News and Articles on Health. Medical research topics.

“Health is not a commodity that you buy from your doctor; it’s a responsibility that every mature human being accepts, embraces, and promises to live out,” says Bastyr University President Daniel K. Church.
Changing our understanding of wellness and what it means to be healthy is one of this university’s primary ambitions.
Changing our understanding of wellness and what it means to be healthy is one of this university’s primary ambitions.
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Located north of Seattle in Kenmore, Wash., Bastyr is the largest university for natural health arts and sciences in the United States. The 32-year-old accredited institution is internationally recognized as a pioneer in natural medicine, melding science and art in a multidisciplinary curriculum with leading-edge research and clinical training. A nonprofit, private university, Bastyr promotes a curriculum founded in science-based natural medicine.

Providing degrees in a variety of curricula, Bastyr offers a range of graduate and undergraduate programs, including naturopathic medicine, acupuncture and Oriental medicine, midwifery, nutrition, health psychology, exercise science, and herbal sciences. With an emphasis on the intrinsic relationship between mind, body, spirit, and nature, Bastyr’s mission is to educate future influencers in the natural health arts and sciences using a model that integrates education, research, and clinical service. “Our people should be leaders when they graduate—not just technically competent professionals, but people who have the ancillary skills necessary to provide leadership in their fields,” Church says.

In addition to educating future practitioners, Bastyr envisions itself as the world’s preeminent academic center for advancing and integrating knowledge in the natural health arts and sciences, in order to transform the health and well-being of the human community. Church highlights the idea of transformation, noting, “We’re not looking for incremental change, for people to be slightly less sick than they used to be. We’re looking for a major transformation, not just a change in health status, but a change in the appreciation of what health really is.”

Clinic Director and Clinic Medical Director at Bastyr, Jamey Wallace, ND, echoes Church’s vision of health transformation. Wallace points out that currently one of the biggest health challenges in the United States is the management of chronic disease. Evaluating lifestyle, diet, stress, and other contributing factors of chronic disease is key to not only treating but also preventing chronic disease. “Imagine a system where we have people coming in on a regular basis to stay healthy and then when something bad happens they can take advantage of the technology. We wouldn’t be spending thousands of dollars a month on some kind of new pill or tens of thousands on surgical procedures; we’d be spending hundreds of dollars on maintaining wellness,” suggests Wallace.

Study Design
The newest of the Francesco Sofi papers, this study added data from 7 prospective studies, published in the last 2 years, to an earlier meta-analysis published in 2008. The statistical analysis of the compiled data correlated adherence to a Mediterranean diet with relative risk of several diseases and overall mortality risk. These new additions included 1 study for overall mortality, 3 studies for cardiovascular incidence or mortality, 1 study for cancer incidence or mortality, and 2 studies for neurodegenerative diseases.

Participants
The number of subjects whose data was compiled varied by condition. For cardiovascular disease incidence and mortality, there were a total of 534,064 subjects with 8,739 events compiled for analysis. For cancer incidence and mortality, there were 1,006,410 subjects and 11,378 events. For neurodegenerative diseases, there were 136,235 subjects and 1,074 cases from which to draw conclusions. The earlier 2008 meta-analysis utilized data from 12 qualifying studies published between 1966 and 2008 with a total of 1,574,299 subjects.

Study Intervention
Adherence to a Mediterranean diet was defined via scores that estimated the conformity of the subject’s dietary pattern with the traditional Mediterranean dietary pattern. Values of zero or 1 were assigned to each of 7 to 9 different dietary characteristics by using medians of consumption among the study participants as the divider. People whose consumption was characteristic of a Mediterranean diet (vegetables, fruits, beans, cereals, fish, olive oil, and a moderate intake of red wine during meals) above the median consumption were given 1 point for each characteristic in which they were above average. A zero score was given to those with consumptions below the median. People whose consumption patterns of components not considered to be part of a Mediterranean diet (red and processed meats, poultry, eggs, or dairy products) was above the median consumption also had a zero assigned, while those at or below the median received 1 point for that category. Different studies varied in the total number of food categories scored. Thus while lowest score was always zero, the highest possible scores varied among the studies from 7 to 9 points for greatest adherence.

Primary Outcome Measures
The study calculated changes in relative risk of either incidence of or mortality from cardiovascular disease, cancer, or neurodegenerative diseases associated with greater adherence to a Mediterranean diet. Relative risk of total mortality was also calculated.

Key Findings
This paper is an update of Sofi et al 2008, adding data from newly published studies. The increased quantity of data did not have a substantial effect on Sofi’s original findings. This new meta-analysis showed that a 2-point increase in adherence to the Mediterranean diet was associated with a significant reduction of overall mortality [relative risk (RR)=0.92; 95% CI: 0.90, 0.94], cardiovascular incidence or mortality (RR=0.90; 95% CI: 0.87, 0.93), cancer incidence or mortality (RR=0.94; 95% CI: 0.92, 0.96), and neurodegenerative diseases (RR=0.87; 95% CI: 0.81, 0.94).

The potential health implications caused by the nuclear disaster in Japan may extend beyond Japanese citizens. The wind and water currents have carried radioactive materials to many parts of the world. Furthermore, concerns are arising regarding consumable goods exported from Japan. Included in this category are dietary supplement ingredients and their finished products. In this issue, you will find several commentaries from manufacturers about some of the proactive steps that they are taking to ensure the continued safety of their products. These manufacturers, along with other dietary supplement manufacturers, are to be lauded for their timely and quick accountability to this situation.

On March 25, 2011, the US Food and Drug Administration (FDA) began detaining all shipments of FDA-regulated products imported from the Japanese prefectures (sub-national jurisdictions) that are in the closest proximity to the Fukushima Daiichi nuclear plant, specifically Fukushima, Gunma Ibaraki, and Tochigi. This is a result of the fact that in mid-March, the Japanese Ministry of Health, Labour and Welfare confirmed the presence of radioactive iodine contamination in dairy and fresh produce from these regions. The FDA’s Import Alert further explains that radioactive iodine has a short half-life of about 8 days and naturally decays, but does pose risk to human health if contaminated food is absorbed into the body prior to its decay. In addition to produce, other at-risk Japanese exports, such as seafood, are being tested by the FDA prior to release into the US market.

It is not clear at this time what degree of risk is represented by dietary supplements with ingredients sourced from Japan. One would presume that there is risk associated with products containing raw materials sourced from, or processed in, the prefectures with proximity to the nuclear power plant. Michael McGuffin, president of the American Herbal Products Association (AHPA), recently released this statement: “AHPA will keep its membership apprised of any additional information of interest that may impact raw materials and ingredients, supply chains, distribution, and members’ ability to market products.” This statement summarizes the current state of watchfulness and caution.

Emerson Ecologics is in the process of soliciting information from each of its suppliers any raw materials that present risk of radioactive contamination and how they are mitigating this risk. Thus far, several companies whose operations are based in Japan have noted that their manufacturing facilities are located in the southern region of Japan, hundreds of miles away from the nuclear reactors, and areas which have not evidenced significant radioactive contamination. These companies continue to monitor the situation. Other companies with raw materials at risk for contamination are subjecting their raw materials to testing. Testing for radioactive iodine and cesium can be done by FDA-certified methodology. This test analyzes Cesium-134/137 and Iodine-131 by means of gamma-spectrometry using a Germanium-detector. Sample quantities of about 1 kg are typically required which effectively restricts the use of this test to raw materials as opposed to finished products. One qualified independent analytical laboratory charges $160 for this test.

At this point in time, the radiation risk to dietary supplements appears to be minimal. That being said, continued vigilance is required on the part of dietary supplement manufacturers to ensure that is parameter of supplement safety remains a non-issue for consumers.

Michael Traub of Ho’o Lokahi clinic in Kailua Kona, HI, also praises the NERC model, saying the residency program improves the services his clinic can offer the community:

Having a resident helps …increase patient care services through the resident’s private practice hours and clinical skill set; provide coverage for my patients when I am out of town; provide assistance for clinical research projects conducted at the clinic; give educational lectures to the public; and volunteer at a variety of health fairs and events, including senior health fairs, free skin cancer screenings, and the Ironman Triathlon World Championship.

Without NERC’s role as facilitator, doctors and students must organize residencies or mentorship opportunities on their own, and the clinic or practitioner must come up with funding for the resident’s salary. And if the residency is to be official, the clinic must have staff on hand to interact with one of the CNME-approved residency programs. All this strains the limits of what small practices can often accomplish. By joining the consortium, partner clinics benefit from NERC’s network of funders and practitioners, relationships with sponsors, and administrative contacts with residency oversight bodies.

At its core, NERC provides member clinics with direct funding for residencies. This support is possible thanks to NERC’s relationships with companies whose natural products NERC clinics dispense. “Sponsors fund our community-based residencies. Without them, we would not have NERC,” says Beeson. To this end, NERC seeks out corporate partners that share NERC’s commitment to advance the practice and promise of naturopathic medicine. Sponsors are companies with whom member clinics already have relationships, not unknown companies that approach NERC looking for a distribution outlet.

Beeson points out that many supplement companies “are founded and run by NDs who value the concept of residencies and furthering the profession.” Such professionals bring proven commitment to the “profession and to the principles of naturopathic medicine.” By approaching companies whose products are already in use in NERC clinics, or whose products or services are of interest to the NERC clinic network, the consortium creates a powerful microeconomy in which effective products can be discounted and clinical capabilities can be improved and enhanced by bringing residents into the clinic and community.

Looking ahead, NERC’s ambition is to help make residencies possible for all naturopathic graduates.
Looking ahead, NERC’s ambition is to help make residencies possible for all naturopathic graduates. Asked about the future, Hudson offers NERC’s vision statement: A healthcare system where naturopathic physicians are optimally educated and prepared for clinical practice; patients are able to become healthier by working with highly skilled clinicians; naturopathic physicians are able to contribute the full scope of their training to all communities, age groups, and socioeconomic classes; and naturopathic physicians have many more job opportunities.

Beeson looks to her and Hudson’s own experiences to postulate about NERC’s potential. “I studied with Dr. Bastyr, and Dr. Hudson studied with Dr. Turska. Through the NERC residency program, we have the opportunity to pass the core principles of the naturopathic art on to the next generation of physicians, and that’s very exciting.”

The Naturopathic Education and Research Consortium (NERC) is a small nonprofit organization making a big impact on the future of naturopathic medicine. Dedicated to increasing postgraduate residency and training opportunities for naturopathic doctors, NERC work has been with clinics across the country to provide official residencies for naturopathic physicians since 2005. Founded by Tori Hudson, ND, and Margaret Beeson, ND, NERC partners with clinics from Maine to Hawaii to create one- and two-year residency opportunities for new naturopathic doctors (NDs).

While students of naturopathic medicine are required to complete as many as 1,500 hours of clinical training in medical school,1 few formal opportunities exist after graduation to help new NDs continue to learn and grow professionally. In the mid-1990s, both Hudson and Beeson enjoyed the benefits of hosting residents in their clinics and saw a clear need for official and approved residency opportunities.
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Before the founding of NERC, two schools—the National College of Natural Medicine (NCNM) and Bastyr University—provided no more than eight positions for resident NDs, and those positions existed in only two or three locations. NERC’s collaboration with practitioners, clinics, schools, sponsors, and residents has created nine off-campus sites nationwide in which residents continue to train under professional supervision in conjunction with residency programs approved by the Council on Naturopathic Medical Education (CNME).2 In 2011, NERC will facilitate 12 off-campus residencies.

“Residencies are crucial to the advancement of our profession in terms of insurance reimbursement and loan repayment,at the very least. More importantly, graduates need paid opportunities to hone their skills in a supervised setting with seasoned naturopaths who can support and educate beyond medical school,” Beeson explains. “These types of relationships are the foundation for passing on the wisdom of medicine as both art and science.”

Besides the clinical competencies they bestow, residencies also foster community connections for clinics, doctors, and patients. Because CNME-approved residencies emphasize integrative medicine, NERC clinics bring together practitioners and clients seeking conventional and complementary health solutions. For evidence of the roles residents play in their practices and communities—and community appreciation for those roles—consider a recent resident experience at Seattle’s Institute of Complementary Medicine (ICM). Eileen Stretch, ND, of ICM reflects on a very positive integrative residency experience:

With support from NERC, we were able to employ JanciKarp, ND, LAc, as a resident for two years. During that time, Karp provided both naturopathic and acupuncture services to our patients, educated the community with a variety of talks and workshops, and built a successful practice of her own within our office. While a resident she rotated through a variety of medical practices, which benefited her education and also benefited the practitioners with whom she worked by being exposed to naturopathic medicine.

Blueberries are a new and attractive option to add to our current assortment of things that improve insulin sensitivity. The best-proven and safest ways to increase insulin sensitivity are still exercise and weight loss. Weight reduction reduces insulin resistance in both children and adults, especially in combination with exercise.

Adding large amounts of cereal fiber to the diet also increases insulin sensitivity. In one experiment, slightly more than 1 ounce a day of oat bran produced significant changes in insulin sensitivity after just 3 days. High-fiber rye breads have a similar beneficial action and have also been shown to lower cholesterol. Any weight gain during these experiments cancels out the benefit.

Low vitamin D levels adversely affect insulin sensitivity. A study published in April 2010 calls into question whether vitamin D will be useful for the general population; low vitamin D levels were only associated with insulin sensitivity in African American women, not Caucasian.9 Obviously there is no reason not to supplement all patients with vitamin D, but it may prove to affect insulin sensitivity in a portion of patients.

Obviously there is no reason not to supplement all patients with vitamin D, but it may prove to affect insulin sensitivity in a portion of patients.

The same might be true of chromium. For years we have given patients with blood sugar problems supplemental chromium. A double-blind, placebo-controlled trial published in July 2009 by Yale University researchers calls this practice into question. After 6 months of supplementation at either 500 or 1,000 mcg/day, insulin sensitivity was no different than in those who had taken placebo. The authors concluded, “Chromium supplementation does not appear to ameliorate insulin resistance or impaired glucose metabolism in patients at risk for type 2 diabetes, and thus is unlikely to attenuate diabetes risk.” However, a paper published 2 months earlier from Louisiana State University reported that some people do respond to chromium. In this study clinical improvement was “more likely in insulin-resistant subjects who have more elevated fasting glucose and A(1c) levels.” The participants in the Yale study were only at high risk for type-2 diabetes. Those in the Louisiana study who responded already had diabetes, and the worse their disease, the better the response.

Until proven otherwise, let us assume that fresh or frozen blueberries will be as effective at improving insulin sensitivity as the powders utilized in the current study. Given that blueberries are thought to provide benefit against a wide range if health disorders, it will be reasonable to suggest daily consumption of blueberries to a large number of patients, especially those with reduced insulin sensitivity.

Seventy-seven percent of participants presented 1 or more magnesium status parameters below the low normal range. Magnesium intake was inadequate in most subjects (82 percent). According to the researchers, “The results presented here show that magnesium intake by the study population was inadequate and that a high percentage of individuals presented alterations in the status of this mineral.”

Subjects had evidence of poor blood glucose control with fasting glucose of 8.1 ± 3.7 mmol/L or 145 ± 66 mg/dL (reference range: 3.6–5.8 mmol/L or 64.8–104.4 mg/dL); 2-hour postprandial glucose of 11.1 ± 5.1 mmol/L (200 ± 91 mg/dL) (reference range: <10 mmol/L or <180 mg/dl), and HbA1C of 11.4 ± 3.0%. The parameters that influenced fasting glucose were urine, plasma, and dietary magnesium, while plasma magnesium was influenced by creatinine clearance.
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Magnesium intake by the study population was inadequate and a high percentage of individuals presented alterations in the status of this mineral.

Practice Implications
This study set out to assess magnesium intake and magnesium levels in patients with type 2 diabetes. More than 325 magnesium-dependent enzymes allow magnesium to function as a cofactor in a wide range of metabolic reactions. The researchers in this study acknowledge that insulin function is dependent on magnesium, which is responsible for the activation of insulin receptors and for stimulation of proteins and substrates involved in insulin signaling. The researchers cite previous research suggesting that magnesium intake of patients with diabetes is very often below recommended levels. They cite evidence that low levels of magnesium may influence the evolution of the disease by generating further complications.

The incidence of diabetes in the United States is 7.8 percent for diagnosed and undiagnosed cases. The National Academy of Sciences has determined that most American men only obtain about 80 percent of the recommended daily allowance (RDA) of magnesium, and women average only 70 percent.

These new data are consistent with a number of earlier publications that suggest both a strong protective effect and possibly a useful therapeutic effect from coffee or caffeine against glioma. Members of the public frequently view coffee in a negative light and will often “give it up” after a cancer diagnosis. At least in the case of glioma, coffee may have benefit, and these patients should be discouraged from discontinuing their coffee consumption.

Holick et al already reported that coffee lowered risk of glioma in January 2010. In this earlier paper, data from 3 prospective cohort studies were combined to yield 335 incident cases of glioma. Consumption of 5 or more cups of coffee and tea per day compared with no consumption decreased risk significantly (RR, 0.60; 95% CI, 0.41–0.87; P(trend)=0.04). The inverse association was stronger in men (RR, 0.46; 95% CI, 0.26–0.81; P(trend) = 0.03).

Other recent studies suggest coffee, in particular caffeine, may be more than protective against glioma and that both may have therapeutic value during treatment of glioma.

In February 2010, Kang et al reported that caffeine might be a useful adjunctive therapy against invasive glioma. After showing that caffeine inhibited migration of glioblastoma cells in various in vitro assays, the researchers showed in vivo that caffeine greatly increased mean survival using a mouse xenograft model of glioblastoma.
Caffeine sensitizes glioma cells to both ionizing radiation and chemotherapy.

Caffeine sensitizes glioma cells to both ionizing radiation and chemotherapy. In February 2010, Sinn et al reported that “caffeine or its derivative pentoxifylline are promising candidate drugs for the radiosensitization of glioma cells.”3 Caffeine also enhances the effect of the chemotherapy drug temozolomide (Temador), which is often used in conjunction with radiation to treat malignant glioma.

One possible explanation for these benefits is that coffee is a peroxisome proliferator-activated receptor (PPAR) gamma agonist. PPAR gamma agonists not only inhibit brain tumor growth,6 but they may also inhibit brain cancer stem cells.

Interestingly, a number of synthetic PPAR gamma agonists are already under investigation for treating brain tumors. Ciglitazone and troglitazone, both synthetic PPAR gamma agonists, are being investigated and showing promise.8,9 Pioglitazone (Actos), a drug already used to treat diabetes, may be of possible use. A 2006 study using a rat glioma model reported that “oral administration of pioglitazone reduced tumor volumes by 76.9%. Subsequent brain tissue analysis revealed induction of apoptotic cell death.”

Leaving all of these interesting details aside for the moment, our bottom line should be that glioma patients should be drinking coffee with the caffeine still in it. The next time a patient with a malignant glioma tells you they have stopped drinking coffee to be healthy, explain to them that it’s better to drink more coffee rather than less.

Design
Prospective cohort study

Participants
31,823 women aged 48 to 83 years who were participants in the Swedish Mammography Cohort

Study “Medication”
Chocolate. Frequency of chocolate consumption was contrasted with incidence of heart failure. The women were followed from January 1, 1998, through December 31, 2006, for heart failure (HF) hospitalization or death. During this period, 419 women were hospitalized for incident HF (n=379) or died of HF (n=40).

Key Findings
Women consuming 1 to 3 servings of chocolate per month compared with no regular chocolate intake, had a 26% lower risk of heart failure. Those consuming 1 to 2 servings per week had a 32% decrease in risk. At higher levels of consumption, risk may increase, but the numbers did not reach statistical significance.

Practice Implications
Moderate consumption of chocolate (1–2 servings/week) might lower risk of heart failure in women, a finding that few will complain about.

Moderate consumption of chocolate (1 to 2 servings/week) might lower risk of heart failure in women, a finding that few will complain about.

A number of recent clinical trials utilizing high-polyphenol chocolate suggest that chocolate exerts a blood pressure–lowering effect in hypertensive individuals. A meta-analysis published in June 2010 combined data from 13 studies and concluded that “dark chocolate is superior to placebo in reducing systolic hypertension or diastolic prehypertension.”
What is striking about the Mostofsky study is that no “special” chocolate was required. Plain chocolate, or at least the chocolate commonly consumed in Sweden, was adequate to produce significant benefit. This is not to say that the special high-polyphenol chocolates may not produce even greater benefit.

While on this topic, mention must be made of the 2009 study by Janszky et al. In this earlier paper, 1,169 Swedish patients were followed after they had been hospitalized with a first heart attack. Chocolate consumption along with hospitalizations and mortality were tracked. Chocolate consumption had a strong inverse association with cardiac mortality. When compared with those of people who never eat chocolate, the hazard ratios were 0.73 for those consuming chocolate less than once per month, 0.56 up to once per week, and 0.34 for twice or more per week. In contrast, intake of other sweets was not associated with cardiac or total mortality.

Thus the data now clearly support our telling patients that weekly consumption of chocolate is not only acceptable but actually recommended for those at elevated risk for heart failure or myocardial infarction.

AE-941 is a standardized, water-soluble shark cartilage extract. The precise composition of the extract is not disclosed, but there is presumption that proteins in the extract are responsible for its activity. In vitro, it has been shown to induce endothelial cell apoptosis, inhibit matrix metalloproteinases, and inhibit vascular endothelial growth factor. Given orally in a mouse, it has demonstrated antimetastatic activity.

This favorable in vitro and in vivo data led to an open-label phase I–II dose escalation study assessing AE-941 (30, 60, 120, and 240 ml/d) in 80 patients with NSCLC. In this small trial there was a statistically significant improvement in survival in patients with Stage III/IV NSCLC (n=48) receiving the higher doses. Median survival time for the high-dose group was 6.1 months vs. 4.6 months in the low dose group (P=0.26).

The current phase III trial of NSCLC is much larger and better controlled than the pilot study. Although recruitment was stopped before the target sample size of 756 patients was met, the final sample size of 384 patients was adequate for statistical analysis. At years 1, 3, and 5, the overall survival rate in the AE-941 group was 59%, 25%, and 14% respectively. In the placebo group, the overall survival rates at 1, 3, and 5 years were 61%, 21%, and 14% respectively. No secondary endpoints resulted in statistical benefit either. This multicenter trial included both academic and community clinics and was well controlled and designed.

It is essential as practitioners that we stay apprised of new information on natural agents that are reputed to have anticancer effects. We should neither be swayed by the popular press nor be dismissive of ideas before all of the evidence is assessed. Shark cartilage is one example of a promising product in vitro that has just not proven itself in large clinical studies. While still sold on the market, there is insufficient evidence to warrant its use, and evidence provides direct refutation of its use in NSCLC. Of course, the supplement also takes an ecologic toll on the shark population, a separate but valid concern regarding its widespread use. The National Cancer Institute provides a comprehensive listing of all of the clinical trial data on the various shark cartilage products.

Limitations
AE-941 is a complex natural product, not a single agent. The company claims it is standardized, although there is no methodology or component breakdown to ensure replication or even consistency from batch to batch. The current study did not disclose batch numbers, so this is an unanswered question regarding the current study. The dose may not have been adequate, although the dose used in the study, 240 ml/d, was the highest level yet tested in a phase I study. The tolerable upper dose has not been set. Lastly, when given orally components in AE-941 may be broken down by digestion before reaching the bloodstream. Without any blood parameters of either ingredients or other blood markers to track, it is unclear whether AE-941 was adequately absorbed intact.

Design
Multicenter, randomized, double-blinded, placebo-controlled phase III trial. Three hundred seventy-nine patients with unresectable stage III non-small cell lung cancer (NSCLC) were enrolled between June 5, 2000, and February 6, 2006. All patients received chemotherapy, including a platinum-based agent, and radiotherapy. Patients were randomly assigned in a 1:1 ratio to receive either 120 ml of AE-941 (Neovastat) (n=188) or an equal dose of placebo (n=191) orally twice daily. The groups were stratified for stage (IIIA or IIIB), chemotherapy regimen, and gender. Assessment of tumor status with computed tomography (CT) was made at baseline, before thoracic radiotherapy (which began day 50), and at 6 weeks post radiotherapy. The primary endpoint was overall survival. Secondary endpoints included time to progression (TTP), progression-free survival (PFS), tumor response rate, and toxic effects.

Key Findings
There was no statistically significant difference in overall survival in those taking AE-941 versus placebo: 14.4 months (95% CI=12.6–17.9 months) vs. 15.6 months (95% CI=13.8–18.1 months). There was also no statistically significant difference between the AE-941 and placebo groups in any of the the secondary endpoints of the trial. Median TTP=11.3 months (95% CI =9.0–16.8 months) in AE-941 vs. 10.7 months (95% CI=9.5–21.6 months) in the placebo group. Similar results were obtained for progression-free survival.

Practice Implications
The use of shark cartilage as an alternative cancer treatment has been touted in lay media for many years. In 1992 William Lane published Sharks Don’t Get Cancer: How Shark Cartilage Could Save Your Life, which coincided with a product he sold, shark cartilage extract (Benefin). The use of shark cartilage is an interesting story of the best and worst in the marketing and development of natural agents. While a product was being sold on the market, much of the scientific community dismissed its use out of hand based on hyperbole and lack of evidence. Meanwhile, there was diligent pursuit of evidence of its anticancer activity by the Canadian pharmaceutical company Aeterna Zentaris, owners of AE-941 (Neovastat).

Up until 2003, AE-941 appeared to be a legitimately promising agent, with data accumulating on its anticancer effects both in vitro and in vivo. This included a 2002 study of advanced cancers that showed a cohort of renal cell cancer patients (n=22) had improved survival in the high-dose (240 ml/d) group compared with the low-dose (60 ml/d) group (16.3 vs. 7.1 months). However, a phase III study presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2003 reported there was no benefit to overall survival when used as a sole agent in patients with kidney cancer refractory to immunotherapy.

The current study, which is much larger and better controlled than any previously published trials, now provides sufficient evidence to refute the use of shark cartilage in patients with NSCLC, and to dampen any enthusiasm of its use as an anticancer agent in general.