Tag Archives: Food and Drug Administration

Improvement in survival without new drugs!

Truly remarkable how cancer survival has improved in children WITHOUT the addition of new drugs.  There is so much more to health than just taking more medication!  Allergy operates in the same way–good avoidance is first, followed by other aggressive medications.

http://www.usatoday.com/news/health/story/2012-06-04/childhood-cancer-progress/55333892/1

Best Immunotherapy for Allergic Rhinitis and Asthma?: Conclusion & Future Perspective

I didn’t think that all of you wanted to read the full article so here’s the link for the “brainiacs” in the group! Comparing drops to shots!

Conclusion & Future Perspective

The  clinical efficacy of SCIT (typical shots)  is well established for both rhinitis and asthma.  SLIT (sublingual drops) has also been validated in regards to rhinitis and asthma.   Two recent meta-analyses in children showed that sublingual delivery of allergen vaccination constitutes a safe and effective alternative to the injectable route to reduce allergic respiratory symptoms and drug intake.  Assessment of possible long-term benefits, including long-term disease remissions, suppression of new allergic sensitizations, and reduction of progression from rhinitis to asthma in children, as has been shown for the subcutaneous route, are future requirements for “proof” of benefits for sublingual drops. 

The immunological effects of SLIT and how these relate to clinical efficacy are yet incompletely understood. Large-scale trials have confirmed the induction of allergen-specific IgG antibodies to be dose dependent. There is no early suppression of allergen-specific IgE antibodies and a transient early increase in specific IgE antibodies as in SCIT.

Current models of SCIT propose the induction of antigen-specific Tregs (cell type in the body), which then orchestrate the observed antibody and mucosal changes observed during treatment. As of yet there is only scarce evidence that such mechanisms operate during SLIT. Comparative clinical studies of sublingual and subcutaneous treatment yielded heterogeneous results demonstrating efficacy of both modes, but SLIT to be a safer approach.

In conclusion, understanding of the interaction of allergen and antigen-presenting cells within the oral mucosa may allow improved targeting of SLIT vaccines. In the near future the combination of allergen products with adjuvants may improve efficacy of immunotherapy via the sublingual route.

So here’s the bottom line:

  • Sublingual drops are not yet approved by the FDA and I can’t bill insurance for the product like allergists now do for subQ shots. 
  • Why not use Rapid immunotherapy to achieve maintenance in ONE month, followed by MONTHLY shots instead of weekly?  With this method, you get the best of both worlds–good, proven benefits at a convenient dosing schedule. 
  • Sublingual drops have to be given multiple days per week and compliance isn’t all that impressive. 

This issue isn’t going away, so stay tuned!

Vaccine update for Adults!

WASHINGTON – The Food and Drug Administration says it has approved Pfizer Inc.‘s best-selling Prevnar 13 vaccine for use in preventing pneumococcal disease in adults age 50 and older. 

The agency’s move on Friday was widely anticipated, coming a little over a month after a panel of federal health experts voted overwhelmingly to recommend the use of Prevnar 13 as a safe and effective vaccine for preventing the bacterial infection in adults.

Pneumococcal disease causes meningitis, pneumonia and ear infection.

Prevnar 13 protects against 13 strains of the disease. It’s already a standard vaccination for infants and young children.

  • Two key late-stage studies of Pfizer's blockbuster pneumococcal vaccine for children show it works at least as well as a rival in adults, a big market the drugmaker wants to tap. By Mark Lennihan, AP–good job on this article!
  • Two key late-stage studies of Pfizer’s blockbuster pneumococcal vaccine for children show it works at least as well as a rival in adults, a big market the drugmaker wants to tap.

What does this mean for you?

  • If you have chronic sinus infections or pneumonias, I will check antibody levels to see how well you fight infection.  If low, you will usually be immunized with Pneumovax™–0.50ml in adults, 0.25ml in children. 
  • Now, I have a choice:  use Prevnar 13 or Pneumovax.  Which one is better?  You would have to ask!
  • Studies haven’t been done with immunodeficient patients comparing the two vaccines, but the FDA now considers Prevnar 13 as effective in normal adults as Pneumovax. 
  • How about the cost?  You guessed it….the Prevnar 13 is ~twice as expensive as Pneumovax™
 Want more information on this subject? Try Up-To-Date

To Test or Not to Test, that is the question!

If you’re like most doctors, who doesn’t spend the winter months prescribing antibiotics and treating upper respiratory infections?  But when is it serious enough to pull the trigger on a detailed work-up for immunodeficiency?

As with everything in medicine, when symptoms are outside of the “norm,” it’s time to intervene and start your work-up.  Consider the following:

1.  Severe infections such as sepsis or recurrent pneumonia are a no-brainer.  Do the work-up!

2.  The average number of yearly upper respiratory infections in a toddler is 8 to 12, so monthly episodes of a snotty nose aren’t that unusual.  I would be suspicious if fluid accumulates behind the ears, or antibiotics are required with every upper respiratory infection.

3.  Parental or patient anxiety should be included in your evaluation.  Remember, checking for antibodies as a screen will go a long way in relieving that nagging question, “is my child normal?”

4.  Remember, our job as physicians is to screen for immunodeficiency, not order every test available after the first encounter.  Signs & symptoms of immunodeficiency evolve and change our outlook as to how much testing is appropriate. 

Some suggestions for your consideration:

Categorize immunodeficiency into 5 subsets.  The appropriate tests to order follow in a logical pattern thereafter. 

1.  Antibody deficiency.  Labs for this diagnosis should include not only IgG, IgA, and IgM, but also specific antibody titers to Strep Pneumoniae.  Most children now receive PCV-7 or PCV-13 and a subset of kids with chronic infections won’t demonstrate a vigorous antibody response to these immunizations.  Interestingly, many of these children will respond to the adult Pneumovax™ and a good diagnostic test for antibody deficiency is to challenge with Pneumovax™ and repeat titers in one month. Want more info? This pocket guide is the best!

Lymphocytes are the traffic cops of the immune system

2.  T and B cell deficiency.  Infections in this category are viral infections that cause sepsis or meningitis, not self-limited colds.  AIDS falls into this category, although there are many T & B cell deficiencies in addition to AIDS.  Most labs will now provide panels that count the T/B and NK cell populations without having to remember each individual test.  As you can imagine, this saves time and headaches.  Don’t forget to order mitogen and antigen stimulation…determines how well lymphocytes respond to infection. Often the absolute cell number fails to tell the entire story.

3.  Neutrophils.  The PacMan of the immune system.  Usually infections due to chronic granulomatous disease (CGD) involve recurrent cellulitis or persistent abscesses.  You can order screens that measure the oxidative burst when a neutrophil is confronted with bacteria! 

This is what happens when neutrophils don't work

There are several prototypes of CGD depending on the missing enzyme, but most of them can’t produce superoxide anions when needed to kill the invading bug.

4.  Complement deficiencies are rare, but easy to measure.  Recurrent infections with Neisseria should raise the red flag.  CH50, C4, and C3 will tell you if further investigation is needed.

Shock because of Neisseria--think complement deficiency

5.  Last but not least, is the INNATE arm of immunity.  When I was a fellow 20 years ago, I was not taught about innate immunity because we didn’t know it existed.  How else does your body recognize a “new” infection without having to wait 7-10 days to mount an antibody response first?  Toll-like receptors are found on most surveillance cells that recognize nucleic components (DNA, RNA & other repeating sequences) found only on foreign invaders like bacteria, viruses, and fungi.  Believe me, you don’t want to memorize the list of Toll-like receptors (TLRs), but it’s a great cure for insomnia.  Labs can measure Mannose-binding protein, but other TLRs will have to wait their turn. 

If you examine a patient (young or old) with chronic infections and at least think of immunodeficiency, that’s a great start and you’ve come a long way!  Have fun with it–you can give someone their life back with the correct treatment.  (Sounds like another post to me!)