Drug Products

Drug Companies and Marketing Practices

The large pharmaceutical companies agreed to hold off any direct to consumer marketing of their drugs after coming under heavy fire from Congress and the FDA regarding the controversial marketing practice. The Congressmen behind the investigation, Michigan Democrats Bart Stupak and John Dingell had wanted a two year moratorium on such advertising. In the end, the drug companies agreed to something that allows them to continue their deceptive marketing practices.
The companies still can pitch their products directly to consumers. They’ll still use hired guns, actors, and celebrities who have no relation to the efficacy of the drug whatsoever. Finally, they didn’t agree to advertise products only when studies have shown they improve clinical outcomes. Drugs are often approved (and advertised) solely based on surrogate markers.
In the end, this isn’t good news for consumers and patients who rely on science rather than marketing practices to ensure their own health and welfare.

Thoughts on Tim Russert’s Passing

The unexpected and untimely death of NBC’s Tim Russert is a blow to the nation that’s come to expect honesty, integrity, and professionalism from Russert. Respect for Russert knew no partisan, religious, ideological, or professional boundaries. He was the consummate journalist who knew how to ask just the right question at the precise moment. He was a gentleman who never succumbed to the tempation of hyperbole or headline grabbing soundbites. He represents the best of his profession and the best of our country. Tim Russert will be sorely missed.

FDA Wants Stricter Eye Contact Lens Solution Controls

Two years after Bausch & Lomb’s Renu eye contact lens solution was linked to serious eye infections, the FDA is recommending new labeling instructions including rubbing the contact lens in order to remove dirt and bacteria in spite of some products marketed as “no rub” solutions.
Of course, this is too little, too late for those who’ve suffered terrible eye injuries because of contaminated lens solutions that actually caused the eye infections in the first place.
According to an article in Forbes, “Advanced Medical Optics’ withdrew its solution last year after government scientists linked it to a rare eye-infecting parasite called Acanthamoeba keratitis. It is not among the bacteria and fungi FDA currently requires products be tested against.
Panelists overwhelmingly said FDA should require companies test their solutions against the parasite before gaining market approval.”

Drug Researchers’ Pay Raises Questions

An investigation by Senator Chuck Grassley has revealed what many have suspected for quite some time, researchers who are funded by pharmaceutical companies often under report or don’t report at all income derived from their work for these very same pharmaceutical companies. The potential for conflicts of interest are obvious when scientists are paid by those who have real pecuniary interests in the outcome of the research. This was not the case two or three decades ago when the federal government financed most of the drug and medical device research. Now that the pharmaceutical companies and medical device manufacturers are the main sources of such financing the reliability of such research is rightly called into question.
This coupled with the fact that FDA warning letters to medical device makers and drug manufacturers have declined by 50% in the last five years makes one wonder about consumer safety.
In another piece of disturbing news, seven doctors have been disqualified by the FDA from doing research. Their disqualifications stem from misconduct such as fraud and disregard for patient safety. The FDA relies on these doctors as they approve drugs and medical devices. The FDA has come under heavy criticism for taking so long to discipline these wayward doctors. In some instances, it tood a decade for them to be removed from their posts!

Tomato Salmonella Risk too High for McDonald’s

If you’re hankering for a Quarter Pounder or a Big Mac, don’t expect to find a tomato as part of your fast food indulgence. McDonald’s and other restaurants have decided to no longer offer sliced tomatoes after fresh tomatoes have been linked to salmonella. Nearly 150 cases of a type of salmonella have been reported around the country since April, including at least 23 hospitalizations, according to the Food and Drug Administration.
The source of the tomatoes has yet to be determined.

Jury Awards $6Million in Taser Death Lawsuit

A federal jury in California has found Taser International responsible for the death of 40-year-old Robert Heston Jr. who was killed after being repeatedly tasered by police. According to reports, the police his Heston with more than 30 shots fired from their Taser stun guns.
The jury found that Taser International located in Scottsdale Arizona had failed to warn police officers that tasers could be dangerous even lethal when fired upon those under the influence of drugs or in conjunction with chest compressions.
In the past few years, Taser International has come under fire from Amnesty International as well as other advocacy groups for the dangerous nature of the taser. Amnesty International has called for a suspension of tasers because of their lethal effects.
The problem with the taser gun is that it is marketed as a safe non-lethal weapon that will aid police officers in subduing suspects.
This is the first jury loss Taser International has suffered since the stun gun has come onto the market and drawn lawsuits because of its dangers.

Heparin Problems Continue

The contaminated heparin that caused worldwide furor a few months continues to make news and the FDA continues to monitor and investigate the issue. FDA has received 97 reports for adverse events associated with heparin-containing devices that occurred between Jan. 1 and May 14. These include 11 deaths and 86 nonfatal events. Contaminated heparin from China has been linked to 81 deaths in the US.

Chicago Archbishop Acts Quickly to Remove a Priest

It’s too bad Cardinal George can’t act as quickly with priest sex abusers as he did with a priest who made what seemed to George politically incorrect comments about Hillary Clinton. One has to wonder what’s wrong with George. A year ago, when one of his young priests was facing serious allegations of sexual abuse of minors, George dragged his feet before removing Daniel McCormack. Yet, Rev. Michael Pfleger, who has a long history of solid pastoral work in Chicago, was immediately removed from his post after disparaging Hillary Clinton in Barack Obama’s former church.
I just don’t understand how George makes these types of decisions. McCormack has been charged with very serious sexual crimes and Pfleger has been charged with nothing more serious than making an impassioned political statement. It makes me think not much has changed in the Archdiocese of Chicago.

Fosamax Linked to Femur Fractures

A study published in the current edition of Orthopedic Trauma associates the drug Fosamax with femur fractures. This is significant since prior to this journal study, Fosamax had been linked to jaw necrosis and not femur fractures. The study noted that these fractures were not occurring in femurs that appeared to be osteoporotic.
The study comes as more bad news for Merck whose bisphosphonates drug Fosamax is already facing lawsuits from those who’ve suffered jaw bone death. Now, Merck may face lawsuits stemming from femur fractures.

Women’s Health Groups Raise Concerns over Eli Lilly’s Marketing of Evista

The concern is not new but now certain advocacy groups’ ire is focused on Eli Lilly’s Evista slick marketing campaign. The campaign touts Eli Lilly’s osteoporosis drug Evista and portrays post-menopausal women in togas. “You’re past menopause and are treating osteoporosis,” the narrator says. “Why not ask your doctor about Evista, the only medicine that treats osteoporosis and reduces your risk of invasive breast cancer?”
Yet, in truth, Evista carries a black box warning from the FDA. In a clinical trial involving 10,000 patients, Evista was shown to actually increase the risk of death after a stroke by 49%.
Two years ago, the FDA fined Eli Lilly because the pharmaceutical company began promoting Evista as a breast cancer drug prior to FDA approval. In addition, Evista’s benefit in treating breast cancer has been spurious.
This latest attempt by Lilly to market a product in order to grow sales rather than concern itself with consumer safety shows the real problem we face with direct to consumer marketing campaigns. These ads play on emotion rather than science and their end goal is to grow sales rather than promote a health benefit.