1968: Concerns about rescue inhalers lead to improved improved safety regulations

Prior to 1968, rescue inhalers were available over the counter (OTC) in Britain. Yet it was about this time that it was realized that the rising tide of asthma related deaths correlated with the introduction of the Medihaler Iso.  As prescriptions and sales of the inhaler spiked in 1960, the death rate started to rise a year later.  The link was obvious.

This revelation generated not just concern among the medical community, but among lawmakers as well.  As a result of this new wisdom, in 1968 OTC sales of the inhalers were banned in Britain under Schedule 4B of the Poisons Regulations Act.  (4, page 162) 

At about the same time, "In June 1967, the Committee of Safety of Medicines issued a warning about the need for care in prescribing and using aerosols, emphasising their great value in treatment, but advising patients or parents to call their doctors if they failed to achieve the relief they usually experienced," according the authors of "Drug delivery to the lungs."

The death rate in Britain duly fell in the succeeding years.  Furthermore, as noted by the authors of "Drug delivery to the lungs:"
When the changes in death rate were compared with estimates of prescriptions, it could be seen that the rise and fall of the death rates had followed the graph of sales of pressurized aerosols almost exactly." (5, page 12)
Similar warnings were  regulations and warnings were issued in other nations, including the United States. Gregg Mittman, in his book "Breathing Space," explains that:
The bronchodilator scare abroad prompted American physicians in the late 1960s to reflect critical on the therapeutic use of inhalers in Asthma treatment in the United States.  As the sales of inhalers jumped form 3.3 million in 1964 to 5.1 million in 1968 in the United States, disturbing reports of patient abuse began to appear.  Many asthmatic patients had become addicted to their bronchodilator inhalers, often grasping them for dear life.  Some asthmatics admitted to going through an inhaler in a day. (6, page 235)
Physicians around the world realized that drugs alone were not going to work, that the entire environment around the patient would have to be investigated.  Likewise, the patient would have to be educated not just about asthma, but about the medicines used to treat it. (6, page 236)

As physicians and their patients became better aware of the risks of overuse of these inhalers, prescriptions and sales declined.  The result of this was a national decline in the asthma death rate, although it still remained higher than the pre 1930s era when asthma morbidity and mortality was considered negligible.

What did not fall, however, was asthma mortality. Studies performed during the 1970s would reveal that asthma morbidity trends have been gradually increasing since the introduction of rescue medicine.  This would be investigated during a spike in asthma deaths that occurred in New Zealand in the 1970s.

References:  See "1940-1970:  Asthma morbidity and mortality spikes"

References.

  1. Beasley, Charles Richard William Beasley, Neil Edward Pearce, Julian Crane, authors of chapter two in the book "Fatal Asthma" edited by Albert L. Sheffer, 1998, New York, Hong Kong, Marcel Dekker, Inc. Chapter two is titled "Worldwide trends in asthma mortality during the twentieth century." 
  2. Woolcock, Ann Janet, author of chapter 14 of the book, "Fatal Asthma," edited by Albert L. Sheffer, 1998, New York and Hong Kong, Marcel Dekker, Inc. Chapter 14 is titled "Natural Histor of Fatal Asthma." 
  3. Sears, Malcolm R., "author of chapter 29 in the book "Fatal Asthma," edited by Albert L. Sheffer, 1998, New York and Hong Kong, Marcel Dekker, Inc.  Chapter 29 is titled "Role of B-Agonists in Asthma Fatalities." 
  4. Jackson, Mark, "Asthma: The Biography," 2009, New York, Oxford University Press 
  5. Bisgaard, Hans, Chris O'Callaghan, Gerald S. Smaldone, editors, "Drug Delivery to the Lung," 2001, New York, Marcel Dekker, Inc 
  6. Mittman, Gregg, "Breathing Space," 
  7. Speizer, F.E., R. Doll, P. Heaf, "Observations on Recent Increase in Mortality from Asthma," British Medical Journal, February 10, 1968, 1, pages 335-339 
  8. Altman, Lawrence K., "The Public Perception of Asthma," Chapter one of the book "Fatal Asthma," edited by Albert L. Sheffer, New York, Marcel Dekker, Inc, pages 3 and 11 
  9. Speizer, F.E., R. Doll, P. Heaf, and B. Strang, "Investigation into use of drugs preceding death from asthma," British Medical Journal, 1968, 1, 339-343Sheffer, Albert L, "Partner Asthma Center's Grand Rounds," asthma.partners.org, http://www.asthma.partners.org/newfiles/ShefferFatalAsthma.html, accessed 10/5/13 
  10. Bendy, Christine J., E.L-Fellah, R. Schneider, "Tolerance to sympathomimetic bronchodilators in guinea-pig isolated lungs following chronic administration in vivo," 1975, British Journal of Pharmacology, 55, pages 547-554 
  11. Yarbrough, J., L.E. Lansfield, and S. Ting, "Metered dose inhaler induced bronchospasm in asthma patients," , Annals of Allergy, Asthma and Immunology," July, 1985, (55)1, pages 25-27 
  12. Grant, Evalyn N., Kevin B. Weiss, "Socioeconomic risk factors for asthma mortality," chapter 17 of the book, Fatal Asthma," edited by Albert L. Sheffer, 1998, New York, Hong Kong, Marcel Dekker, Inc.

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