Diana Zuckerman, Chicago Tribune
July 21, 2016
This article was published in the Chicago Tribune, Baltimore Sun, Orlando Sentinel, Sacramento Bee, and syndicated in many other newspapers across the country.
Imagine that you or someone you love has a potentially fatal disease with no proven treatment, but there is a new experimental treatment available.
Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?
For more than a year, a bill misnamed the 21st Century Cures Act has been a major focus of Congress, with grand promises that it would save the lives of desperate patients, including those with rare diseases.
Despite unusual bipartisan support from Republicans and Democrats, the bill has not become law. Here’s why you should be relieved, rather than disappointed.
The 21st Century Cures Act, which some experts refer to as the 19th Century Fraud Act, is the worst threat I’ve seen to the health of adults and children, whether rich or poor.
Simply put, this proposed legislation is based on hype and hope, not reality.
It has been marketed like a Super Bowl halftime ad campaign featuring families with dying children praising members of Congress for giving them hope. Supporters have included scientists, university officials and investors who are likely to benefit financially, should the legislation become law.
Desperate patients also support it, not realizing it would pave the way for unsafe and ineffective medical treatments. Worse yet, those patients would need to pay hundreds of thousands of dollars a year while being unwitting guinea pigs in experiments that are falsely hyped as “promising treatments.”
There are thousands of patients who urgently need new medical treatments. Many feel like they have nothing to lose, and assume that a promising new treatment is their best hope. But new isn’t always better which is why too many promising new drugs are subsequently found to be a harmful waste of money.
If a patient has only one year to live and the new drug or device kills them even sooner, or causes a stroke or unrelenting nausea or horrible pain that won’t ever stop, it becomes obvious that they had something to lose after all.
That’s why these medical products were still being studied because decades of disasters such as Vioxx, metal hip replacements, DES, and thalidomide have taught us that there is a right way to test medical products. And that testing them the right way and waiting for the results to be conclusive will save more lives than taking short cuts.
One of the most dangerous aspects of the 21st Century Cures Act is that it urges the Food and Drug Administration to settle for preliminary study results based on “surrogate endpoints” which are little more than well-educated guesses that a treatment works, rather than scientific evidence of real benefits such as living longer or having fewer complications. The FDA already relies on those surrogate endpoints for new medical products more often than they should.
For example, a study published in one of America’s most prestigious medical journals found that half of new cancer drugs are approved based on such short cuts, but many of those promising results were later reversed when more conclusive studies show that the drugs do not help patients live longer.
The National Center for Health Research has found that many of those ineffective often toxic drugs cost more than $100,000 per year a cost that can bankrupt individual patients and also bankrupt Medicare.
You’d think Congress would want to stop this travesty, but campaign contributions and the power of well-connected lobbyists have convinced Congress that this bill is a good idea.
If you or a loved one has a deadly disease, whether it is cancer or a rare disease, you deserve treatments that work. If experimental drugs are your only hope, they should be free as part of a study that you can choose to participate in.
Changing the rules so that patients have to buy experimental treatments that could harm them is a dream come true for snake oil salesmen. We all deserve better.
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