Hyping up a vaccine

Despite the intense hype throughout May, a Covid-19 vaccine is no silver bullet. Nor is it close at hand. At the very best, vaccines can play a part in integrated public health strategies to trace, contain and halt the spread of infectious diseases. However, in Britain, the US and most of the rest of the world the search for a vaccine has taken centre-stage to the exclusion of all other considerations.

What progress has been made? Can we be excited by the idea of, at some point, a medical solution? Is the hunt for a vaccine key to ending the pandemic? What is driving this focus of resources on producing a drugbased solution?

Hundreds of potential vaccines are at different stages of development. According to the World Health Organisation (WHO), four of the eight candidate vaccines in clinical evaluation come from China. Another pair are from the US, while the others are collaborations between Germany’s BioNTech, China’s Fosun Pharma and Pfizer of the US, and another between the University of Oxford and AstraZeneca. By mid-day, three seemed to leading the way, one American, one Chinese and one British.

In May, US biotech firm Moderna revealed the first data from a human trial. Its vaccine triggered an immune response in people, as well as protecting mice from lung infections with Covid-19. The results were widely interpreted as positive and sent stock prices surging. But because the data has not yet been published, the details needed to properly evaluate claims are missing.

Tests of other fast-tracked vaccines show that they have prevented infections in the lungs of monkeys with the virus — but not in other parts of the body. The vaccine being developed at Oxford, also now in human trials, protected six monkeys from pneumonia, but the animals’ noses harboured as much virus as did those of unvaccinated monkeys.

A Chinese group reported similar caveats about its early animal tests. Despite uncertainties, all three teams are pressing ahead with clinical trials. In every case, the tests are what are known as Phase 1 clinical trials only, designed simply to test the safety of a drug or vaccine in a small number of healthy volunteers. Phase II trials, the stage the leading pack is now at, test for effectiveness in a larger number of subjects.

The hyped-up responses to the Phase I trials are unheard of, and there is at least a touch of the snake oil huckster about them. This is especially the case since so little information has been provided during these trials, with any drug progressing from them having many more hurdles to overcome before being marketed.

This is particularly the case given that 77 percent of vaccines for infectious diseases make it through Phase I, but only 33 percent progress through the entire process. Looking at Moderna’s press release it is clear that the data it provided is extremely flimsy.

The pharmaceutical giant shows positive results for only eight out of 45 patients, far too few to be statistically significant. There is no data on what happened with the remaining 37 patients. Such omissions are not uncommon in clinical research.

As Ben Goldacre shows in his monumental study of the pharmaceutical industry Big Pharma, negative results rarely make it to the pages of scientific journals because drugs companies have an active interest in suppressing information that may jeopardise sales of their commodities.

Where access to data is possible regarding the Oxford and China-based vaccines, similar limitations to the findings are apparent. Grandiose claims are premised on the slightest progress. This has not, however, stopped vast sums are being thrown at these projects.

It is clear that every project is largely proceeding independently. For each, the concern is to be the first country to develop a vaccine. Reasons for this include the potential for vaccines to enable economies to get back on track within the relentless global competition between national capitals. A successful vaccine would corner the market for a nation’s pharmaceutical industries, as well as boost its political bragging rights.

The situation was well summed up by a spokesperson from Loncar, the giant ‘China Biopharma’ investment company now channeling western investments towards Chinese-based pharmaceuticals. “Let’s suppose China succeeds four months before the US,” it says. “The implication of that is it helps them get their economy fully more open than the US and other areas. Also, think of it in the context of the US [presidential] election in November. Imagine the headline, ‘Chinese People are Getting Vaccinated,’ and we don’t have it yet.”

This global, cut-throat competition means that as bosses seek to corner profitable vaccine markets, and governments move to assert their political superiority, scientists are prevented from sharing data, holding back the role a vaccine could play in any global recovery strategy.

This narrow approach is echoed by Britain’s health secretary, Matt Hancock: “The upside of being the first country in the world to develop a successful vaccine is so huge that I am throwing everything at it.”

Based on the merest suggestion of progress, the UK government has invested, first, £42 million in general financial support, then a further £32 million in developing warehousing and production facilities. At the time of writing, another £65 million has gone to Oxford University. And this at a time when there are still shortages of PPE, no meaningful testing approach and a track and trace strategy that is barely off the ground.

There are serious fears regarding the practicalities of producing and distributing any vaccine should one arise, as shown by the debacle over producing enough drugs to address the ongoing Ebola crisis in West Africa, ongoing since 2014. Even basic arrangements for mass manufacture of drugs are nigh on impossible when left to individual private companies.

As Professor David Salisbury, associate fellow, global health programme, at thinktank Chatham House, and a former chair of the WHO committee on global immunisation, said in May: “There is no global authority that has the money and the influence to direct what the private sector — the pharmaceutical industry — will do.”

Meanwhile, the Global Health Council, a non-profit making health think tank, points out that, in the context of potentially scarce vaccine resources, treatments will go to the rich. This is something already shown in the distribution of scarce testing kits and PPE. In such ways, for-profit health care undermines the development and equitable global distribution of any potential vaccine.

So far during the course of vaccine research, attempts have been made to reinforce countries’ rights to break, if necessary, patent monopolies held by drug and vaccine companies for the sake of public health.

A hard-fought battle over Aids drugs 20 years ago led to the World Trade Organisation Doha declaration on trade-related intellectual property in favour of access to medicines for all in the name of the good of global health. However, drug companies, backed by their home governments, have strongly opposed this.

The pharmaceutical industry has been changing during the course of the this century. It is one of the most profitable industries in the world, with leading names such as Johnson and Johnson, Pfizer, Merck, Roche, GlaxoSmithKline, AstraZeneca among the richest — and most powerful — corporations globally. They exert enormous pressure on their own and overseas governments.

Mergers and acquisitions

The traditional view of the pharmaceuticals industry is of highly innovative companies, fully engaged in the research and development of new treatments. This is no longer the case, with far more attention paid to mergers and acquisitions. In fact, as US historian and political activist Mike Davis points out, the industry has effectively abandoned research on new antibiotics and antivirals.

Of the 18 largest companies, 15 have totally left the field. Heart medicines, addictive tranquilizers and treatments for male impotence have become the profit leaders and the focus of an ever-swelling advertising strategy. Defences against hospital infections, emergent diseases and traditional tropical killers are not considered profitable enough.

Thousands of smaller drug companies have been gobbled up as drug production has become ‘financialised’. This serves numerous purposes as the example of US company Valeant shows.

Valeant has developed a three-pronged strategy to drive its profit growth- acquisition, price gouging and tax avoidance. Typically, Valeant acquires a competitor producing a similar drug to its own. Once bought, ‘synergy’ kicks in, with staff cuts, reductions in money spent on research and other savings. Once it has monopolised the drug, it increases prices. For example, after acquiring the drug Glumetza, used in diabetes, its price increased from just over $500 to $4,400 per month.

Finally, in an example of legal but unethical practice, Valeant executed an ‘inversion’ takeover with a Canadian firm, placing the taxable centre of the company in a relatively cheaper tax area.

This is a similar approach to the one adopted by AstraZeneca, a British firm. It has closed down its research and development facilities while taking over 16 other companies over the past 20 years. In place of its own research, the company has outsourced this work to universities.

Oxford has grasped the potential of this with now 21 departments, faculties and research centres involved in health research. Meanwhile the university’s own Department of Public Health closed in 2013.

And who is actually carrying out the research from which drug companies make their billions? It will be rare for students below PhD level to become involved, but where they are, students are paying hefty fees in order to help develop potentially highly lucrative commodities that boost for companies’ profits.

The core obscenity, however, to this research relationship is that at Oxford around 80 percent of lecturers are on shortterm contracts. Throughout the university sector, pay and conditions have deteriorated in real terms over the past 20 years.

The drug companies have an entirely parasitic dependence on a group of workers in insecure employment, many of whose future prospects depends on them bringing in the funds for research, all to the benefit of drug companies. It is a relationship made in heaven for AstraZeneca and the like.

Universities morph from places of academic study into profit generators for capital. The Academic Drug Discovery Consortium (ADDC) established in 2012, facilitates this. The ADDC is an international body whose sole purpose is to partner up universities with the pharmaceutical industry, a kind of corporate dating agency. It is very lucrative for the corporates and the upper echelons of universities. For example, the discovery of the multibillion-dollar lung cancer drug, Alimta, came from a lab in Princeton in collaboration with giant drug company Lilly. Princeton bosses got $524 million in royalties between 2005-12, all from Alimta sales.

This encapsulates the priorities of a rotten system and is a warning against those making false promises. Don’t believe the hype.