As we explained in a blog post earlier this month, the Food and Drug Administration is going to begin conducting more studies on opioids and forcing drug manufacturers to examine if their products are effective at managing specific chronic pain conditions. While these changes are aimed at helping combat the opioid epidemic, some patients believe the costs for these studies will be passed onto them.
There’s also concerns about cost and access to medications at the local level. Here in Minnesota there has been a bipartisan push to raise registration fees on drug companies to fund treatments and implement more fail-safe addiction policies. A vote on these measures is expected int he coming weeks, but some patients believe these changes forced at the business level will be felt hardest at the consumer level.
Who Funds These Changes?
Cara Schulz, who advocates for patient rights, believes the higher costs and restricted access to medications will affect those who need the drugs the most. Schulz currently takes pain medications to manage discomfort following her stage 4 colon cancer diagnosis.
“I want us to work on ways we can manage addiction, I want people to not be addicted, period. But we can’t say we are going to fix addiction by hurting people who are not addicts and who are just patients trying to be treated by their doctors,” said Schulz, who is in remission.
Instead, Schulz believes the real focus should be on fentanyl and other illicit synthetic substances, not prescription medications. At a minimum, Schulz hopes that patients who meet a certain threshold can earn an exemption so their access to drugs they truly need doesn’t become restricted.
“The method that they’re taking to address this problem puts pain patients and cancer patients squarely in the cross hairs,” she said.
This is something to keep an eye on as we move forward with ways to combat the opioid crisis. With more regulations being forced on big businesses, we have to ensure these costs aren’t just passed down the line to patients. Medication costs are expensive enough in the US, and we won’t be putting the patient first if their medications cost an arm and a leg.
Everyone has advice on living better and longer. Sometimes the advice is complex, sometimes someone is just trying to sell you something, and in a recent StarTribune issue, there was some simple practical advice. The information is from a study of 100,000 people published originally by the American Heart Association. It lists five habits to adopt to live better and longer. It is the straightforward approach to life.
The Five Habits
The first habit for good health is to avoid smoking. The best habit is to never smoke. The dangers of smoking have been known since the early 1960’s. Everything from vascular disease, to lung problems and cancer result from smoking. Quitting smoking does help, never starting is even better as far as the risk is concerned.
The next habit is maintaining a healthy weight. The easiest tool is based on having a body mass index (BMI) that is between 18.5 to 24.9. The formula for is: BMI=703x[(weight in lbs)/(height in inches)(height in inches)]. The number can be looked up in charts. Unfortunately this is a rough guide, and if you are muscular, or have a larger build with “big bone” structure, you may fall into the category of obese. For instance my BMI is 24.3, it is borderline since I have relatively more muscle than fat but I am pretty healthy from a cardiovascular standpoint due to an active lifestyle.
The third habit to increase life is to exercise moderately for 30 minutes a day. This is to walk, swim or work out in any sort of way every day if at all possible. The 30 minutes does not have to be all at once. If you take three ten-minute walks a day, that adds up to the correct amount of time. In addition to the above aerobic conditioning, most health advocates recommend a general strengthening program three times a week to maintain muscle tone. A daily stretching program to reduce muscle tightness and pain is also helpful.
The fourth habit is to drink only a moderate amount of alcoholic beverages. That is on average only 1 to 2 drinks a day. Drinking wine is often better than mixed drinks or beer due to some of the compounds from grapes that have positive health benefits. All alcohol contains carbohydrate-type calories and this needs to be remembered as part of your overall food intake. Excessive intake of alcohol, binge drinking and then averaging out the intake over time does not count. Binge drinking is dangerous.
The last healthy habit is to try to maintain a healthy diet. A healthy diet includes higher intakes of vegetables, fruits, nuts, whole grains, fibers, and stick to fats that are polyunsaturated or long-chain fatty acids. The best meats are fish and poultry as well as white meat (low fat pork). Obtaining protein from vegetable sources like beans and legumes once a week is also highly recommended. Try to reduce the intake of red meat, sugar and fructose sweetened beverages, trans fats, and high sodium salty food. Part of eating healthy is also controlling portion size and avoiding excessive snacking.
Better living is a goal in life. To reach the destination, one must take steps to change if you are not where you want to be. Setting realistic goals and changing one aspect of your life at a time is the best. Furthermore, be accountable to yourself and one another, as that will help you reach your goal. If you need help, work with appropriate experts to reach your goals. Help may be from dieticians, physicians, physical therapists, trainers to even psychologists. Change is difficult, and better health is a life long goal.
Genetic 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.
53793176 – render illustration of blood thinner title on pill bottle, isolated on white.
A number of patients, for a variety of reasons, are on medications that are considered blood thinners. Many patients have heart conditions that require them to be on a medication to reduce the risk of blood clots. Stopping these medications can cause multiple problems from clotting of blood vessels to pulmonary embolisms and strokes. Being on blood thinners can cause bleeding problems with or without medical procedures. The big question is whether a specific interventional procedure has more risk for a bleeding complication or whether it is safer to stop the blood thinner for the time being.
Up until recently, the decision to halt blood thinners was based strictly on the risk of bleeds in the surgical acute care settings. Many times injection procedures are done without imaging guidance and have definite risks based on the location of needle placement. Procedures for pain management are usually done with fluoroscope guidance and often are done to structures that have low risks for complications from bleeding. Until recently, risks were determined based on the rate of complications seen in the surgical procedures, and then the risks were estimated for the interventional procedures.
New Information
Recently, several researchers have actually studied the risk of many interventional procedures on blood thinners and also studied the risk of complications from stopping blood thinners. For most experienced interventional pain doctors, they can site cases from their own experience of complications from stopping blood thinners and bleeding problems. Stopping blood thinners does cause problems with strokes and with blood clots forming in harmful places. Fortunately after over 50,000 injections, only a couple of times has a problem occurred in my practice.
The latest research has been done in Pennsylvania. One hospital system in a part of the state has enrolled virtually every person in the area, thus allowing one to study the characteristics of various problems. The first thing the researchers did was find all the people on blood thinners. Then they looked at the incidence of complications from stopping blood thinners for any medical procedure, and the number is about 0.75 people per 1,000 for a problem like stroke or blood clot of some type.
Then they looked at the risk for bleeding with typical injections that are thought to be low risk for bleeding, like joint injections, transforaminal epidural injections and medial branch blocks. The findings were that only minor bleeds occurred and the overall risk of bleeding was 1/4,000 people. That means it usually is more dangerous to stop blood thinners for most interventional procedures for the patient than it is to continue them. For a patient on blood thinners, it means they should be concerned whether the procedure they are undergoing needs to have their medication stopped.
In my practice, if I know a patient is on blood thinners and the procedure is low risk, I will not stop blood thinners. Not many physicians are comfortable with this as of yet since the research is not widely distributed. If as a patient, you are concerned about stopping a blood thinner, it is wise to ask whether it is necessary to stop the blood thinner and whether the procedure can be done in such a way that bleeding is not a significant risk. Sometimes a different approach to an injection will decrease the risk of bleeding. Lastly, a physician who is very experienced with injections will usually be able to place a needle for injection with less trauma due to their ability to overcome obstacles of the anatomy in the area. Experience does count and being specially trained in the area of interventional pain medicine helps with being up-to-date with the changing standards of care for challenging patients.
The number of opioid prescriptions in the United States has fallen dramatically, and prescriptions now sit at their lowest levels since 2003 according to new data from the Food and Drug Administration.
The data shows that 74 million metric tons of opioid analgesics were dispensed in the first six months of 2018, down more than 16 percent from the first six months in 2017. Although opioid prescriptions have been declining for the past couple years, the bigger decrease in 2018 is likely linked to lawmakers, doctors and patients working against the problem of opioid dependence.
“These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs,” said FDA commissioner Scott Gottlieb, MD.
Not All Good News
If we just look at the headline, it’s easy to infer that this is good news. Fewer patients relying on passive and potentially dangerous treatment options should be a good thing, but there are some drawbacks. For starters, the opioid crackdown is undoubtedly hurting a section of patients who use these medications properly and need them to control their discomfort. I’ve talked to patients who have found it harder to get the medications they rely on, and it’s troubling. Good people are getting caught up in the crackdown on opioids.
Perhaps more shocking is that despite the sharp drop in opioid prescriptions, opioid overdoses continue to rise. Although the data from 2018 wasn’t available, nearly 49,000 Americans died from opioid-related overdoses in 2017. This includes overdoses from fentanyl and heroin, which can be eventualities for individuals who become addicted to opioids.
“It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors,” said Gottlieb. “What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.”
Police data shows that a record amount of fentanyl (1,640 pounds) and heroin (5,500 pounds) have been seized by law enforcement this year, and we’re not even two-thirds the way through the calendar year.
Clearly we’re still losing the war on opioid overdoses, even if we hear headlines that suggest prescriptions are at a 15-year low. Chronic pain patients are caught in the crossfire, and overdose-related deaths continue to surge. We need to invest more money into understanding and treating chronic pain conditions in order to really make a difference.