Congress Passes Bill with Billions for Cancer Research

But some consumer groups say new standards for drug approvals could put patients at risk

Consumer Reports / Teresa Carr / December 7, 2016

Congress has passed the most expensive and far-reaching health reform bill since the Affordable Care Act in 2010.

The 21st Century Cures Act, which garnered widespread, bipartisan support in both the House and Senate, is expected to be signed into law by President Obama soon.

The bill signifies an investment of billions of dollars over the next decade to fight cancer, prevent and treat brain disorders, and harness enormous amounts of data to develop individualized treatments based on person’s environment, genes, and lifestyle.

But the bill also lowers the bar for the kind of scientific evidence companies must provide to gain the Food and Drug Administration’s (FDA) approval for their products. It would mean, for instance, that in some circumstances the FDA could rely in part on individual patient experiences with a drug or device, instead of evidence from large-scale, randomized controlled clinical trials.

Rep. Fred Upton, the Republican from Michigan who chairs the House Energy and Commerce Committee and co-sponsored the bill, says the Cures Act "expedites the approval of drugs and devices and includes literally billions of dollars in additional spending for health research so that we can find a cure and the answers to what patients are demanding today.”

Consumer groups, including Consumers Union, the policy and moblization arm of Consumer Reports, have deep concerns that this effort to speed medical innovation comes with a potentially harmful tradeoff for consumers.

“The unfortunate consequence of 21st Century Cures is that less thoroughly tested medications and medical devices will reach the market,” says Lisa McGiffert, director of Consumer Reports’ Safe Patient Project. “And that means that consumers will have less assurance that a new treatment will help and not harm them.”

More Research Dollars

The bill directs $4.8 billion over the next decade to research, in part, to fight cancer.

“Considering that one in two men and one in three women will be diagnosed with cancer in their lifetime, cancer research funding is an investment in yours, mine, and everyone’s health,” says David Pugach, vice president of federal relations at the American Cancer Society Cancer Action Network, the advocacy arm of the ACS.

Pugach says 21st Century Cures represents a “historic opportunity” to accelerate cancer research. “This includes devoting more resources to improve and use new treatments like immunotherapy,” he says, “where the body’s own defenses are used against cancer—as well as creating ways for researchers to more easily share data so they can see patterns across studies more quickly.”

The bill also allocates funds to treat brain disorders, combat opioid abuse, improve suicide prevention programs, and provide mental health care to children. It establishes a task force for research on women who are pregnant or breastfeeding because these women are typically excluded from medical studies.

Faster Drug Approvals, But Lower Standards

The Cures Act loosens requirements for how drugs are studied and approved that have been in place since 1962.

Here's how it usually works: A company submits evidence from studies done under controlled conditions, comparing patients who received the treatment with those who didn't. The studies typically have to show that people who were given the new drug lived longer or felt better than those who didn't get it.

This kind of research can be expensive and time-consuming for drug companies to collect, says Diana Zuckerman, Ph.D., president of the National Center for Health Research, a nonprofit think tank focused on health research. Cancer drugs, for example, can take several years to show that a drug improves survival.

The Cures Act calls on the FDA to approve some drugs more quickly, based on less thorough testing. The problem with this, says Zuckerman, is that “getting drugs to market faster doesn’t help consumers at all if they turn out not to work or causes them harm.”

What Consumers Should Know

Once the Cures Act takes effect, consumers must be especially careful when considering a new medication or medical device, says Orly Avitzur, M.D., Consumer Reports’ medical director.

"When you have a choice, you may want to consider treatments with a proven track record, as you'll have more assurance that they work and are safe," Avitzur says. "Always make sure someone has taken the time to thoroughly explain all the options to you, and the possible risks and benefits of each."

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

A Generic EpiPen Might Not Be Your Best Option

Consumer Reports / Teresa Carr / August 30, 2016

Mylan is introducing a generic version of its life-saving EpiPen, 

but Consumer Reports has found another low-cost option

Mylan's plan to introduce a generic version of its life-saving EpiPen will cut the price in half, to $300 for a two-pack. But Consumer Reports has found that another low-cost option already exists.

Mylan announced the generic version of EpiPen after members of Congress as well as Consumers Union, the policy and mobilization arm of Consumer Reports, called for the manufacturer to lower the $600 price.

The generic EpiPen will be released in the next several weeks. But that's not your only—or perhaps even the best—option for getting the medicine and auto-injector.

There's already a low-cost epinephrine auto-injector available, the generic version of Adrenaclick. This product delivers the same drug, in the same dosages, but the auto-injecting mechanism works slightly differently.

It lists for about $450 for a two-pack, but we found that you could get it for as low as $140 at Walmart with a coupon from GoodRx.com. Your insurance might also cover it with a lower co-pay than brand-name EpiPens, and you might qualifty for further discounts using coupons through the manufacturer.

Mylan says that their new generic will be identical to their brand-name EpiPen. The generic device for giving yourself an injection with the drug ephinephrine will work exactly the same way to quell severe allergic reactions that interfere with breathing. And, like the brand-name version, the generic will be available in two doses—a 0.3 mg adult strength and a 0.15 mg strength for children.

Mylan told us that generic EpiPen will be available from pharmacies and directly from the company by mail.

Generic EpiPen Might Not Be Cheaper For You

With little competition and many years left on the patent for the EpiPen injector, it's "highly unusual" for Mylan to come out with a generic product to essentially compete with itself, says Stephen W. Schondelmeyer, Ph.D., Pharm.D., a professor of pharmacy economics at the University of Minnesota. "I think the company realized that they overreached on price," he says. "They can cut the price in half and still make a profit."

Even so, the generic EpiPen is overpriced, he says. "We're talking about a lifesaving product that costs a few dollars to make," says Schondelmeyer. "It's hardly a consumer win that the company has now decided to charge only $300."

Mylan told Consumer Reports that it won't offer coupons for the generic EpiPen, so even after it hits the market, some people might find it cheaper to stick with the brand-name version, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists. "It really depends on your individual situation and insurance coverage," she says.

Young advises enlisting your pharmacists' help in pricing the various options—if possible before your healthcare provider writes the prescription. "Your doctor will need to write the prescription specifically for the device you decide on," she says.

For an EpiPen or generic EpiPen, your healthcare provider can simply prescribe the brand-name product. The generic is exactly the same, so pharmacists should be able to substitute it for the brand if you request it. To help lower the consumer's out-of-pocket costs if they are insured, Mylan announced last week it would offer larger discounted co-pay coupons, up to $300, and it expanded its patient assistance programs for brand-name EpiPens. However, those discounts are not available to people with Medicare or other government health insurance programs.

For generic Adrenaclick, your provider should prescribe "generic Adrenaclick" or simply "epinephrine auto-injector." Because those auto-injectors are slightly different than EpiPens, laws in many states prohibit phamacists from substituting one device for the other. (In some states, however, including California, Colorado, Connecticut, Florida, Vermont, and Washington, pharmacists can fill an EpiPen prescription with generic Adrenaclick, according to the drug's manufacturer, Impax Laboratories.) Just make sure that you get trained on the device before leaving the pharmacy, Young says. EpiPens and Adrenaclick pens are very easy to use and have similar instructions, but you want to make sure that you understand exactly what to do in an emergency situation.

More Competition on the Way

One reason Mylan might be coming out with a generic now is to get ahead of the competition. Earlier this year, the Food and Drug Administration turned down an application by drugmaker Teva for a generic epinephrine auto-injector due to "major deficiencies," but the company told us that it might reapply and that its product could enter the market next year.

In addition, Mark Baum, the CEO of Imprimis, a company that compounds drugs, told us that Imprimis is investigating selling epinephrine auto-injectors directly to consumers for about $100 for a two-pack of pens. Baum noted the company plans on selling them by the end of the year.

In the short term, an array of different options could make it more confusing for consumers, Young says. "But in the long run, the competition is likely to help bring down costs."


Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

Fluoroquinolones Are Too Risky for Common Infections

An FDA panel says popular antibiotics such as Cipro are overprescribed and should have stronger warnings about dangerous side effects

By Teresa Carr / Consumer Reports / Last updated: March 07, 2016

Last November, Rachel Brummert, 45, of Charlotte, North Carolina, stood before a panel of experts and described the ever-worsening series of health problems, including 10 ruptured tendons and progressive nerve damage, she’s suffered as side effects of taking the antibiotic Levaquin, a type of fluoroquinolone, for a suspected sinus infection in 2006.

The Food and Drug Administration convened the panel to consider whether the official drug labels for fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, should be changed to more clearly spell out their risks and discourage overuse. Brummert, the executive director of the Quinolone Vigilance Foundation, was one of more than 30 people who spoke during the open public hearing portion of the meeting about how the drugs had an impact on their lives.

“I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” Brummert says.

After reviewing the evidence, the 21-member FDA panel agreed. They voted overwhelmingly that, in most cases, the benefit of fluoroquinolones to treat three common illnesses—bacterial sinus infections, urinary tract infections, and some forms of bronchitis in people with chronic lung disease—was outweighed by the risk of rare, but serious side effects, including irregular heartbeats, depression, nerve damage, ruptured tendons, and seizures.

Currently, those three illnesses account for nearly one-third of all fluoroquinolones prescribed outside of hospitals in the U.S. according to data presented by Janssen Pharmaceuticals, makers of Levaquin, at the FDA meeting.

While the fluroquinolones are essential for treating serious infections such as anthrax, the FDA panel members noted that they are overprescribed for common infections where other treatments would work just as well with less risk. They called on the FDA to strengthen labeled warnings and clarify when the drugs—should—and should not—be used.

Rampant Overprescribing

Over the last 30 years, the FDA has approved five fluroquinolone antibiotics to treat one or more of three illnesses considered by the panel: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

Much of the evidence on the risks of the drugs emerged after the drugs were on the market and used by millions of patients. While medical organizations such as the Infectious Diseases Society of America have updated their guidelines to advise against prescribing fluoroquinolones for milder garden-variety infections—including most cases of bronchitis, sinus infections, and urinary tract infections—many doctors haven’t gotten the message. That's likely because these powerful antibiotics work against a wide variety of bacteria, says Lindsey R. Baden, M.D., an infectious disease physician at Brigham and Women’s Hospital in Boston, Massachusetts, an associate professor at Harvard Medical School, and a member of the FDA panel. That can lead to overprescribing.

“Fluoroquinolones play an important role in treating serious infections such as those caused by bacteria that are resistant to other types of antibiotics,” says Baden. But in the case of less severe illnesses such as a mild bacterial sinus infection or uncomplicated bladder infection, the drugs “should typically be reserved for second-line or even third-line treatment after other antibiotics have failed,” says Baden.

When to Say 'No' to Cipro and Similar Drugs

Below we’ve listed three types of infections where fluoroquinolones are often not the best first choice for treatment along with our medical advisers’ advice about what to do instead.

• Sinus infections. “The vast majority of sinus infections are caused by a virus, not a bacteria and antibiotics don’t work against viruses,” says Baden. Even if bacteria are responsible, the infection will typically clear up on it’s own in a week or so. An antibiotic such as amoxicillin may be warranted if your symptoms last longer than a week, start to improve and then worsen, or are very severe—accompanied by a fever of 101.5 or higher, for example, or extreme pain and tenderness over your sinuses. For more information see Choosing Wisely recommendations from the American Academy of Allergy, Asthma, and Immunology. 
• Urinary tract infections (UTIs). If you have symptoms of a urinary tract infection such as having to urinate frequently, pain or burning when you go, cloudy or bloody urine, and a fever, you may need an antibiotic to treat the infection. Several types of antibiotics are effective against uncomplicated bladder infections; fluoroquinolones are typically only necessary if the infection is resistant to other antibiotics or has spread to the kidneys. Note that people aged 65 and older often have bacteria in their urine, but do not need to be tested or treated for a UTI unless they have symptoms. For more information see Choosing Wisely recommendations from the American Geriatric Society. 
• Bronchitis. As with sinus infections, most cases of bronchitis, or chest colds, are caused by a virus and are not helped by taking an antibiotic. (Read our advice on what to do ease symptoms while your body fights the infection.) One exception: patients with chronic obstructive pulmonary disease (COPD), a condition that causes difficulty breathing, may benefit from antibiotics if they develop symptoms severe enough to require hospitalization. In that case, the best choice of drug depends on the several factors, including which bacteria are prevalent in your area. For more information on using antibiotics to treat respiratory illness in children see Choosing Wisely recommendations from the American Academy of Pediatrics.

All Antibiotics Have Risk

Brummert says she hopes that the FDA will act on the advisory panel’s recommendations. “Curbing unnecessary prescribing of fluoroquinolones could save thousands of Americans from needless suffering,” she says.

Baden points out that all antibiotics—not just fluoroquinolones—should be used more thoughtfully.

“Really, I think the labels for all antibiotics should be strengthened to remind doctors and patients that when the drug is unwarranted, prescribing it has no benefit and exposes patients to needless risk, however small that risk may be,” says Baden. “Antibiotics are overused; as a community we need to be having these conversations about better prescribing based on the balance of benefits to harms.”

Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).