Otherindependent cross-checkabstract checked I-CHM-124 standard review
Many new cancer drugs approved without proof of longer or better life
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.
Overview
Davis C et al.. BMJ 2017 · PMID 28978555 · DOI 10.1136/bmj.j4530
Of 68 new cancer-drug approvals in Europe, only about half showed a survival or quality-of-life benefit after 5 years.
Does the study support the specific claim? Partly · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Check evidence behind new cancer drugs
- How was the study done?
Cohort of EMA approvals
- How many people, animals or samples were studied?
68 indications 2009-13
- What was actually found?
Many approvals with uncertain benefit
- How large was the observed effect?
35% had OS benefit at approval
- What do the results mean in everyday life?
Ask what a new drug adds; proven standard treatments are different
- What are the study's limitations?
New drugs only
- What does it say about Elawady's specific claim?
Partly supports scepticism
- Do the results apply to Germany and Europe?
High
- What can explicitly not be concluded from this study?
Does not apply to established curative chemotherapy or radiotherapy
Scientific in-depth review
1. Full reference
- Authors
- Davis C et al.
- Journal
- BMJ
- Year
- 2017
- Identifier
- PMID 28978555 DOI 10.1136/bmj.j4530
- Verification
- verified – PubMed efetch 2026-10-26 (PublicationType and CommentsCorrections checked); Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract (PubMed lists a Department of Health grant).
2. Research question
What evidence on overall survival and quality of life existed for EMA cancer drug approvals 2009-13?
3. Study design and population
- Study design
- Other – Retrospective cohort study of regulatory approvals
- Population
48 cancer drugs, 68 indications approved by EMA
- Country
Europe
- Period
Approvals 2009-13; median follow-up 5.4 years
- Sample size
68 indications
- Inclusion and exclusion criteria
All EMA cancer approvals in the period
4. Methods and endpoints
- Exposure / intervention
New cancer drugs
- Comparator
Existing treatment or placebo (in pivotal trials)
- Endpoints
Availability and size of OS and QoL benefit; ESMO-MCBS
- Statistical methods
Descriptive
5. Actual results
- Results
Significant OS prolongation at approval in 24/68 (35%; median 2.7 months, range 1.0-5.8); QoL improvement in 7/68 (10%). After a median 5.4 years, 35/68 (51%) showed significant OS or QoL benefit and 33 (49%) remained uncertain; of 23 scorable OS gains, 11 (48%) were clinically meaningful by ESMO-MCBS.
- Absolute risks
Median OS gain 2.7 months where shown
- Authors' conclusion
Most drugs entered the market without evidence of benefit on survival or quality of life; when gains existed they were often marginal.
6. Strengths
- Complete cohort of approvals
- Uses ESMO-MCBS
7. Weaknesses
- Concerns new drugs, mostly for advanced disease, not established curative regimens
8. Risk of bias
- Orienting tool
- ROBINS-I
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Descriptive regulatory analysis.
9. Assessment of the statistical interpretation
Proportions from counts (24/68 = 35%).
10. Relevance to the specific claim
A legitimate, high-quality criticism: many newly approved cancer drugs lack proven survival or quality-of-life benefit. It concerns new drugs for advanced disease and does not apply to established adjuvant and curative treatments with randomised survival benefit.
11. Independent contrary findings
EBCTCG and CONKO-001 (curative settings).
12. Transferability to Germany and Europe
Directly European.
13. Overall methodological judgement
Supports critical appraisal of new drugs, not refusal of proven treatment.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | not applicable |
| Directness | indirect |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None.
15. Linked fact checks
- The archive's 19 chemo/radiation studies are presented on the homepage as 'scientific studies confirming what Dr. Diaa proposed'; the harm-only study selection implies that the harms of chemotherapy and radiotherapy outweigh their benefits. – Studies with mixed or unclear results
- Oncology only buys time: 'survival rates' are meaningless, patients die during treatment, and early diagnosis only makes you 'die early'. – Studies with mixed or unclear results