Tagged Clinical Trials

Seniors Miss Out On Clinical Trials

More than 60 percent of cancer patients are older adults — and that will rise to 70 percent by 2040.  Yet seniors continue to be underrepresented in clinical trials, making it difficult to assess how treatments are likely to help or harm them.

The newest evidence of the problem comes from a Food and Drug Administration analysis, which found that only 25 percent of patients participating in cancer clinical trials were 65 and older. The analysis, which has not yet been published, was presented at the American Society of Clinical Oncology’s annual meeting in June.

Clinical trials investigate the safety and effectiveness of new drugs and therapies, as well as ways to prevent illness and detect conditions early. Their discoveries help guide medical practice.

Yet, older adults are often not included in research studies to any significant extent. This is especially true for cancer patients in their 70s and 80s, according to the FDA’s data:

  • While 19 percent of breast cancer patients are 75 or older, only 4 percent of breast cancer clinical trial participants are of this age.
  • Although 33 percent of colon cancer patients are in the 75-and-up group, a mere 8 percent of patients studied by researchers fell in that age group.
  • While 37 percent of lung cancer patients are 75 or older, only 9 percent of people of that age are represented in lung cancer clinical trials.

The sobering conclusion: “It’s difficult to practice evidence-based medicine in an older population because the data isn’t there,” said Dr. Stuart Lichtman, professor of medicine at Weill Cornell Medical College in New York City and president of the International Society of Geriatric .

And it’s not just cancer. Across medical conditions that disproportionately affect seniors, people 65 and older have a poor showing in clinical trials.

“There’s often an assumption that drugs only need to be tested in younger people and results can be extrapolated,” said Dr. Consuelo Wilkins, an associate professor of medicine at Vanderbilt University Medical Center who, with colleagues, is overseeing a major grant to help bring more seniors,  blacks, Hispanics and other groups into clinical trials. “But we know that how older adults respond to medications and interventions and their risk for adverse events is different based on their physiology.”

Difficulties enrolling older people in research studies extend to Alzheimer’s disease. With National Institutes of Health research funding now at nearly $1.4 billion a year, “we’re going to be seeing more and more clinical trials, but it’s already difficult to get enough people to participate,” said Keith Fargo, director of scientific programs at the Alzheimer’s Association.

Fewer than one-third of people diagnosed with Alzheimer’s are eligible to join clinical trials, he said.

Judith GrahamNAVIGATING AGING

Researchers often find older adults unsuitable for trials for multiple reasons:  Seniors may have multiple illnesses — diabetes and hypertension, as well as cancer or Alzheimer’s disease — that could complicate the study’s results, or they may be taking several medications already that could interact with therapies being examined.

Also, older adults may live alone, and not have someone who can accompany them to the study site for tests and procedures — a significant concern for Alzheimer’s trials, which typically require a caregiver to provide input about the patient’s condition and progress. Or, seniors can’t get around easily. Or they’re frail.

Responsibility falls to a large extent on physicians, said Dr. Richard Schilsky, chief medical officer for ASCO, noting “they don’t ask older adults whether they want to participate or not. It’s a combination of concern that older patients might be unable to comply with a trial’s requirements, which are usually quite rigorous, and concern that specified therapies might be too toxic.”

Two years ago, ASCO issued new recommendations calling for older adults to be included in more clinical trials. But progress has been slow, acknowledged Dr. Hyman Muss, director of geriatric oncology at the Lineberger Comprehensive Cancer Center at the University of North Carolina-Chapel Hill.

“My view is that every patient I see, if they’re eligible for a clinical trial I’ll tell them about it,” he said.

Don’t assume your doctor will be equally forthcoming. “Absolutely, you should take the initiative and ask,” Schilsky recommended. And don’t assume you need to have run out of options before doing so. “Clinical trials aren’t just for people who have no treatment options left — that’s a common misconception,” Schilsky said.

Debbie Earp, 67, joined a trial at the Lineberger this year, after getting a diagnosis of stage 2 breast cancer in early January. Her responsibilities over the four-month study: wearing a Fitbit, tracking how much exercise she was getting on a daily basis, and filling out a questionnaire about how she was feeling each time she got chemotherapy.

Earp said she agreed to participate because “I’ve always exercised and I felt, from a physical and psychological point of view, anything that was going to motivate me during treatment to exercise more would be a good idea.” The goal of the trial was to examine how physical activity affects older breast cancer patients’  response to chemotherapy.

Of course, clinical trials aren’t for everyone. Some older adults are reluctant to consider them because they’re skeptical of unproven therapies. Others may choose to focus on their quality of life instead of aggressive treatments.

There are good resources about clinical trials on the internet, if you know where to look. The National Institute on Aging has prepared materials for older adults, including a list of questions that seniors should ask before deciding whether to join a trial. The FDA has a patient-oriented site that delves into issues such as informed consent — making sure you’re fully informed about the potential benefits and harms of a research study, among other essential information.

For those who want to look for trials on their own, the NIH sponsors ClinicalTrials.gov, a database of studies across the world, searchable by disease and geography. Trials Today is an effort to make the NIH site more consumer-friendly, created at Vanderbilt University. ResearchMatch is another Vanderbilt effort where people who want to participate in studies can sign up and be matched with clinical trial sponsors. And TrialMatch is a one-stop-shop for clinical trials for people with Alzheimer’s disease, their caregivers, and people interested in preventing dementia, currently listing nearly more than 250 scientific studies.

Make sure you run whatever prospects you find by your doctor. “Very few patients have the expertise to understand if a clinical trial is appropriate for them,” Schilsky said. “You really need an expert opinion to help you understand what you find.”

Categories: Aging, Navigating Aging, Pharmaceuticals

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FDA Ruling On Aussie Biotech Could Boost Congressman’s Investment

An Australian biotech company whose largest shareholder is a U.S. congressman has the greenlight to begin human trials in the U.S. for a drug to treat advanced multiple sclerosis.

The Food and Drug Administration’s decision is the first step in a long approval process demonstrating a new drug’s safety and effectiveness before regulators allow it to go on the market. In Innate Immunotherapeutics’ case, it could help the company achieve its stated goal of striking a merger or partnership deal with a larger drugmaker.

Drugs to treat multiple sclerosis, which are taken for life, are some of the most expensive offerings in the U.S., costing about $5,000 a month, or $60,000 a year.

Regulators’ action “means you can do clinical studies. It doesn’t increase the likelihood of approval and it doesn’t mean the FDA is inclined to approve the drug,” said Ken Kaitin, director of the Tufts Center for the Study of Drug Development in Massachusetts.

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Rep. Chris Collins (R-N.Y.), who owns a 16.8 percent stake of the company, is also a member of Innate’s board. The Buffalo-area representative has helped draw other U.S. investors into Innate, including political donors and others with whom he has personal or professional connections.

The Office of Congressional Ethics is investigating Collins’ role, The Buffalo News reported last month.

Innate drew intense public scrutiny earlier this year after Health and Human Services Secretary Tom Price — previously a Republican member of Congress from Georgia — was identified as a shareholder after President Donald Trump nominated him to head up the department that includes the FDA. Price said he learned about the company from Collins.

The secretary sold his shares after he joined HHS.

CEO Simon Wilkinson said the company hopes the FDA will recognize the preliminary trials that Innate has done in other countries so that it can begin late-stage trials in the U.S.

Since the agency did not have any jurisdiction over those trials, it might require Innate to conduct early-stage research in this country, Kaitin said.

“The FDA can basically do whatever they want in this case,” he said.

Innate’s most recent trial, which included 93 participants in Australia and New Zealand, finished in April, and the company expects to announce the results by September.

Innate’s shares rose about 2 percent in Australian trading Wednesday after the company announced the FDA decision.

Categories: Health Industry

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Pursuing the Dream of Healthy Aging

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Credit Paul Rogers

Given their druthers, most people would opt for a long and healthy life. Few relish the idea of spending years, even decades, incapacitated by illness, dependent on caregivers and unable to enjoy the people, places and activities that make life worth living.

In 1980, Dr. James F. Fries, a Stanford University physician who studied chronic disease and aging, proposed that a “compression of morbidity” would enable most people to remain healthy until a certain age, perhaps 85, then die naturally or after only a brief illness.

Now, a prescient group of experts on aging envisions a route to realizing Dr. Fries’s proposal: one or more drugs that can slow the rate of aging and the development of the costly, debilitating chronic ailments that typically accompany it. If successful, not only would their approach make healthy longevity a reality for many more people, but it could also save money. They say that even a 20 percent cut in how fast people age could save more than $7 trillion over the next half-century in the United States alone.

“Aging is by far the best predictor of whether people will develop a chronic disease like atherosclerotic heart disease, stroke, cancer, dementia or osteoarthritis,” Dr. James L. Kirkland, director of the Kogod Center on Aging at the Mayo Clinic, said in an interview. “Aging way outstrips all other risk factors.”

He and fellow researchers, who call themselves “geroscientists,” are hardly hucksters hawking magic elixirs to extend life. Rather, they are university scientists joined together by the American Federation for Aging Research to promote a new approach to healthier aging, which may — or may not — be accompanied by a longer life. They plan to test one or more substances that have already been studied in animals, and which show initial promise in people, in hopes of finding one that will keep more of us healthier longer.

As Dr. Kirkland wrote in a new book, “Aging: The Longevity Dividend”: “By targeting fundamental aging processes, it may be possible to delay, prevent, alleviate or treat the major age-related chronic disorders as a group instead of one at a time.”

His colleague S. Jay Olshansky, a gerontology specialist in the School of Public Health at the University of Illinois in Chicago, said it is often counterproductive to treat one disease at a time. Preventing cardiac death, for example, can leave a person vulnerable to cancer or dementia, he explained.

A better approach, Dr. Kirkland said, would be to target the processes fundamental to aging that underlie all age-related chronic diseases: chronic low-grade inflammation unrelated to infection; cellular degradation; damage to major molecules like DNA, proteins and sugars; and failure of stem cells and other progenitor cells to function properly.

The team, which includes Dr. Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine in The Bronx, and Steven N. Austad, who heads the biology department at the University of Alabama at Birmingham, plans to study one promising compound, a generic drug called metformin already widely used in people with Type 2 diabetes. They will test the drug in a placebo-controlled trial involving 3,000 elderly people to see if it will delay the development or progression of a variety of age-related ailments, including heart disease, cancer and dementia. Their job now is to raise the $50 million or so needed to conduct the study for the five years they expect it will take to determine whether the concept has merit.

The project represents a radical departure from ordinary drug studies that test treatments for single diseases. However, the group, spearheaded by Dr. Barzilai, said the Food and Drug Administration has endorsed their idea to test a single substance for effectiveness against a range of ailments.

“If metformin turns out not to work, there are several other substances in the pipeline that could be tried,” Dr. Barzilai said. “Under the auspices of the National Institute on Aging, three research centers have tested 16 substances in different animal models and got incredible results with four of them.”

Green tea, one of those tested, bestowed no health or life span benefits, despite its popularity. But the drug rapamycin, an immune modulator used following organ transplants, was most effective among those tested, Dr. Barzilai said.

The team is starting with metformin because it is a cheap oral drug — costing about two cents a pill — with six decades of safe use in people throughout the world. Among those with Type 2 diabetes who have taken it for years, there is evidence suggesting that, in addition to diabetes, it protects against cardiovascular disease, cancer and possibly cognitive impairment, Dr. Kirkland said, adding that “it targets the fundamental processes of aging, which tend to be linked.”

Dr. Barzilai said, “Our goal is to establish the principle of using a drug, or two in combination, to extend health span. The best we can expect from metformin is two or three additional years of healthy aging. But the next generation of drugs will be much more potent.”

Dr. Barzilai is already conducting a complementary study of centenarians, the results of which could identify more drugs to delay age-related diseases. He and colleagues are isolating genes that appear to keep these long-lived men and women healthy for 20 to 30 years longer than other people and shorten the length of illness at life’s end. Several studies have already found that individuals with exceptional longevity experience a compression of morbidity and spend a smaller percentage of their life being ill, Dr. Barzilai and his colleague Dr. Sofiya Milman wrote in the “Aging” book.

By analyzing the action of genes that extend health span, “it should be possible to devise drugs that mimic the genes’ effects,” he said. Two such gene-based drugs that show early promise against age-related diseases are already being tested.

But until definitive studies are completed and substances are shown to be safe as well as effective in prolonging health, Dr. Olshansky cautioned against dosing oneself prematurely with widely touted substances like resveratrol, the antioxidant found in red grapes and wine, or growth hormone.

Consumers must exercise caution, he warned, because “there’s an entire industry out there trying to market the products we’re testing before they are adequately evaluated.”

He also emphasized that taking a drug found to ward off age-related ills is not a license to abandon a healthy lifestyle. Doing so “could completely negate the benefit of a compound that slows aging,” he said.

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