Latest Drugwonks' Blog
Peggy Hamburg’s letter to the editor (Washington Post, February 4, 2011)
Drug approval isn't a race between the U.S. and the E.U.
In his Jan. 24 op-ed, "Finding a strategy for growth," Fareed Zakaria missed the mark regarding the speed of drug approvals in the United States and Europe. The facts show that the Food and Drug Administration's review times are somewhat shorter and that approval of new drugs generally occurs sooner in the United States, compared with Europe.The FDA compared marketing approval of 57 novel drugs approved by both FDA and European Union regulators between 2006 and 2010. Of these, 43 were approved first in the United States and 14 were approved first by the E.U. Twenty-seven of these 57 drugs were FDA-designated priority review drugs that provide a therapeutic advance, and all but three of the 27 were approved first by FDA. The median time from marketing submission to FDA approval was 183 days for priority review products, and 396 days for standard review products. In the E.U., those times were 403 days and 449 days, respectively.
The review and approval of new drugs is not a race between FDA and EU regulators, with whom we collaborate and whom we see as colleagues. But we do operate under different laws and procedures. Finally, we note that apart from the FDA's regulatory climate, there are many reasons why industry chooses to work overseas, including reduced labor and production costs.
To get a sense of how divorced from real experience most healthcare policy experts are let me share with you some recent examples..
Here's Jonathan Cohn:
"The idea behind the Affordable Care Act is to strengthen health insurance and give it to more people, which will cost the government money. At the same time, though, it will make the health care system as a whole more efficient, which will save the government money. Over the course of a decade, the costs and savings should be about equal, which means the net cost to the government would be roughly zero -- even as we'd made insurance both more reliable and much more available. That would be a pretty good deal...
Now, if you're worried about the government's long-term fiscal future -- and you should be! -- the key question is what happens after those 10 years. The big worry is that the budgetary burden of health care will become staggeringly heavy in 2030, 2040 and beyond. The only way to avoid that scenario is to slow down the growth of federal health care spending -- that is, to make sure it doesn't keep going up as fast as it's been for the last few decades."
But it begs the question: haven't we been making health care more efficient over the past 20 years? Following Cohn's argument, doing so would have prevented federal health care spending and spending overall not to go up as fast as it's been for the last few decades.
www.kaiserhealthnews.org/Columns/2011/February/020311cohn.aspx
Applying that timeline what do we see?
The rate of increase in healthcare spending is three times slower in the last few years compared to what it in 1970.
Assuming government wasn't doing anything to help, what was? I have some ideas but the point is, health care debates that don't start with accepting the facts as they are instead of some narrative we "feel" is right will go nowhere fast.
In the interest of fairness, here's an example of empty expertise from the conservative perspective:
Here's John McCain on Rx drug costs:
"Americans salaries are being cut, household budgets are slim and millions of Americans are struggling to make their monthly mortgage payment. For these reasons and so many more, Americans should not be forced to wait another day to purchase safe and affordable prescription drugs from outside the United States. But, while Americans all over the country and having to choose between their next meal and their necessary prescriptions, the large pharmaceutical companies continue to pressure Congress to delay consideration of any legislation to allow the importation of safe and lower priced prescription drugs."
The reality?
"Canadians (on average) spent 2.5% of their per capita PDI on prescription drugs in 2007, compared to 2.6% in 2009. Americans spent less of their per capita after-tax income (2.3%) on prescription drugs than Canadians in both 2007 and 2009. Comparable results were found when prescription drug spending as a share of per capita GDP was ana- lyzed. Canadians (on average) spent roughly 1.5% of their per capita GDP on prescription drugs in 2007, compared to 1.7% in 2009 (figure 1). Americans spent the same percentage of their per capita GDP on prescription drugs in 2007 as they did in 2009—roughly 1.7%."
tinyurl.com/4f7x94y
www.fraserinstitute.org/.../fraser.../prescription-drug-spending-Canada-and-US.pdf - Canada
People can have their own opinions, but not their own facts....
Getting the biggest bang for the regulatory buck doesn't mean that the FDA needs fewer bucks.
According to a story on today’s AP wire:
“House Republicans are seeking to keep their campaign promise to cut $100 billion from domestic programs … The hardest hit agencies would include the Food and Drug Administration …”
This is a crucial debate at a time when the agency needs more, not less funding and PDUFA is up for reauthorization. Both the Congressional determination to spend more wisely and the pharmaceutical industry’s desire that PDUFA V returns to first principles are not mutually exclusive. What both groups want is a properly funded FDA that spends its money in a responsible and predictable manner.
For more on the urgent need for smart and timely PDUFA reauthorization, see here, here, here, and here.
“Money is better than poverty, if only for financial reasons”
-- Woody Allen
Here’s the headline:
WASHINGTON — The Obama administration is examining whether the new health care law can be used to require insurance plans to offer contraceptives and other family planning services to women free of charge.
The article by Robert Pear is more about the continuing and hypersensitive debate over contraception than anything else – but there’s another issue.
According to the Patient Protection and Affordable Care Act, insurers must cover “preventive health services” and cannot charge for them. Without getting into the myriad and highly political issues surrounding contraception, an obscured, undiscussed but highly important question relative to the PPACA is – just what is “preventive medicine?”
With dynamic advances in diagnostics, we can now determine (with ever-greater degrees of accuracy and certainty) if someone, say, is prone to develop Alzheimer’s Disease. A recent article in the New York Times, “Two Tests Could Aid in Risk Assessment and Early Diagnosis of Alzheimer’s,” discusses a diagnostic scan that can help physicians determine whether a patient’s dementia is actually Alzheimer’s – allowing earlier and more aggressive treatment. The article also points out that, “… a large study sponsored in part by the National Institute on Aging is scanning healthy people and following them to see if the scans predict the risk of developing Alzheimer’s disease.”
If such a predictive test does become available, would this fall under the codicils of the PPACA’s call for “no-cost preventive screenings?” The impact on payers would be significant. Such a diagnostic would cost significantly more than a prescription for the Pill. And if Alzheimer’s was indeed the diagnosis – treating it is expensive.
The question then arises, is it cheaper to identify and aggressively treat a patient in the early stages of Alzheimer’s (even before there is a significant manifestation of symptoms) or to wait until the late stages – where the real costs lie not only in therapeutics, but in the related expenses of care-giving?
As the Center for Medicine in the Public Interest demonstrated in the paper, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money or Indirect Price Controls”, early intervention saves significant dollars over the course of the disease – even by delaying disease progression. This is a crucial point as there is, at present, no “cure” for Alzheimer’s Disease.
Where you stand often depends on where you sit. Will the PPACA demand that insurance providers provide free “preventive care” for a drug that doesn’t lead to prevention of a disease (like Alzheimer's) but delays its progression (like Aricept)? What about diagnostic screenings that can significantly lower the long-term costs of a non-preventable disease? If you are a payer, it’s a question of short-term costs versus long-term savings. And then, of course, whether the disease state is Alzheimer's Disease or breast cancer -- there’s what’s best for the patient.
And that’s a consideration particularly germane for our nation’s largest payer – Uncle Sam.
Horsham, PA (Vocus/PRWEB) February 01, 2011
Dr. Turner is an experimental research scientist, clinical trialist, and author. Prior to joining Quintiles, he was a clinical submissions scientist at GlaxoSmithKline and president and chief scientific officer at Turner Medical Communications LLC.
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
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That is how Obama, Reid and Pelosi wrote and passed Obamacare.
Why is it surprising that legislation so written also forgot to ask the question....is this constitutional? That is a question Obama has never asked himself about his big government ideas.
The legislation must be totally repealed and/or struck down. Then real reforms are possible.
As a follow-up to my comments on combating counterfeits on a global level (“Peggy’s Regulatory Marshall Plan”), let me share some comments from the Commissioner’s speech Monday at Council on Foreign Relations.
(The speech – as delivered – will be available shortly on the FDA’s website.)
It’s a pleasure to be back in New York and at the Council on Foreign Relations. I have admired this organization for many years and am proud to be a longstanding member.
Some here may have been surprised to see that CFR is focusing on issues of food and drug regulation. But it is highly appropriate, much needed, and very timely.
Our scope and responsibilities are enormous. But it hasn’t always been that way. As you can imagine the world in which FDR created the modern FDA in 1938 was very different from ours.
Back then, most products FDA regulated were domestically manufactured and the data supporting them came from American investigators. And for years, when it came to importation of foreign products, our authority to ensure safety and quality and to protect public health focused on catching problems at the border and then limited overseas inspections. But times have changed.
Today the world in which FDA-regulated products are discovered, developed, processed, and distributed is much bigger. FDA’s traditional model of manufacturing site inspections and border examinations is simply not adequate in today’s transformed world.
In 2010 alone, FDA estimates that more than 20 million import lines of food, devices, drugs, cosmetics, and tobacco arrived at U.S. ports of entry—more than a three-fold increase in regulated imports from a decade ago. Regulated products come from 300,000-plus facilities in more than 150 different countries all over the world. And they come through over 300 ports of entry into the United States.
The numbers are staggering. In the food realm, about 40 percent of fresh fruit and produce and over 70 percent of seafood we eat in the United States come from other countries. And for medical products, a stunning 80 percent of the active pharmaceutical ingredients in our drugs come from outside our borders and about 40 percent of the drugs themselves.
The global supply chain has led to the distribution of unsafe or ineffective products and harm caused by economic adulteration and intentional fraud. You will hear directly from others the tragic toll that the counterfeit trade is taking in many parts of the world. And for all of us, the global supply chain presents many new national and international security threats.
In recent years in this country, we have experienced events—some clearly deliberate and some unintended—with serious implications for health and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, to name just a few.
This is a moment for leaders around the world to create a new vision of how we regulate. We have a shared interest in ensuring the safety and quality of food and medical products and a shared responsibility for safety and quality. By working together to monitor and improve safety and quality globally, we will benefit all the citizens of the world.
What I envision for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators. Some of the work for this is already underway and has been for several years, as regulators around the world have begun to collaborate. But these efforts need to be taken to the next level. We must ask ourselves how we can weave our various efforts into a coherent global system of oversight and safety.
As part of these efforts, regulatory authorities, especially those with the greatest experience and resources, must work together to help build regulatory capacity in those countries that are more resource poor and with still developing systems so that they can produce food and commodities that are safe, wholesome and meet international safety standards. This is surely in America’s vested interest, but it will have broader benefits for public health and economic development within those countries.
In addition to creating a global coalition of regulators, we must create a modern means to share data globally. And, we must use those data and advanced analytics to proactively prevent and identify problems. Detecting and preventing global problems demands global intelligence- sharing and data-mining.
Also, as the new food safety law recognizes and requires, we must also enlist public and private third parties, as well as industry and other organizations, to increase the global safety net. We must do this for foods and medical products. Regulators cannot do it alone.
Finally, we must create the momentum in the U.S. and in the global community to make these changes real—and sustainable. These changes must begin now, but they will take time and the support of many people to fully implement. A strong global safety net will be challenging to weave. But, we can do it together.
So let us continue the conversation today and—as regulators, consumers, academics, industry leaders, and others with expertise—find new ways to ensure the safety and quality of food and medical products and promote the health and well being of the American people and our fellow citizens around the globe.
These issues affect us all and we all must contribute to solutions. Thank you.
Obamacare's Final Chapter
By: Robert Goldberg
Judge Roger Vinson's summary judgment declaring the Patient Protection and Affordable Care Act unconstitutional goes beyond providing legal basis for overturning the requirement to buy healthcare. He demonstrates that the individual mandate is merely a means to solve a political problem created by the faulty drafting of Obamacare. In doing so, he forces the administration and the Supreme Court to overturn his decision by expanding the power of Congress in capricious ways neither the Founders intended or voters will be happy with.
The first part of Vinson's brief rejects the complaint made by the 26 states opposing Obamacare that the required expansion of Medicaid is coercive because it forces hard choices on states it did not agree to. Vinson (citing another court opinion) notes, "The difficulty if not the impropriety of making judicial judgments regarding a state's financial capabilities renders the coercion theory highly suspect as a method for resolving disputes between federal and state governments." Governments cannot use the Constitution to solve a problem created by bad policy.
In making this argument Vinson invokes the original Tea Party. He notes: "It is difficult to imagine that a nation which began, at least in part, as the result of opposition to a British mandate giving the East India Company a monopoly and imposing a nominal tax on all tea sold in America would have set out to create a government with the power to force people to buy tea in the first place."
This is more than a rhetorical flourish. Vinson is setting the stage for shredding the constitutionality and reasoning behind the individual mandate: The American Revolution was started in part by outrage against the tea tax. How greater would that reaction be if citizens were also forced by any government not only buy tea but also to purchase a specific kind of tea from specific companies or risk a penalty.
Under Obamacare, not only is a decision not to buy healthcare against the law, so too is the voluntary purchase of a product other than that specified under Obamacare would trigger a penalty.
Stephanie Cutter, Obama's health care advisor, blogged: "People who make an economic decision to forgo health insurance do not opt out of the healthcare market. As Congress found, every year millions of people without insurance obtain healthcare they cannot pay for, shifting tens of billions of dollars in added cost onto those who have insurance and onto taxpayers." The White House goes further and argues that because other parts of Obamacare might encourage people to postpone getting insurance until they need to, the individual mandate is "necessary and proper." Without it, the healthcare market would collapse.
Which leads Vinson to his second argument: The administration's claim that without the mandate costs and taxes would rise is no better a reason for judicial intervention than the claims of states that Obamacare is forcing them into a lousy financial position. It would be a huge overreach of judicial power to compel people to buy a specific product to rectify a situation created by previous policies. Congress enacted laws requiring hospitals that receive Medicaid dollars to treat all individuals and ask about cost later.
Congress has many options to address the "free-rider" problem just as the states have a range of choices in addressing rising Medicaid costs. (It could impose a healthcare tax on everyone to pay for insurance for the uninsured or bailout states. Or it could change laws to eliminate uncompensated care.)
Hence, Vinson notes: "it should be emphasized that while the individual mandate was clearly 'necessary and essential' to the Act as drafted, it is not 'necessary and essential' to health care reform in general." In fact, the mandate and penalties a prescribed actually reward businesses and individuals for dropping coverage and enrolling in Medicaid. That would -- in Cutter's words -- shift tens of billions of dollars in added cost onto those who have insurance and onto taxpayers.
If Congress can compel purchase of specific products from only government-approved health plans under the Commerce Clause to deal with financial challenges in the healthcare market created by previous policies or compensate with Obamacare's imperfections, nothing can stop it from dictating the terms and conditions of other economic decisions that have a fiscal consequence to a particular market.
Vinson has done more than overturn Obamacare. He's raised the political stakes for Obamacare supporters. Overturning his ruling would force the Supreme Court to "authorize Congress to reach and regulate far beyond the currently established 'outer limits' of the Commerce Clause and effectively remove all limits on federal power." The political response would lead to Obama's defeat or congressional action eliminating the individual mandate. Either way, it is increasingly unlikely Obamacare will be enacted.
I have a cold! Or do I? Can I Google it?
I have a cold.
I noticed this yesterday when I began to experience a sensation that felt as though a small army of ants in sandpaper shoes were marching down my throat in single-file.
I went home, rested, ate some vitamin C, drank some water, and went to bed early. I woke up this morning, and whenever I say anything, I sound sort of like Carol Channing, if Carol Channing kept stopping in the middle of sentences to blow her nose violently.
I think it's one of those common, garden-variety colds. I don't know whose garden this is, but I think he's a bioterrorist.
Every time I get a cold, I try to find a good placebo to take. It doesn't matter if it works. It just has to require a lot of effort and involvement. My ideal remedy for anything is one of those old-timey panaceas like "apply a muskrat to your chest" or "sleep with a goat's bladder under your pillow, with the goat still attached." Apparently, the pioneers did things like this, when they weren't failing to ford rivers, having their oxen die, and catching cholera. If it works, you're cured. If it doesn't, you get to wander around the office for a week with a muskrat tied to your chest and no questions asked.
So for the next few days, I'll be That Person With An Obstreperous Cold. Don't come near me!
After erupting into a violent coughing fit near you and unconvincingly trying to pass it off as an audition for La Boheme, I will probably tell you that "I'm on antibiotics." Nine of out of ten times, this is false. It's just one of those things you have to say to prevent things from getting awkward, like "That wasn't me!" or "I love you."
And there's another problem. Like most Americans, my response to any kind of health crisis -- or, for that matter, any crisis -- is to Google it. According to the Pew Center, more than 82 percent of the Americans who had access to the Internet in 2008 (about 61 percent of all adults) had searched for health information online. This seems great -- more information, more rapidly!
Except that it might not be. As Dr. Robert Goldberg points out in "Tabloid Medicine: How the Internet is Being Used to Hijack Medical Science for Fear and Profit" (this book wears its thesis on its dust jacket sleeve) only one-fourth of those searching for medical information online reported checking the source and date of the information they found. And the sensationalist tendencies of the Internet mean that dramatic but rare diseases often get higher billing in search results than their less intriguing (but more probable) cousins. In one study, researchers who put "muscle twitches" as a symptom into the general search engine LiveSearch found that 50 percent of the results suggested Lou Gehrig's disease. Serves them right for using LiveSearch! Based on my symptoms, a cursory Google search revealed that I am dying of scrofula, a disease that can only be cured by the touch of Louis XIV.
But this is not the only problem. Well-intentioned people post information on their blogs that becomes unduly influential thanks to factors like availability bias. And, as Goldberg notes, "the ultimate danger of Internet searching -- particularly for information about risks and benefits -- is that there is no arbiter of truth to let users know that what they are being told is accurate." That's true of everything online, but in the realm of medicine, fatally so. For instance, I recently read a gripping account that said that, true, one vitamin C capsule had no tangible effect, but if I ate the whole bottle in a sitting, not only would I be instantly cured, but I'd never get scurvy again! I'm going to try this when I get home.
But first, I'm going to CVS. After all, the best part of any cold is the part when you arrive in the pharmacy aisle looking for things to take. They are all brightly colored and going to help you. Suddenly, you want one of everything. Theraflu warming relief? Sign me up! Ricola? Why not? Zicam? That might be a bit much. Theraflu is what we in showbiz refer to as a quadruple threat: A pain reliever/fever reducer/cough suppressant/nasal decongestant! This will even solve problems I don't have yet!
At least, it would have if I hadn't read a large number of vivid online accounts explaining that taking Theraflu was tantamount to having a stranger toss you in a bathtub and remove both your kidneys. The more I read, the clearer it became that absolutely any medicine I tried would be absolutely lethal. I'm one of a new breed of what Dr. Goldberg calls cyberchondriacs -- I know I'm dying of a rare disease, but all the available treatments would be equally lethal! Usually, this works out well, because I am not actually sick. But now, it's a struggle.
Fortunately, a number of recent studies have said that placebos actually do work as actual treatments, even if you know they're placebos -- as long as they don't eat your kidneys.
Maybe I'll have to get that muskrat after all!
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
