Comparisons Are Odious

05/30/2012 02:53 AM |

 

Op-Ed: Comparisons are odious

Agency sets an unhealthy precedent for ‘effectiveness’ research

By Trevor Butterworth Tuesday, May 29, 2012
 
 
Imagine that all the pharmaceutical companies united to create an institute for quality research, and gave it $1 billion to study “comparative effectiveness” — whether drugs still under patent worked better for people than cheaper generics. Imagine that the pharma companies dug farther into their pockets and came up with another $11 million to train physicians, pharmacists and nurses to be ambassadors for this institute, and that these ambassadors would travel the country offering $4 million worth of further education credits to any doctors or nurses who would agree to listen to their spiel.

If you’re thinking that this is, in fact, what Big Pharma already does, remember, this is still a hypothetical exercise. In reality, such a plan would never get by the Food and Drug Administration, which is to drug marketing what the Spanish Inquisition was to heresy. But if, somehow, such a project were ever to happen, you’d seriously doubt whether it would be unbiased, wouldn’t you? It strains credibility to think that the pharmaceutical industry would go to such expense to say that the cheaper drugs were just as good as the expensive ones.

So guess what the U.S. government has gone and done? It’s given $1 billion to the Agency for Healthcare Research and Quality (AHRQ) to study “comparative effectiveness.” And the agency, in turn, is paying a company — Total Therapeutic Management — $11.6 million to recruit and train doctors, pharmacists and nurses to shill the findings of these comparative-effectiveness studies at high-volume medical practices. As a reward for listening to the government’s spiel, you get a continuing education credit from a $4 million fund.

It’s not clear why the government is using taxpayer money to pay people to sit in a doctor’s office and explain the wonders to be found by going to AHRQ’s website (at present, not many). But in case these busy physicians miss out on this wonderful opportunity for no-cost, taxpayer-funded education, the government is spending another $26 million for a national and regional PR campaign to raise awareness about the program.

But here’s the really amazing thing about the government doing what pharmaceutical companies would be hung, drawn and quartered for doing: Because the government is doing this, it doesn’t need government oversight! Yes, the FDA, which normally polices what can and cannot be said in the promotion of health care, will have no jurisdiction at all over what this sales force will tell health care providers about how medicine should be practiced.

The immediate problem with this is simply the reverse of the problem dogging Big Pharma: If you’ve spent a billion dollars on a new drug, you have an interest in touting it as vastly better than the drug that preceded it. But if you have an interest in saving a billion dollars — and the U.S. government, as the world’s largest payer for health care, most certainly has such an interest — then surely you have a corresponding incentive to recommend cheaper treatments.

All of which leads to the multimillion-dollar, devil-in-the-details question: What does “comparative effectiveness” actually mean?

In theory, it means finding the best treatment for any given medical problem. But how are decisions made about what’s best? What if drug A cures 50 percent of people and costs $1 a pill and drug B cures 52 percent of people with the same problem but costs $10 a pill? The cost savings of, say, treating a million people each year on Medicare by using drug A are huge — but what if you happen to be in the 2 percent for whom only drug B works, and there’s no surefire way to figure that out before treatment?

The problem with comparative effectiveness (according to Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner) is that it’s very different from clinical effectiveness. The former aggregates health care outcomes for a given treatment, while the latter addresses variation within those outcomes — what works best and why, for the individual.

In a recent commentary in Drug Information Journal, Pitts warns that comparative effectiveness, as presently conceived, not only risks derailing the development of personalized medicine, it could end up pushing health care toward the slippery slope of rationing. There is always a trade-off between care and cost, but that trade-off keeps changing as medicine advances. What’s crazy expensive today could be far cheaper in five years’ time, and it could trigger further incremental breakthroughs in treatment.

A glance at the AHRQ’s link-heavy website shows that a lot of its reports are already old, while the billion dollars it got from Congress has yet to deliver any major new findings. This isn’t particularly surprising: Comparative effectiveness research takes time. But what if the eventual results end up being out of date — or get challenged as critically flawed? What will a government “comparative effectiveness” health rep say in such cases?

Again, we don’t know, because the government doesn’t think it needs to regulate itself as a provider of health care research and purchaser of health care. Even if you are an opponent of so-called socialized medicine, you, me and everyone else needs socialized regulation for promoting medicine and treatment. Government should play by the same rules it sets for others. In this case, our future depends on its doing so.

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Obamacare and Prostate Cancer

05/29/2012 12:52 PM |

Another deadly taste of ObamaCare
The US Preventive Services Task Force ruled last week that screening for prostate cancer is a waste of money.

Get ready for many more such outrages: This is the agency that will determine which preventive services ObamaCare will require health plans to cover free of charge.

The task force claims that screening all adult men with the PSA (protein-specific antigen) test doesn’t prevent death from the disease. It argues that “the number of men who avoid dying of prostate cancer because of screening after 10 to 14 years is, at best, very small.”

Adding to the “costs” of the test are “false positives” — they tell people they have cancer when they don’t about 10 percent of the time. The task force thinks this problem makes the cost of screening higher than the tiny benefit screening generates for society.

It’s worth analyzing the road to this conclusion, because it tells us a lot about how ObamaCare rations medicine.

First, the task force measures the effect of testing on the death rate from anydisease (all-cause mortality). That’s a bogus benchmark, because, as John Maynard Keynes famously noted, in the long run we all die. In fact, death rates from prostate cancer have dropped 57 percent among men ages 49 to 64 and80 percent among adult men over 75. National Cancer Institute data show that prostate cancers are being detected and treated earlier and that life expectancy is rising as a result.

The task force claims there is no evidence that screening directly reduces prostate cancer. But how, then, did death rates decline, if screening doesn’t work?

It does, of course. As prostate-cancer expert William Catalano notes, PSA screening is why the horror of not diagnosing this cancer until it has metastasized (advanced and spread) has all but disappeared.

The task force states that because the PSA test is imprecise, it will always lead to overdiagnosis. But false positives are a risk of all screening, and the error rate for prostate-cancer screening is no higher than screening for other illnesses or cancers.

Catalano also points out that it’s regular testing — not the test being used — that has likely contributed to raising the odds against the disease.

The task force also claims that the PSA test can’t tell us which tumors to treat. Yet it gives the patient and his doctorstime to figure that out.

For most patients, PSA screening gives a 5-to-10-year lead time — a vital window in which other new techniques (needle biopsies plus improvements in surgery and radiotherapy) can work.

Finally, the task force argues that PSA testing causes men to suffer from painful treatments and endure anxiety about false-positive results. It doesn’t measure this cost or have any data to support it. Worse, it disregards the scientific evidence that treatments reduce suffering and improve quality of life, even if they don’t always increase survival.

In reality, this ban is based on politics, not science. The task force — and similar ObamaCare agencies — applies standards that aren’t achievable. Going forward, new technologies would require decades of data and would have to demonstrate they’re nearly 100 perfect before ObamaCare would cover them.

Unless, of course, the procedure is politically popular: ObamaCare will treat contraception as cost-effective, although there’s no hard data to support that claim.

The value of health-care services, in other words, will be measured by political criteria, not by their ability to reduce suffering and death.

That’s an ugly future, indeed.

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Getting Back on Track with Track and Trace

05/29/2012 08:11 AM |

Counterfeit medicines are growing at such an alarming rate that it finally made it onto the recent Camp David G8 agenda. Counterfeit Avastin has found its way into America’s legitimate supply chain.  It’s not just a theoretical problem any more. Now’s the time to close a major loophole that allows the purveyors of false profits to prey on an unsuspecting American public.

Now’s the time for a national standard for pharmaceutical track-and-trace that would enable manufacturers, wholesalers and distributors to provide documentation or a “pedigree” on the chain of custody of drug products, including identification of each prior sale, purchase or trade of a drug, along with the associated dates and parties involved

Earlier this month, 11 people were charged with the March 2010 record-breaking $75 million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010. Fortunately, all of the stolen drugs from the Lilly warehouse were recovered before they could be re-introduced into the legitimate supply chain. But we won’t always be so lucky.

Criminals are going to continue to attack our drug supply because they are always going to be attracted by the high value of drugs in the U.S. market.  You can’t prevent criminals from making attempts, but you can make it whole lot more difficult.

Now, while the iron is hot, is the perfect time to strike a blow for drug safety. There’s a general placeholder in the Senate version of PDUFA bill that requires more specifics. Now’s the time for the FDA to roll up its sleeves and work with Congress to come up with a national standard instead of leaving it up to each state to come up with it’s own standard (as in California). In many respects, the only thing worse than no standard is to have 50 different standards that would create 50 different ways for counterfeiters to game the system.

This isn’t a new problem. The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President in 1988. PDMA was enacted to (1) ensure that drug products purchased by consumers are safe and effective, and (2) avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs. Both Congress and the FDA recognized that such legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.

In 2004 (during my service as an FDA Associate Commissioner), I served on the agency’s first Counterfeit Drug Taskforce. Our report outlined a framework for public and private sector actions that could further protect Americans from counterfeit drugs, including implementation of new track and trace technologies to meet and surpass goals of the Prescription Drug Marketing Act (PDMA). Our framework called for a multi-layer approach to address the problem and included the following measures:

• Secure the product and packaging
• Secure the movement of drugs through the supply chain
• Secure business transactions
• Ensure appropriate regulatory oversight and enforcement
• Increase penalties
• Heighten vigilance and awareness
• International cooperation

But the devil is in the details and there’s always the danger of allowing the perfect to get in the way of the (public) good. Implementing PDMA has been a nightmare for 1000 reasons – not the least of which is a single, FDA-mandated track-and-trace technology. But time marches on.  Technological advances since 1988 provide a plethora of possibilities. It’s time for the FDA to work with all stakeholders and put a national standard in place.

And the FDA won’t be acting alone. In a May 22^nd colloquy, Senators Enzi and Harkin support moving forward with a more permanent and robust solution. Senator Enzi: “The language in the Manager’s Amendment is a placeholder to show our intent to continue working on this critical, but complex, policy.”  Senator Harkin: “The logical next step in this policy is to work to improve the safety of the drug distribution system that gets drugs from manufacturers to the pharmacists and other providers who dispense them to patients.  The FDA currently lacks the authority to establish a uniform, comprehensive national system to secure the pharmaceutical distribution supply chain.”

The complete colloquy can be found here.

It’s time to give the FDA the authority it needs to put 21^st century track and trace into commission on behalf of the public health.

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Substandard Subcontinent

05/25/2012 06:49 AM |

Compulsory what?

Drug regulation in India-the time is ripe for change

The Lancet

To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.

A damning 118-page report from the Indian Parliamentary Standing Committee on Health and Family Welfare documents its successive failings. It describes a vast, geographically disseminated organisation that is dangerously understaffed: nine officers at headquarters deal with 20 000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.

It is therefore not surprising that, of 42 approved drugs randomly chosen for investigation by the Committee, some had not passed through the correct regulatory channels. But the fact that 11 had no phase 3 studies done, 13 "did not have permission for sale in any of the major developed countries", and there was "no scientific evidence to show that...33 drugs are really effective and safe in Indian patients" points to problems at the very foundations of CDSCO. Its mission of meeting the aspirations ... demands and requirements of the pharmaceutical industry", rather than the protection of patients, is a very shaky foundation indeed.

The Committee's report has several suggestions for improvement. However, rather than trying to overhaul an organisation that is failing so catastrophically, India should seize this opportunity to wipe the slate clean and form a new drug regulatory body.

A smoothly running, professional drug regulatory body is essential to ensure, first, that high-quality, adequately assessed drugs are available to India's population and, second, that India's drug industry is regulated well enough to contribute successfully to India's domestic and export sectors. It should go without saying that whatever action India takes, the philosophy of the drug regulatory body should be the protection of patients, wherever they are.

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Injections vs Pills: Time To Stop Sticking It Cancer Patients

05/24/2012 04:47 PM |

This week the CDC recommended that baby boomers be screened for Hepatitis C.    The motivation behind this recommendation is the development of a new class of Hepatitis C treatments that are in pill form and not injected.  

Simplicity of treatment makes screening more successful.  Yet people who are identified with the disease may have to pay more out of pocket for more effective and convenient care than they do for less effective and time consuming infusions.  

That's because most health plans, following Medicare Part D,  pay 100 percent of the cost of injectble drugs while paying only 70-80 percent of new oral medications.  Since these drugs are expensive -- though relative to dying, permanent disability or the cost of repeated hospitalizations, organ transplants -- they are bargain patients wind up forking over tens of thousands of dollars for treatments do less.  Moreover, because you can take a pill at home the cost of infusion goes away.   

Our system of health care reimbursement is out of whack with the value of new, simpler treatments.  It covers what is cheapest and then only covers in part technologies that  work and are less instrusive if the cheap approach fails.  That, not over use of tests ot treatments, is the biggest source of waste in health care, a source that could be eliminated if we did things right the first time,

Similarly,  all new cancer drugs are in pill form.   They make staying alive and healthier, simpler to do.  They generate value for consumers who can go back to work, eliminate costly procedures such as blood transfusions, stem cell replacements and help avoid the side effects of chemo, which are tantamount to being shoved into a microwave while seasick.  

Maybe Medicare and health plans think they are saving money by forcing people to pay a penalty for better treatments that are more convenient.   They are wrong.   There is mounds of data demonstrating that every dollar spent on new cancer and HIV drugs  offset $7 spent other services.   And the combination of longer life, improved health and increased productivity is not even accounted.   My colleague John Vernon and I have shown that social value of increased health and longevity runs into the trillions.   Advances in cancer alone have allowed people to live longer with fewer disabilities.  If I were in control of my premium dollars, that's where I would want my money to go.

Instead, people -- particularly those with life threatening illnesses that are not caused by poor health habits -- have to pay more for these advances than any other health care service.   Does it make sense to subsidize massage therapy or birthing pools at a higher level than pills that prevent cancer .

We don't need lots of legislation to change the paradigm.   All the employers investing millions in 'wellness programs' could tell insurance plans the game has to change.   States can introduce legislation making parity a requirement.  Some will say this will add to the cost of premiums.  So what?  Studies have shown people are willing to pay more to be protected from catastrophic costs or give up the frills that are covered but never used.   I bet a health plan that covered pills to treat hepatitis C and cancer could keep premiums where they are if they stopped covering the extras like acupuncture, chiropractors, massage therapy,  gym memberships.   

Our way of paying for health insurance and covering benefits is still pre-industrial.   As I had mentioned in a previous post, you have to bribe doctors to use health IT even as thousands of health professionals are paying for iPads and using them in practice.   Simplicity empowers.   Medications are a highly efficient way of treating disease.   I don't mind paying a portion of the cost of these treatments out of pocket.  But it makes neither clinical or economic sense to force consumers to pay a higher percentage of the cost relative to less transformational care.    

If somone running for public office wants an issue to campaign on,  the tax on access to innovation that these co-pays impose is a great one.  In the meantime, companies have to do a better job of showing it's innovative products enhances value by increasing clinical utility for patients and reducing the complexity of care.    No doubt certain interests will oppose paying for progress that could eliminate their jobs or income.  But the last time I checked, the typewriter and bank teller lobbies didh't have much success.   On a related matter, why are we using clincal trial methodologies from the 19th century?  From recruitment to treatment to followup, we can use digital technologies, biomarkers, remote sensors to cut the time and cost of evaluating new products in more than half.   

Digital and personalized health technologies will creatively destroy the existing approach to medicine.  Only regulation and political inertia stand in the way. 

Change can be accelerated by we the patients.  As Eric Topol has written:  "the change will come from the truly empowered, beyond informed, consumer who has access to all the relevant data and is now fully participatory. This transcends the era of internet access to health information that started in the late1990’s, since now each individual should be able to access all of their biologic, physiologic, and anatomical data that was largely unobtainable before. And the earlier in life the better, in order to foster the critically needed emphasis on prevention of diseases—which
has been essentially ignored until now."

It's time to stop sticking it to patients when there are more empowering and powerful pills out there.  Read More & Comment...

Long Weekend at Bernie's

05/24/2012 04:22 PM |

PDUFA passes Senate 96-1. 1= Bernie Sanders, the Senator from Ben & Jerry's.

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Matryoshka HTA

05/24/2012 08:33 AM |

When money speaks – the truth is silent.

-- Russian Proverb

I’ve just returned from Moscow where I was proud to participate in the first ISPOR conference (co-sponsored by the Ministry of Health) on HTA ever held in the Rodina. And it was a very worthwhile experience.

The meeting featured a cast of international HTA all-stars. Some useful take-aways:

Luigi Migliorini (the WHO’s Special Representative to the Russian Federation) noted that the conference was taking place at the same time as the World Health Assembly – which he referred to as “the Duma of the WHO.” Whether he was making a somewhat forced local reference or trying to make some type of political statement is up for debate.

Hans Severens (Erasmus University) spoke about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context. 

If all politics is local – so to must HTA designs and decisions.

Severens said that, “all HTA research is biased.” This reinforces the point made by NICE’s Sir Michael Rawlins that HTA “is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists. There is no known piece of work which tells you what the threshold should be.  It is elusive."

Elusive indeed.

Jérôme Boehm (Health and Consumer Directorate, European Commission) discussed the EC’s work towards developing protocols to share HTA data through a common database – but that “HTA must be a national decision.” He also added that there should be “no interference between market authorization and HTA.”

Wim Goettsch (Deputy Secretary, Medicinal Products Reimbursement Committee, the Netherlands) also affirmed that HTA decisions should be taken at the local level and that it needs to be as much about relative effectiveness (what we in the US refer to as comparative clinical effectiveness). He also pointed to an EU-wide database of HTA studies (www.eunethta.eu) that is becoming the “go-to” source for existing reports and information.

EUNETHTA, describes itself as “focusing on scientific cooperation in HTA in Europe, thirty four government appointed organisations from the EU Member States, Accession Countries and EEA work together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries.”

(Is PCORI aware of this?  If not, they should spend some of their hundreds of millions of dollars doing so – rather than reinventing the wheel.)

And speaking of PCORI, Steve Pearson (Institute for Clinical and Economic Review), reinforced (and seemed to be bemoan) the fact that it cannot use any of its time or resources to address cost issues.

The US needs to learn from the successes as well as the failures of the European HTA experience. HTA isn’t easy. It isn’t foolproof. The science is in its early days and it is imprecise and cost containment is only one of many factors (and, according to all the speakers, not the most important). There isn’t a one-size-fits-all methodology.  As Mark Twain quipped, “For every complex problem there is usually one simple answer – and it is usually wrong.” That’s an adage we should keep in mind.  Alas – there is no universal Michael Moore-like “SiCKO” solution.

HTA cannot make political decisions – or make them any easier. A lesson we must learn as we debate the future of IPAB here at home.

Mira Pavlovic (Deputy Director, HAS) also spoke to the growing importance of EUNETHTA as well as the issues of HTA relative to choosing the best endpoints and comparators. She also addressed one of the 800 pound HTA gorillas – pharmacovigilance. She ended her talk by asking the big question – “Can we think prospectively.”

She also said that , since l’affaire Mediator, new conflict of interest rules have forced her agency to use physicians who have “sheep grazing around their offices.” Baa humbug.

Laura Sampietro-Colom (Hospital Clinic Barcelona and immediate Past-President  of Healthcare Technology Assessment International – HTAi) discussed the importance of international cooperation and data sharing and the organizations own HTA database. She mentioned that AHRQ is a member of HTAi. (Hopefully Carolyn Clancy has shared her password with Joe Selby over at PCORI.)

According to conference organizer Vitaly Omelyanovskiy (Director, Research Center for Clinical and Economic Evaluation and Pharmacoeconomics, Russian National Research Medical University), HTA is the “near abroad” meaning that, while still a foreign concept – it’s not too foreign. Russia’s initial goal, accordingly, is to begin studying international (meaning European) HTA information and experiences so that a more “Russian-style” program can de developed.

The US has much to learn from this thoughtful Russian model because, as Leslie Levin (Head, Medical Advisory Secretariat, Health Quality Ontario) so elegantly put it, “Nobody can do it alone.”

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G8 is not enough

05/23/2012 07:16 AM |

Not enough – but it’s a start.

On Saturday, May 19th, the G8 issued the 40-point Camp David Declaration. Point 9 of the declaration includes:

"To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products."

Not enough – but it’s a start. Just having the issue of drug safety on the agenda is a victory (as is a reaffirmation of the importance of intellectual property).

It's worth noting that according to our national law, any internet pharmacy attempting to sell prescription medicines to US citizens without a state pharmacy license is an illegal internet pharmacy.

Someone should share the G8 statement with Senator McCain and the other ill-advised supporters of drug importation.

The entire Camp David Declaration can be found here.

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Who Do You Trust With Your Prostate: The Government or Your Doctor?

05/22/2012 11:21 AM |

Another insipid, outdate and skewed report on cancer screening from the USPSTF.   How could AHRQ put this junk out, ignoring declining mortality rates from prostate cancer, particularly among the age groups that it claims should just be left to die?


"The challenge of ecologic data is that it is impossible to reliably separate out the relative effects of any changes in screening, diagnosis, or treatment practices (or fundamental changes in the underlying risk of developing or dying of the disease in the population due to a multiplicity of other causes) that may have been occurring simultaneously over a given time period. "

This is pure dissembling BS designed to justify rationing. 

Here is a more measured -- and patient-centered -- approach by urologist William Catalona:


The past half decade has seen a striking reduction of prostate cancer mortality rates in the US and other countries. The decrease has been ascribed, at least in part, to early diagnosis combined with more effective treatment, although there is no proof of a causal relationship.

Nevertheless, to the extent that early detection and effective treatment do reduce prostate cancer mortality and morbidity rates, PSA screening is clearly beneficial to many patients.

Some argue that PSA screening is not beneficial for all men screened because not every prostate cancer patient benefits from early diagnosis and treatment. Some tumors might never be life threatening and rare ones are incurable by the time the PSA level becomes elevated.

However, all available evidence suggests that PSA screening largely detects cancers that have features of clinically important cancers that are destined to cause suffering and death if untreated while they are still curable.

Some also argue that PSA screening is not beneficial to men who are never affected with prostate cancer. PSA screening does provide a feeling of well being in men who have persistently normal results, and even though a normal value can be misleading, with serial screening, PSA eventually reveals the cancer.  Read More & Comment...

Necessary vs. Unnecessary

05/22/2012 03:50 AM |

Dr. Stewart Segal delves into the debate over “necessary” vs. “unnecessary” tests:

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.

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Health IT Has A Facebook Problem

05/18/2012 07:29 PM |

 The Facebook IPO was today's biggest spectator sport.  It wasn't just speculation about how much higher above the launch price of the stock the new public company would generate.  Facebook is a phenomenon that has transformed how we connect faster and more profoundly than we could have imagined even 5 years ago.  Though Facebook has changed the way we use the Web and share information, it is being reshaped more quickly by a massive global shift to mobile technology.  As a Forbes report observes today.  more than 50% of FB use is on mobile devices such as smartphones and tablets.   FB has not yet figured out how it can make money in a mobile and fractionated economy.  It has $10 billion of cash to figure it out but it is likely that FB will only be successful if it changes the way we buy and sell things we value with it's technology.  (As did Apple.)

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.     Read More & Comment...

Limportation

05/18/2012 06:25 AM |

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.

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FDA's Animal Magnetism

05/17/2012 07:11 AM |

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

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FDA Approval of HIV Home Test Paves Way For More Personalized Medicine

05/16/2012 06:46 PM |

This is a building block for personalized and consumer driven medicine.  It will be hard to stop retail sales of other tests, including genomic-based tests that measure treatment response, after this vote.   I can't wait to see the teeth gnashing from Public Citizen, Merrill Goozner and other anti-innovation scolds. 

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."



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University drops student health insurance

05/16/2012 11:44 AM |

The Catholic Franciscan University in Ohio recently announced its decision to drop the student health insurance program on account of the HHS contraception mandate:

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.


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Eggs & Asteroids

05/15/2012 06:18 AM |

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

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Public citizen lobbies to make dying patients wait for new treatments

05/14/2012 02:32 PM |

Public citizen has opposed every new drug that helps patients since its inception... http://medcitynews.com/2012/05/pharma-device-firms-kill-conflict-of-interest-rule-win-accelerated-approval/   Read More & Comment...

Compliance of Champions

05/14/2012 06:33 AM |

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.

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Reps & Reparations

05/13/2012 09:46 AM |

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.

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Plan B "Chutzpah"

05/11/2012 06:15 AM |

For those of you following the Plan B saga, here’s the transcript of the April 27th, 2012 hearing in New York Federal Court.  

The April 27th hearing was supposed to be about whether Teva could intervene (to protect its 3 year exclusivity based on additional actual use/label comprehension studies FDA had acquired) and the court's order to show cause why the USG should not be held in contempt, but it also touched on the plaintiff's motion for a preliminary injunction/summary judgment and the government's motion to dismiss the case (which the judge denied orally at the hearing). 

The most amusing part of the transcript is when the government tries to argue that none of the plaintiffs are 13, so the court can't give relief as to them.  There were 13 years old when the case began, but the case has gone on so long they have reached the age of majority.  

The judge is scathing of the government's argument, saying "Do you know how long this agency -- your agency has done nothing and then you have the chutzpah to come in here and say that thirteen-year-olds who started the case are of age now." (See page 55.)

The judge is pretty scathing of Secretary Sebelius, referring to her logic as "totally ludicrous" (page 12).  He says that if Teva had appealed Sebelius's decision they would have won (page 24), but then later the DOJ lawyer points out that the Sebelius decision is not appealable, since it resulted in a complete response, which is not final agency action -- which the court finds odd (pages 38-43), at one point saying it seems like "blowing smoke."  

Later on the judge says, "this whole thing is an artificial construct at odds with common sense” (page 54) and wonders how the argument could be made with a“straight face” (page 55).  The judge also talks about how the no one can satisfy the Sebelius criteria because there are not enough 11 year olds who are having sex (pages 43-44). Ouch.

The judge also calls the FDA to task for not denying the citizens petition as soon as he remanded it to them (in 2009), and he thinks that as soon as the agency told Teva they needed to do more studies, FDA should have denied the Citizens petition. (This conversation begins on page 50.)

Yep.

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