Latest Drugwonks' Blog
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.
Dr.
Glad that’s settled.
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.
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.
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.
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
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
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
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!
Michael Vick in talks to become PETA spokesman
May 1, 2009 - 2:38pm
Michael Vick has a new job offer waiting for him: PETA spokesman.
The ex-NFL superstar - who is serving prison time for funding an illegal dog-fighting ring - is in talks to do public service ads for People for the Ethical Treatment of Animals, AdAge.com reports.
The new gig is part of a comprehensive PR attempt to transform the disgraced quarterback's image -- and possibly get him re-admitted to the NFL.
Vick's public mea culpas will come in the form of public service announcements, TV interviews, donations to animal-rights organizations, and perhaps even the creation of his own foundation.
Dan Shannon, director of youth outreach and campaigns for PETA says Vick has the potential of truly getting the message across.
"I can do it until I'm blue in the face and it might not convince anybody. Michael Vick sure can. He can say, 'Look, I did it, I was wrong, and it ruined my career,''' Shannon tells AdAge.com.
(Copyright 2009 by WTOP. All Rights Reserved.)
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.
