Health Spectator

Just when vitamin D was beginning to look like the cure-all where cancer is concerned—many studies have proclaimed it instrumental in preventing or slowing cancers of the skin, colon, breast, and prostate, to name a few—a new study announced by the U.S. National Cancer Institute says increased vitamin D consumption does not correlate with reduced cancer mortality. The one exception, according to the study’s authors, may be cancer of the colon.

The study did not involve new research. Rather, it analyzed data for 16,818 subjects who participated in the Third National Health and Nutrition Examination Survey, which inducted participants between 1988 and 1994 and followed them through 2000. Participants were given blood tests to establish a baseline at the beginning of their enrollment; it was from these blood tests that the level of vitamin D (as 25-hydroxyvitamin D) was tested against decreased cancer mortality and found to be lacking. In the case of colorectal cancer, however, the study found a 72 percent reduced risk of death when vitamin D levels were sufficiently high.

The study, authored by D. Michal Freedman, Ph.D., of the National Cancer Institute in Bethesda, Md., and colleagues, was published in this month’s Journal of the National Cancer Institute. The authors believe it is the first study to test vitamin D blood levels—as opposed to supplement consumption—against cancer mortality.

Reuters is reporting that a Senate panel has voted today to approve a path for getting generic biologic drugs to market faster. Biologics—unlike synthetics—are drugs that are derived from living things and are consequently often quite difficult and expensive to make. Because their manufacture is so sensitive to the slightest changes in starting substances or altered processes, there has to date been no mechanism in the U.S. for generic biologics to be produced, unlike the case with the more common “small molecule” drugs such as aspirin.

Perhaps the most commonly known examples of biologics would be vaccines. Less well known would be epoeitin alpha, a member of the class of erythropoietic proteins, marketed as Procrit (sold by Johnson and Johnson) and as Epogen, sold by Amgen.

The entire subject is fraught with controversy, with manufacturers who hold patents for biologics arguing that they cannot be duplicated in the same way that small-molecule drugs subject to traditional chemical manufacturing techniques are.

The area is also one with strong political overtones, as evidenced by the current Senate bill’s authors: Senators Edward Kennedy (D, Mass.), Hilary Clinton (D., N.Y.), Mike Enzi (R, Wyo.), and Orrin Hatch (R, Utah). No doubt democrats see a political windfall in breaking into the previously sacrosanct area of biologics.

The current Senate version of the bill would require generics manufacturers to run at least one clinical trial to demonstrate that their version of the drug was medically no different from the name-brand equivalent. However, a provision that may alarm the name-brand manufacturers allows the FDA to waive the clinical testing by relying on animal testing or other data.

What’s more, the FDA would have the power to declare a copycat drug as interchangeable, meaning that it could be substituted for its name-brand equivalent.

In order to qualify to become a generic, a drug must have been manufactured for at least 12 years and its patent must have expired. Most of the current controversy centers on the 12-year manufacturing requirement. Traditional drug-industry supporters see the time as too short, while generics manufacturers and consumer support groups argue it is too long.

We felt glued to our seats. My wife and I were sitting in a small cafe in southern New Hampshire—the only diners in the place—and on the TV in the corner was Neil Cavuto on Fox TV conducting an interview (a debate, really) about the new over-the-counter weight-loss pill just approved by the Food and Drug Administration: Alli.

A fitness expert was trying valiantly to argue, in effect, that Alli was the work of the devil, pointing out its negative side effects and advocating a saner approach to weight loss that might involve, say, proper diet and exercise. But she was outgunned—outgunned by Cavuto himself and his MD interviewee, Fox’s own health commentator, Dr. Manny.

While watching this one-sided boxing match in which the underdog was throwing all the right punches and still couldn’t seem to score at round’s end, we had an epiphany: What’s most noticeable about all the publicity Alli is getting is that the medical community seems to be bending over backwards to remain neutral or to find positive things to say about the drug.

It may be they’re nonplussed by all the hubbub and by the fact that a prescription drug (Xenical) that had not been particularly popular has now obtained FDA approval for over-the-counter use at half the prescription dosage. In fact, such a move could indicate that manufacturers are trying to perform an end run around doctors themselves. (”Doctors don’t seem to be pushing it, so let’s try direct marketing to consumers ourselves.”) And the FDA has lent its imprimatur to the whole proceeding.

Or perhaps we’ve just not caught the right members of the medical community yet. (After all, drug companies do advertise on TV, which may explain the free-for-all we witnessed on Fox.)

But we’ll be happy to point out that there are negatives to a weight-loss program that depends upon not absorbing fats, which is what orlistat, Alli’s active ingredient, is all about. It works by preventing the pancreas from releasing an enzyme (lipase) that enables the breakdown and absorption of triglycerides by the gut. In simple terms, the fat you eat doesn’t get digested and absorbed by your body. It just passes through to be eliminated by the bowel.

Since triglycerides in the blood are one of those things—along with cholesterol—that your doctor is probably trying to get you to reduce, that’s a good thing, right? Well, not exactly. Actually, the high levels of serum triglycerides your doctor is worried about are caused by eating carbohydrates.

And fats, as it turns out, are an important part of the diet. Ever hear the phrase “essential fatty acids?” In case you haven’t, there are essential fatty acids (EFAs) and essential amino acids, neither of which can be produced by the body, which is what makes them essential in the first place. As T.S. Wiley and Bent Formby, authors of the book Lights Out point out, there is no such thing as an essential carbohydrate. So cutting carbohydrates to lose weight actually makes more sense.

What’s more, as these authors point out, fat-soluble vitamins such as A, K, D and E enter the body by hitching a ride with fatty acids in the gut. If you don’t absorb those fatty acids, you may have to do without those fat-soluble vitamins. The information supplied about Alli clearly states that users are urged to take a multivitamin as a part of the accompanying diet regimen. (Much has been made of the manufacturer’s forthrightness in presenting this warning.) What may not be so clear is that the multivitamin likely will have little effect in increasing the absorption of the fat-soluble vitamins if the body is busy not absorbing fats.

We’ve no doubt that Glaxo SmithKline has a winner with Alli. Since the entry cost to try it is around $50, the curiosity factor alone should account for blockbuster sales. But we won’t personally be tempted, given the pill’s health downside and potentially nasty side effects, which include incontinence and get worse from there. (Let’s just say there are worse ways you can be “glued” to your seat.)

We’ll try to cut back on the carbs and treat our bodies to some “burst” exercise. Anybody have a set of kettlebells they’d like to donate?

While you should consult with a physician before undertaking radical changes to your diet or vitamin and supplement intake, we’ve listed here a few supplements that have become staples on our breakfast table.

This particular list is slanted more to the over-40 and -50 crowd. We’re assuming you probably already take vitamin C, for example, and perhaps a multivitamin or multivitamin/mineral supplement. If not, you might consider doing so, regardless of your age group. (If you’re a vegetarian and eat several servings of fresh fruit per day, you may be able to dispense with the vitamin C.)

Incidentally, we’re not recommending megadoses of anything for normal maintenance. (If you’re trying to cure cancer, you’re going to need megadose antioxidants, for example, but that’s where you part ways with the “normal maintenance” crowd.) Between 500 and 1,000 milligrams of vitamin C should be more than enough for most people, and most sources recommend that normal daily intake not exceed 2 grams (2,000 milligrams).

1) Number one on our list–at least, for those who are over 50–is DHEA. Taken only in small doses (<50 mg/day, around 25 mg/day optimum) this hormone may be far less dangerous than the medical/pharmaceutical community might have us believe, though we can only recommend it in low doses. Some observers link high doses to heart arrhythmia.

DON’T TAKE IT if you’re under 18; we suspect you should at least be cautious if you’re under 35. Since DHEA has been controversial within the medical community, chances are your doctor has heard of it. So discuss with her whether or not you should be taking it and the appropriate dose. Women with estrogen-receptor-linked breast cancer and men with prostate cancer or benign prostate disease are specifically warned against DHEA, since it might aggravate either condition. (Recent research indicates these affects may be due mostly to dihydrotestosterone production, however, which can largely be controlled by supplementation with Saw Palmetto extract.)

Interestingly, the body doesn’t begin producing much DHEA until puberty, and the quantity produced begins to decline around our late twenties. From the 30 mg or so per day produced at age 20, the body’s production steadily declines to the point where we produce around 6 mg at age 80. The reason for this decline is unknown, but it seems safe to say that DHEA’s quantity parallels the body’s sexual activity.

So why bother taking it if it’s still controversial? Well, for one thing, if you’re on statins–and nearly everyone seems to be these days–your production of cholesterol has likely been lowered. The body uses cholesterol to manufacture DHEA. So your own output of DHEA and the sex hormones may be artificially lower to begin with.

Among the benefits attributed to DHEA: reduced levels of fear and anxiety, due most likely to DHEA’s anti-glucocorticoid activity. More generally, according to Gary Null, PhD, author of Power Aging, “when DHEA levels are insufficient, levels of destructive inflammatory cytokines increase, setting the stage for a number of serious conditions [including] heart disease, stroke, cancer, osteoporosis, Alzheimer’s disease and autoimmune diseases such as rheumatoid arthritis.” Null believes that mental decline is in part due to a decline in the body’s store of DHEA.

So get the all’s-clear from your doctor on prostate health if you’re a man or on breast and cervical cancer if you’re a woman. Then you can start reaping the benefits of a hormone replacement therapy that may actually help prevent these diseases.

‘Nuff said.

2) 5-HTP. Again, this supplement is not for everyone, but the older you are, the more likely you are to need its help as a sleep enabler and mood stabilizer. This serotonin precursor has become essential on our personal list. Check with your doctor if you’re on antidepressants. By increasing your body’s supply of serotonin, this supplement can enhance the effects of SSRIs (selective serotonin reuptake inhibitors) such as Lexapro, Prozac, and others.

The good news: We’ve seen 5-HTP successfully substitute for these prescription antidepressants with fewer side effects.

Although most of us are more concerned about shortages, you can overdose on serotonin. Serotonin Syndrome was discovered in the wake of a teenager’s death from it in 1973. It is a rare but serious complication of drug interactions in which the patient can deteriorate rapidly if the physician does not recognize the symptoms. Usually, serotonin syndrome will be caused by mixing monoamine oxidase inhibitors (MAOIs) with other drugs—especially SSRIs—that can increase serotonin availability.

Typical dosage, 50-100 milligrams one to three times per day. We suggest you start out taking a minimal dose (50 mg) at breakfast for a week or two, then increase the dosage slowly from there if you find yourself needing more. Increase the dosage by taking more doses per day. That is, take a second 50 milligrams at lunch, then eventually a third at dinner. Then you can start increasing the individual doses in 50-mg increments. Give each increase in dosage at least a week or two to take effect; stop increasing the dosage when your mood seems to have stabilized.

This is easily the best non-prescription supplement we’ve found for banishing the blues. Come to think of it, it beats the prescription antidepressants as well, in our experience.

Michael Murray, N.D., author of the book 5-HTP: The Natural Way to Overcome Depression, Obesity, and Insomnia, asserts that in combination with St. John’s Wort, 5-HTP successfully manages more severe depressions. For that purpose, he recommends 50-100 mg of 5-HTP and 150-300 mg of St. John’s Wort extract, each taken three times daily.

3) Co-enzyme Q10 or CoQ10 for short. CoQ10 is a powerful antioxidant. It can boost your body’s production and supply of glutathione, a powerful endogenous antioxidant that keeps cancer and even the aging process at bay. Glutathione is largely responsible for mopping up free radicals in the body that can be caused by anything from a night’s excessive drinking to irradiation or chemotherapy. It has been shown to prevent cataracts in rats and is clearly at work in combating oxidative stress.

4) Alpha-lipoic acid. another antioxidant, is so powerful it keeps CoQ10 in working order. Studies have shown it to help in fighting atherosclerosis (it prevents LDL–the bad cholesterol–from oxidizing and forming arterial plaque) and the free radicals that can cause cancer, lung disease, chronic inflammation, and neurological disorders. Also known as lipoic acid, this supplement is quickly reaching superstar status among the research community. In particular, it makes the body’s supplies of vitamins C and E, glutathione, and coQ10 last longer or go farther by restoring them to their non-oxidized state. (Its action on vitamin E is indirect, but it can directly restore the other antioxidants.)

In the wake of our report on links between atrial fibrillation and bisphosphonate drugs such as Fosamax and Reclast, Health Spectator performed a routine follow-up investigation of the health claims and side effects of this class of drugs. We discovered that, contrary to the majority of reports we had read when researching the initial story, other complications from treatment with bisphosphonates were already known.

Specifically, a condition known as osteonecrosis of the jaw (a condition in which the bone tissue of the jaw literally dies) had previously been linked to taking Fosamax. A check of the Merck website on May 6 showed no mention of this possible complication either under side effects or dosing information. Nevertheless, we found that no less prestigious a group than the New York Academy of Science is sponsoring a conference on bisphosphonates and osteonecrosis of the jaw (ONJ) later this month. In fact, that conference is partially funded by Merck & Co., Inc, Novartis, and Procter & Gamble Pharmaceuticals, the major manufacturers of bisphosphonates.

What’s more, it turns out that the bisphosphonates have been associated with cases of osteonecrosis of the jaw since 2003. That’s when reports surfaced of bisphosphonate-associated osteonecrosis of the jaw (BON) linked to use of Zometa (zolendronic acid) and Aredia (pamidronate). Novartis manufactures pamidronate, as well as zolendronic acid under the names Zometa and Reclast. Zometa is used to treat bone loss in cancer patients and others who are undergoing a more rapid form of bone disintegration than occurs in osteoporosis. Reclast has been approved by the FDA for Paget’s disease and is being considered for treating osteoporosis.

For the most part, early reports of BON were associated with dental work, especially dental work that directly affected the jaw, such as tooth extraction. But then it became apparent that some BON episodes were spontaneous and not the result of dental intervention. The odds of suffering from BON are much greater as a result of dental intervention, so patients who are about to undergo therapy with zolendronic acid (or any bisphosphonate, for that matter) are urged to take care of any essential dental work before beginning treatment.

At this point, the possible complications of treatment with bisphosphonates are unfamiliar to many medical professionals, hence the interest in symposia such as the NYAS educational conference on ONJ and bisphosphonates.

Perhaps medical treatments putting cancer into remission are just artificially producing a middle stage of cancer before a more serious metastatic stage begins. That would appear to be one of the implications of a research report appearing in May’s issue of the Journal of Clinical Investigation.

A research team led by Dr. Carlos Arteaga at Vanderbilt University tried suppressing Transforming Growth Factor(TGF)-beta in mice using antibodies. Suppressing TGF-beta stopped the spread of cancer tumors that would otherwise be spread as a result of treatment with radiation or doxorubicin, a chemotherapy agent. Either of these therapies causes TGF-beta to be produced in mice.

What’s more, tests on mice bred for the inability to produce TGF-beta showed similar results: despite the introduction of turmors followed by treatment with radiation and doxorubicin, their tumors did not spread. This research has led Arteaga and his colleagues to speculate that primary cancer tumors use TGF-beta as a signal to cancer cells at other sites in the body.

“We wondered if TGF-beta induced by anti-cancer therapies can serve as a survival signal for tumor cells, thus allowing them to withstand therapy and later recur,” Arteaga said in a statement.

Meanwhile, Arteaga’s team is testing drugs that interfere with TGF-beta to see if they improve survival.

“It probably isn’t just TGF-beta that is having this effect,” the researcher said. Many other compounds, including some immune system signaling chemicals, are also associated with tumor spread and growth.

“TGF-beta may be just the tip of the iceberg,” says Arteaga.

Cancer experts have wondered if the so-called primary tumor—the first and biggest tumor—might somehow suppress the growth of other tumors, and [if] removing or destroying the first tumor might allow other, undetectable, tumors to grow. –newmediaexplorer.org