Monthly Archives: March 2006

Lifestyle and the rise in head and neck cancers

  • 3/31/2006
  • London, England
  • Dr. Thomas Stuttaford
  • The Times Online (www.timesonline.co.uk)

Less than two years before his death in March 2001, John Diamond’s book “C: Because Cowards Get Cancer Too” was published. The book, his column in The Times and a BBC TV series chronicled Diamond’s final illness. This media coverage introduced the subject of head and neck cancers to the general public.

These cancers are becoming more common. John Diamond’s cancer had started in his tongue but had spread to the neck and beyond before it was diagnosed. His column and book were written with absolute honesty and wry humour. Nobody knows if John greeted St Peter with a quip, but he certainly joked to his surgeon when he went into the operating theatre only a day or two before he died. He was bleeding from a tumour site and the surgeon told him that it was necessary to tie off the “bleeding point” — the technical term for a bleeding blood vessel. John looked at his surgeon, nodded his agreement, smiled, produced his notepad and wrote: “What is the bleeding point?”

Last week a number of experts, including Peter Rhys-Evans, of the Royal Marsden, who looked after John, talked in Amsterdam about Erbitux (cetuximab) in the treatment of head and neck cancers. Erbitux, made by Merck, is one of the new monoclonal antibody chemotheraputic agents that targets cancer cells while largely sparing healthy tissue. It has already proved its worth against colo-rectal cancer, and there are encouraging reports of its use with non-small-cell cancer of the lung.

Malignant tumours of the head and neck are classified as head and neck cancers unless they arise in the eyes, brain, ears, thyroid or oesophagus (gullet). They originate mainly in the lips, tongue, mouth, throat, post-nasal spaces and in or around the larynx. They are responsible for 10 per cent of male cancers in the EU and used to be six or seven times more common in men than women. Now, however, these cancers are only about twice as common among men. They are also being seen more frequently in young people, although most still occur in the over-fifties.

They are difficult to diagnose and treat and hard for the patient to bear. They affect parts of the body that can’t be hidden, and impair key activities: after treatment the patient may be disfigured, have impaired speech, and can sometimes eat and drink only with difficulty.

Head and neck cancers may be triggered by smoking, especially when combined with excessive alcohol, which enhances the effect of the tobacco and is described as a co-factor. The probable reason for the change in the proportion of men to women who develop cancer of the head and neck is that younger women are smoking and drinking more whereas fewer men smoke.

A year or two ago an even more disturbing co-factor than alcohol, and possibly also cannabis, was suggested. It was proposed that the increase in oral sex over the last generation might be a relevant factor. Mr Rhys-Evans, who is not only a consultant surgeon at the Royal Marsden but the executive chairman of the Head and Neck Cancer Research Trust, confirmed that HPV, the wart virus responsible for cervical and some other genital cancers, was also found from time to time in tonsils removed because of malignancy.

He suggested that there were many other co-factors, and that even the current rejection of tonsillectomies in childhood has had some influence on the incidence of head and neck tumours.

Unhealed mouth sores, or unexplained lumps in or around the mouth or on the lips, mouth or throat, if they persist for more than a couple of weeks or if people have difficulty or pain when chewing or swallowing, need investigation, as does a persistently but inexplicably blocked or bleeding nose. Investigation will usually show that it is benign, but occasionally the need for radical surgery will be avoided by quick action.

March, 2006|Archive|

Surgical margins and survival after head and neck cancer surgery

  • 3/30/2006
  • Pasadena, CA
  • R Haque et al.
  • BMC Ear Nose Throat Disord, January 1, 2006; 6: 2

Background:
Mixed results exist as to whether positive surgical margins impact survival. The aim of this study was to determine whether positive surgical margins are indeed associated with decreased survival in patients with primary head and neck cancer.

Methods:
We conducted a retrospective cohort study of 261 cases diagnosed with cancer of the larynx or tongue between 1995 and 1999. Cases were followed through December 31, 2002. Survival curves by margin status were generated by Kaplan-Meier methods. Categorical data were evaluated with odds ratios (OR).

Results:
All-cause mortality was markedly higher in cases with positive margins as compared with those with negative margins (54% versus 29%, P = 0.005). This pattern also appeared after adjusting for age and sex (OR = 2.97, 95% CI: 1.29 – 6.84).

Conclusion:
Our findings suggest that positive surgical margin status is associated with increased mortality. This association also generally persists after adjustment for tumor size, stage, and adjuvant therapy.

Authors:
R Haque, R Contreras, MP McNicoll, EC Eckberg, and DB Petitti

Authors’ affiliation:
Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, USA

March, 2006|Archive|

Amgen Files For FDA Approval Of Panitumumab – Update

  • 3/30/2006
  • New York, NY
  • press release
  • TradingMarkets.com

Amgen Inc. said Thursday that it has completed the Biologic License Application submission with the U.S. Food and Drug Administration for experimental drug panitumumab as a treatment for metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens.

Amgen, the world’s largest biotechnology company, is developing the drug Abgenix Inc. , another biotechnology company it is in the process of buying for about $2.2 billion in cash.

Amgen and Abgenix previously announced data from a randomized Phase 3 trial involving 463 patients that showed a 46% reduction in tumor progression rate in patients who received panitumumab every two weeks compared to those who received best supportive care alone.

Full results of the trial will be presented at the 97th Annual Meeting of the American Association for Cancer Research on April 3.

Willard Dere, chief medical officer and senior vice president of Global Development at Amgen, said, “Completing the BLA brings us one step closer to realizing our goal of making panitumumab accessible to patients with metastatic colorectal cancer who have failed available treatment options.”

Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor, a protein that plays an important role in cancer cell signaling.

Panitumumab received Fast Track designation from the FDA in July 2005 for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment. It is being evaluated in clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and head and neck.

March, 2006|Archive|

Amifostine Makes Radiation More Effective, Eases Side Effects

  • 3/30/2006
  • Brazil
  • staff
  • Biocompare.com

Doctors in Brazil have concluded that the drug amifostine eases many of the most common side effects associated with patients receiving radiation therapy to treat their cancer while simultaneously making the cancer more susceptible to radiation. The study was published in the March 1, 2006, issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of ASTRO, the American Society for Therapeutic Radiology and Oncology.

The researchers set out to evaluate, via a clinical investigation of already published work, whether adding amifostine to radiation therapy would prevent common side effects, such as mouth dryness, difficulty swallowing, lung inflammation, bladder inflammation, problems with the esophagus and inflammation of the mucous membranes. In some cases, these side effects can be severe enough that the patients’ treatment has to be suspended or stopped completely – potentially preventing their cancer from being completely cured. The other major purpose of the study was to discover if amifostine would inadvertently protect the tumor from radiation.

The investigators narrowed their research to 14 randomized, controlled trials in which 1,451 patients were split into two groups: one receiving radiation therapy alone and the second receiving radiation therapy in addition to amifostine. Patients taking amifostine were shown to have less radiation-related side effects. The research also showed that the drug did not protect the tumor from the radiation therapy and patients receiving the drug were more likely to have their cancer affected by the radiation than patients not given amifostine.

Taking amifostine does have some drawbacks, with nausea and vomiting being the most common side effects reported. However, the doctors generally were able to control the side effects with anti-nausea medicine.

“Our research shows that adding amifostine to radiation therapy helps reduce side effects while at the same time making the radiation treatments more effective at killing the cancer cells,” said Andre Deeke Sasse, M.D., a radiation oncologist at Nucleo Brasileiro de Oncologia Baseada em Evidencias in Sao Paolo, Brazil. “We recommend that patients undergoing radiation therapy for cancer ask their doctor about adding amifostine to their treatment.”

Source:
American Society for Therapeutic Radiology and Oncology

March, 2006|Archive|

Trends in Smokeless Tobacco Use Among Adults and Adolescents in the United States

  • 3/29/2006
  • Washington, DC
  • David E. Nelson et al.
  • American Journal of Public Health, 10.2105/AJPH.2004.061580

Objectives:
Smokeless tobacco has many adverse health effects. We analyzed long-term national trends in smokeless tobacco use.

Methods:
We used 1987 to 2000 National Health Interview Survey data for adults aged 18 years and older, 1986 to 2003 data from Monitoring the Future surveys of adolescents, and 1991 to 2003 data from the Youth Risk Behavior Survey for 9th- to 12th-grade students to examine overall and demographic-specific trends.

Results:
Smokeless tobacco use among adult and adolescent females was low and showed little change. Smokeless tobacco use among men declined slowly (relative decline=26%), with the largest declines among those aged 18 to 24 years or 65 years and older, Blacks, residents of the South, and persons in more rural areas. Overall and demographic-specific data for adolescent boys indicate that ST use increased for 12th-grade students from 1986 until the early 1990s, but has subsequently declined rapidly in all grades since then (range of relative overall declines=43% to 48%).

Conclusions:
Smokeless tobacco use has declined sharply, especially among adolescent boys. Ongoing prevention and cessation efforts are needed to continue this trend.

Authors:
David E. Nelson 1, Paul Mowery 1, Scott Tomar 2, Stephen Marcus 3, Gary Giovino 4, Luhua Zhao 5

Authors’ affiliations:
1 Centers for Disease Control and Prevention
2 University of Florida
3 National Cancer Institute
4 Roswell Park Cancer Institute
5 Research Triangle Institute

March, 2006|Archive|

Cuba working to use anti-cancer therapies in early stages of disease

  • 3/29/2006
  • Havanna, Cuba
  • Lilliam Riera
  • Gramma Internacional (www.granma.cu)

Cuban scientists, whose field studies of therapeutic vaccines for the treatment of cancer have demonstrated encouraging results, have begun to work toward applying these therapies in the early stages of the disease.

The therapeutic cancer vaccines, produced from component elements of tumors, are not intended to cure patients but to keep the tumor under control for a long period. The drug attempts to stimulate and “teach” the immune system of the affected organism to detect and destroy malignant cells without the disagreeable side effects caused by chemotherapy and radio therapy.

In an article published on March 23 in Granma daily Dr. Luis Enríquez Fernández, head of the vaccine department of the Molecular Immunology Center (CIM) stated that, on the basis of animal experiments, Cuban and other researchers, can predict the value of transferring studies of these new cancer vaccine therapies to patients in the early stages of the disease in whom, theoretically, it would be possible to halt tumor growth for prolonged periods.

“Today, the specialized scientific community has sufficient evidence to begin firmly believing in this possibility and we have already begun working to eradicate this scourge on humanity via a preventative vaccine,” the doctor affirmed.

According to Enríquez Fernández, after nearly 30 years of clinical evaluations of the concept of therapeutic cancer vaccines and with more than 400 clinical trials completed, during which revolutionary advances in immunological thinking have occurred, “we have begun to understand the reasons for which the results obtained so far, although very encouraging, are modest in relation to patient benefits.”

For Fernández the problem is that the majority of these tests have been made on individuals in very advanced stages of the disease, in which the large tumorous mass and accumulated treatments received have profoundly deteriorated immune system functions.

The scientist believes that, in the case of cancer vaccines, the time to test and understand the concept better begins and ends in converting early stage tumors into chronic controlled illnesses, thus extending quality life for the patient.

He also noted that even though there still is no cancer vaccine being distributed for use by oncologists in the world, approximately 105 vaccine candidates exist in different phases of clinical trials, belonging to 64 companies (principally biotechnological) in five countries: the United States, the United Kingdom, Germany, Canada and France.

In Cuba, cancer vaccine field studies began at CIM in 1990. for the first time, that research was accompanied by an innovative cancer research program in an underdeveloped country.

Fernández recalled that after 15 years of labor, the program bore fruit: four original candidates for therapeutic cancer vaccines are being tested on patients throughout the country with the participation of Public Health Ministry specialized services.

“Just last year more than 170 new cases were incorporated into these trials, where the vaccines can prove their efficiency in the types of cancer that most impact the Cuban population: lung, prostate, breast and colon. “

The specialist, who acknowledges that the results obtained are encouraging and recommends the continuation of the studies, announced that two new vaccine candidates for the treatment of cervical and prostate tumors, developed by the Genetics Engineering and Biotechnology Centers (CIGB) in the capital and in the central province of Camagüey, are to enter the clinical trial phase this year.

In the modern laboratories of CIM, part of the West Havana Scientific Complex, 22 products are currently being investigated, which include, in addition to cancer vaccines, monoclonal antibodies such as CIMAher, registered since 2002 and holding a patent in 17 nations, which has shown promising results in head and neck tumors in combination with radiotherapy.

In the case of the therapeutic vaccine against lung cancer, based on the Epidermal Growth Factor (EFG) —a protein closely connected to cellular growth— Granma International reported in 2004 that it is to go through clinical trials in the United States for its later registration there this year, according to José Miyar Barruecos, secretary of the Council of State.

Said vaccine was subjected to clinical trials in Cuba with evident advantages in patient survival.

In a visit to various institutions of the Scientific Complex, two years ago, this weekly learned of the completion of a new pilot plant in the CIGB whose mission would precisely be to make batches of the EGF vaccine for clinical trials.

On July 15, 2004, CIM and the U.S. CancerVax Corporation of California signed a biotechnology technology transfer agreement in Havana in the presence of President Fidel Castro – the first in more than 40 years – for the cooperative production of anti-cancer vaccines. In the United States lung cancer causes more than a half a million deaths per year.

In a video sent to the participants in the signing of the agreement, Dr. Donald Morton, director and chief surgeon at the John Wayne Cancer Institute of Los Angeles, described the Cuban anti-cancer vaccines designed to stimulate the immune system as a unique discovery without precedent.

On this occasion, CIM director Dr. Agustín Lage emphasized the fact that no tradition exists of technology transfer, especially in biotechnology, from the South to the North.

In 2005, in a scientific conference in Havana, Dr. Carlos Borroto, deputy director of CIGB, recalled that during the 1980’s the island only possessed three biotech products, but at the close of the first five years of the 21st century this number has risen to 38. Moreover, the country exports $300 million worth of medicines annually to 51 countries.

March, 2006|Archive|

‘Custom’ Nanoparticles Could Improve Cancer Diagnosis And Treatment

  • 3/29/2006
  • Chapel Hill, NC
  • staff
  • Biocompare.com

Researchers have developed “custom” nanoparticles that show promise of providing a more targeted and effective delivery of anticancer drugs than conventional medications or any of the earlier attempts to fight cancer with nanoparticles. Designed at the molecular level to attack specific types of cancer without affecting healthy cells, the nanoparticles also have the potential to reduce side effects associated with chemotherapy, the researchers say. Their study was described today at the 231st national meeting of the American Chemical Society, the world’s largest scientific society.

The particles, considered the next generation of cancer therapeutics, are the most uniform, shape-specific drug delivery particles developed to date, according to researchers at the University of North Carolina (UNC) in Chapel Hill. Other potential benefits of the tiny uniform particles include enhanced imaging of cancer cells for improved diagnosis and use as delivery vehicles for gene therapy agents, they say.

To date, the UNC researchers have produced a variety of custom nanoparticles from biocompatible organic materials using techniques they adapted from processes used by the electronics industry to make transistors. In cell studies, they have shown that the uniform nanoparticles can attach to specific cell targets, release important chemotherapy drugs inside cells, and hold MRI contrast agents. Animal studies began recently and human studies are anticipated, the researchers say.

“I think this will transform the way one detects and treats disease,” says study leader Joseph DeSimone, Ph.D., a chemistry professor at UNC and director of the school’s Institute for Advanced Materials, Nanoscience and Technology. He has co-founded a company, Liquidia Technologies, to develop and produce the nanoparticles.

Researchers have been experimenting with nanoparticles as drug delivery vehicles for years but have had only limited success in cell and animal studies, DeSimone says. Each carrier has drawbacks with regard to stability in the bloodstream or ability to be directed toward a specific cancer site. In addition, there has been no general method available that allows precise control of the particle’s size, shape and composition, which are considered key features for the success of targeted drug delivery, he says.

Now, DeSimone and his associates at UNC have developed a new fabrication technique that allows, for the first time, unprecedented control over the structure and function of drug delivery nanoparticles. Called PRINT (Particle Replication In Non-wetting Templates), the technique is similar to injection molding and uses principles borrowed from the electronics industry for transistor fabrication, they say. The technique was first detailed last June in the online version of the Journal of the American Chemical Society.

The manufacturing process starts with a silicon wafer that is etched with the shape and size of the desired nanoparticle, resulting in a template. Next, nonstick liquid fluoropolymers are poured into the template and cured to form a fixed mold. The finished mold is then injected with organic materials that can contain imaging agents, anticancer drugs, DNA (for gene therapy) and other materials, depending on the intended function, DeSimone says. The new manufacturing technique uses gentler processing methods that are less likely to harm important organic components than traditional nanoparticle manufacturing techniques, he adds.

The resulting nanoparticles can be as small as 20 nanometers, or thousands of times smaller than the width of a single human hair. The shapes of the particles can also be made to mimic the shapes of objects found in nature like red blood cells or virus particles, DeSimone says.

Source:
American Chemical Society

March, 2006|Archive|

Levels of ET-1 Help Predict Outcomes of Nasopharyngeal Cancer

  • 3/27/2006
  • Iowa City, IA
  • staff
  • cancerconsultants.com

According to an article recently published in the journal Cancer, high levels of endothelin-1 (ET-1) prior to therapy are associated with a worse prognosis in patients with nasopharyngeal cancer.

The nasopharynx is the area above the soft palate (roof of the mouth) and behind the nose. Nasopharyngeal cancer (NPC) is considered a type of head and neck cancer. Approximately 40,000 people in the US are diagnosed with head and neck cancer every year.

Cancers of the head and neck comprise several types of cancer affecting the nasal cavity, sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer that year.

Advanced nasopharyngeal cancer refers to cancer that has spread from its site of origin to different sites in the body. Patients with advanced nasopharyngeal cancer have different prognoses following standard therapies.

Researchers are evaluating different patient and disease variables, or “markers”, to help determine which patients are at a higher risk for developing cancer progression following standard therapies. Those at a higher risk for cancer spread or progression may benefit from more extensive or aggressive therapy.

Researchers from China recently conducted a study to evaluate a possible association between levels of ER-1, a molecule associated with the development and spread of cancer, and outcomes of patients with advanced nasopharyngeal cancer. Levels of ER-1 in a blood sample were measured in 62 patients with advanced nasopharyngeal prior to treatment; these levels were compared with 19 healthy patients (control group).

– Patients with nasopharyngeal cancer had significantly higher levels of ER-1 than the control group.

– At 2 years, patients with nasopharyngeal cancer who had lower levels of ER-1 had a survival rate with no cancer spread to distant sites of 81.1%, compared with 56.7% for those with higher levels of ER-1.

The researchers concluded that higher levels of ER-1 prior to treatment may indicate which patients with advanced nasopharyngeal cancer are at an increased risk of developing distant cancer spread following standard therapy. Future clinical trials will establish variables or markers that indicate which patients are at a higher risk of cancer spread and/or a worse prognosis than others. Patients with a poorer prognosis may benefit from more aggressive therapy or the participation in a clinical trial evaluating novel therapeutic strategies.

Patients diagnosed with nasopharyngeal cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.cancerconsultants.com.

Reference:
Mai H-Q, Zeng Z-Y, Zhang C-Q, et al. Elevated Plasma Big ET-1 is Associated with Distant Failure in patients with Advanced-Stage Nasopharyngeal Carcinoma. Cancer. 2006; 206: 1548-1553

March, 2006|Archive|

Health Journal: The case against vitamins

  • 3/27/2006
  • Pittsburgh, PA
  • Tara Parker-Pope
  • Pittsburgh Post-Gazette (www.post-gazette.com)

Every day, millions of Americans gobble down fistfuls of vitamins in a bid to ward off ill health. They swallow megadoses of vitamin C in hopes of boosting their immune systems, B vitamins to protect their hearts, and vitamin E, beta carotene and other antioxidants to fight cancer.

It’s estimated that 70 percent of American households buy vitamins. Annual spending on vitamins reached $7 billion last year, according to industry figures.

But a troubling body of research is beginning to suggest that vitamin supplements may be doing more harm than good. Over the past several years, studies that were expected to prove dramatic benefits from vitamin use have instead shown the opposite. Beta carotene was seen as a cancer fighter, but it appeared to promote lung cancer in a study of former smokers. Too much vitamin A, sometimes taken to boost the immune system, can increase a woman’s risk for hip fracture. A study of whether vitamin E improved heart health showed higher rates of congestive heart failure among vitamin users.

And there are growing concerns that antioxidants, long viewed as cancer fighters, may actually promote some cancer and interfere with treatments.

Last summer, the prestigious Medical Letter, a nonprofit group that studies the evidence and develops consensus statements to advise doctors about important medical issues, issued a critical report on a number of different vitamins, stressing the apparent risks that have emerged from recent studies. The Food and Nutrition Board of the National Academy of Sciences — the top U.S. authority for nutritional recommendations — has concluded that taking antioxidant supplements serves no purpose.

“People hear that if they take vitamins they’ll feel better,” says Edgar R. Miller, clinical investigator for the National Institute on Aging and author of an analysis that showed a higher risk of death among vitamin E users in several studies. “But when you put (vitamins) to the test in clinical trials, the results are hugely disappointing and in some cases show harm. People think they are going to live longer, but the evidence doesn’t support that. Sometimes it’s actually the opposite.”

Not everybody is buying these results. Consumers remain devoted to their vitamin regimens. Industry groups such as the Council for Responsible Nutrition reject the recent evidence, saying the research is flawed or the people studied were too sick to start with, making it impossible to draw any broad conclusions for the rest of us. “I don’t think it’s black and white,” says Andrew Shao, vice president of regulatory and scientific affairs for the council. “It’s important to know that a lot of these studies have been done in diseased populations. I suppose the expectations are too high. These vitamins are not drugs. They can’t be expected to cure or reverse 20, 30 or 40 years of disease.”

Everyone needs vitamins, which are key nutrients the body can’t make. But micronutrients from foods usually are adequate to prevent vitamin deficiency, which is rare in the U.S. Even so, vitamin B-12 supplements for the elderly and folic acid for women of child-bearing age are recommended.

But the proven benefits of a few supplements pale next to the growing concerns about widespread vitamin use. Nobody knows why high doses of vitamins taken as pills might cause harm. One theory has to do with free radicals, a common byproduct of the normal chemical reactions that occur in cells. Every day cells get damaged due to a variety of factors including sunlight, the foods we eat and natural aging. This creates free radicals, highly reactive molecules that can damage tissues and lead to cancer and heart disease. Although the body has several ways of coping with free radicals, many people believe high doses of vitamins help, mopping up free radicals before they can do much damage.

But the problem is that free radicals may serve an important purpose, sending a powerful signal to the body’s immune system, which enlists its own army of soldiers to fight the free radicals and fix the damage. The theory is that by taking vitamins, we undermine that message system and upset the balance of antioxidants and free radicals in the body. It may be that vitamins clean up the free-radical mess, but the immune system isn’t alerted to fix the damage, allowing disease to set in.

Another concern is that while vitamins from food sources are necessary and good for you, consumers today often scarf down vitamins at levels that are more like a pharmaceutical dose than something found in nature. In a test tube, high doses of a single antioxidant can turn bad, evolving into pro-oxidants — meaning they start to oxidize and create free radicals, causing the very problem you were trying to prevent.

Here’s a look at what science shows about the risks and benefits of some particular vitamins.

Vitamin E

Vitamin E has long been touted as beneficial to heart health, based in part on observational studies that have shown diets rich in fruits and vegetables containing E and other vitamins are associated with a decreased risk of coronary disease. Vitamin E also has been studied as a way to help Alzheimer’s disease and to prevent prostate cancer.

But research into vitamin E supplements has been disappointing. Most clinical trials in recent years have been inconclusive or shown no benefit — and some have suggested harm. The University of California-Berkeley Wellness Letter, from the same institution that discovered the vitamin in 1922, last year said it no longer recommended vitamin E supplements because of the data showing no benefits.

Last year, Johns Hopkins University researchers in Baltimore published a shocking finding. After reviewing the data from 19 vitamin E clinical trials of more than 135,000 people, the analysis showed high doses of vitamin E (greater than 400 IUs) increased a person’s risk for dying during the study period by 4 percent. Taking the vitamin E with other vitamins and minerals resulted in a 6 percent higher risk of dying.

Not everyone agrees with the methods used in the study. And most of the patients were already unhealthy, so the results may not apply to healthy people.

Since the analysis was published, another study of about 9,500 patients evaluated long-term use of 400 IUs of vitamin E daily. The study didn’t show any statistically meaningful differences between vitamin users in terms of cancer, heart attacks or stroke, but the vitamin E takers had a 13 percent higher risk for heart failure.

The risk of taking vitamin E for cancer is also of concern. Last year, the Journal of Clinical Oncology published a study of 540 patients with head and neck cancer who were being treated with radiation therapy. The patients took 400 IUs of vitamin E or a placebo. The supplement reduced side effects by nearly 30 percent. But recurrence rates among the vitamin E users were 37 percent higher. The finding was not statistically meaningful, but has raised concerns that vitamin intake could hinder the effectiveness of treatments.

Not all the vitamin E news has been bad. Last year, the Women’s Health Study evaluated use of 600 IUs of vitamin E every other day by nearly 40,000 healthy women. Overall, there was no benefit of using vitamin E for major cardiovascular events or cancer. But a subgroup analysis found there was a 24 percent lower risk for cardiovascular deaths and a 26 percent reduction in major cardiovascular events among women over 65. The researchers said those findings weren’t conclusive, however, in part because they contradict other clincial-trial evidence.

Another study, called Select, is looking at whether vitamin E and selenium lower risk for prostate cancer. The study won’t finish for several years, but this summer a safety monitoring committee will review the results to date to see whether any significant risks or benefits have emerged. In February, another study reported in the Journal of the National Cancer Institute showed no clear benefit of vitamin E on prostate-cancer risk, although there was benefit among a subgroup of smokers.

The Select trial already offers a cautionary tale on vitamin use, says Eric Klein, head of urologic oncology at the Cleveland Clinic and a Select investigator. Select was started after a study of smokers in Finland looked at beta carotene and vitamin E to prevent lung cancer. While vitamin E users had an unexpected lower risk for prostate cancer, the beta carotene users had a higher risk for lung cancer. “The psyche of the U.S. population is that a nutraceutical can’t be harmful and might be helpful, so why not take it?” says Dr. Klein. “That thinking is just not correct. The message is: Be careful until the data is in.”

Beta Carotene and Vitamin A

Vitamin A is a family of compounds that play a role in vision, bone health, cell division and the regulation of the immune system. Retinol is one of the most usable forms of vitamin A. Several carotenoids, the darkly colored pigments found in many plant foods, can be converted to vitamin A, but beta carotene is the carotenoid that is most efficiently converted to vitamin A.

Although studies have suggested an association between diets rich in beta carotene and vitamin A and a lower risk for many types of cancer, the supplements taken in pill form have proved risky.

The 1994 Finland study of smokers taking 20 milligrams a day of beta carotene showed an 18 percent higher incidence of lung cancer among beta carotene users. In 1996, a study called Caret looked at beta carotene and vitamin A use among smokers and workers exposed to asbestos. The trial was stopped when the participants taking the combined therapy showed a 28 percent higher risk for lung cancer and a 26 percent higher risk of dying from heart disease.

More recently, a 2002 Harvard study of more than 72,000 nurses showed that those who consumed high levels of vitamin A from foods, multivitamins and supplements had a 48 percent higher risk for hip fracture than nurses who had the lowest intake of vitamin A. Notably, nurses who ate a lot of foods high in vitamin A also had higher risk, possibly indicating that too many foods are now fortified with the vitamin. Milk, margarine and breakfast cereals are fortified with vitamin A. High intake of vitamin A has also been associated with a higher risk of birth defects.

Vitamin C

Ever since Nobel laureate Linus Pauling extolled the virtues of vitamin C more than 30 years ago, Americans have been taking handfuls of the pills, convinced the vitamins do everything from preventing colds to fighting cancer. But like other vitamin studies, research into vitamin C has been disappointing.

Last summer, the Cochrane Database of Systematic Reviews looked at the clinical-trial evidence for vitamin C supplements in treating the common cold. Among 23 studies, there was no overall benefit to using vitamin C to prevent colds. However, six studies of marathon runners, skiers and soldiers exposed to significant cold or physical stress showed about a 50 percent reduction in colds with vitamin C use. But the investigators warned that these were extreme circumstances and probably don’t apply to the general population. Vitamin C may slightly shorten the duration of colds, but the investigators said the small difference may not even be noticed by patients.

There are also concerns about risks associated with vitamin C. A 1999 analysis in the British Medical Journal showed that in three studies, vitamin C didn’t lower death rates among elderly people, and may actually have increased the risk of dying slightly. Last year, the cancer journal CA reported that antioxidant supplements, including vitamin C, should be avoided by patients being treated for cancer. Scientists have found that cancer cells gobble up vitamin C faster than normal cells, suggesting that any protection vitamin C gives might be even greater for tumors than normal cells. In 2001 scientists showed that cancer cells may become resistant to chemotherapy drugs after treatment with vitamin C. “It’s a mistake to think that cancer cells … don’t like nutrients,” says Gabriella D’Andrea, oncologist with Memorial Sloan-Kettering Cancer Center in New York and author of the review.

Whether any of the antioxidant vitamins are cancer fighters or cancer promoters remains an open question. Although some data suggest a benefit, others suggest harm. In October 2004 Copenhagen researchers reviewed seven randomized trials of beta carotene, selenium, and vitamins A, C and E (alone or in combination) in esophageal, gastric, colorectal, pancreatic and liver cancer. The antioxidant users had a 6 percent higher death rate than placebo users.

B Vitamins

A regimen of B vitamins, including folic acid, vitamin B-12 and vitamin B-6, has been touted as a way to improve heart health by lowering homocysteine, an amino acid thought to be a risk factor for heart attack. But last week, two studies presented to the American College of Cardiology showed that while the vitamins do lower homocysteine levels, taking them doesn’t lower risk for heart attack.

The patients in the studies weren’t healthy. They had diabetes, heart disease or a history of heart attack. The New England Journal of Medicine said the consistency of the results “leads to the unequivocal conclusion” that the vitamins don’t help patients with established vascular disease.

But the medical community remains divided on whether the vitamins might still be useful for healthy people. “This should not close the book on the investigation of whether B vitamins in a healthy population helps reduce risk of cardiovascular diease,” says Dr. Shao of the Council for Responsible Nutrition.

Not all the research into vitamin B is controversial. Folic acid supplements for women of child-bearing age have dramatically reduced the incidence of neural-tube defects in babies. Elderly people can develop an inability to absorb vitamin B-12 from food, so supplements may be recommended as we get older.

Calcium and Vitamin D

A 2005 study in the British Medical Journal didn’t show any reduction in fracture risk among women who took 1,000 milligrams of calcium with 800 IUs of vitamin D a day. But the Women’s Health Initiative recently suggested that calcium and vitamin D may lower hip-fracture risk in women over 60. Calcium users, however, had a 17 percent higher risk for kidney stones.

Elderly people, particularly those who have dark skin, get little exposure to sunlight and don’t drink milk, are at risk for vitamin D deficiency and are typically advised to take supplements. One study suggests the most benefit comes with about 800 IUs of vitamin D a day.

Most doctors and health experts now suggest that consumers interested in taking vitamins stick to a multivitamin rather than concoct their own cocktails of high-dose vitamins. But even this practice is being questioned because there’s little evidence to support it. In August the British Medical Journal looked at multivitamin use among elderly people for a year, but found no difference in infection rates or visits to doctors.

Researchers urge caution when interpreting results from various vitamin studies. Many factors, ranging from the type of vitamin to the age and health of the participants, may influence the results, says Marion Dietrich, postdoctoral associate in the Nutritional Epidemiology Program at Tufts University. What is clear, however, is the important role a healthful diet plays in preventing illness. Large dietary-intervention studies have shown that a healthful diet reduces risk of cardiovascular disease.

But doctors say many patients view vitamins as a quick fix to compensate for poor eating habits, and resist any suggestion that taking them may not be beneficial. “A lot of people are passionate about their vitamins,” says Dr. Miller of the National Institute on Aging. “I don’t know where they get it from, but it’s not based on scientific evidence.”

March, 2006|Archive|

Cancer drugs can top $100,000 a year

  • 3/27/2006
  • Chicago, IL
  • Jim Ritter
  • Chicago Sun-Times (www.suntimes.com)

A new generation of high-tech cancer drugs is extending patients’ lives, but the costs are stunning.

Take Erbitux, approved for advanced colorectal and head-and-neck cancers. It costs $327 a day, $9,800 a month, $118,000 a year. And that doesn’t count the cost of administering the intravenous drug

New drugs for non-Hodgkin’s lymphoma and for lung, breast, pancreatic, kidney and stomach cancers also cost thousands of dollars a month. Drug companies are seeking to expand the lucrative market by testing the drugs on other cancers. They also are developing new drugs.

“Some of these agents are outrageously expensive,” said Loyola University Health System oncologist Dr. Patrick Stiff.

Expensive to Make

Drug companies make no apologies. They say their new drugs are much more expensive to make than traditional chemo drugs. Companies say they need to recoup the hundreds of millions of dollars it can take to bring a new drug to market. It’s a risky business. Many drugs that work well in the lab and in animals fail in human trials.

For example, Onyx Pharmaceuticals has been in business 14 years and raised $700 million from investors. But so far, Onyx has brought only one drug, Nexavar, to market. Nexavar, for advanced kidney cancer, costs $4,333 a month.

“Given the time, the odds and the cost, there has to be a return for the capital that goes into it,” Onyx CEO Hollings Renton said.

None of the new drugs cure cancer, and for many patients, they don’t help at all. But for some patients who have advanced cancers that have not responded to other treatments, the drugs halt or shrink tumors for weeks or months. And the side effects often are less toxic than standard chemotherapy.

Patients thankful despite cost

Patients typically take the new drugs until the cancer progresses. For example, patients with advanced colorectal cancer took Avastin ($4,400 a month) an average of 10 months in a clinical trial. The median survival was 20 months, compared with 15 months for chemotherapy alone.

Cindy Welker, 44, of Downers Grove, is among the patients who are thankful for Avastin. Although Welker’s colon cancer has spread to her ovaries and abdominal wall, the combination of Avastin and other drugs has held the tumors in check, and Welker feels fine. Her church raised $17,000 to help pay for drug costs not covered by insurance.

Traditional chemotherapy drugs work by killing healthy cells as well as cancer cells. The new drugs, called “biologics,” specifically target cancer cells by, for example, cutting off the tumor’s blood supply. Consequently, patients typically experience fewer side effects.

Industry critics concede that cancer drugs are expensive to develop. But they also give another reason for the astronomical prices: the industry-friendly health care system in the United States.

Most industrialized countries control drug prices, but not the United States. Congress has prohibited Medicare from even negotiating prices with drug companies. So with patents protecting new drugs from generic competition, drug companies “can charge whatever they want,” said University of Chicago oncologist Dr. Mark Ratain.

Conflict of interest for docs?

Many of the new drugs are given intravenously. Unlike pills purchased at a pharmacy, intravenous drugs are sold by doctors, often at a big markup. Critics say it’s a conflict of interest for doctors to profit from the drugs they prescribe.

“The incentives are a little perverse,” said Dr. Deborah Schrag of Memorial Sloan-Kettering Cancer Center.

A recent study published in the journal Health Affairs found that doctors who were more generously reimbursed prescribed more-expensive drugs to patients with advanced breast, lung and colorectal cancers.

When deciding whether to approve a new drug, the Food and Drug Administration considers only whether the drug is safe and effective. The FDA does not consider cost.

“A lot of these drugs are not cost-effective,” Ratain said.

One traditional measure of cost-effectiveness in medicine is to set a maximum cost of $50,000 per “quality-adjusted life year.” A treatment is considered cost-effective if, on average, it costs less than $50,000 to provide a patient with one year of good health.

By that standard, new cancer drugs often aren’t cost-effective. Suzanne Lindley of Canton, Texas, estimates her insurance has paid more than $2 million on the 15 drugs she has taken since she was diagnosed with colon cancer six years ago.

Even though the cancer has spread to her liver, lungs and spine, Lindley remains healthy enough to raise two teenage daughters and coordinate the Colon Cancer Alliance’s buddy program.

Lindley doesn’t believe drugs should be subjected to cost-benefit formulas. “Would you want a price put on your life?” she said.

Even with insurance coverage, patients face high co-pays

Despite the high cost of new cancer drugs, most patients are able to get treatment.

Medicare, Medicaid and private insurers generally cover cancer drugs once the drugs are approved by the Food and Drug Administration. And drug companies say they provide the drugs free of charge to many patients who lack insurance.

But there are gaps. Some insurance plans require patients to pay 10 percent or 20 percent of drug costs, and many patients can’t afford these co-pays. “There still are patients who wind up strapped,” said Suzanne Lindley, coordinator of the Colon Cancer Alliance’s buddy program. “Sometimes they don’t get treatment.”

Several patient-advocate foundations give money to patients to help fund insurance co-pays and Medicare coverage gaps.

Drug companies have donated millions of dollars to the foundations. The money cycles from the foundations to the patients and then back to the companies. In effect, the drug companies are donating money to themselves.

March, 2006|Archive|