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How Well Tested Are New Cancer Drugs?

Posted by medconsumers on December 31, 2006

by Maryann Napoli

With a certain amount of regularity a new cancer drug makes headlines, generating an enormous amount of hope, as well as pressure to make the product swiftly available. In time, we usually learn that the drug’s benefit is much more modest than originally portrayed in the media, and soon oncologists (cancer specialists) begin to prescribe the drug for other forms of cancer without waiting for clinical trials to prove effectiveness. This recurring scenario merits a closer look at the U.S. Food and Drug Administration (FDA) and the basis upon which it approves new cancer drugs.

Tumor Shrinkage
Contrary to popular belief, drug companies are not required to prove that their drugs prolong survival. Until the mid-1980s, all cancer drugs were approved solely on the basis of what researchers call the “tumor response.” In other words, the testing required of a drug company need only show that the drug caused a tumor to shrink, not necessarily to disappear.

Years ago, a change in the approval process was recommended by the FDA’s own Oncologic Drug Advisory Committee. The Committee members, all primarily cancer experts unaffiliated with any government agency, knew that tumor shrinkage often has little or no relation to survival. The Committee proposed the novel idea that a drug company should be required to prove that a drug provides some benefit that is meaningful to the patient, such as increased survival or improvement in symptoms. The Committee argued further that the potential benefit of tumor shrinkage did not necessarily outweigh the substantial toxicity of cancer drugs.

This recommendation was made in the mid-1980s, but change at the FDA comes slowly, as a recent assessment of new drug approvals has demonstrated. From 1990 through 2001, the FDA approved 66 new cancer drugs. Prolonged survival was not proven for 48 drugs. And tumor response was the basis of approval for 35 drugs.

Variations in Endpoints
“The FDA has a certain amount of regulatory flexibility to make an assessment of the side effects versus the efficacy of new products,” said the FDA’s Richard Pazdur, MD, in a telephone interview. He had been asked why so few new drugs have been proven to prolong survival. “The drug company must prove that its product provides a longer life, a better life, or a favorable effect on an established endpoint for a better life,” he explained. The FDA’s flexibility comes into play on the last point about “an established endpoint for a better life.” One example of an established endpoint, says Dr. Pazdur, is a complete response in leukemia-that is, the bone marrow is normal, the blood count have normalized.

Even so, there is a hierarchy of established endpoints. “Survival is the gold standard of endpoints because it is the most meaningful to all people,” cautioned Dr. Pazdur, who is the Director of Oncology Drug Products at the FDA’s Center for Drug Evaluation and Treatment. He explained that there can be no misinterpretation where it concerns survival-the patient is either dead or alive. “Whereas, the other endpoints, such as tumor response rate, are usually determined by x-rays or scans,” he continued. “There can be variations in the radiologists, the techniques of how the x-rays or scans are obtained, which can make it confusing and unreliable. Also, there is a subjective judgment in reading these x-rays and scans.”

Accelerated Approval
These cautions notwithstanding, the FDA still allows the use of tumor shrinkage as the sole endpoint in the approval of certain drugs. In 1992, the agency introduced an accelerated approval (AA) process. The idea behind AA is to get drugs quickly to advanced cancer patients in whom all available options had failed. Consequently, tumor shrinkage was the sole basis of the AA for 10 of 11 new drugs. The rationale: Shrinking a lung tumor might, in the FDA’s view, be “reasonably likely” to alleviate breathing difficulties.

The testing for AA is minimal. The new drug is given to about 30 or so participants who have run out of options. In what is called a Phase II trial, there is no comparison group-everyone in the study gets the new drug. Consequently, this type of trial is not likely to provide a true picture of the drug’s toxicity or efficacy. That’s why a drug given AA must continue to be studied to see if it provides any benefit in terms of increased survival or symptom improvement. “The drug companies usually do a large trial in which the new drug is compared to the standard drug,” said Dr. Pazdur. “This usually takes two to four years, and the proof comes from a usually large trial that compares the new drug to the standard drug.” And what if the drug company does not comply? “We have a process for rapidly removing the drug from the market,” replied Dr. Pazdur.

Still, some not-so-well tested drugs are available for several years following an AA, and oncologists are free to prescribe them for cancers other than the type for which the products received approval. Or, more often, oncologists can add the new product to a multiple-drug regimen, which in itself has never been studied. “Yes, this is called off-label use, which is fairly common in the practice of oncology in the U.S.,” agreed Dr. Pazdur. “But this involves the practice of medicine, and the FDA does not control the practice of medicine.”

Unless their oncologists tell them, cancer patients would not know whether they are being given a drug off-label. “We would like patients to read the drug label to see the approved indications and contraindications,” advised Dr. Pazdur, who said that the information is freely available at the FDA’s Web site.

For more information:

  • To read a drug label, go to www.fda.gov or to the Physicians’ Desk Reference (PDR), which is updated yearly and available at most local libraries and large bookstores. The label is daunting for its extensive length, tiny type and medical jargon-ridden style. It is, however, the only source for results of the FDA-required tests. The section entitled “Indications” will identify the purpose(s) for which the drug has been proven beneficial.If you can’t find your type and stage of cancer listed under “Indications,” this signals off-label use. Unfortunately, only the rare cancer patient well versed in clinical trials will be able to discern whether the label is identifying a drug that has gone through the less-rigorous AA process. For example, capecitabine was given AA (on the basis of tumor response) for advanced breast cancer in 1998. The 2002 Physicians’ Desk Reference describes capecitabine’s testing as a “phase II, single-arm trial,” which signals AA.Another clue can be found under “Indications,” where response rate is described as the basis for the drug’s use for metastasized breast cancer. However, the much watered-down patient version of the capecitabine label (which appears after the information aimed at professionals) does not include an explanation of these terms. The patient’s label makes no mention of the fact that the drug was approved through the accelerated process. Capecitabine is sold under the brand name: Xeloda.
  • Go to the Web site of the National Cancer Institute (www.cancer.gov), click into the following succession of options: “treatment,” “chemotherapy,” and “newly approved cancer treatments.” You will find explanations of phase II trials, off-label drug use (complete with Q and A: “Can off-label drug use be harmful?”), and many other relevant terms. People without access to the Internet can call the National Cancer Institute at 1 (800) 4-CANCER to get this information mailed to them.When recommending a new cancer drug to a patient, oncologists will often quote “response rate” without explaining what it means. Ask. This article has addressed how new drugs receive FDA approval. But once on the market, they are often studied eventually in large randomized, controlled trials as part of a multiple-drug regimen.
  • Ask for the evidence to support a proposed chemotherapy regimen. Here’s one way to phrase the question: “Can you give me a citation for the studies that show this drug or drug-combination will benefit people with my stage and type of cancer? The citation will allow you to do a Medline search (ask the librarian at your local public library) to locate the study and determine the exact nature of the benefit.Medline is a service available through the National Library of Medicine (www.nlm.gov). It provides free access to the abstracts, or summaries, of the studies published in a large proportion of the world’s medical journals. Some public libraries will retrieve the entire article at no charge, but the article can also be purchased on-line.

Posted in Cancer | Tagged: , | Comments Off

New Cervical Cancer Vaccine Should Not Be Mandatory

Posted by medconsumers on December 1, 2006

The new cervical cancer vaccine raises concerns that did not show up in the news coverage about its approval last summer. Usually mass vaccinations are advised for diseases with a high rate of death and/or disability, but cervical cancer doesn’t come close to meeting those criteria. And most important: Is it safe to vaccinate all girls for a disease that afflicts only 9,710 American women yearly and causes 3,700 deaths? The answer might be yes, if the vaccine is risk-free. But the nation’s leading vaccine safety organization raises some serious reservations.

Those reservations were ignored last summer when the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend that all 11- to 12-year-old girls receive the human papillomavirus (HPV) vaccine called Gardasil. This is a major step toward making the vaccine mandatory—at an age well before girls are likely to become sexually active.

Only one company, Merck, makes the HPV vaccine, which is given in three injections over six months and will cost $360. Merck says its trials proved Gardasil is “100% effective in preventing HPV infection in those who do not already have HPV with strains 16 and 18, which together cause about 70% of all cases of cervical cancer.”

These Merck-sponsored trials were submitted to the FDA, and Gardasil was approved. But Barbara Loe Fisher, an advocate for vaccine-safety studies and the president of the National Vaccine Information Center, questions the need for a cervical cancer vaccine given the availability of the Pap test, which she believes has greatly reduced the incidence of the disease. She also sees methodological flaws and major deficiencies in what has been reported to the public about HPV disease and the vaccine.

“Most people who have sex will have experience with HPV, but the majority will clear it from the body and go on to have healthy lives. Only a tiny percentage will have persistent HPV infection and will experience changes over a long period of time that will lead to cancer. On the list of cancers that kill, this is at the bottom,” she said, referring to U.S. women, as opposed to those in developing countries where cervical cancer deaths are far more common.

As a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, Fisher has considerable experience analyzing the lengthy documents submitted by the vaccine companies to the FDA, as well as the agency’s own review of company-sponsored trials. Fisher’s safety concerns center on the type of placebo Merck used in the Gardasil trials. “A true placebo would be a saline solution—something that is innocuous and has no potential to cause a reaction on its own,” she said, referring to the injection given study participants who were assigned to the control group against which Gardasil was compared.

Instead, Merck used a solution that contained aluminum, Fisher explained, and neither the company nor the FDA has publicly disclosed the amount used in the solution. “Aluminum is used as an adjuvant in many vaccines to boost the potency of the vaccine,” she continued, “and though it has been in vaccines for decades, it has never been tested in clinical trials to see whether it is safe.

“We know from animal and human biological mechanism research that aluminum can cause inflammation and brain cell death. Putting it in the placebo [in a clinical trial] violates the principle of the scientific method when trying to ascertain truth,” said Fisher. “To make matters worse, aluminum is also in the Gardasil vaccine which makes it difficult to tell whether the many adverse events reported in the trials were due to the aluminum-containing placebo or the Gardasil,” she explained, referring to the well-documented fact that adverse events will show up in all clinical trial participants, even those given an inactive placebo.

Why would the FDA overlook this potential for confounding trial results? “The FDA has become partners with the vaccine manufacturers in fast-tracking these vaccines and in the process, the precautionary principle has been thrown out,” Fisher responded, adding that most health problems occurring in vaccine trials are often dismissed. “The companies tend to write them off as unassociated with the vaccine.”

Maryann Napoli, Center for Medical Consumers ©
December 2006

Posted in Cancer, Conflict of Interest, Women's Health | Tagged: , , , | Comments Off

Cancers That Do Not Kill

Posted by medconsumers on August 1, 2006

Prevalent and Usually Treated Aggresively

If doctors look hard enough, they will find abnormalities. The problem has escalated with improved imaging techniques like ultrasound and scans that allow them to find tiny cancers and precancerous lesions that, in another era, were not seen beyond the autopsy table. Many, if not most, are inconsequential, but no test can definitively sort out the minority that merit treatment. A lot of unnecessary aggressive treatment is the unhappy result.

Ambiguous findings are so common that they have been given the somewhat wry name of incidentalomas. The word begins with the breezy sound of something found unexpectedly and ends with an ominous ring of cancer. Incidentalomas are found in the kidney, liver, pancreas, adrenal glands, thyroid gland, lung, breast, and prostate—in other words, any organ that can be imaged.

The detection of incidentalomas has been ruining people’s lives well before there was a word for them. Ever since the introduction of the first cancer screening test—the Pap smear—50 years ago. Cancer screening (by definition, a test given to people without symptoms) frequently reveals a type of cancer or a precancer that would have regressed or remained dormant for an entire lifetime. For every person who benefits from early detection, many more are diagnosed with a cancer they did not need to know about.

Based on the combined results of the mammography screening trials, for example, it is estimated: “For every woman who has had her life prolonged [because breast cancer was found on a screening mammogram], five healthy women who would not have received a breast cancer diagnosis had there not been screening will be converted into cancer patients,” according to Jorgensen and Gotzsche (BMJ, 1/17/04). What the public needs is a medical organization that would serve as counterpoint to the American Cancer Society—one that provides a realistic understanding of cancer and all its uncertainties.

The word incidentaloma is more typically applied to a tiny mass, nodule, or lesion found by chance during a biopsy or an imaging test ordered in response to unrelated symptoms. The dilemma they pose was illustrated recently in a New England Journal of Medicine article by John H. Stone, MD, Johns Hopkins School of Medicine, Baltimore. His patient’s puzzling and diffuse symptoms were finally understood after a full-body CT scan identified a problem in the temporal artery. A biopsy specimen found giant-cell arteritis—not cancer, as he had feared. But the relief felt by doctor and patient alike was immediately overshadowed by an unexpected CT-scan finding in the patient’s abdomen: a “5-mm mass in the posterior right kidney. Cannot exclude renal-cell carcinoma.”

The next step was magnetic resonance imaging that produced a report which was not completely reassuring: “consistent with proteinaceous cyst. Recommended follow-up imaging in six months.” As Dr. Stone put it, “Thus, an incidentaloma ruined the patient’s peace of mind and diverted our focus from the otherwise clear path to health.” The most challenging question facing physicians, he wrote, “regardless of the organ in which incidentalomas are found, is what to do with the small ones—the renal mass smaller than 1.5 cm*, the adrenal lesion smaller than 4 cm, and the pituitary abnormality smaller than 1.0 cm. My patient’s 5-mm [about 1/5 of an inch] renal mass challenges the capabilities of any radiologic test ordered in the hope of definitive reassurance. With a growing number of incidentalomas, what to tell the patient remains unclear.”

Although many incidentalomas are clearly cancer, most would never have become life-threatening or symptomatic had they gone undetected and untreated. This is the take-home message from a recent study published in the Journal of the American Medical Association, entitled, “Increasing Incidence of Thyroid Cancer in the U.S., 1973-2005.” The authors, Louise Davies, MD, and H. Gilbert Welch, MD, found a nearly three-fold increase in the U.S. thyroid cancer incidence in this 32-year time period. Yet death from thyroid cancer has always been—and still is—rare, less than 1,500 deaths annually.

Davies and Welch examined other explanations, such as environmental radiation, but traced the increase instead to the widespread use of ultrasound that began in the 1980s. “While thyroid ultrasound cannot diagnose a thyroid nodule as malignant, it can detect nodules as small as 0.2 cm,” they wrote, noting that the physician’s manual examination could only detect nodules that are larger. Ultrasound examinations used to be done in hospital radiology departments, but now more and more thyroid ultrasound machines can be found in doctor’s offices.

“Fine-needle aspiration biopsy is currently our gold standard because it is more likely to produce definitive information,” said Louise Davies, MD, of the VA Outcomes Group, Department of Veterans Affairs Medical Center, White River Junction, Vermont. But, she explained in a telephone interview, fine-needle aspiration may not provide a clear diagnosis, which means undergoing an operation to get a definitive answer, where half or all of the thyroid gland is removed. The latter operation (thyroidectomy) requires life-long thyroid replacement therapy. “Surgeons may recommend removing the whole gland because of the risks associated with re-operation if the nodule turns out to be cancerous,” said Dr. Davies, a surgeon and lead author of the thyroid cancer study.

Asked what people can do to avoid unnecessary treatment, Davies suggested, “Think one step ahead about what you would do, so that you don’t find yourself down a path toward thyroid removal. Consider what you would do if an ultrasound showed a nodule—would you, for example, rather not know you had one in the first place, or would you want to have it rechecked periodically?” She advises people to consider how the thyroid nodule was found, whether it causes symptoms, or if there is a family history of thyroid cancer.

A second opinion about the decision to undergo a fine-needle aspiration is also a good idea, explained Davies. For second opinions, she had this suggestion for choosing a doctor to consult: “If, for example, an endocrinologist suggested you undergo evaluation, then another endocrinologist, a surgeon or a primary care doctor might be a good choice for a second opinion. In any case, choose a doctor at a hospital, or office different from that of the first-opinion doctor.”

Davies and Welch found that the increasing incidence of thyroid cancer is predominantly due to the increased detection of tiny papillary cancers, the most common type of thyroid cancer, usually symptomless, and the least likely to kill. “An untreated 1 cm or less papillary thyroid cancer has a virtually 100% survival rate,” said Davies. “Most worrisome are medullary and anaplastic thyroid cancers, which usually have symptoms.”

The presence of symptoms is key. “If you have a small lump that you can’t feel, but your doctor can, and yet you have no symptoms—that’s an incidentaloma. People should realize if they don’t have symptoms, they have time to wait three to six months to have it evaluated. With incidentalomas, that’s key,” said Davies. “Early detection of an incidentaloma doesn’t necessarily lead to a longer life. Instead, it may just lead to a longer period of time in which you know you have cancer.”

*2.5 cm or 25 mm = 1 inch

How Prevalent is Cancer? How Prevalent are Cancers That Kill?

The following statistics are based either on autopsy studies of people not known to have cancer during their lifetime or ultrasound examination studies of symptom-free people. They show that the prevalence of many cancers—and would-be cancers—is well in excess of cancer diagnosed in the living population. The U.S. cancer death statistics come from the American Cancer Society.

Thyroid:
An ultrasound screening study of 96,278 people found thyroid nodules present in 35% of women age 26 to 35, increasing to nearly 45% of women aged 55 and over. Thyroid nodules were present in 9% of men ages 26 to 35 and increased to 32% in men aged 55 and over.

Several autopsy studies have found that thyroid cancer is present in 36% of all people. In one of these studies, researchers examined extremely thin slices of the thyroid glands of 101 people and found many more, smaller (2-3 mm) thyroid cancers in the slices. This led them to conclude that, if sliced finely enough, virtually everyone’s thyroid would be found to have cancer.

An estimated 1,460 people will die of thyroid cancer in 2006.

Adrenal gland:
Autopsy studies found adrenal masses, 2 mm to 4 cm, in diameter to be present in approximately 10% of people.

Approximately 1 out of every 4,000 adrenal tumors is malignant. Deaths from adrenal cancer are so rare that the ACS does not provide a number.

Kidney:
An ultrasound study of the urinary tract of 729 people found the prevalence of kidney cysts was 1.7% in those aged 30-49 years, 11.5% in those aged 50-70 years, and 22% in those aged 70 years and older.

An estimated 12,480 people will die of kidney and renal pelvis cancer in 2006.

Prostate:
Autopsy studies indicate the presence of prostate cancer in men is 10-42% at age 50-59 years, 17-38% at age 60-69 years, 25-66% at age 70-79 years, and 18-100% at age 80 years and older.

There were 30, 350 prostate cancer deaths in 2005.

Breast:
Autopsy studies show the prevalence of ductal carcinoma in situ, a tiny non-invasive cancer within the milk duct, is 6-16%. Prior to the introduction of mammography screening, this diagnosis represented less than 5% of all new cases of breast cancer, now it is 20%. Since most cases of DCIS are treated with either breast removal or radiation, it is not known how many would have regressed or remained dormant without treatment. However, 78 women whose biopsied tissue was mistakenly diagnosed as benign in the pre-mammography era provided an opportunity for researchers. They did a followup study and found that only 20-25% of these untreated women went on to develop invasive cancer ten years after the biopsy. Some breast cancer researchers believe that the DCIS diagnosed today with improved imaging techniques is even more likely to be inconsequential than these 78 cases indicate.

Evidence that some invasive breast cancers found “early” on a screening mammogram do not always progress to be life-threatening comes from the National Breast Screening Study of Canada. Over 50,000 women in their 40s were randomly assigned to have mammograms or not. 82 more breast cancers were detected in the women given mammograms. (592 invasive and 71 non-invasive breast cancers in the mammography group, compared to 552 invasive and 29 noninvasive breast cancers in the control group.) One would expect a higher survival in the mammography group with its higher rate of cancer detection. But, in fact, the breast cancer death rate in both groups was exactly the same at 16 years.

There were 40,410 breast cancer deaths in 2005.

Maryann Napoli, Center for Medical Consumers©
August 2006

Posted in Cancer, Scans and X-rays, Screening | Tagged: , , | Comments Off

Protopic and Elidel: Eczema Drugs Have a Cancer Risk

Posted by medconsumers on May 1, 2006

Early this year, the Food and Drug Administration issued a warning about two prescription topical creams for the common skin disease, eczema. Both Elidel and Protopic must now include written material for professionals and patients that warns of a cancer risk based on “information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work.”

Though the warning says, “a small number” of people who have used the products “have had cancer (for example, skin or lymphoma),” evidence from the FDA’s own reporting system indicates that this may be an understatement. Pretty alarming for drugs that are applied to the skin, primarily for young children. Doubly so, considering the fact that less than 10% of all serious adverse drug reactions are reported to the FDA.

People with eczema, also known as atopic dermatitis, and parents of children with this chronic skin disorder are often desperate for a treatment that alleviates the severe itchiness and inflammation. Eczema primarily afflicts babies and children, but can continue into adulthood in about 50% or show up  (rarely) for the first time in adulthood. There is no cure. A drug might beat it back for a short time, but flare-ups are common.

Elidel (generic name: pimecrolimus) and Protopic (generic name: tacrolimus) control eczema by suppressing the immune system, and they can be extremely effective in producing improvements. Until they came along, corticosteroid cream was the standard treatment. Hopes for the newer drugs stem from fears about the side effects of corticosteroid cream like thinning of the skin and adrenal gland suppression. Novartis, the company that makes Elidel, and Astellas Pharma (formerly Fujisawa), maker of Protopic, fed these fears by promoting their products as “steroid-free.”

One example is Fujisawa’s fraudulent ad for Protopic that appeared six years ago in Prevention magazine stating, “Breakthrough research has finally uncovered a new kind of medicine for eczema. Made of a natural substance, this new treatment is steroid free.” The ad implies safety. But in reality both Elidel and Protopic are in the same drug class as Prograf, a powerful immunosuppressant drug that prevents liver or kidney transplant rejections. In fact, Protopic and Prograf (generic name: tacrolimus), which comes with a warning of “infection and development of lymphoma,” are the same drug!

FDA Explains Itself

Why hasn’t the FDA withdrawn the drugs, given their obvious dangers and the existence of a safer alternative? “FDA believes that the benefits of Elidel and Protopic outweigh the risks of these products,” responded Julie Beitz, MD, of the FDA’s Center for Drug Evaluation and Research, who would answer questions only by e-mail by way of a press officer. “The  new warnings in the professional labels and in the Medication Guides* for these products convey what our concerns are, however, a causal link has not been established between the reports of cancer and use of these products.”

The FDA warning states that it may “take human studies of ten years or longer to determine whether Elidel or Protopic is linked to cancer.” Despite the lack of long-term data and what is surely an undercount of cancers associated with use of these drugs, Dr. Beitz defends the FDA position, “While there is under-reporting of adverse events to the FDA, we also know that use of these products is great, so relative to all users, the number of reports we have received is small.”

To some dermatologists, the question of whether Elidel and Protopic pose more than a rare cancer risk seems to hinge on how much is absorbed into the skin. In a January 19, 2006 press release that disagrees with the  FDA’s decision to issue an warning, Clay J. Cockerell, MD, president of the American Academy of Dermatology, said, “Because these medications are applied to the skin, virtually none of it gets inside the body.”

That statement was quoted to Dr. Beitz, who commented, “We agree that very little of the drug is absorbed in general, however, we have data to show that some patients do absorb the drug to greater degrees. Additional factors to consider: 1) how long the patient is using the product; 2) how large an area of skin the product is being applied to; and 3) the fact that areas affected with atopic dermatitis are not normal and may allow for more absorption.” Babies under two should not be treated with either drug, according to the FDA warning.

“Infants have higher surface area to volume so they will have higher blood levels of the drug and their skin is more permeable,” said Peter M. Elias, MD, professor of dermatology, University of California, San Francisco, in a telephone interview. “The companies have over-marketed these drugs suggesting, for example that they are safe for infants by showing images of infants [in promotional materials].” The ads implying Elidel and Protopic are safer than corticosteroids are ridiculous, he continued, adding that neither drug has been shown to be safer or more effective than topical steroids in a head-to-head comparison as maintenance therapy for eczema. “Low- to mid-potency steroids are quite safe in eczema, although many clinicians prefer an even less potent agent, such as hydrocortisone, in infants,” said Dr. Elias.

When the FDA was deciding whether to approve these drugs in 2000, Dr. Elias wrote a letter to the agency expressing concerns, particularly about Protopic, which he described as “a powerful and potentially toxic immunosuppressive drug.” In the letter, which remains on the FDA Web site, Dr. Elias told the agency that he is “alarmed at what appears to be a potentially cavalier and uncritical attitude about the indications and long-term safety of topical tacrolimus [generic name for Protopic]. [This drug] is absorbed into the circulation through inflamed skin, and in low-body weight children it can produce transient therapeutic (transplant) drug levels.”

Dr. Elias sees a limited role for the drugs, “Protopic should be reserved for severe, recalcitrant flares of eczema in children and adults, and Elidel for similar bad flares in infants. Elidel might also be useful for periorbital dermatitis due to risk of glaucoma from steroids. But in all these examples, the use should be short term—days, weeks, but not months—and only in conjunction with sunscreens, which should always be used when these drugs are applied to sun-exposed skin. There is no rationale for long-term therapy with either drug.”

Pressure Not to Warn the Public

In the five to six years since the FDA approved each drug, Novartis and Astellas/Fujisawa mounted a massive, often misleading, advertising campaign aimed at doctors and the public. And in the last two years, both companies waged an aggressive campaign against the FDA’s planned warning. Under great pressure not to act, the FDA went ahead and called a meeting of its pediatric advisory committee in February 2005, which recommended a label change warning doctors and patients about the risk associated with both Elidel and Protopic.

The next month, a cancer warning appeared on the FDA Web site. (It is not known how many doctors or patients would think to look on the FDA’s Web site for new warnings.) As of January 2006, a Medication Guide for patients with the warning is supposed to be included with all prescriptions of Elidel and Protopic. The Guide does not spell out the safe duration (if there is one) of short-term use, though makes it clear that neither drug should be the first-choice treatment for eczema.

There are reasons to think that these efforts will go unheeded. Several studies show that only one in ten doctors read the drug label which is the most complete source of information about a drug’s use and harms. (Consumers are not much better.) A recent survey showed doctors are overwhelmed with drug warnings and have difficulty keeping them all straight. In the case of Protopic and Elidel, the dermatologists’ professional organizations were actively working against the FDA’s plan to issue a  warning. The Society for Pediatric Dermatology, in a letter dated November 30, 2005, advised its members to write the FDA to tell the agency that warnings are not warranted because “abrupt discontinuation of these medications out of fear [will result] in disease flares in many children.” Furthermore, the letter claimed that an analysis of the clinical data presented to the FDA have not supported a malignancy risk.

“The great resistance in the dermatologic community to the FDA warning is based in part on the fact that many of the opinion leaders are in conflict of interest situations that too often go undisclosed,” said Dr. Elias, referring to funding from Novartis and Astellas that pays for the speakers bureau, conferences, and continuing education. And he doesn’t think much of the evidence cited to support objections to the FDA warning about Elidel and Protopic. “There are 55 articles about the safety of both drugs that claim to be long term,” Dr. Elias explained. “However, they are not, in fact, long term; the longest study lasted only six months; many are repeats—the same study published in multiple journals—and others are written by the drug company journal editor.” [Note: There are longer studies indicating the drugs are safe and effective, but they are funded by either Astellas or Novartis.]

It is quite possible that one day lawsuits will generate  the publicity needed to adequately warn the public about inappropriate use of Elidel and Protopic. Several law firms now have Web sites specifically devoted to the drugs. One such firm headed by Larry M. Roth has a Web site (www.protopiclawyers.com) that features his detailed article on the history of FDA approval of topical immunosuppressants and reports of serious reactions, complete with extensive footnotes. It describes cancers, deaths, and other severe  reactions reported to the FDA.

In a telephone interview, Laurilyn Cook-Arrington, a paralegal at Larry M. Roth, PA, said the law firm had retrieved this information from the FDA’s Adverse Events Reporting System with a Freedom of Information Act request. (Manufacturers are required “by regulation” to report serious drugs reactions to AERS.) Ms. Cook-Arrington said the firm has been gathering information on topical immunosuppressant drugs for three years. “Hundreds of potential claimants have contacted our firm in the last year. And many of these claims include deaths. Almost 50% of them are made on behalf of children. They involve skin cancers, as well as systemic malignancies like leukemia, Hodgkin’s disease, and multiple myeloma.”

What to do:

  • If you are using Elidel or Protopic, inform yourself about these medications. Start with the warnings at the FDA Web site (www.FDA.gov). Consumers and doctors can report serious adverse drug reactions to the FDA’s Medwatch Program 1(800) FDA-1088.
  • Ask your doctor about prescription emollients to reduce the amount of topical drugs needed to control eczema. According to Dr. Elias, “Topical prescription emollients alter biochemical abnormalities in the skin, lead to fewer flare ups, and fight off infection.” They can be used as the first treatment or as maintenance after short-term treatment with an immunomodulator, explained Dr. Elias, who is also chief science officer at Ceranix, makers of a yet-to-be-available emollient, EpiCeram.

Maryann Napoli, Center for Medical Consumers ©
May 2006

Posted in Cancer, Chronic Conditions | Tagged: , , , , , | Comments Off

Spiral CT Lung Scans for Smokers and Former Smokers

Posted by medconsumers on May 1, 2005

The introduction in the 1990s of a high-tech procedure for scanning the lungs of smokers and former smokers raised hopes that it would spare many of them a lung cancer death. A new study reported in the journal Radiology, however, confirmed the fears of a few physicians who have publicly questioned the premature promotion of this test. Its potential for harm has been verified in the study conducted by researchers at the Mayo Clinic in Rochester, Minnesota.

The spiral computed tomography, or CT, lung scan provides three-dimensional images that allow doctors to find many more tiny lung nodules than would be apparent on the standard chest x-ray. And that is the problem. The high number of nodules and other lung abnormalities found in this new study required extensive investigation and, in many instances, risky surgery before most of them could be classified as benign. This high rate of false alarms can be justified only by a screening test that offers a substantial reduction in lung cancer deaths. And the jury is still out on this important point.

Too Many False Alarms

Funded by the U. S. National Cancer Institute, the study included over 1500 men and women who were given annual CT lung scans. 61% of them were current smokers and the rest were former smokers. After five years, the research team led by Stephen J. Swensen , MD, at the Mayo Clinic in Rochester, Minnesota , found that the false-positive (false-alarm) rate was extremely high. Nodules—749 altogether—that proved to be benign were found in 69% of the participants. In some cases, the lung abnormalities proved to be cancer, but they were a type that would never produce symptoms or become life-threatening.

“Intervention for benign nodules is common and has substantive financial, mortality, morbidity, and quality of life costs,” wrote Dr. Swensen and colleagues. A lung biopsy, for example, is a potentially risky procedure that is typically ordered to rule out lung cancer. A small amount of lung tissue is removed through a telescope-like tube that is inserted down the windpipe (a bronchoscopy) or via a needle inserted through the chest wall. Occasionally, a larger amount of lung tissue must be biopsied which requires major surgery (thoracotomy or thoracic surgery), with the potential for severe complications in people with ailments common to smokers, such as heart or lung diseases.

Lifesaving Benefit Unproven

Here are the Mayo Clinic study’s conclusions: “Screening for lung cancer offers the possibility of reducing mortality from lung cancer. Our preliminary results do not support this possibility and may raise concerns that false-positive results and overdiagnosis could actually result in more harm than good.” They explained overdiagnosis as the detection of slow-growing lung cancers that “a patient dies with and not from,” a phenomenon that is not limited to the lungs. The breast, prostate, thyroid and other organs also contain cancers that would never become symptomatic or deadly if they went undiscovered.

Researchers suspect overdiagnosis whenever a study like this one finds a high number of early-stage would-be cancers but no reduction in the number of people diagnosed with more advanced disease. This strongly suggests that the overwhelming majority of these suspicious abnormalities would never have progressed to fatal lung cancer.

The study was not designed to come to a conclusion regarding the ability of the CT scan to reduce the rate of lung cancer deaths because there were no unscreened participants to serve as a comparison to the people given lung scans. There were only nine lung cancer deaths but 40 deaths from other causes. The investigators, however, point out that the lung cancer death rate was similar to that of an earlier study called the Mayo Lung Project.

The definitive answer regarding the spiral CT scan’s potential contribution to reducing the lung cancer death rate is expected from another National Cancer Institute- financed project called The National Lung Screening Trial. This is the first trial to compare the new technology with the old. 50,000 current or former smokers have already been enrolled. They have been randomly assigned to receive either a chest x-ray or a CT lung scan. After one or two years, each group will have the same screening procedure again. Results will not be published before 2010.

Trial Sponsor Issues Warning

The National Cancer Institute warns about the risks of screening on its Web site:

“Conventional wisdom suggests that the smaller the tumor, the more likely the chance of survival. But no scientific evidence to date has shown that screening or early detection of lung cancer actually saves lives. The National Lung Screening Trial, because of the large number of individuals participating and because it is a randomized, controlled trial, will be able to provide the evidence needed to determine whether spiral CT scans are better than chest X-rays at reducing a person’s chances of dying from lung cancer.”

Maryann Napoli, Center for Medical Consumers ©

Posted in Cancer, Men's Health, radiation exposure, Scans and X-rays, Screening, Women's Health | Tagged: , , , , , , , | Comments Off

Radiation-Induced Heart Damage on the Decline

Posted by medconsumers on May 1, 2005

Radiation therapy now has a lower risk of fatal heart damage to women with breast cancer than it did for women treated in the past. The cardiac harm, however, does not show up until ten or more years after treatment, so it remains unclear whether this adverse effect has been completely eliminated by modern improvements in radiation techniques. These findings were published last month in the JNCI (Journal of the National Cancer Institute, 3/16/05).

As of 2002, about 42% of American women newly diagnosed with breast cancer had the cancerous breast tumor surgically removed (lumpectomy) followed by six weeks of radiation therapy. This has been a valid choice ever since 1985 when a major nationwide clinical trial found that mastectomy (breast removal), lumpectomy plus radiation therapy, and lumpectomy alone all had the same survival rate. Lumpectomy alone, however, was—and still is—rarely offered to women. This is because the same large clinical trial found, in 1993, that the radiation therapy decreased the rate of breast cancer recurrence, though it did not reduce the death rate. Worse, as women treated with radiation were followed beyond ten years, they showed a higher death rate then the women whose breasts were not irradiated.

Obviously, this was not expected. Researchers began to speculate that the anticipated decrease in breast cancer mortality was being offset by an increase in treatment-related deaths. By the early 1990s, researchers knew that there were more cardiac deaths among breast cancer patients given radiation therapy than those whose breasts had not been irradiated. A 1994 analysis showed a 62% increase in heart-related deaths among women treated with radiation. Researchers also knew that women with left-sided breast cancer had higher rates of radiation exposure and higher rates of cardiovascular mortality.

To determine whether the multiple improvements in breast radiation techniques had overcome this hazard, a Texas research team assessed the data from 12 cancer registries around the country. Altogether the registries included 27,283 women with early-stage breast cancer who had been treated with radiation therapy between 1973 and 2000. (Radiation therapy after a mastectomy was the standard breast cancer treatment until the mid-1970s; and it continues to be used in certain circumstances.) Half of the women had left-sided breast cancer, and half had right-sided breast cancer. These registries are broadly representative of the way breast cancer patients are treated across the country.

The researchers, led by Sharon H. Giordano, MD, MPH, University of Texas M.D. Anderson Cancer Center, Houston , found that the risk of death from heart disease decreased over time. For the women diagnosed between 1973 and 1979, the heart disease mortality rate at 15 years was 13% for those with left-sided breast cancer and 10% for those with right-sided breast cancer. For the women diagnosed in the late 1980s, it was nearly 6% and nearly 5%.

Dr. Giordano and colleagues concluded that, due to advances in radiation techniques, the risk of cardiac death associated with radiation after breast cancer “has substantially decreased over time.” Given that radiation-induced heart damage takes many years to develop, the researchers added this caution. “Whether the risk of ischemic heart disease mortality resulting from radiotherapy has been entirely eliminated cannot be determined definitely from this study. Continued follow-up of the women diagnosed and treated in the late 1980s will be necessary to answer this question.”

Where does this leave the woman diagnosed today? If radiation therapy doesn’t prolong life, wouldn’t it be safer to forego this treatment, just have a lumpectomy, and take the small risk of recurrence? “Not quite true,” answered Jack Cuzick, PhD, author of the editorial that accompanied the study. In an e-mail interview, Dr. Cuzick explained, “Recent trials are showing a reduction in breast cancer deaths [in women given radiation therapy], and little effect on other causes of death, so for women at high risk of recurrence and breast cancer death, for example, those with node-positive breast cancer, radiotherapy is a pretty good option.” But, Dr. Cuzick cautioned that there is still uncertainty about the value of radiation therapy for women whose breast cancer death risk is low, for example, those with tumors under 1 cm or ductal carcinoma in situ.

Maryann Napoli, Center for Medical Consumers ©
May 2005

Posted in Cancer, Heart, Women's Health | Tagged: , , , | Comments Off

Radiation Risks Of Full-Body Scans

Posted by medconsumers on October 1, 2004

Full-body scans have been heavily promoted to the public as a means of finding cancer before symptoms appear, but a new report suggests that the radiation doses delivered by these tests are high enough to cause cancer. In last month’s issue of the journal Radiology, David J. Brenner, PhD, and Carl D. Elliston, MA, provided the following lifetime estimates of the risks associated with having one or repeated full-body scans.

“If a 45-year old adult has one screening full-body scan, then many years down the line, one in 1,200 will die from a radiation-induced cancer,” explained Dr. Brenner, in a telephone interview. He noted that this risk is obviously low, but the promotion of these full-body scans as screening tests means that symptomless people are encouraged to accept regular testing.

“A screening test is only going to be useful,” he said, “if it is given annually or biannually.” Then the odds of cancer mortality become much higher. “If a 45-year-old has annual full-body scans until the age of 75 years, then one in 50 will die of a radiation-induced cancer,” estimates Dr. Brenner, who is a radiation biologist, that is, a specialist in the health effects of radiation on the human body. For anyone who starts the same regimen at age 60 years, the odds of a radiation-induced cancer death would be one in 220.

Brenner and Elliston based the estimates of lifetime cancer death risk on the atomic bomb survivors from Hiroshima and Nagasaki who had been exposed to the lowest amounts of radiation. The doses received by these survivors are comparable to those received from full-body scans.

The use of computed tomography, or CT scans, for symptomless people is relatively new. In addition to searching for early-stage cancers, heart scans for calcium in the coronary arteries are also heavily advertised to consumers. Most people undergo screening heart or full-body CT scans at freestanding clinics run by entrepreneurial radiologists, and the $300 to $1,000 cost is usually paid by the consumer. Insurance companies and managed care plans typically do not reimburse for screening CT scans because their benefit is yet to be proven. Furthermore, screening scans lead to false alarms and unnecessary, sometimes risky, testing and biopsies.

There are no statistics regarding the number of people who undergo screening CT scans each year, but there has been a dramatic increase in the number of freestanding CT scan clinics since 2001. Because radiation’s harm is cumulative, there have always been questions surrounding the safety of scanning people without symptoms. Brenner and Elliston are the first to quantify the radiation exposure.

A full-body scan means radiation is delivered from the chin to just below the hips. “The reason for the high radiation dose is that the machine fires in beams of x-rays from different directions providing 3D images—that’s why it’s called computerized tomography,” explained Dr. Brenner. “The patient is getting many separate x-rays. And that’s why the doses are much higher than those from conventional x-rays.”

Dr. Brenner made a distinction between the use of CT scans as a screening method and their use in diagnosing illness in a person with symptoms. The benefit of receiving the correct diagnosis outweighs the radiation risk. “If, say, a person has lung symptoms, the radiation dose [from the lung scan] goes only to that organ plus a small dose to the stomach because x-rays scatter.” But full-body scans are imaging the main organs of the body so they give a significant radiation dose to all those organs.

Unfortunately, it has always been difficult to find honest information about the radiation risks of medical tests. Radiologists have traditionally dismissed medical radiation exposure concerns. A recent survey indicates that physicians who order CT scans may be the least likely to be knowledgeable about radiation risks. Last May, a Yale survey of radiologists and emergency room physicians found that most of them did not believe that scans could increase the risk of cancer.

It is unusual for a medical group or a federal agency to come out a against screening test, but the American College of Radiology does not recommend full-body screening scans and the American Heart Association* does not recommend screening heart scans, citing concerns about the lack of proven benefit and the risks of overtreatment. Neither is explicit about the radiation risks; but the U.S. Food and Drug Administration (FDA) is a notable exception.

On its Web site, the FDA Center for Devices and Radiological Health comes right out and states that the use of CT scans to screen symptomless people has “no proven benefit.” To help people understand the amount of radiation involved, the agency has a radiation dose comparison chart showing, for example, that the radiation received by a CT scan of the abdomen is the equivalent of 500 chest x-rays.

The scans won’t give you peace of mind (a typical selling point), according to the FDA Web site, because a normal finding may erroneously be identified as cancer or a “clean bill of health” may be inaccurate. One would hope there was some independent oversight. Here too, the FDA is explicit about what it does not have the authority to do: “The FDA does not establish dose limits, nor does it address the imaging performance or efficacy of the CT equipment.”

For More Information:

Go the Web site of the FDA Center for Devices and Radiological Health.

To read why the U.S. Preventive Services Task Force is against the use of screening heart scans for calcium in the coronary arteries, go to www.ahrq.gov/clinic/uspstf/uspsacad.htm.

Read these two 2009 articles: one about the excessive amount of radiation associated with CT scans and the other about the radiation dose involved in cardiac CT scans.

Maryann Napoli, Center for Medical Consumers ©
October 2004

Posted in Cancer, Children's Health, Screening, Women's Health | Tagged: , , , , , , , , , | Comments Off

Should I be Tested for Cancer? Maybe Not and Here’s Why

Posted by medconsumers on June 10, 2004

New Book by H. Gilbert Welch: Should I be Tested for Cancer

Americans are keen on cancer screening. In fact a recent survey showed that most would rather have a free whole-body scan than $1,000 in cash. 32% thought that an 80-year-old man who chose not to undergo a colonoscopy was irresponsible. And 74% believe that finding cancer early saves lives “most or all of the time.” Even the common occurrence of an anxiety-producing false alarm, experienced by 38% of those surveyed, did not blunt enthusiasm for cancer screening. Nearly all who had this experience acknowledged its terror-inducing aspect, but were glad they had been tested.

Cancer testing for symptom-free people is accepted as a must-do health maintenance ritual by most Americans, but are they undergoing screening with eyes wide open? How many women, for example, have ever had the pros and cons of Pap testing explained to them? How many even know there is a downside to a Pap test? But screening for any disease is a two-edged sword carrying risks as well as benefits. And sometimes the former cancels out the latter.

One of the authors of the above-mentioned survey, which was published early this year in the Journal of the American Medical Association, is H. Gilbert Welch, MD, MPH, Professor in the Departments of Medicine and Community and Family Medicine at Dartmouth Medical School. Dr. Welch’s new book entitled, Should I be Tested for Cancer? Maybe not and here’s why, serves as a counterbalance to the one-sided information the public receives from their physicians and organizations like the American Cancer Society. (“Your life will be saved.” “Your treatment will be less drastic.”) In fact, his book is downright subversive, as its title suggests consumers can make an informed decision not to be screened.

Dr. Welch writes that his book is for people who “are open to questioning the wisdom of these testing efforts.” It is not for people who need to have simple answers. “None of us likes uncertainty–but this book is full of it.” He describes cancer as a disease that is not inevitably fatal, or even inevitably invasive. Before screening, it helps to know your odds of getting the target cancer. Typically, people are told a given test reduces the odds of dying of cancer by 30%. Dr. Welch says such statistics mean nothing unless you know your odds of getting the target cancer. As an example, he provides a graph based on the mammography screening trials. In the next ten years, of 1,000 American women age 50, six will die of breast cancer without mammography; four will die of breast cancer despite having had mammograms. Therefore, only two out of 1,000 will avoid a breast cancer death because of mammography. His explanation provides not only a realistic expectation of mammography’s benefit but it also illustrates the low odds of dying of breast cancer. News flash: Most women will never get it!

The colon cancer screening trials show a puzzling finding that is rarely conveyed to the public. The people who were randomly assigned to be screened showed a modest drop in colon cancer deaths, compared to the people who were not screened. However, the same trials showed that this benefit was canceled by an inexplicable increase in deaths from other causes, chiefly heart disease.

Screening tests are good at finding something Dr. Welch calls pseudodisease, and unnecessary treatment is the usual consequence. It is the PSA-detected prostate cancer that would have remained dormant, but is usually treated with radical prostatectomy; it is the nodule found during a lung scan that demands a biopsy to rule out cancer; it is the mammography-detected ductal carcinoma of the breast that automatically means breast removal in some areas of the country.

Some high-tech screening procedures are so sensitive that they identify lumps in nearby organs. Dr. Welch relates a written account of a doctor who underwent a virtual colonoscopy, which can “see” beyond the colon. It turned up a kidney mass, a 2 cm liver mass and multiple non-calcified nodules in the lung. After several CAT scans, a liver biopsy, removal of three small sections of his lung, four days of potent painkillers, he began to feel “nearly normal” five weeks later, except for the rib pain caused by the surgical interruption of the nerves during the lung biopsies. “No cancer” was the outcome. The doctor/patient may have been relieved, observed Dr. Welch, but he was also motivated to start asking hard questions about radiologists and their remarkably sensitive imaging tests. “His story certainly makes one wonder whether they are seeing too much.”

Maryann Napoli, Center for Medical Consumers© June, 2004

Posted in Book Reviews, Cancer, Screening | Tagged: , , , | Comments Off

Second pathology opinion for mammography-detected breast cancer

Posted by medconsumers on April 1, 2004

“Screening causes cancer.” When British surgeon and screening critic Michael Baum, MD, once expressed this opinion during a protracted media controversy over the safety of mammograms, it, no doubt, struck many as hyperbole. A recent study of mammography screening in Norway and Sweden, however, shows the comment to have a strong element of truth.

These two Scandinavian countries provide the basis for testing out a prevailing theory about the benefit of screening. Yes, many more cancers are diagnosed once a screening program is introduced, goes the theory, but they are “tomorrow’s cancers” diagnosed today. Then there are the skeptics who look at the long-range statistics and see something quite different. The increase in “tomorrow’s cancers” found in a large group of middle-aged women given regular mammograms, they reason, should eventually result in a corresponding decrease in breast cancer diagnosed later in life.

The skeptics were validated in the Scandinavian study published recently in the British electronic journal, BMJ Online First. After mammography screening was introduced in Norway for women aged 50 to 69 years, the incidence of breast cancer had increased by 54%, according to Per-Henrik Zahl and colleagues at the Norwegian Institute of Public Health, Oslo. The increase was 45% after mammography screening began in Sweden in 1987. Contrary to expectations, there was no corresponding long-term reduction in the rate of women diagnosed with breast cancer. Dr. Zahl and colleagues wrote that the increases in breast cancer incidence were too large to be attributed to causes other than screening, such as hormone therapy.

The significance of these findings is this: Mammography causes many women to be diagnosed and treated for a type of breast cancer that would never produce symptoms or become life threatening if left undetected. Doctors call this overdiagnosis and overtreatment. Unfortunately, most women are not informed of this risk, as they should be, before they consent to mammography screening. A survey of U.S. women’s attitudes toward mammography screening in 2000 showed that only 6% had ever heard that mammograms can find cancers that do not progress.

Whenever researchers address the problems associated with overdiagnosis and overtreatment, they usually focus on the mammography-related massive increases in the diagnosis of ductal carcinoma in situ (DCIS), a type of microscopic cancerous lesion within the milk duct that, in most cases does not progress to life-threatening disease if left untreated. (At least 60% of DCIS will not go on to become invasive and life threatening.).

Dr. Zahl and colleagues, however, have confined their statistics solely to invasive breast cancers, which makes their results even more alarming. The only way women can protect themselves from overtreatment is to give serious thought to the decision whether or not to undergo mammography screening. The risks associated with overdiagnosis and overtreatment are significant enough to make avoiding mammography a reasonable choice for women without breast symptoms. After looking at their survey results, Dr. Zahl and colleagues concluded, “Without screening, one third of all invasive breast cancer in the age group 50-69 years would not have been detected in the patients’ lifetime. This level of overdiagnosis is larger than previously reported.”

Another element of the mammography-related overdiagnosis and overtreatment picture was published within a week of the Scandinavian study. It involves DCIS, which was rare before mammography screening was introduced in the U.S., and now, more than 55,000 women receive this diagnosis yearly. DCIS has been variously called a precancer, a cancer, not a cancer, a high-risk factor. A survey published in the Journal of the National Cancer Institute showed that women are still given unnecessarily aggressive treatment for DCIS (e.g., mastectomy and removal of some of the lymph nodes at the armpit). Conversely, some are undertreated with excision alone for an uncommon type of DCIS called comedocarcinoma that will become invasive and therefore should be treated more aggressively (with radiotherapy).

What you can do:

If DCIS is diagnosed, it is advisable to get a second surgical opinion and a second pathology opinion (see below). With the exception of comedocarcinoma, pathologists are unable to identify which DCIS lesion will progress to invasive cancer and how long it will take to do so.

-To help you decide whether to have regular mammograms, go to this excellent decision-making Web site at the University of California, San Francisco www. mammography.ucsf.edu/inform/index.cfm

-Two of the country’s leading breast pathologists have long been working on ways to distinguish the forms of DCIS that will become invasive from those that will remain dormant. If diagnosed with DCIS, consider a second pathology opinion from Michael Lagios, MD, St. Mary’s Hospital, San Francisco (415) 789-0965 (www.breastcancerconsultdr.com), or David Page, MD, Vanderbilt University, Tennessee (615) 343-0072 (www. breastconsults.com). Both are breast pathologists who will deal directly with breast cancer patients.

Posted in Cancer, Scans and X-rays, Screening | Tagged: , , , , | Comments Off

Second Pathology Opinion for Early Breast Cancer

Posted by medconsumers on August 1, 2003

Why You Should Consider a Second Pathology Opinion for Ductal Carcinoma in Situ
By Maryann Napoli
(August 2003)

Ductal carcinoma in situ now represents one out of every five new cases of mammography-detected breast cancer diagnosed in the U.S. Despite its ominous name, which means cancer within the milk duct of the breast, DCIS is not always destined to become deadly. Only an estimated one-third of all cases will progress to invasive breast cancer, even if left untreated. The massive rise in DCIS is due to the increased acceptance of mammography screening. But the ability to diagnose DCIS has outpaced the knowledge of how to treat it without causing too much harm. A new study conducted in the UK, New Zealand, and Australia provides some partial answers (The Lancet, 7/12/03).

No cancer agency keeps track of how DCIS is treated in the U.S, but uncertainty is clearly reflected in the range of possibilities. This microscopic lesion can be treated with excision plus six weeks of radiation therapy, breast removal, or excision alone. There is also a great deal of uncertainty about the use of the anti-breast cancer hormonal drug tamoxifen following the initial treatment.

The new study conducted by the UK Coordinating Committee on Cancer Research set out to determine which treatment or treatment combination results in a lower rate of recurrence. All of the 1,694 participants had an excisional biopsy and were then given either no further treatment, radiation therapy, or tamoxifen, or both. The recurrence rate was lower in the women given radiation therapy, as compared to women treated with surgical excision alone. But the difference between the two groups was small:TInvasive breast cancer occurred in the affected breast of 2.5% of the women given radiation therapy, compared with 5.3% in the excision alone group.

The median follow-up for this study was only four years–too short a time to know whether radiation therapy actually extends life, or if the adverse effects of radiation itself outweigh the reduced chance of recurrence. (Earlier research showed a slight increase in cardiovascular deaths among younger women given radiation therapy.) This study will have the unfortunate effect of reinforcing the current “treat all to decrease recurrences in a tiny minority” approach to radiation. As for tamoxifen, the new study found little evidence to support its use.

Two of the country’s leading breast pathologists have long been working on ways to distinguish which forms of DCIS will become invasive and which will remain dormant. Consider a second pathology opinion from Michael Lagios, MD, San Francisco (415)789-0965 (www.breastcancerconsultdr.com), or David Page, MD, Vanderbilt University, Tennessee (615)343-0072 (www.breastconsults.com).
Both will deal directly with breast cancer patients.

Posted in Cancer, Screening, surgery, Women's Health | Tagged: , , , , , , , | Comments Off

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