Monday, March 23, 2009

The new HFA inhalers may or may not help the environment and drug companies but are the users the forgotten men?

Here is on article discussing the possible cons of the introduction of the HFA inhalers and the outlawing of the older CFC type (except for Maxair).

Some patients complain they do not work as well and more complain about the increased costs and more than a few physicians have spent time educating patients regarding their use and offering reassurance.

If you wonder, as I do, about how much effect the CFC pulmonary inhalers have on ozone depletion and how much good this prohibition will generate, this reference might offer some information and opinion in that regard.

When I wrote about this before I said:

.. I think this is the first time that the FDA [has banned] a medication or group of medications not because they are thought or proven to be harmful to those who use them but because they are thought to possibly harm folks who do not use it. (OK, the purported skin carcinogenic effect of increased sun rays from the purported decrease in ozone layer thickness would affect everyone- even asthmatics.) Since the task of determining harm to medication users has proven much harder that the FDA or anyone ever thought, it is admirable that the FDA will take on an even more difficult task.

I don't have a tracking on the course this regulation took through the regulatory mechanisms and who supported it, but I cannot help but wonder if we are dealing with still another instance of the "Baptists and the Bootleggers". Since there are no generic versions of the HFA inhalers, guess who the bootleggers would be and would the Baptist role be played be the more radical environmentalists?

3 comments:

Chuck Brooks said...

The customers/patients, like the doctors, have been eliminated as sources of input and concern by the insurance carriers and the bureaucracies that governments use to maintain that monopoly. At teh edge, this cozy relationship could well lead to nationalized health, which in turn would be a wedge for nationalizing everything else.
Chuck Brooks
FutureWare SCG

Anonymous said...

Some folks are having some major problems with the new HFA inhalers.

The most compelling story is at consumer affairs:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html

Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html

More complaints:

https://www.savecfcinhalers.org/Guestbook.php

http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA

http://www.opednews.com/populum/diarypage.php?did=11627

If you are unhappy with the new HFA inhalers, kindly sign the petition to save CFC inhalers.

http://www.savecfcinhalers.org

Also worth mentioning from the FDA website is the following:

http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf

These quotes taken directly from the new drug application for Ventolin HFA.

"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"

"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."

"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol"

"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."

"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."

Anonymous said...

For more information on bringing back CFC Inhalers please check www.savecfcinhalers.org