Monthly Archives: June 2004

Oral cancer knowledge and examination experiences among North Carolina adults.

  • 6/30/2004
  • University of North Carolina, Chapel Hill, NC
  • LL Patton, R Agans, JR Elter, JH Southerland, RP Strauss, and WD Kalsbeek
  • J Public Health Dent, June 1, 2004; 64(3): 173-80

OBJECTIVE: This study assesses knowledge of oral cancer risk factors, clinical signs, and oral cancer examination experience among North Carolina adults.

METHODS: A statewide random digit dial, computer-assisted telephone interview was conducted in 2002. Data from 1,096 respondents, with a response rate of 62 percent, were poststratified to 2000 census data by sex, race, and age group to produce population-based estimates. Knowledge of one sign of oral cancer, four or more risk factors for oral cancer, and having ever had an oral cancer examination were compared in logistic regression models using normalized weights.

RESULTS: Fourteen (95% confidence interval [CI] +/-2) percent of adults had never heard of oral or mouth cancer. Risk factor knowledge was high for 56 percent (95% CI+/-3) and associated in a logistic regression model with younger age, feeling personal factors cause cancer, and nonuse of snuff. One sign of oral cancer (sore/lesion, red or white patch in mouth, and bleeding in the mouth) was correctly identified by 53 percent (95% CI+/-3) with significantly more correct responses from younger people, nonsmokers, and some college education. Only 29 percent (95% CI+/-3) reported ever having had an oral cancer examination when this procedure was described. Most respondents reported exams performed by dentists. In a weighted logistic regression model, older age, being dentate, nonsmokers, alcohol users, and those with some college education were significantly more likely to report having ever had an oral cancer examination.

CONCLUSIONS: Although there is moderate knowledge of signs and risk factors for oral cancer among North Carolina adults, knowledge deficits remain. Oral cancer examinations need to be increased, particularly among tobacco smokers.

June, 2004|Archive|

Lengthy Jail Sentence for Vendor of Laetrile

  • 6/30/2004
  • FDA press release
  • Food and Drug Administration News

Laetrile – A Quack Medication to Treat Cancer Patients.

The Food and Drug Administration (FDA) has announced the outcome of its investigative efforts by the Office of Criminal Investigations, conducted jointly with the United States Attorney’s Office (USAO) for the Eastern District of New York and the New York Division of the United States Postal Inspection Service (USPIS), to bring to justice a businessman who had victimized cancer patients by heavily advertising and selling Laetrile, a highly toxic product that has not shown any effect on treating cancer.

Jason Vale, president of the New York-based Christian Brothers Contracting Corp., was sentenced on June 18, 2004 to 63 months in prison and 3 years of supervised release by a United States District Court in the Eastern District of New York.

“There is no scientific evidence that Laetrile offers anything but false hope to cancer patients, some of whom have used it instead of conventional treatment until it was too late for that treatment to be effective,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “This sentence sends a strong message that we will not tolerate marketing of bogus medicines.”

Following the investigation by FDA, the USAO, and the USPIS, the U.S. District Court for Eastern District of New York placed Vale’s illegal sales and promotion of Laetrile — also known as amygdalin, “Vitamin B-17”, or apricot pits — under injunction in April 2000. Defying the court order, Vale set up a shell corporation in Arizona, and continued to ship the product from the basement of his own home to customers passed on to him by his New York firm. For these activities, Vale was found guilty 11 months ago of three counts of criminal contempt, and ordered to be held without bail pending his sentencing.

Last week, the court also found that Vale, who had made at least $500,000 from his illegal sales of Laetrile, had committed fraud in his marketing of Laetrile. In addition, Vale defrauded the U.S. government by claiming that he qualified for Legal Aid. As a result, Vale was ordered to reimburse the government $31,000 for the costs of his appointed defense attorney.

June, 2004|Archive|

New Surgeon General report links smoking and periodontal disease

  • 6/30/2004
  • Washington DC
  • By Craig Palmer
  • The American Dental Association

A new U.S. Surgeon General’s report on smoking and health expands the list of illness and disease linked to cigarette smoking to include periodontal disease.

The report released at a May 27 National Press Club news conference and posted online at the Office of the Surgeon General and Centers for Disease Control and Prevention Web sites is the 28th dating from the landmark 1964 report of Surgeon General Luther Terry, which cited cigarette smoking as a definite cause of cancers of the lung and larynx in men and chronic bronchitis in men and women. It is also the first in the series to report specifically on dental effects of cigarette smoking, although oral cancer and related premalignant lesions have been addressed in previous reports and the topic is addressed in Oral Health in America: A Report of the Surgeon General issued in the year 2000 and available at the surgeon general’s Web site.

American Dental Association tobacco policy is posted online at ADA.org.

The dental section of the 960-page printed report of the U.S. Surgeon General reviews the epidemiologic evidence for smoking as a causal factor for the most common forms of nonmalignant oral disease. Its major conclusions:

* the evidence is sufficient to infer a causal relationship between smoking and periodontitis;
* the evidence is inadequate to infer the presence or absence of a causal relationship between smoking and coronal dental caries;
* the evidence is suggestive but not sufficient to infer a causal relationship between smoking and root-surface caries.

A 1982 Surgeon General’s report found that cigarette smoking is a major cause of cancers of the oral cavity in the United States. The 2004 report updates that finding to conclude, “The evidence is sufficient to infer a causal relationship between smoking and cancers of the oral cavity and pharynx.”

“We’ve known for decades that smoking is bad for your health, but this report shows it’s even worse,” said Surgeon General Richard Carmona, M.D. “The toxins from cigarette smoke go everywhere the blood flows. I’m hoping this new information will help motivate people to quit smoking and convince young people not to start in the first place.”

In addition to periodontitis, the new illnesses and conditions linked to cigarette smoking include cataracts, pneumonia, acute myeloid leukemia, abdominal aortic aneurysm and cancers of the cervix, kidney, pancreas and stomach. Smoking even contributes to wound infections following surgery and complications from diabetes, the surgeon general said. It harms nearly every major organ of the body, often in profound ways, causing many diseases and significantly diminishing the health of smokers in general. The report concludes that quitting smoking has benefits immediate, “within minutes and hours after smokers inhale that last cigarette,” and long-term and at any age.

Research on smoking and dental disease has been hampered by lack of consensus on case definitions for some diseases; difficulty in measuring oral conditions and consequent use of indices of questionable validity; some incorrect assumptions about disease etiology, pathogenesis, distribution and natural history; and limited capacity for epidemiologic investigations within the dental research community, the report said.

Through an interactive database of more than 1,600 key articles, the surgeon general’s office is aiming to have the latest and most comprehensive information on smoking available to all. The Health Consequences of Smoking Database is available through the surgeon general’s Web site. The database provides detailed information on the specific health effects of smoking and the surgeon general says it will be continually updated as new critical studies are published. Dr. Carmona said, “Using this technology, once a threshold of danger is met, we can quickly alert the American people of new information related to smoking.”

June, 2004|Archive|

Say So Long to Spit Tobacco

  • 6/29/2004
  • By Adam Marcus, Health Day Reporter
  • Forbes.com

Smokers have no doubt been barraged with warnings about the dangers of their bad habit, but those who use smokeless tobacco might also want to heed the health cautions. “Smokeless tobacco is not without health risks,” said Dr. John Spangler, a family medicine specialist at Wake Forest University who studies tobacco use. “Although it doesn’t seem to cause cardiovascular disease or cancers to the same rate that cigarette smoking does, it definitely does cause them.”

It seems a perfect time to stop, since May 31 has been designated an annual World “No Tobacco” Day, when smokers will put away their cigarettes in a gesture to good health.

The American Cancer Society says people who use chewing tobacco and snuff face 50 times the risk of developing cancers in their cheeks and gums as those who don’t chew. Every day, an estimated 24 Americans die of oral cancer — nearly 8,800 a year — according to the Oral Cancer Foundation. The habit is also linked to cancer of the pancreas, kidneys, prostate and possibly the breast, Spangler said.

Chewing tobacco and snuff — another form of the leaf that’s put in the mouth — should be a particular concern for America’s youth. Nearly 10 percent of the nation’s high school students (almost 16 percent of boys and 1.5 percent of girls) say they’ve used smokeless tobacco in the past month, according to the U.S. Centers for Disease Control and Prevention. One misconception about spit tobacco is that it’s chemically more benign than tobacco that’s smoked. Untrue, Spangler said. Both products contain the same litany of cancer-causing chemicals, especially tobacco-specific nitrosamines (TSNAs). However, smokeless tobacco users ingest far greater concentrations of these TSNAs than do smokers, 10 times more, on average, according to the Oral Cancer Foundation. Less serious but by no means pleasant, smokeless tobacco use is associated with cosmetic problems such as chronic bad breath, stained teeth and gum and tissue disease.

One “dip” of spit tobacco is said to contain 10 times the nicotine jolt of a cigarette, and that sends the heart racing, constricts blood vessels, kicks up blood pressure and strains the heart, Spangler said. It also makes spit tobacco more addictive than cigarettes, and therefore potentially more difficult to give up, he added.

Difficult, but not impossible. Herbert Severson is a researcher who studies spit tobacco cessation programs. He and his colleagues at the Oregon Research Institute are launching an online program to help people quit chewing. Like other chewing tobacco cessation efforts, ChewFree.com resembles smoking cessation plans in several respects, but it’s not identical.

“There are subtle differences,” Severson explained. “The kind of withdrawal symptoms people experience with chewing tobacco are a little different.” While smokers may become depressed when they quit, chewers are more likely to become agitated and angry and to see their ability to concentrate suffer. Oral substitutes, such as nicotine gum, are quite important for chewers, and use patterns are different, Severson said. That last point is key, he added, because chewing tobacco often takes on a more central part of a person’s life. Ironically, users — almost always men — may work at smoke-free companies that have indirectly encouraged employees to go smokeless, Severson said. Chewing tobacco also provides background activity for typically male pursuits — hunting, fishing and baseball — when smoking isn’t necessarily possible. “You can use it in a lot of situations where you can’t smoke,” Severson said.

ChewFree.com, which has received funding from the National Cancer Institute, offers tips for successful cessation. It also provides information on a “blending program” that reduces nicotine exposure by mixing tobacco with nicotine-free plants such as mint snuff or herbal alternatives.

Perhaps the most effective component, Severson said, is encouraging men to take a look at the damage chewing tobacco is doing to their mouth. “It’s really quite motivational” to see the lesions that form where the tobacco sits against the gums, he said. Seven in 10 regular users develop these sores; 3 percent to 4 percent of those sores become tumors. Having mouth damage “is directly related to the length of time a man has chewed and the weekly amount,” Severson said.

More information:
For more on the harms of chewing tobacco, oral cancers, and treatments, try the Oral Cancer Foundation at www.oralcancer.org

June, 2004|Archive|

Saliva – a pivotal player in the pathogenesis of oropharyngeal cancer

  • 6/28/2004
  • A Z Reznick1, O Hershkovich1,2 and R M Nagler1,2
  • British Journal of Cancer

Oropharyngeal cancer, which is usually squamous cell carcinoma, is the most common head and neck malignancy and accounts for 2-4% of all new cancers. It is primarily induced by exposure to tobacco. The paradigm of cigarette smoke induced oropharyngeal cancer’s pathogenesis is based on the assumption that a constant direct attack of various cigarette smoke carcinogens causes widespread accumulating cellular and DNA aberrations in the oropharyngeal mucosal cells, in turn eventually resulting in malignant transformation. However, there is never a direct contact between cigarette smoke and the oropharyngeal mucosa. Saliva, bathing the mucosa from the oral cavity to the larynx, always intervenes, and cigarette smoke must first interact with saliva before it reaches the mucosa. The current study investigated the role of saliva in the pathogenesis of oropharyngeal cancer. A synergistic effect of cigarette smoke and saliva on oral cancer cells was demonstrated. This synergism is based on the reaction between redox active metals in saliva and low reactive free radicals in cigarette smoke, which results in the production of highly active hydroxyl free radicals. Thus, when exposed to cigarette smoke, salivary behavior is reversed, and the saliva loses its antioxidant capacity and becomes a potent prooxidant milieu. The devastating role of cigarette smoke-borne aldehydes was demonstrated as well. Based on these results and on our recent reports demonstrating that cigarette smoke destroys various salivary components, including protective ones such as peroxidase, the most important salivary antioxidant enzyme, a comprehensive view of the pivotal role of saliva in the pathogenesis of cigarette smoke-induced oropharyngeal cancer is suggested.

1Department of Oral and Maxillofacial Surgery, Oral Biochemistry Laboratory and Salivary Clinic, Rambam Medical Center and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
2Department of Anatomy and Cell Biology, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel

Correspondence to: Dr RM Nagler, E-mail: nagler@tx.technion.ac.il
Received 5 September 2003; revised 22 January 2004; accepted 3 March 2004; published online 25 May 2004

June, 2004|Archive|

Novel Therapy Shows Promise To Prevent Recurrence Of Head And Neck Cancer

  • 6/27/2004
  • Pittsburgh, PA
  • Dong Moon Shin M.D.
  • University of Pittsburgh Cancer Institute

Promising results from a study led by University of Pittsburgh Cancer Institute (UPCI) researcher, Dong Moon Shin, M.D., suggest that treating head and neck cancer patients with a combination of the biologic agents retinoid, interferon, and vitamin E may lead to improved survival for patients with a locally advanced stage of the disease and result in few negative side-effects. Results from the study will be published in the June 15 issue of the Journal of Clinical Oncology.

The phase II study focuses on patients with squamous cell carcinoma of the head and neck (SCCHN), which has a low five-year survival rate after standard treatment including surgery, radiation therapy or both surgery and radiation. More than two-thirds of patients with SCCHN are diagnosed with stage III or IV cancer, which represent advanced stages of the disease, and are at high risk for disease recurrence or the development of second primary tumors (SPTs).

“Given the poor survival rates from head and neck cancer, the study’s overall survival rates of 98 percent at one-year follow-up and 91 percent at two-year follow-up, are very promising indications of the potential of this treatment for patients with locally-advanced head and neck cancer,” said Dr. Shin, professor of medicine and otolaryngology, University of Pittsburgh School of Medicine and co-director, UPCI Head and Neck Cancer Program. “The finding that there are only mild to moderate negative side-effects from treatment, which primarily include flu-like symptoms and fatigue, is also especially encouraging.”

The study employs the combination of interferon-alfa (IFN-a), 13-cis-retinoic acid (13-cRA) and vitamin E (a-tocopherol) in the treatment of locally advanced-stage head and neck cancer to prevent cancer recurrence, inhibit the formation of SPTs and reduce the toxic effects from treatment. This treatment differs from standard chemotherapy in that it mobilizes the body’s immune system to fight the cancer rather than generally poisoning rapidly dividing cells. Forty-four patients diagnosed with SCCHN participated in the study and were treated for a 12-month period.

Head and neck cancer occurs in the oral cavity, pharynx, larynx, paranasal sinuses, nasal cavity and the salivary glands, and accounts for five percent of all cancers diagnosed in the United States. Nearly 45,000 cases of head and neck cancer are diagnosed annually in the United States, and 13,000 die from causes related to this disease. Survival rates have not improved significantly over the past 20 years and are among the lowest compared to other major cancers. Previous treatment studies over the past two decades have failed to demonstrate improved survival for patients diagnosed with locally advanced SCCHN.

“Until now, we have had little success preventing the development of second primary tumors in patients with head and neck cancer,” said Dr. Shin. “If confirmed by a follow-up phase III study, the results may have a profound impact on reducing the rate of recurrence of head and neck cancer and the formation of SPTs.”

According to Shin, the phase III study will be a randomized, multi-site study (including UPCI) and will enroll 300 patients who have previously received standard treatment for SCCHN.

June, 2004|Archive|

UNIVERSITY OF PITTSBURGH RESEARCHERS FIND PET/CT IMAGING BETTER AT LOCALIZING AND MONITORING HEAD AND NECK CANCER

  • 6/25/2004
  • TORONTO, Canada
  • University of Pittsburg release

University of Pittsburgh researchers have found the combined PET/CT scanner is the most powerful imaging tool available for localizing, evaluating and therapeutic monitoring of head and neck cancer and may be equally useful for other cancers that are difficult to pinpoint.

Results of a study showing PET/CT has a distinct advantage over PET or CT alone were presented today at the annual meeting of the Society of Nuclear Medicine. According to the researchers, the prototype of the combined PET/CT machine at the University of Pittsburgh Medical Center is able to effectively localize cancerous activity in the head and neck, an area of the body that presents substantial challenges to other imaging methods because of densely packed tissue structures and the frequent involvement of lymph nodes.

Separately, computed tomography (CT) and positron emission tomography (PET) do not provide images with the necessary combination of clear structural definition and metabolic activity that is achieved with the PET/CT. “The PET/CT tells us the exact size, shape and location of the cancer and provides a specific target for surgery or other treatment,” said Carolyn Cidis Meltzer, M.D., associate professor of radiology and psychiatry and medical director of the UPMC PET Facility. “The PET/CT can also be used to help us develop the best course of treatment for an individual, then monitor that individual’s progress during treatment.”

Head and neck cancers often have already involved lymph nodes when first discovered and can spread rapidly if they are not found and treated quickly. Images from the combined PET/CT scanner are particularly useful in allowing a radiologist to see cancerous activity at a metabolic level and pinpoint its exact location in the tissue so a biopsy can be performed and proper treatment begun. Tumors among the skeletal muscle, salivary glands and lymphoid tissue in the head and neck area are difficult to separate from healthy tissue in standard PET images, which look like blotches of color amidst fuzzy structures. With CT, unless they are clearly swollen, cancerous lymph nodes may look normal.

Size matters when radiologists evaluate lymph nodes for signs of cancer. Seen by CT, lymph nodes under one centimeter are considered normal and not biopsied. The PET/CT, developed in part by David Townsend, Ph.D., senior PET physicist, professor of radiology at the University of Pittsburgh School of Medicine, and a co-director of the University of Pittsburgh PET facility, works by combining PET technology, in which the scanner reads cellular metabolism of glucose, and CT, which builds a clear cross section of tissue structures using x-rays. “Because head and neck cancer starts small and spreads rapidly, the PET/CT will provide doctors with a means for earlier diagnosis and treatment to potentially save lives,” said Dr. Townsend. “With PET/CT an accurate diagnosis of cancer could be provided months earlier than with any other imaging method.”

The groundbreaking research done by Drs. Townsend and Meltzer in Pittsburgh led the FDA to approve the PET/CT, known commercially as the Biograph, earlier this year for use as a diagnostic and therapeutic tool for cancer treatment. Other authors that contributed to the research are Carl H. Snyderman, Melanie B. Fukui, Daphne A. Bascom, Subash Chander, Jonas T. Johnson, Eugene N. Myers, Marsha A. Martinelli and Paul E. Kinahan.

Study presented at Society of Nuclear Medicine annual meeting in Toronto
TORONTO, June 25, 2004

June, 2004|Archive|

Healthy in Houston: Early detection of oral cancer

  • 6/16/2004
  • Houston, TX
  • By: Kristi Nakamura
  • News 24 Houston / Time Warner Cable

Dr. Timothy Cashion prides himself on having the latest in dental equipment. He says he can pinpoint cavities earlier than ever before. But new technology being developed by Dr. Ann Gillenwater at M.D. Anderson Cancer Center and engineers at the University of Texas in Austin may one day allow Dr. Cashion to offer his patients something more — early detection of oral cancer.

Experts say that when it’s found early, oral cancer has an 80-90 percent cure rate. But unfortunately, they say, most of these cancers are found in late stages. “Unfortunately, many people, even in this country, come in with very late, advanced lesions because they weren’t picked up earlier. And what we’re trying to do is develop a system that will improve our ability to detect those lesions,” said Dr. Gillenwater.

The procedure is called oral spectroscopy. Dr. Gillenwater says the way it works is an oral probe uses light to distinguish between normal and abnormal tissue. As light is shined on the tissue, she says, it hits special molecules called fluorophors, which causes a fluorescence — like glow in the dark. “For instance, if you take a normal cell, as it changes toward becoming a cancer cell, it has changes in its structure, in its size, and also in the amount of these little fluorophors, the molecules that cause the fluorescence. So what we’re designing is a special system where we’re going to be able to look at the depths of the cells that are causing that fluorescence. I think it’s very important that we be able to diagnose these lesions at an earlier stage before my eye, your dentist’s eye, or your doctor’s eye can pick out those changes,” said Dr. Gillenwater. She says it could be a matter of life and death.

June, 2004|Archive|

Formaldehyde Labeled a Carcinogen

  • 6/16/2004
  • Washington, DC
  • By Tom Hamburger and Alan C. Miller
  • Los Angeles Times

A World Health Organization panel has upgraded its assessment of the danger of formaldehyde, declaring for the first time that the chemical is “carcinogenic to humans.” However, the Bush administration states this requires “more study” before implementation of any new regulations.

The warning from the International Agency for Research on Cancer contrasts with the approach taken by the Bush administration in February, when the Environmental Protection Agency approved an industry-backed rule intended to spare many plywood and timber-product plants from strict formaldehyde emission controls. In doing so, the EPA adopted a far more lenient assessment of formaldehyde danger. Administration officials said the controversial change was justified by the “best available science.”

Administration critics Tuesday characterized the international health group’s action as a rebuke of the EPA’S handling of the matter. An industry representative downplayed the international finding, noting that the reclassification of formaldehyde was not a finding of actual risk.

The World Health Organization panel, made up of 26 scientists from 10 countries, reviewed the latest literature and concluded that formaldehyde posed a greater hazard than previously thought.

“Based on this new information, the expert working group has determined that there is now sufficient evidence that formaldehyde causes nasopharyngeal cancer in humans, a rare cancer in developed countries,” said a statement Tuesday from the agency’s headquarters in Lyon, France. Nasopharyngeal refers to the area in the back of the mouth and nose.

The organization’s previous evaluation of formaldehyde had concluded it was “probably carcinogenic.” Review of the latest epidemiological studies “increased the overall weight of the evidence” about the toxic chemical, the expert panel said. The scientists included in their assessment recent studies by the National Cancer Institute and the National Institute of Occupational Safety and Health showing that exposure to formaldehyde might also cause leukemia in humans. The panel concluded that evidence of such a link was “strong but not sufficient” to establish a causal relationship.

The administration adopted its less stringent formaldehyde risk assessment shortly after the leukemia studies were disclosed. The EPA wood products rule did not mention leukemia risk. White House and EPA officials said this was because the two U.S. studies and a third in England appeared contradictory and were not thoroughly reviewed.

The WHO scientists took a different view. The link to leukemia “reflects the epidemiologists’ finding of strong evidence in human studies,” an organization statement said.

It also noted that the international experts had not yet determined how formaldehyde would cause leukemia. The panelists called for more study of leukemia risks.

Administration officials said it was too soon to say what effect the international group’s decision could have on the EPA. “The science on formaldehyde continues to evolve,” EPA spokeswoman Cynthia Bergman said: “We are eager to take a close look at their findings.”

The EPA is doing its own evaluation of formaldehyde and has said it will adjust its risk assessment if it finds merit in the leukemia or other studies.

Betsy Natz, executive director of the Formaldehyde Council Inc., an industry trade association, said the international health agency had “simply tried to answer the question of whether, under any circumstances, formaldehyde could produce cancer in humans.” She noted that some of the cancers cited as a basis for reclassification were based on exposure of workers in decades past, before modern industrial hygiene and safety standards were in place.

Others said the new findings showed that the Bush administration failed to protect the public and called for reconsideration of the timber products rule. “The Bush administration is out of step with the international community on yet another important issue for public health and the environment,” said Rep. Henry A. Waxman (D-Los Angeles). “It appears that EPA’s recent plywood rule downplayed or disregarded scientific information that the World Health Organization finds to be credible and strong.”

A prominent epidemiologist went further. “If the leading international agency on cancer has reevaluated the data and declared formaldehyde to be a human carcinogen, it no longer seems right for the EPA and the White House to ignore these data,” said David Michaels, who was assistant Energy secretary for environment, safety and health in the Clinton administration.

The World Health Organization panel deliberated last week in Lyon and planned to publish a treatise in the next few months.

Formaldehyde occurs naturally in the environment and is produced in large scale around the world for use as adhesives and binders for wood products, pulp, paper and other manufactured products.

OCF Note: Once again the Bush administration puts big business ahead of public health…….. one more thing to add to the list.

June, 2004|Archive|

Cancer Weapons, Out of Reach

  • 6/15/2004
  • By Robert E. Wittes
  • The Washington Post

The cancer research community and the patients it serves took heart a few weeks ago from the Food and Drug Administration’s approval of two new drugs — Avastin and Erbitux. These are antibodies, similar in structure to the infection-fighting proteins that circulate in our blood. Neither is very effective when used alone, but in combination with other chemotherapy drugs, they can shrink tumors, restrain tumor growth and, in the case of Avastin, extend life by a few months in some patients with colon cancer that has already spread to other parts of the body.

There is just one big problem: Both drugs have been marketed at such extraordinarily high prices that many people will simply not be able to afford them.

Although the new drugs help only a minority of patients, they represent significant successes in translating new molecular knowledge about cancer into more effective treatment. In this respect they join other recent entries in the oncologist’s medicine cabinet and are a sign of things to come. Most of us anticipate that truly successful treatment for disseminated cancers will be not with single drugs but with combinations of them, aided by precise molecular testing to guide selection of the most effective drugs for a particular patient.

Now back to the economics. The average wholesale price (AWP, or the average price charged to hospitals and physician practices) of a month of treatment for a normal-size adult is roughly $4,800 for Avastin and $12,000 for Erbitux. Since most colorectal-cancer patients for whom these drugs are medically appropriate receive them not singly but in combination with other chemotherapeutics, the monthly AWP is more like $11,000 for combinations including Avastin and $16,000 for Erbitux. Providers pass these costs on to patients, along with charges that cover the costs of pharmacy and dispensing. Courses of treatment generally last several months, but they can be much longer for patients who respond favorably. In other words, the cumulative cost of treatment can be astronomical.

Access to affordable prescription drugs has been the focus of acrimonious national debate, controversial legislation and regulatory muscle-flexing by the FDA, which opposes, for safety reasons, the importation of prescription drugs from cheaper foreign markets. These new cancer drugs will add fuel to the fire. Although the uninsured and medically indigent may feel the effects of these pricing decisions most keenly, those with insurance will also face a nasty dilemma. The increasing co-pay percentages of most plans and the capping of benefits in others will compel a major financial outlay for those determined to have the treatments. And those who do not want their families to assume the financial burden will be left with bitter resentment.

Third-party payers will not react passively to pricing that increasingly threatens their balance sheets, especially as more drugs like these are commercialized over the next few years. They will carefully scrutinize all proposed uses of expensive new drugs. Historically, an FDA judgment of “safe and effective” — the statutory criterion for drug approval — has almost automatically triggered an agreement by payers to reimburse, which is the real gateway to widespread use and market success. We may now see payers deciding, for the first time, that certain novel “safe and effective” medicines are simply not worth paying for. In addition, payers will surely try to limit “off-label” uses of these drugs — that is, uses other than the FDA-approved ones. Unlike other areas of medicine, physicians have commonly prescribed cancer drugs for a broader array of indications than specifically approved by the FDA, as clinical research routinely reveals additional uses after market introduction. A very high bar to new uses by payers is a virtual certainty.

As desperate cancer patients and their advocacy groups feel critical options narrowing, they will make their sentiments known. When they do, the same members of Congress who incomprehensibly prohibited Medicare from negotiating prices with drug companies will be predictably shocked to find that new drugs cost so much. Congressional committees will hold hearings. Tearful cancer patients and surviving family members will tell their stories to an attentive national audience. Lawmakers will also learn this lesson closer to home, where they will find their own sisters and cousins and aunts in the same boat as everyone else.

The pharmaceutical industry will intone its familiar mantra: The cost of drugs is a relatively small percentage of total health care costs; innovation requires investment; research-based companies need to realize an adequate return on investment; and companies often establish access programs for destitute patients. But these arguments are invalidated by the sheer magnitude of the pricing decisions, which constitute a formidable barrier to the flow of innovation from the research arena to public benefit.

Perhaps their legendary political clout in Washington has convinced drug companies that they can price their goods at arbitrarily high levels. In reaching the stratosphere, however, they are effectively daring the government to impose price controls. This the government must do if the drug industry fails to come to its senses quickly.

The writer is physician in chief at the Memorial Sloan-Kettering Cancer Center in New York.

June, 2004|Archive|