Congress Used Dying Kids and Slick PR to Sell America a Handout to Big Pharma

The 21st Century Cures Act was passed thanks to an army of lobbyists and a PR campaign that preyed on dying children who are unlikely to benefit from it.
December 7, 2016, 10:22pm
Image: Bill Clark/CQ Roll Call via AP Images

The "21st Century Cures Act" is being hailed as perhaps the last great piece of bipartisan legislation before Donald Trump takes over as President. It is undeniably the most important health care law to pass since the Affordable Care Act, and it's being touted by politicians and "patient advocacy groups" as a huge step forward that will affect every American family.

It is also a law with a terribly misleading and harmful name that will function as a handout to the big pharmaceutical companies who shaped the bill that passed, in part due to a manipulative public relations campaign. Indeed, the bill itself was written largely by the healthcare industry, according to emails obtained by InsideHealthPolicy using the Freedom of Information Act.

I am not a healthcare policy expert, but I spent much of 2015 examining "the Cure Culture," the American healthcare and media industrial complex that sells hope and the false promise of full cures for chronic illnesses in lieu of more realistic goals such as bringing down the cost and improving access to existing treatments.

For a decade, I watched my best friend Katelin slowly die of cystic fibrosis, a chronic, incurable disease. Since at least the late 1980s, the Cystic Fibrosis Foundation, politicians, pharmaceutical companies, and researchers have focused the vast majority of their funding and energy on "curing" the disease, while ignoring the needs of patients who simply want to manage their lives with treatments that already exist but are expensive and often inaccessible. An annual supply of Kalydeco, the most effective cystic fibrosis medication, costs patients $311,000 per year. CFF research helped develop that drug; the foundation sold its royalty rights for $3.1 billion.

"We convert diseases into being less mortal," Chris Feudtner, an epidemiologist and ethicist at the Children's Hospital of Philadelphia, told me for that story. "But the idea of a cure is simpler, it's more appealing as a fantasy. It's alluring. What's more curious and interesting is, why do we constantly think we're going to cure things when that never, ever seems to happen?"

#CuresIn4Words: Breakthrough treatments, new hope. More >> #CuresNow

— Energy and Commerce (@HouseCommerce) October 12, 2016

Much of the pitch behind this law has been the same one we've seen with cystic fibrosis, diabetes, cancer, Alzheimer's, and every other chronic disease. Pass this bill, and we will cure what has been, to this point, incurable. It's there in the name: The 21st Century Cures Act.

"It's a very promotable, very winnable approach when you want to get your legislation passed," Gary Schwitzer, editor in chief of Health News Review, told me when I asked him about the legislation and messaging earlier this year. "The word 'cures' is in it, and words matter. The more I talk with patients and the people at the end of the food chain whose needs are supposedly being addressed, they get lost in this discussion."

Support for the law came largely from the pharmaceutical companies—roughly 1,300 big pharma lobbyists pushed for the law—who stand to benefit from clauses that will make it significantly easier to bring drugs and medical devices to the market, and from patient advocacy groups who are funded by the pharmaceutical companies themselves. A study released earlier this month by the Mayo Clinic showed that 75 percent of cancer patient advocacy organizations are sponsored by drug companies.

"The bill has been really slickly put together and it's been put together without a lot of input from patient groups except the ones being paid by the industry," Trudy Lieberman, a journalist who has been studying health care policy for decades, told me. "Essentially, what it does is it's kind of a gift to the device makers actually, and it does a lot of things that probably are not in the best interests of patients, but nobody really knows that."

The law removes many consumer protections that make sure that a drug is safe before it hits the market. It allows for the end of randomized drug trials for drugs that have already been approved for other types of illnesses.

In certain cases, new drugs can now be approved based on "patient experience data" and data summaries, which are considered to be weaker evidence of a drug's efficacy and safety than traditional randomized clinical trials. The law does absolutely nothing to address the cost of these new drugs or the cost of drugs that are already on the market. Even if "cures" do come, nothing has been done to ensure that people who are dying will ever be able to afford them.

Meanwhile, studies have demonstrated that drugs that are rushed to market based on insufficient trials are often harmful or do not work.

"It gets more stuff on the market, some of it is likely to not be good," Lieberman said. "They're pulling this off as if it's the best thing since sliced bread for patients, but drug companies can keep up prices as long as they want and there's no pushback from politicians."

The parts of the 21st Century Cures Act that are uncontroversial, such as increased funding for the National Institutes of Health, are provisions that have wide bipartisan support and, according to Lieberman, likely would have passed in a standard budget bill anyway. There are also parts that are long overdue, such as state grants to battle the opioid epidemic and provisions to support mental health research.

I won't pretend to know whether the law will ultimately do more harm than good, but I will unequivocally denounce the way it was written, promoted, and and hailed as a pro-consumer, pro-America, pro-patient piece of legislation.

Landmark #raredisease art exhibit features familiar #CuresNow advocate >>

— Energy and Commerce (@HouseCommerce) October 4, 2016

In the months leading up to the bill's passage, the House Energy and Commerce Committee published press release after press release in which it trotted out dead or dying children and their families, suggesting that a new law is somehow going to inspire researchers to suddenly cure their diseases. It turned its legislation into a hashtag. It went viral. Meanwhile, the committee relentlessly attacked the Affordable Care Act, a piece of legislation that was the only reason my friend Katelin had health insurance.

The kids the House Energy and Commerce Committee used to sell this bill will almost certainly die before their diseases are cured. I hope for their sake that their families or their insurance companies can afford treatments that are already on the market. When I spoke to Lieberman in May, she made a prediction.

"It might not pass until the night before Christmas, but it will pass," she said. "Device makers will put stuff on market without much oversight. Little Max who promoted the bill will go back to living where he lives and struggle to stay alive."