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Less than one-third of drug studies published in major medical journals answer the fundamental question of which of the range of available medications works best for a particular condition.

So concludes the first wide-scale look at so-called “comparative effectiveness” studies, where experts seek to determine which available medicine is likely to prove most cost-effective for patients. The findings are published in the March 10 issue of the Journal of the American Medical Association.

A focus on comparative effectiveness has been a hallmark of the federal government’s attempts to gain the most from scarce health-care dollars, and in 2009 Congress earmarked over $1 billion for this type of research.

But the new report found that just 32 percent of the 328 drug studies reviewed involved comparisons of medicines that were currently available. The rest involved either drugs in development, or they pitted available drugs against no treatment or a placebo. The studies appeared in six of the leading medical journals between June 2008 and September 2009.

“Research on new therapies is critical for scientific advancement, but we also need data that will help doctors use existing therapies appropriately,” study author Dr. Michael Hochman, of the Keck School of Medicine at the University of Southern California, explained in a news release from the Cambridge Health Alliance.

“We need research that addresses questions such as: Which of the more than 30 blood pressure medications on the market works best and in whom?” Hochman said. “Are certain diets and exercise regimens as good as medications for controlling cholesterol? Is it safe to aim for normal blood sugar levels when treating patients with diabetes? Such information is critical for day-to-day medical decision-making.”

Relatively few studies (11 percent) compared an existing drug to non-pharmacological interventions (for example, exercise/diet or surgery) and less than one-third focused on different medication approaches (for example, achieving an optimal blood sugar level in patients with diabetes).

“Most of the comparative effectiveness studies we reviewed simply tested whether medication ‘x’ is better than medication ‘y,’ rather than addressing fundamental questions such as: How can we use this medication more effectively? When is this medication better than surgery? Which among two effective approaches is the safest?” senior author Dr. Danny McCormick, primary care physician at Cambridge Health Alliance and assistant professor of medicine at Harvard Medical School, said in the news release.

Only 19 percent of the studies reviewed focused on drug safety, and just 2 percent provided data on cost-effectiveness, which would be of great help to patients, physicians and public or private insurers, the researchers noted.

Why do so few drug studies involve available medicines? According to the authors, most such trials are funded by pharmaceutical companies, which are more interested in getting new, marketable products on drugstore shelves. In fact, 90 percent of comparative effectiveness studies were funded by non-industry sources, such as non-profit foundations or governmental agencies.

“Many of our nation’s research priorities are driven by the pharmaceutical industry,” said Hochman, an assistant professor of clinical medicine at Keck. “These companies, not surprisingly, focus most of their attention on new therapies. If we hope to increase the amount and improve the quality of comparative effectiveness studies, the funding will most likely need to come from government institutions.”

SOURCE: Cambridge Health Alliance, news release.

Colon cancer survivors who are moderately or severely obese face tougher survival odds following treatment compared with their normal-weight peers, a new study reveals.

The finding builds on prior research that established that being obese raises the risk for developing colon cancer in the first place.

“Previous studies have shown that obesity does influence the risk of developing colon cancer, but this study takes it one step further,” said study author Dr. Frank A. Sinicrope, a professor of medicine and oncology at the Mayo Clinic in Rochester, Minn. “Because now we know that if you’re obese, you have a higher risk of cancer recurrence or death for patients who have established colon cancer.”

Sinicrope and his colleagues, whose work was funded in part by the U.S. National Cancer Institute, report their findings in the March 15 issue of Clinical Cancer Research.

The American Cancer Society estimates that last year more than 106,000 Americans were newly diagnosed with colon cancer, while nearly 50,000 men and women died from the disease.

To explore a potential connection between obesity and colon cancer survival, the authors analyzed data concerning 4,381 men and women who had been diagnosed with either stage II or stage III colon cancer. All of the patients had undergone both surgical removal of their cancer and subsequent chemotherapy.

Based on body mass index (BMI), which is a measurement that takes into account weight and height, the researchers determined that approximately 20 percent of the patients were obese (above 30 on the BMI chart). Among that group, about seven in 10 patients were classified as “moderately obese” (BMI between 30 and 34.9), while slightly more than one-quarter were “very obese” (BMI of 35 and up).

About 37 percent of the patients were normal weight (BMI of 20 to 24.9), while a similar number were deemed overweight (BMI of 25 to 29.9). Six percent were classified as underweight (BMI under 20).

Tracking all the cancer survivors for an average of eight years, Sinicrope and his associates observed that 36 percent went on to experience cancer recurrence, while 42 percent ultimately died.

Furthermore, the researchers found that, taken as a group, being either moderately or very obese was associated on average with a 19 percent increase in the risk for death, when compared with normal-weight cancer patients.

Although the pool of underweight patients was considerably smaller, the researchers found that the underweight group also had a much poorer survival rate than normal-weight patients. And while overweight patients actually seemed to fare slightly better (by 6 percent) than normal-weight survivors, Sinicrope indicated that more sophisticated obesity measurements that take into account muscle-mass ratios (not revealed by BMI) could yield slightly different results.

Gender differences were also apparent.

With a patient pool that was more or less evenly divided between men and women, the authors found that taken on their own, the most severely obese men faced the highest risk for cancer recurrence and death — tagged as a 35 percent increase, relative to normal-weight patients.

However, women on the lowest end of the obesity scale were linked to a 24 percent increased risk for death — a risk that actually dropped down to 11 percent as obesity rose.

“For now, we don’t really have a clear explanation for why the moderately obese women did worse than the very obese women,” said Sinicrope. “Menopausal status and hormone replacement therapy — which could be protective against colon cancer — could both be factors. But we don’t know which women were pre- or postmenopausal and which were taking this medication.”

As for what general underlying cause accounts for the obesity-survival risk connection, Sinicrope said the question remains unanswered. But he speculated that the association might result from the presence of higher insulin and insulin-like growth-factor-1 hormone levels in obese patients.

“We know the obese patients have higher levels of both these hormones, which have been associated with both obesity and colon cancer risk in the past,” he noted. “So we think that could be playing a role in this risk.”

A number of variables could explain the findings, said Dr. Joseph Martz, chief of the division of colorectal surgery at Beth Israel Medical Center in New York City.

“Obesity is often associated with a higher likelihood for diabetes and other diseases, and overall secondary immune dysfunction. And since colon cancer is somewhat of an immune disease, that is going to be a driving factor,” he noted.

“There is also a good deal of data already regarding the supportive benefit of exercise and activity after colon cancer treatment in terms of prognosis,” Martz added. “So I think that goes along with the concept that obese individuals are less likely to be in shape. Also, there may be some inherent surgical limitations that could compromise the technical ability to achieve complete removal of the cancer and the potentially affected lymph node tissues when operating on an obese person. All of this may play a role.”

On a related front, a separate study published this week in the Journal of the National Cancer Institute provides fresh evidence that being obese does appear to be linked to a higher risk for colon cancer.

However, the research team — led by Peter T. Campbell of the epidemiology research program at the American Cancer Society — also found that the obesity-survival link does not seem to hold for all tumors, but only for those that are so-called “microsatellite stable.” Obese patients who had this common type of tumor had lower five-year survival rates than obese patients with “microsatellite-high” tumors, suggesting that obesity has a varying impact on prognosis, depending on the kind of colon cancer at hand.

SOURCES: Frank A. Sinicrope, M.D., professor, medicine and oncology, Mayo Clinic, Rochester, Minn.; Joseph Martz, M.D., chief, division of colorectal surgery, Beth Israel Medical Center, New York City; 2010, Clinical Cancer Research

It may not be surprising, but a new study offers some proof that patients who are worried about their medications are more likely to have side effects from them.

The study involved patients with a particular kind of arthritis. While more research has to be done in patients with other illnesses to know for sure, “my guess would be that this is happening across a wide range of drugs,” Dr. Yvonne Nestoriuc of Philipps-University Marburg in Germany, the study’s lead author, told Reuters Health. “This is really something that happens in a lot of patient populations.”

While most medication side effects are not life threatening or seriously harmful, she and her colleagues note in the journal Arthritis Care & Research, they can still be “frightening and distressing” to patients, and can also lead to patients not taking drugs as recommended.

People with a variety of illnesses who don’t feel their medications are necessary and are concerned about their side effects are known to be less likely to take these drugs as directed, the researchers add.

To investigate whether these beliefs might be related to experiencing side effects as well, Nestoriuc and her team had 100 rheumatoid arthritis patients complete the Beliefs about Medicines Questionnaire, which explores general and specific beliefs about the necessity and risks of medication. Patients also reported on any side effects related to their rheumatoid arthritis medication and on how much they were bothered by these symptoms.

Rheumatoid arthritis is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. It affects some 20 million people, according to the National Rheumatoid Arthritis Society.

At the study’s outset, 77 of the patients reported having been bothered by side effects. Eighty-seven of the original 100 study participants were followed up at six months; 45 of these patients, or 52 percent, reported being bothered by side effects at this point.

The patients who had concerns about their medications, for example agreeing with the statement that “having to take arthritis medications worries me,” were more likely to have reported having side effects, both at the study’s outset and if they started a new drug during the six-month study period. Side effects typically included rashes, gastrointestinal discomfort, and headaches.

These patients were also more likely to report these side effects to their doctors, take non-prescription medications to deal with them, and change their medication dosages on their own. The only other factor that influenced the likelihood of reporting side effects was age.

Patients with rheumatoid arthritis “who are especially concerned about their arthritis medications, or who expect side effects, are at greater risk of experiencing them,” the researchers say.

“Starting a new drug is a specifically risky time because people tend to misattribute pre-existing bothersome but non-harmful symptoms as side effects of the new drug,” Nestoriuc said.

Doctors may be able to help their patients avoid side effects by talking with them about their concerns before prescribing a new medication, she added, and helping them to get a more “realistic view about the drugs.”

SOURCE: Arthritis Care & Research, online.

As many as one in six Americans is infected with herpes simplex virus type 2 (HSV-2), health officials said Tuesday.

HSV-2, one of the most common sexually transmitted diseases (STDs) in the United States, is a serious, incurable infection that lasts a lifetime, causing recurrent and painful genital sores, according to the U.S. Centers for Disease Control and Prevention.

“Preventing STDs is a public health challenge that we, as a nation, cannot afford to ignore,” Dr. Kevin Fenton, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, said Tuesday during a news conference.

The CDC estimates that 19 million new STD infections occur every year in the United States, almost half of them among young people, Fenton added.

“Young women, African Americans, and gay and bisexual men are especially hard hit,” he said. “It is unacceptable that STDs remain such a widespread public health problem in the United States today.”

The new findings on herpes, which were presented at the agency’s 2010 National STD Prevention Conference, represent data from the 2005 to 2008 National Health and Nutrition Examination Survey, which involves households from across the country.

The prevalence of HSV-2 has remained stable, at about 17 percent of the U.S. population, since the last survey, which was done from 1999 to 2004.

“This stabilization in herpes rates follows a period of declining prevalence, down from 21 percent for the years 1988 to 1994,” La’Shan Taylor, an officer with the CDC’s Epidemic Intelligence Service and author of the report, said during the news conference.

According to the report, women and blacks are the most likely to be infected. In fact, the prevalence among women was 20.9 percent, nearly twice that of men, at 11.5 percent.

Among blacks, 39.2 percent are infected, a rate more than three times that of whites, at 12.3 percent, according to the report. Black women had the highest prevalence of HSV-2, at 48 percent.

“As dark as these numbers are, they are not substantially different from CDC’s previous estimates of these populations,” Taylor said.

The report noted that women also are more susceptible to other sexually transmitted diseases and that the racial disparities found with HSV-2 may be due to more infections among blacks that make them more likely to be exposed to herpes.

The infection rates should also be considered serious because people with herpes are two to three times more likely to become infected with HIV and because having herpes makes it more likely that an HIV-infected person will give HIV to others, according to the CDC.

Taylor said the survey also found that the prevalence of herpes increases with age, from 1.4 percent among those aged 14 to 19 years to 26.1 percent among people aged 40 to 49. “This reflects the fact that, once you are infected with herpes, the infection is lifelong since no cure currently exists,” she said.

The prevalence of herpes was also higher among those who reported having many sex partners, Taylor said. About 4 percent of those with one lifetime sex partner were found to have herpes, compared with about 27 percent of those who reported having 10 or more partners.

In addition, more than 80 percent of people infected with herpes don’t know they are infected, Taylor said, in large part because symptoms can be mild or absent altogether. Symptoms also are often taken to be the sign of another infection.

But people with herpes infection can transmit it to others even if they have no signs of the disease, health officials stressed.

“This latest analysis emphasizes that we can’t afford to be complacent about this infection,” Dr. John M. Douglas Jr., director of CDC’s division of STD prevention, said during the news conference.

“It is important that we promote steps to prevent the spread of genital herpes, not only because herpes is a lifelong and incurable infection but also because of the linkage between herpes and HIV infection.”

Dr. David L. Katz, director of the Prevention Research Center at the Yale University School of Medicine, described herpes as a “bellwether for sexually transmitted diseases … because it suggests that other such exposures may have occurred and because it increases vulnerability when they do.”

“Unfortunately, we have no perfect defense against herpes since it cannot be cured and there is, as yet, no vaccine,” Katz said. Though he predicted that a vaccine would eventually be developed, increased diligence is needed in the meantime, he added.

That should include “heightened awareness among both clinicians and patients, routine dialogue on the topic in all primary care settings, guidance to all patients on prevention strategies and routine availability of condoms and other barrier contraceptive devices,” Katz said.

“The high prevalence of herpes, and the disparities with which it is associated, indicate we can do this job better and more equitably,” he said.

Though there is no cure for HSV-2, drugs can be effective in treating and preventing outbreaks, according to the CDC. However, the agency recommends not having sex during an outbreak, using condoms and limiting the number of sex partners.

Although the CDC does not recommend that people generally be screened for herpes, it says that those at high risk for the infection might want to be screened. They include people with multiple sex partners, those who are HIV-positive, and gay or bisexual men.

Another report presented at the STD conference focused on why young women, no matter what race, appear to be reluctant to be tested for STDs.

Heather Royer, of the University of Wisconsin-Madison, surveyed 302 women, 18 to 24 years old, about their beliefs about STD testing. She found that barriers to testing included:
The majority of women (88 percent) were uncomfortable being tested by a man.
Most women (79 percent) would prefer being tested by a specialist, not a family doctor.
Many women (62 percent) were generally anxious about being tested.
Some women (31 percent) were concerned that the test results would appear in their medical record.

In addition, many women had misconceptions about testing, Royer’s survey found. About 40 percent thought that one test could detect as many as eight STDs, though that is not the case; about one-third incorrectly thought that chlamydia and gonorrhea could be found simply by visual inspection; and 25 percent mistakenly believed that a Pap smear could detect chlamydia and gonorrhea.

Moreover, women who said they were embarrassed to talk about sex with their doctors or fill out questionnaires about their sexual history were twice as likely to have never had an STD test, the survey found.

To reduce the stigma of STDs, Royer said that doctors should be encouraged to make sexual history part of routine care for young women.

SOURCES: David L. Katz, M.D., director, Prevention Research Center, Yale University School of Medicine, New Haven, Conn.; 2010, teleconference with: Kevin Fenton, M.D., Ph.D., director, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, U.S. Centers for Disease Control and Prevention; La’Shan Taylor, Dr.P.H., officer, Epidemic Intelligence Service, CDC; John M. Douglas Jr., M.D., director, division of STD prevention, CDC; 2005-2008 National Health and Nutrition Examination Survey, CDC