No end in sight

03/12/2012 10:56 AM |

Politico correctly notes that the Supreme Court ruling on the ACA will do little to end the debate on President Obama’s health care law:
 
When the Supreme Court's ruling comes down, probably in June, whoever wins will try to make it sound like the final word on the ACA. But everyone knows that just isn't the case. For Republicans, a win would validate their two-year fight against "Obamacare." For Democrats, a win means the ultimate stamp of approval on Obama's signature policy achievement and the chance to accuse Republicans of wasting the past two years fighting a law that's constitutional. If the court strikes the individual mandate but leaves the rest of the law in place, that would leave policymakers in a tough situation. Or, even if the mandate stays, it does nothing to erase the provision's unpopularity.  Read More & Comment...

Living in a post IPAB world

03/09/2012 07:14 AM |

Those who opposed the health care bill are debating whether “repeal and replace” should be the clarion call in the coming election. Regardless of how this debate turns out, those in favor of doing better should focus their immediate attention on identifying and fixing the most harmful parts of the bill. The Independent Payment Advisory Board, or IPAB, should be a top target.

Sometimes dreams do come true.

IPAB needs to go, but the goal of reigning in Medicare expenses is a worthy one. As is, the program’s costs are spiraling out of control: Medicare is projected to accumulate a $38 trillion budget shortfall during the next 75 years.

Not only does IPAB further grease the slippery slope towards government price controls and rationing -- it doesn’t even have any authority over the biggest cost-drivers in Medicare.

Medicare Part A, for instance, is so expensive its reserves will be empty by 2017, according to the Medicare Trustees. Part A covers in-patient hospitals stays. By 2035, the program’s revenues will only finance about half of promised benefits.

Medicare Part B, which covers out-patient services, has similar cost problems. Administrators just raised Part B premiums on nearly a quarter of beneficiaries because expenses have gotten so high. And an analysis from the Congressional Research Service found that without substantial hikes in Part B premiums, the program’s finances are “at risk of exhaustion.”

Yet the IPAB has no power over Part A or Part B.

If left unaltered, Medicare could literally bankrupt this country.

Last June, HHS launched two important new health care cost-saving initiatives.

First, the HHS announced it would make $42 million available to enhance coordination efforts between primary care physicians and other health care providers treating Medicare patients. The potential savings are estimated at $125 billion over the next 10 years.

Second, the HHS launched a $40 million effort to help states combat chronic disease. Chronic diseases are responsible for 75 percent of our health care costs—diabetes, heart disease and strokes alone account for nearly $1 trillion in medical spending annually.

Both initiatives have the promise to save money and lives. Unfortunately, they represent the opposite approach to Medicare cost control set forth in the Affordable Care Act.

On one hand, the two new HHS initiatives show that the Obama administration is making credible efforts to target the areas of the health care system that could produce the most savings. On the other hand, the Affordable Care Act through IPAB seeks to devalue efforts such as these in favor of squeezing doctors and other providers.

The right way forward is to get rid of IPAB and substitute for it a Medicare cost-savings plan that encourages long-term strategic thinking along the lines of these HHS studies.

Support for IPAB is rapidly and rightly collapsing as citizens become better informed about the danger this all-powerful panel of unelected bureaucrats poses to their health care. It’s time to urge Congress to get rid of IPAB and stand up for real Medicare reform.

  Read More & Comment...

Counterfeit Jail Bait

03/08/2012 08:45 AM |

In 2004 I was a member of the FDA’s inaugural counterfeit drug taskforce. Our draft report called for stiffer criminal penalties for the purveyors of false profits – but we were told to remove that particular codicil because it was “outside of our jurisdiction.”

Now? Well, better late than never. Here’s the press release from Senator Grassley’s office:

Senate Approves Leahy-Grassley Bill To Increase Penalties For Counterfeit Drugs

WASHINGTON – The Senate Tuesday night unanimously approved a bill authored by U.S. Senators Patrick Leahy (D-Vt.) and Chuck Grassley (R-Iowa) to increase penalties for trafficking counterfeit drugs.  The legislation responds to recommendations made by the U.S. Intellectual Property Enforcement Coordinator and the administration’s Counterfeit Pharmaceutical Inter-agency Working Group.

The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public.  While it is currently illegal to introduce counterfeit drugs into interstate commerce, the penalties are no different than those for the trafficking of other products, such as electronics or clothing.  The Counterfeit Drug Penalty Enhancement Act will target violators that knowingly manufacture, sell or traffic counterfeit medicines to the United States.

“We cannot allow the counterfeiting of life-saving medicine to be just one more low-risk venture from which international organized criminals can profit,” said Leahy.  “While we should not expect that enactment of this or any legislation will completely deter the serious problem of counterfeit medication entering the American supply chain, it is an important step in the fight.  I urge the House of Representatives to act quickly on this legislation.”

“Worldwide counterfeit medicines are a multi-billion dollar industry, and growing at an alarming pace, especially over the internet.  These medicines pose a serious threat to the health and safety of unsuspecting Americans,” Grassley said.  “The House should act as quickly as possible to ensure that counterfeit drug traffickers are punished accordingly for putting people’s lives at risk with this serious crime.”

The legislation is cosponsored by Senators Michael Bennet (D-Colo.), Richard Blumenthal (D-Conn.), Sheldon Whitehouse (D-R.I.), Dianne Feinstein (D-Calif.), Jon Kyl (R-Ariz.), Christopher Coons (D-Del.), Amy Klobuchar (D-Minn.), and Robert Casey (D-Pa.).  Companion legislation in the House of Representatives was introduced last year by Representatives Patrick Meehan (R-Pa.) and Linda Sánchez (D-Calif.).

It has been reported that counterfeit drugs result in 100,000 fatalities globally each year, and account for an estimated $75 billion in annual revenue for criminal enterprises   Read More & Comment...

Fixing a hole in the ocean

03/07/2012 08:51 AM |

Its old news that expanded access to healthcare doesn’t correlate to broader (or wider) use of services. This lesson from (among other places) the United Kingdom hasn’t gotten a lot of attention on this side of the pond. In fact, the reverse is true. Government-mandated access results in a reduction in usage.

Why? The reason is the role of the gatekeeper – otherwise known as the physician. As Nadine Reibling and Claus Wendt (University of Mannheim) write in their paper, Access Regulation and Utilization of Healthcare Services:

“Since cost containment is at the top of the political agenda, efficiency considerations dominate the political discussions on instruments that regulate access to care. This, however, neglects the fact that such measures also have implications regarding equity of access (Saltman and Busse 2002).”

In other words, equity of access isn’t the same as availability of access. What happens, for example, when physicians choose not to accept Medicare or Medicaid patients?  What value is equity when there is a physician shortage? And what does this say about how we value – and compensate – our healthcare providers. What unintended consequences arise when we ignore the growing gap between equity and access?

In November 2010, the Physician Foundation released the results of a national survey of physicians intended to gauge American physicians’ initial reaction to the passage of health reform and to learn the ways in which they plan to respond to it.

Key research findings include:

* The majority of physicians (60%) said health reform will compel them to close or significantly restrict their practices to certain categories of patients. Of these, 93% said they will be forced to close or significantly restrict their practices to Medicaid patients, while 87% said they would be forced to close or significantly restrict their practices to Medicare patients.

* 40% of physicians said they would drop out of patient care in the next one to three years, either by retiring, seeking a non-clinical job within healthcare, or by seeking a non-healthcare related job.

* The majority of physicians (59%) said health reform will cause them to spend less time with patients.

* While over half of physicians said health reform will cause patient volumes in their practices to increase, 69% said they no longer have the time or resources to see additional patients in their practices while still maintaining quality of care.

A brand new study from the Health Research and Educational Trust brings the matter to our own shores via a study of the Children’s Health Insurance Program (CHIP).

A Comparison of Two Approaches to Increasing Access to Care: Expanding Coverage versus Increasing Physician Fees

Objective

To compare the effects of a coverage expansion versus a Medicaid physician fee increase on children's utilization of physician services.

Primary Data Source

National Health Interview Survey (1997–2009).

Study Design

We use the Children's Health Insurance Program, enacted in 1997, as a natural experiment, and we performed a panel data regression analysis using the state-year as the unit of observation. Outcomes include physician visits per child per year and the following indicators of access to primary care: whether the child saw a physician, pediatrician, or visited an ER in the last year, and whether the parents reported experiencing a non-cost-related access problem. We analyzed these outcomes among all children, and separately among socioeconomic status (SES) quartiles defined based on family income and parents' education.

Principal Findings

Children's Health Insurance Program had a major impact on the extent and nature of children's insurance coverage. However, it is not associated with any change in the aggregate quantity of physician services, and its associations with indicators of access are mixed. Increases in physician fees are associated with broad-based improvements in indicators of access.

Conclusions

The findings suggest that (1) coverage expansions, even if they substantially reduce patient cost sharing, do not necessarily increase physician utilization, and (2) increasing the generosity of provider payments in public programs can improve access among low-SES children, and, through spillover effects, increase higher-SES children as well.

With all the discussions of equity, perhaps it’s time we asked “Who lost access?” And, more importantly, what can we do about it? Otherwise we’re just (Doc) fixing a hole in the ocean.

Net/Net? If you want more access you have to pay for it.

Nothing fixes a thing so intensely in the memory as the wish to forget it.

-- de Montaigne

  Read More & Comment...

Soda Bad, Magnets...Not So Bad?

03/06/2012 04:26 PM |

The Center for Science in the Public Interest..not to be confused with The Center for Medicine in the Public Interest found yet another aspect of everyday life that causes cancer.

This time it's soda, or as we call it in Rochester NY: pop.

Add soda to the list of other things CSPI believes are dangerous including prescription drugs, french fries, Chinese food, plastic, food coloring and transfat (the latter was something CSPI pushed to get introduced in the food supply during the 1980s.)

What CSPI does is find things that sound scary, link them to cancer and other ills in RATs. It then raises money through newsletters and lawsuits.

There is no evidence, but for the CSPI study, that any of the above cause cancer or heart disease or anything else.  As one FDA official said about the soda scare study:

"A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents," said Doug Karas, an FDA spokesman, in a statement.

http://www.reuters.com/article/2012/03/06/us-us-regulators-dispute-idUSTRE8250W620120306

Meanwhile,  little infants can swallow dozens of magnets and, thankfully, survive:
PORTLAND — A 3-year-old girl was recovering Monday at Legacy Emanuel Hospital after doctors removed 37 'Buckyballs' magnets from her intestines.

Payton Bushnell complained to her parents of symptoms that resembled the flu, Legacy spokeswoman Maegan Vidal told KGW. Then, they took her in to get checked.

Doctors took an X-ray and found the balls, clustered in her stomach. She was expected to fully recover and was listed in good condition Monday morning. She has been in the hospital since Feb. 21.

The Oregon toddler was fortunate. In 2006 the government warned about risks from magnets used in toys after at least one child died and almost 19 were injured. As a result, the Consumer Product Safety Commission recalled almost 4 million Magnetix building sets and magnets were included in holiday warnings about dangerous toys. The risk occurs when a child swallows one or more small magnets, which can link together in the digestive tract and perforate the intestines.


http://today.com

Could it be that swallowing buckeyballs is less toxic than swallowing junk science from CSPI?  

I wouldn't even try that experiment on rats.


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PCORI's 20/20 Night Vision

03/06/2012 08:23 AM |

BioCentury reports:

PCORI board votes on research definition

The Patient Centered Outcomes Research Institute (PCORI) board voted 17-2, with one abstention, to adopt a definition of patient-centered outcomes research that begins with a broad summary followed by a list of characteristics. According to the definition, such research "helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options." The research evaluates preventive, diagnostic, therapeutic, palliative or health delivery system interventions; focuses on outcomes such as survival, function, symptoms and quality of life; incorporates a variety of settings and diversity of participants; and "investigates optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives."

The definition does not mention "comparative effectiveness research." PCORI's methodology committee, which drafted the definition, said the research includes many components of comparative effectiveness but is intended to be "broader."

Several board members voiced concerns about the definition's focus on communication and decision-making. NIH Director Francis Collins said the definition does not emphasize research, which he called the "primary function" of patient-centered outcomes research. However, the members also expressed a desire to adopt the definition to allow PCORI to focus on other goals such as developing research priorities and launching an annual research conference. Created by the Patient Protection and Affordable Care Act, PCORI expects to have about $112 million in funding for 2012, of which $90 million will be used for grants.

Dr. Collins’ concern isn’t new. At past meetings, when the discussion of what PCORI’s “legacy should be, the NIH Director said that if the Institute was looking for a unique and non-duplicative research agenda, it would be “a null set.”

PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers.  The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects.  The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it.  PCORI should take the lead.  After all, what’s more patient-centered than real world outcomes data?

PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics.  After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?

PCORI should help to advance the nascent science of adaptive clinical trials. After all, what’s more patient-centric than adaptive clinical trial information?

PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls.  And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.

(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)

PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.

PCORI should beware of information sharing via academic detailing. (Note:  20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.

PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”

In May 2011, PCORI Chairman Eugene Washington introduced Joe Selby as the institute’s first executive director. To which Dr. Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”

Joe – It might be time for those night vision goggles.

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Ezra Klein Contributes To the Dumbing Down About Healthcare

03/05/2012 03:22 PM |

I shouldn't have to waste my time writing a response to Ezra Klein's latest blog about The High Cost of Medical Procedures In the US compared to other countries.   I won't waste yours by summarizing it either.  You can read it at the risk of wiping out some brain cells...

http://www.washingtonpost.com/wp-srv/special/business/high-cost-of-medical-procedures-in-the-us/

His blog is a textbook case of how most health care policy research is a combination of liberal bias and mythic numbers that support a point of view.

Here's the reason medical procedures cost more in the US.   The cost per procedure does not reflect the government subsidy that artificially reduces prices and drive up demand.    Second, the cost per procedure is not the only thing that's controlled.  Waiting is part of the cost per procedure in Europe, Canada and elsehwere.   Ask someone who has to wait for cancer surgery if the lower cost per procedure is worth it.  Would people pay more to get care faster?  They do quite often.   Yeah, neonatal intensive care in the UK or Canada is cheaper.  So if infusion of biologics.  But there's a reason people come to the US from Canada to get neonatal care.  There's more of it when you need.   You see Ezra,  if price doesn't reflect both the true cost - and value -- of a product, people won't produce it.  Unless you are Solyndra or GM's Chevy Volt.  Both are -- or were heavily subsidized -- products that no one wanted.

Which is sort of like health care around the world.  And medical innovation.  Government controls also skew what will be produced.  Innovation and its diffusion is stifled by things like price controls and comparative effectiveness reviews.  Both raise the risk and cost of development and CER delays and reduces market access.  So the way to make a buck is to pump out marginally better products that will get you a slightly higher launch price. 

The US still leads in the number of new drug launches compared to other nations because we reward biomedical innovation, at least for now.   Meanwhile, medical device adoption is faster in Europe.  Cycle times matter more in medical devices and Europe is not as anal-retentive about follow on devices as is our FDA.  Add a medical device tax to the equation and the decline in innovation will accelerate. 

Klein rehashes the 'research' of Gerard Andersen, a hack who makes a living producing memos for congressional Democrats that confirm their belief that price controls would work just fine.  Andersen pushed having Medicare 'negotiate' drug prices like the Veteran's Administration. ( Here's a link to a Frank Lichtenberg study I sponsored a few years ago.  http://democrats.veterans.house.gov/hearings/Testimony.aspx?TID=59775&Newsid=470&Name=%20Frank%20R.%20Lichtenberg,%20Ph.D. )   And the association between controls on innovation and reduced health care well established.  Lichtenberg has looked at access to new cancer drugs in Europe and Australia and concluded that for most types of cancer, newer drugs save lives and displace most costly care. 

That's the same VA whose formulary and price controls reduce access to new drugs and reduce the life span of seniors.  Which I guess saves money too.  

I don't mean to single out Klein.  It's just that his blog -- a blog! -- is an example of the confirmation bias that passes for policy analysis.    Blogs are thought experiments, not science.  And when they rely upon leftwing ideologues with tenure -- like Gerard Andersen -- to prove a point they reduce the sum of human knowledge each time they are read or written.

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Generic Drugs Savings? Orrin not so Oral

03/05/2012 07:54 AM |

Generic Drugs' Effect on Health Costs Unclear, GAO Says

By Emily P. Walker, Washington Correspondent, MedPage Today

WASHINGTON -- Generic drugs were substituted for brand-name drugs 93% of the time in 2010, but whether increased use of generics is actually saving money is up for debate, according to the Government Accountability Office (GAO).

Studies looking at cost savings from use of generic drugs "had mixed results regarding the effect of using these generics, in that some found they raised healthcare costs, while others found they led to cost savings," wrote the authors of a GAO report released Thursday.

The GAO report was requested by Sen. Orrin Hatch, co-author of the 1984 Hatch-Waxman Act, which paved the way for a major increase in the number of generic drugs. In the early 1980s, there were generic versions of just 35% of the top-selling drugs with expired patents; by the late 1990s, almost all of them had generic versions.

Prescription drug spending more than tripled from 2001 and topped $307 billion in 2010, making up 12% of all healthcare spending in the country, the GAO researchers wrote.

However, the growth has slowed markedly since the early 2000s when an increasing number of generic versions of brand-name drugs hit the market. On average, the retail price of a generic drug is 75% less than the retail price of its brand-name equivalent.

The report summarized the findings of peer-reviewed articles, government reports, and studies by national organizations -- including trade and nonprofit organizations -- on the cost effects of increased utilization of generic drugs.

The report authors identified three general groups of studies. The first group estimated the cost savings from relying more on generic drugs. One group of studies in that pool -- sponsored by the generic drug lobby -- estimated the use of generics to have saved the U.S. healthcare system $1 trillion from 1999 through 2010.

Another report, by the Congressional Budget Office (CBO), found that dispensing generic drugs rather than their brand-name counterparts reduced total Part D prescription drug costs in 2007 by about $33 billion.

A second group of reports focused on the potential to save even more through greater use of generics. For instance, the CBO estimated that if generics had always been substituted for brand-name drugs in Medicare Part D, $900 million would have been saved in 2007.

A third group of studies estimated the effect on healthcare costs of using certain generic drugs in cases where questions have been raised about how medically similar they are to the brand-name version. That group of studies compared the lower cost of the drug with the higher cost of increased hospitalizations from using a potentially less effective generic drug.

One study in that group found that depressed patients on selective serotonin reuptake inhibitors (SSRIs) who started on a brand-name SSRI and switched to a generic ended up experiencing an increase of $881 in total healthcare costs because of increased hospitalization rates and emergency department visits.

However, another study found those who began treatment on generic SSRI's had significantly lower costs than patients using brand-name antidepressants.

Another study in that group, done among renal transplant patients, found that total healthcare costs one year following transplantation were about $4,000 higher for patients who started therapy with generic immunosuppressants compared with those using brand-name drugs. That difference was attributed to "the cost associated with needing higher doses of the generic drug or additional immunosuppressants needed to maintain the transplanted kidney in patients using the generic," the report said.

Overall, the studies on whether generic drugs save money were a mixed bag, the GAO said.

Generic drugs must have the same active ingredients, route of administration, strength, and intended use as their brand-name counterparts. They also must be absorbed into the bloodstream at the same rate. Generic drugs are allowed to have different inactive ingredients, such as binding materials, dyes, preservatives, or flavoring agents compared with brand-name drugs.

At the end of the GAO report to Hatch, which was dated Jan. 31, the agency mentioned that it agreed not to publish the results of the report for 30 days. In the meantime, Hatch could have publicized the results, but did not. Requests for comment from Hatch's office did not bring a response.

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Peggy to Liz: "Stop acting and get on with it!"

03/05/2012 07:47 AM |

Bravo.

Dear Colleagues,
 
I am thrilled to announce the permanent appointment of Elizabeth Dickinson as the Chief Counsel of the Food and Drug Administration, effective Monday, March 12, 2012.
 
As many of you know, Liz has had a long and distinguished history at the Agency; she joined the Office of the Chief Counsel in 1994.  Over the years, Liz has served as legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development, and biosimilars; has implemented pediatric exclusivity and pediatric drug development programs; has worked closely with the Department of Justice on dozens of cases addressing Waxman-Hatch issues and preemption; and has coordinated the development of the Office of the Chief Counsel’s flexible workplace program.
 
A graduate of the University of Massachusetts and Northeastern University School of Law, Liz is highly regarded by both her internal colleagues and those across the food and drug bar.  Over the years, Liz has received numerous awards for distinguished service, leadership and her outstanding legal skills.
 
Liz has been serving as Acting Chief Counsel since August 2011, and we have been grateful for her hard work and dedication each day that she has been on the job.  It is terrific to know that she will be serving the Agency in this role permanently as we move forward.  Please join me in congratulating Liz.
 
Sincerely,
 
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

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Guidance Missles

03/02/2012 08:16 AM |

Two important stories from BioCentury:

FDA to hold hearing on biosimilars guidance

FDA will hold a public hearing on May 11 to discuss three recently published draft guidance documents on biosimilars. FDA said the hearing's purpose is to obtain public comment on the drafts, as well as receive input on topics to be included in the development of future biosimilar policies. The guidance documents, released early last month, indicate the agency hasn't settled some important biosimilars policy questions, including requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.

EC seeks to reduce duration of reimbursement decisions

The European Commission proposed a Transparency Directive that would reduce the time limits for member states to make pricing and reimbursement decisions for medicinal products. States would be required to issue a decision within 120 days of approval for an innovative drug and within 30 days for a generic. Current regulations require a decision for all drugs within 180 days. Member states that review the relative efficacy of a product via a health technology assessment would still be subject to the 180-day limit.

Under the proposal, member states would be required to designate an enforcement body with the power to award damages and impose penalties for delayed pricing decisions. Member states would also be required to regularly report to the EC on the time required for individual pricing decisions. The new directive is slated to begin implementation in 2014. EC said pricing and reimbursement decisions can take as long as 700 days for new drugs and up to 250 days for generics. The EC began public consultation on the proposed changes last year.

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Joint Custody

03/01/2012 07:58 AM |

On March 12^th, the FDA’s Arthritis Advisory Committee will meet and discuss the anti-nerve growth factor (Anti-NGF), a drug class that is currently under clinical hold because of the threat of joint damage.  Clinical trials for Pfizer’s tanezumab were suspended in 2010, at the FDA’s request, when some patients’ arthritis worsened to the point of needing joint replacement – and a class-wide clinical hold followed.  (Similar treatments are in early stage development at Johnson & Johnson, Regeneron, Sanofi, Abbott, and AstraZeneca.

Anti-NGF therapies are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain.  And if the fact that, according to Professor Thomas Schnitzer of Northwestern University, “We’ve had over a hundred years without having a major new pain drug,” isn’t enough – Anti-NGF’s are non-opioids.

FDA has tasked the adcomm to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs and whether the risk/benefit balance for these drugs favors continued development as analgesics.

Why a clinical hold? While a Phase II, 450-patient proof-of-concept study showed that tanezumab relieved knee pain when compared to a placebo, a Phase III study (published in the New England Journal of Medicine) showed 16 patients experienced progressively worsening osteoarthritis associated with a form of bone damage known as necrosis, which required total joint replacements.

In an accompanying NEJM editorial, John Wood a researcher at University College, London and a visiting professor at Baylor College of Medicine (a post funded by Pfizer), wrote the joint failure “was most likely caused by excessive wear and tear in the absence of joint pain. Pain has an important role in the avoidance of self-harm, but chronic inflammatory pain has generally been considered to be wholly undesirable.” The tanezumab study “suggests that a complete quenching of pain in patients with osteoarthritis may not necessarily be a good thing.”

In other words, according to a report in the Wall Street Journal:

“Some researchers are suggesting that an experimental Pfizer drug may have liberated arthritis sufferers to such a degree that they became more physically active — and that the subsequent wear and tear on their joints led to joint replacement surgery.”

The drug made people feel “better than [they] ever felt before, and I have a feeling they just overused their joints,” Nancy Lane, a rheumatologist and bone-health specialist at UC Davis Health System in Sacramento. She suggests the drug could still play a role as long as doctors “counsel patients not to overuse their joints.”

What happens when a drug … works too well?  Lane says she has seen this pain-masking situation before, including with the nonsteroidal anti-inflammatory drug (NSAID) indomethacin. “Because this is a new chapter in controlling pain, we didn’t realize we needed to counsel our patients in using their joints that were still diseased. Now we need to figure out how to use it so the risks don’t outweigh the benefits.”

And so the issue of patient education becomes crucial. What happens when a class of drugs is so effective, patients forget they have the underlying condition and behave contrary to their best medical interests? (In plain English – what happens when a therapy is so effective patients over do it and then suffer the consequences?) Hopefully the 3/12 adcomm will spend some quality time discussing this important social science question. Perhaps this issue should be taken up, um, jointly with the agency’s Risk Communications Advisory Committee? Anti-NGF drugs require not only a discussion of benefit/risk – but also the risk of benefit.

Those are, after all, precisely the kind of thorny scientific propositions FDA advisory committees are held to address.

Welcome to 21^st century medicine.

Ladies and Gentlemen, start your engines.

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Depressed About Statin Scare? There's a Pill For That...

02/29/2012 10:57 AM |

Kim Painter of USAToday's healthy perspective blog has a funny take on the statin scare and how dreding the same data in a different way produces contradictory results:

Statin risks and benefits: People who take statin medications to lower cholesterol might also lower their risk of depression, a study suggests. That finding might cheer up patients who just learned that the Food and Drug Administration is adding new warnings about elevated blood sugar and memory loss to statin labels.

Epidemiology of this type is to science what Sparknotes is to writing a novel. 

Kudos Kim!

http://yourlife.usatoday.com/health/healthyperspective/post/2012-02-29/concussions-in-kids-and-kobe-statin-risks-and-benefits-selenium-and-health-safe-airport-scanners-condoms-that-check-in/637023/1
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The Accidental (Medical) Tourist

02/29/2012 09:15 AM |

According to news reports, Sonia Gandhi, the leader of India’s governing Indian National Congress Party, has left the subcontinent for a medical check-up. She made a similar departure from India in August.

Where is she? Thailand? Brazil? Pakistan? Turkey? Or one of the many other nations touting their medical tourism credentials? Top of that list, of course, is India.

We wish Mrs. Gandhi well and assume she is currently being treated in a nation that has an up-to-date pharmacopeia of innovative treatments. That list of countries, it is interesting and disturbing to note, does not include the above-mentioned locations.

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Sleeping Pill Risk Study (and Reporting) Is a Nightmare

02/28/2012 02:58 PM |

Why do a study that looks at the "link" between sleeping pill use and risk of death that does not control for the diseases associated with higher risk of death such as depression, heart problems, anxiety and the impact insomnia has on all?

Why report on such a study with blaring headlines and warnings and bury all the caveats at the end of the study?

Maybe someone who reads this blog can explain why medical journals publish such garbage and why reporters can't take 5 minutes to look at previous research on the subject?

http://abcnews.go.com/Health/Sleep/sleeping-pills-linked-times-increased-death-risk/story?id=15803687#.T00wPMzu6Uo


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What Republicans Should Be Saying About Healthcare Part 1

02/28/2012 11:10 AM |

Here's a piece I wrote on the last Republican debate.  I plan a second installment on what the GOP candidates should be talking about and, to be fair and balance, what the President should say to defend Obamacare beyond the usual platitudes about not denying coverage for pre-existing conditions. 


Republicans Rock the Airwaves

By Robert M. Goldberg on 2.24.12 @ 6:08AM

http://spectator.org/archives/2012/02/24/republicans-rock-the-airwaves

So why didn't Rick Santorum take advantage to explain his real views on prenatal testing?

The most recent installment of the reality TV series, known as the Republican Presidential Debates, drew more cable viewers than The Jersey Shore or any of the cable channels' tributes to Whitney Houston. Never before have so many Americans been directly engaged in political discourse. (There were as many tweets, Google searches, etc. for the Arizona debate than for any other show on TV the other night!)

If you are like me, you were channeling the candidates and thinking of things they should have said but didn't. Why didn't Romney just say that Romneycare's individual insurance mandate was a mistake just as was Santorum's support for No Child Left Behind? Why not add that much of Romneycare -- individual buying at group rates, reforming Medicaid, and having insurance plans add a health savings account to their offerings -- are things Republicans support.

I hoping CNN's John King would have asked Rick Santorum about his views regarding prenatal testing. Santorum could have restated, without the left's media filter, that he doesn't want to ban contraception or prenatal screening.

Instead, he is concerned that prenatal screening, to detect for so-called birth "defects" such as Down's Syndrome, spina bifida, cystic fibrosis and Fabry's Disease, will be used in combination with abortion to place limits on neonatal care to control health care costs for high risk infants.

He is right to be concerned and talk about it. The health systems of Britain, Canada, the Netherlands and Australia discourage life-sustaining treatment for extremely premature or low birthweight babies. In 2005, the Royal College of Obstetrics and Gynaecology (RCOG) announced that "very premature babies were taking up intensive care space that could be used for healthier babies" and suggested that those born at very low gestations should not be intensively treated but rather allowed to die.

It said such infants were "bed blocking" and that due to better medicines and devices, "[t]here has been a constant need to expand numbers of cots to cover the increasing tendency to try and rescue babies at lower and lower gestations."

A review of neonatal intensive care units in Canada found "the majority of medical staff members do not recommend NICU care for an infant born at 24 weeks' gestation…" The review concludes that in some Canadian NICUs, preterm infants are not considered to be persons and, thus, are not treated in the same way as a larger patient. It doesn't help that Canada has severely limited growth in the number of NICUs. But that's by design. Indeed, to keep their babies alive, Canadian parents go to U.S. hospitals. In recent years hundreds have done so. U.S. doctors try to do what their Canadian colleagues cannot or will not, as in the case of Michelle James. Her doctors in Canada could not halt her labor when it began at 24 weeks and were not optimistic about the viability of her pregnancy. In the U.S., doctors succeeded in stopping labor for three weeks, improving her daughter's ability to survive and avoid a disability.

Could the cold calculus of cost-effectiveness be paired with prenatal screening under Obamacare? It already is.

The Agency for Healthcare Research and Quality and a senior advisor to the Patient-Centered Outcomes Research Institute -- the two agencies responsible for producing comparative effectiveness findings -- are already issuing guidance that would ration care to sick, vulnerable infants based on cost consideration and one-size fits all research.

Jean Slutsky -- who works for both AHRQ and PCORI -- heads up a committee that decides what technologies PCORI will examine. Here's what she and two colleagues said about prenatal screening: "Compelling stories of children who died from very rare metabolic disorders that might have been detected with newer, more expensive equipment have created powerful momentum for expanded screening of newborns. But in an era of constrained budgets, state policymakers need to weigh the benefits and costs of new screening programs against those of other equally important programs. Nonetheless, it remains politically risky to frame a health policy decision as being based primarily on cost or cost-effectiveness." That's compassion for you.

AHRQ and PCORI were established to obscure the fact that health policy decisions based on cost are politically cheap. AHRQ claims that there is no benefit for routine use of inhaled nitrous oxide to oxidate the lungs of pre-term infants. Yet dozens of studies demonstrate that newborns with iNO in combination with continuous airway pressure saves the lives of those with severe respiratory failure and pulmonary hyperplasia. It has been shown to save the lives of infants with premature rupture of the membranes (before 24 weeks of gestation). And it is looking at whether spending so much money on care for at risk babies is "cost-effective."

America spends more on at risk infants than any other nation. More babies that once died because they were too sick or small after birth are alive and part of loving families. We lead the world in life sustaining therapies for newborns. Santorum is standing up against the monstrous moral certainty of Obamacare. Amen to that.  Read More & Comment...

IPAB adieu via H.R. 452?

02/28/2012 10:29 AM |

Polly Toynbee, a very left-of-center columnist for the Guardian, writes that, “The NHS was always rationed. What matters is whether it is done rationally or haphazardly, nationally or by postcode, in public or secretly …More treatments are denied without a national or rational debate. A Doctors.net.uk survey of GPs shows most are deeply concerned at rationing by stealth.”

Sound familiar? It should -- it’s a fast-forward look at where we’re going through IPAB.  But maybe not.

Tomorrow, at 10AM in Rayburn 2123, the Committee on Energy and Commerce will meet in an open markup session to consider doing away with IPAB via the Medicare Decisions Accountability Act of 2011.  AKA H.R. 452, this piece of legislation would repeal Sections 3403 and10320 of PPACA – the sections that established and empowered the IPAB.

And Senator John Cornyn has introduced S. 2118, a bill that would similarly eliminate the Independent Payment Advisory Board.

As we enter into election season, it’s time for our elected representatives to go on the record about their positions on healthcare rationing – of which IPAB is Exhibit A.  As Ms. Toynbee writes, Better by far to make these painful choices in the full glare of open public debate.”

Ladies and Gentlemen of Congress -- it's time to stand up and be counted.
 

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The Sharp Tip of the Lancet

02/27/2012 07:52 AM |

According to the World Health Organization, “Counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities.” And, in an editorial, the editors of the Lancet ask, “So what should be done to tackle the growing problem of counterfeit medicines?”

The Lancet makes a strong and straightforward case for action. “The consequences of counterfeit drugs are diverse, as are the solutions, which lie in collective involvement, responsibility, and responses of all interested parties: health professionals, drug regulatory authorities, judicial entities, and drug companies at both national and international levels. Critical to this effort is strengthening of drug regulatory authorities, which should not only be responsible for improving drug standards, but also provide effective recognition of counterfeit drugs and assist other agencies in stopping their trade. This is especially needed in those countries that have either no drug regulation at all or an impaired or corrupted system. Additionally, enactment and enforcement of new laws for prohibiting counterfeit drugs is vital.”

And the editors ask the obvious and troubling question, “So why is there not yet an international fake drug treaty?”

We all know the answer.

The Lancet tells the often uncomfortable and undiplomatic truth that “the Indian and Brazilian Governments and some non-governmental organisations … believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.”

As Prashant Reddy opined in Spicy IP, “Every time an intellectual property issue is brought up by an international organization in the context of public health we presume that there is an 'imperialist/blood thirsty East India type corporation' conspiring against India. The level of paranoia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. It would also be nice if the Government could start articulating its concerns in the language of public health and not in the language of the generic drug industry.”

Amen.

It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety.

Working together to raise the regulatory performance of all nations will help all nations create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.

And here’s the sharp tip of the Lancet, “The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries.”

Memo to New Delhi and Brasilia – get with the program … or get out of the way.

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Counterfeit Avastin: Assad State of Affairs

02/24/2012 08:39 AM |

According to a report in the Wall Street Journal -- About three years before counterfeit copies of Roche Holding AG's cancer drug Avastin surfaced in the U.S., a case in Syria involved fakes of the same drug, showing the company has been grappling with bootlegging of the product for some time.

In 2009, Syrian authorities seized a haul of phony Avastin at a warehouse there, a Roche document shows. The company confirms the case, and acknowledges it has encountered other "individual cases" of counterfeit Avastin in recent years. Until now, the only other known case of Avastin counterfeits, other than the recent U.S. case, was a 2010 incident in Shanghai.

According to officials in law enforcement and the pharmaceutical industry, at least three smugglers were jailed as a result of hauls in Egypt and Syria in 2009 that netted the fake Avastin and other counterfeits drugs. These people said the trio -- who officials said were part of the same counterfeiting network -- were released from Syrian and Egyptian jails last year.

It's unclear whether the Middle East currently produces fake drugs, acts as a transit corridor, or both. Evidence suggests many counterfeits that transit through the Middle East are produced in China. In the same Syrian raids that netted the fake Avastin in 2009, officials found other fake drugs packaged in Chinese-language bags. Authorities also found Chinese-manufactured equipment that the criminals were using to produce fake drugs.

In the 2010 case of counterfeit Avastin that surfaced in Shanghai, 116 patients were given a fake version of the drug. In addition to being used against cancer, Avastin is prescribed to treat an eye disease that causes blindness. The Chinese patients received injections in the eye, and some suffered complications, according to a report on the incident published last year in the New England Journal of Medicine.

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A pox on all their houses

02/23/2012 12:21 PM |

Dr. Marc Siegel recently appeared on Fox news with Megyn Kelly to discuss the danger posed by Chicken pox parties.
 
Watch the interview here:


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Qnexa: A Weight Off Of FDA's Shoulders

02/23/2012 10:44 AM |

Qnexa,  the weight loss drug developed by Vivus, was backed 20-2 by the FDA Endocrine and Metabolic Disease Advisory Committee.   Almost all patients on Qnexa lost about 10 percent of their baseline weight over a year compared to placebo.   Qnexa was rejected last year because of Avandia stoked worries about cardiovascular risks, particularly high blood pressure.   This time around, Vivus did an additional study and focused on cardiovascular endpoints and markers among various subgroups.   The study found among many groups that blood pressure and inflammatory markers declined along with a loss of weight. "  Effects of treatment on biomarkers of cardiovascular disease risk, such as hs-CRP, adiponectin, and fibrinogen, were measured in study OB-303. Treatment with QNEXA Top and Mid dose resulted in statistically significant mean changes in hs-CRP, adiponectin, and fibrinogen. The magnitude of reduction in hs-CRP appears to be comparable to those observed in the JUPITER trial with rosuvastatin."    And Vivus will closely evaluate how people respond to Qnexa in the real world. 

The emphasis on sub-group analysis to establish which patients would benefit most from Qnexa -- with an emphasis on collecting data from everyday patients -- reflects both a shift in the Vivus strategy and a change in FDA's outlook.   I think going forward a Steve Nissen will not be able to trash drugs of companies that he doesn't work for to the advantage of products from firms that he does with a sloppy meta-analysis.   (As as aside, Nissen's  use of a meta-analysis to attack Eric Topol's research on the value of using gene tests to select drugs for stenting procedures was recently laughed off and ridiculed.)  And companies that want to move a new product to market would do well to seek approval based on those sub-groups where the benefits exceed the risk.  And to be able to monitor disease progression and treatment response after market with simple blood tests would advance approval even more.   The more risk can be defined and measured at the subgroup or individual level, the less chance anti-innovation forces will have to block new devices and drugs that have clinical utility. 

That's what The Critical Path was supposed to do.  It sounds like the Qnexa decision was made consistent with that mission.

http://www.fda.gov/.../Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM292317.pdf  Read More & Comment...