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I think inside the Beltway there is this belief that if the executives of each patient group can be called in and massaged/threatened by pols that innovation will be protected silence can be bought. Perhaps it can for a while. But obvious discomfort of comparative effectiveness supporters have in even talking about the process -- they would rather try to silence those who have legitimte questions by attacking them as reactionaries -- suggests that their motives are less than pure. And in any event the measure of process will be the extent to which it targets new technologies instead of trying to develop tools for selecting treatment options that encourage preventive and prospective care.
Which brings me to the event itself. Mike Ferguson, the former Congressman and CMPI fellow moderated the event which included three of his friends and colleagues, Congresswoman Anna Eshoo D-CA, Mike Rogers, R- MI and John Crowley, CEO of Amicus Therapeutics. Unfortunately Elijah Alexander, the former NFL linebacker who has battled multiple myeloma could not join us because early that week he was admitted to the ICU with an infection and low blood cell count.
I can't do justice to the eloquence and passion of our speakers. Eshoo spoke of the importance of encouraging future biotech investment. Mike Rogers talked about how comparative effectiveness guidelines would have "guided" his doctor away from tests that flagged his cancer when he was a teenager. And John Crowley, who's search for a cure to treat his twins rare disease is now the subject of movie with Harrison Ford talked movingly about how government regulation could have made his investment imposslbe. There was bi-partisan agreement that we shouldn't give an inch on any effort to limit incentives or access to innovation for the sake of cost control. Second guessing at any point could easily stifle or discourage research or technologies deemed a waste of money that years in the future could or have culiminated n transformational cures. It is not just a matter of the inability and ineptness of government planners in determining what thousands of patients, scientists and physicians can decide. It is also because innovation generates it's own excitement and inspiration that can be undermined by centralized planning.
As the absence of Elijah and John’s comments underscored, innovation is incremental but also inspirational. To paraphrase Robert F. Kennedy, it is numberless diverse acts of freedom, inspiration and belief that sustains innovation. Each time someone pursues an idea, or acts to improve the lot of others, or seeks to battle a disease that has no cure, that individual sends forth a tiny ripple of hope. Those ripples cross each other from a million different centers of energy and daring and build a current which sweeps away the most daunting afflictions, to energize yet another wave of innovation. Only the impatient hand of government possessed with the arrogant sense it has absolute knowledge can fully stop this process.
In
After President Obama’s “historic” meeting with six major health care organizations, Robert Pear reports that, “confusion swirled in
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,
According to those who were at the meeting, there was some misspeaking by the President.
The
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
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.
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
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,"
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
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,
"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
Okay – it’s a start. And the more people calling for a Critical Path for Comparative Effectiveness the better.
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.
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.
