Hepatitis C Drugs – Too Expensive to Use?

About 46% of Medicaid patients in four northeastern states were denied treatment with new direct-acting antiviral (DAA) drugs, which have been shown to cure more than nine out of ten hepatitis C patients, researchers reported in a new study. These powerful medications include Sovalda (sofoshuvir) and Harvoni (ledinasvir).

By comparison, only 10% of privately insured patients and 5% of Medicare patients were denied treatment said study author Dr. Vincent Lo Re III, an assistant professor medicine and epidemiology in the division of infectious diseases at the Perelman School of medicine at the University of Pennsylvania in Philadelphia.

State Medicaid programs have place stringent pre-approval requirements on the drugs due to their high cost Lo Re explained. A 12-week round of treatment for just one patient can cost as much as $90,000.

However, such tight coverage policies might prove pennywise but pound-foolish. Early treatment of hepatitis C with the new drugs can save billions in health care costs according to another study, published November 23 in the journal JAMA Internal Medicine.

Hepatitis C can do terrible damage to the liver if left untreated, including scarring of the liver and liver cancer, according to the U.S. National Institutes of Health. Serious cases often require a liver transplant. “Medicaid likely will end up spending even more in the long run as hepatitis C patients grow sicker and require more drastic treatment, “said Tom Nealon, chief executive officer of the American Liver Foundation.

About 3.2 million Americans are estimated to have chronic hepatitis C infection, according to background information provided in the JAMA report.

Polypharmacy

Polypharmacy is the use of five or more prescription drugs. In the past eleven years, polypharmacy increased from 10% to 15% for those aged 40-64 years and from 24% to 39% for those over 65 years. Sometimes, the number of daily medications taken by a single patient can be bewilderingly high (e.g., more than 10). As I noted in a recent blog, this is becoming a real issue in my practice. Just imagine the complications for the anesthesiologist assessing the medications and potential interactions prior to surgical intervention.

This data is from a retrospective study from the National Health and Nutrition Examination Survey. It was published in an editorial piece written by Alex Macario, MD in the November 19th issue of JAMA (Journal of the American Medical Association) entitled “Are Americans Taking Too Many Medications?”

Here are a few more statistics for your review:

• The percentage of adults reporting use of any prescription drugs increased from 51% in 1999-2000 to 59% in 2011-2012.
• There was increased use of antihypertensives (from 20% to 27%), antihyperlipidemics (6.9% to 17%) primarily driven by statins; and antidepressants (from 6.8% to 13%).
• Among those interviewed, 4.6% to antidiabetic agents in 1999-2000, which increased to 8.2% in 2011-2012.
• Prescription proton-pump inhibitors (PPIs) increased from 3.9% to 7.8%.
• The 10 most commonly used drugs in 2011-2012 were simvastatin (a statin for high cholesterol), lisinopril (hypertension), levothyroxine (hypothyroid), metoprolol (another antihypertensive), metaformin (diabetic med), hydrochlorothiazide (diuretic), omeprazole (PPI), amiodipine (another antihypertensive), atorvastatin (another statin), and albuterol (asthma).

The author asks the critical question – Is a primary care physician (PCP) managing the patient’s multiple medications to ensure that each is warranted and that the combination is optimal?

My Take:
Are Americans taking too many medications? Yes. Is a PCP managing the patient’s meds? No, they may be pretending to too so, but there is no way to manage polypharmacy. The interactions between the various meds are so numerous and varied that it can not be managed.

I am constantly amazed that a patient can actually walk into my office taking 10 or more medications. I know that I could not function under that drug load, but their bodies slowly adapt over time. They’re alive, but not really living.

The Bottom Line:
If you look at the top nine medications, they all treat diseases stemming from metabolic syndrome – a preventable condition. I have a T-shirt that I wear frequently and it reads:

I take Metformin for the diabetes caused by the Hydrochlorothiazide I take for high blood pressure which I got from the Ambien I take for insomnia caused by the Xanax I take for the anxiety that I got from the Wellbutrin I take for chronic fatigue which I got from the Lipitor I take because I have high cholesterol because a healthy diet and exercise with regular chiropractic care and superior nutritional supplements are just too much trouble!

Wisdom Wednesday: Ending Medical Reversal

This is the title of new book written by Vinayak E Presad, MD and Adam S. Cifu, MD. Medical reversal is the phenomenon of a new superior trial arising that contradicts current clinical practice or the result of many claims that specific treatments have a benefit turned out not to be true.

You’ve all heard the contradictory reports. Coffee is bad for you today, tomorrow it’s good for and by next week it will be bad again.

The medical community is most concerned that these conflicting studies undermine the pubic confidence in medicine and therefore the authority of the doctor. The book claims medical schools spend too much time on the basic sciences and not enough time on practical application.

I believe they need to reverse their concepts of medical reversal. The issue is losing sight of the basic functions and chemistry of the body as it strives to maintain homeostasis. For example, most vitamin B12 injections are cyanocobalamin. This is the inactive form of vitamin B12 found in food. It must be converted to one of the active forms by the cells that line the small intestine upon absorption from the gut. When you inject cyanocobalamin into a muscle, there is no conversion to the active form. The blood levels look great on the lab test, but the patient does not improve. This is biochemistry 101, very basic stuff, that is lost on the doctor that has forgotten much of what they learned early in medical school. They rely of the drug rep to tell them what to use.

The real causes of medical reversal are:

• Flawed understanding of physiology and pathophysiology
• Poor quality studies
• Affected by publication bias and selective reporting
• Made by dishonest investigators
• Based on publication subject to the influence of Big Pharma or other conflicts of interest

You are familiar with a few of these – recommending aspirin to prevent heart attacks in patients that have never had a heart attack (primary prevention), the use of cardiac stints in stable heart patients, and the prescribing HRT (hormone replacement therapy) using known carcinogenic compounds.

Heart Stints Ineffective?

Angioplasty – the procedure used to open narrowed or blocked arteries – doesn’t seem to lengthen life for people with stable heart disease and chest pain, a new study finds.

After 15 years of follow-up, the study found that people who had angioplasty fared no better than those who had their heart disease treated with medication and lifestyle changes alone.

“Stenting is effective and improves survival when performed early in the course of a heart attack,” said lead researcher Dr. Steven Sedlis, an associate professor of medicine at NYU Medical School in New York City. “But the benefits of routine stenting for patients with stable heart disease have been uncertain and highly controversial.”

Co-author Dr. William Boden, a professor of medicine at Albany Medical College in Albany, N.Y., said, “We know that in heart attack patients, angioplasty can be lifesaving.” But in patients with stable heart disease – even those with chest pain – medication and lifestyle changes may be the best way to minimize the risk of heart attacks and heart-related death, he said.

About one million angioplasties are done each year in the United States, and about 500,000 are done in patients with stable heart disease, Boden said.

“Patients need to understand what they are getting an angioplasty for,” Boden said. “If they are being told that it’s going to reduce the risk of heart attack or it’s going to make them live longer, they’re getting the wrong message.”

AMA “Ban Prescription Drug Ads”

Direct-to-consumer advertising for prescription drugs and medical devices drives up health care costs and should be banned, the American Medical association said Tuesday.

Currently, ads for drugs to treat diabetes, depression, impotence and more deluge TV viewers. This drives demand for expensive treatments, the nation’s most influential doctor group said when it adopted the new policy.

“Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices,” Dr. Patrice Harris, the association board chair-elect, said in an AMA news release.

“Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate,” she added.

Hoping to make prescription drugs and medical devices more affordable, the new policy also calls for a physician task force to study the issue, a campaign to demand choice and competition in the drug industry, and greater transparency in prescription drug prices and costs.

The United States and New Zealand are the only countries that permit direct-to-consumer ads for prescription drugs, according to the AMA.

This type of advertising is big business. Ad spending by drug makers increased 30% from 2012 to 2014, reaching $4.5 billion, according to market research firm Kantar Media.

Meanwhile, prices of generic and brand-name prescription drugs have risen steadily in recent years, including a 4.7% increase in 2015.

The high cost of prescription drugs is the top health care priority for Americans, according to a Kaiser Family Foundation report released las month.

Wisdom Wednesday: 23ANDME

For the first time genetic testing is available directly to the consumer (you) at an FDA approved lab for $199. Just google “23ANDME” to reach the web site for genetic testing.

They will mail you a home kit. You return it with a saliva sample and they will analyze your DNA for genetic variants.

Variants are genetic snippets that are associated with a variety of health conditions. You actually have two snippets for every genetic trait – one from your mother and one from your father. As long as your parents are not too closely related, you chances of having defects in both gene snippets are relatively rare. For example, having a pair of defective snippets for the conversion of folic acid to its biologically active form (5-MTHF) only occurs in 8% of the population. However, we know very little about why your body chooses a particular snippet of DNA to reproduce a RNA copy. Each snippet is used about 50% of the time. It does appear that under stress, the body tends to use the defective snippet more frequently.

While having a pair of defective snippets for folic acid is rare, 25% of the population in the U.S. has one defective snippet for conversion. The same is true for vitamin B6 and vitamin B12. That means I see patients with one or more genetic defects every day.

Until recently, genetic testing was very expensive, upward of $500 dollars for one genetic snippet. Now advances in genotyping chips has allowed multiple panels of testing for a reasonable price.

The ACE gene codes for the Angiotensin-1 converting enzyme. This enzyme has a pivotal role in regulating blood pressure. A defective snippet can reduce exercise performance, cardiovascular fitness, glucose balance and salt sensitivity.

Junk Food Not to Blame for America’s Obesity Epidemic

Despite their bad reputation, junk food, fast food and soda aren’t the root cause of American’s obesity epidemic, Cornell University researchers contend.

While these sugary and salt-laden foods may not be good for your health, the scientists found no significant difference in how much of these foods either overweight or normal weight people consumed – The real problem, according to the researchers: too many Americans eat too much.

“These are foods that are clearly bad for you and if you eat too much of them they will make you fat, but it doesn’t appear to be the main driver that is making people overweight and obese,” said lead researcher David Just, co-director of the Cornell Center for Behavioral Economics, in Ithaca, N.Y.

“For 95% of the country, there is no relationship between how much fast food and junk food they’re eating and their weight,” Just said. “Because of the bad habits we have, with all our food, just eliminating junk food is not going to do anything.”

But that doesn’t mean it’s OK to eat junk food. “These foods aren’t good for you,” he said. “There is no good argument for soda in your diet.”

Just said a broader approach is needed to fight the obesity epidemic. “We are eating too much generally. We need to cut back on our total consumption. We need to be better about exercising,” he recommended.

For the study, Just and his colleague Brian Wansink, director of the Cornell Food and Brand Lab, used the 2007-2008 National Household and Nutrition Examination Survey to analyze a sample of about 5,000 adults in the United States.