Dean's World

by George L Gabor Miklos PhD and Phillip John Baird MD PhD

Statement

George L Gabor Miklos and Phillip John Baird are Director and CEO, respectively, of Secure Genetics and Integrated Diagnostic Pathology. The former is a molecular genetics-based data evaluation company, the latter a clinical diagnostic pathology company. Neither is affiliated with, nor receives any monetary compensation, gifts or other payments in lieu, from pharmaceutical companies, government funding bodies or private institutions in the cancer or drug development areas.

In the movie A Few Good Men, there is a heated exchange between the military characters portrayed by Tom Cruise and Jack Nicholson, an exchange which is relevant to the War on Cancer.

Jessep: You want answers?
Kaffee: I want the truth!
Jessep: You can’t handle the truth!

The distinction between answers and truth is perfectly illustrated in the cancer arena where competing interests form a volatile mix. The patients want cures, the media want stories, the researchers want grants, politicians want votes, the doctors want to save lives and the pharmaceutical companies want to sell drugs.

The War on Cancer has become a global industry where fact and fiction have become indistinguishable and where the truth often goes missing. Some truths are airbrushed out, leaving doctors to deal with the fears and financial predicament of their patients. What do the front lines in cancer treatment and management really look like?

To better appreciate them, we attempt to provide the latest facts. The medical ones can be checked at the National Cancer Institute, (http://seer.cancer.gov), the American Cancer Society, (www.cancer.org), the Armed Forces Institute of Pathology, (www.afip.org) and in the referenced scientific articles. The business figures are from The Wall Street Journal, BusinessWeek, Forbes, CNNMoney and pharmaceutical companies.

THE FRONT LINES OF CANCER

The patients

Dina Rabinovitch, author of Take off your party dress; when life’s too busy for breast cancer, reveals the day to day traumas of a breast cancer patient with an advanced form of the disease (1). The cancer has spread to other organs and her third different drug treatment is underway. It began with chemotherapy and intravenous doses of the blockbuster drug Herceptin (2) and when the cancer returned, Omnitarg was prescribed. Now the regimen is; five pills per day of the latest miracle drug Tykerb, plus eight daily tablets of the chemotherapeutic agent Xeloda every two weeks out of three, plus two morphine tablets and a diclofenac every morning and evening.

She states bluntly; "My cancer keeps recurring. Nobody can tell me why. I did the genetic screening and I don’t, apparently, carry the faulty genes. So angry and increasingly so cynical about these doctors in whom I have to put complete trust."

The costs of anticancer drugs

In 2007, the costs per patient for major anticancer drugs were summarized in the Journal of the National Cancer Institute (3). If used for a full year, the two blockbusters, Herceptin for breast cancer and Avastin for lung cancer, would cost $36,000 and $106,000, respectively. For colorectal cancer, Erbitux and Vectibix would cost $120,000 and $96,000, respectively, while for breast cancer Tykerb would amount to $35,000. Cancer drugs represent 40% of all Medicare drug expenditures.

These skyrocketing costs place doctors in the position of having to advise their patients about whether the clinical benefits are worth the financial burden. Nearly a third of them report discomfort in telling patients about costs and another 20% do not consider it to be their role. Many physicians say they are not health policy persons and just want to do the best job for the patient (3).

Physicians are trained to save lives and have little time to evaluate the effectiveness of a blockbuster drug or genetic test. Furthermore, cancer genetics has moved so rapidly that most doctors do not have the specialist molecular and statistical knowledge to make informed decisions about molecular tests, the clinical claims of which are usually overstated and often have little validity (4-8).

Patient time and incentives

The director of the American Society of Clinical Oncology, Dr Peter Eisenberg, states that the system does not value a doctor’s time with patients (9). The system also provides incentives to prescribe drugs with the highest profit margins and many doctors follow the money, after all, oncology is a business (10). Dr Richard Deyo of the University of Washington points out that; there are plenty of patients for whom there’s little hope, who are terminally ill, whom chemotherapy is not going to help, who get chemotherapy (11). What choice do oncologists have? By ending treatment the doctor would be acknowledging that hope is gone. Treatments therefore go ahead.

Pharmaceutical sales

In 2006, the breast anticancer drug Herceptin and the colorectal anticancer drug Avastin generated $2.6 and $1.7 billion in sales, while Erbitux generated $1.1 billion in the colorectal market. Worldwide, anticancer drug sales are expected to rise nearly 20% per year through 2010 to reach between $60 and $70 billion (12). All large pharmaceutical companies strive to produce new anticancer drugs. GlaxoSmithKline, for example, predicts it will launch five new anticancer drugs in the next three years (13).

The media

The public’s desperation for cancer cures distorts its perceptions of breakthroughs and miracle drugs. With headlines such as "Breakthrough liver cancer treatment found" (14) and the spectacular but completely incorrect, "US scientists have cracked the entire genetic code of breast and colon cancers, offering new treatment hope" (15), it is a wonder that oncology wards are not completely deserted. Unfortunately they are working at full capacity. Breakthroughs have become totally devalued and are accepted uncritically by the public, charitable organizations, politicians and the media.

The fascination with cancer cures is illustrated by the media’s attention to celebrities. In the 1970s it was Betty Ford and Happy Rockefeller with breast cancer. In the 1990s, it was General Norman Schwarzkopf and Time magazine Man of the Year Andy Grove, both with prostate cancer. Currently it’s Elizabeth Edwards whose breast cancer has spread to the bone marrow and White House Press Secretary Tony Snow, whose colorectal cancer has spread to the liver. Snow’s message is that "...a lot of conditions... are now curable or people are racing toward cures" (16). Celebrities serve as pillars of hope, but their comprehension of cancer cures conflicts with clinical reality. Cancers that have spread are quite unlike diabetes and heart conditions where people live for decades by taking fairly harmless drugs (17).

Governmental institutions

Far away from the frontlines of the War on Cancer, the directors of various institutions vigorously defend the progress in curing cancer. No matter how implausible, almost anything is said to attract more funding. The previous director of the National Cancer Institute, Andrew von Eschenbach, outlined an extraordinary goal; eliminating death and suffering from cancer by 2015 (18). This statement was so misleading that senior scientists were aghast at such overt distortions of scientific reality (19). It is also a very dangerous statement as it provides false hope to patients. Some cancer sufferers, believing it to be true that death and suffering from cancer will be eliminated by 2015, could delay seeking treatment in the hope that a pill will soon be available to cure their cancer.

When it’s all said and done, where are all the promised cancer cures since Richard Nixon signed the National Cancer Act into law on the 23rd of December 1971?

In terms of the fiery exchange that began this essay, do we wish to face the truth, or not? The choice is an intensely personal one. If readers prefer not to know the facts, they should read no further.

(Part II, "Do Not Listen to What They Say — Go See," should appear tomorrow. --Dean)

This New York Times article on the current sorry state of cancer treatment seems like a good kickoff to the cancer article I promised but did not deliver due to personal matters last week. Tomorrow I will begin to post the series as promised. For starters, I publish here the references for the article, so that as pieces appear people can through links see the references for themselves:

REFERENCES

Here also are the titles to the various article sections, just to whet your appetite:

THE FRONT LINES OF CANCER
The patients
The costs of anticancer drugs
Patient time and incentives
Pharmaceutical sales
The media
Governmental institutions

DO NOT LISTEN TO WHAT THEY SAY -- GO SEE.
Patients rarely die from a primary tumor
Facts and figures from the American Cancer Society
Facts and figures from the National Cancer Institute
Different cancers respond differently to chemotherapy and radiation
Blockbuster drugs

THE CHICAGO DRUG SHOW
The 2007 progress report

THE CANCER CELLS THAT LEAVE HOME HAVE EXTRA DNA CAPABILITIES
Normal cells
Cancer cells
The danger lies in the diversity within a cancer cell population
The cancer cells that leave home have increased informational diversity
Most cells in a primary tumor never leave

DRUG RESISTANCE AND THE RETURN OF CANCER
Normal cells are inflexible in a crisis
Cancer cells have additional flexibility in a crisis
How different is drug resistance in each person?
Handling the truth

NEW FRONTIER OR YET ANOTHER UNFULFILLED PROMISE?
Personalized treatment for the individual patient
DNA profiling
Single letter mutations
Drug combinations
The reality of massively disrupted DNA contents

THE EARLIEST STAGES OF CANCER
Once four DNA copies are attained, all hell breaks loose
The mutationists
The BRCA1 and BRCA2 breast cancer genes

CANCERGATE
Finding all the mutations in all cancers
The fatal flaw
Cancer genes
The Delusionists and the Spin Doctors
The clinical deliverables: patients are still waiting…and waiting…and waiting

THE HOPE

FAILURE IS NOT A CRIME. FAILURE TO LEARN FROM FAILURE IS.

Well, Ron warned you there would be catblogging.

This story about a cat that seems to know when people are about to die is making the rounds, but it's really not that shocking. More than one test has shown that dogs can smell cancer (in fact, in one of the tests, the dogs were so insistent about a woman who had tested negative they sent her to a specialist, and it turned out the dogs were right and the test was wrong). It's not surprising cats have similar abilities. For an obligatory carnivore like a cat, knowing when something is about to die is a valuable skill.

What these stories say to me is that genetic engineering can greatly enrich our lives. Clearly an augmented sense of smell could be incredibly useful, and not just to doctors.

This week Dean's World will be featuring a blockbuster article, in multiple parts, by the director of a molecular genetics-based data evaluation company, and the CEO of a clinical diagnostic pathology company. Neither is affiliated with, nor receives any monetary compensation, gifts or other payments from pharmaceutical companies, government funding bodies or private institutions in the cancer or drug development areas. And what they have to say about the current state of cancer research is deeply disturbing and really rather damning in parts.

To give you a taste, here's the outline:

THE FRONT LINES OF CANCER
The patients
The costs of anticancer drugs
Patient time and incentives
Pharmaceutical sales
The media
Governmental institutions

DO NOT LISTEN TO WHAT THEY SAY — GO SEE.
Patients rarely die from a primary tumor
Facts and figures from the American Cancer Society Facts and figures from the National Cancer Institute
Different cancers respond differently to chemotherapy and radiation
Blockbuster drugs

THE CHICAGO DRUG SHOW
The 2007 progress report

THE CANCER CELLS THAT LEAVE HOME HAVE EXTRA DNA CAPABILITIES
Normal cells
Cancer cells
The danger lies in the diversity within a cancer cell population
The cancer cells that leave home have increased informational diversity
Most cells in a primary tumor never leave

DRUG RESISTANCE AND THE RETURN OF CANCER
Normal cells are inflexible in a crisis
Cancer cells have additional flexibility in a crisis
How different is drug resistance in each person?
Handling the truth

NEW FRONTIER OR YET ANOTHER UNFULFILLED PROMISE?
Personalized treatment for the individual patient
DNA profiling
Single letter mutations
Drug combinations
The reality of massively disrupted DNA contents

THE EARLIEST STAGES OF CANCER
Once four DNA copies are attained, all hell breaks loose
The mutationists
The BRCA1 and BRCA2 breast cancer genes

CANCERGATE
Finding all the mutations in all cancers
The fatal flaw
Cancer genes
The Delusionists and the Spin Doctors
The clinical deliverables: patients are still waiting…and waiting…and waiting

THE HOPE

FAILURE IS NOT A CRIME. FAILURE TO LEARN FROM FAILURE IS.

REFERENCES

Although it's not all bad news, much of what it says about what should be called the government-sustained research-industrial complex, and the helplessness of most physicians and patients in the face of it, and the gullibility of the press, is quite astounding.

Watch for it to appear over the next week. I expect it to make waves.

Minor point: Here's a Dean's World search on Norman Borlaug.

He's been one of my biggest heroes for many years now. What a great man.

Now ask me some time about Rudy Rummel.

A friend of mine is blown away by this site: TED.

Seems a little like the '90s vision of the web to me, but it's kinda cool. Good design anyway. Maybe it's what the web is really evolving toward: the elite running the show. I guess that's probably inevitable.

Kinda puts the whole Terry Schiavo thing in a new light, doesn't it?

Scans of the 44-year-old man's brain showed that a huge fluid-filled chamber called a ventricle took up most of the room in his skull, leaving little more than a thin sheet of actual brain tissue.

"He was a married father of two children, and worked as a civil servant," Dr. Lionel Feuillet and colleagues at the Universite de la Mediterranee in Marseille wrote in a letter to the Lancet medical journal.

After all, if he'd been unconscious and on life support, with this MRI they'd almost certainly have said he was brain-dead and pulled the plug.

I'm in favor of voluntary euthanasia, and Schiavo definitely showed very little sign of recovering intelligence (and maybe never would have), but this just goes to show we probably need to err on the side of life.

Discovered this site today and I thought I'd pass it along. Many of the photos are breathtaking and shows me the utter insignificance of man when it comes to manipulating these massive weather systems. We're dwarfed in the presence of the full power of nature. We're but a speck of sand on the shore bracing ourselves against the terrible storm heading our way. What can we really do against such power?

More to the point, how arrogant do we have to be to think our trifling lives have any impact at all on such forces?

It comes to me like this: Even arch-environmentalists do not want to believe they are subject to the whims of nature. By demanding others take care not to disturb the so-called balance of nature they are, in reality, exerting effort to control a force that doesn't care a lick about them and would wipe them out without so much as slowing down.

Carbon emissions may go up or down but it doesn't matter. Nature has been tearing apart continents, setting fire to land, and wiping out species long before we ever came onto the scene. What makes you think "Mother Nature" is at all concerned about a talking ape?

The Placebo Effect has been well-known for generations in medical circles. At least in the case of pain drugs, a recent U of M group may have found a possible explanation for not just that, but also the lesser-known "nacebo" effect.

Pretty cool.

Okay, first, watch this amazing story:

Now ask yourself the question that the newscasters and just about everyone else isn't asking:

Why are researchers and disability advocates not right now studying this kid and his mom's techniques to learn how to do what he can do? Kid's got no eyes but he can play video games and foosball and rollerblade on the goddamned street without assistance. Yes he's a great brilliant kid, and inspiring, but why aren't we scrambling like crazy to figure out what he and his mom have figured out-- and turning it into a training program? I mean, holy cow, just look at what they've accomplished! Study! Learn from them! Even sighted people might benefit. If he can do it so can others probably, right???

(Link of the weekend, by the way.)

No, really.

And you thought Pamela Anderson and Paris Hilton were just dirty, slutty girls, when in actuality they were saving lives. Shame on you for being so narrowminded!

We're only just scratching the surface of what's eventually going to be possible with bioengineering.

Vic Stein, in comments to the earlier excellent thread, restates the facts in a marvelously succinct way, despite the best efforts of the FUD squad to label as "strawmen" the accurate description of the actual arguments by actual conservatives that Rachel Carson is directly responsible for the deaths of millions in Africa and that DDT is the magic bullet by which the West rid itself of malaria and which would eradicate the disease in Africa today if not for the evil enviroloons who hold a continent hostage with their liberal lunacy. Says Vic,

The claim that Carson killed millions is based on a bunch of falsehoods and deliberate misrepresentations of both Carson and the fight against malaria.

Carson did not, in fact, advocate stopping the use of DDT to fight malaria (and indeed, the "ban" in the US had an explicit exception for exactly this purpose). She thought that it was criminal that were using it so widely in industrial agricultural uses when we didn't know the full effects of having so much of this chemical in the environment and because she believed there was lots of good evidence that it was harmful (note that while a lot of her original claims are overhyped, the book is still out on whether DDT really is "safe" at all)

She also SPECIFICALY noted that widespread agricultural use (the main thing she opposed) could potentially HARM the potency of DDT against malaria. In fact, she was correct, because in the many countries that did NOT stop using it so widely, resistence DID develop and deaths DID increase. Who is to blame for those deaths? The "Carson worse than Hitler" crowd basically include them in their math for all the people she supposedly killed, and yet they were a direct result of people NOT listening to the warnings about resistence.

The reality is that widespread indescriminate DDT use is NOT a good longtime strategy against malaria IF there is no infastructure in place to wipe malaria out compeltely, (as there was in the US). THIS is the primary reason the WHO and others abandoned widespread spraying: they only had so many resources, and simply spraying DDT over the whole country wasn't going to solve the problem when there wasn't a way to make the fix permanent and the inevitable outcome (which DID come in several places) of this strategy was the immunity of mosquitoes to DDT entirely (taking that weapon out of the arsenal). Did hysteria over DDT play a part in this? Yes. But again, DDT simply was not a magic bullet in the first place (which is exactly what the Carson/Hitler crowd implies with their attributing ever single malaria death to her). The idea that this move stabbed the "only real cure" for malaria in the back is just silly.

Furthermore, the switch from DDT to treatment in many places reduced deaths, so it's very hard to argue that it was a bad move period. And, more importantly, it ended up preserving the potency of DDT, so that when much more effective methods of using it were eventually discovered (the indoor regimen) it was still effective. However, the indoor regimen is still today considered just one tool out of many necessary to keep malaria at bay. Used alone, or even used at all, mosquitos STILL develop and have developed resistence to it. It has to be used as part of a comprehensive strategy to get rid of the problem in such a way that it can't easily come back. The main problem in Africa is finding the money to pay for ANY sort of anti-malaria regimen in the first place, not overcoming hordes of environmentalists to be able to use the one and only thing that works.

Ironically, the most effective proven single tool against stopping the spread of malaria right now is treated bed nets. Why ironic? Because when people try to deploy these things, now they get hordes of people who have no experience at all in malaria are screaming about why they aren't spraying the country with DDT.

'nuff said.

It turns out that Area 51 actually exists.

I therefore now declare that the US government is engaged in a massive coverup of reality, which every President since Harry Truman has been a part of. Truman, Ike, Kennedy, Johnson, Nixon, Ford, Carter, Reagan, Bush I, Reagan, and Bush II: all clearly a part of it. Unless maybe something was hidden from them.

I mean, how can you deny it??? I dare you to prove me wrong!

[snicker]

Ugh. I see that the PR officer who for decades denied seeing any alien spacecraft or bodies at Roswell signed a deathbed confession taking it all back. The full text of his affidavit is apparently right here.

Assuming the affidavit itself is not a forgery (might it be?) I find myself more annoyed by this than anything. Let's assume for the moment that it's all true. There was an alien spaceship with bodies recovered. There was a massive coverup by the government. And not only this guy, but everyone else in the military involved kept their mouths completely shut for decades. For what reason?

At bare minimum, Walter Haut is a complete jerk in my mind. Either he covered up something extraordinarily important for decades for no good reason, or, if there were good reasons he failed to say what they were. Either way, he's a liar or a senile crank who left a deathbed confession in a way that no one could ask him any pointed questions about.

I would actually very much like to believe in alien visitors from outer space. The problem is, I gave up believing in it many years ago, because the evidence is so slim. Things like this just annoy me. Why didn't you have the courage to expose yourself to cross-examination, Haut? And if as you claim there were military personnel crawling all over the wreckage site and guarding the vehicle and bodies, why have none of them come forward either? And what possible reason would the military have for keeping this all secret for a half century? And why would they continue to keep it a secret even now? "We don't want to cause public panic" is a ridiculous answer.

How annoying.

*Update* Oh, I see there's more to his story than I thought. Now it looks even more like he was a crank and a liar.