Editor claims drug companies have a “parasitic” relationship with journals
BMJ 2004; 330 doi: https://doi.org/10.1136/bmj.330.7481.9 (Published 30 December 2004) Cite this as: BMJ 2004;330:9All rapid responses
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Though this may not be the right forum to discuss Richard Horton's testimony to the Committee, I cannot resist:
first: I entirely agree with the notion that it is much easier to publish in some of the major journals (transatlantic, maybe) if the paper is supported by a major pharmaceutical company (transatlantic), especially if the results are seen as positive. If the study disculps a vaccine of risk, then there is a combined pressure of industry and public health (WHO), which tends to facilitate publication. On the other hand it is very difficult to publish papers that raise questions as to the safety of vaccines (eg, hepatitis B and central demyelinating diseases).
Second: I completely disagree with Richard Horton's opinion of the yellow card system. His comments are typical of a common misunderstanding of the objectives of the system. It is not an epidemiological system. It is an alert system. Its sole objective is to detect new adverse drug reactions. It is in no way designed to quantify common reactions. There are other methods for that. Proper epidemiology is based on previous hypotheses, as has been stressed again recently. Spontaneous reporting generates the hypotheses that can be tested with epidemiological methods or clinical trials. Yellow card have proven again and again that they find new adverse reactions, and that nothing can replace them.
third: regular revisions, and proper pharmacoepidemiological studies post- marketing are also indispensible, at the very least to see how drugs are actually used, and whether benefits suggested by premarketing clinical trials can be expected in real-life situations. For instance the way NSAIDs were used in the Vigor and Class trials demonstrating (more or less) the benefits of Cox2 inhibitors represent at most 10% of all NSAIDs users. In all other cases, shorter-term and lower-dose use results in lower GI risk, so that the real benefits of COX2 selective inhibitors have never really been confirmed in real life, despite all the money spent on them.
fourth: Premarketing evaluation of drugs is probably about as good as it'll get, unless so much time and money is put into new drugs that research will effectively cease. What is needed is faster access to market at a lower cost to promote research into new molecules, and better post-marketing surveillance, to remove useless or unnecessarily dangerous drugs once this has been demonstrated.
Again, complex issues, no simple answers.
thanks for reading this. I hope reason will prevail, eventually, and some balance.
Nicholas Moore
Competing interests: who doesn't have competing interests? I've been working in the field for years, and am strangely fond of it
Competing interests: No competing interests
Operating within this cultural background vaccine products must be more inherently unsafe than any other pharmaceutical products, since anyone who criticises them is an "enemy" or "pariah". Public vaccination programmes could only ever become safe if it was possible to discuss them openly and without moral opprobrium being heaped on those who express concerns, and without professionals being subject to victimisation and humiliation. The present situation is indeed - even in the abstract - insanely dangerous.
It is indicative of the present "reality" that it is highly improbable that these thoughts will be transferred to the hard edition of BMJ where they could be considered by a much wider readership.
Competing interests: Parent of an autistic child
Competing interests: No competing interests
Is it not the simple reality that if you report, monitor or investigate adverse reactions to vaccination you become 'A PUBLIC ENEMY'?
Competing interests: Parent of an autistic child
Competing interests: No competing interests
"He (Richard Horton) also hit out at the way drugs were regulated in Britain and decried as "nonsense" the yellow card scheme system for reporting adverse reactions.
"This is the worst possible way of doing epidemiology," he said. Instead what was needed was a five year periodic review of each drug at every stage on the market. "It would clear out the dross," he said."
But not apparently MMR. In the case of MMR it is apparently a good idea to not report, investigate or monitor adverse reactions and to persecute those who do.
And it is also apparently alright to publish opaque, unverifiable epidemiology supporting its safety - see Stone: 'A letter the Lancet failed to publish' 22 December 2004 [1].
Is not the truth that when it comes to enforcing government vaccine programmes morality goes topsy-turvy?
[1] http;/bmj.bmjjournals.com/cgi/eletters/329/7467/64#90113
Competing interests: Parent of an autistic child
Competing interests: No competing interests
Here is a welcome example of transparency in action. The editor of the Lancet has shown fortitude in the face of real threats to the journal's integrity.
I do think that it is fair for journals to publish research papers commissioned and/or funded by drug companies, as long as the authors declare it in their 'conflict of interest' statement. I think that such declarations should also include author affliations to agencies (for example international humanitarian organizations) whose vested interests are served by journal publications, even when drug companies are not directly implicated.
Competing interests: None declared
Competing interests: No competing interests
Loss of integrity
The scientific process depends upon trust: we assume that authors are honest. We also assume that any outside influence, such as the involvement of pharmaceutical companies, or more importantly their money, will be openly acknowledged. In medicine, the influence of drug companies on authors may be in terms of direct funding. Another form of influence involves setting the perceived climate of what is acceptable in terms of career advancement. If referred papers are essential for promotion and the pharmaceutical industry controls the journals, then they have the medical profession in their pockets. The existence of ghostwriters and marketing companies, who subcontract their publications to apparently respectable experts, is particularly worrying. Ghostwriting should have no place in journals purporting to report primary scientific results. Unfortunately, it appears to be a lucrative and growing activity.
The peer review process is certainly not perfect and has many inherent problems. Experts in the field are often not completely open to new ideas and novelty can be suppressed. The purpose of peer review is presumably to ensure that there are no glaring errors in the experimental methods or analysis. However, referees sometimes go far beyond this remit and reject papers because they do not fit the current model, or replicate previous research and are thus assumed to contribute nothing new. This is a mistake, because replication is at the centre of the scientific method. Replication of experiments is essential, whereas peer review is merely a quality check on the published paper.
The experience of publishing in a peer-reviewed journal is not always helpful to the final product. The referees’ comments can occasionally seem trivial, or even inane. Despite this, we amend the text, resubmit and the paper is eventually seen in print. Scientists use this process to filter out their own errors before publication and to get a stamp of approval from the journal.
Publication in refereed journals has long been the standard for scientific excellence, but for medicine this gold seal is becoming tarnished. Those editing the journals admit that pharmaceutical and related companies exert both indirect and direct pressure, even on prestigious journals. Ghostwritten drug studies, little more than marketing propaganda, are published. Another way the industry can protect its market is by promoting biased studies of antioxidants, such as vitamin C and E, and other forms of preventative medicine that could compete with drug sales,
Pharmaceutical companies apparently believe that scientific papers are simply a branch of marketing. If a study in a prestigious journal will guarantee five years of extra sales, they can allocate millions of pounds to recruit and control the experiment. Researchers who claim not to be influenced by such apparent generosity are deluding themselves. This escalation of deceit in the medical journals threatens scientific progress. Let us not forget that the pharmaceutical companies make their profits from the sick.
It is becoming hard to differentiate real science from marketing, good studies from bad. Many people no longer trust medical science. If the medical endeavour is seen as unreliable, then everyone will suffer. Even the pharmaceutical companies are vulnerable to such a loss of faith: unless they clean up their act, they may find they have killed the goose that laid the golden egg.
Competing interests: None declared
Competing interests: No competing interests