HealthDot Pharma Report 04

Resource Alert

HealthDot Pharma Report sponsor Knowledge Source has a new publication that provides consumer insights on the leading 25 drugs not readily available elsewhere.

Called “Pharmaceutical Brand Briefings,” this quarterly series of pharmaceutical drug brand briefings is a unique source of market intelligence for the pharmaceutical and healthcare industry. Each report integrates MedTrackAlert’s exclusive consumer insights with Knowledge Source’s analysis on the leading pharmaceutical drug brands’ performance and activities.

“Pharmaceutical Brand Briefings” is available at Knowledge Source’s Web site. You can access it here.

In Episode IV of the HealthDot Pharma Report we travel from the United States to Africa to Asia and back with a focus on diabetes debates (Avandia), online pharma fraud, the dangers of counterfeit malarial drugs, Nigeria’s lawsuit against Pfizer, a sensitive case of erectile malfunction and close it out with a look at Pharma Med (or combination) devices.

Diabetes Drug Avandia May Increase the Risk of Heart Attack

We start in Washington with a growing controversy surrounding GlaxoSmithKline’s diabetes drug Avandia. The company’s on the defensive after a report in the New England Journal of Medicine said that Avandia can increase the risk of heart attack by more than 40 percent.

Glaxo dismisses the report and says its own patient studies are more reliable and prove the drug’s safety.

Outside experts say that the company’s studies are inconclusive.

Rep. Henry Waxman, a California Democrat and chair of the House Committee on Oversight and Government Reform, had enough of the back and forth and called for a congressional hearing.

In it, he chastised the Food and Drug Administration for failing to protect consumers, and called for stricter industry regulation.

But where the proverbial poo really hit the poverbial fan was during testimony by Dr. John Buse, the soon-to-be president of the American Diabetes Association.

Dr. Buse testified that company executives threatened to sue him in 1999 when he first raised questions about Avandia’s safety. He stated that that executives wanted to hold him accountable for a $4 billion drop in the company’s stock.

In a letter to SmithKline at the time, Buse wrote: “Please call off the dogs. I cannot remain civilized much longer under this kind of heat.”

For it’s part, Glaxo said in a statement: “We regret if, at any time, Dr. Buse felt the conduct of any employee was contrary to the spirit of open, scientific debate.”

At the hearing, the FDA reported that it is ordering Glaxo and rival Eli Lilly to add black box warnings to their respective diabetes drugs. Black box warnings are the most serious a drug label can bear.

Online Pharma Fraud

We here at the Pharma Report love incoming mail, especially those that outline business opportunities.

And that’s why we were especially excited to gain the acquaintance of Mr. James Lugard, a Nigerian resident and self-declared Head of Foreign Operations at a well known bank.

While he hasn’t told us what this well known bank actually is, he has told us that he has upwards of $10 million that’s been laying dormant in in the bank coffers. Better yet, he wants to share the bounty with us. All we have to do is send him some federal IDs and social security numbers to get the process started.

We think this sweet. And we thank Mr. Lugard for providing us access to easy cash.

And while we may be discerning purveyors of all things Internet, we worry that others aren’t quite so savvy. So too does the FDA.

The agency recently issued a warning against 24 Web sites it says peddle counterfeit drugs of all varieties, from weight loss pills to antidepressants.

Many of these sites operate outside the geographic and regulatory borders of the United States, leaving it up to consumers to judge their authenticity.

So while we all receive email advertising cheap Viagra, Cialis and Valium, the FDA now tells us that buying pills from virtual pharmacies is probably not a good idea.

Our low-cost pharma stash may really end up being very different and potentially harmful drugs.

Counterfeit Drugs

Counterfeit drugs may hit our pocket books at home, and leave us anxiously waiting if the Viagra we think we bought is actually a dud.

Around the globe though, fake drugs are leading to health catastrophes.

So says a a collaborative project involving Oxford University, Bankok’s Mahidol University and the Welcome Trust as the study the fake anti-malarials in South East Asia.

The group has discovered that in some areas 30-50% of drugs bought from pharmacies are actually fakes.

To make matters worse, the fakes contain low levels of anti-malarial drugs in order to bypass detection.

These trace amounts aren’t strong enough to kill parasites. Instead, they increase parasite resistance to real anti-malarials. In turn, global resistance to the last generation of malaria drugs has emerged in Cambodia, Laos, Vietnam and Burma.

The criminal network flooding the market is transnational and in southeast Asia, a common thread is that the network is predominantly ethnic Chinese.

The Chinese government is becoming more open about the problem. It recently announced a five-year plan to combat a wave of international health scandals such as a recent case where fake drug ingredients from a Chinese company ended up killing over 300 in Panama.

In late May, the former head of the national food and drugs agency, Zheng Xiaoyu, was sentenced to death for taking bribes and dereliction of duty.

Nigeria Sues Pfizer

Back in Africa, Nigeria sued Pfizer, accusing it of carrying out carrying out improper trials for an anti-menegitis drug in 1996.

The case stems from a period where thousands were dying across northern Nigeria and thousands more were paralyzed by the disease.

Pfizer tested a new antibiotic called Trovan which was given to some of the sick children. About 200 died and more developed deformities.

The Nigerian government now wants $7 billion in compensation, and says that Pfizer never had the authority to conduct the trial.

Pfizer denies this, saying the trials were carried out according to local and international law.

Erectile Malfunction

If there’s one thing Viagra and Cialis have taught us, it’s that an erection can be a beautiful thing.

Blue skies, midnight moons and streaming sunshine on a Sunday morning.

On the flip side, Christopher Woods learned the hard way that erections aren’t always all they’re built up to be.

According to court papers, the Massachusetts native is suing pharmaceutical giant Novartis AG over a health drink it makes called Boost Plus.

Evidently, Woods bought the vitamin infused beverage at a local pharmacy, drank it and woke up the following morning with, quote, an erection that would not subside.

This is known as severe priapism, a painful and potentially harmful medical condition in which the erect penis does not return to its flaccid state.

How harmful? It can lead to impotence, or worse, blood clotting and thus gangrene and therefore penis removal.

As a result, Woods underwent surgery to have a Winter shunt implant. The procedure moves blood from one area to another and is used. The lawsuit say that Woods had subsequent problems requiring further surgery.

His lawsuit seeks unspecified damages.

Discussion

3 comments for “HealthDot Pharma Report 04”

  1. HealthDot Pharma Report 4…

    Try it, you might like it!…

    Posted by Trusted.MD Network | June 27, 2007, 11:10 am
  2. Micahel, I am very impressed.
    Well done.
    dhl

    Posted by d h leavitt | July 3, 2007, 11:29 am
  3. Wry commentary.

    Engaging format.

    Outrageous and yet too true to be dismissed…

    I predict a cult following.

    Congratulations.

    Warm regards,

    Synthia

    Posted by Synthia Laura Molina | July 3, 2007, 12:40 pm

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