Blame it on Brio

05/15/2009 05:57 PM |

In Great Britain they speak of “bespoke” healthcare.  Here at home, it seems, we are talking about “misspoke” healthcare.

After President Obama’s “historic” meeting with six major health care organizations, Robert Pear reports that, “confusion swirled in Washington as the companies’ trade associations raced to tamp down angst among members around the country.”

For those of you who missed the details or were otherwise caught up in the NHL and NBA playoffs, the President announced that, from 2010 to 2019, the major players in American healthcare pledged to cut the rate of growth of national health care spending by 1.5 percentage points each year or about $2 trillion over all.

However, Pear writes, “Health care leaders who attended the meeting have a different interpretation. They say they agreed to slow health spending in a more gradual way and did not pledge specific year-by-year cuts.”

And here’s the fun part:

“Nancy-Ann DeParle, director of the White House Office of Health Reform, said “the president misspoke” on Monday and again on Wednesday when he described the industry’s commitment in similar terms. After providing that account, Ms. DeParle called back about an hour later on Thursday and said: “I don’t think the president misspoke. His remarks correctly and accurately described the industry’s commitment.”

Thanks for the clarification, Nancy.

According to those who were at the meeting, there was some misspeaking by the President.

The Washington office of the American Hospital Association sent a bulletin to its state and local affiliates to “clarify several points” about the White House meeting.

In the bulletin, Richard J. Pollack, the executive vice president of the hospital association, said: “The A.H.A. did not commit to support the ‘Obama health plan’ or budget. No such reform plan exists at this time.”

Moreover, Mr. Pollack wrote, “The groups did not support reducing the rate of health spending by 1.5 percentage points annually.”

Two other lobbyists who attended the White House meeting confirmed Mr. Pollack’s account.

One of the lobbyists, Karen M. Ignagni, president of America’s Health Insurance Plans, said the savings would “ramp up” gradually as the growth of health spending slowed.

David H. Nexon, senior executive vice president of the Advanced Medical Technology Association, a trade group for makers of medical devices, said “there was no specific understanding” of when the lower growth rate would be achieved.

Maybe it was a typo on the teleprompter.

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CMPI's Continuing Odyssey (Project)

05/15/2009 11:36 AM |

CMPI: Health Reform Must Support Rather than Impede Medical Innovation

Health Leaders Launch "The Odyssey Project" to Foster Continued Medical Progress

 

Washington, DC (May 15) -- Yesterday, the Center for Medicine in the Public Interest (CMPI) launched The Odyssey Project, a new initiative to ensure that support for medical innovation remains a top priority in any healthcare reform effort.

 

"The Odyssey Project will provide a forum for discussing medical progress over the past half century," said Peter Pitts, President of CMPI. "It will create a roadmap for ensuring that public policy continues to offer patient-centered prescriptions for America’s healthcare challenges and that policymakers understand that support for innovation is the path to more efficient and better health care."

 

The Odyssey Project is a multiyear effort focused on bringing comprehensive information into the reform debate to educate the public and national policymakers about how biomedical innovation, far from being a major source of rising health care costs, has been and will continue to be the most important source of solutions to the challenges facing our healthcare system. The Project will propose fundamental changes in attitudes, regulations, health policies and healthcare financing that focuses on the near-term potential of new technologies and services that advance personalized medicine and allow individuals to save money while improving their health.

 

Rep. Mike Rogers (R-Mich.), a member of the House Energy and Commerce Subcommittee on Health and a leading advocate for high-quality, accessible health care said that The Odyssey Project is about improving health care.

 

"The Odyssey Project is exciting because it is ultimately about saving lives and improving health care for American families," Rogers said. "Medical innovation is an American trademark. America does innovation better than anywhere else in the world, but the support of policymakers is crucial if we are to continue finding solutions and developing life-saving medicines and treatments."

 

CMPI Vice President Robert Goldberg highlighted the importance of technology to saving lives. "Medical technology is not a costly burden to be contained, but the solution to humanity's greater challenges," Goldberg said. "It's counterproductive to reduce health spending by diminishing access to innovative new therapies. Indeed, over the past 50 years, the commercialization of medical discoveries and the development of more effective ways of integrating the use of these products to sustain individual health has produced enormous economic benefit to our nation and added to the health status of countless Americans. Policy changes that impede innovation will not save money or provide for better health."

 

Elijah Alexander, a former NFL star who is currently the president of the Tackle Myeloma Foundation, spoke of the importance of medical innovation in his own life, as a cancer patient. "Drugs come from private companies, and that requires years of trial and error by dedicated researchers," Alexander said. "Profits drive investment, and investment supports research. If I had been diagnosed with multiple myeloma 10 years ago -- before the drug that has saved my life, Revlimid, was developed -- I would probably not be here today."

 

Mark Thornton, the President of the Sarcoma Foundation of America, called on policymakers to protect America's standing as the epicenter of medical research. "The SFA heartily endorses the goals of The Odyssey Project -- to keep the United States at the forefront of medical innovation and to help develop a range of new treatment options for the diseases that plague our people. We look forward to working with CMPI to accomplish those goals."

 

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It's the Bishop!

05/14/2009 12:01 PM |

According to the Pink Sheet, “Senate Finance Committee Chairman Max Baucus, D-Mont., plans to propose patient protections for federal comparative effectiveness research that draw a clear line separating information gathering and coverage decisions. The "pro-patient safeguards," as they're being called, would take the next step after previous Baucus statements that seek to distance comparative effectiveness from insurance coverage decisions, according to Finance Committee staffer Shawn Bishop.”

Further, “One provision would bar CMS from having ‘automatic links to a study’ in a coverage decision, Bishop said. Creating safeguards via legislation suggests Baucus is taking seriously opposition to comparative effectiveness research and is sensitive to criticism that comparative studies could lead to a "one-size-fits-all" health care system.”

This news from an event sponsored by our good friend the very smart Ellen Sigal of Friends of Cancer Research.

Friends of Cancer Research makes four key recommendations:

1) A comprehensive comparative effectiveness research program should be developed to identify the most effective health options.

2) The program should link data from public and private entities.

3) CER studies should support the development of personalized medicine.

4) Processes should be developed to ensure information from CER is incorporated into clinical practice.

Ellen's not the only Sigal who knows how to build from the ground up.

Another of our smart friends, FDA Center for Drug Evaluation and Research Director Janet Woodcock, advised policymakers to include a key coordinating component as part of any upcoming bill: a clinical trial network.

"I have a lot of experience in this," Woodcock said. "A clinical trial network needs to be set up" in order to increase the number of trial investigators participating in CER studies.

"We need to lower those barriers in order to get more participants," Woodcock said, adding that a "first-time investigator is also a last-time investigator" due to the red tape involved in conducting a clinical study in the U.S.

Okay – it’s a start.  And the more people calling for a Critical Path for Comparative Effectiveness the better.

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Cereal Killer

05/13/2009 11:32 AM |

That's right -- a warning letter from the FDA for Cheeerios.

What's next?  A black box-top?

I spoke with senior officials at the agency yesterday who were incensed that the Minneapolis field office sent out this letter.  Just another example of the right hand not knowing what the left is doing.  Interpret that as you like.

First sponsored Google links, now this.  Is the FDA saying people should stop eating cholesterol-lowering cereals? Isn't that exactly the opposite of what the FDA wants people to do?  Whatever happened to "Better Health Through Better Nutrition?"

My favorite part of the letter reads thus:

"Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application."

And voila, a new potential marketing opportunity -- follow-on cereals!
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86ing Free Speech

05/13/2009 11:17 AM |

No free speech please, we’re European

According to a new European Court of Justice (ECoJ) ruling, information about medicines produced by third parties such as journalists may constitute advertising, even though they have no connection with the product’s manufacturer or marketer.

For those here in the US who believe in the First Amendment this is quite startling news.  For those who would seek to limit the pharmaceutical industry’s right to advertise it might very well be a roadmap – and then some. 

The ECoJ cited Article 86 of European Union (EU) Directive 2001/83/EC, which defines the concept of medicines advertising.  And according to the wisdom of the court, it “does not rule out the possibility that a message originating from an independent third party may constitute advertising, nor does [it] require a message to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising.”

Moreover, the EcoJ added, such “advertising…is liable to harm public health,” even when it is carried out by “an independent third party outside any commercial or industrial activity.”

Like journalists.  Or patient groups.  Or doctors.   It’s carte blanche for an almost complete gag order on anyone who wants to discuss anything to do with medicines.

86? Shades of 1984.

According to a report in Pharma Times, the details of the case are as follows: In 2003, Danish journalist Frede Damgaard, published information on his website about Hyben Total, a product licensed in Denmark as a treatment for a wide range of conditions - including gout, kidney and bladder disorders, sciatica, diarrhea and diabetes - until 1999, when the national regulator refused it a marketing authorization. It is still sold as a medicine in Sweden and Norway.

Mr. Damgaard’s positive description of Hyben Total’s effects on the symptoms of gout and arthritis led to his being prosecuted in the Danish courts, on the grounds that it constituted advertising of a medicinal product whose sale was not authorized in Denmark, thus contravening Directive 2001/83/EC.

When it comes to freedom of the press in Europe, it seems that the prime directive isn’t freedom of speech, but Directive 83 or Article 86. Talk about bureaucracy contravening basic human rights!

Mr. Dangaard appealed, claiming that his discussion of Hyben Total could not be held to constitute advertising as he had no interest in selling the product, and also that the court decision contravened EU protections of freedom of expression.

The Danish Regional Court of Appeal then referred the case to the ECoJ for a preliminary ruling, and last November an Opinion handed down by Advocate General (AG) Damaso Ruiz-Jarabo Colomer backed Mr. Damgaard, noting that “a lack of connection between the author of the information and the sellers or manufacturers of the medicinal product and the non-commercial or non-industrial nature of the activity of that independent third party may…be strong indications that a message does not have promotional content.”

The AG added that this was not an isolated case; similar situations had arisen recently over statements about melatonin made in a widely-broadcast news program in Spain, and also in the Czech Republic, where a collection of media features entitled “Yesterday Viagra, today Cialis” had been published.

Indeed, it seems that freedom of the press is breaking out all across Europe.  And it must be stopped.

AG Ruiz-Jarabo Colomer concluded that it is up to the individual EU states’ national authorities and courts “to ensure the correct balance between, on the one hand, the objectives of protecting health and promoting the rational use of medicinal products and, on the other, the right of the party concerned to freedom of expression, taking into account the special protection afforded to the party concerned, if it is established that he is a journalist.”

But in its recent ruling on the case, ECoJ said that Article 86 “is to be interpreted as meaning that dissemination by a third party of information about a medicinal product…may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently…of the manufacturer and the seller of such a medicinal product.”

Where is the European media’s outrage on this ruling?  And what will we hear from their American cousins?

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The Wrath of Rahm

05/12/2009 12:40 PM |

Does anyone really take the hastiliy assembled presentation on cost containment pledge of the health care "stakeholders" seriously?   Does the term "hostage situation" come to anyone else's mind?  The "stakeholders" were summoned by Rahm Emanuel to give cover to Obama and the Democrats because they were $2 trillion short to pay for their proposals... so guess what?  Their letter promises to deliver $2 trillion in savings over ten years by "aligning quality with efficiency, health IT, prevention" all the usual stuff and the administration promised it can be done AND provide coverage to 45 million (meaning 23 million) Americans without rationing, cutting payments to providers,or reducing quality...

Why go to Star Trek when you can watch science fiction unfold at the White House?









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When "23" comes on before "24"

05/12/2009 12:00 PM |

If you like "24" how about "23?" That's how long I appeared on yesterday's Lou Dobbs show. I had about 23 seconds to comment on the President’s meeting with some of America’s healthcare leadership.

My soundbite:  "Taking $2 trillion and somehow magically moving the numbers around to make it look like costs aren't going up as fast may be a political victory, but at the end of the day, will it really in essence change the paradigm of the health care crisis in this country?

Short answer, "no." 

(The full Lou Dobbs transcript can be found here.)

Today’s house editorial in the Wall Street Journal says it better:

Signing On to an Obama 'Dream'
Health providers agree to Obama health plan's notion of cost savings.

At a news conference yesterday, President Obama said, "I will not rest until the dream of health-care reform is achieved in the United States of America." Normally dreams cost you nothing, but Mr. Obama's determination not to rest until his becomes reality is likely to cost plenty. Yesterday a coalition of private health-system providers, seeing no exit from the administration's reform plans, signed on to the dream.

They agreed in principle to try to shave 1.5 percentage points off the growth rate of U.S. health-care costs over the next decade, about $2 trillion. This vague, probably illusory promise isn't much as a matter of policy, but it is a major political development in what is the Obama Presidency's No. 1 priority.

The private groups are calculating that they can better influence this year's bill if they're "partners" instead of villains. They've no doubt seen what happened to Wall Street and Chrysler bondholders. All the same, they must surely know they have made a Faustian bargain that in time will result in price controls and restrictions on care.

The Obama Administration, by contrast, is convinced that it is smart enough to engineer more efficient medical practices out of D.C. The dominant White House voice on health policy is Peter Orszag, the budget chief. He cites research out of Dartmouth that shows health-care spending varies wildly between regions, often with little or no correlation to health outcomes.

Mr. Orszag champions "comparative effectiveness research" -- studying the patterns of clinical practice to determine which drugs and treatments work best. The Administration thinks it can use such analysis to weed out wasteful or unnecessary care by paying more "if the treatment has been shown to be effective and a little less if not," as Mr. Orszag recently told the New Yorker.

The irony is that the history of post-1965 U.S. health care policy is littered with similar government attempts to control health spending, not least comparative effectiveness. The "managed care" movement of the 1990s grew directly out of the peer-review panels created by Congress in 1972 to monitor the quality and appropriateness of care for Medicare and Medicaid patients.

Under managed care, doctors and hospitals had to undergo prior "utilization review" by HMOs to reduce unnecessary hospitalizations, surgeries, tests, prescriptions and so on. This cost-effectiveness gatekeeping disciplined health spending. What happened next to this version of the dream is known to all.

Administrative hassles led to a consumer backlash, with patients feeling they were getting inferior care in return for insurer profits. The political class eventually forced the HMOs to dilute or end most of their cost-control strategies.

Democrats have now acknowledged that the managed care dream will work only if government is the one doing the managing. That is, we can only control costs with a new government entitlement. More is less.

But you can only allocate a scarce resource in two ways: market prices or brute force. In health care the brute force will come as price controls and waiting lines for rationed services. The implicit assumption in the providers' deal announced yesterday seems to be that the private companies will do the price controlling so the government won't have to do it for them.

But when the savings prove illusory, as in the past, the feds will step in and order them to do so. To win a false reprieve for themselves and give cost cover to the politicians, these private CEOs are offering to make themselves even more unpopular with patients. By that point, most patients will have no choice but to assent, since most of them will be in one government program or another.

Lest anyone remains in doubt about the ultimate goal here, Ralph Neas of the leftist National Coalition on Health Care got out a quick statement throwing ice water on the industry's concession. With perfect clarity Mr. Neas said: "Voluntary efforts -- without legislated requirements and enforcement -- have not worked well in the past."

The only benefit here is that it is now possible to see where this issue is headed: A new legislated entitlement for the middle class will ensure that the next great health-care argument to engulf the political system is going to be over how and when to ration care.

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Barbara and the Boss

05/11/2009 11:37 AM |

Good news.  Seems like Senator Barbara Mikulski (D, MD) agrees that doctors should be able to practice patient-centric (vs. cost-based) medicine. Here’s an exchange that took place between her and FDA Commissioner-designate Peggy Hamburg at the latter’s confirmation hearing:

Senator Mikulski: "As we take a look at reforming health care and improving access, one of the things that we have to be able to do is get value for what we pay for, which also goes to the efficacy of pharmaceuticals, biologics and medical devices. What role will you play in the health care debate to give us ideas and recommendations on efficacy?"

Dr. Hamburg: "I very much look forward to being involved in health care reform efforts around these important issues and making sure that drugs, vaccines, diagnostics and devices are as appropriately used as possible to make a real and enduring difference in health in this country.”

Senator Mikulski:  "I hope you're at the table too and I hope FDA's at the table because I don't want ... what drugs the American people have access to determined by insurance company formulary gatekeepers. I would hope that it would be based on efficacy as well as safety so that a clinician when they were prescribing not only knows what is safe ... but also what has the greatest efficacy and therefore gets the most value for health care."

Bravo.

Dr. Hamburg also put to bed the rumor that she would be “joint commissioner” with current Acting (and pending Principle Deputy) Commissioner Josh Sharfstein:

Dr. Hamburg: "I know that Dr. Sharfstein is very broadly knowledgeable about FDA and in fact is already there serving in an acting role. And I will, I'm sure, benefit from his early experience there as I make the transition if the Senate does choose to confirm me." She added, but "I am very eager to take on a broad range of challenges, and should I be so honored to serve, I would be the commissioner."

Glad that’s settled.

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Money for Nothing (and Your Scrips for Free?)

05/08/2009 10:37 AM |

The President's FY 2010 Budget for FDA request is $3.2 billion -- a 19% increase from FY 2009. Mostly it’s more money spent the right way. 

Mostly.

Let’s look at the numbers.

* The FY 2010 request includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. It includes increases for current law user fees and for infrastructure to support critical agency operations.

* The FDA proposes four new user fees to facilitate Protecting America’s Food Supply ($259.3 million) via the registration and inspection of food manufacturing and processing facilities. (They’ll be a hue and cry over this one); the re-inspection of facilities that fail to meet Good Manufacturing Practices and other safety requirements. (Grime doesn’t pay); the issuing of export certifications for food and feed. (Don’t have a cow).

* Safer Medical Products ($166.4 million) – This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review. (It’s about time).

* Current Law User Fees ($74.4 million) – In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million). Mazel tov – but still not enough.

* Follow-on Biologics – The budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation. (Nobody said FOBs were going to be easy – or inexpensive to produce.)

So far so good – but here’s the big mistake:

* Drug Importation -- $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.

Here we go again. $5 million down the toilet just to placate the lunatic fringe.

State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.

And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

Remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA."

Shameful.

This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.

And, speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”

In late July of 2008, the Canadian supplier for the program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.

And such programs won’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office (CBO) showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally mentioned in foreign drug importation schemes.

That’s millions of dollars in addition to the $5 million in the President’s budget proposal.

This is not the pathway to safer drugs. In fact, it’s precisely the opposite.

What drug importation does present is the opportunity to import de facto price controls. Is this the President’s agenda?  It certainly has been for his Chief of Staff, Rahm Emanuel, during his tenure as the Congressman from Blagojevich-ville.

In order to combat this back-door to the eradication of intellectual property rights, innovator pharmaceutical companies would likely restrict their sales of medicines to foreign nations to a certain fixed amount.  This is precisely what some threatened to do when Canadian pharmacies began selling medicines designated for their domestic market to Americans.

In 2003, upset by this logical strategy to protect their intellectual property, Minnesota’s then-Attorney General Mike Hatch, thumped his chest and announced the state’s intention to sue drug companies for their attempts to keep drugs earmarked for sales in Canada in Canada. Mr. Hatch’s announcement got a lot of news coverage and garnered him a prominent speaking engagement in front of the Families USA national conference in Washington, DC (after me and before Senator Ted Kennedy). What got hardly any coverage was the ensuing decision by a Federal judge who dismissed the case, “Denied as Moot.”

Mr. President, please review Surgeon General Richard Carmona’s report on the issues relative to drug importation.  That report can be found here.

$5 million to study drug importation?  Money for nothing.
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The Fight Between Comparative Effectiveness and Personalized Medicine

05/07/2009 09:33 PM |

This blog has not be afraid of a fight when it comes to characterizing poorly designed CER as an excuse for rationing new technologies.  On the other hand, those who oppose CER have to do a lot more than just bleat about it's negative consequences.   It has to stop spending money on lobbyists and start spending money on researchers who can create a science-based path for the approval and use of diagnostics and clinical data for selecting and evaluating treatments, preventing illness and improving health.  And it has to spend money to demonstrate that it can do all of the above. 

The current approach to reimbursement will not suffice.  Case in point, the preliminary CMS decision not to pay for gene-guided warfarin testing until long term randomized clinical trials determine if such tests actually reduce bleeding and clots over the long term.   It is not the right way to go... in a long term study (> 8 - 12 weeks) it is impossible to link initial dose to long term outcomes of bleeds/clots unless one were to let INR fluctuate freely which is clearly unethical.    And loading dose is what PgX testing is all about since the major risk is in overdosing in the first month of treatment. 

That being the case I was glad to see the approach taken by Sean Tunis and Alan Garber in their NEJM article on how CER could be used to advance personalized medicine.   I was particularly interested to see that Tunis and Garber were open to using post hoc subpopulation analysis to generate leads for benefit where one size fits all previously showed none existed  We will see if this is merely a sop or the beginning of a shift in approach that is sensitive to advances in science and other considerations. 

In addition, AHRQ is holding a symposium on alternative study designs to take into account heterogeneity of treatment effect. 

These are well overdue signs that CER will not be manipulated overtly by political masters.  However more needs to done.  Money needs to be allocated to accelerate the testing of predictive markers for treatment selection and for health outcomes evaluations in prospective, observational settings.  And legislation needs to be introduced to insure that the absence of evidence does not become the rationale for absence of reimbursement by insurers, public or private.   That is, both should pay for new technologies as along as their is a "meaningful" effort to link use to efforts to measure value and clinical benefit and that such information and the clinical practices associated with the technology are shared.

In any event,  I commend Garber and Tunis (Tunis and Garber) for their article and hope that more such efforts are in the offing.

Read more here.










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Swine Exploit Swine

05/06/2009 12:15 PM |

What does Interpol -- the world’s largest international police organization – know that the supporters of drug importation don’t?  That criminals will exploit any opportunity to sell counterfeit drugs.

Interpol report that around 3%-4% of spam mails currently being circulated are related to swine flu, and this number is expected to increase. Hundreds of new web pages related to swine flu have been created in the past week alone

“It has been seen time and time again that following a global threat or natural disaster, criminals exploit the situation for their own financial gain and in this situation they are searching to take advantage of people’s fears about their health,” said Jean-Michel Louboutin, executive director of police services at Interpol.

“By responding to spam swine flu emails or attempting to order medication on-line through illegal and unregulated websites, people are risking their wellbeing and their money,” and any unsolicited emails containing deals or links to websites offering swine flu-related information packs or medicines “should be treated with extreme caution,” he warned.

Criminal organizations and individuals involved in the production of counterfeit pharmaceuticals may also attempt to take advantage of the current health situation through the manufacture of fake antiviral drugs, added Mr Louboutin.

“Any product which can be manufactured can be counterfeited, and while there is so far no evidence to suggest that fake antivirals are being manufactured in response to the swine flu outbreak, this is an area which we will continue to monitor in order to identify any cases if or when they emerge,” he said.

National authorities around the world have also issued warnings to the public, with David Pruce, director of policy at the Royal Pharmaceutical Society of Great Britain (RPSGB), pointing out that the current fears about swine flu offer a “golden opportunity” for counterfeiters to offer fake supplies of drugs, particularly Roche’s Tamiflu (oseltamivir) and GlaxoSmithKline’s Relenza (zanamivir) over the Internet.

The public should not be taken in by spam e-mails offering to supply these antivirals, said Mr Pruce. “Most of the drugs offered in this way turn out to be counterfeit and may contain anything from sugar to more dangerous substances that can seriously put health at risk,” he added.

Those supporting drug importation from foreign countries take note – you can’t put lipstick on a pig.

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CMS Redefines Redundancy

05/06/2009 02:38 AM |

While personalized medicine stakeholders were meeting with HHS Sec. Sebelius to discourage duplication of CMS and FDA review and validation of Dx here's what CMS decided:

Finding insufficient evidence demonstrating that pharmacogenomics-guided warfarin dosing improves health outcomes for Medicare beneficiaries, the Centers for Medicare & Medicaid Services this week determined that pharmacogenomic testing to predict warfarin responsiveness is "not reasonable and necessary."

Instead, CMS proposed a more "appropriate" alternative, employing a "coverage with evidence development" strategy, in which it would pay for PGx-based warfarin dosing only for Medicare beneficiaries who are part of a prospectively designed, randomized-controlled trial showing pharmacogenomics-guided dosing strategies improve health outcomes over standard dosing methods.

I guess requiring a RTC when FDA doesn't is not duplication. It is outright delay and derailment of Dx.

Read more here

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Fake It Until You Can Make It?

05/05/2009 12:19 PM |

According to the Associated Press, “The Food and Drug Administration has found at least 20 Web sites that may be fraudulently marketing products with claims that they guard against or cure swine flu.”

The FDA has also found at least 20 other sites offering products for swine flu -- including antiviral medications being sold without a doctor's prescription (including Tamiflu), dietary supplements with exaggerated claims, and flu diagnostic and protection kits.

This is what happens when public officials openly promote buying medicines over the internet. It emboldens criminals to sell their snake oil to frightened Americans.  Supporters of “safe” importation “from Canada” take note – you cannot call for “safer” drugs and foreign drug importation at the same time.

Drat that reality!

The complete AP story can be found here.

And it’s all strangely reminiscent of former Illinois Governor (and potential future felon) “Wrong Way” Rod Blagojevich’s purchase of 700,000 doses of flu vaccine from non-FDA approved sources.  By the time his purchase went through, the legitimate vaccine supply had been augmented and he refused to pay for the shipment.  (Maybe that should be added to the federal indictment?)

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The Cost and Value of Comparative Effectiveness Research

05/04/2009 10:40 PM |

For all the assertions about the value of comparative effectiveness research (and money now being spent on it) there is actually very little theoretical or empirical research on the impact of such studies on things you might want to know about:  Costs for one thing.  There is the small question about whether the research has actually produced conclusions that could be considered clinically reliable or meaningful.  Then there is the question of the impact a quality of life threshold derived from an initial review of a relatively new product that itself reflects a value judgment will shape the rate of  Investment in future technologies.  

A recent paper entitled: Economic Evaluation and Comparative-Effectiveness Thresholds: Signals to Firms and Implications for R&D Investment and Innovation John A. Vernon University of North Carolina at Chapel Hill, Joseph H. Golec University of Connecticut - Department of Finance and me address that last issue. 

Here's the abstract and a link to the article:

Abstract:     
In this article we describe how reimbursement cost-effectiveness thresholds, per unit of health benefit, whether set explicitly or observed implicitly via historical reimbursement decisions, serve as a signal to firms about the commercial viability of their R&D projects (including candidate products for in-licensing). Traditional finance methods for R&D project valuations, such as net present value analyses (NPV), incorporate information from these payer reimbursement signals to help determine which R&D projects should be continued and which projects should be terminated (in the case of the latter because they yield an NPV < 0). Because the influence these signals have for firm R&D investment decisions is so significant, we argue it is important that reimbursement thresholds reflect the economic value of the unit of health benefit being considered for reimbursement. Thresholds set too low (below the economic value of the health benefit) will result in R&D investment levels that too low relative to the economic value of R&D (on the margin). Similarly, thresholds set too high (above the economic value of the health benefit) will result in inefficiently high levels of R&D spending. The U.S. in particular, which represents approximately half of the global pharmaceutical market (based on sales), and which seems poised to begin undertaking cost effectiveness in a systematic way, needs to exert caution in setting polices that explicitly or implicitly establish cost-effectiveness reimbursement thresholds for health care products and technologies, such as pharmaceuticals. In this paper we consider how cost-effectiveness thresholds influence R&D spending because firms react to payer reimbursement signals and guidelines.

Read article here
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Health Care Costs: International Edition

05/04/2009 05:34 PM |

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Nuts!

05/04/2009 12:11 PM |

In a new Harris Interactive/HealthDay online survey (conducted in mid-April, via a nationally representative sample of 2,495 adults aged 18 and over), 47 percent of respondents believe the FDA does a poor job when it comes to monitoring the safety and effectiveness of new prescription drugs. 

The good news is that this is an improvement over the 58 percent disapproval rating noted in a similar poll last year.

Some other interesting findings:

* 49 percent of Americans have a negative view of the job the FDA is doing. 48 percent have a positive assessment.

* 6 percent of respondents say that the FDA's oversight of imported foods is "excellent.” 21 percent say it’s "poor."

* 8 percent of poll respondents feel the agency is doing an "excellent" job of making sure new prescription drugs are safe and effective, or monitoring the safety of prescription drugs after they arrive on the market.

* 11 percent believe the FDA does an "excellent" job of handling recalls of prescription drugs. Overall, 43 percent think the agency's handling of recalls is "good," 28 percent "fair," and 12 percent "poor."

* 56 percent of those surveyed feel positively about how the FDA handles food recalls, while 40 percent feel negatively. Confidence about drug recalls was less robust.

* 59 percent said they feel that food safety should be the FDA's most important priority, followed by ensuring the safety and effectiveness of prescription drugs (37 percent). The safety of imported food came in third at 30 percent.

* 47 percent of respondents felt negative and an equal number positive about how the FDA ensures the safety and effectiveness of new prescription drugs. In 2004, 56 percent were positive and 37 percent were negative.

* More individuals (53 percent) felt positive than negative (40 percent) about how the FDA handles drug recalls in 2009, versus an opposite trend in 2008: 39 percent positive and 53 percent negative.

* Roughly the same percentage of people feel positive and negative about how the FDA monitors drugs after they are approved.

* About one-third (35 percent) of respondents say the FDA approves new drugs too slowly, 19 percent too quickly, and 18 percent think the process is about right.

* Only one-quarter feel "very confident" about the safety of over-the-counter medicines such as cough and cold medicines; 24 percent feel the same about prescription drugs, both brand names and generics. But only 14 percent feel this way about herbal remedies and nutritional supplements.

Obviously, some of these findings are somewhat contradictory – and that’s not surprising considering that many of the questions overlap and the responses are based on what people “think” they know about the FDA.  But, all that aside, it is a snapshot in time of people’s general attitudes about the agency that regulates more than a quarter of the American economy.

What explains the improvement of the numbers year-over-year?  Is the “Obama FDA” in April 2009 any different from the “Bush FDA” from January 2008?  The answer, technically, is nothing is different.  But with a new administration (and particularly this one) comes higher expectations.  And the agency’s expeditious approach to pistachios seems to have given the FDA a kick-start to public redemption.

Well, nuts!

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Next Up: Craigslist Killer As Match.com Spokesman?

05/01/2009 09:29 PM |

Because it's Friday and because I am staying at home in a tub filled with Purell under the advice of Joe Biden:

On May 21, Michael Vick will be transferred from a federal prison in Kansas to home confinement in Hampton, Va. (AP)

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Peggy Pandemic

05/01/2009 11:40 AM |

What's it going to take to get the Senate to act on Peggy Hamburg's nomination, a flu pandemic?

While FDA has made all the right moves in dealing with the swine flu issue (specifically by naming Jesse Goodman to oversee the agency’s role in addressing the problem) there’s one more thing that only the United States Senate can do to help – confirm Peggy Hamburg as Commissioner. Now.

After all, she’s only one of the world’s top experts in flu pandemics – serving as vice chair of the IOM’s Forum on Microbial Threats (where she served along side Dr. Goodman and the FDA’s current “Food Czar,” David Acheson.

It’s time for us to use all the weapons at our disposal to combat the swine flu -- and Peggy Hamburg is a powerful one.  Let’s get the confirmation process underway and expedite a Senate vote.

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Ace Ventura, Autism Detective

04/30/2009 01:19 PM |

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The other Stossel and the same old Angell

04/30/2009 11:16 AM |

From the pages of Forbes ...

How To Maintain FDA Standards
Don't follow Marcia Angell's recommendations.
Bruce Gingles and Thomas P. Stossel,

For over 100 years, the U.S. Food and Drug Administration has balanced bringing important new medical products to patients with ensuring their safety. No drug or device is 100% safe, but physicians have steadily obtained ever more effective tools that increase patient longevity and quality of life.

Still, critics we dub "pharma-scolds" depict the FDA as a stooge of medical-products manufacturers and demand that the agency develop a more adversarial relationship with the pharmaceutical industry. One inveterate fault-finder, whose opinion is often sought by credulous audiences, is Marcia Angell, former acting editor in chief of the New England Journal of Medicine and author of The Truth About the Drug Companies. In an April 6 piece in The Boston Globe, Angell made sweeping recommendations that, if enacted, will set back patient care.

First, Angell wants to eliminate the "user fees" drug companies currently pay the FDA to evaluate their products. Such fees, she argues, confer "employee" status on the agency. But these companies have no input into the FDA's final decision to approve or deny new drug applications. Substantial research shows that user fees benefit patients by allowing the agency to hire additional staff to process new drug applications in a timely manner.

And many other federal agencies--even the post office--supplement their budgets with user fees. Taxpayers clawing their way out of an economic recession should appreciate that the industry pays in part for its own regulation.

Next, Angell wants the FDA to exclude industry consultants from advisory committees on new products. But evidence shows that the most productive scholars have industry relationships, and that such relationships have no effect on their recommendations for drug approval. It seems Angell would rather have the FDA get less useful advice than turn to experts who work with companies to develop life-saving products.

Angell also wants direct-to-consumer advertising for new products banned for three years after they're launched, limiting market penetration so that side effects not detected by pre-approval trials will affect fewer patients. But since rare complications emerge only after widespread product use, her recommendation is illogical. Banning this advertising, as Angell suggests, would mainly serve to keep useful products from patients who need them.

This brings us to Angell's worst idea: discouraging "me-too" products--drugs developed as variants of new medicines--based on the incorrect presumption that such products increase costs without adding clinical value. Once a new drug is approved, Angell suggests, no more drugs should be approved for the same general purpose unless it is judged superior to the first product in head-to-head clinical trials.

But Angell fails to understand that most useful innovation is evolutionary, not revolutionary. Tweaking antibiotics, for example, counteracts the penchant of disease-causing microbes to develop resistance to them. Radically curtailing second-generation products makes neither medical nor economic sense and borders on murderous absurdity.

The introduction of "me-too" products by multiple companies facilitates testing of the products in different clinical indications, expanding their versatility and benefit to patient. Competition among brand products reduces prices, and sales of incrementally beneficial products provide the revenues to support the research and development of the occasional breakthrough drug.

If the first cholesterol-lowering drug (called a statin) for preventing heart attacks had been not Merck's ( MRK - news - people ) Mevacor, but Bayer's ( BAY - news - people ) Baycol--which was later shown to have potentially fatal side effects--and the FDA had delayed the introduction of new statins because it was waiting for evidence from head-to-head trials, patients who needed to cholesterol reduction and had only Baycol available would have been without any alternative. As another example, lanidomide is not materially more effective than thalidomide (from which it is derived) as a treatment for the disease multiple myeloma, but it lacks thalidomide's side effects.

Angell also wants the FDA to exclude surrogate measurements--like cholesterol, which correlates with heart attack risk--as criteria for approval of second-generation products, because such measurements don't always predict clinical outcomes. Instead, Angell thinks companies should conduct expensive trials to document clinical benefits.

However, surrogate values are frequently predictive. Scientists use surrogate markers to make reasonable predictions about actual outcomes in patients--giving patients faster access to new treatments. FDA approved both thalidomide and lanidomide based on surrogate measurements. Abandoning them would make a perfect enemy of the good.

Last but not least, Angell wants to accelerate FDA approval of generic products, alleging that the "FDA takes roughly twice as long to approve them as to approve brand-name drugs." Generics are the ultimate "me-too" products--they're just cheaper copies of older drugs.

Generics are fine, but Angell draws a false comparison. User fees do shorten the time between the filing of a new drug application and an FDA decision; pre-application development time for innovative products is far longer than for generics. A better metric is to compare actual numbers of new drug and generic drug approvals: In 2008, the FDA approved 21 innovator drugs and 90 first-time generics.

In short, Angell's calls for reform would lead to decreased patient access to lifesaving new products, higher drug prices and less competition between pharmaceutical companies. As public policy, that's a prescription for bad health.

Bruce Gingles is vice president of Cook Group, a medical device company. Thomas P. Stossel is a professor of medicine at Harvard University and a senior fellow at the Manhattan Institute for Policy Research.

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