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, PhD, National Center for Health Research, on behalf of Cancer Prevention & Treatment Fund, in Our Bodies Ourselves:  March 24, 2017

Last week the media discovered that breast implants can cause cancer. Rather than causing breast cancer, experts now say that breast implants can cause a type of lymphoma (cancer of the immune system) called anaplastic large cell lymphoma (ALCL).

You’ll be excused for thinking this is news. The truth is that experts have known that breast implants cause ALCL since at least 2013, and some of the foremost plastic surgeons in the country were discussing it behind closed doors since at least 2010.

The U.S. Food and Drug Administration (FDA), which is responsible for making public information about the risks of medical devices, including breast implants, first published a report on its website about ALCL and breast implants in 2011. At that time, they said there was evidence that implants might possibly cause ALCL. The FDA’s report came months after anarticle published in Allure magazine stated that plastic surgeons and their medical societies were studying the possible link between breast implants and ALCL.

Articles subsequently published in medical journals concluded that breast implants cause ALCL. But despite the growing evidence, the FDA didn’t update its website to officially report that breast implants really can cause ALCL until last week. That’s when the media realized it was a real story.

If you think women should have been told this sooner, here’s what you need to know:

In May 2016, the World Health Organization published a report that included the term breast implant associated ALCL (BIA-ALCL). A few months later, the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease. The guidelines (you need to sign up for a free account to see them) include a guided algorithm for surgeons and oncologists to test for and diagnose the disease. The authors conclude that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants are  implanted must be evaluated.

They also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years to make sure the ALCL is eliminated.

Why didn’t plastic surgeons or the FDA make that information more widely available? I’m sure there are women and their doctors who would have benefited from that information in the last few months.

In 2015, plastic surgeons who had denied any link between breast implants and cancer for more than two decades published an article in a plastic surgery journal about 173 women with ALCL that was caused by their breast implants.

However, plastic surgeons across the country focused on reassuring women that BIA-ALCL is “very rare” and the FDA echoed that mantra.  But, although rare, it seems that BIA-ALCL is not “very rare.”  In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., the Australian Department of Health estimates that BIA-ALCL affects as many as one in 1,000 women with breast implants.

The estimates of plastic surgeons and the FDA are much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. than in Australia. Given the dramatic increase in BIA-ALCL diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

For women with ALCL, it doesn’t matter how rare it is. The sooner it is diagnosed, the more likely it can be cured easily by removing the implants and scar capsule surrounding it. At later stages, women will need chemotherapy and are less likely to survive, according to research conducted at the MD Anderson Cancer Center that was published in 2013.

The study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis. You can read more about the study here.

ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.

A published response in the same medical journal urged physicians to respond quickly and to check patients who have swelling near their implants for ALCL. This would require cytology testing rather than testing for bacteria.

This news is especially important to women who undergo mastectomies to prevent cancer or for DCIS or very early breast cancer, either of which is equally likely to be cured with a lumpectomy instead. Women trying to beat cancer by undergoing a radical surgery they don’t need are unlikely to do so if breast implants will put them at risk of developing a different type of cancer.

The news is equally frightening to cosmetic surgery patients. Many health insurance companies refuse to cover the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. We now know this can result in undetected ALCL, which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.

Women deserve to know the facts.  And they deserved to know them years ago.

Read the full article here. 

Diana Zuckerman, PhD, National Center for Health Research, on behalf of Cancer Prevention & Treatment Fund:  March 9, 2017

The goal of the American Health Care Act is to replace the Affordable Care Act (ACA) with something better, but instead it represents a giant step backward for health care for all Americans. This proposed plan will cover far fewer Americans than the Affordable Care Act (ACA), and insurance will pay for less and cost more. The proposed tax credits and Health Savings Accounts (HSAs) will not begin to provide adequate health insurance for Americans covered under the ACA, particularly low-income patients.

A substantial number of people who had health insurance for the first time under ACA will lose it. The proposed 30% surcharge for those who let their insurance lapse is an insufficient incentive for healthy people to purchase insurance. Since the surcharge is the same for patients whose insurance lapses for 2 months or 20 years, it actually discourages healthy patients from buying health insurance until they have substantial medical expenses. The lack of healthy patients in the insurance pool means higher premiums and deductibles for all of us. And, as more uninsured patients end up in hospitals needing expensive medical care for cancer, heart disease, or other serious illnesses, that uncompensated care means higher hospital costs for all of us.

The very obvious shortcomings of the proposed TrumpCare bill are the reasons why hospital organizations, the American Medical Association (AMA), AARP, and many insurers are all against this legislation. It would disrupt the marketplace, create confusion and uncertainty, and reduce or strip health care coverage from millions of Americans.

Meanwhile, the bill would provide tax breaks for the wealthy at the expense of those losing health coverage. The legislation also would serve to severely reduce Medicaid benefits over time, by eventually turning the Medicaid coverage now provided into block grants to states, many of which might spend the funds on issues other than health care.