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Oncological pies in the sky

This just in from the Hastings Center, which deals with bioethics and public interest issues…

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Unrealistic Optimism Appears Common in Early Cancer Trials

Study suggests it may compromise informed consent

GARRISON, N.Y.—Can optimism be ethically problematic? Yes, according to a new study, which found unrealistic optimism prevalent among participants in early-phase cancer trials and suggested that it may compromise informed consent.

Many cancer researchers and ethicists assume that hope and optimism in the research context are “always ethically benign, without considering the possibility that they reflect a bias,” write the authors of the study, which appears in IRB: Ethics & Human Research. “Others have claimed that unrealistic expectations for benefit are a result of misunderstanding and that the proper response to them is to provide patient-subjects with more information…” But the study cast doubt on both assumptions.

The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009. Questionnaires assessed signs of unrealistic optimism, as well as participants’ understanding of the trials’ purpose. Unrealistic optimism, which social psychologists define as being specific to a situation and consider a form of bias, is distinct from “dispositional optimism,” which is a general outlook on life and is neither realistic nor unrealistic. Individuals can have one form of optimism without the other.

Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials.

However, a substantial majority of the respondents – 72 percent – accurately understood that the purpose of the trials was to advance knowledge with the potential to benefit future patients and not necessarily to benefit them. Misunderstanding the purpose was not significantly related to unrealistic optimism, the study found.

The authors said that unrealistic optimism has the potential to compromise informed consent “by interfering with the ability to apply information realistically.” They concluded: “Improving the consent process in oncology research will require us to do more than address deficits in understanding. It will require us to pay more attention to how patient-subjects apply information to themselves and to become more aware of the social-psychological factors that might impair decision-making in this context.”

The authors are Lynn A. Jansen, PhD, of Oregon Health and Sciences University; Paul S. Appelbaum, MD, of Columbia University; William M.P. Klein, PhD, of the National Cancer Institute; Neil D. Weinstein, PhD, of the University of Arizona College of Medicine; Jessica S. Fogel, BA, of Columbia University; and Daniel P. Sulmasy, MD, PhD, of the University of Chicago.

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January 24, 2011 Posted by | Academia & Non-Profit, Corporate | , , , | Leave a comment

Report: Cancer diagnostics market could hit $90 million by 2014

In our October issue, we’re continuing our special report series on trends in cancer research. This month, which is the third installment of a five-part series, discusses the challenges and rewards of developing companion diagnostics for cancer treatment.

To view the story, see “Two are better than one.” We also take a look at recent developments in the field of biomarker research in our story, “Biomarkers: How Good a Test Are They?”

Cancer treatment is one area where the era of personalized medicine is arriving, according to market research publisher Kalorama Information. In its recent report, “The Worldwide Market for Cancer Diagnostics,” Kalorama predicts a $90 million market for pharmacodiagnostics, tests that determine whether a treatment matches the individual patient, by 2014.

According to the report, the information gleaned from the Human Genome Project and pharmacogenomics research by the drug industry is making possible individualized drug therapy based on the genetic makeup of a patient. The concept has been talked about for some time, but Kalorama notes in its biennial review of the cancer testing market that with five U.S. Food and Drug Administration (FDA)-approved test and treatment products, including tests for Herceptin, Gleevec, Erbitux and Tarceva, and with many others in development, pharmacodiagnostics has moved beyond the concept phase.

“Personalized medicine is not occurring overnight, but it is occurring,” says Shara Rosen, lead diagnostic analyst for Kalorama Information. “More and more physicians are using these tests, and more pharma companies are getting involved and looking to in-vitro diagnostic (IVD) companies for biomarker tools.”

The report says that while personalized medicine strategies are not new—it’s been eight years that Herceptin package inserts have labeled tests for therapy-responsive patients—the increase in drug and test development points towards greater utilization of these products.

According to Kalorama, histopathology IVD companies Dako, Ventana Medical, Roche Diagnostics and Third Wave Technologies (acquired by Hologic in 2008) lead the market with FDA-cleared tests. Oncotype DX was launched in the United States in 2004, where it has since been adopted as the standard of care for treating early-stage breast cancer. Oncotype DX is recommended in the guidelines of the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN), and is extensively reimbursed in the United States. Physicians use Oncotype DX to predict the likelihood of chemotherapy benefit, as well as the likelihood of recurrence, for patients with early stage breast cancer, in order to make individualized treatment decisions about the addition of chemotherapy to hormonal therapy.

By 2025, one in five new drugs could be labeled with a companion test, many of which will be cancer drugs, according to Kalorama. Many of the new companion tests are being developed as diagnostic/prescription partnerships. There are scores of these cancer co-development projects underway. Companies such as Qiagen/DxS, MolecularMD and Roche/454 Life Sciences launched CE Marked test kits in 2008 and 2009. These tests are performed using blood instead of biopsied tissue.

Kalorama believes better-than-average growth levels will drive more companies to this area.

“This trend to personalized medicine is expected to create a huge market for cancer diagnostics in combination with the commercialization of the therapy,” Rosen says. “We expect pharmacogenomics, predisposition diagnostics and molecular diagnostics to show 25 to 30 percent annual growth over the next five to 10 years.”

In our November issue, we’ll examine the role of academic research in oncology. You can also view our previous reports:

Getting down to basics

Pharmacogenomics harnesses power of prediction, personalization

The big picture

Let’s work together

October 28, 2010 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , | Leave a comment

Too many cooks at the cancer pot?

This may sound almost heretical from a guy who writes about pharma and biotech business deals and research for a living, but have we perhaps gotten to the point where there are too many organizations in the oncology arena, whether trying to market a product or find a breakthrough around which to build a product?

It’s almost physically uncomfortable for me to voice such a theory, given how pervasive cancer is as a worldwide threat to human life. After all, with such a huge killer of people, wouldn’t you want as many people as possible looking for as many ways as possible to thwart tumors from stealing away precious years and robbing people of quality of life even when they don’t actually lose their lives?

And yet I find myself thinking of the “green” and “organic” movements, and wonder if they are precursors to where oncology is going.

Think about it. The green movement was supposed to be about wise use of resources and a shift toward energy efficiency, reduction of waste, more recycling and the like. But now it seems like many companies want to label themselves as “green” because they use recycled paper coffee cups in the cafeteria or because they encourage carpooling (even though they’re emitting who-knows-what into the air from the business itself). It’s become a gimmick or label, instead of being a worthwhile goal in and of itself.

The organic movement, too, has been corrupted so as to be almost meaningless in many cases. The federal standards to be considered “organic” are too lax, and many big companies slap the word “organic” on unhealthy food items as a sales tool. Also, many foods are labeled as “natural” to suggest they are healthy. Well, lard is natural, but if I consume it straight from the package daily, I will likely need a quadruple bypass eventually.

I fear that oncology, which is justifiably one of the biggest areas of interest in pharma, biotech and diagnostic research, is heading down a similar path.

These concepts began to swirl in my brain a bit some months back when I was interviewing a source for an article dealing with gene-based therapies. He had made an offhand comment about how so many companies were entering the ‘omics space in general—from genomics to proteomics to metabolomics and beyond—that he wondered if there were too many companies trying to jump onto the bandwagon, and he added, “much like we’ve seen with oncology.” He pondered whether they were all there for the sake of the science or if many of them were there to simply make money on the next hot thing. He worried that the cacophony and clutter of too many cooks in the ‘omics kitchen might spoil the broth. And in his mind, he had already seen that happen with oncology.

The thoughts began to come to a full boil when I was doing research for my “Foursome aims to be outsourcing force” article for the October 2010 issue of ddn, and I noticed this tidbit in another article about the merger of Averion International, Trio Clinical Research, Fulcrum Pharma and Clin-Research/ADDPLAN into one global biopharmaceutical and medical device development services organization:

While both Averion and Fulcrum Pharma share a specialty in oncology studies, Donnelly said the company’s focus will be more about bringing new processes and techniques to drug development rather than touting therapeutic expertise in specific areas. “Everybody out there is saying, ‘We are the oncology CRO.’ It’s the largest market out there, so everyone wants to be that. But we want to take that knowledge to the next generation as far as being able to do adaptive trials with it. That’s a differentiator,” he said.

Imagine that. Companies that were known for their oncology expertise, but the field is so crowded that to stand out, they downplay their oncology focus a bit.

It suggests that perhaps things have gotten too crowded.

It’s not that I begrudge anyone making money off of an oncology discovery or product. Far from it. Also, I appreciate the many new strategies and innovations that are helping to provide more hope for people who have been touched by cancer or who fear they might be.

But what I really want to see in the field are academic institutions, companies and other entities who are passionate about beating cancer.

What I fear, though, is that perhaps some are in it just for the money or prestige. They want to be the one who comes up with the next big idea or gets rich from it, and might be willing to put something other than their hearts and minds into the process to make sure that happens. They might be willing to rush, or cut corners, or overlook simpler and cheaper solutions.

It’s not likely a huge problem yet. But I wonder if it will become one. I would hate to see cancer become merely a market opportunity or a fad. I want organizations and the researchers within them to want to beat cancer, because I feel that’s the motivator that will truly lead to cures.

October 13, 2010 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , , , , | Leave a comment

Companion diagnostics ready to soar

As I’ve worked with companies putting together the next installment in our Trends in Cancer Research series, I’ve learned that pharma seems to be realizing that it needs to collaborate with diagnostic companies to stratify patients and to make safer, more effective drugs.

The development of companion drugs and diagnostics has the potential to improve treatment outcomes, enhance patient compliance with prescriptions and eliminate the need for insurers to pay for expensive therapies that often prove to be ineffective.

And the available information on biomarkers that indicate whether a therapy could work on a particular individual continues to grow rapidly.

Still, it can be a daunting task to develop drugs and companion diagnostics.

One company—Eli Lilly & Co.—has announced plans to build a diagnostics capability. A big part of the company’s innovation strategy is providing improved outcomes for individual patients—which it says can be achieved through tailored therapies.

Several technologies exist that enable the development of biomarkers into companion diagnostics. PCR, microarrays and expression profiling are being used to improve the sensitivity and selectivity of companion diagnostics. Next-generation sequencing and proteomics are two other growing areas of interest.

Biomarkers that are validated have the ability to lead to safer and more effective products, especially when developed into a companion diagnostic.

There certainly are challenges, such as identifying the right biomarker early in the discovery process; developing a robust biomarker assay in advance in the clinic; developing companion diagnostics well before reaching Phase III trials; and gaining approval of a drug and diagnostic at the same time.

An example of just how far this area has come is the World Companion Diagnostics Summit—to be held Dec. 1-2 in Boston. The summit will be addressing exactly these most crucial challenges, and has been developed in collaboration with the companion diagnostic pioneers from Roche, Genentech, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Amgen, Abbott, Qiagen and Dako.

According to the website, the meeting has “evolved from the urgent need for those committed to personalized medicine to come together and share expertise that will underpin the path for making companion diagnostics a reality.”

Workshops will be held Nov. 30 and Dec. 3.

The summit will provide the scientific community an opportunity to have an open discussion of strategies for developing companion diagnostics and making strides in the quality and efficacy of research results. In the end, hopefully, we will all be winners.

(Note: If your company or institution is doing pharma or biotech research and development the oncology arena and would like to serve as a source for the last installment in ddn’s Trend in Cancer Research series, contact David Hutton at hutton@drugdiscoverynews.com.)

September 27, 2010 Posted by | Corporate, Dealmakers | , , | Leave a comment