Contributing Member of the Healthcare Councils

GLG News by this Author

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

They'll fix this before the end of the month

July 2, 2008

Analysis of:Medicare fees to doctors fall Tuesday | news.yahoo.com

If this isn't fixed, it won't be long before cognitive specialties, like internal medicine and neurology, start capping their practices and not allowing new Medicare patients.    

This may have a market after all

July 2, 2008

Analysis of:Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA | www.medicalnewstoday.com

Here comes a prescription version of generic Zyrtec syrup.  At first glance, we wonder how it will compete with over the counter Zyrtec.  But wait...there may be a market for this drug    

Next-Generation Xolair (omalizumab) sounds pretty good

June 18, 2008

Analysis of:Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com

This drug seems much more effective at reducing free-IgE levels than is Xolair.  Overall, Xolair has given many patients a tremendous improvement in their quality of life, but it hasn't fulfilled many of its promises. Frankly, some of Xolair's benefits are disappointing, particularly in the 40 or 50% of patients who use it without achieving great results.  In particular, Xolair patients who are on Advair 500/50 can sometimes get down to Advair 250/50, but it's been difficult tapering them to lower doses of inhaled corticosteroids.

Xyzal--Just overpriced Zyrtec

April 4, 2008

Analysis of:New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com

 A bottle of 30 Generic Zyrtec can be purchased for $15.  No one is going to get Xyzal that inexpensively. There are no head to head studies showing Xyzal to be better than Zyrtec.  Even though Xyzal claims a 6% sedation rate compared to Zyrtec's 14% rate, it's not apples to apples.  In the Zyrtec study, placebo made 8% sleepy, whereas placebo only made 2% sleepy in the Xyzal study. Thus, either way, the drug was much more sedating than the placebo.

Slowly but surely, Primary Care gets the message about preventing asthma

April 4, 2008

Analysis of:FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 | www.pipelinereview.com

Use of Asmanex will continue to increase with this approval down to age 4. Its dose counter tells you exactly how many doses are left in the device.  Pulmicort uses a system that counts down 120---90---60---30---0. A lot of patients on Pulmicort complain to me about this "approximate" dose counter.  Also, Asmanex is easier to use than Pulmicort , but you get less for your money. Pulmicort 180 gives you 120 doses in each cannister; Asmanex only gives you 30 or 60.  Therefore, a Pulmicort prescription will last a patient two months unless they're taking 4 puffs per day. With the recent possible bad news about Singulair and suicide, parents may be less hesitant to try inhaled steroids.  Especially if their child with asthma already has a brittle psychiatric history.

Singulair increases risk of Suicide? Don't just poo-poo the possibility

April 4, 2008

Analysis of:FDA Investigating Possible Link Between Singulair and Suicide | www.foxnews.com

It is difficult to imagine why taking Singulair would increase the risk that someone would complete suicide.  After all, what does a leukotriene receptor antagonist have to do with mental health?  I don't know. But doctors, ask yourself, have you ever had a Singulair patient stop taking it because it caused headaches?  I have had dozens of them stop taking it because of headaches.  When they attempt to try it again, the headache comes back.  But the package insert says that the risk of headache is no greater than it is in people who took placebo. Try explaining that to the patient who got the headache--it's very real to them.

Alvesco... Finally, a Safe inhaled steroid

January 23, 2008

Analysis of:ALVESCO(R) gains FDA approval for the U.S. market | www.pipelinereview.com

State of the art care for asthma over the past 20 years has involved giving the patient steroids to treat "late phase asthma", the mucus, edema and inflammation that happens on the INSIDE of the airways. Alvesco is different from every inhaled steroid that has come before it.  It is less likely to cause steroid side effects.

So there ARE alternatives to HFA bronchodilators

September 7, 2007

Analysis of:Current Contents: Withdrawal of albuterol inhalers containing CFC propellants | nejm.org

Key Points of this article: 1)  CFC helps destroy the ozone layer in the stratosphere 2)  CFC albuterol is being banned in 2008 3)  CFC-containing metaproterenol (Alupent and generics) will still be available 4)  CFC-containing Combivent (albuterol plus ipratropium) will still be available 5)  Over the counter Primatene Mist (epinephrine) will still be available 6)  Maxair Autohaler (Pirbuterol) will still be available

Hello, I'm here to sell you Allegra D, and Xyzal, but not Allegra or Zyrtec!

September 7, 2007

Analysis of:New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com

Take Zyrtec and sort out the right-handed molecules from the lefties.  Send all the lefties home, and you have levocetirizine, a.k.a. Xyzal.  Like Zyrtec, Xyzal is owned by UCB http://www.ucb-pharma.com/products/ .  But unlike Zyrtec, Xyzal will not be marketed by Pfizer.  Instead, UCB has enlisted sanofi-aventis, the company that brought Seldane, and then Allegra, to market        

Xyzal: Single Isomer Zyrtec, but still SEDATING. Yawn

June 12, 2007

Analysis of:FDA Approves XYZAL(R) (Levocetirizine Dihydrochloride) Tablets For The Relief Of Seasonal And Year Round Allergies, And Chronic Hives | www.medicalnewstoday.com

Levoceterizine is the left-handed isomer of ceterizine (Zyrtec).  It gives all the antihistaminic effect of Zyrtec with, maybe, half the sedation.  But it ain't non-sedating!  Look at its own data:  6% sedation with Xyzal, 2% with placebo.  As such, I must respectfully disagree with one of my colleagues on this board who described it as 'Zyrtec without the side effects'.

Marketing to Research: "Give us these results in your next study"

March 13, 2007

Analysis of:Steroid-Free Astelin(R) Nasal Spray (R) Demonstrated Seasonal Allergy Symptom Improvement Within 15 Minutes in Clinical Study | www.drugnewswire.com

This is one of those studies where the marketing department calls us research and says, "Here's the conclusions to your next study.  Now design and perform a study to reach these results and this conclusion."  Unfortunately, I'm not kidding, and doctors aren't fooled.

Years ago, Astelin designed a head-to-head trial against Beconase AQ and Claritin and was ruled more effective than that combination.  The problem was, Beconase AQ had already been replaced by the more powerful Flonase and Claritin was the weakest antihistamine in a group that included Allegra 60 mg and Zyrtec 10 mg.

But Astelin is a good "sixth man," to borrow a phrase from March Madness and the NCAA basketball tournament.  If a patient uses daily Nasonex and Singulair, but they still have symptoms, we often recommend Astelin as a stop-gap measure to help out.    

Ciclesonide. Can we have our cake and eat it, too?

March 13, 2007

Analysis of:No Additive Adrenal Suppression Seen With Intranasal Ciclesonide Added to Inhaled Fluticasone | www.medscape.com

I think the correct way to say it is, "You can eat your cake, and have it too", but no one knows what I'm talking about. 

This study looked at what happens when you add a nasal steroid (ciclesonide) to someone who is already on Advair 500/50.  Please note that one of the authors has a slight, but critical, miscalculation.  He wrote that a patient on Advair 500/50 would be just under the critical level of fluticasone where we would worry about adrenal suppression since they only receive 500 mcg/day.  However, the article states that the patients were on Advair 500/50 twice daily = 1000 mcg of fluticasone per day.  That's well above the critical level of 800 mcg/day where fluticasone has been shown to cause adrenal suppression.  Here's the quote from the article: 

"The inhaled corticosteroid fluticasone propionate, at a dose of 500 mcg, combined with salmeterol at a dose of 50 mcg, was taken in the conventional manner of twice daily."

Zileuton competes with inhaled steroids, not Singulair. It needs to pay for those Liver Function Tests for increased acceptance.

February 26, 2007

Analysis of:Controlled-Release Zileuton Tablets Shows Safety Profile Similar to Placebo: Presented at CHEST | www.docguide.com

Zileuton is much more than just Singulair taken 4 times a day. Its a much better leukotriene antagonist. Its benefit is comparable to inhaled steroids, and, alone, it can improve a patients pulmonary function test results for the volume of air blown out in the first second (FEV1). Singulair and Accolate have never been shown to improve a patient's FEV1

Four times a day dosing is pretty much a non-starter, though. I have a few patients on it, but it's a tough sell. Mostly for patients who need a stronger maintenance asthma drug than Singulair, but who refuse to take inhaled steroids for some reason.

Besides that four times a day dosing, there's the need to monitor liver function tests. That's not only a pain, but it's expensive. Except that it's not expensive at all. If you go to the lab for liver function tests with no insurance, it costs you $100. For the same test, Medicare or private insurances pay less than $10.

Spacers DO matter with HFA inhalers

February 23, 2007

Analysis of:Low-Cost Bottle-Spacer Bronchodilator Treatment May Be Effective in Children | www.medscape.com

This article points out that any device which holds the asthma medicine so that you can co-ordinate the puffing with the inhaling allows you to increase the percentage of the medicine that gets into your lungs.  As another reviewer correctly points out, this is very, very important in inhalers that use chlor-fluorocarbons (CFC's) as their propellant.  CFC inhalers shoot the medicine out at 70 miles per hour.  After it travels 2-3 inches, it's still moving fast when it reaches the back of your throat; there, it has to make a sharp turn to get down into your lungs.  It ain't easy making a sharp turn at 60 mph, and most of the medicine lands on your throat, not making it down to your lungs.        

Xolair's anaphylaxis: Still helpful for severe asthma. Also give the patient an Epi Pen or Twinject

February 23, 2007

Analysis of:FDA Orders Black Box Anaphylaxis Warning for Omalizumab (Xolair) | www.medpagetoday.com

BACKGROUND
 
Xolair is the first Biotech drug for allergic asthma.  It works by blocking the effect of IgE, the allergic antibody (an antibody is an infection-fighting protein that your body produces to fight foreign invaders.  An allergic response to dust mites or pollen happens because your immune system mistakes that harmless substance for a dangerous germ and mounts a defensive response)

Xolair has been very helpful in some patients with severe asthma, especially in terms of increasing Quality of Life.  We haven't been able to put someone on Xolair and stop their Advair totally, but we can usually drop them from Advair 500 to Advair 250.  But I have lots of stories of patients who are now able to enjoy their garden, or go for a ride on their motorcycle.  And who barely notice their asthma symptoms unless they catch a cold or get a big exposure to whatever they're allergic to.

What DOES work for runny noses

August 11, 2006

Analysis of:Antibiotics Not Warranted for Runny Noses | www.forbes.com

Antibiotics are overused, somewhat because patients demand, request, or expect them.  Also because doctors may be too busy to explain why they are not always appropriate.  This article provides further proof that antibiotics (which treat bacteria) are not helpful against colds (caused by viruses).  Antibiotic overuse not only wastes limited healthcare resources, but also leads to more resistant organisms.  Since antibiotics are only taken for one or two weeks, then stopped, drug companies aren't as motivated to discover breakthroughs as compared to anti-depressants or anti-hypertensives, which are typically taken daily for years at a time.

Page : 11 to 16 of 16