A balanced Perspective
Our national (and international) culture(s) have become very focused on immediate gratification. Any news cycle that does not keep up with “Breaking News” each and every day is soon relegated to the back. It is no wonder we have cynical exploitation in tabloid style hyper sensationalism as well as apathy and lack of reasonable action on part of the public.
Here then is my honest take on what is at stake when this virus comes back this fall during our peak flu season. Notice I said “when“, not “if”. Most if not all experts agree H1N1 will be the driving force behind the 2009 flu season. No ifs or buts about it. Flu Pandemics tend to happen in waves, a relatively “easy” early summer wave followed up by a fall wave that is much more devastating. See the classic 1918 flu waves below, for the United States. There is some concern that with the speed and frequency of air travel in our modern world there may not be the “breathing time” between successive waves that we saw in 1918.
Flu and common cold: very different beasts
Almost all of us have had head colds at one time or another. But if you have been fortunate enough not to have had full blown flu until now and assume it is like a bad head cold, please think again. My family (my Mom, brother and I) got the 1957 pandemic flu. I was 9 years old and I felt I was dying. I almost did. Raging high fever, loss of consciousness, deliriums, unmitigated projectile vomiting that left us seriously dehydrated – it was very frightening experience. It left me and my brother weak as kittens for many weeks after we recovered. Flu is like a common cold? Not on you life! When you get the flu you will surely know the difference.
What makes H1N1 different from last year’s flu?
Flu viruses circulate through their human hosts for many years, changing out bits of themselves as they mix and match snippets from different strains. It has been a while since there has been a truly novel flu strain that majority of us have not seen at one time or another. The “bird flu” (H5N1) that created a stir a couple of years ago was one such. Since our bodies had no experience of this particular flu virus, an alarming number of people who got infected with it died. The latest tally on WHO H5N1 site lists 262 deaths in 433 confirmed human infections. Fortunately for our species, this bird virus was not very good at infecting humans. As we discussed in a prior article, bird viruses are used to the higher temperature of birds and have a tough time thriving in our colder human bodies.
But the H1N1 flu virus getting WHO’s Pandemic 6 status is a very different beast. For starters, it seems to have originated in pigs (with a few bits of DNA thrown in from human flu viruses and bird viruses as well). This promiscuous virus has proven to be able to infect anyone it comes into contact with at will. Dozens of countries have documented cases of human-to-human transmission. People sitting a couple of rows ahead of an infected passenger on airplanes have come down with the same infection – proving droplet transmission (brought about by sneezing and coughing) happens all too easily with this virus. As for schools, day care centers and other similar germ factories, this virus is very good at passing from child to child with little hindrance. The CDC has declared that just about all of the flu cases in the USA during this otherwise off season (our flu season typically ends in late April) represents H1N1 infections. So much so that most states have stopped bothering to test and confirm for H1N1. Take a look at chart below from the CDC and you can see how the dark blue (novel H1N1) dominates the picture starting around week 17.
Folks, this virus is not going to go away. It will infect more and more people until our species gradually develops familiarity with it, just as we did with all previous varieties, over a matter of a few years. The trick is getting from here and now to then and there, in one piece.
One-Two Punch
What made the 1918 flu virus so very dangerous with millions of people getting killed around the world? There are two things that a dangerous killer virus has to do. First, it must be able to pass from person to person (human-to-human transmission) with relative ease. H5N1 could not do that and we dodged a bullet. But H1N1 has proven itself to be quite able to spread easily. In a matter of a couple of months it has literally circled the globe and infected thousands (most likely hundreds of thousands) of people in almost all countries.
The second thing that a killer virus has to be able to do is be so devastating in its effect on the host that it kills a large percentage of the people it infects. As I mentioned above, H5N1 killed more than half of the people it infected. Fortunately for us, thus far the CFR (case fatality rate or the number of cases that died) is still quite low for H1N1. Neither H1N1 nor H5N1 have learned both of the tricks needed to have massive human casualties. The nightmare scenario that no doubt keeps up public health officials from getting a good night’s sleep is the possibility of these two viruses meeting up in some Asian countries where H5N1 has become well entrenched. If the two viruses share (exchange DNA snippets) and the trick each one has learned, thereby spawning a new version that knows both tricks, we will be in for a very bad time indeed.
The Optimistic Scenario
For the sake of argument let us assume we luck out, H1N1 continues to infect human populations across the world as it has already shown itself capable of doing, but it does not learn massive killing capability. Experts project roughly one third of the human population (6 billion, give or tak a few hundred million) will get infected. That is 2 billion people getting quite sick. How will our healthcare systems handle that kind of patient load? How will poor countries handle it? How about groups of people with chronic health conditions that require frequent access to healthcare resources?
If we get lucky and the case mortality remains low, say a mere 0.1%, or one person out of every 1,000 infected people, we are talking of “only” 2 million people dying worldwide. No doubt, the actual death toll will fall much more heavily on poor and crowded countries with scarce medical resources and poor hygiene. Mind you, this is the optimistic scenario. A mere two million people dead, many of them people in the prime of their lives, individuals who were bread winners and home makers.
Implications for CLL Patients
Let us continue with the optimistic and hopeful scenario I suggested above, but see if anything changes when we drill down and look at our patient community as opposed to the general healthy public.
What is the single characteristic reported about the deaths we have witnessed thus far with H1N1? Health officials have been quick to point out that many of the victims had underlying health conditions. Here is the list of risk factors CDC has on their site:
chronic cardiovascular disease (congestive heart failure and cardiomyopathies) chronic pulmonary disease including chronic obstructive pulmonary disease and emphysema diabetes mellitus alcoholism chronic liver disease, including cirrhosis cerebrospinal fluid leaks functional or anatomic asplenia including sickle cell disease and splenectomy immunocompromising conditions including HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome; those receiving immunosuppressive chemotherapy (including corticosteroids); and those who have received an organ or bone marrow transplant
I have highlighted some of the more obvious risk factors our guys are likely to have, both because of the CLL and the age group we are likely to be in. You may argue with me about some of the ealrier bullet points, but there is no way of avoiding a whole host of risk factors listed under the last bullet.
What does that mean? Well, even if swine flu H1N1 retains its low case fatality rate that we see right now in the general public and does not learn any new tricks along those lines between now an d the fall flu season, the case fatality rate is likely to be much higher in at-risk populations. That means CLL patients are at much higher risk of dying if they get the H1N1 flu, compared to the general otherwise healthy population.
Killer Pneumonia
Just about all the case fatalities in the USA had been on ventilators for massive pneumonia prior to death. Unless you are new to CLL Topics and Updates, you are by now familiar with my often repeated statement: the single biggest cause of death in CLL patients is pulmonary infections and pneumonia. Put these two pieces of the puzzle together and you understand why I am deeply concerned about the risk posed by H1N1 pandemic to our patient community. Unless you are extra vigilant about avoiding infection in the first place, there is a one in three chance you will get infected. Once infected, you are much more vulnerable to viral pneumonia. Given our sleeping-on-the-job immune systems, there is much higher chance that the viral pneumonia due to H1N1 can pick up addition life threatening bacterial pneumonia. Have I scared you sufficiently? I hope so. Rather that than you walking into this fall’s flu season blissfully unaware of your particular risk status. Mind you, the scenario I have considered is the optimistic one.
Pneumonia Vaccinations
The CDC has a full section recommending pneumonia vaccinations. Here is link to the section, please visit it and read all the details. Below is a quote:
“During influenza outbreaks, pneumococcal vaccines may be useful in preventing secondary pneumococcal infections and reducing illness and death. Currently, two vaccines are available for prevention of pneumococcal disease, a 23-valent pneumococcal polysaccharide vaccine (PPSV23) and a 7-valent pneumococcal conjugate vaccine (PCV7)”
CDC’s Advisory Committee on Immunization Practices (ACIP) recommends a single dose of PPSV23 for all people 65 years and older and for persons 2 to 64 years of age with certain high-risk conditions (listed above). People in these groups are at increased risk of pneumococcal disease as well as serious complications from influenza. A single revaccination at least five years after initial vaccination is recommended for people 65 years and older who were first vaccinated before age 65 years as well as for people at highest risk, such as those who have no spleen, and those who have HIV infection, AIDS or malignancy.”
Do you know when you got your last pneumonia vaccination? Was it longer than 5 years ago? Did you know which type of vaccine you got, the PPSV23 or the PCV7? Did your spouse get the shot too? If you are not sure how to answer any of these questions, I strongly urge you to talk to your GP about getting a PPSV23 shot right away. Yes, there is ALWAYS the question about whether or not your immune system is still able to mount much of a response to any vaccination, but I think it is prudent to get whatever help you can get. And the CDC advisory committee’s recommendation of PPSV23 for at-risk populations like CLL patients is very compelling.
The other obvious action item is to make sure your immediate family and those around you stay as healthy as possible – a case of “herd immunity” protecting you as well. If your spouse is over 65 or has any of the risk factors listed above, it is important to get him / her to get the shot as well.
Housekeeping
Normally “Updates” software does not let through live links in the comments section – a way of avoiding spam and links to sites peddling Viagra, cheap knock-off watches and degrees, or free money from Nigeria. But for this article I will allow comments with live links to go through (provided they are related to the topic under discussion and not blatant marketing ploys). It means a lot more admin work for me (or Radha, our webmaster). But I think it is worth the extra work to make sure we get access to all the credible information out there. I am hardly an expert on this subject, I defer to people like Peter Carpenter on it.
26 comments on "Pandemic 6 Declared: What it Means to CLL Patients"
According to Dr. Hamblin, CCL people shouldn’t get live vaccines. Is the PPSV23 vaccine a live vaccine?
The advisory panel of the CDC voted unanimously to upgrade their guidance on pneumococal vaccinations. You can read their detailed report here:
http://www.medicalnewstoday.com/articles/126810.php
Some other links that might be useful:
http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-ppv.pdf
http://www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm
I have not seen anything to suggest this vaccine has live virus in it and contraindicated for our members. I will keep looking and report if I see anything that raises a red flag for me.
I don’t understand one of your recommendations. Should we get the PPSV23 or the PCV7? Which is recommended for CLL?
Will Medicare pay for the vaccines?
We had pneumonia shots [and shingles vaccine] just before I was diagnosed in Dec 2006.
Jane:
It is not (repeat, NOT) my recommendation. I would be stepping out of line in giving such a recommendation since I am not a medical doctor.
As I mentioned in the article, this is the latest recommendation of the CDC. I provided the link to their site where they make a case for the PPSV23 vaccine for folks like CLL patients. Here is the link again, for your convenience:
http://www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm
I strongly urge you to refer to this link as well as the links I provided in my comment above. I also urge you to consult your own GP.
As for Medicare, I am not familiar with Medicare’s payment policies. Anyone else cares to chime in on this front?
The PPSV23 vaccine is not a “live” vaccine. It is safe, but may not work as well in CLL patients as in patients without CLL. Another vaccine to consider is the hemophilus vaccine (HIB vaccine) for those of us who are immunocompromised.
As soon as my CD4 count indicates some semblance of return toward normal after my alemtuzumab I intend to be revaccinated for pneumococcal infection as well as HIB. I received the pneumococcal vaccine in 1/07 at the time of diagnosis. There is no cost effective means by which to test the efficacy of this vaccine in individuals.
Jane Marie should check with her physician, but most likely had the pneumococcal vaccine in 12/06. She should discuss the pros and cons of revaccination depending upon her interval history.
Good luck to all and remember to wash your hands,
Rick
Rick,\
I just began my 6 month FCR chemo course yesterday, which will put me finishing up in November. Do you have any suggestions as to what to do if you are in or just over a course of chemo?
I have read that vaccines are not near as effective with this group.
Thanks,
Mark
Chaya,
Thank you so much for this great article.
Bless you
Chaya,
Many thanks for your research and the tip of my hat on the graphics! I’m sure we all appreciate the reminder about the pneumonia shot, especially in these times.
For those with remaining questions about which shot to get, you might want to refer to Terry Hamblin’s blog on the issue (November 19, 2007) and there is an abstract comparing the two on PubMed 18444818 in elderly individuals. Regardless, one or the other type of pneumonia shot is better than none.
Also, early reports stated that Tamiflu works to reduce the symptoms of Swine Flu, if taken early enough. But as time has passed, that initial claim is being reconsidered because it doesn’t help everyone. Also, Relenza (which is used with an inhalor) reduces the symptoms of swine flu. To be effective the drugs have to be administered within the first 48 hours of the onset of symptoms, according to the CDC. So if you start to have flu symptoms, go to your PCP or urgent care center as quickly as possible. They have to run tests to determine whether it’s Swine Flu and need that information – not only to treat and advise you, but to report it as well.
I work part time in a hospital and know the CDC has stockpiled Tamiflu in that site, much to the dismay of the inhouse pharmacy. Although the press seems to be downplaying this issue right now, a lot is going on behind the scenes.
Ann
If I remember correctly, when I asked Dr. Hamblin about getting vacinated a few years ago he said the conjugated vacine (PCV7) might have a better chance of working in CLL patients. I got both
John
Just a comment about live vaccines:
My husband’s oncologist at UCSF advised, when asked, for my husband (CLL and two chemos–RF and PCR in four years) and me to get the Herpes zoster vaccine. It uses a live virus. He said that UCSF’s patient records show that immunocompromised patients, including those with CLL, are mounting a credible response without any risk.
George
Dear Chaya
many thanks for a helpful timely paper.
Do we get the Flu vaccine (once it is finalised for this year) as well as the Pneumoccal and HIB if we have not had before?
would be interested in your comment to earlier commentator on timing of vaccine for those just started on FCR.
with thanks and appreciation
Farhang
Dear Mark and Farhang,
You must remember that I am neither a CLL expert nor an infectious disease expert, so what I say is not to be taken as gospel.
There are several types of vaccine against the pneumococcus (the most common bacterial cause of pneumonia). There are numerous subtypes of these bacteria which have a special polysachharide (sugar like) coating and the so-called polysaccharide vaccine (Pneumovax) that is principally given to adults.65 yoa and those post splenomegaly or with immunocompromise is directed against 23 of the most common strains. It is directed against the polyscaacharide (sugar like) coating on these bacterai. While reasonably effective, it requires a reasonably good immune system to elicit an ideal response, largely because the polysachharide antigens employed are large molecules.
The so called conjugate vaccines (Prevnar and Synflorix) use smaller pieces of the molecules and cover respectively 7 and 10 of the most common serotypes of pneumococcus. They are recommended for use in children because they induce a better response in those with less sophisticated immune systems.
Dr. Hamblin (whom I will quote directly in a moment) has speculated that these vaccines may be more beneficial in patients with CLL whose immune systems are already compromised, but I’m not sure that there is any good data to confirm this.
Here’s a quote from Dr. Hamblin on this issue: “As a result conjugate vaccines have been introduced for vacinating infants against both haemophilus influenzae and pneumococus. Studies have already shown that CLL patients do respond better to conjugate Hib vaccines but hitherto there are no data for Prevenar. Readers should note that haemophilus influenzae is nothing to do with influenza, and that it is not a significant pathogen in CLL. Pneumococcus is by far the most important pathogen in CLL pneumonia and one for which a decent vaccine is urgently needed.
So what did they find? As expected the immune response to Prevenar in CLL patients was significantly worse than for normal controls. However, if the vaccine had been administered at an early stage in the disease, before commencement of chemotherapy and the development of hypogammaglobulinemia, almost 40% of the patients developed a significant response to at least six antigens.
There is one further caveat, the serotype coverage of the 7-valent conjugate vaccine against invasive pneumococcal infections in patients ≥65 years was only 56% compared to that of 86% in 23-valent polysaccharide vaccine. So even in patients with early stage disease who have never had treatment and have not developed hypogammaglobulinemia, only about a quarter of patients will be protected against pneumonia by this vaccine, which is, I suppose better than nothing, but there is a lot more yet to do.”
POSTED BY TERRY HAMBLIN
The Pneumovax was given to me at diagnosis. I had 2 courses of alemtuzumab and to date do not have adequate T cell function, so I presume that vaccination for me should await a return of better T-cell function. The general advice is to repeat this vaccine every five years in immunocompromised people and in those post splenectomy (post splenectomy patients are at risk of septicemia from encapsulated bacteria such as pneumococcus and hemophilus), but there is an increased risk of local reactions when the vaccination is repeated.
AS TO THE QUESTION of vaccination during a course of FCR, for example, I would presume that it is unlikely to be of benefit, but probably would be safe using “killed vaccines”. I would HOWEVER suggest that this be discussed with one’s own CLL specialist.
Clearly it is best to be vaccinated early…before any therapy and, hopefully, before the immune system becomes further compromised by the disease.
I am a big proponent of prevention because it works much better than treatment. careful handwashing and social behavior is of extreme importance.
I do have Tamiflu, but I would advise people to use it judiciously…no one knows for sure how often you can shoot these arrows and emptying one’s quiver too soon may not be prudent. It is also very expensive, so I would suggest that people carefully discuss when and how to use it with their personal physicians and not simply browbeat their doctors into dispensing it at the drop of a hat.
Overuse of drugs such as this as well as antibiotics can bring unwanted results, though both types of drugs are clearly very important for all of us to have available.
Alas, I have rambled on too long and Chaya will likely give me a ticket for loitering.
Good luck,
Rick
Warning. Research what your GP/family Dr may tell you about the vaccines….live vs. non-live.
I know a local GP/family Dr. who told a CLL patient it was a good idea to have the shingles vaccine,
which we all know is a NO! NO! because it is a “live” vaccine.
No to live vaccines, and be sure the
person advising you on vaccines is also a CLL expert. GP’s aren’t always “in the know”.
Great infomation, Chaya, and all those that followed. Thanks much for keeping ahead of this.
Shirley
I also want to say that I have not had treatment yet,but Ihave been around for a while (7 yrs). I had my IGs tested about a year ago, they were below normal, but not alot. I had the two vacinations about a year apart.
i don’t think your suppose to have them together,but I’m not a doctor.
I tried the Zantac “trick” when I got the PCV7 shot. Who knows if any of it worked.
john
Chaya,
I had a PPV 2 years ago at my work place for my annual ck up. Is this the same as the PPSV23? Should my husband get one as well? He doesn’t remember how long it has been since his last one. He is going to be 62 in August.
Thank you for this latest report on the HINI virus. I sent it to all of my close family and friends.
Many Blessings to you and all of the research you do to help us.
Anita
Anita:
Yes, your husband should get a pneumonia shot as well, in my layperson opinion. SOmetimes GP’s suggest waiting until a person is 65 years old. But in this case, given you have CLL, it is very easily justified that he should be protected as well and thereby give you a better chance of avoiding getting sick.
As for the type of vaccine: you should check with your doctor but I do not believe PPV2 is the same as PPSV23.
Chaya,
Jer2911 is right about the GP’s not always knowing which vaccines we should have. I also had a GP suggest that I should have the shingles vaccine. I repeatly asked her, “Are you sure that I should have the vaccine.” and she said yes. Finally, I told her it was a live vaccine, and that I was advised not to have a live vaccine. Incidently, I found out that I shouldn’t have a live vaccine at a support group meeting for CLL, not my oncologist. A school in my area of upstate New York just confirmed a case of swine flu, so it is still going strong, not waiting for the fall. Thank you for all your information.
Jean
Making bad situations worse..
We are just beginning to see the effects of increased case load on health services in the Southern Hemisphere – countries down under are just getting started on their annual flu season. Australia and Argentina are hardly ‘third world’ countries and yet it is amazing how quickly things are spinning out of control, this early in the game!
http://www.theaustralian.news.com.au/story/0,,25628852-2702,00.html?from=public_rss
http://www.chinapost.com.tw/international/americas/2009/06/12/211891/Flu-fears.htm
Traditionally, the southern hemisphere countries have acted as the sentinals (lab rats?) providing guidance for vaccine manufacture by late fall, for use in Europe and USA. This year will be no different. Aussies and Kiwis (and South American countries) will bear the early brunt of H1N1 pandemic. But the chances that any kind of a vaccine will be available in time for them are slim to none. A special note of concern and warning to our Australian and New Zealand members: your best protection is going to be prevention, prevention and more prevention.
Chaya is absolutely correct about prevention being the most powerful tool for CLL’ers to use in dealing with a pandemic.
Prevention requires three critical steps:
1 – knowledge about what to do
2 – a commitment to taking the necessary steps
3 – taking those steps
The knowledge can be found in many places of varying quality and accuracy. One good source (I am biased as I was responsible for its creation) is the Citizen’s Guide for Pandemic Preparedness which can be downloaded for free from:
http://instedd.org/flumanual
The commitment is the difficult step – it is easy to talk about being prepared but it is much more difficult to actually do what needs to be done. The urgency which comes with the arrival of a pandemic often comes too late for us to be able to do what needs to be done. You and your family have to make preparedness a priority. Social distancing is the best means of preventing infection in the absence of a highly effective vaccine. A test – do you have the food, water, medical and sanitary resources to remain in your home for 3 or 4 weeks without any physical contact with the outside world?
Once you have the knowledge and the commitment then taking the necessary steps to be properly prepared to survive a pandemic is relatively easy.
I encourage each of us to use Chaya’s wonderful blog as both a resource and as a forum to discuss prevention and preparedness, but remember your chances of survival are largely controlled by how well you have prepared.
sawarren
Chaya,
I have a low Ig. Will having IVIg infusions (very expensive) help in prevention of pneumonia?
Chaya,
Thank you so much for your timely article. And thanks also to Rick for his timely comments.
Rita
sawarren:
IVIG (intravenous immunoglobulin) infusions do give some level of protection against community acquired infections in people with low IgG levels. But as you pointed out, IVIG therapy is very expensive and chronically in short supply. I doubt the short supply will get any better in the months to come and it may get a whole lot worse. I would not be surprised to see more draconian rules regarding who can get access to IVIG.
By the way, does anyone have insight and information regarding status of blood and blood product supplies? Peter, does your group think we have reasons to worry about safety and availability of blood products during a pandemic? This is a special need that many of our members face and I wondered how blood drives and donations would work during a flu pandemic. We all depend on the kindness of strangers to survive.
Blood and blood products will be in very short supply in the event of a pandemic primarily because the donor base will shrink dramatically. There is no better place to pick up an infection that in a health care facility and that is also true of blood banks. People who are practicing social distancing, including doctors and nurses, will avoid coming into close contact with other people and hence will avoid blood donor sites.
Here is the WHO’s official statement:
“Temporary loss of blood donors and the impact on the blood supply:
As infection spreads through any population, the number of blood donors available at any one time decreases. This is due to infection in the donors themselves; infections in the families and contacts of donors; restrictions on movements, including blood collection activities in areas where outbreaks have been recorded; and the unwillingness of some individuals to donate due to a perceived risk of infection through being in close contact with others.”
Even getting IVIG therapy during a pandemic is a risk/benefit issue. While the benefits of the therapy remain constant, the exposure risk in going to a facility to get the therapy will have increased.
Here is an interesting excerpt from the AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply:
Ethical considerations for withholding transfusions for patients whose prognosis is very poor, with or without transfusion, should be explored. For example, patients with relapsed leukemia that is not thought to be treatable may not be able to receive transfusions.
Thanks, Chaya, as usual this is very valuable information.
Beth Havey
Hello Chaya, Please comment on the “jab and dab”importance when one gets a vacine shot – flu or pnuemonia. Thank you, Stan Wencley
Stan:
“Jab & Dab” is still in the realm of a concept in the process of getting tested. As I mentioned on an earlier post, the rate of progress of this clinical trial in the UK has been disappointingly slow. I feel very frustrated about it, especially since we funded it with our hard earned cash.
The concept is using imiquimod (trade name Aldera) as a topical cream and then getting the vaccination at the same spot. Imiquimod is a “TLR activator” which is thought to make dendritic cells more active as antigen presenting cells and therefore increasing the chances of the vaccination actually working in immune compromised patients such as CLL folks. You can read more about it and the scientific rationale behind this concept by clicking on the links:
http://www.clltopics.org/SponsoredProjects/LHF.htm
http://www.clltopics.org/SponsoredProjects/JabNDab.htm
But please be sure to understand that this is still just a concept, not proven in a clinical trial. While Aldera has enviable safety profile (it is FDA approved for actinic keratosis – pre skin cancer, as well as genital warts) and furthermore we are talking of topical application and not systemic use, there is no guarantee that using it in combination with flu vaccinations will be any more effective than simple vaccination without any bells and whistles.
If you plan to go ahead with this approach I strongly urge you to discuss the whole concept with your doctor before you do anything. Guys, this is not an empty CYA style caveat on my part. Untested concepts all sound wonderful but very few actually pan out in clinical trials. Please be careful out there.
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