Saturday, April 11, 2020

NEW DRUGS AND NEW QUESTIONS AND PROBLEMS

     The medicine is changing fast and new medicines are invented  and used daily and many are good  and some will be gone in future. But with new  drugs we have new problems . Whenever there is new drug on the market the pharmaceutical company calls it ' Launching' the new drug . That stimulates many people to market it .The company has drug reps and their managers  and superiors  and ad campaign  and meetings  and studies etc This is the only way to 'educate ' physicians about the new drugs  and the indications , dose  and side effects etc. There are some drugs that have limited use  and number of patients that can use it are less. So the cost is high . These drugs, when the number of patients that have been diagnosed or have that disease, are less than 250,000 in US, then these drugs are called 'orphan drugs'.This brings me to today's story.
     I had seen this 74 years old patient 2 years ago . She had scars in the lungs  and she had the scars which were diffuse  and they were in both lungs  and since we did not know that cause of the Fibrosis, it is called Idiopathic Pulmonary Fibrosis, IPF. There was no treatment in past that was effective. We have tried many different drugs including steroids. Few more came  and were tried  and were proved to be not effective  and many patients with true IPF would die in 3-4 years . So may be 4 years  ago or so , 2 new drugs were approved  and they were suppose to slow the decline  and the studies did confirm that. The cost is $30000 or so per year! So we had something that we can offer. But the problem is there are many patients that DO NOT GET WORSE. The patient had fibrosis  and I did not know the cause of the fibrosis  and she did not want biopsy. She had fibrosis even 3-4 years  ago when she had CT scan done by some one else . So she had IPF . But she had not been evaluated by lung specialist . I did the usual tests  and she had reduction in her lung capacity  and she also had oxygen saturation dropping when she slept and walked  and so I started her on oxygen and talked to her about the new drugs - by now theses drugs were not NEW . She had some colon issues in past. The common side effect is nausea  and diarrhea.So she was very reluctant for the new medicines to be added. After follow up for almost a year she had nt gotten much worse . The problem with this diagnosis is that only few -may be 20-30 % get worse  and if the treatment is started earlier , then response is better. So I decided to start her on meds  and told her that she can go to Mayo clinic  and get an opinion .
          She went to Mayo clinic  and she saw number of physicians  and had SAME TESTS  repeated . She was told that she had Fibrosis but she did not have TYPICAL IPF They thought she should consider some other suppressant medications . I will  not go in details of the types conditions that could lead to fibrosis.The first line of treatment is steroids for the diagnosis that they thought she had and she has been treated with it . The steroids do not work for IPF. They told her her to stop the medication that I had started  and she had taken for less than month. The patient came to me  and wanted me to DECIDE AS TO WHAT TO DO . My problem was that Mayo did not do any new tests  and what they told her was their opinion and there was no proof for it  and I did not want to try something that would suppress the immunity.in this older lady . I also knew that she had used steroids  and that would have been first line of treatment and also that she had this for few years .
I was stuck . The new drugs are approved for only Fibrosis of unknown etiology and not for fibrosis of any other etiology . My reason for starting her on the drug was simple .She had done steroids  and the CT scans were abnormal for number of years . So if she has other causes of Fibrosis , we can not use drug . She did not want much drugs anyway as she felt she had not worsened
    The problem and questions that we have is cost and indications  and the side effects. So at present movement We are going to do follow up on her CT scan and breathing test  and other things  and then decide. She does not want biopsy to get definitive diagnosis  and does not want drugs  and so this is the only options . . 

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