Following the Sept. 11 terror attacks, the medical technology industry has found a new reason to push for faster acceptance of groundbreaking diagnostic and related health care systems and ways to get both those and other essential products to the public in rapid fashion. In response to the threat of bioterrorism, the Advanced Medical Technology Association (AdvaMed; Washington) quickly formed the Medical Technology Preparedness Council, launched to help encourage the adoption of whatever medical technologies are needed to battle such attacks. And two medical distribution groups have teamed up to focus on the logistics of supplying those products during a time of crisis.
Late last month, AdvaMed's Preparedness Council appeared before a hearing of the House Energy & Commerce Committee to provide an overview of medical devices currently in development and different ways that public and private sectors can work together to contribute to the safety of Americans.
"The more we know, the less we will be terrorized," said Rep. Jim Ramstad (R-Minnesota), chairman of the caucus. "New precautions will reduce terrorism – we need to hear more about detecting pathogens." Echoing his words, Rep. Anna Eshoo (D-California) said she believes vaccines and devices needed to solve the newest health threats are already on the shelf or in development. "It is important that we take what you tell us about technologies and medicines into the highest echelons of government. I'm in the 'hope business.' I believe some very important things can come out of what has happened in our country."
Susan Alpert, PhD, MD, medical advisor to AdvaMed's Preparedness Council, pointed to the key role being played by the FDA in developing bioterror countermeasures. "This is one key element of the broader public/private partnership that we are building," said the former high-ranking FDA official. And David Feigal, director of the FDA's Center for Devices and Radiological Health, underlined the need for rapid action. "We are beyond talking about emergency plans," he said. "Beginning Sept. 11, we've had to ask how our products are involved, we've had to look at the supply of products and the vulnerability of products."
As an example of how companies are responding, the Mayo Clinic (Rochester, Minnesota) and Roche Diagnostics (Indianapolis, Indiana) recently reported their development of a DNA test for anthrax that can identify the presence of spores within an hour as opposed to days. Less Wold, chairman of the department of pathology at the Mayo Clinic, told the caucus that without government involvement, it would have been nearly impossible for the Mayo Clinic and Roche to quickly develop the DNA test, which is based on Roche's LightCycler instrument for polymerase chain reaction (PCR)-based assays. "This discovery is significant because it will bring testing to a local level and allow doctors to monitor those who have been exposed and to alleviate the anxiety of those who have not been exposed," Wold told the caucus. "Involvement of the government was essential in this product and we will need additional help from the government to finish this task. It is critical for us to receive quick response from the FDA as this moves forward."
Richard Naples, vice president for regulatory submissions at Roche, said the company has shipped the first anthrax kits for environmental testing to 24 labs across the U.S. The company hopes to make the first test available this month under an FDA-approved investigational device exemption (IDE) to a broader range of labs to analyze human blood and tissue.
In the distribution sector, the Health Industry Distributors Association (HIDA; Alexandria, Virginia) and the Association for Healthcare Resources & Materials Management (AHRMM; Chicago, Illinois) have teamed up to provide necessary tools, information and plans to deliver products to a disaster site. "The medical products distribution industry plays a critical role," said HIDA vice president of communications Wendy Mann. And she added, "The unexpectedness of an emergency like Sept. 11 is what we need to deal with now."
Following the Sept. 11 attacks, HIDA met with the Office of Emergency Preparedness (OEP), a government agency, and Mann described two outcomes of the meeting: first, to communicate a system to medical products distributors, detailing who will be called upon, when and how; and second, to offer the OEP its expertise in moving products quickly through a distribution channel. "We need to have a plan to support distribution during a disaster," Mann added. "That is what's needed most."
Collaborating with government agencies and others in the health care industry is nothing new. "There was a similar task force [to address] Y2K," said AHRMM president-elect Al Cook. "I think you're seeing the beginning of a larger group in the works. Other groups will probably be joining."
In addition to working with the OEP in recent weeks, HIDA has worked with the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) in creating plans to distribute flu vaccines.
PTO to keep user fees next year
The U.S Patent and Trademark Office (PTO) does not receive taxpayer money. Rather, it is fully funded by user fees, which are expected to generate upwards of $1 billion in FY02. The House of Representatives last month passed legislation enabling the PTO to keep all of those fees. According to Rep. John Conyers (D-Michigan), who spoke on the House floor in favor of the legislation, "the appropriators and the administration treat PTO like a savings and loan and divert its money every year for other government programs. To date, more than $600 million in fees has been diverted since 1992, and this year alone the appropriators are taking $200 million."
Introduced by Reps. Howard Coble (R-North Carolina) and Howard Berman (D-California), the Patent and Trademark Office Authorization Act of 2002 (HR2047) gives the PTO the authority to keep its money but also requires that the agency develop both a strategic plan for the next five years and an electronic system for filing and processing patent and trademark applications.
Todd Dickinson, a patent attorney in Washington and a former undersecretary of commerce for intellectual property and director of the U.S. Patent Office, told The BBI Newsletter's sister publication, BioWorld Today, that the PTO favors retaining all fees paid for patents. "What will happen over time, if funds continue to be diverted, the time it takes to get the patent application through the process and out as a patent itself will continue to grow," Dickinson said. Under current operations, Dickinson said that, on average across all technologies, it takes about two years. "But if the diversion continues, the time will grow and within five years it will be up to a three-year process, from start to finish."
In FY02, the PTO projects a 12% increase in patent filings and an 84% increase in FY06, Lila Feisee, director of intellectual property for the Biotechnology Industry Organization (Washington), said in a prepared statement. The PTO also has reported a projected 400% increase in patent applications waiting for action by 2006 (from 256,520 in fiscal 2002 to 1.29 million in 2006).
From genes to drugs in lung cancer?
Researchers at the Stanford University Medical Center (Stanford, California) reported that they have uncovered a group of genes that could distinguish between different forms of lung cancer. This finding may help doctors predict individual treatment strategies and may someday lead to better lung cancer drugs.
"What this means is that we can distinguish between different types of lung cancers, which was not possible before, and that those differences have clinical consequences," said David Botstein, MD, professor of genetics and senior author on the study, published in the Nov. 13 issue of the Proceedings of the National Academy of Sciences.
Doctors currently categorize lung tumors into one of four types: small cell, squamous cell, large cell and adenocarcinoma. When doctors diagnose a small-cell tumor, they can provide a fairly accurate prognosis. But other tumor types, particularly adenocarcinomas, respond very differently to standard treatment.
"Lung adenocarcinomas may appear morphologically similar; however, the patients differ in survival and possibly drug sensitivity," said Mitchell Garber, a post-doctoral student and first author on the paper. "At present, the pathologist cannot determine patient survival for those diagnosed with adenocarcinoma."
Garber thought these differences may arise from gene variations within the tumor. If that's the case, doctors would have an additional tool for distinguishing how tumors will grow, helping to determine the best course of treatment for each patient. "The short-term goal is to know the fingerprint of a tumor that has a poor prognosis," Garber said. "That will give the clinician an incentive to look a little harder within this patient for additional tumors."
To find out whether genetic differences exist between lung tumors, Garber obtained RNA from 67 lung tumor samples and six normal lung samples. RNA is produced by active genes and can be used to identify which genes are being expressed in a given sample. He then exposed the RNA samples to a gene chip – a glass slide dotted with 17,108 human genes. If a sample contained RNA corresponding to a gene on the chip, the RNA would bind to the spot and produce a visible signal. The bigger the signal, the more RNA, and therefore the more gene expression. With this technique, Garber grouped his samples according to those that expressed a similar subset of genes.
Garber said that tumors in subtypes 1 and 3 were initially diagnosed with different stages of the disease. Those in subtype 3 all had more advanced tumors while those in subtype 1 had less advanced tumors, consistent with the survival rates of the two groups. However, those in subtype 2 had a mixture of more advanced and less advanced tumors. Without the genetic analysis, doctors would not have classified these patients in similar subtypes, nor would they have predicted survival.
Botstein said this ability to distinguish between lung tumors could help doctors target therapy. "For those in the subset lucky enough not to have such serious disease, you may want to consider a much less toxic treatment option," he said. Botstein noted that while adenocarcinomas account for 30% of all lung tumors, they comprise 56% of lung samples in this study. He predicts that a larger, more representative trial would uncover similar genetic subtypes within other tumor categories.