'Wrong Site' Surgeries On The Rise

May 25, 2006,

The horrific stories of patients going in for surgery on one part of their body, only to have another part operated on, is on the rise. A recent article in USA Today. The horrors include mistakingly removing wrong limbs or organs, slicing into the wrong side of the body, or performing surgery on the wrong patients. A study published in the Archives of Surgery found the events on the rise, and although rare, is unacceptable.

Another facet to the problem is the fact that some hospitals don't report any of these types of events. Some states require their hospitals to report any such event. Other states do not require public disclosure of the mistakes.

Ban On Mercury in Children's Vaccines Facing Stiff Opposition

May 23, 2006,

Just when we thought mercury would be phased out of all childrens' vaccinations, the poison makes a return. The following is excerpted from a recent LA Times article:

"The push for legislation comes long after the uproar over continued use of thimerosal, a mercury-based antibacterial agent, appeared to subside in 1999, when manufacturers began phasing it out of routine pediatric vaccines.

But the controversy flared anew when flu shots containing thimerosal were added to the childhood immunization schedule in 2004 and the CDC refused to recommend thimerosal-free shots for infants and pregnant women.

Angered by the CDC's refusal — and fearing a backslide into more thimerosal use — state lawmakers and anti-mercury advocates began pushing for outright thimerosal bans."

Read the full article here.

Doctor Sues Pfizer For Fraudulent Misrepresentation

May 21, 2006,

This week, David Longmire, M.D., an Alabama neurologist and specialist in neuropathic pain evaluation and management, filed a lawsuit against Warner-Lambert, Inc. and its parent company, Pfizer for fraudulent misrepresentation, concealment and deceit.

This lawsuit arises out of a May 13, 2004 prosecution in which Warner-Lambert and its Parke-Davis division, acquired by Pfizer in 2000, pled guilty to charges that it criminally violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 331 et seq. associated with its marketing and sales practices for their epilepsy drug known Neurontin.

Related to the 2004 case, Dr. Longmire's lawsuit charges that Warner-Lambert defrauded him by exploiting his medical expertise and reputation and luring him to unwittingly participate in a deceptive scheme to market Neurontin for certain unapproved uses, commonly known as "off-label" uses.

Read the full article here.

Scientific Researchers Breaking the Rules

May 19, 2006,

A recent flurry of gross scientific misconduct has brought light on a disturbing new trend-scientists engaging in everything from twisting test results to achieve a certain result to flat out fabrication and falsification. The world saw the worst when the breakthroughs in stem cell cloning by a South Korean researcher were found to be completely faked.

More close to home, in December we learned that Merck employees withheld critical data from the VIGOR study which first linked Vioxx with heart attacks. Another study released last October indicating that NSAIDs reduced the risk of oral cancer turned out to be completely fabricated.

Not to shift accountability away from the scientists who perform these studies, but the current environment for scientific research is fertile ground for fraud and malfeasance. Using drug companies as an example, millions of dollars go in to research for new and existing drugs. If the researchers do not already work for the drug company, they are handsomely rewarded to perform the study. The lure of big money has a way to create or mold a study that caters to goals of the financiers. To produce unbiased studies of significance, this financial carrot needs to be removed from the scientific process.

Read more about the trend in Forbes online here.

Fraud and Safety Concerns Surround Antibiotic Ketek

May 17, 2006,

The Wall Street Journal recently reported that Senator Grassley of the Senate Finance Committee demanded a probe into the FDA's handling of safety concerns with the popular antibiotic Ketek. Produced by Sanofi-Aventis, the drug is being linked to liver failure and deaths.
Most disturbing is the fact that a researcher who worked on a major study of Ketek pleaded guilty to charges that she fraudulently reported false and inaccurate data to the study. The FDA required Sanofi-Aventis to perform the study after earlier studies raised concerns about the liver toxicity of the drug. The full extent of the problems relating to the study in question have not been fully revealed to the public.

Read more in the Wall Street Journal online here.

Teflon Lawsuits Consolidated in Des Moines, Iowa

May 15, 2006,

The first round of hearings in the recently consolidated Teflon products liability lawsuit were heard in the U.S. District Court for the Southern District of Iowa. The suits allege that Teflon maker DuPont failed to warn of a known carcinogen used to make Teflon called perfluorooctanoic acid, or PFOA. In 2004, DuPont paid $16.5 million to the government to settle allegations that the company hid information regarding the chemical's potential dangers.

Read more in the Des Moines register here.

Bausch & Lomb ReNu With MoitureLoc Permanently Withdrawn From Market

May 13, 2006,

A team from Bausch & Lomb met with officials from the FDA on Friday to address concerns about its 'MoistureLoc' line of contact lens solution. A breakout of a rare eye fungal infection is being linked to the brand. Bausch & Lomb shared results of their internal investigation into the outbreak with the FDA, and the FDA supported their decision to recall the product.
It will be interesting to see what litigation uncovers about the company's knowledge of the link, and their efforts (or lack thereof) to curb the problem.

Study Links Mercury Preservative in Vaccines With Immune System Dysfunction

May 11, 2006,

"A new UC Davis study links a mercury-containing preservative once prevalent in many children's vaccines to immune system dysfunction in mice.

The findings are sure to heighten the debate over whether vaccines play a role in causing autism, especially since there is growing evidence that many autistic children have irregular immune systems.

The researchers released their results with an abundance of caution, stressing that numerous questions remain about thimerosal's effect on humans and its relationship, if any, to the recent rapid rise in the numbers of autistic children.

The study is a road map for future investigations of the effect mercury from a variety of sources has on developing immune systems, said senior author Isaac Pessah, a UC Davis toxicologist."

Read the full article in the Kansas City Star here.

Insurance Suit Involving Undervaluing Cars Settles For $92 Million

"The Lakin Law Firm of Wood River and the Chicago law firm of Freed & Weiss LLC filed the lawsuits in 2001 against multiple providers of car insurance. The lawsuits alleged the companies used a computer system to routinely pay below-market values for vehicles wrecked beyond repair.

The final settlement was approved in December by Madison County Associate Judge Ralph Mendelsohn, but Lakin attorney Richard Burke on Monday said the period during which the defendants could have sought an appeal only recently expired.

Burke said roughly 3 million people were eligible to make claims for $5 to $132. The plaintiff attorneys were awarded $16.1 million in fees, to be paid by the defendants."

Read the full article in the Belleville Democrat here.

Which Drug Is Better? Depends On Who Pays For The Study

"Pharmaceutical giant Eli Lilly and Co. recently funded five studies that compared its antipsychotic drug Zyprexa with Risperdal, a competing drug made by Janssen. All five showed Zyprexa was superior in treating schizophrenia.

But when Janssen sponsored its own studies comparing the two drugs, Risperdal came out ahead in three out of four.

In fact, when psychiatrist John Davis analyzed every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study.

"On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis and others wrote in the American Journal of Psychiatry."

Read the full article in the Washington Post here.

Study Further Shows How Cox-2's Cause Heart Attacks

"Painkillers called COX-2 inhibitors may increase the risk of heart attacks by raising blood pressure and making the blood more likely to clot, researchers said on Thursday.

They do so by the same mechanisms that they use to reduce pain and inflammation, said University of Pennsylvania School of Medicine researcher Dr. Garret FitzGerald, who led the study.

But the finding shows that a new generation of anti-inflammatory drugs could avoid the problem, FitzGerald reported in the Journal of Clinical Investigation."

Read the full article from Reuter's here.

Doctor Sentenced to 15 Years For Diluting Chemotherapy Drugs

"A Crossville, Tenn., oncologist blamed her nurses, her busy schedule and complicated billing procedures as she was sentenced to 15½ years in prison yesterday after shortchanging her patients of chemotherapy drugs.

But the family members of cancer patients under her care, in asking the judge to give Dr. Young Moon a maximum sentence, said her greed was the reason she shorted their loved ones of life-saving medications.

"It's one thing to lose your mom, and to find out it's because of malicious behavior just adds to it," a choked-up Diana DeWitt, 47, a Nashville musician, told U.S. District Judge Todd Campbell yesterday."

Read the full article in the Tennesean here.

GM To Recall 400,000 Pick-Up Trucks

"General Motors Corp. is recalling about 400,000 pickup trucks due to defective brake lights.

The affected vehicles are the Chevrolet Colorado and GMC Canyon from the 2004-2006 model years and the 2006 Isuzu i-280 and i-350.

GM said some vehicles may permanently lose brake-lamp function or have brake lamps that are always on. On vehicles with cruise control, that function also becomes inoperative."

Read the full article in Business Week here.

UnitedHealth's CEO Makes Billions While Health Care in Crisis

April 29, 2006,

A recent article in the Wall Street Journal points out yet another CEO the makes millions, even billions, in industries that are in crisis.

"Unrealized gains on [CEO] Dr. McGuire's options totaled $1.6 billion, according to UnitedHealth's proxy statement released this month. Even celebrated CEOs such as General Electric Co.'s Jack Welch or International Business Machines Corp.'s Louis Gerstner never were granted so much during their time at the top.

Dr. McGuire's story shows how an elite group of companies is getting rich from the nation's fraying health-care system. Many of them aren't discovering drugs or treating patients. They're middlemen who process the paperwork, fill the pill bottles and otherwise connect the pieces of a $2 trillion industry.

The middlemen credit themselves with keeping the health system humming and restraining costs. They're bringing in robust profits -- and their executives are among the country's most richly paid -- as doctors, patients, hospitals and even drug makers are feeling a financial squeeze. Some 46 million Americans lack health insurance."

Read the full article on WSJ.com here.

Fosamax Linked to Rare Jaw Disorder

April 27, 2006,

Fosamax is a widely prescribed drug to treat osteoperosis. The drug is included in a class of drugs called bisphosphonates, which work by inhibiting the bone function which removes old bone so that new bone may be laid.

The drug, as reported in the Journal of Oral and Maxillofacial Surgeons, is linked to a rare and serious jaw bone disorder called Osteonecrosis of the Jaw or "ONJ". Individuals who have dental work while on the drug are especially at risk.

Fosamax, manufactured by Merck, had sales of over $1 billion dollars last year alone.

Read more here.