Compounding the compounding issue

10/19/2012 06:32 PM |

The breathless overreaction to tainted steroid drugs from compounding pharmacies is inaccurate and misleading. Compounding is an important component of increasing excess and allowing people to use medicines they would not otherwise be able to tolerate.. Many of these drugs are the difference between life and death literally. So media accounts that flog the claim that patient groups manipulated the FDA to watered-down safety standards is unfortunate and damaging. Here's a more science based look at compounding..http://www.usciences.edu/smc/bulletin_96_04_spring07.pdf  Read More & Comment...

A Continued Attack on Physicians?

10/19/2012 11:59 AM |

An emergency room physician offers his perspective on the supposed problem of upcoding:

This is where it gets interesting. The feds and some consumer watchdogs view this trend as clear evidence of fraud and abuse, that the physicians are “upcoding” the visit levels to increase their income. On the other hand, I’ve spent the last decade trying to educate physicians on how to document the patient encounter so that you can accurately capture the legitimate value of the service provided. So I look at that trend and think to myself “Job well done.”

From the perspective of a practicing physician, the rules that govern the documentation required to capture a service level are deliberately onerous and designed to produce downcodes. They require the doc to collect far more data than is actually necessary based on the actual condition of the patient. You forget to check one box, you leave out one required element, and despite the complexity, gravity and risk of a patient’s condition, you will not be paid for the service. For years, we have been losing money to these archaic rules (they date from 1995), and we have been struggling to stem the leakage of revenue from our practices.

The industry responded to these rules by developing tools to comply with them. The first thing was to have professional coders. Prior to 2000, a substantial majority of ER charts were hand-coded by the physician; now that is quite rare. Then we got templated paper records which prompted the docs to get all the required data points. Now we have EMRs which do the same thing more efficiently. It’s no surprise that as an industry we have gotten better at meeting the guidelines.

And then there is the fact that the ER is a different place than it was in 2000. Our patients are older and sicker. We do more in the ER than was true in the past. Patients are rarely directly admitted any more, but rather get the majority of their admitting workup done in the ER. I don’t know how much of the skew in the above graph is due to these factors, but they shouldn’t be disregarded.

But I don’t like where this is going. The government is desperate, understandably, to save money on healthcare expenditures. They seem to have assumed their conclusion that the increased coding levels is fraudulent and unjustified, and there seem to be few voices disagreeing with them. Furthermore, there is some inappropriate upcoding, and it’s very easy for a patient with an egregious bill or a certain physician (or group) who pushed the envelope too far to be held up as anecdotal proof that doctors are all a bunch of thieves.

Read the full piece here.

 
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GMP Value

10/18/2012 09:09 AM |

An article in today’s New York Times discusses the crucial issue of drug manufacturing and Good Manufacturing Practices (Lapses at Big Drug Factories Add to Shortages). High quality drug manufacturing of medicines is a serious public health problem --  but FDA regulatory oversight is also at issue.

At present, 30% of manufacturing capacity is off-line due to FDA inspection issues. That’s a lot of capacity. In fact, according to the agency, 43% of reported potential shortages were due to manufacturing problems.

Safety is non-negotiable and alleviating a shortage by shorting GMPs is a bad and dangerous pathway. Expediency causes as many problems as it solves.

That being said, regulatory discretion must be part of the solution. With 30% of production capacity off-line because of FDA issues, the agency must work with manufacturers to find creative, science-based solutions. If you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.

The FDA might allow some temporary fixes that fall in line with that thinking. According to the FDA’s Jouhayna Saliba (senior regulatory program manager at the FDA's Drug Shortage Program). If a company discovers impurities that could be filtered out, the agency might allow the product to be shipped along with filters and explanations of how they are to be used in order to avoid a shortage, she said.

But who inspects the inspectors? Per that 30% of manufacturing capacity off-line due to FDA issues, perhaps the FDA should undertake an agency audit to see why there’s been such a jump in GMP issues. It’s hard to believe that year-over-year, production quality control has suffered such a significant lapse. Is there something wrong in the way FDA inspectors (many of them still wet behind the ears and eager to please) are doing their jobs?

It’s a question worth asking – and answering.   Read More & Comment...

Cognitive Dissonance on Biosimilars

10/18/2012 08:37 AM |

FDA is stressing the abbreviated part of the biosimilar development pathway, assuring sponsors that they can limit their required clinical demonstration with early analytical work. Rather than clinical evidence, characterization data will play a more significant role since (according to the agency) the purpose of a biosimilar development program is to establish a product’s similarity to the reference product, not safety and efficacy

The nascent pathway has “created cognitive dissonance in industry,” said Janet Woodcock. “People are going to have trouble with this.”

This represents, according to the Pink Sheet, “a tonal shift” for officials, who for most of the pathway’s young life emphasized the complexity of biosimilar products and how clinical studies were expected to be a key part of applications.

Woodcock said sponsors can limit their required clinical programs by bringing extensive characterization data early in the development process.

“The amount of clinical evidence needed, we conceive, is related to the amount of residual uncertainty that remains after you’ve done those less costly, actually more quantitative, and less time-consuming analytical and functional studies.”

 According to Kathleen Uhl, deputy director in CDER’s Office of Medical Policy, “The product development for a biosimilar is not a one-size-fits-all. Agency scientists will evaluate the applicant’s integration of [these] various type[s] of data and information to then provide an overall assessment that the biological product is biosimilar to a reference product.”

“What’s most important to illustrate here is the foundational elements of the analytics,” Uhl said. “The more extensive the analytical and functional comparative characterization, then it’s likely to permit a selective and targeted approach to subsequent non-clinical and clinical studies in order to determine biosimilarity.”

Predictability, as with biosimilarity, is in the eyes of the beholder.

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In Cancer Care, Value Matters More Than Cost

10/17/2012 02:40 PM |

An editorial  in the NYT -- " In Cancer Care, Cost Matters" --explains why Memorial Sloan Kettering has decided not to use a new angiogenesis drug from Sanofi called Zaltrap.   I am sure the article will trigger an either or debate about rationing, especially among those who hate medical progress because it's a product of capitalism (Marcia Angell, Merrill Goozner, Maggie Mahar) but the editorial is more thoughtful and science-based than those who will wave it around to make the case for rationing.  

Read the entire article but here's the gist of the piece:


"AT Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer: we are not going to give a phenomenally expensive new cancer drug to our patients.

The reasons are simple: The drug, Zaltrap, has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price — at $11,063 on average for a month of treatment — is more than twice as high.Ignoring the cost of care, though, is no longer tenable. Soaring spending has presented the medical community with a new obligation. When choosing treatments for a patient, we have to consider the financial strains they may cause alongside the benefits they might deliver....

This is particularly the case with cancer, where the cost of drugs, and of care over all, has risen precipitously. The typical new cancer drug coming on the market a decade ago cost about $4,500 per month (in 2012 dollars); since 2010 the median price has been around $10,000. Two of the new cancer drugs cost more than $35,000 each per month of treatment.

The burden of this cost is borne, increasingly, by patients themselves — and the effects can be devastating. In 2006, one-quarter of cancer patients reported that they had used up all or most of their savings paying for care; a study last year reported that 2 percent of cancer patients were driven into bankruptcy by their illness and its treatment. One in 10 cancer patients now reports spending more than $18,000 out of pocket on care."

...Avastin costs roughly $5,000 a month: very expensive in its own right, yet less than half of Zaltrap’s price tag. And while the side effects in both drugs are roughly equal, doses of Avastin generally take less time to administer than those of Zaltrap, which makes Avastin more convenient for patients."

When all is said an done, cancer drugs are less than 7 percent of all prescription drug spending.   The objections regarding price -- all things being equal -- overlook the cumulative contribution of medical innovation to longer survival, greater health value and lower treatment costs compared to caring for someone who is terminally ill.  

But the NYT editorial doesn't say all new drugs are useless or shouldn't be used until and unless proven cost-effective, the default position of the professional class making a bundle off of comparative effectiveness grants.  

Rather, it takes into account something the comparative effectiveness crowd never considers:   convenience to patients -- a key element to the value proposition in terms of adherence and outcomes. 

Avastin actually takes less infusion time – the standard being 90 1st dose, 60 2nd dose, then 30 thereafter.  Zaltrap is 60 minutes each time.  Avg number of doses in the trial is 7 and change, so infusion time for Avastin is about 2hours less for average patient.  That doesn't seem like a big deal but over the course of months, the waiting and preparation not only imposes a cost on patients but could also discourage compliance.  

So what if people don't respond to Avastin.  Will the Sanofi drug be used.   And is it really a matter of selecting one over another.  A recent study asked this  post-avastin question.  Sticking with Avastin  (but changing the chemo) prolongs life as much as changing the chemo and going from Avastin to zaltrap.  Response rates in the study were small but showed that within a subset of patients being treated for cancers guided by a VEGF-mechanism for longer periods of time increaes survival.   

Clinical trials that seek to compare an existing product with a new one are costly and difficult to run because who wants to enroll in them?  But the Sanofi drug could be used if it is found to work in a group of patients based upon KRAS mutation or variations in the VEGF signaling pathway..    Information like this can be obtained during clinical trials or in real world settings.  The cost and time of producing such findings are dropping as is the process of matching such results to meaningful patient-level outcomes including "hassle" and quality of life.  

Perhaps a better title for the op-ed should be In Cancer Care,  Value Matters More Than Cost.   Does a product prevent a disease from spreading?  Does it reduce the time and cost that someone with cancer have to bear?  Does it reduce the complexity of treating an illness?  And finally, what is the most effective, most convenient and less toxic treatment for individual patients?

Those are the questions MSK sought to ask and answer in a compassionate way.



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A Wrinkle in Time

10/17/2012 09:06 AM |

FDA calling.

The agency has again warned Avon to stop advertising its Anew skin care products using language that makes them sound like drugs.

In September, the regulator had warned L'Oreal SA for making similar claims.

In a letter dated October 5^th, FDA warns that the claims on the company's website implies products are intended to affect the structure or function of the human body.

That would make them drugs.

Speaking of DSHEA reform …

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App Sense Makes the Heart Grow Fond

10/16/2012 07:48 AM |

It is common sense to take a method and try it. If it fails, admit it frankly and try another. But above all, try something.

-- Franklin Roosevelt

At a recent social media discussion with a Big Pharma regulatory executive, the question on the table was, “What rules apply when there are none?

The answer, “You use your judgment.”

Wise words.

What about blocking or otherwise avoiding user-generated content?

“When you try to block interaction, all you succeed in doing is driving it underground.”

Words to the wise.

Science is nothing but developed perception, interpreted intent, common sense rounded out and minutely articulated.

-- George Santayana   Read More & Comment...

Another Way Not To Stomach Obamacare...

10/16/2012 01:10 AM |

Surgeons remove teen's stomach after she drinks liquid nitrogen cocktail

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Compare and Contrast with Clarity: The FDAMA 114 Rules of Engagement

10/15/2012 12:56 PM |

Per a new PhRMA white paper, FDA guidance on the supporting evidence drug companies need for the health care economic data they send to formulary managers should specifically allow for use of a range of data sources, not limited to adequate and well-controlled clinical trials.

The white paper urges the agency to develop formal regulatory guidance on Sec. 114 of the FDA Modernization Act of 1997, which allows drug companies to proactively disseminate health care economic information to formulary committees within certain limitations.

In the 15 years since FDAMA was passed, FDA has yet to issue formal guidance on Sec. 114. As a result, “many biopharmaceutical companies are reluctant to engage in these communications,” PhRMA points out, and “the promise of FDAMA Sec. 114 has not been fully realized.” A recent analysis of FDA enforcement actions over the past 10 years supports the premise that drug companies have been slow to engage in promotional activity under Sec. 114.

Sec. 114 requires that economic information be supported by “competent and reliable scientific evidence,” which was intended as a more flexible standard than the “substantial evidence” standard for drug approvals, PhRMA maintains. The “competent and reliable” standard was drawn from the Federal Trade Commission’s standard for supporting promotional claims.

The white paper outlines a number of data elements that should satisfy the competent and reliable scientific evidence standard. They include: methods for establishing economic costs and consequences that are widely accepted by experts in the field using a clear, pre-defined study protocol; an “accurate and balanced assessment of the economic consequences of a drug therapy, consistent with the current weight of credible evidence”; a representative study population; and information that allows the reader to determine how the research was conducted.

PhRMA recommends that FDA allow the competent and reliable standard to be satisfied with data obtained through a number of different methods, including observational study designs, database reviews and other economic modeling techniques. “There should be no pre-specified number or type of study required to substantiate a claim."

For example, “a claim that a drug is more cost-effective than a competing drug may be made where the cost savings are due to reduced resource utilization resulting from improved efficacy outcomes, decreased administration or monitoring costs, or where the difference in cost is due to the drug causing fewer adverse events, as long as these differences are supported by competent and reliable evidence.”

PhRMA argues that FDA should not consider such a statement a comparative clinical claim, which would trigger the “substantial evidence” requirement involving clinical trials.

Companies should be permitted to disseminate data on the “real world” economic implications of a therapy on health outcomes, according to the white paper. For example, “if a manufacturer conducts a competent and reliable study investigating the impact of a drug indicated for the treatment of diabetes mellitus on costs associated with cardiovascular care, the manufacturer should be permitted to proactively disseminate such data to appropriate audiences.”
 

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Less Chatter, More Action More Quickly

10/12/2012 04:06 PM |

Does the chatter about health care and innovation increase in inverse proportion to doing something that makes lliving longer easier and cheaper to do?

Or is just just because rent-seeking behavior, especially in health care,  is all about making money by charging admission fees to show up to conferences where the usual talking points about CER, value-based purchasing, etc are shared?  Is Don Berwick actually being paid to talk about Medicare activities that consist of charging people to talk about Medicare?  Yes. 

So here's a refreshing point of view.  Enough of using social media to just talk and spread the fertilizer around.. how about using it to take action against disease more quickly..

http://www.forbes.com/sites/ashoka/2012/10/12/lets-move-from-breast-cancer-awareness-to-collaboration-around-solutions/


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Morning Joe (Biden)

10/12/2012 09:11 AM |

Senator Joe Biden voted against the Medicare prescription drug benefit (Part D). Vice President Biden warned said that a Romney Administration would take it away.

This proves one thing -- Part D is a big success.

No up-for-reelection veep, on a nationally televised debate during a tight race is going to be against a program with approval ratings above 90%, universally acknowledged as improving the health of seniors, and is regularly coming in below budget estimates.

What neither Vice President Biden (not surprisingly) nor Congressman Ryan (surprisingly) mentioned is the reason Part D is so successful -- its design as a public/private partnership.

Vice President Biden mentioned (although not by name) the Non-Interference Clause – and that we should do away with it. Wrong. He did not mention it was designed by then Senator Tom Daschle and the late Senator Ted Kennedy during the debate over ClintonCare.

The first question to ask is, what did Senators Tom Daschle and Ted Kennedy know that President Obama does not?  The answer is that allowing the Federal government to directly negotiate for Medicare drug prices is a bad idea.  That’s why they (Daschle and Kennedy) drafted the original language for the Non-Interference Clause.

Politics aside, consider the facts:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

And in the words of the American vox populi (aka, USA Today):

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

Many of the President’s men and women are ready with the following talking point, “Look at how successful direct Federal negotiation works for the Veteran’s Administration,” suggesting that allowing the feds to directly negotiate for Part D is no different from the current VA scenario. But suggesting that the Veteran’s Administration “negotiates” prices for prescription drugs is a false premise. 

Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.” The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.” The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.

A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.

There’s a big difference between negotiating and mandating – and it’s not a thin line. A negotiated Part D plan is but the first step towards a more strident program of government price controls.

The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. 

Say it is so, Joe.

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(Re)Admitting Mistakes

10/11/2012 03:36 PM |

In a WSJ op-ed a while back,  Donald Berwick, Ezekiel Emanual and someone else I don't remember claimed that Obamacare and Medicare reform was really all about using market forces.  I've discussed the absurdity of this claim in previous posts but then again it I fully expect anyone who flacks for the Obama administration on almost anything to say the exact opposite of the facts.   Three million young adults have health insurance thanks to Obamacare?  Who cares if the real number is under 250,000.    Millions of seniors got rebates and free drugs?   Let's ignore the fact that the administration is shoving more new drugs under Part D so they don't have to pay a larger share under part B.

Ditto this claim that market forces and pay for performance will save Medicare tons.   

Here's the lede about the results of yet another Medicare demonstration project that saved no money...


Medicare penalty fails to curb hospital-acquired infections
By Karen Cheung-Larivee

Four years after the Centers for Medicare & Medicaid Services discontinued payments for preventable hospital-acquired conditions (HACs), new research finds that the policy had no effect on curbing infections, published today in The New England Journal of Medicine.

In October 2008, CMS discontinued additional payments for preventable HACs, according to the American Society for Healthcare Risk Management:

Vascular-catheter-associated infection
Catheter-associated urinary tract infection
Pressure ulcers (stage III and IV)
Falls and trauma
Surgical site infection after bariatric surgery for obesity
Certain orthopedic procedures
Bypass surgery (mediastinitis)
Administration of incompatible blood
Air embolism
Foreign object unintentionally retained after surgery
Although the policy only cut back an average of six-tenths of a percent of Medicare revenue, according to The Boston Globe, it was a high-profile policy change toward a pay-for-performance approach to reimbursement.

Researchers looked specifically at data from 2006 through 2011 on central catheter-associated bloodstream infections and catheter-associated urinary tract infections and compared infection data against rates of ventilator-associated pneumonia, which is not under the nonpayment policy.

The result: Researchers found "no evidence that the 2008 CMS policy to reduce payments for central catheter-associated bloodstream infections and catheter-associated urinary tract infections had any measurable effect on infection rates," study authors wrote.

Still, researchers acknowledged that hospital infection rates are falling overall.

Although infections rates have generally dropped since 2006, it wasn't because of the Medicare penalties, U.S. News and World Report's HealthDay reported.

"It had really nothing to do with the CMS policy," Grace Lee, associate professor at Harvard Pilgrim Health Care Institute and Harvard Medical School, told The Boston Globe.

The downward trend was happening well before policy implementation, due to hospitals taking charge of infections. Hospitals may already haven taken big steps to control infections in the years prior, Lee said.

The overall improved infection rates also may have more to do with rigorous coding procedures, in which case, the improved rates demonstrate better administrative skills rather than better quality, HealthDay noted.

The research strengthens some providers' discontent with the federal agency's "stick" approach, in which CMS halts reimbursement for what it deems preventable or avoidable events.

American Hospital Association Vice President Nancy Foster told The Wall Street Journal the study should make policy makers "take a step back and say, 'Are payment penalties the right way to go; do they actually add to the efforts?' on reducing infections and other hospital-acquired conditions?"

Post-election,  the $10 billion or so in new money for all these demonstration projects should be ripe for elimination.   

The best way to stop an infection from spreading is to get at the underlying cause....  Read More & Comment...

Uncle Sam's Secret CME

10/11/2012 11:30 AM |

As previously reported (‘Heavy Meddle,” May 3, 2012), when our tax-payer funded government detailers call to schedule an appointment with a “high-volume” prescriber, one of the enticements they offer are free CME credits.

Who accredits those CME credits?  Here’s how Barry Patel, CEO of Total Therapeutic Management (the company contracted by the AHRQ to handle it’s so-called “academic detailing” program) responded:

“One of AHRQ’s contractors, PRIME, Inc., coordinates accreditation for the CE/CME modules presented during the visits. PRIME works with the appropriate accrediting bodies for the different types of clinicians taking part in the visits, including doctors, nurses, pharmacists, physician assistants, and others.”

I shared Mr. Patel’s response with ACCME and asked how they felt about free CME being offered as an enticement to a physician. Here is the response I received:

“Questions about credit should be asked of the credit systems."

Punt!

When I pressed for an answer, this is what I was sent:

"You are welcome to refer to our Web site for information about our accreditation requirements and accredited providers. We do not comment on specific accredited providers or activities and we do not have any further comments to make at this time."

That’s the nadir of ACCME.

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From Buproion to Biosimilars

10/10/2012 08:13 AM |

According to an article in BioWorld Today:

The FDA’s decision last week that an approved generic bupropion wasn’t comparable to GlaxoSmithKline plc’s antidepressant Wellbutrin XL 300 mg (bupropion) raises questions about the hurdles biosimilar developers may face along the new regulatory path.

Those challenges likely would be exacerbated when developing biosimilars to drugs such as antidepressants, which fall into a narrow therapeutic index, according to Pitts. In April 2010, the Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs constitute a distinct group and that the FDA should develop a formal list of those drugs, he pointed out. In an 11-2 vote, the committee also concluded that existing bioequivalence standards were not sufficient for drugs in the narrow therapeutic index group.

“The issue with biosimilars is interchangeability,” Pitts told BioWorld Today. Differences between small-molecule drugs like Wellbutrin and biosimilars are iteratively more complicated than they are with generics because they involve not just the chemical composition of the product but also the manufacturing process.

“When it comes to biosimilars, you’re talking about molecules that are between 5,000 and 20,000 atoms,” he added. “The question is whether a 5,000-atom biosimilar is less difficult than a 20,000-atom biosimilar. Of course it is.”

Thus, biosimilars developers must prepare to contend with “many, many more ways to cut safety and efficacy” data, Pitts added.

The Budeprion/Wellbutrin decision indicated the FDA now realizes that issues of similarity exist even with small molecules, Pitts said. “With biosimilars, it’s going it’s going to be a billion times more complicated,” he cautioned.

Still, the fact that the FDA is feeling its way along the biosimilars regulatory pathway and potentially revisiting its general approach to extrapolation should give biosimilars developers pause, Pitts suggested.

“Ten years from now, when the FDA has more experience dealing with this, [the pathway] will be more predictable,” he said. “But now, every biosimilar that comes before the FDA for review is going to be a de novo experience. It’s going to be a very difficult, very risky and very problematic process. From a business standpoint, you have to ask yourself: Is this a worthwhile proposition?”

Tough questions with no easy answers.

The complete Bioworld Today article can be found here (bottom right, page one).

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Signal-to-Noise Toys

10/09/2012 09:18 AM |

In case you think that, by avoiding more active engagement in social media, adverse event reporting isn’t going to catch up with you – think again.

The Wall Street Journal reports that, “Scientists are sifting through massive quantities of freely available data scattered across the Internet, aiming to catch potentially deadly problems with prescription drugs more quickly—even ahead of federal regulators.”

Researchers from the University of Virginia and West Virginia University have developed mathematical recipes that computers use to filter billions of pieces of data from patient comments in online chats, websites and news stories to detect serious adverse drug reactions.

They then catalog the complaints and determine when they rise to a level that deserves medical or regulatory attention. Similar techniques have been used to detect bioterrorism threats, study crowd and consumer behavior and map out how infections spread.

The goal is to be able to alert the medical community about possible negative drug reactions much earlier so they can use it their clinical practices, as well as to warn the FDA about potential new adverse reactions.

The challenge for researchers, they say, is to sort through tons of "noise," the reams of information that aren't relevant, accurate or important, and to recognize useful signals. Researchers hope to use continually improving computer algorithms—programs that detect key patterns or relationships between words—to make recognition of important signals more accurate, says Ahmed Abbasi, a professor of information technology at the University of Virginia's McIntire School of Commerce in Charlottesville.

In preliminary data, they found that 80% of the time, their formulas detected potential adverse event patterns three months earlier than the FDA issued warnings, said Dr. Adjeroh, a computer science professor at West Virginia University in Morgantown. In some cases, they were years ahead of the FDA's warnings. The researchers were recently awarded a $130,000 grant from the National Science Foundation Smart Health and Wellbeing program to launch a bigger project in this area.

Such big-data approaches move away from a reliance on voluntary reporting and clinical intuition. "There's always been this struggle between intuition and data," says Dr. Abbasi. "There's a paradigm shift where data-driven decision-making is being increasingly adopted."

Note to industry:  Lead, Follow, or Get Out of the Way.

Suggestion to industry:  Lead.

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All Partners, Foreign and Domestic

10/09/2012 09:01 AM |

You can use all the quantitative data you can get, but you still have to distrust it and use your own intelligence and judgment.

-- Alvin Toffler                                             

Last week (October 1 at the at the Center for Strategic and International Studies), FDA Commish Peggy Hamburg noted that the recently enacted FDA Safety and Innovation Act provides the agency with new authorities surrounding information-sharing with foreign regulators, as well as user fees to pay for some of those activities.

Information-sharing “makes complete sense. There’s too much work to be done, you have to do it together across nations with an agreed-on set of standards and outcome measures. But if we rely on an inspection done by another country and then there’s a problem, everybody’s going to say, ‘How could you possibly have let that happen?’ So I think we do have to be realistic about that.”

If FDA takes action based on information collected by other regulatory authorities “and something goes wrong, there’s going to be a price to pay. So I think that there’s going to be a pendulum that’s going to go back and forth as we move towards systems that hopefully will work in a more enduring way.”

In other words, there has to be political accountability for domestic regulatory decisions. No argument there. But that doesn’t mean the use of non-US data should be verboten. And it doesn’t mean there shouldn’t be a predictable way the agency uses such data in domestic regulatory matters.

That is both “realistic” and “enduring.”

No foreign policy, no matter how ingenious, has any chance of success if it is born in the minds of few and carried in the hearts of many.”

-- Theodore Roosevelt

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High V

10/08/2012 09:10 AM |

From PDUFA V to Pangea V. 

FDA is ordering operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers.

It also follows the FDA’s launch last Friday of a campaign to warn consumers that the vast majority of online pharmacies do not follow laws or pharmacy industry standards and their products could harm or even kill people. The campaign includes a new website, www.fda.gov/BeSafeRx, that explains the risks of fake online pharmacies and how to tell the difference between those websites and legitimate ones.

The FDA has sent warning letters to three companies behind most of the 4,100 websites it identified as illegally selling potentially dangerous, unapproved drugs. It’s also seized some illegal medicines, filed civil and criminal charges against companies and individuals, and contacted Internet registrars and service providers, asking them to suspend the 4,100 websites.

According to the FDA one business, called CanadaDrugs.com, operates 3,710 of the targeted websites. Another company, identified in the warning letter as Eyal Bar Oz, runs more than 200 sites. A third company, called Arkadiy Kisin/White Forest Solutions, also operates more than 200 sites.

The drugs include various versions of the erectile dysfunction drugs Viagra, Levitra and Cialis, as well as an unapproved contraceptive called Norplant, an unapproved generic version of the influenza treatment Tamiflu, an unapproved antibiotic called Baycip TZ, and a drug for stomach disorders that also increases production of breast milk but is not approved because it’s been linked to irregular heartbeats, cardiac arrest and sudden death.

The warning letters say that the websites have been offering unapproved drugs to U.S. consumers. The letters, sent to the companies between Sept. 18 and 21, order them to reply within 10 business days.

As yet -- no reported replies.

The warning letters to the three companies are part of a simultaneous crackdown on online sellers of counterfeit and illegal medical products, involving police and regulators in 100 countries around the world. The fifth annual campaign coordinated by Interpol, the international police agency, is known as the International Internet Week of Action, and also as Operation Pangea V.

Let's hope that, in the case of Pangea, "V" also stands for "Victory."

 

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Washington Didn't Sleep Here

10/05/2012 11:28 AM |

Last night in Seattle I was honored to speak at a dinner sponsored by the Washington Policy Center (where I am an adjunct scholar). The attendees were physicians, hospitalists, representatives of the biotech industry, provider organizations, and state legislators. The topic was:  Biosimilars: The Precarious Struggle Between Cost-driven Health Care Policy and Patient-centered Care.

Why a “precarious struggle?”

Because physicians live in a world where cost concerns of patients, insurance companies and the government chaff against the freedom to practice the art and science of patient-centered care.

At the same time, legislators are constantly bombarded with public policy schemes that claim to solve the problem of providing more health care dollars at a time of historic belt cinching. To paraphrase H.L. Mencken, for every complex problem there is a simple solution — and it is usually wrong.

These are the tensions that exist in the world of health care reform and biosimilar medicines that will cause problems in examination rooms and legislative chambers nationwide because they prevent people from having a clear understanding of what biosimilar drugs are and how they impact patient treatment.

A policy of forcing the use of “cheaper” medicines also has a chilling effect on medical innovation and economic investment.

Wanting something to be true (whether a “magic pill” for a state’s budgetary woes or a “risk-free” way to reduce a patient’s medical expenses) should not cloud the judgment of lawmakers or physicians. Careful consideration of the advantages and disadvantages of biosimilar drugs should be the guiding principle for both physicians and legislators to ensure we “first do no harm.”

Policymakers must seek out the counsel of physicians, medical and disease organization and, yes, also patient groups as they consider ways to address and implement health care reform. Biosimilars are but the most recent addition to that complicated and highly political conversation. When it comes to biosimilars, partisanship must be put aside because a legislative misstep based on a misunderstanding of the science (or the blinders of party loyalties) could have significant unintended consequences not just for budgetary reform, but for patient health and safety.

My remarks were based on a new paper, a primer on biosimilar drug policy for both policymakers and physicians. It can be found here.

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Conservative Case For Obamacare: A Post Debate Perspective

10/04/2012 02:40 PM |

If you are part of the small circle of people who lay claim to being a health policy "expert" then you have read and commented on J. D Kleinke's NYT op-ed, The Conservative Case For Obamacare.   JD ( who I have known for at least 20 years) asserts that Obamacare is really based on conservative principles and but for the fact that it covers contraception and that the credit went to the President and not Republicans, conservatives would like the new law.  

Conservative health policy types have written op-eds or posted blogs refuting Kleinke's claim.  Tom Miller, also of AEI,  sums up the response of Kleinke's critics when he writes that Kleinke's op-ed:

"Recycles a fact-challenged rewriting of health-policy history and combines flawed analysis with wishful thinking.
Kleinke argues that the individual mandate and health exchanges of the Affordable Care Act (ACA) were, and should remain, sound conservative ideas meriting Republican support. He imagines that, but for crass political calculations, Republican leaders would be taking credit for what President Obama borrowed from them."

I am not going to pile onto Kleinke.  I woud only add that he wrote nothing new.   The claim that Obamacare is based on conservative proposals and ideas -- and it a carbon copy of 'Romneycare' is a standard Democratic talking point.    Indeed, President Obama stated as much in last night's debate.  

 The New York Times published his piece for three reasons:

1.   He is a resident fellow at AEI, a conservative think tank.  If Jonathan Livingston Gruber had written the article, it would have seen the light of day, which by the way, is a fitting final destination for all of Gruber's work. 
2.   In the article he made the ad hominem assertion that social conservatives want the government to tell women they can't have abortions.  
3.   He endorsed the liberal's view that conservatives made up things like death panels to scare people. 

Without attempting to put words into JD's mouth or op-ed,  I think what he was really trying to say is Obamacare uses the rhetoric of the marketplace, retains in a half-baked way reforms such as HSA and uses tax credits to pay for private coverage, many on the left still dislike the new health law because it's not single payer.   That's the true measure of how market driven Obamacare is and, as a result, conservatives should claim ownership
Indeed, the last line in his NYT piece states: 

"The real problem with the health care plan — for Mr. Romney and the Republicans in general — is that political credit for it goes to Mr. Obama. Now, Mr. Romney is in a terrible fix trying to spin his way out of this paradox and tear down something he knows is right — something for which he ought to be taking great political credit of his own."

Let's grant Kleinke his argument for a moment, that the use of exchanges, tax credits and an individual  mandate to reform healthcare are conservative ideas.   He ignores the most important conservative objections to Obamacare:

1.   It uses price controls to cut spending in Medicare, takes about $60 billion from Social Security and eliminates market choices for seniors to pay for Medicaid for the middle class.   
2.   It uses and creates agencies that will, decide what all health plans should cover,  tell doctors what procedures are "best",  and will 'control'  Medicare spending by deciding what new technologies and treatments to pay for.  

Finally,   conservatives object to Obamacare because it imposes new taxes on most Americans and compells them to buy a product, the price and composition of which is determined by the government.   

The Soviet Union used market mechanisms for it's 5 year plans.   It set prices, decided upon both the array of goods to be produced as well as where they would be sold and at white price.   One year Soviet factories made a lot of shoes for left feet only.   

And all of this would be nearly laughable if people were not compelled to buy the products at the prices set.   But that's in fact what Obamacare is (and Romneycare isn't):  a government created market that only functions because it taxes people and forces them to buy only government developed and subsidized insurance products.  As Grace Marie Turner noted:  "According to a research arm of Congress, the Congressional Research Service, over time, “families will both pay higher penalties and reach the cap at lower income amounts.” This new ObamaCare tax will, like the Alternative Minimum Tax, hit more and more people over time as incomes rise."

I don't know if JD doesn't understand that how a market is organized is more important than calling something a market or if he just using the rhetorical stance to suck up to the NYT.   One thing I do know:  JD has always been an articulate supporter of making consumers more responsible for health care decisions.  In 2003 I sponsored a Manhattan Institute forum where he said: 

"We have come to expect that health insurance should pay not just for disease, but also for impairment, discomfort, and vanity. Why shouldn’t it? Everyone wants something for nothing. It’s human nature. That’s the real problem. The problem isn’t how much better we are getting at finding new medications as a society. The problems is the fact that the health insurance enterprise is gargantuan and ever expanding, along with being inefficient and generating incredibly archaic and bizarre rules.

What’s the solution for this? It’s the simplest thing in the world. Reform the tax code. If people are going to insist on buying everything, down to the $200 deductible with their employer’s money, which is really their money, they should simply continue to do so - but direct that spending personally. It should fall outside of the health insurance premium. Deductibles should be raised to something resembling what we had decades ago, when insurance was involved only when someone got really sick. The premiums for this type of coverage are much lower. And the difference can be set aside, pre-tax, for all that routine spending. This way, for a great deal of the health care entereprise generally, we get consumers far more involved and bureaucrats far less involved."

That's one of the most concise and thoughtful summation of a new health care payment model I ever heard.   JD is not only as smart as the people criticizing him, he has also run and set up health care companies.   That's the JD I know and learned from.    

I disagree with his NYT op-ed and think his characterization of Obamacare as market-driven is either misguided or misleading.  And I believe this attack on the pro-life community was a cheap shot.   

But as Mitt Romney showed in his deft defense of the Massachusetts health reform, there's a grain of truth and insight in what Kleinke wrote.   Tax credits, market competition and increase consumer responsibility are the core of conservative health proposals  have become mainstream, the leading health systems are far and away more efficient and consumer-driven then, say, the VA where delay and sub-substandard care for wounded warriors is the norm.    And as the President demonstrated, liberals see any market-driven changes in our health care system as a threat to a single payer government run system like those in Canada or Great Britain.  Why would the president repeatedly defend a government panel established to decide what new technologies and treatments should be used and whether to pay for them?    Repealing Obamacare means shutting down a government run marketplace and expanding consumer choice.

As JD notes: It's the simplest thing in the world.  



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"D"lightful

10/04/2012 09:28 AM |

A new poll sponsored by Medicare Today (an initiative of the Healthcare Leadership Council) shows that 90% of seniors are satisfied with Medicare Part D -- and approval has constantly risen since the plan came on line in 2006.

"Nearly seven years later, 9 in 10 Medicare beneficiaries have prescription drug coverage," says the poll. "Satisfaction among those with Medicare Part D has grown 12 points from 78% to 90%. Most are very satisfied with their coverage and say their plan offers excellent value, reasonable costs, and convenience."


Seniors "feel peace of mind" with the prescription drug program, and regard it as "a safety net."



Among other poll findings show that without Part D:

-- 84% report that out-of-pocket drug costs would be higher.

-- 61% would be unable to fill all of their prescriptions.

-- 53% would be more likely to cut back or stop taking medicine altogether.



Cooperation and partnership between the free market and Uncle Sam works.

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