The FDA said it was concerned about trial data suggesting that adding a fibrate drug to a statin increased the risk of cardiac events in women and will convene an advisory committee meeting next month to review the findings.
The agency was reacting to a new analysis of the ACCORD-Lipid trial, which tested the addition of delayed-release fenofibric acid (Trilipix) to simvastatin (Zocor) in diabetic patients.
Main results from the trial, announced in March 2010, indicated that the combination did not reduce cardiovascular events relative to patients receiving only the statin drug.
Emil Corwin, who retired at age 96 from the Food and Drug Administration as the oldest federally employed public affairs officer, died of cardiac arrest March 15 at his home in Chevy Chase. He was 107.
Mr. Corwin, who began his career in the 1920s as a journalist in Massachusetts, joined the FDA in 1974, when he was 70. He flirted with retirement four years later but returned to his desk after a week away from work. He was quick to point out that his sons retired before he did. More
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By Cole Petrochko, Staff Writer, MedPage Today
The FDA has approved the first x-ray mammography device that provides 3-D images of the breast.
Approval of the Selenia Dimensions System was based on two studies asking radiologists to review 2-D and/or 3-D images from over 300 mammographies. Radiologists who viewed the 2-D and 3-D models were 7% more accurate in distinguishing cancerous and noncancerous cases than those who only used a 2-D image, an FDA statement said. Full Article
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By John Gever, Senior Editor, MedPage Today
Metal-on-metal hip implants have disadvantages as well as advantages, according to the FDA, and the agency is making the case directly to patients on its website.
In a set of web pages unveiled Thursday, the FDA cited problems that can arise from the inevitable release of metal particles as patients flex their new joints. Adverse reactions in the bones in which the implant is embedded also occur in some patients.
"Metal-on-metal hip replacement systems have unique risks in addition to the general risks of all hip implant systems," the agency warned. Full Article
Older adults use the highest proportion of medical and pharmaceutical treatment, but are vastly underrepresented in clinical trial research. A recent review of publications based on randomized control trials (Zulman et al 2011) shows that this is not only a product of the under-recruitment of older adults. In addition to the use of age limits and other exclusion criteria that tend to preclude older individuals, most clinical research fails to look at outcomes of particular relevance to older adults. Further, many published studies employ statistical methods that may misrepresent the significance of age in their findings.
Except in autopsy, there has never been a way to diagnose Alzheimer's disease – until now. Last week, the U.S. Food and Drug Administration gave tentative approval to a new screening for early detection in living persons of the unique plaques that define Alzheimer's.
The test, involving a PET scan that uses a dye to make the plaques visible, is relatively inexpensive. The FDA approval is contingent on radiologists and physicians being trained in how to read the scans to help avoid false positives – something that can be done, according to the CEO of the company that developed the dye, in months not years.
A senior director at the Alzheimer's Association expects the test to be available before the end of this year.
In a New York Times story earlier this week, Dr. Norman Foster, a professor of neurology at the University of Utah, discussed a patient with a memory deficit who could have benefited from the test:
“I wish I had had the ability to do an amyloid PET scan to allow an earlier diagnosis,” Dr. Foster said. Approval of the scan, he said, “would be a historic advance in neurology and in the daily management of patients with memory complaints.”
Nothing this big comes along without new, difficult and disturbing questions. In an online video from The Picker Report, the TGB Geriatrician, Dr. Bill Thomas, and dementia expert Dr. Al Power, also a geriatrician, took a whack a some of them.
Long-term care insurance has always been unaffordable for many people and this test, as the doctors note, makes that worse, although it will be interesting to see how the new health care law, which no longer allows denial of coverage for pre-existing conditions, will be applied in this case.
And, there are workplace issues; would people be denied employment if their Alzheimer's test were positive?
The biggest personal question the two doctors discuss briefly is, of course – would you want to know, when you are still cognitively healthy, that you have the plaques identified with Alzheimer's, particularly since there is no treatment.
Practically, it makes sense. People can plan ahead and they might use their time - which could be many years still - differently than if they didn't know. But it could also be detrimental leading to depression and other life difficulties.
I've given this a great deal of thought in the past few days. If the scan showed no plaques, I'm home free and I wouldn't wonder every time I forget someone's name if I'm entering the early stages of Alzheimer's.
If the test were positive, however, I know I would monitor myself for every minor bit of forgetfulness. How far gone am I? Is my memory loss serious yet? How do I know I'm forgetting things if I don't remember what I once knew?
Is this something I want to discuss with anyone beyond my physician? Do I tell relatives? Friends? If so, when? Who decides when I am no longer capable? My physician? My health care proxy?
Because I live in Oregon which has a Death with Dignity law, would I want to take advantage of that before my mind is an empty shell? But if my brain is heading south, how would I know when I've hit the tipping point, so to speak? Obviously, one can make an informed decision to choose to die only when one's mind is coherent, so there are legal questions too.
It is difficult to work out and there are no precedents yet, no guides from others' experience.
But at my age, nearly 70, I've tentatively come down on the side of wanting to know, although I won't be first in line when the test becomes available. I'm certain there are ramifications that haven't occurred to me yet.
(I think it is an even tougher question for people who are a good deal younger than I am. Would you want to know 20 or 30 or 40 years before the disease begins to be evident? I'm glad I'm too old to confront that.)
Most of the people reading this blog are, like me, older than 50. So the question today is: do you, at your age now, want to know if your brain shows the Alzheimer's plaques? And will you have the test when it becomes available?
This is not a question that can be tossed off easily like what to have for dessert and you may not have an answer today. But I think it is useful for all of us to begin the conversation.
Automated home health monitoring may finally become practical with the HealthTune 360 from Boston LifeLabs. Cambridge, Mass. start-up Boston LifeLabs recently announced a new product for at-home health monitoring, which the company plans to make available within a few weeks in the U.S. pending FDA approval.
Theresa M. Michele, M.D., Simone Pinheiro, Sc.D., and Solomon Iyasu, M.D., M.P.H. - New England Journal of Medicine
Chronic obstructive pulmonary disease (COPD) is a leading cause of
death worldwide, and the rate of COPD-related death is increasing.1
No current drug therapy alters the progressive decline in lung function
that characterizes this disease. In 2004, the Food and Drug
Administration (FDA) approved the use of tiotropium delivered by the
HandiHaler device, the first long-acting anticholinergic bronchodilator
for treatment of COPD. Trials supporting tiotropium’s approval
demonstrated sustained bronchodilation over a 24-hour period. More
recent studies have shown that treatment with the tiotropium HandiHaler
reduces COPD exacerbations. Concerns have been raised, however, about
tiotropium’s safety. In particular, disparate sources have identified
stroke, cardiovascular events, and death — which have been studied as
individual or composite end points — as possible adverse outcomes.
The content, formatting, and word count of leaflets pharmacies hand out with medicines are inconsistent and should be subject to FDA guidance, researchers say.
Among written instructions given out with prescriptions of lisinopril (Prinivil, Zestril) and metformin (Fortamet, Glucophage, Glumetza, Riomet), about half failed to include directions on use and raised questions about comprehensibility, Almut G. Winterstein, PhD, of the University of Florida, and colleagues reported in the Aug. 9/23 issue of Archives of Internal Medicine.
"Private sector initiatives to provide useful [consumer medication information] have failed," they wrote. "Research is needed on effective information selection and presentation in terms of effects on comprehension, retention, and appropriate patient actions to derive optimal drug benefit."
The FDA regulates label information and guides that accompany drugs with safety concerns but not the content and format of consumer medication information (CMI) documents. The agency does, however, have a set of eight standards for CMI leaflets:
State drug name and indication
List contraindications
Include directions about use
Note precautions and potential harms
List symptoms of possible adverse reactions
Include general information and encourage patients to ask questions
Be scientifically accurate
Be comprehensible and legible
To assess the consistency of these documents, "professional shoppers" filled prescriptions for lisinopril and metformin in a national sample of 365 independent and chain pharmacies.
The U.S. Food and Drug Administration has approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.
People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.
The health insurance system isn't the only thing getting revamped should Congress pass a health bill; both the Senate and the House bills include provisions that might mean big changes for the food, drug and medical devices industries. Continue Reading
Health and Human Services (HHS) Secretary Kathleen Sebelius and
Agriculture (USDA) Secretary Tom Vilsack, the co-chairs of the Obama
Administration's Food Safety Working Group, unveiled a new consumer Web
site today at www.foodsafety.gov. The site is designed to help
consumers and families get all the latest information on food safety and
food recalls in one convenient place.
The new site will feature information from all the agencies across the
federal government that deal with critical food and food safety
information, including preventive tips about how to handle food safely,
alerts on life-saving food recalls, and the latest news from the key
agencies.
Consumers can sign up in one easy place to receive email and RSS alerts
on recalled or potentially unsafe food and hear from the top scientific
experts across the government on food safety. Later phases of the site
to be launched will include recall feeds for texting and mobile phones.
The site will also feature a foodsafety.gov widget that the public and
the media are encouraged to download and promote on their Web sites and
social networking sites. The widget will instantly update viewers with
the latest food safety recalls and will be a valuable public health and
safety tool.
Leaders from HHS and USDA praised the new site and said it would be a
valuable tool in their efforts to keep our food supply safe and
consumers healthy.
"The highest mission of any government is keeping its citizens safe. In
this administration, we see public health as an essential part of that
mission and this new website as an essential way we will can help keep
people safe from unhealthy food and food handling practices and
up-to-date on critical food recalls," Secretary Sebelius said.
"Consumers no longer will have to search around in different places
trying to figure out which agency manages which food product. All the
information that they will need will be one easy place at
foodsafety.gov."
"Protecting the health and well-being of the American people is a
fundamental responsibility of the federal government. Our new and
innovative approach to connecting consumers to food safety information
in an easy and timely manner is a critical improvement in this effort,"
said Agriculture Secretary Tom Vilsack.
"This site focuses on prevention by highlighting the steps both
businesses and consumers can take to avoid illness," said Food and Drug
(FDA) Commissioner Margaret Hamburg. "It also will be a clearinghouse
for information on the latest FDA rules and guidance."
"Health departments and the Centers for Disease Control and Prevention
(CDC) rely on information from many places, including consumers, when it
comes to tracking food-borne illnesses across the country and the
world," said CDC Director Dr. Tom Frieden. "With this new Web site,
consumers will quickly know who to contact if they believe they became
ill from eating a certain food. Those reports of illness can help us
identify potential outbreaks sooner and strengthen our efforts to
protect Americans from unsafe food and food-borne illness."
"Protecting the American people from food-borne illness is a critical
mission of the U.S. Department of Agriculture. Our work is designed to
prevent outbreaks of food borne illness from occurring and to react
quickly and decisively to contamination in the food supply," said Jerry
Mande, Deputy Under Secretary for Food Safety at USDA. "The new
foodsafety.gov site will provide families with a one-stop online shop
for all the latest information they need to reduce the danger of
food-borne illnesses."
By Cole Petrochko, Staff Writer, MedPage Today - The FDA has issued two final rules expanding access to investigational drugs for seriously ill patients who have no alternatives and regulating drug developers' charges for those medicines.
FDA officials said the rules essentially clarify three decades of piecemeal changes in FDA policy regarding investigational drugs for patients who are out of options but don't qualify for a clinical trial.
Read More
By Todd Neale, Staff Writer, MedPage Today - If a new prescription drug has not been proven more effective than similar medications, the label should make that clear, a group of researchers asserted in the New England Journal of Medicine.
This comparative effectiveness data is just as important as information regarding the risks and benefits of a drug or device, according to Randall Stafford, MD, PhD, of Stanford University, and colleagues.
An FDA requirement for label information would allow patients, physicians, and insurers to better judge whether a drug is simply a "me-too" product or a real advance, they wrote in an online perspective article.
Read MoreLink to Full New England Journal of Medicine Article
Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits
FDA recognizes that the manufacturers, packers, and distributors (sponsors) of prescription human and animal drugs, including biological products for humans, have a First Amendment right to engage in the truthful and non-misleading advertising of their products. An advertisement is misleading, however, if it fails to disclose certain information about the advertised product's uses and risks. Thus, for prescription drugs and biologics, the act requires advertisements to contain ``information in brief summary relating to side effects, contraindications, and effectiveness'' (21 U.S.C. 352(n)). FDA is responsible for enforcing the act and implementing regulations.
FDA regulations require that prescription drug advertisements that make claims about a product must also include risk information in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the content and presentation of the information. Advertisements that draw attention to the name of the product but do not make representations about the product's indication(s) or dosage recommendations are called reminder advertisements. As a general matter, reminder ads may mention the proprietary and established name of the product and (optionally) contain information about the product's ingredients, dosage form, quantity, price, and manufacturer (21 CFR 202.1(e)(2)(i)). Other written, printed, or graphic information is not prohibited in reminder ads as long as that information does not make a representation or suggestion relating to the product beyond those permitted.
Reminder ads allow sponsors to distribute price sheets, pens, notepads and other minor giveaways featuring the name of the drug product to physicians and other healthcare professionals without requiring a full disclosure of the product's risks. As DTC promotion has increased, sponsors have chosen to create reminder ads for consumers.
On November 1 and 2, 2005, the agency held a part 15 public hearing (70 FR 54054, September 13, 2005) on the topic of direct-to-consumer advertising of prescription drugs and restricted medical devices. During the hearing, the agency received several comments in connection with the potential impact of coupons and other price incentives on consumer perceptions of DTC-advertised products. Sponsors may use ads as a vehicle to offer price incentives to consumers (e.g., ``free trial,'' ``buy six get one free''). Coupon promotions are widely used in many product categories and have been the topic of many academic studies. Certain types of coupons, most notably those that appear in the body of an advertisement itself (i.e., are embedded in the advertisement), can positively affect perceptions of the brand.
People tend to rate owned objects more favorably than those they do not own, even when those objects have been assigned to them at random. This has been termed the ``mere ownership'' or ``mere possession'' effect. An interesting extension of this effect is provided in research by Sen and Johnson which has shown that consumers rate a product more favorably when they are simply given a gift certificate or a coupon for that product or service. Other research has examined the effect of warranties. People who viewed an ad with a high warranty perceived the product as being less risky compared to people who saw an ad with a medium or low warranty.
Based on this body of consumer research, the inclusion of a coupon or other price incentive in the body of a DTC ad may affect consumers' perceptions of the risks and benefits of the prescription drug. For instance, consumers may assign more weight to benefit claims in cases where a coupon or other price incentive is embedded in the advertisement. For ``simple'' consumer products, coupons and free trial offers may enable the customer to test new products while minimizing their financial risk of testing the product. For products that consumers can readily test and ones where performance can be adequately verified (termed ``search'' goods by economists), coupons and free trial offers provide both the consumer and manufacturer an efficient mechanism for matching consumers and products. For more complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals.
The proposed exploratory study will examine what impact, if any, the presence of coupons in DTC advertisements may have on consumers' perceptions of product risks and benefits and the overall impression of the product in DTC full-product and reminder advertisements.
The Food and Drug Administration (FDA) is announcing a public workshop entitled Sentinel Initiative: Structure, Function, and Scope. The workshop is co-sponsored by the Food and Drug Administration and the eHealth Initiative Foundation, and convened by the Engelberg Center for Health Care Reform at the Brookings Institution.
The workshop is intended to bring together academia; government; patient, consumer, and provider groups; health care data owners; industry; and other interested organizations for an update on the current status of the Sentinel Initiative and to allow for comment from all interested stakeholders. Specific topics for discussion include potential governance models and their implications, and approaches for ensuring continued involvement of all stakeholders as the Initiative evolves.
Date and Time:
The public workshop will be held on December 16, 2008, from 9 a.m. to 3:30 p.m.
Location:
The public workshop will be held at the Omni Shoreham Hotel, 2500 Calvert Street NW., Washington, DC 20008.
The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products'' (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the same title (69 FR 21778, April 22, 2004) (proposed rule).
This final rule affirms the interim final rule's requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act). The statement includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement).
This final rule also affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement.
This final rule implements provisions of the Best Pharmaceuticals for Children Act (the BPCA) and the Food and Drug Administration Amendments Act of 2007 (FDAAA).
DATES:
Effective Date: This final rule is effective November 28, 2008.
Compliance Date: The compliance date for this final rule is July 1, 2009.
Introduced September 28, 2008 by Rep. Christopher Cannon [R-UT] and referred to the House Judiciary Committee
TITLE I--Federal internet site for consolidation and translation of information on diseases and other conditions
TITLE II--Patient and practititoner rights regarding practice of medicine
TITLE III--Additional forums for exchange of health information
TITLE IV--Legal immunity of drug and device companies
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