Court Case: How One Drug Company "Buried" Evidence Showing Its Drug Caused Diabetes

If you have a strong stomach, take a look at this news story:

AstraZeneca Seroquel Studies ‘Buried,’ Papers Show.

The data is coming out ten years after the malfeasance described here which resulted in the information being hidden from doctors that the expensive new drug, Seroquel, was less effective than older, cheaper drugs, and that there was solid evidence that it caused both weight gain and diabetes.

As many of you have learned the hard way, the diabetes that the atypical psychotic drugs like Seroquel causes may be irreversible. It is probably not caused by the weight gain experienced in people who take these drugs, as the story suggests. Instead, as is so often the case, the weight gain probably occurs after it breaks something that causes blood sugars to rise high enough to increase insulin resistance.

What's really tragic here is that people took Seroquel because the company hid the data suggesting it was less effective than halperidol, an older drugs whose problems were well understood.

But my reason for highlighting this study is not just because of what it shows us about how Seroquel was marketed, but because it alerts you, once again, to the techniques that have been used by all the drug companies selling expensive new drugs and makes you aware of how far they are willing to go to convince doctors to prescribe these new drugs to you even when they have internal documents warning that these drugs may not be effective and that they may do patients harm.

Because it takes at least a decade for the real problems with widely prescribed drugs to become evident enough that drug makers are forced to surrender internal documents to the court, it will be another 8 more years until the public learns about the mismarketing of today's new drugs. Between now and that time, hundreds of thousands of people will experience irreversible, life-altering side effects from ineffective drugs that in some cases will end their lives prematurely and in others, as is the case with Seroquel, will add other chronic disorders to their health burden.

But because so much ugly truth has leaked out about the drugs of a decade ago, there is a change in how drug companies are operating. Today's drug company will commit errors of omission rather than squelching of results. If you don't do a study looking into something that a reasonable scientist would assume should be investigated, given how a drug affects the body, you won't end up with a result you have to hide.

So you won't be seeing studies looking to see if people taking Januvia have a higher rate of cancer if they keep taking this drug longer than the 18 months that acceptance trials lasted, even though the mechanism by which Januvia works is known to shut off tumor fighting genes. This is true, even though there was a slight hint in acceptance testing that even in 18 months cancers were rising in people taking Januvia. The company cleverly spun the way it reported tumors so that this finding was obscured.

Several non-drug company researchers who work with DPP-4, the protease suppressed by Januvia, have told me that this is a valid concern and one that should be investigated. But given the role drug company money pays in research today, no university is going to sponsor research of this kind. They are too dependent on that drug company money which would be shut off were they to blow the whistle on this highly profitable new family of drugs.

You have only to look at how the maker of Avandia threatened the university that employed the researcher who tried to blow the whistle on Avandia's relationship to heart attack, to see the power of this threat. Avandia's heart attack risk stayed hidden and the researcher was muzzled. Few universities can afford to defend lawsuits threatening $4 billion dollar damages.

Read about the $4 Billion Law Suit Used to Muzzle the Avandia Whistle Blower HERE.

By the same token, you won't find much new research looking into the incidence of blindness in people who took Avandia or Actos for more than a decade, though we now know it increases macular edema. You won't find studies that follow people who took Avandia or Actos for 15 years to see how many of them end up in nursing homes with broken hips, though we know these drugs increase the incidence of serious osteoporosis in older women.

Drug companies pay for most drug studies, and they have learned from what happened to Avandia to avoid doing any studies of already successful, approved drugs that might turn up anything troubling.

And even when they do conduct studies they are careful to avoid asking any questions but those where they already know the answer. When testing the effects of powerful new statins, for example,they don't include measures of cognitive function, before and after people spend five years on the drugs, because if they were to do so, they'd have to let you know that whatever benefits these drugs have are countered by their tendency to cause cognitive problems in older people.

Bottom line: Be wary. Don't believe everything you read in published studies because the data has often been analyzed in ways that obscure important findings, or the study design itself or the selection of study subjects may have been tinkered with to provide a result that would boost sales. Remember that negative studies often do not get published.

Take as few pharmaceutical drugs as you possibly can. When possible take older drugs that have survived the test of time, whose real side effect profile is known, and which are out of patent so that there is no financial motivation for companies to promote them with tricks.

A Place for Patients in the Health Care Discussion?

I have a grave concern that the discussion about health insurance reform taking place at the highest levels of government it taking input from everyone but us, the patients.

Insurers, doctors, and drug companies are involved. So are organizations like the American Diabetes Association. The latter present themselves as if they were advocates for patients, but those of us who have been involved in diabetes advocacy for any amount of time know that this is not, in fact the case. This organization and others like it (American Heart Association, American Cancer Society) raise money from patients, but primarily serve the needs of those who profit from patients: drug companies, food companies, and doctors.

Because there is no organization of patients--most of whom are too sick or overburdened with just getting through daily life to spend their time in political activity--patients are at serious risk.

For example, the idea that "evidence based medicine" is the solution to cost cutting means that the poorly designed and badly conducted studies that "prove" that testing blood sugar is useless for people with diabetes may mean that you won't be given test strips any more. The studies that "prove" that lowering A1c is worthless--again poorly designed and sloppily conducted, may keep you from getting the drugs you need. There are bad studies that show that insulin is worthless for Type 2s. There are studies that pretty much prove that you would be better off going to a Witch Doctor than an MD for help with diabetes.

And if health reform goes in the direction it looks like it may be going, the witch doctor may be the only doctor your new health care will pay for you to see. With a huge co-pay.

I am really worried about this.

Diabetes on a Budget

Diabetes is expensive. Test strips, drugs, and food that doesn't raise your blood sugar all cost money, but for a lot of us, the money to pay for these necessities has become hard to find. If you are finding yourself in a crunch here are a few ideas that may help.

Test Strips
If you don't have insurance coverage test strips are obscenely expensive and the cost is getting worse every month. Still, used properly they can be the most powerful tool you have in the battle to avoid blindness, amputation, and kidney failure--all of which have been linked to blood sugars that stay above 140 mg/dl for a few hours each day.

You can often find deals on brand name strips online. Amazon features several merchants offering Test Strip Deals. From the customer feedback it appears that these are legitimate, though you may receive strips that are a few months from their expiration date. This should not make any difference in how they function.

Some people have found good test strip deals on eBay. Avoid ordering strips when it is very hot, as they may be damaged by sitting in a very hot truck.

The Relion brand meters and strips sold at Wal-mart are much cheaper than the name brand strips. In my experience they do not appear to as accurate as the Ultra meters, but they are similar to the Accu-Cheks. Meter accuracy is a whole nother topic which we won't go into here. If you are not using insulin to achieve very tight control, the Relion meters are fine. If you are, you might want to pay a bit extra for the name brand strips.

The drug store generic brand strips I used to recommend though slightly less expensive than the name brand strips have become much more expensive. I no longer recommend them.

To cut down on how many strips you use, make it a policy to ask yourself, before you test, "What action will I take based on the reading I am about to see?" If you do not plan to use your test result to make a specific change in your food intake or drug dose, don't test. It is easy to get into the habit of testing and to test because you are curious, rather than because the result you see will cause you to take action.

If money is really tight and you cannot afford test strips, you may be able to extract useful information from the urine test strips that measure glucose in urine. These come in packs of 50 and should not cost more than $10. You can use a scissors to cut each strip into 3 or 4 thinner strips without affecting the strip's function. How useful these strips will be for you depends on your own personal "renal threshold for glucose." This is the blood sugar level at which you start to dump glucose in your urine.

How high this level might be varies from person to person. At one extreme, there are people who will see glucose in their urine when their blood sugar is slightly over 140 mg/dl (7.7 mmol/L). At the other, there are people like me who only see glucose in their urine when their blood sugar goes over 250 mg/dl (13.8 mmol/L). Few people will fall at these extremes. Most people will spill a detectable amount of glucose in their urine when their blood sugar exceeds 160 - 180 mg/dl (8.9 - 10 mmol/l) for more than a short time. It is important to understand that it takes time for high blood sugars to translate into high glucose in urine. So a high result on a urine test strip tells you that your blood sugar was high 2 or 3 hours before.

If you have some blood sugar test strips and your money is running low, it might be a good idea to buy some urine test strips and to see if you can determine how high your renal threshold for glucose is. Test your urine with a strip two hours after you see a high value on your blood sugar meter test strip. If your threshold is not too high, you may be able to use the urine test strips to confirm that you are avoiding dangerous highs.

Many people who developed Type 1 diabetes in the 1930s and 1940s were able to maintain their long term health long term without access to reliable testing. If you use whatever strips you can afford to determine how high a set amount of carbohydrtae raises your blood sugar, and scrupulously avoid eating more than the amount that pushes your blood sugar over your chosen blood sugar targets, you can preserve your health too.

Type 2 Diabetes Drugs
Though doctors are much too quick to prescribe the newest, most expensive diabetes drugs there is little evidence that these new expensive drugs are any more effective than the older drugs that are available as generics. With most pharmacies and supermarkets selling generic drugs for $4 a prescription, you can afford these effective diabetes drugs.

The best drug for most people with Type 2 diabetes is Metformin. Plain Metformin and Metformin ER, the extended release form that is easier on the stomach, are both available as generics. Some generic brands appear to be stronger than others, so if you aren't happy with the results you are getting with one brand, ask the pharamacist to try another, or if that isn't a possibility, switch your prescription to another pharmacy that dispenses a different generic brand. The pharmacist will tell you which brand they dispense if you ask.

Amaryl is also available as a generic. It is a sulfonylurea drug. Though this is not a drug I recommend to people who have a choice of medications, if you don't have a choice and it lowers your blood sugar, Amaryl is a lot better than nothing. Avoid glipizide as its potential for causing heart attack appears to be higher than that of Amaryl, though its effect on blood sugar is similar.

Insulin
If you do not have health insurance coverage you will find the analog insulins most doctors prescribe obscenely expensive. These include Lantus, Levemir, Humalog, Novolog and Apidra. Fortunately there are older, insulins that are much cheaper which you can use instead. These cheap insulins are sold only at Wal-mart and are the Relion Novolin R, a faster acting insulin, and the Novolin NPH, which is a longer acting insulin. (Other pharmacies may sell NPH and R but they sell them at a much higher price.)

These insulins have different activity curves than do the analogs. Read Dr. Bernstein's Diabetes Solution for complete instructions on how to figure your doses with these insulins. The R insulin works best with a lower carbohydrate intake. NPH can be made to act as a basal insulin if you use it very cautiously and understand that it does have a peak.

If you cannot make these insulins work, ask your doctor to file the paperwork to get you insulin via one of the hardship programs that help people who are insulin dependent. If he can't, call the largest regional hospital in your area and ask to speak to a social worker about how to sign up for one of these programs.

Here is another useful resource if you are low income:

PPARx.org

Thanks to Bamagal for contributing this link.

Food
If you have been eating a low(er) carb diet you may have come to rely on expensive meats and fresh vegetables and fear that it is not possible to control your blood sugar on cheaper fare. This is not true. There are long discussion threads on how to eat a very low carb diet on a budget HERE.

A crockpot is a worthwhile investment as you can use it to turn tough, cheap cuts of meat into delicious stews. Shop carefully and only buy meat on sale. You can often find good deals on meats like pork chops and roasts (pork chops have been selling for $2 a lb in my region recently.) Often the better quality meat on sale is much cheaper than hamburger or other ground meat which people think of as bargain fare. Chicken thighs and mixed parts are often on sale at very cheap prices. Even chicken breast goes on sale from time to time at $2 a lb. Fresh ground store brand sausage may also be a good, cheap, filling choice.

Frozen vegetables are as nutritious as fresh and can be bought in cheaper larger sizes.

Cheese may seems expensive when you look at the per pound cost, but you can get high quality nutrition from eating only a few ounces. Cheese, too, goes on sale from time to time and you can stock up when your favorites are on sale.

Eggs continue to be a great food bargain. Omelets or fritattas made with cheese and/or frozen veggies are low carb and very good for you.

If you have tips to help others manage diabetes on a budget, please post them in the comments section. (Click on the "n comments" link immediately below this message to get to the comments section.)

Avoid Phosphates and Preserve Your Kidneys

I first became aware of the relationship between phosphate consumption and kidney failure a few years ago when I read the study that linked the consumption of brown cola drinks containing phosporic acid--both diet and regular--to the likelihood of developing end stage renal disease. (Diabetes Update: Coke Adds Death).

Now there is more evidence accumulating that phosphates present elsewhere in the food supply might also be posing a threat to kidney health.

Science Daily: Hidden Phosphorus Food Additives Dangerous To Kidney Disease Patients

The researchers cited in the article above point out that the problem of overconsuming phosphorus is not limited to people on dialysis.

This should be an issue of concern to anyone with diabetes because so many of us have already suffered some damage to our kidneys from the years of undiagnosed high blood sugar that usually precede a Type 2 diabetes diagnosis. This early damage, which is usually revealed by a higher than normal result on the microalbumin urine test, can be reversed if we lower our blood sugars and keep them in the normal range.

But if we are at risk the last thing we need to be doing is further stressing our kidneys.

The Case Western Reserve University's Medical School, where this research on hidden phosphates was done, provides a web site that provides lists of the menu items sold at fast food chains that contain dangerous amounts of phosphates. You'll also find, at the bottom of the page links to relevant published peer-reviewed studies.

Fast Food, Phosphorus Containing Food Additives, and the Renal Diet

After reading this article, I realized that the baking powder I use to make low carb pancakes--the one many of us use because it does not contain aluminum compounds, contains phosphates.

Here's the solution I came up with to replace the baking powder: Combine 1 teaspoon lemon juice with half a teaspoon of baking soda. It worked fine.

A Simpler Link to "test, Test, Test"

The one problem with my diabetes site is that the page names are computer generated and hard to remember. So I just put together a new, easy to remember link that will take you to the page that describes how to get your blood sugar under control. This is my rewritten, updated version of the Jennifer's Advice page that is posted around the web and which has helped thousands of people join "The Five Percent Club."

Either version will work:

http://bloodsugar101.com/testtesttest.php

http://phlaunt.com/diabetes/testtesttest.php

This should make it easier to remember the link so you can pass it on to friends who might find it helpful.
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In other news, I just received word that J.C. Hartmann, one of the founders of the alt.support.diabetes newsgroup and one of the first promoters of the "5% club" concept has died at the much too young age of 57. I do not know the details, but I do know that the world has lost a wonderful, helpful person.

Alt.support.diabetes during its heyday was a supurb source of support and information for people with diabetes. It became overwhelmed with spam over the past couple years and I no longer recommend it, but without it I would not have anywhere near the understanding of how many different ways people have found to control their diabetes and recover normal health.

Quite a few of the early web diabetes pioneers have passed on. Ottercrittr and Jude Crouch, for example. They both died of cancer. Both were very good people who left enduring legacies in the help they gave to others.

Type 2 Diet Poll Results

UPDATE: Added 7 more data records collected from posting poll of Low Carb Friends discussion board. All statistics were reanalzyed, but the medians did not change.

I also added an analysis of the data from those who maintained weight losses for 5+ years.
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I've taken the information contributed by people who responded to the poll in the comments posted to the previous post and done what I could to standardize the responses in a way that makes it possible to analyze this data.

Fifty-one people contributed data. Of these 49 had Type 2, 1 had MODY and 1 had Type 1.

Two reported a weight gain.
One maintained a stable weight for 40 years but is probably not a Type 2.
Three reported no weight loss or a completely regained the weight they originally lost.

Weight Loss
Of those who lost weight and maintained some of that loss, 42 contributed information which allowed me to calculate what percentage of their starting weight they were able to lose and maintain.

The time framee people reported for their diet ranged from 40 years to just started, with a median time of 2 years.

The amount of weight loss that had been maintained ranged from 190 to 6 pounds, with a median maintained loss of 50 lbs.

The percentage of starting weight that was maintained ranged from 50% to 3% with a median maintained percentage of starting weight lost of 20%. The standard deviation of percentage of starting weight lost and maintained, which is a measure of how closely these percentages cluster around the mean was 10.5%. So most people who maintained maintained a weight loss that was between 9% and 31% of their starting weight.

This is probably the most important statistic of all as it gives you a very good idea of what a realistic weight loss is that you can expect to maintain.

People lost weight using a variety of techniques. Cutting back on carbohydrates was the most common. Thirty-eight respondents reported following some form of a Low Carb diet. Thirteen people reported using ketogenic diets--Atkins, Bernstein or under 60 grams a day of carbohydrate. However, it is possible some of the others who merely reported "low carb" diets were also eating ketogenic diets.

Fifteen respondents attributed weight loss to portion control or counting calories. Ten cited walking. Ten cited "exercise." These methods were often combined and occurred with and without carbohydrate restriction. The biggest weight loss was reported by someone who had Gastric Bypass who reports that severe health problems resulted.

Weight Regain
Twelve people reported significant weight regain. In general, the greater percentage of original body weight they had lost, the more they were likely to regain.

What really stands out is that after regaining, the weight at which these dieters who regained weight were finally able to maintain at was very close to a 20% loss from their starting weight.

This suggests very strongly that a 20% loss from starting weight is the most maintainable weight loss for most people.

Long Term Maintainers
There were 13 people who maintained their weight loss for 5 or more years. This is 25% of all people reporting and a remarkably high percentage. This result might be skewed by the self-reporting nature of this survey.

The largest percentage loss (excluding the loss from surgery) was 33% but 7 of the 10 for whom I have weight loss percentage information maintained a weight loss of 20±3 lbs of their starting weight. This is yet another bit of information that points to 20% as the ideal weight loss percentage to shoot for.

Blood Sugar Control
Five respondents out of 44 who had Type 2 reported that their blood sugar control had improved and they could tolerate more carbohydrate. One with IGT reported significant improvement.

Another 4 reported that they could tolerate slightly more carbohydrate.

Thirty-five reported no change in blood sugar control after weight loss with three stating emphatically that it did not help their blood sugar at all or that blood sugar control got worse.

However, the most important statistic relevant to blood sugar control was that all but 7 respondents reported that they continued to control their carbohydrate intake. So reported blood sugar "improvement" in most cases was dependent on continuing to eat a carbohydrate restricted diet, not because of any true change in their ability to metabolize carbohydrates.

Conclusions
These results suggest that a realistic weight loss that you can expect to maintain would be one that ranged between 10 and 30% of your starting weight, with 20% being the most likely maintainable percentage of weight loss.

They also suggest that losing weight will rarely normalize your blood sugar or "reverse" your diabetes. However, if you use a low carbohydrate diet approach of any type, you can expect to improve your blood sugar control if you continue to stick to some form of carbohydrate restriction.

Those who lost weight relying on portion control and/or exercise may also have to maintain those behaviors to retain any improvements in blood sugar control.

There is no clear cut weight loss advantage to any particular diet plan, as far as producing weight loss. Low carb diet plans appear to be somewhat easier to maintain long term if they lower carbohydrate enough to keep blood sugars controlled and avoid the hunger several people reported with higher carbohydrate weight loss diets.

People lost and maintained weight loss for several years on very low carb and moderate carb plans. Weight gain occurred on various plans too, independent of the carbohydrate intake.

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Note: Please feel free to continue to contribute data to the poll in the previous blog post. If enough new information comes in, I will reanalyze it.

Please Participate: Poll About Diabetes and Weight Loss

Satisfy my curiosity by answering the following questions by replying in a comment:

1. Did you lose weight intentionally after your diabetes diagnosis?

2. How much did you lose? What percentage of your starting weight was this?

3. How did you lose it?

4. Did you keep the weight off 1 and 5 years after you lost it?

5. Did the weight loss make a difference in your blood sugars in terms of changing how much carbohydrate you could eat without spikes?