Celebrex a Risk at Higher Doses (400 mg+)

If you type in Celebrex at the top of this blog and hit enter, you'll find a number of posts on that drug.

From pharmalot.com and other sites, this 'news' which has been discussed for more than two years:

Patients taking the largest dose of 400 mg twice a day tripled their chance of a heart attack or stroke, compared with people taking a placebo, according to a study presented today at the American College of Cardiology meeting. The study confirms earlier concerns that prompted the FDA three years ago to warn that Celebrex and other painkillers, including ibuprofen and naproxen, should be prescribed at the lowest dose possible.

The 200 milligram dosage is the most commonly prescribe dose of the medication.

Posts are collected here.

Total Body Formula Recall - Information You Can Use

Total Body Formula has been recalled. The liquid dietary supplement products may cause severe adverse reactions, including nausea, vomiting and diarrhea, joint pain and fatigue. These symptoms can be followed by hair loss, nail brittleness and neurological abnormalities (such as numbness and other odd sensations in the hands, arms, legs or feet).

Read more below; if you have concerns or questions, call me at Toll Free 866-755-LAWS, or email me at ageorgialawyer@yahoo.com.


Consumers are being told not to buy or use Total Body Formula in Tropical Orange and Peach Nectar flavors and Total Body Mega Formula in Orange/Tangerine flavor. These products are available in 32-ounce plastic bottles and are distributed by Total Body Essential Nutrition of Atlanta.

The products have been distributed in: Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Lot numbers include: 4016801, 4016802, 4024801, 4031801, 4031802 and 4031803.

From the FDA:

The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products.

The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.

Chrondylosis and Pain Pumps (PAGCL)

Medical experts have reported that if you think you may have developed Postarthroscopic glenohumeral chondrolysis, (PAGCL), a painful condition caused by the deterioration of cartilage (a dense connective tissue that, among other things, allows movement in joints) around the shoulder area, there are several things you should do. Here’s what they recommend:
See your doctor

While this is always the obligatory first step and fairly obvious to most, it’s important to see your doctor right away as he or she can take an x-ray to determine how much, if any, cartilage has deteriorated in your shoulder. From there, your doctor can recommend whether prescribing anti-inflammatory medications will help or if further surgery is a viable option.

In some cases, patients must undergo a procedure known as arthoplasty which reconstructs the shoulder using metal and plastic parts to replace the damaged shoulder joint. However, this option is obviously major surgery and may require a great deal of recovery time.

Understand your symptoms

As any medical professional will tell you, shoulder pain can be the result of a variety of factors including bursitis, arthritis, rotator cuff tear, tendonitis – and the list goes on and on. To determine if you have PAGCL, consider whether you have any of these symptoms:

Shoulder pain whether in motion or at rest

A narrowing of the joint space in the shoulder area (which will be detected on an x-ray)

Clicking, popping or grinding of the shoulder (called Crepitus)

Shoulder stiffness or weakness

Decreased range of motion

Medical experts who understand PAGCL say that these symptoms generally occur between three months to a year after someone has had shoulder surgery and used a pain pump directly afterwards to manage the pain during recovery.

Multiple sources all over the web.

ING Georgia: 1/2 Marathon

Sunday I ran in the ING Georgia 1/2 Marathon, and did it on a cold, windy, wet, miserable day. Ran it for a friend in the military, and ran it carrying a flag of the USA for the whole race. Came in at just about 2 hours.

Thanks to those who wished me luck; today will be an aspirin day.

The Public Library of Law

From their site, which you can find here:

"Welcome to the world's largest free law library.

Searching the Web is easy. Why should searching the law be any different? That's why Fastcase has created the Public Library of Law -- to make it easy to find the law online. PLoL is the largest free law library in the world, because we assemble law available for free scattered across many different sites -- all in one place. PLoL is the best starting place to find law on the Web.
What is available on PLoL?

* Cases from the U.S. Supreme Court and Courts of Appeals
* Cases from all 50 states back to 1997
* Federal statutory law and codes from all 50 states
* Regulations, court rules, constitutions, and more."

It's free and worth a look.

More Bad News for Heparin?

Another maker of the blood thinner Heparin has announced a recall, warning that the drug may be contaminated. B. Braun Medical Inc. has recalled 23 lots of Heparin but said in a press release that there had been no reports of adverse events.

Last month, Baxter International Inc. on at least a temporary basis stopped making multiple-dose vials of the injectable blood-thinning drug Heparin because of reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

For more information on Braun, go here.

Florida Justice TV

I'm a member of the Florida Justice Association, the FJS has launched Florida Justice TV.

From the site:

2008 Session Week 3 Update

An update from Frank Petosa on the events of week 3 of the legislative session in Tallahassee.

Georgia Technology CLE: 3/26/08

If you'd like to see the information from this seminar, let me know. email me at ageorgialawyer@yahoo.com

Philly Judge: No Preemption in a Paxil Case

Collins adv. Glaxo, which you may find here.

A Philadelphia State Court Judge has denied a defense MSJ which would have served to dismiss the state law claims of a family whose husband and father committed suicide while taking Paxil, in Collins v. SmithKline Beecham, d/b/a GlaxoSmithKline.

A few highlights:

“Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not preempt a State's ability to allow one of its citizens to inquire into whether the manufacturer breached that duty.” (Order at p. 9)

More later.

LawProse: Video of Interviews with Suprem Court Justices

Compelling stuff, much of it is unvarnished. Enjoyable video footage:

From the site:

In 2006-2007, Bryan Garner interviewed eight of the nine Justices about legal writing and advocacy. These are the complete interviews. Because the files are large, the videos may take a few moments to start playing.

LawProse is making these interviews available as a public service. Anyone may freely use these videos for educational purposes, with appropriate attribution to Bryan Garner or LawProse.

For more go here:

A New Website for Documents: JD Supra

Worth a look. Not sure if it will ultimately succeed, as many organizations (such as a Georgia Trial Lawyers Association) have sites where documents are shared/stored. The site is new - and I hope it does well:

http://www.jdsupra.com/

From their site:

For anyone in the legal community - lawyers, law firms, law schools, law professors & their students, public interest groups - JD Supra is not just a resource, it’s also a showcase:

* As a legal professional, you post your court filings, decisions, forms and/or articles to JD Supra’s database, a free tool for legal research. You also create an in-depth professional profile that is freely available simply by browsing or keyword searching, or via link from any of your posted documents.
* Consumers use JD Supra to find lawyers who have worked on cases similar to theirs, or to research a legal issue or a prospective lawyer’s filings, decisions, and articles.
* Journalists use the documents and profiles to build story ideas and find credible contacts. (In fact, we encourage you to flag your most interesting and "hot" documents for listing in our Scoop section, which we created with the media in mind.)
* Your peers and colleagues use JD Supra as a robust research tool, both for their own practices and to find like-minded colleagues and referrals.
* Anyone can search JD Supra for free, and so the benefits to you are enormous.


IMHO - "benefits to you are enormous?" Well, I'd be happy with even a modest benefit.

Zyprexa Litigation News

In the news at the end of last week, the NYT reported that a Lilly executive had encouraged the promotion of its schizophrenia drug Zyprexa for a use not approved by federal regulators.

The report said John Lechleiter, set to become chief executive in April, wrote an e-mail in 2003 discussing the use of Zyprexa by children and teenagers, although it is only approved for adults with schizophrenia or bipolar disorder.

The state of Connecticut has sued Lilly accusing it of illegally marketing and concealing its serious side effects. It faces similar accusations in Alaska as well.

For more, go here.

Imported Heparin to be Tested

Today the FDA ordered the detention of all imported supplies of heparin blood-thinner products so they could be tested for possible contamination. Heparin is derived from pig intestines, and used in dialysis and heart procedures, among other surgeries, to avoid blood clots.

Five companies have agreed to test for the contaminant, which is a chemical similar to heparin, FDA officials said. The agency would not name the companies or say where they are located, but said they represented the majority of the U.S. heparin market.

Source and more here.


Heparin chronology:

On January 17, 2008, Baxter International, Inc., initiated a recall of nine lots of its heparin sodium injection. This recall was initiated after Baxter noticed a severe spike in the reporting of adverse events. The initial recall focused only on multi-dose vials in two sizes: 1000 units/mL 10 mL vials and 1000 unit/mL 30 mL vials. The recall noted that Baxter had not observed significant increases in adverse events to its other heparin products.

-On February 11, 2008, Baxter issued an update on its recall of its heparin products. The update noted that since the initial recall, Baxter was notified of reactions related to lots of heparin sodium injection other than the nine lots recalled (same size as nine lots and different sizes). The update announced that Baxter decided (after discussion with the FDA) to not recall further lots of heparin due to market needs for heparin. While Baxter suspended the manufacture of additional vials, Baxter continued to distribute its existing products. Healthcare professionals were advised to balance the need for heparin with the increased possibility of reaction.

-On February 14th and 15th of 2008, the Wall Street Journal reported that the active ingredient in Baxter's heparin was supplied by a company known as Scientific Protein Laboratories (SPL). SPL maintains facilities in Wisconsin and China. The active ingredient in Baxter’s heparin is manufactured at both facilities. The facility in China was not inspected by the FDA prior to the reported increases in adverse events. The articles did not explicitly link the adverse events to problems with the facility in China.

-On February 28, 2008, Baxter expanded its recall of all remaining lots of all sizes of its multi-dose vials of Heparin Sodium injection, as well as single dose vials, and its heparin lock flush products. The recall notes that Baxter expanded the product removal as a precautionary measure after the FDA confirmed adequate market supply of heparin without Baxter’s presence. The recall notes that despite the expanded recall, the vast majority of adverse reactions reported occurred with Baxter’s multi-dose products. Baxter did not recall its heparin IV bag solutions in this recall.

-On March 5th, 2008, the FDA briefed the media on the Baxter heparin situation. The FDA announced that it discovered a "heparin-like molecule" in the active ingredient in heparin manufactured by Scientific Protein Laboratories (SPL), and supplied to Baxter to make its heparin. This molecule appears similar to heparin, but is considered a contaminant of the heparin. The molecule’s presence was confirmed in both samples of crude heparin (active ingredient only) and in end-product heparin. Because of the molecule's similarity to heparin, routine tests did not detect its presence. The details as to how the molecule found its way into SPL's product are currently unknown. FDA scientists have found that the molecule accounts for 5-20% of the mass of samples tested. According to the FDA, there is an association between the molecule and the severe reactions recently experienced by those taking Baxter heparin. However, the FDA has not yet established a direct causal link. The FDA is continuing to study Baxter heparin and the contamination with this heparin-similar molecule.

Jargon and Tech: Speak English for Cryin' Out Loud

This is a message (or plea) to those in the Tech World: Speak English.

I know it's hard. I know you get caught up using words like scalability, GIGO, WYSYWYG -- pronounced "wizz ee wig")and modularization. It makes you feel special. For me though, when you when you use tech jargon, I feel like I'm being bamboozled.

I'm pretty tech savvy, but when you tell me that my order hasn't been completed "through provisioning" I have to ask you to speak English to me, and now you've lost my confidence and likely my repeat business.

Pharma in bed with Democrats?

From WaPo.com:

The pharmaceutical industry is now saddling up to the Democratic Party, and it has worked to block Democrats top prescription-drug initiatives.

From the article:

"In the year since they took over on Capitol Hill, Democratic leaders have been unable to pass either a bill allowing reimportation of drugs from Canada or a measure requiring negotiation of drug prices under Medicare. Neither is likely to reach the president's desk this year. Lawmakers on both sides of these issues say the primary reason is the influence, now redirected, of the drug lobby.

Drug companies have gone on a hiring binge, retaining Democratic lobbyists in dozens of major firms. This strategy, which K Streeters call "clogging the system," prevents adversaries from hiring anyone from those consultancies."

For more, go here:

Tech Tip: Buy a .com With Your Telephone Number

With domain names becoming somewhat scarce, one easy .com buy is: Buy your office telephone number.

Attorney Bill Harrell has already done this, and it's a no brainer. The firm website is www.forjustice.com, and their number is 251-1111.com. Surely it is simply redirected to the main site.

A good friend who advertises in various media adds the tagline, "our website's the same as our number ...."

Online File Sharing from EatLime.com

EatLime speeds up online file sharing by allowing a recipient to begin downloading the file as soon as you start uploading it. So, no more waiting for the file to finish uploading before the download starts. File size up to 1GB will work.

Thanks to Lifehacker.com.

From the site:

EatLime is an easy-to-use free service that allows anyone, anywhere to transfer large files over the Web, Email, or Instant Messenger (IM).

EatLime offers an improved file transfer technology (patent-pending) with the vision to be the premier destination for direct data delivery.

Joseph Wambaugh's "Hollywood Crows" In My Inbox

Just arrived, so expect a book review in short order. I get to it after wrapping up "The French Quarter: An Informal History of the New Orleans Underworld."


The Synopsis:


When LAPD cops Hollywood Nate and Bix Rumstead find themselves caught up with bombshell Margot Aziz, they think they're just having some fun. But in Hollywood, nothing is ever what it seems. To them, Margot is a harmless socialite, stuck in the middle of an ugly divorce from the nefarious nightclub-owner Ali Aziz. What Nate and Bix don't know is that Margot's no helpless victim: the femme fatale is setting them both up. But Ms. Aziz isn't the only one with a deadly plan.
In HOLLYWOOD CROWS, Wambaugh returns once again to the beat he knows best, taking readers on a tightly plotted and darkly funny ride-along through Los Angeles with a cast of flawed cops and eccentric lowlifes they won't soon forget.

I'm a Wambaugh fan, so I hope it's worth the read ... .

CT Sues Lilly Over Zyprexa

Connecticut is joining at least nine other states suing drug maker Eli Lilly and Co. over the antipsychotic drug Zyprexa.

Attorney General Richard Blumenthal says Connecticut's lawsuit seeks to recover more than $190 million that the state's medical assistance program spent on Zyprexa over more than a decade. The charges: Lilly ran an illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including treating children.

For more go here.

Kmart and $1 OTC Meds

Kmart Pharmacy has announced that it would offer its customers a choice of ten over-the-counter medications from the chain's American Fare brand for $1 with every prescription purchase. The medications will be offered through the company's new American Fare Dollar Program.

Kmart said the medications include aspirin, ibuprofen, children's pain reliever, baby aspirin, nasal decongestant, cough suppressant, anti-diarrhea medication and cold and allergy tablets.

Source here.

A smart approach. Well done Kmart.

Former NFL Player Challenges TX Malpractice Caps

Former Dallas Cowboy football player Ron Spring has been in a coma since late 2007 after having surgery to remove a cyst; he is one of several plaintiffs challenging Texas' medical malpractice cap in a lawsuit filed at the end of February.

In Springs' case, the claim is that anesthesiologist Joyce Abraham and plastic surgeon David Godat were negligent in a 2007 cyst removal procedure in which Springs suffered a severe reaction to anesthesia, resulting in cardiac arrest.

The lawsuit challenges the 2003 Medical Malpractice and Tort Reform Act that limits awards in Texas. The lawsuit asks the court to declare the cap unconstitutional. In 2003 the Texas Legislature passed the Medical Malpractice and Tort Reform Act, which set an award limit of $250,000 per plaintiff in cases where medical malpractice had been proved.



Source: The International Herald Tribune.

Hormone Replacement Therapy: Cancer Risk Stays

Menopausal women who took estrogen and progesterone do risk cancer for more than two years after the drug ingestion ended, according to the most recent results of a government study that has revealed a series of sobering findings about the once-popular hormone therapy.

The study of more than 15,000 women who took the hormones for more than five years found that the chance of developing cancer remained elevated well after they quit, which many did after an earlier stage of the study showed that the risks outweighed the benefits.

For more go to the WaPo report here.