The FDA Opens Its Vast Files on Drug Side Effects to the Public

ucm354989The FDA quietly unveiled plans to make adverse event reports more widely available through a project called openFDA. Instead of simply publishing unwieldy quarterly files, openFDA will let software makers tap directly into the data to build user-friendly and easily searchable programs for doctors and consumers.

Thousands of times each day, the U.S. Food and Drug Administration receives reports about unwanted side effects of the prescription and over-the-counter medications it oversees. They stream in from patients and doctors—and from drugmakers, which are required to relay accounts of problems. This data, cataloging reactions as mild as rashes and headaches and as serious as internal bleeding and death, help the agency monitor drug safety.

It’s also almost impossible for anyone outside the agency to use. The FDA publishes quarterly bulk files—the most recent one covers to the end of 2012—but they’re a blizzard of cryptic information that can only be deciphered with expertise and complicated software.

Patients and physicians trying to use the FDA’s database on their own are in the wilderness. Since each file from the FDA covers three months, creating a complete record of problems associated with a particular drug over a period of years means deciphering and piecing together dozens of monster files. Currently, patients or doctors who want to see a report on a specific drug have to file a Freedom of Information Act request with the government.

Once the information is easier to use, software developers will step in to meet the public’s demand for drug information. Mobile apps will let consumers compare over-the-counter drugs while they shop in the pharmacy, and software to immediately alert pharmacists when a company issues a recall. DrugCite currently uses the FDA’s archives to let users search for side effects by medication.

This should also shed some light on vaccine studies. I have already read a lot of web chatter that a definitive link has been uncovered. We should hear more about this in the future if true.

Recalls, Market Withdrawals and Safety Alerts

2010_47-engCurrent Recalls, Market Withdrawals and Safety Alerts – Less than 60 days old.

Recall and Safety Alert Archives – Older than 60 days and by year.

Safety information about human medical products – MedWatch.

Safety information about products affecting animal health – Animal & Veterinary Recalls & Withdrawals.

More complete listing of Biologic Recalls and Market Withdrawal information – Biologics Recalls.

More complete listing of Medical Device Recalls – Medical Device Recalls.

Additional safety information about cosmetic products – Cosmetics Recalls and Alert.

Recalls of raw (fresh and fresh frozen) oysters, clams, mussels, and whole and roe-on scallops.

Retail-based Clinics for Pediatrics

1779254_749379118413517_1304800456_nThe American Academy of Pediatrics is formally recommending that parents do not bring children to retail-based clinics as they are generally not part of the child’s medical home and do not provide the high-quality, regular preventive care they need. Despite the clinics’ potential as a disruptive innovation in medicine, I happen to agree with the AAP.

The AAP recommendation is an ivory tower broadcast of the obvious but one that will fall on deaf ears. Consumers want convenience, and pediatricians in the current model do not have time to meet the consumers’ needs. There is no solution to this oil and water mixture. The ACA and the move to large employed-physician groups will accentuate this divide.

Some enlightened physicians will see that they must, for themselves and their patients, leave the system that delights to hold them down in this un-winable game of “health maintenance.” They will find that direct pay and concierge medicine delivers “better medicine, better business and better outcomes.” Patients will meet them at the crossroads of health and faux-wellness if the physician learns how to truly deliver wellness and is an advocate to their patients.

Mysterious polio-like illness affects kids in California

child-polio-californiaDoctors believe they’ve identified as many as 25 California children suffering from a mysterious, polio-like virus capable of paralyzing limbs. The best-case scenario is complete loss of one limb, the worst is all four limbs, with respiratory insufficiency, as well. The median age of those stricken is 12.

Parents should not panic. This is really very rare and is isolated to California. The CDC is watching closely but has not become involved yet.

The question in my mind is why has a rare virus affected these children and not affected adults – if this really is being caused by a virus.

Here are the facts as reported by the media. The cause of most of these cases is not known. Some clinical and laboratory features, such as the pattern of inflammation seen in the spinal cord on MRI, are consistent with a viral process. Samples from two of the children tested positive for enterovirus 68, a rare virus that has been linked to severe respiratory illness in the past.

The medical histories on these children are not available so I cannot look for pre-existing conditions to explain their vulnerabilities.  I can look to common sense though to shed practical light on this situation and to allay fears all parents must be having.

Assuming these were/are healthy children then they developed this condition as a result of a vulnerability to this bug while most people are not and/or they built up toxins that resulted in a neurological condition.

Here are some reasons that could make once susceptible:

1. They had an innate genetic vulnerability; and/or

2. They had a genetic mutation occur as a result of generational toxin exposure from living in a modern world; and/or

3. They had a genetic mutation occur as a result of the radiation from Fukushima melt down; and/or

4. They were unable to detoxify and eliminate these toxins because of genetics; and/or

5. They were unable to detoxify and eliminate these toxins because of poor diets and/or inadequate supplementation; and/or

6. They had a weakened immune system from environmental toxins such as pesticides, poor diet, poor supplementation, Japanese radiation, dysbiosis from previous antibiotic use, among others.

My point here is we live in a toxic soup and our bodies need help to maintain proper and healthy functioning.

  1. Eat organic to limit toxic exposure,
  2. Diet with plenty of phytonutrients to assist mitochondrial, antioxidant and detoxification functions,
  3. Limit carbs, gluten, dairy and animal fats,
  4. Exercise,
  5. Clean out the gut and restore balance of proper probiotics and microbiome since this is the major detox and immune pathway of the body,
  6. Educate yourself on a functional body,
  7. Hydration,
  8. Sleep for 7-9 hours a night with a regular bedtime,
  9. Health relationships and a strong sense of community, and
  10. Good fish oils to protect cell membranes and reduce inflammation.

Unusual illnesses like the one devastating children in California may be the result of our lifestyles, genetics and understanding of the body. Sometimes infections and disease are unavoidable but stack the odds in your favor. Find a doctor that will help you heal by addressing the missteps in biological and physiological functions at their root causes rather than throwing antibiotics and immune suppressants to cover symptoms from occurring.

It is hard to change your food culture, but if you want to keep your family safe then this must be addressed. The idea of eating and living in unhealthy ways because it feels good or because this is your family culture, only to seek a symptom-control approach once the body starts to break down is crazy thinking. Sadly this is the prevailing approach in this country and around the world. Fight your temptations to slothfulness and gluttony. Chronic disease and vulnerability to illness can be largely prevented. You make this decision by the small daily decisions on how you choose to personalize your life.

“Eco-Friendly” (Mercury) Fluorescent Bulbs – How to Dispose of Safely

570A patient recently called after finding one of those curly, new fluorescent  “environmentally friendly” bulbs that had broken in her house.  She was concerned as she had heard that they are toxic when exposed to air.

Indeed they are!

The EPA has an excellent website for just this situation and what to do in case of breakage of a compact fluorescent light bulb or CFLs.

After reading all of the pertinent information, I feel as though there must be a good joke here somewhere…

How many decon-haz-mat suits do you need to change a light bulb?

Mercury is a known neurotoxin and a potential carcinogen.  Although the mercury contained in the new bulbs is only about 1% of that found in the old-fashioned thermometers, I feel more comfortable in a house full of tiny people with the good old incandescent bulbs.   Yes, they are not nearly as energy-efficient, but they do make your skin much prettier in the evening!

In case you have a breakage, here are the basics:

1. Remove all people and pets from the vicinity for at least 10 minutes.

2. Turn off your central air conditioning and open windows for several hours.

3. Without touching, carefully place broken parts in an airtight jar/plastic bag.

4. Use duct tape to get up those really tiny bits.

5. Wipe down area with wet paper towels & then place all refuse in the jar/bag.

6. Place the jar/bag outside & then later to the recycling center. (The recycling center – like you need something else to do but this is a hazardous material and must be disposed of properly.)

7.  Avoid vacuuming as this aerosolizes the toxic particles, but if you must then throw out the bag filters with your bulb and clean machine up the wazoo.

8.  Wash your hands.

9.  Go shopping for nicer bulbs.

In the end, light bulb jokes are not all that funny.