Friday, May 06, 2005

Hero Corporation Comes Through!

<>
In an earlier post, I covered the plight of Amanda Twellman-Dieppa, who has Hodgkin’s Disease and worse, has relapsed and does not have a favorable prognosis. Unfortunately, the emotion of Amanda’s condition led to a confrontation with Medarex, who is developing a drug which may help Amanda’s condition. Unfortunately, the Twellman-Dieppa family chose the wrong method, but Mr. Drakeman, President of Medarex, stepped up to the plate in a big way.

SaveAmanda.com has an update, confirming that “a resolution has been reached, which meets the needs of the family and the goals of Medarex”. Details, as you might expect when an exception to all the normal rules is made, are being kept private, but considering the immense risk that Medarex is accepting in this case, the company’s actions are nothing short of heroic. The company was falsely accused of being uncaring and greedy, was hounded by a biased national radio host*, and faced a growing wave of unfair accusations through the Internet rumor mill; very few voices presented Medarex’s perspective, or tried to balance the known information. Despite the public pressure from both sides, the huge risk of allowing its competitors to see the results of MDX-60, and the embarrassment of hundreds of false rumors directed against them, Mr. Drakeman and the directors of Medarex stayed on mission to find a way to help Amanda. There is no way to know for sure whether MDX-60 will work, and even if it’s completely successful, it means years of recovery at best. Since my own mom had breast cancer, I understand that ‘success’ means remission, which is just another word for waiting for the possibility the cancer could still come back.

I am very thankful that Amanda will get the drug she believes is her best hope. I appreciate the determination her father showed in making sure he did everything he could. And most of all, the courage and idealist spirit showed by the directors at Medarex, though it will be ignored by most, is worthy of great praise on the record.


(* The radio host, it should be mentioned, grudgingly admitted that Medarex and it's President, Mr. Drakeman, have been invaluable in helping Amanda.)

Wow

[]
I was trying to think of a great article for today, and a few ideas came up. But they will have to wait for another day, because I found a tremendous article on a critical need we all face; How to really be a follower of Christ.

Timothy George and John Woodbridge wrote a powerful book, entitled “The Mark of Jesus", and excerpted it into an article, using the books of 1st and 2nd Corinthians to show historical examples from the missions of Paul. It’s a bit lengthy, but if you want to really be a Christian, or if you are curious about what a Christian should be like, you must read this article. Read the whole thing, as they say.

(grateful hat tips to Worthy Thinking, and to Oh How I Love Jesus)

UPDATE: I meant to write 1st & 2nd Corinthians, but actually wrote "Chronicles". Thanks Romeocat for the catch! The entry is now corrected.

Thursday, May 05, 2005

Was Jesus Sinless?

+++
The question about whether of not Jesus sinned has come up, as well as whether this matters in relation to His atonement for the world. In these days of Absolute Moral Relativism, the notion that Jesus Christ may actually have been exactly as the Gospel accounts describe Him, runs headlong into the humanist dogma, which thinks itself enlightened and tolerant, to grant the Son of God status as a ‘good teacher’, but not as the Lord God’s only begotten Son. So, a defense of the Lord’s perfection, once accepted as obvious as the corrupt nature of Man, is necessary.

There is an abundance of Scripture which refers to Jesus Christ. Unfortunately, much of the Old Testament is rejected by non-Christians in that context, and so for the purpose of this discussion I will leave aside the Old Testament passages which I believe specifically mention Jesus the Christ, and bear directly with New Testament passages when speaking of Jesus directly, and only refer to the Old Testament when addressing the Jewish position on sin.

To answer the question of whether Jesus sinned, requires a basic agreement on the meaning of ‘sin, especially as practiced in Jesus’ day. Accordingly, I have selected verses which bear on the general description of sin, and on the actions of the Jewish authorities in Jesus’ specific case.

First, the functional starting point – does it matter? To that, I reference Ezekiel 33:12, which reads:

“The righteous man, if he sins, will not be allowed to live because of his former righteousness.”

So, if Jesus Christ had sinned, even though He was perfectly righteous, He would have been made unfit to be the Savior of the world in that moment. This is exactly why satan tried to tempt Him in the wilderness, and a point on which I may not yield.

So, what else does God have to say about sin before the coming of Christ? Quite a bit, actually. Consider what these verses say:

“The Lord says:
"These people come near to me with their mouth
and honor me with their lips,
but their hearts are far from me.
Their worship of me
is made up only of rules taught by men”
(Isaiah 29:13)

The law is from God, not what men demand.

“He has showed you, O man, what is good.
And what does the LORD require of you?
To act justly and to love mercy
and to walk humbly with your God.”
(Micah 6:8)

To love God and act in that love, is to not sin at all.

“The day of the LORD is near
for all nations.
As you have done, it will be done to you;
your deeds will return upon your own head.”
(Obadiah 1:15)

You get back what you do. Sin, therefore, must be to do a thing which is destructive and evil. To do good would only bring good back to yourself.

“Rend your heart
and not your garments.
Return to the LORD your God,
for he is gracious and compassionate,
slow to anger and abounding in love,
and he relents from sending calamity”
(Joel 2:13)

God is not concerned with what happens on the outside, but what happens on the inside, in your heart.

“For I desire mercy, not sacrifice,
and acknowledgment of God rather than burnt offerings.”
(Hosea 6:6)
Again, we see plainly that God is concerned not with technicalities, but the heart and soul of a person.

“Do not seek revenge or bear a grudge against one of your people, but love your neighbor as yourself. I am the LORD.”
(Leviticus 19:18)

Even in the book most often quoted as onerous and burdensome, God speaks plainly about love and doing good.

Therefore, the notion of sin must be considered not by what is written in ink, but in what pleases and serves God.

Further, we have the example of how Jesus was treated in His own life. Consider the words and actions of the Pharisees and Levites in these situations:

“Jesus stepped into a boat, crossed over and came to his own town. Some men brought to him a paralytic, lying on a mat. When Jesus saw their faith, he said to the paralytic, "Take heart, son; your sins are forgiven."

At this, some of the teachers of the law said to themselves, "This fellow is blaspheming!"

Knowing their thoughts, Jesus said, "Why do you entertain evil thoughts in your hearts? Which is easier: to say, 'Your sins are forgiven,' or to say, 'Get up and walk'? But so that you may know that the Son of Man has authority on earth to forgive sins...." Then he said to the paralytic, "Get up, take your mat and go home." And the man got up and went home. When the crowd saw this, they were filled with awe; and they praised God, who had given such authority to men.”
(Matthew 9:1-8)

See how the Pharisees are answered, and how by doing what is good Jesus rebukes them.
“While they were going out, a man who was demon-possessed and could not talk was brought to Jesus. And when the demon was driven out, the man who had been mute spoke. The crowd was amazed and said, "Nothing like this has ever been seen in Israel."
But the Pharisees said, "It is by the prince of demons that he drives out demons."
(Matthew 9:32-33)

See how Jesus does a blameless thing, and His enemies seek an insulting explanation. Who in this point pleases God more?

“At that time Jesus went through the grainfields on the Sabbath. His disciples were hungry and began to pick some heads of grain and eat them. When the Pharisees saw this, they said to him, "Look! Your disciples are doing what is unlawful on the Sabbath."

He answered, "Haven't you read what David did when he and his companions were hungry? He entered the house of God, and he and his companions ate the consecrated bread—which was not lawful for them to do, but only for the priests. Or haven't you read in the Law that on the Sabbath the priests in the temple desecrate the day and yet are innocent? I tell you that one greater than the temple is here. If you had known what these words mean, 'I desire mercy, not sacrifice,' you would not have condemned the innocent. For the Son of Man is Lord of the Sabbath."

Going on from that place, he went into their synagogue, and a man with a shriveled hand was there. Looking for a reason to accuse Jesus, they asked him, "Is it lawful to heal on the Sabbath?"

He said to them, "If any of you has a sheep and it falls into a pit on the Sabbath, will you not take hold of it and lift it out? How much more valuable is a man than a sheep! Therefore it is lawful to do good on the Sabbath."

Then he said to the man, "Stretch out your hand." So he stretched it out and it was completely restored, just as sound as the other. But the Pharisees went out and plotted how they might kill Jesus.”

(Matthew 12:1-14)

Jesus not only explains the law, but provides a historical context. Se how the Pharisees do not answer, but accept His truth.

“Then some Pharisees and teachers of the law came to Jesus from Jerusalem and asked, "Why do your disciples break the tradition of the elders? They don't wash their hands before they eat!"

Jesus replied, "And why do you break the command of God for the sake of your tradition? For God said, 'Honor your father and mother' and 'Anyone who curses his father or mother must be put to death.' But you say that if a man says to his father or mother, 'Whatever help you might otherwise have received from me is a gift devoted to God,' he is not to 'honor his father’ with it. Thus you nullify the word of God for the sake of your tradition. You hypocrites! Isaiah was right when he prophesied about you:
" 'These people honor me with their lips,
but their hearts are far from me.
They worship me in vain;
their teachings are but rules taught by men.'"

Jesus called the crowd to him and said, "Listen and understand. What goes into a man's mouth does not make him 'unclean,' but what comes out of his mouth, that is what makes him 'unclean.' "

(Matthew 15:1-11)

“Break the tradition”? See how cumbersome these men become, that even a habit they have become used to, is now considered a requirement!

“Some Pharisees came to him to test him. They asked, "Is it lawful for a man to divorce his wife for any and every reason?"

"Haven't you read," he replied, "that at the beginning the Creator 'made them male and female,'and said, 'For this reason a man will leave his father and mother and be united to his wife, and the two will become one flesh'? So they are no longer two, but one. Therefore what God has joined together, let man not separate."

"Why then," they asked, "did Moses command that a man give his wife a certificate of divorce and send her away?"

Jesus replied, "Moses permitted you to divorce your wives because your hearts were hard. But it was not this way from the beginning. I tell you that anyone who divorces his wife, except for marital unfaithfulness, and marries another woman commits adultery."

The disciples said to him, "If this is the situation between a husband and wife, it is better not to marry."

Jesus replied, "Not everyone can accept this word, but only those to whom it has been given.”

(Matthew 19:3-11)

Jesus again explains the law and more, shows us that some of the old law was not what God desired, but what man was willing to accept.

“Then little children were brought to Jesus for him to place his hands on them and pray for them. But the disciples rebuked those who brought them.

Jesus said, "Let the little children come to me, and do not hinder them, for the kingdom of heaven belongs to such as these."

(Matthew 19:13-14)

Could Jesus be more plain? It is not about deeds against a standard, or knowledge of a code of rules, but the purity of heart.

Now, after all this, you would think that the Pharisees would have had a lengthy list of accusations to place against Jesus, but when they arrested Him, they couldn’t even agree on their stories:

“The chief priests and the whole Sanhedrin were looking for false evidence against Jesus so that they could put him to death. But they did not find any, though many false witnesses came forward.

Finally two came forward and declared, "This fellow said, 'I am able to destroy the temple of God and rebuild it in three days.' "

Then the high priest stood up and said to Jesus, "Are you not going to answer? What is this testimony that these men are bringing against you?" But Jesus remained silent.

The high priest said to him, "I charge you under oath by the living God: Tell us if you are the Christ,the Son of God."

"Yes, it is as you say," Jesus replied. "But I say to all of you: In the future you will see the Son of Man sitting at the right hand of the Mighty One and coming on the clouds of heaven."

Then the high priest tore his clothes and said, "He has spoken blasphemy! Why do we need any more witnesses? Look, now you have heard the blasphemy. What do you think?"

”He is worthy of death," they answered.”

(Matthew 26:59-66)

Note that carefully. Not that Jesus broke any point of the law, not any of the Commandments, except that they claimed He blasphemed, and if Jesus is the Son of God then that charge was false.

So they take Jesus to Pilate, but once there, they no longer accuse Jesus of Blasphemy, but Sedition and Insurrection against the Caesar by claiming to be a king.

The matter is plain, from that perspective – even the Pharisees could not find a law Jesus had broken.

OK, now I sense the people who don’t accept the Bible as literally true, will protest that I am taking the accounts at their word, and that very possibly the Sanhedrin did in fact press Moses’ law against Jesus. To that, I answer look at what happened. Jesus was not stoned, as is the customary punishment for Blasphemy. He wasn’t even flogged by the Sanhedrin, which we know was an option through the events mentioned in the Book of Acts. Nope, the Sanhedrin sent Jesus off to Pilate and Herod. Why? Because they had no religious basis on which to kill him, and depended on the Secular government for that. So, on that basis, the sole conclusion available, is that the Sanhedrin could not indict Jesus convincingly on a charge of violating the law. IF they could, they could have discredited Him, which would have done exactly what they wanted.

Now, returning to the Person of Christ, what signs do we see that support His sinlessless? Consider these verses:

“Do not think that I have come to abolish the Law or the Prophets; I have not come to abolish them but to fulfill them. I tell you the truth, until heaven and earth disappear, not the smallest letter, not the least stroke of a pen, will by any means disappear from the Law until everything is accomplished.”
(Matthew 5:17-18)

Jesus said this at the start of His ministry. Would His disciples have included this in the Gospel according to Matthew, if they believed He had broken the Law? Would Jesus have said this, if He was going to violate the Law?

“All things have been committed to me by my Father. No one knows the Son except the Father, and no one knows the Father except the Son and those to whom the Son chooses to reveal him.”
(Matthew 11:27)

Jesus enjoys a special relationship with God the Father. Who could say this, except the one man who never sinned?

“After six days Jesus took with him Peter, James and John the brother of James, and led them up a high mountain by themselves. There he was transfigured before them. His face shone like the sun, and his clothes became as white as the light. Just then there appeared before them Moses and Elijah, talking with Jesus.

Peter said to Jesus, "Lord, it is good for us to be here. If you wish, I will put up three shelters—one for you, one for Moses and one for Elijah."

While he was still speaking, a bright cloud enveloped them, and a voice from the cloud said, "This is my Son, whom I love; with him I am well pleased. Listen to him!”

(Matthew 17:1-5)

We see here Jesus speaking to the writer of the Law, and to its most effective defender. That speaks to His authority. Also, there is no chance, at all, that the most Holy and Perfect LORD would say this statement, if Jesus were simply a good teacher.

"When the Son of Man comes in his glory, and all the angels with him, he will sit on his throne in heavenly glory. All the nations will be gathered before him, and he will separate the people one from another as a shepherd separates the sheep from the goats. He will put the sheep on his right and the goats on his left.

"Then the King will say to those on his right, 'Come, you who are blessed by my Father; take your inheritance, the kingdom prepared for you since the creation of the world. For I was hungry and you gave me something to eat, I was thirsty and you gave me something to drink, I was a stranger and you invited me in, I needed clothes and you clothed me, I was sick and you looked after me, I was in prison and you came to visit me.'

"Then the righteous will answer him, 'Lord, when did we see you hungry and feed you, or thirsty and give you something to drink? When did we see you a stranger and invite you in, or needing clothes and clothe you? When did we see you sick or in prison and go to visit you?'

“The King will reply, 'I tell you the truth, whatever you did for one of the least of these brothers of mine, you did for me.'

"Then he will say to those on his left, 'Depart from me, you who are cursed, into the eternal fire prepared for the devil and his angels. For I was hungry and you gave me nothing to eat, I was thirsty and you gave me nothing to drink, I was a stranger and you did not invite me in, I needed clothes and you did not clothe me, I was sick and in prison and you did not look after me.'

"They also will answer, 'Lord, when did we see you hungry or thirsty or a stranger or needing clothes or sick or in prison, and did not help you?'

"He will reply, 'I tell you the truth, whatever you did not do for one of the least of these, you did not do for me.'

"Then they will go away to eternal punishment, but the righteous to eternal life."

(Matthew 25:31-46)

Jesus has authority to judge all men, including those who God deems righteous. That speaks for itself.

Jesus, alone of all men, lived a sinless life. This is borne out by a close look at how God created His Law, how even Jesus’ enemies weighed His actions, by the effects and results of Jesus’ words and deeds, and by the authority which is reserved for Christ Jesus. In my opinion, one can only pretend Jesus sinned, by denying Whom He Is.

Wednesday, May 04, 2005

The Story Has 2 Sides - Amanda and Medarex

In his best-seller, “Blog”, columnist and talk show host Hugh Hewitt explained why blogs are passing news analysts in popularity: “The public has the final say. There is no going back, only an endless effort to capture and keep audience based on credibility.” (pg 94). That credibility is the seed for the blogosphere’s growth and character. Sometimes it’s vital for blogs to band together to defend a fellow blogger. Sometimes, it’s necessary for one blog to step in to be sure the story remains balanced.

Tuesday afternoon, Hugh Hewitt posted the story of Amanda Twellman-Dieppa, who contacted him to ask for support in her quest to gain access to an experimental cancer drug. According to Amanda, she has cancer which has relapsed, and in her opinion only an experiemntal drug she calls “CD30” has any chance of saving her life, but she says the drug company, Medarex, refuses to allow her access to the drug, even though she says the Food and Drug Administration has promised special permission to ensure she can take the drug. Hewitt checked our her website, decided he found it credible, and says he tried to get Medarex’s side of the story. By airtime of his radio show, Hewitt had made up his mind to pick a side, and pushed his audience to press Medarex to release the drug. One of Hewitt’s callers pointed out that he had only presented one side of the story, which Hewitt rather angrily denied, saying “she’s dying, and we can’t wait.” The caller suggested that one day wait to get the other side wouldn’t hurt the matter, and could allow a balanced presentation. Hewitt was not interested in that option. Hugh's one of the good guys, but on this call I don't believe he has covered all the bases. So, I decided to look into the matter myself.

Hewitt’s website has links to Amanda’s website (which has become unavailable, probably due to high traffic), and the website for Medarex. This allowed me important reference information, for which I thank Mr. Hewitt.

Hewitt began with Amanda’s statement to him, which in part reads as follows:

I am 22 years old and I have cancer. I was diagnosed when I was 16 years old, went through chemo and radiation and was in remission until I relapsed when I was 19 years old. I went through a grueling stem cell transplant and received my lifetime amount of radiation and once again went into remission until February 25, 2005.”

One thing which bothered me right off the bat, is that Amanda does not specify what sort of cancer she has in this statement. Since I was unable to access her website, it’s possible that this information is on her website, but neither Amanda nor Mr. Hewitt were specific about this point. This is a concern, because there are many types of cancers, some which move rapidly (like cancer of the liver) and some which grow comparatively slowly, some which can be treated with a number of options, and some which are difficult to treat.

Another point of concern showed up when I reviewed the information at Medarex. Medarex did not refer to a drug called “CD30”, but their 2004 Annual Report mentioned promising hope for a drug they called “MDX-60”, which is primarily being developed as a treatment for Hodgkin’s Disease, and the statement says the drug was especially effective in treating “relapsed CD-30 lymphomas”.

The National Institute of Health identifies “CD 30” not as a drug, but as a class of treatment, called “anti-CD 30 immunotoxins for the treatment of cancer”, specifically “a novel therapeutic agent to treat Hodgkin's disease and anaplastic large cell lymphoma, NCI has made a panel of recombinant immunotoxins specific for CD30 using Fvs of newly produced anti-CD30 monoclonal antibodies (MAbs) and a truncated mutant of Pseudomonas exotoxin. CD30 is highly expressed on both Hodgkin's disease and anaplastic large cell lymphoma. NCI is curently seeking cooperative partners to work with the Laboratory of Molecular Biology in the development and clinical application of immunotoxins directed against CD 30 epitopes found on cells in Hodgkin's Lymphoma and anaplastic large cell lymphoma.

Significantly, the NIH says that anti-CD 30 immunotoxins are in a “current state of development” known as “in-vitro demonstration of toxicity.

Further, the NIH notes that in developing drugs for this purpose, companies working on the drug will operate under an agreement known as “CRADA” (Cooperative Research and Development Agreement) . CRADA terms include:

* Term of the CRADA will be up to five (5) years
* No funding from the Government is available to Collaborator under a CRADA.
* Non-exclusive license option available for background rights. Exclusive license rights may be available in a specified field of use.


In plain english, the NIH expects drug labs to develop the drugs, but at their own cost and risk, and without a guarantee of an exclusive license, should a viable drug be discovered.

Looking deeper into Medarex, I found that Medarex began in 1987 as a New Jersey company, went public in 1991, and specializes in Monoclonal antibodies. Their specialties are “MDX-10” for melanoma treatment, and “MDX-60” for Hodgkin’s Disease (both entering or in “Phase II” of clinical trials in 2005)

22 “UltiMAb” products in clinical trials in 2004. Eight reached Phase II or III, meaning most of their work is in very early stages.

"MDX-60" is the product used in conjunction with “relapsed CD-30 lymphomas”, in Phase I and II trials. This is the product most likely referred to by Amanda Twellman-Dieppa.

"MDX-10" is already in “fast track” study in conjunction with the FDA, for treatment of metastatic melanoma, meaning that "MDX-60" has a back seat..

FDA assigned “Orphan Drug” designation for "MDX-60" in treatment of Hodgkins Disease. This means that using the drug for any other purpose can result in revocation of this designation, with significant tax penalties for the company.

Also, I found a “2005 Proxy Meeting Notice”, which shows company will have a meeting of the Shareholders on May 19. The notice specifies that any actions the company may take before the May 19 meeting, will be decided and approved at a prior meeting on March 22, 2005.

So, if you’re a director at Medarex, here’s what you see:

You're a relatively new, relatively small comany which has two major drugs in various phases of advanced research, but neither is in anything like near-release stages, certainly not for FDA submission. A woman and her family are demanding you release a drug still in “in-vitro” testing to them, and this request does not come from the FDA or the woman’s doctor, and there are no effective releases from liability, should something go wrong (like a patient facing death in a year, suddenly dying from an unexpected heart attack). There is no information about whether “MDX-60” is the only drug with a reasonable chance of success, nor in fact any empirical data to show “MDX-60” will be effective in the specific case. Further, release of the drug will be public record, so it’s success or failure will provide pivotal data to your competitors. Even if the drug does work, there is a risk that the extended use of the drug would result in increased tax costs, which the eventual sale of the drug would not cover. And finally, you have no authority to make a decision between March 22 and May 19, because of a blackout window in the Shareholders’ Meeting terms. In those conditions, what would you say to Mr. Hewitt, if you represented Medarex?

Maybe Medarex can find a way to make this work. Maybe there is some negotiating position with the FDA which can happen. But Hewitt’s assumption that Medarex doesn’t want to help Amanda, or that Medarex is operating out of greed, does not fairly present both sides. This article presents Medarex’s side, to give some balance to this story. It also reminds us that as bloggers, we have a strong and unending responsibility to seek the truth. It also, as a sidenote, illustrates some of the difficulties in drug reform initiatives: We need to focus on the patients, but never to the point of forgetting the needs of the companies which provide the miracle cures we now take for granted or worse, expect on our terms without delay or conditions.


UPDATE: The "Save Amanda" site is back up, but is very thin on facts. Amanda and her family still do not explain what sort of cancer she has, there is no medical support whatsoever, least of all to explain why MDX-60 is alleged to be the "only" drug which has any chance of successful treatment. I have also emailed Mr. Hewitt the notice of this article, so that he will have fair opportunity to respond.

UPDATE II: As it happens, I cross-posted over on Polipundit. Some of the more salient comments follow:

a4g reported (9:26 AM) that at the end of his show on Tuesday, Hugh spoke with Amanda’s father, who says that he has spoken with the President of Medarex, and found him very kind and sympathetic.

I pointed out (9:54 AM) that “the reason I am concerned about the absence of a doctor’s comments, is that we have nothing to indicate that MDX-60 will be more effective than other options. Amanda says MDX-60 is ‘it’, but given the level of its development, that seems an emotional assumption, rather than the judgment of a medical professional.
Next, what if MDX-60 kills her immediately, then it turns out another drug could have saved her? If Medarex ignores protocols here, there are all sorts of liability and performance issues that can fall on the company. What good would it do to give Amanda the untested drug, if the result not only does not save her life, but destroys the company and hurts countless other people, because the research is set back by the loss of the company? Don’t say it can’t happen, because it’s happened before.
Finally, there is a basic issue of fairness here. Hewitt put this up on his national radio show, but only addressed one side of the story. I genuinely hope that Amanda can receive the treatment that will save her life, but to coerce a private company to take risks, purely on an emotional argument with no empirical support at all, can hardly be called the right way to go about this.”


~B observed (9:58) this raises the question of whether it is acceptable for “dying patients to demand access to unproven drugs in an effort to extend and or save their lives at the risk of crashing the company developing the drug.”

Buckland (10:20) observed “The part I don’t like about this is the perception it leaves – if you want an unapproved treatment, the way to get it is to scream loudly and make accusations. Working within the system is for losers (and eventually dead ones).
The FDA puts some really stringent rules in place concerning the hurdles that a drug has to clear in order to come to the public. This is why it takes many years and successful trials to bring the drug to the public.
The drug has to be safe and effective. Those concerns have to be balanced. OxyContin is a great pain reliever, but the safety is less than optimal due to high addiction rates. However on balance it’s good. Such tradeoffs are made by companies and the FDA hundreds of times per year. There are exceptions, but on balance the system works well.
My guess is that the company will work out a way for Amanda to get the medicine, possibly through enrolling her in a trial of some kind. It may or may not do her any good, and it may or may not have side effects...

Non-Hodgkins Lymphoma (NHL) is extremely rare in people under 50, while Hodgkins Lymphoma is much more common in young people. However the fact that she had a marrow transplant hints that it is NHL, since that’s the only form of lymphoma that a transplant does any good for. It’s not an accepted treatment for Hodgkins Lymphoma.
Another possibility is that she has the more common Hodgkins Lymphoma and the family convinced the doctors to experiment with a marrow transplant (she calls it stem cell transplant), even though it has no history of working on Hodgkins Lymphoma. That would explain the public pressure to get the “wonder drug” now, and also explain why there’s no definitive statement on the type of cancer on the website.
My heart goes out to the family. It seems that they’re thrashing about, trying to find a cure for their daughter. Maybe I would do the same. However pushing for treatments that won’t help won’t do any good for anybody. And publicly pushing for drugs that aren’t ready for the public will tend to dry up the supply for those who really need them.”


I followed up again (10:46) with unanswered questions: “Why is MDX-60 the only option?
Why should a drug in early stages of testing be released to a patient with no compatibility vectors considered?
The page you referenced clearly (and in bold letters) claims Medarex is “CHOOSING PROFIT OVER LIFE” without a shred of evidence to back up that claim. Why do you ignore that issue?
There is not a single piece of medical opinion anywhere. There is nothing from her GP or any Lymphoma specialist, to support her demand for this specific treatment regimen. Why not?”


Buckland observed (11:04) “According to the Lymphoma Information Network , there are roughly 131,279 cases of Hodgkins Lymphoma in the US. All are fighting their own demons and those of the medical industry in order to do what’s necessary to survive. Each can tell a story of a disinterested doctor or a treatment that didn’t work as expected.
So if Hewitt found a new demon in the form of a drug company, so be it. And getting a new drug with unknown efficacy and side effects may be just what she needs. But if this in any way delays research on this or other drugs by diverting scarce resources to her above all of the other 131,278 cases then it’s a bad thing.
In the 1980’s the organ transplant world went through this. A reasonably fair system was set up for the allocation of scarce donor organs. However “resonably fair” is not at all fair if you are the one denied a life saving organ. So very sad cases mounted publicity campaigns, complete with sobbing Moms and beautiful children to get the needed organ.
And it worked. The cases that could mount the best publicity drive got the livers, no matter where the need was. Eventually the system corrected and went back to more of a dispassionate approach to these horrible choices.
There is a very good case that drugs as a whole go through too many trials before reaching the consumer. There’s also a case to be made that certain specialty drugs should be exempt from more (they are somewhat exempt now) of the rules and regulations. However I’m hard pressed to come up with a logical argument that the people who can get on the radio or build a website should go to the front of the line
.”

Jim m noted (11:47) “A couple of thoughts…I have worked in the oncology/transplant industry for 14 years now. Stem cell transplants(Bone marrow is almost never used any more as the primary source of cells) are done for Hodgkins Lymphoma. It is rare. Most cases respond well to therapy and such aggressive therapy is not necessary.
The company’s reluctance is quite understandable. “Compassionate Use” exemptions from the FDA are common, however these are typically requested by physicians who are participating in a company sponsored study. The Medarex website indicates that MDX-60 is in Phase II trials, but does not specify whether or not these trials are active or complete. In any case is seems clear that Amanda’s physician is not participating in any Medarex trial. Also it would take longer than just a few days to get the drug to Amanda. While the company might e able to ship the drug, the hospital where she would be treated would have to have any treatment plan approved by their investigational review board and the physician and staff need to be trained in the drug’s use. These issues would delay administration of the theray significantly.
The idea that the company is being greedy is simply nuts. They are required by law to follow very strick regulations regarding the use of an unapproved drug. Improper release of a drug would bring severe penalties to the company and possibly delay the approval of the drug if trials are successful.
As to the notion that this is her only hope. Please go to www.clinicaltrials.gov and search for hodgkins lymphoma. You will find 101 open trials for this disease. Many are for advanced disease. This family as seized upon one opportunity among many and clearly has decided not to pursue the many other options that are currently available.”


These profound thoughts add great value to this matter.

Tuesday, May 03, 2005

Heaven - Members Only?

...

Over at BelieffNet, I got into it with a member whom I will refer to as a Christian Exclusionist (CX). Now, I truly believe that everyone needs Christ Jesus as their Lord, but it just doesn’t make sense to threaten people with damnation. The simple fact, as I see it, is that the Holy Spirit moves us if we are going to accept Jesus, so there’s no good purpose in calling someone lost, just because it may not be their time yet. Worse, the CX was telling other Christians on the board that they were ‘heretics’ and ‘deceivers’, simply because they brought up Scripture indicating God might forgive everyone of their sins, and save the whole world.
This is a mystery from God, so far as I see it. What I mean is, we can see part of the truth, but not all, anymore than any person can tell the fate and resolution of every person of the earth. Some things we just have to accept on faith.
The CX presented these verses for his side:

John 14:6
John 8:24
John 3:3
Acts 4:12
2 Corinthians 6:1-3


I thought it would be enlightening to examine them in greater detail, to see their context and meaning:

In John 14:6, Jesus was speaking to His Disciples in the Upper Room, privately. This was not a saying to the crowd at large, but to men already promised as Christ’s disciples. Do you see the distinction, especially since this is a statement not made to the crowds in such words. Also, in this same chapter, Christ explained “In my Father’s house there are many rooms” (John 14:2). What might that saying mean? Also, Jesus said “it is the Father living in me, who is doing His work” (John 14:10). This means that what Jesus is saying, comes from the Father. This is critical to understanding how Christ may be relevant, after all, to people who lived and died without ever hearing the name. In that same chapter, Jesus also said about the Holy Spirit, “The world cannot accept Him, because it neither sees Him nor knows Him” (John 14:17). Therefore, if anyone shows signs of the Holy Spirit, they must be right with the Father in their hearts, or else they could not have the Spirit! Further, Jesus in that same chapter explained “Whoever has my commands and obeys them, he is the one who loves me.” (John 14:21) That is, the words of a doctrine are not the measure, but whether one does what is right.

In John 8, before verse 24, Jesus addressed the matter of the woman caught in adultery. Jesus knows her guilt, but instead of acquiescing to her death, He simply wrote on the ground, then said “If any one of you is without sin, let him be the first to throw a stone at her” (John 8:7). When the men went away, Jesus asked the woman, “Woman, where are they? Has no one condemned you?’
“No one, sir
’ she said.
Then neither do I condemn you,’ Jesus declared. ‘Go now, and leave your life of sin.” (John 8:10-11)

After this, the Pharisees, angry that Jesus did fall for their trap (see verse 6), tried to claim Jesus was speaking without authority. Jesus explained, “You judge by human standards; I pass judgment on no one.” (John 8:15). The verse you cited (24), in that light, is quite a different thing, a warning to change but not a threat. Jesus was not speaking to people trying to do what was right, but warning the Pharisees that if you embrace sin, you cannot be free of it.

In John 3:3, the CX quoted Jesus’ words to Nicodemus, but stopped short of the full explanation. Jesus explained to Nicodemus, “no one can enter the kingdom of God unless he is born of water and the Spirit.” (John 3:5). Jesus went on to further explain that “the Spirit gives birth to spirit” (John 3:6), meaning that the distinction is not part of this mundane, physical life at all, but a creation of a spiritual being. Jesus warned that “whoever does not believe stands condemned already” (John 3:18), not to threaten the non-Christian but to explain our need for Christ; after all, it would be fair to say that Peter did not believe at the moments he denied Christ, and that Thomas did not believe until he saw Christ risen from the dead, yet neither of those men was condemned for all time, as you seem to think. John the Baptist explained that salvation comes from God, as do all good things, saying “A man can receive only what is given him from heaven” (John 3:27), which is to say that we cannot choose to believe, but will believe as God makes it possible for us.

In Acts 4, Peter and John are seized by the Sadducees (Acts 4:1-3), and brought before the Sanhedrin. The verse (4:12) cited was part of their explanation for how they healed a crippled man. Note further that they specify that Salvation is found “in no one else”, and under “no other name under heaven” (Acts 4:12). They do not deny truth of justice and obedience, but simply explain the name of the Savior, to prove to the Sanhedrin that the Jesus put to death on the cross was and is the promised Messiah, the Anointed One who would be the servant through whom the Father would work Salvation (see also Acts 4:25).

Finally, I found the 2 Corinthians 6:1-3 citation interesting, for in that same chapter Paul wrote that a believer should act and speak “in purity, understanding, patience and kindness; in the Holy Spirit and in sincere love” (2 Corinthians 6:6). This is a crucial element to the message.

So, a deeper look at the verses, shows that God acts with complete Sovereignty, that forgiveness and love are His hallmarks at all points, and that no one may act in love for God or their neighbor without the Holy Spirit’s presence. I note also, that the only Gospel account he cited was John. I wonder if one might consider the Beatitudes, or perhaps the faith of the Centurion? These too speak to God and Christ, in a gentler manner than some seem aware.

Monday, May 02, 2005

Deliberate Ignorance

[]

President Bush has signed the Family Movie Act of 2005 into law, and Hollywood is outraged.

"Censorship!" screams Rob Reiner.

"A Nefarious and Sneaky Little Document" sneers the lefty blog Filmbrain.

Why? Is Bush preventing directors and producers from making films as they see fit?

Nope. He just wants Americans to be able to edit out the nudity, violence, profanity, and all those things most of us are sick of, but which Hollywood seems to think is absolutely necessary. Americans have said for decades that they want cleaner movies, and revenues from the top grossing films bears that out.

It speaks to the matter then, that Hollywood producers/directors not only think they have the right to make a film as they please (which they do), but that they also have the right to force people to watch whatever they put up there (they have no such right).

I have a very simple solution for Hollywood: Start making films the way people want to see them, and get rid of the trash, and there will be no market for companies and filters to remove the filth. How about you make films which attract people on the strength of the story, the acting, things like that?

Otherwise, we're gonna wash your film out before our kids see it.

Sunday, May 01, 2005

Honor

[][][][]

The first human right is not usually considered among the rights: Honor. Yet it is a critical element to human life, to live with honor. In fact, whole cultures have based the right to life on honor. In Japan centuries ago, a Samurai who disgraced his name was expected by his community to kill himself. In ancient Greece, warriors carried huge bronze shields into battle, and if a warrior fled battle, he left his heavy shield behind, so their mothers and wives told the warriors to come home with their shields, or on them. Countless cultures have allowed duels on the matter of honor, even to the point of homocide on a point of personal image. Honor today is a more idealistic notion, but it still matters to many people; what parent does not want their child to live honorably, and to bring honor to the family?

Why would I regard honor as a right given to us humans? It comes down to the fuel of life. We need air, water, food, shelter, health, and so on, but even when we have all those things, sometimes we do not have everything we need. We still need a reason to strive, a reason to take on responsibilities and do the right thing when it is difficult, a reason to do something for someone else’s gain. That is where honor matters. Some cultures give rewards for honorable works, and it is generally true that governments, businesses, and communities consider honor in awarding jobs, promotions, and in enhancing their own reputations, since they too crave honor.

So, what is honor? Honor is more than meeting a need, but rather is that quality which makes a deed or word or thought better than without that quality. For instance, when men are working, each looking to his task, that is one thing, but a man who helps them work as a team and accomplish better results, is honorable for making that advantage happen. Also, a man who gives up something to his own cost, so that his comrades might gain a great victory, or perhaps prevent a great loss, acts in honor, like a man whose heroism saves his group from destruction. In this world, we consider teaching especially honorable, because a teacher performs a great service for little reward. We consider our military veterans honorable, because of their service and sacrifice to our nation and its ideals. But even in more ordinary lives, we still consider courtesy honorable, we consider charity honorable, and we consider growth honorable, whether it is exercise for our bodies, study for our minds, or improvement for our spirits.

Honor comes from God, and is one of the great rights of Humanity.