Bush, Colorectal Cancer and Erbitux

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"The doctor of the future will give no medicine, but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease."
- Thomas Edison

Cancer is a political problem more than it is a medical problem.

Everything you never wanted to know about the Bush dynasty George Bush: The Unauthorized Biography by Webster G. Tarpley & Anton Chaitkin printed in full on the Internet. Read it for FREE!

"No man is good enough to govern another man without that other's consent." - Abraham Lincoln

Know your enemy 1, 2, 3, 4

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com
Newsletter #121 02/22/04
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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 147,500 people will be diagnosed with cancers of the colon or rectum this year and some 57,000 will die from the disease.

The announcement this 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, or reach us at 1-800-980-1234 (814-238-3367 when calling from outside the US).


ERBITUX APPROVED

Erbitux (cetuximab), the drug at the center of the Martha Stewart stock trading scandal, was approved by the US Food and Drug Administration (FDA) on Thursday, February 12, 2004. Erbitux is considered a last-ditch treatment for cancers of the colon or rectum, which have spread to other parts of the body. In its approval announcement, FDA specified that Erbitux should be used in combination with a commonly used chemotherapy drug, irinotecan (Camptosar or CPT-11), in patients who have not responded to that drug alone. Erbitux was also recommended for patients who cannot tolerate irinotecan (Pollack 2004).

Erbitux was the latest beneficiary of FDA's accelerated approval program, which allows the agency to approve products for the treatment of cancer and other serious diseases based on what they consider to be "early evidence" of effectiveness. Despite the fact that the evidence for Erbitux's effectiveness turned out to be exceedingly slender, the approval was greeted with expressions of enthusiasm from the oncology and investment communities.

"This has enormous potential," said Robert Mayer, MD, director of gastrointestinal oncology at the Dana-Farber Cancer Institute in Boston. "And this is only the first wave. There are several more [such drugs, ed.] underway. That's why this is such a very exciting time."

"This is tremendous vindication for the company," said Cory William Kasimov, a biotechnology analyst with Ryan Beck & Co, speaking of the drug's developer, ImClone. "All these years they were right - this was an effective drug."

But is it really an effective drug?  Let us try to clarify what Erbitux does - and does not - do. This task is complicated by the fact that the clinical trials on which approval was based have not yet been published in peer-reviewed medical journals. (A search of PubMed reveals only two published clinical trials of Erbitux, neither of which relates to colorectal cancer.) So when all is said and done we have only the company's and the FDA's word on the safety and effectiveness of this drug.

But by the FDA's own admission, the drug is of limited effectiveness. The approval itself states that Erbitux has NOT been proven to increase cancer patients' survival time. Nor is there any mention of complete responses. And although some scientists have talked in hopeful terms about Erbitux possibly improving cancer patients' quality of life, there is no proof of this, either. "Currently," said a statement from Bristol-Myers Squibb, which has an agreement to distribute the drug, "no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux." This seems unambiguous.

So, if Erbitux doesn't improve quality of life or increase survival, what use is it? According to the FDA, what the drug can do is temporarily shrink some tumors, especially when used in conjunction with irinotecan. In studies, when Erbitux was given in this way, the combination partially shrank tumors in 23 percent of selected patients, with an average response duration of 4 months. Used alone, Erbitux shrank tumors in only 12 percent of patients with a duration of response of one-and-a-half months. It was on the basis of these less than impressive results that the drug was approved.

But isn't the whole point of cancer treatment to increase overall survival rather than to temporarily shrink tumors?  Absolutely. But so far, Erbitux has failed that crucial test. Also note that in this trial, there was no control group. The only comparison made was between Erbitux alone and Erbitux plus chemotherapy. We therefore do not really know how survival with Erbitux compared to the use of other treatments, or to giving just supportive care.


Side Effects

Erbitux is one in a generation of so-called "targeted" therapies for cancer that emerged in the 1990s. One of the promises of targeted therapies was that they would be far less toxic than standard chemotherapy. Prior studies claimed that Erbitux is "well tolerated and adverse events are mild and manageable" (Hollywood 2002). But in the current clinical trials Erbitux, alone or in combination, was responsible for many disturbing adverse events.

According to Bristol-Myers, the most common of these was an acne-like rash, which occurred in fully 90 percent of patients. This may sound like a minor complication, but it is not always so. In fact, this rash was rated grade 3-4 (i.e., serious to severe) in 12 percent of patients.

But the side effects of Erbitux, alone or in combination, are more than skin-deep. In fact, the FDA reports that in trials, 10 percent of patients receiving Erbitux plus irinotecan and 5 percent of patients receiving Erbitux alone discontinued treatment primarily because of adverse events (FDA 2004). In the study that led up to FDA approval, 73 percent of patients who completed treatment with the combined Erbitux/irinotecan regimen exhibited weakness and malaise, 72 percent experienced diarrhea, 55 percent suffered nausea, 41 percent experienced vomiting and 45 percent had abdominal pain.  Meanwhile, 34 percent of patients experienced fever, and 30 percent suffered constipation. In addition, skin problems such as dryness and fissuring were common, and inflammatory or infectious conditions, especially of the eyes, were also seen.

Bristol-Myers concedes that some patients suffered even more severe reactions:  "...severe infusion reactions, rarely fatal, and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), hives, and low blood pressure, occurred in 3 percent with the administration of Erbitux." Ninety percent of these reactions, including the drop in blood pressure and difficulty breathing, came after the first infusion of the new agent. While the risk of such severe reactions might be justified if the drug extended life significantly, it seems an unwarranted risk when the agent is so manifestly ineffective and the anticipated gains so modest.

Interstitial lung disease (ILD) has also been reported after use of this drug. This is a condition that occurs when the lungs become inelastic due to scarring of the tissue between the air sacs. The FDA, making a fine distinction, said that it is difficult at this time to determine if ILD was actually caused by Erbitux, or was merely found in association with the treatment. They therefore chose to give Erbitux the benefit of the doubt. However, the same lung disease has been clearly associated with the administration of a similar targeted agent, Iressa, leading to that drug's withdrawal from the market in Japan.


Sensationalist Hoopla

So here we have yet another drug winning approval after showing only minor activity of dubious significance. This is a far cry from all the sensationalist hoopla that greeted Erbitux's appearance just a few years ago. At that time, Dr. Sam Waksal was the toast of Manhattan, throwing lavish caviar and champagne parties in his Picasso-adorned Soho loft and cultivating a social circle that eventually included Mick Jagger, Martha Stewart, and other celebrities (Agovino 2002).

The cure for cancer seemed at hand! Today, of course, the unfortunate Dr. Waksal is serving out a seven-year prison sentence for insider trading on ImClone's stock. Martha Stewart is on trial for her alleged involvement in that same scandal. Now, too, we know that Erbitux is of minimal significance in the fight against advanced colorectal cancer. But back in those halcyon days, Time magazine ran a cover story on the new generation of anti-cancer drugs, including the rising star Erbitux (then called IMC-C225). Time claimed that the drug was "effective in treating colon tumors" and said that "just this year researchers at Sloan-Kettering showed that the drug could dramatically boost the effectiveness of standard colorectal cancer chemotherapy." (Lemonick 2001).

Dr. Leonard Saltz, a celebrated colorectal cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, was quoted as saying the results were "staggering." Erbitux "weakens the tumor enough for chemotherapy to finish it off," he enthused. Combined with chemotherapy agents, we were assured, Erbitux would "pack a triple punch". Time's reporters gushed on like this for nearly eight pages! (Lemonick 2001) In July 2001, Erbitux was touted on the cover of Business Week, and the New York Times called it the "two billion dollar molecule." Wall Street stock analysts posted "buy" ratings and the stock price soared. There were few dissenters from this triumphalist chorus. Critics who warned that most of these anti-cancer drugs were being oversold were either ignored or dismissed as habitual naysayers (Moss 2002).

However, Dr. Saltz, the erstwhile enthusiast for Erbitux, has apparently reconsidered his position. After the drug's recent approval, he told New York Newsday that, in reality, the drug is only a "modest step forward. You can't call it a breakthrough and you can't call it revolutionary."  Dr. Saltz added, "we still have an awful lot of patients who are dying of this disease, and I see them every day" (Marshall 2004).

Although, as Bristol Myers readily acknowledges, Erbitux does not extend life, doctors still extol its ability to shrink the size of tumors. Reducing the size of a tumor could alleviate pain and discomfort, said Daniel Laheru, MD, an oncologist at the Johns Hopkins Kimmel Cancer Center, Baltimore. One certainly hopes so. But no evidence for this indication appears in the FDA's or Bristol-Myers' statement on the approval and the data itself is so far unavailable for independent scrutiny. There is therefore no proof that Erbitux actually alleviates pain and discomfort. On the contrary, it appears to cause considerable side effects (some of them serious) in many of those who receive it.

Another hope is that Erbitux may shrink previously inoperable tumors so that doctors can then remove them surgically. But this indication is also speculative. After all, the drug has been approved specifically for the treatment of advanced colorectal cancer, which has recurred or spread throughout the body. The rationale for using it to assist in the removal of isolated tumors therefore is hard to fathom. In any case, this would only be of benefit to a small minority of patients.


Targeted Receptors

Erbitux is certainly different from standard chemotherapy in that it targets specific proteins that are involved in cancer growth. It is a specially manufactured type of protein called a monoclonal antibody, which blocks a molecule called "epidermal growth factor receptor" (EGFR) that spurs cancer cells to grow. This genetically engineered molecule actually contains both human and mouse components. Very high tech.

While chemotherapy could be compared to saturation bombing, targeted drugs are intended to be more like 'smart bombs.' Such therapies are supposed to be more effective than chemo and to have fewer side effects because they are so well focused on just the malignant cells. The dream of Sam Waksal and many others was that by targeting cancer-specific proteins they would be able to pinpoint the malignancy but leave normal cells unharmed...in other words, to create the long-sought "magic bullet" for cancer. However, to date very few of these targeted treatments seem to be panning out. Most are turning in surprisingly mediocre performances. Cancer once again turns out to be able to survive and work its way around such attacks.


A Financial Bonanza

Now that it has gained approval, however, Erbitux will be rushed into full-scale production and made available for advanced colorectal cancer patients in just a few weeks. If history is a guide, we will start to see Erbitux advocated and then used 'off label' for the treatment of other stages of colorectal cancer as well as for other kinds of cancer entirely, such as cancers of the pancreas, ovaries, fallopian tubes, peritoneal cavity and lung (all of which are currently in clinical trials with this drug).

As of this writing, ImClone and its Big Pharma partner, Bristol-Myers Squibb, have not specified a price for the agent, but according to the New York Times it will be "comparable to other biotechnology drugs, which can cost tens of thousands of dollars a year" (Pollack 2004), Newsday speculates that the cost will be $20,000 per year per patient (Marshall 2004). Others believe it will be even higher, between $25,000 and $30,000 per year (Coghill 2004). (A similar drug, Gleevec, costs over $25,000 per year per patient.)

There is a huge market at stake. Approximately 147,500 Americans will be diagnosed with the disease this year and 57,000 people will die of it. Since Erbitux targets EGFR, it is only supposed to be given to patients who test positive for that marker. But that will prove to be no hardship for the company, since EGFR is expressed in up to 77 percent of all colorectal cancers. The number of US patients eligible for Erbitux will thus be in the tens of thousands. This fact has not escaped Andrew G. Bodnar, a senior vice president of Bristol-Myers. The Erbitux approval, he said, "begins our return to the position that we intend to occupy in the field of oncology, which is one of pre-eminence."

FDA's approval of Erbitux was accompanied by bizarre gyrations in the price of ImClone stock, reminiscent of the 2001 scandal that led to Waksal's and Stewart's legal troubles. The drug agency broke with its usual practice and released its announcement in the midst of Wall Street's trading day, rather than before or after the stock market's close. When word came that FDA was about to announce its decision, ImClone's stock's price plunged by more than $9 per share, on rumors that the drug would once again be rejected, as it was in 2001. The sell-off was so intense that the Securities and Exchange Commission (SEC) had to stop all trading in the company's stock. When trading resumed after hours, and the favorable news had been digested, ImClone's shares surged by 30 percent, to more than $45. Lucky the person who guessed that Erbitux would in fact be approved! The SEC is investigating this latest financial imbroglio.


Political Payback

This approval could be seen as a gift from the Bush Administration to Bristol-Myers Squibb, a company that was among the President's top ten donors in 2000. According to an online public interest newsletter:

"Executives at drug giant Bristol-Myers Squibb were pressured to make maximum donations to the Bush campaign in 2000. Reluctant donors were warned that CEO Charles A. Heimbold, Jr. would be informed if they failed to give. Bush later named Heimbold as Ambassador to Sweden. More importantly, since 1999 the pharmaceutical industry pooled $42.1 million for Bush and other GOP candidates." (Aaron 2004).

"For Bristol-Myers," the New York Times said, "the approval represents a delayed payoff for the unprecedented $2 billion deal it signed with ImClone for marketing rights in September 2001. Bristol was desperate for a new product to replace its cancer drug Taxol, which began facing generic competition" (Pollack, 2004). The approval sends a clear message that the Bush Administration will never stand in the way of the drug industry's headlong rush for megaprofits.


(To be completed, with references, next week.)



--Ralph W. Moss, PhD


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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, 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-20/103-4018872-4386244


To order my book Questioning Chemotherapy please click or go to:
http://www.amazon.com/exec/obidos/ASIN/188102525X/cancerdecisio-20/103-4018872-4386244


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/ref=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:
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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:
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Food and Drug Administration. Newly approved cancer treatments: Erbitux.
Updated: 02/13/2004. Retrieved February 19, 2004 from:
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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:
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Moss, RW. Another one bites the dust. Cancer Decisions, January 28, 2002.
Accessed February 19, 2004 from:
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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:
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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.
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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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