Tag: pharmaceuticals

The Rule of Thirds

Nov 1, 2018

By Marya Zilberberg, MD

When I was a medical student, I did a lot of rotations at the Boston VA in JP. I loved my patients there — they were patient and kind and stoic. One of the best rotations I did was Hematology, where Lou Fiore was my preceptor. Lou was not only an excellent teacher, but also a terrific doctor and a good human being all around. He used to start our days together by saying, “I’m gonna teach you one thing today.” And teach us he did, at least one thing per day. Now I teach. And on occasion I have used the Lou Fiore “I’m gonna teach you one thing today” promise. Well, today is one of those days: I’m gonna teach you one thing.

And here is that thing. I am sure I am not the first one to notice this, but I still think of it as the “Zilberberg rule of thirds.” The gist of it is that, for clinical research purposes, one can think of patient populations crudely in thirds: there is one third who are too sick to benefit from any of our interventions, there is one third who are too healthy, so that no matter how we try to tweak, their outcomes will not change, and the middle third, which comprises the “sweet spot” for intervention. So it is a fool’s errand to pursue proof of concept studies in either of the bracketing thirds, since it is only the middle third that is likely to show a signal.

Pharmaceutical manufacturers do not always appreciate this trichotomy. Look at Vioxx, for example: when used in patients who were essentially healthy, an unacceptable safety signal arose that drove the drug off the market. Same for SSRIs, where the ill-conceived enthusiasm for treating marginal depression cases seems to be debunking the entire serotonin hypothesis. The flip side is sepsis research: septic shock patients are so far gone that it is difficult for any single therapy to alter their outcomes. Just look at the Xigris story, as well as myriad other therapies that tried and failed. This is the rule of thirds at its most pronounced.

In HEOR the rule of thirds holds as well. To prove cost effectiveness the following questions need to be asked:

1. Is the disease in question prevalent?

2. Is the economic impact of the disease known and substantial?

3. Does the diagnostic/therapy in question alter the course of the disease in such a way as to be significant?

If the answer to any of the questions above is “no,” you really need to think carefully about the value proposition.

Some of you will bring up the inter-individual differences, the heterogeneous treatment effect, etc. And yes, these are supremely important. However, though the framework I propose here is simplistic, we have to start somewhere. To be sure, there is a more nuanced approach to this beast, but generally, one will not go wrong by asking these questions before committing huge resources to a project, particularly if the answer to question 2 or 3 is a resounding “no.” So, even in health economics it behooves one to know the Zilberberg rule of thirds: choose the right population where the diagnostic/therapeutic advance and its costs can be justified by a substantial gain in the outcomes.

And that is your one thing for today.

Marya Zilberberg, MD, MPH, is a physician health services researcher with a specific interest in healthcare-associated complications and a broad interest in the state of our healthcare system. She is the Founder and President of EviMed Research Group, LLC, a consultancy specializing in epidemiology, health services and outcomes research. She is also a professor of Epidemiology at the University of Massachusetts, Amherst. Dr. Zilberberg blogs at Healthcare, etc.

Barking Up The Wrong Tree: Affordability, Not Cost Growth, Is The Policy Challenge

May 8, 2012• 6

By Jeff Goldsmith

A recent spate of commentaries on the continuing health spending moderation raise an important policy question: If the cost curve is well and truly bent, why are we investing so much of our policy energy on bending it further, when the more pressing problem is the declining percentage of Americans that can afford our health system’s astronomical costs?

Health spending the past two reported years (2009 and 2010) have grown in the high 3 percent range, the lowest growth rates since Dwight Eisenhower’s last year in office (1960), five years before Medicare. Medicare’s actuaries have pointed to the recession as a root cause. Yet even Medicare spending growth has subsided to about 5 percent in 2010, a development hard to attribute to recession since so few Medicare patients have first-dollar cost exposure. This analyst’s extensive industry contacts suggest no spending rebound in 2011 and 2012, despite an aging population and fee-for-service’s pernicious volume-increasing incentives in full force.

Pharmaceutical spending. The two most explosive cost problems of the 1980’s and 1990’s, pharmaceutical spending and imaging — which together now represent about 20 percent of total health spending — are now seeing low single digit growth, and seem likely to remain quiescent. In the pharma case, the main contributor is the ruinous outflow of branded drugs from patent protection, and the failure to replace them with new protected drugs. This outflow continues unabated until 2018. Branded drug prescriptions are shrinking by 5 percent per year, and the only things preventing pharmaceutical sales from actually declining are brand price increases and growth in generics, which now represent almost 80 percent of prescriptions, according to IMS Health. While specialty drugs (biologicals) remain a concern, those too begin losing patent protection in earnest in the next few years.

The Latest Big Pharma Scandal

Feb 2, 2012• 3

By Shannon Brownlee

Imagine yourself in front of your computer, looking up information about a drug prescribed by your doctor. Your Internet search tells you that there is a cheaper, maybe even a generic version available, but you have just paid top dollar for the brand name drug. You also learn that another treatment may be safer than the prescription you just filled. Now imagine you discover that your doctor gets paid by the manufacturer to promote the drug to other doctors.

There are various words for this sort of financial transaction, when, say, a radio disk jockey is paid by a recording studio to play a song or a broker is paid to tout a stock — both of which, by the way, are illegal. In medicine it’s called a financial conflict of interest, although “pharmapayola” is in some ways more accurate. It’s perfectly legal, and it’s rampant. In a survey published in the Archives of Internal Medicine in 2010, 28% of physicians reported that they received some kind of payment from a drug company to serve on a speaker’s board, as a consultant, or on an advisory board. Other bennies handed out by companies included free drug samples, tickets to sporting events, meals at five-star restaurants and all-expenses paid trips to medical meetings in nice locales.

As of this year, doctors who accept gifts and payments from drug and device makers will see their names on the web, the result of the 2010 Physician Payment Sunshine Act, one of the most controversial provisions in the health care reform law. Companies will be required to report any gift or payment to a doctor or academic researcher over $10, whether it’s in the form of stock options, speaking fees, box seat tickets, knickknacks for the doctor’s office or travel to a medical conference. Doctors will also be required to disclose payments and gifts.

The Health Assurance – Disease Insurance Plan

Feb 4, 2010• 24

By NORTIN M HADLER, MD

The American health care delivery system is reprehensible for the degree to which it tolerates the under-treatment of those in need and supports the over-treatment of those who are entitled. It invests vast wealth in its own entropy. I don’t want to belabor all this shamefulness. The best we can do is to superimpose rationality on the current system—iron clad, science supported, and patient driven rationality with the goal of assuring health and providing recourse when that assurance falls short. We are advantaged by a cadre of physicians who are culled from the ranks of the best and the brightest and who would like nothing better than to do what is right by their patients. The moral charge to our society is to design a system that exists for no reason other than to provide for the wellbeing of both the sick people and the sick peoples amongst us¹. To begin to do so demands confronting 3 of the current system’s most intransigent and least recognized moral lapses: licensing overtreatment, institutionalizing conflictive relationships, and promoting perverse incentives.Continue reading…

Health 2.0 Tools: The power of Twitter

Oct 23, 2009• 6

The power of Twitter is real kids, and not for what you think. Used properly Twitter is an information filter. Exhibit A is what happened to the Von Schwebers who run PHARMASurveyor. They were a huge part of the Tools Panel which featured interoperation among 8 members of the Health 2.0 Accelerator at Health 2.0 a couple of weeks back. Then last week they were at an AHRQ conference on Drug Interactions when this happened. Erick von Schweber’s email picks up the story ..

The Chief Medical Officer of Express Scripts is doing his talk, about halfway through, and then tells this rather academic audience of scientists and researchers that there’s something new they need to attend to. It’s called Health 2.0, he says, and he puts up a PowerPoint slide with screen captures from WebMD, HealthVault, Healthline, DoubleCheckMD, etc. Then he tells the audience that the prior week he saw tweets about something new in the space, so he checked it out. He says this is the next major leap ahead in drug safety. So up comes a series of four slides, all screen grabs of PharmaSURVEYOR. And he calls us the Accelerator and explains what we do, disclaiming that he had no knowledge that we’d be there at the conference (I had moderated that morning’s session on making DDI evidence more relevant to patients and physicians; Hansten and Horn were my speakers, the guys who introduced the term “drug interaction” in the mid-sixties). He tells the audience that they must go to PharmaSURVEYOR as well as begin thinking in terms of consumer generated healthcare.

Now it just so happens that the Chief Scientist of Express Scripts but not the Chief Medical Officer had been to Health 2.0 and (I assume) seen the Tools panel demonstrations. But, and this will amaze no one, busy executives at big corporations don’t always immediately communicate all of their learnings with each other. So how did the Chief Medical Officer find out? He probably saw a re-tweet of the #health2con hash tag. That, ladies’n’genelmen, is how our kids is learning these days.

And do you want to see the incredible tools panel from Health 2.0 which contained both the accelerator integration project (in two parts), the debut of Keas, and Eliza showing the first Health 2.0 marriage? Funny you should ask.

Reminding Washington of What the Health Care Debate is About

Sep 12, 2009• 6

By ROB DAY

This summer, we witnessed countless demonstrations on the health care debate across the country. The media has broadcast and written about impassioned pleas from conservatives and liberals alike, each swearing, with an alarming level of certainty, that their way is the only way. As we enter the fall and as Washington returns to work, Americans must ask themselves what really matters when it comes to reform. From my standpoint, while I think it’s a good thing the country is discussing much-needed health care reform, there is one important element missing from this enthusiastic debate. The patients. Individual Americans, and their best interests, are, or at least should be, at the core of any health care dialogue. Some will be much more affected than others, regardless of what the makeup of the final language that is passed.

Kamen: Healthcare Debate “Backward Looking”

Aug 7, 2009• 27

Segway inventor Dean Kamen thinks the wonkish debate over healthcare reform in Washington is largely missing the point. In an interview with Popular Mechanics editor-in-chief James Meigs and deputy editor Jerry Beilinson, Kamen tells the magazine:

“We now live in a world where technology has triumphed, in many ways, over death. The problem with that is that it’s enormously expensive. And big pharmaceutical giants and big medical products companies have stopped working on stuff that could be extraordinary because they know they won’t be reimbursed, according to the common standards. We’re not only rationing today; we’re rationing our future. ““If you project forward these horrific costs of treating everybody and you want to assume we are not going to respond to that by making the therapies better, simpler and cheaper and in some cases completely wiping out the [diseases], well you know what? We might actually get to that situation—if we stop investing in technology, if we stop believing that the future ought to be better than the past. ““If somebody in this country wants to explain to me that we ought to be spending about twice as much supporting sports as on all of our pharmaceuticals, then stop spending.” “I think this debate shows a fundamental lack of vision, a lack of confidence, a lack of understanding of what’s possible.”

Eliminating Medication Waste in Long-Term Care Can Help the White House Pay for its Health Plan

Jul 14, 2009• 26

By CARLA CORKERN

The news of an $80 billion White House deal with drug companies to lower Medicare drug costs targets $30 billion in savings for consumers covered by Medicare Part D, but the sources of the remaining $50 billion in savings that is supposed to accrue to the government “have not been identified at the moment,” according to an Administration spokesperson.

With the Administration scrambling to find ways to pay for a much-wanted healthcare package estimated to top a trillion dollars in just 10 years, every few billion in potential savings counts. That’s why the government should take a close look at the extraordinary amount of medication waste that is literally flushed down the toilet every year in long-term care (LTC) facilities.

The United States spends an estimated $1.25 billion annually on direct cost of wasted medications in LTC settings – and this is before the Baby Boomer generation has entered the scene. Long-term care facilities, pharmacies, wholesalers and manufacturers are expected to incur an additional quarter billion in costs annually due to the labor, distribution and operations costs for distributing and disposing of unused medications. Throughout this process there are 800,000 medication errors made every year in these facilities.

In February of 2009, The American Society of Consultant Pharmacists (ASCP) surveyed its membership – pharmacists that work in the LTC industry – on the topic of unused medications. The top three concerns of respondents were preventing diversion, developing cost-effective disposal procedures, and reducing the overall amount of pharmaceutical waste.

Where does all this waste and error originate? A majority of the approximately 17,000 LTC facilities in the U.S. receive medications in punch cards, cassettes, and/or unit-dose packaging that are delivered on a daily basis by a local or regional offsite LTC pharmacy. These medications are predominately covered through Medicare Part D.

The most prevalent type of packaging is disposable 30-day punch cards, often referred to as “bingo-cards,” which are sent when the prescription is ordered and every time it is refilled. However, when a prescription is discontinued or the patient is transferred, discharged, or passes away before the supply is exhausted, the unused medications are either destroyed onsite or sent back to the pharmacy.

However, the ability to return and credit unused medications was not addressed when Medicare Part D was created. And, because no electronic claim crediting process is available, pharmacies must bill upfront by dispensing the entire supply of medications, up to 30 days, with any unused medications becoming waste. The pharmacy gets paid either way, because there is no incentive to offer credit for unused medication.

A pharmacy that wants to offer credit for unused medication must use what is known as post-consumption billing – but this requires a hassle that creates cash flow delays and reporting burdens that make it all but impossible to manage.

Baby Boomer demographics indicate long-term care facilities will soon be the new epicenter of spiraling medication costs, and the waste occurring today is astounding. Medication distribution systems in LTC have not fundamentally changed in decades. In addition, the current systems are riddled with errors that cost untold billions, and our environment is tainted with unused medications that are flushed or incinerated ever year. The only group that really benefits from this mess is the pharmaceutical companies.

The U.S. taxpayer can no longer afford the status quo. While policymakers have their sights set on major reform, they should pursue the needless waste that is growing in this segment of healthcare.

To do that, policymakers and regulators should look for ways to increase automation of medication dispensing in long-term care facilities. This process is well established in acute care settings, where waste has been virtually eliminated and patient safety has improved dramatically.

Now is the time to incentivize long-term care facilities and the pharmacies that serve them to replace the status quo with systems that will free up taxpayer dollars for health reform, and deliver safer care to our rapidly growing senior population.

The other Michael Jackson mega-mix

Jul 6, 2009• 1

By MATTHEW HOLT

Never ones to be shy with an interesting view into celebrity pharmacology (and truth be told responding to a little tickle from me) the inventive folks at PharmaSurveyor have added Michael Jackson to their celebrity drug cocktail page.

It’s an interesting way to show the dangers of multiple drug regimens, and a great way to show off PharmaSurveyor’s computational capabilities of analyzing multiple drug regimens at once. (PharmaSurveyor calls those assessments surveys). You can find it on www.michaeljacksondrugs.net which has a static picture of Michael Jackson’s survey and links to the interactive one on PharmaSURVEYOR.com. (FD I’m an advisor to PharmaSurveyor with a few stock options)

Drug Suspected in Michael Jackson Death Subject of Recall

Jul 3, 2009• 5

By SHERI FINK

Results of Michael Jackson’s toxicology tests have not yet been released, but suspicions have centered on the powerful anesthetic and sedative drug propofol, also known by the brand name Diprivan. It was reportedly found in Jackson’s house, and a nurse who worked with him said he begged for propofol to help him sleep.

Now, some lots of propofol are being recalled for contamination.

Last night, the Centers for Disease Control and the Food and Drug
Administration advised clinicians immediately to stop using propofol
from two lots found to be tainted with elevated levels of endotoxin, a
toxin made by bacteria. Regulators said Teva Pharmaceuticals, the
manufacturer, had begun a voluntary recall of the lots.