Monthly Archives: January 2010

Johnson & Johnson Charged with Kickbacks

Federal prosecutors have charged pharmaceutical company Johnson & Johnson with paying tens of millions of dollars to Omnicare Inc as an inducement to buy their products and recommend them to nursing homes. The payments were made from 1999 to 2004 when Omnicare purchases tripled to $280 million. The federal complaint alleges that a “substantial portion” of these were charged to Medicaid.
According to the Wall St. Journal, “Omnicare was in a unique position to encourage sales of preferred products, prosecutors said. The company’s pharmacists reviewed the medical charts of nursing-home patients monthly and their drug recommendations were followed by doctors more than 80% of the time, they said.
In November, Omnicare agreed to pay $89 million to settle charges related to the alleged kickback scheme. IVAX Pharmaceuticals, a unit of Teva Pharmaceutical Industries Ltd., agreed to pay $14 million to settle related allegations.”

Johnson & Johnson Failed to Act on Tylenol Contamination

In 1982, Johnson & Johnson was hailed for its efforts to deal with a catastrophic event-the lacing of its product with cyanide. Years later, the company has been hailed for its proactive approach in dealing with a cataclysmic crisis. Yet, in 2010, the same company has been hit with an allegation that it ignored consumer complaints that its pills smell “musty”. According to the FDA, the company disregarded consumer complaints about the funny smell. It took more than five months and and FDA investigation for the company to respond to the allegations.
What happened in the intervening years for such a collapse to occur? Perhaps, complacency or the perception of a lack of federal oversight led Johnson & Johnson to delay action on an important consumer complaint. The FDA is saying the problem is systemic within the company. One would think the huge pharmaceutical company would jump on such a potential health safety nightmare.

Zicam Cold Remedy Manufactuer Set to Spend $30 Million on Marketing

Consumers will soon witness the effects of Zicam manufacturer Matrixx Initiatives new marketing push. The company has hired the national marketing firm Cramer-Krasselt to advertise their products some of which were removed from the marketplace after complaints surfaced that use of these nasal spray cold remedies were linked to anosmia, a loss of the sense of smell.
Zicam lawsuits have already been filed against Matrixx for causing this loss of the sense of smell. In spite of the legal issues, Matrixx executives have pledged to re-enter the marketplace with the $30 million ad campaign. Whether a new marketing initiative will prove successful in the light of the health issues associated with some Zicam products is yet to be seen.
Since the Zicam cold remedy recall last year, Matrixx officials have continued to deny any association between their products and the loss of smell in users. They’ve also defended their failure to notify the FDA concerning approximately 800 reports of loss of smell after using Zicam. Matrixx officials have argued that they had no legal obligation to notify the FDA since their products are marketed by the company as homeopathic. However, in its warning letter about the Zicam products recalled, the FDA noted that it can and will intervene in homeopathic remedies when such remedies may pose a health risk to the general public.
Three Zicam products — Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids Size – were involved in the subsequent FDA recall.
Anosmia can be a devastating and permanent injury that affects a person’s life including an inability to detect smoke, fire, or spoiled food products. It has also been linked to a potential risk in the increase of depression.

FDA Warns 4 Drug Companies Over Marketing Campaigns

The Food and Drug Administration has issued warning letters to four pharmaceutical companies over inaccurate claims they’ve made in their marketing campaigns. The four companies are Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon.
FDA cited drug maker Eli Lilly for its incomplete marketing claims concerning its antidepressant drug Cymbalta. The FDA noted that Lilly did not adequately display the potential side effects of the drug, a requirement for all approved pharmaceuticals.
In its warning to Cephalon, the FDA noted that the drug company neglected to provide the proper information concerning side effects for its lymphoma drug Treanda. Treanda has been associated with infections and skin reactions which have not been properly identified in the company’s marketing materials.
Amylin was charged with overstating the effectiveness of Byetta, a drug used to treat diabetes. In addition, Amylin has been promoting Byetta for unapproved uses, according to the FDA.
Bayer received a warning letter from the FDA due to its over-stated claims concerning its contraceptive Mirena.
While the FDA monitors and controls how pharmaceutical companies market their drugs, doctors are free to prescribe drugs for unapproved uses. However, the drug companies are forbidden by law to promote such uses of their drugs.

Study Suggests Link Between Contraceptive and Bone Loss

The popular, injectable contraceptive known as Depo-Provera has been linked to significant bone loss in women taking the drug. The study shows bone loss in 45% of women taking the contraceptive drug to be as high as 5%. The new study appears in January’s issue of Obstetrics and Gynecology. It’s estimated that more than 2 million women use Depo-Provera including 400,000 teenagers.
At this point, the women most at risk of bone loss are those who use Depo-Provera and smoke and/or don’t receive a sufficient amount of calcium in their diet.
The popular contraceptive depot medroxyprogesterone acetate, better known as DMPA or Depo-Provera is a hormone injection that lasts for 3 months preventing pregnancy. The injection contains synthetic progesterone and no estrogen.
Depo-Provera has carried a black box warning since 2004 concerning potential bone loss in users.

More Anemia Drugs to Undergo FDA Safety Review

Aranesp is not the only anemia drug to catch the ever more watchful eye of the FDA. Now, Procrit and Epogen will have to undergo another FDA safety review. It’s the fourth time since 2007 that these drugs have been reviewed for safety concerns. On Wednesday, the New England Journal of Medicine published a commentary by safety officials who noted “major concerns” with the drugs’ safety in treating those suffering from anemia as a result of chronic kidney disease.
Amgen, the manufacturer of both Epogen and Aranesp, has witnessed its sales slip since 2007 when the FDA began changing the labels due to safety concerns. Procrit is sold by Johnson & Johnson but manufactured by Amgen.
In its response to the comment in the New England Journal of Medicine, an Amgen official stated, ““highlighted areas of incomplete understanding”.

New Study Says Amgen’s Aranesp is Not Only Dangerous But Ineffective

Amgen’s anemia drug Aranesp received a black box warning in 2007 over serious safety concerns linking the medication to an increased risk for heart attacks and strokes. Now, researchers at UT Southwestern Medical Center have found that Aranesp is no more effective at treating anemia than an inactive placebo. Ironically, the study was funded by Aranesp’s manufacturer Amgen. Besides being ineffective in treating anemia, the study found that Aranesp actually doubled the stroke risk in patients taking the drug.
“If a clinician is treating a patient for fatigue and other symptoms of anemia and the symptoms do not improve, they should consider stopping the drug because it may expose the patient to increased risk of stroke,” said Dr. Robert Toto, professor of internal medicine at UT Southwestern and senior author of the study, which was published in The New England Journal of Medicine.

Medical Device Company Settles with US Department of Justice

Spectranetics, a Colorado-based medical device manufacturer, has settled its dispute with the US Justice Department. The medical device company has agreed to pay the government $4.9 million in civil damages and a $100,000 forfeiture to resolve claims that Spectranetics illegally imported and distributed unapproved medical devices to doctors in the United States. Other allegations include conducting a clinical study that was not in compliance with federal regulations and marketing products for purposes not approved by the FDA.
The civil settlement resulted in an investigation dating back to 2003 and concerned the submission of false Medicare claims.
Spectranetics, which manufactures lasers, lead wires, and other peripheral medical devices, avoids criminal prosecution by agreeing to pay the civil penalty. In addition, the settlement includes an admission of wrongdoing on the part of the company, an agreement to implement remedial measures so that such illegal activity is not repeated, and continued cooperation in the ongoing criminal investigation.

Police May Be Liable For Taser Use

A federal appeals court in California has ruled that police officers who use their Taser weapons during routine traffic stops may be held liable. The United States Court of Appeals for the Ninth Circuit in San Francisco said that use of the Taser against unarmed suspects who pose no threat may lead to legal liability for the police officer. Judge Kim McLane Wardlaw wrote that Carl Bryan did not threaten the officer nor try to elude the officer that had stopped him. The judge noted these are two of the three elements considered by the US Supreme Court in determining if significant force is justified. The third element concerns the nature and severity of the offense which prompted the police stop in the first place. In this case involving Carl Bryan, the judge noted that “traffic violations generally will not support the use of a significant level of force.”
The case is seen by many court observers as significant and may be the first step in determining judicial standards for the use of Tasers by police officers.