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Right to Try? Or Right to be Exploited Before You Die?

April 17, 2017News Stories & EditorialsCPTFadmin

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

Alzheimers 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.

What If Ryan Gets His Wish and Trumpcare Becomes Law

March 15, 2017news-you-can-useCPTFadmin

Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

March 15, 2017In the News, News Stories & Editorials, news-you-can-useCPTFadmin

Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the full article here.

Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

January 20, 2017Breast Cancer, Breast CancerCPTFadmin

Mingxin Chen, MHS and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.[1] The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years. However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Reference

Stevens, W. G., Harrington, J., Alizadeh, K., Berger, L., Broadway, D., Hester, T. R., . . . Beckstrand, M. (2012, November). Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientraʼs U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel. Plastic and Reconstructive Surgery, 130(5), 973-981.

2016 study explains why so many cancer drugs don’t work

December 30, 2016New Cancer ResearchCPTFadmin

Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Most of us know cancer patients who received drugs that drained their energy and joy of living but didn’t seem to benefit them. In some cases, the cancer stopped growing within a few months and even began to shrink, but ultimately the patient did not seem to live even a day longer.

Why is that?

A key problem is that cancer drugs do not have to be proven to prolong anyone’s life in order for the Food and Drug Administration (FDA) to approve them. Researchers at the National Cancer Institute and Oregon Health & Science University reviewed all the cancer drugs approved by the FDA from 2008 to 2012 (Kim & Prasad). They found that 26 of the 54 cancer drugs were not required to be proven to prolong or save lives, but instead were approved based on what are called surrogate markers, which are “signs” such as tumor shrinkage that are expected (but not guaranteed) to predict patients’ longer life.

Once the drugs were approved, thousands of patients started taking these drugs and paying for them, despite the lack of evidence of a meaningful health benefit. However, the FDA did require the companies to keep studying the drugs to find out if those medicines were actually extending lives.

The answer, unfortunately, is that many of these drugs did not help patients live longer or better. Only five of the 36 drugs were proven to help patients live longer. Eighteen drugs (50%) failed to extend life and 13 (36%) have unknown impact on survival because no data on them are available to the public. Since companies are very good at sharing information when their drugs are proven effective, experts assume that means those 13 drugs are not proven to work.

In November 2016, the National Center for Health Research published a study looking more carefully at those 18 ineffective drugs. We found that only one was proven to improve quality of life – which isn’t surprising, since cancer drugs so often cause nausea, vomiting, hair loss, and exhaustion. Two made quality of life worse, and the other 15 new cancer drugs either did not improve quality of life (6), or there is not enough evidence to know if they do or not. We also looked at the cost of those cancer drugs and found something that doctors, patients, family members, and lawmakers need to know: the new cancer drugs that are not proven to benefit patients in any way cost just as much as the ones that are effective – up to $170,000 per patient. In fact, the most expensive of the 18 cancer drugs was a thyroid cancer drug (Cabozantinib, also called Cabometyx or Cometriq) that had no benefit to survival compared to placebo, and also caused patients to have a worse quality of life.

Meanwhile, the ineffective cancer drugs remain on the market and Medicare and insurers are still paying for them. When the president of the National Center for Health Research asked FDA officials why they take so long to rescind the approval of ineffective cancer drugs, they stated that they still think those drugs might be effective, but that it is difficult to prove. They pointed out that once a cancer drug is approved, it is very difficult to keep patients in a clinical trial long enough to know if the drug actually saves lives. We agree it is difficult; if a patient is in a clinical trial and not doing well, he or she is likely to drop out, whether they are on the new drug, old drug, or placebo. But that’s a major problem: if the FDA is approving cancer drugs on short-term, inconclusive data, and then requiring better studies that they know are unlikely to be completed appropriately, that’s quite a Catch-22. It means that the FDA is approving cancer drugs knowing that we’ll never know if they are safe and effective or not.

This article is based on this study in JAMA Internal Medicine.¹

Table 1. Most New Cancer Drugs That Don’t Help Patients Live Longer Also Don’t Improve Their Quality of Life

^aFDA review notes that sponsor stated one study found a difference in deterioration of QoL that was statistically significant in favor of bevacizumab.

^b On November 18, 2011, FDA revoked accelerated approval of the breast cancer indication for bevacizumab.

^c One subgroup analysis of Japanese patients found a QoL benefit.

^d Includes any combination of the other categories (better, no statistical difference, worse).

P.S. In 2019, cancer therapy drug Lartruvo failed to meet the main goal in a late-stage trial testing the therapy in patients with advanced or metastatic soft tissue sarcoma. Read more here.

Letter to Senators on the Innovation for Healthier Americans Bills

November 10, 2016LegislationCPTFadmin

Patient, Consumer and Public Health Coalition: November 8, 2016

The Honorable Lamar Alexander
United States Senate
Washington, DC 20510

Dear Senator Alexander:

The undersigned nonprofit organizations represent members of the Patient, Consumer and Public Health Coalition, which includes more than 6 million healthcare providers, public health experts, and consumer and patient advocates. We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).

A number of leading medical experts, including a former Commissioner of the FDA, Dr. David A. Kessler, believe that the bill “could lead to the approval of drugs and devices that are less safe or effective than existing criteria could permit”. We believe that the far-reaching measures described below will significantly impact public health and safety and should therefore not be rushed into law in the final brief weeks of this Congress.

For example, the PATH Act, in both the House and Senate versions, would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway. Unfortunately, these antibiotics could then be widely advertised in order to increase sales, even though they may be much less safe or effective than older, less expensive antibiotics.

The MEDTECH Act, also in both Senate and House (Section 2241) versions, would prevent the FDA from collecting adverse events caused by flawed electronic medical records and decision support software. A study by the National Center of Health Research found that these types of health IT devices can cause like-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments.

The Advancing Breakthrough Devices for Patients Act, versions of which are in both House and Senate bills, would encourage shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include sufficient numbers of women, men, seniors, and racial and ethnic minorities. Moreover, a recent study of high-risk medical devices found that the median number of participants is currently only 65 patients, which is already too small to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for people of color. The House bill is even worse; for example, Section 2221 would permit companies that manufacture life-saving devices such as heart valves and stents, to be modified without submitting the new devices for FDA approval, as is now required.

Alarmingly, the bill in its current form also allows anecdotal and easily manipulated sources of health data to be used to approve new drugs (Section 2121). It effectively would eliminate clinical trial drug testing for new medical uses (called “indications’ in the bill). This measure also would result in the widespread use of medications for uses that are not approved by FDA, causing inevitable patient harm. (Section 2012: Facilitating responsible communication of scientific and medical development).

In addition to the extensive dilatory effects on FDA’s ability to protect the public health, the bill also extends exclusivity provisions for the pharmaceutical industry, discouraging the use of cheaper generic drugs, and having the practical effect of increasing or maintaining higher drug prices, at a time when the vast majority of Americans are frustrated with and angered by rapidly increasing drug prices. For example, the Advancing Hope Act, passed by the Senate, would continue the existing pediatric priority review voucher program through 2022. A recent GAO review of the program concluded that the program has questionable benefit. And, by allowing drug makers to buy a priority review, the bill undermines FDA’s ability to set its work priorities based on public health needs.

There also is serious concern concerning whether the additional $550 million dollars allocated to FDA by the House version of the bill would be sufficient to carry out the extensive mandates outlined by the legislation. FDA already is severely under-funded and cannot absorb unfunded mandates without dire consequences to its regulatory effectiveness and ability to protect public health.

The House version of the bill also weakens reporting requirements for the bipartisan Physician Payments Sunshine Act (“Sunshine”), a medical payments disclosure measure which is being successfully administered by the Centers for Medicare and Medicaid (CMS). The Sunshine Internet data base has provided the public with a useful and readily accessible transparency tool that can be used to discover which physicians and surgeons are accepting payments from the pharmaceutical and medical device industry, how much, and for what purpose.

Until the Sunshine data base was established a few years ago, doctors were accepting hundreds of millions of dollars annually in undisclosed payments from industry, much of which was intended to influence drug prescribing practices and the physicians’ brand choice of medical devices. The Sunshine Act does not prohibit or discourage these payments, merely makes them part of the public record, and allows patients and consumers to decide whether such payments influence their own medical treatment and choice of physicians.

In addition to weakening safeguards for patients and increasing the availability of treatments that are not proven either safe or effective, neither the House nor Senate bills include provisions to lower drug prices. A recent study by a researcher at the National Cancer Institute found that most cancer drugs approved during a recent 5-year period are not proven to improve the health of cancer patients. The National Center for Health Research assessed the cost of those ineffective drugs and found that they cost the same or more as cancer drugs that are proven to work. A recent letter to Congress by a coalition of more than a dozen labor and public interest groups asked the Congress to delay consideration of the Cures/Innovation bills until there are measures included to lower drug prices. We agree, but we also point out that several provisions in these bills would have the opposite impact, since many new drugs would be sold without clear evidence of efficacy, and yet those new drugs will inevitably cost more than older, more effective and less expensive treatments.

Sincerely,

National Center for Health Research
American Medical Student Association
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Breast Cancer Coalition
Center for Medical Consumers
Connecticut Center for Patient Safety
Institute for Safe Medication Practices
Jacobs Institute of Women’s Health
Mothers Against Medical Error
MRSA Survivors Network
National Physicians Alliance
National Women’s Health Network
Our Bodies Ourselves
Quinolone Vigilance Foundation
TMJ Association
Washington Advocates for Patient Safety
WomenHeart
Woody Matters

For more information, please contact Jack Mitchell at jm@center4research.org.

Pro&Con: Experience Well-Suits Her to Deliver Affordable Care to All

September 26, 2016News Stories & EditorialsCPTFadmin

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

SouthCoastToday affordable care 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.

Stop Cancer Now Lap-a-thon: November 6, 2016

September 19, 2016EventsCPTFadmin

The second Stop Cancer Now Lap-a-Thon at Tuscarora High School is fast approaching! See photos from the first Lap-a-thon here.

In order to participate on Sunday, November 6, 2016, please register to participate by donating $20, or make a donation of any size. Donations over $20 will be considered a contribution to the Cancer Hotline, which provide individualized assistance to anyone who calls or emails the Cancer Prevention and Treatment Fund!

If you would like to create or join a team, please write the name of the team in the comments section. (You can also participate without a team.)

The teams with the most members and the team that raises the most money will win a prize at the Lap-a-Thon.

Thank you!

MyPlate: A New Alternative to the Food Pyramid

June 13, 2016Diet, Habits, & Other BehaviorsCPTFadmin

Caroline Novas, Cancer Prevention and Treatment Fund

A goal of the U.S. government is to help guide adults and children to be as healthy as possible. “MyPlate” replaces the familiar “food pyramid” diagram that underwent several changes in the 19 years since it was first introduced.^[1] The MyPlate model shows the five food groups (fruits, vegetables, proteins, grains, and dairy) in a place setting. It is designed to be easier to understand when you think about what types of food to include in each meal that you eat.

How Does MyPlate Work?

The plate is divided into four unequal sections to represent different food groups. Vegetables make up the largest section, followed by grains. Fruits and vegetables fill half the plate while proteins and grains fill the other half.

One of the most noticeable things about MyPlate is that it includes no distinct meat section. Instead, “protein” includes fish, shellfish, eggs, beans, peas, nuts, and seeds in addition to meat. In addition to recognizing the benefits of a plant-based diet, another big change is the elimination of the “oils” or “fats” section included in the food pyramid.

A small blue circle on the side of the plate represents dairy. This simple model is designed to make it easy for consumers to see what an ideal meal should look like, without too many restrictive details.

Critics of MyPlate say it shouldn’t include dairy, which they argue is unnecessary for a healthy diet. Critics also say it is important to give information about the size of the plate.

History: From MyPyramid to MyPlate

For over 100 years, the U.S. Department of Agriculture (USDA) has provided Americans with different types of food guides and pyramids to encourage healthy food choices. Since 1992, the Food Pyramid has been the dominant model. The idea behind the original 1992 Food Pyramid was that the foods we should eat most are the ones that form the base of the pyramid, while those we should eat less of are near the top. However, these guidelines were unclear and difficult to follow. The Food Pyramid was based on servings, but there was no clear guidance about serving size, and no guidance on the total number of calories recommended per day.

Because of these problems a new pyramid – MyPyramid — was introduced in 2005. Food groups were coded by stripes in widths corresponding to the recommended servings from each group. All the stripes tapered toward the top of the pyramid to remind people that each food group includes both healthy and unhealthy choices, such as foods with added sugar or “solid” fat. Although an improvement over the old Food Pyramid, MyPyramid was criticized as confusing to many consumers. The USDA hopes that MyPlate will provide a simple, easy to understand visual method for consumers to eat healthfully.

How Do I Plan Family Meals with MyPlate?

MyPlate is based on the 2015-2020 Dietary Guidelines for Americans, which provides detailed instructions for planning healthy meals and snacks. These guidelines are fairly long, but there are some simple points to take away:

Make half your plate fruits and vegetables. Try to choose whole or cut-up fruits without added sugars, and vary your vegetables; try different types and cooking them different ways (raw, steamed, roasted, sauteed) but try to avoid fried.
Switch to 1% or skim milk, cheese, and other dairy options. Avoid full-fat dairy products.
Half of your grains should be whole grains. Grains are the largest portion of MyPlate, and half of those should be whole grains. Look on labels for the word “whole”– not multigrain or seven grain. Brown rice and whole wheat pasta also count. Try to stay away from grain-based desserts and snacks, such as baked goods
Vary your protein. Try different types, such as seafood, eggs, beans, unsalted nuts, lean meat and poultry.
Watch out for sodium, saturated fat, and added sugars. Use nutrition labels to help you choose food and drinks that contain less sodium, fat and added sugar. Bread can have as much salt as salty snacks, for example. Many fruit juices have little fruit and lots of sugar, and sweetened coffee drinks can contain a lot of sugar and fat. Try to drink water instead of sugary drinks.
Get more physical activity. Most Americans don’t get enough physical activity. Daily exercise is important to overall health. Kids, especially, should have limited “screen time,” and be encouraged to play outdoors rather than watching TV or using the computer.

For more guidance, the USDA offers the ChooseMyPlate.gov website. You can use the website’s SuperTracker tool to create a personalized plan just for you. It also has other resources to help you find healthy recipes, calculate your BMI (body mass index), and learn more about how to maintain a healthy diet.

MyPlate information is also available in 20 different languages, including Spanish.

MyPlate can be a helpful basic guideline for kids and adults to know how much to eat from each food group, but it’s important to also follow the additional guidelines above for healthy eating.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

ChooseMyPlate.gov. Retrieved June 7, 2011, from United States Department of Agriculture. http://www.choosemyplate.gov/index.html

Ovarian Cancer: What Are the Treatment Options?

May 14, 2016Ovarian Cancer, Treatment & ManagementCPTFadmin

By Lea Simms and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

Ovarian cancer is the 5^th leading cause of cancer death in women in the U.S. Approximately 21,000 women will receive a new diagnosis of ovarian cancer in 2015. [1]

Ovarian cancer begins in or near the ovaries, which is part of the female reproductive system. There are two ovaries, one on either side of the uterus, connected to the uterus by the fallopian tubes. Ovarian cancer is often undetected until it has spread to the uterus, pelvis, and abdomen.[2]

Like all cancers, treatment is much more successful in the early stages when the cancer has not yet spread.[3] Women over the age of 55, women who have a family history of breast or ovarian cancer, and women who have had trouble getting pregnant or have never been pregnant are all at increased risk for ovarian cancer.[4]

To find out more about who is at risk and what to do about it, see our article Ovarian Cancer: who should be concerned and what can they do?

Traditionally, there have been three different types of ovarian cancer described:[5]

Epithelial
Germ cell
Stromal

Epithelial tumors are the most common type: 85%-90% of all ovarian cancers are epithelial.[2]These tumors start from the layer of cells that cover the outside of the ovaries or line the inside of the fallopian tubes, and can then spread to other parts of the body. There are four different types of epithelial ovarian cancer: serous (the most common), mucinous, endometroid, and clear cell. These different types of epithelial cancer describe how the tissue looks under the microscope and also the behavior of the cancer.

Germ cell tumors are a rarer form of ovarian cancer, in which the tumor starts growing in the germ cells that produce the eggs. Germ cell tumors make up about 2% of ovarian cancer cases and have a very high survival rate of 90%.[2] This type of cancer is most commonly seen in women under 25 years old (ovarian cancer research fund). There are several types of germ cell tumors: teratomas, dysgerminomas, endodermal sinus tumors, and choriocarcinomas.

There are also stromal tumors which begin in the tissue cells that hold the ovary together. Stromal tumors are diagnosed in about 1% of women with ovarian cancer and have a high survival rate of 75%.[2]

Like most cancers, ovarian cancer is probably not a single disease, but is made up of several different types of cancer that start in different places in or near the ovaries. Each type of cancer has its own unique genetic make-up, place where it begins to grow, and way of spreading. For example, the most common form of ovarian cancer, high-grade serous carcinoma, is now thought to start in the fallopian tube instead of the ovary [6]. New treatments for ovarian cancer are in the early stages, but the goal is to develop treatment options for these specific types of ovarian cancer.

Benign ovarian tumors are not cancerous and can be treated by removal of all or a part of an ovary. Tumors that are cancerous can metastasize (spread) and can be fatal. The stage of the tumor is used to describe how much it has spread ranging from stage I (only within the ovary or fallopian tube and has not yet spread) to stage IV (has spread to outside organs like the liver or lungs). The grade classifies the tumor on how much it looks like normal tissue: 1 is the most like normal tissue and 3 is the least like normal tissue. These classifications are used to determine what treatment is recommended.[1]

Treatments

If you were diagnosed with ovarian cancer, your medical team will recommend one or more treatment options. The main treatments for ovarian cancer are:

The most common recommendation for all stages of ovarian cancer is surgery followed by chemotherapy.[1]

Surgery

Surgery for epithelial ovarian cancer has two main goals: to stage and debulk (remove) the tumor. Staging refers to the doctors looking to see how far the cancer has spread and then taking tissue samples to test in a lab. Usually this means the doctor will remove the ovaries, uterus, cervix, fallopian tubes and omentum (fatty tissue around these organs), and then remove tissue and fluid samples from the abdominal cavity and pelvis.[1] The surgeon will then remove as much of the tumor as possible, which is called debulking. If the disease seems to be limited to one or both ovaries, the surgeon will biopsy the pelvis and abdomen to find out if the cancer has spread. Sometimes debulking is not possible because the patient is not healthy enough or the tumor may be attached to other organs. In these cases, chemotherapy will be used to treat the cancer that can’t be surgically removed.[1]

Research has shown that if the cancer is caught early enough, a woman can be safely treated without removing her uterus (read more about it http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/). Women with later stage ovarian cancer usually must undergo surgery that removes the uterus and thus causes infertility.[7]

For germ cell tumors and stromal tumors the main goal of surgery is to remove the cancer. Germ cell tumors are usually treated with a hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of ovaries and fallopian tubes). If the cancer is found in one ovary, then only one of the ovaries and a fallopian tube will be removed to preserve the woman’s fertility. Stromal tumors are treated by removing the cancerous ovary, unless the cancer has spread to other areas, in which case a hysterectomy or bilateral salpingo-oophorectomy will be performed.[1]

Chemotherapy

After surgery, patients with epithelial ovarian cancer are treated with chemotherapy. Typical chemotherapy is a combination of 2 or more drugs, every 3-4 weeks, with 3-6 cycles. A cycle is a schedule of regular doses of drugs followed by a rest period.[2]

The chemo drugs are given by mouth, injected into a vein (Intravenous chemotherapy also known as IV), or injected through a catheter directly into the abdomine (called intraperitoneal chemotherapy or IP). IP therapy works by bringing the toxic drugs in a concentrated form to exactly where the cancer is, while IV therapy aims to kill cancer cells wherever they might be located.[5] In 2006, researchers reported that on average, patients receiving IP chemotherapy lived 65 months, compared to 50 months for patients receiving IV chemo only [8]. That is why the National Cancer Institute currently recommends IP administration of chemo to treat ovarian cancer. However, this recommendation may soon change. In 2016, a study of 1,560 ovarian cancer patients surprisingly found no difference in survival for women receiving IP chemo compared to other traditional methods [9]. This is important because IP therapy tends to cause worse side effects.[5]

Although IP and IP/IV administration has been shown to have benefits and has been recommended by the National Cancer Institute, the combination tends to have worse side effects.[5] That is probably why most eligible patients do not receive a combination of IP and IV chemotherapy.[7]

There are many different types of chemotherapy drugs and research has shown that giving a combination of drugs in the initial treatment of ovarian cancer is more effective.[10] Most doctors prescribe a platinum compound such as cisplatin or carboplatin and a taxane compound such as paclitaxel or docetaxel.[1] A very large study in 2006 compared 198 clinical trials of 48,440 women being treated for ovarian cancer and found that the regimen that best prolonged survival is a platinum and taxane combination with intraperitoneal administration.[8]

Hormone Therapy

Hormones or hormone-blocking drugs can stop the growth of tumors. Tamoxifen is an anti-estrogen drug that is common in the treatment of breast cancer and some ovarian stromal tumors.[1] There have been no large studies of Tamoxifen for ovarian cancer, however. It is generally used as a second-line therapy for recurrent stromal tumors or tumors that do not respond to standard chemotherapy. Since side effects are generally mild, it is considered a less toxic choice for women who cannot tolerate the side effects of standard chemotherapy. However, tamoxifen can increase the risk of serious blood clots in the legs, so patients should be aware of this risk before considering it.[1]

Targeted Therapy

Targeted therapy uses genetically engineered drugs such as bevacizumab (Avastin) and olaparib (Lynparza) to attack the cancer cells. In several studies, Avastin has been shown to have some effectiveness in delaying the progression of ovarian cancer but it is not clear whether it helps patients live longer, and it has substantial side effects that can harm quality of life.[11][12]

Olaparib (Lynparza) is approved by the FDA for the treatment of ovarian cancer in women with BRCA1 or BRCA2 mutations as a last resort for women who have had three or more prior unsuccessful treatments of chemotherapy.[13] It has not been proven safe or effective for other ovarian cancer patients, but two studies are underway to see if the drug can be a useful treatment for women with BRCA mutations who have previously tried at least one platinum-based chemotherapy treatment.[14][15]

Radiation Therapy

Radiation therapy is not common for ovarian cancer. Radiation therapy uses high energy x-rays or particles to kill the cancer cells. It is sometimes used for recurrent cases when the cancer is confined to a small area.[2]

Which types of treatment you and your doctor decide to go with depends on the type of ovarian cancer you have and how it has advanced.

Clinical Trials

Clinical trials are used to help find new treatments for cancer.[2] If more effective treatments are found through clinical trials, they may become the standard treatment. If the new treatment is found to be less effective or have worse side effects, it probably will not be approved by the FDA and will not be available in the future. Patients can enter clinical trials at different stages of their cancer treatment, but some trials may only be open to patients who have not yet started treatment. Remember: the treatments tested in clinical trials are not proven to be effective and the side effects are often unknown. The new treatment may be worse than standard treatments, better, or identical in terms of effectiveness or side effects. For those reasons, clinical trials are usually chosen by patients who have no other good options for treatment. See here for the National Cancer Institute’s list of clinical trials: http://www.cancer.gov/about-cancer/treatment/clinical-trials.

The Latest Research

New research suggests that the most common route of treatment (first surgery, then chemo) might not be the most effective route of treatment. There is now evidence that having chemotherapy first, then followed by surgery, may be more effective for women with ovarian cancer, especially with epithelial ovarian tumors.[16] Research has shown that chemotherapy prior to surgery improved the debulking of the tumor[17][18] and that patients also had fewer surgical complications and better post-operative recovery.[19]

The latest research, by Dr. Sean Kehoe and his team of doctors, took place in 87 hospitals in the UK and New Zealand.[18] The study randomly assigned 552 women with stage III or IV ovarian cancer to either the “Primary Surgery Group” (surgery followed by 6 cycles of chemotherapy) or to the “Primary Chemotherapy Group” (3 cycles of chemotherapy, then surgery followed by 3 more cycles of chemotherapy). The study measured overall survival rate as well as progression free survival (delaying the spread of cancer) and quality of life. At the conclusion of the study, 231 patients in the primary surgery group had died as had 220 in the primary chemotherapy group. Although the number of patients that died was similar, the Primary Chemotherapy group lived 1.5 months longer on average and had fewer adverse side effects and fewer toxic effects than the Primary Surgery group. The median survival rate (how long they lived after treatment) for the Primary Surgery group was 22.6 months compared to 24.1 months for the Primary Chemotherapy group. These results are also consistent with observational studies that showed similar results in survival rates.[20]

Although the differences in survival rate and duration of survival were similar, the chemotherapy group did have marginally better outcomes. This new finding may change the way doctors treat ovarian cancer and gives women another option rather than immediate surgery.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

How is ovarian cancer treated? (2015, March 12). Retrieved June 8, 2015, from http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-treating-general-info
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. (n.d.). Retrieved June 8, 2015, from http://www.cancer.gov/types/ovarian
Ovarian cancer. (n.d.). Retrieved June 16, 2015, from http://www.mayoclinic.org/diseases-conditions/ovarian-cancer/basics/definition/con-20028096
Waghray, P. (n.d.). Ovarian cancer: Who should be concerned and what can they do? Retrieved August 12, 2015, from http://dev.stopcancerfund.org/uncategorized/ovarian-cancer-who-should-be-concerned-and-what-can-they-do/
Types of Ovarian Cancer. (n.d.). Retrieved June 16, 2015, from http://www.ocrf.org/about-ovarian-cancer/what-is-ovarian-cancer/types-of-ovarian-cancer
Perets R, Drapkin R. It’s totally tubular… riding the new wave of ovarian cancer research. Cancer Res. 2016;76(1):10-17.
Bromberg, J. (n.d.). Patients under 50 with early-stage ovarian cancer: Safe treatment with no loss of fertility. Retrieved August 12, 2015, from http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/
Armstrong DK, Bundy B, Wenzel L, et al. Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer. N Engl J Med. 2006; 354:34-43.
Walker JL, Brady, MF, Wenzel L. A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study. Annual Meeting on Women’s Cancer. March 19-22, 2016. San Diego, CA. Presentation.
Kyrgiou, M, G Salanti, N Pavlidis, E Paraskevaidis, and JPA Ioannidis. n.d. “Survival benefits with diverse chemotherapy regimens for ovarian cancer: Meta-analysis of multiple treatments.” Jnci-Journal Of The National Cancer Institute 98, no. 22: 1655-1663. Science Citation Index, EBSCOhost (accessed August 12, 2015).
Garcia A, Singh H. Bevacizumab and ovarian cancer. Ther Adv Med Oncol. 2013; 5(2): 133–141. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3556875/
Li, J., Zhou, L., Chen, X., & Ba, Y. (2015). Addition of bevacizumab to chemotherapy in patients with ovarian cancer: a systematic review and meta-analysis of randomized trials. Clinical & Translational Oncology: Official Publication of The Federation of Spanish Oncology Societies And of The National Cancer Institute of Mexico.
Lynparza (Olaparib) label. (2014, December 1). Retrieved August 13, 2015, from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1). (2013, April 30). Retrieved August 13, 2015, from https://www.clinicaltrials.gov/ct2/show/NCT01844986
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. (2013, June 7). Retrieved August 13, 2015.
Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol 2006; 103: 1070–76.
Vergote I, De Wever I, Tjalma W, Van Gramberen M, Decloedt J, van Dam P. Neoadjuvant chemotherapy or primary debulking surgery in advanced ovarian carcinoma: a retrospective analysis of 285 patients. Gynecol Oncol 1998; 71: 431–36.
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Hou JY, Kelly MG, Yu H, et al. Neoadjuvant chemotherapy lessens surgical morbidity in advanced ovarian cancer and leads to improved survival in stage IV disease. GynecolOncol 2007; 105: 211–17.
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