Tag Archive | "American Medical Association"

Surgery prevents breast cancers in high-risk women

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Women with mutations in the well-known BRCA1 or BRCA2 genes who have their breasts and ovaries removed are much more likely to survive than women who do not get preventive surgery, U.S. researchers said on Tuesday.

The study shows the benefits of genetic tests that give women with a family history of cancer the chance to take steps to increase their chances of survival, they said.

“This is the first study to prove women survive longer with these preventive surgeries and shows the importance of genetic testing when there is a family history of early breast or ovarian cancer,” Dr. Virginia Kaklamani of Northwestern University in Chicago wrote in a commentary about the study published in the Journal of the American Medical Association.

Women with mutations in the BRCA1 or BRCA2 genes have a 56 to 84 percent higher risk of developing breast cancer during their lifetimes.

Those with the BRCA1 mutation also have a 36 to 63 percent higher risk of ovarian cancer and those with the BRCA2 mutation have a 10 to 27 percent higher risk of ovarian cancer.

Because of this, many women make the difficult choice to have their breasts or ovaries and fallopian tubes surgically removed to reduce their risk.

Dr. Susan M. Domchek of the University of Pennsylvania School of Medicine in Philadelphia and colleagues studied the effectiveness of these procedures, comparing rates of cancer and death in 2,482 women who had the surgery with those who decided against it in favor of frequent cancer screenings.

No woman who had a mastectomy developed breast cancer during the three years of follow-up testing.

Seven percent of women who decided against a mastectomy were diagnosed with breast cancer in the same period.

“Our results confirm that risk-reducing mastectomy is associated with a significant reduction in breast cancer risk,” Domchek and colleagues wrote.

Women with BRCA1 and BRCA2 mutations who had their ovaries and fallopian tubes removed had similar results.

About 10 to 20 percent of breast and ovarian cancers are due to BRCA1 or BRCA2 genes. “Most of these women will die of ovarian cancer, so you can save 20 percent of them with the prophylactic surgery,” Kaklamani said.

“And you can save the majority of women who would have died of their breast cancer,” she added.

She said primary care physicians, gynecologists and women “need to be more aware that these tests exist.”

Dr. Sandhya Pruthi, a breast cancer expert at the Mayo Clinic in Rochester, Minnesota, who counsels women with BRCA mutations, said the study adds more evidence that the surgery can help save lives, but the choice is never easy.

“It’s not cookie-cutter medicine,” Pruthi, who was not involved in the study, said in a telephone interview.

She said women need to come to terms with the psychological issues involved in having their breasts removed, and younger women who have their ovaries removed must contend with early menopause symptoms.

“It’s not a decision made on a single visit,” she said.

According to the American Cancer Society and the International Agency for Research on Cancer, 1.3 million new breast cancer cases are diagnosed around the world every year and it kills 465,000 women annually, making it the leading global cancer killer of women.

Source: Reuters

Popularity: 1% [?]

Only some epilepsy drugs may raise suicide risk

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While all epilepsy drugs carry a warning about an increased risk of suicidal behavior, it may only be certain newer medications that are connected to the hazard, a study published Monday suggests.

In a study of 44,300 UK patients who used epilepsy drugs between 1990 and 2005, researchers found an increased risk of suicide, attempted suicide or “self-harm” only among current users of certain newer medications that have previously been linked to a risk of depression.

Those drugs include topiramate (Topamax), tiagabine (Gabitril), levetiracetam (Keppra) and vigabatrin (Sabril).

The findings, published in the journal Neurology, add to a debate about the Food and Drug Administration’s decision, in 2008, to require all epilepsy medications to carry a warning about the risk of suicidal behavior.

The move arose from the findings of an FDA “meta-analysis” of 199 clinical trials testing 11 different epilepsy medications. That analysis, which combined the results of all the trials, found that patients receiving medication had a higher rate of suicidal thoughts and behavior during the study periods than those given a placebo — 0.4 percent, versus 0.2 percent.

The analysis was not, however, able to distinguish whether the risk was associated with any particular drugs. And critics argued that requiring all epilepsy medications to carry a suicide warning was too broad a measure, as the drugs are not all alike.

These latest findings offer some support for that contention. But they do not mean that the drugs implicated in this study are the only ones connected to suicide risk, according to the researchers and others who reviewed the study.

For one, the findings are based on a review of information from a database — a study design that cannot prove cause-and-effect.

Moreover, there were only a small number of documented suicides, suicide attempts or instances of self-harm (self-inflicted injuries without a clear intent of suicide), according to Dr. Frank Andersohn and his colleagues at Charite-University Medical Center in Berlin.

The researchers found 453 cases among all 44,300 patients, based on a UK database of electronic medical records.

They then attempted to look at the risk of suicidal behavior and self-harm according to different categories of epilepsy drug. Topiramate, tiagabine, levetiracetam and vigabatrin were grouped together as newer drugs with a “high” risk of depression — based on the fact that in clinical trials, more than 1 percent of patients using the drugs developed depression.

Another group included four newer medications considered to have a low depression risk: gabapentin (Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal) and pregabalin (Lyrica). The other two groups were barbiturates and older epilepsy drugs like valproate (Depakine, Epilim) and carbamazepine (Carbatrol, Tegretol).

Overall, the researchers found a three-fold higher risk of suicidal behavior or self-harm among current users of the group including topiramate, tiagabine, levetiracetam and vigabatrin, as compared with patients who had not used any epilepsy medication in the past year.

However, the numbers, again, were small.

There were only two cases each among current users of topiramate, levetiracetam and vigabatrin, and none among tiagabine users.

The findings, therefore, need to be “interpreted with caution” and confirmed in future studies, Andersohn and his colleagues write.

The results also differ from those of a study published in April in the Journal of the American Medical Association. In that study, researchers found that new users of gabapentin, lamotrigine, oxcarbazepine and tiagabine had a higher suicide risk than those on topiramate — one of the drugs linked to an increased risk in this latest study.

An editorial published with the study agrees that the research is a “good initial attempt” at looking at a complicated question, but more work is needed.

Epilepsy itself is linked to a higher-than-average risk of depression and suicide, pointed out Dr. Josemir W. Sander of the University College London in the UK, one of the editorial authors. That, he told Reuters Health in an email, can make it hard to “disentangle” the potential effects of epilepsy medications themselves.

“The fact that each study into this issue seems to come up with different answers just confirms my belief that this does not have an easy answer,” Sander said.

A limitation of the current study is that it lacked detailed descriptions of patients’ epilepsy type and any co-existing psychiatric disorders, according to Sander.

There is “no doubt,” he explained, that there are many different subgroups of people with epilepsy, and certain patients are more vulnerable to any increased risk of suicidal behavior linked to medications.

For now, Sander said, it is important for people with epilepsy to have a psychiatric evaluation before starting a new drug — a step the FDA has advised doctors to take.

Indeed, the key message for people with epilepsy is that the most important factor in their risk of suicidal thoughts or behavior is whether they have a history, or a family history, of depression or anxiety, according to Dr. Andres Kanner, a professor of neurological sciences at Rush Medical College in Chicago, and chair of the American Epilepsy Society’s task force on the psychiatric aspects of epilepsy.

Certain epilepsy medications may facilitate the development of suicidal thoughts and behavior in vulnerable people, Kanner told Reuters Health, but any risk linked to a drug itself would be small.

“Make sure your doctor knows if you have a history of depression or anxiety,” Kanner advised, noting that that includes a personal or family history. The doctor can then consider that in the overall management of a patient’s epilepsy.

Going forward, Sander said there remains an “urgent” need for clinical trials looking at individual epilepsy drugs in different subgroups of patients, to get a clearer picture of each medication’s full risk “profile.”

The study was funded by drugmaker Bayer Schering Pharma, and two co-authors on the work have served as consultants for Novartis and Sanofi-Aventis — makers of two of the medications not linked to suicide risk in this study.

Sander and his co-author on the editorial have ties to several makers of epilepsy drugs — including ones that were and were not linked to suicide risk in this study. The companies include UCB (maker of Keppra), Pfizer (Neurontin) and GlaxoSmithKline (Lamictal).

Kanner has also received research support from various companies that make epilepsy drugs.

Source: Reuters

Popularity: 4% [?]

Study highlights suicide risk associated with anticonvulsants

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The safety of anticonvulsant drugs is being highlighted again after the publication of a study in the Journal of the American Medical Association that found that some of these medicines might be linked with a higher risk of suicide. “This exploratory analysis suggests that the use of gabapentin, lamotrigine, oxcarbazepine, and tiagabine, compared with the use of topiramate, may be associated with an increased risk of suicidal acts or violent deaths,” the study’s abstract notes. Pfizer sells gabapentin as Neurontin, while Novartis sells oxcarbazepine as Trileptal.

The researchers, headed by a team from Brigham and Women’s Hospital in Boston, looked at data in patients aged 15 years and older who began taking anticonvulsant therapy between July 2001 and December 2006 to assess the risk associated with individual drugs. The study identified 26 completed suicides, 801 attempted suicides, and 41 violent deaths in the 297,620 new episodes of treatment. “Gabapentin users had increased risk in subgroups of younger and older patients, patients with mood disorders, and patients with epilepsy or seizure when compared with carbamazepine,” the abstract notes.

However, the study was not large enough to draw any deeper conclusions on the scale of risk between these drugs. Risks were “pretty much even” among these medicines, and “it’s not easy to draw conclusions about which one is the most risky,” researcher Elisabetta Patorno tells Reuters.

But Ewald Horwath, professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, says the study’s findings may be somewhat misleading. He said it failed to place enough weight on why patients were being treated with these drugs in the first place, and pointed out that many were taking the anticonvulsants for bipolar disorder and depression, illnesses which are themselves “associated with higher suicide rates,” reports HealthDay news.

In 2008, the FDA mandated warning labeling for anticonvulsant medications regarding the increased risk of suicidal thoughts and behaviors. The decision was based on a meta-analysis not sufficiently large to investigate individual drugs.

Source: FiercePharma

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Gene variant protects against Alzheimer’s: study

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People with a gene linked to long life and good health are also less likely to develop Alzheimer’s disease, U.S. researchers said on Tuesday.

They said people with two copies of a certain version of the cholesteryl ester transfer protein or CETP gene had significantly slower memory declines compared with people who had different versions of the gene.

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“We’ve known for a long time that genetic factors matter in Alzheimer’s disease,” said Dr. Richard Lipton of Albert Einstein College of Medicine at Yeshiva University in New York, whose study appears in the Journal of the American Medical Association.

Lipton said most studies have sought to identify genetic variations that increase the risk of developing Alzheimer’s disease, such as APOE4.

“Instead, we looked for genes that protect against Alzheimer’s disease, and also for genes that might promote healthy brain aging,” Lipton said in a telephone interview.

An estimated 26 million people globally have Alzheimer’s disease, the most common form of dementia. The disease starts out with mild memory loss and confusion but escalates into complete memory loss and an inability to care for oneself.

Lipton’s team examined a variant of the CETP gene that is already associated with exceptional longevity and cardiovascular health.

They analyzed the DNA of more than 500 people who did not have dementia at the start of the study. The team also did annual memory tests.

After at least three years of follow up, 40 people developed dementia.

“We found in people who carry the longevity variant of CETP, there was a 70 percent reduction in the risk of Alzheimer’s disease, and the rate of annual decline on tests of memory was much lower,” Lipton said.

“That proved our hypothesis that at least this genetic variant associated with longevity was also associated with successful brain aging and protected against the onset of Alzheimer’s,” he said.

It is not exactly clear how this gene could protect the brain, but Lipton said people with the longevity variant of the CETP gene tend to have high levels of high density lipoprotein or HDL, the so-called “good” cholesterol that protects against heart disease.

“One possibility is the longevity gene promotes successful brain aging by preventing vascular disease,” he said.

Or, he said, the gene may have a direct protective effect against Alzheimer’s.

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“Understanding the mechanism would allow you to discover drugs that mimic the genetic defect,” Lipton said.

Drug companies are already targeting the CETP gene in the hopes of raising levels of HDL or good cholesterol. Pfizer’s drug torcetrapib showed early promise, but the drug had excessive side effects, and Merck & Co now has a drug in late-stage clinical trials.

Despite decades of research, doctors still have few effective treatments for Alzheimer’s disease, which is expected to affect 100 million people by 2050.

Source: Reuters

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Study: Drugs work best for severe depression

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Yet another study is calling the efficacy of antidepressants into question. New research published in the Journal of the American Medical Association suggests that only patients with severe depression truly benefit from the drugs. Those suffering from mild to moderate depression get little or no help from those drugs, and that help may simply be due to seeing a doctor, learning about depression, and other circumstances, the researchers conclude.

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What about all those studies that show antidepressants work better than placebo? You know, the studies that helped these drugs get approved? Well, the researchers told the Los Angeles Times that many studies only include patients with severe depression. “[T]here is a tendency to generalize the findings to mean that all depressed people benefit from medications,” lead author Robert J. DeRubeis of the University of Pennsylvania said.

The researchers looked at six randomized, controlled studies with a total of 718 patients, who were adults with levels of depression ranging from mild to very severe according to a common depression-rating scale. Scores on that scale at the beginning of the study and at the end were compared. Very severely depressed patients who took antidepressants had a significantly larger improvement in their scores than did very severely depressed patients who took placebo. But mildly to moderately depressed patients using placebo saw about the same improvement as those who took the drugs.

Other studies have come to similar conclusions. But as the Wall Street Journal Health Blog points out, this doesn’t necessarily mean that antidepressant drugs don’t work in mildly depressed folks. It may just mean that placebo works against mild depression, too.

Source: FiercePharma

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Zyprexa, Seroquel expanded to teenagers

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The FDA has approved the use of Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel in teenagers with schizophrenia and bipolar disorder. But the agency will be looking for more data on the side effects of these antipsychotics, and whether those side effects are worse in teenagers then they are in adults.

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Antipsychotics are already linked to an increased chance of weight gain and diabetes. And next week an FDA advisory panel will discuss what additional warnings will be necessary for use of the drugs in pediatric patients. A study published last month in the Journal of the American Medical Association found that kids on certain antipsychotics added 8 percent to 15 percent to their body weight in less than 12 weeks on the drugs. Pediatric patients on Zyprexa put on the most weight, but patients on several other drugs in the same class gained at least some weight. Given the significant side effects, the FDA will surely have more to say on the matter.

As part of the approval, the FDA said that the antipsychotics should be part of a comprehensive treatment program, which may include psychological, educational and social interventions. Antipsychotics were the best-selling class of drug in 2008, with $14.6 billion in sales.

Source: FiercePharma

Popularity: 3% [?]

Glaxo Curbs Funding to Commercial Medical-Education Programs

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Against a backdrop of continued scrutiny about drug makers’ influence on doctors and medical education, GlaxoSmithKline announced today that it will no longer fund so-called medical-education programs offered by commercial providers.

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Instead, beginning in 2010, it will fund only independent medical education programs “that are clearly designed to close gaps in patient care, and that demonstrate support for the optimal performance of healthcare professionals,” according to a company statement. This means only academic medical centers with “strong track records for delivering high quality programs” will receive future funding, the company adds on its blog.

Drug company funding of continuing medical-education programs hit $1.2 billion in 2006, raising concern about some doctor groups, including the American Medical Association, which has been trying to come up with a new ethics policy that would limit industry influence on continuing education for doctors.

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Glaxo, like other pharmaceutical companies, have been making efforts to increase transparency by capping payments to physicians and reporting those payments publicly. It has also limited political donations.

Source: The Wall Street Journal

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Serotonin Gene’s Link With Depression Not Valid, Says Study

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A gene long thought to be a risk factor for depression when combined with environmental stress doesn’t appear to be associated with increased depression risk after all. That’s the finding of research published in the Journal of the American Medical Association that analyzes pooled data from 14 different studies.

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A highly publicized paper published in 2003 showed that individuals with a version of a serotonin-system gene, 5-HTTLPR, who experienced more life stressful life events had greater risk of depression.

Since then, many scientists have devoted themselves to studying that gene and to research that examines the interaction between genes and environment on mental illness. One company began offering a test of the gene to measure one’s likelihood of getting depressed and clinicians have wondered if they should test their patients as well.

But the finding hadn’t been properly replicated, say the authors of the JAMA study, prompting the team to conduct the meta-analysis.

“One of the concerns of the research team that we raise [in the paper] is that this needs to be much more carefully filtered before it’s used for prime time with the public,” study author Kathleen Merikangas, referring to the genetic findings, told the Health Blog. Merikangas is a senior investigator at the National Institute of Mental Health.

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The researchers took data from 14 previously published studies, recoded and re-analyzed them according to the same criteria as the 2003 study. The results showed there was no relationship between the gene, stressful events and risk of depression, nor between the gene and depression itself.

“We do not see that there is evidence for the interaction between the serotonin transporter gene, stressful life events and depression,” Merikangas told the Health Blog. The focus on this particular gene and environment interaction “is somewhat of an oversimplification of the very complicated pathways that lead to both clinical depression and depression that is a human emotion,” she said.

Merikangas said that the research team hopes researchers will “think more carefully” about studying gene and environmental interaction.

Avshalom Caspi, a Duke professor and one of the authors of the original 2003 study, told the Health Blog in an email that the new JAMA study ignores scientific evidence that indeed shows that the carriers of the gene are excessively vulnerable to stress and “misrepresents” some other studies. Also, he said that the findings in the meta-analysis vary widely and that the quality of the individual studies varies as well.

“What is needed is not less research into gene-environment interaction … but more research of better quality, and a more thorough and thoughtful evaluation of it,” Caspi wrote in his email.

Source: The Wall Street Journal

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The FDA’s Big Bad Wolfe

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The new drug safety czar brings dangerous ideas.

Since Barack Obama was elected, there has been much hopeful talk about addressing this country’s health care problems. Unfortunately, some of the ideas discussed have been bad ones and, therefore, will have predictably bad consequences.

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Consider the FDA’s recent appointment of Dr. Sidney Wolfe to a four-year post at its Drug Safety and Risk Management Committee. Wolfe comes from Public Citizen, a group Ralph Nader founded.

What spurred Wolfe’s appointment were three ideas: (1) drugs are either safe or dangerous, and dangerous ones should be kept off the market, (2) the FDA doesn’t do enough to assure that the drugs we use are safe and (3) the FDA is too close to the pharmaceutical industry.

All three ideas are dead wrong.

Over the last few decades, Wolfe has helped drive 16 drugs from the market. One of these, Propulsid (cisapride), activates electrical rhythms in the stomach to help push food through the digestive tract.

It was found to have killed 80 heartburn patients due to an irregular heartbeat and, therefore, pulled from the market. Does that mean Wolfe did the right thing? Not if you talk to the cerebral palsy patients Propulsid allows to digest food without extreme pain.

Drugs, even the maligned thalidomide, aren’t all good or bad; after being found to cause birth defects in the ’50s and ’60s, thalidomide has been FDA approved and back on the market for a decade. Wolfe needs to learn that a poison for one person may be a lifesaver for another.

The FDA isn’t weak on safety. The problem is that some drugs expose safety issues only after being on the market for years, long past the FDA’s review and approval process. Critics think this implicates the FDA.

A 2002 Associated Press story illustrated their point of view: “One in five new drugs has serious side effects that do not show up until well after the medicine has received approval, according to a study that exposes what one researcher calls an alarming game of medical Russian roulette.”

The unstated implication is that the FDA could and should approve only safe drugs. How are drugs deemed safe? Well, only by long-term usage by many millions of patients. Wolfe even admits this. But giving drugs to a large number of patients for long-term use before they are proven safe is deemed by some to be “Russian roulette.”

So we have a Catch-22. The only feasible alternatives are never to use any new drug or to use new drugs that may have problems that will show up only after lots of experience. Which is better: the possibility of health or the guarantee of illness?

The FDA has taken a “better safe than sorry” approach and Wolfe will forge an even “safer” approach. Wolfe and the FDA shouldn’t forget who the real enemy is: disease.

One single disease, lung cancer, kills more Americans each year than the combined U.S. casualties from combat in the Revolutionary War, the War of 1812, the Mexican War, the Spanish-American War, World War I, the Korean War, the Vietnam War and the Persian Gulf War.

A lung cancer victim dies every few minutes. And cancer is just one of the threats. There is also heart disease, stroke, infectious diseases, pneumonia, diabetes, Alzheimer’s and influenza, among others. The biggest killer is heart disease, which kills more Americans each year than the combined U.S. combat casualties in all wars.

In total, these diseases kill about two million Americans a year. Is it prudent for the FDA to be so cautious when four Americans–your parents, your friends, your neighbors–are dying each minute?

What about the FDA being too close to industry? To those of us who study the pharmaceutical industry, this claim is absurd.

If the FDA is so close to industry, why are so many good drugs being rejected? We’re referring to drugs that are similar to drugs now on the market, and to drugs that were approved years ago by scores of other developed countries. How can we explain that, from 1963 through 2003, while pharmaceutical research and development expenditures grew by an inflation-adjusted factor of 20, the number of new drugs approved each year in the U.S. only doubled?

Why does the FDA miss 20% of PDUFA dates, the promised approval or rejection dates as required by the Prescription Drug User Fee Act? Why is the FDA so capricious and inscrutable?

Another popular misconception is that the FDA and its outside advisers have pro-industry conflicts of interest. Interestingly, despite his own claims, one of the people who showed this to be a non-issue was none other than Sidney Wolfe.

In a 2006 study looking at supposed conflicts of interest in which advisers to the FDA had ties to industry, Wolfe and four other authors published an article in the Journal of the American Medical Association that drew on 76 product-specific meetings of FDA advisory committees that involved yes or no votes on individual drugs.

Their findings? None of the 76 voting outcomes would have changed had voters with supposed conflicts of interest been excluded. That didn’t stop the authors from making a conclusion that contradicts their findings: “Ideally, all panels of scientific experts advising a federal decision-making body would be free of financial conflicts of interest with the affected companies.” So much for the scientific method.

Wolfe is so antagonistic toward the pharmaceutical industry and new medicines that a drug-safety advocate once asked, “Is there any drug Sid Wolfe likes?”

The biases the FDA and the American people should be wary of are those that prevent good decision making. Ties to industry aren’t a problem. Sidney Wolfe’s bad ideas are.

Source: Forbes

Popularity: 4% [?]

Some breast cancers may clear up without treatment: study

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A significant portion of invasive breast cancers may regress on their own without treatment, a new study that is bound to provoke controversy suggests.

The study, published Monday in the journal Archives of Internal Medicine, suggests breast cancer screening may be leading to over diagnosis of cancer, with upwards of 22 per cent of cases likely to resolve themselves without treatment.

Once a breast cancer is found, it wouldn’t currently be considered ethical not to treat. So — if the theory is correct — large numbers of women may be having surgeries, radiation, chemotherapy and other treatments that would never have been needed if their cancers hadn’t been detected.

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“If we are right, then this is a kind of paradigm shift,” said lead author Dr. Per-Henrik Zahl, a senior statistician with the Norwegian Institute of Public Health.

Zahl, who admitted he has been trying to get the study published for about four years, said the risks of over diagnosis of breast cancer are real.

Radiation can do significant and permanent damage to the heart and coronary arteries. Chemotherapy can cause cognitive confusion. And surgery that involves the removal of lymph nodes can cause lymphedema, the painful swelling of the arm closest to the involved breast.

Dr. Patrick Remington has been studying the idea of self-limiting breast cancers since the early 1990s, when the introduction of breast screening programs showed a sharp and sustained increase in the incidence of the disease in the United States. He is convinced some invasive breast cancers do regress; they have become known as LMPs or cancers of “limited malignant potential.”

“I would say a very good guess would be about one out of three women have cancers detected today that would not have progressed otherwise,” said Remington, a professor of population health sciences at the University of Wisconsin. Remington was not involved in this study.

He notes some other types of cancers — prostate and recently lung — have been shown to spontaneously regress in some patients.

In the case of prostate cancer, some physicians urge an approach known as watchful waiting, where patients are monitored to see if their disease is progressing; only then is it treated. That approach is not currently an option with breast cancer.

Several journals refused to publish study

Zahl’s findings are likely to spark heated debate. In fact, he acknowledged several journals refused to publish the study before it was accepted by Archives of Internal Medicine, a journal published by the American Medical Association.

An editorial in the journal stressed that the findings are consistent with several observations about breast cancer that have troubled investigators for years.

And the editorial’s authors, Dr. Robert Kaplan of the UCLA School of Public Health and Dr. Franz Porzsolt of Germany’s Clinical Economics University of Ulm, said the hypothesis of breast cancer regression, while counterintuitive, is “difficult to rule out.”

“We know from autopsy studies that a significant number of women die [from other causes] without knowing that they had breast cancer,” they noted.

Dr. Steven Narod, a leading breast cancer researcher at Toronto’s Sunnybrook Health Sciences Centre, agreed the findings are persuasive.

Some breast cancers disappear on their own

“I do agree with them that the best explanation of the findings is that about 10 to 20 per cent of the breast cancers … disappeared on their own,” he said.

“I’m still a bit skeptical and there’s alternative explanations, but I think this one is worth paying attention to.”

In what Narod described as an “elegant” study design, Zahl and his colleagues used the introduction of a breast cancer screening program in Norway to explore the question.

They compared breast cancer rates among nearly 120,000 women who had three rounds of mammography between 1996 and 2001 to those among nearly 110,000 women of the same age range (50 to 64) in the five-year period preceding the start of the breast cancer screening program. Those women, known as the controls, had one mammogram.

In statistical terms, the two groups of women were identical. Their educational profile was closely matched, they had roughly the same average family income and the same average number of children. So the rates of cancers in the two groups should have been equal.

In fact, the women who hadn’t been regularly screened had 22 per cent fewer breast cancers.

The authors explore a number of arguments about why that might be. They noted for instance that use of hormone replacement therapy in the part of Norway where the women lived increased substantially between 1996 and 2001, the period when the screened women were undergoing regular mammograms. HRT use is linked to increased risk of breast cancer.

Looking for an explanation

But the authors conclude none of the potential other explanations could account for such a large difference between the two groups.

“All the caveats that could be explored have been explored in terms of accounting for the things that people would call … weaknesses” of the study, agreed Dr. Cornelia Baines, a professor in the University of Toronto’s school of public health and co-principal investigator of a landmark study into mammography, the Canadian National Breast Screening Study.

Baines, who has been diagnosed with breast cancer that was earlier missed in a mammogram, said the findings are important.

But she added that even if Zahl and his co-authors are correct, there’s no way currently to put the findings into application.

“The incontrovertible truth is that once you’ve screened a woman and you find an abnormality, you have to biopsy,” she said.

“If you biopsy, you have to follow through with surgery if the biopsy reveals malignant tissue. You can’t stop that. You can’t say: ‘Well, I’ve been screened and there is a chance that this is over diagnosis.’ You can’t do that.”

No scientific reason for why cancers regress

Finding ways to answer the questions raised by the study will be difficult, experts said. Remington noted even if doctors could differentiate, women and-or their health-care professionals might still opt for treatment to play it safe.

He suggested, though, studying women whose cancers regress on their own could teach scientists how to trigger the same response in women whose cancers aren’t self-limiting, and maybe even to prevent breast cancer from developing.

In the meantime, Baines said, this study may serve as an important reminder to women and the medical community.

“What is important and it seems to me it’s been ignored for a long, long time is that …screening doesn’t only have upsides. It has downsides,” she said.

“And if women want to accept the downsides and proceed with screening, then that’s great. But I personally believe that they should only make that choice when they are fully informed. And a lot of them have not been fully informed about the over diagnosis scenario.”

Source: cbcnews.ca

Popularity: 6% [?]

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