The National Campaign to Save CFC Asthma Inhalers
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The Gang of Nine (aka the U.S. Stakeholders' Group on MDI (metered-dose inhaler) Transition) was convened at the request of the U.S. EPA in 1996. EPA asked The American Lung Association to organize this group, ostensibly to 'educate doctors and patients' about the impending transition from CFC (chlorofluorocarbon) inhalers to HFA (hydrofluoroalkane) inhalers per the Montreal Protocol, which is enforced in the U.S. by the Clean Air Act. We were told that CFC inhalers needed to be banned because their negligible global emissions threatened the ozone layer, increased ground UV-B radiation, and increased skin cancer rates. All of these explanations are patent LIES. They have NO BASIS IN FACT.
The real reason CFC inhalers were banned was because of the EPA's desire for bureaucratic expedience at the Montreal Protocol (at the expense of *patient safety), as explained below by Drusilla Hufford (EPA's lead official on the CFC inhaler ban, and FDA liason) at the FDA's April 11, 1997 PADAC meeting (p.88):
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*"Based on our results and those of others*, clinicians should avoid using new drugs (Ed. like HFA inhalers) when older, similarly efficacious agents (Ed. like CFC inhalers) are available." Journal of the American Medical Association, May, 2002.
*US General Accounting Office. FDA Drug Review: Post approval Risks, 1976-1985. Washington, DC: US General Accounting Office; 1990. Publication GAO/PEMD-90-15.
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Here's Drusilla Hufford's brilliant explanation of why CFC inhalers needed to be banned:
"I would like to just very briefly try to provide you a little historical context, if I could. At the outset of policy discussions for controlling the ozone layer problem, the majority of U.S. uses of these chemicals were in the major air conditioning and refrigeration uses, that Chris O'Donnell has mentioned.
"About a third of the problem, though, was made up of very small uses. CFCs were so industrially ubiquitous they found their way into things like mold release agents, dental applications, many, many small-use solvent cleaning applications, and so early on, the parties to the Protocol and certainly those in the U.S. environmental community and the regulatory community faced the question of should there be any kind of move to exempt small uses on the basis of their smallness.
"Because small uses then in the aggregate represented such a large portion of the problem, the decision was made to go ahead and address the problem as a whole, because if we ended up exempting an individual use based on its smallness (Ed. such as CFC inhalers), it would be very difficult when the next small user came in, to say, well, no, we need to hold the line here."
(We don't think it would have been "very difficult" at all to explain why a medical exemption for CFC inhalers needed to be made. And Ms. Hufford failed to mention that two permanent exemptions for ozone-depleting substances were made: 1) pesticide methyl bromide, for its QPS (Quarantine/Pre-shipment) application (the spraying of produce in wooden crates) is not regulated by the Montreal Protocol, and 2) all commercial and military rockets inject large amounts of ozone-depleting substances directly into the stratospheric ozone layer, and these emissions are not regulated by the Montreal Protocol. Obviously, CFC inhalers could have been and should have been similarly exempted from the Montreal Protocol's ban of ozone-depleting substances.)
Ms. Hufford repeated the same argument six months later (bottom of page 1): "The problem for the ozone layer is that if the U.S. were to argue that our remaining uses are so small that we ought be allowed to continue using them indefinitely, it's likely that a lot of other countries would make similar arguments about their uses, and the result of that kind of change would be a problem for the ozone layer."
(EPA has since determined that HFA emissions are powerful global warmers (much worse than CFC emissions), and so the drug companies (through IPAC, The International Pharmaceutical Aerosol Consortium) are now hard at work developing a new medical propellant to eventually replace HFAs, through the Copenhagen Accord, believe it or not. As was the case in the CFC inhaler to HFA inhaler forced transition, we fully expect that the international community will mandate the transition from HFA inhalers to the new inhalers currently under development when the HFA inhalers start to lose their patents and go generic in a few more years.)
The U.S. Stakeholders' Group on MDI Transition consists of the following three patient front groups and six medical associations, all of which are heavily subsidized by IPAC in various ways:
The American Lung Association (ALA)
The Asthma and Allergy Foundation of America (AAFA)
The Allergy and Asthma Network Mothers of Asthmatics (AANMA)
The American Academy of Allergy, Asthma and Immunology (AAAAI)
The American Academy of Pediatrics
The American Association for Respiratory Care (AARC)
The American College of Allergy, Asthma and Immunology (ACAAI)
The American College of Chest Physicians (ACCP)
The American Thoracic Society (ATS)
The Stakeholders' group (which, in reality, was never anything other than a high-powered PR agency for IPAC (the drug companies) and the EPA) pressured the FDA to speed up the ban of CFC inhalers, despite the fact that the replacement HFA inhalers never underwent large scale, *real world, thorough, U.S. postmarketing studies to seriously evaluate their safety and effectiveness for forty million U.S. patients.
*'Real world' postmarketing studies would have included a much larger, broader, more realistic group of patients who used (in this case) CFC inhalers for many different diseases (the way these inhalers were used in the real world), as opposed to the tiny pre-approval clinical trials, which tested only mild/moderate asthmatics (no severe asthmatics, COPD patients, cystic fibrosis patients, lung cancer patients, etc. Even the FDA acknowledged the importance of doing postmarketing studies on HFA MDIs, but IPAC, and the *EPA, refused.)
*Notice how close the relationship was between IPAC leading member 3M Pharmaceuticals (maker of the first HFA albuterol MDI, Proventil HFA), and the EPA was (pages 2-3):
“But the proposal does have some supporters. 3M Pharmaceuticals, manufacturer of the only non-CFC inhaler currently approved by the FDA and beneficiary of decreased competition resulting from the proposal as written, seems to have a close relationship with the EPA. It wrote to five EPA officials last November, addressing them by their first names, to complain that the FDA was still approving cheaper generic CFC inhalers. Two months later, EPA Assistant Administrator Mary Nichols wrote to the FDA complaining that it “has continued to approve CFC generic MDIs with no end in sight.” In May, Nichols sent out a letter to hospitals and health-maintenance organizations that mentioned the 3M product by name and encouraged health-maintenance organizations and hospitals to “take direct steps to promote environmental health” by adding it and future non-CFC inhalers “to your formularies and preferred products list.
“When North Carolina GOP Rep. Richard Burr asked an EPA official at a hearing on July 30th where he received the list for this mass mailing, he admitted it came from 3M. An incensed Burr, noting that it was illegal for a company to use FDA approval in promotions, asked a House Commerce subcommittee to investigate.
“The EPA’s Hufford defends the letter as “try[ing] to educate the community about the issue.” She says that in the future, however, “we would not try to save the money” and would buy a list. Asked if the EPA consulted with, 3M on the letter and mailing, Hufford told Insight, “I don’t recall particular things, but I think it’s highly likely that we consulted with individual companies.” 3M did not return Insight’s phone calls.
“Ironically, some of the other supporters of the FDA proposal are the very people who have invoked asthmatic children to support the new air-quality standards. The American Lung Association, or ALA, whose sweetheart lawsuit against the EPA resulted in the new air regulations, and that has supported the regs with radio and television ads and a press conference featuring asthmatic children, is taking a curious position for a group whose motto is “When you can’t breathe, nothing else matters.” Indeed, the ALA is accused by Lieberman and other critics of now being more of an environmental than a public-health group. It has issued a press release opposing the Stearns bill to stop the FDA proposal.”
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This is the correspondence the Stakeholders sent to the FDA in coordination with their IPAC drug company masters, demanding that the FDA speed up the ban of CFC inhalers:
January 29, 2003 STAKEHOLDERS' CITIZEN PETITION TO THE FDA
March 7, 2003 IPAC SUPPORTS THE CITIZENS PETITION
June 3, 2003 EDWARD ALLERA OPPOSES THE CITIZEN PETITION
July 21, 2003 STAKEHOLDERS' ATTACK ALLERA
September 3, 2003 IPAC SUPPORTS THE CITIZEN PETITION
October 28, 2003 NANCY SANDER'S AANMA SUPPORTS THE CITIZEN PETITION
February 11, 2004 STAKEHOLDERS SUPPORT THE CITIZEN PETITION
March 8, 2004 IPAC SUPPORTS THE CITIZEN PETITION
April 1, 2004 STAKEHOLDERS SUPPORT THE CITIZEN PETITION
April 7, 2004 EDWARD ALLERA OPPOSES THE CITIZEN PETITION
April 20, 2004 HONEYWELL SAYS IT CAN AND WILL PRODUCE ALL THE CFC-11,12 THE US NEEDS FOR CFC MDIs (STAKEHOLDERS LIES TO THE CONTRARY NOTWITHSTANDING, Ed.)
Why did the Stakeholders say they wanted the FDA to expedite the ban of safe, effective, inexpensive, reliable CFC asthma inhalers?
They gave three reasons for this in their January 29, 2003 Citizen Petition to the FDA (see link above):
1. "...increased health benefits from reduced depletion of the ozone layer,..."
This is a lie. There is no evidence to support the assertion that the negligible emissions from CFC asthma inhalers threatens the ozone layer, increase ground level UV-B radiation, or increases skin cancer rates. Nor is there any evidence that ozone layer depletion is responsible for increased rates of skin cancer. (See the bottom half of the HFA MDIs: Just The Facts page.)
2. "...increased certainty that their asthma and COPD medications will be available in the future,..." (Referring to the supposed uncertainty of availability of the required amounts of CFC-11,12.)
This is a lie. Honeywell addresses and dismisses this lie in their April 20, 2004 letter. (See link above.)
3. "...and improved management of their diseases."
This is idiotic. The idea that safe, effective, reliable, inexpensive lifesaving CFC asthma inhalers should be banned so that patients would have a reason to visit their doctors and review their asthma treatment plans is simply too stupid to warrant any discussion.
So what was the real reason the Stakeholders wanted the FDA to expedite the ban of safe, effective, reliable inexpensive CFC asthma inhalers?
First possible reason:
Undoubtedly, some of the leaders of these nine organizations were (and probably still are) naive, enviro-freak, 'useful idiots' who bought the lie that CFC inhaler emissions were harmful to the ozone layer- and accepted this lie at face value, without asking for any evidence.
For example, University of Miami Professor of Medicine Adam Wanner, M.D., pulmonologist, past president of the American Thoracic Society (one of the nine Stakeholder organizations), and "Ozone Clan soldier" (we kid you not, see page 13, second paragraph from the bottom), recently provided this lie to the media:
"... health care providers should explain to patients the exact reason why these costlier drugs (HFA inhalers) must be used:
"... to protect the ozone layer so deadly UV radiation won't pour through the Earth's atmosphere."
For his patients' sake, we sincerely hope that Professor Wanner is a better pulmonologist than he is an atmospheric physicist. But he is obviously a deeply compassionate, caring physician, as shown by his sympathetic advice to asthma patients who are suffering terribly, and in some cases, dying, because of their inability to tolerate HFA inhalers:
"The common good should not be totally forgotten by patients who have asthma."
It's not enough for Professor Wanner to lie about the dangers of CFC inhaler emissions, and mischaracterize the safety and efficacy data about HFA inhalers. Dr. Wanner also feels compelled to give ethics lessons to patients who are suffering due to the medically, scientifically and morally indefensible ban of CFC inhalers, something he has aggressively pushed for as a member of MATOC (the United Nation's Medical Aerosol Technical Options Committee) since 1995.
Second possible reason:
The second possible reason for the Stakeholders' decision to petition the FDA to speed up the ban of CFC inhalers was their failure to either read, understand, or (more likely) GIVE A DAMN about the data showing the greater danger of HFA inhalers, as well as the inferior efficacy of HFA inhalers.
Dr. Wanner, again:
"Efficacy-wise, little separates HFA from CFC inhalers, said Wanner, professor of medicine at the University of Miami School of Medicine."
Dr. Wanner's assertion is refuted by GlaxoWellcome itself (now GlaxoSmithKline) in its New Drug Application to the FDA for its own product, Ventolin HFA (and remember, everything you are about to read applies only to mild/moderate asthmatics; no severe asthmatics, COPD patients, cystic fibrosis patients, etc. were tested in these "more limited" (according to FDA Office of New Drugs Director Dr. John Jenkins) 'bridging approach' pre-approval clinical trials.
Severely ill patients are usually never tested in pre-approval drug trials- this is why postmarketing studies needed to have been done in this case, where CFC asthma inhalers were going to be suddenly and completely replaced- something that had never happened before.
The HFA trials, however, were unique because the FDA took IPAC's (the drug companies) advice and permitted the drug companies to conduct these "more limited" 'bridging approach', watered down, pre-approval clinical trials.
Furthermore, bear in mind that Ventolin HFA is unique among HFA rescue inhalers because it does not have the bronchoconstrictor ethanol as a solvent as the other three do, and yet Ventolin HFA is still less effective and more dangerous than CFC albuterol according to the following data.
NOTE: Ignore all of the nonsense about what is considered to be "statistically significant" in these ridiculously small clinical trials; focus on the fact that in virtually every trial, CFC albuterol is safer and more effective than Ventolin HFA.
As FDA master medical reviewer and 28 year FDA safety officer and whistleblower David Graham MD, MPH points out, the use of tiny clinical trials is a deliberate strategy used by the drug companies in order to hide the dangers of test drugs:
"The classic approach of industry and FDA has been to do studies that are too small to conclusively identify that a risk is real," he added. "They can conclude, therefore, that there is no risk." FDA Safety Officer David Graham, MD,MPH.
"Graham charged that "FDA standards of evidence give drugs and drug companies a free pass on safety."
Ventolin HFA efficacy and safety data:
p.1 "... the (Ventolin) HFA product consistently demonstrated a numerically smaller effect size compared to the reference CFC (albuterol) product."
p.3 "However in the multiple-dose adolescent and adult studies, albuterol HFA (Ventolin HFA) showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC."
p.3 "There was other evidence that the HFA formulation delivers a lower/less effective dose on a per actuation 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 actuations 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. This difference in albuterol "back-up" use" was numerical in SALA3005 but was statistically significant in SALA3002."
p.3 "Throat irritation and cough (Ed. a major symptom of asthma) were seen in slightly greater numbers of albuterol HFA (Ventolin HFA) patients than either placebo or CFC albuterol controls."
p.3 "... Ventolin HFA's effect and duration of action appear to be slightly less on average than CFC Ventolin (in the prevention and maintenance treatment of bronchospasm in adults and children, and in the prevention of exercise-induced bronchospasm).
p.3 "According to the Statistical review [Dr. Gebert, 1/14/99], there were statistically significant differences between the products for onset of action and for peak effect on Day 1 in study SALA3005 (p=0.011). The CFC product had a faster onset of action and a greater peak effect."
Professor Wanner, again:
"However, HFA does penetrate deeper into the airways and potentially could have more systemic side effects, he said. No data have shown this, though, and HFA has short-term and long-term safety profiles comparable to CFC."
Really, Professor?
This is what Schering-Plough itself says about its own product, Proventil HFA:
“Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol).” (Sixth paragraph from the bottom)
These are not systemic side effects, Professor Wanner?
How about these, Professor:
p.6 (Ventolin HFA NDA) "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."
(And remember, we can't blame these problems on ethanol, because Ventolin HFA has no ethanol. These problems are caused by other inactive ingredients and impurities unique to Ventolin HFA.)
NOTE: The placebo HFA did worse than albuterol CFC. What does this say about the safety of HFA-134a propellant?
NOTE: Albuterol HFA did much worse than placebo HFA. What does this say about the safety of the impurities and inactive ingredients in albuterol HFA?
NOTE: Albuterol HFA did much worse than albuterol CFC. What does this say about the credibility of the QUACKS who ASSURE us that albuterol HFA is just as safe as albuterol CFC?
VENTOLIN HFA's Adverse Reactions chart (page 5) shows the following differences in adverse reactions compared to CFC albuterol:
The incidence of THROAT IRRITATION in two 12 week clinical trials was 10% for Ventolin HFA vs. 6% for CFC albuterol.
The incidence of VIRAL RESPIRATORY INFECTION in two 12 week clinical trials was 7% for Ventolin HFA vs. 4% for CFC albuterol.
The incidence of COUGH (a common asthma symptom) in two 12 week clinical trials was 5% for Ventolin HFA vs. 2% for CFC albuterol.
NOTE: There were no adverse reactions occurring more frequently in CFC inhalers compared to Ventolin HFA.
PROVENTIL HFA's Adverse Reactions chart (page 3) shows the following differences in adverse reactions compared to CFC albuterol:
The incidence of TACHYCARDIA (rapid heart beat) during the 12 week clinical trials was over 7% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of VOMITING during the 12 week clinical trials was 7% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of FEVER during the 12 week clinical trials was 6% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of BACK PAIN during the 12 week clinical trials was 4% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of ALLERGIC REACTIONS during the 12 week clinical trials was 6% for Proventil HFA vs. 4% for CFC albuterol.
The incidence of RESPIRATORY DISORDERS during the 12 week clinical trials was 6% for Proventil HFA vs. 4% for CFC albuterol.
But Professor Wanner says there's "no data" to show that albuterol HFA has more systemic side effects than albuterol CFC. That's his story, and he's sticking to it.
We refer you to the HFA MDIs: Just The Facts page to see three years of FDA MedWatch data, safety/withdrawal data from a large United Kingdom postmarketing study, and a New Zealand study, all of which further support our position that albuterol CFC is much safer than albuterol HFA, regardless of what 'experts' such as Professor Wanner say.
Third possible reason:
It is also likely that most of the politically inclined leaders of these Stakeholder organizations were pleased that they would 'have a seat at the table'; they probably enjoyed their proximity to U.S. and U.N. political power.
Fourth possible reason:
And certainly, IPAC's massive financial contributions to these nine Stakeholder organizations, in various ways over many years, helped these phony 'patient advocate' nonprofit organizations (aka patient front groups) and Men of Science In White Coats overlook the fact that the ban of CFC asthma inhalers was medically, scientifically and morally bankrupt.
We know one thing for sure.
None of these nine organizations gave a damn about patient safety, because all of them pressured the FDA to speed up the ban of CFC asthma inhalers (at the behest of their drug company masters) despite the fact that simple common sense dictated that large scale, real world postmarketing studies of HFA inhalers be done before depriving 40 million patients of their lifesaving CFC inhalers.
PLEASE DONATE TO OUR CAMPAIGN TO PERMANENTLY LEGALIZE CFC MDIs HERE
The real reason CFC inhalers were banned was because of the EPA's desire for bureaucratic expedience at the Montreal Protocol (at the expense of *patient safety), as explained below by Drusilla Hufford (EPA's lead official on the CFC inhaler ban, and FDA liason) at the FDA's April 11, 1997 PADAC meeting (p.88):
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*"Based on our results and those of others*, clinicians should avoid using new drugs (Ed. like HFA inhalers) when older, similarly efficacious agents (Ed. like CFC inhalers) are available." Journal of the American Medical Association, May, 2002.
*US General Accounting Office. FDA Drug Review: Post approval Risks, 1976-1985. Washington, DC: US General Accounting Office; 1990. Publication GAO/PEMD-90-15.
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Here's Drusilla Hufford's brilliant explanation of why CFC inhalers needed to be banned:
"I would like to just very briefly try to provide you a little historical context, if I could. At the outset of policy discussions for controlling the ozone layer problem, the majority of U.S. uses of these chemicals were in the major air conditioning and refrigeration uses, that Chris O'Donnell has mentioned.
"About a third of the problem, though, was made up of very small uses. CFCs were so industrially ubiquitous they found their way into things like mold release agents, dental applications, many, many small-use solvent cleaning applications, and so early on, the parties to the Protocol and certainly those in the U.S. environmental community and the regulatory community faced the question of should there be any kind of move to exempt small uses on the basis of their smallness.
"Because small uses then in the aggregate represented such a large portion of the problem, the decision was made to go ahead and address the problem as a whole, because if we ended up exempting an individual use based on its smallness (Ed. such as CFC inhalers), it would be very difficult when the next small user came in, to say, well, no, we need to hold the line here."
(We don't think it would have been "very difficult" at all to explain why a medical exemption for CFC inhalers needed to be made. And Ms. Hufford failed to mention that two permanent exemptions for ozone-depleting substances were made: 1) pesticide methyl bromide, for its QPS (Quarantine/Pre-shipment) application (the spraying of produce in wooden crates) is not regulated by the Montreal Protocol, and 2) all commercial and military rockets inject large amounts of ozone-depleting substances directly into the stratospheric ozone layer, and these emissions are not regulated by the Montreal Protocol. Obviously, CFC inhalers could have been and should have been similarly exempted from the Montreal Protocol's ban of ozone-depleting substances.)
Ms. Hufford repeated the same argument six months later (bottom of page 1): "The problem for the ozone layer is that if the U.S. were to argue that our remaining uses are so small that we ought be allowed to continue using them indefinitely, it's likely that a lot of other countries would make similar arguments about their uses, and the result of that kind of change would be a problem for the ozone layer."
(EPA has since determined that HFA emissions are powerful global warmers (much worse than CFC emissions), and so the drug companies (through IPAC, The International Pharmaceutical Aerosol Consortium) are now hard at work developing a new medical propellant to eventually replace HFAs, through the Copenhagen Accord, believe it or not. As was the case in the CFC inhaler to HFA inhaler forced transition, we fully expect that the international community will mandate the transition from HFA inhalers to the new inhalers currently under development when the HFA inhalers start to lose their patents and go generic in a few more years.)
The U.S. Stakeholders' Group on MDI Transition consists of the following three patient front groups and six medical associations, all of which are heavily subsidized by IPAC in various ways:
The American Lung Association (ALA)
The Asthma and Allergy Foundation of America (AAFA)
The Allergy and Asthma Network Mothers of Asthmatics (AANMA)
The American Academy of Allergy, Asthma and Immunology (AAAAI)
The American Academy of Pediatrics
The American Association for Respiratory Care (AARC)
The American College of Allergy, Asthma and Immunology (ACAAI)
The American College of Chest Physicians (ACCP)
The American Thoracic Society (ATS)
The Stakeholders' group (which, in reality, was never anything other than a high-powered PR agency for IPAC (the drug companies) and the EPA) pressured the FDA to speed up the ban of CFC inhalers, despite the fact that the replacement HFA inhalers never underwent large scale, *real world, thorough, U.S. postmarketing studies to seriously evaluate their safety and effectiveness for forty million U.S. patients.
*'Real world' postmarketing studies would have included a much larger, broader, more realistic group of patients who used (in this case) CFC inhalers for many different diseases (the way these inhalers were used in the real world), as opposed to the tiny pre-approval clinical trials, which tested only mild/moderate asthmatics (no severe asthmatics, COPD patients, cystic fibrosis patients, lung cancer patients, etc. Even the FDA acknowledged the importance of doing postmarketing studies on HFA MDIs, but IPAC, and the *EPA, refused.)
*Notice how close the relationship was between IPAC leading member 3M Pharmaceuticals (maker of the first HFA albuterol MDI, Proventil HFA), and the EPA was (pages 2-3):
“But the proposal does have some supporters. 3M Pharmaceuticals, manufacturer of the only non-CFC inhaler currently approved by the FDA and beneficiary of decreased competition resulting from the proposal as written, seems to have a close relationship with the EPA. It wrote to five EPA officials last November, addressing them by their first names, to complain that the FDA was still approving cheaper generic CFC inhalers. Two months later, EPA Assistant Administrator Mary Nichols wrote to the FDA complaining that it “has continued to approve CFC generic MDIs with no end in sight.” In May, Nichols sent out a letter to hospitals and health-maintenance organizations that mentioned the 3M product by name and encouraged health-maintenance organizations and hospitals to “take direct steps to promote environmental health” by adding it and future non-CFC inhalers “to your formularies and preferred products list.
“When North Carolina GOP Rep. Richard Burr asked an EPA official at a hearing on July 30th where he received the list for this mass mailing, he admitted it came from 3M. An incensed Burr, noting that it was illegal for a company to use FDA approval in promotions, asked a House Commerce subcommittee to investigate.
“The EPA’s Hufford defends the letter as “try[ing] to educate the community about the issue.” She says that in the future, however, “we would not try to save the money” and would buy a list. Asked if the EPA consulted with, 3M on the letter and mailing, Hufford told Insight, “I don’t recall particular things, but I think it’s highly likely that we consulted with individual companies.” 3M did not return Insight’s phone calls.
“Ironically, some of the other supporters of the FDA proposal are the very people who have invoked asthmatic children to support the new air-quality standards. The American Lung Association, or ALA, whose sweetheart lawsuit against the EPA resulted in the new air regulations, and that has supported the regs with radio and television ads and a press conference featuring asthmatic children, is taking a curious position for a group whose motto is “When you can’t breathe, nothing else matters.” Indeed, the ALA is accused by Lieberman and other critics of now being more of an environmental than a public-health group. It has issued a press release opposing the Stearns bill to stop the FDA proposal.”
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By the way, this is what Schering-Plough says about its product, Proventil HFA:
“Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol).”
And this is what GlaxoWellcome (now GlaxoSmithKline) says about its product, 'ethanol-free' Ventolin HFA:
"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."
Does this sound like equivalent safety to you?
“Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol).”
And this is what GlaxoWellcome (now GlaxoSmithKline) says about its product, 'ethanol-free' Ventolin HFA:
"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."
Does this sound like equivalent safety to you?
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This is the correspondence the Stakeholders sent to the FDA in coordination with their IPAC drug company masters, demanding that the FDA speed up the ban of CFC inhalers:
January 29, 2003 STAKEHOLDERS' CITIZEN PETITION TO THE FDA
March 7, 2003 IPAC SUPPORTS THE CITIZENS PETITION
June 3, 2003 EDWARD ALLERA OPPOSES THE CITIZEN PETITION
July 21, 2003 STAKEHOLDERS' ATTACK ALLERA
September 3, 2003 IPAC SUPPORTS THE CITIZEN PETITION
October 28, 2003 NANCY SANDER'S AANMA SUPPORTS THE CITIZEN PETITION
February 11, 2004 STAKEHOLDERS SUPPORT THE CITIZEN PETITION
March 8, 2004 IPAC SUPPORTS THE CITIZEN PETITION
April 1, 2004 STAKEHOLDERS SUPPORT THE CITIZEN PETITION
April 7, 2004 EDWARD ALLERA OPPOSES THE CITIZEN PETITION
April 20, 2004 HONEYWELL SAYS IT CAN AND WILL PRODUCE ALL THE CFC-11,12 THE US NEEDS FOR CFC MDIs (STAKEHOLDERS LIES TO THE CONTRARY NOTWITHSTANDING, Ed.)
Why did the Stakeholders say they wanted the FDA to expedite the ban of safe, effective, inexpensive, reliable CFC asthma inhalers?
They gave three reasons for this in their January 29, 2003 Citizen Petition to the FDA (see link above):
1. "...increased health benefits from reduced depletion of the ozone layer,..."
This is a lie. There is no evidence to support the assertion that the negligible emissions from CFC asthma inhalers threatens the ozone layer, increase ground level UV-B radiation, or increases skin cancer rates. Nor is there any evidence that ozone layer depletion is responsible for increased rates of skin cancer. (See the bottom half of the HFA MDIs: Just The Facts page.)
2. "...increased certainty that their asthma and COPD medications will be available in the future,..." (Referring to the supposed uncertainty of availability of the required amounts of CFC-11,12.)
This is a lie. Honeywell addresses and dismisses this lie in their April 20, 2004 letter. (See link above.)
3. "...and improved management of their diseases."
This is idiotic. The idea that safe, effective, reliable, inexpensive lifesaving CFC asthma inhalers should be banned so that patients would have a reason to visit their doctors and review their asthma treatment plans is simply too stupid to warrant any discussion.
So what was the real reason the Stakeholders wanted the FDA to expedite the ban of safe, effective, reliable inexpensive CFC asthma inhalers?
First possible reason:
Undoubtedly, some of the leaders of these nine organizations were (and probably still are) naive, enviro-freak, 'useful idiots' who bought the lie that CFC inhaler emissions were harmful to the ozone layer- and accepted this lie at face value, without asking for any evidence.
For example, University of Miami Professor of Medicine Adam Wanner, M.D., pulmonologist, past president of the American Thoracic Society (one of the nine Stakeholder organizations), and "Ozone Clan soldier" (we kid you not, see page 13, second paragraph from the bottom), recently provided this lie to the media:
"... health care providers should explain to patients the exact reason why these costlier drugs (HFA inhalers) must be used:
"... to protect the ozone layer so deadly UV radiation won't pour through the Earth's atmosphere."
For his patients' sake, we sincerely hope that Professor Wanner is a better pulmonologist than he is an atmospheric physicist. But he is obviously a deeply compassionate, caring physician, as shown by his sympathetic advice to asthma patients who are suffering terribly, and in some cases, dying, because of their inability to tolerate HFA inhalers:
"The common good should not be totally forgotten by patients who have asthma."
It's not enough for Professor Wanner to lie about the dangers of CFC inhaler emissions, and mischaracterize the safety and efficacy data about HFA inhalers. Dr. Wanner also feels compelled to give ethics lessons to patients who are suffering due to the medically, scientifically and morally indefensible ban of CFC inhalers, something he has aggressively pushed for as a member of MATOC (the United Nation's Medical Aerosol Technical Options Committee) since 1995.
Second possible reason:
The second possible reason for the Stakeholders' decision to petition the FDA to speed up the ban of CFC inhalers was their failure to either read, understand, or (more likely) GIVE A DAMN about the data showing the greater danger of HFA inhalers, as well as the inferior efficacy of HFA inhalers.
Dr. Wanner, again:
"Efficacy-wise, little separates HFA from CFC inhalers, said Wanner, professor of medicine at the University of Miami School of Medicine."
Dr. Wanner's assertion is refuted by GlaxoWellcome itself (now GlaxoSmithKline) in its New Drug Application to the FDA for its own product, Ventolin HFA (and remember, everything you are about to read applies only to mild/moderate asthmatics; no severe asthmatics, COPD patients, cystic fibrosis patients, etc. were tested in these "more limited" (according to FDA Office of New Drugs Director Dr. John Jenkins) 'bridging approach' pre-approval clinical trials.
Severely ill patients are usually never tested in pre-approval drug trials- this is why postmarketing studies needed to have been done in this case, where CFC asthma inhalers were going to be suddenly and completely replaced- something that had never happened before.
The HFA trials, however, were unique because the FDA took IPAC's (the drug companies) advice and permitted the drug companies to conduct these "more limited" 'bridging approach', watered down, pre-approval clinical trials.
Furthermore, bear in mind that Ventolin HFA is unique among HFA rescue inhalers because it does not have the bronchoconstrictor ethanol as a solvent as the other three do, and yet Ventolin HFA is still less effective and more dangerous than CFC albuterol according to the following data.
NOTE: Ignore all of the nonsense about what is considered to be "statistically significant" in these ridiculously small clinical trials; focus on the fact that in virtually every trial, CFC albuterol is safer and more effective than Ventolin HFA.
As FDA master medical reviewer and 28 year FDA safety officer and whistleblower David Graham MD, MPH points out, the use of tiny clinical trials is a deliberate strategy used by the drug companies in order to hide the dangers of test drugs:
"The classic approach of industry and FDA has been to do studies that are too small to conclusively identify that a risk is real," he added. "They can conclude, therefore, that there is no risk." FDA Safety Officer David Graham, MD,MPH.
"Graham charged that "FDA standards of evidence give drugs and drug companies a free pass on safety."
Ventolin HFA efficacy and safety data:
p.1 "... the (Ventolin) HFA product consistently demonstrated a numerically smaller effect size compared to the reference CFC (albuterol) product."
p.3 "However in the multiple-dose adolescent and adult studies, albuterol HFA (Ventolin HFA) showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC."
p.3 "There was other evidence that the HFA formulation delivers a lower/less effective dose on a per actuation 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 actuations 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. This difference in albuterol "back-up" use" was numerical in SALA3005 but was statistically significant in SALA3002."
p.3 "Throat irritation and cough (Ed. a major symptom of asthma) were seen in slightly greater numbers of albuterol HFA (Ventolin HFA) patients than either placebo or CFC albuterol controls."
p.3 "... Ventolin HFA's effect and duration of action appear to be slightly less on average than CFC Ventolin (in the prevention and maintenance treatment of bronchospasm in adults and children, and in the prevention of exercise-induced bronchospasm).
p.3 "According to the Statistical review [Dr. Gebert, 1/14/99], there were statistically significant differences between the products for onset of action and for peak effect on Day 1 in study SALA3005 (p=0.011). The CFC product had a faster onset of action and a greater peak effect."
Professor Wanner, again:
"However, HFA does penetrate deeper into the airways and potentially could have more systemic side effects, he said. No data have shown this, though, and HFA has short-term and long-term safety profiles comparable to CFC."
Really, Professor?
This is what Schering-Plough itself says about its own product, Proventil HFA:
“Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol).” (Sixth paragraph from the bottom)
These are not systemic side effects, Professor Wanner?
How about these, Professor:
p.6 (Ventolin HFA NDA) "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."
(And remember, we can't blame these problems on ethanol, because Ventolin HFA has no ethanol. These problems are caused by other inactive ingredients and impurities unique to Ventolin HFA.)
NOTE: The placebo HFA did worse than albuterol CFC. What does this say about the safety of HFA-134a propellant?
NOTE: Albuterol HFA did much worse than placebo HFA. What does this say about the safety of the impurities and inactive ingredients in albuterol HFA?
NOTE: Albuterol HFA did much worse than albuterol CFC. What does this say about the credibility of the QUACKS who ASSURE us that albuterol HFA is just as safe as albuterol CFC?
VENTOLIN HFA's Adverse Reactions chart (page 5) shows the following differences in adverse reactions compared to CFC albuterol:
The incidence of THROAT IRRITATION in two 12 week clinical trials was 10% for Ventolin HFA vs. 6% for CFC albuterol.
The incidence of VIRAL RESPIRATORY INFECTION in two 12 week clinical trials was 7% for Ventolin HFA vs. 4% for CFC albuterol.
The incidence of COUGH (a common asthma symptom) in two 12 week clinical trials was 5% for Ventolin HFA vs. 2% for CFC albuterol.
NOTE: There were no adverse reactions occurring more frequently in CFC inhalers compared to Ventolin HFA.
PROVENTIL HFA's Adverse Reactions chart (page 3) shows the following differences in adverse reactions compared to CFC albuterol:
The incidence of TACHYCARDIA (rapid heart beat) during the 12 week clinical trials was over 7% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of VOMITING during the 12 week clinical trials was 7% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of FEVER during the 12 week clinical trials was 6% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of BACK PAIN during the 12 week clinical trials was 4% for Proventil HFA vs. 2% for CFC albuterol.
The incidence of ALLERGIC REACTIONS during the 12 week clinical trials was 6% for Proventil HFA vs. 4% for CFC albuterol.
The incidence of RESPIRATORY DISORDERS during the 12 week clinical trials was 6% for Proventil HFA vs. 4% for CFC albuterol.
But Professor Wanner says there's "no data" to show that albuterol HFA has more systemic side effects than albuterol CFC. That's his story, and he's sticking to it.
We refer you to the HFA MDIs: Just The Facts page to see three years of FDA MedWatch data, safety/withdrawal data from a large United Kingdom postmarketing study, and a New Zealand study, all of which further support our position that albuterol CFC is much safer than albuterol HFA, regardless of what 'experts' such as Professor Wanner say.
Third possible reason:
It is also likely that most of the politically inclined leaders of these Stakeholder organizations were pleased that they would 'have a seat at the table'; they probably enjoyed their proximity to U.S. and U.N. political power.
Fourth possible reason:
And certainly, IPAC's massive financial contributions to these nine Stakeholder organizations, in various ways over many years, helped these phony 'patient advocate' nonprofit organizations (aka patient front groups) and Men of Science In White Coats overlook the fact that the ban of CFC asthma inhalers was medically, scientifically and morally bankrupt.
We know one thing for sure.
None of these nine organizations gave a damn about patient safety, because all of them pressured the FDA to speed up the ban of CFC asthma inhalers (at the behest of their drug company masters) despite the fact that simple common sense dictated that large scale, real world postmarketing studies of HFA inhalers be done before depriving 40 million patients of their lifesaving CFC inhalers.
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