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Myeloma Clinical Trials Downplay Side Effects
What would you say if I told you that myeloma clinical trials downplay side effects? Meaning, when oncology writes up the results of a given clinical trial for, say, a new chemotherapy drug, the authors overwhelmingly use the terms
- well-tolerated and
- tolerable
If you are a myeloma patient who underwent chemotherapy, how did you feel about your side effects such as
- nausea/loss of appetite
- fatigue
- alopecia
Raise your hands. Did you find them “well-tolerated?” Or possibly “tolerable?”
To be fair, if you wanted to participate in a clinical trial for your incurable blood cancer, you would have participated regardless of the expected side effects. I’m highlighting the research linked and excerpted below in an effort to establish two things:
- First, clinical trials are highly biased, according to research and
- Second, clinical trials are usually paid for by Drug companies.
When I was diagnosed with multiple myeloma, I participated in two clinical trials. I had to sign a waiver first. Did you sign a waiver when you entered your clinical trial?
I think clinical trials for myeloma are necessary yet include both risks and benefits.
Participating in an oncology clinical trial can have both risks and benefits, and individuals considering participation should carefully weigh these factors. Here are some general risks and benefits associated with participating in oncology clinical trials:
Benefits:
- Access to New Treatments:
- Participants may have access to cutting-edge treatments that are not yet available to the general public. This can be especially valuable for individuals with advanced or rare cancers.
- Contribution to Medical Knowledge:
- Participation in clinical trials contributes to the advancement of medical knowledge and helps researchers understand the effectiveness and safety of new treatments. This, in turn, may benefit future patients.
- Comprehensive Medical Care:
- Clinical trial participants often receive close monitoring and comprehensive medical care. This can include regular check-ups, additional diagnostic tests, and careful management of side effects.
- Emotional Support:
- Being part of a clinical trial may provide emotional support as participants often work closely with healthcare professionals who are experts in their field.
Risks:
- Unknown Side Effects:
- Since experimental treatments are being tested, the potential side effects may not be fully understood. There is a risk of experiencing unforeseen adverse effects.
- Treatment Ineffectiveness:
- The experimental treatment may not be effective for every participant. There is a possibility that the new therapy may not be as beneficial as standard treatments.
- Time and Commitment:
- Participation often involves a significant time commitment for frequent medical visits, tests, and follow-ups. This can be burdensome for some individuals, especially those with busy schedules or travel constraints.
- Randomization and Placebo Use:
- Some trials involve randomization, where participants are assigned randomly to different treatment groups. In some cases, a placebo may be used. This means that participants may not have control over the specific treatment they receive.
- Confidentiality Concerns:
- There may be concerns about the confidentiality of personal medical information, although clinical trials are conducted with strict privacy and ethical standards.
- Financial Considerations:
- While some costs may be covered by the trial, there could be additional expenses not covered by insurance. This may include travel costs, childcare, or other logistical expenses.
Key Considerations:
- Informed Consent:
- Before participating, individuals must provide informed consent. This involves understanding the details of the trial, potential risks, and benefits. Participants should feel comfortable asking questions and seeking clarification.
- Consultation with Healthcare Team:
- It’s crucial to discuss the decision with one’s healthcare team, including oncologists and primary care physicians, to ensure a thorough understanding of the potential impact on one’s health.
- Trial Eligibility Criteria:
- Participants must meet specific eligibility criteria for each trial. Understanding these criteria is essential in determining if one is a suitable candidate.
Signing the waiver that I mentioned above is tied to the first Key Consideration above- informed consent. If the research papers for myeloma clinical trials are biased there is no way that patients can give informed consent.
Have you been diagnosed with multiple myeloma? Are you considering entering a clinical trial? If you would like to learn more about preventing the short, long-term and late stage side effects from chemotherapy and radiation let me know- thanks-
David.PeopleBeatingCancer@gmail.com
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma
“Results Of the 65 RCTs included, 56 (86%) used minimizing terms when describing treatment-emergent AEs. The most frequently used minimizing terms were well-tolerated or tolerable in 29 trials (45%), manageable in 18 (28%), and acceptable in 16 (25%).
Grade 3 or 4 AE rate in the examined RCTs ranged from 23% to 94%, with a median of 75% (IQR, 59%-82%). A univariate regression analysis demonstrated no association between the use of minimizing terms and grade 3 or 4 AE rates (odds ratio [OR], 1.35 [95% CI, 0.88-2.10] per 10% AE rate increase; P = .17) or grade 5 AE rates (OR, 3.16 [95% CI, 0.27-12.7] per 10% AE rate increase; P = .45).
Conclusions and Relevance These findings suggest that trial investigators and sponsors regularly use minimizing terms to describe toxic effects in MM trials, and use of this terminology may not reflect actual AE rates in these studies.
Instead of using these terms, trial investigators should highlight event rates and patient-reported outcomes, to allow clinicians and patients to better evaluate the true tolerability of AEs…
Sponsorship bias in clinical research
“Results: Bias in favour of industry is apparent in every one of the themes examined with the result that research funded by industry undermines confidence in medical knowledge.
Conclusions: Bias induced by commercial concerns can be countered in one of two ways. The first is to erect a firewall between the money and the people doing the research and the data analysis. The other approach is to develop an entirely separate funding source that is independent of the pharmaceutical industry…”