Public health and WHOWho pays for drug trials—and why are the results so often too good to be true?
Sources: 8 · Article: 8 996 characters
Jerzy Zięba claims that the drug manufacturer analyzes the results itself and uses its own laboratories.
- He recommends that at least two other centers confirm the studies and that independent scientific institutions perform the statistical analysis of the results.
- The STOP NOP Association says that the pharmaceutical industry sponsors research on drugs and vaccines, and that major financial interests can put pressure on medical research.
What the authors write
Stowarzyszenie STOP NOP
The pharmaceutical industry sponsors research used to develop drugs and vaccines.
„This is very disturbing, given that all this research (sponsored by industry) is used to develop drugs/vaccines supposedly intended to help people, train medical staff, educate medical students, and so on.”Jest to bardzo niepokojące, biorąc pod uwagę fakt, że wszystkie te badania (sponsorowane przez przemysł) są wykorzystywane do tworzenia leków / szczepionek mających rzekomo na celu pomóc ludziom, szkolenia personelu medycznego, edukowania studentów medycyny itd.
Jerzy Zięba
The drug manufacturer analyzes the results itself, uses its own laboratories, and does not have them independently verified.
„The problem, however, is that after the clinical trial data have been collected, the manufacturer itself analyzes the results and processes the statistical data, uses only its own laboratories, and, without any oversight or independent verification, and without review by any other external centers, submits this information to the FDA to obtain authorization to market the drug.”Problem jednak polega na tym, że po zebraniu danych wyniku testów klinicznych, sam producent przeprowadza ich analizę, opracowuje dane statystyczne, korzysta tylko z własnych laboratoriów i w sposób zupełnie niekontrolowany, bez żadnej niezależnej weryfikacji, nie oceniany przez jakiekolwiek inne ośrodki zewnętrzne, przekazuje te informacje do FDA w celu uzyskania zezwolenia na wprowadzenie tego leku do obrotu.
Stowarzyszenie STOP NOP
Major financial interests in drug development and marketing can put pressure on medical research.
„The huge financial stakes in developing and marketing drugs and medical devices may have placed undue pressure on the pharmaceutical industry to influence medical research, as well as health policy and practice.
Materials and methods: A literature review and an analysis of the various ways in which the pharmaceutical industry directly or indirectly permeates the broader healthcare system.”Ogromne udziały finansowe włożone w opracowanie i marketing leków i wyrobów medycznych mogły wywoływać nadmierną presję na przemysł farmakologiczny by wpływać na badania medyczne oraz politykę i praktykę w zakresie zdrowia.
Materiały i metody: Przegląd literatury oraz analiza różnych dróg, którymi przemysł farmakologiczny bezpośrednio lub pośrednio przenika do szerzej rozumianego systemu opieki zdrowotnej.
Jerzy Zięba
Reliable studies should be confirmed by at least two other centers, and their results should be independently analyzed statistically by other scientific institutions.
„One of the requirements, for example, is that such studies should be confirmed by at least two other scientific centers somewhere in the world, and that their results should be statistically analyzed by independent scientific institutions, and so on. Such requirements are always followed, particularly in studies involving various types of medical experiments, for example.”Jednym z wymogów jest np. to, że badania takie powinny być potwierdzone przez co najmniej dwa inne ośrodki naukowe gdzieś na świecie, że wyniki powinny być opracowane statystycznie przez niezależne jednostki naukowe itd. Tego typu wymogi przestrzegane są zawsze, w szczególności w badaniach dotyczących różnego rodzaju eksperymentów medycznych, np.
Stowarzyszenie STOP NOP
In the cited assessment, much of the scientific literature may be untrue, partly because of conflicts of interest.
„“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies based on small samples with tiny effects, invalid exploratory analyses, flagrant conflicts of interest, and an obsession with pursuing fashionable trends of dubious value, science has taken a turn toward darkness.” Source: The Lancet.”„Ta sprawa przeciwko nauce jest dosyć oczywista: duża część literatury naukowej, przypuszczam, że połowa, może najzwyczajniej w świecie być nieprawdziwa. Nadszarpnięta badaniami opartymi na zbyt małej próbie z mizernymi wynikami, niemającymi podstaw analizami wyjaśniającymi, jawnym konfliktem interesów a także z obsesją gonienia za modnymi trendami o małej wartości – nauka uczyniła zwrot ku ciemności.” Źródło: The Lancet.
Stowarzyszenie STOP NOP
In the cited opinion, the medical industry buys off the medical professions in matters of teaching and research as well.
„“The medical profession is being bought by the medical industry, not only in the practice of medicine, but also in teaching and research. Academic institutions in this country are allowing themselves to become paid agents of the pharmaceutical industry. I consider this disgraceful.” Arnold Seymour Relman (1923–2014), Professor of Medicine at Harvard University and former editor-in-chief of the New England Medical Journal
Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC1126053/
We truly live in interesting times.”„Zawody medyczne są kupowane przez przemysł medyczny, nie tylko w kwestiach praktyki medycznej, ale także nauczania i badań. Instytucje akademickie tego kraju godzą się na to, by stawać się płatnymi agentami przemysłu farmaceutycznego. Uważam to za niegodne.” Arnold Seymour Relman (1923 – 2014), Profesor Medycyny Uniwersytetu Harvard i były redaktor naczelny New England Medical Journal
Źródło: https://pmc.ncbi.nlm.nih.gov/articles/PMC1126053/
Doprawdy, w ciekawych czasach żyjemy.
Research from PubMed · Europe PMC
We selected 2 studies with the best, positive results. This is a selection, not a full review of all research.
Total number of studies on this topic in PubMed: 45 343.
A review of 500 studies found that 36% were funded by the pharmaceutical industry, and most studies—regardless of funding source—reported results favorable to the drug being studied.
Aim of the study: The pharmaceutical industry has become a major source of funding for biomedical research. Our general observation is that pharmaceutical industry employees are appearing with increasing frequency as coauthors of clinical trial publications. To characterize clinical trial funding, reporting, and sources; investigate author-industry affiliation; and describe clinical outcome trends over time.
Results: Of the 500 clinical trials reviewed, 181 (36%) involved pharmaceutical industry as an independent (n = 104) or joint (n = 77) sponsor and 180 (36%) involved a peer-review funding source; the balance (139; 28%) lacked any declared sponsorship. The percentage of industry-sponsored clinical trials increased to 62% during 1997-2000. The percentage of nonprofit sponsored clinical trials remained constant over time, while the percentage of those without funding declaration declined. Reported author affiliation with industry increased to 66% of clinical trials sponsored only by industry. An increase in the percentage of clinical trials with reported author-industry affiliation was observed for all journals. Regardless of funding source, the majority of clinical trials reported clinical outcomes that favored the study drug.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
An analysis of FDA approvals found that industry funding increased after 2016, and that studies supporting approvals raised concerns about the strength of evidence for safety and effectiveness.
Aim of the study: The 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024.
Results: Since 2016, the number of studies supporting approval has steadily declined. Beginning in 2017, the modal number of studies per approval fell to one. Industry sponsorship increased while NIH-supported studies decreased. Average time to public posting of results exceeded the one-year statutory limit. In the post-2016 period, FDA approvals were supported by fewer studies and by a greater proportion of industry-sponsored studies. Although this may accelerate access to new therapies, it raises concerns about the strength of evidence for safety and effectiveness.
Money for the studynot stated
Do the authors have ties to companies?no — the authors say so
Did a manufacturer help with the study?NO
Type of studyobservation of people
“Not stated” does not mean nobody paid — the database does not always record it.
Perspectives and opinion materials
The content below presents the authors’ opinions, interpretations and hypotheses. It is not treated as equal to scientific studies and systematic reviews.
Orthomolecular Medicine News Service Opinion material
„During Fauci's tenure, NIAID funding and strategic emphasis heavily prioritized: Vaccine platform development Antiviral pharmaceuticals Pathogen-targeted countermeasures Large-scale federally funded prophylactic micronutrient trials were comparatively rare. Institutional marginalization does not require a written ban.”During Fauci's tenure, NIAID funding and strategic emphasis heavily prioritized: Vaccine platform development Antiviral pharmaceuticals Pathogen-targeted countermeasures Large-scale federally funded prophylactic micronutrient trials were comparatively rare. Institutional marginalization does not require a written ban.
Orthomolecular Medicine News Service Opinion material
„Funding This research received no external funding. Institutional Review Board Statement Not applicable.”Funding This research received no external funding. Institutional Review Board Statement Not applicable.
Orthomolecular Medicine News Service Opinion material
„[42] However, the clinical efficacy remains controversial since the gold standard for an investigational drug would be to conduct randomized controlled trials -- which is difficult without patent benefits for vitamin C. Apparently, with limited funding, one has to work much harder on vitamin C research.”[42] However, the clinical efficacy remains controversial since the gold standard for an investigational drug would be to conduct randomized controlled trials -- which is difficult without patent benefits for vitamin C. Apparently, with limited funding, one has to work much harder on vitamin C research.
Pisaczek does not judge who is right. It shows what was written and where to read it. Every sentence above has its source.