Let’s Revive America’s Culture of Cures and Innovation (Ted Cruz's Op-Ed)

The FDA denies approval to cures for diseases because of decades-old research standards that don’t make sense for today’s science.

America has always been a pioneering place. It has spurred innovation and offered hope and opportunity to millions of people from around the world. Many of our greatest innovators have been doctors and researchers who have risked everything to save lives. Yet now scientists and patients are too frequently being denied the opportunity to advance medical cures.

We continue to lose far too many of our loved ones to the “invisible graveyard,” as economist Alex Tabarrok has described: lives that could have been saved but for a bureaucratic barrier that rejects medical cures and innovation. In 2015, 700,000 Americans are expected to die of Alzheimer’s; nearly 600,000 lives will be taken by cancer. Moreover, millions of Americans suffer from countless chronic diseases that significantly impair their daily well-being. For instance, 25.8 million are afflicted by diabetes, and 30 million are afflicted by rare diseases, 95 percent of which have no known treatment.

These numbers are more than mere statistics: Each is a member of our family, a friend, a neighbor. Just one cure could rescue millions among us from suffering. While we will never know how many lives could have been saved by research, we can search for cures to save those who otherwise would fall prey to those same diseases.

We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself. Right now, the Food and Drug Administration stifles new treatments, operates with decades-old methodology, and discourages scientific development.

The FDA model is risk-averse, by its very nature obstructing promising innovations. It largely assumes that the biology of patients is the same, rather than recognizing that individuals’ genetic makeup varies widely. As a result, the only drugs the agency tends to approve are those that help a broad spectrum of patients and harm close to no one. That method may work to fight diseases that affect us all in a similar way, such as smallpox or cholera, but it does not work for diseases such as Alzheimer’s and cancer, which are highly tailored to each individual’s genetic makeup. In medicine, a one-size-fits-all approach ignores the diversity of the human person and limits the discovery of innovative cures to a small segment of those afflicted with disease.

We now have the tools to reveal individuals’ biological differences at the most basic level. Biomarkers, or signs at the molecular level, enable the efficacy of a drug to be tested without waiting for the clinical effects of the treatment to surface. In other words, we can anticipate and prevent a disease without having to wait for symptoms to show up, often years later, when it’s too late. Yet the FDA continues to operate on a backwards model that largely rejects forward-looking discovery.

It’s past time to unleash a supply-side medical revolution, so that instead of simply caring for people with debilitating diseases, we cure them. For this reason, I am introducing legislation to reform the FDA and champion innovation. Right now, a number of drug companies and investors are fleeing the U.S. market. In reporting recent sharp drops in biotech stocks, the Wall Street Journal noted that economists cite as one of the key reasons the fear of a Hillary Clinton– or Bernie Sanders–imposed diktat of price controls. And as scientists and investors abandon the U.S., the FDA continues to prevent life-saving drugs from coming into the country. Take, for example, the multiple-sclerosis drug Lemtrada, which has been approved and used in Europe, Canada, Mexico, and Australia. Research has demonstrated that patients who are prescribed Lemtrada are only half as likely to relapse as those prescribed a leading drug in the U.S., but the FDA has refused to approve Lemtrada because the trials did not fit within the agency’s placebo testing requirements. Patients are getting sicker, and the FDA’s outmoded scheme is keeping them that way.

The bill I am introducing takes the first step to reverse this trend. It provides for reciprocal drug approval, so that cures and medical devices that are already approved in other countries can more expeditiously come to the U.S. It requires the FDA to respond to the treatment sponsor within 30 days of its application. The legislation also ensures that the FDA is more accountable to Congress, and ultimately the American people, so that the FDA’s risk-averse approach does not stand in the way of medical advances. Beyond reforming reciprocity, we need to modernize the FDA’s approach, expand the Accelerating Medicines Partnership (AMP), and embrace a culture of innovation, as foundations like XPrize are doing. If we welcome new medical treatments, we will set in motion a new era of medicine that seeks not simply to care for those afflicted with disease, but to free them from it. Cures not only save lives, but also time and resources; with a cure, we eliminate the enormous costs of chronic care.

If we want to keep good doctors and researchers here, and if we want the best scientists to bring their best solutions, we have to start by welcoming new discoveries, rather than cutting them off. An eminent example to follow is that set by the legendary cancer researcher Dr. Emil J. Freireich, now 88. As Malcolm Gladwell recounts in David and Goliath, Dr. Freireich survived a harrowing childhood in Chicago and went on to earn a medical degree. He spent his lifetime achieving what others supposed was impossible. As a young doctor, Dr. Freireich was stationed at the leukemia ward of the National Cancer Institute, where 90 percent of children bled to death within their first six weeks at the hospital. Determined to find a cure, he discovered the need for platelet transfusions, and perfected the method of giving them. The clinical director told Freireich he was crazy and threatened to fire him. But soon, the treatment began to work, the bleeding stopped, and his pioneering perseverance saved — and continues to save — thousands of children who are living their dreams. As Dr. Freireich now warns: “There’s always resistance to innovation.” But, like the great doctor, we must persist in our search for cures.

It’s time to open wide the frontier for innovation. We have an opportunity to unharness solutions that could be the difference between a lifetime of pain and suffering, even death, and a life full of promise and strength. America has always chosen the latter, and I am confident we will again.

My grandmother has terminal cancer. She says there are treatments she would try if they were available to her.

She’s in her 90s and knows she isn’t going to live forever but says she would try new treatments and medications if not for her, then for people who come after.

I think Senator Cruz is totally on the mark here..

Agree, but he also hit on the reason investment is dropping even if the FDA process became easier - democrats. There is always a chance the rats will impose their communists agenda. I never worried much about that years ago, but half the GOP would probably vote for it today.

The current system is a cronyism system with Big Pharma paying off congress critters, and they putting pressure on Big Pharma. Many of the drugs are poorly tested, much of the results are hidden until the law suits start in.

My 16 year old very healthy, active gymnast grand daughter was given that unnecessary Gardasil 3 shot series, she now has Rheumatoid Arthritis which is progressive, and Fibromyalgia a muscle disease that is also progressive and there is no cure for either you can only manage the symptoms with high side effect drugs. It has ruined her life. And will eventually put her in a wheelchair. Spain and Japan have BANNED GARDASIL. The manufacture hid the full facts from the FDA.

To add to what I posted, Sen. Cruz is correct on the proven European drugs and treatments. Hubby’s knee ortho has used a procedure he learned in England for partial knees that works better than the ones our medical ortho’s use.

Stem cells are going to be a big part of the future in treating sickness, those from adults, not these baby killer ones.

But he needs to expand the bill to include those of us who are on Medicare and Tricare Life as we are EXCLUDED from such treatments. DOD has just informed us that the pilot program that was put in place in 2014 that all daily meds must be either Military base obtained or Express Scripts. It is a DOD MANDATE. Only a 1 time fill when the Base Pharmacy is closed or on the weekends, can be gotten at a private pharmacy. It’s a pain in the butt, for base you are limited to what they have, and refills come out of Pensacola. For Express Scripts who have been known for fraud, they just stuff what is ordered in your mail box UN Photo ID signed for. We are talking Thousands of $$ retail in drugs every 3 months. Which leaves them open to neighborhood kids to take or thieves for making their drugs, or just selling on the street, depending on the types of drugs. Between the 2 of us that is a retail of $4 K every 3 months for 5 name brand drugs, that the base does not carry. The rest are filled at the base. The new narcotics laws means you have to have a new script that says CHRONIC PAIN every month, or you will only get a 2 week supply. It can’t say severe pain, it must say CHRONIC PAIN. Many seniors live in chronic arthritis pain or other health issue caused pain. Makes things harder on the patient.

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