Sharing private medical data

http://www.bbc.co.uk/news/uk-16026827

Are we happy about this or not?

Interesting one!

"Not sure about this" is my initial reaction. Will have a read up on it and furnish you with my wisdom in due course ;-)

Just had a skim read through.....this bit caught my eye: "Under the plans, which were unveiled as part of the Autumn Statement, NHS records would be made anonymous and then made available to private firms."

I guess that leads the debate down the "is data, strictly speaking, 'private' once it's been made anonymous?".

As long as there are guarantees that this "private" data can't be reverse engineered back to an individual (fat chance?) then I've no problem with this initiative in principle if it leads to better results whilst maintaing the "free at the point of use" ethos.

In other words, I'm keeping a pragmatic open mind on this one for now.

I'm always happy, come what may.

I've got mixed feelings. Mr TF works in the pharma industry and I can see that his future would be more secure if there were more clinical trials. I've taken part in two clinical trials and I also 'belong' to the UK Biobank. As far as I know, my data is anonymised and I'm happy to be a guinea pig if the trials hasten treatments.

But I'm concerned about my data going astray if it were given to a drugs company. At the very least I would hope, if security could be absolutely guaranteed, that the NHS gets paid for this information.

I wonder how much influence the pharma lobby has with the government though and I do think the control for the research that the drugs companies do should be hospital / university research teams and not the companies themselves.

Well if it made a lot of consultants get their fingers out in organising treatment etc Im all for it.

Well if it made a lot of consultants get their fingers out in organising treatment etc Im all for it.

What a strange thing to say! Why do you say this?

I am strongly in favour of it. If you are a DM reader it might be a bit scary that in theory someone might possibly be able to access your info.

If you have a serious illness like MS Parkinsons, cancer, etc, etc it can only be good news to put researchers in a potential contact with peoplewho can possibly help with research and potentially try out drugs that have passed the initial saftey tests.

It will advance medical research in the UK which is very bogged down by a very slow approval system and N.I.C.E. and hopefully help uk patients and the uk industry and the ballance of patients.

I know we desperatly need drugs that help people with Primary Progressive Multiple Sclerosis, Maybe this will lead to some.

Is the data being sold or given away?

The pharma industry has tonnes of cash - and this data would save a company millions on market research... I bet we could persuade someone like ICI to cough up several hundred million for this each year if the government plays it right...

The pharma industry does indeed have loads of cash and I used to criticise the industry for, as an example, charging huge amounts for drugs especially for third world countries.

But it's been pointed out to me just how expensive research is. The equipment used in research and testing is very, very costly and a large number of drugs never get past the FSA (in the US) and the equivalent regulating body in the UK. So companies may have spent millions developing a new drug only for it to fail in the approval process.

Having said all that, it irritates me the way their PR departments manipulate people who are ill into pressurising NICE for approval for drugs that have little efficacy.

I am strongly in favour of it. If you are a DM reader it might be a bit scary that in theory someone might possibly be able to access your info.

If you have a serious illness like MS Parkinsons, cancer, etc, etc it can only be good news to put researchers in a potential contact with peoplewho can possibly help with research and potentially try out drugs that have passed the initial saftey tests.

 

It will advance medical research in the UK which is very bogged down by a very slow approval system and N.I.C.E. and hopefully help uk patients and the uk industry and the ballance of patients.

 

I know we desperatly need drugs that help people with Primary Progressive Multiple Sclerosis, Maybe this will lead to some.

Sounds to me like the lobbyists have been hard at work or a top Tory is receiving brown paper bags, thin end of the wedge and all that and i can see at some point in the future the data being made available to insurance companies in all it's glory. Don't the government have more important things to be getting on with?

I am strongly in favour of it. If you are a DM reader it might be a bit scary that in theory someone might possibly be able to access your info.

If you have a serious illness like MS Parkinsons, cancer, etc, etc it can only be good news to put researchers in a potential contact with peoplewho can possibly help with research and potentially try out drugs that have passed the initial saftey tests.

 

It will advance medical research in the UK which is very bogged down by a very slow approval system and N.I.C.E. and hopefully help uk patients and the uk industry and the ballance of patients.

 

I know we desperatly need drugs that help people with Primary Progressive Multiple Sclerosis, Maybe this will lead to some.

This.

I don't care if some geezer in a lab coat knows I have asthma, and besides all the data is anonymous anyway. If it helps the progression of medical sciences i'm all for it.

There's one thing I don't understand. One of the aims is to increase the number of clinical trials taking place. If this data is anonymous, how will the clinical trials teams know who to contact?

I participated in clinical trials because I'd seen a poster on the staff bulletin board at the hospital at which I worked and volunteered.

I'm also a bit worried that the plan is to speed up the time it takes to get from research to availability for treatment. Consultants and doctors are to be given the right to prescribe these drugs if they think they are pertinent, before they've necessarily cleared the licencing authorities.

Now I know as fact and not hearsay that medics are targetted by pharma companies (conferences at ski resorts anyone?). I hate to say it really, but it would cause me to doubt the reason for a doctor prescribing a new drug treatment.

The licensing authorities are there for a very good reason. Mr TF has to jump through hoops testing new drugs over and over again to prove both efficacy and purity before they're licensed.

I'd be more worried my data would go astray in the NHS than in pharma. Regulations are tight and there are data classification procedures in place to safe guard data. In fact only the clinical study sites have the distinct personal identifies and the pharma companies do not need them to analyse the data.

There's one thing I don't understand. One of the aims is to increase the number of clinical trials taking place. If this data is anonymous, how will the clinical trials teams know who to contact?

In simple terms Pharma replies on Key Opinion Leaders in each therapeutic field to help plan trials.

I participated in clinical trials because I'd seen a poster on the staff bulletin board at the hospital at which I worked and volunteered.

 

I'm also a bit worried that the plan is to speed up the time it takes to get from research to availability for treatment. Consultants and doctors are to be given the right to prescribe these drugs if they think they are pertinent, before they've necessarily cleared the licencing authorities.

that can only happen if the patient is enrolled in a clinical trial, even if it's an open access program so that there is control of it's use and data collected for reporting on safety.

Now I know as fact and not hearsay that medics are targetted by pharma companies (conferences at ski resorts anyone?). I hate to say it really, but it would cause me to doubt the reason for a doctor prescribing a new drug treatment.

There is ABPI code of conduct that governs what pharma can do. You should report it.

The licensing authorities are there for a very good reason. Mr TF has to jump through hoops testing new drugs over and over again to prove both efficacy and purity before they're licensed.

Somehow this thread reminded me of the following:-

Six men were in intensive care in a north London hospital last night after a pharmaceutical company's trial went wrong.

Regulatory authorities have suspended the drug trial and are investigating in collaboration with the police.

The six were healthy volunteers, paid to take part in the earliest stage of human testing of a potential new medicine for

inflammatory diseases such as rheumatoid arthritis and leukaemia. The volunteers were needed to establish whether there

were any side effects or obvious problems with the drug before it was tested on people who have the conditions.

http://www.guardian.co.uk/society/2006/mar/15/health.medicineandhealth2

Doesn't seem like it was nearly 6 years ago though, anyone know what finally happened to those brave men?

There seem to be a lot of myths around clinical research, patient data and the 'big bad' pharma industry - which seem to have been enhanced by poorly researched and ignorant media. I work as a consultant for a clinical research organization and have worked in this industry as an independent for over 15 years.

1. First up the issue at hand - Data and confidentiality. We are talking about totally anonymous data. No names etc - so there is no chance of this data leaking to insurance companies and your life premiums going up - total myth. ALL clinical study data is already anonymous and Pharma companies NEVER have access to patient personal data - it’s not actually something they are interested in as they are looking for efficacy and safety data in as large as possible numbers... so really not sure why anyone would worry about this.

2. Big bad Pharma taking to doctors to conferences - yes it is common that most international conferences have industry sponsored elements, be it exhibitions, meet the expert sessions or what are known as satellite symposia, in which a company will fund a 2 hour program to talk in many cases exclusively about the current data of various ongoing studies for investigative or approved products - if talking about unapproved products, these have to be independent and the program approved by CME bodies as 'educational' - yes some speakers will have their expenses covered for this - but in all cases such expenses are listed and documented so that those listening can make their own minds up about the independence of the speaker.

3. Yes certain internally recognized experts are consulted by pharma for advice and insight - this is managed by the company’s researchers or medical affairs groups, not marketing and these experts will provide independent advice on clinical trial protocols, adverse event management, etc - clinical things. The various national and international governing bodies such as the ABPI have strict codes of practice that govern this. In addition whenever an expert acts as an advisor to a company, this has to be FULLY DISCLOSED on all published proceedings, scientific papers, or published data form studies that were supported by a company.

4. Why the need for this data? Well for various reasons - the biggest is looking at outcomes data. This is the REAL WORLD data for how effective a treatment is outside of very strict protocols used in clinical studies. For a drug to come to market takes usually around 10-12 years of strictly regulated clinical studies - that takes 10-12 years out of a patent life on no more that 20-25 years and the costs vary but are typically between 500mil and 1bn USD. So a company has around 10 years to recoup the development cost and cover the huge costs associated with the compounds that fail during phase 1 and phase 2 of the clinical development process. In addition, many modern medicines such as novel cancer treatments (monoclonal antibodies, and targeted therapies) are expensive to manufacture so some treatments can cost between £10,000-£20,000 for a cycle... which sounds a lot, but when you consider that the percentage of drug spend by the NHS is around 10% of its budget, the biggest cost of treatment is the actual hospital care.

5. As a result of such expensive drugs, most governments have a system of health technology assessment (HTA) (NICE is England, SMC in Scotland) in which they assess a new drug based on its VALUE - does it meet strict criteria for demonstrating benefit over existing treatments - They use a system known as calculating a Quality Adjusted Life Year (QALY) and the compound has to be below a threshold for it to be considered for reimbursement.

This in principle means that the NHS will only pay for drugs that should a distinct benefit to patients. However, what it means in practice is that drugs that could work in certain patients or improve life expectancy by 3-4 months may not be covered by the NHS. In addition, the system can provide both false negatives and positives, in that the initial HTA is done on clinical study data, which can often be better or worse than how the drug will perform in the REAL WORLD setting.

So a better way is assessing a drug's benefit on an ongoing way by measuring real world outcomes. These systems already exist in some cases with pricing and reimbursements levels set on a sliding scale dependent on the benefit they have... but the systems are disjointed, admin heavy and can in some cases cost more to manage than the savings the NHS might make, but they do mean patients can get access to new and expensive treatments if their doctors think it is worth a try... it is a benefit to patients in the long run.

6. Drug companies being evil? Well they have made mistakes, some deliberate for which they always get found out and heavily fined, but on the whole the strict governance both internal and external means that a tight ship is the generally the order of the day.

7. Finally, in response to the ‘6 guys in London’ from 6 years ago… again need to dispel a few myths –

This was what was called a Phase 1 study – this is typically the first time a drug is tested in humans (Usually in health volunteers) – these studies are performed well in advance of any patient based clinical studies. They are designed usually to see if the drug is even active in humans and if so, safe - things like dose escalation studies and also the biochemistry is studies (Pharmacokinetic/dynamic) in effect to find out what would be the best, safe dose for patient.

Prior to Phase ones, extensive animal testing will have been done with the final series usually in primates. The drug used in this Phase 1 had been through and passed primate studies as required by the HMRC who govern such studies. The initial dose that was given was 1/10000 of the level seen as safe in humans – so the autoimmune reaction seen in these patients was an extremely rare incidence.

Because of the risks in Phase 1 (which are actually extremely small) only certified units under the strict controls and Governance of the HMRC can perform such studies – the training the levels of equipment and have to be second to none. The protocols have to be approved by the HMRC and be considered ethical as well as the comprehensive scientific review of mountains of preclinical data. However, as we saw, things can happen that are unexpected, and dealing with the consequences is not going to be easy as its NEW never before seen reaction – so experience of the lead investigators is vital. In this case, everything was done by the book to help these volunteers.

Without such brave volunteers, no new medicines would ever come to market, so it’s a vital part of any clinical development program.

I don’t work for the industry just in it, so have no interest in defending pharmaceutical companies when they get it wrong – but will get annoyed when the media misrepresent the facts and cause panic, questions and in some cases false hope. All the above information is in the public domain and it’s not rocket science, which is why I just wish the media took their responsibility more seriously when dealing with medical stories and presented well researched and accurate accounts, not sensationalist rubbish designed to sell more papers.

Thanks FC, it's always welcome to have views from those who actually know what they are talking about. An excellent post and most welcome on this thread!

HMRC? Do you mean the MHRA, FC?

In the Te Genero trial there were some basic procedure errors by the unit. Probably to save money such as dosing too many patients at the same time and not following up on infusion reactions.

http://www.grandcharity.org/news.php/80/medical_breakthrough_for_multiple_sclerosis

As my mother suffers from this, I am also strongly in favour.

... which is why I just wish the media took their responsibility more seriously when dealing with medical stories and presented well researched and accurate accounts' date=' not sensationalist rubbish designed to sell more papers.[/quote']

Don't we all FC, don't we all, and in every area, not just this one.

HMRC? Do you mean the MHRA, FC?

 

In the Te Genero trial there were some basic procedure errors by the unit. Probably to save money such as dosing too many patients at the same time and not following up on infusion reactions.

yep... that post was done in word and spell checker got me... ;-(

Re the Te Genero trial, as I understood it the 6 patients were dosed in sequence - and the time between each patient receiving a dose was considered too short, but in line with the original protocol - although I could be mistaken. IRCC the monitoring was criticised in the follow up but not to the extent that it was considered negligent.

I guess by the avatar you are a Healthcare professional of some sort - The point I was trying to make really though was in the way the media reporting leads to development of urban myth, especially around healthcare, medicine and the pharma industry. Perhaps what is most annoying though is when it directly impacts on patients, worse case being the 'Breast Cancer Cure' headlines offering false hopes, or in this case, despite me believing Cameron is a ****, it actually makes sense, if there was a national accessible database that could be used quickly and simply to assess outcomes in specific patient segments - cetainly be a big step forward in enabling outcomes related reimbursement and risk share schemes.

Whilst it doesn't tend to cover pure research articles so much, the Behind The Headlines section on NHS Choices is always worth a read whenever an article comes out in the press, to get the background and facts on a story, without the media spin: http://www.nhs.uk/News/Pages/NewsIndex.aspx

We use it professionally and direct patients towards it when they contact us to ask about stories in the media. It's a good resource that needs more exposure.

Whilst it doesn't tend to cover pure research articles so much, the Behind The Headlines section on NHS Choices is always worth a read whenever an article comes out in the press, to get the background and facts on a story, without the media spin: http://www.nhs.uk/News/Pages/NewsIndex.aspx

 

We use it professionally and direct patients towards it when they contact us to ask about stories in the media. It's a good resource that needs more exposure.

What a great site - have bookmarked it. Thanks for posting it.

Whilst it doesn't tend to cover pure research articles so much, the Behind The Headlines section on NHS Choices is always worth a read whenever an article comes out in the press, to get the background and facts on a story, without the media spin: http://www.nhs.uk/News/Pages/NewsIndex.aspx

 

We use it professionally and direct patients towards it when they contact us to ask about stories in the media. It's a good resource that needs more exposure.

It would appear that not everyone thinks Bazian (the company that supplies the articles to NHS Choices) are impartial.... http://www.patrickholford.com/index.php/blog/blogarticle/who_funds_nhs_anti-vitamin_propaganda/

That said, that blog is written by a supplier of health suppliments, but is still perhaps a valid critique of supposedly "unbiased" reports.

Either way, good to see the NHS working in tandem with private companies to come up with a good service to the public.

.......

 

Either way, good to see the NHS working in tandem with private companies to come up with a good service to the public.

That'll be a first (almost) since most private intrusion into the NHS seems to exist to rip off the service.