April 28, 2007
Lilly under Scrutiny on Capitol Hill
From the article:
According to Mr Gottstein in a February 13, 2007, interview with the Anchorage Daily News, Lilly's hidden document showed the rate at which Zyprexa causes diabetes, massive weight gain and other metabolic problems and that Lilly trained sales staff to mislead doctors about the drug's association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly. [Emphasis mine]
Families of deceased Zyprexa victims want criminal prosecutions. "Lilly executives should go to prison for knowingly being responsible for people's deaths, shattered families; ruined and grieving families," says Ellen Liversridge, whose 39-year-old son gained nearly 100 pounds while taking Zyprexa before he lapsed into a coma and died 4 days later of profound hyperglycemia in October 2002.
"Thanks to the FDA," she says, "there was no warning on the label of Zyprexa even though two other countries had made Lilly place warnings about diabetes, hyperglycemia, and death."
For its part, the secret documents show that Lilly was not the least bit concerned that patients like Ellen's son were developing diabetes. The company's one and only worry was that sales would fall when the news about Zyprexa's link to diabetes became made public. A July 7, 2003, "Diabetes Update" memo discussed the company's strategy to counter the negative impact on doctor's prescribing habits when news of the FDA's decision to add a black box warning about the diabetes risk to the label of Zyprexa became public.
"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Update said, "solely on the basis of personal fear (of being sued)."
To ward off the drop in Zyprexa prescriptions because doctors were afraid of being sued, the Update said Lilly should offer to indemnify doctors, in other words, cover any lawsuits filed against doctors as a result of prescribing Zyprexa. "Indemnification represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees," the Update stated.
This plan was apparently successful with doctors after the risks of Prozac became public when documents disclosed in litigation that were also kept hidden under a court order were revealed in a subsequent lawsuit. "Our experience with Prozac," the Lilly memo states, "confirms the impact and goodwill of such an initiative."
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What a great drug for Lilly! It costs more than $300 a month AND it grows the market for Lilly's expensive insulins by creating many thousands of new, permanent, diabetics. Gotta love it. And if a bunch of people have to die to increase profits, well, you can't make an omelet without breaking eggs.
Personally, I'd like to see the executives of these companies, the ones that knew that their drugs caused unnecessary deaths when prescribed off-label, and then put all their efforts into increasing off-label prescribing, hauled up on murder charges.
This is murder. The victims are as dead as if drug company goons had opened fire on them with a Glock. And there are thousands of these victims, far more than died at VTech. So why do the people who do this get away with only a wrist slap?
I'll finish with one last quote from the article linked above:
In the case of Zyprexa, Lilly has so far agreed to pay about $1.2 billion to settle cases out of court with roughly 28,000 victims. But here again, $1.2 billion for claims spanning a 10-year period amounts to petty cash for a drug with sales of $4.36 billion in 2006, and a 10% increase to $1.108 billion reported in the first quarter of 2007, over the first quarter of 2006.
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KILLING PEOPLE SURE IS PROFITABLE!!!!!!
April 27, 2007
So I'm back to using the ER (Extended Release) taking all 1500 mg at one time at 10:30 in the morning so that I get best coverage during Lunch and an early Dinner.
If you're having problems with diarrhea, nausea, etc, on regular Metformin, be sure to talk to your doctor about switching the the ER form. They cost the same amount. The Metformin ER is also available at Wal-Mart as a $4 prescription.
April 26, 2007
My suspicion is that if you have found that you respond strongly to a relatively low dose of a sulfonylurea drug such as Amaryl or glipizide (the sulfonylurea drug found in Glucovance) you may respond strongly to Byetta and possibly Januvia, though everything I'm hearing suggests that far fewer people respond to Januvia than Byetta.
If you have no response to these drugs, it may indicate that you've gone past the point where stimulating your beta cells with any drug is going to produce insulin because you no longer have enough functioning beta cells left to respond to beta cell stimulation.
Januvia, if its safety concerns are addressed, may turn out to be the drug of choice for people with prediabetes or forms of diabetes in which fasting blood sugar is still fairly well controlled and loss of post-meal blood sugar control is the main problem.
However, what disturbs me is that I hear from far too many people who are walking around with dangerously high blood sugars who inquire about Januvia because they hope they can add another pill to their regimen in order to avoid going on insulin. This is a tragically misguided approach.
Insulin always works. For everyone. These newer drugs work only for some people and many times they do not lower blood sugars anywhere near a healthy level. I am disturbed by the number of doctors who, based on postings on the Byetta blog, are putting patients on Byetta who have blood sugars well over 250 mg/dl after meals. This is a level known to cause blindness, kidney failure, amputation and heart attack death. Most of the time, after taking Byetta for several months, these patients still do not have blood sugars that are anywhere near the complication-avoiding level of under 140 mg/dl at 2 hours which is recommended by the endocrinologists who make up the American Association of Clinical Endocrinologists.
In the old days, doctors defended not putting their patients on insulin saying the patients wouldn't take shots. Well, taking Byetta involves taking two shots a day and unlike insulin, Byetta shots can sting and often puff up into insect-like weals. Two shots a day of insulin, properly dosed could bring the blood sugar of these people down to a safe level. Byetta, which costs more than twice as much, does not.
So if you are already on a lot of oral medication and are still going over 250 mg/dl after meals, you probably should start out with insulin, get your blood sugars down to a safer, more manageable level to save whatever functioning beta cells you still have left, and then see if Byetta or Januvia can improve matters for you.
Neither of these drugs will help if your beta cells are dead, and the research we cite on our Organ Damage page makes it clear that prolonged exposure to blood sugars over 150 mg/dl kills beta cells dead. Only insulin, dosed properly, is 100% guaranteed to lower blood sugar.
Even scarier are the patients who report they are on insulin but are still getting extremely high blood sugars especially after meals. Clearly they are on a "one size fits all" insulin regimen that does not take into account their carbohydrate intake or their personal level of insulin resistance.
These regimens (many involving 70/30 insulin mixes) should be totally discredited by now, because they don't give good enough blood sugar control, but they are still used by many family doctors who were trained a decade ago or longer and are not well educated in how to use modern insulin. Some of these people,too, are on Basal insulin alone when they need meal-time insulin to control their dangerously high post-meal blood sugar spikes.
If you are on insulin and still getting very high blood sugars, you need to do two things. One is to read "Jennifer's Advice to Newbies" and try out Jennifer's advice for a month.
If that doesn't help, you must find a doctor who will work with you to find an insulin regimen that does control your blood sugar. When you've got your blood sugars under pretty good control, then you can start fooling around with new and experimental drugs. But the time to do that is when you aren't going into the over 200 mg/dl red zone after every meal!
April 24, 2007
It's Not Just Pet Food
Here's what stuck out to me, "Currently, most of the world's vitamins are manufactured in China. Unable to compete, the last U.S. plant making vitamin C closed a year ago. One of Europe's largest citric acid plants shut last winter, and only one vitamin C manufacturer operates in the West."
The rest of the article explains that there is no oversight of the food ingredients and vitamins coming into this country from China at the level where you'd detect poisons like lead, pesticides, and other toxic chemicals. We know that these are a huge issue with Chinese products destined for human consumption because there's a long history of Chinese people being poisoned by the products of the same manufacturers who are now selling their products to the rest of the world.
The Chinese have been pursuing what has turned out to be a very successful strategy whose goal--almost attained--has been to shut down competing factories all over the world by offering products at extremely low prices that factories elsewhere can't match. This is made possible by the Chinese government's manipulating the value of their country's currency so that the $.30 an hour they pay a worker has a buying power, in China many times that of $.30 in the U.S. or for that matter any other developed nation.
When there are no more factories left, of course, the Chinese manufacturers will be able to raise their prices, because it will take decades for other countries to rebuild their manufacturing infrastructures. And you don't even want to think about the military implications of the fact that the U.S. has lost most of its machine shops, steel mills, hard goods factories, etc. and that most "American" manufacturers are getting their "American" products manufactured in cheap Chinese factories because our laws (thanks to Republican friends of big business) allow a company to slap a "Made in America" label on imported item as long as one or two steps in the manufacturing process are done in the U.S..
But to get back to Diabetes. We all know what happened with the poisoned pet food. But that problem came to light because kidney failure in younger pets is not common, so when veterinarians started seeing a lot of kidney failure in younger pets, they raised the alarm.
The problem is that doctors expect to see kidney failure in people with diabetes of all ages. People with diabetes take a lot of vitamins and supplements--far more than the usual patient--but because of this expectation, if there was a toxic chemical in their pills--which is very likely and which, has, in fact, already occurred with some supplements made in China--doctors would be very slow to pick up on it.
It only took a handful of pet deaths to turn up toxic pet food. How many deaths of humans will it take until we notice the toxins caused by cheap Chinese-imported food and vitamin ingredients in human food? And how many of them are already occurring and being attributed to "diabetes" and "obesity"?
I've stopped taking vitamin supplements My original motivation was the large research study that showed that ingesting chemical antioxidants seemed to increase, rather than decrease mortality. With the latest news in view, one has to ask whether this may have had something to do with undetected toxins in the antioxidants used in the study, which probably came from China, given that as the article above states, they have driven all other countries out of the vitamin business.
I suggest you take a long hard look at the handfuls of supplements you're chugging, too, since they, too, probably come from China, and may have been processed with water laced with lead and industrial waste, to say nothing of doctored with ingredients not listed on the label, some of which are dangerous (but very cheap) prescription drugs.
I am also cutting way back on processed foods that might contain the questionable imported food additives. I already avoid hydrolyzed vegetable protein (MSG/soy product) because of its known unhealthy effect on appetite, but I'm adding gluten, guar gum, and a few other ingredients which were cited in the article above to my list of things to avoid. I don't eat a lot of processed food as it is, but it looks like I'm going to be eating a whole lot less.
Even so, it isn't possible to avoid everything dangerous. The irony with the pet food poisoning was that the supposedly "organic" pet foods turned out to be more toxic to pets than the cheap stuff I buy my kitty at Stop & Shop. That should be a warning to those of you who think that paying top dollar at Whole Foods protects you. A scan of the ingredients of most boxed and bottled "health food" products reveals that, besides the truckloads of sugar and starch that make them far from "healthy" for people with diabetes, they also contain lots of possibly imported ingredients like guar gum and gluten. As long as food manufacturers can buy an ingredient from China for one tenth of what it costs elsewhere, that isn't going to change.
April 20, 2007
I posted some more information about Januvia in a comment on my original post questioning some possible side effects. Here's the link. Scroll down to the bottom of the comments see the new information:
Januvia Side Effects Post
April 19, 2007
If you take regular metformin WITH meals, it won't get active until long after your food hits the system, which means your blood sugars will be higher than they need to be.
Once I got the timing straightened out, it seems to me that the identical dose of regular metformin gives me slightly better control than the ER version did.
But itis very hard to remember to take 3 different pills 2 hours before meals. (I usually eat breakfast a couple hours after I wake up.) So it is a trade off. The ER is convenient. I can take it all at once. But the 3 regulars give me better control at 2 out of three meals.
The regular is also tougher on the digestive tract. After 2 weeks of using it my body seems to have just about adapted, but the first week when I switched, even though I'd been taking 1500 mg of Metformin ER for years, it was Newbie City all over again, and it was a good idea to be near a bathroom at all times.
April 18, 2007
The background to this story, discussed at length and documented at:
is that in 1998 when the ADA's experts took another look at the diagnostic criteria that ensure that half of all people diagnosed with diabetes in the U.S. already have neuropathy and other complications at the time of diagnosis, they announced it wasn't cost effective to use the Oral Glucose Tolerance Test to diagnose people with Type 2 diabetes and told doctors to diagnose diabetes using only the Fasting Plasma Glucose test.
Researchers quickly documented that this test missed diabetes in significant numbers of women and people
of color. That is because they tend to develop diabetes in a pattern where the post-prandial blood sugar becomes extremely high long before the fasting blood sugar deteriorates. These high blood sugars cause glucose toxicity that kills beta cells and it also causes neuropathy--long before the ADA's fasting test will flag diabetes.
Despite the evidence that the fasting test was inadequate the ADA refused to change its recommendation to use only the fasting test for diagnosis, despite heavy criticism and the refusal of WHO to go along with this recommendation.
Now, finally, only nine years since the ADA's revamp of their diagnostic criteria which urged doctors to eliminate this test, they've changed their mind and are now telling doctors to use the oral glucose tolerance test for people at risk of diabetes.
The reason for this--I can't call it "sudden"--change of mind, appears to be that the ADA's experts now have decided that people with Impaired Glucose Tolerance should start taking Metformin since there is a lot of evidence that this drug can slow the progression of to diabetes. This evidence, however, is quite old. It is discussed on our Oral Drugs page.
There is, in fact, a lot more evidence that if people with Impaired Glucose Tolerance cut way back on their carbohydrate intake, they can normalize their blood sugar while they still have some beta cells left and many not need any drugs. But you won't hear that from the ADA, funded as it is by big junk food, food service and Big Pharma companies.
As usual, Dr. Meyer B. Davidson is railing against this suggestion that people be given OGTTs before they have developed neuropathy and early kidney damage because this testing is expensive. (Neuropathy is a lot more expensive, especially when it progresses to impotence or amputation). Dr. Davidson, who was a part of the ADA's 1978 expert committee as well as the more recent ones, has always volubly opposed any suggestion that people with Type 2 diabetes get a timely diagnosis. He has published many opinion pieces in the medical press arguing against early diagnosis and he also opposes the use of meters by people with Type 2 diabetes to test their blood sugar at home. He has probably done more to keep people with diabetes from getting diagnosed and treated than anyone else alive. One can only hope that he will retire soon.
My guess is that the other reason that the ADA battleship is starting to turn around on the issue of timely diagnosis is that people with IGT are a huge untapped market for the drug companies. They are a particularly juicy market for their new, and extremely expensive incretin drugs. So far, at least according to my endocrinologist, it is looking like the oral incretin drugs work much better in people with IGT than those with Type 2 diabetes. That is partly because by the time you are diagnosed using the ADA's fasting glucose test and their too-high diagnostic criteria so many of your beta cells are dead that you can drown your pancreas in GLP-1 and not much will happen. So early diagnosis means more profits for the drug companies.
Given how dependent the ADA is on Big Pharma money, if their paymasters want an earlier diagnosis, they'll get it.
This is good news for people with diabetes. I've been calling for it for 4 years online, and Europeans have been using the OGTT for the last decade. With the ADA's blessing insurers will be more likely to pay for the OGGT, too.
The bad news is that once patients get diagnosed with abnormal blood sugars, the ADA will continue to tell them that all they need to get better is to eat sugary fruits, "healthy" grains and chug those $5.65 pills each day that will counter the carbs their "healthy" diet unleashes on the blood stream. That will keep their Big Pharma donors happy.
If you are diagnosed with prediabetes or impaired glucose tolerance after a glucose tolerance test, before you start popping pills, be sure to visit Jennifer's Advice to Newbies--The Best Diabetes Page on the Web.
April 14, 2007
If you may recall, Merck continued to sell Vioxx long after the company had internal information suggesting that the drug caused heart attacks and stroke. Well, this past week they were back looking for FDA approval of another drug which is closely related to Vioxx.
Let me quote Mr. Harris's article:
"A panel of federal drug advisers voted 20 to 1 Thursday to reject an application by Merck to sell its pain pill Arcoxia because of concerns that the drug could cause as many as 30,000 heart attacks annually if widely used."
Further on Harris reports:
"The studies showed that Arcoxia caused nearly three times as many heart attacks, strokes and deaths as naproxen, a popular pain pill sold as Aleve, but was no more effective in curing pain. Patients taking Arcoxia suffered worrisome increases in blood pressure."
"Merck sells Arcoxia in 63 countries"
"In early studies, Merck compared Arcoxia with naproxen and found that Arcoxia was far more dangerous to the heart. So the company switched to comparing it with diclofenac, a pain medicine that is popular outside the United States and is widely believed to be more dangerous to the heart than naproxen. The company claimed that its trials showed that Arcoxia was no more dangerous than diclofenac."
Here's the punchline:
"A Merck spokeswoman, Kyra Lindemann, said the company was 'disappointed in today’s outcome.'
“'We continue to believe that Arcoxia has the potential to become a valuable treatment option,' Ms. Lindemann said, adding that Merck would continue to sell the drug outside the United States.Why does this matter for people with diabetes?
Because every doctor or researcher I have contacted in the past two weeks asking about whether the DPP-4 inhibition caused by Merck's Januvia could promote the change of melanocytes into melanoma--a cancer known to become malignant in response to DPP-4 inhibition--has told me that ONLY MERCK would have the studies to answer that question and that I should contact them.
Yesterday's news also carried reports on the business page that Merck's stock price leapt on news of high profits from selling Januvia, which is right now their big new moneymaker.
Given the role that Januvia plays in their business plan, and this evidence that the company is willing to sacrifice the lives of tens of thousands of people to earn its profits, what hope do you think there is of getting a straight answer about Januvia's cancer risk.
If the company ever researched Januvia's effects on other DPP-4 related functions, like preventing cancer--which we can guess they have, since they've published a study showing it might be helpful for the inflammation of arthritis--any result that suggested any danger to the people taking Januvia has gone to the same place as Karl Rove's incriminating emails.
April 12, 2007
So this week I'm taking 500 mg of regular metformin before meals (3 times a day) instead of the 1500 mg of Metformin ER which I've been taking at 10:30 AM.
So far, I'm not seeing any dramatic difference in the blood sugars, and, in fact, the post-lunch number isn't as good as before. I have noticed a stronger gastrointestinal effect: more gas and more frequent bowel movements. I'm going to give it a few more days but it looks to me like the Metformin ER has as strong an effect on the body with the advantages of less side effects and less need to remember to take the pill, since I take them all at once.
Dr. Bernstein contends in his latest book that the Glucophage brand of metformin is stronger than the generics. I haven't checked this out, but I did take the Glucophage XR version for a month without noticing anything dramatic. However, I have noticed very significant differences between other generic brands of metformin. If you aren't getting good results with yours, it might be worth asking the pharmacist if he has another generic brand you can try and see if it makes a difference. My pharmacist always fills my ER prescription with the Teva brand ever since I mentioned I was seeing much better numbers with it.
April 9, 2007
Here is the link to a page on my "What They Don't Tell You About Diabetes" web site that has links to the relevant peer-reviewed research that documents the effects of DPP-4 on both wound healing and the turning of normal melanocytes to maglignant melanoma cells.
Scroll down to the "Januvia" section to find the links and discussion of this topic.
I wish to reiterate here that my experience with Januvia was very positive and it was with great regret that I gave it up. But as a melanoma survivor, I do not feel it is safe to take this drug until I can get a solid answer to the question, "Since we know that DPP-4 inhibition is closely connected with the transformation of normal melanocytes (pigment cells) into malignant melanoma, do we know that inhibiting DPP-4 with Januvia (sitagliptin) does not promote this transformation?"
The cancer testing reported in the Prescribing Information does not answer this question because the in vitro testing does not look at the kinds of cancer cells that are uniquely sensitive to DPP-4 inhibition and the rodent tests are questionable because rodents are not at great risk for melanoma given that they are covered with fur.
In addition, rodent life-spans are short, as was the period in which this new drug was testing. So we know nothing about the effect of DPP-4 on slow growing human cancers over a five or ten year period. This is a drug that will be taken every day for decades if it works, so this is not a trivial issue.
Prostate cancer cells are also sensitive to DPP-4 inhibition, and since many men in their 50s have slow growing prostate cancers, establishing that Januvia's inhibition of this protease does not promote the invasiveness of that slow-growing cancer is important, too.
So, to reiterate: I am not stating that Januvia promotes cancer. I'm stating that I cannot find any peer-reviewed research into whether Sitagliptin's DPP-4 inhibition has an effect on DPP-4 sensitive cancer cells. I do find a body of research that establishes that DPP-4 inhibition is a significant feature of some cancer cells at the time they become malignant and that restoring DPP-4 expression can reverse the malignancy.
If we had not seen evidence over the past couple years that drug companies suppress laboratory evidence that could hurt the sales of their expensive drugs, I wouldn't be so concerned. But we have seen this process exposed repeatedly over the past couple years.
Januvia was approved much more quickly than any other drug that uses a novel method to achieve its ends. The DPP-4 protease it inhibits is used all over the body, not just in the pancreas and digestive system, so suppressing it enough to get dramatic effects in the pancreas can be expected to cause dramatic effects elsewhere in the body, some of which might turn out to be tragic.
If you can point me to data that addresses this issue, please let me know. I'm not happy about having my blood sugars go back to where I'm probably going to have to go back on insulin at meals.
I tried Byetta, but it was like getting hit by a truck. Obviously, I'm very sensitive to small amounts of GLP-1 or Januvia wouldn't have worked for me. Byetta sent me into hypo territory and pushed my blood pressure way, way up. Then I saw higher than usual blood sugars in the hours after it started wearing off. If I'm going to be injecting something, fast acting insulin is a much better choice for me. I didn't gain weight during my year on insulin because I use small doses and tailor it closely to my carb intake.
April 6, 2007
Here's what's changed now that I'm off the drug:
1. My appetite has returned. Not that ravenous "feed me or I'll kill you" hunger thing that comes from blood sugar fluctuations, but my appreciation for whatever it is that is in my mouth. This makes me realize my interest in food had been really muted, possibly by some change in the brain or digestive system. Not so coincidentally, that explains why I was able to diet at an average of 1150 calories a day for a whole month while on the Januvia.
Here's an example of what I mean: For the last couple weeks while on the Januvia when we'd gone to the local pizza house for our usual lite dinner of 1/2 slice of cheese pizza with a huge salad, I'd found I could barely choke down the salad, which I remembered as being one I really liked. Yesterday we went in and after a few bites of salad I thought, "This salad is great!" I enjoyed every bite.
2. My digestive system is working again. I had noticed bloating after almost every meal, no matter how small, on the Januvia as well as increasing constipation. A few people on the diabetes.blog.com Januvia blog had insisted that this could not be caused by Januvia, claiming it did not cause delayed stomach emptying. But within 3 days of stopping Januvia I stopped experiencing bloating and everything started moving through the whole digestive system quite comfortably. One "side effect" of the normalizing of the digestive system is that my weight dropped another two pounds though I'm eating more than I did all last month. I think this reflects less stuff in the stomach and gut.
3. I am still getting frequent sinus headaches, alas, so it's possible I developed a mild sinus infection while on the Januvia which will take a while to resolve, or that the headaches aren't related, though headache is a commonly reported side effect with both Januvia and the other incretin drug, Byetta.
4. My blood sugar stayed excellent for several days after stopping the Januvia and it is still tough to decide if it is worsening. I'm not seeing as many readings in the 80s, but I am still seeing some, and since I never saw a reading in the 80s before starting insulin fifteen months ago, that is news. My fasting blood sugars went into the low 90s the last couple days and today it was back up to 106 mg/dl, though I slept in late which might have affected this. But my usual fasting blood sugar with metformin but no other drug is 108-120 mg/dl both waking and 4 hours after a meal, so I'll be looking at those fasting numbers very carefully in the next couple days.
I'm wondering if perhaps I was taking more Januvia than I needed, hence the growing effect on the digestive system. I am not all that big, and the "one size fits all" Januvia dosing has always made me wonder. Why should 141 pound me be taking the same dose as someone who weighs 280 lbs? So if I ever go back to Januvia I'll try taking a lower dose. But for now, I'm staying off it.
At the doctor's suggestion I will try Byetta now that the Januvia is officially cleared out of my system. (The Januvia Prescribing Information states that using radioactively labeled Januvia they were able to demonstrate that it is 100% eliminated from the body in one week.)
But I'm going to wait a bit longer to see if the remaining blood sugar improvement goes away or if the combination of the year on meal-time insulin and the 3 months of Januvia taught my beta cells some new tricks.