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.

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.

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.

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”.

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.

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.

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.

While the medical device company has already suffered revenue loss, market share, and some confidence of the industry, Medtronic has not seen the end of its Sprint Fidelis defibrillator lead woes. A new report by UBS Investment Research stated that lead failures could accelerate over time. In citing an independent analysis, UBS noted that defibrillator lead failure rates could hit 30% at four years. Medtronic’s numbers suggest a much more modes 3% failure rate at 3 years.
When Medtronic first introduced its newer Sprint Fidelis defibrillator leads, they were praised by the company as the newest breakthrough in medical device technology, far superior to the older Sprint Quattro models. However, the new models have been prone to fracture causing erratic and painful jolts of electricity to the heart. Further exacerbating the problem is the fact that patients who’ve suffered fractured defibrillator leads face the unpleasant choice of having the leads extracted and replaced. There is considerable risk involved in such procedures and at least 3 deaths have been attributed to defibrillator lead extraction.
The Supreme Court has ruled that Medtronic can not be held liable for a device that had previously met the FDA standards. But that may change if Congress passes the Medical Device Safety Act. The bill has received bipartisan support and President Obama has indicated his approval of the measure.

A lay group that has spent the better part of this decade documenting cases of Catholic priest abuse in the United States now claims there’s a significant link between what has occurred in the US Catholic Church and the ongoing Irish priest abuse scandal. BishopAccountability.org has documented more than 70 cases of Irish priests emigrating to the United States where they’ve abused in the United States as well. We blogged on the topic and the disturbing connection back on August 14th in a post entitled “Irish Priest Abuse Has US Connections”.
It’s a well-known fact that in the 19th century and the early part of the 20th century, the United States was considered missionary territory and many foreign born Irish priests came to the United States to serve in US dioceses across the country. The full extent of the connection is still under investigation and may take years for the depth of the relationship to be uncovered. However, we do know that a number of these priests are now documented sexual abusers of the young and innocent in this country.
In studying this relationship, Irish Central, a periodical targeting Irish-Americans, has quoted the founder of Bishop Accountability in exploring this issue.
“Bishops in Ireland just like bishops here have been moving accused priests around even though they know they are dangerous,” said Terence McKiernan, founder of BishopAccountability.org. “Unfortunately the places where they put them include our own backyard. So the Irish crisis, basically has become our crisis, too.”
In the 19th and 20th centuries, American bishops often took trips to Ireland to recruit seminarians and priests for service in the United States. Because of the scarcity of priests, these bishops were more often concerned with staffing their parishes with priests without doing any type of background checks on these men. As we’ve learned from the documents discovered in the litigation process, some of these men were problems in their home dioceses and the bishops were only too happy to send them elsewhere, even the United States.

A new Zicam shareholder lawsuit filed last week in U.S. District Court in Phoenix Arizona claims Matrixx Initiatives’ executives withheld adverse safety reports from its shareholders as company executives dumped shares of Matrixx stock just prior to the FDA recall of some Zicam intranasal products. The lawsuit claims that company officials have known as far back as 1999 that the nasal products had safety issues.
Since the product recall, Matrixx has faced lawsuits claiming Zicam users have contracted anosmia, a loss of the sense of smell. The company has denied those claims and has been successful in fighting those claims in several federal court cases. However, a new study now links some Zicam products with anosmia.
The shareholder lawsuit claims that Matrixx CEO William Hemelt sold $379,000 in company stock while Timothy Clarot, vice president of research and development, sold $2,000,000 in stocks. According to the lawsuit, the two company executives sold the stock using knowledge of non-public information about Zicam.