An Evening with Dr Mark Land (CCSG Patron)
An Evening with Dr Mark Land (CCSG Patron)
Meeting date: November 15, 2000
Venue: AstraZeneca House, Epsom, Auckland.
Dr Lane is the Patron of the CCSG and spoke to about 40 people
at a meeting of CCSG members on November 15th, 2000. Also in
attendance was Dr Alan Fraser, a member of the CCSG Advisory
Panel.
The issue raised was that of new therapies to treat IBD, specifically Infliximab (Remicade®), used to treat severe Crohn's disease. Although many new agents have been reported as "promising" in the CCSG News, very few have made it to NZ to be used with patients. Dr Lane described the long and costly process of bringing a drug from just a concept to a point where it can be approved for use in humans. New agents that are thought to have a role in the treatment of IBD are developed by scientists and a patent may be taken out on the agent. The patent may last 20 years. The new agent may then be tested on cells cultured in the laboratory or on animals. If successful then preliminary trials can be undertaken to test the drug on a small number of patients. Such trials are experimental and are carried out to assess the effect of the drug on the human body. Then clinical trials on specific patient populations can be carried out on a greater number of patients. Finally, once enough clinical data has been collected and the drug is approved for use in patients by the appropriate government authority then it can be sold and prescribed. The process to gain registration for a drug can take 12-14 years of the patent's life so the drug company has only 6-8 years to sell the drug and recoup the cost of the drug's development (and make a profit too). As a result of the long development time and the short duration of the patent, these new drugs are expensive. (The drug may be registered for use in NZ but not subsidised. This is why the charges on some drugs are more than others).
Question: How does Remicade work?
Dr Lane: It blocks the inflammation process. Useful for
Crohn's and rheumatoid arthritis, but not for UC. 60-70% of patients
feel better from taking Remicade and remissions is usually achieved
after 1 week. Patients may not have to continue with their prednisone.
However, it only works for 812 weeks. Some people will get
no response, some people will get a response that will last a
year, but the average is 12 weeks. So we will still use prednisone
Remicade is going to be expensive in NZ and we can't afford
to use it for every person with Crohn's. The reality is that
prednisone works for the vast majority of people. The problem
is that some have to use an awful lot and they get frequent side-effects
from its use. It is those people that this drug will be targeted
at and also those who do not respond to prednisone. Even with
Remicade, patients will need to use maintenance drugs such as
Pentasa or use Azathioprine a bit more aggressively. It is hoped
Remicade will act as a bridge to maintenance therapy.
Question: Why can't it be taken as a pill?
Dr Lane: It cannot be absorbed. It is a protein and needs
to be infused into the body via a blood vessel.
Question: Where is drug development for I.B.D heading?
Dr Lane: We are learning more and more about what chemicals
can switch the inflammation on and off. Many of these are being
developed as possible treatment for IBD. There are a number of
other drugs in the research process that are at least 3 years
away. Another drug that is looking promising is Thalidomide for
the treatment of Crohn's. Over the years Thalidomide has had
some very bad press but it has since been discovered that it
has some good effects on the immune system.
There are a whole variety of possibilities. But what we want
is a drug that will treat the disease without having nasty side
effects . One of those currently in development may be the one.
Question: Why do more drugs seem directed at Crohn's
rather than UC?
Dr Lane: UC has a surgical outcome which is reasonably
definitive whereas Crohn's always comes back. Many of the drugs
used for Crohn's are also effective for UC, such as Pentasa,
although Entocort is for Crohn's only because of the way it is
released and therefore not appropriate for UC. The incidence
of Crohn's disease appears to be greater than that for UC although
there is no hard evidence to support this. It is a belief held
by most specialists. Why? Not known. It appears that there is
an increase in Crohn's but UC numbers remain stable.
Question: Is IBD more prevalent in men or women?
Dr Lane: It seems to be non-selective.
Question: I suffer from exhaustion. Is there any vitamin
I can take to help?
Dr Lane: You probably need to get your Crohn's under better
control. Iron, Vitamin B12, folate your doctor can tell
from a simple blood test whether you have any deficiencies. Maybe
a broad-spectrum multi-vitamin would help but I couldn't guarantee
it.
Question: I've got Crohn's and experience severe bloating.
I've tried antibiotics and it won't go. I look pregnant, what
can I do?
Dr Lane: You could possibly have an infection. Also IBS
(irritable bowel syndrome) symptoms include bloating. Nobody
knows what causes IBS. It could be fluid retention or gas.
Question: Do they know where Crohn's is most prevalent
in the world?
Dr Lane: Temperate climates. Common countries are Australia,
New Zealand, South Africa, Finland, Sweden, UK, Canada, and the
USA. Climate is a strong predictor, as is the country you were
born in, and your race, e.g. the prevalence of Crohn's is very
high in Jews.
Question: I was diagnosed with Crohn's in March. I
improved and don't need medication now, but if it does come back
when should I go back to my doctor?
Dr Lane: Some people are lucky and go into remission,
but most have regular flares so take maintenance drugs. Drugs
reduce the severity of flares. Drugs also reduce the likelihood
of relapses. You either take medication constantly or only when
have flare up. Constant medication is called maintenance therapy.
It is good to see your specialist a few times to learn how to
maintain your own disease. Talk to your doctor on how to manage
acute attacks and whether to take maintenance drugs. It's all
about finding balance managing the disease and side effects
of drugs. Understand your own disease.
Question: My 13 yr old daughter was recently diagnosed
with Crohn's and is taking prednisone. When will I expect to
see side effects ?
Dr Lane: Depends on dose and length of time they are taken.
On high dose she may experience poor sleep patterns therefore
it is better to take your dose in morning rather than at night.
Question: Can a child be born with UC?
Dr Lane: Very rarely.
Question: What of the effect of Alcohol?
Dr Lane: Not a problem in moderation, but don't do it
before you go driving.
Question: At what age is Crohn's most common?
Dr Lane: The 15 35 age group
Question: Is there a chance you can be weaned off Pentasa
and live happily ever after?
Dr Lane: A small possibility and you can't predict who
it will happen with. The more surgery you have the more likely
it is you will need maintenance therapy because the recurrence
rate is already high. Of those who have had surgery, 50% will
have either another operation or another flare-up within 5 years.