Latest Drugwonks' Blog
Docs formulate a list of differential diagnoses. Based on the list of possible causes of a particular problem, docs order diagnostic tests and procedures.
When I started in medicine over 30 years ago, we called the process ”rule out,” meaning we ordered tests to narrow the list of possible diagnoses until we found the right one. The more complex the disorder, the more tests are ordered.
In reality, docs don’t own a crystal ball. If they did, they would know which tests were going to be positive (necessary) and which were going to be negative (unnecessary). Since docs don’t have the ability to see into the future accurately, diagnoses and test ordering boils down to an educated guess.
To make matters worse, diseases are dynamic, forever changing. An eighteen year old comes in with a severe tonsillitis. Her mono test is negative.
Obviously, the test was not necessary since the test is negative. Right? Wrong! Ten days later she is seen again by another doc. Her mother states, “I took her to Dr. X 10 days ago and he didn’t know what he was doing. He wasted my money on a negative mono and strep test. Can you help her?” After explaining that a negative mono test is meaningless (as Dr. X had previously warned her), the new doc orders a repeat test which is now strongly positive. Diseases are dynamic and our ability to diagnose them correctly often improves with time as the disease evolves and changes.
Read the full piece here.
If it ever needs a reminder of how to spend billions to accelerate it's uselessness, FB can take a look at the monumental waste of money devoted to health IT and it's various spawn -- electronic medical records, e-prescribing, clinical decsions tools, and so on. This is not the most politically of correct statements. Everyone LOVEs health IT and predicts that it can save billions in medical spending, improve patient care, accelerate drug development, make stir-fry...
Let's set aside that no one has taken a hard look at whether health IT has done any of this. All we have are small, uncontrolled, observational studies that wind up proving health IT is 'transformational.' Ironically, the same group of underachieving health policy 'experts' who push comparative effectiveness research, who claim that industry sponsored research is corrupt and that doctors who receive industry (i.e. evil drug companies) support are conflicted, have no problem with anecdote-based reports paid for by health IT firms or companies that get paid to promote health IT or using the findings to reinforce their faith in health IT. And they have no problem with doctors getting health IT money or loans. But I digress.
The big problem with all the health IT hoopla is the fact that it's being lavished on technology and tools that are useless in a mobile environment. And apps that merely ape enterprise-based systems such as health information exchanges don't count. Those are about to become as outdated as typewriters and TVs with antennas or PCs for that matter. In my opinion, they already are. A big share of the blame goes to the establishment of the government health IT gravy train. The morass of standards, accreditation criteria, meaningful criteria, silly interoperability standards (requiring everyone to share clinical data the same way everywhere) have guaranteed that anything launched in the past five years or in the future, will be (or is) obsolete. Two quick examples, government sponsored health IT never anticipated integrating genomic information and clinical data. It never anticipated that both types of information could be generated, shared and stored by consumers themseves on something called a cloud.
One health IT veteran told me in exasperation that if the government had tried to standardize the 'meaningful' use of the internet we would be stuck with Mozilla. There would be no other browsers (what a quaint term!). Imagine if every company had to buy and sell products using the same accredited criteria, methods and interface. There would be no Amazon, eBay, Netflix, you name it.
Hence, health IT has a very big Facebook problem. The good news is that most people (meaning consumers) find electronic medical records, most health apps and other mobile health devices as boring, confusing and pretty much useless. There are dozens of companies promising their health info tools will reduce medical errors, improve patient outcomes, etc. But few of them make medical care or staying healthy simpler. The fact that we have to pay doctors to use health IT should tell you about it's capacity to provide that benefit. Did we have to pay physicians to use antibiotics instead of iron lung machines to treat TB? No one is paying health professionals to use iPads. Bribing and forcing doctors to use e-prescribing tells you something about whether most systems are really making prescribing safer and easier. Morever, the vast majority of doctors block out drug interaction alerts in e-prescribing systems for one very good reason: they slow down prescribing and never take into account benefits and risks of a treatment for specific patients.
BJ Fogg, a leader in figuring out how to get people to do things (which is really 90 percent of health care) observed:
"There are two paths to increasing ability. You can train people, giving them more skills, more ability to do the target behavior. That’s the hard path. Don’t take this route unless you really must. Training people is hard work, and most people resist learning new things. That’s just how we are as humans: lazy.
The better path is to make the target behavior easier to do. I call this Simplicity. In my Behavior Model I sometimes replace Ability with Simplicity. I hope this isn’t confusing. Ability is the correct general term in the model, but in practice Simplicity is what persuasion designers should seek. By focusing on Simplicity of the target behavior you increase Ability."
Facebook is seeking to find a way to make connecting, communicating and consuming, simpler. in the main BigHealth IT, which was conceived by technologists coming off a bad acid trip, has never given a rip about simplicity or ability. It's all been about the government money, not us.
Yes, dear reader, once more into the abyss.
Byron Dorgan may be gone, but the song remains the same.
On Monday, expect Senator McCain (with the misbegotten assistance of senators Vitter, Snow, Stabenow and other “usual suspects”) to try and tack on this importation amendment to PDUFA.
For shame.
While it is likely that cooler heads will prevail (since Leader Reid and HELP Chairman Harkin are likely to vote “nay”), vigilance is required to once again squash this bad idea that is so deleterious to the public health.
As the saying goes, nothing dies harder than a bad idea.
As seen in The Hill …
Animal health and human health are inextricably linked
The Food and Drug Administration’s long-awaited policy announcement on antibiotic use in food animals has accomplished an almost impossible Beltway feat – just about everyone’s happy about it.
The new policy aligns antibiotic use in animals and humans and eliminates the use of antibiotics as growth promoters, similar to the European ban on antibiotic growth promoters. The FDA’s new guidance requires that all medically important antibiotics used in animal agriculture be administered with the supervision of a licensed veterinarian for therapeutic purposes -- meaning disease treatment, control and prevention. Use for growth promotion will be phased out. Medicines will now be used in animal health much the same way they are by humans –to address disease and under the watchful eye of a licensed medical professional.
FDA’s action is in line with to a letter sent to the White House in July, 2009 by 20 public health advocacy groups, including the Alliance for the Prudent Use of Antibiotics, the Infectious Disease Society of America and the Pew Campaign on Human Health and Industrial Farming. The letter expressed support for “the FDA’s calls for phasing out the use of antimicrobial drugs for growth promotion and feed efficiency, and for requiring that all other uses of these drugs be carried out under the supervision of a veterinarian.”
To achieve those worthwhile goals, the FDA engaged in a consensus-building stakeholder process and, judging by the almost universal positive reaction to the FDA announcement, it was a successful endeavor.
Some claim this is an issue that should be addressed through federal legislation or legal action. However, the collaborative, stakeholder process proved to be superior in at least two ways:
First, it achieved the desired outcome faster. The FDA discussed the various issues at length during the process. Second, the action avoided unintended consequences. Legislative bans on antibiotic growth promotion uses in Europe resulted in increased animal death and disease. While the transatlantic outcomes are the same – eliminating antibiotic growth promoters – the FDA’s collaborative provided for a smooth and savvy transition.
The bottom line is that FDA has begun to implement significant public health change in the most practical way possible. Animal health is inextricably linked to human health. This FDA action minimizes antibiotic use in food animals, maintains the tools necessary to protect animal health and, most importantly, enhances the protection of human health.
Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a member of the Animal Health Institute’s Board of Scientific Advisors
Home HIV test should be sold in retail stores, US panel urges
Published May 16, 2012
NewsCore
A Food and Drug Administration advisory panel Tuesday asked the agency to let an HIV test be sold in retail stores so consumers do not have to go to a health facility to get tested for the virus.
The mouth-swab test, made by OraSure Technologies Inc., is sold commercially to health professionals to be used at facilities.
If approved by the FDA, the test results could be obtained in the home like tests for pregnancy and blood sugar. The FDA usually follows panel recommendations.
The test was reviewed Tuesday by the FDA's blood-products advisory panel, which is made up of non-FDA medical experts.
The panel voted 17-0, saying the "projected benefits" of OraSure's in-home HIV test outweighed the "potential risks of false positive and false negative results." The panel also voted 17-0 in support of a question that asked if the data submitted by OraSure showed the test was safe and effective.
If the OraQuick In-Home HIV Test is approved, it would mark the first time that HIV test results could be obtained in the home. Other home HIV tests require a fluid sample to be sent to a laboratory for testing.
About 1.2 million people in the US are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials estimate 20 percent of people with HIV do not realize they are infected and risk spreading the virus.
OraSure argues the test would most benefit people at risk who have never been tested or do not get tested regularly.
One concern about the home test is it does not appear as accurate as tests conducted by health professionals. The company conducted a study of the home test in 5,662 people who also took a traditional HIV laboratory test that used blood. Blood tests showed 114 people were positive for HIV. Of that group, 106 reported positive tests via the home test, and eight reported a negative test.
It is not clear if the home test provided a negative result or if people read the test incorrectly. Still, FDA officials said the home-use test would likely encourage more people to get tested. "We believe there would be public-health benefits" of a home-based HIV test, said Richard Forshee, an FDA associate director for research. "But an individual risk remains in the form of an increase in the number of false negatives."
A Catholic university in Ohio said Tuesday it is being forced to end a student health insurance program over the Obama administration's contraception mandate and costs associated with other provisions of the health care overhaul.
Franciscan University in Steubenville, Ohio, said it has so far excluded contraceptive services and products from its health insurance policy for students and will not participate in a plan that “requires us to violate the consistent teachings of the Catholic Church on the sacredness of human life.”
In its decision to drop coverage, the school cited the contraception mandate, but also a requirement that the maximum coverage amount be increased to $100,000 for policyholders -- claiming that would have made premiums skyrocket. A university official told Fox News Radio the students’ basic $600 policy was going to double in cost in the fall and triple next year and that the school’s insurance provider said the increases were the result of the federal Patient Protection and Affordable Care Act.
"This is putting people in a position where they are having to choose between their faith and their morality, and now an unjust cost," said Mike Hernon, the school’s vice president of advancement. "These sorts of regulations from the government are forcing our hand in a way that's really wrong."
Read the full story here.
When it comes to Congressional action on drug shortages, “newer” is not always “better.” An earlier PDUFA discussion draft (House side) would have mandated the FDA to:
… include a list of the drugs that are subject to the requirements of section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)), as amended by subsection (a), if the manufacture of such drug is to be discontinued, or an interruption of the manufacture of the drug that is likely to produce a drug shortage;”
Nice. Clear. Matching authority and expertise.
The current version reads:
IN GENERAL. -- A manufacturer of a drug subject to section 503(b)(1) -- (1) that is -- (A) life-supporting; ‘(B) life-sustaining; or (C) intended for use in the prevention or treatment of a debilitating disease or condition; and (2) that is not a radio pharmaceutical drug product, a product derived from human plasma protein and their recombinant analogs, or any other product as designated by the Secretary, shall notify the Secretary of a discontinuance of the manufacture of the drug, or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the manufacturer’s supply of the drug, and the reason for such discontinuance or interruption, in accordance with subsection (b).
Very vague as to what drugs fall into these categories and what, precisely, those circumstances might be.
The Senate-side language is equally unclear:
IN GENERAL.-- A manufacturer of a drug -- (1) that is -- (A) life-supporting; (B) life-sustaining; (C) intended for use in the prevention of a debilitating disease or condition; (D) a sterile injectable product; or (E) used in emergency medical care or during surgery; and (2) that is not a radio pharmaceutical drug product, a human tissue replaced by a recombinant product, a product derived from human plasma protein, or any other product as designated by the Secretary, shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States.
Considering the high profile nature of this issue and the need for manufacturers to err on the side of both patient safety and legal prudence, lack of clarity will very likely lead to reporting everything, thus exacerbating a signals-to-noise problem at an already over-burdened FDA.
Perhaps the best solution is for Congress to require the FDA to compile and publish a list of drugs that must be reported to the agency when circumstances leading to potential shortages arise. This would allow companies to determine when they need to contact the FDA – and allow them to do so more swiftly and efficiently. Such legislative authority would also focus the FDA’s energy on the most critical drug shortage situations – allowing them (with their limited staffing resources – it’s worth repeating) to address them with greater skill and alacrity.
Noise proves nothing. Often a hen who has merely laid an egg cackles as if she laid an asteroid.
-- Mark Twain
Just as the Supreme Court is weighing the compensation system for pharmaceutical sales representatives at GSK (will the word "sales" ever be the same?) so too is ... GSK.
I was recently briefed by a senior GSK executive on that topic as well as about the company’s pending agreement in principle with the DOJ.
I wanted to talk details. He wanted to talk about Deirdre Connelly, GSK’s President for North America Pharmaceuticals and her views of a post-settlement company.
His meeting. His agenda.
Specifically, I learned that Deidre’s favorite topic, “is the future and how potential recidivism will not be tolerated.”
GSK, according to my interlocutor, is a company that’s ready to look ahead with some fresh ideas.
We’ll have to wait and see on the specifics (of both the DOJ settlement as well as what those new approaches may be) – but a recent speech by Ms. Connelly (at the CBI 8th Annual Pharmaceutical Industry Compliance Congress) lays out some initial propositions – about values, compliance, and a new model for pharmaceutical representative roles, responsibilities – and compensation.
Here are some snippets from that oration.
Since January of 2009, the Justice Department has reached settlements totaling nine billion dollars against healthcare companies. These cases involved alleged false claims, fraud, and FDA violations.
As someone who decided more than 25 years ago to pursue a career in the pharmaceutical industry, I ask myself: what’s going on? Why is this happening? What went wrong?
The answer, I believe, is that, in some ways our industry lost its way, and failed to fully appreciate the evolving expectations of our stakeholders.
Society holds our interactions with our customers – healthcare providers and payers – to a higher standard. And it should. Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence.
To be fair, our industry has made significant changes in how we operate over the past several years. What our critics either are unaware of – or choose to ignore – is that our industry adopted the PhRMA Code almost ten years ago, which serves as a baseline for how we should work with healthcare providers and institutions. The industry then strengthened the code in 2009, making additional changes in areas such as meals, continuing medical education, support for educational and professional meetings, and the use of consultants and speakers, among other things.
But negative perceptions remain. Some of this has to do with long-running government investigations, litigation over past practices, and the resulting news coverage that makes it look like we still take doctors on trips to exotic locations –which we don’t. Some of it is because we haven’t done enough to communicate what we do and don’t do. Some of it is because industry bashing is good politics. Some of it is because we still make mistakes. No matter the reasons, at the end of the day, we must regain the public’s trust in our industry.
So, what should we do?
Of course, we must comply with the laws and regulations that govern how we in the pharmaceutical industry are required to operate our business. That is not subject to debate or open to interpretation. It’s a given.
But our customers need to understand – that beyond compliance – we operate from a core set of values that underpins every decision we make and every action we take. A values-based culture creates a framework and a mindset in which compliance with rules and regulations is not the ceiling, but the floor from which our organizations should operate.
In my mind, three key elements make it happen: First, you have to be willing to break the mold and fundamentally change your approach to certain aspects of your business. Second, you must align your resources with your values. And, third, you must demonstrate leadership based on those values.
To help ensure that the behavior of our representatives is consistent with our values, we’ve also decided to break the mold and change the way we provide incentive compensation to our sales representatives.
In the past, like other companies, we based the variable portion of the compensation for our sales force on the volume of prescriptions they obtained in their sales territory. That is no longer the case. We are now in the process of putting in place a new incentive compensation system in which individual sales representatives are not bonused on scripts, but on three factors: an assessment of their scientific and business knowledge; feedback from customers in their region, including demonstration of our values; and overall performance of the business unit they support.
Importantly, we’re shifting our focus from obtaining the next script to providing the information and support our customers want and need. We may not be able to provide all our customers with everything they want, but what we do provide will be aligned with what they need to treat their patients better.
As part of our performance management process, our employees have a values and integrity objective included in their annual performance plans. They are evaluated for not only “what” they do, but also “how” they do it. This enables us to incorporate a behavioral component into our performance evaluation process, further supporting our commitment to the company’s values.
We’ve also made a significant investment in establishing 60 Integrity Champions who provide training and support so that we can further ingrain accountability for values and compliance throughout the business.
Ultimately, you get returns from what you invest in and what you reward.
But I believe the greatest imperative for us, as leaders, is to look forward and examine what more we can do to ensure our practices are in step with societal expectations.
Our customers are watching.
The complete text of Ms. Connelly’s speech can be found here.
The Seventh Circuit Court of Appeals has ruled that Eli Lilly does not owe a former rep overtime.
According to a report in Medical Marketing and Media, “Wednesday's decision, which reversed a lower court's ruling that the rep was entitled to overtime, deals a blow to the Obama administration. The Labor Department had backed the rep’s overtime claims, and the Office of the Inspector General sided with sales reps in Christopher v. SmithKline against GSK which revolves around the same issue: are sales reps considered outside sales teams or more like typical employees?
The focus of these cases turns on what these employees can or cannot do: regulations bar sales reps from taking drug orders from doctors. Plaintiffs say being deprived of that final step puts labor laws on their side, because it marks them as employees, not as outside sales forces, and therefore eligible for overtime.
Pharma companies counter that reps facilitate sales by showing up and talking with doctors about drugs. The companies say these visits trigger sales and are therefore sales calls, which would put the reps in the category of employees who are not eligible for overtime.
Meanwhile, the Supreme Court has yet to choose sides—it heard arguments in Christopher v. SmithKline Beecham April 16, but has not yet issued an opinion.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
