Mathy and Andy Downing’s daughter, Candace, hanged herself five years ago when she was just 12 years old.  Candace seemed to be a happy girl and left leaving no note or indication as to what had caused the drastic change.  According to her father, “We had no warning.  Absolutely no warning.”

The Downings blame Candace’s suicide on the antidepressant drug Zoloft and are seeking answers as to why their physician, Matheme Selassie, prescribed the powerful drug to a child whose only complaint was some anxiety over school.  Now, it turns out, some answers may be found in their physician’s activities. Selassie was paid around $12,000 to make speeches hyping Zoloft, with some of the payments from Zoloft drug maker Pfizer.  The Downings believe the money influenced the prescription. (more…)

European regulators want tougher warnings for Procrit and Aranesp, similar to those recently added to the drugs in the United States.  On Thursday, a European Medicines Agency (EMEA) panel recommended blood transfusions to treat anemia rather than the drugs, saying the risk of tumor progression and death outweighs their benefits in patients with “reasonably long life-expectancy.”

Procrit and Aranesp are known as erythropoiesis-stimulating agents (ESA).  All are made by Amgen, but Procrit - marketed as Eprex in Europe - is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement. In the United States, Amgen markets a third ESA, called Epogen. (more…)

Merck & Co. has failed in its quest to convince federal regulators to expand approval of Gardasil for older women.  Yesterday, the Food & Drug Administration (FDA) said it was delaying its  approval of  Merck’s application at this time because it had questions regarding Gardasil’s effectiveness in women ages 27 - 45.  Gardasil is already approved for use in girls and women ages 9 - 26.

Gardasil was approved by the  Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers. (more…)

Drug maker Pfizer has reached a settlement with the US Justice Department over Clean Air Act Violations that occurred at its pharmaceutical plant in Groton, Conn.  The settlement, which includes a $975,000 civil penalty, is the first of its kind involving industry-specific standards for airborne emissions during pharmaceutical manufacturing.

In the original complaint, the government charged that Pfizer failed to properly conduct pressure tests to identify leaks and failed to repair leaks, seal open-ended pipes and document leak tests. The alleged violations took place between October 2002 and December 2005. According to the complaint, these violations presented the risk of excess emissions of hazardous air pollutants from the plant. (more…)

he Center for Public Integrity, a Washington, DC-based watchdog group, said that big pharmaceutical’s spending on lobbying increased exponentially and in a coincidence with the Democratic control of Congress in 2007.

The group reported that drug companies spent a massive $168 million on drug lobbying last year, which is up a whopping 32% from 2006.  Those expensive efforts paid off a number of issues important to drug makers and issues the law firm of Parker Waichman has reported on on numerous occasions.  For instance, last year alone, big pharmaceutical: (more…)

Heart imaging contrast agents need to be subjected to more studies in order to insure their safety, a Food & Drug Administration (FDA) advisory panel said yesterday.  The contrast agents, sold under the brand names Definity and Optison, have been linked to more than 200 serious cardiac reactions and 11 deaths.

Definity, marketed by Lantheus Medical Imaging, and Optison, distributed by GE Healthcare, are used during echocardiograms, ultrasound imaging procedures that take a detailed, moving picture of the heart. In October 2007, the FDA said that it knew of at least 7 deaths associated with the administration of either Definity or Optison. Four of those fatalities occurred either during infusion or within 30 minutes following the administration of the contrast agent. The FDA said that most of the serious but non-fatal reactions also occurred in the same time frame. (more…)

Antipsychotic drugs use to reduce symptoms of agitation, aggression, and violence in dementia patients is on the rise, as can be seen in soaring sales of antipsychotics like Risperdal, Seroquel, and Zyprexa.  These drugs experienced a $4 billion dollar increase in sales since 2000 for a total of $13.1 billion in 2007, due, in part, to an increase in such prescriptions in nursing homes.  As a matter-of fact, researchers estimate that nearly 30 percent of all nursing home patients have received antipsychotic drugs at one time or another.

But, a 2006 study of Alzheimer’s patients revealed that in most, antipsychotics provided no significant improvement over placebos in treating aggression and delusions.  A year earlier, the Food and Drug Administration (FDA) ordered newer antipsychotics be labeled with a “black box” label warning of an increased risk of death.  Last week, the FDA required a similar warning on older antipsychotics, as well.  First generation antipsychotics, like Haldol, carry a significant risk of repetitive movement disorders and sedation.  Second-generation antipsychotics, called atypicals, are commonly prescribed because the risk of movement disorders is lower; however, they can cause sedation and can contribute to weight gain and diabetes; some experts cite a lack of research for these drugs used in behavioral problems.  If patients begin showing behavioral symptoms of dementia, doctors said, they should have complete medical and psychiatric workups first, especially if symptoms develop suddenly. (more…)

Earlier this month, Tyson Foods Inc. announced it would “voluntarily withdraw” advertising and labels that claim its poultry products do not contain antibiotics; this, following a federal court injunction stopping the practice and to settle a false advertising lawsuit brought by Perdue and Sanderson farms. It seems there is some controversy over antibiotics in Tyson chicken products, despite its claims to the contrary. Meanwhile, on the day Tyson resolved one federal lawsuit, it was hit with another filed in the same court on behalf of customers accusing Tyson of consumer fraud, breach of express warranty, and unjust enrichment.

Perdue’s issues stem from Tyson’s claims that its chickens were “raised without antibiotics” and, later, “raised without antibiotics that impact antibiotic resistance in humans.” In April, a U.S. District Court in Baltimore ruled that Tyson remove the claims from its advertising while the suit was pending and set a May 15 deadline to stop Tyson from running any of the “raised without antibiotics” advertisements. The injunction followed a suit by Perdue Farms Inc. and Sanderson Farms Inc.; both claiming Tyson’s advertising was misleading. Although Tyson appealed the ruling, in May, the 4th Circuit Court of Appeals in Richmond, Virginia, denied a motion by Tyson to stay the order. (more…)

For the second time since April, health officials in Canada have issued a warning about Chantix, Pfizer’s anti-smoking medication.  This time, Health Canada is warning that Chantix - sold in Canada as Champix - has caused unusual feelings of agitation, depressed mood, hostility, changes in behavior or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, in some users.

In April, Health Canada issued an alert warning that Chantix has been linked to 107 adverse reactions in Canada.  According to the ageny nearly half of those reports involved psychiatric behavior.  In its latest alert, Health Canada has said that in the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported in patients taking the drug. (more…)

When doctors were recently asked which commonly prescribed medications they would avoid, they came up with the following eight.  Perhaps you might want to reconsider these medications as well.  At a minimum, speak to your doctor, as there are safer options for all of these medications.

• Advair:  This asthma medication contains the long-acting beta-agonist (LABA) salmeterol.  A 2006 study of 19 trials, which was published in the Annals of Internal Medicine, revealed that with regular use, LABAs can increase asthma attack severity.  Salmeterol is more widely prescribed than other LABAs, thus the danger is greater and may contribute to as many as 5,000 asthma-related deaths in the United States annually.  Another study that same year led the US Food and Drug Administration (FDA) to label Advair with a “black box,” the FDA’s strongest warning.   (more…)