Metformin (GlucoPhage) Cancer and the FDA.

Some more info on Metformin preventing Cancer:

The biguanide metformin, which is widely prescribed for the treatment of type II diabetes, might be a good candidate for lung cancer chemoprevention because it activates AMP-activated protein kinase (AMPK), which can inhibit the mTOR pathway.

Metformin reduced lung tumor burden by up to 53% at steady-state plasma concentrations that are achievable in humans. mTOR was inhibited in lung tumors but only modestly

These studies show that metformin prevents tobacco carcinogen–induced lung tumorigenesis and support clinical testing of metformin as a chemopreventive agent.

Metformin and Cancer

Here is some more info:

EASD: Metformin Still Hot Topic in Cancer Prevention

This old drug could well perform a new trick for cancer prevention -- and even treatment -- Michael Pollak, MD, of McGill University in Montreal, told attendees at the European Association for the Study of Diabetes meeting. "If someone had just synthesized metformin in a cancer lab it would be considered a very important scientific development in the context of oncology," he remarked to reporters at an EASD press conference.

We discovered actually that there was a lot of common ground in the way that stressed cells respond to metabolic signals and stress signals providing much more of a bridge than we realized between metabolism and cancer," he said. This "caught everyone by surprise," Gale noted. However, that was only because the link between type 2 diabetes and cancer had been mostly forgotten, according to Jeff M. Holly, PhD, also of the University of Bristol.

The altered metabolism required by all tumors was a main thrust of research after Louis Pasteur first recognized this fact in the 1860s, Holly pointed out at the press conference.

The oncology field may be gearing up for trials using metformin as a treatment for nondiabetics with cancer, but it's controversial whether levels of the drug would be high enough in the target tumor area to produce an effect, Pollak added. Metformin lowers blood glucose levels through action in the liver -- which in turn makes insulin levels fall. Some tumors remain dependent on endogenous insulin despite insulin resistance in the patient. Not all diabetes treatments have the same effect, since most treatments lower glucose levels by increasing insulin -- just what a tumor that thrives in an insulin-rich environment needs to grow.

Source

reply to post by Lebowski achiever


Cool. Thanks for replying.
My mom said there are some side effects like when they raised her dose it caused very bad diarrhea, but I would say the pros outweigh the cons. Good luck and keep us posted.

Courageous thread, and I'll add one to the hug pile -- not for sympathy, but for support!

I'm not sure if this is the information you're seeking, but these articles claim that BMS lost it's glucophage patent in September of 2000.

Status: Patent expired in September 2000.

www.express-scripts.com...

The patent on Bristol-Myers Squibb's diabetic drug Glucophage, which brought in sales of $1.7 billion, expired in 2000 and generics are expected to soon be on the market.

www.allbusiness.com...

Though, this article says 2002.

The patent on BMS’s Glucophage, which had sales over $2 billion in 2001, expired in January of 2002. One month later, more than 85% of that drug’s market share had been taken by generic alternatives.

www.dddmag.com...

Does that help?

reply to post by Pseudonaut


Yes that is great info. Thanks. I am just wondering if there is a distinction between European and World patents?

reply to post by GogoVicMorrow


I have found that in the past few days the pain is less pronounced and I am now on 3 times a day for Paracetamol and 2 times a day Diclofenac. Before it was 4 and 3 respectively. I am hoping the reason is because this is working. I won't know for sure until the PET Scan that I will have before the Chemo, when I have it. I am thinking about saying I want Chemo, have the PET Scan, see if they have shrunk, and If they have, I won't have the Chemo at all.

My father is fighting prostate cancer and my mother and I are both diabetics who use Metformin. I get free meds due to a provincial proscription program so Metformin flows like water in our households. I'm going to do some research here and see if i can siphon my own supply for my father.

reply to post by Cheerfulnihilist


Good luck to you!

Here are some medical studies regarding Prostate Cancer and Metformin:

A total of 1,001 cases of PCa and 942 controls were available for analysis. In Caucasian men, metformin use was more common in controls than in cases (4.7 vs. 2.8%, p = 0.04), resulting in a 44% risk reduction for [Prostate Cancer] (adjusted OR = 0.56; 95% CI 0.32–1.00).

www.ncbi.nlm.nih.gov...

AACR: Metformin Brakes Prostate Tumor Growth

"Combining metformin with bicalutamide significantly reduces prostate cancer cell colony formation rates more effectively than either drug in monotherapy," said Vasundara Venkateswaran, PhD, assistant professor of surgery at the University of Toronto............"this combination regimen may potentially improve prostate cancer specific survival through a direct anti-proliferation mechanism."..............She suggested that metformin use, in addition to impacting prostate cancer growth, "may improve overall survival rates by reducing the cardiovascular morbidity and mortality that accompanies hormone-induced metabolic syndrome.".

www.medpagetoday.com...

Hi there just wanted to say please be careful when taking this drug metformin that you do not end up with a low blood sugar crash because cancer therapy can make you lose your appetite

I would suggest to be on the safe side that you get yourself a blood sugar monitor.

Also some one told me that almonds are very good for people with diabetes and also for people with cancer
so it is also good to see this link between the two here.



anyway 3 almonds a day is the recommended dose ...(as long as you do not have a nut allergy)


stay cool and stay positive .....

Here is also some disconcerting information on the FDA and Off-Label medication (ie, Prescribing drugs for ailments that they were not originally intended for).

On October 2, 2003, Philadelphia Assistant U.S. Attorney Virginia Gibson delivered a speech to the Pharmaceutical Compliance Forum noting the importance of the recent “Neurontin” decisions and signaling the government’s new willingness to use the False Claims Act to restrict or even eliminate a manufacturer’s ability to promote the off-label uses of its product.

An off-label drug is not necessarily dangerous. In fact, for many diseases, it is the best or even the only course of treatment available. Pharmaceutical manufacturers, however, with certain minor exceptions, are not permitted to encourage off-label use of their product.

leda.law.harvard.edu...

reply to post by xsheep


Thanks for that! I am taking it with meals and have not experienced any ill effects, except for gastric troubles that are passing. Low blood sugar symptoms are quite pronounced and I am looking out for them but have not had any. I eat almonds, linseed (flaxseed) and take a whole lot of vitamins. I haven't had a loss of appetite, yet.

Originally posted by Lebowski achiever
reply to post by Pseudonaut

 

Yes that is great info. Thanks.

I am just wondering if there is a distinction between European and World patents?

Yeah, I was wondering that too. It is strange that we can't find more info online...

Ah! I found something good! Washington Post article. Lebowski achiever, check this out:

www.washingtonpost.com...

reply to post by Pseudonaut


Very interesting! Now as I have found and stated in my original post, BMS only had the distribution rights in the US and didn't actually manufacture it. Merck and it's subsidiaries still did that, and I think, until they lost the patents. It looks like that that was in 2001. I bet they are kicking themselves they didn't know about the anti-cancerous properties until it was too late. They may have had their extension.

I still have some questions remaining but I think through your help we have answered one:

-Patents Lost in 2001 Worldwide (hence they only had the distribution rights and Merck's subsidiary still manufactured it).
-Why was there a delay in getting this drug approved?
-Did big Pharma actively block the approval until a deal could be made with Merck?
-Did the sale of a Merck company to BMS in november 1994 seal the deal? (FDA approval came one month later)

I am currently looking into BMS and their lobbying expenditure per year. This is an amazing website. However, there seems to be little historic data around the time I want information (1994 in particular). It still makes for interesting reading, though.

www.opensecrets.org...

The company has lobbied against efforts to add a prescription drug benefit to Medicare, to expand generic drug use, and to allow importation of cheaper pharmaceuticals from Canada.

reply to post by Lebowski achieverTo Lebowski Achiever and others regarding Metformin
A just published study in Taiwan can be found at www.biomedcentral.com/1471-2407/11/20

The above study looked at 490,000 people taking metformin and compared their cancer rates to the general cancer rate and found a very significant reduction in cancer ocurrances. They were looking mainly at certain specific cancers but said the results would apply to most types. Their overall conclusion was: "METFORMIN USERS WERE LESS LIKELY TO DEVELOP CANCERS OF ANY TYPE" They recommend that clinical trials should be done as soon as possible with Metformin. Another new treatment for cancer seems to be just around the corner. This is from a smsll public company out or Calgary called ONCOLYTICS BIOTECH. They have a virus that is given by I.V. which attacks cancer cells and destroys them but leaves normal cells undamaged. This is derived from the common cold reovirus to which we are all immune but cancer cells are not. There is an article in the current Readers Digest about it. A man with a fist sized lung tumor had it shrunk down to thumbnail size in six months. This drug has been in clinical trials for a few years now and must be getting close to being released. It will be a blockbuster. Go to www.oncolytics.ca to see how it works. I suggest we use Metformin to keep cancer at bay until this drug gets licenced then it can take over to save us. There must be some truth to this as the stock price of the co. has been rising rapidly.Go to www.stockhouse.com and punch in the symbol T.ONC to see their chart then read some of the bullboard comments. Lets hope that big pharma doesn't buy them out then bury the treatment so they can keep selling billions of dollars worth of chemo drugs. Best of luck from CURESEEKER

reply to post by cureseeker


That is great info. However, They are only in Phase II so have a few years to go yet.

reply to post by Lebowski achiever


That sounds like a good plan. Do whatever you can and everything you can, while sticking to your beliefs about what is best for you. I'm not a religious guy, and I've never sent energy, but you have my complete and best wishes.

reply to post by GogoVicMorrow


Thanks so much. This week has been not so good. I've had a lot of pain in the past few days and I am a bit disheartened but that could be because I have a cold that could exaggerate any aches and pains I may have. I have also been looking into the P53 Gene. If mine is defective than it could mean the Metformin is helping but I am just not sure as not all cancer cells have a defective copy of that gene. I wish there was a way I could find out.

Have a good weekend one and all. Hope I can shake this cold. I have been taking vitamin D like a Mofo but to no avail. Bummer.

reply to post by VneZonyDostupa


You sanctimonious...you *had* to do it didn't you!

Here's this bloke, bearing his soul and wanting to discuss possible alternative cures for cancer, and you try and pick a fight with someone trying to help him?!

Who the hell do you think you are, proclaiming what is snake oil and what works...did you know about Glucophage too? No..you didn't.

So you're not exactly the all encompassing repository of human knowledge regarding alternative cures for diseases then are you! The only reason you're not rubbishing Metformin is because it's a pharma drug instead of a natural one.

*I'm* sickened that you chose to try and make political capital out of someone offering the OP genuine help.

OP...get well soon mate. I'd be interested in what dosage you plan to maintain and how long do you estimate before you expect to see an improvement?

Personally, i'd be seriously looking into every alternative therapy i could find, but that's me. I see no harm in chewing on a few Apricot seeds, while sipping your lemon and blackberry juice, after chowing down on a gelcap of Hemp oil!

Combination therapy man. A little of each, may be what breaks it's hold, and makes you really unattractive to cancer hopefully!

All the best OP...PMA..positive mental attitude.