Latest Drugwonks' Blog
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!
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?
Why go to Star Trek when you can watch science fiction unfold at the White House?
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
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
They agreed in principle to try to shave 1.5 percentage points off the growth rate of
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
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
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.
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
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.
