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House bill offers hope to the ill, and the Buffalo Niagara Medical Campus

WASHINGTON – The House of Representatives on Friday gave gravely ill people like Michael J. Maloney of Cheektowaga a bit of hope, while promising that research institutions like those at the Buffalo Niagara Medical Campus will get a chance at far more federal money.

By an overwhelming bipartisan margin of 344 to 77, the House passed the 21st Century Cures Act, a bill – including provisions pushed by Rep. Chris Collins, R-Clarence – that aims to speed up medical research and bolster funding for it for the next five years.

Both Maloney and Candace Johnson, president and CEO of Roswell Park Cancer Institute, said the legislation is hugely important.

“It’s so significant for us who are looking for some ray of hope,” said Maloney, 64, who was diagnosed with ALS – the currently incurable nervous system disorder also known as Lou Gehrig’s Disease – in 2012. “This is moving us light years forward” in terms of medical research, he said.

Johnson agreed.

“This is really wonderful news,” Johnson said. “This solution of sustained and predictable funding is really a much-needed boost for researchers, and it’s the first in a decade.”

Yet in a way, the bill is a throwback to earlier times, in that it’s the kind of bipartisan compromise that has become increasingly rare in this era of left-right acrimony.

Collins said the bill came together largely because Rep. Fred Upton, the Michigan Republican who chairs the Energy and Commerce Committee, “did a yeoman’s job” in working with both Democrats and Republicans.

“It is the culmination of years of work and will help revolutionize how the health care industry develops cures to deadly diseases,” Collins said of the legislation.

A member of the Energy and Commerce Committee, Collins authored a provision that will force the Food and Drug Administration to draw up guidelines for adaptive clinic trials, in which researchers monitor how patients are reacting to a drug and modify the dosage accordingly. That provision also aims to use modern research on the human genome to weed out participants in clinical trials who may be subject to adverse effects of the experimental treatment being tested.

“Some of these laws haven’t been changed since the human genome was mapped in 2001,” said Rep. Tom Reed, a Corning Republican who strongly supported the bill. “With such dramatic advances in medical technology, it’s only fair that our laws keep pace.”

At the same time, though, Collins may have a vested interest in seeing the bill become law. He’s the largest shareholder in Innate Immunotherapeutics, an Australian drug research firm that currently has no drugs up for approval at the FDA, but that could someday.

Collins said he informed the House Ethics Committee of his investment in the drug research firm, which, according to his personal financial disclosure statement, is valued at between $5 million and $25 million. But Collins said that rather than being a conflict of interest, his work on the 21st Century Cures Act is proof of what he can bring to Congress.

“The fact that I have a longstanding background in biotechnology and drug development lets me bring my experience into Congress in a positive way,” he said.

Collins also authored a part of the bill that removes a cap on the number of researchers the FDA can hire, while streamlining the FDA hiring process and dramatically boosting researcher salaries so the agency can compete with private industry in pursuing the best scientists.

While Republicans were primarily interested in the parts of the bill that streamline the approval process for new medical treatments, Democrats pushed for a boost in medical research funding.

As a result, the bill boosts funding for the National Institutes of Health by nearly $8.75 billion over five years, with the increase paid for through sales of oil from the nation’s Strategic Petroleum Reserve as well as modest cost-saving measures in Medicaid and Medicare.

What’s more, the bill sets that funding in stone up front rather than leaving it up to the whims of lawmakers who draw up the annual bills appropriating money to the federal agencies.

That fact prompted 70 of the most fiscally conservative Republicans to oppose the bill, but the increased and guaranteed funding won widespread praise from most lawmakers of both parties.

“It’s a major step forward,” said Rep. Brian Higgins, D-Buffalo, who has been pushing for an increase in medical research funding for years. “I suspect that Roswell and other companies at the Buffalo Niagara Medical Campus will benefit tremendously from this.”

Higgins noted that because of funding cutbacks in the past decade, the National Institutes of Health currently approves only one in six of its applications for research funding – whereas it previously approved one in three such proposals.

Higgins said he has some concerns that the bill might go too far in streamlining the approval process for new drugs, and he’s not alone in that sentiment.

“As often happens, well-funded pharma lobbying was more effective than experts’ concerns about patient safety,” said Diana Zuckerman, president of the National Center for Health Research.

Higgins said he hopes the Senate takes a close look at those patient safety concerns, but others aren’t sure that will happen.

“The strong bipartisan support for the Cures Act in the House, together with broad support from the Obama Administration, are strong indications that the Senate will approve the Cures Act with small changes,” Ross Muken, an analyst at the Evercore ISI investment advisory firm, said in a research note.

The House itself made small changes from an earlier version of the bill, adopting an amendment offered by Rep. Louise M. Slaughter, D-Fairport, that requires the Centers for Disease Control and Prevention to study whether the bill will encourage the overuse of new antibiotics, which could quickly render them ineffective.

“Taxpayers shouldn’t foot the bill for practices that make antibiotics less effective,” said Slaughter, a supporter of the bill and microbiologist by training who for years has worked to curb the overuse of antibiotics.

The central focus of the bill, though, is to speed up the approval of new treatments and to provide more money for their development.

With that in mind, Maloney, the ALS patient from Cheektowaga, visited Collins, Higgins and Sen. Charles E. Schumer, D-N.Y., when he was in D.C. for a conference in May to push for passage of the bill.

“I’m very appreciative of this,” Maloney said of the House’s action. “With this legislation, hopefully we’ll streamline the approval process and look at a more collaborative approach and have much more funding for potential treatments.”

Noting that most ALS patients have a life expectancy of only three to five years after their diagnosis, Maloney said, in terms of research into new treatments for the disease and others like it, “time is of the essence.”

News wire services contributed to this report.