When the Pharmaceutical Benefit Manager
Won’t Let You Go On Vacation

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I  leave for vacation in the morning and it was not music to my ears when I heard that the pharmaceutical benefit manager (PBM), the company that reviews your drug use for your health plan or employer, denied an early refill for a maintenance medication. At 4 PM, my local drugstore told me that the pharmaceutical benefit management company for my health plan, would advance me three pills before I leave on vacation –a one day supply.

We discussed how long I would be away. Ten days. The PBM told the druggist to have me pay list price out of pocket for my maintenance medication, fill out a form, and eventually I would be credited for something. I wasn’t thrilled when I was told the out-of-pocket expense would be something on the order of $500. Who can afford that –and just before a vacation?A PBM should know better than to put someone in such a tough situation. I have been warned by my doctor that it is dangerous to abruptly stop taking these medicines.

The drugstore was as fed up as I was. My local drugstore did the decent thing of advancing me for ten days, letting me complete my order when I get back.

I am hoping that drugstores don’t go the way of bookstores. I like a real person in a real drugstore near my home.

It makes me wonder whether a remote PBM really should be in the business of medication therapy management. I have found that their records are out of date. Sometimes they call me to discuss a medication that I haven’t taken for two years or send a print-out based on medicines that I stopped a long time ago, begging me to go mail order so I can get immense savings. They send me charts of drug savings via mail order (which, BTW, seem to be getting less of a savings than they were a few years back). When they started mail order, in some parts of the country you could get three months of medicines for the cost of two. But I don’t think that ever was the case in my neck of the woods (New York City), but then, I don’t live in California or Seattle.

So I think the PBMs have some work to do to get people to think they are up to good. I think you are generally allowed one advance per year for a vacation. It may not be enough in the mobile society that we live in today.

Then there are the disease management calls that people around the country tell me that they get. They know that they are disease management because they are health savvy. And it’s not as if they are against them, but they get no warning, and suddenly a total stranger from a company you never heard of, wants to discuss your chronic illness. It’s uncomfortable. I don’t think the average person out there has a clue what pharmaceutical benefit managers are either.

A friend of mine with rheumatoid arthritis told me that these strangers call her and treat her as if she is on the road to falling off a cliff even though she has never been hospitalized and doesn’t use outpatient services much. Of course, disease modifying drugs for rheumatoid arthritis are costly. Another friend told me that people call, claiming to represent the PBM, to discuss his diabetes, and recommend actions that he could take to improve his outcomes. That is certainly reasonable, but I don’t know many people who take too well to people calling them out of the blue to discuss personal business. Besides, I know what a PBM is, but how many people out there have a clue?

Just a heads-up for the PBM and insurer: it would be nice if you notified us that these calls were going to come in. Sending an email or a snailmail would be nice. The contacts would inspire more confidence if you were working in real time. Otherwise, they sometimes sound like robocalls or like who-knows-who got a hold of your medical records.

The experiences that I mention here seem pretty out of touch and a bit inflexible. How can anyone trust your wisdom if you can’t even let us go on vacation, and go with the medications deemed essential to our good health? What’s your thought? Is there a better way?

(Footnote for readers: I will be posting on this semi-vacation (really change of location). I look forward to conversing with you here and on twitter at lauranewmanny. There is a lot of news even though it is late July–and I will be posting.)


My $5,000 Tooth and the Institute of Medicine Dental Report

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What a coincidence! The Institute of Medicine released a report today titled Improving Access to Oral Health Care for Vulnerable and Underserved Populations and I am one step further in my saga of trying to save a tooth! It is looking good in the save-the-tooth department, but this dental care is breaking my wallet. I lost a bit of time this week blogging and working because of pain. I don’t have the money to pay for this.

I am sad to say that no matter what I do, in New York City, this was bound to cost me thousands of dollars. I have no dental insurance. Not mentioned in the report are the extraordinary numbers of Americans out of work. Affordability is mentioned, of course, but the report doesn’t get into fixing that very much. Dental care is a luxury for people unemployed or under-employed and I put myself in that camp. I have been in a tizzy about what to do most of this week.

The Limits of Shared Decision Making

The shared decision making (SDM) people would have thought the world of my dentist, who kept trying to explain various treatment options, as if I was sizing up whether to buy a sofa, or a loveseat and a chair, or two chairs. Missing from the script was any discussion of dollars, as if it was a variable that was beyond the scope of the decision-making. I think that is a big mistake. I was buoyed this week, when an SDM proponent told me that the community is debating just how to bring $$ into treatment discussions.

I investigated the $$ situation on my own. I quickly learned that the cheapest course of care would have been pulling the tooth and getting a flipper (a tooth that you remove at night).  This is the course of action that the poor and the vulnerable get. But the other options—#2 – a root canal plus a post, core, and crown, can put you out a few thousand dollars. That is what I opted for. Option 3 is a tooth pull, combined with an implant,  a crown, and depending on the tooth, possibly a sinus flap, that can put you out thousands of dollars. It’s not uncommon to see payment plan brochures at dental offices, meaning that in the end, the dentist gets these fees, plus you shell out interest, bringing your out of pocket costs way up.

In high school, I had an after-school job with a dentist, who ended up removing teeth in an emergency for a lot of first-generation immigrants. Aside from preparing his instruments, my job was to hold the hands of these people; many came to the office in agony. Some had tried unsuccessfully to pull their own teeth. For the most part, we didn’t see these people again for a bridge. Some lived with a half a set of teeth. It was one of the first jobs where I felt that I was helping people feel better. I cannot say it is reassuring to see that, years later, I am in the same predicament as new immigrants in seeking dental care. I have worked hard all my life, but I cannot afford quality dental care.

Well, I am glad that Congress got the IOM panel to look at dental care for the poor and underserved, but I know that the Health Resources and Service Administration and the California Healthcare Foundation did not quite have me in mind when they solicited this report. It addresses vulnerable and underserved children, Medicaid, and Medicare patients, showing that in 2006, 4.6 million children missed dental check-ups, only 38 percent of retirees had dental coverage,  Medicaid providers are poorly reimbursed. I agree that these are  high-priority populations for basic dental coverage.

The report recommends expansion of the use of dental hygienists and assistants in areas of high need, underserved areas. The American Dental Association praised the report in a statement, particularly applauding the recommendation of increasing Medicaid reimbursement and support  for dental training programs.  If initiatives come forward that threaten the income of dentists in caring for less vulnerable, patients , it would not surprise me if ADA caused a ruckus.

I am glad that dental health care is being discussed nationally, but I can’t say the IOM report is cause for encouragement. Across town from the Institute of Medicine, major efforts are afoot to dismantle Medicare and Medicaid. I don’t see dental care becoming affordable for the vast numbers of Americans.

Inattention to Drug Safety in the Elderly
Leaves Generations At Risk

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This post originally appeared in a slightly different form in Scientific American’s guest blog on June 30, 2011.

My frail, 92-year-old mother was prescribed 80 mg of the cholesterol-lowering drug, or statin, simvastatin (Zocor) for years, possibly decades. She fell four times in the last four years of her life: the last fall was the least forgiving. Doctors diagnosed her with rhabdomyolysis and acute kidney failure; she was dead within 8 weeks.  She died in December 2007.

The MedlinePlus encyclopedia defines rhabdomyolysis as “the breakdown of muscle fibers and release of their contents (myoglobin) into the bloodstream.”[More specifically, myoglobin is the protein part of muscle fiber that transports oxygen through muscle.] In severe case, “the myoglobin breaks down into potentially harmful compounds, blocking the kidneys, causing damage such as acute tubular necrosis or kidney failure. Dead muscle tissue may be caused by any condition that results in damage to skeletal muscle, especially trauma.”

The FDA Safety Communication, issued on June 8, 2011, states that symptoms to watch for are: “muscle pain, tenderness or weakness, dark or red-colored urine, and unexplained fatigue” and be brought to the attention of a health professional. Rhabdomyolysis is a medical emergency. It is not uncommon after crush injuries, falls, and athletic feats.

FDA’s safety warning for high-dose simvastatin struck a chord in me because the 80 mg dose of simvastatin was the same given my mother.

FDA’s Simvastatin 80 mg Warning

FDA’s Drug Safety Communication on high-dose simvastatin to reduce the risk of muscle injury  state:

  1. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drugs.
  2. Patients taking simvastatin 80 mg have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class.
  3. Muscle problems typically occur in the first year of use.
  4. FDA did not place any caveats on use of 80 mg in the elderly or in people who are high fall risks. It is well known that rhabdomyolysis occurs with falls.

FDA also applied the same restrictions to Vytorin, which combines 80 mg simvastatin with ezetimibe, and Simcor, which combines 80 simvastatin with niacin. FDA leaves the issue of people already on 80 mg simvastatin for one year or more to the discretion of physicians, pointing out that rhabdomyolysis cases are most likely to occur during the first year of taking a high dose. FDA is taking a major step to improve the public’s health. Whether FDA went far enough is debatable.

The consumer health advocacy group, Public Citizen considers 80 mg simvastatin unsafe and wants it off the market to protect the public. On its Worst Pills, Best Pills website  (subscribers only), it presses for a recall of 80 mg dose and urges consumers, no matter how long they have been on it, to ask their doctor for an alternative that is weaker.

According to FDA’s Safety  Communication, approximately 2.1 million patients in the US were prescribed a product containing 80 mg simvastatin in 2010.

An article in the Nov. 13, 2010 Lancet sounded an alarm that high-dose simvastatin could be hazardous. In a blinded randomized trial of more than 12,000 survivors of acute myocardial infarction, investigators found two (0·03%) cases of myopathy in patients taking 20 mg simvastatin daily, compared with 53 (0·9%) cases in the 80 mg group.

This finding could not be ignored. FDA pressed forward in further analyses. Even as my mother was in crisis, doctors told me that they were astounded that such a high-dose statin was given to a low-risk, frail, elderly woman.  By low-risk, she had no history of cardiovascular disease and she met the widely used and time-tested Framingham Risk Factor criteria. She did not smoke, had moderate, well-controlled hypertension, but a high cholesterol. I sensed deterioration months before she was diagnosed with rhabdomyolysis.  She walked everywhere.

The author and her mother celebrating her 90th birthday in the Canadian Rockies.

One night, she called me, saying: “All of a sudden I feel exhausted, like my legs won’t support me, and I keep stopping and sitting down. I just don’t think I can do it anymore.”

Prescribing Simvastatin in the Elderly

Who knew whether it was normal aging?  Her doctor did not think much of these changes.

There is no consensus on treatment in elderly patients, but many physicians worry that high doses are more dangerous in the elderly and that scientific data is scant. Rodney Hayward, MD, University of Michigan, professor of public health and internal medicine, told me that sometimes, fatigue and muscle weakness are attributed to aging, but that you must look at dosing. “Unfortunately, people don’t realize that an excessive dose might be causing loss of appetite, muscle problems, and not eating enough. The most common adverse event with the high-dose statins are the myopathies, pain in the muscles. And if the old are not doing well, the sensible thing is to taper down.”

Also, of critical importance, “as people age, the risks and benefits of people being on medicine change,” said Hayward. “Processing through the kidneys is increasingly less effective. You want to be aware of how many medications, and how many doses people are on, and reconcile that with the amount of benefit and risk.”

I thought that my mother had an eating disorder.  She ate very little; it was all low-fat, low cholesterol, and low salt. She was 5’ 1” and weighed about 105 pounds. Her refrigerator was pretty empty.

Rita Redberg, MD, director of women’s cardiovascular services, the University of California San Francisco, said: “Most trials of hyperlipidemia have not included enough women to determine gender-specific benefits and harms. Therefore, meta-analyses and systematic reviews become imperative.” But particularly glaring is the reality that most studies have never demonstrated a survival benefit for low-risk women like my mother who are on statins. Both Redberg and Hayward said that they know of no studies showing that low-risk people taken off statins are at increased risk for cardiac events.

Hayward, Redberg, and many other physicians argue that doctors should be far more cautious in prescribing medications for the elderly. “High-dose statins should almost never be used in the elderly,” said Hayward. “In fact,” he added: “I almost always use low doses of statins in people over 75 unless they have known heart disease, since most of the benefit of statins is achieved with low doses and there are good reasons to be concerned about the safety and tolerance of higher doses of statins in the elderly.” In particular, he stressed: “With stepped-up dosing, the risk for harm escalates disproportionally.” Moreover, he said:  “Most of the benefit from the simvastatin is in the initial dose. “

Other Factors in Overtreatment

Another issue of concern is whether overtreatment with high-dose statins could be directly related to how pharmaceutical companies promising very low levels of low-density lipoprotein (LDL) cholesterol (AKA “bad cholesterol,” Setting targets this low may be inappropriate for the elderly.

Also adding to the problem of overmedication are pay for performance (P4P) programs, which tie specific targets in cholesterol-lowering to payment. Target setting is controversial, yet widely practiced, and Hayward is hardly alone in his criticisms. One notable exception that may actually help keep the elderly healthy is that in HEDIS performance measures, people over age 75 are excluded from lipid-lowering targets.

Treatment Protocols for the Elderly

Arguments pressing for treating the elderly differently have been commonplace for decades because the elderly have been under-represented in clinical trials; hence, guidance on practice are not science based.

We are really in new terrain now, with an aging boom and more pills available for any symptom than could ever have been predicted.  The number of people in the oldest age group, namely age 85 and over, is projected to grow from 5.8 million in 2010, to 8.7 million in 2030, and 19 million by 2050. People age 75 and over were largely excluded from clinical trials and subgroup analyses by age are barely beginning.

This should be a compelling reason for FDA, the Centers for Medicare and Medicaid Services, and Congress to back drug safety initiatives in the elderly.  Many health researchers are also urging further study of potentially inappropriate medications (called PIMs) in elderly patients. Archives of Internal Medicine highlighted the problem in the June 13, 2011 issue, and there is a growing literature on it.

A recent study of elderly ICU survivors found that 85 percent were discharged with 1 or more potentially inappropriate medicines, with more than 50 percent in that group discharged with medications deemed more harmful than beneficial (Morandi et al, 2011). The authors press for more attention to appropriateness reviews, with the rationale for starting each therapy in the ICU, and discussion of when it can be stopped.

Brian Strom, MD, professor of public health and pharmacology, University of Pennsylvania, raises other issues.  “The problem is Congress and our research agencies, who fund so little work on the pharmacology of the aged and other demographic subgroups, and their risk of drug interactions. And, the phenomenally small, and shrinking by 60% (down to $5.1 million/year), amount of money being spent supporting (FDA’s} Centers for Education and Research and Therapeutics, who are charged with doing studies that industry would not fund, and with changing prescribing to be more rational.”

Caregiver Remorse

The entire experience of trying to find quality care for my mother was made especially difficult because of the dearth of good clinical practice guidelines and science guiding chronic care. I think it is way too much to ask family and caregivers to take this on. Now both my parents are dead. I see friends and family struggle under heavy odds, trying to get good quality care with physicians  practicing with little science.

This is where Congress, FDA, and the Centers for Medicaid and Medicare Services must step up, expand funding, and beef up post-marketing drug surveillance. A treasure trove of medication safety data is deemed proprietary, and even the FDA is restricted in the circumstances under which it can review the original data, according to Hayward. “Since the results of trials are often preferentially published, objective review of these data could improve the public’s health. “No one has the right to inspect this data except the FDA,” said Hayward. “Most of the trials data are industry supported and the industry can hide safety data,” he said, “but with public pressure, medication ineffectiveness and harm may be detected.”

Without well-funded research, subgroup analyses of the aged (ages 85-100), and postmarketing surveillance, the US is operating in too much darkness and uncertainty for the public’s health. Many generations of Americans will continue to suffer.