A model to unlock the money of wealthy people to get more disease cures through clinical trials

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There are over 100,000 people in the world worth more than £20 million($30 million). According to medical statistics, between three and five people in every 100,000 get neuroendocrine cancer every year. So, three to five supremely wealthy people will have neuroendocrine cancer.

For £1 million($1.5 million) , sell one or two of the rich but sick people a place in a relevant clinical trial.

The researchers agreed to rename the drug after anyone who donated the first £1 million.

Dominic Nutt, a communications specialist, had neuroendocrine cancer and helped organize an Indiegogo campaign. He had an a piece in the Telegraph that said that said “‘Would I take an untested cancer treatment myself? Hell, yes!’”

They ran an independent peer review to check the research. They’d bothered world experts in Canada and Oxford and Manchester and London. All had been happy to talk and agreed that Essand’s work was interesting, not quackery, and had potential.

The balance of the money came from an Arizona oilman called Vince Hamilton. He’d read the articles in the Financial Times over breakfast in a café in Geneva. He too had neuroendocrine cancer. The money needed was small in his terms – less than a tenth of his wealth. Just as the organizers had hoped, he understood the unwritten offer instantly [the funder would get the experimental drug]. He contacted Uppsala and offered Essand the balance in return for guaranteeing him access to the new drug as soon as it was ready. In fact, he went considerably further. Vince not only donated this vast sum of money to enable Uppsala to start a clinical trial, he immediately put his business expertise to work to find out how to lower the costs, and shortly afterwards set up a $20 million fund to promote research into further drugs to treat neuroendocrine cancer.

In June Essand took the virus back out of the freezer and started the process of setting up a trial, with the funders both promised access to the drug the second it was ready. Because of all the regulatory delays involved in starting human tests, this would be in one to two years’ time.

Why not extend the principle of selling trial places, to raise money for other Uppsalas and other diseases: not just neuroendocrine cancer, or just cancer, but any illness? There are over 12 million millionaires in the world – any one of these would want to buy a place on a trial if it might purchase relief or stave off death. Every one of them has people they love for whom they’d pay good money to get an extra chance. Why not set up a charitable or private body that would arrange these ‘sales’?

Finding candidate drugs and treatment

Select number of peer-reviewed research projects that have produced a compound or intervention that could treat a certain disease, but that have stopped research because of a lack of funds. Crucially, they have not stopped because the science has been shown to be no good. Such projects will typically deal with rare diseases (and 54 per cent of cancer deaths are from less common cancers) or with diseases that progress so slowly that it can take up to a decade to reach their end point (such as the death of the patient), making the trials expensive. Other reasons why such research might not be able to secure traditional funding is that the science is novel, and the large, established funders are generally conservative and want to stick with what they know, or the research team has been worn out by bureaucratic fighting, and wants to do a different project that’s easier to promote.

Get the drugs funded

Place the selected projects into a ‘market’, which is open to the crowd: people offer specified sums to get a given project up and running, in return for specified benefits – the most expensive of which is a place on the clinical trial. Other benefits might include (if possible): naming the new drug or procedure, as at Uppsala; naming the entire project.

An early-phase clinical trial might involve 15 or 20 people; so, to set up a personal trial, the wealthy donor also has to pay for 14 to 19 poorer patients. There is no way round that. The donor is shackled to beneficence. Savulescu believes this necessary generosity is vital to funding medical care in the future. People don’t understand that there’s an extraordinarily limited health budget.

Solution that handles lawsuit issues

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 honorable.”

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.

Instead of paying to set up a trial that the rich person can join, he is paying to set up the trial, which provides the rich person with the material so he can set up, in effect, his own separate trial, just for him. What’s more, the main trial, which he is funding, doesn’t even have to be specifically for research into the rich person’s disease – it just has to be for a medication that his consultant believes could also benefit his disease.

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.”

SOURCES: Mosaic science, UK Telegraph,

A model to unlock the money of wealthy people to get more disease cures through clinical trials

by

There are over 100,000 people in the world worth more than £20 million($30 million). According to medical statistics, between three and five people in every 100,000 get neuroendocrine cancer every year. So, three to five supremely wealthy people will have neuroendocrine cancer.

For £1 million($1.5 million) , sell one or two of the rich but sick people a place in a relevant clinical trial.

The researchers agreed to rename the drug after anyone who donated the first £1 million.

Dominic Nutt, a communications specialist, had neuroendocrine cancer and helped organize an Indiegogo campaign. He had an a piece in the Telegraph that said that said “‘Would I take an untested cancer treatment myself? Hell, yes!’”

They ran an independent peer review to check the research. They’d bothered world experts in Canada and Oxford and Manchester and London. All had been happy to talk and agreed that Essand’s work was interesting, not quackery, and had potential.

The balance of the money came from an Arizona oilman called Vince Hamilton. He’d read the articles in the Financial Times over breakfast in a café in Geneva. He too had neuroendocrine cancer. The money needed was small in his terms – less than a tenth of his wealth. Just as the organizers had hoped, he understood the unwritten offer instantly [the funder would get the experimental drug]. He contacted Uppsala and offered Essand the balance in return for guaranteeing him access to the new drug as soon as it was ready. In fact, he went considerably further. Vince not only donated this vast sum of money to enable Uppsala to start a clinical trial, he immediately put his business expertise to work to find out how to lower the costs, and shortly afterwards set up a $20 million fund to promote research into further drugs to treat neuroendocrine cancer.

In June Essand took the virus back out of the freezer and started the process of setting up a trial, with the funders both promised access to the drug the second it was ready. Because of all the regulatory delays involved in starting human tests, this would be in one to two years’ time.

Why not extend the principle of selling trial places, to raise money for other Uppsalas and other diseases: not just neuroendocrine cancer, or just cancer, but any illness? There are over 12 million millionaires in the world – any one of these would want to buy a place on a trial if it might purchase relief or stave off death. Every one of them has people they love for whom they’d pay good money to get an extra chance. Why not set up a charitable or private body that would arrange these ‘sales’?

Finding candidate drugs and treatment

Select number of peer-reviewed research projects that have produced a compound or intervention that could treat a certain disease, but that have stopped research because of a lack of funds. Crucially, they have not stopped because the science has been shown to be no good. Such projects will typically deal with rare diseases (and 54 per cent of cancer deaths are from less common cancers) or with diseases that progress so slowly that it can take up to a decade to reach their end point (such as the death of the patient), making the trials expensive. Other reasons why such research might not be able to secure traditional funding is that the science is novel, and the large, established funders are generally conservative and want to stick with what they know, or the research team has been worn out by bureaucratic fighting, and wants to do a different project that’s easier to promote.

Get the drugs funded

Place the selected projects into a ‘market’, which is open to the crowd: people offer specified sums to get a given project up and running, in return for specified benefits – the most expensive of which is a place on the clinical trial. Other benefits might include (if possible): naming the new drug or procedure, as at Uppsala; naming the entire project.

An early-phase clinical trial might involve 15 or 20 people; so, to set up a personal trial, the wealthy donor also has to pay for 14 to 19 poorer patients. There is no way round that. The donor is shackled to beneficence. Savulescu believes this necessary generosity is vital to funding medical care in the future. People don’t understand that there’s an extraordinarily limited health budget.

Solution that handles lawsuit issues

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 honorable.”

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.

Instead of paying to set up a trial that the rich person can join, he is paying to set up the trial, which provides the rich person with the material so he can set up, in effect, his own separate trial, just for him. What’s more, the main trial, which he is funding, doesn’t even have to be specifically for research into the rich person’s disease – it just has to be for a medication that his consultant believes could also benefit his disease.

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.”

SOURCES: Mosaic science, UK Telegraph,