By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.

By Margaret Dayhoff-Brannigan, PhD

April 2015

Measles is in the news, and many parents are wondering if their children are at risk. Here is what you need to know.

In 2014, there were 644 cases of measles in the United States, which is the most we have had in 14 years. 1 As of April 3, 2015, there have been 159 cases of measles, which is on track to be just as high as 2014. Most of these were linked to an outbreak in Disneyland in California. Measles is very easy to catch, even from someone who doesn’t yet feel sick. That’s why even a seemingly healthy person visiting Disneyland could infect many other people. Most people that get measles have not been vaccinated.

There are two doses of the measles vaccine that are required for full immunity. Most children get the first dose when they are between 12-15 months old, and the second dose when they are around 4-6 years old.2

The measles vaccine works in more than 96% of people that get both doses.3 Scientists have repeatedly shown that the MMR (Measles, Mumps and Rubella) vaccine is very safe, but since there are rare, but serious reactions, some parents are afraid to vaccinate their children. However, 95% of kindergarteners in the U.S. have had the measles vaccine. Occasionally, cases of measles are brought to the U.S. by visitors from countries where measles is more common.4 Anyone who is not vaccinated is at risk of catching and spreading the disease, and that puts us at risk of a widespread outbreak.

 

What is measles?

Measles is a very contagious disease that is caused by a virus. A person with the measles may infect 90% of the unvaccinated people around them. One person with measles can easily spread the disease to 12-18 other people before they even know they are sick.5

The most common symptom of the measles is a rash, which appears 3-5 days after you catch the virus. It is an itchy red rash that usually starts at the head and then spreads to other areas of the body.6

Other symptoms can include:

  • Fever
  • Cough
  • Bloodshot eyes
  • Runny nose
  • Sore throat
  • Muscle pain

Measles used to be considered a normal part of childhood, and many adults alive today had measles as children. However, measles cases today tend to be a more serious disease because children do not inherit antibodies from their biological mothers, if those mothers were vaccinated rather than having measles themselves. Some studies suggest that 15-25% of children or adults that get measles will need to be hospitalized, and some will die even with the right treatment.7,8,9 These frightening statistics are because pregnant women and children and adults who have HIV, cancer, or are malnourished are especially at risk of having complications, hospitalizations and death due to the measles.7,10 In rare cases, measles can cause the brain to swell, which can lead to deafness or brain damage.11

 

How can we protect ourselves?

The best way to prevent the measles is to get vaccinated. The second dose of vaccine was not recommended until 1989, so if you were born between 1957 and 1989 you may have only received one dose, which does not protect as well as both doses. If you are unsure if you have been vaccinated or if you only got one dose, you should consider getting vaccinated again as an adult. Young children (under 5) and adults (older than 20) are more likely to suffer from measles complications.9 If you live in an area where there are a lot of cases of the measles, such as Arizona, and you are unsure if you have had two vaccinations, your doctor might recommend a booster shot.12 Check with your doctor for more information.

Infants under 1 year old and children and adults with compromised immune systems (such as patients with cancer, HIV, or pregnant) should not get the vaccine. If everyone else gets vaccinated, these people will be protected by what is called “herd immunity”. This means that if an unvaccinated person is around people who were vaccinated, there is no one to infect them with the disease.

There are communities in the U.S. where many children are not vaccinated, and those communities are more likely to be harmed by measles. Children and adults who are not able to be vaccinated because of their health status or because they are too young, are in greater danger if they live in a community where more people were not vaccinated.

 

Vaccine Safety

In 1998, Andrew Wakefield published a study stating that the measles vaccine could cause autism.13 It was later determined that his data were fraudulent and he had a financial stake in an alternative vaccine, and he lost his medical license.14 There have been reports from parents that their very normal children have had serious health problems, including autism, after being vaccinated. This has resulted in fear and opposition to the vaccine. However, there have been more than 80 scientific studies that conclude that the vaccine does not cause autism.3,4,5 In 2008, the US Court of Federal Appeals issued a ruling that the MMR (and other vaccines) do not cause autism or autism spectrum disorders.15 There is a compensation fund for the very rare cases where children are injured by vaccines, developing conditions such as anaphylaxis(severe allergic reaction), encephalopathy (disorder of the brain), or a sequel (chronic disease) developing during the time period. However, based on the evidence and court rulings autism is not eligible for compensation.16

For many years, parents were concerned about the risks of thimerosal (made from mercury) that was used in the MMR vaccine. Thimerosal was eliminated from all routinely recommended vaccines administered to children starting in 2001.17 Adult vaccines that contain trace amounts of thimerosal have less mercury than a can of tuna fish, so they are considered safe.

While some vaccines are produced in eggs, they do not contain any egg protein and are safe for children with allergies.11 If your child can tolerate small amounts of egg, such as in baked goods, then there is unlikely to be a problem with any vaccines. Talk to your pediatrician or allergist if you are concerned about egg allergy.

With MMR, or with any vaccine, there is a risk of an allergic reaction or other side effects, such as fever, rash, or pain at the injection site. Seizures are an extremely rare side effect. Most of these risks are much less serious than measles. More information about important vaccines can be found here.

By Margaret Dayhoff-Brannigan, PhD

April 2015

The flu is hitting hard and you may have friends and family that are getting sick. Here is the information you need to know about current treatment options for the flu.

Your best protection from catching the flu is to get a flu vaccine (more information here). The vaccine does not work 100% of the time, but there are other simple steps you can take to prevent flu, such as washing your hands with soap frequently and avoiding contact with sick family, friends or coworkers.

If you have the flu, there are several prescription medications available including: oral oseltamivir (Tamiflu), inhaled zanamivir (Relenza), or the intravenous drug peramivir (Rapivab).18 However, studies show that these medications only help you recover one day faster from the flu. Rather than going to the doctor’s office to get examined and get a prescription, you might prefer to stay home and rest and drink plenty of fluids.

Over the counter (OTC) medications don’t cure the flu but they can help you feel better by treating symptoms such as aches, coughs, and sore throats. A list of safe options can be found here. Antibiotics do NOT work against the flu because it is caused by a virus and not by bacteria.

Tamiflu is heavily advertised, but many doctors believe that Tamiflu does not work well enough to justify the high cost of the drug, or the CDC recommendation that all patients take it.19 These doctors point out that there is very little high quality evidence that Tamiflu reduces the rate of serious complications from the flu. Since Tamiflu gets so much attention in the media, you may want to know more.  Here is the info that you need to help you decide if you want to try it for yourself or a loved one.

 

Is Tamiflu (Oseltamivir) effective for treating the flu?

Tamiflu is a prescription antiviral medication used for treatment of the flu and to prevent catching the flu if you have been near someone sick. It has been heavily advertised, but there is lots of controversy over whether or not it is actually effective.

On average patients who start taking Tamiflu within 48 hours of getting sick will recover one day faster than patients who do not take anything.  Roche, the makers of Tamiflu, claim that Tamiflu also reduces the number of patients who have serious complications from the flu, such as pneumonia (by 44%) or hospitalization (by 63%).20 However, the Tamiflu only worked in patients who had tested positive for the flu on a laboratory test, not patients with flu-like symptoms who subsequently were found to not have the flu. Other researchers examined the same study data and concluded that Tamiflu does not reduce hospitalizations or other complications when analyzing all people who went to the doctor because of flu-like symptoms.21 This means that if your doctor prescribes Tamiflu without giving you a flu test, it is less likely to help you get better. That’s because many patients who think they have the flu have a cold instead, and they will not benefit from Tamiflu.

Similarly, when Tamiflu was used to prevent the flu in people exposed to confirmed cases of flu, it was able to reduce their likelihood of getting sick by as much as 55%.4

Tamiflu has been approved for use in adults, infants as young as 2 weeks, children, and pregnant women. Tamiflu does not work as well in patients that are over 65.22

 

Is Tamiflu safe?

The most common side effects of Tamiflu are:

  • Nausea
  • Vomiting
  • Diarrhea
  • Stomach pains
  • Dizziness
  • Headaches

The more serious side effects include:

  • Seizures
  • Sudden confusion
  • Delirium
  • Hallucinations
  • Unusual behavior
  • Self-injury

The serious side effects are very rare, but tend to occur more often in children, so if your child is taking Tamiflu and you notice any of these symptoms, speak to your doctor immediately and discontinue use of Tamiflu.23

You should also stop using Tamiflu immediately and seek medical attention if you have any signs of allergic reaction, including hives, difficulty breathing, swelling of the lips, tongue or throat or skin rash.

To help the FDA determine how common these Tamiflu side effects are, it is important to report any side effects to the FDA by calling 1-800-FDA-1088.

With all these risks, and so little benefit, why take Tamiflu?  The director of the Centers for Disease Control and Prevention thinks it is worth it, but experts in the field disagree. As a patient, you should weigh the risks and benefits before deciding if Tamiflu is right for you. If you can start taking Tamiflu quickly within 48 hours of getting flu symptoms and a positive flu test, it is more likely to work, but still may only shorten your flu by one day.  Patients such as pregnant women, infants, or patients with a weakened immune system are more at risk of complications from the flu and might be more likely to benefit from Tamiflu, but should talk to their doctors to weigh the risks and benefits before deciding.

 

Other treatments

As mentioned above, there are two other FDA-approved antiviral medications to treat the flu virus. However, these medications are not better than Tamiflu at treating the flu, and also have serious side effects.

Inhaled zanamivir(Relenza) is FDA approved for the treatment of flu in children and adults ages 7 and older.24 Rapivab is given intravenously in a hospital, doctors office or clinic, and was approved by the FDA in December 2014 for patients 18 and older with uncomplicated flu.25  However, it was shown to only reduce fever 12 hours earlier than placebo, which means it usually provides even less relief than Tamiflu. Relenza is inhaled and can cause serious breathing problems in patients. Both drugs must be taken within 2 days of the first flu symptoms in order to work, similar to Tamiflu.

You may wonder why the FDA approved these flu treatments that have such modest benefits.  It is important to understand that when the FDA approves a drug or device, that doesn’t mean the scientists there recommend it for patients to use.  It only means that they think it has some benefit for some patients, and that the average patient is more likely to benefit than to be harmed.  However, as with many other medications, some patients will not benefit at all, and some may be very seriously harmed.

By Joce Sterman, WJLA-TV (ABC News)

April 2, 2015

WASHINGTON (WJLA) – After using social media to shine a light on potential problems with a permanent birth control device, a group of concerned women finally got the chance to share its concerns with the Food and Drug Administration, in person.

Essure permanent birth control. (WJLA photo)

The 7 On Your Side I-Team told you in January about claims of complications with a product called Essure. On Thursday, we caught up with the group as it continued its crusade to try and get the device pulled from the market.

Angie Firmalino and others associated with a Facebook group focused on problems the members say are linked to Essure came to Washington, D.C. Thursday to take part in an official meeting with the FDA. Media were not allowed to attend. The FDA says representatives from its Office of the Commissioner, Women’s Health, Compliance, Chief Counsel and other departments were in attendance.

Firmalino and other representatives of the Facebook group spoke at the meeting, expressing their concerns and experiences with Essure. Thousands of complaints have been logged in the FDA’s database related to the device. Bayer, which makes the product, says “it stands behind the safety and efficacy of Essure.” But for women like Firmalino, voicing the concerns they’ve had for years was a relief.

“It was validation,” Firmalino said. “It’s nice to have some validation that they’re finally listening and they may actually look at this and something may come of this.”

Something already has. After a Citizen’s Petition was filed with the FDA, the agency forwarded it to its Office of Compliance and agreed to investigate. Bayer says it is cooperating with the FDA and will respond to any of the agency’s questions. The company says the petition comes from a law practice already engaged in lawsuits against Bayer.

Dr. Diana Zuckerman, president of the National Center for Health Research, is working with the Facebook group.

She said of the FDA meeting, “They hear a lot of complaints from a lot of different patients. It doesn’t always get anywhere. The impression is they’re really listening.”

Zuckerman says during the FDA meeting the agency heard not only about claims of complications, but also claims of problems with the clinical testing that got Essure on the market more than a decade ago, when it was manufactured by a different company, Conceptus.

“I don’t know what’s going to happen next,” Zuckerman said. “But I do think that the FDA will be following up in a concerted way.”

See original article and video here.

Diane Ng

March 2015

Many people turn to over-the-counter medicines when they need relief from allergy and cold symptoms or have trouble falling asleep.  That’s why you might be concerned about a new study showing that one of the most common of those drugs—Benadryl—could lead to serious health problems, including dementia.

Benadryl has many uses.  Although often taken for allergy symptoms, the same dose of the same ingredient (diphenhydramine) is used in most over-the-counter sleeping pills, and also used for motion sickness. We’ve known since 2012 that people who regularly take Benadryl or other sleeping pills to fall and stay asleep are more likely to get cancer and tend to die earlier than people who don’t take sleep medication.  A 2015 study, however, found that taking Benadryl also seems to increase a person’s chances of developing dementia.

Most people who take Benadryl don’t even know it, since the pills they buy in their local drug stores have many different names (such as Tylenol PM, Simply Sleep, Unisom, ZzzQuil, Compoz Nighttime Sleep Aid, Simply Right Sleep Aid, Allermax, and Equate Nighttime Sleep Aid).26 Drugs containing diphenhydramine aren’t the only ones linked to an increased risk of dementia. The 2015 study, led by a researcher from University of Washington, found an increase in dementia linked to a type of drug known as anticholinergics. These drugs are known to help dry out a runny nose or tearing eyes and also to make you sleepy; they work by blocking acetylcholine, a chemical that sends messages to and from the brain and helps start muscle contractions.

In addition to Benadryl, other anticholinergics include tricyclic antidepressants such as Tofranil (Imipramine), Elavil (Amitriptyline), and Sinequan (Doxepin),27 and medicines for overactive bladder such as Toviaz (fesoterodine); Ditropan, Gelnique, and Oxytrol (all with the generic name oxybutynin); Vesicare (solifenacin); and Detrol (tolterodine).28 These are just a few of the many names for these drugs – if you are taking tricyclic antidepressants or medicines for overactive bladder, check them out online to see if they are similar to the drugs listed above.

The 2015 study showed that the longer and more consistently people took anticholinergics, the more likely they were to develop dementia.29 The study included more than 3,000 men and women who were 65 or older, and they were randomly chosen from among members of the Group Health system in the Seattle area. None of the men and women had dementia at the time that they were selected for the study, and all had belonged to the health plan for at least 10 years. Using patient health records, study participants were then divided into 5 groups based on how much they used anticholinergic drugs in the 10 years before the study began (which means they were age 55 or older). These were calculated as objectively as possible, based on information including the number of times such drugs were purchased at pharmacies belonging to the Group Health system. A limitation of the study is that the purchase of over-the-counter anticholinergics at other pharmacies would not have been included.

The researchers followed the study participants for over 7 years on average to see who developed dementia. Those who had the highest exposure to these drugs (equivalent to taking an anticholinergic every day for more than three years), had a 54% higher risk for dementia compared to those who did not use anticholinergics at all. Those who had between 1 and 3 years’ worth of exposure (366-1,095 days) had a slightly higher risk for dementia than the patients with no exposure, but the difference was not statistically significant. This means it could have happened by chance. The general trend was the greater the use (as measured in days) of anticholinergics, the higher the risk of dementia. However, only the highest exposure (more than three years) had a link to dementia that researchers can say for sure was not a chance occurrence.

Taking Benadryl or other anticholinergic drugs occasionally probably won’t harm you. But, it’s important to remember that, according to this study, the more you take—and this means either the dose or the number of days—the higher your risk of developing dementia. Some of the people in the high exposure group may have been taking very low doses but they took them for a long time. Even if you think you’re not taking a lot of Benadryl or these other drugs, using them for years could put you at risk.

BOTTOM LINE

While we can’t be absolutely sure that Benadryl (diphenhydramine) or other anticholinergic drugs cause dementia, there is now one study that suggests that it might.  When added to other studies showing a link between diphenhydramine and cancer and earlier death, it certainly raises questions about whether this very common and inexpensive medication, sold in supermarkets and drug stores across the country, is too dangerous to take on a daily basis for more than a few weeks.

All drugs tend to stay inside your body longer as we get older.  All patients, and especially those who are 55 or older, may want to avoid regular or long-term use of anticholinergics and sleeping pills. Benadryl is both an anticholinergic and a sleeping pill, so that is of even greater concern.

Many people assume that if a drug is sold without a prescription in your neighborhood store, it is safe for you to take as often as needed.  That is not true, because drugs are not tested for very long-term use before they are allowed to be sold.  Whether you have allergy symptoms, trouble falling asleep, a bladder that keeps you running to the bathroom more than you’d like, or even depression, there may be safer ways of coping with or treating the problem. And, the strategies that don’t involve medications are the ones with the least risks.

Essure is a widely used device intended to provide permanent birth control for women. According to the FDA, the permanent sterilization device Essure is 99.8% effective at preventing pregnancy if used correctly over 5 years.30 However, a study published in Contraception in April 2014 found that Essure is far less effective than previously reported by the FDA and by Bayer, the company that sells Essure. If one takes into account the women who do not have correct Essure placement or sufficient occlusion, or do not return for a mandatory 3-month follow-up test to confirm that the procedure worked, 10% of women undergoing an Essure procedure will become pregnant within 10 years.31 This is 3-4 times higher than the pregnancy rate for women who use surgical methods to permanently prevent pregnancy.2

The National Center for Health Research’s Dr. Diana Zuckerman and Dr. Laurén Doamekpor recently published a response to this study, also in Contraception, highlighting the need for more research to examine and verify the long-term effectiveness and safety of Essure. Their response also briefly described their survey of more than 900 women who have reported experiences of chronic pain, heavy bleeding, autoimmune symptoms, depression, and other adverse events as a result of Essure.32

The authors of the original study also published a reply in the same journal to Dr. Zuckerman and Dr. Doamekpor’s article, expressing similar concerns about the lack of sufficient data on the safety and effectiveness of Essure.33  Accurate information about how well Essure works and its long-term safety are essential so that women who do not want more children can make an informed choice regarding their contraceptive options.

Rebecca Silverman

March 2015

Many children and adults are not getting enough sleep.  There are always good excuses – Too much work to do!  I just got an email or text message that I need to respond to! – but the bottom line is you need more sleep and it’s much better to find ways to fall asleep naturally than to rely on sleeping pills.

Regardless of your work and family obligations, these are some ways that you can improve your sleep:

  • Establish a routine: Going to sleep and waking up around the same time each day helps regulate your body and promote a consistent sleep cycle.34 Avoid sleeping late on the weekends because doing this throws a wrench into your sleep cycle, making you more tired during the week.
  • Exercise: Daily exercise has been proven to help people sleep. However, exercise right before bed is not a good idea because it can keep a person awake for longer. Studies suggest that you should exercise no later than 5 to 6 hours before your normal bedtime.
  • Finish eating 2-3 hours before bedtime: Eating a large meal before bed can make it difficult to fall asleep. Avoid drinking liquids close to bedtime to prevent trips to the bathroom during the night.35
  • Avoid Caffeine, Nicotine, and Alcohol: Caffeine, which is found in coffee, chocolate, tea, and some soft drinks, keeps people awake. Smokers often experience light sleep due to nicotine, and alcohol makes it difficult to fall and stay asleep until morning.
  • Avoid naps: While you may be tired during the day, naps can interfere with getting a full night’s sleep.
  • Wear a sleep mask: Research shows that sleeping in total darkness allows your body to produce as much of the hormone melatonin as possible, which is responsible for regulating your body’s internal clock, thus allowing you to sleep longer and deeper.
  • Do not take sleeping pills: A study on the danger of sleeping pills found that people who take prescription sleep medication are significantly more likely to be diagnosed with cancer or die earlier than people who don’t take them. According to a 2012 article in Consumer Reports, people using popular sleeping pills like Ambien take 33 to 46 minutes to fall asleep and only get about half an hour more sleep than if they had not taken a pill in the first place.36

If you have sleep apnea there are things you can do to improve your condition:

  • Lose Weight: Even losing a little weight can reduce symptoms.37
  • Use a mouthpiece:  A dentist or orthodontist can make a custom-fit plastic device to wear in your mouth while sleeping that helps keep your airways open. Mouthpieces may need to be adjusted or replaced over time.38
  • Continuous positive airway pressure machine (CPAP): The CPAP machine blows air into your throat to keep your airways open while you sleep. The machine uses a mask that fits over your mouth and nose, or just over your nose. While studies show that CPAP masks can result in significant improvement in symptoms of sleep apnea, some people find the masks bothersome or uncomfortable.39 CPAP treatment may cause side effects in some people, including a dry or stuffy nose, irritated skin around the face, dry mouth, and headaches.
  • Surgery: Surgery to remove tissue from the back of the throat has been used to treat severe sleep apnea. The University of Maryland Medical Center reports that success rates for this surgery are rarely higher than 65% and often deteriorate with time, averaging about 50% or less over the long term.40 More research is needed to compare surgery to the other treatments for sleep apnea.

March 27, 2015

My name is Dr. Anna Mazzucco.  Thank you for the opportunity to speak today on behalf of the National Center for Health Research.   After completing my Ph.D. at Harvard Medical School, I conducted research at the National Institutes of Health before joining the Center’s staff.  Our research center conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to health professionals, patients, and policymakers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the FDA’s budget, so that it can do its job well. Those are the perspectives I bring today.

Our organization does not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.

The FDA stated that their proposal is intended to “ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling.”  This is the heart of the matter before you today.

As FDA noted, when generic versions are available, it is the generic version that is dispensed 94% of the time.  This proposal has implications for millions of Americans who assume that they have the same legal protections and most up-to-date information, regardless of whether their drug is a brand name or not.

The current situation creates a terrible double standard, making patient with generic drugs second class citizens.  And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label.  This is completely unacceptable.

The proposed rule applies equally to brand name drugs and generic drugs.  This is consistent with current law, since brand name and generic drug companies are already “required to conduct surveillance, evaluation, and reporting of postmarketing adverse drug experiences” and, if necessary, propose revisions to the drug’s labeling.  This proposal would ensure that those responsibilities are brought across the finish line to patients.

Some may argue that by the time generic versions enter the market, any safety issues with the brand name version should be well known.  From the FDA’s own study, we know that is not true.  Unfortunately, the FDA found that the median time from initial approval of the drug product to the time of making a safety-related labeling change was 11 years.

Generic drug makers and some others have speculated that allowing generic companies to initiate labeling changes will cause confusion among patients.  We strongly disagree:  Patients are smart enough to understand why different labels may differ. 

Even so, the FDA’s addresses those concerns by requiring generic and brand name companies to begin the process with FDA to harmonize their labeling within 30 days.  The FDA also proposes to establish a Web page where the FDA would promptly post information regarding the labeling changes proposed.  The Web page would provide information about safety-related labeling changes and a description of the proposed labeling changes and the source of the information for them, such as adverse event reports, journal articles, clinical trials, or epidemiologic studies. The new final labeling will be posted on the FDA Web page.

We completely agree with the FDA that concerns about temporary differences in labeling between generic drugs and brand named drugs are outweighed by the benefit to the public health that comes from updating labels with drug safety information.

The proposed rule will save lives and improve the quality of lives of patients who take generic drugs.  It will provide the most current information about the risks, hazards and side effects of drugs—crucial information for patients and their health care providers.  Patients have told us that they expect that information from the FDA.

And we strongly agree that patients deserve that information.

 

 

The National Center for Health Research

Cordially Invites You to Our

2015 Foremother and Health Policy Hero

Awards Luncheon

Friday, May 8, 2015 at Noon

 The Cosmos Club of Washington, D.C.

2121 Massachusetts Ave NW

Please join us and WJLA’s Maureen Bunyan on May 8th, the Friday before Mother’s Day, at the elegant Cosmos Club in Washington, D.C. as we celebrate our 16th  anniversary as a national charity!

Help us honor these wonderful 2015 Foremothers:

  • Jodie Bernstein is one of our nation’s  foremost consumer advocates.  As director of the Bureau of Consumer Protection at the Federal Trade Commission (FTC), she was the country’s top Cybercop, making the Bureau a model for consumer protection agencies around the world. Her new initiatives involved protecting children and adults who shop online, subprime lending, privacy protection, and fraud prevention.  Described in a Washington Post magazine cover story in March as an audacious woman “before audacious was in,” she mentored, nurtured and inspired generations of consumer protection advocates.
  • Karen Mulhauser has dedicated her life to key progressive causes, and was one of the early leaders of the modern women’s movement.  She is Chair of the UN Association of the USA and has been a founding force behind many progressive nonprofit advocacy organizations, including the Women’s Information Network and Public Allies. She served as Executive Director of nonprofit groups dedicated to women’s reproductive rights and against nuclear war, and has been a leader in improving race relations and increasing voter registration.  She has provided support, encouragement, and mentoring to scores of women in Washington, DC.
  • Our 2015 Health Policy Heroes are two physicians who have become the most visible and effective patient advocates in the country:  Dr. Amy Reed and Dr. Hooman Noorchashm.  Both were Harvard Medical School faculty when Amy was treated for what was assumed to be a benign uterine fibroid.  The medical device used to treat her, a power morcellator, pulverized her fibroid, and with it, a hidden cancer.  They subsequently learned that Amy’s metastatic uterine cancer was not a “rare complication” of the device, and are working actively to warn patients and doctors, get morcellators off the market, and find a cure for uterine cancer.

We hope you will take advantage of this great opportunity to meet these inspiring women, previous Foremother honorees, and many of D.C.’s other movers and shakers. Lunch is from noon to 1:30, preceded by a 11:30 champagne reception for honorees, patron guests, and sponsors only.

Prices below are valid through Friday, April 24.  

Seats are limited and tickets are not available at the door.

Regular lunch tickets are available for a donation of $100 each. Patron Tickets ($175 per ticket) include a champagne reception with honorees at 11:30, priority seating, and a listing in the program.  A Patron table for 10 is $1,700. Sponsorships are also available, from $1,000-$5,000. Prices are scheduled to increase after April 24.

The National Center for Health Research is the leading national organization dedicated to improving the health and safety of all adults and children. Donations for this event support our Cancer Prevention and Treatment Fund helpline.

To reserve a ticket, you may donate online here (write “Foremothers Luncheon” in the comments box and be sure to provide contact information). Or, send a check payable to “NCHR,” to 1001 Connecticut Ave, Suite 1100, Washington, DC 20036.

For more info, contact Amelia Murphy at aam@center4research.org or (202) 223-4000.

By Diana Zuckerman, PhD and Brandel France de Bravo, MPH

March 10, 2015

480294317The President of the United States has expressed concern that one in five college women are being sexually assaulted. In response, pundits who have no statistical expertise are dissecting the accuracy of those numbers—instead of talking about the undisputed fact that too many college women are being sexually assaulted.

This year, 173 people in the U.S. came down with the measles, and that is being treated as an epidemic requiring urgent action. Surely, campus rape deserves at least as much public health attention.

Yet it seems that if only 1 in 7 college women are raped, or 1 in 10, or 1 in 20, then campus parties featuring date-rape drugs, gang rapes, and other types of forced sexual activity are of less concern than whether the president’s statistics are exactly correct.

We disagree with that premise. But as public health researchers, we’re taking a look at those statistics anyway.

We read the article by Christopher P. Krebs, PhD, and his colleagues, which was published in a peer-reviewed journal and based on a study funded by the National Institute of Justice, to find out more about the “1 in 5″ statistic. Then we called Dr. Krebs to find out more.

Dr. Krebs and his colleagues studied more than 5,000 women at two large public universities. They found that one in five of the seniors said they had been sexually assaulted at some point during college.

Critics have pointed out that the definition of sexual assault includes unwanted kissing and sexual touching, and there is debate about whether those behaviors are serious or just “boys will be boys” behaviors. But the statistics speak for themselves: Most of the women who reported experiencing unwanted, nonconsensual sexual contact in an anonymous survey had experienced rape—oral, vaginal, or anal—not just other types of unwanted touching.

About 1 in 7 female seniors (15 percent) reported being raped since entering college. Those rapes happened because the women were either physically forced or threatened, or because they were incapacitated and unable to give consent. Of the students who had been raped during college while incapacitated, a substantial minority said they had definitely or probably been given a date-rape drug without their knowledge.

Although Dr. Krebs and his colleagues never claimed that the study was representative of all colleges in the U.S., other studies conducted at colleges and universities across the country have yielded similar statistics. A 2004 study done by Harvard faculty at 119 colleges nationwide found 1 in 20 of the 24,000 women had been raped during that school year (in the previous seven months). Over the course of four years, that would likely be similar to 1 in 7, since the likelihood of being raped tends to be higher for younger college women.

The White House didn’t just quote Dr. Krebs’ research; White House staff talked to him to make sure they understood how the study was done and how it should be interpreted. “We all realize that more research is needed,” Dr. Krebs told us. “I’m in the process of working on a larger study, but the first step is to make sure that we are asking the right questions and asking them in the right way.” The team will survey approximately 20,000 undergraduate women and men at 10 schools that differ in size and geography, including public and private schools and two-year and four-year schools.

We are glad that a more comprehensive study is being planned, but clearly better data are not the answer. Whether the most accurate statistics of campus rape are 1 in 5, 1 in 7, or 1 in 20, remember that there are about 10 million women who are attending colleges in the U.S. Even 1 in 20 would mean 500,000 women who have been or will be raped before they graduate. Campus rape and other types of sexual assault are a huge problem for colleges and an enormous tragedy. Most colleges have done a terrible job of preventing them or ensuring justice for the students involved.

Too much media attention has been focused on individual victims, but the “he said/she said journalism” is missing the point. And so is the punditry challenging the exact statistics.

If any other traumatic event affected ½ million college students, we would be focused on finding a systemic solution. It’s long past time to do that to prevent campus rapes and bring justice to those involved.

Read original post here.