Professor George Ebers

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Re: Late to the game

Postby HarryZ » Tue Feb 08, 2005 6:56 pm

Art,

Why does it cost that much? Because that's what the market has proven it will bear, is my guess.


I guess there could be a lot of ethical debate on whether a drug company should be able to charge "what they think the market will bear" when it comes to important medications.

Biogen has told everyone how good Tysabri is, based on one year data of a couple of trials. They have carefully crafted a marketing and sales plan which has gone so far as to predict the number of patients that are likely to change from the current CRABs. They have done webcasts with paid panel members to promote the drug. From what I have been told, nobody does this better than Biogen and they really have done a "sell" job with Tysabri despite the infusion costs reaching $ 4000.00 per session.

Should they be allowed to charge whatever they can get or should a reasonable profit based on development costs be allowed? That question could be debated for hours!!

At the same time, some docs are disturbed by the fact that Tysabri really hasn't proven itself yet due to a lack of research data which normally happens before a drug can be distributed in mass. Sure hope that 2 year data is as good as the one year data!

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Postby art » Tue Feb 08, 2005 7:44 pm

I'm not sure where you are getting the $4000/infusion price, that's twice what it costs.

As to whether they should be allowed to do this - I don't see the point in arguing it unless you're going to put in the effort to change the law. The fact is that they *can* do this, and they are.

It isn't really an economically different situation than with the ABCR drugs. Is it right or wrong? What's that matter unless you take action based on that result. What action are you proposing?
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Postby BioDocFL » Tue Feb 08, 2005 8:35 pm

It would seem that, although the drug companies can make predictions about the size of the demand for their product at one point in time, they do not know how long they have to sell that particular drug before a competitor comes out with something better. So they have to try to recover their investment and make some profit quickly, facing the uncertainty. Plus their current drug has to recoup some of the costs of the failed drugs that never made it to market. A balance of greed, competitive paranoia, compassion to help patients, responsibility to shareholders and employees, changing laws and insurance involvement (or lack thereof)...it must be difficult to figure the right price to set.

Someone came up with an equation to estimate how many intelligent civilizations there might be in our galaxy. The final result could vary by quite a bit based on some of the initial estimates, such as how many viable solar systems there could be in the galaxy. Drug pricing might be about as complicated when you take in all the pressures and uncertainties.

High prices do keep the drug companies interested and busy in researching the diseases. Marketing and economics can be strange. You could almost wonder that, if prices were even higher, would that lead to quicker turnover of drugs with new ones coming out sooner. Each one would supposedly have to be an improvement in some fashion.
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Postby HarryZ » Tue Feb 08, 2005 10:06 pm

Art,
I'm not sure where you are getting the $4000/infusion price, that's twice what it costs.


The wholesale cost of Tysabri is $ 1800.00 That is before the institution buying it applies its mark-up. It has been confirmed by two separate sources in another thread that when they checked with their docs who would do the infusion, the final cost billed to the insurance company would be $ 4000.00! This includes the infusion cost and monitoring afterwards.


It isn't really an economically different situation than with the ABCR drugs. Is it right or wrong? What's that matter unless you take action based on that result. What action are you proposing?


I'm not proposing any action other than commenting on the huge cost of the drug. I read comments on various MS forums about the cost of Tysabri and opinions are all over the map on this.

An interesting note though....in Canada, the Federal Gov't purchases drugs from pharmaceuticals on a large scale because of the health care system that it uses. That lowers the cost of the drug significantly. That is why many people in the US purchase the drugs here. If a pharmaceutical company wants to raise the cost of the drug, they have to show just cause as to why they are increasing it. If they can't justify the increase, it doesn't happen. Of course, in the US, no such situation exists and the companies can charge what they want. Again, the opinions on this are all over the map.

Just comments for discussion.

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Postby OddDuck » Wed Feb 09, 2005 5:17 am

Oops.....had to delete this. Correct post is below.
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Postby OddDuck » Wed Feb 09, 2005 5:30 am

Art said:

While the NMSS says they funded the research that lead to Tysabri, I think they may be overstating the case a bit such that they wouldn't have any claim on the returns from the drug. I've asked the scientist in charge of Tysabri at Biogen Idec what research they funded and he wasn't aware of what it was. (Similarly with Interferons). His guess is that it was some very early work 10 years ago or something. You won't get any IP from that. The drug was developed by Elan and Biogen Idec, they'll get the profits.


Ok, this is an example that with under 5 minutes of looking it up, can be cleared up (and another example of how information can be twisted and rumors run rampant). Besides, the NMSS would not be able to directly accept any "profits" from the marketing of ANY drug. Art, you know that. That's illegal. Why imply in any way, shape or form that they could, even if they were more "directly" involved?

First, if you will go back to what the NMSS really said, which was (and I highlight), you will see that they never said they were DIRECTLY involved with the creation of the actual drug Tysabri:

To give you but one example, the new drug Tysabri was developed from research done to try to understand the how immune cells leave the blood stream and get into particular organs (the nervous system in the case of MS). When the researchers (one of whom was in fact funded in part by NMSS) were looking at the question, they weren’t really thinking about creating a new drug for MS. They were trying to study how these immune cells move from one place to another and the rules governing that process in the context of MS. At that time scientists had great difficulties answering that very important question. These researchers came up with some molecules which helped them answer their question, and in the course of doing that someone came up with the idea that these sorts of molecules might be another possible way to help treat MS. Looking back one can say that that initial work was a true advancement, even though at the time they didn’t appreciate just how big an advancement that would be. I am optimistic that there are lots so similar examples out there.


The above statement by the NMSS is true. This next article is an example of what the NMSS is referring to. Please note that part of the original research into adhesion molecules WAS done by this gentleman with the support of the NMSS. His initial work (with some others) DID lead to Biogen picking up and running with the ball. Please Note (again I will highlight):

From Bench to Bedside: Dr. Lawrence Steinman receives the 2004 John Dystel Prize for MS Research by Gary Sullivan

Professor Lawrence Steinman, MD, of Stanford Medical Center, has been chosen by a committee of his peers to receive the 2004 John Dystel Prize for Multiple Sclerosis Research. Dr. Steinman is being honored for his major contributions to scientific understanding of MS-like disease models, and for translating these findings to the development of novel therapeutic strategies for people with MS.

In MS, myelin (the fatty tissue that protects nerve fibers in the brain and spinal cord) is lost, resulting in a disruption of communication from the brain to other areas of the body. This “disconnect” causes the many symptoms that people with MS know only too well—blurred vision, weakness, pain, numbness, and so on.

“MS starts in a few trees and then starts burning the whole forest,” said Lawrence Steinman, MD, a professor in Stanford University's departments of Neurology and Neurological Sciences, Pediatrics, and Genetics, and chair of the Stanford University Program in Immunology. Dr. Steinman has spent his life working on ways to put the MS fire out.

As Patricia O'Looney, PhD, director of Biomedical Research at the National MS Society, put it, “Dr. Steinman is an innovator who uses the most current technological advances in other areas of medicine and adapts them for MS research. His work is among the most exciting and innovative in the field.”

In addition to his advances in MS research, Dr. Steinman has published nearly 325 papers or book chapters related to basic and clinical neuroimmunology. He has served as a scientific and medical advisor to the National MS Society and as a member of the Immunological Sciences Study Section of the National Institutes of Health. He was the associate editor of the Journal of Immunology from 1991 to 1995, and is currently associate editor of Neurobiology of Disease.

T cells and the creation of an MS model

In the 1980s, fresh out of Harvard University and internships and fellowships at Stanford University Hospital and Weizmann Institute in Israel, respectively, Dr. Steinman was among the first MS investigators to focus on T cells. T cells, which are white blood cells, are considered the master cells of the immune system. They make the chemical messengers that prompt the system to work. Dr. Steinman investigated T cells that were specifically targeted against one of the major proteins in myelin.

Dr. Steinman and colleagues used these myelin-aggressive T cells to induce an MS-like disease in mice: experimental autoimmune encephalomyelitis, or EAE. The study, published in the September 1985 issue of Nature, led Dr. Steinman to test experimental therapies on mice with EAE designed to block T cells from attacking the protein in myelin.

How do you block a T cell? Dr. Steinman and colleagues designed monoclonal antibodies to adhere to the myelin-aggressive T cells—specifically to their “adhesion” molecules, sticky Velcro-like molecules on T cell surfaces. Adhesion molecules enable T cells to pass from the blood–stream into the central nervous system. By blocking them, the T cells could not stick to and pass through the blood-brain barrier. Dr. Steinman's research ultimately led to the development of Antegren, which is now in early clinical trials as an MS therapy. (See “Promising results in early Antegren trial” in the Winter 2002 InsideMS.)

Altered peptide ligands


But there's more than one way to block a T cell.

In the January 1996 issue of Nature, Dr. Steinman and colleagues published a study involving mice wherein the T cells were blocked another way. Specifically, Dr. Steinman found a way to alter the myelin “docking sites” found on the surface of myelin-aggressive T cells and change the way these T cells behave in the mice. Again, this innovative research has led to a possible therapy called “altered peptide ligands” that is now in early clinical trials in people with MS.

Using the latest technology

Some of Dr. Steinman's recent research employs a new and very sophisticated lab tool: DNA microarrays, which can sort through hundreds of genes in tissues at once, sensing whether a gene is switched “on” or “off” in a given cell. Using DNA microarrays, his research team is delving into the human genetic structure. Using brain tissue from people who had MS and comparing it with tissue from people who did not have the disease, Dr. Steinman and colleagues found an unexpectedly high expression of a proinflammatory molecule called osteopontin in the people with MS.

In studies with mice, a similar link between osteopontin and EAE was discovered.

“The activity of the gene controlling osteopontin was totally unexpected,” Dr. Steinman said. “Osteopontin sounds like something to do with bones, but it plays a key role in the immune response. This finding is taking us into some very interesting directions.”

Will the cure for MS be a vaccine?

Dr. Steinman's early research suggests that the initial immune attack in MS is directed against one specific protein. But the attack then spreads to other segments of that protein or to other proteins in myelin. This kind of escalating attack is called “epitope spreading”.

Dr. Steinman and his researchers studied epitope spreading by tracking another kind of immune cell, called the B cell, which produces antibodies. Antibodies “tag” substances for destruction by other immune components. In MS, B cells present fragments of myelin proteins to the T cells, which can then initiate the immune attack against myelin. The study on epitope spreading, published in Nature Biotechnology (2003 Sep; 21[9]: 1033–1039), showed that the mice with the most diverse B-cell responses—meaning that their B cells reacted to many different myelin protein molecules—had the largest number of relapses of EAE. Using this information, Dr. Steinman and colleagues designed customized “cocktails” of the DNA that instruct several of the relevant myelin proteins involved in such B cell responses to the disease. The goal was to induce the immune system to tolerate—instead of attack—all of the proteins in myelin. In studies with mice, the DNA “vaccines” reduced both relapse rates and epitope spreading. Now, early safety and pilot clinical trials involving people with MS are planned.

The next 60 yards


When describing the progress of MS research, Dr. Steinman switches from the forest-fire metaphor to football, admitting that he and other researchers have made gains with “one or two first downs. We have about 60 more yards in the field before we score a touchdown. Until we get the disease cured, it's presumptuous to call any step a big one,” Dr. Steinman said. “They're all small steps.”

The John Dystel Prize for MS Research is given jointly by the National MS Society and the American Academy of Neurology and is funded through the Society's John Dystel Multiple Sclerosis Research Fund. Society National Board member Oscar Dystel and his late wife, Marion, established this fund in 1994 in honor of their son John Jay Dystel, a lawyer whose promising career was cut short by progressive disability from MS. (John died of complications of the disease in June 2003.) The Dystel Prize is the only professional award given annually to honor outstanding contributions to MS research.


Ok, that settles THAT matter, before rumors again go rampant.

Now, as for Biogen ever receiving some "assistance", indirectly from MS Societies (this is just an example, but will show again how little informed employees of pharma companies even are regarding their own company's "background" and involvements, shall we say kindly)........I QUICKLY found the following. Again, I will highlight in RED this time. Please Note:

Wednesday, September 18, 2002
Young Scientific Investigator Session


....The Blood Brain Barrier as a Target for
Treatment
33
ADHESION MOLECULES AND THEIR ROLE IN PATHOGENESIS
Antel JP, Biernacki K, Seguin R, Prat A
Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada

Abstract Body: Cellular immune trafficking across the blood brain barrier(BBB) involves a series of molecular interactions between such cells and the cells and extra cellular matrix (ECM) that comprise the BBB. These interactions include the processes of cell-cell adhesion; chemoattraction, and ECM degradation by matrix metalloproteinases (MMPs). With specific regard to adhesion molecules, expression of these molecules is up-regulated on lymphocytes and monocytes when such cells are activated, as is observed to occur in concert with active phases of multiple sclerosis (MS). In situ studies of central nervous system (CNS) microvessels derived from MS cases, demonstrate upregulation of the ligands for a number of adhesion molecules on endothelial cells (ECs) when compared to ECs from non-inflammatory control cases. To model the role of cell-cell adhesion in cell trafficking across the BBB, we have examined the interaction of lymphocytes and monocytes derived from the peripheral blood of MS patients and controls with human brain (HB)ECs derived from non-inflammatory surgical tissue specimens. These HBECs constitutively
express moderate levels of ICAM-1 but only very low levels of VCAM-1. Expression of both of these adhesion molecules is up-regulated when the HBECs are exposed to supernatants from Th1 cytokine producing CD4 T cell lines. Th2 cytokine producing cell lines neither up-regulate nor inhibit adhesion molecule expression. Using a Boyden chamber assay system,
we can demonstrate that both lymphocyte and monocyte migration across a barrier of HBECs grown on a fibronectin matrix can be inhibited by antibodies directed at ICAM-1 but not VCAM-1. Antibodies directed at the VCAM-1 ligand VLA-4 do inhibit migration, implicating VLA-4 binding to an alternate ligand (Connecting Segment (CS-1) fragment of fibronectin) as the functional event. Adhesion molecules remain targets for therapeutic intervention in MS (eg anti-VLA-4 antibodies). Neither Copaxone nor intereferon (IFN) directly modulate adhesion molecule expression on HBECs. However, IFN treated lymphocytes induce VCAM on the HBECs with a subsequent release of soluble VCAM-1 (sVCAM) ( Calabrese et al 2001). sVCAM binding to its ligand VLA-4 would provide a means to down-regulate trans-endothelial migration.

Disclosure: J Antel has received honoraria from TEVA Marion, Schering,
Biogen and Serona
Funding: Supported by Multiple Sclerosis Society of Canada


CLINICAL TRIALS OF AGENTS TARGETING THE BLOOD BRAIN
BARRIER: SUCCESSES AND FAILURES

Miller D
NMR Research Unit, Institute of Neurology, London, United Kingdom

Abstract Body: Several lines of evidence implicate blood brain barrier
(BBB) abnormality as an important component in the development of
multiple sclerosis lesions. New lesions exhibit BBB breakdown and
perivascular lymphocytic infiltrates. The location of lesions around cerebral
venules suggests that BBB breakdown may have a key role in lesion
genesis. Serial MRI studies using gadolinium-chelate contrast agents
have demonstrated BBB breakdown as a consistent feature of new lesions
in relapse onset MS. However, new or enlarging lesions may develop without BBB breakdown in primary progressive MS and possibly in other
forms of the disease. Diffuse abnormalities of the normal appearing white
matter also occur, and the relationship of these to BBB breakdown is
uncertain. It is however, likely that BBB breakdown is more extensive than the regions of gadolinium enhancement that are detectable to the eye.

There is good evidence for low grade leakage in chronic lesions, and it may also exist in normal appearing white matter. Using gadolinium
enhanced MIR, there is a relationship of BBB leakage with relapses, but
not with progressive MS. Many immunosuppressive and immunomodulatory treatments have been shown to suppress new areas of focal BBB leakage.

High dose intravenous steroids have a similar but transient effect on
pre-existing and new enhancing lesions. Recently, the monoclonal antiadhesion molecule antibody, anti-VLA4 (natalizumab), has shown dramatic effects in reducing by 90% the frequency of new areas of BBB leakage, but unlike intravenous steroids, does not effect the existing areas of leakage. Natalizumab treated patients also experienced a reduced relapse rate by 50% in the 6 month placebo controlled exploratory trial, and exhibited increased well being compared to those on placebo. Two year studies of this agent are now underway to evaluate its long term safety and efficacy, and in particular the effect on disability. Such long term studies are important, in view of the uncertain relationship between focal BBB changes and progressive disability.

Disclosure: D Miller has received grants from Elan and Biogen for MRI analysis in clinical trials of Natalizumab
Funding: MS Society of Great Britain and Northern Ireland.


My point in this short exercise is only to provide evidence of how "word of mouth" things can become distorted, and how you can't always believe everything you hear. Especially when things can be so easily confirmed.

Thanks,

Deb
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Postby bromley » Wed Feb 09, 2005 7:26 am

OddDuck and co,

I think I raised the issue of whether NMSS could take a share of the success of a treatment which it had partly funded during development. My interest came from the NMSS' 2004 Review which stated that:

'The U.S. FDA approved Tysabri® (natalizumab, Biogen Idec and Elan Corporation) to reduce the frequency of clinical relapses in relapsing forms of MS. Tysabri (formerly Antegren) is a monoclonal antibody given by monthly infusion into a vein. Results from the first year of ongoing clinical trials showed that Tysabri reduced the relapse rate up to 66%, reduced the development of new MRI-detected lesions, and showed other benefits. This approach was first explored in laboratory animal research in part with funds provided by the National MS Society to Stanford investigators'.

I just thought that if the NMSS had thrown in some money which contributed in some way to a successful treament - should it not be seeking a return on that early investment which it could then re-invest in research. Even if the return was small in percentage terms (eg 1%) it could still raise significant sums of money. Government's do this all the time when they fund the development of defence equipment - if the equipment is subsequent exported the Government receives a % of the revenue.

If Tysabri is ever introduced in the UK, it will be interesting to see what our National Health Service pays compared to US insurers. The UK Health Service has a risk sharing agreement in relation to the CRAB drugs. We also have something called the Prescription Pricing Authority which, I understand, negotiates a 'fair' price for drugs.

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Postby flora68 » Wed Feb 09, 2005 8:08 am

:|
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Postby OddDuck » Wed Feb 09, 2005 8:52 am

Bromley,

No. Simply put (so as to not get into the complex IRS rules and regulations, and Federal Laws), in the United States it is highly illegal for a non-profit organization to receive funds from "for profit" activities, especially from for-profit corporations. They can't do that. It's pretty complicated, but direct exchange of funds cannot happen. And would they get caught at it? Yes........in a heartbeat.

If a corporation wants to "contribute" unrestricted (operative word there) money to a non-profit organization to use as the non-profit chooses, that can be done. Can a non-profit receive funds directly or proportionately from a marketed and profit-making activity of a corporation? No.........unequivocably no.

I hope that explains.

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Postby art » Thu Feb 10, 2005 9:11 am

Nonprofits are allowed to generate funds from for-profit activities. I quote from Nolo Press' "How to Form a Nonprofit Corporation in all 50 states":

"Can a Nonprofit Corportation Engage in For-Profit Pursuits?"
Yes, reglular commercial business activities can also be used to finance nonprofit operations. However, to avoid jeopardizing the nonprofit's federal 501(c)3 tax exemption, these profit-making activities must be incidental sidelines, not substantial operations, of the nonprofit organization."

Owning Intellectual Property on research you fund and licensing it is completely acceptable. Check out your local nonprofit educational institution who does any research. I'm sure they have a technology licensing office and do just that. MIT, for example, makes quite a huge amount of money licensing out the results from research they did.

My comments on the NMSS participation (which, mind you, is a completely different org than the MS Society of Canada and the UK MS Society) is just to say that their contribution, while probably important, is unlikely to be at the level most readers assume when they read that they funded the research that lead to the new treatment. I merely point out that 2 of the most involved individuals in the development of Tysabri and of Avonex did not know what their role was. Perhaps it was not as great of a role as is implied. There is a big difference between a technically true statement and the impression it leaves on the general listener. But I'm sure you understand this.

Isaac Newton could claim that he did the research that lead to the creation of most inventions we have today. While true, it might lead people to believe he invented them himself should his PR people phrase it appropriately.
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Postby BioDocFL » Thu Feb 10, 2005 9:27 am

I work for a not-for-profit private research institute. We have patent attorneys on our staff to help with patent applications and other contracting. The institute is pretty generous too: the researcher gets 1/3, the department gets 1/3, and the institute gets 1/3. Most organizations are nowhere near that generous. That motivates the researchers and also puts money back into research. Of course there would have to be some licensing agreement reached with an outside company for the manufacture and distribution.

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Postby OddDuck » Thu Feb 10, 2005 12:13 pm

Art and Wesley,

What you two are referring to and what I said are totally different things.

I also work for a HUGE non-profit, (and have for many many years) as you know Art, in their very legal department (I AM a paralegal) and recently had to do this very research we are talking about here.

You have to be careful about what kind of interactions you do with "for-profit corporations", Art. I'm telling ya. And how and in what ways you accept "money" from "corporations".

It's corporate vs. non-corporate. Not "licensing", etc. You have to dissect it legally a little farther down than that.

But am I going to get into a legal debate with you here? No. Suffice it to say, I WORK in law, and for a non-profit, and part of my responsibility is to help advise the "attorneys" what to tell their clients. Who do you think gives the "attorneys" this kind of information in the first place? If you think attorneys do all their own "research", think again.

Besides, there are many types of "non-profit" regulations and ways to organize under the IRS. Not just 501(c)(3). Charities, private foundations, educational institutions, research institutions, and on and on and on.

Bottom line? I stand by my original statement. For a non-profit organized in the way that the NMSS is, it is illegal for them to directly accept a share of profits from a for-profit CORPORATION from the marketing and sale of a drug.

(Come on, if it was, why isn't the NMSS just rolling in the dough, huh? Come on. Go check out their financials. Find me where they have a line item called "profit from sale of drugs". Right.)

Why do you think the term "unrestricted", when it is referred to a donation from a corporation to a non-profit, is even used in the first place?

The NMSS is not a "research institute". That is organized under a different regulation under the IRC 501. Again, I won't go into it all, but there are several sub-categories of "non-profits".

I stand by my original post. And it is backed by the attorneys I know.

(Art, your attorneys and ours have disagreed before about this stuff, so let's not even go there, ok?) It's obvious we'll have to agree to disagree. But remember, what holds true for a non-profit such as yours, Art, (or yours, Wesley) does not hold true for ALL non-profits.

The one I work for, especially, just as an example.

Again, we agree to disagree.

Thanks.

Deb
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Postby art » Thu Feb 10, 2005 12:22 pm

I'll inform the thousands of nonprofits who receive licensing royalties to expect to hear from your lawyers! :roll:
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Postby OddDuck » Thu Feb 10, 2005 12:25 pm

Ok......Then tell me, Art.

Why DOESN'T the NMSS accept "royalties" then, as you call them, from the sale of drugs that they have been involved in the research of?

Besides, profits from the sale of drugs is not "licensing".
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Postby OddDuck » Thu Feb 10, 2005 12:37 pm

I'll tell you what.

Let's start here: http://www.irs.ustreas.gov/pub/irs-pdf/p557.pdf

Then, after you figure all that out, just to begin with, then factor in the fact that the NMSS also has "membership", thereby making it even more complex.

Then, factor in the complexities of "public support", then factor in percentages, and on and on.

Research it all for a few hours, if you don't get a headache after you realize the true complexity of it all (because it gets much more "minute" than you ever expected).

And remember, you haven't even begun to scratch the surface of the NEXT stop you have to go to from here! This is just the tip of the iceberg. That's just the IRS regs! We haven't even begun to scratch the surface of Federal laws, yet. We won't be done figuring out all the complexities of the IRS regs for quite a while, before we can even begin to move on to how Federal, i.e. Federal Anti-Kickback, Stark, and other laws governing financial relationships in the healthcare field (including pharmaceutical companies), for example (and heaven forbid, STATE and local laws) may apply.

It's just not that simple.

Deb
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