Continued from here.
Leo7: I left a reply to your post on the previous thread after Bronco Bill closed it. Again, I am sorry for your loss.
From the end of the first thread:
Many Cats – at 23:27
Leo7: You have my sincerest condolences on the loss of your friend.
As I said, virtually everyone I know in drug R+D has drug safety as a paramount concern and for the others, the legal system keeps them honest. I know NOTHING about what happens after drugs hit the market, but I worry a little (and I have NO proof to base this on) about whether or not the bean counters start to take over and companies begin to look at the bottom line for their shareholders. It can take more than a decade of research and investment to bring a drug to market and if that drug fills a specific niche, the company has a limited time to recoup its investment through its patent coverage before generics can be made or before competitors come up with a similar formulation. At the point of initial release, you see heavy promotion to the physicians to prescribe the drug. This is not bad thing because: 1. We need drugs (osteoporosis, high cholesterol and avian influenza are all bad) 2. Drug companies need to be profitable or they won’t be in business to make new drugs (and we all are looking for an avian influenza drug that works) 3. Drugs are tested as well as is reasonably possible for safety before they are approved, but that is the rub. Drugs can’t be tested for decades before they are released and only after the drug is released—when thousands of people (male, female, pregnant or not, infants, children and the elderly), on all types of other medications, and in all type of health are exposed to the drug for extended periods—will the full spectrum of the drug’s effect, good AND BAD, become known. Researchers do the best they can, as do the folks in manufacturing and quality control to ensure the best possible product. And so do the marketing folks, who SINCERELY believe they are helping to bring suffering patients a new drug, and so do the salesmen, who SINCERELY believe they are helping to spread the word about a great new product to help people (as I said in a previous post, most salespeople I know are quite ethical). The problem I see is when a drug goes out to the marketplace and “previously unforseen complications” arise, there must be (again, I am ASSUMING) intense pressure felt in some levels of management to keep the new drug on the market, because of the costs, the investment in advertising and image, and the need to remain profitable. I worry that some companies may look at the risks (lawsuits from harmed individuals) versus benefits (number of people helped and return on investment) and make decisions based on the finances of cost/benefit analysis. I have no real complaint about that (we did have a thread about how do you ration ventilators, since you know someone will die as a result of your decision) EXCEPT that the REAL POTENTIAL CONSEQUENCES associated with these drugs MUST BE MADE CLEAR so that people, like your friend can decide whether they want to take the drug. If they are REALLY INFORMED about the full spectrum of possible complications, they may even help to bring any problems to the attention of their doctors. I am so sorry your friend was not supplied with enough information about the side effects of statins, which are advertized so benignly, to think to ask for a blood test when his doctors did not. I would hope that companies would find their images enhanced by being totally up front about potential problems and how to spot them rather than burying the problems in the very very fine print of their patient information sheets. There should be an OBVIOUS statement UP FRONT rather than leaving it to the physician to discuss or the patient to wade through. The lack of this type of IMMEDIATELY VISIBLE warning system leaves people mistrustful of pharmaceutical companies and will likely hurt them in the long run legislatively. The real tragedy is that it can leave families like your friend’s without loved ones.
While I have full faith in the good intentions of drug manufacturers, I still will not take drugs without LONG track records except in unusual circumstances and this is why. Peace to your friend’s family.
Many Cats. I would appreciate your opinion of anti-virals in general and the listed and observed side-effects in particular…and whether you would take them personally or give them to your family. Thanks.
I wasn’t going to re-post because of the length, but thanks, BB
bump
Hi, Tom DVM!
First of all, there is a song by Johnny Cash (I think) with the lyrics “I’ve been everwhere, man…”
That parallels my career path. I REALLY wanted to remain vague about my background because when you have breadth, you usually don’t have a lot of depth and, truth be told, if I were in a “credential comparison” game with anyone, I have 10 letters after my name (3 of those are just like yours…). I was working on what would have been another 8 (Dipl. ACVP), but had to quit for health reasons.
I was a neuroscientist before I was a vet. and even though it may sound like I was heavily involved in antiviral research from some of my comments, I worked part-time for several years in a lab involved in that line of research while I was in vet. school. I did electron microscopic analysis on some proprietary compounds. My graduate work involved the use of transmission electron microscopy (TEM) to map out the neurochemical circuitry of a few specific brain areas and my business mid-level management experience came as a result of my TEM expertise. I worked for an electron microscope manufacturer for a brief period (after PhD, before vet. school) and served our customer base in the US and Canada. Many of these customers were researchers in the pharmaceutical industry, and many of them became fast friends. I worked with lots of customers with interests in everything from imaging milk via TEM (they did it!) to looking at bioluminescent (glow-in-the-dark) mushrooms. I have lots of exposure to lots of areas (as you can see), but I lack what you have: extensive experience in one area. I am not a practicing vet. because I was not as good at it as I wanted to be (you have my great admiration and respect for doing what you do) and so I have locked myself away in an ivory tower and am teaching pre-professionals at this point. Because I don’t have a lot of depth, I am reluctant to post all but the most obvious kinds of scientific statements as I do not want to disgrace any of my institutions which were foolish enough to grant me my degrees and am a little annoyed that you have smoked me out since I can’t retract any of my prior posts.
All that said, if you still want what you now see is my ILL-FOUNDED opinion on antivirals in general—many strike me as akin to chemotherapy drugs in that you walk a fine line between killing the disease and killing the patient. As far as specific side-effects of any of the anti-virals under consideration for H5N1 treatment, in my again ill-founded opinion, they are less dangerous than many other antiviral classes and worth the risk if faced with an infection of H5N1. None of the antivirals have a greater than 50% CFR as does H5N1, so yes I would take them and give them to my family if H5N1 came knocking. There were studies previously in mice that showed that a much lower dose was effective prophylactically than is currently suggested by WHO. The current WHO recommendation is essentially 1 pill a day for prophylaxis, but this does not take into account patient weight, so it is just a blanket recommendation. Unfortunately, the mouse studies were done some time ago and, as we all know the virus is changing, so I would be hesitant to reduce the recommended dose, but I would if there were new data to show efficacy at lower dosages (although I doubt we will see that in a timely fashion). I would want my family to take it prophylactically if H5N1 were around, but I suspect in reality you would need it therapeutically because H5N1 would likely hit before you had any forewarning. My gravest concern at this point is what are the implications of only slowing down the virus. I posted on a previous thread that I had a cat who had been infected with FIP which is 98% fatal in untreated cases. I put her on an experimental protocol using interferon. It only succeeded in prolonging the infection to the point where my dear cat became a giant virus factory and she died a horrible death. I should have euthanized her from the start but instead I put her through a torturous, agaonizing death (I told you I was a lousy vet.) and my great fear is that these antivirals may not be up to the task and only result in prolonging the agony for our loved ones. It is hard to know what to do, but I would still try to pull out all the stops and hope to have the courage to stop treatment if it looked as if it would only do more harm than good. We are damned if we do AND damned if we don’t on this one. For what it’s worth.
P.S. the drugs I worked on interfered with viral replication processes, so they were very different from the neuraminidase-inhibitors and the amantidines.
Don’t tell Monotreme about this. He might expect me to actually say something intelligent.
Leo7,
I am so sorry for the loss of your friend. As Many Cats so eloquently pointed out, taking any medication is never straightforward. There are many points in the whole process of bringing a drug to market that can fail the ultimate consumer - the patient. The regulatory agencies do try their best, but as Many Cats again pointed out, once the horse is out of the gate, drug companies watching their profit will have little incentive to investigate newly discovered side effects, because of research cost + litigation risk. So unless severely pressurized, they would rather not know. Physicians are also often under pressures of time to independently look up every drug that they prescribe.
These are of course not good enough reasons or excuses for someone to lose a life, but sadly that’s the reality. Having said that, again looking at it from an individual’s point of view is often different from looking at it from a public health point of view. Crass as it may seem to say so, regulatory agencies, drug companies, and physicians are constantly weighing the cost/benefit of any drug, and cost includes how many people dying from side effects vs how many people saved from illnesses. The best we can hope for is often nothing more than the awareness of docs to look out for risk factors or side effects for each individual patient.
In the case of the possible use of statins for pandemic flu, what incentives are there for drug companies to undertake any research? They already reap in big profits from Lipitor and such. A pandemic may not even happen, as far as they are concerned. In order to alter the license to have the drugs be used in a pandemic, they will have to go through efficacy trials as well as new studies on adverse reactions. Now what if as a result of that they discover some other adverse reaction that was not known before? This may very well bring down their previous comfortable profit from selling statins just for the current applications, as patients and docs shy away from them. I need to emphasize I am only saying this hypothetically, as there is currently no evidence that the incidence of adverse reactions is unacceptably high, despite what happened to your friend. However, IF they find anything, they would be under threat of litigation for all the people who have been taking the drug before.
All this with the background that now that there are generic statins, the motivation to fund any further research for any reason is even less.
Many Cats,
Thank you for your most excellent series of posts. Your experience and insight is much appreciated. I think a lot of us paying attention to the issue of treatment for pandemic flu know how frustrating it is that there isn’t a clearcut answer to so many things. The need for informed risk communication is even more profound because of that.
Many Cats. You’re sneaky and Thanks. /:0)
anon 22. The pharmaceutical companies won’t re-license, Statins will be prescribed under extra-label use.
Many Cats, BB, and Anon 22:
Thank you for your support. I posted it because I know there are people getting drugs other ways than through MDs. Personally I don’t know of a more lethal combination than wine, acetaminophen and a statin (all mentioned for AF)on the liver. I hoped to ring a bell to wickians to have their blood checked before taking them or other drugs that could have serious organ effects even for a short time. If it comes out in a month that a drug like a statin would be helpful if taken for longer than 30 days for AF…I thought people would begin them without realizing the danger or getting their titers drawn. If it helps one person to take precautions, then its worth it. I’ve also noted the standard is falling back to yearly lab work for people taking statins, and leaving it on the patient to call the doctor if symptoms occur. Our friend jogged nearly every day and ran at local events. He thought his muscle aches were caused by running longer, older, new weight work out, anything, but something serious. Once you start taking prescription drugs you’re off the wellness continnuium and on the disease track. Again, thanks to all for caring and sharing with me.
I just received a file from Fedson with a proposal for bringing scientists together to investigate the possibilities around statin use in a pandemic. I started a new thread to raise awareness and discussions on the proposal itself and any questions for Dr Fedson.
Is there any appreciable difference between various statin prescriptions other than their prescribed strength, i.e. generic vs. Lipitor vs. Vytorin (sp?)?
Rural Dweller – at 20:45 “Is there any appreciable difference between various statin prescriptions other than their prescribed strength, i.e. generic vs. Lipitor vs. Vytorin (sp?)?”
If you are talking about possible efficacy in influenza, the answer is we have no data on that. If you are talking about statins for ‘normal’ indications such as high cholesterol, the best thing to do is to follow the advice of the prescribing physician.
Sorry, can’t get more specific than that. :-)
How about Red Yeast Rice instead of the statins. This is where the statins came from but this is much safer as it has not been “fooled” w/ by man. Written by Rita Elkins M. H.
There are safer alternatives to Statins that don’t risk Hepatic damage & Total Global Amenisa.
I am currently taking red rice yeast. I am sensitive to three different statin cholesterol drugs.More than 1200 mg per day of red rice yeast, produces the same side effects that I get with the statins. Have only been on them 45 days and haven’t had a new cholesterol test, but if what I’ve read about the stuff is correct, there should be a pretty good drop in total cholesterol. The price difference between the “food supplement” red rice yeast and prescription statin drugs is unbelievable.
Just Carla, worked wonderfully for me. I now only take it twice a week, and my Chol remains at a good level.And has for 4 years.
I have heard there are side effects to statins, but never knew what they are..can someone tell me, as I am afraid to take the lipitor I have, and I should be taking it daily..1 dose.
I have heard there are side effects to statins, but never knew what they are..can someone tell me, as I am afraid to take the lipitor I have, and I should be taking it daily..1 dose.
re: statin side effects
muscle pain (it really is flu-like), even the muscles in the back of my head hurt. Weakness, it got to the point I was having trouble rising out of chairs. It affects the sphincter muscles of the body as well. If you have to go to the bathroom, you better already be there or you’ll have an accident. My legs and feet swelled, turned shiny and purple and for a long time, I had freckles all over my lower legs because the blood pooled there. (for the record, I had never had trouble with leg swelling or the circulation in my lower legs before statins.) My doctor didn’t recognize the symptoms and sent me to the emergency room. Had to switch doctors to finally find out what was really wrong.
These side effects did not just show up all of a sudden, they appeared gradually, with the intensity growing a little every day. Once you’ve had a reaction to the statins, the symptoms are more easily recognized and you know when to stop taking the drugs and call your doctor.
Just Carla @13:57 Thankyou for replying ! That sounds not too good to me. Is there any shortness of breath associated with their use ? ( not that the symptoms you mention aren’t scary ) I think what you went through was aweful to say the least. I just dont know if it is worth the try. It sounds really scary….yikes
I never reached the point of shortness of breath, thank goodness. Just had two weeks of wondering what in the world was wrong with me. The side effects are rare, that’s why the doctors didn’t immediately recognize them. It was scary, but I survived. LOL The insanity was letting the doctor even talk me into trying a second and third kind of cholesterol medication. Thank you Cactus for your reply. It is good news to me.
I’m on max dose Lipitor (several years). Never any problem. Cholesterol lowered from 479 to 180. I’m a happy camper with the numbers everyone is so concerned about. But I don’t think lower numbers necessarily save your life.
Rd, you`re so right. Have tended many heart attacks where the patient had “good” numbers.