Posts Tagged ‘FDA’

Progress on the painkiller front

Sunday, January 27th, 2013

In the January 25, 2013 online edition of The New York Times I found a highly significant article titled “F.D.A. Likely to Add Limits on Painkillers.” An advisory panel to the Food and Drug administration wants to strengthen the current rules about such drugs as Vicodin, a frequently prescribed powerful pain pill.

Money sometimes blocks the adoption of sensible rules

Similar recommendations failed to make it through Congress last year; they were lobbied against by business interests with considerable heft behind them.

Now Vicodin and other drugs made from hydrocodone aren’t the worst problem, but, as you’ll see, they are a way to call attention to medications that for the past four years have caused more deaths in the United States than traffic accidents, or those from illegal drugs including heroin and cocaine.

I went back to an article in the Journal of the American Medical Association, AKA JAMA. It was published on Dec 14, 2011 in the section called “Vital Signs,” and was a CDC look at overdoses of prescription opioid pain relievers (OPRs) in the US, especially during the 1999-2008 time frame. The news was stark; in 2007 nearly 100 people died from these drugs every day, with death rates that have tripled since 1991.

Between 1999 and 2010 the sales of OPRs quadrupled with enough prescribed to give every single one of us US adults a standard dose of these medications every 4 hours for a month. The health-care cost of abuse of these drugs is staggering, estimated at $72.5 billion a year.

Of the total number of US 2008 deaths from drug overdoses (36,450), OPRs were involved in 14,800 and the years of potential life lost before age 65 was comparable to the figure from motor vehicle accidents. I was startled, but in retrospect not entirely surprised that a study showed 3% of American physicians accounting for 62% of the OPRs prescribed.

Some of those doctors are anesthesiologists, oncologists or other physicians fully trained in pain control and working in highly specialized hospital-associated units. Their use of these medications is appropriately aimed at patients with cancer, those with severe acute injuries and perhaps some others whom almost all of us would agree should have whatever it takes to minimize agonizing pain.

But some who prescribe for dough can end up in jail

Others in the group of “mega-prescribers,” however, may not be pain specialists; they could be working for “pill mills.” That has happened in a number of states with some of those doctors being accused at this stage and several others being convicted and facing jail sentences.

But the new rules, which have to be approved by the FDA and then by the Department of Health and Human Services before they actually take effect, make enormous sense to me: refills forbidden without a new prescription; no fax or phone prescriptions, only written ones; and drug distributors being forced to store OPRs in special vaults.

The Times article today notes the panel was not monolithic in their voting (19 to 10) with some highly skeptical that the suggested changes would do much to alter the current surge of inappropriate or illicit drug use in America. One commented that oxycodone-containing products already are in a more restrictive category.

One of the subject matter experts quoted was Dr. Nathaniel Katz, an anesthesia assistant professor at Tufts University medical school. Katz served as Chair of the FDA’s Advisory Committee, Anesthesia, Critical Care, and Addiction Products Division, from 2000 to 2004 and thinks the recommended rule was largely symbolic, giving a message both to doctors and patients. He commented that the OPRs the panel was voting on are a relatively minor player. Katz now devotes much of his time to a clinical research company that’s attemting to develop new treatments for pain.

Vicodin and like drugs containing hydrocodone are the most widely prescribed OPRs, but are responsible for a minority of deaths with medications containing oxycodone or methadone, although less commonly given to patients, accounting for two-thirds of the drug overdose deaths.

So the question now is whether the proposed new rules make it over the remaining hurdles.

I hope they do.

 

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Posted in Congress, FDA, hydocodone, opioid pain relievers (OPRs), oxycodone, pharmaceutical industry | No Comments »

Pain Part two: Physiology & pharmacology

Sunday, December 23rd, 2012

some drugs are legal and some aren’t

In my last post I went through the history of medications used to treat pain and  how one of those, originally a trademarked drug, became the terribly addictive, unfortunately popular, street drug, Heroin. Before I discuss controversies in the use of legal pain medicine we need to review some basic pharmacology and physiology.

The term opiate refers to chemicals extracted naturally from the opium plant with the most familiar being morphine and codeine. Opioids, on the other hand, are semi-synthetic derivatives of opium such as oxycodone and hydrocodone. These are controlled drugs, supposedly available only by a doctor’s prescription.

In 2004 the FDA issued a statement on an extended release form of oxycodone called OxyContin approving its usage, but cautioning its potential for abuse. In 2009 an FDA panel voted (in a fairly close vote) that two combination pain pills be taken off the market. They were only the tip of the iceberg; there’s a host of such mixes of an opioid with standard non-narcotic pain medicine such as acetaminophen (Tylenol) or acetylsalicylic acid (AKA aspirin) or even ibuprofen (Motrin). Oxycodone + acetaminophen is called Percocet and hydocodone  + acetaminophen is marketed as Vicodin. A 2012 363-page summary (sic) report  from HHS’s FDA Center for Drug Evaluation and Research makes it clear that many of the earlier recommendations have still not been implemented.

The International Association for the Study of Pain has a shorter summary of the physiology of pain. I suppose it’s intuitively true, but it certainly wasn’t my first thought that pain is a protective mechanism. When I burned my hand on a hot stove as a child, I learned to avoid repeating the process (although I confess that hasn’t been 100% successful). These days if I turn on a burner on my gas range, I also turn on its built-in light as a warning signal.

There’s a  part of our nervous system that warns us of pain (Med-speak for this is nociception from the Latin word nocere, to hurt). It’s a separate section from the part that tells our brain of a pleasant smell, or a nice taste or other sensations that won’t harm us. Some of our nerves end in nociceptors, unspecialized fibers that convert a number of unpleasant, potentially harmful stimuli into signals to our brain that shout (not literally), “Careful there; that’s dangerous!”  Nerve cell receptors, in simplest terms, are spots for chemicals to latch on to give signals.

In the 1960s and 70s, receptors for opiods were found in parts of the human nervous system. Some endogenous (produced in our bodies) chemicals can also bind there: two kinds of those are dopamine and endorphins.

Endorphins come in 20 or so types, are most commonly released in response to stress or pain and act to reduce our pain perception much as morphine does. In general they are not felt to lead to addiction or dependence (my only quibble with this statement is the “runner’s high” as I vividly remember my Nephrology Fellow who ran 10 miles at a time, twice a day; when he got married his wife persuaded him to cut down to ten miles once a day). Eating chocolate, hot chili peppers and having sex can can cause endorphin release and acupuncture, message therapy and meditation are felt to also stimulate the levels of these beneficial chemicals.

pain comes in many different shapes

When our cells are damaged, as in a bad sunburn, our peripheral nociceptors are activated by a variety of chemical substances that the injury produces or releases. At the same time other chemicals are released that dilate blood vessels in the affected area leading to swelling, redness, and a localized warmth. The resultant increase in local blood flow and inflammation itself promote healing and help protect the injured area against infection.

I think that’s enough background; next I’ll write of problems with pain pills.

 

 

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Posted in endorphins, noiciceptors, oxycodone, physiology of pain treatment | No Comments »

Arsenic: it’s in juices too, along with lead

Tuesday, February 28th, 2012

Any arsenic or lead here?

In September of 2011 Dr. Oz, the Columbia University cardiothoracic surgeon turned TV personality, reported on a problem with apple juice. His show is often on one of the six screens in front of our health club’s exercise bikes. I didn’t know much about him and routinely read a book on the recumbent bike I ride for an hour, so I paid little attention…then.

His comments applied only to apple juice. He had commissioned an independent lab to check the arsenic level in five brands of  juice. They  found 10 of the 36 samples had arsenic levels higher than the EPA’s drinking water standard of 10 parts per billion (ppb).

The FDA called his publicizing the results of his study “irresponsible and misleading,” saying drinking all brands of apple juice is safe. What he hadn’t asked the lab to do was to determine if that toxin was in its inorganic form, felt to be dangerous, or in the less dangerous organic form. The FDA said they retested the same batches of juice and found the levels of the more toxic form to be well within safe limits, “almost zero.”

Their standard for combined organic and inorganic arsenic is 23 ppb; foods or beverages measuring above that level get retested to determine how much inorganic arsenic is present.

Let’s think about that cutoff level; drinking water, to be “safe” used to have less than 50 ppb, more recently 10 ppb has been set as the upper limit. As I’ve mentioned before, the state of New Jersey now has a standard of 5 ppb.

But in at the end of November, 2011, the website, MedPage Today briefly noted the results of a confirmatory study. Consumer Reports decided to measure both arsenic and lead in apple juice and grape juice. Nine of the 88 samples they had checked exceeded the “safe” limit.

This is supposed to be safe

Then in January, 2012, Consumer Reports.org published their full report online. That article mentioned that 25% of their samples had lead levels over the FDA’s bottled-water limit of 5 ppb. And of the 10% of the samples with elevated arsenic amounts, most was the highly toxic inorganic variety.

That report is well worth reading. The Consumers Union group, an advocacy offshoot of Consumer Reports urged that new limits be set for these toxins in juice: 5 ppb for lead and 3 ppb for arsenic. Groundwater contamination with those toxins was implicated in the elevated amounts found in fruit juices. Human activities release three times as much arsenic into our environment as do natural sources

Then in early February two senior members of Congress, one from New Jersey and one from Connecticut, introduced the “Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012,” AKA the “APPLE Juice Act of 2012.” If it passes, the FDA would be required to establish standards for arsenic and lead in fruit juices in two years time.

The other issue, of course, is how much juice kids actually drink. The American Academy of Pediatrics recommends no juice until age 6 months, and no more than 6 ounces a day until age six. The reality is over a third of a sample of 555 children, 25% of those age two and under and 45% of kids aged from 3 to 5, exceeded those limits.

We’ve got a long ways to go, but at least we’re hearing about these threats to the health of our kids and grandkids.

 

 

 

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Posted in arsenic, Consumer Reports, EPA, FDA, food contaminants, fruit juices, groundwater contamination, lead, medically-oriented background info | No Comments »

What sweetener do you use: Part 6; the fake sugars

Wednesday, February 1st, 2012

Nearly a month ago I started to write a post on the “Fake sugars,” I had read an article on them in the Personal Journal section of The Wall Street Journal, but got distracted when I realized I needed to think about (and write about) table sugar and high fructose corn syrup.

they're all sweeter than sugar

So now I’m finally going to start on the artificial sweeteners. There are four major ones that WSJ reviewed (they even had a panel of tasters): Sweet’N Low, Equal, Splenda and Truvia. They came on the market, respectively, in the 1970s, 1980s, 2000 and 2008. All have zero calories per packet, whereas table sugar has 15 or 16, depending on who you read, per teaspoon. They cost much more than sugar and are considerably sweeter. A Mayo Clinic article online reviews the general subject and terms these chemicals as intense sweeteners.

The National Cancer Institute mentions that they are regulated by the FDA and, in an August 2009 online paper, states there is “no clear evidence that the artificial sweeteners available commercially in the United States are associated with cancer risk in humans.”

The most recent addition to this mix, called Truvia when it’s made by Coca-Cola and Cargill, or PureVia when it’s parents are PepsiCo and Merisant, comes from a plant called Stevia, found in South America. Stevia has a curious history in the United States; it was added to teas by Hain Celestial until the FDA got an anonymous letter questioning its safety in late 2007. At  that point the FDA banned its use in foods, but in 2009, faced with major industry interest, Stevia by-products were approved as food additives (but not Stevia itself).

Stevia, saccharin and the real sugar

Now Truvia and PureVia are being used in a wide range of processed food and beverages. A cousin to the chemical they contain has been extensively used in Japan for over twenty years without major side effects being noted and Stevia, the parent plant, has not only been used for centuries in South America, but also touted for its supposed health benefits.

So why do I have some lingering doubts, in fact some major concerns about all of these chemical food additives, not excluding Truvia and PureVia?

As best I can tell the vast majority of the research on them has been sponsored by the same companies that profit from them. I fail to see independent, carefully performed, double-blind controlled studies especially on the “new two.” Some research has been done on their chemical components, including one four-month study on type 2 diabetics that did not show either high blood pressure or high blood sugar as a result of consuming the active agent in Truvia.

But it’s not just diabetics who are being exposed to the chemicals in these sweeteners. Most of us are, if we consume a diet drink or anything labeled “light.” And medical history informs us that untoward effects may show up in relatively small number (or perhaps even large numbers), years later.

So I’m going to avoid “fake sugars” whenever I can. And perhaps, just perhaps, someday I’ll find out I was being smart in doing so.

 

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Posted in additives, blood sugar, chemistry, Fake sugars, Food Additives, Food and Drug Administration (FDA), Food Choices, Food safety, medically-oriented background info | No Comments »