U.S. Approves First 3D Printed Pill [Reblog]

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The Food and Drug Administration has approved the first 3D printed pill.

 

The medicine, Spritam (levetiracetam), helps to treat epilepsy. Previous levetiracetam tablets did not dissolve easily, but the new version boasts porous layers that make it easily dissolvable, according to a press release from the company, Aprecia Pharmaceuticals. A spokesperson for the FDA confirmed to the Associated Press that Spritam is the first 3D printed prescription tablet to gain approval.

Seizure medication is often too large and difficult to swallow—particularly for the elderly and children—making advances in 3D printing key for epileptics and other who suffer from seizures, according to the company.

[Reblog] Illnesses, injuries linked to medical devices a ripe area for investigation #ahcj15

From the 14 May 2015 post by the Association of Health Care Journalists

Most medical devices marketed in the United States do not need formal approval from the U.S. Food and Drug Administration.

Members of a panel at Health Journalism 2015 on medical device coverage provided a variety of advice for reporters covering and of the implants, instruments and diagnostic tools common to the modern medical machine.

Moderator of the session was Chad Terhune, aLos Angeles Times reporter who recently found himself chasing an outbreak of carbapenem-resistant enterobacteriaceae (CRE) linked to dirty duodenoscopes. Contributing to the discussion were panelists USA Today investigative reporterPeter Eisler and Scott Lucas, associate director of accident and forensic investigation at the ECRI Institute.

A recent CRE outbreak at Ronald Reagan UCLA Medical Center illustrates the broader issues of medical device approval and oversight. The Olympus scopes used at the Los Angeles hospital, and at other facilities around the nation where the superbug infected patients, did not require any formal study or approval from the FDA before hitting the market because they were considered “substantially equivalent” to a previous models. Equivalency, Eisler explained, allows thousands of devices to move from labs to patients with little more than a short 510K statement that the manufacturer files with the FDA.

Only 10 percent of devices, such as those which “sustain or support life, are implanted, or present potential unreasonable risk of illness or injury” fall into the FDA’s “premarket approval’” category requiring a greater level of regulatory scrutiny, including safety and effectiveness studies, before sale.

Things are not much better once devices hit the market.

…

It is important to understand that medical devices seldom stand alone, he said. They are usually part of much broader systems used to deliver care safely to patients. When a patient dies after a ventilator fails, for example, it may be that alarms, communications networks or staffing protocols designed to quickly detect and report the failure did not work.

Thus, if reporters want to understand what went wrong in a specific incident, they should ask about more than the device itself. “The system approach to an investigation is key to finding the answer,” Lucas said.

Also be aware that hospitals are supposed to have detailed plans that tell employees what to do when there is a problem with a device. Sequestering machines that malfunction, and downloading data from them before it is purged, are examples of best-practice steps that reporters can ask about.

Handling the pitch

So what should a reporter do when he or she receives a glowing pitch from a local hospital about the latest device?

Terhune suggests starting with Medicare’s open payments database to see if the doctors involved have a financial interest in the device that’s being pitched. While a financial interest is not necessarily a deal breaker for coverage, it is something reporters should know about going in and make sure they can adequately address in their coverage.

Next, look at whatever FDA approval process was required for the device

..,

Related articles

• FDA Shows How Patient Opinions Support Device Approvals
• What Triggers a Recall? The FDA’s Role
• Health Apps as Medical Devices: What It Means for Consumers
• FDA approves the Medicines Co’s pain drug device Ionsys
• Synchromed II Implantable Infusion Pump Systems: FDA Consent Decree To Limot Use
• FDA panel highlights problems with medical scopes
• Health Research: National Library of Medicine & FDA Now Provide Public Access to Global Unique Device Identification Database

[News release] Publication bias and ‘spin’ raise questions about drugs for anxiety disorders

From the 30 March 2015 Oregon State University news release

A new analysis reported in JAMA Psychiatry raises serious questions about the increasingly common use of second-generation antidepressant drugs to treat anxiety disorders.

It concludes that studies supporting the value of these medications for that purpose have been distorted by publication bias, outcome reporting bias and “spin.” Even though they may still play a role in treating these disorders, the effectiveness of the drugs has been overestimated.

In some cases the medications, which are among the most widely prescribed drugs in the world, are not significantly more useful than a placebo.

The findings were made by researchers from Oregon State University, Oregon Health & Science University, and the University of Groningen in The Netherlands. The work was supported by a grant from the Dutch Brain Foundation.

Publication bias was one of the most serious problems, the researchers concluded, as it related to double-blind, placebo-controlled clinical trials that had been reviewed by the U.S. Food and Drug Administration. If the FDA determined the study was positive, it was five times more likely to be published than if it was not determined to be positive.

Bias in “outcome reporting” was also observed, in which the positive outcomes from drug use were emphasized over those found to be negative. And simple spin was also reported. Some investigators concluded that treatments were beneficial, when their own published results for primary outcomes were actually insignificant.

“These findings mirror what we found previously with the same drugs when used to treat major depression, and with antipsychotics,” said Erick Turner, M.D., associate professor of psychiatry in the OHSU School of Medicine, and the study’s senior author. “When their studies don’t turn out well, you usually won’t know it from the peer-reviewed literature.”

This points to a flaw in the way doctors learn about the drugs they prescribe, the researchers said.

“The peer review process of publication allows, perhaps even encourages, this kind of thing to happen,” Turner said. “And this isn’t restricted to psychiatry – reporting bias has been found throughout the medical and scientific literature.”

…

Press Announcements > FDA launches drug shortages mobile app

Press Announcements > FDA launches drug shortages mobile app.

From the 4 March 2015 announcement

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”

App users can search or browse by a drug’s generic name or active ingredient, and browse by therapeutic category. The app can also be used to report a suspected drug shortage or supply issue to the FDA.

The agency developed the drug shortages app to improve access to information about drug shortages, as part of the FDA’s efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages.

The app is available for free download via iTunes (for Apple devices) and theGoogle Play store (for Android devices) by searching “FDA Drug Shortages.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[News article] Could a wireless pacemaker let hackers take control of your heart?

From the 9 February 2015 Science article

Medical devices don’t get regular security updates, like smart phones and computers, because changes to their software could require recertification by regulators like the U.S. Food and Drug Administration (FDA). And FDA has focused on reliability, user safety, and ease of use—not on protecting against malicious attacks. In a Safety Communication in 2013, the agency said that it “is not aware of any patient injuries or deaths associated with these incidents nor do we have any indication that any specific devices or systems in clinical use have been purposely targeted at this time.” FDA does say that it “expects medical device manufacturers to take appropriate steps” to protect devices. Manufacturers are starting to wake up to the issue and are employing security experts to tighten up their systems. But unless such steps become compulsory, it may take a fatal attack on a prominent person for the security gap to be closed.

For more on privacy and to take a quiz on your own privacy IQ, see “The end of privacy” special section in this week’s issue of  Science.

Related articles

• Problem FDA inspection findings in trials seldom reflected in medical literature
• U.S. FDA Commissioner Margaret Hamburg to step down
• FDA Grants Priority Review for Janssen’s Three-Month Schizophrenia Treatment
• High Profile Breast Cancer Drug Now FDA-Approved
• Under Hamburg, FDA Cozied Up to Industries It Regulates, Protected Corporations More Than Patients
• Ignyta’s (RXDX) Entrectinib Granted FDA Orphan Drug Designation

[News article] New York Attorney General Targets Supplements at Major Retailers

From the New York Times article By ANAHAD O’CONNOR, FEBRUARY 3, 2015

The New York State attorney general’s office accused four major retailers on Monday of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.

The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.

The investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements, which are exempt from the strict regulatory oversight applied to prescription drugs.

The Food and Drug Administration has targeted individual supplements found to contain dangerous ingredients. But the announcement Monday was the first time that a law enforcement agency had threatened the biggest retail and drugstore chains with legal action for selling what it said were deliberately misleading herbal products.

Among the attorney general’s findings was a popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality,” that contained only powdered garlic and rice. At Walmart, the authorities found that its ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat — despite a claim on the label that the product was wheat- and gluten-free.

—-
Here are the products in the cease and desist letters from the Attorney General

Related articles

• N.Y. attorney general says herbal supplements at 4 retailers are fake
• What’s In Your Herbal Supplements?

[Reblog] SurroundHealth – 2015 Top 10 Predictions in Public Health

SurroundHealth – 2015 Top 10 Predictions in Public Health.

Excerpt from the 6 January 2015 post

Ready or not, the Affordable Care Act (ACA) is once again heading to the Supreme Court. At stake is whether the law allows consumers purchasing insurance through the Federal portal to extend the same discounts that states provide. Eliminating the discount could gut the exchange’s value to federal consumers. In the meantime, it’s enrollment as usual for 2015. Share this this updated ACA enrollment guide from the IOM.

2. Defending Safety Net and Programs and Regulations

• Medicare Private voucher program proposal. With a new GOP majority, I expect to revisit proposals to privatize Medicare. The American Public Health Association (APHA) is on record opposing such a policy move as undermining the foundation of Medicare’s guaranteed coverage. Brace yourselves for some ideological power-plays over health care access for seniors.
• Access to Abortion Services. APHA supports Access to abortion and ensuring the availability of qualified practitioners. The access to safe and legal abortion services at the state level has narrowed rapidly across the majority of US states since 2013. Now, this sharply partisan issue is likely provoke both Congressional challenges and more states to seeking to restrict these services, especially for low-income women.
• Environmental Protections. Expect attacks on environmental regulations and the Environmental Protection Agency (EPA). Republicans are candid that their goal is to end the EPA. Clean air standards and more may be threatened.

3. New Vaccines

• Ebola Vaccine. Likely the most fast-tracked vaccine trials ever, I’m not the only one predicting that we’ll see an ebola vaccine in 2015. Together with infection control protocols established for the affected West African countries, this will hasten the end to what had seemed an intractable crisis—though we’re not likely to snuff out ebola completely within the year.
• HPV Nonavalent Vaccine. Merck’s nine-valent HPV vaccine received FDA approval in 2014. It’s very likely that this will replace, or partially replace, their current quadrivalent (4-valent) version. The newer vaccine will increase the percentage of cancer-causing HPV types prevented from 70% to 90% and potentially prevent tens of thousands of cancers per year. It may only need 2 doses instead of the current 3. The Advisory Committee on Immunization Practices (ACIP) should make a recommendation in the first half of 2015 with rollout later in the year.

4. National Policy on Police Violence in Communities of Color

Related articles

• Affordable Care Act Enrollments Way Up
• FDA Approves Meningitis B Vaccine Used to Treat Outbreak at Princeton University

[Press release] MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials

MD Anderson and Bayer collaborate to create symptom assessment questionnaires in clinical trials 

From the press release

MD Anderson News Release 1/23/2015

When cancer patients take part in a clinical trial to develop new therapies, they and their physicians want to know how they will feel and function during treatment. A new collaboration between Bayer and The University of Texas MD Anderson Cancer Center will go straight to the patients to learn how certain investigational new drugs affect them. The project will involve the use of questionnaires to assess how a drug may impact a patient’s disease-related symptoms.

“Fit-for-purpose patient-reported-outcome (PRO) measures are an invaluable resource for helping us to better understand how patients are actually being affected by new therapies,” said Charles Cleeland, Ph.D., chair of symptom research at MD Anderson. “This will be especially important in the developmental pathway of new drugs, given that these PRO measures will enhance information about treatment tolerability and potential symptom-reduction benefit earlier in the drug development process.”

Charles Cleeland, Ph.D.

The information will be beneficial in further evaluating the drug if it progresses to later stages of clinical development and is tested in larger numbers of patients. The importance of having data on the symptom burden or benefit conferred by therapy is often not recognized until late in that process.

“For patients and their physicians, knowing the probable effects of a treatment can help with decisions among treatment options when therapeutic outcomes are similar but symptomatic effects are not,” said Cleeland.

…

 Related Resources

• ClinicalTrials.gov
  • registry and results database of publicly and privately supported clinical studies of human participants conducted around the world

  • What Information Can I Find on ClinicalTrials.gov?

    Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:

    • Disease or condition
    • Intervention (for example, the medical product, behavior, or procedure being studied)
    • Title, description, and design of the study
    • Requirements for participation (eligibility criteria)
    • Locations where the study is being conducted
    • Contact information for the study locations
    • Links to relevant information on other health Web sites, such as NLM’s MedlinePlus® for patient health information and PubMed® for citations and abstracts for scholarly articles in the field of medicine.

    Some records also include information on the results of the study, such as:

    • Description of study participants (the number of participants starting and completing the study and their demographic data)
    • Outcomes of the study
    • Summary of adverse events experienced by study participants
  • More information at ClinicalTrials.gov
    • Learn about clinical trials
    • MedlinePlus® Clinical Trials Information

      MedlinePlus is a Web-based health information service of the National Library of Medicine. It explains health topics using language that is easy to understand. Visit the Clinical Trials page (also available in Spanish) or the interactive tutorial on clinical trials (also available in Spanish) to learn more about clinical research and find answers to common questions.

Related articles

• MD Anderson and Bayer Announce Collaboration to Create Symptom Assessment Questionnaires in Clinical Trials
• Drug Development’s Long And Winding Road

[News] The coming revolution in much cheaper life-saving drugs | Medication Health News

The coming revolution in much cheaper life-saving drugs | Medication Health News.

From the 22 January 2015 post

Recently the FDA has approved the first “biosimilars” to be available in the United States.  In order for a drug to be considered biosimilar, the law requires that the copycat drug is “highly similar” to the reference drug, and does not have “clinically meaningful” differences. Biosimilar drugs will offer lower-cost competition as they tend to cost between 20 – 30 % less than the original branded drug. According to the Federal Trade Comission, Biosimilar products are estimated to take 8 to 10 years to develop and will cost the manufacturers up to $200 million to produce.With this new class of drugs, patients will be able to save thousands on their medications. Has your company/employer began exploring the budgetary effects of biosimilars? How will this new class of biosimilars affect health care spending in the US?

For additional information click here

Photo courtesy of [ddpavumba]  freedigitalphotos.net

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[News] New regulations proposed for off-label uses of drugs, devices — ScienceDaily

New regulations proposed for off-label uses of drugs, devices — ScienceDaily.

Excerpts

Date:January 22, 2015

Source:University of California, Los Angeles (UCLA), Health Sciences

Summary:Researchers have proposed a system for off-label drug prescriptions combining reporting, testing and enforcement regulations, and allowing interim periods of off-label use. This would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

---

 

Medicine drugs (Photo credit: Wikipedia)

Off-label use of drugs and medical devices — using approved remedies in unapproved ways — has long been a part of medicine. The practice provides public health benefits but also presents some risks.

For the most part, the U.S. Food and Drug Administration allows physicians to prescribe drugs and devices off-label in the same way they are prescribed for their approved uses. The FDA couldn’t require approval for each off-label use because the burden for approval would be so high that few off-label uses would be approved, which would deprive patients of effective treatments for which the drugs weren’t originally intended.

As a result, health care providers have had to make their own decisions about using drugs off-label, often in the face of uncertain evidence.

To address that issue, researchers from the David Geffen School of Medicine at UCLA have proposed a system combining reporting, testing and enforcement regulations, and allowing interim periods of off-label drug prescription. Their recommendations, published in the Duke Law Journal, would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

….

The authors’ proposal comprises three elements:

• Improved reporting of off-label use through disclosure of diagnostic codes in reports to the FDA, in detailing data that pharmaceutical companies obtain on physicians’ prescribing habits, and in reports to the FDA and Medicare/Medicaid reimbursement requests. This information, which would omit details that could identify individual patients, could then be shared with academics and pharmaceutical companies for use in research. • Expansion of post-market testing requirements for off-label use of drugs and medical devices. • A tiered labeling system for drugs consisting of “red box” warnings that prohibit certain off-label uses; informed consent from patients receiving prescriptions for off-label use of some drugs that currently carry “black box” warnings, which identify drugs that pose a significant risk of serious or life-threatening adverse effects; and the creation of a new “grey box” warning that blocks Medicare Part D and Medicaid reimbursements by the Centers for Medicare and Medicaid Services.

“The improved reporting, testing and enforcement regulation would work together to produce a more layered range of regulatory responses,” the authors write. “The FDA, armed with better information about the extent of off-label use and adverse effects, would be in a better position to require post-market testing and to discourage off-label use with new types of warnings if manufacturers fail to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.”

The report can be found at: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=3785&context=dlj

 

Related articles

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[Report] Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.

…
In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.

…
In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

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High-Cost Generic Drugs — Implications for Patients and Policymakers — NEJM

High-Cost Generic Drugs — Implications for Patients and Policymakers — NEJM.

Excerpt

It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.

….

 

Meanwhile, there is little that individual consumers can do. Some drug companies, such as Amedra, offer assistance programs for indigent patients, but these programs often have complicated enrollment processes, and they do not offer an effective general safety net.5 Some patients instead seek to acquire these drugs in other countries, since many of them are widely and inexpensively available outside the United States, but such foreign sources may be of variable quality. Until regulatory and market solutions are implemented to reduce prices for these older drugs, patients requiring such drugs and the physicians treating them will continue to be faced with difficult choices.

Related articles

• Generic drug competition and pricing nightmares

Caution: Some Over-the-Counter Medicines May Affect Your Driving

 

http://www.fda.gov/forconsumers/consumerupdates/ucm417426.htm

From the FDA Web site

Anyone who operates a vehicle of any type—car, bus, train, plane, or boat—needs to know there are over-the-counter medicines that can make you drowsy and can affect your ability to drive and operate machinery safely.

Over-the-counter medicines are also known as OTC or nonprescription medicines. All these terms mean the same thing: medicines that you can buy without a prescription from a healthcare professional. Each OTC medicine has a Drug Facts label to guide you in your choices and to help keep you safe. OTC medicines are serious medicines and their risks can increase if you don’t choose them carefully and use them exactly as directed on the label.

According to Ali Mohamadi, M.D., a medical officer at FDA, “You can feel the effects some OTC medicines can have on your driving for a short time after you take them, or their effects can last for several hours. In some cases, a medicine can cause significant ‘hangover-like’ effects and affect your driving even the next day.” If you have not had enough sleep, taking medicine with a side effect that causes drowsiness can add to the sleepiness and fatigue you may already feel. Being drowsy behind the wheel is dangerous; it can impair your driving skills.

Choosing and Using Safely

You should read all the sections of the Drug Facts label before you use an OTC medicine. But, when you know you have to drive, it’s particularly important to take these simple steps:

First, read the “active ingredients” section and compare it to all the other medicines you are using. Make sure you are not taking more than one medicine with the same active ingredient. Then make sure the “purpose” and “uses” sections of the label match or fit the condition you are trying to treat.

Next, carefully read the entire “Warnings” section. Check whether the medicine should not be used with any condition you have, or whether you should ask a health care professional whether you can use it. See if there’s a warning that says when you shouldn’t use the medicine at all, or when you should stop using it.

The “When using this product” section will tell you how the medicine might make you feel, and will include warnings about drowsiness or impaired driving.

Look for such statements as “you may get drowsy,” “marked drowsiness will occur,” “Be careful when driving a motor vehicle or operating machinery” or “Do not drive a motor vehicle or operate machinery when using this product.”

Other information you might see in the label is how the medicine reacts when taken with other products like alcohol, sedatives or tranquilizers, and other effects the OTC medicine could have on you. When you see any of these statements and you’re going to drive or operate machinery, you may want to consider choosing another medicine for your problem this time. Look for an OTC medicine that treats your condition or problem but has an active ingredient or combination of active ingredients that don’t cause drowsiness or affect your ability to drive or operate machinery.

Talk to your healthcare professional if you need help finding another medicine to treat your condition or problem. Then, check the section on “directions” and follow them carefully.

Here are some of the most common OTC medicines that can cause drowsiness or impaired driving:

• Antihistamines: These are medicines that are used to treat things like runny nose, sneezing, itching of the nose or throat, and itchy or watery eyes. Some antihistamines are marketed to relieve cough due to the common cold. Some are marketed to relieve occasional sleeplessness. Antihistamines also can be added to other active ingredients that relieve cough, reduce nasal congestion, or reduce pain and fever. Some antihistamines, such as diphenhydramine, the active ingredient in Benadryl, can make you feel drowsy, unfocused and slow to react.
• Antidiarrheals: Some antidiarrheals, medicines that treat or control symptoms of diarrhea, can cause drowsiness and affect your driving. One of these is loperamide, the active ingredient in Imodium.
• Anti-emetics: Anti-emetics, medicines that treat nausea, vomiting and dizziness associated with motion sickness, can cause drowsiness and impair driving as well.

“If you don’t read all your medicine labels and choose and use them carefully,” says Dr. Mohamadi, “you can risk your safety. If your driving is impaired, you could risk your safety, and the safety of your passengers and others.”

Please visit, Over-the-Counter Medicines and Driving, for the audio and slide presentation for more about driving and OTC medicines and with practice looking at Drug Facts labels.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

For More Information

• Driving When Using Medicine – Links to Additional Resources
• FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
• Driving When You Are Taking Medications
• Over-the-Counter Drug Facts Label – Video
• Medicines in My Home
• National Transportation Safety Board
• National Highway Traffic Safety Administration

Related Consumer Updates

• Allergy Meds Could Affect Your Driving
• Some Sleep Drugs Can Impair Driving
• Some Medications and Driving Don’t Mix[ARCHIVED]

Related articles

• Certain Meds, Driving Can Be Deadly Mix: FDA
• FDA: Allergy medications may make you too drowsy to drive
• FDA Slashes Starting Dose For Sunovion Pharmaceuticals Inc.’s Lunesta; Warns Risk Of Next-Day Impairment
• New GF Food Labels
• FDA Proposed Nutrition Fact Label
• FDA seeks pet owner help on dangerous jerky treats
• Lock it Up: Medicine Safety in Your Home
• Beware of Fraudulent ‘Dietary Supplements’
• Black Licorice: Trick or Treat?
• FDA warns that tattoo inks can cause infections

Recent additions to the NLM Drug Information Portal include clinical experience with drugs and dietary supplements

 

 

 

 

 

 

From the NLM-TOX-ENVIRO-HEALTH-L Digest – 2 Oct 2014 to 7 Oct 2014 (#2014-19)

The National Library of Medicine (NLM) Drug Information Portal (http://druginfo.nlm.nih.gov) is a free web resource that provides an informative, user–friendly gateway to current drug information for over 53,000 substances. The Portal links to sources from the NLM, the National Institutes of Health (NIH), and other government agencies such as the U.S. FDA.

Current information regarding consumer health, clinical trials, AIDS–related drug information, MeSH® pharmacological actions, PubMed® biomedical literature, and physical properties and structure is easily retrieved by searching a drug name. A varied selection of focused topics in medicine and drug–related information is also available from displayed subject headings.

The Drug Portal retrieves by the generic or trade name of a drug or its category of usage.  Records provide a description of how the drug is used, its chemical structure and nomenclature, and include up to 20 Resource Locators which link to more information in other selected resources.   Recent additions to these Locators include clinical experience with drugs in PubMed Health (http://www.ncbi.nlm.nih.gov/pubmedhealth), substances reviewed in NLM LiverTox (http://livertox.nih.gov/), information from the Dietary Supplement Label Database (http://dsld.nlm.nih.gov/dsld/), and drug images in the Pillbox beta (http://pillbox.nlm.nih.gov/) database.

Data in the Drug Information Portal is updated daily, and is also available on mobile devices.

More information can be found at http://www.nlm.nih.gov/pubs/factsheets/druginfoportalfs.html

Related articles

• NLM Technical Bulletin, Sep-Oct 2014, NLM Resource Update: Drug Information Portal
• Recent additions to the NLM Drug Information Portal include clinical experience with drugs and dietrary supplement information

[Article] How Sweet It Is: All About Sugar Substitutes

How Sweet It Is: All About Sugar Substitutes.

 

From the 19 May 2014 FDA article

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Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods. They can be used alone to sweeten foods and beverages such as iced tea or coffee, or as an ingredient in other products. There are a number of sugar substitutes on the market from which to choose.

“Sugar substitutes are called ‘high-intensity’ because small amounts pack a large punch when it comes to sweetness,” says Captain Andrew Zajac, U.S. Public Health Service (USPHS), director of the Division of Petition Review at the Food and Drug Administration (FDA).

According to Zajac, unlike sweeteners such as sugar, honey, or molasses, high-intensity sweeteners add few or no calories to the foods they flavor. Also, high-intensity sweeteners generally do not raise blood sugar levels.

The FDA has approved a new high-intensity sweetener called advantame.

Advantame—which does not yet have a brand name (such as Sweet’N Low, a brand name for saccharin, or Equal, a brand name for aspartame)—has been approved as a new food additive for use as a sweetener and flavor enhancer in foods, except meat and poultry.

Examples of uses for which advantame has been approved include baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings, and syrups.

How Do You Know It’s Safe?

FDA is required by law to review all new food additives for safety before they can go on the market. The process begins when a company submits a food additive petition to FDA seeking approval. One exception is for substances “generally recognized as safe,” or GRAS, because those substances are generally recognized by qualified experts as safe under the conditions of intended use and are exempt from the food additive approval process.

Zajac explains that the agency’s scientists thoroughly review all the scientific evidence submitted by a company to ensure the product is safe for the intended use.

“In determining the safety of advantame, FDA reviewed data from 37 animal and human studies designed to identify possible toxic (harmful) effects, including effects on the immune, reproductive and developmental, and nervous systems,” Zajac says.

Advantame is chemically related to aspartame, and certain individuals should avoid or restrict the use of aspartame. To that end, FDA evaluated whether the same individuals should avoid or restrict advantame, as well.

People who have phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Newborns are tested for PKU using a common “heel-prick” test before they leave the hospital.

Foods containing aspartame must bear an information statement for people with PKU alerting them about the presence of phenylalanine. But advantame is much sweeter than aspartame, so only a very small amount needs to be used to reach the same level of sweetness. As a result, foods containing advantame do not need to bear that statement.

Five Already on the Market

The last high-intensity sweetener approved by FDA was Neotame (brand name Newtame) in 2002. The other four on the market, and are:

• Saccharin, was first discovered and used in 1879, before the current food additive approval process came into effect in 1958. Brand names include Sweet‘N Low
• Aspartame, first approved for use in 1981. Brand names include Equal
• Acesulfame potassium (Ace-K), first approved for use in 1988. Brand names include Sweet One
• Sucralose, first approved for use in 1998. Brand name is Splenda

In addition to the six high-intensity sweeteners that are FDA-approved as food additives, the agency has received and has not questioned GRAS notices for two types of plant/fruit based high-intensity sweeteners: certain steviol glycosides obtained from the leaves of the stevia plant (Stevia rebaudiana (Bertoni) Bertoni) and extracts obtained from Siraitia grosvenorii Swingle fruit, also known as Luo Han Guo or monk fruit.

While these high-intensity sweeteners are considered safe for their intended uses, certain individuals may have a particular sensitivity or adverse reaction to any food substance. Consumers should share with their health care provider any concerns they have about a negative food reaction.

In addition, FDA encourages consumers to report any adverse events through MedWatch: FDA’s safety information and adverse event reporting program.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

openFDA – More than 3 million adverse drug event reports at your fingertips.

openFDA

 

 

 

From the Web site

OpenFDA offers easy access to FDA public data and highlight projects using these data in both the public and private sector to further regulatory or scientific missions, educate the public, and save lives.

What does it do?

OpenFDA provides API and raw download access to a number of high-value structured datasets. The platform is currently in public beta with one featured dataset, FDA’s publically available drug adverse event reports.

In the future, openFDA will provide a platform for public challenges issued by the FDA and a place for the community to interact with each other and FDA domain experts with the goal of spurring innovation around FDA data.

We’re currently focused on working on datasets in the following areas:

• Adverse Events: FDA’s publically available drug adverse event reports, a database that contains millions of adverse event and medication error reports submitted to FDA covering all regulated drugs.
• Recalls (coming soon): Enforcement Report and Product Recalls Data, containing information gathered from public notices about certain recalls of FDA-regulated products
• Documentation (coming soon): Structured Product Labeling Data, containing detailed product label information on many FDA-regulated product

We’ll be releasing a number of updates and additional datasets throughout the upcoming months.

 

 

Related articles

• FDA launches openFDA to provide easy access to valuable FDA public data
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• Open Data: U.S. Food and Drug Administration Launches openFDA
• FDA Launches openFDA, Gives Developers Access to Public Health Data Sets

 

[News Article] The Steep cost of Life Saving Drugs

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Medication Health News

With many new drugs being brought to market, there has been increased talk about the pricing of many agents. Today, drugs in question include Evzio, a new naloxone auto-injector and  Sovaldi, a new antiviral for hepatitis C. These agents could save many lives, but their potential high costs could be a barrier to many of the patients of need. How should we solve this dilemma?  Should the subsidies be provided to those in need of these therapies?  What are your thoughts?

For additional information, please see the news analysis in the New York Times.

Image courtesy of [ddpavumba]/FreeDigitalPhotos.Net

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[Reblog] JAMA papers raise questions about FDA drug and device approval

JAMA papers raise questions about FDA drug and device approval.

JAN24 2014

Posted by Gary Schwitzer in FDA

An important series of papers was published in the Journal of the American Medical Association this week.

“Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” by Dr. Joseph Ross and colleagues, concluded that the quality of clinical trial evidence used by the FDA as the basis of approving new drugs varies widely.  A couple of interesting data points:

• in the seven-year period of analysis, 37% of drugs were approved on the basis of a single pivotal trial.
• trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 45% of drugs approved. (See our primer, “Surrogate markers may not tell the whole story.”)

In an opinion piece,  “Opening the FDA Black Box,” Drs. Steven Goodman and Rita Redberg said the study:

“…raises a host of questions needing further exploration. Despite the FDA requirement for evidence from a minimum of 2 randomized clinical trials supporting an effect on health outcomes, 37% of product approvals were based on only 1 trial, 53% of cancer trials were nonrandomized, and an active comparator was used in only 27% of non–infectious disease trials. Surrogate end points were used in almost all approvals via the accelerated approval process and in 44% of nonaccelerated approvals. Trials were comparatively short, with most lasting less than 6 months, even those assessing chronic treatments for chronic diseases. Cancer drugs, perhaps predictably, were more often approved via the accelerated process and with weaker designs.”

Another paper looked at the reasons that FDA marketing approval for new drugs was delayed or denied.

And a fourth paper looked at FDA regulation of medical devices, “a process that has received relatively little attention,” according to Goodman and Redberg, who continued:

In USA Today, Liz Szabo wrote a good summary of the JAMA papers under the headline, “Not all FDA-approved drugs get same level of testing: Evidence behind FDA-approved drugs and devices often has major limitations.”

Read the entire article here

Related Resources

• ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human             participants conducted around the world.
When available, study results information is included in the study record under the Study Results tab. See How to Find Results of Studies for more information on finding results entered in the results database.

Results (after 2008, only those required by US federal requirements) include
–Participant data (how many started the trial, dropped out, etc)
—  Information about participants (age, gender, blood pressure readings, etc)

[Speaking of gender…]

Good to know, most drugs can affect women and men differently

    —   Outcome (results of taking the drug plus any placebo), with statistics

    –Adverse effects , serious and other (this was not required before 2008)

• Evaluating Health Information (from my personal Google site)

  • Research Articles Summarized for Us All

  • How to Read a Research Paper

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Another take on the “relaxation of standards”

• Drug Approvals Take Customized Approach Based on Disease
• [Reblog] Last week “clinical trial system broken”; this week “luxury journals distort/damage science”
• Newly published survey shows drug shortages still have major impact on patient care
• [Reblog] Misleading BMJ news releases may be one reason journalists report on more observational studies
• Does taking multiple medicines increase risk of being admitted to hospital? Yes and no
• [Reblog] Who is making your medical app?
• [Reblog] What happens to medicine when it has no heroes?

[Magazine Article] The Trans-Fat Ban as a Model of Slow Health Policy

Poster from New York City’s board of health encouraging consumers to limit trans fat consumption (Photo credit: Wikipedia)

 

From the 8th November 2013 article in The Atlantic

 

..Taking trans fats off the GRAS list won’t remove them from the food supply. Manufacturers can still petition the FDA for exceptions. But it goes a long way toward getting them out.

…

what the announcement really shows is how public health works: slowly, based on mounting scientific evidence, against constant and mounting headwinds of public ridicule and, much more important, industry lobbying and advertising.

..Companies seldom change unless they have to, which they say means unless consumers ask them to. If you don’t want trans fats or gluten or genetically modified organisms, fine with us! Just tell us with your food dollars! This is of course a way of saying that they don’t want government telling them what to do, and gives them a chance to shape the public opinion they say they simply obey, with millions of dollars in ad campaigns and lobbying.

..

The lesson, though, is not that the public shouldn’t trust science, because one year’s saturated-fats-are-evil message will eventually become next year’s hey-butter-is-great-when-you-look-at-Crisco. The road to strong public recommendations isn’t clear, as scientific research is slow and zigzags. Both food makers and scientists can be guilty of jumping the gun, depending on what they think they can sell or who they can get to fund big studies and endowed chairs.

..

The analogy I’m building toward is, of course, sugar-sweetened drinks. Scientific consensus has built to practically the bursting point that sodas make kids fat. Soda makers deride the officials who try to do something about it, and work as hard as they can to cast doubt on science. Mayor Bloomberg, though fairly trim, was their fattest target, in the Mrs. Doubtfire costume they dressed him up in when he tried to impost a portion limit on sodas in restaurants and movie theaters. Now that he’s leaving, they’ll find another target.

But opinion will change, national bodies start to fall into line as they did on trans fats and are doing with sugary drinks. The most outspoken enemies of sugar, like Robert Lustig, are trying to take it off the GRAS list–something that CSPI petitioned the FDA to do last February, asking it to study and determine safe levels of high-fructose corn syrup. The chance of an FDA announcement of that in six years seems pretty unlikely now. But soda makers already have more than dozens of low-sugar and sugar-free drinks: they have scores and scores of them. They’ve quietly been working to solve the problem, while spending (often literally) untold sums not to risk their core products. The advocates against trans fats who seemed so crazy even six years ago, when the New York trans fat ban went into effect, are seeming a lot less crazy today.

…

 

Read the entire article here

 

 

 

 

 

Related articles

• NYC’s Bloomberg led the way on trans fats ban (miamiherald.com)
• Trans fat doesn’t stir much ‘nanny state’ debate (fngnutrition.ca)
• FDA’s Proposed Trans Fat Ban: An Attack on Freedom (heritage.org)
• No more trans fat: FDA banning the artery-clogger (webpronews.com)
• No more trans fat: FDA banning the artery-clogger (conservativeread.com)
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[Brookings Conference] Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access

 

Check back after the conference, audio and/or video of the conference should then “be up”

From the Brookings Institute Web page

On November 4, the Engelberg Center for Health Care Reform convened an expert workshop “Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access.”

In an effort to address the undertreatment of common diseases and conditions, the U.S. Food and Drug Administration is exploring how a regulatory expansion of the nonprescription drug class might increase access to medications. This initiative, known as the Nonprescription Safe Use Regulatory Expansion (NSURE), is exploring how health care professionals and innovative technologies can serve as a condition to the safe use of drugs in a nonprescription setting.

Understanding the impact of NSURE on reimbursement and patient access to medication will be critical to the initiative’s success in addressing medical undertreatment. At this expert workshop, a wide range of experts and stakeholders explored previous effects from prescription-to-nonprescription medication switches, identified potential incentives for coverage of nonprescription drugs with Conditions of Safe Use, and investigated potential mechanisms for reimbursement.

This expert workshop was the third in a series of meetings that explored the NSURE initiative. To explore previous discussions regarding the potential role of health care professionals as a Condition of Safe Use within the NSURE initiative, please visit our expert workshop, “Nonprescription Medications with Conditions of Safe Use as a Novel Solution for Undertreated Diseases or Conditions”. To explore previous discussion regarding the role of technology in supporting the safe and effective use of nonprescription products, please visit our expert workshop, “Innovative Technologies and Nonprescription Medications: Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care”.

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• Big pharma is finding new ways to expand drug life cycle by transitioning drugs from Rx to OTC (medcitynews.com)
• No age limit on morning-after pill (wjla.com)
• Common Non-Opioid Pain Medications (mnphysicalmedicine.com)

 

[FDA Consumer Update] Pain Medicines for Pets: Know the Risks

From the 5 November 2013 FDA Consumer Update

Pain Medicines for Pets: Know the Risks

 

Your 9-year-old German Shepherd is limping, and you think that arthritis may be setting in. A trip to the veterinarian proves that you’re right—it’s osteoarthritis, a degeneration of the cartilage and bone that affects joints. The veterinarian prescribes a non-steroidal anti-inflammatory drug (NSAID).

NSAIDs are a class of drugs extensively used in both human and veterinary medicine for their anti-fever, anti-inflammatory and pain-relieving properties, and they are the most commonly prescribed pain relievers for animals. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs work by blocking the production of chemicals produced by the body that play a role in inflammation.

“Scientists consider NSAIDs the cornerstone of osteoarthritis therapy in dogs,” says Melanie McLean, D.V.M., a veterinarian at the Food and Drug Administration (FDA). Some NSAIDS are also used to manage pain after surgery in both dogs and cats. No NSAID has been approved for long-term use in cats.

NSAIDs carry risks as well as benefits, however, and all dogs and cats should undergo a thorough physical examination by a veterinarian—including a discussion of the pet’s medical history— before beginning NSAID therapy. McLean notes that it’s also important that you talk to your veterinarian about possible side effects, including those that could signal danger.

Risks and Side Effects

NSAIDS are associated with gastrointestinal ulcers/perforations, kidney, and liver toxicity (damage done by exposure to medications or chemicals) and must be used cautiously in animals with pre-existing kidney or liver problems.

Because most liver-associated toxicities occur during the first three weeks, it’s especially important to closely monitor the results of blood tests during the early stages of long-term NSAID treatment in dogs. Also, before starting long-term treatment with NSAIDs in dogs, blood tests should be conducted to establish baseline data and then repeated on a regular basis. McLean recommends that you talk with your veterinarian about how often this blood work should be done.

Some of the most common side effects of NSAIDS in animals reported to FDA are:

• vomiting
• decreased to no appetite
• decreased activity level
• diarrhea

While your animal is taking NSAIDs, continuously monitor the pet for these side effects as well as looking for blood in the feces, tar-like stools, yellowing of the whites of the eyes, or yellowing of the gums. If you see these, call your veterinarian immediately, McLean says. Other reported side effects include stomach and intestinal ulcers, intestinal perforation (a hole in the wall of the intestine), kidney failure, liver failure and death.

Giving two NSAIDs at the same time, or giving an NSAID with a steroid, such as prednisone, can significantly increase the risk and severity of side effects, especially gastrointestinal toxicity.

Risks associated with NSAIDs are detailed on the package inserts and the client information sheets that accompany all FDA-approved veterinary oral NSAIDs.

Are OTC Meds for People Safe for Pets?

McLean says that it’s not unusual for pet owners to want to give their animals NSAIDs or acetaminophen (Tylenol and other brands, which are not NSAIDs) straight from their own medicine cabinets. “Many people don’t realize that a medicine that’s safe for people may not be safe for dogs or cats, or that a dose that is safe for people may not be safe for their pets,” she notes.

In fact, some over-the-counter (OTC) human pain relievers can be toxic, or even deadly, in pets. McLean suggests that you check with your veterinarian first if you want to give your animal OTC human drugs.

“You should always check with your veterinarian first before giving your animal any kind of medication, prescription or over-the-counter,” she notes. Similarly, pet owners should not assume that a medicine that is safe for one animal is necessarily safe for another.

Communication with your veterinarian is essential. Before giving your animal an NSAID:

• Make sure you know what the medication is being prescribed for, how much to give and how long to give it.
• Discuss possible side effects and symptoms, especially those that require an immediate call to the vet.
• Tell your veterinarian if the pet has a history of gastrointestinal problems, such as stomach ulcers, or surgery on the stomach or intestines.
• Tell your veterinarian if your pet is on any other medications or supplements.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Nov. 5, 2013

For More Information

• Treating Pain in Your Dog
• Medications for Your Pet … Questions for Your Vet
• FDA Basics Webinar on Advice to Dog Owners Whose Pets Take NSAIDS

Related Consumer Updates

• Medication Errors Happen to Pets, Too
• Medications for Your Pet: 10 Questions to Ask Your Vet [ARCHIVED]
• Purchasing Pet Drugs Online: Buyer Beware

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• [FDA Press Release] Why Are Jerky Treats Making Pets Sick? – FDA asking consumers to report illnesses (jflahiff.wordpress.com)

 

[FDA program aimed at health care providers] Truthful Prescription Drug Advertising and Promotion

This page is geared towards health care providers, but it may be of interest to others.

From the US FDA (Food and Drug Administration) Web page 

FDA’s Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program’s goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency: e-mail BadAd@fda.gov or call 855-RX-BADAD.

Continuing Medical Education Video itself is free for anyone to view (http://www.sigmatech.com/BadAd/courses/index.htm)It covers what is legal/illegal for pharmaceutical companies and their representatives when advertising their products at different venues

Prescription drug advertising must:

• Be accurate
• Balance the risk and benefit information
• Be consistent with the prescribing information approved by FDA
• Only include information that is supported by strong evidence

What types of promotion does OPDP regulate?

• TV and radio advertisements
• All written or printed prescription drug promotional materials
• Speaker program presentations
• Sales representative presentations

OPDP does not regulate promotion of:

• Over-the-Counter Drugs
• Dietary Supplements
• Medical Devices

Common Violations:

• Omitting or downplaying of risk
• Overstating the effectiveness
• Promoting Uses Not Addressed in Approved Labeling

• Misleading drug comparisons

 Examples of Violations

Example of Omission of Risk

You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.

This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Uses Not Addressed in Approved Labeling
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.

This presentation would be illegal because it promotes an unapproved use.

Example of Overstating the Effectiveness

“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”

This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.

Frequently Asked Questions

1. Can I report anonymously?

Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.

2. Will OPDP be able to stop the misleading promotion?

In many cases, yes, especially if the appropriate evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.

3. What will happen to my complaint once I have contacted OPDP?

The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.

4. How do I learn more?

To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.

Related articles

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[Press release] FDA issues proposed rule to help ensure the safety of food for animals

From the FDA press release

FDA issues proposed rule to help ensure the safety of food for animals

The U.S. Food and Drug Administration today issued a proposed rule under the FDA Food Safety Modernization Act (FSMA) aimed at improving the safety of food for animals. This proposed regulation would help prevent foodborne illness in both animals and people and is open for public comments for 120 days. The proposal is part of the Food Safety Modernization Act’s larger effort to modernize the food safety system for the 21st century and focus public and private efforts on preventing food safety problems, rather than relying primarily on responding to problems after the fact.

The proposed rule would require makers of animal feed and pet food to be sold in the U.S.to develop a formal plan and put into place procedures to prevent foodborne illness. The rule would also require them to have plans for correcting any problems that arise.  The proposed rule would also require animal food facilities to, for the first time, follow proposed current good manufacturing practices that address areas such as sanitation.

“The FDA continues to take steps to meet the challenge of ensuring a safe food supply,” said FDA Commissioner Margaret A. Hamburg, M.D. “Today’s announcement addresses a critical part of the food system, and we will continue to work with our national and international industry, consumer and government partners as we work to prevent foodborne illness.”

The proposed rule would help ensure the safety of food for animals and prevent the transmission of agents in food for animals that could cause foodborne illness in both animals and people. People can get sick by handling contaminated food, such as pet food.

“This proposed rule on animal food complements proposed rules published in January 2013 for produce safety and facilities that manufacture food for humans to set modern, prevention-based standards for food safety,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “They also work in concert with standards proposed in July 2013 to help ensure that imported foods are as safe as those produced domestically.”

The FDA will hold three public meetings on the Proposed Rule for Preventive Controls for Animal Food Facilities. The first meeting will be held on November 21, 2013 at the FDA Center for Food Safety and Applied Nutrition in College Park, MD. The second meeting will be on November 25, 2013 at the Ralph H. Metcalfe Federal Building in Chicago. The third meeting will be held on December 6, 2013 at the John E. Moss Federal Building in Sacramento, CA. For more information, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

And from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm371395.htm

….The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma

 

And from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm371395.htm

For the first time, the Food and Drug Administration (FDA) is proposing preventive measures to protect all animal foods from disease-causing bacteria, chemicals and other contaminants.

This includes the food that pet owners give their dogs, cats and other companion animals, and the feed that farmers give their livestock.

Preventive Controls for Food for Animals is the fifth rule that FDA has proposed this year as part of the food-safety framework envisioned by the 2011 FDA Food Safety Modernization Act that focuses on preventing foodborne illnesses.

Daniel McChesney, Ph.D., director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine (CVM), explains that this rule proposes establishing a whole new set of protections for animal foods. Currently, the agency primarily gets involved when there is evidence of contaminated animal food on the market.

“Unlike safeguards already in place to protect human foods, there are currently no regulations governing the safe production of most animal foods. There is no type of hazard analysis. This rule would change all that,” says McChesney.

McChesney notes that human and animal health are intertwined. People can get sick when pet food is contaminated by disease-causing bacteria like Salmonella. When such food is handled by pet owners and placed on kitchen surfaces, the bacteria can spread to foods consumed by their family.

And if an animal has eaten feed contaminated with a chemical like dioxin and then enters the food supply, consumers could likewise absorb the chemical, putting their health at risk.

By helping to prevent the contamination of animal foods, the proposed rule protects pets and people alike, he says.

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Requiring a Safety Plan

This proposed rule would create regulations that address the manufacturing, processing, packing and holding of animal food. Good manufacturing practices would be established for buildings, facilities and personnel, and would include cleaning and maintenance, pest control, and the personal hygiene of people who work there.

It would also require facilities to have a food safety plan, perform an analysis of potential hazards, and implement controls to minimize those risks. Those controls would have to be monitored and corrected as needed.

While this rule is similar in many ways to the Preventive Controls for Human Food rule that FDA proposed in January 2013, McChesney explains that it is different in a number of ways because animals face different hazards.

For example, he says, the proposed animal rule doesn’t address allergens—substances that could cause an allergic reaction. That’s because animals don’t get the kind of life-threatening allergic reactions that people do. They might get a skin reaction but not the kind of physical shock that a food allergen could trigger in a person.

On the other hand, contaminants that endanger animals are sometimes tolerated better by people and were not as great a concern in crafting protections for human food. For example, some animals are much more vulnerable to aflatoxin, a toxin caused by mold, and could die after consuming food containing the toxin.

The animal rule is also designed to prevent nutrient imbalances in animal foods. Unlike people, who get their foods from many sources, an animal’s food is meant to be a complete and balanced diet, explains McChesney. If a food doesn’t have enough of a particular nutrient, the animal has no way to make it up. For example, cats need thiamine (also known as Vitamin B1) but their bodies don’t produce it. If they don’t get enough in their food, they can suffer severe neurological problems.

The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.

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Import Rules Add Safeguards

The proposed animal rule would work in concert with two rules proposed in July 2013 to help ensure that foods exported to the United States are held to the same FDA food safety standards applied to foods produced in the United States. Together, the three rules would help ensure the same level of safety for domestic and imported foods for animals.

In one of the most infamous examples of pet food contamination, dogs and cats across the country were sickened and killed in 2007 when melamine, a chemical used to make plastic, was added to pet food ingredients imported from China. McChesney noted that FDA received about 18,000 calls from anxious pet owners at the time.

The requirements proposed in both the animal and import rules are designed to help prevent that from happening again, he says.

Overall, McChesney says that the animal food supply is very safe. However, with the marketplace becoming more global and more diverse, more protections are needed. When you buy food for your animals, those ingredients could come from anywhere in the world, so animal food producers and their suppliers, no matter where they are based, have to be held to the same high standards, he says.

“Whether in the home or on the farm, people take the safety of their animals very seriously, and so do we,” says McChesney.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Oct. 25, 2013

Related articles

• FDA Looks to Finally Regulate Pet Food (onegreenplanet.org)
• FDA proposes strict new safety rules for animal food (nbcnews.com)
• FDA proposes rule to control animal food manufacture (examiner.com)
• FDA wants to make pet food safer (cnn.com)
• FDA Proposes Stringent Guidelines on Animal Food After Wave of Deaths (guardianlv.com)
• Pet Foods Face First-Ever FDA Rule 6 Years After Dog Treat Scare – Bloomberg (bloomberg.com)
• FDA Proposes Pet Food Safety Rules After Jerky Treats Sicken 3,600 Dogs And Cats (medicaldaily.com)
• FDA Proposes New Pet Food Regulations (webpronews.com)

[FDA Press Release] Why Are Jerky Treats Making Pets Sick? – FDA asking consumers to report illnesses

From the 22 October 2013 FDA press release

If you have a dog or cat that became ill after eating jerky pet treats, the Food and Drug Administration (FDA) would like to hear from you or your veterinarian.

The agency has repeatedly issued alerts to consumers about reports it has received concerning jerky pet treat-related illnesses involving 3,600 dogs and 10 cats in the U.S. since 2007. Approximately 580 of those pets have died.

To date, FDA’s Center for Veterinary Medicine (CVM) has conducted more than 1,200 tests, visited jerky pet treat manufacturers in China and collaborated with colleagues in academia, industry, state labs and foreign governments. Yet the exact cause of the illnesses remains elusive.

To gather even more information, FDA is reaching out to licensed veterinarians and pet owners across the country. “This is one of the most elusive and mysterious outbreaks we’ve encountered,” says CVM Director Bernadette Dunham, DVM, Ph.D. “Our beloved four-legged companions deserve our best effort, and we are giving it.”

In a letter addressing U.S. licensed veterinarians, FDA lists what information is needed for labs testing treats and investigating illness and death associated with the treats. In some cases, veterinarians will be asked to provide blood, urine and tissue samples from their patients for further analysis. FDA will request written permission from pet owners and will cover the costs, including shipping, of any tests it requests.

Meanwhile, a consumer fact sheet will accompany the letter to veterinarians so they can alert consumers to the problem and remind them that treats are not essential to a balanced diet. The fact sheet also explains to consumers how they can help FDA’s investigation by reporting potential jerky pet treat-related illnesses online or by calling the FDA Consumer Complaint Coordinator for their state.

 

What to Look Out For

Within hours of eating treats sold as jerky tenders or strips made of chicken, duck, sweet potatoes and/or dried fruit, some pets have exhibited decreased appetite, decreased activity, vomiting, diarrhea (sometimes with blood or mucus), increased water consumption, and/or increased urination.

Severe cases have involved kidney failure, gastrointestinal bleeding, and a rare kidney disorder. About 60 percent of cases involved gastrointestinal illness, and about 30 percent involved kidney and urinary systems.

The remaining cases reported various symptoms, such as collapse, convulsions or skin issues.

Most of the jerky treats implicated have been made in China. Manufacturers of pet foods are not required by U.S. law to state the country of origin for each ingredient in their products.

A number of jerky pet treat products were removed from the market in January 2013 after a New York State lab reported finding evidence of up to six drugs in certain jerky pet treats made in China. While the levels of these drugs were very low and it’s unlikely that they caused the illnesses, FDA noted a decrease in reports of jerky-suspected illnesses after the products were removed from the market. FDA believes that the number of reports may have declined simply because fewer jerky treats were available.

Meanwhile, the agency urges pet owners to be cautious about providing jerky treats. If you do provide them and your pet becomes sick, stop the treats immediately, consider seeing your veterinarian, and save any remaining treats and the packaging for possible testing.

 

What FDA Is Doing

More than 1,200 jerky pet treat samples have been tested since 2011 for a variety of chemical and microbiological contaminants, from antibiotics to metals, pesticides and Salmonella. DNA testing has also been conducted, along with tests for nutritional composition.

In addition to continuing to test jerky pet treat samples within FDA labs, the agency is working with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), an FDA-coordinated network of government and veterinary diagnostic laboratories across the U.S. and Canada. (A summary of the tests is available on Vet-LIRN’s webpage.)

Inspections of the facilities in China that manufacture jerky products associated with some of the highest numbers of pet illness reports did not identify the cause of illness. However, they did identify additional paths of investigation, such as the supply chain of some ingredients in the treats. Although FDA inspectors have found no evidence identifying the cause of the spate of illnesses, they did find that one firm used falsified receiving documents for glycerin, a jerky ingredient. Chinese authorities informed FDA that they had seized products at the firm and suspended its exports.

To identify the root cause of this problem, FDA is meeting regularly with regulators in China to share findings. The agency also plans to host Chinese scientists at its veterinary research facility to increase scientific cooperation.

FDA has also reached out to U.S. pet food firms seeking further collaboration on scientific issues and data sharing, and has contracted with diagnostic labs.

“Our fervent hope as animal lovers,” says Dunham, “is that we will soon find the cause of—and put a stop to—these illnesses.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Oct. 22, 2013

 

For More Information

• Animal & Veterinary
• Veterinary Laboratory Investigation and Response Network
• Pet Food
• Jerky Pet Treats
• FDA Facts: Jerky Pet Treats (PDF – 216KB)
• FDA Voice Blog: Help Us Find Out Why Jerky Treats Are Making Pets Sick

Related Consumer Updates

• Caution to Dog Owners About Chicken Jerky Products
• Dog Treats May Present Health Hazard [ARCHIVED]
• No Bones About It: Bones Are Unsafe for Your Dog

Related articles

• Hundreds Of Dogs Dead From Eating Jerky Treats; FDA Isn’t Exactly Sure Why (huffingtonpost.com)
• Help Us Find Out Why Jerky Treats Are Making Pets Sick (scienceblog.com)
• Jerky treat mystery: Nearly 600 pets dead; still no source, FDA says (nbcnews.com)

 

State Medicaid Coverage Limited in Treating Painkiller Addiction — Stateline

Source: A Public Health Approach to Drug Control in Canada, Health Officers Council of British Columbia, 2005 (Photo credit: Wikipedia)

 

State Medicaid Coverage Limited in Treating Painkiller Addiction — Stateline.

 

Excerpts from the 17 July 2013 article at Stateline Daily

 

To Mark Publicker, a doctor in Portland, Maine, who practices addiction medicine, it’s a clear case of discrimination. You wouldn’t deprive a diabetic of insulin. You wouldn’t stop giving hypertension drugs to a patient with high blood pressure after successful treatment. You wouldn’t hold back a statin from a patient with high cholesterol…

..

Many private insurance companies and state Medicaid agencies across the country impose sharp limitations on access to medications used in the treatment of the addiction to prescription painkillers known as opioids.

A report commissioned by the American Society of Addiction Medicine found that Medicaid agencies in just 28 states cover all three of medications that the Food and Drug Administration has approved for opioid addiction treatment: methadone, buprenorphine and naltrexone. The study also found that most state Medicaid agencies, even those that cover all three medications, place restrictions on getting them by requiring prior authorization and re-authorization, imposing lifetime limitations and tapering dosage strengths. The study was done by the substance abuse research firm Avisa Group.

“Now that we finally have medications that are shown to be effective and cost-effective it is shameful to throw up roadblocks to their use,” said Mady Chalk, director of the Center for Policy Research and Analysis at the Treatment Research Institute, which researches all aspects of substance abuse.

By any measure, there is an epidemic in the misuse of prescription drugs, most of it involving abuse of opioid painkillers such as OxyContin or Percocet. The Centers for Disease Control and Prevention reported that 12 million Americans acknowledged using prescription painkillers for nonmedical reasons in 2010.

…

 

 

 

Related articles

• Painkiller addicts hit Medicaid limits (usatoday.com)
• Prescription drug overdose deaths skyrocket among women (bangordailynews.com)
• Sharp Rise in Women’s Deaths from Overdose of Painkillers (articles.mercola.com)
• Doctors prescribe narcotics too often for pain, CDC chief says – Los Angeles Times (latimes.com)
• Newly born and withdrawing from drugs: As number of Maine babies exposed to opiates rises, experts explore new options (bangordailynews.com)
• How Long-Term Use of Painkillers Affects the Brain (painkillersaddiction.wordpress.com)
• CDC Chief: Doctors Prescribe Pain Killers Too Often (counselheal.com)
• Many Preventive Services Not Available To Medicaid Beneficiaries (medicalnewstoday.com)
• Accepting or Rejecting the Medicaid expansion provision contained in the ACA will be determined by outcome of the Virginia Governor’s race this November. (coherentramblingsforcoherentminds.wordpress.com)

 

Herbal and Dietary Supplements Can Adversely Affect Prescribed Drugs, Says Extensive Review

Dietary supplements, such as the vitamin B supplement show above, are typically sold in pill form. (Photo credit: Wikipedia)

Those of you who follow this blog know I continually harp on the necessity of sharing your use of complementary/alternative therapies as well as supplements with your health care providers.

From the 24 October 2012 article at ScienceDaily

A number of herbs and dietary supplements (HDS) can cause potentially harmful drug interactions, particularly among people receiving medication for problems with their central nervous or cardiovascular systems.

Those are the key findings of an extensive research review published in the November issue of IJCP, theInternational Journal of Clinical Practice.***

Researchers examined 54 review articles and 31 original studies. They found that the greatest problems were caused by interactions between prescribed drugs and HDS that included ingredients such as St John’s Wort, magnesium, calcium, iron or ginkgo.

“Consumer use of HDS has risen dramatically over the past two decades” says co-author Dr Hsiang-Wen Lin from the College of Pharmacy, China Medical School, Taiwan.

“In the USA, for example, it is estimated that more than 50 per cent of patients with chronic diseases or cancer use them and that many patients take them at the same time as prescribed medication.

“Despite their widespread use, the potential risks associated with combining HDS with other medications, which include mild-to-severe heart problems, chest pain, abdominal pain and headache, are poorly understood.”

Key findings of the review included:

• The literature covered 213 HDS entities and 509 prescribed medications, with 882 HDS-drug interactions described in terms of their mechanisms and severity.
• Warfarin, insulin, aspirin digoxin and ticlopidine had the greatest number of reported interactions with HDS.
• More than 42 per cent of the drug interactions were caused by the HDS altering the pharmacokinetics of the prescribed drugs — the process by which a drug is absorbed, distributed, metabolised and eliminated by the body.
• Just over 26 per cent of the total were described as major interactions.
• Among the 152 identified contraindications, the most frequent involved the gastrointestinal system (16.4%), neurological system (14.5%) and andrenal ⁄ genitourinary diseases (12.5%).
• Flaxseed, echinacea and yohimbe had the largest number of documented contraindications.

Related Resources

• Evaluating Health Information (links at Health/Medical News and Resources by yours truly) 
• Drugs, Supplements, and Herbal Information (MedlinePlus)Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more.Browse dietary supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions.
• Dietary Supplements Label Database (US National Library of Medicine) offers information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent …
• Drugs and Supplements (sponsored by the Mayo Clinic)  Somewhat lengthy drug and over-the-counter medicationinformation with these sections: description, before using, proper use, precautions and side effects. From Micromedex, a trusted source of healthcare information for health professionals. Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.

Related articles

• Combining popular supplements with prescription drugs could cause heart problems (dailymail.co.uk)
• Drug Companies Sell Most Dietary Supplements (caringtouchspa.com)
• Risks of Mixing Drugs with Herbal, Dietary and Energy Supplements (swisschiropractic.wordpress.com)
• NIH launches free database of drugs associated with liver injury (jflahiff.wordpress.com)
• Tips for Older Dietary Supplement Users (nutritionucgiblog.com)
• FDA warns of dangerous dietary supplements (thechart.blogs.cnn.com)

**Unfortunately this article is only available through paid subscription.
Ask for an available copy at your local public, academic, or medical library. (Many academic and medical libraries will help anyone who walks in, call ahead and ask for a reference librarian)

If your library does not have it, ask about Interlibrary loan. You may be able to get a copy from another library at little or no cost.

Patients Tell How Magnetic Therapy Lifted Their Depression

TMS (Photo credit: jeanbaptisteparis)

 

From the 15 October 2012 article at Science Daily

 

Three patients who have suffered periodic major depression throughout their adult lives told an audience attending a Loyola Grand Rounds presentation how their lives have been transformed by a new magnetic therapy.

The treatment, called transcranial magnetic stimulation (TMS), sends short pulses of magnetic fields to the brain.

“I feel better now than I have in a very long time,” said patient Jannel Jump. “I’m living a life now, rather than hiding from it.”

Another patient said TMS brought him out of a depression so severe he couldn’t get out of bed.

And a third patient said TMS “has helped me to have a glass-is-half-full outlook. I’m in a much better spot today.”

The Food and Drug Administration approved TMS in 2009 for patients who have major depression and have tried and failed at least one antidepressant. The FDA has approved one TMS system, NeuroStar®, made by Neuronetics, said Dr. Murali Rao, MD, DFAPA, FAPM, Chairman of the Department of Psychiatry and Behavioral Neurosciences at Loyola University Chicago Stritch School of Medicine….

 

Related articles

• Study Evaluates Magnetic Therapy For Tinnitus (medicalnewstoday.com)
• Is magnetic therapy effective for tinnitus? (sciencedaily.com)
• Magnetic therapy can ease depression, doctors say (usatoday.com)
• Magnets can cause cancer cells to “self-destruct” (sott.net)

 

NIH launches free database of drugs associated with liver injury

 

From the 12 October 2012 news release

A free source of evidence-based information for health care professionals and for researchers studying liver injury associated with prescription and over-the-counter drugs, herbals, and dietary supplements is now available from the National Institutes of Health. Researchers and health care professionals can use the LiverTox database to identify basic and clinical research questions to be answered and to chart optimal ways to diagnose and control drug-induced liver injury.

Drug-induced liver injury is the leading cause of acute liver failure in the United States, accounting for at least half of cases. It occurs at all ages, in men and women, and in all races and ethnic groups. Drug-induced liver disease is more likely to occur among older adults because they tend to take more medications than younger people. Some drugs directly damage the liver, while others cause damage indirectly or by an allergic reaction. The most important element to managing drug-induced liver injury is to identify the drug that’s causing the problem and appropriate steps to eliminate or reduce damage to the liver.

“Because drug-induced liver disease is not a single, common disease, it is very difficult to diagnose, with each drug causing a somewhat different pattern of liver damage,” said Jay H. Hoofnagle, M.D., the major creator of LiverTox and director of the Liver Disease Research Branch at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Doctors have to rule out all other causes of liver disease before saying that a patient has drug-induced injury liver.”

LiverTox has a searchable database of about 700 medications available in the United States by prescription or over the counter. Over the next few years, another 300 drugs will be added. The database offers these features:

• An overview of drug-induced liver injury, including diagnostic criteria, the role of liver biopsy, descriptions of different clinical patterns and standard definitions.
• A detailed report of each drug, including background, case study, product package insert, chemical makeup and structure, dose recommendations and references with links.
• An interactive section, allowing users to report cases of drug-induced liver injury to the LiverTox website. Reports will be automatically forwarded to the Food and Drug Administration’s (FDA) MedWatch program. MedWatch allows the public and health care professionals to report adverse events, product defects, or product use errors. The FDA uses the information to monitor product safety.

“LiverTox is the result of a significant scientific collaboration between the national and international clinical and research communities, the NIDDK and the National Library of Medicine (NLM),” said Steven Phillips, M.D., co-sponsor of LiverTox and director of NLM’s Division of Specialized Information Services. “LiverTox demonstrates the importance of using informatics to provide easy access to evidenced-based information to clinicians and researchers that will improve the health and well-being of all and help prevent unnecessary morbidity and mortality, worldwide. I hope the dynamic LiverTox model can be used to create a new suite of databases that can identify drug-induced injury to other organs such as the heart, kidney, and lung. The National Library of Medicine is honored to be part of this significant scientific endeavor.”

Related articles

• NIH launches LiverTox a free database of drugs linked to liver injury (hslnews.wordpress.com)
• NIH launches free database of drugs associated with liver injury (medicalxpress.com)
• Drug Induced Liver Dysfunction Lab Values (jessicamhpower.wordpress.com)

 

“What Doctors Don’t Tell You” magazine – reviewed in BMJ and Quackometer

From the blog item by Gary Schwitzer at HealthNewsReview.org

Dr. Margaret McCartney, who helped launch the PrivateHealthScreening.org site we wrote about yesterday, has a piece in the BMJ this week, “What a new consumer health magazine doesn’t tell you.”  (Subscription required for full access.) Excerpts:

“It looks just like any other magazine on the shelves of the newsagent aimed at middle aged women: glossy, 100 pages, with a smiling, confident looking woman on the cover. What Doctors Don’t Tell You, a monthly magazine that launched in September 2012, claims to explain how to “discover treatments that are safer and more effective.” …

In the October issue’s news section the article “Thyme is better for acne than creams” starts, “Thyme is more effective than prescription creams for treating acne . . .The herb outperformed pharmaceuticals in a series of laboratory tests, killing the actual bacteria that cause acne . . . Not only is thyme more effective, but it’s kinder on the skin too, say the researchers. Most pharmaceuticals cause a burning sensation and irritation to the skin, whereas thyme and other herbal preparations have none of these side effects.” The article references the Society for General Microbiology’s spring conference in Dublin this year. This research was reported through a press release; it was an in-vitro model; and the researchers did not compare side effects with current prescription creams.

Another article says, “Army personnel with noise deafness and tinnitus are commonly deficient in B12, but enjoy an improvement in symptoms after taking B12 vitamins.” The study referred to contained 12 patients receiving vitamin B12 and was not a randomised controlled trial.

The editorial on Gardasil, headed “Lock up your daughters,” warned that “your doctor and your daughter’s school nurse are not likely to tell you about the 100-plus American girls who suddenly died after receiving an HPV [human papillomavirus] vaccine.” Although there are valid concerns about the long term efficacy of HPV, to suggest that it has led to death is alarmist and does not reflect or explain the evidence collated by the Food and Drug Administration. Informed choice has to be about fair information, not scaremongering; we should hardly wish for a repeat of the measles, mumps, and rubella (MMR) vaccine debacle.

Although medical journals carry advertisements for drugs, the ones in this magazine are an extraordinary shrine to non-evidenced based medicine. …

It is right to criticise medicine, but the same standards must be applied to all interventions, “alternative” or not. We now realise how important it is to ensure that fair evidence, free of bias, is used in making medical decisions. There is no point in substituting bad medicine for bad science, and it is not clear from this magazine where the hierarchies of evidence stand, and the limitations and uncertainties that arise in research are not consistently explained. The magazine’s liability statement—“the publishers cannot accept any responsibility for any damage or harm caused by any treatment, advice or information contained in this publication”—should perhaps be better printed on the cover, in an unmissable font.”

She’s not the only one giving What Doctors Don’t Tell You a critical eye. The Quackometer blog refers to “Fifty Shades of Quackery.”

I’ll show you a screenshot from that blog that should be titillating enough to send you there to see more.

“It looks just like any other magazine on the shelves of the newsagent aimed at middle aged women: glossy, 100 pages, with a smiling, confident looking woman on the cover. What Doctors Don’t Tell You, a monthly magazine that launched in September 2012, claims to explain how to “discover treatments that are safer and more effective.” …

In the October issue’s news section the article “Thyme is better for acne than creams” starts, “Thyme is more effective than prescription creams for treating acne . . .The herb outperformed pharmaceuticals in a series of laboratory tests, killing the actual bacteria that cause acne . . . Not only is thyme more effective, but it’s kinder on the skin too, say the researchers. Most pharmaceuticals cause a burning sensation and irritation to the skin, whereas thyme and other herbal preparations have none of these side effects.” The article references the Society for General Microbiology’s spring conference in Dublin this year. This research was reported through a press release; it was an in-vitro model; and the researchers did not compare side effects with current prescription creams.

Another article says, “Army personnel with noise deafness and tinnitus are commonly deficient in B12, but enjoy an improvement in symptoms after taking B12 vitamins.” The study referred to contained 12 patients receiving vitamin B12 and was not a randomised controlled trial.

The editorial on Gardasil, headed “Lock up your daughters,” warned that “your doctor and your daughter’s school nurse are not likely to tell you about the 100-plus American girls who suddenly died after receiving an HPV [human papillomavirus] vaccine.” Although there are valid concerns about the long term efficacy of HPV, to suggest that it has led to death is alarmist and does not reflect or explain the evidence collated by the Food and Drug Administration. Informed choice has to be about fair information, not scaremongering; we should hardly wish for a repeat of the measles, mumps, and rubella (MMR) vaccine debacle.

Although medical journals carry advertisements for drugs, the ones in this magazine are an extraordinary shrine to non-evidenced based medicine. …

It is right to criticise medicine, but the same standards must be applied to all interventions, “alternative” or not. We now realise how important it is to ensure that fair evidence, free of bias, is used in making medical decisions. There is no point in substituting bad medicine for bad science, and it is not clear from this magazine where the hierarchies of evidence stand, and the limitations and uncertainties that arise in research are not consistently explained. The magazine’s liability statement—“the publishers cannot accept any responsibility for any damage or harm caused by any treatment, advice or information contained in this publication”—should perhaps be better printed on the cover, in an unmissable font.”

She’s not the only one giving What Doctors Don’t Tell You a critical eye. The Quackometer blog refers to “Fifty Shades of Quackery.”

Related Resource

• Patients want to understand the medical literature (with links to resources for patients)(jflahiff.wordpress.com)

• patientINFORM plain language summary Web sites are provided by participating publishers to help patients or their caregivers more fully understand the implications of research and to provide links to the full text of research articles they’ve selected from participating journals. The publishers allow readers following links from patientINFORM material on the health organizations’ sites to access the full text of these articles without a subscription, and they provide patients and caregivers with free or reduced-fee access to other articles in participating journals.
• “Summaries for Patients” are brief, non-technical summaries of studies and clinical guidelines published inAnnals of Internal Medicine. The Summaries aim to explain these published articles to people who are not health care providers.
• Consumer’s Guide to Taking Charge of Health Information (Harvard Center for Risk Analysis)
• How to Evaluate Health Information on the Internet (US National Cancer Institute)
• Quackwatch (a private corporation operated by Stephen Barrett, MD)

• …And a Rumor Control site of Note (in addition to Quackwatch)

   National Council Against Health Fraud National Council Against Health Fraud is a nonprofit health agency fousing on health misinformation, fruad, and quackery as public health problems. Links to publications, position papers and more.

Related articles

• What Doctor’s Don’t Tell You and the HPV Vaccine (jdc325.wordpress.com)
• New study finds HPV vaccine is safe (fox6now.com)

Move for Food Freedom!

RELATED ARTICLES

• How food safety regulations do not necessarily lead to greater food safety(thebovine.wordpress.com)
• The FDA’s powers are increasing and farmers should be worried(EndtheLie.com)
• The Sickening Nature of Many Food-Safety Regulations (txwclp.org)
• The Food Safety Modernization Act (foodservicewarehouse.com)

One Mover's Blog

“Food Safety Now!”

Who wouldn’t rally behind such a cause?

This has been the battle cry of those in the uppermost echelons of our food regulatory bodies and public health departments for years now. With each widely-publicized food-borne disease outbreak comes more proposed controls on who, where, when, why and how we can put food on our tables. With such names as The Food Safety Modernization Act, it’s hard to argue against the proposals…at least until you peel away the layers.

The vast majority of these bills are simply means to control the food supply; and thereby control the citizenry. Sure there are some well-intentioned, pure-hearted advocates of food safety out there. You’ll always see some grieving mother who’s child fell victim to a tainted chicken finger but the legislation seldom addresses the source of the problem. The majority of the food-related regulations that are proposed (these bills are chock…

View original post 396 more words

Database Is One-Stop Resource on Kids’ Medications

From an FDA Consumer Update

When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.

To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children differently from the way they work in adults.

The Food and Drug Administration (FDA) has been working hard on this project. To make it easier for parents and health care professionals to find information on pediatric medications, the FDA created a database that covers medical products studied in children under recent pediatric legislation.

The Pediatric Labeling Information Database is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ritalin (Photo credit: Wikipedia)

From the summary at Full Text Reports (May 5, 2012)

Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Source:  Institute of Medicine
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.
To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.

The free full text report is at http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx

Related articles

• Ethical and Scientific Issues in Studying the Safety of Approved Drugs (bespacific.com)
• IOM report concludes that the FDA is not doing its job (madinamerica.com)
• IOM report recommends US expand drug safety monitoring after approval (eurekalert.org)
• IOM report recommends US expand drug safety monitoring after approval (medicalxpress.com)
• How Do Docs Prescribe Kids’ Meds? Guess (abcnews.go.com)
• IOM Addresses Drug Safety (lawprofessors.typepad.com)

Dietary Supplement Advisory Items: Cancer Prevention & Food Supplements

As many of you readers know, I continually advise to learn the facts before using dietary supplements.
They are not regulated by the FDA for efficacy(preventing or curing conditiions], just for safety.

Two recent items…

The “Crazy” World of Diet Supplements | FOOD, FACTS and FADS

Excerpt from the blog..

A popular herbal supplement, Aristolochia, commonly sold as birthwort has recently been linked to kidney failure and kidney and bladder cancer.  This herb is commonly prescribed in Taiwan as part of traditional medicine and it was recently observed that nearly 12% of that country’s population suffers from chronic kidney disease.  Now the herb has been conclusively associated with these diseases through gene analysis.

This herb is not marketed in the U.S. since 1994 following FDA warnings. Since cancer may take years to develop, it still may be a causative substance even since it’s ban. In the case of supplements, manufacturers must ensure safety, efficacy, and proper labeling but this regulation does not appear to be enforced. Due to the passage of a supplement…

Beware Of Dietary Supplements For Cancer Prevention

Excerpt from the 26 April Medical News Today article

Government regulators and the scientific community should work to ensure that they give clear guidance to the public about dietary supplements and cancer risk, according to a commentary published in the Journal of the National Cancer Institute.

Evidence from animal, in vitro and observational studies has suggested that taking dietary supplements may lower cancer risk. However, the small number of randomized controlled studies, the gold standard in evidence-based medicine, has not confirmed this – and some studies have actually shown that supplements may increase cancer risk. Still, the supplement industry is booming, with estimated annual sales at $30 billion in the U.S. …

Related Resources

• Evaluating Health Information (links at Health/Medical News and Resources by yours truly)
• Dietary Supplements Label Database (US National Library of Medicine)

 offers information about label ingredients in more than 6,000 selected brands of dietary supplements. It enables users to compare label ingredients in different brands. Information is also provided on the “structure/function” claims made by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Companies may not market as dietary supplements any products that are intended to diagnose, treat, cure or prevent …
 

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• Supplements and cancer prevention: A cautionary tale (eurekalert.org)
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• Over 60 Billion Doses a Year and Not ONE Death, But Still Not Safe? (articles.mercola.com)
• Traditional Chinese Medicines – Some Are Dangerous (jflahiff.wordpress.com)
• The “Crazy” World of Diet Supplements (foodworksblog.wordpress.com)
• Unregulated supplements are a tragedy (jflahiff.wordpress.com)
• Beware of Fraudulent Weight-Loss ‘Dietary Supplements’ (dietarysupplementreporter.wordpress.com)
• Balancing the risks and benefits of dietary supplements (bioidenticalhormoneexperts.com)
• Should Chocolate Be Added to the Colon Cancer Prevention Diet? Recent Study Says Yes (berries.com)
• Herbal remedy blamed for high cancer rate in Taiwan study (library2humanities.wordpress.com)
• Herbal remedy used to treat kidney ailments causes kidney ailments (boingboing.net)
• Dangers in herbal medicine (continued) – DNA sequencing to hunt illegal ingredients (somethingaboutscience.wordpress.com)
• Yet more evidence that “natural” doesn’t necessarily mean “safer” (scienceblogs.com)
• Dangers in herbal medicine – the link between Aristolochia plants and urinary tract cancer (somethingaboutscience.wordpress.com)
• Herbal Medicine and Aristolochic Acid Nephropathy (sciencebasedmedicine.org)
• Herbal Remedy Ingredient Tied to Cancer, Kidney Failure (ihafs.org)
• Evidence Mounts That Diet, Exercise Help Survivors Cut Cancer Risk (wnyc.org)

FDA Warns About Stem Cell Claims

Cell Basics: What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized?. In Stem Cell Information World Wide Web site. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2009. cited Sunday, April 26, 2009

Consumer Updates — FDA Warns About Stem Cell Claims

From the 6 January 2012 US Food and Drug Administration (FDA)

Stem cell therapies offer the potential to treat diseases or conditions for which few treatments exist.

Stem cells, sometimes called the body’s “master cells,” are the precursor cells that develop into blood, brain, bones and all of your organs. Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases.

But the Food and Drug Administration (FDA) is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.

FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

FDA has approved only one stem cell product [Flahiff’s emphasis], Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.

Regulation of Stem Cells

FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.

“Stem cells can come from many different sources and under the right conditions can give rise to many different cell types,” says Stephanie Simek, Ph.D., deputy director of FDA’s Office of Cellular, Tissue and Gene Therapies.

Stem cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.

Umbilical cord blood is collected from a placenta with the birth mother’s consent. Cord blood cells are then isolated, processed, and frozen and stored in a cord blood bank for future use. Cord blood is regulated by FDA and cord blood banks must follow regulatory requirements.

But there are many other stem cell products, including other cord blood-derived products, that have been reviewed by FDA for use in investigational studies, says Simek.  Investigational products undergo a thorough review process as the sponsor prepares to study the safety and effectiveness of the product in adequate and well-controlled human studies (clinical trials).

As part of this review, the sponsor must show how the product will be manufactured so that FDA can make certain that appropriate steps are being taken to help assure the product’s safety, purity and potency. FDA also requires that there be sufficient data generated from animal studies to aid in evaluating any potential risks associated with the use of these products.

Consumers need to be aware that at present–other than cord blood for certain specified indications–there are no approved stem cell products.

Advice for Consumers

• If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body,” says Simek. Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
• If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used in solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.

Thwarting a Stem Cell Scheme In December, 2011, three men were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval. According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce.  She faces up to 3 years in prison and a fine of up to $10,000. The consultant, an assistant professor, used university facilities to manufacture stem cell products. He then sent the products back to the lab, which sold them to a man representing himself as a physician licensed in the U.S. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases. The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases. “Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” says Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations (OCI), Kansas City Field Office. “FDA will continue to aggressively pursue perpetrators who expose the American public to the dangers of unapproved stem cells and ensure that they are punished to the full extent of the law.” FDA’s OCI worked the case with the Federal Bureau of Investigations and the Internal Revenue Service’s Criminal Investigations Division.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Related Resources

• Stem Cells (Medline Plus)  has links to overviews, news items, specific conditions,  research (including clinical trials and research news from reputable organizations), directories and organizations
  
• Stem Cell Information(US National Institutes for Health) includes links to
  • Information (stem cell basics, FAQs, ethics, and more
  • Research topics (information and updates from the scientific community)
  • Federal policy

Related articles

• FDA Warns About Stem Cell Claims – Information You Should Know (regcompliance.wordpress.com)
• Stem Cells: Worldwide Markets for Transplantation, Cord Blood Banking and Drug Development (prnewswire.com)
• American scientist arrested in stem-cell clinic sting (blogs.nature.com)
• FBI crackdown on unproven stem cell therapies (newscientist.com)
• FBI crackdown on unproven stem cell therapies (newscientist.com)
• 3 Arrested for Peddling Miracle Stem Cell Cure (foxnews.com)
• Stem Cell Fraud: A 60 Minutes investigation (cbsnews.com)
• Legislator says stem cells helped ” Times Record News (wingright.org)
• Flexible Adult Stem Cells, Right There In Your Eye (medicalnewstoday.com)
• What Is Autologous Stem Cell Transplantation? (everydayhealth.com)
• Video: Preview: Stem Cell Fraud (cbsnews.com)
• FDA Approves Cord Blood For Stem Cell Transplant (medicalnewstoday.com)
• The FDA, Politics and Journalistic Fraud: The Stem Cell Battle in America (erasetheneed.wordpress.com)
• Texas prepares to fight for stem cells (nature.com)

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Concerned about the safety of your drugs or medical advices? Wish to report a serious medical product problem online?
The US Food and Drug Agency (FDA) can help.

Medwatch is the FDA gateway for clinically important safety information and reporting serious problems with human medical products.

Safety Information includes

• DailyMed (National Library of Medicine)
  Current Drug Prescribing Information
• Medication Guides
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
• Postmarketing Drug and Biologic Safety Evaluations
  Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
• Current Drug Shortages
  
• Recalls and Alerts
  • MedWatch Safety Alerts for Human Medical Products
  • FDA Patient Safety News Video Broadcasts
  • FDA Drug Safety Newsletter

Medwatch also encourages anyone to report serious problems with human medical products

• Report a Serious Medical Product Problem Online
• Reporting Unlawful Sales of Medical Products on the Internet
  

Want to stay informed with MedWatch updates? Here are some options…

Stay Informed

• Subscribe to MedWatch Safety Alerts
• Join the MedWatch E-list
• About the MedWatch E-list
• Follow MedWatch on Twitter
• MedWatch Safety Alerts RSS Feed
• RSS News Feed Help

Related Resource

Track medication safety from your iPhone

Now available for free in the iTunes store!

Stay up to date with the latest news and government safety alerts for the prescription medicines you take. Submit any side effects you experience to the US Food and Drug Administration (FDA) to make drugs safer for everyone.

MedWatcher is a mobile tool for both healthcare professionals and the general public.

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• FDA: Do not use ShoulderFlex Massagers (gloucestercitynews.net)
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A Better FDA? Why Not? « GxP Perspectives

 

Image via Wikipedia

A Better FDA? Why Not?  [From the December 2011 GxP Perspectives Blog]

Is FDA necessary? Most people I know would say yes. We need a strong, independent, effective FDA. Does FDA need improvements? Again, most people I know can point to numerous issues that FDA could handle better. Today, in the Business Section of the New York Times, there is an article on why we need government and the benefits of better government. Yes, the article by Robert H. Frank is about the Tompkins County New York Department of Moter Vehicles, but he outlines some basic principles for better government. Like better use of technology to make government more efficient. FDA is making similar efforts regarding technology. That’s great and I encourage the development. Here are three other areas that I think that FDA can improve:

1. Consistent training for field investigators….

Click here to read the entire blog item

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Don’t Be Fooled By Health Fraud Scams

 

From the FDA site (click here to read entire article)

Red Flags for Fraud:

• CURE ALL! For unrelated diseases
• QUICK FIX! Within days
• ANCIENT REMEDY! Or a secret formula
• REVOLUTIONARY! Or new science
• AMAZING RESULTS! Difficult to verify
• MY TUMOR SHRUNK! Unproven testimonials
• ACT NOW! Limited availability
• LOSE WEIGHT! No diet or exercise
• MONEY-BACK GUARANTEE!

Visit FDA’s Health Fraud Scams Website!

 

 

The science of public health was still in its infancy in the 19th and early 20th centuries when early incarnations of the modern Food and Drug Administration (FDA) tried to protect consumers from “snake oil salesmen” and other shifty characters who swindled the sick and gullible.

Back then the agency was known as the Division, and later the Bureau of Chemistry. Its agents pursued the traveling con men who sold tonics and elixirs—such as “miracle oil” supposedly made from snakes—with promises to cure whatever ails you. Labels did not list ingredients and unsuspecting buyers only found out through bitter experience that they were at best ineffective and at worse deadly.

FDA is still on the case—more than a century later.

The agency has created a new Internet resource to help consumers recognize and protect themselves from the 21st century versions of these bogus health products.

FDA’s Health Fraud Scams website (www.fda.gov/healthfraud) pulls together videos and articles on how to avoid fraudulent schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

The site also provides links to government resources on health fraud involving FDA-regulated products, such as drugs, dietary supplements, tobacco products, alternative medicines, medical devices, and cosmetics.

Gary Coody, R.Ph., national health fraud coordinator at FDA, calls the site “one-stop shopping” for people who want to learn how to recognize and avoid health fraud scams. Anyone can search the site to see if FDA has taken an action against a product or company. However, just because a product is not listed does not mean that it is legally marketed or safe to use……..

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Are Health Apps the Cure for Anything That Ails You?

Currently health apps do not have to pass any standards for scientific validity. In fact, some could be harmful!
This article gives an overview of current regulation and evaluation efforts by the government, medical societies, and others.

Excerpts from the Health Care Blog item  Are Health Apps the Cure for Anything That Ails You?

With about 9,000 consumer health apps currently available in the iTunes store, it seems like almost all smart phone users can download their way to better health these days.

“Apple isn’t testing apps for their scientific validity,” said Dan Cohen, a social worker who has reviewed apps for their effectiveness.

Given the stakes, it’s no surprise that the government is starting to regulate these smart phone applications. Just last month, the Federal Trade Commission brought its first cases against the makers of two health apps. Each claimed to cure acne with colored lights emitted from cell phones.

“Smart phones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” the FTC chairman said, when announcing the crackdown. The agency cited the makers of AcneApp, which had sold about 11,600 downloads of its $1.99 app, and the developers of AcnePwner, which sold 3,300 downloads of its 99 cent app.

The Food and Drug Administration (FDA), meanwhile, proposed regulations this summer for apps that could be considered medical devices. The agency, which sought comments on its proposals until Oct. 19, may focus on apps that are accessories to established medical devices used by doctors, such as smart phone apps that can display X-rays.

It could also regulate apps that transform smart phones into medical devices by using sensors or other attachments. Already, the FDA has approved gadgets that turn smart phones into blood pressure-monitoring cuffs and pocket ultrasound machines.

Apps that connect to consumer devices, such as blood glucose meters, may be regulated, too, if the apps display or analyze the meters’ readings, the FDA says.

The majority of health apps will almost certainly not be considered medical devices and will escape government scrutiny. But some app developers are voluntarily going through the laborious FDA clearance process, in part, to convince the medical community that their products have real clinical value.

WellDoc, a Baltimore-based health care company, got FDA approval last year for its DiabetesManager, which provides automated diabetes coaching for patients. The app also was tested in a randomized clinical trial conducted by the University of Maryland’s medical school, which found that patients had a statistically significant improvement in their blood glucose levels after using the app for a one-year period.

Scientists have found flaws with other apps.

When a George Washington University professor conducted the first content analysis of behavior-modification apps, she discovered that few of the 47 smoking-cessation apps available in 2009 followed evidence-based health guidelines. Lorien Abroms, a public health professor, concluded that the apps had “serious weaknesses” because they did not link to quit lines or clinics or suggest ways for smokers to get social support from family and friends.

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• FDA Proposes Health ‘App’ Guidelines (jflahiff.wordpress.com)
• FTC Charges mHealth Apps With False Advertising – No Scientific Evidence for Curing Acne So There’s Not An App for That (ducknetweb.blogspot.com)
• FTC Approves Final Settlement Orders Against Marketers Who Claimed Their Mobile Apps Could Cure Acne (ftc.gov)
• Should Mobile Medical Apps Require FDA Approval? (informationweek.com)
• FDA Review of Some Medical Apps May Be Increased (socialtimes.com)
• Is It Really FDA Approved? (everydayhealth.com)
• Mobile Medical Apps Supervision By FDA, Agency Seeking Input (medicalnewstoday.com)
• FTC: Smartphone apps do not cure acne (news.consumerreports.org)
• Can the iPad cure what ails us? (macworld.com)
• Apps for What Ails You (technologyreview.in)
• FDA will have a plan for healthcare mobile apps in 2012. In the meantime… (medcitynews.com)

Fish Hazards and Controls: More Than a Fish Story

From the FDA Web page

The Hazards Guide is a roadmap for commercial fishermen and processors to follow to ensure that consumers don’t become ill from parasites, pathogens (bacteria, viruses, fungi), or natural toxins (poisonous substances produced by living organisms) in the seafood they eat.

In April 2011, FDA released the fourth edition of the Hazards Guide and posted on the FDA website an introductory video to the guide for the seafood industry.

The Hazards Guide gives fishermen and seafood processors the latest scientific information on contaminants that can be present in their products and where they need controls to eliminate them.

For example, research conducted by FDA gave the agency new insights on what was needed to control scombrotoxin in the processing of tuna and mahi-mahi. Scombrotoxin is one of the most common causes of fish-related “food poisoning” in the U.S….

Related Resources

• Fresh and Frozen Seafood: Selecting and Serving it Safely
• Fish and Fishery Products Hazards and Controls Guidance
• Cooperative Program Ensures Safe Shellfish (slideshow)
• Cooperative Program Ensures Safe Shellfish (Consumer Update)

Related articles

• “Seafood Processors, Importers Face FDA Scrutiny” and related posts (foodsafetynews.com)
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• NYT: Something fishy about seafood labels (msnbc.msn.com)
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Rising reports of bad reactions to drugs

http://www.fda.gov

Rising reports of bad reactions to drugs

From the March 28 2011 Health Day news item   By Alison McCook

NEW YORK (Reuters Health) – Official reports of negative reactions to prescription drugs have increased dramatically over the last decade, according to a new study.

In a U.S. Food and Drug Administration (FDA) database launched in 1969, researchers found that over half the reports of “adverse events” suspected to be caused by a particular drug or device date from just the past 10 years.

The FDA currently receives about half-a-million such reports of health problems, and even deaths, associated with medical products each year. In 2000, they came in at a rate of nearly five for every 10,000 office visits in which at least one prescription was written. By 2005, that rate had risen to nearly seven per 10,000 visits, according to the new analysis published in the Archives of Internal Medicine.

Between 2000 and 2010, the number of reports coming in grew steadily by more than 11 percent every year. By 2010, they added up to 2.2 million reports — 55 percent of the entire database total.

Study author Dr. Sheila Weiss-Smith of the University of Maryland in Baltimore cautioned that the number of reports does not equal the true number of negative reactions to drugs.

Manufacturers are required to report to the FDA any health problem they suspect stems from one of their products, but for doctors, patients, lawyers, and anyone else who reports these reactions, it’s entirely voluntary, she told Reuters Health.

It’s hard to estimate how many negative reactions to drugs actually occur, Weiss-Smith noted. Some experts suggest official reports represent one-tenth of the number of actual negative reactions, but she said she doesn’t trust that figure. “We just don’t know. We don’t know what percentage of events actually gets reported.”…
…More people are taking drugs, and for longer times, which increases the potential for bad reactions, and negative interactions between drugs, she said….

…Negative reactions can occur from a variety of drugs, and patients need to take steps to protect themselves, Weiss-Smith urged. “Drugs are chemicals. And you’re putting something in your body. You need to know what it is.” [Editor Flahiff’s emphasis]She recommended that everyone tell their doctors what they are taking, and try to go to one pharmacy, “so someone can keep track of all the different things,” preventing negative interactions.

If you keep adding drugs to your daily routine, talk to your doctor about whether you can cut back on others, so that you are only taking the minimum necessary amount, she said. Read all the material that comes with medicines, and tell someone immediately if you start to feel unwell. “If something doesn’t feel right, talk to your doctor, talk to your pharmacist.” [Flahiff’s emphasis]

Are you looking for information about a drug? to use for consultations with your health care provider?
Please use reputable resources that strive to provide unbiased information.
Pharmacists are great sources of information. Practicing pharmacists are college graduates (many with Master’s degrees) that are state licensed. Many give free information at their place of business, they seldom ask if you are one of their customers!!

Also, don’t forget librarians as your personal, professional guides to information in print and online resources.
Contact your local public, academic, or medical library. Many medical and academic libraries, especially those state funded, give at least some assistance to the public. Call ahead. You may be pleasantly surprised!

And, as always, contact me( jmflahiff who virtually resides at yahoo.com)

Some examples of good drug information Web sites

Drugs, Supplements, and Herbal Information (from a MedlinePlus page)

Prescription and over-the-counter medication information contains answers to many general questions including topics as what a drug is used for, precautions, side effects, dietary instructions, and overdoses. From the American Society of Health System Pharmacists

Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.

Drugs and Supplements (sponsored by the Mayo Clinic)

Somewhat lengthy drug and over-the-counter medicationinformation with these sections: description, before using, proper use, precautions and side effects. From Micromedex, a trusted source of healthcare information for health professionals. 

Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.

Drug Information Portal

A good central source of drug information by the US government (the National Institutes of Health). It links you to information on over 12,000 drugs from trusted consumer drug information sources, the US Food and Drug Information, and LactMed (summary of effects on breastfeeding), It also gives any summaries from medical and toxicological articles (however, some whole articles may not be for free on the Internet).

Related Articles

• Online Medical Advice Can Be a Prescription for Fear (jflahiff.wordpress.com)
• Drug Information Product DailyMed Mobile Version Launched (jflahiff.wordpress.com)
• Fewer fill “dispense as written” prescriptions – study (reuters.com)
• What’s In OTC Painkillers? Most Americans Don’t Know
• Study shows pharmacies’ software systems miss potentially dangerous interactions (Eureka alert, May 2011)