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Post by peppy on May 7, 2018 17:16:53 GMT -5
I do not mean to fight with you aged. I just disagree that there is that much undiagnosed COPD individuals that meet the non smoking criteria.
What Causes COPD Over time, exposure to irritants that damage your lungs and airways can cause chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. The main cause of COPD is smoking, but nonsmokers can get COPD too. Smoking About 85 to 90 percent of all COPD cases are caused by cigarette smoking. When a cigarette burns, it creates more than 7,000 chemicals, many of which are harmful. The toxins in cigarette smoke weaken your lungs' defense against infections, narrow air passages, cause swelling in air tubes and destroy air sacs—all contributing factors for COPD. Your Environment What you breathe every day at work, home and outside can play a role in developing COPD. Long-term exposure to air pollution, secondhand smoke and dust, fumes and chemicals (which are often work-related) can cause COPD. Alpha-1 Deficiency A small number of people have a rare form of COPD called alpha-1 deficiency-related emphysema. This form of COPD is caused by a genetic (inherited) condition that affects the body's ability to produce a protein (Alpha-1) that protects the lungs. www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/symptoms-causes-risk-factors/what-causes-copd.html=========================================================================================== The lung org missed a cause. Meconium asperation will cause COPD by another name. These people are under 18. Funny how objective, well vetted data is paramount when it supports our guts, but not so much when it does not. ( Not targeting you, Peppy.) od, I do not want to pay to read it. Here is what I could see. COPD is a chronic disease universally undiagnosed. Findings from several epidemiological investigations have shown that 75% or more of patients with COPD remain undiagnosed, without substantial changes in recent years.1,2 This fact is mainly related to a scarcity of clinical suspicion and underuse of spirometry, but probably also to an inherited nihilism on the effectiveness of treatments in the early stages of COPD. Although spirometry is a non-invasive, safe, and cost-effective procedure, it can be difficult for some patients to do, it needs adequately trained technicians, and it is more time-consuming than are other diagnostic tests, such as a sphygmomanometer or a blood test to diagnose hypertension or diabetes. You are correct, I do have an attitude about COPD. It is an awful disease. I do believe it is however recognizable. It may be the country we live in is so impoverished that people suffering from COPD can not afford to see a physician. Nothing sends me a physician faster than an airway problem, however that is just me. An ABC kind of gal. (Airway, Breathing, Circulation) However, if I was working at say 3M and had this; data show perfluorochemicals (PFCs) widely distributed in a dozen sites around 3M’s St. Paul facility, including two chemicals that the company phased out three years ago. The research, repeatedly impeded by state pollution control chief and former 3M executive, Sheryl Corrigan, shows some of the highest concentrations of PFCs ever recorded anywhere in the world. I see your point. |
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Post by sophie on May 7, 2018 18:14:53 GMT -5
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests. In this case it is because it is directly linked to the black box warning. Aren't kidney and liver disease measured by blood tests (that's a question, I don't know I just thought they were) and so you get the requirement with some drugs for ongoing blood tests as well. Yes, BUN/creatinine is a general guideline for kidneys AST/ALT/GGT, among others for liver While it's true that any good primary care physician will screen lab work yearly, I would still prefer my loved ones to get screened for COPD before starting on Afrezza. Whether that's an FEV1 test or a questionnaire about shortness of breath/wheezing, chronic cough, etc. Assuming Afrezza can cause an acute exacerbation of COPD, it would pose a much higher risk of immediate, severe complications and death than kidney or liver failure, which typically are much more indolent and would present with other warning signs before death. You run the risk of acute respiratory distress with COPD immediately vs a few days of warning even with severe kidney failure and much longer with liver disease. You better believe that doctors do screen for specific diseases if a medication has a high rate of harmful side effects. It would boil down to how often Afrezza causes bronchospasm in COPD. Then, of that, how severe was it? Medical literature often recommends against medical screening if the cost and complications are "worth" more than the few people who get missed because they don't screen. For instance, current guidelines recommend against screening PSA for prostate, against manual breast exams in women, against yearly mammograms in low risk, etc. So if it's a minor side effect, meaning bronchospasm isn't severe, or if only a few people out of the many tested got it, then screening would likely not be necessary. However, if most to all COPD patients get severe bronchospasm, it should most definitely be screened for before starting treatment. |
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Post by agedhippie on May 7, 2018 20:11:57 GMT -5
The same could be said for many drugs that, for example, could have dangerous consequences if used with other drugs or diseases (kidney, liver) and yet they do not require the doc to perform additional tests. The label doesn't "require" the doctor to do anything. It's merely a warning: "WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients" If the doctor and the patient see fit to ignore the warning, then that's their right. On the other hand, if the doctor does chose to ignore the warning and something bad happens in consequence, then the doctor faces a malpractice suit. When the label says "Before initiating Afrezza,..." that is a mandatory action. A warning is entirely different and is not mandatory. The doctor can ignore the mandatory action if in their judgement it is unnecessary (in which case assume the risk of a malpractice suit if something bad happens), or a patient can refuse the exam and waive their rights. |
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Post by sayhey24 on May 7, 2018 20:12:05 GMT -5
There seems to be a lot of confusion around the FEV1 requirement in the REMS. It was not for COPD. It was there as a concern about lung function lose upon initial use and the fact PWDs loose lung function faster than non-PWDs.
COPD was a second concern but the use of afrezza and its benefits have been determined to out-weight the concern.
In short, MNKD as part of the 3 year REMS requirement had to submit clinical data for the first 3 years. As has been discussed on this board many times afrezza users tend not to lose lung function and some are reporting better lung function. Few have reported any bronchospasm to the point where it is no longer considered a high risk concern.
As a result the REMS communication plan is no longer required and the REMS is no longer required. Changes to the label to reflect this requires an sNDA. Once negotiated and approved we will hear the results.
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Post by agedhippie on May 7, 2018 20:24:08 GMT -5
There seems to be a lot of confusion around the FEV1 requirement in the REMS. It was not for COPD. It was there as a concern about lung function lose upon initial use and the fact PWDs loose lung function faster than non-PWDs. COPD was a second concern but the use of afrezza and its benefits have been determined to out-weight the concern. In short, MNKD as part of the 3 year REMS requirement had to submit clinical data for the first 3 years. As has been discussed on this board many times afrezza users tend not to lose lung function and some are reporting better lung function. Few have reported any bronchospasm to the point where it is no longer considered a high risk concern.
As a result the REMS communication plan is no longer required and the REMS is no longer required. Changes to the label to reflect this requires an sNDA. Once negotiated and approved we will hear the results.LOL. No, read the FDA letter and then you don't have to guess. The requirement is to complete the mailshot, that's done. Same as Trulicity did. |
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Post by mnholdem on May 7, 2018 21:22:30 GMT -5
Locking this thread.
A big Thank You! to all who contributed to the discussion.
Original Post by kite
FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary
WESTLAKE VILLAGE, Calif., April 25, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza.
“We are pleased that the FDA determined that a communication plan is no longer necessary to ensure the benefits of Afrezza outweigh its risks and that a REMS is no longer required,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “We are grateful for the FDA’s guidance and expediency in this process, and we look forward to advancing our goal of establishing inhaled insulin as a preferred treatment option for individuals with diabetes who require mealtime glucose control.”
The FDA approved the original REMS for Afrezza in June 2014, and a REMS modification took effect in April 2015. The REMS consisted of a communication plan intended to inform prescribers of Afrezza of the potential risks associated with the use of Afrezza as described in the boxed warning. Two subsequent REMS assessments were conducted following Afrezza’s approval, and both assessments found that the communication plan met its goals.
The release of the REMS means that no further assessments are necessary; had it not been released, additional assessments would have been conducted at seven years post-approval. The Afrezza website, www.afrezzarems.com, will be inactivated, and the Company will no longer be required to distribute the Afrezza fact sheet at scientific meetings.
About Afrezza®
Available by prescription, Afrezza® (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Read more: mnkd.proboards.com/thread/9858/determines-afrezza-rems-communication-plan?page=1#ixzz5EsB6zbdI
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