© Jean Jullien at Handsome Frank

Lanciano’s solution to the problem is best illustrated by an example.

Let’s say a wealthy individual is diagnosed with a mid-gut neuroendocrine tumour. He gives £2 million to the Dating Agency, which then hands it across to a biotech company that has a promising new but underfunded drug for this type of cancer. The £2 million is used to produce 100 doses of the potential medication. As soon as the drug is manufactured to the correct standard for human testing, the biotech company gives ten of the doses back to the Dating Agency and uses the remainder to run its trials, conduct further tests, etc. One of these ten donated doses is guaranteed to be given to the donor, which leaves nine doses for the Dating Agency to distribute to poorer patients. In total, therefore, the donor is now paying for all the people on the trial to have the drug, plus a further nine people who can’t join the trial for whatever reason but are suitable for a compassionate usage exemption.

The next part is the critical one, and is composed of several elements:

1. The donor’s consultant now sets up what in the USA is called a ‘Physician IND’ (a ‘physician-initated investigational new drug’ to give it its full name). In effect, this gives the consultant regulatory approval to run a bespoke trial for the donor using the company’s drug. The advantage of this, from the company’s point of view, is that it removes their liability if the wealthy individual dies. In the phraseology of medical litigation, a Physician IND “transfers ownership of the data” from the company to the physician. It takes about three to six weeks to arrange.

2. The nine other, poorer patients who can now be treated must also get their consultant’s approval to use the new drug. In each case, their consultant must set up a bespoke IND. There is no legal requirement for these extra doses – it is entirely a matter of PR. As a Guardian journalist I spoke to recently said, “If you didn’t have them, I could write the editorial against your modified proposal this instant. One rich person getting a medical exemption for a new drug, but no one else can afford it? It looks rotten. These extra nine doses keep the thing looking honourable.”

3. All of the people being treated with the new drug under this scheme agree to supply their data (i.e. the details of their illness, what happens to them while taking the drug, etc.) to the Dating Agency.

It took me two cups of coffee and a £12 croissant to get Lanciano’s scheme straight. “So, the donor hands over his money in return for a promise that he will get his dose of the drug as soon as it’s made…”

“Exactly. Which means he can fund any new trial into any drug that his physician agrees might be suitable for his condition. If he has mid-gut carcinoid, the trial he funds could be into small cell lung cancer – it doesn’t even have to be a trial for his specific disease. But since small cell lung cancer and mid-gut carcinoids are both neuroendocrine tumours, and the preclinical and clinical studies that we’ve already done show that our compound might help in both cases, the wealthy individual’s physician can reasonably apply for the right to use our virus.”

I took another bite of the gold-plated croissant, and lapsed again into the role of the wealthy individual. “So, instead of me paying you to set up a trial that I can join, I’m paying you to set up the trial, and then to provide me with the material so I can set up, in effect, my own separate trial, just for me. What’s more, the main trial, which I’m funding you to run, doesn’t even have to be specifically for research into my disease – it just has to be for a medication that my consultant believes could also benefit my disease.”

“This is an industry-wide problem. Of course, the scheme shouldn’t be limited to one donor or one supplier. Let’s say five wealthy people with mid-gut neuroendocrine cancer put their money into the Dating Agency, and in return they each get access to trial drugs. The money in the Dating Agency is then handed out to, say, four or five different companies all wanting to run trials into different new treatments for this disease. You want to promote as much new research as possible. Pounds go to the companies and doses come the other way, to the patients. Let’s say the companies agree to hand over 5 per cent of the doses, so if they make 1,000 doses the Dating Agency gets 50 – they’ll be for a range of different potential new treatments. The most appropriate one can now be selected for each patient. Five donors only need to consume five doses, so you have 45 doses left over for other people.”

Meanwhile, these drug companies will be getting the usual calls from all over the world asking for access to drugs for compassionate usage, just as Lanciano’s company had Nancy Pelosi and the father of the four-year-old on the phone. But now the companies can reply, “Oh yes, perhaps something can be done. Contact the Dating Agency, because they have 45 doses to distribute. If your case is suitable, they will give you one and all you have to do is set up a Physician IND with your doctor.” That doctor will then assume legal responsibility and ensure that a sick child isn’t given 100,000 times the recommended adult dose.

Lanciano admitted, however, that one can never rule out the possibility of a lawsuit being filed against the doctor and the doctor’s institution, but insisted his proposal will make such litigation unlikely. Everyone will have signed waivers; the protocol will have been developed and reviewed by a set of respected specialists, including ethicists and the regulatory authority; and the patient, who’ll be about to die anyway, will have directed the physician to take the risk.

The advantage of the Dating Agency gathering up several donors to finance a variety of companies, producing a variety of drugs, is not simply that it encourages more research and makes more potential medications available to all the donors. It’s frequently the case that while one treatment will help one person, it will, for some unknown reason, be no good for somebody else who apparently has exactly the same complaint. That was the case with Dido. Nothing worked after chemotherapy put the tumours into a brief retreat, even though the other interventions were specifically designed to combat her illness.

Model 3. In this example case, five donors with various types of neuroendocrine cancer give £2 million each to the Dating Agency. The Dating Agency then passes on £10 million in grants to a variety of companies that have drugs for neuroendocrine cancer close to trial stage. In return the Dating Agency receives a certain percentage of the various drugs manufactured, say a total of 50 doses. Five doses are then handed back to the donors to be taken as part of their Physician INDs (or whatever the equivalent is in their countries). This leaves 45 doses to be distributed to 45 other patients, for their Physician INDs. In other words, five donors are offering potential benefits to all the participants on five trials (around 100 people) plus a further 45 patients on special exemptions: a total of around 145 people who would otherwise not have a chance in the world of accessing these potential medications. CC-BY: Bret Syfert

Lanciano is a corporate man, and a drug entrepreneur and plutocrat himself. He is involved in several venture capital programmes. But he also knows what it means to have cancer. His wife died of it. His sister, mother and father-in-law too. “I have a certain type of cancer myself,” he revealed, almost as an aside, during another of his illustrations about how his version of the Dating Agency would work, “and I know where I am, and I’m letting the industry develop and just kind of waiting to see what happens to my disease. But if all of a sudden I realise I’ve only got 18 months, maybe I’ll take some of my millions and plop it down in the Dating Agency and say, ‘I’m going to do that and that’, and get the drug real fast. If the mechanisms are in place it can happen pretty quick.”

“And there are no such mechanisms in place at the moment?”

“No. Nothing. Nothing even close. What would be really brilliant is to have this agency also include an outreach capacity. There are so many millionaires and billionaires in the world. You’re going to have a wealthy Saudi king, you’re going to have an Indian maharajah and Silicon Valley billionaires and millionaires – all of them wanting to have access to this. They have brothers and mothers and sisters and, you know, they don’t want them to die,” he said. And then he repeated it, with genuine compassion and perhaps some fear: “They don’t want them to die.”