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FDA Reexamining Opioids For Chronic Pain

/ Thomas Cohn, MD

FDA effectivenessThe Food and Drug Administration has announced that it will require drug companies to conduct studies to determine if prescription opioids are effective in treating chronic pain.

A number of studies have already suggested that pain controlling opioids are ineffective beyond 12 weeks, and many industry professionals say that continued opioid use after this period can increase a person’s likelihood of developing a dependence or addiction. The FDA wants to supervise the new studies to determine if certain changes, like the following, need to be made:

  • Changing the labeling on certain opioids
  • Imposing special rules for prescribing, dispensing and taking certain opioids
  • Prohibiting use of certain opioids in some cases

“We are going to impose a mandate on existing products . . . to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction,” said FDA Commissioner Scott Gottlieb.

Some Don’t Agree

While it may seem like a good move that the FDA is appearing to take a step in the right direction of opioid abuse, others say the new measures are nothing more than a stall tactic for big pharma. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said the FDA ordered a similar measure in 2013 and that they already have all the research they need to make changes that could help protect the public.

“Here we go again,” Kolodny said in an interview. “That’s exactly what the FDA said to us in 2013. . . . Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.’ ”

However, Gottlieb argued that the research would be aimed at immediate, extended-released and long-acting opioid tablets that are given for pain care outside the healthcare facility. The studies would also cover current medications on the market to examine if new applications of the pain reliever could be more effective. The FDA will also be conducting a second study that is out to determine if opioids can actually cause users to become more sensitive to pain.

A similar study was carried out back in 2013, but Gottlieb said those studies were difficult to carry out because the FDA could only ensure post-marketing studies on safety, not effectiveness. They now have the authority to demand effectiveness research as part of an act passed back in October.

The opioid crisis killed 47,600 people in 2017, but there’s hope that the new research can lead to effective changes. There’s still plenty of work to be done, but with more control over effectiveness research, there’s hope on the horizon.

How Regular Exercise Keeps Your Body Young

/ Thomas Cohn, MD

old fitnessNew research published in the Journal of Applied Physiology revealed that regular exercise can have your muscles acting as if you are decades younger than your actual age.

According to researchers, older men and women who exercised regularly for decades had muscles that were indistinguishable in many ways from the muscles of healthy 25-year-olds. These older men and women also had much higher aerobic capacities than most individuals their age, making them biologically about 30 years younger than their chronological age, the study’s authors conclude.

Previous studies have found that older athletes have healthier muscles, brains and immune systems than individuals of the same age who are sedentary. However, those studies have concentrated on competitive athletes, not recreational exercisers. This study suggests that you don’t need to be a professional athlete to see many of the same benefits of regular exercise.

Exercise Study

For the study, researchers looked at the health of individuals who took up regular exercise during the fitness boom of the 1970’s. They were most interested in individuals who maintained that hobby through the next 40-50 years, with activities like running, cycling, jogging or swimming, even if they never competed in these activities.

28 men and women fit the bill, and they were compared to a second group of age-matched older individuals who had not exercised during adulthood, as well as compared to a third group of active young people in their 20s.

Each group was tested in a lab setting to measure their aerobic capacities, and tissue samples were also taken to look for the number of capillaries and levels of enzymes in muscles. The higher the numbers, the better the muscle health.

After looking at the findings, researchers were surprised to find that the muscles of the older exercisers resembled the muscles of the young group, and their aerobic capacities were about 40 percent higher than inactive individuals their age. They also concluded that the active older group had cardiovascular health similar to that of people about 30 years younger.

These findings are amazing, and they help us understand why regular exercise is so important. Exercise can literally roll back the clock and slow down the aging process, which can help prevent problems like pain or degeneration-related issues. So take care of your health while you’re young, and continue exercising as you get older. If you do this regularly, you can prove that age really is nothing more than a number, and we are in control of our health!

Drug Screening In Chronic Pain Clinics

/ Thomas Cohn, MD

drug testing Most pain practices have the occasional patient who they suspect are on controlled substances. Since drug abuse has always been a major problem in society, and because clinics prescribe medications, most practices also screen patients for appropriate drug use and abuse.

At the clinical level, drug screening is done in a number of ways, including testing blood, urine, or saliva samples for the presence of drugs. Some tests only show that a narcotic is present in the body, while others can tell how much of a drug is present. Depending on the circumstance, a provider may choose anyone of the different types of tests. Now a breathalyzer-type test is being developed to test for drugs of abuse.

Breath Tests For Drugs

A breath analyzer test has been done for decades for alcohol and now is being developed for marijuana, cocaine, fentanyl, PCP, and methamphetamine. These use a chemistry technique known as mass spectrometry so the test can identify the presence of certain chemicals and also help determine the level in the breath and possibly in the blood. Unfortunately for many of the compounds tested, there is not a standard for which these chemicals may cause impairment.

With marijuana, for example, we have no idea what level in the body correlates to any level of impairment compared to alcohol. The nice thing about this technique is that it is quick with the analysis being done in about 15 seconds. Currently the technology is very new and thus costly, but in the future it should be about $10,000 for a unit and be very portable.

For places looking to detect a very limited number of drugs of abuse, the breath analyzer will be good. For the pain practitioner, drug testing is more comprehensive. Usually a semi-quantitative screen of either urine or blood is used for drug screening. Most pain physicians want to know if the drugs a patient is supposed to be taking are in their systems and whether there are drugs that are present like street drugs that should not be in their system.

Most doctors also want to know if there are drugs not declared by the patient that may also be dangerous if taken with drugs they have prescribed. For the honest patient, drug screening should not be a worry. For those patients that are using street drugs or misusing their drugs, random testing often finds the problem. The patients who are misusing drugs often make mistakes and doctors discover them sooner or later.

In the midst of the opioid crisis and the high rate of misuse of prescription medicines, safe prescribing of any treatment for a pain patient always becomes a concern. There are many treatments for pain with medications being only a limited modality in the overall scheme of options. The use of addictive medications such as opioids is even less attractive since it often worsens pain and becomes ineffective over very short period of time for many people. Drug testing is one of the tools toward safe prescribing that needs to be implemented in pain clinics throughout the country.

Genetic Testing And Its Role In The Chronic Pain World

/ Thomas Cohn, MD

genetic testingGenetic testing is one of the hot new topics in society and medicine. There are multiple companies providing a variety of types of genetic testing and for a wide assortment of circumstances. The most common we here about is for determining our heritage and background.

These are meant to tell us roughly what our genes tell us about where our ancestors are from  Most of these genetic tests take a very small look at selective areas of our chromosomes and do not perform a comprehensive analysis. The tests usually look at select genes that control a limited number of proteins in the body, not even a full one percent of the genetic information on our chromosomes.

These genetic tests that are marketed to consumers have limited value beyond curiosity for the average person. The accuracy is probably as good as a well researched family tree at best. Last year, a couple of these tests were done on a set of identical triplets. These three women have exactly the same genes, but the profiles produced from the genetic tests were not close to being identical. The take home message is that these tests are not at the level that they should be trusted beyond just stoking curiosity in one’s heritage. Any information above that level is mostly speculative.

The common genetic testing companies include 23 and Me as well as Ancestry.com. Besides providing basic information about likely ancestral history, they now are reporting the risk one might have toward some diseases. These include risk of Alzheimer’s and some types of cancer. However, most of these tests have recently been shown to have a false positive rate of 40 percent or higher. This is a result of these tests looking at only a small portion of genes in the total amount of chromosomes, and this approach is not very accurate. Further, these companies that are doing this commercial work often are not following procedures that have adequate quality controls. Thus a significant amount of false information is now being rendered to the average consumer, prompting often further expensive medical testing for the truth.

For the paranoid, these genetic testing results are often in public databases. Your genetic code is now available to the world and without your permission others could access this personal information. In the future this may be the next reason for a denial for insurance since you may have a gene linked to a “possible” medical disease. The government is certainly using the information in cold case databases. The “Golden Gate” murderer in California was traced down through this method. The next venue will likely be paternity cases for adoptions and artificial insemination or similar circumstances.

Medical Value of Genetic Testing

In the medical world, genetic testing does have some value, but in specific areas. The most significant so far are two general areas, identifying diseases that are genetically linked, and to help with finding the right medication for a person. In pain medicine, the ability to process certain medications to be effective in the body sometimes requires certain enzymes. For instance, the ability for hydrocodone (Norco, Vicoden, or Lortab) to be effective requires an enzyme to convert it to an active drug. Without that particular enzyme, hydrocodone is ineffective. Interestingly, all my children happen to be missing the enzyme and when they have had surgery they have had to explain this to all their treating physicians. Another common problem is that certain enzymes are needed to make some antidepressant drugs helpful. If the medication is not working, the patient may not be able to effectively use that particular class of drugs. Most of the time it is more effective just to switch to a different medication than to try to do testing, however if a simple switch does not work, then enzyme or genetic testing may be indicated.

Certain medical diseases definitely are genetically linked. Random genetic testing in someone who does not have medical issues is likely to be costly and currently not especially useful. However, if the person has significant medical issues, clearly identifying a known genetic disease can be helpful in order to know what future issues may be likely. Many of my pain patients happen to have hypermobility of the joints that is linked to abnormal connective tissue. There is a wide range of severity, but it can lead to significant problems from spine curvature, to eye problems and cardiac or vascular aneurysms. It is also often a dominant trait and can pass on to 50 percent of a person’s offspring. Knowing the disease can help in the long-term care and prevention of dangerous complications.

For the curious about ancestry, genetic testing can be fun, but the information may or may not be overly accurate. Know that the information may become part of a public database and the future problems of others knowing this information about you may have a negative impact on your life. If you have certain medical conditions, genetic testing now may become helpful in managing your disease. If you are having problems with a medical condition, sometimes looking deep into a person’s genetic code may reveal helpful guidance, but this should be done with the help of an appropriate medical professional.

Is Cryotherapy Worth The Trouble?

/ Thomas Cohn, MD

cryotFor the stars, major sports athletes and the exercise enthusiasts, one of the newer trends is cryotherapy. In short, it involves immersing oneself in extreme cold after an intense workout. The intense variety is a liquid nitrogen vapor chamber with the head outside and the body exposed to minus 292 degrees Fahrenheit for at the most three minutes. It is supposed to prevent inflammation and promote faster recovery from intense physical activity. The main focus of treatment is for athletes, but there have been claims that it helps a number of conditions like Multiple Sclerosis, Rheumatoid Arthritis, migraines, fibromyalgia, Alzheimer’s, chronic pain and anxiety.

Cooling, ice and cryotherapy work on the premise of decreasing inflammation throughout the body. Cryotherapy is an inexpensive treatment, probably costing about $15 per session, but that can add up quickly if you do it after every workout. During a workout, the body produces increased waste products of metabolism. In general, these do not necessarily cause pain and inflammation. In fact, after a workout, one may want to flush the waste products out of the body versus rapidly cooling down the body and decreasing the body’s elimination of any of these waste products. Furthermore there is absolutely no scientific evidence to prove that cryotherapy works or helps athletes or any of the above illnesses.

Simpler is Often Better

Local inflammation can be helped with icing in the initial phase during the first 24 to 48 hours. An ice pack is an inexpensive and simple way to decrease blood flow to an area and diminish inflammation. After the first 48 hours, heat is helpful to increase blood flow and get rid of any inflammatory products left over. Throughout that time, adequate hydration of the body is needed so the natural processes can eliminate waste products versus accumulating locally and causing pain.

Fads for health often are merely just hype. Many are costly, and most have little to no scientific basis to be helpful. Whole body cooling for instance, if not done extremely carefully, can easily stress the heart and cause frostbite burns. Further, it may cause vessel constriction and prevent the body from eliminating waste products produced with exercise. Most fads are often an exaggeration of practical strategies for a problem. Changing hydration with drinking a sport’s drink to getting intravenous hydration with vitamins after athletic events, or slowing down and breathing deeply after a race compared to wearing an oxygen mask and breathing pure oxygen gas are both examples of this. There really is no science behind any of these trends and mostly are targeted at high profile individuals who are then emulated by others.

As far as cryotherapy goes, it surfaced a couple of years ago and the science is still not present. In 2016, the Food and Drug Administration actually posted a statement saying there is no evidence of any of the claims of helping athletes or curing diseases. Maybe the best advice the old KISS principle, keep it simple stupid, and try the ice pack when needed.