Tag Archives: 21st Century Cures Act

“Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.”


Drug-makers stand to benefit from act

By Staff Reports

1/6/17 8:19 PM

Will patients benefit from the passage of the 21st Century Cures Act? After listening to politicians and reading the headlines, most people might think it’s the best thing ever to come along for patients.

“A new day for medical research is on the horizon,” proclaimed Rep. Fred Upton, the outgoing chairman of the House Energy and Commerce Committee which had just won a major victory last week. “The House and the Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology,” Upton said in the GOP’s weekly radio address. “We needed to do better. And with 21st Century Cures, we will.”

Media headlines mirrored Upton’s victory declaration. Headlines like this from the Wall Street Journal, “House Passes Health Bill to Speed Drug Approvals, Boost Biomedical Research” seemed to say it all: faster drug approvals, more money for research, less pesky regulation.

Or was there more to the story? Not everyone thinks the Cures Act will be wonderful for patients. But their voices were drowned out in the slick public relations campaign Upton’s committee waged over the past few years using some 200 or so patient advocacy organizations to push for the bill. Most of those groups have strong ties to the drug and medical device industry.

A recent study by Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, found that three-quarters of 68 cancer advocacy groups he studied disclosed sponsorship from pharmaceutical companies. Some groups received money from as many as 16 or 17.

Prasad told me, “Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.” Prasad and others say the Cures Act actually lowers the regulatory standards for drugs and devices. It’s a step backward for patients.

In a nutshell the Act turns current regulatory practice on its head.

Randomized trials, the gold standard for medical research, may disappear if a drug company wants to sell a medicine for a different condition than the one it’s already approved for. Instead it can use “real world evidence” to show the drug also works for a new indication. Such “evidence” could be observational studies, which are less reliable than randomized trials, but are cheaper and take less time.

The FDA can use patient experience to inform its regulatory decisions — information about the impact of a disease or related therapy on patients’ lives. The data can come from patients, family members, caregivers, patient advocacy organizations, disease research foundations and drug manufacturers.

The agency can approve new drugs on the basis of data summaries rather than requiring the FDA to independently analyze study results for a new drug indication. Drug makers would have to submit all their data, but the FDA would not have to review it.

And although the bill authorizes billions for new medical research at the National Institutes of Health (NIH), the funding is not guaranteed, and the NIH would have to fight Congress for the money.

The Cures Act is the culmination of a 20-year effort by the drug industry and Beltway think tanks to loosen standards and permit new uses for drugs already approved in order to expand their markets. It can be traced back to the 1997 FDA Modernization Act, which was then — as the Cures Act is now — sold on the promise of getting cures to market faster. The 1997 law loosened regulatory standards and reduced the number of clinical trials needed for drug approval.

Are the changes brought about by the earlier law a harbinger of what’s to come?

The reporting by John Fauber and his colleagues at the Milwaukee Journal Sentinel offers a cautionary tale. In the past few years the paper has reported how drug and device makers have spent huge sums of money to sell drugs for conditions that were once thought to be part of everyday life.

The reporters found that drug companies turned conditions such as overactive bladder, adult ADHD and premenstrual dysphoric disorder into medically treatable ailments. They reported that the latter was not even recognized as a mental disorder until 13 years after the first drug treatments were on the market. “Drugs used to treat the various medicalized conditions don’t work that well and often have side effects that are nearly as common as the benefit,” Fauber told me.

Are we turning the calendar back to 1933 when a book called “100,000,000 Guinea Pigs” was published exposing the dangers of patent medicines? Federal oversight of drugs was pretty lax then, and patients died. It’s obvious drug makers will benefit from looser regulation. It remains to be seen whether patients will, too.

Trudy Lieberman, a journalist for more than 40 years, is a contributing editor to the Columbia Journalism Review, where she blogs about health care and retirement at cjr.org. She can be reached at trudy.lieberman@gmail.com. This column was distributed by The Rural Health News Service.

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House passes medical cures bill


By Peter Sullivan – 11/30/16 06:40 PM EST

House passes medical cures bill

The House on Wednesday passed a medical innovation bill aimed at curing diseases, with the measure securing bipartisan support after months of negotiations.
The legislation, known as the 21st Century Cures Act, passed 392-26. It seeks to speed up the Food and Drug Administration’s approval of new drugs while investing new money in medical research. 

The package also includes a range of other healthcare priorities, including $1 billion over two years to fight the epidemic of opioid addiction and $1.8 billion for Vice President Biden’s cancer “moonshot.”
The opioid money releases some pressure from a long-running dispute between the parties. Congress passed a bipartisan opioid bill before the election, but Democrats criticized that measure for lacking funding.
The cures legislation also includes a mental health portion that seeks to reorganize and improve accountability for government mental health programs.
Republicans have portrayed the mental health bill, sponsored by Rep. Tim Murphy (R-Pa.), as their response to mass shootings, though that messaging has been emphasized less now that it is part of a larger package.

Democrats agree reforms are needed in mental health, though they note that the bill lacks funding. They say the bigger policy response to mass shootings should be gun control.
House leaders are hoping that the bipartisan vote Wednesday puts pressure on the Senate, which is expected to take up the cures bill sometime before leaving town next month.
The bill faces a bumpier path in the upper chamber, where Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have blasted it as a giveaway to pharmaceutical companies.
Still, enough Democrats are expected to support the measure to get it across the finish line.

“This bill, which expedites the approval of drugs and devices, includes literally billions of dollars in additional spending for health research so that we can find the cures and the answers to what patients are demanding today,” said House Energy and Commerce Chairman Fred Upton (R-Mich.), the measure’s main sponsor. 

The White House gave the measure a boost on Tuesday night by announcing that it “strongly” supports passage, pointing in particular to the opioid funding and the funding for the cancer moonshot.
The liberal detractors note that the new research funding, which is helping to bring some Democrats on board, is not mandatory funding, meaning it is not guaranteed.

Still, the $4.8 billion over 10 years is set aside in a separate fund and not subject to the usual budget caps.

Sanders and Warren have denounced the bill as helping out pharmaceutical companies, in part by lowering the FDA’s regulations for approving their new drugs, while doing nothing to deal with the hot-button issue of high drug prices.

Some consumer groups have also criticized the measure, fearing that in speeding up the FDA’s approval process, it would lower safety standards.
The measure allows for ideas like sometimes using “real world evidence,” rather than more rigorous and time-consuming clinical trials, in drug approvals.
Rep. Frank Pallone (D-N.J.), a lead negotiator on the bill in the House, rejected criticisms of the FDA changes.

“It’s just a way of trying to address these cures in a more effective way, the way the public has asked for, without sacrificing any safety,” Pallone said.

The mental health portion of the legislation establishes a new assistant secretary for mental health in the Department of Health and Human Services as well as a chief medical officer. Murphy argues that these positions will bring more accountability and medical knowledge to the Substance Abuse and Mental Health Services Administration, an agency he has criticized as ineffective.
The bill also authorizes grants for areas like suicide prevention.

The mental health measure is significantly scaled down from the more sweeping version originally proposed by Murphy, though. It does not lift restrictions on Medicaid paying for care at mental health facilities, which would have cost billions of dollars.

The measure also includes elements from a companion mental health bill in the Senate from Sens. Chris Murphy (D-Conn.) and Bill Cassidy (R-La.).
Both the Cures and mental health portions of the bill come after more than a year of bipartisan negotiations.

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