A medical researcher who played a role in the development of both Gardasil and Cervarix recently asserted that neither HPV vaccine would do much to reduce cervical cancer rates in the U.S. According to a report on chattahbox.com, Dr. Diane Harper also said the HPV vaccines should not be administered to girls under 15.

Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. Cervarix, approved by the Food & Drug Administration (FDA) just this month, protects against two strains of HPV that cause more than 70% of cases of cervical cancer in women. (more…)

It looks like federal health regulators aren’t backing down when it comes to recalled Zicam Nasal Cold Remedies. According to a Reuters report, Matrixx Initiatives Inc., the maker of Zicam products, said the Food & Drug Administration (FDA) is “unwilling to reverse its position regarding the warning letter” it issued over Zicam nasal remedies earlier this year.

In June, the FDA said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA. (more…)

Yet another study has linked significant weight gains in children to some antipsychotic medication. Forbes reported that an emerging study found that weight gains of 10-to-20 pounds were not unusual in children during their first three months on the medications like Zyprexa, Seroquel, Risperdal and Abilify. Also, cholesterol, triglyceride, and other metabolic “parameters” were elevated, said Forbes.

It has long been known and we have long written about the association between weight gain and antipsychotics; however, this new study points to even deeper increases, said Forbes. Tracking 272 children, aged four to 19 ,who were initially prescribed popular antipsychotic medications between 2001 and 2007, the researchers discovered that while increases in weight were dependent on the drug, the gains appeared in the entire spectrum of atypical antipsychotic medications, reported Forbes. The study was conducted at the Zucker Hillside Hospital in Queens, New York and the findings are being published in the Journal of the American Medical Association, said Forbes. (more…)

The Chicago Tribune broke with an expose on how some powerful psychotropic medications are being administered to nursing home residents in Illinois without consent and without valid psychiatric diagnoses. Some of these elderly have suffered from a variety of adverse responses that include, said the Tribune, “tremors, dangerous lethargy, and a higher risk of harmful falls or even death.”

Psychotropic medications include antipsychotics, antidepressants, and anti-anxiety medications, explained the Tribune. (more…)

Another class of medication appears to have some links to skin cancer, according to recent research. Inflammatory bowel disease (IBD) patients are the latest who have experienced higher risks for developing skin cancer, WebMD Health News is reporting.

WebMD Health News noted that the study was presented at the American College of Gastroenterology’s annual meeting in San Diego, California. Millie Long, MD MPH one of the researchers from the University of North Carolina, Chapel Hill, said that the issue is likely connected to IBD medicines, said WebMD, with some drugs riskier than others. ”Patients on immunosuppressant medications, particularly of the thiopurine class, have an increased risk of skin cancer, greater than three times, compared to patients with IBD who do not use these medications,” Long told WebMD. Purinethol and Imuran are examples of thiopurines, WebMD pointed out. (more…)

Although drug and medical clinical trials are necessary to rooting out potential problems and dangers with medicines and procedures, study authors are known to often minimize negative data on such trials. The LATimes wrote that, according to an emerging report, this is the case more often than not.

“The reporting of harm is as important as the reporting of efficacy in publications of clinical trials … However, harm is frequently insufficiently reported,” quoted the LA times citing the French researchers writing in a study being published in today’s edition of the Archives of Internal Medicine. Often, research highlights the positives while skating over risks, adverse events, and problems with efficacy and safety, to name a few. (more…)

European regulators are taking another look at Tysabri. According to The Wall Street Journal, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is concerned that Tysabri may have a higher rate of a rare brain infection called progressive multifocal leukoencephalopathy, or PML, than previously disclosed.

According to the Journal, Tysabri is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options. In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. (more…)

A third Rituxan patient has developed a serious and often fatal brain infection called progressive multifocal leukoencephalopathy (PML). According to a statement posted on the Food & Drug Administration (FDA) Web site, this is the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.

Rituxan, a powerful medication that suppresses the immune system, is the most important and widely used cancer drug for lymphoma. It is also approved as a therapy for rheumatoid arthritis, and is used off-label to treat multiple sclerosis, lupus erythematosus and autoimmune anemias. (more…)

A recently released report has found that the U.S. Food and Drug Administration (FDA) does not move as quickly as it could in banning health professionals from drug research roles who are known to have convicted crimes, the Wall Street Journal just reported.

In one of the cited cases, the agency took 11 years to debar a physician criminally convicted 53 offenses, including “bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license,” said the Journal. Unbelievably, the agency does have authority to ban doctors from patient safety overview in clinical trials when those doctors break or ignore federal regulations, said the Journal. Moreover, the agency is mandated to debar or disqualify those doctors who have been committed crimes such as fraud, reported the Journal. The Government Accountability Office (GAO) issued the report. (more…)

A congressional investigation has revealed that drug makers have been the biggest contributors to the National Alliance on Mental Illness (NAMI). According to The New York Times, NAMI is one of the most influential treatment advocacy groups in country, but has long been criticized for its ties to the pharmaceutical industry.

We have long reported on the financial arrangements between the medical community and industry. Critics of such relationships assert that they enable the medical products industry to unduly influence research and treatment decisions. One of those critics, Sen. Charles Grassley (R-Iowa), has been waging a campaign over the last several years to shed more light on those financial relationships. (more…)