Thirty patients have died after taking a Vertex (VRTX) Pharmaceuticals treatment for cystic fibrosis, according to a government database, news that sent the company’s share price down as much as 4% on Wednesday morning.

The deaths, reported to the Food and Drug Administration’s database of side effects, relate to patients who took Symdeko, a Vertex medicine approved last year. Reports to the database are commonly submitted by health care professionals and often contain incomplete information about how patients died and what other medicines they were taking. It’s also unclear whether any of the deaths are directly related to Symdeko.

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  • Vertex provides the drug for free across Europe on an individually assessed compassionate use basis, predominantly for sufferers with critically low lung function (sub 40%). Unfortunately, those with such low lung function will correlate with earlier deaths.

    • I personally am very thankful for the development and approval of Pulmozyme, which is manufactured by Genentech. I attribute much of my daughter’s preserved lung function to the effects of this drug, even more so than the Vertex drugs. A similarly irresponsible article could also make the same point though- that patients are dying while taking Pulmozyme- which would also be true. This again is the fault of the disease and not the medication.

    • I wanted to show that when you enter “Pulmozyme” in this database, a death toll of over 200 appears when we talk about a drug that is a priori safe and has been proven for years …

    • To be completely clear, I simply wanted to tell the author of this article that “Pulmozyme” and many other drugs could suffer the same type of attack!

  • It’s MRSA, Methicillin Resistant Staphylococcus Aureus, NOT “MERSA”
    Your article is written irresponsibly. As many respondents have already stated, CF is fatal, and many factors may have resulted in the deaths of CF patients who just HAPPENED TO BE taking a Vertex drug. In no way should their deaths be equated with the medication unless a correlation is actually found. The disease process itself likely killed the patients, and the positive effects of the Vertex drug(s) were insufficient to save their lives.

  • Also, CMsgBoards- I am thoroughly impressed that you have never been hospitalized. At the ripe age of 6 years old, my child has had 8 surgeries and 6 hospitalizations. I wish it were different for the rest of us, but your case sounds like the exception rather than the rule. Keep rocking it and know how fortunate you are!

  • Shame on you, Damian Garde. Although you are trying to make a name for yourself as a national biotech reporter, you obviously know very little about the biotech about which you are reporting. Cystic Fibrosis is a death sentence to EVERY patient, and the FDA-approved Vertex drugs have given more time to many, many patients living (or dying) with CF. Guess what? Until CF is cured, EVERY patient that takes a Vertex drug will die!!! This is not the fault of Vertex but the natural course of this terrible disease. As a Master’s degree-holding healthcare professional and parent of a child with CF, I find the way in which you presented this information offensive. Thankfully, I have the critical thinking skills to understand the facts beyond those proclaimed in your article. But what about those people (some of whom have commented on this thread) who lack such skills? I suppose that’s why you’re just a biotech reporter and not an actual biotech scientist.

    • Hi Caroline. This is not true. I am 36 years old with CF, on Kalydeco with 95% lung function. I have never been hospitalized. I have no reason to think of CF as a death sentence, other than in the sense that life itself is a death sentence. No reason to be overly negative.

    • Congratulations! I appreciate hearing that, and every day I hope/pray/believe that I will be able to say the same about my child. I imagine that you attribute at least some of that success to the drug Kalydeko, which Vertex provides to you? The point I was trying to make to this uninformed reporter is that the way he presented this statistic about 30 people dying while taking Symdeko unfairly casts stones at Vertex. I admit that the aggressive way I addressed him and the issue at hand would make anyone affected by CF (myself included) uncomfortable. My child has a full, happy life with an FeV1 of 110% predicted value and is by no means a victim- by the grace of God, countless hours of vest treatments, and the drugs that we fundraise so vigilantly for companies like Vertex to provide.

    • Bravo Caroline Kelly! You could not be more accurate on your comment about this article. Our 20 year old was considered a healthy Cf’er, until recently, as the passage of time slowly deteriorates its victims. Now that she is on Symdeko, she has been holding steady, has more energy and eagerly awaits the approval of the triple combo therapy that will transform her young life. My husband and I applaud you for standing up for Vertex, knowing full well the results we are seeing in front of our own eyes. Many blessings to your family!

  • Unfortunately, despite all the advancements, cystic fibrosis is still an incurable disease that takes the life of too many, including many young patients. I am a healthcare provider and I care for these patients each day. These medications will not reverse severe advanced disease – the only treatment at that stage is lung transplant. In order to properly assess whether the deaths could be linked to the drug, one would need to know much more information including the stage and severity of the patient’s disease prior to initiation of Symdeko. Gene therapy is what we need for cystic fibrosis.

  • Unfair reporting. The header to this article is misleading since their were a variety of factors that could have led to the deaths of these patients. CF is a complicated disease and we don’t k ow where these patients were with their disease progression. This article only serves the purpose to hit a panic button without truly understanding the circumstances/medications and current disease state of each patient that passed away. Vertex has provided hope and significant quality of life to patients that haven’t had either. I would urge every reader to be very skeptical of headlines like the one from this author!

  • I’d wait for more data on why these people died. Kalydeco, Orkambi, and Symdeko have improved the lives of people with Cystic Fibrosis IMMENSELY. I can’t say Symdeko was not a factor in these deaths. But further work is needed to determine IF Symdeko is a factor. IF it was then it is VERY important to know under what conditions, etc., it might have adverse reactions.

  • We can no longer expect any of the regulatory agencies to protect us. Through a process known as Regulatory Capture, none of our Government Agencies are functional anymore. They have been turned over to the industries that are profiting, from misinformation, misleading and deceptive marketing, and outright corruption.

    The media profits from the same industries, so the real story is not being told. It is really clear that this drug was released too soon and without the appropriate safety guarantees. The only motivator anymore is profit, not patient safety, or public health. Currently politicians who are firmly in the pocket of the pharmaceutical and other industries, make decision based on profit for their funders. We see an opiate epidemic, and disastrous results from the corrupt practices of these corporations. The FTC failed to regulate pharma marketing, and the media that depend on this funding kept quiet, and spread lies and misinformation.

    • There are approximitaly 75,000 people in the world with a diagnosis of cystic fibrosis. When I was born with it the average life span was 7 years old. Today the life span is 40 plus years and climbing. To say that this drug was released to market too soon is a quick judgement call. Cystic fibrosis is a terrible disease and the fact that there is no specified reason given for the 30 deaths it would be wrong to link those 30 deaths to Symdeko as the cause without more information. I would encourage anyone who does not know a lot about cystic fibrosis to do the reasearch on all the areas of the body that are effected by this disease. Orkambi, Kalydeco, and Symdeco have provided a lot of hope and for the CF community. It has also made the hardships of living with this disease more bearable with the improvements in quality of life.

    • Are you American?
      I take Symdeco
      You sound very bitter,and seem to believe that large organisations are corrupt,misinform, or lie.
      Do you believe we landed on the moon? or you you believe in dubious conspiracy theories!

    • Cystic Fibrosis is a terminal disease. Until it is cured, EVERY patient who takes a Vertex drug will die. This is not due to negligence or greed on the part of Vertex pharmaceuticals but rather the natural course of this terrible disease. Also, because CF affects such a small percentage of the population (~30,000 Americans), it is considered an “orphan disease”. That means that research of treatments for CF is NOT federally funded. I can’t attest to the accuracy of your statements with regards to other drugs and pharmaceutical companies, but politicians don’t push legislation in favor of funding drugs that specifically treat the underlying cause of cystic fibrosis (which is exactly what Symdeko does). This article was written in such a way as to misinform you about Cystic Fibrosis and the drug Symdeko.

  • Well ,well .this is one more of the drugs . medications or products within the health care system or industry . It is a drug that i have heard of relatively at a low margin or percentage .hence forth i am unable and or lack the authority and extensive information about it to comment . and or interpret it at a level of prudence ,factual and broad confidence as such . Not with standing all and or most of the things or products so named drugs have and are consisted of a significant degree of negatives , side effects and uncertainties . hence there fore one should avoid as best as possible to avoid taking these drugs as less as is humanely possible . The magic wands are to endeavor to keep and stay as hygienic , healthy and clean as again as possible . One the main criteria is to ensure to wash our hands as often and regular each day . and even more so to wash them properly .inclusive within the inner sections of our finger nails . any and every food items purchase at any stores that are able to be washed must be done so again extensively . The new and deadly factor is The Antimicrobial Resistant Super Bugs That are killing tens upon tens of thousands of humans from the year of 2015 to the year of 2020 and costing the One Hundred Trillion Dollars To The year of 2030 to quote ,unquote The World Health Organization?s Report of The year of 2014 with the two hundred fifty seven pages of information., data and statistics .. Hospitals are The Death Cells for this and more such as Mersa . As best as possible run away and stay away from Hospitals . i thank you Trevor. Merchant . Wednesday . August . 28. 2019 at 4. 39 p.m daylight savings time . New York City .

    • No idea what you’re trying to get at Trevor, but scrubbing meticulously under my fingernails isn’t going to make my lungs function normally.

      I take symdeko and have seen amazing results. I am curious to hear how these 30 people died. Will be following this story

    • Ohh man!! What a waste of my time reading tour crap. CF is a genetic desease….pretty sure you can’t fix it by washing tour hands.

    • CDC advises against rinsing store-bought poultry before cooking. You can check it out at CDC.gov.

      Of course people on Symdeko die. They have cystic fibrosis, a FATAL genetic defect. This medication is not supposed to cure the disease, but to prolong lives. So instead of needing a lung transplant at 25, you don’t need one till 45 or 55.

      FYI, I am a physician & my son is on a Veratex CF modulator, Kalydeco. I fully expect him to live long past current media major survival of 35… In part due to Vertex pharmaceuticals.

      And it is MRSA not mersa. It stands for methicillin-resistant Staphylococcus aureus. And it is a big deal in cystic fibrosis patients.

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