Emma Court, Marketwatch: July 28, 2017

A Food and Drug Administration announcement Friday that included a proposal to lower nicotine levels in cigarettes to non-addictive levels sent cigarette maker shares plunging. […]

Health experts said that the Friday announcement focused on important public health priorities, including examining the effect flavors, such as menthol, have in attracting young people to tobacco products and approaching any changes so as to avoid a spike in black market activity.

But they also expressed skepticism about the real-world effects of Friday’s news, and concern about its pushback of reviews for products like cigars and hookah tobacco until 2021 and things like e-cigarettes until 2022. The aforementioned products are already on the market but have come more recently under FDA regulation. […]

And the announcement’s intent matters less than “not just what they ask for, but what they require,” said Diana Zuckerman, president of the National Center for Health Research.

Extending the product review timeline keeps harmful products on the market longer, Dobbins said.

For its part, the FDA said that extending the review deadlines will give the regulator more time along with giving companies “additional time to develop higher quality, more complete applications informed by additional guidance from the agency.” […]

Though the Friday announcement appeared to be a negative for cigarette makers, it could be “an opportunity over the long term for reduced-risk products,” said Wells Fargo Securities analyst Bonnie Herzog, such as Altria and Philip Morris’ smokeless iQOS devices. “We see this as an opportune entry point for long-term investors and would recommend building positions on today’s broad weakness.” […]

Read the original article here.

Sheila Kaplan, The New York Times: July 11, 2017

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday. […]

But consumer advocates point to recent problems where initial reports of device malfunctions did not involve any injuries, but later evidence — sometimes additional devices showing flaws or reports indicating patients were harmed — began to surface. They pointed to cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. […]

Critics of relaxing the rules say this is not the right time to ease oversight when so much already goes undetected.

“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” […]

Mike Stankiewicz, Bloomberg BNA: July 10, 2017

More than one thousand medical devices, including umbilical clamps, menstrual cups, and dentures, will be exempt from an FDA clearance process.The Food and Drug Administration removed 510(k) notification requirements for some moderate-risk devices under steps established by the 21st Century Cures Act ( Pub. L. No. 114-255), a 2016 law intended to speed new drugs and devices to the market and reduce regulatory burdens. The newly exempt devices include commonly used items like dentures, menstrual cups and scented menstrual pads, umbilical clamps, and certain hearing aids. […]

The 21st Century Cures Act requires the FDA to determine which class II devices no longer require the premarket clearance.The FDA said the exemption will help industry by eliminating costs and time required to comply with regulations. […]

The Advanced Medical Technology Association, a medical device industry group, praised the FDA’s move.

“This action supports a risk-based review process for identifying lower-risk, well-established products for exemption and allows FDA to better focus its review resources to support the public health,” Janet Trunzo, senior executive vice president of technology and regulatory affairs at AdvaMed, told Bloomberg BNA July 10.

But Diana Zuckerman, president of the National Center for Health Research, a Washington-based nonprofit, said the FDA is going in the wrong direction because patients could be hurt by the moderate-risk devices.

“In addition to risks to patients, these FDA actions mean even less information about the devices that will be available to doctors and their patients,” she told Bloomberg BNA July 10. “How can doctors and patients make informed medical decisions without any any public information about these products? And how can medical care in the U.S. be made more affordable without requiring scientific evidence about safety or effectiveness for treatments that physicians are choosing for their patients?” […]

Read the original article here.

Bottom Line Inc., July 3, 2017

First comes the shock of a cancer diagnosis. Then comes the flurry of questions: Is there a cure? Is there a treatment? What drug do I take? Will it work?

Sometimes the answers are easy to find. People with chronic myeloid leukemia, for example, can take imatinib (Gleevec) and have an 80% chance of surviving for 10 years. 

But other cancer patients aren’t so lucky. They may be given an option of taking a chemotherapy medication that won’t help them live longer—and that will make their lives more miserable in the bargain. […]

We asked Diana Zuckerman, PhD, president of the National Center for Health Research, a nonprofit organization in Washington, DC, to explain why many new cancer medications have so few benefits…and what you or your loved ones can do to get the treatment you need and deserve—at a reasonable cost.

Rushing Cancer Drugs to Market

One big reason these drugs aren’t very effective is a sped-up approval schedule that puts many new cancer drugs in the hands of patients before they’ve been thoroughly vetted. 

Consider this: From 2002 to 2014, the Food and Drug Administration (FDA) approved 71 drugs for a variety of types of cancer—but fewer than half of these drugs have been shown to extend patients’ lives by at least two-and-a-half months, the minimum standard. Many of them came with hefty price tags of more than $10,000 a month. For some of these chemo drugs, the story is even worse—they didn’t improve survival at all. As if that weren’t bad enough, some of these new drugs have side effects that are as dangerous as the cancer they are supposed to treat.

How did this happen? In the quest to get potentially lifesaving medications to people who desperately need them, the FDA approves drugs before the information about their real benefits has been determined. […]

While stopping tumor growth or reversing it is a promising sign, physicians know that it can be temporary and sometimes followed by rapid tumor growth. […]

If you have cancer, you’re probably more interested in living longer than in simply avoiding death from cancer. For example, if the drug you take causes liver toxicity or a stroke that can kill you before the cancer would, it’s not doing you any good.

Not All Drugs Get Follow-Up Studies

When drugs are approved only on the basis of the way cancerous tumors respond, the FDA usually requires follow-up studies to prove that the drugs are truly beneficial, such as helping patients live longer or improving their quality of life for the weeks, months or years that they have left.

That process makes sense—as long as the FDA enforces it. […]

Yet all these drugs are still on the market. One reason is that postapproval studies that could result in removing a drug from the marketplace are very difficult to conduct. Example: It is difficult to conclusively prove whether these cancer drugs are effective because patients are less willing to participate in further clinical trials on a drug that’s already been approved.

The problem may get worse. The FDA is currently evaluating ways to overhaul its processes and speed up approval of all types of drugs, including cancer treatments, in its effort to get life-saving drugs on the market faster.

Little Consideration for Quality of Life

A drug that increases a cancer patient’s well-being and comfort is also considered worthy of FDA approval even in cases where living longer is not likely. But a recent study published in JAMA Internal Medicine looked closely at 18 drugs that had no survival benefit to see what effect they had on patients’ quality of life. The majority of the drugs either contributed to a worse quality of life—for example, patients suffered from diarrhea, fatigue, sleep disturbances or memory loss—or the evidence was mixed (which means the research was inconclusive, with some studies suggesting that treatment was helpful and other studies suggesting it was harmful). […]

Making the Right Treatment Choices

A cancer diagnosis is stressful under any circumstances, but if your cancer doesn’t respond to standard treatments, the choices get tougher. The choice is always the patient’s—for some people, living another two months is worth possible side effects. But there is no excuse for chemotherapy that won’t help extend life and makes you more miserable in the final days.

Unfortunately, you can’t always count on your doctor to help you sort through the options. Many doctors will list all the drugs out there because they want you to have a say in your own care. They also assume that FDA approval means that the advantages outweigh the dangers and may not realize that the studies are inconclusive.

To make an informed decision, though, you need to know the benefits and risks of the medications that are being offered. Here’s how…

Ask your doctor specific questions. Will this drug help me live longer, or will it just cause the tumor to shrink? What are the side effects and how dangerous or unpleasant are they? If you don’t get answers, ask your health-care provider to do some research and give you a summary of the results. Then do some digging on your own.

Use reputable sources for your research. Google searches can send you straight to a misleading advertisement for a drug as well as other misinformation from a variety of sources. Go to Drugs.com instead, where you’ll find the proven risks and benefits of each medication. Look for the sections on risks, side effects, adverse events and contraindications to find out what the problems might be. Check what the drug has been approved to treat. For example, some treatments used for prostate cancer are FDA approved to treat prostate “problems” or “health” but are not proven to treat prostate cancer.

You might also search on Google Scholar or PubMed to find journal articles written by scientists and medical experts who have studied the treatment you are considering. Again, read carefully to see whether there is any evidence that the drug improves “overall survival.”  If the drug improves “progression-free survival,” that doesn’t mean patients live longer.

Get impartial help. The Cancer Prevention and Treatment Fund, the primary project of the National Center for Health Research (where I work), offers a no-cost cancer help hotline to help patients sift through their choices. This organization doesn’t accept any funds from companies that make any medical treatments. Send an email to info@stopcancerfund.org with the type of cancer treatment you’re considering, and someone will reply with relevant and meaningful information that can help you make a smart decision.

Read the original article here.

Michelle Llamas, Drugwatch: June 20, 2017

Adverse events data collected from the U.S. Food and Drug Administration shows that reports of cancer linked to power morcellators are down while reports of injuries from Essure Permanent birth control are up in 2017.

Power morcellators are drill-like devices used to cut tissue into smaller pieces during gynecological surgeries. They have been on the market since the 90s, but it wasn’t until 2014 that the FDA warned about the risk of upstaging cancer. […]

“The decline in morcellator reports doesn’t mean women should be any less cautious,” [data analyst Madris] Tomes told Drugwatch. “Patients still need to ask questions.” […]

Essure Adverse Events on the Rise

While the number of morcellator cancer reports is decreasing, reports of injuries linked to Bayer’s Essure Permanent Birth Control device are on the rise.

Doctors implant Essure metal coils into each fallopian tube. After about three months, scar tissue builds up and prevents pregnancy. But since the device hit the market in 2002, the FDA received thousands of adverse events. […]

Data Reporting Problems at the FDA

There are several reasons why warnings about Essure and morcellators didn’t reach the public sooner.

One of the biggest issues is how the FDA receives and reports data on medical device adverse events. In fact, the FDA admitted it didn’t have the current data on the device at a 2016 meeting to discuss Essure device safety, according to Tomes.

In 2016, the FDA reported five deaths linked to Essure. Tomes did an independent data review and found more than 300 fetal deaths and more than 10,500 adverse events.

It highlighted a big problem with how the FDA managed injury reports. It also called into question how reliable the agency’s reports are. […]

To complicate matters, device manufacturers may also be holding back information. […]

Advocacy Remains a Key Force in Reducing Adverse Events

Madris Tomes attributes a number of factors to the decline in morcellator reports, including refusal of insurance companies to pay for morcellator surgeries, hospitals banning the device and FDA safety communications.

But the personal stories and convictions of women affected by these devices led to the most action. […]

Legislation Aimed at Making Devices Safer, Preserving Legal Rights

Because of women and their families who spoke out about morcellators and Essure, the issue of medical-device safety has reached Congress. Now, a number of bills aimed at improving safety are pending in Congress. […]

The Medical Device Safety Act seeks to remove this protection and allow patients to file lawsuits against manufacturers.

The bill has the support of consumer advocacy groups, including Consumers Union (the policy arm of Consumer Reports) and The National Center for Health Research (NCHR).

“If a patient dies from the use of a PMA-approved medical device, there is no accountability for that person’s surviving family,” Lisa McGiffert, director of Safe Patient Project, and Diana Zuckerman, president of NCHR, wrote in a letter to the Committee on Energy and Commerce. “H.R. 2164 merely allows states to determine how best to protect patients from unsafe medical devices, just as the law allows states to protect patients from unsafe prescription drugs.” […]

The journey has been emotionally moving for Amanda Rusmisell and her fellow advocates at Essure Problems. Even today, speaking about it brings her to tears.

“I’ve seen women from all backgrounds whose lives were ruined by Essure,” she said. “But I’ve had the opportunity to see women helping women. We’ve come together to form a grassroots organization, and we made it to Congress.”

Read the original article here.

Emma Court, Marketwatch: June 21, 2017

Back in fall of 2016, the Food and Drug Administration put out an important new rule telling companies they had to remove certain chemicals from their antibacterial soaps, or else not market them at all.

Two of the most common anti-bacterial chemicals, triclosan and triclocarban, are usually found in both liquid soaps and bar soaps, the FDA noted then.

But what the regulator didn’t say is just how many other places those chemicals can be found, everywhere from clothing to body products, household items, playgrounds, exercise equipment and more.

More than 200 scientists and medical professionals from around the world have signed on to a statement warning about the chemicals could have harmful effects on humans and the environment. […]

But there’s evidence that these antibacterial chemicals have no major health benefits for consumers, the Tuesday statement said, referring to epidemiological studies and a 2003 Centers for Disease Control and Prevention advisory committee report.

But they’ve been linked to increasing allergen sensitivity and disruptions to hormones, the endocrine system and possibly the reproductive system, the statement said, though some of the evidence is from animal studies and may not transfer over to humans.

Because of their possible role in hormone disruption, these chemicals may be especially harmful for pregnant women and children.

Animal studies have also suggested triclosans could have an effect on the microbiome, which includes gut bacteria, according to the statement. […]

The September FDA decision “means a lot” and speaks to the potential harms of these chemicals, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

The regulator wouldn’t have changed its mind if the data were ambiguous, she said.

“What’s really clear is that for a lot of uses, the risks outweigh the benefits,” she said. “And the risks outweigh the benefits to the individual, but also the environment.”

Read the original article here.

Diana Zuckerman, PhD, and Megan Polanin, PhD, National Center for Health Research, Our Bodies Ourselves: June 15, 2017

When Angelina Jolie publicly announced her double mastectomy four years ago, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies – even some women with the “breast cancer genes.”  You’ll be surprised by what we’ve learned.

A 2007 review of 10 studies found that the risk of getting breast cancer for an average woman with BRCA1 is 57%. The risk is 49% for a woman with BRCA2. Although frightening, this is far from the inevitable breast cancer diagnosis that many women expect. And, keep in mind that the lifetime risk of breast cancer is very different from the risk of getting breast cancer in the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14% chance of getting breast cancer before she turns 50. We’re willing to bet that is a much lower risk than most women assume. With regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives.

Most women are diagnosed with breast cancer at early stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). Yet American women are undergoing mastectomies at a higher rate than women in other countries, including prophylactic mastectomies. Breast cancer experts believe that many women undergoing mastectomies do not need them and are getting them out of fear, not because of the actual risks.

For many years, experts have known that women who undergo mastectomies for the non-invasive condition called ductal carcinoma in situ (DCIS) or for early-stage breast cancer do not live longer than women undergoing lumpectomies. However, the latest research goes a step further:  A 2016 study of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or bilateral (double) mastectomy. They were also less likely to have died of breast cancer. In 2016, Harvard cancer surgeon Dr. Mehra Golshan reported that of almost half a million women with breast cancer in one breast, those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast. These are just the latest studies – for more information about the years of consistent evidence that less radical surgery is better, see this article.

And yet, an increasing number of U.S. women with early-stage breast cancer are choosing to have both their breasts removed “just to be safe.” A 2015 study conducted by researchers at Vanderbilt University reported that, for women diagnosed with early-stage breast cancer in one breast, the rates of double mastectomy increased from 2% to 11% from 1998 to 2011. Researchers found that decisions to have a double mastectomy increased more for two groups of women: 1) Women with ductal carcinoma in situ (DCIS) where there are abnormal cells inside a milk duct in the breast that won’t spread and aren’t dangerous unless breast cancer develops later; and 2) Women with cancer only in one breast that has not spread to the lymph nodes. This year, researchers from Emory University reported that the percentage of women over 45 getting double mastectomies for early-stage breast cancer in one breast increased from 4% to 10% in less than a decade. For women ages 20-44, the percentage tripled from 11% to 33%. To some extent, geography was destiny: in five Midwestern states (Nebraska, Missouri, Colorado, Iowa, and South Dakota), 42% of the women who got surgery had a double mastectomy.

The bottom line is that women with DCIS or early-stage breast cancer have more effective and less radical treatment options than mastectomy. Even women with BRCA1 or BRCA2 may never develop breast cancer, and if they do, they may not need a mastectomy. We need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

So, the good news for women newly diagnosed with cancer is that mastectomies are not the best choice for most women if they want to live longer. Women should be aware of treatment choices for breast cancer and encouraged to make decisions based on their own unique situations. For each woman, it is important to weigh her own risk of cancer — in the next few years, and not just over her lifetime – and the risks of various treatments. Each woman should make the decision that is best for her, based on information, not on fear.

See the original blog post here