Mara Lee, Modern Healthcare: May 1, 2017

Diana Zuckerman, PhD, National Center for Health Research, on behalf of Cancer Prevention & Treatment Fund: April 17, 2017

My friend Gwen went from being a healthy woman living a happy life to being diagnosed with a fatal cancer in a very short period of time. The doctors tried one toxic chemotherapy after another. All were approved by the FDA, which means they had been proven to work for some patients. But none of them worked for Gwen, and she became a shadow of her former self, living her last months on earth in a limbo of a life, hoping one of these treatments would do some good.

The Goldwater Institute, a conservative think tank that promotes “Right to Try” legislation, has a different view of medical care for dying patients. In their fantasy world, experimental drugs that haven’t even been proven to work forany patients will save the lives of thousands of desperately ill patients, if only the U.S. government would mind their own business and get out of the way.

Unfortunately, this doesn’t make sense. If patients can’t be saved by drugs that are proven to work, what’s the chances that an unproven experimental treatment will save them?

Even more important, under current law all patients in the U.S. have the right to try experimental drugs that have at least some evidence of safety and effectiveness. So why lower the standard to include treatments with no evidence that they work at all?

Many people don’t understand how the current system works, and — understandably — want dying people to have another chance. As a result, Goldwater lobbyists have convinced more than 30 states that they should give patients the “Right to Try” experimental drugs. Those laws haven’t worked very well, however, and there is no evidence to show how many patients have benefited compared to how many have been harmed.

Now the Goldwater Institute is going a giant step further: they are trying to convince Congress to pass a federal Right to Try law that is much, much more dangerous than the state laws.

Here’s what the Goldwater Institute and their supporters are saying. Let’s set the record straight.

They say that the proposed federal law would merely give patients in all 50 states the rights that patients have in states with state Right to Try laws. NOT TRUE.

Under the state laws, companies can’t charge more for the investigational treatments than their “actual cost” to the manufacturer, because federal law prevents profits on experimental drugs. However, they are lobbying for a national Right to Try Act that specifically allows companies to determine what they will charge for their experimental drugs. That means desperate patients and their frantic loved ones can be exploited by scam artists and greedy companies selling unproven treatments.

They say that “promising new treatments” take more than a decade to be approved by FDA. NOT TRUE.

Effective treatments may take a decade to develop, but that is not the fault of the FDA.  The average drug is approved about a year after its pivotal studies are submitted to the FDA. An article in Cancer World concluded that the FDA approves drugs an average of 6 months faster than the European medical agency.

They claim that the law would greatly increase the number of patients gaining access to promising experimental drugs. They complain that in 2015, FDA only allowed 1,300 patients to have access to experimental drugs through their Expanded Access program. NOT TRUE.

The FDA is approving 99% of the applications submitted to them by doctors whose patients want to participate in the program. Only 1,300 patients gained access to experimental drugs because most doctors aren’t requesting it and the companies that are asked to make their drugs available are not always willing or able to do so. They may not have enough of the experimental drug available, or they may believe that the specific patient requesting the drug is more likely to be harmed than helped by the drug.

They even give an inaccurate example. The Goldwater Institute has stated that “most” of the 78 patients treated by an “oncologist” under the Texas Right to Try law “are doing very well.” NOT TRUE.

The doctor they are referring to, Ebrahim Delpassand, is a radiologist, not an oncologist, and he has not said “most are doing very well.” He testified before the Senate that the treatment “has helped many” of the patients, but he doesn’t say how many or to what extent the treatment helped.  He also hasn’t said how many were hurt by the treatment.  None of that information has been made public and the doctor has refused to answer questions from skeptical reporters.

They say “something is wrong” because “fewer than one-tenth of 1 percent of terminal patients can take advantage of the FDA’s compassionate use exception.” NOT TRUE.

Experimental drugs are just that: not proven to work or to be safe. Patients can die sooner and in agony from experimental drugs, especially those that have only gone through tiny, preliminary studies of a few healthy volunteers or patients (as the proposed national law would allow).

Only about 15% of the drugs that complete those types of preliminary studies are eventually proven to be safe or effective. The other 85% are either not safe, not effective, or both. That is a very important reason why most patients (and their doctors) do not seek experimental treatments even when they know they can.

Our patient protections are working. Major pharmaceutical companies are not lobbying for this legislation, but those who oppose FDA safeguards are. If you want to prevent the exploitation of desperate patients, contact your Senators and Congress and let them know.

This article originally appeared on Our Bodies, Our Blog. 

Diana Zuckerman, SouthCoast Today, Seattle Times, Sacramento Bee, Norfolk Daily News, New Bedford Times, Bellingham Herald, and other publications across the country: September 23, 2016

As her president husband’s point person on health care in the 1990s, Hillary Clinton learned what is needed to make health care affordable for everyone and how hard — but worthwhile — it will be to achieve that outcome.

She knows the issues inside-out, and her current proposals as a presidential candidate reflect her knowledge and commitment.

Excuse me while I mix a bunch of metaphors to describe the challenges ahead. Improving access to affordable health care in our country will require a complex juggling act, fitting together hundreds of puzzle pieces, and compromises from the major players, many of whom are on opposing teams.

The good news is that there are fewer uninsured Americans today than at any other point in our nation’s history. Likewise, people no longer are one illness away from financial disaster because of pre-existing medical conditions or because their age or health problems make them uninsurable.

The bad news is that many Americans say they don’t support President Barack Obama’s marquee Affordable Care Act, commonly called Obamacare, or are skeptical of it because co-payments and deductibles are increasing.

Fortunately, Clinton’s proposals to improve the situation are achievable — if Congress wants to improve access to health care instead of just complain about it.

Here are a few of her proposals:

— Reducing the price of prescription drugs. Nearly everyone agrees this is an important goal, but Big Pharma’s army of lobbyists have made it a tough one to achieve. Clinton has proposed several solutions, and my favorite is the simplest: scrutinizing prescription drug ads before they are allowed to bombard consumers. The U.S. is one of only two countries that allow these ads to be directed at consumers rather than just toward doctors. Also, as if watching the ads isn’t annoying enough, pharmaceutical companies deduct the cost of the ads from their taxes but still count advertising as a research-and-development expenditure. Yes, really, advertising costs are included in the “costs of developing new drugs.” The misleading ads encourage inappropriate and expensive prescriptions that cost us billions of dollars and ought to be more heavily scrutinized, as Clinton has proposed.

— You’ve probably never heard of Federally Qualified Health Centers, but 25 million Americans get their care from these clinics every year. Clinton proposes doubling that investment to provide care for more Americans. Legislators like to get credit for bringing home federal money and ought to go along with this idea.

— Reducing the backlog of generic drug applications. Generic drugs are generally less expensive and, in turn, force brand-name manufacturers to lower their prices. Clinton proposes that generic drug manufacturers help pay for reducing the backlog, since the move will benefit their bottom lines.

— Expanding Medicare to make it available — not required — for people 55 and older, instead of only people 65 and older. The cost of Medicare, which is not free, is different for every person and based on income. Americans generally love Medicare, and many would benefit, so if Congress is functioning, this could become law.

— Expanding Medicaid in every state. Medicaid provides health care to the poorest Americans in all 50 states, but 19 states have refused federal funds to expand it. The number of states participating in this expansion has slowly increased as it has become obvious that red states, such as Kentucky, have benefited the most. Expanding coverage in all 50 states will be tough, but Clinton’s plan to use incentives should nudge things in that direction.

These are just a few ways Clinton proposes to make health care more affordable. It won’t be easy, but as a senator, Clinton was able to work with both parties to get legislation passed.

One big plus is that several of her proposals reflect her awareness that the Food and Drug Administration could help reduce the cost of our health care instead of increasing it. Just this week, the agency tentatively approved a drug that will cost $300,000 a year despite there being little evidence that it works. In improving the nation’s health care environment, preventing skyrocketing costs of unproven treatments is a great place to start.

Diana Zuckerman is president of the National Center for Health Research. She received a doctorate in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. Readers may write her at NCHR, 1201 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. Distributed by Tribune Content Agency LLC.