There’s been some research on this in the past. But none of it is as hopeful as these most recent findings.

Before we go any further, we want to let you know that the research is still in the preliminary stages. A definite conclusion – based on human trials – hasn’t yet been reached. But this news offers so much hope that we wanted to pass it along as soon as we heard about it. And if the research turns out to be true…you’ll want to be taking this extract now.

Dr. Rajesh Agarwal may be the man who’s going to prove it works. He leads research at the University of Colorado Cancer Center. His recent study shows the extract can kill head and neck cancer cells. But it didn’t harm healthy ones.

Dr. Agarwal says his results show “a dramatic effect.” He thinks his solution is vital because cancer cells grow very fast. The extract creates “unfavorable” conditions for cancer cells. So the cancer cells can’t grow…and then they die.

Stops Cancer in 2 Ways

The potential cancer cure is grape seed extract. It comes from whole grape seeds. These seeds are known to be high in vitamin E, linoleic acid, flavonoids, and polyphenols. One of those polyphenols is resveratrol, which has been in the news lately as a possible cancer remedy.

Dr. Agarwal tested grape seed extract on animals…and found it fights cancer in two ways. It damages the DNA of cancer cells. And it stops cancer cells from repairing.

Dr. Agarwal says he saw “absolutely no toxicity” from the extract. So that means it’s safe to use. He’s going to test the grape seed oil in human trials next. He thinks it may be an effective alternative treatment. And that’s good news for people who want to avoid conventional treatment.

The Effective Dose

Researchers think that 50 mg – 100 mg is the best dose. But their results are preliminary until a long-term study is conducted.

You won’t have any problem finding grape seed oil. You can pick it up online or at any health foods store. But you’ll find it’s mostly available in capsule form.

As we said earlier, it can’t hurt to start taking it now. It’s safe, natural and risk free. And research may prove down the road that it’s the key to preventing cancer.

To your best health,

Michael Jelinek,

Managing Editor, NHD “Health Watch”

But even if you’ve pitched those little yellow or pink packets, you and your loved ones may still be getting sweeteners every day. And you’ll never believe how you’re getting them. That’s because they come from the last source you’d ever suspect.

Poison From the Purest Source

A new report shows that 28 million Americans get artificial sweeteners every day. But they have no clue that they do.

The report comes from Dr. Douglas Mawhinney. He’s a leading scientist with the Southern Nevada Water Authority (SNWA) in Las Vegas. And before that he was a top toxicology researcher at Cornell University.

He looked at water samples from 19 different water plants. And he found that 15 of them pump out water that contains sucralose.

That’s a chemical usually marketed as Splenda. And it’s already the number one artificial sweetener in foods and drinks. But his new report shows that even people are getting it than we think.

And that’s a problem. Plenty of research shows that sucralose is one of the worst things for your health.

Packets of Death

A study from Duke University showed how bad it is for you. It was headed by a top researcher there – Dr. Bahie Abou-Donia. And you can read about his results in the Journal of Toxicology and Environmental Health.

He fed sucralose to lab rats for 12 weeks. At the end of the 12 weeks, he found that the rats on the sweetener had put on weight.

But then he decided to find out what was going on at the cellular level. So he killed half the rats, sliced them up and took a look inside.

And this is what he found.

The sweetener had destroyed the good bacteria in their guts. And that’s bad news for health. Plenty of research shows these good bacteria helps fight disease.

“Studies suggest these bacteria protect you not just from food-borne pathogens but from cold-causing germs,” says Dr. Justin Sonnenburg. He’s a top immunology doctor at Stanford School of Medicine.

And that’s not the only reason that these packets of poison are bad for you.

If you have any doubts how destructive they are…let us introduce you to Dr. James Bowen.

He got his MD from Johns Hopkins University School of Medicine. He was in the National MS School of Fame for his research and work. And U.S. News named him one of their Top Doctors.

But the real reason we’re telling you about him is because he’s spent 30 years looking into artificial sweeteners.

“Lying on the artificial sweetener issue has been the FDA’s Modus Operandi ever since Donald Rumsfeld put aspartame on the market,” he says.

And he says the truth is, these sweeteners are “toxic and patently unsafe for human use.”

Sweeteners Are One Chemical Bond Away from Bleach

“Synthetic sweeteners are unsafe for human consumption,” says Dr. Bowen.

And if you have any doubts about that, you should know they share a root source with things we all know are deadly.

“Sucralose is simply a chlorocarbon,” says Dr. Bowen

That might not mean much to you. It doesn’t have to. But you should know that other chlorocarbons are used in:

• Bleach
• Disinfectants
• Insecticides
• Hydrochloric acid

In fact…these things are so deadly they were even used in a WWI poison gas!

“It’s nature’s attack dog,” says Dr. Bowen. “A ferocious atomic element.”

And this connection explains why the Duke study got the results it did.

“Sucralose delivers chlorine into our cells through normal metabolization,” says Dr. Bowen. “This makes them effective insecticides and preservatives. Preservatives kill anything alive to prevent bacterial decomposition.”

So it’s easy to see why the Duke researchers found out that sucralose kills all the good bacteria in your gut.

“We shouldn’t be fooled into accepting toxic chemicals on the blessing of the FDA,” says Dr. Bowen. “In terms of long-term human toxicity we should regard sucralose with its chemical cousin DDT.”

But that’s not all that’s bad about sucralose.

The final bit of evidence against it comes from animal tests.

“Sucralose has been found to shrink (immunity) and produce liver inflammation in rats and mice,” says Dr. Bowen

And he’s right. Studies show that sucralose can make your liver swell and your kidney calcify.

“They attack the human nervous system and many other body systems including genetics and the immune function,” he says.

How You Can Keep Your Water Pure

Now you know just how bad artificial sweeteners are for you. So if you’re smart you’ll want to cut them out of your diet altogether.

But the fact that your drinking water may contain them doesn’t have to be a problem.

All you have to do is opt instead for bottled water. If you go this route though remember to buy water…that comes in glass bottles.

That’s because plastic bottles sometimes contain estrogen mimics and bacteria.

The other thing you can do is buy a filter to make sure your water is purified. And these filters also take care of other toxins that can also seep into your tap water.

Wishing you good health,

Ian Robinson

Editorial Director, NHD “Health Watch”

The study says a South American tea can kill colon cancer cells.

The research comes from Dr. Elvira de Mejia. She’s a leading food chemistry researcher at the University of Illinois.

She’s impressed by what the tea is capable of. She says it can make cancer cells literally self-destruct.

But that’s not the only way the tea combats cancer. She says it also slashes markers of inflammation. And that’s important because inflammation can trigger cancer growth.

Mechanism Leads to Cell Death

The tea is called mate tea. It comes from the yerba plant. (That’s a shrub that mainly grows in South America.) Mate tea is often compared to green tea because of its many health benefits. But their components are pretty different. Green tea is high in epigallocatechin gallate. Mate tea on the other hand is high in chlorogenic acid.

Dr. de Mejia says the tea damages the DNA of cancer cells and kills them. She thinks a compound in mate tea called caffeoylquinic acid (CQA) is what does the trick. As she increased the CQA concentration…the cancer cells died. And she thinks that’s because CQA reduces inflammation.

“There’s ample evidence to support drinking mate tea,” she says. “Especially if you have reason to be concerned about colon cancer.”

More Results Coming Soon?

Dr. de Mejia and her team are finishing another study on mate tea. It’s an animal study that looks at the effects of mate tea on colon cancer.

These early results certainly offer hope. And the next step will be testing it out in human trials.

In the meantime, you can buy mate tea bags in health food stores or online. Large supermarkets are now also starting to carry the tea. So you should have no problem picking it up.

As we’ve said, mate tea is all-natural and totally safe. So there’s no reason not to try it out.

It’s also very high in antioxidants, vitamins, and minerals. Those include vitamins B and C, manganese, potassium, zinc, quercetin, theobromine and theophylline. So those ingredients alone mean it’s loaded with health benefits.

We’ll follow these tea trials as they progress. And we’ll let you know when the newest results are available.

To your best health,

Michael Jelinek,
Managing Editor, NHD “Health Watch”

We’re going to tell you about a new way of tackling arthritis pain today…and one that’s been clinically proven to work. It’s safe, effective and comes from an all-natural source.

Dr. Edzard Ernst is the prize-winning doctor behind the research. He’s a leading scientist at the famous University of Exeter in the UK. And he was the very first professor of complementary medicine in the world.

Dr. Ernst says clinical data shows that this extract really works “for the treatment of osteoarthritis.” And you can read about his findings in the journal Clinical Rheumatology.

His findings are backed up by one of the best research institutions in the world – The Cochrane Library.

Their scientists also say that the extract works better than other remedies. And they’re convinced that the evidence is solid.

Evidence Based on 500 People

The remedy comes from a vegetable extract. It’s called avocado-soybean unsaponifiables (ASU).

Dr. Ernst used four different clinical studies to see if this extract actually works. And he found that it really makes a difference for people with knee and hip pain.

He says it helped treat arthritis in just six weeks. And patients didn’t need their painkillers anymore. That’s because it doesn’t just mask pain. Instead it treats the real problem behind arthritis: inflammation.

Using ASU to Treat Arthritis

Most of the clinical research shows that 300 mg is the best dose for arthritis. You can find it online or at a health foods store. And it’s available in capsule or tablet forms.

The research shows that the avocado oil in ASU is one of the reasons it works so well. So you may want to add it to your diet. You can cook with avocado oil and it has a high smoke point. So think about using it the next time you cook on a high heat.

This new treatment is good news for people with arthritis. But we still have another option for you that may be the best yet.

We’re revealing it today in this month’s newsletter. It’s a three-tier program that includes a two-part supplement combination. These two supplements helped bring a doctor out of his wheelchair and back on his feet in just two weeks.

To your best health,

Michael Jelinek,
Managing Editor, NHD “Health Watch”

We’ve looked at the best studies out there…from the most credible doctors…to put together a three-tier lifestyle therapy that can banish pain for good. And it works by combating the actual cause of arthritis…instead of just masking the pain.

We’ve discovered a celebrated M.D. who uses two naturally derived supplements to rebuild cartilage...without any risky side effects. He was so wracked with arthritis pain as a young man that he’d spend days in a wheelchair. But he tested these supplements on himself…and they helped him take his first steps to regaining robust health.

But these supplements are just the last part of our three-tier therapy. We’ve also talked to other doctors about how your diet can reduce pain naturally. And we’ve looked at research on how one other lifestyle choice can repair damaged joints.

In this issue we’ll also reveal:

• One natural weight-loss compound that can change eating habits in just 2 weeks…

• A 2 part combo that fights memory loss…

• The fruit extract that cuts inflammation and pain symptoms by up to 59%...

Just one year ago, sales of Lipitor reached a heady $10.8 billion.

But that’s not going to happen this year. That’s because it’s the latest statin to lose its patent protection. And it was one of the last statins to be patented. Now Lipitor will have to compete against low-priced generic versions. And that means the days of $10.8 billion profits are over.

But if there’s one thing that these drug companies are really good at, it’s making money. And they think they may have figured out a way around this problem.

The profits are down on selling these things as cholesterol-lowering drugs. So…sell them for something else. And as if by magic, a brand new study may let them do just that. That’s because it claims that statin drugs can treat flu.

It may sound like a bad joke, but we’re being serious.

What shouldn’t be taken seriously perhaps is the study itself. One quick review shows that it just doesn’t stand up to scrutiny. It’s a sham study designed to grab headlines. And some credible doctors are speaking out against it. They’re saying the same thing that we are: That this study was shamelessly manipulated to get these bogus results.

Building a Case

The new study was headed up by Vanderbilt’s Dr. William Schaffner. And you can read about his findings in the Journal of Infectious Diseases.

He looked at 3,043 people hospitalized with flu between 2007 and 2008. One third of them were treated with statins. The other two thirds were given antiviral drugs. And he found that people getting statins were 41 percent less likely to die than those getting antivirals.

Naturally, the media has picked up on this study. They’re reporting that flu patients who aren’t treated with statins are almost twice as likely to die.

But if you look at the study you’ll see it’s pretty much meaningless. It wasn’t a controlled study. And it didn’t compare the effects of statins against a controlled placebo group. Instead it just randomly compared two groups of people who had been hospitalized with the flu. One group were on statins, the other on antivirals.

But that’s not the worst part. The study didn’t account for other health issues – other than flu – that the (mostly senior) patients were dealing with when they were hospitalized.

So why would anyone conduct such a headline-grabbing study?

Here’s one reason…you should know that at the end of the study, researchers have to list financial conflicts of interests. And Dr. Schaffer has more than most.

In fact, he’s a paid consultant for:

• Pfizer
• Sanofi Pasteur
• Novartis
• Dynavax
• Merck
• GlaxoSmithKline

Mixed Reviews

The study has had a mixed reception from scientists. But certainly one educated expert isn’t buying the results.

“I’m not convinced that statins are protective,” says Dr. Jeffrey C. Kwong.

And he should know. He’s been doing his own research on statins and flu for years. He’s also a top researcher for the Institute for Clinical Evaluative Science in Toronto.

He’s says there are many underlying health reasons why one group would perform better than the other.

He thinks people who take statins already have some health issues. Because they’re dealing with these issues, they’re probably eating a healthier diet and exercising more to balance them. Thus they are a more health-conscious group than regular people. And that means they’re probably in better shape when they enter the hospital.

“The people who receive statins are inherently different from people who don’t receive statins,” he says.

Given the limitations of the study, that means the statins themselves may have made no difference at all in the outcome.

And yet, some doctors are excited by the results.

Dr. Cam Patterson is one of them. He’s from the University of North Carolina at Chapel Hill.

He thinks the results are great news and is eager for more trials to see “whether we should be giving statins to every patient who is hospitalized with influenza.”

But then again, this shouldn’t come as too big of a surprise either. Not when you know he’s a long-time paid consultant to Pfizer.

According to ProPublica – a Manhattan-based investigative news bureau run by the former managing editors of the Wall Street Journal and New York Times – he received almost $50,000 from Pfizer for “speaking” fees in 2011 alone.

Why You Should Be Wary of Statins

There’s no real proof to show that statins can treat flu. And plenty of evidence to show why drug makers would want to make even more money off their drugs than they already do. (See Statins Are Big Business.)

Statins until now have been used to lower cholesterol and combat heart attacks and stroke. But the truth is, studies show they don’t do much to even help people with heart disease.

Recent studies show that statins don’t prevent heart attacks. When you look at the absolute reduction in risk (as we told you about recently) they only save about two people out of 1,000.

“That’s not clinically significant,” says Dr. Steven W. Seiden. He’s a cardiologist in Rockville Centre, N.Y.

He says prescribing statins to combat any health issue just doesn’t make sense.

“The benefit is vanishingly small,” he says. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.”

And another heart doctor agrees. Dr. Mark A. Hlatky – of Stanford University – says you should think twice about taking them for flu or heart disease.

“There may be long-term harm from healthy people taking a drug like this,” he says.

That’s because statins aren’t just useless against flu. As we’ve told you before, they can cause plenty of serious harm.

A recent study in the British medical journal The Lancet showed they increase your risk for diabetes. And other studies suggest they may cause memory loss, fatigue and nerve damage.

Tackling Flu the Safe Way

The truth is there’s a safer and much more effective way to protect against flu…and you don’t need to take a statin – or get a flu shot.

As we’ve often said, the best way to fight flu is to boost your immune system. And an easy way to do this is by eating wild-caught salmon.

Another great way is to get out in the sun for 20 minutes each day and enjoy some natural rays.

What do both of these things have in common? Vitamin D – and it’s a sure way to boost immunity. There’s plenty of scientific proof that boosting immunity is a big factor in preventing flu. So your best bet against flu is to make sure you’re getting enough vitamin D.

If you want to be sure you’re getting enough, you can always get it in supplement form. Just be sure to take 5000 IUs each day.

Wishing you good health,

Ian Robinson

Editorial Director, NHD “Health Watch”

You make it in your own body. And it’s created through a reaction to the foods you eat.

The problem is that if you’re not eating the right foods, you may not be making enough of it. The easiest way to be sure is to get it in supplement form. But you’ll want to be to be certain that the supplement you take has been shown to work in clinical trials.

That’s why we’re going to tell you about the work that Dr. Brian M. Berman is doing. He’s the man with the research that shows this supplement really works. He’s also the director of the University of Maryland Center for Integrative Medicine.

He says this supplement is just as good as nonsteroidal anti-inflammatory drugs (NSAIDs). But it doesn’t have the bad side effects.

Other doctors have looked at his findings and say his research is for real. They think the supplement can really make a difference to people with arthritis.

One of them is Dr. Hyla Cass. She’s an integrative medicine expert with 20 years of nutrition experience.

She says loads of clinical studies show that it “reduces pain, stiffness and inflammation.”

11 Studies Show Success

The supplement is called S-adenosylmethionine (SAMe). It’s pronounced “Sammy.” It’s a natural compound that your body makes and it contains sulfur.

Dr. Berman looked at 11 different studies. He was interested in how SAMe measured up against placebo or NSAIDs for treating arthritis. The first thing he discovered was that SAMe reduces pain and improves movement. And it does that just as well as any NSAID. .

But then he discovered what gives SAMe the edge on NSAIDs.

“There’s significantly less adverse effects,” he says.

A New Way to End Arthritis

First discovered in Italy in the 50s, it’s now available to buy in the US.

You can get it online or at health food stores. And most versions come in tablet form.

There’s scientific research that shows SAMe is safe at specific doses, for a specific time frame.

A dose of up to 600 mg each day is thought to be safe for up to two years of use. A higher dose of 800 – 1600 mg is safe for up to 42 days.

We’ll be sure to update you on the latest findings on this supplement.

And in the meantime, be sure to check out our newest issue of our Natural Health Dossier newsletter. The monthly issue arrives this Friday.

To your best health,

Michael Jelinek,

Managing Editor, NHD “Health Watch”

We’ve told you before how age-related macular degeneration (AMD) is becoming a major health issue. And we’ve given you one nutrient that can reduce your risk of blindness by 43 percent.

But now this new research shows that one vine fruit – with antioxidant properties – may also protect your eyes.

The study was led by Dr. Silvia Finnemann. She’s a top scientist at Fordham University in New York. And you can read about her results in Free Radical Biology and Medicine.

She says the fruit “was remarkable” for protecting eyesight. She also says this fruit can protect your vision in old age…even if you haven’t eaten it since you were a kid.

From the Vine to the Eye

The eye-protecting fruit is the grape. While the study was conducted on animals, these early results are still very hopeful. Adding grapes to your diet certainly won’t hurt you. And they may be able to protect your eyes in old age.

For her study, Dr. Finnemann used mice that were prone to developing retinal damage in old age. She compared three different diets on them to see which one offered the most eye protection.

The three diets were a grape-enriched diet, a normal diet, and a diet with lutein added to it. Lutein, as you may know, is a popular nutrient used in vision supplements. It has plenty of research to prove it works. And that’s where Dr. Finnemann had her breakthrough. Lutein worked pretty well…but grapes worked even better.

Prevents Blindness in 2 Ways

So how do grapes help your eyes? Actually, they do it in two ways. First, they decrease the build-up of lipofuscin. Those are “wear-and-tear” pigments linked to AMD.

Second, they prevent oxidative damage to the retinal pigment epithelium cells (RPE). These cells support photoreceptors in the retina that help convert light to sight.

AMD is a result of oxidative damage over time. So it makes sense that grapes can help. That’s why Dr. Finnemann thinks a lifelong, natural antioxidant diet will benefit your vision.

That’s good news for the aging population. AMD is the leading cause of blindness in this group. So it’s smart to take protective measures, like eating grapes, to prevent AMD from developing.

You can get grapes in any grocery store. Most nutritional experts recommend red grapes for their high antioxidant value. You’ll also find red grapes have decent amounts of resveratrol, quercetin, and catechins.

We’ll continue to follow this research and let you know if there are any updates.

To your best health,

Michael Jelinek,

Managing Editor, NHD “Health Watch”

You may also remember that we spilled the beans on Lasik eye surgery, when we talked to a former FDA chief about it. And how he told us that the FDA should never have approved it in the first place.

That story fired up at least one Lasik eye surgeon and kicked off a fiery debate between them. (If you didn’t see those articles, you can read both of them here.)

Since then we’ve gotten tons of feedback on this issue, with many of you asking us to look into it further.

So we decided to go back to the source and do another interview with the former FDA chief himself.

His name is ­Dr. Morris Waxler. And in this interview, we dig even deeper into what he knows about the FDA.

“I think the agency is structurally deficient,” he tells us. “And it really can’t do its public health job adequately.”

This comes from a guy who was a leader at the FDA for four years…and still has friends who work there.

He also reveals:

• The real problem with the FDA approval process…
• Why he thinks too many crimes have been committed in the case of the laser eye devices…
• Why he originally approved the devices…
• How the FDA has responded to his speaking out…

Keep reading below to get our full interview with Dr. Waxler…

NHD: Can you tell us what you did at the FDA?

DR. WAXLER: I was in the Office for Device Evaluation, in the Division of Ophthalmic Devices. Within that division there were branches that covered different kinds of devices – implants, contact lenses. And then there was a division that covered a variety of ophthalmic devices such as Lasik machines and other kinds of capital equipment.

NHD: So you focused on Lasik machines?

DR. WAXLER: Yes I did. I was working there as a reviewer to review Lasik devices. Then I was asked to be the chief of that branch.

NHD: And how long were you chief?

DR. WAXLER: I was chief for four years.

NHD: And it was during that period that the Lasik devices were approved?

DR. WAXLER: Correct.

NHD: When did you retire?

DR. WAXLER: In 2000.

NHD: And when were the devices approved?

DR. WAXLER: The first devices that were approved were the PRKs, where they didn’t take a slice of the cornea without making a flap. And those devices were approved, the first one, probably ’93. Then when I became chief, the devices were approved for Lasik. The first one was probably ’95, ’96, maybe ’97.

It was actually a very complicated process because Lasik requires two pieces of machinery. In addition to the laser, you need a microkeratome, which makes the slice for the flap in the cornea. And that device had already been on the market for other purposes. So when we decided to make the laser companies responsible for Lasik, they said the Lasik device included both of those products. That is the laser that removed the tissue from under the flap, as well as the microkeratome which made the flap. So it was a bit of a complicated process. Because initially the laser companies didn’t want to be responsible for Lasik. All they wanted to be responsible for was removing the tissue. FDA folks above my pay grade decided that they had to be responsible for the entire product.

NHD: When you left the FDA, did you leave on good terms?

DR. WAXLER: Oh, absolutely.

NHD: Do you have any personal reasons for wanting to discredit the agency?

DR. WAXLER: Absolutely not. I still have lots of friends there. I got many awards for my work in that branch, and there were never any personal issues. In fact, the only reason I’m back on this issue is I was asked several years ago (by patients that were injured)…why did I approve this terrible device? I listened to that for a couple of years before I decided to look at it in more detail.

NHD: In your position, what role did you actually play in the approval?

DR. WAXLER: A branch chief is the first line manager of a team of technical experts that review the document. The reviewers would review the document and technical information from the manufacturer. And then they would make their recommendations to me, and I would have a critique of the review. Then I would make my recommendation to the division director.

In this particular instance, my engagement was much more hands on than many branch chiefs because there were lots of illegal lasers that were on the market. I was involved in compliance actions against these various folks who were illegally using and producing these devices. So I did a bit more than most branch chiefs did. And also I was very much involved in making sure the ophthalmologists and the refractive surgeons conducted the proper studies.

NHD: When you were reviewing the information at that time, were you aware of the persistent adverse side effects that the lasers presented?

DR. WAXLER: At that time? Good question. Very good question. Well, I would say “yes” and “no.” I was caught up in my job, which was to get these manufacturers under regulatory control. When I came on the scene, there was a sort of Wild West mentality to refractive surgery. Refractive surgeons felt FDA should move out of their way. This was something that the refractive surgeons knew how to do on patients’ eyes. And they took umbrage with the FDA trying to stick their nose in it. So my task was to make sure that FDA processes worked and that everybody that manufactured these devices be under regulatory control. And from that perspective, I was successful.

I think what I wasn’t completely aware of was the extent to which there were the longer-term consequences for patients’ eyes. Partly because…in retrospect, what I realized is that refractive surgeons whom I admired and had tremendous reputations were basically playing a game with me. They kept information. They minimized certain problems. So I assumed as clinicians they would be honest and straightforward with regards to these problems.

I knew there were these night-driving problems. And I knew there were these halos and glare and loss of contrast sensitivity. There were long discussions about that. But the refractive surgeons, their power…not just their monetary power…but their stature in the world, they have a lot of presence and “authority.” They exuded that sort of authority. And I’m afraid that I succumbed to that – the halo they had over their heads – and ignored the halos they produced in people’s eyes.

So I wouldn’t say I ignored it. I just assumed these were minimal kinds of issues. And so it wasn’t until much later, when I saw that the agency had a graph that showed all of these nighttime problems…and all of these glare and halo problems. When I saw the graph on the FDA’s website that says all of these are gone by six months, I said this is ridiculous…we know they’re not gone by six months. When I was there, they were called adverse events and they persisted for a long time.

So I started to explore. And I found out that that graph was actually produced by the industry. And there’s no data behind that research graph. In fact, I went back and reviewed that data. It shows that 20 percent of the eyes that are treated have these persistent problems for much longer than a year.

And one of the most amazing things to me is that the agency still has that graph on its website. And I’ve talked to them several times about it. I urged them to get rid of that graph or explain what the data is. And they will not even do that. It’s just totally incorrect.

NHD: So you did review the documents prior to approval?

DR. WAXLER: Oh, absolutely.

NHD: And it did show that there would be some side effects. But you’re saying that the industry misrepresented how severe and long-term the effects were?

DR. WAXLER: Correct.

NHD: Now the information you’ve seen has convinced you that the original information was misrepresented. How are you finding all this evidence now?

Dr. Waxler: Two sources basically. The first source is from actual data that’s on FDA’s website that anybody can go to. I went back and analyzed the data that exists for each company, and not just the original ones. Some of the refractive surgeons now say that I’m misrepresenting their data by only looking at the early machines. That’s not correct. If you look at my analysis, I include all Lasik devices that have been approved, even the most recent ones. At least up to the time that I published my petition.

I went back to each of the data tables that are on the FDA’s website that came from the company. And I just went down and re-analyzed that data. I looked at how many halos, what was the percentage of halos, and what time after surgery. It took me months and months of hard work. It was not computer work because I had to go in and analyze them by hand.

And then I also analyzed the published literature, the peer review literature. You’ll see a comparison in my petition of the published literature with these same problems and the literature the manufacturers submitted to the agency. And they’re very close to each other. So I don’t think there’s any doubt that there’s 20 percent, or even more, adverse events.

The problem is…what the refractive surgeons and manufacturers want to say is that these should not be called “adverse events.” But these are problems that persist. And they are adverse events. They’re adverse to seeing well. So it’s a word game that the manufacturers and refractive surgeons are playing because they get paid an enormous amount of money to take a few minutes to cut someone’s eye and so-called reshape it.

NHD: So if you were still working for the FDA, do you feel you would have had the independence to be able to look at it from the point of view that you look at it now?

DR. WAXLER: Absolutely. If I was completely aware of what was going on, I would have recommended disapproval. Maybe it would have removed me, I don’t know. But I can’t speak to that issue. That’s all hypothetical. But I certainly know what I would do. I would not have approved it.

NHD: Do you think that this is an isolated situation? Or is there something inherently wrong with the FDA approval process that leads to such risks to public health?

DR. WAXLER: I’m afraid to say it’s the latter…mostly because Congress over the years has developed an approval structure for devices that puts the agency in a very awkward position. It’s a system that favors the manufacturers. It does not favor the public. It’s not a public health law from the standpoint of really primarily trying to protect the public.

Even if you look deeply into the way the studies are conducted…these studies are conducted to get the best possible results. Not to determine what the realistic outcome will be. Not to determine the real risk benefit. What’s the real risk benefit in this situation? We should’ve been right from the beginning, from a public health point of view.

We should’ve said: What is the risk of getting your eye cut and tissue removed in order to correct your vision to 20/20 when you have alternative and much less risky products on the market? You have glasses, you have contact lenses. There was never any such comparison.

You cannot take off a Lasik. Once you do Lasik, your eye is cut. You cannot remove Lasik. You can’t treat any problems you create. With contact lenses, you can remove the contact lenses. With glasses, if you’re having halo or glare or something, you can remove the glasses…get a better prescription.

So I think the agency is overwhelmed because it doesn’t have the resources, but it’s also structurally deficient. And it really can’t do its public health job adequately.

And recently there was a review of FDA regulations, focused on the pre-market notification process, that essentially came to the same conclusion…

So I think it’s a structural problem. I think what my friends at the agency would say was that they did the best with the information they had. And I agree. I think I did the best that I could at the time, but I wasn’t aware of all the forces and all of the willingness of people to outright lie and also to withhold information and to shape the words so they would be in their best interest…and not in the best interest of the patients. They don’t really have the patient’s interest at heart. They wanted to make money. That was the entire effort. And we, the agency, helped them. Again, my focus was to make sure they were under regulatory control. So I did a really marvelous job of doing that. But I didn’t do a marvelous job of protecting the public health. And that’s just the way it is. And I can’t change that…that was then.

NHD: So you filed a petition to the FDA?

DR. WAXLER: Right.

NHD: And you’re asking them to seize all FDA approved lasers…to remove FDA approval…and issue a public health advisory? And also investigate Lasik crimes?

DR. WAXLER: Correct.

NHD: So you believe that the FDA and the Lasik industry knowingly misled the public and that there’s some sort of criminal activity here?

DR. WAXLER: Of course, I didn’t have access to all of the information that’s needed to make a declarative statement. But I know enough. I know a lot of the details of what happened. And in retrospect, I can say that, yeah, there were crimes that went on. The agency has all that information. The agency has the power to look into it, and that’s what I want the agency to do. But I don’t know if they’re doing it or not, because as far as I can tell, they’re not doing anything.

NHD: When you say that crimes went on, is it the FDA you believe committed the crimes? Or is it the industry, the manufacturers?

DR. WAXLER: I don’t think the agency people committed any crimes, including myself. We were trying to do the best we could. We were misled about a lot of information. We were getting partial information. The information we were given [was for] the best patients only. And so there were a variety of tricks that were played on us collectively that led us to the patient decisions.

There’s one exception, though. The graph that I spoke of. It still sits on FDA’s website. It shows that there are no glare, halo…that these sorts of problems do not exist after six months. That graph came from the industry. There’s no data that’s the basis for that graph. Somebody from the agency put that graph on FDA’s website. So someone, or some individuals in the FDA, is personally responsible for doing that. To my way of reading it, I don’t know what kind of crime it is. I’m not a lawyer. But it’s false. It’s misleading. It’s the very thing the agency should not be doing. They shouldn’t be misleading patients that are going to that website.

NHD: But you believe that the manufacturers have acted criminally?

DR. WAXLER: Absolutely. I can point to several instances where they have just withheld information. They distorted information. They would claim that…they couldn’t get file information from 20 percent, 30 percent, 40 percent of the patients that had surgery. And the agency, we went along with that, saying that these patients were so well off that they didn’t want to come back in. That’s a lousy way to run a clinical trial. They should have 90 percent of patients surveyed. That’s their responsibility, to make sure they follow up with patients. But they didn’t, and we let them get away with that…

I can’t say why exactly we did that, except that I think there was a lot of trust involved. There were many very well-known ophthalmologists involved in this. And trust is something that we had, I had…and that misled us.

QUESTION: So how a big a problem do you think this is, and how big a threat to the public?

DR. WAXLER: You have 20 percent of patients who are going to have persistent eye problems. You’re not cutting a marble. It’s not cutting a piece of plastic. You’re cutting a live piece of tissue that has nerves running through it. So almost all patients that have Lasik have problems with dry eyes. For some people it’s a big problem. For some people, it’s a small problem. So Lasik inherently causes eye problems. It doesn’t make a better eye. It creates a sick cornea.

I say patients, but they’re not really patients. They are people that have normal corneas that are not shaped exactly like everybody else’s corneas. It’s a natural variation in the particular shape of a cornea. So this kind of a fix is no fix at all. It’s actually creating an unnatural cornea, a cornea with lots of bumps and irregularities in it. And sometimes the bumps and the irregularities create halos at night, vision problems at night, loss of contrast sensitivity. And, in addition, a long-term risk is undermining the strength of the cornea and producing a bulging cornea. So I think it’s a very high risk, a totally unnecessary risk.

NHD: What has been the agency’s reaction to your petition?

DR. WAXLER: Pretty much nothing. The only thing I’ve gotten in response was that they haven’t been able to make a decision. They’ve had six months to look at this information, and they can’t make a decision. They can’t even make a decision about this graph that sits on their website that’s totally and completely incorrect…and which I have demonstrated in my petition is totally unsupported by the data the agency has in its own files. And where did that graph come from? It came from industry without any supporting data. So, I mean, if they can’t even pull that graph off the website, it’s really, really puzzling. It doesn’t make any sense at all.

NHD: Why is this so important to you? Why do you want to fix this problem?

DR. WAXLER: Because I finally realize that people are being injured by something I did. And although I don’t blame myself, I want to set it right. I don’t want that to be something I’m remembered for. And I’m thankful, actually, for patients that persisted in challenging me to look back at what had been done. Otherwise, I would have gone along merrily saying, “Well, I did a good job.”

So I do feel passionate about it, and I can’t understand why others can’t see the need to do something differently.

Wishing you good health,

Ian Robinson

Editorial Director, NHD “Health Watch”

The study was just published in the Journal of Agricultural and Food Chemistry. It comes from Dr. Ling Zheng, a top researcher of cellular biology at Wuhan University in China.

We want to let you know up front that Dr. Zheng’s research is the early stages. But it builds on earlier findings that show this drink may help prevent diabetes. Dr. Zheng has taken a look at that early research and he’s done his own studies to take it further. He tested three components in the drink. And he’s found one that really stands out.

Three Components Tested

The drink we’re talking about is coffee. The three components Dr. Zheng tested are caffeic acid, cholorgenic acid, and caffeine. And he tested them against abnormal protein deposits.

These deposits are found in people with type 2 diabetes. They can form from a substance called human islet amyloid polypeptide (HIAPP), which is found in the pancreas. Dr. Zheng figured that if the compounds can block HIAPP, they can stop the deposits from forming. And that would help prevent or treat diabetes.

He found caffeic acid to work the best out of the three. Caffeic acid isn’t related to caffeine. But it is a rich antioxidant and anti-inflammatory. There was one other thing that’s also worth mentioning. Decaffeinated coffee has higher levels of caffeic acid than caffeinated coffee. So the researchers think decaf coffee may give you better benefits.

Dr. Zheng’s research was all lab-based and his results are preliminary. But there’s plenty of evidence that shows coffee may help with diabetes.

One bit of evidence comes from a study published in the Archives of Internal Medicine. It shows that people who drink more coffee lower their risk of type 2 diabetes.

The Right Way to Drink

Dr. Zheng offers a tip that we’ve told you about before: If you drink coffee, make sure it’s black.

“The cream and sugar served with coffee” won’t help people with diabetes, he says.

But if you can’t stand drinking your coffee black…we have some options to help you.

The first thing you can do it use coconut milk as a creamer substitute. It’s loaded with healthy fats and it has a creamy flavor. If you don’t like coconut milk…you can always use almond milk instead.

The second thing you can do it cut sugar by using a little bit of honey or agave nectar instead. But it’s always best if you avoid adding all sweeteners to your coffee.

To your best health,

Michael Jelinek,

Managing Editor, NHD “Health Watch”