Chemotherapy for Late-Stage Cancer Patients
Is Just Plain Unethical
January 11th, 2017 by Holly Cornish
Doctors and patients should question whether a particular test or treatment is really necessary.
No need to take my word for it. This is the advice of the Academy of Medical Royal Colleges (AMRC), A UK organization that represents 22 medical colleges.
In October 2016, they listed 40 routine medical procedures that have little or no effect or benefit for the patient. One of these was chemotherapy for patients with advanced or late-stage cancer.
It’s time to just state it plainly: Chemotherapy for late-stage cancer patients is an immoral practice. Medical and government authorities, if they have any integrity at all, should put a stop to it.
The AMRC said that chemotherapy is toxic, can cause great harm, may fail to achieve a meaningful response, and raises false hope.
The following month, Peter H Wise, a retired consultant oncologist, went further. Writing in the British Medical Journal, he questioned, among other practices, the ethics of how the government approves very expensive drugs that yield only small survival benefits in metastatic cancer.
Let’s take a quick look at the arguments he put forward. . .
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Chemotherapy increases survival by 3 months
To be absolutely fair, there have been improvements in five-year survival rates, with an increase from 49% in 1975 to 68% in 2010. But Dr. Wise asks “how much of the [19%] improvement….can we attribute to drugs?”
In 2004, doctors for the Northern Sydney Cancer Centre in Australia reviewed five-year survival benefits attributable to cytotoxic chemotherapy – and nothing else — in malignancies of Americans and Australians. All the subjects of the study were adults.
Of 155,000 Americans included, important effects were seen in some cancers: testicular (37.7%), Hodgkin’s disease (40.3%), cervix (12%), Non-Hodgkin’s lymphoma (10.5%) and ovarian (8.9%). But these represented just 8.3% of all cases.
The remaining 91.7% included the most common cancers, such as breast, colorectum, lung and prostate. For people with advanced cases of these cancers, survival rates were extremely low.
Of all cancers included in the review, drug therapy increased five-year survival by only 2.1%, which equates to an average lifespan increase of only three months.
Italian researchers writing in the British Journal of Cancer found that 14 consecutive new drugs approved by the European Medicines Agency (EMA) for adult solid cancers improved overall survival by an average of 1.2 months. (A solid cancer is one that affects an organ such as breast, liver or prostate, as distinguished from a bodily fluid like blood or lymph. Most cancers are solid.)
Of 48 new drugs approved by the FDA between 2002 and 2014, the average overall survival benefit was 2.1 months.
It would seem that little of the 19% improvement in five-year survival is due to chemotherapy.
Drug trials: Do patients understand
what they’re signing up to?
There are also ethical questions regarding participation in drug trials.
Studies suggest patients may feel pressured to enroll, believing this to be their only option. Although they take part in the hope of personally benefiting, this is a rare outcome. Most patients don’t realize the trial is for the betterment of other patients in the future.
This caveat is personal for me. One of my best friends, who had leukemia, died in reaction to an experimental stem cell treatment. He had been doing well before volunteering to be a guinea pig (leukemia is pretty treatable). He left behind a wife and ten-year-old whose lives were devastated by the loss.
I have a small bit of personal experience with drug trials. I participated in one as a college student, many decades ago, because, frankly, I needed the money and they were paying. When I had a bad reaction and withdrew from the trial, the doctor who was running the project severely criticized me.
Even if there is a positive outcome from a chemo drug trial, this doesn’t ensure the results will be replicated outside of the trial setting. Quite often the result of a trial is just a few extra weeks of life compared to the average for patients with the same disease who are not treated with the experimental drug.
Such results are NOT significant. And the drugs, if approved, are then marketed as a “new breakthrough’ – extremely expensive, of course. Oncologists promptly start treating their patients with the new drug when there are older, less expensive chemo drugs available that work just as well.
Only three percent of cancer patients take part in trials. In the other
97%, staffing and procedures can be quite different with no guarantee of similar outcomes.
The value of such trials is also questionable.
Previous university-based trial procedures have been replaced by outsourcing to commercial contract research organizations (CROs) responsible only to the company that hired them. These are increasingly conducted in low/middle income countries, a practice called offshoring.
A study which looked at the effect of outsourcing described “the extreme lack of transparency of CROs in particular and the pharmaceutical sector in general.” The authors concluded that many of these trials “place patients at ethical risk.”
Speeding up drug approval
The most meaningful measure of a drug’s worth is overall survival – from the time the drug is first taken until the patient’s death.
However, in the pressure to speed up the drug approval process, many trials look at other measures of “success” – so-called “surrogate endpoints” — such as early shrinkage of the tumor, the overall response to the drug, and progression-free survival – the time that passes without the tumor becoming larger or spreading.
All these are measured by imaging, but in the vast majority of cases, they don’t have much connection to overall survival. It’s depressing news – even for patients using some alternative treatments – but tumor shrinkage doesn’t necessarily mean you’re getting better. Tumor size is a symptom; effective cancer treatment tackles the root causes such as toxins, high blood sugar, and a weak immune system.
The “surrogate endpoints” like tumor shrinkage are also used by the FDA and EMA for accelerated approval. Yet 45% of drugs given accelerated approval by the FDA never go on to win full approval because follow-up trials did not confirm they added time to the patients’ lives.
The risks of approving ineffective or unsafe drugs was further compounded in 2012 when the FDA introduced its “breakthrough” category of drugs. For these, preliminary evidence indicates the drug may show substantial improvement over existing drugs.
I can understand that late-stage patients may be willing to roll the dice on an experimental drug. There’s an active, noisy political movement demanding access to drugs that aren’t yet FDA-approved.
But what doctors should do is explain to patients that these new drugs will extend life only a few weeks, if at all, and that the patient should consider gentle, effective alternative therapies. I can’t guarantee results, but I’ve met plenty of late-stage patients who made amazing recoveries when they turned to alternatives.
In addition to overall survival, oncologists consider quality of life an important factor in cancer care, yet improvements in quality of life from chemotherapy are tiny, and even where they do exist, they don’t last long.
In my opinion, the words “chemotherapy” and “quality of life” don’t even belong in the same sentence.
The ethical principles of fairness and equity must be questioned when drugs are given such a low threshold for approval, for the treatment of types of tumors that don’t respond well — and with benefit to so few patients.
In the United States, massive resources – many, many billions of dollars – are spent on chemotherapy for late-stage cancer patients. The money is almost entirely wasted and could be better spent elsewhere in our bankrupt, overburdened medical system. Money is literally being taken from babies to fund this out-of-control cancer industry.
The fast-tracking of chemotherapy drugs may benefit a tiny number of patients, about the same way the lottery benefits a few winners. Some people do recover or see a substantial life extension, not just a few weeks. But the real winners are the drug companies with 22% profit margins on national cancer drug sales of $50 billion.
Another doubtful ethical practice is the so called revolving door, whereby the drug industry hires people who used to work for the regulatory agencies. “Thus the regulator risks being regulated by the industry that it has been appointed to regulate,” says Peter Wise.
Another winner may be the oncologist. A study published in the Journal of Clinical Oncology found that a considerable number of oncologists, mainly the independent ones who work for themselves rather than a hospital, enjoy an increase in their income when they administer chemotherapy.
Patients expect too much
Cancer treatment represents a considerable financial burden even for patients with insurance. In fact, it’s a major cause of personal bankruptcy. Yet consent forms are often neither issued or signed.
Few patients are fully informed that four out of five cancer drugs bring on side effects – nearly all of which are serious. They also don’t understand that the treatment itself can kill them.
Not being aware of the dismal treatment outcomes – much less the nontoxic, natural alternatives — patients hardly ever question the oncologist’s proposal for chemotherapy. An ethical system is one where patients are empowered. They are given accurate and impartial information so that consent is genuinely informed.
In a study published in the New England Journal of Medicine, three-quarters of terminally ill patients believed chemotherapy could cure them.
How can people make an intelligent decision when they believe such nonsense?
The same article reports that only one late-stage patient out of four is told that supportive care is an option. Supportive care can enhance the quality of life and even extend life. It’s all but certain that another round of chemo is not going to extend such a patient’s life. It’s going to make what life they have left completely miserable.
If you or someone you love is faced with this choice, why not be comfortable instead, and even throw in some harmless alternatives — like immune-supporting supplements and natural anti-inflammatories, not to mention getting off the sugar and other refined carbs? I repeat, these simple, safe steps often lead to dramatic turnarounds.
Dr Wise concludes that “aggressively targeting the less than ethical actions of stakeholders in the heavily veiled medical-industrial complex may be the only way forward: current market driven rather than health driven priorities and practices do not benefit cancer patients.”