The Honorable Yvette Alexander
1350 Pennsylvania Avenue NW, Suite 404
Washington, DC 20004
Re: E-cigarette Regulations in the District of Columbia
Dear Chairwoman Alexander:
The popularity of e-cigarettes has risen because of claims from manufacturers that they are safer than conventional tobacco-containing cigarettes. This has led to an increase of e-cigarette usage among children and in public spaces, including areas that have been designated as “non-smoking.” E-cigarettes deliver nicotine much like a conventional cigarette, except in a vapor that is formed when the liquid inside of the replaceable cartridge is heated. These liquid cartridges have been reported by the manufacturers to be safer than tobacco cigarettes, but a recent study has reported that several of these cartridges contain chemicals that have been shown to cause cancer in humans.1
We appreciate all of your hard work and efforts to pass legislation that would allow the District of Columbia (DC) to regulate e-cigarettes the same way as conventional cigarettes, and also prevent them from being sold to minors under the age of 18. The Food and Drug Administration (FDA) is still working on rules regarding the safety of these e-cigarette devices, but we already have substantial evidence that these devices contain chemicals that are harmful. We urge you not to wait for the FDA to determine rules, because meanwhile thousands of DC residents could be exposed to harmful vapors from these loosely regulated products.
We would be glad to help in any other way as well.
Diana Zuckerman, PhD, President
Varlet et al. Toxicity Assessment of Refill Liquids for Electronic Cigarettes International Journal of Environmental Research and Public Health. 2015, 12:4796-4815.
By Arielle Duhaime-Ross, May 2015
A company called Cur is developing a promising new pain-relieving product, according to Mashable, Fast Company, and PC World. Problem is, the company is doing it by launching a $50,000 crowdfunding campaign on its own website prior to filing for the necessary FDA clearance. The move could doom the product before it ever hits the market — or it could point to a glaring loophole in FDA regulations. If funding a product in anticipation of receiving said product doesn’t count as a purchase, then the field of medical device regulation is about to get really messy.
“Sounds pretty illegal to me,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit that analyzes medical treatments in order to see how safe and effective they are. “Even if there is some sort of a loophole for crowdfunding of an advanced purchase of an unapproved product, it certainly sounds like it’s a sale — they’re saying it’s ’50 percent off for 30 days’ — and they can’t sell it if it’s not approved.”
Cur (pronounced “cure”) is a transcutaneous electrical nerve stimulation machine — or a TENS machine — that backers can obtain by funding the campaign to the tune of $149. These medical devices use electrical currents to stimulate nerves and muscles in order to relieve pain. They’re especially popular with physical therapists who use them for pain management, despite the fact that the data on the effectiveness of TENS machines is sorely lacking. (In fact, the American Academy of Neurology gave them a big thumbs down for treating chronic back pain in 2009.)
But Cur is different from other TENS machines, which often come in the form of a large box with a bunch of dials and wires. For one thing, Cur is completely wireless and regulates itself thanks to sensors that include an accelerometer. Cur is also very small, and can be easily concealed under clothing. This means that a user can wear it at work or during a run without asking for help from a professional, says Cur founder Shaun Rahimi, a biomedical engineer who has worked for companies like Abbott Laboratories and NeuroPace.
“Within 5 seconds, it measures your muscle responses, [meaning] how your muscles are twitching in response to the current that’s delivered,” he says. “So you put this on, you don’t even have to press a button. It’s attached, it starts, it detects how strong it is [compared with] where it should be using the muscle twitches, and then it sets the level that way.”
If it works the way Rahimi says it does, Cur could be extremely popular with chronic pain sufferers. But launching a crowdfunding campaign before receiving FDA clearance for the device is a risky move. After all, the FDA forbids marketing directly to consumers for unapproved medical products. And when crowdfunding functions as a pre-order system, campaigns that sport slick videos and slogans look a lot like marketing.
The “FDA regulates pre-approval or pre-clearance promotional activities for medical devices,” says Ellen Flannery, a lawyer and partner at Covington & Burling LLP who specializes in developing strategic plans for obtaining FDA marketing clearance. A device that lacks marketing clearance is considered “investigational,” and a company can’t promote, advertise, or accept orders for a medical device prior to getting FDA clearance, she says. The regulatory agency “considers such activities to be ‘commercialization’ of the unapproved device.” And although the FDA makes exceptions for trade shows, those exceptions only apply after a company has filed for clearance — a step that Cur has yet to take. “We are close to submitting the package [to the FDA], but we’re still a few months away,” Rahimi says.
TENS devices have been been around for a long time. They’re “50 times over approved,” which means that Cur doesn’t have to go through a whole bunch of human testing to gain clearance, Rahimi explains. The company just has to make sure that their validation tests demonstrate that Cur is similar to existing TENS devices and file for “substantial equivalence.” “We’ll file for the [substantial equivalence] in August, and assuming that three- to four-month pathway continues, that means winter we’ll be shipping the product to our early backers on crowdfunding,” he says. Cur plans to ship the product after their TENS device gets cleared by the FDA.
Rahimi explains that the campaign “isn’t a pre-order at all.” But when he describes what he’s doing, it sounds a lot like Cur is marketing directly to consumers. For instance, he says that one of the reasons Cur decided to forgo launching a campaign on well-known crowdfunding websites Kickstarter and Indiegogo is because the Cur website can be customized to “speak to the consumer in a more direct way, with visuals — it’s a prettier website.” He also admits that he launched the campaign to find out more about Cur’s customers. “I think if I have a crowdfunding campaign that shows a little more data about the demand for the product… I think that gives me a lot more leverage with the [venture capital],” he says.
Backing Cur’s campaign means “contributing” to the company’s efforts rather than buying a product, according to the button at the bottom of the order form. For companies like Cur, crowdfunding isn’t a “contract of sale” because these orders sometimes go unfulfilled. And that’s the idea that could make enforcing the FDA’s rules against taking orders for unapproved medical products difficult. Regardless of whether a product is safe or effective, you’re making a “donation” that comes with “a reward” at the end of a certain period. Indeed, Cur’s website includes language designed to protect the website from looking like a pre-ordering system: By making a contribution on or after May 13, 2015 you acknowledge and agree that you are contributing (i.e., making a donation) to a work in progress and not making a direct purchase. Your reward is the number of Cur Devices you contribute towards.
But Rahimi’s own statements suggest that Cur’s campaign violates certain FDA rules. For example, he told The Verge that the product is finished, which means that the campaign isn’t going to fund research. “The product’s done. We made sure to have that happen before we started the crowdfunding campaign,” he says. But the FDA clearly states that a company that has filed for substantial equivalence can’t “take orders, or be prepared to take orders” that could result in “contracts of sale for the device” unless those sales have to do with with research or investigational use.
Looking at the Cur website without thinking that the company is selling a product is pretty hard; you can see the words “get Cur now” right at the top. “What I find fascinating is that nothing about this [campaign] says that you’re donating money until you get to this crowdfunding [page],” Zuckerman says. This is the ultimate of ‘don’t forget to read the fine print’ — everything else about this suggests that you’re buying a product.”
The website does state that the product has yet to receive FDA clearance thanks to statements like “ships Winter 2015, after FDA approval” below the price tag. But finding out what that means isn’t easy. The FAQs on Cur’s website offered no information about the process surrounding the product’s FDA clearance at the time of publication.
It’s hard not to wonder why the Cur team couldn’t wait a few months to get FDA clearance. When asked, Rahimi explained that the money is necessary to get through the FDA regulatory process. “Right now we have enough money to get through all these processes, but it just helps us move faster,” he said. “The money is useful now in terms of building the company. And the FDA processes are not inexpensive.” For most startups, this explanation could be considered reasonable. But when dealing with people’s health, “going fast” isn’t always ideal.
How the FDA will respond to this campaign is unclear; the agency declined to comment on this story. It’s still possible that a crowdfunding campaign that targets consumers will be interpreted as “investigational use” geared toward a large, and extremely diverse number of “investors.” But scrolling through Cur’s website suggests a far murkier outcome. “It’s a pre-order for something that they may never be able to sell,” Zuckerman says. “And to me, it’s hard to feel confident about the integrity of the product given the lack of integrity of the website. If they have a legitimate product, then the company shouldn’t be selling it this way.”
Congress is working on a bill called 21st Century Cures that would lower the standards for approving drugs and medical devices. They say it will benefit patients, but it was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law currently requires.
If you want safe medications instead of expensive, ineffective ones, please add your name to this letter by clicking HERE or by sending an email with your name, city, state and zip to firstname.lastname@example.org.
And please spread the word to friends and relatives that care about safe medical products!
As patients and consumers from across the country, we are writing to share our very strong opposition to several sections of the 21st Century Cures legislation. A few of the issues of particular concern to us follow. We are not lobbyists, we are American taxpayers, and we hope you will improve the bill to better reflect the needs of regular people like us.
1. Subtitle D: Modern Clinical Design, Section 2062 and 2063
FDA standards have developed over the last 100 years so that Americans could trust that medical products are proven safe and effective in scientific studies on humans. Randomized clinical trials are the gold standard to make sure that a new drug, device, or vaccine is safe and effective. This section encourages the FDA to lower its standards to even include anecdotes that the bill calls “clinical experience.” Please remember that clinical experience resulted in tragedies such as birth defects from thalidomide and deaths from Vioxx.
Whether the FDA is reviewing a drug for a new use, for long-term studies after a drug is already approved, or for a new drug, the FDA should compare the drug to standard treatment to make sure its benefits are greater than its risks for most patients. That means it needs to be studied on hundreds of men and women, of different ages and different races.
In medicine, physicians are looking for “evidence-based medicine” not the opinions of a few doctors. That’s why this section is so dangerous for patients: it would allow the use of individual experiences or summaries of studies (instead of the details of the studies)
2. Sections 2121: Approval of Drugs for a Limited Population of Patients
We all worry about antibiotic resistance, but this section tries and fails to address it. It discourages the FDA from relying on randomized clinical trials that evaluate the impact of a drug on real patients, and instead encourages the FDA to rely on preliminary data. That might be justified for patients who would otherwise die without an experimental drug, but unfortunately there is no way for the FDA to prevent these drugs from being promoted and prescribed for all patients. Millions of patients could die as a result.
3. Section 2123: Encouraging the Development and Use of New Antimicrobial drugs
This section would pay a bonus to hospitals to prescribe new antibiotics and anti-fungals. But, these drugs should be used only when needed, to preserve their effectiveness as long as possible. Many frail elderly patients are put on antibiotics whenever they get sick, in order to prevent pneumonia. If Congress encourages hospitals to prescribe these new drugs, it encourages overuse and inappropriate use. The result: fewer effective antibiotics and a Medicare system that goes broke even sooner than many have predicted.
4. Subtitle L, M, and N: Medical Devices:
FDA standards for medical devices are lower than for drugs, resulting in patients harmed from artificial hips, unsafe stents, contact lens solution, surgical mesh, and many other common devices. The device sections in this proposed legislation would lower the standards even more. How does that make sense?
Section 2221, Third-party Assessment: When a company wants to make changes to a medical device that is already on the market, FDA scientists should decide if the changes will change the safety and effectiveness of that product. Companies should not be allowed to choose to pay a 3rdparty to decide if FDA needs to review those changes. That is just common sense.
Section 2222, Medical Device Approvals: This section lowers the standards FDA uses to approve high-risk medical devices such as heart, brain, and spinal implants. It would allow approval based on case studies, which include only one or two patients. But the experience of a small number of patients is not necessarily typical of what will happen to most patients, especially patients of the opposite sex or different age. It would also allow evidence from peer reviewed medical journals instead of evidence from the actual patient data. Unfortunately, studies in medical journals can be inaccurate, incomplete, or biased.
Health Software: Electronic medical records and other health software help doctors make medical decisions about their patients. That’s why it is important that the software works well and won’t crash when the patients’ lives are at stake. FDA should evaluate these devices at least as carefully as they evaluate hip and knee implants, for example.
5. Section 3041: Reducing Transparency in the Sunshine Act for Physicians Payments
We are glad that Congress previously required companies to make public their payments to physicians. That law helps patients know if their doctors have a financial relationship with a company that makes a drug or device that the physician is recommending. So we are very disappointed that Congress has already proposed a loophole for fees or gifts to doctors that are intended for “continuing medical education” purposes at fancy resorts or other meetings. It also would exempt expensive gifts such as medical textbooks and journals. Although we want doctors to be up-to-date in their education, we believe doctors make enough money to buy these themselves.
As patients and consumers from across the country, we ask you to pause before passing this bill. You’re moving too fast on a law that will affect every single person in this country. We deserve a better bill and a more careful review of the fine print that could save lives if done correctly, and cost many lives if it isn’t very carefully evaluated and revised.
Name, city/state, zip code
[The list of names is growing! Add yours by clicking HERE or by sending an email with your name, city, state and zip to email@example.com]
May 14, 2015
My name is Dr. Anna Mazzucco, and I 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. Those are the perspectives I bring today.
Our nonprofit organization conducts research, analyzes data from the research literature, compares the risks and benefits of medical products, and also explains the evidence so that it is understandable to patients and providers. Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.
The FDA received 146 adverse event reports for duodenoscopes between 1997 and 2015, including 13 deaths. As infections are not always traced to the source, and the MAUDE system is voluntary and known to be under-utilized, these numbers are very likely underestimates of the true number of infections spread via these devices.
More than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed every year in the U.S. These patients assume that the devices used during their procedure are clean and safe. As duodenoscopes allow physicians to perform potentially life-saving procedures quickly and less invasively, adequate safety measures must be used for patients to continue to benefit from these devices without fear of receiving a potentially deadly infection.
The CDC released interim guidance in March to address duodenoscope contamination. We urge the panel to recommend that these guidelines be implemented in all healthcare facilities. Among these recommendations, staff training and annual competency re-verification with direct observation should be top priorities. That’s needed because studies have shown that lack of compliance with decontamination protocols is widespread.
Decontaminating and sterilizing these devices is challenging for many reasons, including because of their design. Therefore, we strongly advocate for ongoing monitoring of these devices through the CDC-recommended surveillance program, even in the absence of a known outbreak. This should include routine culturing, which is already the standard procedure in Australia and parts of Europe, and holding duodenoscopes out of use until results are complete. Even when decontamination protocols are strictly followed, these additional safeguards are still needed, so that outbreaks would be identified and contained as quickly as possible.
We enthusiastically support increased transparency with patients during the informed consent process about the risks of infection transmission during the ERCP procedure. Patients are entitled to full disclosure of the potential risks of any procedure or treatment they receive.
In addition, patient notification measures should be in place at all healthcare facilities that perform ERCP procedures. Rapid response to potential outbreaks relies on the ability of healthcare facilities to track their duodenoscopes and inform the relevant patients at the first sign of danger.
Lastly, the FDA report highlighted past deviation from manufacturer’s instructions and use of cleaning accessories, which are not cleared by the FDA for this purpose. These deviations were not reviewed by the FDA as factors which may contribute to contamination. Since these deviations seemed to be quite common, they deserve further investigation. We ask that the panel consider requiring that warning labels should be placed on duodenoscope packaging AND in areas where they are cleaned. These warnings would remind decontamination staff that duodenoscopes should be re-processed according to the manufacturer’s instructions.
Thank you for the opportunity to speak today.
This year’s awards luncheon was held at the Cosmos Club in Washington DC. We honored Jodie Bernstein and Karen Mulhauser as Foremothers and Dr. Hooman Noorchashm and Dr. Amy Reed as Health Policy Heroes. It was a huge success and a wonderful honor to be able to hear from such inspirational leaders!
Honorees Dr. Hooman Noorchashm, Jodie Bernstein, Dr. Amy Reed, Karen Mulhauser, with our Emcee, Autria Godfrey, WJLA anchor
NCHR president Dr. Diana Zuckerman
Our 2015 Foremothers, Karen Mulhauser and Jodie Bernstein
A full house claps for the honorees
Dr. Diana Zuckerman and Autria Godfrey with former and current Foremothers: Anne Hale Johnson, Ambassador Connie Morella, Karen Mulhauser, Jodie Bernstein, Dr. Omega Logan Silva.
NCHR Research Assistant Amelia Murphy is moved by Dr. Amy Reed’s remarks
Honoree Jodie Bernstein
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.
Honoree Karen Mulhauser on left
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.
Honorees Dr. Amy Reed and Dr. Hooman Noorchashm
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.
Dr. Hooman Noorchashm and Dr. Amy Reed with two of their children, Joseph and Nadia.
NCHR staff: Dr. Diana Zuckerman, Paul Brown, Christina Silcox, Anna Mazzucco, Nick Jury, Katy Wang, Alisha Malkani, Elena Gerasimov, and Amelia Murphy
One of our first Foremothers, Anne Hale Johnson
We gratefully acknowledge our 2015 sponsors:
The Cooper-Rothenberg Group
at Morgan Stanley
at Morgan Stanley Wealth Management
Negin Noorchashm Griffith, MD, FACS
Diplomate, American Board of Plastic Surgery
May 8, 2015
Re: The Dietary Guidelines for Americans, 2015
Dear Dr. Olson, Dr. Casavale, Ms. Rihane, and Dr. Bowman:
The National Center for Health Research presents these comments on the expert report prepared for the eighth edition of the Dietary Guidelines for Americans (DGA) by the Dietary Guidelines for Americans Committee (DGAC). Overall, we strongly support the conclusions and policy recommendations in the report. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from any agricultural or food manufacturing industries, and have no conflicts of interest in making our recommendations.
We strongly agree with the Dietary Guidelines Advisory Committee’s assessment that the overall body of evidence identifies a healthy dietary pattern as one that is:
higher in fruits, vegetables, whole grains, low or non-fat dairy, seafood, legumes, and nuts;
lower in red and processed meats
low in sugar-sweetened foods and drinks and refined grains; and
lower in sodium.
We commend the DGAC for emphasizing overall dietary patterns, and suggest that the final recommendations give several examples of healthful patterns. This is not only educational but may improve participation, as some people may find one pattern more appealing or easy to follow than another.
We urge USDA and HHS to:
Strengthen their efforts to encourage all Americans to make half their plates fruits and vegetables at every meal;
Promote policies that increase children’s access to more fruits and vegetables in school meals and the school food environment;
Promulgate guidelines that increase access to more fruits and vegetables in all federal nutrition programs, including financial incentives for people to buy more fruits and vegetables.
We have several specific comments below:
The DGAC notes the importance of implementing comprehensive nutrition standards to increase fruits and vegetables in school meals. School-based changes that include nutrition education and parent involvement are especially effective in increasing children’s fruit and vegetable consumption.
We support the DGAC’s proposal to change language regarding meat from “choose lean meat and poultry” to “limit red and processed meats.” That is an important change, based on clear, consistent, and still-mounting evidence of the link between regular consumption of red and processed meats and certain types of cancer, including colorectal cancer. This recommendation has a significant potential to improve the country’s health and is already supported by experts in the field.
We support the DGAC’s recommendations to reduce consumption of added sugars. Also there should be a line on added sugars on the Nutrition Facts label that includes a percentage of a Daily Value of added sugar and the total amount of sugar in both grams and teaspoons. We support the DGAC’s conclusions on the need for policies that address over-consumption of added sugars including:
Economic and pricing approaches;
Continued efforts to reduce added sugars in foods and beverages in school meals and snacks;
Limiting the advertising of foods and beverages high in added sugars to young children, youth, and adolescents;
Health promotion policies to reduce the availability of sugar-sweetened beverages in post-secondary institutions and worksites;
A recent prospective study of more than 11,000 people found higher risks of cardiovascular mortality with increasing consumption of added sugar. Those who consumed between 10 and 25 percent of their calories from added sugars had a 30 percent higher risk of dying of a heart attack, stroke, or other cardiovascular event than those who consumed less than 10 percent. The risk was nearly three times higher for those who consumed more than 25 percent of their calories from added sugars.1
Added sugars should be reduced in the diet, not just replaced with low-calorie sweeteners. Instead, they should be replaced with healthy options, such as water in place of sugar-sweetened beverages. We also support the DGAC’s emphasis on water as the primary recommended beverage.
The Dietary Guidelines for Americans should continue to recommend that consumers replace foods made with refined grains with 100% whole grains. The Guidelinesshould warn consumers that foods with labels such as “8 grams whole grain” or “made with whole grains” may be mostly refined grain, and should advise instead to look for products that are “100% whole grain.” Many consumers don’t realize that products with less than 100% whole grain have been refined. The guidelines should also give examples of healthy portion sizes for grains. These practical statements would help people follow the Guidelines by avoiding foods with high amounts of refined grains.
Reducing sodium intake is important. However, we recognize that more evidence is needed to define the optimum sodium intake for many people, and we encourage the DGAC to revisit these specific recommendations as more data become available. Meanwhile, Americans will continue to have difficulty reducing their sodium intake unless there are changes to the food available. Prepared frozen meals, which many families rely on for inexpensive and easy-to-prepare meals, are often extremely high in sodium. Fast food and restaurant foods are often even higher in sodium. Reducing sodium in the foods purchased or made available through schools, government programs, and workplaces is also essential to achieving the enormous health benefits of sodium reduction across the population. As the Committee advised, HHS and USDA should work with the food and restaurant industry to lower the amount of sodium in food by modifying the GRAS status of salt and establishing sodium limits for foods.
These changes will be difficult to make and the government needs to make it easier by working with restaurants and food manufacturers to reduce salt and sugar and increase fruits and vegetables in frozen foods and other convenience foods that families rely on.
We support the DGAC’s recommendations that most Americans should rely on healthy diets, not vitamin or mineral supplements, to lower their risk of cancer, heart disease, and other illness. Most research does not support claims that dietary supplements prevent of cancer or cardiovascular disease.2
We ask that the DGAC clarify their recommendations on egg consumption. Given the controversy over the significance of dietary cholesterol, the DGAC should place egg consumption in the context of the overall dietary patterns that have been shown to confer health benefits.
We commend the DGAC’s recognition of sustainability as an essential component of federal dietary guidance. Consistent with current scientific literature, the DGAC notes that diets high in animal-based foods, particularly red and processed meats, are associated with an increased risk of heart disease, diabetes, and cancer, and worse environmental outcomes.
In summary, we support many of the recommendations in the DGAC and hope to work towards healthier eating habits to ensure a healthy future. Please let us know if we can be of any further assistance in these efforts.
The National Center for Health Research
Contact: Paul Brown at (202) 223-4000 or firstname.lastname@example.org
[i] Yang, Q., Zhang, Z., Gregg, E. W., Flanders, W. D., Merritt, R., & Hu, F. B. (2014). Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Internal Medicine, 174(4), 516-524. (We note that the findings were remarkably robust, as they were “largely consistent across age group, sex, race/ethnicity (except among non-Hispanic blacks), educational attainment, physical activity, health eating index, and body mass index.”)
[ii] Fortmann, S. P., Burda, B. U., Senger, C. A., Lin, J. S., Beil, T. L., O’Connor, E., & Whitlock, E. P. (2013). Vitamin, mineral, and multivitamin supplements for the primary prevention of cardiovascular disease and cancer: A systematic evidence review for the US preventive services task force. Evidence Syntheses (108).
May 5, 2015
Contact: Elena Gerasimov
202-223-4000 or 702-287-2163 (cell)
Washington, D.C. – Two trailblazing women and a courageous physician couple will be honored by the National Center for Health Research at its 11th annual luncheon at the Cosmos Club on May 8, the Friday before Mother’s Day.
The Foremother Awards honor lifetime achievements by distinguished DC- area women who broke down barriers for other women and whose inspiring work improved the lives of adults and children across the country. “While protecting American families from online predators and empowering women and minorities, our 2015 Foremothers were also noteworthy for how they accomplished so much – by encouraging and supporting others,” says Dr. Diana Zuckerman, president of the National Center for Health Research.
The Health Policy Hero Awards celebrate extraordinary recent accomplishments. This is the first year that the honorees are patient advocates: two physicians, a husband and wife, Dr. Amy Reed and Dr. Hooman Noorchashm. In the two years since Dr. Reed underwent a “routine” medical procedure with a medical device that mistakenly spread her small, treatable cancer throughout her body, she and her husband have convinced the Food and Drug Administration to issue a very strong warning discouraging its use, and many physicians and insurance companies have dramatically restricted the use of the device, saving thousands of lives.
Receiving the Foremother Awards this year are Jodie Bernstein and Karen Mulhauser.
Jodie Bernstein is one of the nation’s foremost consumer advocates. Serving as the first female Director of the Federal Trade Commission’s Bureau of Consumer Protection, she transformed the Bureau into the model for consumer protection agencies around the world. Ms. Bernstein was dubbed the country’s “Top Cybercop” for her efforts to protect online privacy, assure safe online shopping, and prevent identity theft. Her initiatives included cracking down on subprime lending and spearheading the government’s first investigation into marketing of violent movies, music, and video games to children.
Karen Mulhauser has dedicated her life to key progressive causes, and was one of the early leaders of the modern women’s movement. Shortly after the Supreme Court decision on Roe v. Wade, she became the director of the Washington, D.C. office of National Abortion Rights Action League. She subsequently started the Women’s Information Network for D.C.-area young women starting political and policy careers, worked to strengthen voter registration efforts, established the Citizens against Nuclear War coalition, and led delegations to Geneva, Reykjavik, and the Soviet Union demanding reversal of the arms race. Ms. Mulhauser currently chairs the Steering Committee of over 150 chapters of the United Nations Association-USA.
Award-winning broadcast journalist and anchor of WJLA/ABC-7’s 6 p.m. weeknight newscasts, Maureen Bunyan, will be the Mistress of Ceremonies. Ms. Bunyan was awarded seven local Emmys and is a founder of the National Association of Black Journalists and the International Women’s Media Foundation.
The National Center for Health Research is dedicated to improving the health and safety of adults and children by using research to develop more effective treatments and policies. We study a wide range of medical issues. The event supports NCHR’s major program, the Cancer Prevention and Treatment Fund, which helps adults and children reduce their risk of getting cancer and provides assistance in choosing the safest, most effective treatments. www.stopcancerfund.org
By Roni Caryn Rabin, New York Times
May 3, 2015
When a new contraceptive implant came on the market over a decade ago, it was considered a breakthrough for women who did not want to have more children, a sterilization procedure that could be done in a doctor’s office in just 10 minutes.
Now, 13 years later, thousands of women who claim they were seriously injured by the implant are urging the Food and Drug Administration to take the device off the market and to warn the public about its complications.
Troubling long-term data on women using the device, called Essure, was published on Friday after an unusual eight-year delay. Several patients have sued Bayer HealthCare Pharmaceuticals, and representatives of patient groups plan to meet with officials of Bayer, the manufacturer, on Tuesday to discuss their concerns.
The device is a small metal and polyester coil placed into a woman’s fallopian tubes in order to make her permanently sterile. The F.D.A. approved Essure after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.
Since then, the agency has received more than 4,000 reports of serious complications related to the device, including severe back and pelvic pain, heavy prolonged menstrual periods, and coils that pierced the fallopian tubes and lodged in other organs.
According to a citizens’ petition filed with the F.D.A., an inspector was given records of 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired a majority interest in the company. Both the agency and Bayer say Essure’s benefits outweigh the risks.
Essure is sold in at least 23 countries, Bayer officials say, and about 750,000 devices are in use worldwide. Company officials declined to say how many American women use Essure, but said serious complications were relatively rare.
“There are no signals, nothing that would indicate a problem with Essure,” said Dr. Edio Zampaglione, vice president for United States medical affairs and women’s affairs at Bayer. “The events being reported and seen are expected for this type of procedure.”
But in interviews with more than a dozen patients, many said the risks were anything but expected.
Angie Firmalino, a 42-year-old mother of four in Tannersville, N.Y., said she had experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009.
Eventually doctors discovered that the coils had somehow lodged in her uterus and had broken apart. She has had several operations, including a hysterectomy, to remove the fragments.
In 2011, Mrs. Firmalino created a Facebook page to warn friends and family about the device. The page now has nearly 17,000 members.
“If I had any idea of the possible consequences of Essure, I would never have chosen it,” said Mrs. Firmalino, who still takes ibuprofen daily to manage her pain.
In 2000, Kim Hudak was a 28-year-old mother with a 7-year-old son when she volunteered to participate in an early trial of the device. But as soon as she received the implant, she said, she developed a sharp pain in her right hip that did not go away. Her menstrual periods became very painful, and she developed a slew of symptoms including fatigue, migraines and joint pain that often kept her from working full time.
“It felt like I had a really severe case of the flu, and those were the good days,” said Ms. Hudak, now 43, who works in sales in Cleveland. “I had years and years of doctors telling me I was crazy.”
Ms. Hudak has filed a $1 million claim against Bayer seeking reimbursement for injuries and lost wages.
Yet many women do well with Essure and recommend it.
“I had it done during my lunch hour, and I ran a half-marathon shortly afterward,” said Cindy Dossett, 54, of Newburgh, Ind.
She required another procedure to curb menstrual bleeding after getting the implant, but over all, she said, “it’s a pretty easy process.”
Essure was the first device to offer women an alternative to tubal ligation (commonly known as having one’s “tubes tied”) and, as such, was considered a game changer, experts said.
The small coils are placed in the fallopian tubes vaginally, without a surgical incision and with minimal anesthesia.
Once inserted, the coils — made of a nickel titanium alloy and a polyesterlike fiber called polyethylene terephthalate, or PET — trigger an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing sperm from reaching an ovum. The scarring process can take three months, and women must use other contraceptives until testing confirms the tubes are blocked.
But pain and other serious side effects emerged early in clinical trials required for approval.
In a safety trial that enrolled 269 women ages 23 to 45, the device was successfully inserted into 200 patients. In nine of them, a coil perforated the fallopian tube, was expelled or lodged elsewhere in the body, according to a 2003 report in the journal Human Reproduction.
Trial participants were asked to keep diaries, and nearly one in 10 participants recorded painful intercourse, while one in eight had painful menstrual periods during the first three months.
In a subsequent trial of 518 women, only 449 were able to rely on the device. On 21 occasions, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.
At the time, F.D.A. officials were concerned that the trials had followed women only for a year or two, while the implant was meant to last a lifetime. The agency approved Essure in 2002 on condition that the investigators continue to monitor the women who participated in the trials for four more years.
The F.D.A. said only 171 women in the smaller trial were followed for five years. A heavily redacted report, posted on the F.D.A. website, shows that five women had hysterectomies and that at least one became pregnant.
Participants reported 270 adverse events, including dozens involving pain and heavy menstrual periods. The investigators determined that only 17 of these were caused by Essure and attributed the rest to other factors. They concluded that pain and bleeding were therefore rare among users.
Although the monitoring period ended in 2007, long-term data on women in the larger trial was published only last week in the Journal of Minimally Invasive Gynecology.
Of the original 518 participants, whose average age was 31, only 366 — about 70 percent — were followed for the full five years.
Fifteen women had hysterectomies. The investigators concluded that only two of these major operations were “possibly” related to Essure.
Thirty-eight percent experienced unusually heavy periods on a recurring basis. One in 20 patients had recurrent pelvic pain, one in 15 had recurrent painful periods, nearly one in 25 had recurring pain with intercourse. Investigators said just one had persistent pain, however.
Because there is no other device like Essure on the market, and because Bayer will not say how many American women have it, experts find it difficult to judge whether the risks are disproportionate. Manufacturers are not required to include control groups in clinical trials, as is standard in drug trials, so there is no comparison group.
F.D.A. officials said they were concerned about the coils moving outside the fallopian tubes, but did not believe the device was flawed.
“The agency believes the benefits outweigh the risks in appropriately selected patients who are adequately informed,” said Dr. William Maisel, deputy director for science and chief scientist in the F.D.A.’s Center for Devices and Radiological Health.
Dr. Zampaglione said women who underwent surgical sterilization were also more likely than other women to undergo hysterectomy. A 1998 study of women undergoing surgical sterilization in the 1970s and ’80s also found high rates of subsequent hysterectomies, he said.
The slowly accumulating data and patient reports, however, have made other experts uneasy.
The National Center for Health Research, a nonprofit group, has begun analyzing adverse event reports related to Essure, looking for patterns of complications.
“The fact that 16,000 women with children and a lot of things to do are willing to take the time to talk about this is very, very unusual,” said Diana Zuckerman, president of the group, referring to Mrs. Firmalino’s Facebook page. “I can’t think of another device like this.”
Dr. Aileen Gariepy, an assistant professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, has calculated that nearly one in 10 women with Essure would get pregnant over a 10-year period, a much higher rate than that among women who undergo tubal ligation.
She finds it troubling that the long-term study published last week did not include data on 30 percent of the trial participants.
In clinical trials, she said, “the most common reason patients are lost like this is because they had a problem.”
Physicians familiar with Essure are now deeply divided. Many use it regularly and say they have had tremendous success.
“It’s the best thing out there,” said Dr. Jeffrey Bittner, a gynecologist in Ottumwa, Iowa. “It’s easy, it’s safe, it’s effective — it’s hard to beat. A doctor who doesn’t tell patients that is not being honest.”
Others have become disillusioned.
“When Essure came out, I was very enamored by it and did a lot of Essures all the time, until I started seeing patients come back with problems and referred to me with complications,” said Dr. Mitchell D. Creinin, professor of obstetrics and gynecology at U.C. Davis Health System in Sacramento.
“It’s a great technology. I’m just not sure it’s ready for prime time.”
WASHINGTON — Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.
The draft bill presented at a hearing in the House on Thursday represents a less aggressive streamlining of the drug approval process, critics of the earlier draft said, and seems to have secured strong bipartisan support.
The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.
Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety — for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety.
The bill’s supporters said it was a work in progress that had been assembled in one of the most collaborative, transparent processes Congress has seen in years. The sponsors held eight hearings and more than a dozen round-table meetings in districts across the country to gather comment.
“We have a chance to do something big, and this is our time,” Mr. Upton said.
His co-sponsor, Diana DeGette, Democrat of Colorado, said the lawmakers had made “tremendous progress,” recalling “that hokey video” that she and Mr. Upton made to promote the effort last year.
The draft — at about 200 pages it is half its former size — seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.
The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.
Diana Zuckerman, the president of the National Center for Health Research, said earlier versions of the legislation had “considerable micromanaging of the F.D.A. and enormous power given to industry.”
She added, “Most of that is gone.”
But she cautioned that the bill still held numerous provisions she believed put people at risk, including ones she described as lowering standards for the approval of medical devices and antibiotics. The bill would increase the work the F.D.A. must perform, but not the money it receives, and Dr. Janet Woodcock, an agency official who testified Thursday, said that was a concern.
“We are very stretched in our resources,” she said.
One point that is likely to concern the F.D.A. is a provision that would reduce its authority to regulate some software associated with medical devices.
An earlier version of the bill would have let drugmakers use quicker measures for a drug’s effectiveness during testing — for example, changes in blood sugar level instead of a more final outcome, like development of diabetes. The new draft instead suggests ways the F.D.A. could use those alternative measures, called biomarkers.
The F.D.A. says it already uses them in a substantial share of drug approvals, and Dr. Woodcock told the lawmakers Thursday that the agency did not need additional authority on this count. Progress has been slow in adopting more biomarkers, she said, because they often did not produce enough evidence to allow scientists to draw firm conclusions.
“You have to know those biomarkers are reliable before you can take a chance on a human life,” she said.
By Coulter Jones, John Fauber, and Kristina Fiore, Journal Sentinel
In the months before the U.S. Food and Drug Administration did an about-face on diet drugs, agency officials participated in a series of meetings at George Washington University.
Among the others in attendance: Drug companies, weight-loss clinics, medical societies and academic physicians specializing in weight loss — what Diana Zuckerman, president of the National Center for Health Research, calls the “weight-loss industrial complex.”
The aim: Get new diet drugs on the market.
The group even produced a 24-page report — Obesity Drug Outcome Measures — that encouraged the goal.
“The one thing they all had in common: They needed products to sell,” said Zuckerman, who attended the meetings, which were financed in large part by drug companies.
In all, drug companies have spent more than $60 million in lobbying and other payments since 2010, when they began an intense push to get new diet drugs on the market, a Milwaukee Journal Sentinel/MedPage Today investigation found.
Much of their effort was aimed at convincing the FDA to start approving new diet drugs again, despite decades of harm caused by diet pills found to be unsafe after approval in the past.
Money also was used to lobby Congress, which prodded the agency to start approving the new products. And money was given to medical groups and doctors that encouraged use of diet pills.
The seven companies connected to the new drugs spent:
■ $51 million lobbying the FDA and Congress on a host of issues, including obesity.
■ At least $4 million since 2013 on sponsorships of medical societies that encouraged use of drugs to treat obesity.
■ At least $5 million on travel, food and speaking fees paid directly to physicians. The number is likely much higher, but publicly-reported data covers just the last five months of 2013.
The Journal Sentinel/MedPage Today review only examined money spent since 2010. That’s when a push to get new diet drugs approved began from drug-makers Orexigen, Takeda, Eisai, Arena, Vivus, Novo Nordisk and Shire Pharmaceuticals.
In the wake of the spending, the FDA — which had not approved a new diet drug for 13 years — has allowed five potentially harmful products on the market in the last three years, including two in the last four months.
Three of the drugs had previously been rejected by the agency.
With an estimated 35% of adult Americans being obese, according to the U.S. Centers for Disease Control and Prevention, the FDA’s switch opens a potentially lucrative revenue stream for the drug companies.
“They spend a lot of money and time lobbying for their cause,” said Jeanmarie Perrone, a medical doctor and drug safety researcher at the University of Pennsylvania who was on an FDA advisory committee for the diet drug Belviq and voted against its approval.
“I can’t believe the number of conflicts of interest I see, even in academia, around these issues,” she said. “It is really hard to find an uninterested person.”
Perrone said she opposed approval for several reasons, including concerns about potential cancer risk and heart valve damage, and because many of those in the clinical trial gained back weight after they stopped using the drug.
Public health, private enterprise
The latest diet drug push was propelled with a fusion of public health, private enterprise and politics — and plenty of drug company money.
In 2010, the FDA rejected two new diet drugs citing concerns about cardiovascular safety. Two months earlier, the agency had removed the drug Meridia from the market — a rare step. In doing so, the agency cited a just-completed clinical trial that had linked the drug to increased heart attacks and strokes.
Then, in the fall of 2011, the U.S. Senate stepped in.
Calling the “absence of novel medicines to treat obesity” a concern, the Senate Appropriations Subcommittee on Agriculture, which oversees FDA funding, directed the agency to report back on “steps it will take to support the development of new treatments for obesity.”
The agency responded three months later with a four-page report to the Senate, stating its commitment “to working with pharmaceutical companies to bring new obesity drugs with favorable benefit-risk profiles to the market.”
Within six months, new diet drugs started to come to market. First, Belviq was approved in June 2012. Then Qsymia was approved in July. Both had been rejected two years earlier.
A third previously-rejected drug, Contrave, would later win approved as well.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency did not feel pressured by Congress to green light new diet drugs.
“There’s congressional pressure about everything, because they do constituent service, but that doesn’t affect our decisions,” she said.
Medical societies soon started to release first-ever guidelines on the treatment of obesity. The guidelines, which can have a major influence on how doctors make treatment decisions, called for treating obesity as a disease and described how diet drugs could be used to treat it.
In November 2013, the Obesity Society, in partnership with cardiovascular organizations, issued a guideline that urged doctors to diagnose and treat obesity at every clinic visit.
In the spring of 2014, the American Association of Clinical Endocrinologists released new recommendations for diagnosing and treating obesity. In 2012, the group had released a position statement on obesity that urged clinicians to recognize obesity as a disease.
And earlier this year, the Endocrine Society released a guideline focusing on the use of drugs to treat obesity. It marked the first time any guideline made specific recommendations on the use of the new diet drugs.
Money to societies
Collectively, the medical societies have received at least $4 million from companies that manufacture diet drugs.
According to records provided by the Obesity Society, the group has received $393,000 in contributions from obesity drug-makers since 2011.
Drug companies also gave money to the popular ObesityWeek, a weeklong conference for doctors who treat obesity. The conference is presented by the society and the American Society for Metabolic and Bariatric Surgery but is a separate entity.
Eisai, the maker of Belviq, donated $300,000 to the 2013 and 2014 ObesityWeek events, according to information from the Obesity Society. Vivus, Takeda and Novo Nordisk each gave at least $200,000 to the conferences.
In a statement, the Obesity Society said its relationships with industry “have furthered the Society and our members in seeking meaningful, evidence-based solutions for obesity” and that its policy is to keep those relationships transparent, including posting them on its website.
Meanwhile, the endocrinologists’ association received $3.2 million from obesity drug-makers in 2013, according to federal tax filings. That accounted for nearly 30% of its 2013 revenue of $11 million.
The group has spent $400,000 lobbying Congress since 2010, mostly on issues related to diabetes, which is closely tied to obesity, according to data from the Clerk of the House of Representatives and Secretary of the Senate.
Association president R. Mack Harrell said in an email that “there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, it is a commonality of interest that is healthy, desirable, and beneficial.”
The Endocrine Society — a separate physician group for endocrinologists — would not reveal how much money it has received from obesity drug companies, and the information was not clear from publicly-filed tax records. However, its website lists three diet-drug companies — Eisai, Novo Nordisk and Takeda — as 2014 and 2015 corporate contributors.
The organization has spent at least $750,000 on lobbying.
In a statement, the group said it “takes conflicts of interest very seriously” and has a “firewall” preventing industry financial support from having any affect on guidelines, noting that conflicts of interest among members of its guideline writing committee are reviewed and members can recuse themselves.
Payments to Doctors
Millions more from diet drug companies went directly to doctors.
According to the federal Open Payments database, the manufacturers of Belviq spent at least $4.1 million on travel, food and speaking fees to doctors on behalf of the drug in the last five months of 2013. Meanwhile, Qsymia makers spent $1 million in that same period.
The publicly-available data only covers that period, which is before the other three drugs were approved.
The Open Payments system was created as part of the Affordable Care Act in the wake of media reports that exposed financial conflicts among drug companies and doctors as well as U.S. Justice Department investigations into unethical drug company behavior.
In the case of the just-released treatment guidelines from the Endocrine Society, the chair of the panel was Caroline Apovian.
She is listed in the disclosure section of the society’s obesity guidelines as having a “significant financial interest or leadership position” in four obesity drug companies: Eisai, Vivus, Orexigen and Takeda.
Open Payments data shows she received at least $31,000 in travel, food and speaking fees from diet drug-makers in the last five months of 2013.
Apovian has leadership positions with two different organizations that get funding from diet drug companies. She is chairwoman of the Endocrine Society and a board member of the Obesity Society.
Asked about the payments, Apovian said because of her expertise in the field, she is often sought out by drug-makers to serve on scientific advisory boards, which compensate her “time, travel and expenses.” She said she is transparent about the money she receives.
“Despite the growing problem of obesity in this country,” Apovian said, “there are still very few qualified experts in the field today.”
Three other members of the group that issued the Endocrine Society guidelines received at least $50,000 combined from diet drug-makers for the same type of work during that time period, according to the Open Payments website.
One of the panel members did not disclose his payments from drug companies. Christopher Still received more than $40,000 from Eisai and Vivus in 2013 and worked as a speaker and consultant for Novo Nordisk and Takeda in 2014. After the omission was pointed out by reporters, the society said Still had filed an updated disclosure statement.
The diet drug companies spent $19.7 million — more than a third of their lobbying total — in 2011 and 2012, the period when the FDA began approving diet drugs again.
Since then, the lobbying money has continued to flow, with more than $22 million spent in the last two full years.
Eisai, which markets Belviq, said in a statement that it is currently lobbying for the Treat and Reduce Obesity Act in order to educate members of Congress about the obesity epidemic. A primary focus of that legislation is to get Medicare to cover obesity drugs.
Qsymia drug-maker Vivus said in a statement that the company “has invested funds in the normal course of acceptable business practice as set forth by federal reporting guidelines.”
Saxenda drug-maker Novo Nordisk “advocates on industry issues of impact to our patients and business,” said company spokeswoman Marisa Sharkey. She said the company “strenuously advocates for legislation and regulatory action impacting people with diabetes, hemophilia and growth deficiencies.”
Shire Pharmaceuticals spokeswoman Gwen Fisher said the company has never lobbied Congress on behalf of Vyvanse, a drug approved to treat binge eating disorder. Nor has it lobbied on the condition itself.
“We adhere to the highest of ethical standards and abide by all legal and regulatory requirements,” Fisher said in an email.
The meetings at George Washington University — which included regulators, drug-makers and weight-loss physicians — were held between November 2011 and July 2012. Financing came from five diet drug manufacturers.
A George Washington spokeswoman declined to say how much money the companies provided.
But Scott Kahan, a physician and weight-loss expert with the university, estimated the cost was about $200,000. He said drug companies paid most of that.
Kahan said in his view there was no conflict in accepting drug company funding.
Zuckerman, president of the National Center for Health Research, said the meetings underscored industry’s influence on the approval process. The organization is a nonpartisan group that promotes health and safety, including working to get unsafe medicines removed from the market.
“There was enormous pressure on the FDA to approve weight-loss products,” said Zuckerman. “In response, the FDA had an apparent change of heart and started approving drugs with very little benefit and substantial risk.”
John Fauber is a reporter with the Journal Sentinel. Coulter Jones and Kristina Fiore are reporters with MedPage Today. This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.