The coronavirus outbreak has many patients worrying about whether they will be able to continue receiving their medications. The FDA is actively working on ensuring that this doesn’t happen and while they have already made some progress, they will continue to take additional measures. You can read the latest FDA Supply Chain Update in its entirety here.
The information below represents the more salient points of that update, IMO:
Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China.
Also, as part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China. We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs.
The FDA is using all our existing authorities to address COVID-19, and we welcome the opportunity to work with Congress to further strengthen our response capabilities and emergency preparedness. There are four specific proposals included in the President’s budget that would better equip the FDA to prevent or mitigate medical product shortages.
Lengthen Expiration Dates to Mitigate Critical Human Drug Shortages: Shortages of certain critical drugs can be exacerbated when drugs must be discarded because they exceed a labeled shelf-life due to unnecessarily short expiration dates. By expanding the FDA’s authority to require, when likely to help prevent or mitigate a shortage, that an applicant evaluate, submit studies to the FDA, and label a product with the longest possible expiration date that the FDA agrees is scientifically justified, there could be more supply available to alleviate the drug shortage or the severity of a shortage.
Improve Critical Infrastructure by Requiring Risk Management Plans: Enabling the FDA to require application holders of certain drugs to conduct periodic risk assessments to identify the vulnerabilities in their manufacturing supply chain (inclusive of contract manufacturing facilities), and develop plans to mitigate the risks associated with the identified vulnerabilities would enable the FDA to strengthen the supply chain by integrating contingencies for emergency situations. Currently, many medical product manufacturers lack plans to assess and address vulnerabilities in their manufacturing supply chain, putting them, and American patients, at risk for drug supply disruptions following disasters (e.g., hurricanes) or in other circumstances.
Improve Critical Infrastructure through Improved Data Sharing and Require More Accurate Supply Chain Information: Empowering the FDA to require information to assess critical infrastructure, as well as manufacturing quality and capacity, would facilitate more accurate and timely supply chain monitoring and improve our ability to recognize shortage signals.
Establish Reporting Requirements for Device Manufacturers: The FDA does not have the same authorities for medical device shortages as it does for drugs and biological products. Among other things, the FDA proposes to require that firms notify the agency of an anticipated meaningful interruption in the supply of an essential device; require all manufacturers of devices determined to be essential to periodically provide the FDA with information about the manufacturing capacity of the essential devices they manufacture
I am copying a post recently received from New PCI publcizing a short ASCO survey on how you embrace exercise and diet. As many know, AnCan strongly endorses exercise as part of any cancer management program; and sensible diet may also be significant and rarely hurts. I have taken the survey and encourage anyone previously diagnosed with any type of cancer to do so. (rd)
The American Society of Clinical Oncology (ASCO) has put together a brief research survey to learn more about patients’ experiences with cancer care. Specifically, ASCO is interested in patient’s perspectives on how things like diet, exercise, and weight management are incorporated into cancer care.
The survey should take most people no more than 10 minutes maximum to complete. All questions are optional, and ASCO has stated clearly that no personally identifiable information will be collected.
If you are an individual with a personal history of prostate cancer (or cancer of any other type), please click here to take this patient survey. Thanks for your help to ASCO in seeking to improve cancer care.
If you know others who are > 18 years of age and who have been diagnosed with any form of cancer, ASCO would also appreciate it if you passed information about this survey on to those people too. ASCO is seeking the widest possible range of responses to this survey from the cancer patient community.
Our Board Member and Moderator, Ken Anderson resides in Phoenix and is living with metastatic prostate cancer. He recently uncovered this article on a longstanding controversy over why many trials are not well reported. (rd)
Seems the topic of clinical research and the data identified when the trials conclude has been around for years but one that I have just recently been forced into exploring in depth. At this point in my prostate cancer journey, certain second line hormone threapy drugs, that I would have hoped extend my life for years, have failed after just a couple months. This seems to be true for others and at the moment no one seems to know why. Is it from starting up front with aggressive treatments like chemotherapy? That may have forced my cancer to change just enough so something within the cancer cell activated and my cancer no longer has the required structure to allow these newer drugs to help extend life.
At this time I am fully aware that managing disease progression and cancer burden is the goal. As we move through these drugs and exhaust the Standard of Care outlined by our medical oncologists, our next option is to look for clinical trials. The data from these trials, both good and bad, has value. I can only hope that even when the data is not published, it is at minimum shared among our finest medical institutions and doctors.
An article published in Science this past month helps outline some of the Centers of Excellence that are doing a fine job with making the data available and others that are not doing so well. Find the article here.
We can only hope that the FDA and the NIH will start to use the power they do have to force more active reporting. The data from these trials, no matter the outcome, should be published in a timely manner.
Editor’s Pick: Should a man with aggressive disease (Gleason 4+5) trade off allopathic medicine for QoL?
Still no GtM transcripts ….. and we had a lot of technical difficulties with audio this week – apologies!
Gleason 8/9 diagnosis – what next?; QoL vs allopathic treatment for another G9 man who deferred action; monitoring post-18F DCF Pyl scans; Intermittent HT working; frequency of scanning with metastatic disease; experiencing docetaxel + carboplatin; chemotherapy + darolutamide; leg cramps on startin abiraterone + prednisone
Jane Brody, the New York Times doyenne of medical journalists, has recently penned two articles on the PSA test and Prostate Cancer Active Surveillance (AS). I use the term ‘doyenne’ with the greatest respect to our Advisory Board Member and AS Moderator, Howard Wolinsky, another fine medical writer, who ironically Brody prominently biographies in her second piece. Congrats to Mr. W !!
The articles, while informative and generally helpful, lack perspective and accuracy. I would not go quite so far as to be grouped a bedfellow of “The Chumpster” and charge this widely read and esteemed daily with ‘Fake News’ ; but errors of inclusion and ommission are all the more significant given the prestige of the New York Times. Here are just a few suggested corrections:
The PSA test is about information NOT treatment . At AnCan we strongly endorse widespread PSA testing because if you don’t know, you can’t treat. Overtreatment is down to poor communication between doctor and patient …..NOT the test.
The quoted European PSA study was actually corrected post intial publication and its results endorse PSA testing.
Epidemiological measures like the number of tests needed to save one life are infuriating to this pundit …… how do you value a life?
There is no mention that prostate cancer specific deaths have actually risen in the past couple of years. Is it a coincidental correlation that this follows the USPSTF recommendations against testing by a suitably long enough time period to allow disease specific death? Both Howard (on MedPage Today) and I have written about this – see these Blog post.
Dr. Eggener at my alma mater, the University of Chicago, is reported to have indicated about 5-10% of men choosing active surveillance progress and require treatment. In our view that number is grossly understated – Dr. Peter Carroll’s UCSF cohort reports it at much closer to one-third, and I believe that has been endorsed by other studies like the Canary Trial, and Dr. Klotz’ Sunnybrook cohort
Gleason 7 disease, whether it be 3+4 or 4+3, is never low risk. Anytime you have a 4 in your Gleason score, you are at least intermediate risk, and your prostate cancer must be treated seriously ….. that does not mean certain men with 3+4 Gleasons cannot consider AS. They can, and there is extensive literature.
Not all Gleason 6 disease should be reclassified IDLE , Dr. Eggener- it depends vey much on volume.
I could go on … but you get the idea! And it does not take away from the deserved kudos for our intrepid AS Warrior, Howard Wolinsky, who we recently welcomed as an additonal moderator to our Active Surveillance Prostate Cancer Virtual Group. That is becasue we are expanding the AS moderator team to accomodate a second meeting in response to the enthusiastically large atttendance for just one meeting a month! That, by the way, is this Wednesday, March 3 …. please join us.
Those of you who have followed me for years know I am totally committed to exercise. I strongly believed and endorsed its positive effects for disease control, especially for cancer. long before it was fashionable or well documented. I started a cancer exercise program at UCSF within 18 months of being diagnosed myself in 2007, that has flourished. At the time there was a paucity of evidence …. now it is abundant. Some of that evidence is well documented on the Research Page of our MedaFit site.
Our regular paritcpants in the High Risk/Recurrent/Advanced Prostate Cancer Virtual Group will know we have two particpants who swear by Dragon Boat Racing ….. Richard Foody who paddles for the MSKCC team.trained by guru Donna Wilson, as you can see.
And Advisory Board Member, Richard Wassersug PhD who paddles out West for his Vancouver based Butts in a Boat team. Richard’s colleagues recently published an academic paper in the February 2020 Issue of the Journal of Psychosocial Oncology that, to none of our surprise, concludes:
Physical activity improves quality of life in men with PC and recreationalphysical activity interventions may be attractive supportive care options for PC survivors with both physical and psychosocial benefits. Joining a sportfocused care group may increase social support and elicit positive psychological growth and future interventions may benefit from integrating the unique characteristics of dragon boating into peer support programs formale cancer survivors.
You can read the full Dragon Boat PCa study 2020 by clcking on the live link. Kudos to both Richards on their Dragon Boat Paddling!
Me on the other hand ….. am very happy in my single scull – the exercise without the social part!
Editor’s Pick – it ain’t over til the Fat Lady sings, so wait until the very end to hear us uncover a rarely used form of ADT that been around since 2006 and is given annually.
Please note that changes made by both GoToMeeting and YouTube make the transcript unavailable this week. We are investigating if we can resolve.
Viewing our videos; testosterone spikes after recurrent shot – but is this an error?; coronavirus precautions; spot radiation experience; TP53 mutation; is it worth treating the primary with metastatic disease; coordinating local and quarterback doctors; MPCP; starting hormone therapy; Eligard vs Lupron; Vantas – a 12-month LHRH pellet
Read Peter Kafka’s recent thoughts on getting your medical team to work in unison. This is not a hypothetical either – Peter has a quarterback doc in S. California, lives on Maui, and wants to do chemo locally. (rd)
A Tale of Two Doctors
I know that some of you, like myself, rely on the expertise of a doctor at a Center of Excellence or a larger medical facility that might be a good distance away from home and then choose to get treatment for your disease locally. This brings up the situation of two doctors communicating and working together on your treatment plan. This is the circumstance I find myself facing at the moment.
For the past six years I have relied upon a trusted genitourinary medical oncologist, Dr. Jeffrey Turner at Prostate Oncology Specialists, to guide and manage my treatment course on this aggressive prostate cancer journey I am on. Now that I have progressed to the point that a regimen of chemotherapy is called for, I have chosen to carry out this treatment at my local cancer center here on Maui. So, I have been interviewing the few Maui-based medical oncologists to determine who could work under the direction of Dr. Turner.
One of the doctors I met with the other day was a young man who appeared to be quite knowledgeable, not long out of medical school and therefore perhaps lacking in practical experience. This doctor let me know right out of the gate that he did not agree with Dr. Turner’s treatment plan. He thought it was far too aggressive and that he would not advise it. He had statistics and studies to back up his argument. I think that he had my “best interests” at heart, letting me know that the side effects of chemotherapy can be quite harsh that is why he utilizes this protocol further along in the journey.
I listened to his argument, and understood where he was coming from, but I realized that he, like many doctors was more interested in treating the disease and not the person. Good medical schools can probably be quite proficient in teaching doctors how to select the right treatment modality off the shelf for any particular disease. But behind the disease is a person – me – who might present some unique aspects of the disease that require thinking outside the box and perhaps a more aggressive approach to treatment than the “standard of care”.
Convention says that the English alphabetical order begins with A and ends with Z. But if we are treating the person rather than just the disease it might be called for to end the alphabet with WZYX. We haven’t left out anything, just changed the order a bit. I think for those of us who might be facing (prostate) cancer with perhaps some unusual factors, it behooves us to find expert physicians who will manage the treatment of US and not just the disease. And then if necessary, find a local doctor who will coach on the field. And yes, I did find my man!
Editor’s Note – this is not a new problem to us. Just recently another of our participants asked his local oncologist to speak with his QB doctor at a renowned Center of Excellence in another state. The call took place in the patient’s presence, they waltzed around each other and appeared to arrive at the same conclusions, when in fact they did not agree at all. The call was not conducted on a speakerphone.
The lesson here is to make sure you are party to 3-way conversations. Doctors may accord each other professional courtesy before considering the patient’s interest. At least be sure what each one is suggesting before they speak so you can challenge an unexpected final recommendation.
Editor’s choice: Learn first hand about certain side effects from the immunotherapy drug, nivolumab (Opdivo).
Pharmokinetics of Lupron – explained a little; side effects of immunotherapy anti-PD1 drug Opdivo; treating liver metastasis; getting palliative doc involved; durolutamide results; starting ADT froom scratch; monitoring G5+5 PCa after you come off LHRH; what to know when starting chemo; neuropathy and maybe how to prevent it from chemo
Chat Log
Russ Smith (to Everyone): 7:20 PM: Turns out I was given a script today for Casodex.
Ken Anderson (to Everyone): 7:22 PM: Russ
Ken Anderson (to Everyone): 7:22 PM: good to know!
Our regular paritcpants in the High Risk/Recurrent/Advanced Prostate Cancer Virtual Group will know we have two particpants who swear by Dragon Boat Racing ….. Richard Foody who paddles for the MSKCC team.trained by guru Donna Wilson, as you can see.
Me on the other hand ….. am very happy in my single scull – the exercise without the social part!