Monday, December 26, 2011

Lawyers: Jumping in to Twitter in 2012? A Do/Don't Do List

LONDON, ENGLAND - JUNE 01:  A close-up view of...
Image by Getty Images via @daylife
Having just completed year three on Twitter, I've been spending some time looking at how so called experts tout the site to lawyers. I was considering attending a seminar in January that has at least two hours devoted to all things social media. The CLE brochure lost me, however, when it breathlessly explained to me that one hour would be devoted to "getting new clients through social media like Twitter."


Having read that type of pitch for probably the 500th time, and seeing no real explanation for lawyers new to Twitter, here's my Do/Don't List. Think of it as Twitter 101. You can't become a millionaire via social media quickly any more than you can graduate from law school and litigate a multi-million dollar case in US District Court. Before you count your money, learn the basics. 




1.Do select a name that will identify you and/or your firm. I've seen many Twitter accounts with names like "AZ Personal Injury" or "Accident Lawyers." This isn't the yellow pages. Whether it's your first and last name, or your firm name, or (like me) a geographic ID that ties in with your business, website, or blog, focus on how others will find/see you. 


2. Do explain your practice or firm in the profile:  Obviously, with an account like @ageorgialawyer, you know where my practice is based. The profile is equally important. Mine says:

Injury/Pharma Lawyer in Atlanta/Savannah, licensed in FL &GA, Litigator. Runner, College Football Fan , Labs owner.
Atlanta, Savannah, FL · http://www.ageorgialawyer.blogspot.com

It helps to list your city or a telephone number. Website or blog? I know that I will click on that link at some point.  Describe what you do, but don't go overboard, remember this is a profile. If you work in the personal injury field, why clutter  your profile with "Personal Injury, Wrongful Death, Divorce and Bankruptcy" 
when you can keep it simple? 

3.Don't be too pithy, vague, or hip in your profile: To me there is nothing more irritating to stumble upon a twitter account, only to read this: "Biglaw maven." Or better, "lawyer/rock star in the land of commercial litigation." Yes, nothing says rock star like a photo of a balding, over 40, horn rimmed glasses head shot of a guy in a grey suit.

4.Do select an avatar or image that might possibly make you stand out:  I think that head shots work just fine. I also appreciate a firm logo, or a pic of a lawyer's office. Do us all a favor though. No more courthouse. I actually was working up a list, and in one lawyer's list of followers, there were 3 twitter accounts in a row with a courthouse. Also, skip the scales of justice. 

For me I have been using a pic of my three labradors since starting my blog nearly seven years ago. It's a conversation starter, and if you came to my office you'd likely see one of those animals here. Plus, I have a face for radio. 

5.Don't EVER make your account private: One of the biggest mistakes I see for new lawyers is locking or making your account private. Stupid. Got it? Dumb. Just really stupid, and it makes you look uninformed to the ways of Twitter. Twitter's purpose is to start conversations, pass along information (among other things).  In other words, you miss out on what makes the site valuable

6. Don't use a validation service for potential followers.  Placing barriers in the way of communication is essentially the same thing as locking your Tweets. What is the point of joining a network if you don’t want to communicate? Take the time to filter out followers on your own. If @GuyKawasaki and @MariaShriver don't use a validation service, why should you? Could you imagine going to a lawyer social and demanding to see a business card before you shook a person's hand?
    
7. Do realize that whatever you want your Twitter account to be, your goal(s) will change after about 3-4 months: I know what some lawyers are thinking even now as 2012 nears - "I'll go on Twitter and get lots of cases!" or ... "Twitter will make my blog hum with visitors!" Sure. Well, not really. 

I started off thinking that way, changed my mind about six months in, and now appreciate Twitter for what it is - essentially a news service ticker with some funny comments, wry insight, and spam mixed in. It's a bit like news talk radio - you get information, it might make you mad, or you can ignore it at your leisure.     

For me Twitter does help update others with blog posts. If that is all it does, you are ahead of the game, business wise. 

8.  Do know that it's okay to be human on Twitter: While I may not be crazy about reading a tweet  about what you are making for dinner, or worse - clicking on a pic of it - you don't have to be a 140 character version of a billboard. 

To me, I like to see  that @btannebaum is not only a lawyer, but a "Type II Diabetic." Or that Gwynne Monahan (@econwriter5) not only writes cogent posts, but is also unafraid to complain about having to run errands for family - a twitter post she had during the holidays. I know that @lizstrauss not only links to useful news/tips, but that her pix of the lakefront in her hometown are worth a look nearly every day.   

I am a voracious consumer of legal news, but I also connect on Twitter with runners, with beach people, with folks who like music, and with smartasses (you know who you are). I post about my trail runs and SEC football. It's ok if you post about your 3rd grader'sschool honor. It gives me some measure of comfort that Twitter is not a bot site. 

9.Don't spam with me with repeated crap about your firm: By this I mean - be careful about how often you post on Twitter, in a row, rapid fire style.  I've stopped following someone who will post 15-40 times in a row within 5 minutes. This is not what Twitter is best at - spamming those who follow you. 

Use your judgment, post when reasonable, and back off if you start hammering away. 

10. Don't tweet something to another person on the site, then get in a huff when someone (like me) comments.   Just before you hit the "tweet" button remember that others may see it, especially if you use a hashtag like #Obama.  

In one instance, I found someone ripping in to a judge, and there was a # hashtag in the tweet. When I replied to the author's diatribe, I received back a curt "butt out, that wasn't for you to read." Well, I did, and I replied.  

Remember that whatever you post is the equivalent of it being said in a crowded grocery store line for all to hear. So, toughen up when you get blindsided out of nowhere. If someone does not like what you wrote, it comes with the territory. Respond, ignore, or even block.  

That's the start of my list - if you want to add to it, send it to me on Twitter.   
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Friday, December 23, 2011

Happy Holidays 2011

Merry Christmas, and see you after the holidays, from the folks at our office. 

Thursday, December 22, 2011

Bad News for Qnexa


Vivus, which makes an experimental weight-loss pill, received bad news this week after an ingredient in the medicine was claimed to be associated with oral clefts in babies whose mothers took it in pregnancy. Vivus’s diet pill, Qnexa, combines topiramate with the appetite suppressant phentermine.
Earlier in 2011, the FDA asked Vivus earlier this year to use existing databases to determine the risk of oral cleft in children whose mothers took topiramate. The drug is used to prevent migraines and seizures, and is marketed as Topamax.  
The analysis, dubbed Fortress, found the risk of cleft palates or cleft lips was 5.44 times higher for the group in which mothers had taken topiramate alone or in combination with other anti-seizure drugs in the first trimester of pregnancy, Vivus said yesterday in a statement.
From the Vivus briefing documents submitted to the FDA:
QNEXA, or VI-0521, is an investigational weight-loss therapy that is a novel combination of low-dose immediate-release phentermine (1/8 to 1/2 of marketed dose) and controlled-release  topiramate (1/16 to 1/4 of marketed dose); both drugs are approved and marketed in the United States. The prescription use of these drugs spans more than 50 years for phentermine and more than 13 years for topiramate. Phentermine hydrochloride, at a labeled dose up to 37.5 mg/day (Adipex-P package insert 2005; Appendix 1), is the most prescribed weight-loss drug with approximately 6.1 million prescriptions written in 2009 (Information Management System [IMS] data). The phentermine label, restricted to short-term management of obesity, limits its clinicalpplication for the chronic treatment of obesity and weight-related co-morbidities. The primary mechanism of action of phentermine for weight loss is an anorectic effect occurring through the release of norepinephrine in the hypothalamus.  
Topiramate is approved for treatment of seizure disorders at recommended doses up to 400 mg/day and for migraine headache prophylaxis at recommended doses up to 100 mg/day (Topamax  package insert 2009; Appendix 1). More than 9 million prescriptions were written in 2009 for topiramate (IMS data). Available pharmacological evidence suggests that topiramateinduced weight loss may result from increased satiety due to decreased gastrointestinal motility (Topiramate Summary Basis for Approval 1995), increased taste aversion (Supuran 2008), increased energy expenditure, and decreased caloric intake (Bray 2003; Richard 2000; Richard 2002; Picard 2000). Moreover, published clinical studies have shown that topiramate monotherapy produces significant and dose-related weight loss in conjunction with clinically meaningful improvements in lipids, glycemic control, and blood pressure (Ben-Menachem 2003; Wilding 2004; Bray 2003). While the positive effects of topiramate on co-morbidities are primarily driven by weight loss, data from nonclinical and clinical studies provide evidence for additional positive effects of topiramate on glycemic parameters, blood pressure, and lipids (Stenlöf 2007; Astrup 2004) that are independent of weight reduction. Topiramate, however, is not approved for weight loss and is also associated with dose-limiting side effects, which prevent or limit its use as a single agent at the doses necessary to produce significant weight loss or cardiometabolic benefits.  




Wednesday, December 21, 2011

From 2008: The First Christmas without Pudge (my oldest lab)

The post I've copied is probably the one most personal to me on this site. While our house now has one helluva playful lab named Bruno (he puts the NO! in Bruno), I always think back to the first real confidant I had - a dog named Pudge who died at 14. Here's my holiday post - and somewhere I hope Pudge is chasing cats on a cloud ... 




******* (2008)   




I tend to post simply about things that interest me: News regarding pharmaceutical litigation, tech items of interest. What most folks comment on in emails? The pictures of the dogs - to the right on this blog. 

This year, along with the happiness of the season, there is some sadness in my home. My 14 year old yellow lab named Pudge won't be around. He died earlier this fall. If you aren't a dog person, it's hard to explain. If you are ...

Pudge was the biggest and most rambunctious pup of the litter. He - like me - could be headstrong, aggravatingly persistent, funny, and high energy (all at the same time). He loved water (like his dad) - from a hose, a dirty puddle, even a half empty creek. 

Pudge heard countless closing arguments from me while on our runs together. If I put on my running shoes, he knew what it meant: Running and talking. LOTS of talking from me.  

He spent weekends sleeping and snoring away at the office as I prepared for trials. His favorite spot was always next to my chair as I would sit, dictating away. When I mean next to me, it was quite literally next to me, with his rump touching my leg. Pudge would look up from time to time as I worked, and the "thump thump thump" of his heavy tail hitting the floor seemed to say that he knew that my drivel was directed towards him. I cannot tell you how many times a dictated transcript would include (upon its return) a sentence like "Plaintiff deposed witness "B Smith" who ... Pudge lie down, get out of the trash can .... " as he happily distracted me. My office typed exactly what I said, and his name was in many a draft of a document.    

Christmas time usually meant his tail wagging around the tree with a crash, followed by an ornament breaking for all to hear. No wine glass was safe on the coffee table when he was in the house. If there was a fire going in the fireplace, you would have to step over his content body as he quite literally spread out in front of it. 



As Pudge aged, the runs ended; the walks started, then became shorter, the car rides less frequent. I had to pick him up and put him into my truck  his arthritis was so bad. His tail? Wagging like crazy.  We went from closing arguments on our walks to opening statements. Towards the end, he was totally deaf and partially blind. We communicated with hand signals more often than not. His tail still wagged furiously, though, even when he was ill. 

Through it all, Pudge made me and then my family laugh. He barked madly at strangers, and guard my kids when each was little.  He was as much my law partner, the silent one we lawyers all dream about, and the one who never argues about strategy or long hours, as he was my friend. This Christmas won't be the same without him at our house.  

As I go about my end of the year tasks at the office, there is one less confidant in my life. I hope Santa rectifies that this year with another dog to add to the menagerie in our home. It won't be the same, but I hope that if a dog needs rescuing, love, and care, I know Pudge will be there in spirit and memory.


****
PS: Santa did bring us another dog, Bruno. He's a rescue. When we took him for a walk with our remaining brood, he fit right in. 


Even now, he is eerily like Pudge. He sits next to me when I work, his rump to my knee. I know we have extended his life by rescuing him, and he seems to appreciate that just fine. 


If you are thinking about a dog, go the rescue route, at least to look. It will be worth it ,


      

Merry Christmas to all


M

Holiday Time 2011

Some oldies but goodies in these few posts:

Snow in NOLA, 2008

December 2011, Conserve Hip Systems and possible failure?


In 2009, the FDA approved the Conserve Hip Systems, made and sold by Wright Medical Technology, Inc. 
Since 2009, there have been more than two hundred adverse reports where people claimed that the Conserve Hip Implant failed to do what it was promised to.  
At year end, there is now a pending Petition for an MDL regarding those cases. The issues relate to the Conserve Plus Total Hip Replacement System and the Conserve Plus Resurfacing System. The total replacement system has four parts--  a metal femoral stem, metal femoral head, metal modular neck and the metal Conserve cup. The resurfacing system has two components: the metal femoral head cap and the Conserve Plus metal acetabular cup. Both systems are intended to be used as a hip-replacement implant when a patient’s hip joints are damaged or diseased as a result of fractures, osteoarthritis, rheumatoid arthritis and avascular necrosis.
The common component in both systems—and what is at the heart of the lawsuits—is the “Conserve cup”, which is a cast cobalt chromium molybdenum piece that holds the metal femoral head, mimicking the natural movement of a hip joint. It is that unlined cobalt part that is allegedly causing serious harmful effects to patients who receive the implant device. The problem is that these two metal components cause the release of metal particles around the hip joint and surrounding tissue. As a result, a high percentage of patients have developed metallosis and biologic toxicity and are experiencing a high and early failure rate of the device.
Our office is investigating people who think this product failed after implant. 

From the FDA site:
CONSERVE® Plus Total Resurfacing Hip System - P030042
Picture of the CONSERVE® Plus Total Resurfacing Hip SystemThis is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
 Product Name: CONSERVE® Plus Total Resurfacing Hip System
PMA Applicant: 
Wright Medical Technology
Address: 
5677 Airline Road, Arlington, Tennessee 38002
Approval Date:
 November 3, 2009
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030042a.pdf 
 What is it? The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because only the surface of the ball (femoral head) is removed to implant the femoral head resurfacing component.
 How does it work? The CONSERVE® Plus Total Resurfacing Hip System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).
  • The cup replaces the damaged surface of your hip socket (acetabulum).
  • The cap covers the ball-shaped bone at the top of your thigh (femoral head), and the cap has a small stem that is inserted into the top of your thighbone.
The cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.
 When is it used? The CONSERVE® Plus Total Resurfacing Hip System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Degenerative joint diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.
The CONSERVE® Plus Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
 What will it accomplish? The CONSERVE® Plus Total Resurfacing Hip System is intended to relieve pain and improve hip function.

FDA to investigate death of patient who was prescribed Gilenya?

English: Logo of the .
Image via Wikipedia
News today that follows the report earlier this month on Gilenya:


The FDA has received a report of a patient with MS who died within 24 hours of taking the first dose of Gilenya.   

FDA has said it cannot conclude whether the drug  resulted in the patient's death, but was evaluating the case.
The patient was also treated with two other drugs, and had completed 6 hours of monitoring after the first Gilenya dose without incident.
The drug's maker said it was investigating whether Gilenya caused the death of a 59-year-old patient who had just started therapy with the drug. 




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Tuesday, December 20, 2011

December 2011 News: Multaq gets a Black Box Warning

The FDA has told that Sanofi must add a black box warning to Multaq, taking this action after a company study linked the tablet to higher rates of heart attack, stroke and death in a subset of patients.

The boxed warning will possibly address the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the Food and Drug Administration. 

The label, written by the FDA in cooperation with drugmaker Sanofi, instructs physicians to check patients' heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued. 

The FDA said Monday that Multaq remains a beneficial drug when used appropriately. 

Source:  http://finance.yahoo.com/news/FDA-adds-new-heart-warning-apf-3993337584.html?x=0

Wednesday, December 14, 2011

Another Setback for Avastin to Treat Breast Cancer? Treatment


Another trial of Avastin as a treatment for metastatic breast cancer has failed to meet the mark. The drug lost its approval recently last month as a treatment for breast cancer.
The latest trial  - had it met with success  may have helped obtain new approval for use, is because the study  tested Avastin as a treatment for the roughly 20 percent of breast cancers that have elevated levels of the Her2 protein. The old and now revoked approval was for the other 80 percent of tumors that are Her2-negative.

Tuesday, December 13, 2011

Death Involving Patient Taking Gilenya Makes News

Novartis AG has reported that a multiple sclerosis patient died in November after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.
Multiple sclerosis (abbreviated MS, known as disseminated sclerosis or encephalomyelitis disseminata) is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms. 
MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other effectively. In MS, the body's own immune system attacks and damages the myelin.


Whether Gilenya had any effect in this  death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker wrote. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.
Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It is  among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. 
Read more at the source of this post. MS is a devastating disease that affects the loved ones of the person diagnosed with the condition, and it has a profound impact on many lives. Let's hope this is an abnormal and rare result, because the promise of any drug for MS sufferers gives them some hope. 


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Monday, December 12, 2011

Federal Judge Grants Permanent Injunction Against Brooklyn Sleep Products

This news from the CPSC:

A federal judge granted a default judgment a and permanent injunction  ordering Brooklyn Sleep Products Inc., of Brooklyn, N.Y., and its president Francisco Chavez, to stop manufacturing, importing, renovating and selling mattresses until they provide evidence that their mattresses comply with federal flammability laws.
 
Additionally, United States District Judge Roslynn R. Mauskopf of the Eastern District of New York ordered Brooklyn Sleep Products and Chavez to recall all mattresses, mattress sets or mattress pads sold to consumers that failed federal flammability tests. If the firm fails to comply with the judge's order, it can face fines of $1,000 per day.


In 2008, CPSC conducted inspections and collected mattress samples at Brooklyn Sleep Products' facility in Brooklyn, N.Y., and at retail stores selling the firm's mattresses in Fall River, Mass., and Providence, R.I. CPSC collected a non-compliant mattress made by Brooklyn Sleep products at a Newark N.J. store in 2010. The mattresses failed flammability tests conducted by CPSC for open flames.

Find the Judge's Order here: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12039.pdf

HCG Product Warnings in the News

The U.S. Food and Drug Administration and Federal Trade Commission issued seven warning letters to companies marketing over-the-counter HCG products that are labeled "homeopathic" for weight loss.
Human chorionic gonadotropin, also known as HCG, is a hormone produced by the human placenta and found in the urine of pregnant women, the FDA said. HCG is FDA-approved for the treatment of some cases of female infertility and other medical conditions, but there is no FDA-approved HCG drug product for weight loss and there is no evidence that HCG helps in weight loss. 

Homeopathy is a medical philosophy that believes the body can heal itself.
The letters warn the companies that they are violating federal law by selling drugs that haven't been approved and by making unsupported claims for the substances. 

"Deceptive advertising about weight loss products is one of the most prevalent types of fraud," said David Vladeck, director of the FTC's Bureau of Consumer Protection. "Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence."
The "homeopathic" HCG products recommend taking the drug while on a very low calorie diet, which could in fact result in increased risk for side effects, including gallstone formation, electrolyte imbalance, and heart arrhythmias, the FDA said. 

Source: http://www.marketwatch.com/story/feds-issue-7-warnings-to-firms-for-hcg-products-2011-12-06

Lawyer Marketing: I'm being spammed by Scumbag Lawyers


What you see above is an excerpt of a little experiment I conducted. It seems that somehow,  some way, attorneys have decided that spamming millions of email boxes is the new way to generate cases or case 'leads.'

In one of my personal email boxes I received out of the blue a solicitation - from a law firm - telling me that if I had been injured by Avandia, now is the time to make a claim. So I set up another email account, and used that address to fill in the blanks. Hidden way down at the bottom of the spam link was language in small font indicating that unless I checked the box, I would agree to accept other 'similar' emails in the future.

I checked the box to opt out, but purposely made errors in the questionnaire. When corrected the checkbox was now blank, in essence having me agree to opt in to future emails.

Well, I hit send. Guess what? A pro forma 'rejection' or no representation came my way. Is that that end of it? Of course not ... what you see in the screen shot is what the inbox for that other email account looks like. I've been asked if I have any claim relating to these drugs/products: 1)Zoloft 2)Mesh patch 3)Asbestos 4)Prozac; 5)Actos 6)Avastin; 7)Paxil; 8)Tylenol 9)SSRI meds.

By my count there are more than 200 emails soliciting me for information or a potential case. Why? Where are the Bar Associations regarding email spam by lawyers in far flung states seeking cases? How can this be allowed to happen?

These scum - and that is the only way to describe them - know little about the litigation involved included in the spam emails. In fact, I have been cold called to see if I was interested in 'qualified leads' that come from this type of spam. Non lawyers are selling the data. I'm not interested in this type of sale, but I am interested in finding a way to turn in those who are practicing in this way.     

Get ready law spammers. I'm sending these along to the Bar Associations in your state. Will it do any good? Stay tuned.  
       

Prempro Jury Verdict Settled

Image representing Pfizer as depicted in Crunc... 
Pfizer has agreed d to settle claims that its menopause drugs caused cancer in three women who won a $72.6 million jury award earlier this week, a lawyer said.

The New York-based company agreed to resolve claims by Susan Elfont, Bernadette Kalenkoski and Judy Mulderig that hormone-replacement drugs made by two Pfizer units caused their breast cancer, Ted Meadows, a lawyer for the women, said in an interview today. A Philadelphia jury awarded the three women $72.6 million in compensatory damages on Dec. 6.
“They’re just glad to be able to go on with their lives,” said Meadows, who declined to disclose the amounts of the settlements because they are confidential.

The accord comes a day before jurors were to begin hearing testimony in a second phase of the case. The panel would have been asked to decide whether Pfizer should face punitive damages over its handling of the menopause drugs.


“The parties have entered into a mutual agreement to resolve this case under confidential terms,” Chris Loder, a Pfizer spokesman, said in a telephone interview. The earlier verdict will be set aside as part of the settlement, he said.

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Concern that diabetes drugs like Byetta and Januvia are linked to Pancreatitis?

עברית: Byetta 10 mcgImage via WikipediaThere may be dialogue concerning these meds, given a report/study published in a gastroenterology journal.  The journal article is titled: Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies.


The study noted that Glucagon-like peptide-1−based therapy is gaining widespread use for type 2 diabetes, although there are concerns about risks for pancreatitis and pancreatic and thyroid cancers. There are also concerns that dipeptidyl peptidase-4 inhibitors could cause cancer, given their effects on immune function.


The article's conclusion: That case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1−based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.


Read the full article here: http://www.gastrojournal.org/article/S0016-5085(11)00172-7/fulltext
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Sunday, December 11, 2011

Multaq Report on Risk to AF Patients

Atrial fibrillationImage via Wikipedia
Final results from the PALLAS study showed that risk of stroke, heart attack or death from cardiovascular causes was 2.2 times greater for patients taking Multaq (dronedarone) than for those on placebo.


The illustration to the right shows atrial fibrillation. A-fib) is the most common cardiac arrhythmia (abnormal heart rhythm). It is a common cause of irregular heart beat, identified clinically by taking a pulse. Chaotic electrical activity in the two upper chambers (atria) of the heart result in the muscle fibrillating (i.e., quivering), instead of achieving coordinated contraction. The presence of AF can be confirmed with an electrocardiogram (ECG or EKG) by the absence of P waves and an irregular ventricular rate. Presence of AF in a population increases with age, with 8% of people over 80 having AF
Multaq is licensed to treat adults who have had atrial fibrillation (AF) in the past, or who currently have intermittent AF, but PALLAS was evaluating it in patients who were 65 years old or more with permanent AF and other risk factors for vascular events.
The trial was halted in July after researchers found evidence of serious vascular events and deaths - less than a third of the planned 10,800 patients eventually took part.
Delegates at the American Heart Association’s Scientific Sessions 2011 were told that 43 people taking Multaq, and 19 in the placebo arm, suffered a stroke, heart attack, systemic blood clot or cardiovascular death.


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Yaz News for December 2011

The FDA's report of its study of women using contraceptives:


Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints


We conclude that the study results add to the small body of literature which shows that the NGMN transdermal patch is associated with higher risk of VTEs relative to standard CHC pills and provides another positive finding to the increasing  body of evidence linking DRSP to increased risk of VTE relative to standard low-dose
CHC pills.  DRSP was associated with higher risk of ATE in new users overall with this finding restricted to women in the 35-55 years age group only.  The finding of increased risk of VTE with the ETON vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.

Source: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf

Thursday, December 08, 2011

Does Lantus Double Cancer Risk? Diabetics Study Released

Lantus more than doubled the risk of developing cancer among people with diabetes, researchers are now claiming.

LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.


Diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk, according to the study presented yesterday at the San Antonio Breast Cancer Symposium. Researchers examined medical records of 23,266 patients in southern Sweden.

The drug's maker noted flaws in the study. The population was too small and had flaws that make it impossible to definitively address any potential risk from Lantus, according to Riccardo Perfetti, vice president for medical affairs at Sanofis. 

The drug's label is found at various sites, including this one: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=39109

 Read more at the source: http://www.bloomberg.com/news/2011-12-06/sanofi-s-lantus-doubled-risk-of-cancer-in-study-of-diabetics-study-finds.html?cmpid=yhoo