Dirty secrets of medical research

 

Medical science, which has always been respected, has now been placed on a higher pedestal due to the Covid-19 pandemic.

Everyone is now aware of the crucial role played by researchers, doctors and health workers, including the person keeping the hospital floor clean and sanitised. And they have rightly been applauded.

All of us, especially the health authorities, look to medical science for protection against the SARS-CoV-2 virus and its variants, just as we do for other diseases.

In the effort to control the spread of Covid-19, Malaysian health authorities insist that their decisions are based on “science and data” or “science and facts”.

Despite public complaints about side effects and “adverse events” following vaccination, health authorities say the number is very small. Complaints about people dying after a vaccination jab have elicited the familiar response that there is “no causal link” between the death and the jab.

Health minister Khairy Jamaluddin and health officials insist no one has died due to the vaccine, although family members of the dead say otherwise.

Those suffering “adverse events” become mere numbers to be added to the health ministry’s statistics.

But where does this “science and data” come from? It comes from research done by medical scientists in laboratories and elsewhere, whether in the public or private sector.

If the research is flawed, the treatment will also be flawed. Funding for research usually comes from the government but many major pharmaceutical firms also fund research and clinical trials. In the US today, industry funds most medical research.

How credible are medical research findings, especially those in which big pharma is involved?

Writing in the Journal of Law Medicine and Ethics in 2013, Donald W Light, Joel Lexchin and Jonathan J Darrow say: “Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits.

“The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created,” they say in their paper “Institutional corruption of pharmaceuticals and the myth of safe and effective drugs”.

Writing about funding for scientific research in the journal Frontiers in Research Metrics and Analysis in 2021, Sergio Sismondo of Queen’s University, Canada, says most pharmaceutical company sponsored clinical trials “are designed, organised, audited, analysed, and written up by the companies and their hired subcontractors”.

Makes you wonder if this is also the case with the Covid-19 vaccines which have been pushed onto people by big pharma and desperate governments wanting to protect their people.

All this work, Sismondo says, happens behind the scenes, obscured by the form of academic publication.

He claims the pharmaceutical industry suffers from “epistemic corruption” which he defines as a knowledge system that loses integrity and ceases to provide the trusted knowledge expected of it.

“There is now abundant evidence that the involvement of pharmaceutical companies corrupts medical science.”

He adds: “It is not just that there is a body of medical science perverted by industry largesse. Instead, much of the corruption of medical science via the pharmaceutical industry happens through grafting activities: Pharmaceutical companies do their own research and smoothly integrate it with medical science, taking advantage of the legitimacy of the latter.”

He cites studies which show that, “Put simply, if a pharmaceutical company funds a trial, the chances of results and conclusions in that company’s favour are increased.”

Sismondo says roughly 70-75% of the pharmaceutical industry’s expenditure on clinical trials go to contract research organisations (CROs), rather than to independent researchers in the form of grants.

“Even when it appears that industry-sponsored trials are led by academic or other actors, and that their subjects are recruited via independent clinics, hospitals and academic medical centres, it is most likely that at a higher level they are run by CROs working for pharmaceutical companies, and analysed by company statisticians and others.

“Manuscripts are most likely drafted by ghostwriters on structures created by publication planners, and then shepherded through to publication by those planners, with limited opportunities for their academic and other independent authors to contribute. The published articles, then, are largely creations of the companies, even if the nominal authors include independent researchers. All of this constitutes the ‘ghost-management’ of medical research.”

Could this be the case with some of the research into Covid-19 and the efficacy of the vaccines?

How effective is clinical trial supervision by the authorities? According to an AP report in 2007, “Over a six-year period, the Food and Drug Administration inspected just one of every 100 trial sites, raising questions about the agency’s ability to ensure the safety of study participants”.

The observation was made by the US’ health and human services department inspector general Daniel Levinson. Hopefully, the situation would have improved.

We can only hope that Malaysian regulators are more careful and that they carry out proper on-site inspections when trials are done and not just depend on the reports submitted by those conducting the trials.

This pandemic has taught us the need for good medical scientists and I hope the government will allocate more money to send some of our scientists for further professional studies and to recruit additional doctors and researchers to do more of our own researches.

It is not surprising that the Georgetown University Medical Center, which studies the pharmaceutical industry, finds that industry-sponsored research is more likely to have outcomes favouring the sponsor, and more likely to conceal results that do not favour the sponsor.

“Principal investigators who have financial ties to the drug manufacturer outside of study funding are more likely to have study results that favour the manufacturer’s drug. Financial ties include being an adviser, consultant, speaker, or employee, receiving honoraria, gifts of travel or food, owning stock, or holding a patent related to the publication.”

If a study is not favourable, the trial results are “hidden by being published only in pooled-study publications rather than stand-alone publications”, says GUMC’s PharmedOut project fact sheet on “Industry Sponsored Research”.

That’s clever but duplicitous.

Pharmaceutical firms hire medical education and communication companies that identify authors for pre-prepared manuscripts, determine where to publish manuscripts, and publish articles with industry-friendly messages, the fact sheet adds.

“Industry-sponsored studies are more likely to have conclusions that do not accord with study results. For example, industry-sponsored studies are more likely than non-industry sponsored studies to conclude that a drug is safe, even in the presence of statistically significant harms.

“Important study limitations may not be mentioned in industry-funded research. A study of positive RCTs (randomised controlled trials) of antidepressants used to treat anxiety found that only 17% of limitations noted in US Food and Drug Administration reviews were mentioned in the subsequent publication of the trial.”

Another fact sheet from PharmedOut notes that pharmaceutical companies use ghostwriters and guest authors to market drugs, downplay the risks of certain treatments, and target competing treatments.

“The full extent of ghostwriting, guest authorship and ghost management is difficult to ascertain; but it is estimated to affect between 25% and 35% of articles. Studies have shown that ghostwritten and ghost-managed articles are widely cited, and documents disclosed in litigation reveal the reach and influence these articles have on medical practice.”

It notes that a study of 630 authors in six high-impact journals found that 21% of the articles had honorary authorship, ghost authorship, or both.

Big pharma also influences journals in other ways, especially via advertisement revenue; and publishing articles critical of industry may cause a backlash from big pharma.

Giving an example, the fact sheet says, the Annals of Internal Medicine published an article that criticised the scientific accuracy of drug advertisements. Soon after, the journal lost more than US1 million in advertising revenue.

But this is not to say that all research articles are tainted; they are not. There are still many reliable research reports because there are still many ethical scientists.

Our problem is in sorting out the good from the tainted.

So, as we have seen in this series, kickbacks and influence peddling can go all the way from research to delivery of the product to doctors and hospitals.

I find that scary, as we expect medicines to heal us and we trust researchers and manufacturers to be honest.

We also trust those responsible for checking the quality, potency and manufacturing process of medicines to be honest. And we certainly expect ministers, health officials and medical practitioners to be honest because, ultimately, health is wealth. - FMT

The views expressed are those of the writer and do not necessarily reflect those of MMKtT.