Tysabri was pulled from the US market in 2005 after the MS drug had been linked to a rare but dangerous drug infection, progressive multifocal leukoencephalopathy (PML). Biogen, Tysabri’s manufacturer has revealed that 11 brain infection cases have been linked to Tysabri since the drug came back on the market in 2006. Both cases come from Europe.
While Tysabri has been known to successfully treat the symptoms of multiple sclerosis, prolonged use of the drug has been associated with PML. The New England Journal of Medicine reported the latest 2 brain infections and noted a study by Dr. Igor Koralnik of Harvard Medical Center that showed an increase in the virus that causes PML in patients that took Tysabri for a year or longer.
Tysabri, marketed jointly by Biogen and the Irish company Elan Corp Plc, is popular with MS patients as well as doctors. It’s estimated that some 43,000 patients are currently using the drug. Tysabri is an important drug in the Biogen family of pharmaceuticals and has been responsible for a large part of the company’s profits so it comes as no surprise the company is downplaying this latest New England Journal of Medical report.

Dietary supplements was the focus of a lengthy article in the Wall St. Journal a few weeks ago. The report was highly informative and offered the consumer ways in which dietary supplements could be checked. After reading the article, I came to the conclusion that it would take hours of research to determine that a dietary supplement was safe. Actually, the article said that after doing the proper research, one could be reasonably certain a substance was safe.
This is disturbing since most of us conclude that products sold in health food stores such as GNC are safe and healthy for consumption. Even if we read the product’s label we can’t be certain that the product is safe since we don’t always know how natural ingredients react in combination with other natural ingredients. The labeling may not even be accurate.
If you think I’m exaggerating ask Philadelphia Phillies pitcher JC Romero who was suspended late last year for using banned substances. Romero swears he was suspended after consuming dietary supplements purchased at a New Jersey GNC store.
The problem with dietary supplements and so-called natural products such as kava kava concerns the fact that these so-called natural products aren’t regulated in the same fashion as prescription drugs.
In the last nine months, the FDA has issued more than 70 warnings concerning the potentially dangerous side effects of natural products including dietary supplements and weight loss products. It’s a growing problem with no solution being offered at the present time.

Pharmaceutical companies and medical device manufacturers have been hiring ghostwriters to hawk their wares for some time now. That’s been a known fact for quite some time. What hadn’t been known until recently is the prevalence of the practice. A NY Times story estimates that a “study also reported a ghostwriting rate of 7.9 percent in JAMA, 7.6 percent in The Lancet, 7.6 percent in PLoS Medicine, 4.9 percent in The Annals of Internal Medicine, and 2 percent in Nature Medicine.”
This is troublesome considering these ghostwritten articles are published in what are considered by industry professionals as scholarly journals. Doctors and researchers rely on these articles and base their treatments on the supposed science underlying these articles. However, it seems that the medical device companies and pharmaceutical companies view the journals as just another marketing tool to push their products.

Massachusetts’ highest court will decide today if Rev. Paul Shanley, perhaps the most notorious of the Boston priests accused of sex abuse, should receive another criminal trial. The hearing will center around the theory of repressed memory which played a central role in his 2005 conviction.
Critics of repressed memory call it “junk science” and have attacked the notion that a traumatic event such as the sexual abuse of a minor can be hidden or repressed for years and then suddenly re-surface after a triggering event recalls the traumatic memory of the sexual abuse.
Shanley’s trial in 2005 received nationwide attention in part because of the sheer number of those who accused him of sexual abuse. Shanley’s own past history as a priest who advocated sexual activity between men and boys didn’t help matters. Shanley was known to be active in the North American Man/Boy Love Association and spoke at several of their conferences.
Like many other priest sex abusers, Shanley was a charismatic figure who surrounded himself with troubled youth. He was well-known in Boston as the “street priest” for his work with runaways and kids who had become involved in drugs. It wasn’t until the Boston priest abuse scandal erupted in 2002 that Shanley’s dark past came to the forefront. While the public may not have been aware of Shanley’s sex abuse until 2002, officials from the Archdiocese of Boston had known Shanley presented a threat to minors since the early 1970’s. Internal church documents reveal that Cardinal Medeiros and other top officials of the Archdiocese including auxiliary bishops knew about Shanley’s problem and did nothing about it except to transfer from one parish to another. At one point, they even recommended him for priestly work in California.
The Shanley case serves as a stark reminder that the Church does not police itself. It also demonstrates why making the internal church documents public is so important. These church documents reveal a pattern and practice of hiding pedophile priests who continue to abuse children until they are finally caught by law enforcement. That’s why the Catholic Church continues its fight to keep these documents secret and out of the public eye. The Diocese of Bridgeport is taking this fight all the way to the US Supreme Court at parishioners’ expense, no less.

Man’s best friend has been used to find illegal drugs, missing persons, fugitives, even bed bugs. Now, a Florida Atlantic University professor wants to put dogs to work in detecting the defective drywall that’s been destroying homes in Florida and around the country.
The Chinese drywall that’s so adversely impacted the construction industry since 2000 emits sulfuric fumes that corrode electronic equipment and metal components in the home. However, the fumes can be difficult to detect and pinpoint.
“It seems to me that here is a way to detect the presence of reactive drywall in a non-destructive and more cost-effective way,” said Gene Ouellette, associate director of FAU’s Institute for Design and Construction, who came up with the idea to investigate whether dogs could be trained to spot bad drywall.
Why not try it? It’s probably cheaper and more effective than ripping apart homes to find the defective drywall. It’s also quite possible a trained canine could detect the defective drywall before the signs of its damage begin manifesting themselves. Once the signs of defective Chinese drywall are present (corroded electrical components, etc) the damage has been done and thorough remediation is most likely the only solution.
At least one company involved in canine training is eager to pitch in. American K-9 Detection Services of Lake Mary, Florida is looking into training canines for the task.
“The more I read about Chinese drywall, the more I’m committed to getting some dogs trained and get them out there to help,” said Mark Mahler, American K-9’s president. He said that training of the dogs could begin in a matter of weeks.

Hydroxycut lawsuits continue to mount after the weight loss/diet supplement was removed from the market after reports associated the popular product with liver damage. Later this month, a hearing will determine whether the hydroxycut lawsuits should be consolidated before one judge in an MDL (multidistrict litigation). Such an MDL has been used before in other drug lawsuits such as fen-phen and vioxx. An MDL, if approved, allows for centralization and consolidation of pre-trial discovery and motions. The MDL proposal has petitioned that the cases be heard before the U.S. District Court for the Southern District of California

Supreme Court Justice Antonin Scalia has passed a request from the Catholic Diocese of Bridgeport on to the full Supreme Court. The case involves sealed church documents concerning priest abuse lawsuits. Last week, Associate Justice Ruth Bader Ginsberg denied Bridgeport’s request to keep the documents sealed and out of the public view.
The Diocese of Bridgeport maintains that the documents are protected by the First Amendment because they concern the church’s personnel files and the Diocese’s handling of priest transfers and determinations about priests’ fitness for ministry.
In 2001, the Diocese of Bridgeport secretly settled 23 priest abuse lawsuits for an undisclosed sum. In all likelihood, the sealed documents contain information about former Bishop Edward Egan’s role in the transfers and handling of priests accused of sexual abuse.
The Connecticut Supreme Court has already ruled that the documents are public record and should be unsealed. The US Supreme Court will make a decision by September 29.
Justice Antonin Scalia, a devout Catholic whose son is a Catholic priest, did not comment on the documents before submitting them to the full Court.

It’s not just any Chinese drywall lawsuit either. This time it’s the Lieutenant Governor of Florida.
It been public knowledge for quite some time now that Lt. Gov. Jeff Kottkamp’s North Fort Myers’ residence has been contaminated with the rotten drywall.
Kottkamp and his wife Cynthia have filed a federal lawsuit against Knauf Gips KG and Knauf Plasterboard Tianjin Co. LTD. for using the contaminated drywall material in their home. The Kottkamps are perhaps the most famous of the Chinese drywall victims but they share in the suffering of hundreds of families across the United States who’ve been affected by the contamination.
The drywall lawsuits have affected another Florida public official-Gary Aubuchon, a state representative and owner of Aubuchon Homes. Some of the homes built by Aubuchon have had the defective drywall and Aubuchon may become involved in the lawsuits. Presently, the victims are focusing their efforts on the manufacturers and distributors of the Chinese drywall.

Pfizer Inc. has agreed to pay a $2.3 billion penalty to settle a civil suit over the drug company’s illegal promotional practices. The settlement is the largest ever for violations of federal law concerning a drug company’s promotion of a product for off-label use.
While it’s common and accepted practice for doctors to prescribe drugs for off-label use, it’s illegal for drug companies to promote their products for uses other than those approved by the FDA.
The $2.3 billion settlement concerns Pfizer’s promotion of Bextra as well as other Pfizer products.
The US Justice Deparment, along with the Department of Health and Human Services plan a news conference for later today to announce the historic settlement.

An article in the NY Times highlights how the pharmaceutical industry has gone to great lengths to maintain its profit margins by continuing to market brand name drugs over their generic counterparts.
The article points to Lexapro as an example of this practice. Lexapro, sold by Forest Laboratories, was developed as a way to continue to market a brand name psychiatric drug after its Celexa brand’s patent expired. Forest Laboratories did this by slightly adjusting the molecular structure found in Celexa so that it could introduce a new drug (Lexapro) to the market. In their marketing materials, Forest Lab officials touted Lexapro as superior to Celexa in fighting depression even though no such evidence is available to make such a claim. In fact, the FDA quickly approved Lexapro because it considered the new brand name drug as practically interchangeable with the older version Celexa.
So, what’s the difference? It’s price and profits. According to the NY Times article, a month’s supply of Lexapro sells for $87.99 while a generic version of Prozac goes for $14,99 That’s quite a difference in price and profit.
Drug companies make huge profits on their brand name drugs. Once the patent expires and the drug becomes available as a generic, the profit margin is lost. So, the marketing plan seems to be to continue to churn out “newer, superior” forms of the same drug to keep the profit margins. In order to do this, doctors must be convinced that the brand drug is superior. This requires a substantial marketing effort for the pharmaceutical companies.
While it’s not illegal to educate healthcare professionals about the benefits of a drug, it is illegal to pay doctors to prescribe a particular drug. In recent years, prosecutors have been arguing that some companies have crossed the line. The Times cites a recent lawsuit as a case in point.
“In February, federal prosecutors in Boston announced a civil lawsuit against Forest claiming that the company illegally marketed both Lexapro and a closely related antidepressant, Celexa, for use in children and paid kickbacks to doctors to induce them to prescribe the medicines to children.”
One could argue that the fine line is crossed when doctors are inundated with free lunches provided by drug companies as well as huge consulting fees for promoting the industry’s products. In politics, there are stringent rules concerning what lobbyists can provide elected officials. Such rules are much looser or non-existent when it comes to the relationship between the pharmaceutical industry and doctors.
The NY Times notes the following, “t is impossible to unpack all of the reasons for these prescriptions, but some industry critics say one reason could be the money doctors make from Forest. Psychiatrists make more money from drug makers than any other medical specialty, according to analyses of payment data. And Forest gives more money and food to doctors than many of its far larger rivals. Vermont officials found that Forest’s payments to doctors in 2008 were surpassed only by those of Eli Lilly, Pfizer, Novartis and Merck — companies with annual sales that are five to 10 times larger than Forest’s.
Forest’s 2004 plan for marketing Lexapro offers detailed information about how the company planned to direct this money to doctors.
Under “Rep Promotional Programs,” the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers in one year.”
Isn’t it time these relationships are regulated? Isn’t it time doctors’ prescription decisions are based solely on sound science rather than a paycheck or other forms of remuneration?