Herceptin "Winner" Has Lost to Cancer
by Heidi Stevenson
It's with sadness that we note Ann Marie Rogers' death from breast cancer, the disease she tried so hard to fight by forcing the United Kingdom's taxpayers to cover the experimental treatment, Herceptin. She won the public relations battle less than three years ago, but it did not help with her fight against cancer. There was a clear winner, though—Genentech, the drug's manufacturer. Because of Rogers' battle, Herceptin is being made available to thousands of women in the UK.
In spite of Rogers' death only three years later, the mainstream media is reporting that Herceptin is an effective treatment that prolongs lives. This claim, though, is made without a shred of evidence. Barbara Clark, a breast cancer survivor, former nurse, and friend who helped fight the battle for Herceptin stated, "I was with her in court on the day that she won and we just cried because we thought that we had both been given a second chance at life. Unfortunately, Herceptin hasn't worked for her, but she saved so many lives." It's natural to want to believe that one's efforts were for the general good, but that does not necessarily make it so.
In truth, Mrs. Rogers did not win a legal battle. Rather, she won a public relations battle. The courts had refused her claim. However, the PR campaign funded by Genentech was successful. Shortly after her case was turned down, Health Secretary Patricia Hewitt succombed to pressure and intervened with the Primary Care Trust. This resulted in a snowball effect throughout the UK, so that Herceptin is now often used in early-stage breast cancer.
In 2006, Mrs. Rogers was in the early stages of breast cancer that had been defined as aggressive. Unfortunately, she made the mistake of assuming that her best chances were with mainstream medicine's toxic chemotherapy, a technique that causes almost unendurable misery and has never been shown to provide extended life in exchange for that trauma. Apparently, it didn't occur to her to look into alternatives.
Herceptin's Adverse Effects
Before continuing, let's take a look at the full range of Herceptin's effects. The most common effects, those that you can expect to experience, include:
Chills, Cough, Diarrhea, Dizziness, Dyspnea, Fever, General Weakness, Headache Disorder, Infection, Nausea, Pain, Skin Rash, Vomiting
So, like all the other toxic drug treatments for cancer, you can expect to be made utterly miserable—and that's just the beginning. Beyond that, there are the so-called "less frequent" and "rare" effects of Herceptin.
Less Frequent:
Anorexia, Cardiomyopathy, Cardiotoxicity, Chronic Heart Failure, Fatigue, Insomnia, Myalgia, Paresthesia, Rhinitis, Thromboembolic Disorder
Rare:
Adult Respiratory Distress Syndrome, Allergic Reactions, Anaphylaxis, Anemia, Angioedema, Bronchospastic Pulmonary Disease, Glomerulonephritis, Hypotension, Hypoxia, Interstitial Pneumonitis, Left Ventricular Failure, Leukopenia, Pleural Effusions, Pruritus of Skin, Pulmonary Edema, Pulmonary Infiltrates, Respiratory Depression, Urticaria
Could Ann Marie Rogers have actually been killed by Herceptin? We'll likely never be informed. However, heart failure is a well known result of the drug. As is an abnormally low number of white blood cells, the ones that fight infections, so the patient is at risk from bacterial invasions. Pneumonia could have killed her. Kidney inflammation could have been the culprit.
Is it too strong to suggest that she may have been killed by the rapacious profit-making of a pharmaceutical company? Considering the tens of thousands who died from Vioxx, it isn't a great stretch.
In 2005, the year before Mrs. Rogers won—lost?—her fight for Herceptin, the FDA was warned that cardiotoxicity is a significant risk of the drug. Of course, the news media smoothed this information over by calling it an "acceptable" risk. According to Professor John Toy, Cancer Research UK's medical director, a study documenting the risk "shows that by stopping the drug in the women who have an adverse reaction, and successfully treating the heart problem, the Herceptin treatment can safely restart." In other words, the unfortunate patient, whose system has been weakened and harmed by Herceptin, can be treated with yet more toxic drugs, thus allowing a return to Herceptin treatment. Does that make you feel cozy?
Is Herceptin Effective?
Trials show some life extension with use of Herceptin, but these trials compare Herceptin only with other chemotherapy treatments. They do not even consider comparison with women who choose alternative therapies. Since there has been no proof that breast cancer survival is extended through the use of any chemotherapy, one must question the validity of such comparisons. None of these trials appear to consider quality of life.
Herceptin is often touted as having a 50% improvement over other chemotherapy treatments. However, this is a twisting of statistics. The 50% figure comes from a study that shows a three-year survival rate of 75.4% for conventional chemotherapy alone and 87.1% for those also on Herceptin. That's an improvement of 11.7% as shown in the figure between the green lines. The 50% figure comes from the convoluted method of first subtracting 75.4% from 100% (24.6%), then subtracting 87.1% from 100% (12.9%). 12.9 is about half of 24.6. This is where the acclaimed 50% improvement in survival rate comes from, which represents nothing but playfulness with figures. At best, Herceptin has been shown to provide no more than an 11.7% survival rate after three years, and then only in comparison with other chemotherapy treatments.
Herceptin's History of Hype and Deception
In the Lancet Oncology (2006, 7:22-3), the Clinical Director of NICE, Professor Peter Littlejohns, analyzed the trial data and stated, "For every 100 suitable patients prescribed Herceptin," he wrote, "94 will have been exposed to the side effects without any benefit, at a cost of £400,000 per recurrence prevented."
The story of Herceptin is a history of hype and fraud. The manufacturer, Genentech, played a masterful game in publicizing it and pushing it through the approval process. They stopped a major trial early and produced a paper called, "Randomized trials stopped early for benefit". The claim was that it would be unfair to the women on placebo not to have access to such a wonderful drug. It was great theater and provided wonderful grist for the media. However, as the Journal of the American Medical Association (2005:294:2203-9) criticized it, saying that the results showed, "implausibly large treatment effects" and suggested that "clinicians should view the results of such trials with scepticism".
Comments by The Lancet (2005;366:1673) were even stronger:
The best that can be said about Herceptin's efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgments. It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer.
This didn't even slow Genentech down. The company had already been producing press releases, which were dutifully reprinted by the news media, for years. Claims of efficacy were made on flimsy results from brief trials. One study published in the Seminars in Oncology (1999;26S:89-95) found that 9 of 37 patients had "responses" to Herceptin during an 8 month trial, and a second study in the same journal (1999;26S:78-83) stated that 5 of 43 patients had "responded" during a 5 month trial. Neither study had a control group, nor were they blinded.
These trials were shaky at best, but the news reports, which came directly from Genentech's press releases, stated that Herceptin was "a significant medical break-through". The second study's lead author, Memorial Sloan-Kettering's Dr. Larry Norton, was quoted as saying, "This is the biggest difference I have ever seen in advanced breast cancer—unlike anything we have ever seen before." Huh? I suppose he couldn't resist the limelight—or did he have another motive? Perhaps it was a career move? Since then, he has been a co-author in at least two other studies (JAMA. 2005;293:1073-1081 and 2006;295:1658-1667.) Dr. Berry, the lead author in both of them, has close ties to Big Pharma. Along with consultancies with Bristol-Myers Squibb, Eli Lilly, and Novartis, he also receives speaking fees from AstraZeneca and Pfizer. Dr. Citron consults with Amgen and Genentech and receives speaking fees from Amgen, Genentech, and AstraZeneca.
These over-the-top quotes from seemingly top-notch doctors and researchers, which seem to be induced primarily by offering wealth and fame, serve one purpose: to create excitement and buzz in the public. Obviously, Genentech was brilliant in this manipulation, but even more was done. They also manipulated support groups and charities. We'll take a look at two examples.
In the UK, the cancer charity BACUP has stated that Herceptin is a "breakthrough" and that its results with early-stage cancer are "impressive". They do not even discuss its significant risks, nor do they comment on the inadequacies of the studies. About 10% of its funding came from pharmaceutical firms. (BACUP has since merged with MacMillan, forming MacMillan Cancer Support.)
On going to BreastCancer.org, a familiar name pops up immediately, Dr. Larry Norton!* His photo is on the main page of the site under "Meet Our Experts", with text stating that the Professional Advisory Board helps, "with the conception, creation and revisions of our award-winning content." The organization has taken tens of thousands of dollars from Genentech. Oddly enough, BreastCancer.org has called Herceptin "a very effective treatment". They cite and publish articles that make the same claims that are demonstrated above as fraudulent. Their website clearly pushes women into mainstream medicine's cancer treatments, even to the point of stating, "Breastcancer.org does not recommend alternative medicine." Their logic is that mainstream medicine's treatments should never be replaced by alternatives, though they offer absolutely no documentation to support the idea.
*Note: This may not prove true with every visit to the site, as different experts are featured randomly.
For Genentech, the money spent on support groups is chump change. The amount of lucre made from Herceptin is enormous. During its first year, the NHS spent about £100 million for it, and that figure is expected to increase dramatically.
If we consider only mainstream treatments for breast cancer, the real cost of Herceptin becomes apparent. It's expensive, very much so. One example clearly demonstrates the issue. The UK's Norfolk and Norwich University Hospital Trust has provided figures comparing costs of other adjuvant cancer treatments. Their figures show that the total cost of the adjuvant treatments, not including Herceptin, is £503,000. This treats 355 patients with a cure rate (their term) of 16 extra patients. The cost of Herceptin to treat the number of patients who qualify for it, 75, is £1,940,000, providing a cure rate of 3 extra patients. Thus, Herceptin cures three-sixteenths the number of patients for nearly five times the money. Either way you look at it, people die. The question is, who? And how many?
We all hope that Ann Marie Rogers has found peace. We hope, too, that her last three years were comfortable and happy. Our hearts go out to her. That, though, should not cause us to lose balance. This is the time to try to regain it—to make a point of looking at her experience, taking all factors into account, and deciding whether to continue providing Herceptin. Her life can serve an even greater purpose than she had imagined when she became a pawn in the push for Herceptin approval.
For more information about cancer, its causes and treatments, see the panel to your right.
