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

05/16/2012 06:46 PM |

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

Home HIV test should be sold in retail stores, US panel urges
Published May 16, 2012
NewsCore

A Food and Drug Administration advisory panel Tuesday asked the agency to let an HIV test be sold in retail stores so consumers do not have to go to a health facility to get tested for the virus.

The mouth-swab test, made by OraSure Technologies Inc., is sold commercially to health professionals to be used at facilities.
If approved by the FDA, the test results could be obtained in the home like tests for pregnancy and blood sugar. The FDA usually follows panel recommendations.

The test was reviewed Tuesday by the FDA's blood-products advisory panel, which is made up of non-FDA medical experts.
The panel voted 17-0, saying the "projected benefits" of OraSure's in-home HIV test outweighed the "potential risks of false positive and false negative results." The panel also voted 17-0 in support of a question that asked if the data submitted by OraSure showed the test was safe and effective.
If the OraQuick In-Home HIV Test is approved, it would mark the first time that HIV test results could be obtained in the home. Other home HIV tests require a fluid sample to be sent to a laboratory for testing.

About 1.2 million people in the US are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials estimate 20 percent of people with HIV do not realize they are infected and risk spreading the virus.
OraSure argues the test would most benefit people at risk who have never been tested or do not get tested regularly.

One concern about the home test is it does not appear as accurate as tests conducted by health professionals. The company conducted a study of the home test in 5,662 people who also took a traditional HIV laboratory test that used blood. Blood tests showed 114 people were positive for HIV. Of that group, 106 reported positive tests via the home test, and eight reported a negative test.

It is not clear if the home test provided a negative result or if people read the test incorrectly. Still, FDA officials said the home-use test would likely encourage more people to get tested. "We believe there would be public-health benefits" of a home-based HIV test, said Richard Forshee, an FDA associate director for research. "But an individual risk remains in the form of an increase in the number of false negatives."



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University drops student health insurance

05/16/2012 11:44 AM |

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

A Catholic university in Ohio said Tuesday it is being forced to end a student health insurance program over the Obama administration's contraception mandate and costs associated with other provisions of the health care overhaul.

Franciscan University in Steubenville, Ohio, said it has so far excluded contraceptive services and products from its health insurance policy for students and will not participate in a plan that “requires us to violate the consistent teachings of the Catholic Church on the sacredness of human life.”

In its decision to drop coverage, the school cited the contraception mandate, but also a requirement that the maximum coverage amount be increased to $100,000 for policyholders -- claiming that would have made premiums skyrocket. A university official told Fox News Radio the students’ basic $600 policy was going to double in cost in the fall and triple next year and that the school’s insurance provider said the increases were the result of the federal Patient Protection and Affordable Care Act. 

"This is putting people in a position where they are having to choose between their faith and their morality, and now an unjust cost," said Mike Hernon, the school’s vice president of advancement. "These sorts of regulations from the government are forcing our hand in a way that's really wrong."
 
Read the full story here.


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Eggs & Asteroids

05/15/2012 06:18 AM |

When it comes to Congressional action on drug shortages, “newer” is not always “better.” An earlier PDUFA discussion draft (House side) would have mandated the FDA to:

… include a list of the drugs that are subject to the requirements of section 506C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)), as amended by subsection (a), if the manufacture of such drug is to be discontinued, or an interruption of the manufacture of the drug that is likely to produce a drug shortage;”

Nice. Clear. Matching authority and expertise.

The current version reads:

IN GENERAL. -- A manufacturer of a drug subject to section 503(b)(1) -- (1) that is -- (A) life-supporting; ‘(B) life-sustaining; or (C) intended for use in the prevention or treatment of a debilitating disease or condition; and (2) that is not a radio pharmaceutical drug product, a product derived from human plasma protein and their recombinant analogs, or any other product as designated by the Secretary, shall notify the Secretary of a discontinuance of the manufacture of the drug, or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the manufacturer’s supply of the drug, and the reason for such discontinuance or interruption, in accordance with subsection (b).

Very vague as to what drugs fall into these categories and what, precisely, those circumstances might be.

The Senate-side language is equally unclear:

IN GENERAL.-- A manufacturer of a drug -- (1) that is -- (A) life-supporting; (B) life-sustaining; (C) intended for use in the prevention of a debilitating disease or condition; (D) a sterile injectable product; or (E) used in emergency medical care or during surgery; and (2) that is not a radio pharmaceutical drug product, a human tissue replaced by a recombinant product, a product derived from human plasma protein, or any other product as designated by the Secretary, shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug in the United States.

Considering the high profile nature of this issue and the need for manufacturers to err on the side of both patient safety and legal prudence, lack of clarity will very likely lead to reporting everything, thus exacerbating a signals-to-noise problem at an already over-burdened FDA.

Perhaps the best solution is for Congress to require the FDA to compile and publish a list of drugs that must be reported to the agency when circumstances leading to potential shortages arise. This would allow companies to determine when they need to contact the FDA – and allow them to do so more swiftly and efficiently. Such legislative authority would also focus the FDA’s energy on the most critical drug shortage situations – allowing them (with their limited staffing resources – it’s worth repeating) to address them with greater skill and alacrity.

Noise proves nothing. Often a hen who has merely laid an egg cackles as if she laid an asteroid.

-- Mark Twain

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Public citizen lobbies to make dying patients wait for new treatments

05/14/2012 02:32 PM |

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

Compliance of Champions

05/14/2012 06:33 AM |

Just as the Supreme Court is weighing the compensation system for pharmaceutical sales representatives at GSK (will the word "sales" ever be the same?) so too is ... GSK.

I was recently briefed by a senior GSK executive on that topic as well as about the company’s pending agreement in principle with the DOJ.

I wanted to talk details.  He wanted to talk about Deirdre Connelly, GSK’s President for North America Pharmaceuticals and her views of a post-settlement company.

His meeting.  His agenda.

Specifically, I learned that Deidre’s favorite topic, “is the future and how potential recidivism will not be tolerated.”

GSK, according to my interlocutor, is a company that’s ready to look ahead with some fresh ideas.

We’ll have to wait and see on the specifics (of both the DOJ settlement as well as what those new approaches may be) – but a recent speech by Ms. Connelly (at the CBI 8th Annual Pharmaceutical Industry Compliance Congress) lays out some initial propositions – about values, compliance, and a new model for pharmaceutical representative roles, responsibilities – and compensation.

Here are some snippets from that oration.

Since January of 2009, the Justice Department has reached settlements totaling nine billion dollars against healthcare companies. These cases involved alleged false claims, fraud, and FDA violations.

As someone who decided more than 25 years ago to pursue a career in the pharmaceutical industry, I ask myself: what’s going on? Why is this happening? What went wrong?

The answer, I believe, is that, in some ways our industry lost its way, and failed to fully appreciate the evolving expectations of our stakeholders.

Society holds our interactions with our customers – healthcare providers and payers – to a higher standard. And it should. Society expects our business to be conducted openly and transparently and in a way that does not create even a perception of inappropriate influence.

To be fair, our industry has made significant changes in how we operate over the past several years. What our critics either are unaware of – or choose to ignore – is that our industry adopted the PhRMA Code almost ten years ago, which serves as a baseline for how we should work with healthcare providers and institutions. The industry then strengthened the code in 2009, making additional changes in areas such as meals, continuing medical education, support for educational and professional meetings, and the use of consultants and speakers, among other things.

But negative perceptions remain. Some of this has to do with long-running government investigations, litigation over past practices, and the resulting news coverage that makes it look like we still take doctors on trips to exotic locations –which we don’t. Some of it is because we haven’t done enough to communicate what we do and don’t do. Some of it is because industry bashing is good politics. Some of it is because we still make mistakes. No matter the reasons, at the end of the day, we must regain the public’s trust in our industry.

So, what should we do?

Of course, we must comply with the laws and regulations that govern how we in the pharmaceutical industry are required to operate our business. That is not subject to debate or open to interpretation. It’s a given.

But our customers need to understand – that beyond compliance – we operate from a core set of values that underpins every decision we make and every action we take. A values-based culture creates a framework and a mindset in which compliance with rules and regulations is not the ceiling, but the floor from which our organizations should operate.

In my mind, three key elements make it happen: First, you have to be willing to break the mold and fundamentally change your approach to certain aspects of your business. Second, you must align your resources with your values. And, third, you must demonstrate leadership based on those values.

To help ensure that the behavior of our representatives is consistent with our values, we’ve also decided to break the mold and change the way we provide incentive compensation to our sales representatives.

In the past, like other companies, we based the variable portion of the compensation for our sales force on the volume of prescriptions they obtained in their sales territory. That is no longer the case. We are now in the process of putting in place a new incentive compensation system in which individual sales representatives are not bonused on scripts, but on three factors: an assessment of their scientific and business knowledge; feedback from customers in their region, including demonstration of our values; and overall performance of the business unit they support.

Importantly, we’re shifting our focus from obtaining the next script to providing the information and support our customers want and need. We may not be able to provide all our customers with everything they want, but what we do provide will be aligned with what they need to treat their patients better.

As part of our performance management process, our employees have a values and integrity objective included in their annual performance plans. They are evaluated for not only “what” they do, but also “how” they do it. This enables us to incorporate a behavioral component into our performance evaluation process, further supporting our commitment to the company’s values.

We’ve also made a significant investment in establishing 60 Integrity Champions who provide training and support so that we can further ingrain accountability for values and compliance throughout the business.

Ultimately, you get returns from what you invest in and what you reward.

But I believe the greatest imperative for us, as leaders, is to look forward and examine what more we can do to ensure our practices are in step with societal expectations.

Our customers are watching.

The complete text of Ms. Connelly’s speech can be found here.

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Reps & Reparations

05/13/2012 09:46 AM |

The Seventh Circuit Court of Appeals has ruled that Eli Lilly does not owe a former rep overtime.

According to a report in Medical Marketing and Media, “Wednesday's decision, which reversed a lower court's ruling that the rep was entitled to overtime, deals a blow to the Obama administration. The Labor Department had backed the rep’s overtime claims, and the Office of the Inspector General sided with sales reps in Christopher v. SmithKline against GSK which revolves around the same issue: are sales reps considered outside sales teams or more like typical employees?

The focus of these cases turns on what these employees can or cannot do: regulations bar sales reps from taking drug orders from doctors. Plaintiffs say being deprived of that final step puts labor laws on their side, because it marks them as employees, not as outside sales forces, and therefore eligible for overtime.

Pharma companies counter that reps facilitate sales by showing up and talking with doctors about drugs. The companies say these visits trigger sales and are therefore sales calls, which would put the reps in the category of employees who are not eligible for overtime.

Meanwhile, the Supreme Court has yet to choose sides—it heard arguments in Christopher v. SmithKline Beecham April 16, but has not yet issued an opinion.

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Plan B "Chutzpah"

05/11/2012 06:15 AM |

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

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

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

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

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

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

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

Yep.

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46-Love

05/11/2012 06:10 AM |

The U.S. House Energy and Commerce Committee voted 46-0 on Thursday to pass the PDUFA reauthorization   Read More & Comment...

CDC Plays Politics With Whooping Cough Outbreak

05/10/2012 06:00 PM |

Washington State is a hotbed of anti-vaccine sentiment.  It had a very liberal policy that allows parents not to immunize their kids for religious or philosphical reasons..  Here's a copy of the exemption form

http://www.doh.wa.gov/cfh/immunize/documents/coe2011.pdf

So why is the CDC punting on the whooping cough outbreak in Washingon?  Here's the CDC spokesperson on the epidemic:

'Adults and teens need booster shots so they don't give pertussis to the babies in their lives, said CDC spokeswoman Alison Patti
"We want to create a cocoon of protection around them," she said. "We're really worried about keeping babies safe."

 Patti emphasized that pertussis isn't spreading because of an anti-vaccine movement. Among possible reasons for the recent spike are that diagnoses in teens and adults are getting better and doctors are doing a better job with reporting, she added.'

This is nonsense.   While outbreaks go in five year cycles, the incidence has skyrocketed in places where anti-vaccine sentiment is strongest: including Idaho, New Mexico, Madison, WI,  Woodstock, NY and Vermont.  

Under Obama, the CDC has been ducking the source of vaccine resistance and in some cases, caving into it.  Perhaps its because their anti-sugar allies are also anti-vaccine or because the states essential to the president's re-election are also the one's where the anti-vax movements are strongest..  

This is pure speculation on my part.  But in any event, the lack of leadership on immunizations at the CDC is troubling.  Bad enough that CDC is using cost-effectiveness analysis to decide whether it's worth paying for new vaccines under Obamacare.  Ignoring a principal threat to herd immunity is even worse. 


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FDA Impatience Is Great News For Patients

05/10/2012 05:37 PM |

The FDA signaled that it supported a new accelerated pathway for approval of new drugs for serious diseases that use biomarkers and show high response in early trials.    

U.S. may speed approval of 'breakthrough' drugs


When the Critical Path was launched, the goal was to align the approval of drugs with the science of drug development.  That process was derailed after the Vioxx panic.  It is now back on track thanks to a bi-partisan effort on Capitol Hill, support from the Obama administration and the persistence of Janet Woodcock and Peggy Hamburg at the FDA.   This is a great day for innovation and patients, at least in principle.   

There will be those who see this reform as a sop to evil, profit making drug companies...  Such as Merrill Goozner:  "Pfizer last week won Food and Drug Administration “accelerated approval” for Xalkori (crizotinib) for a rare form of metastatic lung cancer that strikes about 3 percent of people — almost always non-smokers — who come down with the disease. That’s about 10,000 patients per year in the U.S., and perhaps a similar number abroad. Multiply that times the $115,200 a year the company plans to charge for Xalkori, and they’ve got themselves a billion dollar blockbuster.  Through this period where there will be no concrete proof of efficacy, Pfizer will get to charge an outlandishly high price for the drug. Is there a way to put pressure on the company to complete the trials in a more timely fashion, so that the paying public knows that it is truly getting value for its health care dollar and not subjecting patients to some pretty rough side effects (nausea, diarrhea, etc.) for no benefit?"

Goozner is either ignorant or willfully misleading.  By definition accelerated approval will be reserved for treatments that show significant benefits in specific groups of patients through well-characterized biomarkers and clinical endpoints.   That will cut the time required for approval and reduce costs. (If Goozner can figure out a way to reduce the cost of producing new biologics for small groups of people, he should start his own biotech company.)  The price of drugs will be relative to their value.  Or should be.   

The question is, as accelerated approval is adopted will CER just add back delay and access.   Let's hope the courageous impatience of the FDA, the Obama administration, Congress and the public is shared by the CER crowd and PCORI.    


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The Scoop on PDUFA

05/10/2012 06:43 AM |

It’s time to excise the Ben and Jerry’s Clause from the Senate HELP Committee’s draft of PDUFA.

That would be the amendment (adopted this April) that would require an evaluation of the so-called “prize fund approach” to drug development.

It’s same old and tired and false proposition put forth by Bernie Sanders – the independent Senator from the great state of Ben and Jerry’s – since time immemorial.

It’s not a new idea. The “prize” model has been used in the past—in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance.

The experience in the United States hasn’t been much better. The federal government paid the father of American rocketry, Robert Goddard, $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, U.S. expenditures on liquid-propelled rockets amounted to around $10 billion.

Senator Sanders wants to replace a patent system that has fueled innovation allowing the average American lifespan to increase by almost a full decade over the past 50 years with a prize program that has a solid record of failure. As the healthcare economists Joe DiMasi and Henry Grabowski have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. DiMasi, director of economic analysis for the Tufts Center for the Study of Drug Development, and Grabowski, director of Duke University’s Program in Pharmaceuticals and Health Economics, said, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

Who could support the idea of a prize? As DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals.” That’s because, as they note, governments and insurers are focused “myopically on managing health care costs” and are not likely to be “strong advocates for funding new drug development that can increase individual quality of life and productivity.”

Those who support this idea view it as a solution to all the world’s health care ills. “Research is risky, new drugs are too expensive, and industry focuses far too much of its effort on drugs of minimal medical significance,” Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, has said. “The prize fund solves all these problems by disconnecting the incentives for generating breakthroughs from the price that individual patients or their insurers must pay.”

Not.

According to Jamie Love, director of Knowledge Ecology International, “By separating the markets for innovation from the markets for the physical goods, the Prize Fund would ensure that everyone, everywhere, could have access to new medicines at marginal costs.”

Not.

Here’s Jamie’s spin on Senator Sander’s legislation -- a highly revisionist history.

The truth of the matter is that the promotion of innovation and the creation of new medicines cannot be based on a top-down process. Rather, they should be based on bottom-up solutions by the actual players involved in this process—companies, research institutions, and the regulatory and IP authorities.

Clearly Senator Sanders and Jamie Love do not concur. And that is their privilege.

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IOM Obesity Study Weighed Down By Bad Science

05/09/2012 05:59 PM |

I will have a lot more to say about the IOM report: Accelerating Progress in Obesity in another post.  But for now, I urge anyone who intends to read it not to if you care at all about science.   The report uses BMI as a measurement of obesity.  And as the following article and segment from NPR (produced in 2009) shows, the IOM -- with the help of HBO, CDC and a bunch of other nurtitional busybodies -- is basing it's recommendation for government micromanagement of our daily lives on a measure that is politically correct but scientifically useless.  


Top 10 Reasons Why The BMI Is Bogus
by KEITH DEVLIN



The BMI Formula
BMI = weight in pounds/(height in inches x height in inches) x 703

The 703 is to convert the index from the original metric version of the formula.

CDC Recommendations:
Below 18.5 = Underweight

18.5 to 24.9 = Ideal

25.0 to 29.9 = Overweight

30.0 and above = Obese

text size A A A July 4, 2009
Americans keep putting on the pounds — at least according to a report released this week from the Trust for America's Health. The study found that nearly two-thirds of states now have adult obesity rates above 25 percent.

But you may want to take those findings — and your next meal — with a grain of salt, because they're based on a calculation called the body mass index, or BMI.

As the Weekend Edition math guy, I spoke to Scott Simon and told him the body mass index fails on 10 grounds:

1. The person who dreamed up the BMI said explicitly that it could not and should not be used to indicate the level of fatness in an individual.

The BMI was introduced in the early 19th century by a Belgian named Lambert Adolphe Jacques Quetelet. He was a mathematician, not a physician. He produced the formula to give a quick and easy way to measure the degree of obesity of the general population to assist the government in allocating resources. In other words, it is a 200-year-old hack.

2. It is scientifically nonsensical.

There is no physiological reason to square a person's height (Quetelet had to square the height to get a formula that matched the overall data. If you can't fix the data, rig the formula!). Moreover, it ignores waist size, which is a clear indicator of obesity level.

3. It is physiologically wrong.

It makes no allowance for the relative proportions of bone, muscle and fat in the body. But bone is denser than muscle and twice as dense as fat, so a person with strong bones, good muscle tone and low fat will have a high BMI. Thus, athletes and fit, health-conscious movie stars who work out a lot tend to find themselves classified as overweight or even obese.

4. It gets the logic wrong.

The CDC says on its Web site that "the BMI is a reliable indicator of body fatness for people." This is a fundamental error of logic. For example, if I tell you my birthday present is a bicycle, you can conclude that my present has wheels. That's correct logic. But it does not work the other way round. If I tell you my birthday present has wheels, you cannot conclude I got a bicycle. I could have received a car. Because of how Quetelet came up with it, if a person is fat or obese, he or she will have a high BMI. But as with my birthday present, it doesn't work the other way round. A high BMI does not mean an individual is even overweight, let alone obese. It could mean the person is fit and healthy, with very little fat.

5. It's bad statistics.

Because the majority of people today (and in Quetelet's time) lead fairly sedentary lives and are not particularly active, the formula tacitly assumes low muscle mass and high relative fat content. It applies moderately well when applied to such people because it was formulated by focusing on them. But it gives exactly the wrong answer for a large and significant section of the population, namely the lean, fit and healthy. Quetelet is also the person who came up with the idea of "the average man." That's a useful concept, but if you try to apply it to any one person, you come up with the absurdity of a person with 2.4 children. Averages measure entire populations and often don't apply to individuals.

6. It is lying by scientific authority.

Because the BMI is a single number between 1 and 100 (like a percentage) that comes from a mathematical formula, it carries an air of scientific authority. But it is mathematical snake oil.

7. It suggests there are distinct categories of underweight, ideal, overweight and obese, with sharp boundaries that hinge on a decimal place.

That's total nonsense.

8. It makes the more cynical members of society suspect that the medical insurance industry lobbies for the continued use of the BMI to keep their profits high.

Insurance companies sometimes charge higher premiums for people with a high BMI. Among such people are all those fit individuals with good bone and muscle and little fat, who will live long, healthy lives during which they will have to pay those greater premiums.

9. Continued reliance on the BMI means doctors don't feel the need to use one of the more scientifically sound methods that are available to measure obesity levels.

Those alternatives cost a little bit more, but they give far more reliable results.

10. It embarrasses the U.S.

It is embarrassing for one of the most scientifically, technologically and medicinally advanced nations in the world to base advice on how to prevent one of the leading causes of poor health and premature death (obesity) on a 200-year-old numerical hack developed by a mathematician who was not even an expert in what little was known about the human body back then.

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AMA and Personal Injury Bar On Opposing Sides Of Expanded Rx-OTC Switch Proposal

05/09/2012 03:58 PM |

As I noted yesterday  (AMA Seeks To Derail Consumer Health Revolution) the AMA and other lobbying organizations for medical professions sounded the alarm against the FDA's Rx-OTC proposal ( http://tinyurl.com/18r).     

You would think (if you accept the stereotype) that trial lawyers would warn against the proposal as well.  But Greg Webb, a blogger for the Injury Board Blog Network has penned a measured and thoughtful piece on the FDA's safe use proposal for expanded OTC access.. 

"Representatives of the American Medical Association (AMA) and the American College of Allergy, Asthma and Immunology (ACAAI) have gone on record objecting to the proposed new safe-use class of medications. Roland Goertz, MD, president of the American Academy of Family Physicians (AAFP), stated that the safe-use designation where pharmacists dispensed medications without a patient having to see a doctor first, “could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients.”[1]

Health insurers reportedly have tentatively "approved" of the measure. Without proper safeguards, there is some concern that patients may obtain drugs that they may not need. The insurers also would have to determine how to cover drugs that fell into this category. Additionally, the health insurers were in favor of "expanding access" to helpful medications.

Because pharmacists are more easily accessible than physicians who require appointments for frequently costly office visits, the FDA believes that the “safe-use” designation may benefit many Americans who presently go untreated with legitimate medical needs. Doubtless the collection of comments and the promulgation of a new regulation on safe-use medicines by FDA (requiring additional debate) will cause more lines to be drawn in the sand of looming health issues. Is this the wave of the future for certain medications? Much of it makes sense, and ultimately would save money by preventing potentially unnecessary doctors' visits. What are the unintended consequences?"

Mr. Webb's article is well worth reading because it lays out the FDA proposal clearly.  It is also noteworthy because it shows that the AMA and other groups are more hysterical about the Rx-OTC issue than the trial bar.     Read More & Comment...

Living off the Land of the Fat

05/09/2012 06:48 AM |

The FDA has proposed a benefit-risk assessment system for weight loss devices that would use available safety data for a device to set efficacy thresholds for a pivotal trial of that device. BioCentury reports that the proposal came in briefing documents issued to FDA's Gastroenterology and Urology Devices Panel ahead of a meeting on Thursday and Friday to discuss issues in the development of devices placed endoscopically or laparoscopically.

Devices would be classified into one of three risk levels based on the percent of patients who experience mild, intermediate and severe adverse events over one year. For example, to qualify for the lowest risk category, devices can have high rates of the most mild events (up to 100%), low rates of events of intermediate severity (2-5%), and very low rates of the more severe events (<0.1%).

Each level of risk would set corresponding efficacy endpoint targets for pivotal trials. Targets for the least risky devices would be based on endpoints used for weight loss drugs, while targets for the highest risk devices would be based on the two FDA-approved obesity devices, which the agency said fall into the high risk category. Those are the Lap-Band adjustable gastric banding system from Allergan and the Realize adjustable gastric band from the Ethicon Endo-Surgery.

FDA also proposed that efficacy be measured using percent total body weight loss instead of the current standard of percent excess weight loss. The panel is part of the Medical Devices Advisory Committee.

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All for One and One for PDUFA

05/09/2012 06:45 AM |

Yesterday the U.S. House Energy and Commerce Committee's health subcommittee voted unanimously to pass the PDUFA reauthorization bill. A full committee vote on the draft is expected Thursday and a full House vote is expected later this month.

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AMA Seeks To Derail Consumer Health Revolution

05/08/2012 02:20 PM |

Are you afraid of your drugstore and what you might do there?  The AMA is....  

 Medscape Medical News

Pharmacists Dispensing Without Rx 'Scary,' Say Med Societies
Robert Lowes

May 2, 2012 — Imagine a patient walking into a pharmacy, self-diagnosing a cough at a kiosk with medical software, and then getting a drug from a pharmacist in the back of the store, all without a physician's prescription.

The US Food and Drug Administration (FDA) is imagining this scenario, much to the alarm of the American Medical Association (AMA) and other medical societies, which see the beginnings of an end-run around physician authority.

Sandra Fryhofer, MD, chair-elect of the AMA Council on Science and Public Health, said her group continues to "strongly support" the status quo of 2 drug classes — prescription and traditional OTC. In exploring how new technologies and new roles for pharmacists might expand the portfolio of OTC drugs, the FDA should not "undermine the relationship that a patient has with his or her physician."

"In our view, lack of oversight from a practitioner could be a serious concern," said Dr. Fryhofer.

The FDA has not provided any evidence showing that patients with hypertension, hyperlipidemia, or asthma can diagnose and manage these conditions by themselves, she noted. "The balance of medical evidence strongly suggests otherwise." She also estimated that patients would pay more out-of-pocket for drugs that insurers would shift into the OTC safe-use category.

Bobby Lanier, MD, speaking for the American College of Allergy, Asthma and Immunology (ACAAI), raised similar concerns, but more pointedly.

"The new proposals here being discussed are chilling and scary," said Dr. Lanier. "You are facilitating bad behavior by not having (patients) talk to a clinician. In our mind, there is no substitute for a clinician."

Which brings to mind the fact that when the FDA decided to move painkillers and allergy meds OTC, you heard the same dire warnings.  Now the same groups are seeking to change an Obamacare law requiring a doctor's prescription for OTC drugs purchased through a Flexible Spending Account.  Not necessary and too much of a hassle according to the AMA and other medical lobbies.   In Dr. Lanier's words,  it's ok to facilitate bad behavior with existing OTC products but not new ones.  

The FDA should be commended for promoting more consumer-driven care.  As Peter and I demonstrated in our recent survey on cough medicine usage, the vast majority of Americans like OTC access because it makes health care simpler and therefore more likely.   Doctors are behind the curve on the consumer revolution.  Rather than trying to derail it, doctors should embrace new ways of connecting with patients and finding ways to help consumers help themselves.   http://cmpi.org/uploads/File/CMPI_CoughSurvey_KeyFindings.pdf


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Measuring the Marigolds

05/08/2012 07:08 AM |

BioCentuty reports:

House moves closer to Senate on PDUFA

The U.S. House Energy and Commerce Committee posted a new draft PDUFA reauthorization bill that is more closely aligned with the Senate PDUFA bill than previous versions. Changes that reflect the Senate bill include dropping sections that would add jobs creation and economic development language to FDA's mission and adding a section that would create an expedited development pathway for breakthrough drugs.

However, several items in the House draft bill are still not in the pending Senate version, including provisions to increase public participation in crafting guidance documents and creation of a new priority review voucher system to encourage development of therapies for rare pediatric cancers. The House draft also requires that FDA provide Congress a 60-day notice prior to issuing guidance on the regulation of laboratory-developed tests. The Energy and Commerce Committee's health subcommittee is scheduled to meet Tuesday (today) to deliberate on the draft bill.

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"Safe Use Drugs" -- the Saga Continues

05/08/2012 07:03 AM |

Per today’s Washington Times, “Health insurers gave a tentative thumbs-up Monday to the Food and Drug Administration’s proposal to make drugs treating chronic conditions available without a prescription by classifying them in an all-new category.”

Insurance companies cautiously support the idea but warned Monday in a letter to the FDA that a host of complications could arise.

Without the right safeguards in place, patients could obtain drugs they don’t need and it’s unclear who would be held liable if they do, said Robert Zirkelbach, spokesman for America’s Health Insurance Plans.

Insurance companies also would have to figure out whether and how they would cover drugs that fall into the new category.

“Expanding access is something that we support, but these other issues would have to be addressed for this to work if they decide to move forward with that,” Mr. Zirkelbach said in an interview.

If the FDA decides to move ahead with the plan, it would create a third category for classifying drugs.

Called “safe use” drugs, patients wouldn’t need a prescription but neither could they obtain them over the counter. Instead, people could only buy the drugs after diagnosing their ailments online or in the pharmacy.

Seeking a way to expand access to drugs for Americans who struggle with common conditions such as high cholesterol, migraines and diabetes, the FDA has raised the idea several times over the past decade and brought it up again in March, asking the public to weigh in.

It’s uncertain whether the agency will sign off on the new policy since the idea has faltered in the past under opposition by doctors and other medical providers. The American Medical Association has said it could open the door to drug misuse and expects that out-of-pocket costs will rise for patients.

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Loggerheads, Wiser Heads and Troubled Intermediaries

05/08/2012 06:44 AM |

When it comes to addressing and solving the drug shortages, what are the most important variables to consider?

According to Healthcare Intermediaries: Competition and Healthcare Policy at Loggerheads? -- a new white paper by the American Antitrust Institute, a key question “is whether high levels of consolidation in intermediary markets and potentially exclusionary conduct have caused or exacerbated shortages.”

“One major protection against shortages is a stable supply chain, which is largely determined by the number and diversity of suppliers. The concept of supply chain “fragility” is increasingly relevant in operations research, marketing, economics, and even sociology. Supply chains featuring only a few competitors and high entry barriers at critical junctures are excessively exposed to the risk of disruption and collapse following an exogenous shock … but a fragile supply chain can also be inefficient when it “fails” because of excessive consolidation that leaves few suppliers.”

Intermediary conduct can, “threaten to impair the achievement of healthcare policy goals such as affordable healthcare, choice in medical products, a stable supply chain, and diversity of supply.”

The paper points out that sterile injectables. In 2010, 60 percent of sterile injectables (which accounted for 80 percent of the drugs in shortage) were sole-sourced. Markets for specific drugs are likely to be even more concentrated because only one or two firms produce them. Markets for generic drugs – which accounted for 60 percent of sterile injectables and 50 percent of all shortages – are also concentrated. In 2010, the top three firms accounted for about 70 percent of the generic sterile injectable market and 90 percent of the generic sterile injectable oncology segment of the market.

Indeed, the FDA notes that while demand in the generic and oncology segment of the market is robust, the supply system is “vulnerable to drug shortages because a large supply disruption is difficult to make up with alternative suppliers.” This is compounded by low demand and supply elasticities for certain drugs, stringent product manufacturing quality controls, dedicated production lines, and “just-in-time” manufacturing and inventorying practices.

Among other suggested next steps, the paper recommends that regulatory initiatives designed to address drug shortages “should focus less on reporting requirements and more on the analysis of competition in intermediary markets and upstream markets for drugs, and medical devices and supplies.”

A paper worth reading with conclusions worth debating.

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Massachusetts Doubles Down On Obamacare

05/07/2012 11:11 AM |

Language from Bill H.4070 "An Act relative to Health Care Quality Improvement and Cost Reduction Act of 2012" introduced in the Massachusetts House of Representatives:

" The division shall have the power to design and to revise, consistent with this chapter, a basic schedule of health care services that enrollees in any health insurance program implemented by the division shall be eligible to receive. Such covered services shall include those which typically are included in employer-sponsored health benefit plans in the commonwealth. The division may promulgate schedules of covered health care services which differ from the basic schedule and which apply to specific classes of enrollees. The division may promulgate a schedule of premium contributions, co-payments, co-insurance, and deductibles for said programs, including reduced premiums based on a sliding fee, and other fees and revise them from time to time, subject to the approval of the division of insurance; and provided, however, that such schedule shall provide for such enrollees to pay one hundred per cent of such premium contributions if their income substantially exceeds the non-farm poverty guidelines of the United States office of management and budget."

Compared to this bill, Obamacare is free market reform.    Read More & Comment...