Biggest health reform bill since Obamacare in 600 words

[frigidmagi]

vox

After three years of wrangling, the House on Wednesday passed the biggest health reform bill since the Affordable Care Act.

The $6.3 billion 21st Century Cures Act is a controversial, bipartisan effort that’s been in the works since April 2014. As its name would suggest, it’s been touted as legislation that’ll help get medical cures to patients faster.

But health researchers have been calling the Cures Act "lipstick on a pig" and the "19th Century Fraud Act" — for good reason. The bill’s research spending is offset by cutting public health spending elsewhere. And researchers worry the bill could seriously damage the regulatory authority of the Food and Drug Administration, and compromise patient safety.

The funds promised for research aren’t guaranteed
At first glance, it’s not hard to see why this law passed the House in a landslide. It seems like a really helpful bill.

At a time when the health research community is desperate for funds, the Cures Act would increase money for the National Institutes of Health (NIH) on the order of $4.8 billion over 10 years. These funds would support President Obama’s signature research programs, including the Brain Research and Precision Medicine initiatives.

The bill also includes $1 billion in funding over two years to help state governments with opioid painkiller abuse prevention and treatment programs, and it would expand Medicaid to children with severe mental illnesses. This is all good news.

Yet there are significant strings attached to this money. For one, the NIH funds aren’t actually guaranteed — they will only materialize if future Congresses sign off on them.

Second, nearly half of the funds for the legislation are going to be paid for cutting $3.5 billion from public health efforts like immunizations and tobacco prevention. We already underfund public health in the US. As of 2012, more than 17 percent of US GDP was spent on health care — drugs, doctors, hospitals — while only 3 percent of the health budget went to public health measures.

So we have a bill that’s supposedly giving us medical cures by cutting some of the basic public health funds that were established to prevent diseases from happening in the first place.

The bill does scary things to the FDA
The main reason health researchers have been freaking out, however, has to do with what the bill will do to the FDA.

Right now, before a new drug can come on to the market, the drugmaker needs to present high-quality evidence in the form of randomized clinical trials (the gold standard of medical evidence) to the FDA.

This bill could erode that standard. For example, it’ll allow drugmakers to submit "real-world evidence" as proof their drugs work when they're seeking approval of a new indication (or use) for an existing drug. So companies can put forward safety monitoring data or observational studies.

Unlike clinical trials, these types of data aren't very rigorous — they’re just observations about things that are already happening, not experiments with placebo controls. Drugmakers could conceivably find any correlation they want in the data and present them as proof their products work. (The researchers I spoke to said this opens the door for data dredging, and there’s really no way to know whether a drug is safe or effective based on that kind of research.)

The bill would also allow drug companies to submit "summary-level reviews" for new indication approvals, instead of raw data, which the FDA currently requires. This would limit the ability of FDA reviewers to analyze and crunch data behind a drug for themselves, forcing them to rely on summaries created by pharmaceutical companies.

So there are some good things in the giant Cures Act, some good-seeming things, and some scary things that are potentially really dangerous. Now it'll be up to the Senate to decide whether these trade-offs are worth it.

Clarification: I clarified that this post to note that the "real world evidence" can be used in applications for new drug indications.

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