Enlarger Aortic Root

when I was 15 I had been diagnosed with and enlarger aortic root with a diameter of 4 centimeters. the other day for my one year check when I am 16 my root had enlarged .2 centimeters and now is at 4.2 centimeters. I was wondering what is there that could be done. What are some treatments?...what can I do and what cant I do?....and am I going to need surgery?.. .

[kenkeith]

When the aortic root increases to a size greater than 4.0 cm it is referred to as an aneurysm and growth is closely monitored and grows about 0.2 cm a year.  If and when the size reaches 5.0cm, surgical intervention begins to be an option to prevent rupture.  

Do you have a bicuspid syndrome?  That would be the aorta valve with two leaflets instead of three, and the syndrome includes a tissue vulnerability of the aorta vessel wall that is usually subjected to medical problems in the 3 decade of life (sometimes for the valve as well as the vessel).

It is necessary to avoid high blood pressure, and avoid any heavy lifting. There isn't any medical therapy available.  Thanks for sharing and take care.
  

[Pat_H]

does the aortic root always grow at a rate of .2 cm a year?... will the aortic root ever stop growing?.. and how is the surgery done?... thank you for giving me some answers..

[nickppatel]

kenkeith is absolutely wrong that there isn't any medical therapy available.  There is.  I've posted about it here repeatedly.  You need to investigate angiotensin receptor blocker (ARB) therapy.  ARBs are a class of drugs that have been clinically proven to halt and even reverse aortic root dilatation in humans.  They include valsartan, telmisartan, and other drugs that end in -sartan.  The key is to take a high enough dosage - for most people, this is about the maximum FDA-approved dose.  In particularly large people, the required dose may be higher.

You should quickly find a cardiologist who is knowledgeable about connective tissue disease and ARB therapy.  It is cutting edge and most physicians/cardiologists are unaware of this treatment.  You might contact Dr. Hal Dietz at Johns Hopkins for a referral in your area.

[nickppatel]

By the way, Pat, regardless of whether you have Marfan Syndrome or not, you might Google "losartan" and "Marfan Syndrome" to read articles on this topic.  I don't think losartan is the best ARB, but it's the one being used in the current studies.  All ARBs seem to work, some better than others. Efficacy is usually dose-dependent.

[kenkeith]

QUOTE:....."necessary to avoid high blood pressure, and heavy llifting".  Beta blocker helps control high blood pressure!

Medhelp: Doctor's Answer by CCF-M.D.-MJM,
"Blood pressure is important, but so is the hearts force of contraction.  First, you should be on a beta blocker to decrease the force or pressure change per unit time (the so called dp/dt).  Second, the best blood pressure is the lowest blood pressure you can tolerate without symptoms. >>>>> Unfortunately, neither of these measures guarantee that you will not progress.  That is why your aortic should be imaged routinely".<<<<<>>>>> It is important to note that treated patients continued to have abnormal aortic growth and aortic dissections, and therefore such therapy does not preclude the need for surgical correction. Significant previous aortic root dilatation correlated negatively with therapeutic response."<<<<<<

[kenkeith]

**"Interestingly, selected studies suggested that ß-blockade either had no effect or worsened stiffening indexes in 35% of individuals with MFS.21 Increased body weight or an end-diastolic aortic diameter >40 mm was significantly associated with lack of desired response,17 suggesting that ß-blockers must be given at an adequate dose and early in the course of the disease to optimize the potential benefit".

**From the Department of Internal Medicine, University of Texas Medical School at Houston (D.M.M.); Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, Md (H.C.D.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, Calif (D.C.M.).

[skydnsr]

ARB therapy for thoracic aortic aneurysms is a cutting-edge intervention, and if I had a presurgical aneurysm, I would try it.  Unfortunately, I did not find out about my aneurysm until it was already big enough that I needed surgery.  Also, I had severe aortic regurgitation at the time, which was another indication for surgery.  

But if one of my young relatives were to turn up with a similar aneurysm (God forbid), I would definitely encourage them to pursue high-dose ARBs.  You need to control blood pressure anyway, so what's the harm in using the drug that shows promise of reducing the aneurysm?  If you end up having to have surgery anyway, then that is the outcome that was expected in the first place.  

[kenkeith]

QUOTE: does the aortic root always grow at a rate of .2 cm a year?... will the aortic root ever stop growing?.. and how is the surgery done?... thank you for giving me some answers..

>>>>Yes, there can be a differential on rate of growth  A consideration for intervention is recommended when a small aortic aneurysm grows more than 0.5 cm within 6 months.
"Surgery to repair an aortic aneurysm involves removing the damaged section of the aorta and replacing it with a synthetic tube (graft), which is sewn into place. This procedure requires open-abdominal or open-chest surgery, and it will take you several months to fully recover".

>>>nickppatel, is probably the most knowledgable on this forum based on the experience with the subject, and I respect his opinion as I have read and answered his prior posts, but if I remember correctly,  there wasn't an answer to my questions several months ago regarding the basis and what method was followed in measuring the progress of his/her condition.

nickppatel provides a perspective, but I haven't found anything definitve other than reducing and maintaining low blood pressure. Often the underlying cause is a vessel tissue disorder exacerbated by high blood pressure and a lack of elasticity of the vessel and an ARB doesn't restore elasticity or change the composition of vessel cells.

[Pat_H]

my doctor had gotten back to me and said the growth of my aortic root (which is .2 cm in one year).. was not important because my body had grown with the aortic root.. so is there still a chance that it will still grow and that i am going to need surgery?

[skydnsr]

Actually, it is believed that losartan, an ARB, does work at the cellular level to inhibit and/or reverse the progression of aortic root aneurysms, at least in some cases.  For one publication, see the article, "Recent Advances in Understanding Marfan Syndrome:  Should We Now Treat Surgical Patients with Losartan" by Peter Matt et al in the Journal of Thoracic and Cardiovascular Surgery, 135:389-94.  There is an abstract that can be accessed on the internet.  Anyone who wants to know more can look up the work of Dr. Hal Dietz, who is prominent in this area of research.  

As I say, this is cutting edge stuff.  Clinical trials are still underway, but it looks like a very promising approach.  And if you need to control blood pressure anyway, what's the downside to using an ARB, such as losartan?  I can't see any downside.  At worst, you are eventually going to have to do whatever it is that you were going to have to do if you didn't try the ARB therapy.  The safety and efficacy of ARBs as a class of antihypertensive drugs is well established.  

[skydnsr]

Pat, I don't think you know yet how much it is going to grow.  That's why the doctor is having you come back and be monitored from time to time.  It's like trying to predict how tall you are going to be.  You just don't know until it happens.  Your aortic root is already bigger than normal, though, so you have to keep up with your check-ups.  Maybe you, your parents, and your doctor will want to look into this ARB therapy and see if it might be a good thing for you to try.  

[kenkeith]

Pat_H, unfortunately the growth of the aorta root is positively related to body size, age and gender.  I wish it goes well for you,

[kenkeith]

skydnsr, what is your source? Do you have special knowledge or something....?  Pat's doctor acknowledges a growth factor, and everything I have read concurs.

[skydnsr]

What is my source about what, kenkeith?  About the need for future monitoring?  Simply that any aortic root over four cm is too large.  Even though Pat_H is still growing, his aortic root has surpassed the diameter that would be expected in an adult.  Therefore, whole-body growth does not account for the entire 4.2 cm.  Even a 4cm root is of a size that many doctors would already consider to be an aneurysm.  I have seen you state that yourself in your posts.  At 4.5, some surgeons will operate, especially if the patient is bicuspid or has Marfans, and 4.2 is gettng pretty close to 4.5.

Some doctors would just call a 4.2 cm aortic root "dilated" and would not define it as an aneurysm, but I wouldn't expect any cardiologist to say that a 4.2 cm aortic root in a 16 year-old boy doesn't ever need to be re-checked.  Pat_H can let us know what his doctor said about coming back for future scans if he wants to, but I would just be very surprised if the doctor does not want to follow him.  His root may not have grown "too fast" during the past one year -- I'm not disputing his doctor's opinion about that or anything else -- but at some point, it did grow too fast, or at least, it grew too much.  Otherwise, it would not be 4.2 now.

So, we have someone who has an aortic root that is too big, whether you use the word aneurysm or not, and the person who owns that aortic root is only 16 years old.  Pat_H has a lot of time left on earth for his aortic root to potentially grow even bigger.  At any rate, there is no evidence that it has stopped growing, yet.  In fact, the evidence suggests the contrary.  While his root may not have grown faster "than expected" in the past year, it certainly did not stop growing and let the rest of him catch up with it, either.

Pat_H's aortic root doesn't have but a fraction of a centimeter left to go, before some doctors might consider him to be a surgical candidate.  If he were my son, I would want him to continue to be monitored.  That's where I'm coming from.  If he were 70 years old, and/or if he had had scans every five years for the past 20 years that were all stable, it would be different.

This is a peer support forum, and as someone who has had an aortic root aneurysm, I am Pat_H's peer.  I have read everything I can get my hands on for the past seven years about thoracic aortic aneurysms and bicuspid aortic disease.  We all have our areas of specialized interest.  Usually, our respective interests are based on something that has happened to us personally.  For instance, I notice that you know a lot about mitral valve disease and congestive heart failure.  

Generally, the comments that I post are a combination of logical observation and easily verifiable information.  I try to be transparent.  People can take what they want, and leave the rest.  Anyone who wants to be pointed to a more authoritative source can ask, and I will do my best to help them find it.  I can always share where I learned something myself, if anyone wants to know.  

This site seems to discourage the posting of links, or I would do it more often.  To me, it is better to post a link to the source for something, so people can check it out for themselves, rather than just stating some point of medical information on your own and forcing people to wonder if you even know what you are talking about.  

[kenkeith]

QUOTE:" .,...doctor acknowledges a growth factor (aneurysm), and everything I have read concurs"..... I believe the subject has been the growth of the aortic root?.  And if there is therapy for regression of the aortic root size that you seem to have knowledge?

QUOTE:"This site seems to discourage the posting of links, or I would do it more often".  That's a good point so I try to summarize the relevant information, and post a link for further information if there is further interest. For individuals such as I who may not care to go to a link, a brief summary of the information is usually sufficient. Thank you for understanding...appreciate your input regarding the subject posed.

[nickppatel]

Since you insist that I provide evidence that's easily accessible via Google, here you go.  (By the way, my own story is that I had increases in aortic root dimensions for a number of years.  It hit 3.9cm and that's when I began taking max-dose ARBs.  Root regressed to 3.7cm and has been there for years.  I know many others who have experienced the same - visit marfanlife.net/bb3 to read their stories or to talk to them.)

http://www.jstage.jst.go.jp/article/circj/advpub/0/0809250096/_pdf

http://www.icirculation.com/special/KHS/images/5.pdf

Benjamin Brooke et al., Angiotensin II Blockade and Aortic-Root Dilation in Marfan’s Syndrome, 358 NEW ENG. J. MED. 2787, 2787 (2008) (establishing angiotensin receptor blockers’ efficacy in halting aortic root dilatation in Marfan patients)

Ahimastos et al., Effect of perindopril on large artery stiffness and aortic root diameter in patients with Marfan syndrome: a randomized controlled trial, 298 J. AM. MED. ASS’N 1539, 1539 (2007) (similarly establishing angiotensin converting enzyme inhibitors’ efficacy in halting aortic root dilatation in Marfan patients).

http://www.hopkinsmedicine.org/hmn/F07/feature1.cfm

Reed E. Pyeritz, Marfan Syndrome:  30 years of research equals 30 years of additional life expectancy, 95 HEART 173, 174 (2009) (citing Jennifer Habashi et al., Losartan, an AT1 antagonist, prevents aortic aneurysm in a mouse model of Marfan syndrome, 312 SCIENCE 117-21 (2006) to describe success researchers have had in reversing and fully normalizing aortas in mice genetically engineered to have Marfan Syndrome).

http://www.nature.com/ajh/journal/v16/n1s/abs/ajh2003891a.html

[kenkeith]

Aortic aneurysms are only represented in about 5% inclusion with Marfin Syndrome.  However, links posted conclude showing promise need larger study, inconclusive, mouse studies positive, etc.  However, there are many govt. trial studies in progress for Marfin syndrome and 2013 is the date for completion.



Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Official Title  ICMJE  Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Brief Summary  The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome. >>>Note tests for limitation<<<<

Detailed Description  Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy.

1 Recruiting  Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome Condition:  Marfan Syndrome

Interventions:  Drug: placebo;   Drug: Losartan

2 Recruiting  Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients Condition:  Marfan Syndrome
Interventions:  Drug: Losartan and nebivolol;   Drug: Losartan;   Drug: Nebivolol

3 Recruiting  Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers Condition:  Marfan Syndrome
Interventions:  Drug: Losartan;   Drug: Placebo

4 Recruiting  A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome Condition:  Marfan Syndrome
Interventions:  Drug: Losartan and Atenolol or Propranolol;   Drug: Atenolol or Propranolol

5 Recruiting  Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome Condition:  Marfan Syndrome
Interventions:  Drug: Atenolol;   Drug: Losartan

6 Recruiting  Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome--Pediatric Heart Network

[kenkeith]

10 June 10
http://www.nationwidechildrens.org/marfan-syndromePrevention of Aortic Dissection

Progressive aortic dilation increases the risk of dissection, a tear between the walls of the aorta, Aortic dissection is very serious and can be fatal. Our goal is to prevent aortic dissection by lowering the blood pressure transmitted to the aorta (medical therapy; avoidance of competitive sports), avoiding a blow to the chest (avoidance of contact sports like football and basketball) and surgery.

Medication
Beta blocker medications have been shown to reduce the RATE of aortic growth over time, and are considered and/or recommended when the diagnosis of Marfan's Syndrome is made. Examples of beta blocker medications include: Toprol (metoprolol), Tenormin (atenolol), Inderal (propranolol), Corgard (nadolol).

Alternatives for patients intolerant to beta blockers (usually due to wheezing, coughing or asthma symptoms) include calcium channel blockers (verapamil), angiotensin receptor blocking agens (valsartan) or angiotensin converting enzyme inhibitors (lisinopril).

[nickppatel]

You are correct that no large-scale studies have been completed YET.  However, there is AMPLE anecdotal and small-scale scientific evidence that this treatment works in humans.  Given the strong evidence thus far, and the fact that patients have little-to-nothing to lose by trying the ARB medications (they reduce blood pressure anyway, as skydnsr pointed out), I think most people will go for the ARB use.  What they DO have to lose otherwise is their lives by aortic dissection or rupture if they continue using beta blockers which are NOT significantly helping the Marfan community or others with enlarged aortic roots.

The mere fact that a large-scale study has not been completed should not necessarily stand in the way of a patient discussing the evidence gathered thus far with his or her (well-read/informed) physician and making an informed choice as to whether or not to take ARBs.  To argue otherwise as you are doing takes the pros and cons (i.e., what you risk by taking the drug vs. what you risk by NOT taking it) out of the clinical picture.

Continue advocating beta blockers if you wish, but I think most people who do the homework for themselves and think about what they have to lose by taking the drug vs. what they have to gain by taking it will choose to take the ARBs.  

They saved my life and the lives of several of my friends.  I know that much.

[kenkeith]

QUOTE: "Given the strong evidence thus far, and the fact that patients have little-to-nothing to lose by trying the ARB medications (they reduce blood pressure anyway, as skydnsr pointed out), I think most people will go for the ARB use."

I was shocked to read that a mother would even consider giving her child a large dose of any drug that has not gone through the PHASE lV TRIAL. There is a little bit of poison in every drug but with that aside, it is utterly irresponsible to subject a child to a mega dose of any drug!!!  An adult can assume the risk for themselves, but to subject a child...Its outrageous.

Also, I haven't advocated any medication; I don't where that comes from either.  I am reporting what has been researched on the subject!  Why would I advocate beta blockers, doesn't make sense?  

For your information and anyone else PHASE IV TRIAL studies to delineate additional information including the drug's risks, benefits, and optimal use.  

[nickppatel]

First, this drug is hardly new.  It's used by millions of people every single day, including minors.  The ARB safety profile is well-established.  Can you point me to literature that shows substantially adverse effects from ARB use?

Second, this person is 16 and is hardly a "child."  A minor, yes, but less than 2 years from adulthood.  His/her body is not the same as a 5-year old's. The drug has been shown to be safe in people younger than 16.

Finally, I encourage you to change your paradigm.  I understand that you are trying to approach the issue scientifically, but I still think you fail to consider all of the facts and RISKS of doing NOTHING.  When a person who is nearly an adult faces very fast aortic growth and a drug that has been shown to be safe and effective (albeit in separate studies) in stopping aortic growth in people both older and younger than that person, and if that drug is widely available on the market and can be prescribed to lower BP if nothing else, then what is there to lose?

Let me pose a question to you.  You yourself said that it's important for someone w/ aortic dilatation or aneurysm to lower BP.  Your own words.  Would you disagree with a doctor who prescribes an ARB like telmisartan to lower BP?  Why or why not?  I'd be extremely interested in hearing your answer to this question.

[kenkeith]

I don't think we will agree on the issue so it doesn't make sense to continue this discussion....we can agree to disagree. But to answer your questions:  I'm not a doctor, but everything I have read for aorta aneursym says to lower blood pressure with beta blockers and not engage in heavy lifting so I provide that information...I don't advocate. You're advocating ARB!  I'm merely providing another point of view by the professional community, and you are rejecting the information. I don't agree nor disagree with a doctor's instructions to an adult that has legal standing to chose and is aware of the medical circumstances and risk.

An individual aged 16 does not have legal standing to make decisions (a child), and inaddition the individual would still be in the physical growth category!  That's the point.

[kenkeith]

Dictionary meaning of child in the medical sense of the word: >>>>A person who has not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted<<<<.  A study that has not completed phase lV of study is not considered safe....and it may be malpractice for a doctor to prescribe a large (mega) dose to a child before phase lV of a study, and in my opinion it is irresponsible for a parent to subject a child to the risk.  

[skydnsr]

What started out as a seemingly rational discussion has taken an interesting turn.  Let me offer this.

There is such a thing as off-label drug use.  At this time, ARB therapy for aortic aneurysms would be considered an off-label use of ARBs -- unless, of course, the patient was hypertensive and needed an ARB for blood pressure control, totally aside from any aneurysm considerations.  If an ARB were indicated for the purpose of treating hypertension, and if the person did also have an aortic aneurysm, and if the aneurysm shrank while the individual was taking the ARB, then I guess it would either be considered an "additional therapeutic effect" or maybe just a happy coincidence.  

For those who might not be familiar with the term "off-label use," I suggest googling it.  It means using pharmaceuticals in a manner for which they have not been officially approved.  It is done everyday and is a huge part of the practice of medicine.  I doubt there is anyone reading this who has never taken an off-label prescription.  I think the only people who might have been able to completely avoid all off-label drug use would be those who have "never been sick a day in their lives," meaning people who have rarely or never taken any medication whatsoever.  In regard to children in particular, many or most of the drugs that are prescribed for them are in fact off-label, because of the difficulties -- ethical and otherwise -- of doing pharmaceutical research on children.

Most doctors could hardly practice at all, if their ability to prescribe drugs on an off-label basis were to be taken away.  Clearly, prescribing a drug when there is an absence or a paucity of controlled studies to validate a particular indication for the drug does not, in and of itself, constitute malpractice.  If it did, then pretty much any physician would be guilty of malpractice on a regular basis.  

For some insight, here are some quoted facts, with sources, from the Wikipedia article on Off-Label Use:  "Off-label use of medications is very common. Up to one-fifth of all drugs are prescribed off label and amongst psychiatric drugs, off-label use rises to 31 %.[Archives of Internal Medicine 166:9, 1021-1026].  New drugs are often not tested for safety and efficacy specifically in children. Therefore, it is believed that 50-75% of all medications prescribed by pediatricians in the U.S. are for off-label indications [NPR Interview with Dr. Sidney Spiesel, broadcast 10-22-08 and available in the program archive section of the NPR website]."

It seems reasonable that in all medical situations, both the patient (and parents, if the patient is under 18) and the doctor need to weigh the risks and benefits of treatments, especially when considering off-label drug use.  The same is true in situations in which a proposed treatment is FDA-approved and fully validated.  In fact, it just seems obvious that both the risks and benefits of any treatment should always be weighed.  

But to totally rule out off-label prescribing as unsafe is something that I have never before heard seriously proposed.  To define off-label prescribing -- out of hand -- as malpractice on the part of the doctor and irresponsible on the part of a consenting parent is not something that the medical profession or the FDA has ever agreed with.  Anyone who thinks that all precription drugs are fully validated for all purposes for which they are legally used -- much less for all populations and at all possible dosage levels -- is invited to find out how things are done in actual practice.

[nickppatel]

Thanks for your input.  I'm a law student and I recently wrote a lengthy, scholarly article on Marfan Syndrome, ARBs, off-label use and how it all ties together in a legal framework.  I concur with everything you've written.

[kenkeith]

QUOTE: "Anyone who thinks that all precription drugs are fully validated for all purposes for which they are legally used -- much less for all populations and at all possible dosage levels -- is invited to find out how things are done in actual practice."

I think most of us know what unapproved drug usage involves...aspirin for heart conditions is a good example, and seems to be now the standard of care. Unapproved use is entirely legal: The FDA doesn't regulate the practice of medicine, so physicians can use drugs for any appropriate purpose, approved by the FDA or not. However, there is a delicate balance between appropriate regulation for public protection and the medical provider's judgement.

Suffice to say as stated in my prior post the prescribing health provider runs the risk of medical malpractice for prescribing off-label medication for a condition not approved by the FDA. ...."off-label prescribing bears some inherent liability risk for the physician. In Richardson v. Miller, for example, the court held that the fact that a drug use was off-label could be introduced as evidence that the prescribing physician deviated from the standard of care." To give a child a  large dose of medication that hasn't gone through phase lV of a trial study for safety is irresponsible.  If an adult knows the risk and accepts, no legal or ethical violation, I remain prophetically agnostic on that issue to repeat myself.










  

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[kenkeith]

"But to totally rule out off-label prescribing as unsafe is something that I have never before heard seriously proposed.  To define off-label prescribing -- out of hand -- as malpractice on the part of the doctor and irresponsible on the part of a consenting parent is not something that the medical profession or the FDA has ever agreed with.  Anyone who thinks that all precription drugs are fully validated for all purposes for which they are legally used -- much less for all populations and at all possible dosage levels -- is invited to find out how things are done in actual practice"

First, no one has stated unapproved medication is unsafe or safe.  My discussion relates to legal liability and ethics for a medical provider to provide unapproved medication, and please I'm not referring to aspirin.  You attribute a weak argument to my postion and then easily refute as if you have special knowledge on the subject.

Anyhow, Just read your  acclaimation about your scholarily endeavor regarding the subject of responsibility and how that relates to unapproved medication, ethics, and the legal liability of a medical provider :).  I haven't read anything you have written on this  thread that is not common knowledge.  Do you have any authority to refer to on the subject?  I gave Richardson v. Miller.  Are you familar with the case?  This should be interesting because I am prepared to argue the legal and ethical pros and cons of unapproved mediction (medication) from a legal and ethical perspective.  Am I your peer, I ask humbly?  You can relate to your written paper but stay rational, and nickppatel can help you.

Let me give you some information that you seem not to accept: to promote off-label status undercuts the FDA's ability to ensure safety and efficacy. It removes incentives for manufacturers to conduct studies on safety and efficacy. Also, it encourages manufacturers to seek FDA approval only for the narrowest, most-easy-to-support indications.

[nickppatel]

Quote: "Suffice to say as stated in my prior post the prescribing health provider runs the risk of medical malpractice for prescribing off-label medication for a condition not approved by the FDA. ...."off-label prescribing bears some inherent liability risk for the physician. In Richardson v. Miller, for example, the court held that the fact that a drug use was off-label could be introduced as evidence that the prescribing physician deviated from the standard of care.""
>>Ok, let's talk about Richardson.  Has this case law been adopted by other states?  If so, which ones?  If not, why do you think it would have any binding authority whatsoever in the vast number of remaining jurisdictions in the US? Are you aware that states vary drastically on the legal tests they use to determine whether a physician's off-label use was permissible, and this fact by definition precludes the Richardson case from applying to many states? Do you realize that the quote you provided only mentions that the fact that off-label use was prescribed can be entered into evidence, and that the court itself said that that fact in and of itself does not establish liability?  Why did you fail to mention the crucial fact that the drug in question had a warning label that specifically warned against the off-label use in which the physician engaged?  Are you aware that the court of appeals merely remanded the case for a new trial and did not find the physician liable?  Are you aware that the Richardson court actually PRAISES off-label use because it's able to keep pace with technological innovation while the FDA is not?  What did the trial court on remand hold and why?

Quote: "To give a child a  large dose of medication that hasn't gone through phase lV of a trial study for safety is irresponsible.  If an adult knows the risk and accepts, no legal or ethical violation, I remain prophetically agnostic on that issue to repeat myself."
>>I reiterate skydnsr's argument.  Off-label use is legal.  The courts say so.  It requires no phase-IV trial.  It is not necessarily irresponsible.  

[skydnsr]

kenkeith, you want to deny that you called off-label prescribing unsafe:  "First, no one has stated unapproved medication is unsafe or safe."  But these were your words above that:  "A study that has not completed phase lV of study is not considered safe."  I would say that "unsafe" and "not considered safe" are close enough to rank as synonyms, at least as far as I'm concerned.  

You also say that, "to give a child a  large dose of medication that hasn't gone through phase lV of a trial study for safety is irresponsible.  If an adult knows the risk and accepts, no legal or ethical violation..."  So which is it?  Is it irresponsible parenting, or is it no ethical violation?  In my book, irresponsible parenting is prima facie unethical.  

It's okay for different people to know different things.  It was no shame for you not to have known about the early research on ARB therapy for aortic aneurysms.  

[kenkeith]

You miss the point.  I stated a doctor runs the RISK of a malpractice liability suit. Yes, laws differ from state to state...FAD is a federal agency,  Yes, prescribing unproved medication does have utility, but that doesn't obsolve the risk for malpactice suit. It is irresponsible for a parent to risk a child's future health by providing medication that has not been approved by the FDA for a specific malady, and I am not talking about an aspirin ( likeness alluded to in another post ).  I am very familar with the FDA and its input involving medication, drug companies liability, doctor's vulnerability, etc. I have been a plaintiff in several lawsuits as a major stockholder. We know about drug recallls, etc that has not been approved or failure to do the necessary clinical trials, etc. The unfavorable outcome should not have happened...lives were lost!.

Generally I am guided by the adherence to the principles of good clinical practices  including adequate human subject protection that is universally recognized as a critical requirement to the conduct of research involving human subjects.  Obvioulsy, you are not.  If what works for you so be it, and that is a good outcome for you as an individual, but I am coming from general, comprehensive, fundamental law and doctrine.  You are emotional with the subject, and if you can't see the doctrine involved on behalf of the general population that is your right and you can act accordingly but don't impose your belief to advocate a shortcut to complete trial studies and involve children who can't make decisions for themselves.  Adults with full knowledge of the circumstances as explained to them by their doctor can do as they please and the doctor can practice medicine as he may wish.  

You are a Marfin person, and as previously stated only 5% of AA have that disease.  

[skydnsr]

If you are referring to me, no, I do not have Marfan's.

[Claire_MHModerator]

Folks, we're getting pretty far afield from the original poster's question.  You've all presented your views and it's pretty clear that nobody is going to change his/her min, so let's end it here.  In the meantime, it appears that the original poster has dropped out of the conversation.

[kenkeith]

"kenkeith, you want to deny that you called off-label prescribing unsafe:  "First, no one has stated unapproved medication is unsafe or safe."  But these were your words above that:  "A study that has not completed phase lV of study is not considered safe."  I would say that "unsafe" and "not considered safe" are close enough to rank as synonyms, at least as far as I'm concerned".

>>>>You can become unconcerned.  In the context, my safe and unsafe statement is/was not an issue...it is the RISK...and unsafe conditions can be the consequences. That aside my comments relate to ethical conduct of the doctor and irresponsibility of the parent. Completion of phase 4 of a trial study provides a risk of unsafety.  

"You also say that, "to give a child a  large dose of medication that hasn't gone through phase lV of a trial study for safety is irresponsible.  If an adult knows the risk and accepts, no legal or ethical violation..."  So which is it?  Is it irresponsible parenting, or is it no ethical violation?  In my book, irresponsible parenting is prima facie unethical".  

>>>>>That is true. An adult can accept any medical treatment available.  Its a free country.  But the adult parent has to meet a higher standard for their growing child.  That is their obligation, and it would be irresponsible for a parent to subject their child to unnessary RISK.  It would be unethical conduct for a doctor to treat the child with a heavy doses of unproved medication, and this may pertain to the subject mediation  Does that pertain to all unapproved medication? Obviously, it does not, and that is a silly and a pedestrian question, because anyone who takes an aspirin knows it is not approved for many symptoms and conditions that have shown to be effectively treated.

I'm not going to comment on the rest of your statements other than to say they are rude, insulting, and untrue.  It seems you have an agenda to try impress, and that basically indicates some type of insecurity.    

I agree with the moderator, all questions have been answered, and no need for further comment on this thread.