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29 Feb 2004 21:50:01 -0000

" Cancer Decisions "

THE MOSS REPORTS Newsletter (02/28/04)

 

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com

Newsletter #122 02/28/04

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COLORECTAL CANCER

 

 

 

Despite advances in the screening, early detection and

treatment of colorectal cancer, it remains the third

most common cancer in the US. About 147,000 people

will be diagnosed with cancers of the colon or rectum

this year and some 57,000 will die from the disease.

 

 

The announcement last week that the drug Erbitux had

been approved for the treatment of advanced colorectal

cancer will surely have raised many people's hopes.

Since much of medicine's ability to hold cancer in

check depends on early diagnosis, it is especially

heartening when we hear that there is a new treatment

specifically designed for advanced cases. Yet, as

this week's newsletter shows, Erbitux, far from being

a breakthrough, is in essence another vivid example of

the way in which the politics and economics of cancer

have come to overrule the basic science of cancer

research.

 

 

A cancer patient's best hope of success is to arm him

or herself with as much detailed, objective

information as possible so that he or she can

carefully weigh the choices and decisions that lie

ahead. To that end, for the remainder of the month

of February we are offering our Moss Reports on colon

and rectal cancer at a special discounted price of

$247, a savings of $50.

 

 

You can order reports via our website,

www.cancerdecisions.com, or reach us at 1-800-980-1234

(814-238-3367 when calling from outside the US).

 

 

 

ERBITUX APPROVED, PART TWO

 

 

 

(Last week I discussed the approval of ImClone's new

" targeted " agent, Erbitux, and showed how the drug had

minimal effects against colorectal cancer.)

 

 

Analysts speculate that the US market for Erbitux could

go to $1.5 billion annually and the worldwide market

to $2 billion per year (Coghill 2004). Bristol Myers

should therefore quickly recoup what seemed like a

ridiculous research investment of $2 billion in a very

short time, thanks to the FDA's compliant policy of

accelerated approval. Oncologists who sell anticancer

drugs in their offices - the so-called " chemotherapy

concession " - will also benefit from this largesse

(Abelson 2003).

 

 

The cost will be borne by individual patients, by

Medicare and other insurance companies, private and

governmental. And what will society get for this

billion-dollar expenditure? If the latest clinical

trials are any guide, we will neither see cures nor

even significant prolongation of life. Perhaps there

may be temporary symptomatic relief for some, if a

tumor is blocking the colon or lungs. Hopes will be

raised and hopes will be dashed. However, more

predictable are the side effects and the peculiar

reactions (acne-like rash, difficulty breathing, etc.)

that will be experienced by hundreds or thousands of

patients, further taxing a medical system that is

already at the breaking point.

 

 

 

Patient's Perspective

 

 

 

Many cancer patients and their advocates have waited

with growing impatience for this new generation of

targeted drugs to come to market. They have often been

frustrated with the slow pace of the approval process.

In the past I, too, have complained about the

reluctance of FDA to approve new treatments. What has

now happened, however, is that FDA has done a

flip-flop. Not long ago, the agency was agonizingly

slow in approving new treatments. They picked over

every last detail of a drug application. But now they

seem to be rushing to the opposite extreme and to be

approving cancer drugs based on inadequate proof of

safety or efficacy.

 

 

Pressure to approve Erbitux came not just from industry

but from some patient advocacy groups. " Sufficient

evidence of safety and efficacy existed more than two

years ago to justify making Erbitux available to dying

patients with no remaining treatment options, the same

indication the FDA approved today, " said Frank

Burroughs, president of the Abigail Alliance for Better

Access to Developmental Drugs. " Tens of thousands of

colon cancer patients waited and died. "

 

 

I sympathize with Mr. Burroughs (who lost his own

daughter to cancer) in his desire to make new drugs

available to patients as quickly as practicable. Any

unnecessary delay is deplorable and any unnecessary

death is a tragedy. However, there is still no evidence

from rigorous clinical trials that the patients about

whom Mr. Burroughs spoke so harrowingly would in fact

have lived longer had they had earlier access to

Erbitux. As an FDA spokesperson took pains to point

out, the delay in approval did not mean unnecessary

deaths because " all these treatments for advanced

cancer don't cure people. " Even now, she said, it is

not known whether Erbitux prolongs life, only that it

shrinks tumors and delays their growth (Pollack 2004).

That's a striking admission from an unexpected source.

 

 

FDA commissioner Mark B. McClellan, MD, PhD, himself

put a positive spin on the drug's approval. " … FDA

staff work hard to ensure doctors and patients can have

confidence in the safety and effectiveness of new

therapies such as Erbitux, " he said. " FDA believes it

is crucial for cancer patients to have many proven

treatment options in their battle against this

disease. " But notice how the catch phrases " safety and

effectiveness " and " proven treatment options " are

conflated with the idea of true patient benefit. We are

asked, against all evidence, to believe that the

partial and temporary shrinkage of tumors is a

desideratum in its own right and a reliable predictor

of increased survival. This requires an unwarranted

leap of faith.

 

 

 

Bitter Irony

 

 

 

Some readers might say, " What's wrong with approving a

new drug, even if it only shrinks tumors? The more

drugs we have available, the greater the spectrum of

choices. "

 

 

Certainly the range of pharmaceuticals available for

the treatment of cancer is expanding rapidly. Yet when

looked at from the perspective of complementary and

alternative medicine (CAM), there is a bitter irony

here. Many non-conventional and non-toxic treatments

for cancer have repeatedly failed to get approval as

cancer treatments. These include treatments for which

there is more documentary evidence of success than can

be said for Erbitux. In my first book, The Cancer

Industry, I showed how FDA has historically joined

other major institutions (the so-called " cancer

establishment " ) in putting insurmountable barriers in

the way of promising less-toxic treatments. There are

102 such treatments in my book Cancer Therapy, most of

which have been shunned by the FDA. There is simply no

economic incentive to investigate these treatments,

and this points to a systemic flaw in our entire

drug-development system.

 

 

Non-conventional treatments are still held to the gold

standard of randomized controlled trials (RCTs) that

can demonstrate a significant increase in overall

survival. Surrogate markers (such as changes in test

scores) are deemed insufficient. Case histories, no

matter how compelling, are derided by the orthodox

medical establishment as " mere anecdotes. " Even citing

these is said to demonstrate the scientific naïveté of

those who espouse CAM.

 

 

But with accelerated approval a different - and

markedly lower - standard of proof is required of

patented drugs emerging from Big Pharma and its

partners. For these privileged players, phase III

trials showing actual life prolongation have become

passé. Multi-billion dollar corporations, which,

perhaps not coincidentally, make huge contributions to

political campaigns, need only show that their drug

shrinks tumors for a month or so. That has become

enough to get dubious agents into mass circulation.

 

 

Meanwhile, Dr McClellan, the same FDA commissioner

under whose jurisdiction Erbitux was approved,

announced a few weeks earlier that he intended to crack

down on " dangerous " food supplements. Using concern

over the herb ephedra (sometimes included in

weight-loss formulas) as his springboard, Dr. McClellan

pledged to step up FDA's scrutiny of the effects of a

broad range of other herbal supplements. " When these

regulations are finalized later this year, the public

will not be faced with 'buyer beware' any longer, "

McClellan proclaimed. So it's " buyer beware " for herbs,

but " full steam ahead " for highly toxic drugs!

 

 

 

Science By Press Release

 

 

 

We are often told that the difference between

'legitimate' and 'alternative' treatments is that the

former are proven through rigorous clinical trials and

then scrutinized by the scientific community through

publication in peer-reviewed journals, whereas the

latter are based on scanty and anecdotal evidence. Yet

Erbitux's approval was not based on peer-reviewed

studies published in standard journals. Instead,

doctors and investigators must rely on FDA summaries

and drug company websites. " Science by press release "

has now become a standard way of presenting information

on new treatments. The obligation to first present

one's data to the scientific community through the

painstaking process of peer-reviewed publication,

followed by carefully documented attempts by

independent scientists to replicate any alleged

benefits, is now ancient history. What matters is to

get the drug to market willy-nilly. Meanwhile, no one

in authority seems to find anything wrong with this new

commercialized way of presenting medical findings.

 

 

Without full-scale and open scrutiny, however, how can

cancer researchers as well as the rest of the

interested public evaluate claims of efficacy or

safety? How can we trust scientific experiments that

are carried out by those who have the greatest

incentive for coming up with positive results? How can

we trust a government agency that shows favoritism to

Big Pharma and a corresponding hostility to herbal and

complementary medicine?

 

 

Simply put, accelerated approval is a process that

overwhelmingly benefits Big Pharma. The FDA should

return to a standard by which drugs are approved based

on the only criterion that really matters: an

unequivocal demonstration that such drugs extend life.

If drug companies can get accelerated approval for

their products, then it should be possible for

alternative treatments to be similarly fast-tracked. We

must do away with a two-tiered system that is about as

democratic as the waiting line at one of Manhattan's

exclusive nightclubs.

 

 

To order my book The Cancer Industry please click or go to:

 

http://www.amazon.com/exec/obidos/ASIN/1881025098/cancerdecisio-20/103-4018872-4\

386244

 

 

To order my book Questioning Chemotherapy please click or go to:

 

http://www.amazon.com/exec/obidos/ASIN/188102525X/cancerdecisio-20/103-4018872-4\

386244

 

 

To order my book Cancer Therapy please click or go to:

 

http://www.amazon.com/exec/obidos/tg/detail/-/1881025063/qid=1077575526/sr=1-4/r\

ef=sr_1_4/104-4668718-8311906?v=glance & s=books

 

 

 

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--Ralph W. Moss, PhD

 

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References

 

Aaron, Craig. Bush League Politics. Retrieved February 19, 2004 from:

http://progressivetrail.org/articles/031123Aaron.shtml

 

Abelson, Reed. Drug sales bring huge profits, and scrutiny, to cancer

doctors. New York Times, January 26, 2003.

Retrieved February 19, 2004 from:

http://maillist.linuxmednews.org/pipermail/mednews/2003-January/000295.html

 

FDA approves Erbitux for colorectal cancer.

Retrieved February 13, 2004 from:

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01024.html

 

Agovino, Theresa. Ex-ImClone CEO: A very social scientist. Samuel Waksal had

vast ties to the rich and powerful. Associated Press, June 27, 2002.

Retrieved February 19, 2004 from:

http://www.sun-sentinel.com/business/local/bal-clone26,0,4474874.story?coll=sfla\

-business-front

 

Bristol-Myers Squibb press release:

http://www.bms.com/news/press/data/fg_press_release_4345.html

 

Bush Contributors Exposed. KnowTheCandidates.org. Retrieved February 19, 2004

from:

http://www.knowthecandidates.org/ktc/bushcontributors.htm

 

Coghill, Kim. ImClone's Erbitux receives long-awaited FDA approval. BioWorld

Online.

Retrieved February 19, 2004 from:

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadli\

nes_article & forceid=32123

 

Food and Drug Administration. Newly approved cancer treatments: Erbitux.

Updated: 02/13/2004. Retrieved February 19, 2004 from:

http://www.nci.nih.gov/clinicaltrials/developments/newly-approved-treatments/pag\

e6

 

Hollywood E. Clinical issues in the administration of an anti-epidermal growth

factor receptor monoclonal antibody, IMC-C225.Semin Oncol Nurs. 2002May;18(2

Suppl 2):30-5.

 

Marshall, Randi F. FDA approves Stewart scandal drug. New York Newsday, Feb.13,

2004.

Retrieved Feb.14, 2004 from:

http://www.nynewsday.com/news/local/manhattan/ny-biz-erbitux0212,0,4757990.story\

?coll=nyc-topheadlines-left

 

Moss, RW. Another one bites the dust. Cancer Decisions, January 28, 2002.

Accessed February 19, 2004 from:

http://www.cancerdecisions.com/012802.html

 

Moss, RW. Report from ASCO: Trials and Tribulations of a New Cancer Drug.

Cancer Decisions, May 29, 2002. Accessed February 19, 2004 from:

http://www.cancerdecisions.com/052902_page.html

 

Pollack Andrew. New York Times. ImClone cancer drug behind Stewart trial finally

is approved by F.D.A. Retrieved February 13, 2004 from:

http://www.nytimes.com/2004/02/13/business/13biotech.html?ex=1077339600 & en=9f80e\

9bbb371299d & ei=5062 & partner=GOOGLE

 

Lemonick M and Park A. New Hope for cancer. Time. May 28, 2001.

 

Szabo Liz. FDA approves drug at center of ImClone scandal. USA Today, 1/13/2004.

Retrieved February 13, 2004 from:

http://www.usatoday.com/money/industries/health/drugs/2004-02-12-erbitux-ok_x.ht\

m

 

Walon L, Gilbeau C, Lachapelle JM. [Acneiform eruptions induced by cetuximab]

Ann Dermatol Venereol. 2003 Apr;130(4):443-6. French.

 

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IMPORTANT DISCLAIMER

 

The news and other items in this newsletter are

intended for informational purposes only. Nothing in

this newsletter is intended to be a substitute for

professional medical advice.

 

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