is this a performance enhancing drug?

At our SCM meet this past weekend we had an out-of-state visitor swimming. She was a very serious swimmer, arrived a week early to acclimate, came with a bit of an entourage, and did some pretty amazing times (45-49). We also saw her taking frequent hits from a very large inhaler always just before her races as she was warming up and behind the blocks. Any thoughts?.
  • I absolutely stand by that statement and I don't believe I exaggerated at all. There was no conspiracy to ban these meds. This was carefully planned and studied. In the case of some inhalers, the drug deposition actually improved. For most patients the difference is minimal. They do taste different -- and people who don't use a spacer are aware of that. I was ready to respond only because treating airway obstruction is what I do -- I have a lot of information and experience. Recent political reports have suggested that the CFC ban is a recent change, part of some over arching conspiracy and likely to harm people. That's not true. But you don't have to believe me -- I may be too naive to see these dark conspiracies. The generics are in the pipeline anyways so I guess they'll have to ban HFA next.
  • Former Member
    Former Member
    This is just not true. The pulmonary deposition is as good or better with HFA than compared to CFCs (depending on which med you use) and all physiology efficacy studies have shown them to be the same. In addition, every respiratory specialist that I know --and I know a lot -- feel that they are equivalent. Do you really stand by this statement, or did you perhaps exaggerate a little bit? "all studies" and "every respiratory specialist" you know?!? Really? So the news that there are people who claim that HFA inhalers suck must have come as a real surprise to you. Hmm, yet you were so ready to respond. Strange. The conspiracy isn't that a few people who stood to make Billions got CFC inhalers banned. It was that hundreds of thousands of patients got together and simultaneously claim that the new inhalers don't work as well.
  • Please see extensive reference list from this review: Expert Rev Respir Med. 2008 Apr;2(2):149-59. Albuterol HFA for the management of obstructive airway disease. Colice GL. Clinical efficacy From the preclinical formulation work, it was expected that albuterol HFA MDI would be as effective a bronchodilator, on a puff-per-puff basis, as albuterol CFC MDI. This expectation was confirmed in dose-response studies in patients with asthma . One puff of albuterol HFA MDI improved FEV1 significantly more than placebo, but the bronchodilator effect was less than with two puffs. The bronchodilator effects of two puffs from an albuterol HFA MDI were comparable to those of two puffs from an albuterol CFC MDI. In a pivotal Phase III study, adult patients with asthma were randomized in a blinded fashion to self-administer two puffs of either albuterol HFA MDI, albuterol CFC MDI or an HFA placebo MDI four-times per day for 12 weeks. At week 12, the bronchodilator effects of albuterol HFA MDI were significantly greater than placebo and comparable to the group randomized to treatment with albuterol CFC MDI . The bronchodilator effects from both albuterol products decreased from baseline after 4 weeks of dosing (i.e., tachyphylaxis), with repetitive albuterol exposure occurring. Studies in children with asthma confirmed that the bronchodilator effects of two puffs of albuterol HFA MDI were comparable to those achieved with two puffs of albuterol CFC MDI after regular dosing for 2-4 weeks . Asthma patients who had been stabilized on regular treatment with albuterol CFC MDI were studied after being switched to regular treatment with albuterol HFA MDI . No evidence of loss of asthma control was found and serial spirometry confirmed that albuterol HFA MDI provided comparable improvements in FEV 1 as were previously seen with albuterol CFC MDI. Two large postapproval studies, using diary card-recorded measures of peak expiratory flow and asthma symptoms, showed that patients randomized to albuterol HFA MDI treatment had comparable asthma control as those receiving albuterol CFC MDI . In adults and children with asthma and exercise-induced bronchospasm, treatment with albuterol HFA MDI prior to exercise was significantly better than placebo and comparable to albuterol CFC MDI in preventing postexercise falls in FEV1 . ----- (excerpted below): 73 Dockhorn R, Vanden Burgt J, Ekholm BP et al. Clinical equivalence of a novel non-chlorofluorocarbon-containing salbutamol sulfate metered-dose inhaler and a conventional chlorofluorocarbon inhaler in patients with asthma. J. Allergy Clin. Immunol. 96, 50-56 (1995). 74 Langley SJ, Sykes AP, Batty EP et al. A comparison of the efficacy and tolerability of single doses of HFA 134a albuterol and CFC albuterol in mild-to-moderate asthmatic patients. Ann. Allergy Asthma Immunol. 88, 488-493 (2002). 75 Bleecker ER, Tinkelman DG, Ramsdell J et al. Proventil HFA provides bronchodilation comparable to ventolin over 12 weeks of regular use in asthmatics. Chest 113, 283-289 (1998). * Pivotal Phase III study comparing regular use of albuterol HFA MDIs with albuterol CFC MDIs over 12 weeks. 76 Shapiro GS, Klinger NM, Ekholm BP, Colice GL. Comparable bronchodilation with hydrofluoroalkane-134a (HFA) albuterol and chlorofluorcarbons-11/12 (CFC) albuterol in children with asthma. J. Asthma 37, 667-675 (2000). 77 Shapiro G, Bronsky E, Murray A et al. Clinical comparability of ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthma. Arch. Ped. Adolescent Med. 154, 1219-1225 (2000).
  • If there is a noticable difference between the delivery methods, than the subjects know which they are getting. Reference 75 mentioned some time to onset variable that needed talked around.
  • Former Member
    Former Member
    I found this excerpt although I cannot verify the source or the exact procedures of the experiment, but I will look for it. 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. Methacholine is a drug that will induce bronchioconstriction in individuals with bronchiohyperactivity (asthma, COPD) when inhaled. So a methacholine challenge is when a subject inhales methacholine.
  • Former Member
    Former Member
    Do you really stand by this statement, or did you perhaps exaggerate a little bit? "all studies" and "every respiratory specialist" you know?!? Really? So the news that there are people who claim that HFA inhalers suck must have come as a real surprise to you. Hmm, yet you were so ready to respond. Strange. The conspiracy isn't that a few people who stood to make Billions got CFC inhalers banned. It was that hundreds of thousands of patients got together and simultaneously claim that the new inhalers don't work as well. I admit that my "universal" statement was a bit exaggerated, but I've worked in 3 different retail pharmacies at the time of the switch and I can honestly say dozens upon dozens of patients complained that that drug was not effective as it previous was. I've heard many other pharmacists agree with this. I've had teachers at my school verify these statements as well. I am going to call up one of the most brilliant guys I know on the pharmaceutical world and see what his take is. He is literally one of the top pharmacists in the world and has done a lot to advance some aspects of drug delivery and IV protocol. He's been a clinical pharmacist at some of the top hospitals in the world and has lead many pharmaceutical organizations. I know he prefers the CFC to the HFA but I'll see what info I can get out of him. Aside from our main argument here, I do know, however, that there is a lot of information that suggests that HFA's are not as safe as CF'C's, having more adverse effects. There definitely is a financial incentive for the switch from CFC's to HFA's. The pharmaceutical industry is probably one of the most corrupt entities in history. If you work in pharmacy, follow drug prices, follow the products on the market, you can easily see corruption and drug companies taking advantage of patients. Almost all the top FDA executives have ties to drug companies. It's a really messed up world and its no wonder health care is becoming exponentially expensive. If the US made a law that drug companies could only sell drugs at the same price that they do in other countries, we would save billions. Drugs in America cost 2-10x as much as they do in other countries. Additionally, drug prices in America have doubled, tripled, and even quadrupled in the past 10 years. Drugs that have been around for years price's have skyrocketed. I had a pt that was in the donut hole and could not afford his $700/month Seroquel. We sent him to a Turkish pharmacy that used the exact same medicine and packaging and it cost him $350 for 2 months (175/month). It's incredible. Fluticisone (Flonaze) used to cost around $7-8, not it costs $20 in the door. The list is endless. Drug companies have a huge incentive to take one the top prescribed drugs, albuterol (probably within the top 20, maybe 30 drugs prescribed), delete the ~$5-$10 generic option, and replace it with a brand name inhaler like Ventolin or Proventil and charge $40-$60. It's not a conspiracy. It's how the drug company works. And what better time, at the height of environmentalism, to sound the alarm that people's inhalers are going to destroy the ozone layer. The whole ozone layer hype occurred literally 15 years ago. In reality, the fair option would have been would be to replace the HFA with the CFC's and incur no price change in the drug. After all, its just albuterol which has been around for ages. Why should a new propellent allow the insurance companies to escalate the price significantly?