In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.
To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.1 The study included 1,788 participants with 3,506 breast implants.
Re-operation, Rupture, and Capsular Contracture
The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.
The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.
In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.
There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.
For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.
Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.
The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.
Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years. However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.
January 6, 2017
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Comments of National Center for Health Research on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”
(Docket No. FDA-2016-1149)
The National Center for Health Research is a non-profit think tank focused on research and policies that improve the quality of medical care in the United States. We strongly oppose the off-label promotion of approved or cleared medical products. For patients, the evidence clearly indicates that off-label use increases the chances of adverse events and decreases the likelihood of benefit.2 For companies, widespread off-label use of medical products provides substantial financial benefit and a clear disincentive to conduct research to determine whether those off-label uses have benefits that outweigh the risks. The easier it is for companies to sell products for off-label uses, the less likely those companies are to submit applications for new indications to the FDA. In other words, most of the benefits of off-label promotion are to companies and their stockholders, and not to patients or consumers.
Even more worrisome, most patients are not adequately informed when devices or drugs are used off label. We have trained hundreds of patient advocates, and a recurring story is that patients are not told that a medical product was being recommended, prescribed, or used for an indication that was not approved by the FDA. Patients should always be informed about the risks and benefits of any medical device, prescription drug, or biologic. In addition to clear and understandable information that the physician explains orally to the patient, the physician should provide a short, understandable informed consent form for patients to read and sign whenever a medical product is prescribed or will be used off label.
Advocates of off-label promotion claim that it is essential for good medical care. There is no evidence to support that. Advocates also claim that as long as off-label communications are truthful and scientifically sound, they should be permitted. In an ideal world perhaps the FDA could carefully monitor off-label promotion to ensure that it is truthful and scientifically sound. Clearly, the FDA does not have the resources to do that and notifying patients or physicians about the risks of off-label use has not been a priority. As a result, patients are being harmed, in some cases catastrophically.
Some posit that if a study is published, especially in a peer-reviewed journal, that is a reasonable standard of being truthful and scientifically sound. Numerous staff at our Center have published in peer-reviewed journals and also serve as peer reviewers for a wide range of medical, public health, and health policy journals. We know from experience that peer reviewers have limited information about the scientific accuracy of the articles they review. Their ability to judge the scientific accuracy of a manuscript is completely different from FDA scientific reviewers, who have the opportunity to scrutinize the data provided by the sponsors and can even reanalyze data using different statistical tests. We also know that the results presented in these publications are often biased by design, execution, or selective reporting. Clinical evidence, although it can be informative, is subject to even more bias. Moreover, medical journals exist that will publish almost anything submitted. In fact, the president of our research Center has been invited to be an editor of several journals specializing in medical issues she knows nothing about. Numerous Coalition members serve as peer reviewers, and have reported that even publication in a peer-reviewed journal does not guarantee that the study results and interpretation are unbiased and accurate.
It is easy to talk about adverse events that result from inappropriate off-label use of medical products, but that abstract concept is insufficient. Below are photos that explain the issue much better. In 2008, the Journal of Neurosurgery: Pediatrics published a case report describing a terrible complication from the off-label use of Infuse, a recombinant human bone device that is approved for adults and contraindicated in children. This off-label disaster occurred at Washington University’s St. Louis Children’s Hospital. You can see how the child’s scalp and face became dangerously swollen as a result.
One would expect that this published article would have resulted in a warning from the FDA about the off-label use of this product in children, but it didn’t. Two years later, a girl treated at Cincinnati Children’s hospital had the same adverse reaction from the same off-label use of the same product, Infuse. Her photo is below.
How did the FDA respond? At first, they did nothing. After years of being urged to issue a warning by a patient advocate, the agency finally did so, but the warning wasn’t designed to get much attention or even to be understandable to physicians or families. Instead of specifying that the warning was for Infuse, the FDA warning says the following:
Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier or scaffold to be used as bone graft substitutes. Once combined, these products are surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone.
In addition to not naming the product, instead of issuing a strong warning to doctors or families about the off-label use in children, the warning is very understated:
The FDA has approved these products for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use.
These products are not approved for any use in patients under the age of 18 who are still growing (skeletally immature).
Even the FDA’s recommendations are very understated, referring to the fact that the product’s “safety and effectiveness has not been reviewed” for children, rather than stating that children had been irreparably harmed by Infuse.
The FDA recommends against routine use of these products in patients under age 18 because their safety and effectiveness has not been reviewed or approved for use in this population.
Consider alternatives such as autograft bone, allograft bone, and bone graft substitutes that do not contain recombinant proteins or synthetic peptides before using bone graft substitutes containing recombinant proteins and synthetic peptides in patients under age 18.
Carefully consider the benefits and risks before using these products in any patient. If considered the best or only option, inform parents/guardians and patients about the risks and benefits of using the product when discussing surgical options.
The above warning can’t be justified as lack of FDA resources or FDA’s lack of knowledge of how to get reporters’ attention and physicians’ attention. A quick look at the FDA website homepage shows how FDA relies on press releases and press conferences to let the world know when they approve a new product, and how they use public relations terms like “breakthrough” or “first new treatment in over a decade” to make sure the public will pay attention. Unfortunately, the FDA rarely uses their press and communications teams to warn physicians, patients, or family members about the dangerous off-label use of medical products, whether it is devices like Infuse or drugs that have been found to be ineffective or unsafe for popular off-label uses.
Patients deserve better and so do physicians. In the case of Infuse, the product is sold to children’s hospitals, where its use is always off-label. That means that the company that makes Infuse, Medtronic, is already promoting its off-label use by reaching out to children’s hospitals to sell their product. Has the FDA ever contacted children’s hospitals to warn them? That would be a relatively easy strategy.
As previously noted, companies currently have very little incentive to test their drugs, biologics, or devices for new indications once they are on the market. If off-label promotion is allowed by the FDA, the companies have even less incentive to conduct well-designed studies and submit applications for approval for those other indications.
Companies and their lawyers argue that off-label promotion is a free speech issue. This seems hypocritical, since the very same companies have made it almost impossible for patients harmed by their drugs and devices to talk about their experiences. Instead, companies that settle with patients who have been harmed by their products, either for approved indications or off label, insist on non-disclosure agreements that make it impossible patients to exercise free speech and share information with other patients and their physicians.
These non-disclosure agreements help explain why it is so rare for the FDA to hear from patients harmed by medical products, whether devices or drugs. Companies actively recruit patients to lobby on their behalf, to Congress and to the FDA, but they do what they can through legal strategies and settlements, to keep patients who have been harmed from speaking up. In addition, patients who were harmed, especially those seriously harmed, are unlikely to have the resources they would need to know when opportunities are available to contact the FDA about an important issue, such as off-label promotion. They are even less likely to have the resources needed to attend FDA public meetings.
The FDA knows that medical product manufacturers frequently provide misleading information to promote off-label uses. Major drug manufacturers have been fined billions of dollars for off-label marketing tactics. For example, many companies making atypical antipsychotics have promoted their use for dementia patients, despite the lack of efficacy and the known risk of fatalities. Unfortunately, these fines are perceived as just the cost of doing business. If the FDA loosens the current restrictions on off-label promotion of medical products, even more patients will be harmed.
As a nonprofit think tank that does not accept funding from companies that make medical products, the National Center for Health Research scrutinizes research to determine the treatments, programs, and policies that improve health care. Based on research showing the clear risks and relatively modest benefits to patients, and the even greater costs to public health when there is inadequate evidence to make informed decisions, we strongly oppose allowing companies to promote medical products for off-label uses. These views are based on evidence and have been confirmed by speaking with hundreds of patients harmed by medical products that they did not know were being used off label.
Physicians want wider Medicare coverage for leadless pacemakers, arguing the current reimbursement proposal puts the device out of reach for too many patients.
Last month, the CMS proposed limited Medicare coverage for leadless pacemakers that are used in federally approved clinical studies.
The agency collected public comments on the decision through Dec. 14 and received around 50 comments, mostly from cardiologists. They called for the CMS to cover Food and Drug Administration-approved leadless pacemaker devices for all Medicare beneficiaries who meet FDA-approved indications.
Medtronic’s Micra Transcatheter Pacing System is the only leadless device now on the market with FDA approval. It was approved for patients suffering from abnormal heart rhythms and is not intended for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that may be too small for the device.
In its proposed coverage decision issued in November, the CMS said additional studies were needed to support further reimbursement for the device, concluding there’s not enough evidence to determine long-term health outcomes or to identify who would be most likely to “experience overall benefit or harm.” […]
Experts agreed with the CMS that more research is needed. Evidence shows that while the leadless pacemaker eliminates some of the key drawbacks of existing pacemakers, they also increase the likelihood of some complications and may introduce new ones, according to Dr. Jay Ronquillo, director of biomedical informatics at the National Center for Health Research, a no-for-profit think tank focused on health research.
“At this point, there is no reason for patients to feel cheated if Medicare doesn’t cover the cost of leadless pacemakers, because leadless pacemakers may be no better, and possibly worse, than pacemakers with leads,” Ronquillo said.
By Philip Perry
December 17, 2016
President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. For the last 50 years, commissioners have all had a medical background, either as a doctor or a researcher, but not this Silicon Valley investor. He is familiar with government. In 2002 under the Bush administration, the candidate did a stint as the principal associate deputy secretary for the Department of Health and Human Services.
O’Neill has close ties with billionaire and PayPal co-founder Peter Thiel. Thiel is aiding the Trump team with its Defense Department transition. O’Neill and Thiel were colleagues at Clarium Capital Management. The possible appointee also spent some time managing the Thiel Foundation and a biotech incubator called Breakout Labs. At the latter, he helped biomedicine and food science startups develop and gain a foothold in the market.
Currently, the prospective commissioner is a managing director at Mithril Capital Management, a company owned by Thiel. An inside source close to the Trump team told Scientific American that Thiel was advocating for O’Neill. Yet, some of the investor’s past statements have raised concerns. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what he called “progressive approval.”
“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety,” he said in that same speech. “Let’s prove efficacy after they’ve been legalized.”
This is causing alarm among those in Big Pharma and the medical community. What about the placebo effect? Patients could falsely believe they are getting better, when in fact a new medication does nothing for them. What’s more, it may reveal a naiveté on the part of O’Neill, as many say it is impossible to separate safety from efficacy during the assessment process.
President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, “throw the entire U.S. healthcare system into turmoil.” In a legal sense, the 1962 Kefauver amendment would have to be repealed, a law which states that drugs must be proven safe and effective before they can make it to market. […]
Read the full article here.
Diana Zuckerman, PhD
Most of us know cancer patients who received drugs that drained their energy and joy of living but didn’t seem to benefit them. In some cases, the cancer stopped growing within a few months and even began to shrink, but ultimately the patient did not seem to live even a day longer.
Why is that?
A key problem is that cancer drugs do not have to be proven to prolong anyone’s life in order for the Food and Drug Administration (FDA) to approve them. Researchers at the National Cancer Institute and Oregon Health & Science University reviewed all the cancer drugs approved by the FDA from 2008 to 2012 (Kim & Prasad). They found that 26 of the 54 cancer drugs were not required to be proven to prolong or save lives, but instead were approved based on what are called surrogate markers, which are “signs” such as tumor shrinkage that are expected (but not guaranteed) to predict patients’ longer life.
Once the drugs were approved, thousands of patients started taking these drugs and paying for them, despite the lack of evidence of a meaningful health benefit. However, the FDA did require the companies to keep studying the drugs to find out if those medicines were actually extending lives.
The answer, unfortunately, is that many of these drugs did not help patients live longer or better. Only five of the 36 drugs were proven to help patients live longer. Eighteen drugs (50%) failed to extend life and 13 (36%) have unknown impact on survival because no data on them are available to the public. Since companies are very good at sharing information when their drugs are proven effective, experts assume that means those 13 drugs are not proven to work.
In November, the National Center for Health Research published a new study, looking more carefully at those 18 ineffective drugs. We found that only one was proven to improve quality of life – which isn’t surprising, since cancer drugs so often cause nausea, vomiting, hair loss, and exhaustion. Two made quality of life worse, and the other 15 new cancer drugs either did not improve quality of life (6), or there is not enough evidence to know if they do or not. We also looked at the cost of those cancer drugs and found something that doctors, patients, family members, and lawmakers need to know: the new cancer drugs that are not proven to benefit patients in any way cost just as much as the ones that are effective – up to $170,000 per patient. In fact, the most expensive of the 18 cancer drugs was a thyroid cancer drug (Cabozantinib, also called Cabometyx or Cometriq) that had no benefit to survival compared to placebo, and also caused patients to have a worse quality of life.
Meanwhile, the ineffective cancer drugs remain on the market and Medicare and insurers are still paying for them. When the president of the National Center for Health Research asked FDA officials why they take so long to rescind the approval of ineffective cancer drugs, they stated that they still think those drugs might be effective, but that it is difficult to prove. They pointed out that once a cancer drug is approved, it is very difficult to keep patients in a clinical trial long enough to know if the drug actually saves lives. We agree it is difficult; if a patient is in a clinical trial and not doing well, he or she is likely to drop out, whether they are on the new drug, old drug, or placebo. But that’s a major problem: if the FDA is approving cancer drugs on short-term, inconclusive data, and then requiring better studies that they know are unlikely to be completed appropriately, that’s quite a Catch-22. It means that the FDA is approving cancer drugs knowing that we’ll never know if they are safe and effective or not.
Table 1. Most New Cancer Drugs That Don’t Help Patients Live Longer Also Don’t Improve Their Quality of Life
b On November 18, 2011, FDA revoked accelerated approval of the breast cancer indication for bevacizumab.
c One subgroup analysis of Japanese patients found a Quality of Life benefit.
d Includes any combination of the other categories (better, no statistical difference, worse).
By Dennis Thompson, U.S. News & World Report, HealthDay
December 7, 2016
WEDNESDAY, Dec. 7, 2016 (HealthDay News) — The U.S. Congress has passed sweeping bipartisan health care legislation intended to expand medical research and speed up approval of new drugs and medical devices.
The $6.3 billion bill, called the 21st Century Cures Act, is a complex grab bag of initiatives amounting to nearly 1,000 pages that President Barack Obama is expected to sign into law.
In a statement released Wednesday, Obama signaled his support for the bill.
“We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,” he said. “This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”
The Senate passed the bill today by a vote of 94-5, and the House passed an almost identical version on Dec. 1, at 392-26. […]
A number of provisions in the 21st Century Cures Act also are aimed at swift approval of new drugs and devices. These would allow the U.S. Food and Drug Administration to:
- Rely on data summaries and “real world evidence” instead of hard clinical trial evidence when weighing the approval of existing drugs for new uses. Right now, for example, the FDA now must consider “patient experience” and anecdotal data in its review process.
- Use a “limited population” approval pathway for new antibiotics that would rely on a risk-benefit analysis weighing the needs of patients facing severe and untreatable infections against the possible harms to them.
- Expand its programs for expedited approval of breakthrough medical technologies for patients with life-threatening diseases that have limited treatment options.
Many have applauded the new measures, but critics say these the moves could raise the risk of harmful treatments getting to the marketplace.
“The FDA over all these decades has developed a way to know what products work and which ones don’t, but in the last decade they have been pushed to lower those standards,” Diana Zuckerman, president of the National Center for Health Research, told U.S. News & World Report. “With this bill, they’d lower them even more.” […]
Read full article here.
December 5, 2016
Passing a complicated health bill in the rush of a lame-duck session is always problematic. Passing a 996-page bill that was negotiated behind closed doors and includes provisions that were never voted on before represents the kind of legislative sausage that the world’s greatest deliberative body should reject.
While the bill includes some positive measures, the most important ones – funding for the National Institutes of Health (NIH) and the Opioid bill that previously passed – are not guaranteed in this legislation. Unlike the earlier version of the 21st Century Cures Act that was passed in 2015, the funding is not mandated in the new version. The funding would need to be approved by Congress every year, which would be a challenge given the opposition to this funding that has already been expressed by the Heritage Foundation.
Excessive Spending on Ineffective Cancer Drugs:
A new study, published in a journal of the American Medical Association last week, shows the danger of that kind of change. The study found that most newly approved cancer drugs do not help patients live longer or have a better quality of life. In fact, patients taking the most expensive cancer drug in the study ($170,000 per patient) did not live longer than patients taking placebo and felt significantly worse. And yet all 17 ineffective new cancer drugs are still being sold, contributing to the skyrocketing cost of health insurance and undermining the financial viability of Medicare. An editorial in the same journal points out how this harms patients and our healthcare system.
Harm To Stem Cell Therapies Research:
The Accelerated Approval for Regenerative Advanced Therapies section (Sec. 3033) makes it much easier for experimental stem cell treatments to be approved by the FDA without adequate testing to ensure their safety. Stem cell treatments are promising, but they are still highly unpredictable. Patients have become blind as a result of bones growing in their eyes, and disabled as a result of mucus growing in their spines, for example. Patients will be harmed and the development of effective stem cell research will be delayed if these treatments are sold to desperate patients before they are adequately studied.
Weaker Drug and Device Approval Thresholds:
Several other provisions in the bill would also drastically lower standards for the approval of prescription drugs and devices. For example, it would allow FDA to rely on companies’ summaries of their study results, instead of requiring the FDA to review the data itself, as is current law when companies want to sell drugs for new indications (treatments). It also encourages the FDA to make approval decisions based on “real world evidence” that is not necessarily scientifically sound. The FDA currently reviews and scrutinizes scientific data provided by companies, which is necessary to make sure the benefits outweigh the risks for any approved indication. Providing summaries would also reduce information about the possible risks to particular demographic groups, such as women or patients over 65. The bill also allows off-label promotion of medical products under certain circumstances. This reduces or even eliminates the incentive for companies to conduct scientific research to prove that their products are safe and effective for new indications.
Lower Antibiotic Standards:
Another section of the so-called “Cures” bill would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway. The bill would not require that the antibiotics be studied on the target population that the new drugs would be approved for. In other words, it is possible that the antibiotics would not meet the urgent need that they are intended for. Unfortunately, these antibiotics could then be widely advertised and used by patients who are not likely to benefit, and could be seriously harmed by them. In the long run, that would contribute to antibiotic resistance.
Weakening of Health IT Regulations:
The medical IT section of the bill would deregulate electronic medical records and decision support software. A study by the National Center of Health Research (NCHR) found that these types of health IT devices can cause life-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments. The Breakthrough Devices section (Sec. 3051) encourages shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include sufficient numbers of women, men, seniors, and racial and ethnic minorities. Moreover, a recent study of high-risk medical devices found that the median number of participants is currently only 65 patients, which is already too few to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for minority populations.
The bottom line:
By Andrew M. Seaman, Reuters Health
December 1, 2016
Researchers evaluated studies done on 18 cancer drugs approved between 2008 and 2012 by the U.S. Food and Drug Administration (FDA). None of the drugs had been found to prolong life, and only one had enough evidence to say it improved quality of life. Yet, all but one retained its approval status.
“We were shocked to find that these drugs don’t save lives and don’t improve quality of lives,” said lead author Diana Zuckerman, who is president of the National Center for Health Research and the Cancer Prevention and Treatment Fund in Washington, D.C.
To ensure a cancer treatment’s safety and quickly get it to market, the FDA sometimes approves a drug if it meets “surrogate” research goals instead of the gold-standard endpoints the agency usually looks for. Surrogate endpoints – like tumor shrinkage and time until the disease progresses – don’t take as many years to document as those used in the traditional approval process, so the drug can get on the market sooner.
“We don’t really know if people live longer or improve based on those outcomes,” said Dr. Vinay Prasad, of the Oregon Health and Sciences University in Portland. In a 2015 study, Prasad and colleagues found that 36 cancer drugs were approved by the FDA between 2008 and 2012 based on those early endpoints.
Of those 36 approved drugs, 18 did not help patients live longer, later studies showed.
For the new study, Zuckerman and her colleague Tracy Rupp analyzed additional data on those 18 drugs to estimate their costs and to see if they at least improved patients’ quality of life.
The price of the drugs ranged from about $20,000 to nearly $170,000, the researchers estimated in a report in JAMA Internal Medicine. […]
To read the full story, click here.
By Diana Zuckerman, The Health Care Blog
November 23, 2016
A major proposed law that alters the way the Food and Drug Administration (FDA) approves drugs and medical devices has been wending its way through Congress since 2014. Momentum is building on Capitol Hill to pass the legislation in the current “lame-duck” session of Congress.
That shouldn’t happen.
The House passed its version of the legislation—the 21st Century Cures Act (hereafter the Cures bill) —in July 2015. The Senate health committee created and passed 19 related bills, under the banner “Innovation for Healthier Americans,” this past spring.
Sen. Lamar Alexander (R-Tenn) pushed, without success, to get the legislation to the Senate floor this past summer. Now, he and proponents—which include the pharmaceutical and medical device industries and dozens of research and patient groups who get support from those industries—seek to pass the legislation in the lame-duck session.
The election of Donald Trump may add to momentum to pass the legislation now, or undermine its chances both now and in 2017. It’s not yet clear.
Proponents’ main arguments for lame-duck passage are:
(a) The need to foster innovation at the FDA and bring new drugs and devices to market sooner;
(b) The House bill would increase funding for NIH, by $9 billion over 5 years;
(c) The Obama administration’s “cancer moonshot” and precision medicine initiatives dovetail with the intent of the House legislation, and funding for both may be folded into any final legislative package;
(d) Americans expressed anger at their government in the election and Congress should pass this bipartisan legislation to demonstrate that lawmakers can work together to get things done.
Some provisions of the House and Senate bills take steps in the right direction. And I join the overwhelming chorus of voices supporting increased funding for medical research and FDA.
But enough problems remain with this complex legislation to caution strongly against its hasty passage in lame-duck session.
First, a major premise of the legislation is, in fact, wrong—namely that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared to other countries. In fact, at least two-thirds of the novel drugs approved each year from 2012 to 2015 in the U.S. were approved here before they were in any other country. That’s because many newly approved drugs are currently being reviewed through existing FDA expedited review programs.
Ignoring those facts, the Cures bill and Senate legislation seek to speed-up drug and device approval by weakening many of FDA’s safety and effectiveness standards, without strengthening post-market tracking and evaluation of products. The Senate bills are a significant improvement over the House’s Cures Act in this regard, but they, too weaken current FDA approval standards.
The second reason to delay consideration of this legislation until 2017 is that must-pass FDA funding is up for renewal next year. This is the mandatory every-five-year process that sets “user fees” for companies applying for approval of prescription drugs and biologics, medical devices, generic drugs, and biosimilar treatments (“generic” versions of biologics).
And there’s a third, equally compelling reason to delay consideration to 2017. Over the past six months it’s become clear that the public is fed up with rising costs of prescription drugs and other medical products. A series of price hikes has amplified the outrage—most recently, over the 5-fold increase in the price of life-saving EpiPens.
A survey of 1,205 consumers in October by the Kaiser Family Foundation, for example, found that prescription drug prices are the public’s #1 health policy concern. Sixty-three percent of respondents agreed that the government should take action to lower drug prices.
Thus, if President Trump and newly elected lawmakers want to be responsive to one of the public’s main healthcare concerns—and demonstrate the ability to work together—they should commit to tackling the issue of prescription drug prices and costs.
Consumer groups weigh in
Three consumer coalitions wrote letters this month to Congressional leadership calling for consideration of the FDA legislation to be put off until next year.
- AFL-CIO and the American Federation of State, County and Municipal Employees joined the Center for American Progress to tell lawmakers: “there is no justification for moving forward with legislation that provides substantial benefits to the drug industry without asking for something in return.”
- 18 nonprofit organizations representing the Patient, Consumer, and Public Health Coalition expressed opposition to numerous provisions in the legislation and said it has the potential to raise drug and device prices.
- Public Citizen, Consumers Union, and 11 other groups criticizedthe legislation for lowering FDA standards.
I agree that spending is very likely to increase when standards for approval are lowered without ensuring that unsafe or ineffective (and thus money-wasting) medical products can be much more quickly taken off the market.
In addition, new funding for the cancer moonshot and precision medicine initiatives, while laudatory, could yield new and expensive drugs that are not as rigorously evaluated for effectiveness before approval and not thoroughly assessed after they are approved.
A recent study of cancer medicines painfully illustrates that dilemma and the need for more linkage between the results a drug yields and its value in the marketplace—one of the major policy solutions under discussion to restrain drug prices and spending.
Researchers at the National Cancer Institute and Oregon Health & Science University reviewed all the cancer drugs approved by the FDA from 2008 to 2012. Two-thirds were approved based on biomarkers or other surrogate endpoints, usually tumor shrinkage over a relatively short period of time. As a condition of approval, the makers of these medicines were required to conduct post-market studies to assure their medicines were actually extending lives.
The answer, unfortunately: many were not. After a median follow-up of 4.4 years, only five drugs that had been approved on the basis of a surrogate endpoint were proven to help patients live longer. Eighteen drugs (50%) failed to extend life and 13 (36%) have unknown impact on survival because no data on them are publicly available.
The National Center for Health Research looked at the cost of those cancer drugs and found something that lawmakers and the Trump administration need to know: new cancer drugs that are not proven to work cost just as much as the ones that are effective – up to $170,000 per patient. Meanwhile, the ineffective cancer drugs remain on the market and Medicare and insurers are still paying for them.
The new administration and Congress should combine the elements of the Senate bills that improve the quality of medical care with new measures that make substantial progress on constraining drug prices and spending. Initial focus should be on three issues:
- Price gouging by companies that have created new “profit centers” by buying, repurposing or repackaging older medical products and boosting their prices 3 to 10-fold or more;
- The rising cost of new specialty, biologic, and cancer drugs that have not proven to be as effective or more effective than older drugs, and which are leading to substantial increases in Medicaid and Medicare costs and private sector insurance premiums; and
- Rising out-of-pocket costs resulting from insurance coverage design that puts consumers at risk for hundreds or thousands of dollars in annual expenses for very expensive medicines.
FDA reform legislation presents a unique opportunity for a new administration and Congress to demonstrate good will and bipartisanship—and achieve an early win in 2017 for the American people and public health. Changes are needed, however, to make sure this legislation does more good than harm.
Diana Zuckerman is president of the National Center for Health Research in Washington, D.C.
Ben Adams, FierceBiotech
November 23, 2016
We know it’s a top priority for Congress, but a group of panelists speaking at an “emergency briefing” in the U.S. Senate this week hosted by an anti-FDA legal co have urged lawmakers to not “rush a closed-door negotiated version of the bill during the lame-duck session.”
The 21st Century Cures Act, which is essentially seeking to speed up its regulatory processes for new meds and medical devices even further while adding billions in research dollars to the NIH and new funding to the FDA, has been in Congress for around a year but the biopharma industry, which is backing the bill, wants it pushed through asap.
But not all are happy for its to go through as is, with law firm Emord and Associates, which is run by Jonathan Emord, a man described as having “defeated the food and drug administration more times in federal court than any other attorney in American history,” looking to “expose the under-the-radar consequences” of passing the bill.
Justin Bogie, senior policy analyst in fiscal affairs at the Heritage Foundation, said on the issue of mandatory funding in the bill that this tends to put programs on “autopilot” and then they are not adequately reviewed to see if they are beneficial.
He said: “Congress should reject the 21st Century Cures Act in its current form . . . This bill would set a bad precedent that could have negative impact on other legislation, and the budget as a whole, in the future.”
Panelist Dr. Diana Zuckerman, president of National Center for Health Research, said a large number of drugs that showed promise in early stages of review went on to be proven ineffective, or worse, in later stages, adding that this was a concern given that the bill will allow for approval based on early stage indicators. […]
See the full article here.
November 22, 2016
November 8, 2016
The Honorable Patty Murray
United States Senate
Washington, DC 20510
Dear Senator Murray:
The undersigned nonprofit organizations represent members of the Patient, Consumer and Public Health Coalition, which includes more than 6 million healthcare providers, public health experts, and consumer and patient advocates. We respectfully urge you to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame duck session of Congress. While the House version of the legislation provides additional funding for the National Institutes of Health (NIH), both the House and the Senate versions contain more controversial measures which would lower safety and approval standards for drugs and medical devices at the Food and Drug Administration (FDA).
A number of leading medical experts, including a former Commissioner of the FDA, Dr. David A. Kessler, believe that the bill “could lead to the approval of drugs and devices that are less safe or effective than existing criteria could permit”. We believe that the far-reaching measures described below will significantly impact public health and safety and should therefore not be rushed into law in the final brief weeks of this Congress.
For example, the PATH Act, in both the House and Senate versions, would allow antibiotics to be approved based on minimal evidence of safety and effectiveness through a “limited population” approval pathway. Unfortunately, these antibiotics could then be widely advertised in order to increase sales, even though they may be much less safe or effective than older, less expensive antibiotics.
The MEDTECH Act, also in both Senate and House (Section 2241) versions, would prevent the FDA from collecting adverse events caused by flawed electronic medical records and decision support software. A study by the National Center of Health Research found that these types of health IT devices can cause like-threatening problems when they miscalculate incorrect drug dosages for chemotherapy drugs and other treatments.
The Advancing Breakthrough Devices for Patients Act, versions of which are in both House and Senate bills, would encourage shorter and smaller clinical trials for medical devices. These smaller studies make it impossible to include sufficient numbers of women, men, seniors, and racial and ethnic minorities. Moreover, a recent study of high-risk medical devices found that the median number of participants is currently only 65 patients, which is already too small to adequately evaluate safety and effectiveness for both men and women, let alone for elderly men and women compared to young adults, or for people of color. The House bill is even worse; for example, Section 2221 would permit companies that manufacture life-saving devices such as heart valves and stents, to be modified without submitting the new devices for FDA approval, as is now required.
Alarmingly, the bill in its current form also allows anecdotal and easily manipulated sources of health data to be used to approve new drugs (Section 2121). It effectively would eliminate clinical trial drug testing for new medical uses (called “indications’ in the bill). This measure also would result in the widespread use of medications for uses that are not approved by FDA, causing inevitable patient harm. (Section 2012: Facilitating responsible communication of scientific and medical development).
In addition to the extensive dilatory effects on FDA’s ability to protect the public health, the bill also extends exclusivity provisions for the pharmaceutical industry, discouraging the use of cheaper generic drugs, and having the practical effect of increasing or maintaining higher drug prices, at a time when the vast majority of Americans are frustrated with and angered by rapidly increasing drug prices. For example, the Advancing Hope Act, passed by the Senate, would continue the existing pediatric priority review voucher program through 2022. A recent GAO review of the program concluded that the program has questionable benefit. And, by allowing drug makers to buy a priority review, the bill undermines FDA’s ability to set its work priorities based on public health needs.
There also is serious concern concerning whether the additional $550 million dollars allocated to FDA by the House version of the bill would be sufficient to carry out the extensive mandates outlined by the legislation. FDA already is severely under-funded and cannot absorb unfunded mandates without dire consequences to its regulatory effectiveness and ability to protect public health.
The House version of the bill also weakens reporting requirements for the bipartisan Physician Payments Sunshine Act (“Sunshine”), a medical payments disclosure measure which is being successfully administered by the Centers for Medicare and Medicaid (CMS). The Sunshine Internet data base has provided the public with a useful and readily accessible transparency tool that can be used to discover which physicians and surgeons are accepting payments from the pharmaceutical and medical device industry, how much, and for what purpose.
Until the Sunshine data base was established a few years ago, doctors were accepting hundreds of millions of dollars annually in undisclosed payments from industry, much of which was intended to influence drug prescribing practices and the physicians’ brand choice of medical devices. The Sunshine Act does not prohibit or discourage these payments, merely makes them part of the public record, and allows patients and consumers to decide whether such payments influence their own medical treatment and choice of physicians.
In addition to weakening safeguards for patients and increasing the availability of treatments that are not proven either safe or effective, neither the House nor Senate bills include provisions to lower drug prices. A recent study by a researcher at the National Cancer Institute found that most cancer drugs approved during a recent 5-year period are not proven to improve the health of cancer patients. The National Center for Health Research assessed the cost of those ineffective drugs and found that they cost the same or more as cancer drugs that are proven to work. A recent letter to Congress by a coalition of more than a dozen labor and public interest groups asked the Congress to delay consideration of the Cures/Innovation bills until there are measures included to lower drug prices. We agree, but we also point out that several provisions in these bills would have the opposite impact, since many new drugs would be sold without clear evidence of efficacy, and yet those new drugs will inevitably cost more than older, more effective and less expensive treatments.
National Center for Health Research
American Medical Student Association
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Breast Cancer Coalition
Center for Medical Consumers
Connecticut Center for Patient Safety
Institute for Safe Medication Practices
Jacobs Institute of Women’s Health
Mothers Against Medical Error
MRSA Survivors Network
National Physicians Alliance
National Women’s Health Network
Our Bodies Ourselves
Quinolone Vigilance Foundation
Washington Advocates for Patient Safety
For more information, please contact Jack Mitchell at email@example.com.
September 28, 2016
As her president husband’s point person on health care in the 1990s, Hillary Clinton learned what is needed to make health care affordable for everyone and how hard — but worthwhile — it will be to achieve that outcome.
She knows the issues inside-out, and her current proposals as a presidential candidate reflect her knowledge and commitment.
Excuse me while I mix a bunch of metaphors to describe the challenges ahead. Improving access to affordable health care in our country will require a complex juggling act, fitting together hundreds of puzzle pieces, and compromises from the major players, many of whom are on opposing teams.
The good news is that there are fewer uninsured Americans today than at any other point in our nation’s history. Likewise, people no longer are one illness away from financial disaster because of pre-existing medical conditions or because their age or health problems make them uninsurable.
The bad news is that many Americans say they don’t support President Barack Obama’s marquee Affordable Care Act, commonly called Obamacare, or are skeptical of it because co-payments and deductibles are increasing.
Fortunately, Clinton’s proposals to improve the situation are achievable — if Congress wants to improve access to health care instead of just complain about it.
Here are a few of her proposals:
— Reducing the price of prescription drugs. Nearly everyone agrees this is an important goal, but Big Pharma’s army of lobbyists have made it a tough one to achieve. Clinton has proposed several solutions, and my favorite is the simplest: scrutinizing prescription drug ads before they are allowed to bombard consumers. The U.S. is one of only two countries that allow these ads to be directed at consumers rather than just toward doctors. Also, as if watching the ads isn’t annoying enough, pharmaceutical companies deduct the cost of the ads from their taxes but still count advertising as a research-and-development expenditure. Yes, really, advertising costs are included in the “costs of developing new drugs.” The misleading ads encourage inappropriate and expensive prescriptions that cost us billions of dollars and ought to be more heavily scrutinized, as Clinton has proposed.
— You’ve probably never heard of Federally Qualified Health Centers, but 25 million Americans get their care from these clinics every year. Clinton proposes doubling that investment to provide care for more Americans. Legislators like to get credit for bringing home federal money and ought to go along with this idea.
— Reducing the backlog of generic drug applications. Generic drugs are generally less expensive and, in turn, force brand-name manufacturers to lower their prices. Clinton proposes that generic drug manufacturers help pay for reducing the backlog, since the move will benefit their bottom lines.
— Expanding Medicare to make it available — not required — for people 55 and older, instead of only people 65 and older. The cost of Medicare, which is not free, is different for every person and based on income. Americans generally love Medicare, and many would benefit, so if Congress is functioning, this could become law.
— Expanding Medicaid in every state. Medicaid provides health care to the poorest Americans in all 50 states, but 19 states have refused federal funds to expand it. The number of states participating in this expansion has slowly increased as it has become obvious that red states, such as Kentucky, have benefited the most. Expanding coverage in all 50 states will be tough, but Clinton’s plan to use incentives should nudge things in that direction.
These are just a few ways Clinton proposes to make health care more affordable. It won’t be easy, but as a senator, Clinton was able to work with both parties to get legislation passed.
One big plus is that several of her proposals reflect her awareness that the Food and Drug Administration could help reduce the cost of our health care instead of increasing it. Just this week, the agency tentatively approved a drug that will cost $300,000 a year despite there being little evidence that it works. In improving the nation’s health care environment, preventing skyrocketing costs of unproven treatments is a great place to start.
Diana Zuckerman is president of the National Center for Health Research. She received a doctorate in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. Readers may write her at NCHR, 1201 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. Distributed by Tribune Content Agency LLC.
You can read the original article here.
Elected officials at the local, state, and federal level are responsible for representing the interests of their constituents. In order to know your interests, your elected officials must hear from you!
Tips for visiting your representative
If you are very knowledgeable about your issue, and want to have more of an impact, it is often wise to follow up your letter or phone call with a visit to your elected officials. Often, if your representative is unable to schedule a meeting, they will designate an appropriate staff member to meet with you. Here are some tips to help you have an informative and effective meeting with any national, state or local official:
Schedule in advance
If you are there to talk about specific bill, be sure to visit http://www.congress.gov a day or two before to see if the official is a sponsor or co-sponsor. If they support a bill that you support (or something similar), be sure to thank them, even if you want to talk about how the bill could be improved.
Make it clear why you are knowledgeable about the topic, such as explaining that you are a researcher, health professional, patient, or whatever. It helps to briefly say why the issue is personally important to you. REMEMBER: they are there to represent you so don’t be apologetic or intimidated.
Consider bringing brief written materials, such as an issue brief or a one-page list of concerns, which you can leave with them. You may be able to get these materials from a think tank or research center website, or you may write them yourself. Bring only the one or two pages you most want them to look at. If you are there about a medical issue, do not bring all your medical records.
Send a thank-you note
Sending a thank-you note
Sending a “Thank You” note can be a great way to remind your representative about why you visited as well as it being a polite way to show your appreciation for their time. If legislation is pending, you may want to mention the bill number and stress the level of urgency involved. Click, here for information on how to properly email your representative. The letter below is only a suggested format:
Elected officials at the local, state, and federal level are responsible for representing the interests of their constituents. In order to know your interests, your elected officials must hear from you!
Tips for calling your elected officials
(here is an example based on a made up bill)
Calling your elected officials is another effective way to share your views on issues and legislation. While you will generally not be able to speak directly with your U.S. Representative or Senators by telephone, their staff will note your comments and share them with the legislator.
If you want to your senators or representative to support or oppose a particular bill, check Congress.gov to see if he or she is already a sponsor or cosponsor of the legislation before calling. If you support the bill and he or she already sponsored or co-sponsored it, you can call and thank them. If you support a bill that they didn’t sponsor or co-sponsor, you can ask them to co-sponsor it and vote for it. If you oppose the bill and they didn’t so-sponsor it, thank them for not co-sponsoring and let them know you want them to vote against it.
The same general tips when you write your U.S. Representative or Senators apply when you call:
Offer your name and address
Follow up with a letter
Finding phone numbers
Click here to find phone numbers for your U.S. Congressional representatives at the Senate and House of Representatives websites.
You may also be connected through the Capitol operator by dialing (202) 224-3121.
You can share your views with the President by calling White House staff at (202) 456-1414.
Contacting state and local officials
The tips listed are also useful when calling your state and local elected officials. You can find out how to contact your state and local officials about state and local issues at https://www.usa.gov/elected-officials. State government directories can also be found on the Library of Congress website at http://www.loc.gov/rr/news/stategov/stategov.html. Remember that state and local officials may have only one staff person to help with phone calls, so be brief.
Elected officials at the local, state, and federal level are responsible for representing the interests of their constituents. In order to know your interests, your elected officials must hear from you!
Tips for writing your email
Because of time-consuming security precautions, it takes weeks or months for a letter to reach a Member of Congress, regardless of how it is mailed. Instead, you should send your letter electronically by typing it directly on their website or by emailing your representative and/or senators. Keep in mind that public officials, especially those at the federal level, receive thousands of emails and online letters each week. Many won’t even read emails from people who are not their constituents- so make sure to say you are one of their constituents! Here are some tips to help get your letter noticed (click the tip to expand):
Make it easy to read
Send a personal email
Include your name and address
Finding your Congress person’s email address
You can find email addresses and phone numbers for your U.S. Congressional representatives at http://www.contactingthecongress.org/. The President’s email address is firstname.lastname@example.org.
Even though this is email, you should start the email as you would a formal letter. For example:
Dear Senator LASTNAME:
House of Representatives:
Dear Representative LASTNAME:
Dear President LASTNAME:
Contacting state and local officials
The tips are also useful when writing to your state and local elected officials. You can find out how to contact your state and local officials about state and local issues at https://www.usa.gov/elected-officials or your local library for representative addresses and information about state and local issues. Additional state government directories can be found on the Library of Congress website at http://www.loc.gov/rr/news/stategov/stategov.html.
Below is a selection of articles discussing the controversial 21st Century Cures Act:
iHealthBeat, August 13, 2015
New Haven Register, July 16, 2015
The New England Journal of Medicine, June, 25, 2015
Click on the links below to learn more:
On the week after Thanksgiving, 2016, the House of Representatives is planning to pass a newly revised bill called the 21st Century Cures Act that its advocates claim will result in life-saving new drugs and medical devices. But does it?
The bill promises to increase funding for the National Institutes of Health (NIH), but will that promise be fulfilled? There is great concern that the promise won’t be kept, given the strong pressure to cut federal spending by many Tea Party Republicans. But wishful thinking has resulted in strong lobbying from medical schools, researchers, and some patients.
Whether or not it provides any funding for the NIH, the bill has a high cost to patients, because the bill weakens the scientific requirements of the Food and Drug Administration (FDA) for new medical products. Many would be approved that are less effective and less safe than those already available to patients – and they would cost more, too. This has the potential to hurt millions of patients.
The House and Senate will be voting soon. They need to hear from you.
Click on the links below to learn more:
- Allows anecdotal/unreliable and easily manipulated sources of health data to be used to approve new drugs.
- Encourages smaller, shorter term studies that are less likely to accurately measure the safety and effectiveness of new medical products. Smaller studies are a step backwards for health experts who believe that new treatments should be proven safe and effective for women as well as men, people of color as well as whites, and adults of all ages, including those over 65.
- Weakens the Physicians Sunshine Act, which requires pharmaceutical and device companies to publicly report when they provide funding or gifts to physicians.
- Weakens patients safety by lowering standards of scientific evidence required to prove that new drug treatments and new medical devices are safe and effective.
- Allows companies to disseminate “scientific information” that may not be accurate and was not scrutinized as part of the FDA approval process. This opens the door for widespread use of medications for treatments not approved by the FDA. (Facilitating responsible communication of scientific and medical developments.)
- Exempts potentially life-saving medical software from FDA review. Reduces FDA’s authority to regulate electronic health records systems and other medical software. Research shows that health IT software that is defective have caused deaths and permanent harm before the defects are discovered and corrected.
This bill greatly benefits the pharmaceutical industry and medical device manufacturers. Patients and researchers like that it promises to provide additional funding for the National Institutes of Health, the FDA, and opioid programs, but the bill does not guarantee that those promises will be fulfilled.
By lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefiting most patients. And it is an added burden on patients and physicians, because they need to decide which of the new treatments to try, without knowing if they are safe or effective.
Click on the links below to learn more:
Sexual assault on campus has become a hot-button issue, resulting in debates on the merits of personal stories of campus rape, the statistics estimating the scope of the issue nationally, and the best solution to the problem. This article looks at the best data regarding sexual violence on campus based on research by Brown University, RTI International, Harvard School of Public Health, and the Post-Kaiser Family Foundation. Importantly, the findings from these studies reinforce the growing evidence of how often sexual assaults occur on college campuses.
What were the studies?
A study conducted by Dr. Kate Carey of the Brown University School of Public Health and her colleagues, found that 1 in 5 (20 percent) freshmen women were victims of attempted and/or completed rape. This study looked at levels of rape over the school year and following summer. It included 483 female freshmen at an unnamed private college in upstate New York.4
The two larger studies conducted at public universities were led by Dr. Christopher Krebs at RTI International. Combined, more than 5,000 were surveyed and they found that 1 in 5 (20 percent) of female seniors reported being sexually assaulted and approximately 1 in 7 (15 percent) reported being raped since entering college.5
A national study, conducted by Dr. Meichen Mohler-Kuo and colleagues at the Harvard School of Public Health, studied the prevalence of rape among women at 119 U.S. colleges and universities. It found that approximately 1 in 20 (4.7 percent) of the college women surveyed, who included freshman, sophomores, juniors, and seniors, had been raped since the beginning of the current school year.6
The most recent study, conducted by Rutgers University, was consistent with what’s going on at campuses across the country. Rutgers-New Brunswick, with about 48,000 students, conducted a survey last fall through an electronic questionnaire at the request of a White House task force on prevention of campus sexual violence. The response rate was 28 percent. Results indicated that twenty percent of undergraduate women who answered a survey last fall at Rutgers University said they experienced unwanted sexual contact in their time as students. In addition, when the definition of sexual assault was expanded to include unwanted remarks about physical appearance and persistent unwanted sexual advances, 24 percent of undergraduate women reported experiencing sexual violence before they started college at Rutgers.7
Why do the numbers differ?
There is a range of results in the rates of rape among college students. There is no conclusive way to know exactly why these statistics vary, but the following are a few differences among the studies that might contribute to these varying numbers.
Even when the same definition of rape is used in different studies, the women varied in terms of their year in college and the time frame studied. The Carey study found that 1 in 5 freshmen women were victims of attempted or completed rape during their first year of college or the subsequent summer. The Krebs study found that 1 in 7 senior women were the victims of attempted or completed rape since entering college. These numbers would be expected to be higher than the number of women raped in any specific year in college, although some rape victims may leave college and would therefore not be in a study of seniors. The Mohler-Kuo study examined female students from all class years and found that 1 in 20 of these students was the victim of completed rape on campus during the current academic year. This statistic is lower than that found by the other two studies because it only considers rapes during a single year, rather than throughout a woman’s time in college. Since freshmen women are more at risk for rape than women who are sophomores, juniors, or seniors, that at least partially explains why this statistic is lower than the other two studies.
The definition of rape is not universal. Each of the studies provided participants with a definition of rape, and those definitions varied. In 2012, the legal definition of rape changed from “the carnal knowledge of a female, forcibly and against her will” to a more comprehensive term that defined rape as to “the penetration, no matter how slight, of the vagina or anus with any body part or object, or oral penetration by a sex organ of another person, without the consent of the victim.”8 The more recent study by Carey reflected the post-2012 definition, which defined rape as “anal, vaginal, or oral penetration” and also distinguished between incapacitated rape and rape by force. The Krebs study, conducted in 2005 and published in 2009, defined five levels of sexual contact but only “unwanted sexual intercourse” was considered rape in their analysis, and they also distinguished between incapacitated rape and rape by force. Both studies also defined rape as both completed and attempted rape. The Mohler-Kuo study, which was based on Harvard School of Public Health College studies from 1997, 1999, and 2001, used the legal definition of completed rape at the time the surveys were completed. These different definitions of rape could help explain the different statistics in these three studies.
In addition, studies vary depending on how the question is framed and who is answering. One study conducted by the University of Kentucky reported 4.9 percent of students experienced unwanted vaginal, oral or anal sex in the past year, attacks that could amount to rape or forcible sodomy. However, the university did not say how many of the reported victims were women or undergraduates, making it more difficult to compare to other study results.
The scope of these studies was different. As previously noted, the Carey study was conducted at only one private college, the Krebs study at two large public universities, and the Harvard study at 119 college and universities, which make for more representative studies.
What does football have to do with campus rape?
According to law enforcement agencies serving Division I universities, reported rapes increased by 41% on days when there are home football games, when statistically controlling for different days of the week or time of year.9 Reported rapes increased 57% when the underdog home team suddenly wins against tough competitors. With 128 schools in Division 1A, the impact would be estimated at 253 to 770 more rapes each year. What’s the price tag for all of this? Taking both the tangible and intangible costs into account, each rape has a social cost of $267,000, for a total of $68 to $205 million a year. The researchers believe that the increase in alcohol consumption is probably the reason for the increase in rapes that is associated with football games, since arrests for disorderly conduct, DUI, and public intoxication also increase on home game days. The impact of other sports events haven’t been studied, but those that influence drinking on campus are likely to have an impact on rape.
What does this mean?
The results of these studies on different campuses and focusing on different issues indicate that campus rape is a common occurrence across the U.S., regardless of definition and type of college. Alcohol is a major factor, but not the only one.
What can we do?
The overwhelming sentiment moving forward is that it is time to stop focusing on the exact numbers and instead evaluate the impact of programs aimed at reducing campus rape. A comprehensive solution will require political policy, university outreach, and individual commitment to stopping sexual assault.
In 2010, an article in the Journal of Forensic Nursing evaluated seven programs that aimed to eliminate sexual assault on campus. It found that educational interventions directed at college-age men can produce “beneficial changes in the attitudes and beliefs of rape and sexual assault.”10 It did not measure actual impact on sexual assault or rape, however.
In 2014, the Center for Disease Control (CDC) released a report entitled “Preventing Sexual Violence on College Campuses: Lessons from Research and Practice” for the White House Task Force to Prevent Students from Sexual Assault. This report evaluated many of the different initiatives aimed at preventing sexual assault in middle and high schools. They recommend that the programs that were found to work, such as dating violence prevention and sexual assault intervention programs, be adapted and used for college students.11
In 2015, The Washington Post reported the Education Department’s Office for Civil Rights is investigating over 130 schools for their handling of sexual-violence allegations. Rutgers University, started a campaign entitled “The Revolution Starts Here: End Sexual Violence Now”, for students, faculty and staff to mobilize to combat the problem. Michigan State University, has resolved an investigation of two complaints and is taking positive steps to correct violations of anti-discrimination law uncovered during the probe. Using Rutgers and Michigan State as examples, Universities are improving their commitment to addressing sexual harassment and sexual violence.12
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
NPR – the Diane Rehm Show
July 30, 2015
Listen to NCHR president Dr. Diana Zuckerman explain her concerns about a new health bill.
Earlier this month, the House of Representatives overwhelmingly passed the 21st Century Cures Act. Its authors say it will modernize the way medical treatments are developed and brought to market, offering hope to those suffering from diseases like cancer, Alzheimer’s and an array of rare illnesses. The bill includes nearly $9 billion for research at the National Institutes of Health, and attempts to streamline the approval process at the U.S. Food and Drug Administration. But critics warn we may be trading speed for safety. As the bill moves to the Senate, we discuss balancing patient safety and innovation.
Listen to the conversation here.
By Sabriya Rice, Modern Healthcare
July 25, 2015
Essure could become a poster product for critics of the current regulatory process. Diana Zuckerman, president of the Washington, D.C.-based advocacy group National Center for Health Research, said her group heard Essure complaints from more than 900 women this year when it conducted an online survey. “If even half of what I’ve heard is true, there are still many problems,” Zuckerman said. The main issue, she added, is the questionable accuracy of the manufacturer’s clinical data about the product. […]
But the National Center for Health Research’s Zuckerman said it’s not enough for physicians to provide counseling based on the existing clinical data about Essure. “It doesn’t do any good to share data if the data you are sharing are inaccurate,” she said. […]
July 22, 2015
The Medicare Evidence Development and Coverage Advisory Committee of the CMS voted that it has moderate confidence that there is sufficient evidence for at least one intervention that improves most forms of lower-extremity peripheral artery disease.
The panel’s vote could serve as a basis for a National Coverage Decision from the CMS. There is currently no CMS national coverage pertaining to therapies for lower-extremity PAD, though some are covered on a state-by-state basis,Tamara Syrek Jensen, JD, director of CMS’ coverage and analysis group, said at the meeting.
After a review of the existing evidence, the panel voted that it has low confidence that there is sufficient evidence for at least one intervention that improves asymptomatic PAD in the short term; moderate confidence that there is sufficient evidence for at least one intervention that improves asymptomatic PAD in the long term, intermittent claudication in the short and long term andcritical limb ischemia (CLI) in the long term; and moderate-to-high confidence that there is sufficient evidence for at least one intervention that improves CLI in the short term.
“We have a conflict between what we know logically should work [and] data that … just aren’t very good,” panel member Diana Zuckerman, PhD, president of the National Center for Health Research Cancer Prevention and Treatment Fund, said. She was one of several panelists who emphasized the need for more long-term data.
Read full article here.
By Sabrina Tavernise, The New York Times
July 7, 2015
Out-of-pocket spending on most major birth control methods fell sharply in the months after the Affordable Care Act began requiring insurance plans to cover contraception at no cost to women, a new study has found. Spending on the pill, the most popular form of prescription birth control, dropped by about half in the first six months of 2013, compared with the same period in 2012, before the mandate took effect.
The study, by health economists from the University of Pennsylvania, analyzed health insurance claims from a large private insurer with business in all 50 states and the District of Columbia. It evaluated the effect of the Affordable Care Act, the biggest piece of social legislation in decades, on women’s pocketbooks. It estimated that savings from the pill alone were about $1.4 billion in 2013.
Cost has long been a major obstacle to women getting birth control, and declines in what they pay for contraceptives have the potential to increase access and reduce unplanned pregnancies. About half of the 6.6 million pregnancies a year in the United States are unintended, far higher than in most developed countries.
The study, published online in Health Affairs on Tuesday, was not able to definitively establish whether the law drove women’s falling expenditures on birth control, but experts said the magnitude and timing of the decline suggested that it was.
The study did not address whether free or cheaper birth control led to fewer unintended pregnancies. Findings from pilot studies in St. Louis and Colorado suggested that when cost was not an issue, birth control use increased and women tended to choose the most effective methods, such as long-acting intrauterine devices and implants. That helped drive down rates of abortion and unintended pregnancy in both states.
“We have no doubt that the cost makes a difference,” said Diana Zuckerman, the president of the National Center for Health Research in Washington. “When you have free contraception, it’s going to affect pregnancy and abortion as well because money matters.”
The Affordable Care Act requires insurance plans to cover the full cost of preventive services, including prescription contraception. The mandate for contraception began in August 2012, and insurers were supposed to comply by the beginning of new plan periods, which for many women was Jan. 1, 2013.
Read full story here.
July 13, 2015
Thank you for the opportunity to speak today. I am Dr. Christina Silcox, I have a PhD in Medical Engineering and Medical Physics from MIT and Harvard Medical School, and I am a senior fellow at the National Center for Health Research. Our research center scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. These are the perspectives I bring here today.
MDUFA should protect the public health by improving the safety and efficacy of all medical products, whether PMA or 510(k). That requires higher user fees, performance standards that focus on the quality of the review and not just the speed, and reviews that provide patients, consumers, and healthcare providers with information about how well the product works compared to other similar products on the market.
The new MDUFA legislation should:
- Substantially increase the FDA resources for both 510(k) reviews and PMAs.
- Require higher standards of safety and effectiveness for devices that can potentially sustain life, save lives, or harm lives. They should be held to at least as high as standards for prescription drugs.
- Focus on safety and ensure that only safe predicate devices can be used for the 510(k) clearance process.
- Focus on post-market surveillance of all medical devices.
A major concern is that the medical device user fees are too low to adequately support the Center for Devices and Radiological Health’s (CDRH) efforts to clear or approve safe and effective medical devices in a timely manner.
Although the PMA and NDA process are similar, the FDA charges much smaller user fees to review medical devices than it charges to review prescription drugs, even when the same companies make devices and pharmaceuticals. The simple fact is that the user fees for 510(k) reviews and for Premarket Approvals (PMAs) are a small fraction of the actual cost of the reviews. This exacerbates the lack of resources at CDRH. For example, currently the FDA charges a standard fee of only $5,018 for a 510(k) submission (half that amount for small companies) and $250,895 for an original PMA (one-quarter that amount for small companies), compared to user fees ranging from $1.2 to $2.3 million for a New Drug Application (NDA).
The user fees for PMAs and NDAs should be comparable. Why should a drug that prevents clods from forming have a $2M user fee while a device that does the same have a fee that is less than a quarter million dollars?
The inadequacy of the fees for the 510(k) is especially egregious. User fees of only a few thousand dollars do not provide the FDA the resources needed to assure the safety and effectiveness of medical devices reviewed through the 510(k) process.
And now we are talking about using user fees for post-market surveillance as well. $5000 certainly does not provide resources for robust post-market surveillance.
And with 21st Century Cures, we have the potential for third-party reviews of PMAs. This would eliminate supplemental PMA user fees, leaving nothing for post-market surveillance of those devices.
The argument can be made that Congressional appropriations should fill in the difference. But we can see with 21st Century Cures that Congress is not willing to do so. They appropriated less than a third of the amount of money that would be needed to implement all the reforms required in that bill.
Another concern is ensuring higher standards for safety & effectiveness.
Part of the MDUFA improvements should be the assurance that a device will not be cleared as “substantially equivalent” to a previously recalled device, or to a device that was cleared on the basis of a predicate device that was substantially equivalent to a recalled device.
In conclusion, reauthorization of MDUFA gives Congress and the FDA an opportunity to strengthen CDRH by increasing its resources, holding medical devices to higher safety and effectiveness standards, and ensuring that predicate devices cited for new devices are safe.
Thank you for the important work that you do on behalf of the public health, and thank you for your consideration of our views.
The Associated Press
June 25, 2015
WASHINGTON (AP) — Federal health regulators are reviewing the safety of an implantable contraception device after receiving reports of unusual side effects from patients, including fatigue, depression and weight gain.
The Food and Drug Administration says those problems have not been established in studies of the device and are not listed on the product label. But the agency scheduled a September 24 public meeting to consult outside experts about the overall safety of the Essure implant, which is marketed by Bayer.
Regulators said that their review of two follow-up studies conducted by Bayer “found no conclusive evidence” of new or widespread complications “definitely associated” with the device. The company studies were designed to evaluate the safety of the procedure used to implant Essure, the device’s safety after implantation and its effectiveness in preventing pregnancy.
Despite those findings, the FDA says it has continued to receive reports of complications from patients. A review of the agency’s complaint database turned up more than 5,000 reports of problems linked to Essure. The problems most commonly reported by patients included abdominal pain, menstrual irregularities, headache and weight fluctuations. The agency stressed that patient reports are voluntarily submitted, and have a number of scientific limitations, including “incomplete, inaccurate, untimely, unverified, or biased data.”
Diana Zuckerman, president of the National Center for Health Research, said she is pleased the FDA is looking into concerns about Essure.
“Our center is studying more than 900 women who have had problems with Essure permanent birth control, including chronic debilitating pain, abnormal bleeding, and pregnancy,” Zuckerman said in an emailed statement.
Read the full story here.
Dr. Diana Zuckerman, PhD
July 10, 2015
We are greatly disappointed by the passage of the 21st Century Cures Act today. We share Congress’ desire to increase funding for NIH, but there are dangerous provisions in this bill that undermine scientific evidence used to approve medical products. However, this was a very technical 350+ page bill, and many Members of Congress did not have the time to fully evaluate the public health implications of the scientific wording.
As often happens, millions of dollars spent on pharmaceutical and device company lobbying were more effective than the efforts of health experts to explain their concerns about patient safety. When campaign contributions and lobbying overwhelmingly support industry wish lists and mislead many patient advocates, as happened here, industry will win. If this bill becomes law, rat and test tube studies will be used to approve medications instead of studies of patients, and patients will be harmed.
By Carolyn Johnson, The Washington Post
July 8, 2015
The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments.
But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective.
It’s not exactly easy to oppose a widely-supported bipartisan bill that is often referred to as just “Cures.” But opponents say the proposed law is full of flaws, starting with its name and its key premise: that bottlenecks in the regulatory process are a big reason we haven’t cured cancer, Alzheimer’s, and a panoply of rare diseases.
To drug companies and patient advocates, expedited access to drugs and devices might seem like a huge boon. But critics are worried that the law will relax America’s standards for evaluating new drugs and devices, which are approved based on careful review of evidence — including rigorously designed clinical trials. The bill offers up a slew of new ways to evaluate drugs: for example, allowing antibiotics to be approved based on what would today be considered preliminary evidence — animal and test tube studies and very small trials in people. New medical devices could be approved based on “case histories” — potentially of just a handful of patients.
“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit, non-partisan think tank that does not accept money from drug or medical device companies.
Here are a few of the provisions that have sparked debate:
-The bill would allow antibiotics to be approved based on laboratory and animal tests and small, early clinical trials.
-The bill allows companies to seek expedited drug approval based on so-called “surrogate endpoints” — early indicators that a drug is working, such as whether a tumor has stopped growing in cancer.
A study published last month in the journal JAMA Internal Medicine found that efforts to expedite cancer drug approval by using such criteria has resulted in the approval of many cancer drugs that do not extend life, but do have side effects.
-The bill also threatens disclosure requirements that are intended to limit pharmaceutical companies’ influence on physicians. The bill would allow physicians to receive speaking fees and gifts from companies without disclosing them, as long as they were for medical education.
Read full story here.
November 4, 2013, Grand Magazine
By Diana Zuckerman, PhD
The sights and smells of wonderful food can put your willpower to the test during the holidays.
Studies show that most of us gain at least a pound over the winter holidays. Some — those who are physically active — will take off that extra weight in the spring. Unfortunately, most Americans are overweight to begin with and not active enough, and so tend to gain more than a pound or two during the holidays and to hold on to them. Year after year, those “few extra pounds” add up, increasing the risk of heart disease, diabetes, breast cancer, and colon cancer.
Fortunately, it is possible to enjoy holiday fare without gaining weight.
Here are a few proven ways to help curb the urge to overindulge:
- Ignore the old kitchen-table advice to eat before the party so you won’t be so hungry you’ll eat too much at the celebration. The adage, “With the food comes the appetite,” is true. Studies show that, hungry or not, people eat food that is put in front of them.
- At a party or buffet, stand or sit away from the food (or smell of food). That way, you’ll be less likely to go for seconds or thirds.
- At meals and parties, try not to sit or stand near people who eat and drink a lot.
- Eat fewer and smaller portions of high-fat, high-carb, and high-calorie foods.
- Put smaller portions on your plate. At a buffet or your own dinner party, use a smaller plate, which helps to reduce portions.
- Forget the age-old parental admonition to “clean your plate.” People may be starving all over the world, but your overeating won’t change that.
- Watch the booze. The calories in alcoholic beverages can be more than in dessert and less filling. A mere 10 ounces of wine is 200 calories. A 1.5-ounce shot of liquor is 105 calories. Mixed drinks, such as eggnog, daiquiris, and mojitos, can be 350 calories or more per 8 ounces, and one margarita, pina colada, or mudslide is 600 to 850 calories! Beer is 100 to 150 calories per 12 ounces but more filling.
- Get enough sleep. You are more likely to overeat if you’re tired. Lack of sleep also slows your metabolism, making it even easier to gain weight.
Cheers to a happy, healthy holiday!
See original story here.
By Diana Zuckerman, PhD
National Center for Health Research
Swallowing difficulties caused by neurological diseases, stroke, or cancer are very difficult to prevent. Many swallowing difficulties can’t be prevented, but some swallowing difficulties attributed to aging and dementia can be delayed or prevented by reducing tooth loss and sedation.
Tooth Loss. Having fewer teeth makes it more difficult to adequately chew food, and this makes it harder to swallow food. As people age, they may forget to brush their teeth as often or as carefully as they used to, and a common side effect of many prescription medications is dry mouth, which also leads to tooth loss. Reducing the use of unnecessary medications that cause dry mouth could be very effective. In addition, reminders by caregivers to brush teeth after every meal can increase the likelihood that a person will brush his or her teeth at least once a day.
Sedation. Atypical antipsychotic medications such as Seroquel, Abilify, Zyprexa, and Geodon, are frequently prescribed to elderly patients who are depressed or agitated despite warnings about their risks. These drugs are often chosen because they tend to cause sedation, which may calm an elderly person but is a well-established cause of swallowing problems.13
Reducing Swallowing Problems by Making Liquids Thicker
Thickened drinks are normal drinks that have a thickener added to make them thicker. They are often recommended for people who can no longer swallow normal fluids safely, because drinks go into their lungs, causing coughing, choking or more serious risks such as a chest infection and aspiration pneumonia.
The goal of “thickeners” is to make all liquids, including beverages and soups, a thicker consistency that is less likely to cause aspiration. Thicker liquids travel more slowly down the throat and that makes them easier to control. If someone with swallowing problems drinks water, juice, or coffee, it can travel down the throat so quickly that the muscles and nerves used for swallowing don’t act quickly enough, and some of the liquid can get into the lungs. Thickened drinks move more slowly, giving the body more time to control and direct the fluid toward the stomach.
The products sold as commercial thickeners come in different textures and flavors, so you can try different ones to see which one your family member or patients like best. Thickeners are intended to be used with beverages. You don’t need to use commercial thickeners for foods, since soup and other foods can be easily thickened with powdered potatoes (used for instant mashed potatoes), rice cereal, tapioca, or Jell-O, for example.
If the person you’re caring for is losing weight, feeling full too quickly, or choking on thickened foods, stop using them and talk to the doctor about other options.
It may surprise you that physicians are not usually the experts that determine thickeners are needed. In nursing homes and other facilities, it is usually a speech pathologist who reviews the person’s swallowing ability, and decides whether they need thickened liquids. The Speech Pathologist will recommend one of three different thickness levels: the worse the swallowing problem, the thicker the drink. The three thicknesses are:
- Mildly Thick, also called nectar thick or cream thick, which can be drunk out of a cup
- Moderately Thick, also called honey thick, is similar to a milk shake, and pours slowly. Unlike real milk shakes, these do not get thinner as they melt. They are often eaten with a spoon, rather than drunk from a cup
- Extremely Thick, also called Pudding Thick, Mousse, or extra thick, can’t be poured and must be eaten with a spoon.
Are They Safe?
There are no serious concerns about the safety of thickeners for adults. The only known risk is if the patient refuses thickened fluids, which could potentially cause dehydration. For that reason, it is important to balance the need for thickened fluids with the effort to find a product that the patient likes.
Do thickeners reduce aspiration?
A study of speech pathologists found that most recommend thickeners for patients with swallowing disorders, even if they have never read a study indicating that their patients will benefit.14 One-third used pre-thickened liquids, and those who mixed the drinks themselves often were not well trained to use it and usually made the liquids too thick or too thin, especially when trying to achieve honey thickness. The choice of which thickener to use did not seem to be related to which the patients preferred, and many of the patients were not happy with the thickened liquids.15 Since patients had no say in which thickeners were used by those speech pathologists, it is impossible to know if the patients would have preferred other thickeners to Thicken Up, Thick It, and Thick & Easy, the three powdered products that were used by almost two-thirds of the providers.
Speech pathologists in those studies reported that patients were more neutral about nectar thickness fluids, and more negative about the thicker fluids.
Researchers from Northwestern University hypothesized that dementia patients and Parkinson’s patients might be better off with changing the way they swallowed rather than using a thickener. They studied 711 patients with swallowing problems who were between the ages of 50-95. 16 All the patients were studied using 3 different strategies for reducing aspiration: putting their chin down while drinking thin liquid, nectar thick liquids with a spoon or cup, or honey thick liquids with a spoon or cup. The researchers were surprised to find that the thickened liquids reduced the chances of aspiration more than merely placing the chin down while swallowing, with the honey-thick fluids least likely to cause aspiration.
The Parkinson’s patients in that study were asked what strategy they preferred; the dementia patients weren’t asked because of concerns that they could not accurately recall the three strategies. Unfortunately, the patients preferred the least effective strategy (chin down posture) and their least favorite strategy was the most effective (honey thickness).17
While the reason for using thickened liquids is to prevent aspiration pneumonia, there are very few studies that have examined whether they are effective at reducing this risk. A small, randomized controlled trial from 2011 monitored patients prescribed thickened liquids for dysphagia from conditions like stroke, neurodegenerative conditions, or cancer for development of lung complications like pneumonia.18 They found that patients allowed to have unthickened water had an increased risk of pneumonia, and patients with degenerative neurologic disorders and low mobility were at greatest risk.
In summary, the research shows that thickened drinks, particularly honey-thick fluids, can reduce the chances of aspiration, but that patients generally prefer fluids that are less thick. Some patients appear to be more at risk than others so it is important to consider each patient’s preferences and risk factors when deciding whether to use thickeners and how thick to make them. What these few studies don’t evaluate is whether some thickeners are better tasting or more effective than others. That’s the next question.
Choice of Thickeners for Your Patient
Whether you are working with elderly patients in a nursing home or other facility, or helping an elderly patient at home, you can buy pre-made thickened drinks or you can make your own thickened drinks with a powder or gel thickener. Pre-mixed thickened drinks are sold in single serve cups or in cartons or large bottles. They last about 6 months and don’t need to be refrigerated until they are opened. This is convenient – especially for elderly persons who would otherwise have to mix the product themselves. However, in addition to being expensive and coming in a limited number of flavors, these pre-packaged products tend to be thicker than drinks you thicken yourself 19 and may not taste as good. As a result, the patient may just refuse to drink them, risking dehydration or malnutrition.
Instead, you can make the liquid the thickness that works best for each patient by buying powder or gel thickeners.
Most thickeners are either starch- or gum-based. Starch particles expand by capturing the fluid, which means they keep absorbing more liquid and get thicker after they are prepared. As a result, they may be too thick 20 or more minutes after they are prepared. They also get thicker when refrigerated. In addition, starches chemically interact differently depending on the fluid.20 For example, the acid in orange juice may thicken more quickly with starch but get thinner later, which is different than what happens if you use a starch thickener with water or apple juice.
Gum-based thickeners usually must be vigorously shaken or blended with the base fluid to appropriately thicken it. However, if mixed properly, gum-based thickeners will maintain relatively stable thickness over time for many fluids.21 This could be important, especially for drinks that a patient may want to drink over a long period of time. However, be aware that some drinks, such as adult nutritional beverages, contain ingredients that may interact with the gum thickener and form clumps.
How do gum-based thickeners taste, compared to powdered or pre-made products? One small study 22 found that elderly patients found thickened juice equally acceptable if thickened with a natural ingredient (raspberry apple sauce or chocolate pudding), powdered commercial product (Thick-It) or commercial gel product (SimplyThick), but patients much preferred hot chocolate thickened with chocolate pudding or SimplyThick. The authors stated that they selected Thick-It as the powdered brand because previous research and suggested it had better taste than other commercial powdered thickeners such as Quick Thick, Thicken Up, and Thick & Easy commercial brands.23 Since any of these products may improve over time, and different patients may have different preferences, it is worth trying different products to see what is preferred.
In summary, thickening ingredients are safe and can be effective for reducing aspiration. However, more information is needed to determine which thickened fluids taste best and are more likely to be enjoyed by patients. In the absence of research on large number of patients, caregivers need to take the time to decide what products work best for their patients. The goal should be to make the fluids thick enough to be effective at reducing aspiration, and tasty enough to ensure that the patient drinks enough fluids every day.