitive Edge Labs P-Plex, 90 caps
• Competitive Edge Labs X-Tren, 90 caps
4Ever Fit D-Drol, 60 caps
• Gaspari Novedex XT 60 Caps
Gaspari Halodrol Liquigels, 60 gels
• iForce 1,4 AD BOLD 200, 60 Caps
• iForce MethaDROL, 90 caps
• iForce Dymethazine, 60 caps
• Monster Caps, 60 caps

Doc Seeks Plea Deal in Faking Research About Pfizer and Merck Drugs

Scott Reuben, a Massachusetts anesthesiologist, is seeking a plea deal with federal prosecutors over charges that the doctor faked research intended to support the benefits of Merck and Pfizer drugs. The drugs include Vioxx, Bextra, and Celebrex. According to the Associated Press, Reuben has agreed to plead guilty in exchange for a more lenient sentence. Federal prosecutors have said Reuben faced up to a 10 year prison sentence and a $250,000 fine.
The federal prosecutors have charged Reuben with receiving payments from the pharmaceutical companies in exchange for favorable research about the companies’ drugs.
The allegations against Reuben call into question the veracity and independence of research performed at the behest of pharmaceutical companies. Many doctors have depended upon such “scientific” research in order to properly prescribe drugs and therapies for their patients.