The Diabetes Economy

When your doctor writes you a prescription is it really for your health, or the financial health of a pharmaceutical company? You’d think that your doctor would do what is best for you, but in many cases they guidance they get from the FDA and the medical community is biased and based on the wishes of the pharmaceutical industry.

Take for example diabetes drugs. in 1997 a group of experts met with the american Diabetes Association and modified the definition of what type 2 diabetes is. With that one recommendation all of a sudden 1.9 million Americans suddenly had type 2 diabetes.

The same thing happened in 2003 where they change the definition of pre-diabetes and all of a sudden 25 million people had pre-diabetes. In the years that followed they found drugs that could treat pre-diabetes if exercise didn’t work. Sadly for many people they’d much rather take a pill than exercise. So with those changes in how a “Disease” is defined boosted diabetes drug sales to over $23 billion last year.

Now why would you want to lower your blood sugar? Wouldn’t it be to reduce heart disease, stoke, loss of limbs, or blindness due to diabetes?  Well of the 30 new diabetes drugs intruded in the past decade none was tested to see if it lowered the risk of any of the side effects of diabetes, they only lowered the blood sugar level. Worse yet some of the side effects can be dangerous. In one investigation they found 3,300 cases where these patients died from the side effects of the drugs and another 20,000 were hospitalized.

Yes, diabetes is a serious disease and increasing at epidemic rates. Rather than focusing on reversing the disease there is a who economy around diabetes drugs which is fueled by organizations and doctors with financial ties to drug companies. this was found by MedPage Today and the Milwaukee Journal Sentinel investigations.

How much corruption is there? Below are some numbers:

  • The organizations that lowered the diabetes and pre-diabetes thresholds each received millions from drug companies.
  • In one instance 13 of 19 members of a committee were paid more that $2,000,000 each in consulting and speaking fees by the companies that make the drugs. This is a way drug companies frequently funnel money to doctors and other organizations  – They pay them to speak and industry meetings and to lend their expert consulting advice to the drug companies.

This isn’t just a problem for diabetes drugs, but for many drugs. Take statin drugs for cholesterol control. Every couple of years the the healthy cholesterol target level is lowered, and in the stroke of a pen (or keyboard) millions more people are put on statin drugs like Lipitor, Crestor, Zocor and many others, and with that billions of dollars flow to the pharmaceutical companies.

They say there is no cure for type 2 diabetes, yet for many people those who begin exercise, lose weight, and greatly reduce their junk food consumption, they can get off of diabetes drugs and insulin injections.

A low glycemic diet is the secret. That is a diet which greatly reduces the foods that spike your blood sugar such as sugar, white flour, white rice, potatoes, etc.  Replace those with 100% whole wheat and grain, wild rice (key is it cooks for 30+ minutes). Also lots of vegetables, good fats, lean meats, and fruits.  Change the diet, lose weight, and exercise and you’ll feel better, look better, and avoid the problems of diabetes plus the other

 

Source: MedPage Today. Dec 12 2014 The Slippery Slope: A Bittersweet Diabetes Economy 

What they don’t tell you about the latest “Scientific” research

Did you ever notice how many reports there are on the news about nutiritonal supplements not working, organic food is no better, and if you remember way back, that smoking wasn’t harmfull either.  But then there is another whole segment of the population (like me) who do say supplements can make a difference, organic is better, etc. So who is right?

This is all about the design of studies and the statistics they use. Lets look at each of these:

Design of Research Studies

Without going into great detail, lets just say that if someone has a preconceived idea of how they want the results to turn out they can design the study to support that. For example:

  • A study a year ago said that calcium didn’t promote bone growth as well as the popular prescription drugs for osteoporosis. The recommendation – Get off of calcium and just take the drugs.  The study looked at people supplementing with just calcium, or calcium plus vitamin D. The result, little bone regrowth. What they left out of the design was including magnesium, boron, silicon, and vitamin K. To regrow bone you need these in addition to calcium and vitamin D.  Had they included all these ingredients in the supplements, then the results would have been much different as many other studies have shown.
  • A recent study said that supplementing with calcium led to increased risk of arteriolosclerosis (hardening of the arteries). Same as the study above, they left out several key ingredients like magnesium. If calcium and magnesium are taken in a 2:1 ratio, then there is no arterial hardening, or much less.
  • How the subjects are selected. There was a very widely published study several years ago saying vitamin E had no effect on heart health. There were two problems here, one was they only looked at people who already had had a heart attack and could vitamin E alone prevent a second heart attack over a fairly short time. The other common problem is that they look at a single vitamin in isolation like they were studying a drug. You never eat a food that has only vitamin E, foods have a whole range of vitamins and minerals. For example vitamin E and C work in conjunction with each other.

Fun with statistics

Statistics are very complex and few people are truly experts at statistics and statistical model design. You many times hear about some results on the 5:00 news. If you look at the summary of the study they will often say “Researchers found that in a meta-analysis of……”  They key word there is meta analysis.
Meta analysis isn’t a separate study, but what the researchers have done is culled over a number of other  studies and then done some analysis on the combined results of those studies. Meta analysis isn’t inherently bad, but like above, it is often how they select the studies for inclusion in the analysis. Their selection criteria can swing the results any way they want.

Follow the Money

Now the real root of the problem with many studies – Who paid for the study.  There was a study done of medical research studies and how often the results turned out supporting the sponsors product or company. If you look at many of the studies which find that vitamins and minerals don’t work, they are often funded by a pharmaceutical company.  Pharmaceutical companies know that high quality supplements can be very effective against a number of conditions, but they want the public to take their highly profitable drugs, so they commission a study and guess what, if someone pays you $300,000 to study something, you’re probably going to give them the results they want, so you get another $300,000 to study something else.
Like the recent study which came out of Stanford a few weeks ago which said that organic foods are no healthier than conventionally grown foods. Guess who funded his study? Yep, the food industry which does not want to list Genetically Modified Organisms (GMO) on the label. If a food is contains GMO ingredients it can’t be labeled organic, so if they can dissuade people from buying organic, then they can hope they can get one step closer to defeating the California ballot measure to require disclosing GMO ingredients.  This was the same researcher who back in teh 60’s was publishing studies which said smoking cigerates wasn’t harmful – he was funded by the tobacco industry then.

Aspirin May Cut Colon Cancer Deaths

Study Shows Long-term, Low-Dose Aspirin Cuts Risk of Aggressive Colon Cancer
Long-term use of low-dose aspirin reduces colon cancer risk, U.K. researchers find.
Low-dose aspirin takers have a 24% lower risk of colon cancer and a 35% lower risk of dying from colon cancer, find University of Oxford researcher Peter Rothwell and colleagues.
“The new findings on the effect of low-dose aspirin should be included in advice given to the public,” Rothwell says in a news release.
The findings are based on analysis of 20-year follow-up data from five clinical trials. All of the studies were performed before sigmoidoscopy and colonoscopy became widespread methods of screening for colon cancer. It’s not clear whether better screening reduces the benefit seen for aspirin.
And aspirin can have serious side effects, including severe stomach bleeding. While low doses of aspirin reduce this risk, people should consult a health care provider before adding aspirin to their daily health regimen.
However, the findings suggest that aspirin has a particular effect on more aggressive and faster growing colon cancers, particularly those in the proximal colon, which can be detected by colonoscopy but not by sigmoidoscopy.
This makes the study findings significant, says Alison Ross, senior science information officer at Cancer Research U.K.
“This is the first large study to show that low doses of aspirin may be effective in protecting against bowel cancer,” Ross tells WebMD via email. “Once it’s confirmed that the benefits of taking low-dose aspirin outweigh the risks, clear guidelines will be needed to help doctors inform their patients about long-term use.”
Alison Ross, senior science information officer at Cancer Research UK, says via email: “Aspirin can have side effects, including stomach ulcers and internal bleeding. It should not be taken regularly without first talking to your doctor.”
The Rothwell study appears in the Oct. 22 early online edition of The Lancet.

New study questions effectiveness of popular cholesterol drugs

A widely prescribed and expensive cholesterol drug is not as effective as niacin, a cheap vitamin, in helping to unclog coronary arteries in people already taking statins, the standard medicines used to lower cholesterol, according to a new study.

The research, which appears Monday in the New England Journal of Medicine, is sending rumbles through the medical community because it is the third recent study to raise questions about the effectiveness of Zetia and its sister drug, Vytorin, highly profitable pharmaceuticals made by Merck & Co.

“This is the third strike,” said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “The studies are telling us that it doesn’t appear to produce benefits. This is a drug used by millions of Americans, a very big seller, in a health-care system where costs are a major issue. And the question has to be, is this the right approach?”

Vytorin and Zetia are among the most popular prescription drugs. Last year, physicians in the United States wrote a total of more than 29 million prescriptions for them, and worldwide sales totaled $4.56 billion, according to Merck.

Although the drugs have been shown to reduce cholesterol, there is no evidence that they prevent heart attacks, strokes and other cardiovascular problems.

Top Merck executives are vigorously defending their drugs and have dismissed the new research as limited.

“I don’t think a clinician or a doctor or a patient should use this as the basis for any decision-making whatsoever,” said Richard Pasternak, vice president of Merck research laboratories. “I worry that people might unnecessarily come off a drug that is approved and accepted.”

He and other critics said the study appearing Monday involved just 200 patients, was ended early, and examined what is known as a surrogate marker — the amount of plaque on artery walls — rather than evaluating the rate of heart attacks and stroke.

Because plaque can clog arteries and restrict blood flow to the heart and brain, cardiologists view plaque as a good indication for the risk of heart attack and stroke.

The study has been highly anticipated by the medical community and financial analysts, and is the buzz at the annual meeting of the American Heart Association, which began Sunday in Orlando.

Introduced in 2002 and 2004 amid heavy direct-to-consumer marketing, Zetia and Vytorin became blockbusters for Merck and Schering-Plough, which had collaborated on their development. The companies recently merged.

But new research has placed the drugs under greater scrutiny and the number of written prescriptions has been slipping, although together they still represent big business for Merck.

Last year, a study released by Merck showed that Zetia did not reduce plaque in arteries compared with patients taking only statins, which are much less expensive and available in generic form. Although released in January, the study had been completed in 2006, prompting a class-action lawsuit alleging that Merck intentionally withheld unfavorable results of a clinical trial. The company paid $41.5 million in August to settle the claims.

Another study published last year showed a potential increase in cancer among patients taking Zetia and Vytorin, compared with those taking only statins.

Taken as a whole, the new research is unnerving, said Harlan Krumholz, a Yale University cardiologist. “The accumulating evidence isn’t giving you any confidence,” he said. “This is a very expensive drug being used without any strong evidence that it’s benefiting patients.” Zetia and Vytorin should be “drugs of last resort, if used at all,” Krumholz said. “And anyone who uses it should make sure patients are informed that they’re taking a gamble.”

Statins, such as Lipitor, have long been used to lower cholesterol and reduce cardiovascular disease. They inhibit the production of LDL, or low-density lipoprotein, often called “bad” cholesterol, which can lead to plaque buildup in arteries.

Zetia, the brand name for ezetimibe, uses a different mechanism. It blocks the absorption of cholesterol from food in the intestines. It has been shown by Merck to lower LDL by 18 percent on average. It is designed for patients who cannot tolerate statins, or for whom high-dose statins are not working.

Vytorin is Zetia combined with a statin, simvastatin, in one pill.

The study released Monday followed about 200 patients who were already taking statins. Some were also given Niaspan, a modified form of Vitamin B, or niacin. The rest took Zetia. Researchers took images of the artery leading to the brain to measure the thickness of the artery walls over 14 months.

The patients who took Niaspan had less plaque in their arteries and also had higher levels of high-density lipoprotein or HDL. Known as “good” cholesterol, HDL is believed to remove cholesterol from the arteries and carry it back to the liver, where it is passes from the body.

The patients who took Zetia had more plaque in their arteries but lower levels of LDL. They also had more heart attacks, strokes and other cardiovascular problems than the patients taking niacin. Merck President Peter Kim said the fact that Zetia lowers LDL cholesterol makes it valuable. “It’s very well established that lowering LDL saves lives,” he said.

Roger S. Blumenthal, a cardiologist at Johns Hopkins, criticized the new study in an editorial also published Monday in the New England Journal of Medicine. Blumenthal, who has been a paid speaker for Merck, noted that the new study was halted early, which meant results from 40 percent of the participants were not included in the final analysis.

The study’s author, Allen J. Taylor of Walter Reed Army Medical Center and Washington Hospital Center, said the trial ended early because the results were quickly apparent. “It couldn’t be more clear,” Taylor said. “It would have been unreasonable to continue the experiment because the trial had met its objective — niacin is superior to ezetimibe.”

Kim said any conclusions about Zetia and Vytorin should wait until Merck completes a large-scale clinical trial. It involves 15,000 patients and is not expected to yield results until at least 2012.

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Big Pharma Funded Recent anti Multivitamin Study

Below are the names of two of the pharmaceutical companies who were some of sponsors that funded the study I wrote about yesterday that Multivitamins are not effective against cancer and heart disease.

Author Affiliations: Amylin Pharmaceuticals, Inc, San Diego, California (Dr Patterson); and Medstar Research Institute, Washington, DC (Dr Thomas).

 

Regarding Medstar, they are involved in research and development of new drugs to treat a variety of diseases.
Here are a few statements taken from their own web page under research.

 

Perhaps most important is the chance to help scientists discover new medicines. evaluating if an investigation drug or device is better than one that is currently in use.
There may be some risk in participating in a trial. There may be unanticipated unpleasant or life threatening side effects to the treatment being studied. Because effectiveness is often what is being studied, the trial may conclude the experimental treatment may not be as effective as the established therapy.
So perhaps there is some conflict with complementary medicine, as many mds. do not believe in the benefits of supplements but are committed to the use of pharmaceuticals.