THE MOSS REPORTS

If it had not been for the National Cancer Institute-sponsored clinical trial of the use of drugs like Celebrex and Vioxx – so-called COX-2 inhibitors – in the prevention of cancer, we, the public, might still be blissfully ignorant of the dangers posed by these bestseller drugs. Quite by accident it was discovered that patients taking these drugs over the long term as a means of holding colorectal cancer at bay had a doubled risk of heart attacks, strokes and sudden death. The trial was halted and the drugs withdrawn from the market.

This discovery highlights some of the gaping holes in our drug safety monitoring system. Once a drug is approved for use, it is simply presumed safe. There is an almost total lack of post-market surveillance. After the FDA has licensed the drug the onus for raising safety concerns shifts almost entirely to individual doctors, who may or may not ‘connect the dots' when a patient (who is often already sick and possibly taking many medications) dies unexpectedly.

The truly pernicious aspect of the COX-2 story is that senior drug company executives apparently were well aware of the link between COX-2s and premature death, yet did nothing to warn doctors or the public.

During the thirty years that I have been monitoring the world of cancer research and treatment, I have seen many potentially useful and non-toxic treatments ignored or dismissed out of hand, while the FDA has approved drug after drug on the slenderest evidence of safety and effectiveness. I have consistently advocated for a level playing field in the testing and licensing of cancer treatments. Cancer patients deserve the best treatment available, and they are not going to get it unless all potential treatments, conventional and alternative, are tested with equal thoroughness.

The Moss Reports is a comprehensive library of more than 200 reports, each one dealing in depth with both the conventional and the alternative treatment of a different kind of cancer.

If you would like to order a Moss Report for yourself or someone you love, you can do so from our website, www.cancerdecisions.com, or by calling Diane at 1-800-980-1234 (814-238-3367 from outside the US).

We look forward to helping you.

TRUE CONFESSIONS

I took Vioxx. That's right, along with tens of millions of my fellow Americans, I succumbed to the promise of safe and rapid pain relief, and fell for the charms of Merck's brand of the COX-2 pain killer, rofecoxib.

How could I have done this? What about natural medicine—the homeopathic and herbal treatments I could have taken instead? What about the wonders of sour cherry juice? Right, right. But in the meantime, I had a crippling lower back pain, bad enough to require immediate help. I went to see my friendly small town doctor. He regards me as a "difficult patient" at best, with an entrenched resistance to pharmacological solutions to all of life's ills.

"Well, we do have something that works quite well in these situations," he said, a bit sheepishly. "Would you like to try it?" This time, he found me in a vulnerable state. Desperate, really. Frankly, if he had offered me high grade ‘China White' heroin I might have lurched for it, and thanked him profusely for facilitating my addiction.

What was more, the first dose was free. That's right, after I agreed to try it, he returned from his dispensary with an armful of cheery orange and blue boxes, given to him by some detail person from Merck. And Merck was respectable, I reminded myself. After all, not only did they publish the Merck Manual, they helped sponsor my local public radio station. You can't get much more respectable than that. Ads for the wonders of Vioxx were also a familiar interlude on most of the serious TV programs that I watched. In fact, Merck had spent more than half a billion dollars on TV ads, promoting the drug to potential consumers like me.

I had written favorably about COX-2 inhibitors, the class of drugs to which Vioxx belongs. It was well known that this glamorous new category of analgesics had an inhibiting effect on cancer. So I convinced myself that I was also striking a blow against cancer while relieving myself of pain. And indeed the drug worked wonders, just as advertised. The backache disappeared in a day or two and I was left with a slightly euphoric feeling. I almost looked forward to my next backache so I could enjoy the product once again.

Thus began my career as not just a user but a downline pusher of patented pharmaceuticals. A close relative shared my inherited back problems. So I let him also share my cache of high power pain relievers. Down East last spring, I found a poor suffering soul in a B&B whose own supply of COX-2 inhibitors had run out. Wasn't I the generous one! Finally, at a medical conference, I encountered a CAM colleague who was troubled by a persistent headache. Despite all sorts of homeopathic potions and skeletal adjustments she had been suffering for months. I offered up my stash. Naturally, she resisted. Four years of naturopathic medical school will do that to some people. But finally, she succumbed to my blandishments.

I felt like Satan in Paradise Lost, whispering darkly in her innocent ear. Why stick to fuddy-duddy principles, when you can have fast and immediate relief? You will be pain-free. Late fallen myself from Heaven, I plotted the fall of others from their state of bliss, to quote John Milton. Or something like that. The next day she admitted sheepishly that she felt much better. Here was a marvel they hadn't mentioned at John Bastyr naturopathic college. She had discovered something new. It was called Conventional Medicine.

However, no sooner had I returned home than I was struck once again with backache, and on reaching for my Vioxx, discovered to my dismay that the cupboard was now bare. My largesse had caught up with me. Oh well, not to worry, I said. I have a health plan with excellent drug benefits. My primary care doctor, a go-to guy, obligingly phoned in a prescription. However, I was thunderstruck when the pharmacist demanded $80 for 30 pills. I refused the prescription.

A week later I heard the bad news about Vioxx. Users in a clinical trial had double the risk of heart attacks, strokes or sudden death. After first denying that there was any danger, Merck did an about-face and abruptly pulled Vioxx off the market. Editorialists lauded Merck for its candor. But then it turned out that senior company personnel had known about this heart attack problem for over four years. Praise quickly turned to outrage. The Lancet, in a scathing editorial, estimated that 27,000 excess deaths had occurred in the US alone on account of the company's cover-up. This was followed by similar revelations about the danger of three other major pain-relievers, Celebrex, Bextra and Aleve. I felt as if I had escaped with my life.

Meltdown?

On the cancer front, Iressa, which was once touted as the harbinger of a bright new era in targeted cancer treatment has now been shown in a large clinical trial to have no better effect in treating lung cancer than a sugar pill. (This was, incidentally, a failure I had written about as early as 2001.) Other drugs, such as some of the major statins, also seem poised for extinction.

Are we now facing the Armageddon-like meltdown of Big Pharma that some individuals have been predicting for quite a while? Frankly, I doubt it. Pfizer may have pulled its New Age ads for Celebrex depicting women of a certain age doing Tai Chi in the park, but the Food and Drug Administration (FDA) has allowed the drug to stay on the market, so that Pfizer can milk the last billion or so out of remaining supplies.

When Aleve (naproxen) was also shown to be associated with a significantly increased risk of heart attacks the news hardly caused a ripple. The media was already bored with the painkiller-causes-heart attack thing. The message now was "don't worry, be happy."

"All of this is very scary to patients, but there is no need for panic," said Dr. Hayes Wilson, an Atlanta rheumatologist. Patients who take Aleve short-term, as directed, and who have no known risk of heart disease, he said, should have no reason to be scared. Wall Street certainly wasn't showing much concern. "Pharmaceutical stocks, which have been volatile for months over related life-threatening results, shrugged off the latest drug disappointment..." said a stock report after the Aleve revelations (Yahoo Financials, Dec. 21, 2004).

We seem to have gotten inured to Enron-style corporate scandals. But the saddest part of all this has been the utter failure of the FDA to protect consumers from avoidable danger. When it comes to orthodox medicine, tens of thousands of deaths will get you what amounts to a slap on the corporate wrist.

But the other side of the FDA's coziness with Big Pharma is its unyielding hostility towards alternative medicine. Just imagine what would happen if some alternative treatment was found to have killed 27, much less 27,000, people! By contrast, for alternative medicine, the FDA's rule is ‘one strike and you are out.' The merest allegations that an alternative remedy may have associated dangers are enough to get the remedy summarily removed from circulation. For example, laetrile; hydrazine sulfate; MGN-3; Benefin -and a host of other products and services have been banned, based on minimal indications of danger.

The FDA is now part of a three-country North American task force, called MUCH, whose express goal is to shut down alternative clinics in Mexico. In fact, the medical graveyard is full of relatively innocuous treatments that the FDA has aggressively prosecuted, while conventional medicines that kill thousands of people each year are still being prescribed!

We are beginning to hear renewed calls from well intentioned individuals for reform of the FDA. After all, here is a clear instance of the watchdog being asleep on the job. But any FDA reform that does not seriously address its entrenched bias against complementary and alternative medicine (CAM) will fail. Worse, when the dust clears, this "reformed" FDA will be in a strengthened position to crush the few remaining rivals to Big Pharma.

And that will be a major headache indeed.

References:

Anderson, Virginia. Doctors caution Aleve users not to feel panicked. The Atlanta Journal-Constitution, Dec. 22, 2004. Accessed Dec. 23, 2004 from:
http://www.ajc.com/news/content/health/1204/22aleve.html

Iressa: Astra-Zeneca. Gefitinib (Iressa) lung cancer ISEL trial shows no overall survival advantage in a highly refractory population. December 17, 2004. Accessed January 7, 2005 from:
http://www.astrazeneca.com/pressrelease/4245.aspx

To read some of my earlier statements on Iressa, click or go to:

http://www.cancerdecisions.com/Townsend/Aug2001.html

http://www.cancerdecisions.com/102302.html

http://www.cancerdecisions.com/060603.html

http://www.cancerdecisions.com/092703.html

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.

CancerDecisions® PO Box 1076, Lemont, PA 16851 Phone Toll Free: 800-980-1234 | Fax: 814-238-5865 Copyright © 1996-2005 All Rights Reserved