Posts Tagged ‘patti doherty’
“Relieves, helps, aids, protects, reduces, may help to slow…”
Fill in the blank for many products (particularly those labeled nutraceuticals or cosmeceuticals) whose marketers some times “claim” that they can do all or some of the above.
These claims can be dangerous, as shown by a recent report in FDA’s Medwatch. The report provided public notification of an “undeclared drug ingredient” in Fruta Planta, a dietary supplement imported from outside the United States. The FDA had received multiple reports of adverse events associated with the use of the product, which included cardiac events and, in one case, death.
There is an increase in consumer focus on health and wellness due to the growth of the population over the age of 65, the rising costs of healthcare, and an interest in preventive natural treatments that extend beyond traditional medicine. Also, alternative treatments are easily accessible without a prescription at local stores (grocery or pharmacy), from alternative health providers, or via the Internet. The demand for such products is growing, but with that demand comes added pressure for U.S. governmental regulation.
Within this product area, there are claims of improved health, wellbeing, reduced risk of disease, increased energy and vitality, and prevention of the inevitable aging process. All of which are huge temptations for consumers.
There is also increasing federal surveillance of products that make claims indicating they could potentially be drugs, in which case they would fall under FDA’s new drug application purview. Claims for skincare products such as “rejuvenates, repairs or restructures” or “molecules absorb and expand, exerting upward pressure to ‘lift’ wrinkles upward” could be considered drug claims, as well.
To define these terms:
- Nutraceutical (The combination of the words “nutrition” and “pharmaceutical”):a food or a food product used to prevent or treat a condition.
- Cosmeceutical (The combination of the words “cosmetics” and “pharmaceutical”): an organically active product that alleges to be medically beneficial. Cosmeceutical only refers to products that are applied topically (balms, creams, ointments) and not ingested. Cosmeceuticals may also have nutraceuticals as part of the ingredient list.
Under the broad categories of nutraceuticals and cosmeceuticals are an array of terms such as nutrigenetics, nutrigenomics, nutricosmetics, functional food, nutrification, dietary supplements, and functional beauty.
Some of the ingredients in these products come from sources such as herbs, teas, fruits, and essential oils and are increasingly labeled “organic,” “all natural” or “ethical.”
Chemicals used in cosmeceuticals and nutraceuticals may be extracted from food products such as antioxidants (as found in red wine), probiotics (as found in yogurt), prebiotics (as found in onions and garlic), and Omega-3 fatty acids (as found in fish or algae sources).
Typically, nutraceuticals are not regulated in the same way as a pharmaceutical but there are industry standards put forth by organizations such as the American Nutraceutical Association, which works with the FDA to help assure a product is safe. Cosmetics fall under the FDCA (Food and Drug Cosmetic Act), but cosmeceuticals are not covered by the FDCA. Clinical evidence of nutraceutical products differs widely—some have been tested with scientific rigor similar to pharmaceuticals and can demonstrate benefit and others have minimal evidence to substantiate their claims.
There is increasing concern over the claims and mislabeling made by companies whichmislead and potentially harm the consumer. Sometimes foreign and domestic products do not indicate how much or what ingredient(s) are actually in the product. Not until there are reports of unexpected side effects from taking the product does it come to the attention of the public.
Manufacturers of nutraceuticals and cosmeceuticals may benefit from accurate disclosure of ingredients, inspections of manufacturing plants, and development of better guidelines on product claims. These requirements would help to prevent contaminated products from reaching the consumer and better inform the consumer about product ingredients. The addition of new technologies in bioanalytic testing to detect tainted products or significantly elevated amounts of a potentially dangerous ingredient will be critical to these growing markets.
So what happens now that nutraceuticals and cosmeceuticals are becoming more commonplace? Will regulation guidelines become more distinct? The first step might be standardizing definitions of these two new words because each one is viewed by the FDA as more like a dietary supplement than a pharmaceutical.
What do you think about this topic? Do you take nutraceuticals or use cosmeceuticals? Do you believe their claims? Should the FDA regulate these classes of products? Please share your thoughts here.
Tags: ana, cosmeceuticals, cosmetics, dietary supplements, FDA, fdca, nutraceuticals, patti doherty, regulation
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“I looked in the Yellow Pages. ‘Furniture Movers’ we’ve got; ‘Strange Phenomenon’, there’s no listing.” – Diane in Poltergeist
I had to laugh at one of last week’s headlines on the Daily Scan from Genome Web. It was titled, “They’re Baaaaaack!” Before reading the article, I imagined it had something to do with the Poltergeist series of movies where chaos and unexplained phenomena occur – objects careening through the air along with visitations from old and terrifying ghosts. But when I read the article, it had to do with the revisiting of the direct-to-consumer genetic (DTC) tests rather than some type of paranormal activity. Not exactly a poltergeist but nevertheless a phenomenom that 1) won’t go away, 2) is somewhat chaotic, and 3) is worth following.
From March 8-9, 2011, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee will host a public meeting. The group will take comments and make recommendations on DTC tests. Several issues are on the agenda with the focus on the risk and benefits of such tests and the potential availability to consumers without a physician’s prescription.
Proponents of DTC tests believe that consumers who wish to purchase and take the tests should have easy access to information about their genetic makeup. Such access, the proponents argue, would allow consumers to make informed decisions with regard to such things as whether they are carriers of a certain genetic disease, have a predisposition to develop a particular cancer, or whether they will respond to a particular medical treatment. In essence, information obtained from DTC tests would empower consumers to take control of their own health.
Those who are uneasy about the risks related to DTCs are concerned about test results being misinterpreted and acted upon in the absence of other important substantiating information. They argue that physicians play an important role as gatekeepers of medical information.
Developers of DTC tests are another category of influence on this issue. They play a role in helping to shape the debate around the level of scientific evidence needed to support the test claims.
In the movie Poltergeist, the character Marty explains: “Poltergeist disturbances are fairly short duration. Perhaps a couple of months. Hauntings can go on for years.”
We may not know until months after the Advisory Committee meeting whether we are dealing with a poltergeist or a haunting when it comes to the phenomena of DTC genetic tests, but we do know “they are here” and they will make an impact on the future of healthcare.
Where do you come down on this issue? Are the tests important for consumer empowerment or do physicians need to be involved via the traditional prescribing process? What role should developers play in setting standards for scientific evidence? What should be the FDA’s role in this process? Please share your thoughts with us.
Tags: DTC Genetic Tests, fda's medical devices advisory committee, medical devices, molecular and clinical genetics, patti doherty, poltergeist and DNA
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I had the very fortunate opportunity to meet with Dale Alverson, M.D., Medical Director of the Center for Telehealth and Cybermedicine Research at the University of New Mexico and current President of the American Telemedicine Association (ATA). Dr. Alverson has been instrumental in bringing telemedicine to New Mexico for the last several years, and is now actively engaged in bringing telemedicine to the rest of the world.
Telemedicine, defined by the ATA, is the use of medical information exchanged from one site to another via electronic communications to improve patients’ health status. Closely associated with telemedicine is the term “telehealth,” which is often used to encompass a broader definition of remote healthcare that does not always involve clinical services. Videoconferencing, transmission of still images, e-health (including patient portals), remote monitoring of vital signs, continuing medical education and nursing call centers are all considered part of telemedicine and telehealth.
Dr. Alverson presented at the ATA’s Fourth Annual (2010) Mid-Year Meeting in Baltimore this past September. His presentation was entitled “The Perfect Storm.” He described significant changes occurring – and which will continue to occur – given the current conditions in the U.S. healthcare system and the convergence of some key elements within, including:
- Need for effective and affordable health care
- Need for access to care
- Integration of new and emerging technologies
Following are excerpts from my interview with Dr. Alverson:
Q: What is the significance of telemedicine?
A: Telemedicine is becoming a standard of care and is utilized in many healthcare programs including early detection and early intervention programs.
There is evidence that telemedicine/telehealth programs have favorable outcomes. One example is the success of a program in New Mexico called the ECHO (Extension for Community Healthcare Outcomes), which is led by Sanjeev Arora, M.D. This program has shown improved outcomes for patients with hepatitis C infection who may not otherwise be able to receive the care and treatment needed for their condition. Through the ECHO program specialists collaborate with healthcare providers in rural areas of New Mexico and provide quality healthcare to patients living in areas where access to care may otherwise be limited or nonexistent.
The ECHO telemedicine model has reached beyond the treatment of hepatitis C to address several other chronic illnesses. Additionally, the program provides rural practitioners access via videoconferencing to a much larger professional community enabling the rural practitioners to enhance and expand their skills.
One of the major funding sources for the ECHO was from AHRQ (Agency for Healthcare Research and Quality, Dept of Health and Human Services) under THQIT (Transforming Healthcare Quality through Information Technology).
There are many other projects developing across the U.S. and many new and innovative technologies in the market. During this time of urgency to create change in healthcare, there are also many unsolved issues that need to be addressed as telemedicine becomes a standard of care.
Q: What role does the ATA play?
A: The ATA is the leader in telemedicine. The organization began in 1993 with the purpose to create standards, guidelines, and policies and to serve as a resource to distill information to its members. The ATA works in collaboration with several federal agencies, such as the FDA, FCC, CMS, VA, DOD, as well as with international stakeholders, industry, and others involved in healthcare.
Q: What questions still need answers before the full potential of telemedicine can be achieved?
A: We need answers to questions such as:
- What are the best devices to use given there are so many and that the technology is changing and improving everyday?
- Who is reviewing the data coming through the device?
- How is the data acted upon?
- What will be done with the data?
I was fortunate to talk to Dr. Alverson, a thought leader in telemedicine, and I look forward to sharing additional insights from this rapidly evolving and important segment of the health care sector.
Do you feel there are other related questions that should be addressed? If so feel free to make suggestions here, and stay tuned for more information on this critical topic.
Tags: ATA, Dale Alverson, health innovation, healthcare, mHealth, patti doherty, public health, telemedicine
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A recent issue of The New Yorker included an interesting article by Jonah Lehrer entitled, The Truth Wears Off—Is there something wrong with the scientific method? The article focuses on the “decline effect,” which has been observed and debated in various studies in disciplines ranging from psychology to pharmacology to biomedical research. One of the observations is: As more trials were conducted with a given agent, the less efficacious that agent appeared. In many cases, the agent was no better than its predecessor, even though the initial study results were significant.
Read the rest of this entry »
Tags: biotech, FDA, jonah lehrer, JP Morgan Healthcare Conference, life sciences, medical technology, patti doherty, product development
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I once read a blog about imprecise metaphors in which the author wrote that it’s easy to find a needle in a haystack, but immensely difficult to find a particular piece of hay in that haystack. Needle: Obvious. One piece of hay versus another: Not so obvious.
In these mercurial times in the life sciences and technology industries, attempting to identify information that is significant and useful can be as overwhelming as trying to find that one piece of hay.
Every day we encounter immense amounts of data and then we must pause for a moment to select what is essential and applicable to the topic at hand.
At Popper and Company, we keep a sharp eye toward emerging technologies whether it be in the development of point-of-care tests, regulatory and reimbursement issues, personalized medicine, the global expansion of mobile medicine or other areas of interest.
However, along with reviewing current literature and research material to stay informed and to support our clients, we often go directly to independent opinion leaders – who are experts in a specific area or niche – and engage with them in in-depth conversations and through surveys on a particular topic of interest. Through these communications, we often can identify opportunities and strategic direction for our clients and almost always can help to discern the individual piece of hay from the stack.
Adding value through personal interactions is an important piece in our work, and a key distinguishing factor to how we make a difference for our clients. Over the years, Popper and Company has established relationships with a broad array of thoughtful opinion leaders who range from top scientific experts, to CEOs of both large and small life science companies, to academicians, to practicing clinicians.
What have you learned from a recent conversation with an expert? Is there a thought leader in your organization we should connect with? Please let us hear from you and help keep the dialogue flowing.
Tags: information overload, life sciences, needle in the hay, patti doherty, Popper and company
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