Wednesday, June 25, 2008

IT'S OK TO TAKE ROSI!

Mention ACCORD, ADOPT, DREAM, VADT and RECORD to anyone and chances are many would respond in the negative. These are acronyms for medical trials pertaining to diabetes. For example, ADOPT is actually short for A Diabetes Outcome Progression Trial and ACCORD is Action to Control Cardiovascular Risk in Diabetes Study Group.

Last weekend I was in a medical workshop discussing the updates in Diabetes treatment and for two days I was overwhelmed with the above jargons. To ease us of the burden of absorbing all these packed and meticulous information, the drug company responsible was kind enough to hold it in Westin Langkawi, a beautiful spa resort perched on a hill, facing a small bay not far from Kuah Jetty.


Our room



Avandia or Rosiglitazone (or Rosi, as used by some presenters, implying how comfortable they are with the drug now despite the recent controversy that shrouds it) is a fairly recent oral hypoglycemic agent, used to treat Diabetes. Its usage was on the rise and was getting global acceptance, despite its steep pricing, as it is a diabetic drug in a class of its own with a coveted ability of preserving the pancreatic beta cells and it is thus beneficial especially to young type 2 diabetic patients.


At Temurun Waterfalls on the way to Datai Bay

However, last year, someone called Steve Nissen (who has a fitting resemblance to Salman Rushdie), came out with a meta-analysis that gave a shocking conclusion that Avandia gives an increased risk of cardiovascular events. The finding nearly caused Avandia to be taken off the shelf! After rigorous effort, GSK (the drug company that produces Avandia) managed to retain it in the market albeit a caution tag that comes with the label i.e. Avandia is not to be given to patients with a known heart disease.

Essentially the workshop was to impress upon us that the study done by Steve Nissen was seriously flawed and that Avandia is still a safe drug and should be given to especially the young type 2 diabetics as it gives good glycemic control, bringing down the HbA1c to below 7%, besides preserving the beta cells function in the pancreas as well as giving kidney protection in the long run.

Firstly, to begin with, the study was actually a meta-analysis, meaning that it was a retro review of other trials done before and thus to make a major conclusion out of such a study is rather uncalled for. Scrutinizing Steve Nissen’s meta-analysis, we would find numerous flaws. He had looked into 42 trials and out of it, only 2 were big trials i.e. ADOPT and DREAM which consisted of more than a thousand patients. The rest were small trials with more or less 100 patients. Nissen had made ADOPT, DREAM and all the small trials as the 3 arms of the study and for many of his analysis, the p was never significant in the first 2 arms but was compounded when averaged with the 3rd arm which was the collection of the small trials. To add salt to injury, some of the small trials were not even trials to prove CV events with Avandia but was included nonetheless.

All these prove to show that researchers would go all out to produce journals to attain good resume. However, many a time, these studies are bogged down with many mistakes and weaknesses and if they get published, imagine the impact it will have on us. KKL told me that there was even a published clinical study which was only done on one single rat! Btw, you might be interested to read this published paper. Someone we know is one of the researchers!

One of the available villas.


Nevertheless, it was a very insightful workshop that has enlightened me on many issues. Besides, staying in Westin was a splendid retreat for both iKelah and I, not to mention the endless array of food provided in all the meals. Heavenly experience indeed!


18 comments:

BingBing said...

Asalamalaikum Doc. Rosa, Greetings from London. Remember me? Hanis's friend? I've just popped over from her blog - if you see her can you let her know? Jzk :)

I remember there was a meta analysis performed some years ago regarding the link between oral contraceptives and breast cancer. As far as I am aware, the benefit of this kind of study was that it collated all the other studies together and produced a more statistical meaningful result because the sample number would be much greater.

Anyhow, just passing by... your pics look AMAZING! Glad you enjoyed your conference :o)

dith said...

Wa'alaikum salam Dina!

How are you doing?

Thaks for dropping by. I will convey your salam to Hanis, insyallah. Hanis is busy with her 6 kids right now, hehe.

Re: meta-analysis, you should know better, :p. But for this particular analysis, only 2 big studies were taken whilst the rest were very small ones and as Dr Peter Yen of Singapore presented, there were many blatant flaws in it.

Take care!

ikelah said...

Love the workshop and the island trip.

got some updates regarding T2DM and some URLs' to search for more and had been doing that for the past week.

Love the island tour. I had been here for the third time but only this time did I really learned how to get around.

Lots of things to do actually besides the famous makam mahsuri, beras terbakar, pulau dayang bunting, the marinas' and the cable car.

Gotto know there are a few geo parks; Machingchang Cambrian, Kilim Karst and Dayang Bunting geoforest itself which is under UNESCO.

We circled the Island by road; Jalan Air Hangat stopping at the jetty to Kilim, Durian Perangin Waterfall to Tanjung Rhu. Then along Jalan Teluk Yu to Datai Bay stopping at The Datai and Temurun Waterfall. We drove west to Machinchang passing by the langkawi Cable car, Habour Park near Burau Bay,took Temoyong Road back to Westin after a short stop at Kuah.

The day before, we drove along Chenang Beach stopping not far from Awana Porto Malai. We passed by laman Padi, beach road by the airport towards Park habour.

As for now I am planning to visit Langkawi again. this time I'll not miss the trip to Kilim Geopark.

Has said...

DITH,

Firstly, mixer tu nak buat apa ye? Pening dok fikir your comment, tak faham.

Drug company ni, depa buat untung atas nasib malang pesakit. Tapi kadang2 pesakit juga tak nak tahu lebih. Sangat percaya kepada doktor mereka. I just wonder how many doctors have the real insight and the time and will to read other than the propaganda set by the companies.

Kalau gi farmasi hospital, pesakit ambil ubat, beg plastik kiri kanan. Hairan, sanggup depa telan all those medications. Nampak gayanya orang kita, telan ubat supaya boleh makan sedap. Padahal semua tu tak perlu. Makan makanan yang betul, makanan yang jadi ubat. Kencing manis, banyak herba yang boleh tanam sendiri untuk mengawal. Malah kawan saya baru tunjuk experimental study dia buat dengan tikus yang kencing manis! Guna sumber asli dapat pulihkan buah pinggang tikus yang rosak akibat diabetes, dan tahap gula tiku pun terkawal.

Tapi endrocrinologist sendiri yang meremehkan kajian semumpama itu.

ikelah said...

has, herba apa tu? mana tau boleh buat ikhtiar.

Maman said...

next time ajak maman pulak

Pak Andak said...

Ajak saya juga.

dith said...

ikelah- planning for such trip is not cheap

Has- You wrote that you hope Medical Tribune won't give you another glucometer so I said request for a mixer pulak!

I think changing of our eating habits need to start from young. Kalau dah berpuluh tahun makan lauk lemak, kari etc, tetiba nak change to makan herbs jek, :p

Maman- set!

Pak Andak- nak ikut kenalah guna nama sebenor. Mana boleh bawak stranger

Queen Of The House said...

Nice place .... but I think the double beds were kinda redundant ;) I know ... orang bagi free, ambik je lah. Maman boleh occupy the extra bed, so next time jangan lupa bawa dia.

Jamil said...

How come you get to stay in a nice resort in Langkawi to learn about drugs used to treat diabetes while I have to do it in a measly seminar room located in a hospital ward?

Return the fairness and justice to this world!

dith said...

QOTH-
Memang nak bawak Maman tapi we flew on Fri which was school day and he had tuitions that can't be missed!

Jamil-
That is the difference between a real doctor and a not so real one! :p

JoKontan said...

I thot you gonna write about VVti,iVTEC, MIVECs, ABS, VSC, TC,..Hmmm.

As always, beautifuuuul pictures.

momad said...

eh eh mak, seronok nye... find this very useful. and easy to understand, cause I HAVE TO STUDY EPI NOW! OH, please just pray to Allah that I'll pass and can go home already...

OOD said...

DITH,

it just so happened that on 17th nanti ni, i will be attending a product launch (by Minister M*OSTI) on a new product called diabega*rd). It is polypeptide-k extract from bitter gourd. Studies have shown that it is equivalent in structure to human insulin. Clinical trials (main2) conducted in Kelantan, shows that it helps not just to control diabetic but even to cure it. I know, such far-fetched breakthrough claims! The med also is claimed able to help improve pancreas functions. The med is being sold now as nutraceuticals, no claims can be put on the box yet, but a full blown clinical trial will be conducted with CDC of GH soon. Then it can be sold as drugs.
It is to be taken sublingually and available at pharmacies. Watch me on tv for the launch, tau. 17 July, Tech Park Malaysia, officiated by Max Ong.

dith said...

Jo- that's your forte!:))

Momad- insyallah. May Allah make it easy for you in your exams. Ameen

Ood- Oooh! But I thought this drug has been in the market for quite sometime already? Anyway I'll be fixed to the the tv this 17th, looking for an anak ikan !

zyryx said...

salam dith
sorry if this is out of topic, but do you know of any eng-malay medical dictionaries out there or in the net, or simply how did you translate english symptoms etc into malay ones?
i tend to get confused, and my meager medical malay vocab doesn't help...

dith said...

hmm...don't think there's any such dictionaries or maybe I am unaware. Maybe Jamil or the rest can help?

For a start:

dyspepsia- angin

flatulence- kuat buang angin

gaseous distenstion/ bloated- kembung

melena- berak berdarah

hematuria- kencing berdarah

So you see, it's easy in malay because you could easily improvise by describing the signs symptoms in easy malay words or sentnces.

If I were you, don't get so worked out by it. You'll get by!

Ku Keng said...

With such a idyllic surrounding why bother to go the lectures?

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