Christmas is just around the corner, and it seems that once again some companies cannot resist the temptation to invent new diseases from scratch — as if the ones we already have were not enough. This is “disease mongering”.
"Disease mongering" is the "commodification of diseases". It represents the most extreme expression of pharmaceutical marketing, and consists of the systematic promotion of a drug — including through the massive funding of scientific conferences aimed at encouraging its use — combined with the surreptitious modification of the diagnostic "boundaries" of the condition the drug is supposed to treat. In simple terms, to put it plainly: if a pharmaceutical company managed to gain the agreement of part of the scientific community that hypertension could be diagnosed at 135/85 instead of 140/90 as is standard practice today, the very next day millions upon millions of new patients would be prescribed antihypertensive drugs, with a sharp increase in profits for the manufacturers.
The misuse of unnecessary drugs can cause adverse and iatrogenic effects that are dangerous to health, but no law capable of having a serious international impact has ever been passed, and so in practice there are no sanctions: it continues to happen, across many conditions, as demonstrated by the illuminating documentary produced by Rai 3 "Inventori di Malattie".
When it is promoted at the expense of the most vulnerable among us — children and adolescents — this profit-driven behaviour is particularly reprehensible. ADHD is a typical case of disease mongering: a disputed syndrome of hyperactivity and attention deficit in childhood, "treated" with psychotropic drugs, useful for "fixing the attention" of children who are too agitated and distracted. These are amphetamine derivatives, administered every day to millions of children worldwide, Italy included, amid general indifference. They do not resolve the behavioural problem — when their administration is stopped, every single symptom present before the treatment returns — but they resolve very effectively the need of Novartis, Eli Lilly and other big pharma giants to distribute generous dividends at the end of the year.
To frame the problem more clearly, it is worth recalling how another pharmaceutical multinational, Glaxo, was investigated when it emerged that the company had not published two scientific studies demonstrating that Paxil, their paroxetine-based psychotropic drug for depression, "could induce suicidal behaviour in children and adolescents", on the grounds that publishing the negative results "would have damaged the drug's commercial profile". The fine the company subsequently paid was, however, infinitely smaller than the total sales revenue, with little regard for any harm that molecule may have caused.
Still on the subject of antidepressants, when — thanks to the Freedom of Information Act — Professor Irving Kirsch was able to gain access to all the research data, getting his hands on the confidential reports of the companies that produce these psychoactive molecules, he discovered that they are no more effective than a sugar pill. Kirsch compelled the US Department of Health to bring out of the drawer what would otherwise never have entered the public domain: 47 controlled clinical trials that confirmed that only 10–20% of patients experience a benefit genuinely attributable to the pharmacological action of the molecule, while 80–90% of depressed patients feel better, but solely thanks to the "placebo" effect. "Everyone knows this," Kirsch declared, "but they keep quiet out of self-interest".
At a conference organised by the independent pharmacovigilance committee "Giù le Mani dai Bambini"®, for which the author of this piece volunteers, Dr Bobbio gave an extremely accurate definition of "disease mongering": "The term was first used in 1992 by Lynn Payer when, in her article 'Disease mongers: how doctors, drug companies, and insurers are making you feel sick', she denounced how demand for services, treatments and products was being increased through the 'widening' of the diagnostic criteria for certain diseases. Payer identified, in particular, three mechanisms: turning common complaints into medical problems, making them appear dangerous, and proposing therapies whose benefits are exaggerated and whose risks are underestimated. 'In English,' continued Bobbio, 'to monger corresponds to a pejorative sense of the word to sell: a fishmonger sells fish, a warmonger sells war'".
Just to demonstrate that these practices involve a great many medicines in everyday, common use — and not only the more dangerous psychotropic drugs — a further example of disease mongering is again presented by Dr Bobbio, and concerns "the information-and-propaganda campaign to raise awareness among doctors of the need to treat constipation, in anticipation of the commercialisation of a drug, Tegaserod, which would have allowed 13% of patients to have one additional bowel movement per week. For three years in Italy the 'National Week for the Diagnosis and Treatment of Constipation' was organised, until the drug was withdrawn from the market due to the risk of cerebrovascular incidents. The following year, the 'Week' was no longer organised, demonstrating that the great 'scientific' interest in constipation was in reality driven by purely commercial interests.
As a journalist colleague denounced in a commentary article on this phenomenon, in the journal AboutPharma, "manipulation occurs through a well-orchestrated combination of scientific conferences, editorials, websites and popular magazines that insist in a uniform way on the same theme. Moreover, international opinion leaders, the so-called 'influentials', often have million-dollar contracts with manufacturers and, in practice, influence the entire scientific community, while sector journals survive thanks to advertising from pharmaceutical companies, and the mainstream mass media are simply chasing sensationalism, doing little more than copy-pasting press releases from pharmaceutical companies' press offices".
Manipulating information is — unfortunately, I would add — very easy, not least because the various Ministries of Health and health regulatory agencies such as our own AIFA — Agenzia Italiana del Farmaco stand by and look on, tolerating it: in Italy, as in many other Western countries, as far as I can recall, no information campaign against disease mongering has ever been launched. The reason — to come full circle — is explained by Professor Emilia Costa, a psychiatrist of considerable renown with an impressive scientific curriculum vitae: "Often, the majority of the experts on the technical-scientific committees of regulatory health institutions are also consultants to pharmaceutical companies. If we look at the FDA, which is the agency that 'sets the standard' to be followed even outside the United States, we see that it collects 500,000 dollars from manufacturers for every marketing authorisation for a new drug that it issues — it is obvious that it is incentivised to issue as many as possible. Would it not be better," Costa proposes, "to have a system that provided for a 'fund' still fed by the pharmaceutical companies, but not tied to the 'number' of authorisations issued"?
There are also other ways to influence scientific research, constantly employed by pharmaceutical multinationals: failing to correctly register a study at the notification stage on official databases, so as to be able to "adjust" the final results more easily relative to initial expectations, or alternatively excluding from the study, once under way, the "refractory" patients — that is, those who have not responded as expected — so as to distort the results in a direction more favourable to the drug.
To cite more recent events, on 9 September 2014 a financial analysts' blog published an enthusiastic review of a new psychotropic drug for children, Metadoxine, produced by the American pharmaceutical company Alcobra, capable of acting on the functioning of neurotransmitters by improving children's attention.
Here too, we are faced with yet another case of "recycling" a molecule whose patent has long since expired: it is in fact a drug that has been used for over thirty years to treat hangovers, and whose mechanism of action — it is candidly admitted — in relation to symptoms of childhood inattention remains unknown. It would raise a smile, were it not so dramatically true, that there is a claim to use this molecule to treat children on the basis of a single study, sponsored by the manufacturer itself, lasting a mere 7 weeks and involving just over a hundred patients — adults, at that — which demonstrated an efficacy in reducing inattention symptoms of approximately 70%, while in the same study the control group recorded improvement in 50% of cases using a simple sugar pill. Yet financial analysts couldn't stop singing its praises…
Meanwhile, another multinational pharmaceutical company that has recently become very "aggressive" in its marketing of psychiatric drugs for children, Shire, is testing an old antihypertensive drug that was never approved for sale due to its excessive side effects at a research facility in Pisa coordinated by Prof. Masi, who is by no means opposed to administering psychoactive molecules to children. Guanfacine — this is the name of the "stateless molecule" in search of a condition to "treat" — is intended to open up the childhood psychiatry business in Italy for Shire, a market that to date has been underexploited — Italy is the 5th largest pharmaceutical market in the world, yet psychiatric drugs for minors are still sold in relatively small quantities — to such an extent that, in violation of every professional and legal standard, the company had commissioned a well-known public relations agency to promote the condition — and therefore the drug intended to treat it — in our country, even before the drug itself had been approved, as evidenced by the engagement contracts found during an inspection by the Carabinieri NAS at the PR agency's premises. This, then, is what some children will find under the Christmas tree, if guanfacine is approved for sale against all reasonable caution: a new psychiatric drug that children themselves will be able to swallow in order to "be what the grown-ups want", to satisfy our adult desire for normality, and to swell the billion-euro balance sheets of the manufacturers still further.
All of this is reality, demonstrated — again thanks to science — by a number of courageous independent studies, increasingly rare, as well as by the work of investigative journalists of courage. A reality that daily shapes our lives and our health, lining the pockets of pharmaceutical companies and their shareholders — among whom, it should be said, are also the "inattentive" citizens who rarely check where their savings are being invested by their trusted bank.
It is tiresome to quote the dead, but the then Director General of Merck, Henry Gadsen, once declared: "Our dream is to make drugs for healthy people." This sentence is highly representative of the greed of certain individuals and certain companies, who — almost as though compelled to repeat themselves — cannot find their way out of the mental labyrinth that invariably leads them to profit at any cost.
Who knows whether one day they will invent a drug to cure themselves…? A profitable one, of course.