Latest Drugwonks' Blog
While Kohl's ban is unlikely now, supporters will continue to push for the measure in other ways, the senator's staff member said. "We hope it happens at some point."
I don’t agree.
While physician-prescribing data shouldn't be available for marketing purposes, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they're communicated via "Dear Doctor" letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans - developed for physicians who prescribe higher-risk therapies - are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), "Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others."
The AMA has a web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing-data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA's program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered legislation on either the state or federal level now or in the future.
Bouquets to Senator Bob Menendez (D. NJ) who had the following to say about legalizing drug importation, “Health-care reform and lowering costs does not mean we should roll the dice with the health and safety of the American people.”
And Brickbats to Senator Byron Dorgan (D, ND), who said he will object to any amendments to the Senates healthcare reform bill until objections are lifted to a vote on his importation proposal.
“I fully expect to get a vote and I expect we will win,” Dorgan said.
But at what cost to drug safety and the public health?
According to the FDA -- in a December 8th letter to Senator Sam Brownback (R, KS) -- the Dorgan scheme doesn’t address “significant safety issues related to confusion in distribution and labeling” of foreign and domestic drugs.
Dorgan said the FDA letter overlooks “dramatic new safety provisions” in the legislation and said political concerns were prevailing in the decision to delay.
“There are people walking on egg shells” out of concern that the drug industry will oppose the bill, Dorgan said.
Not so. The concern is over drug safety. And appropriately so.
http://online.wsj.com/article/SB10001424052748704240504574586260904799386.html?mod=rss_Today%27s_Most_Popular
Inside-the-Beltway chatter has it that some members of the Republican caucus are getting ready to support Senator Dorgan’s drug importation amendment in the misguided belief that it will serve as a healthcare reform “poison pill.”
Not.
The theory is that if the Dorgan Organ passes, then Big Pharma will throw its weight against the legislation.
Not.
This strategy is ill-considered for a multitude of reasons. Let me mention three:
(1) Volume. Big Pharma has more immediate big fish to fry, most notably protection of the Non-Interference Clause and a future with many more Medicare-eligible seniors having their on-patent prescription medicines paid for via Part D. And filling the doughnut hole (another part of “the deal”) is a crucial part of this strategy. Immediate (and likely permanent) increases in volume trumps the many negatives of drug importation. Short sighted? Certainly. But these are public companies with patent expiry issues, reimbursement worries and questionable pipelines. Big Pharma – while against drug importation – won’t go to the mat at this stage in the process.
A vote for drug importation minus Secretarial Certification is a very big mistake – regardless of motivation.
He explains his giddiness as follows:
“…the emerging bills will deliver what most on the left would have considered a miracle a few years back. Nearly $900 billion will be spent over ten years to achieve near-universal coverage. Insurance companies will never again deny people coverage based on pre-existing conditions. New limits on out-of-pocket costs as a percent of income will mean that no American will ever go bankrupt from medical costs again. And, thanks to the Senate’s Tuesday deal, Americans aged 55 to 64 who lose coverage (and can't find affordable new coverage on their own) would be able to buy into Medicare, with help via new subsidies—an idea the left has craved since President Clinton first pushed for it in the late 1990s.”
Miller continues: “Make no mistake: these changes would bring America at long last into the community of civilized wealthy nations.”
Ah, yes, socialized medicine is upon us.
In the words of Hillary Clinton: “The sky will open, the light will come down, celestial choirs will be singing and everyone will know we should do the right thing and the world will be perfect.”
One hates to burst Mr. Miller’s bubble of euphoria, but his comments bear no resemblance to the realities of the health care situation. Government-run health systems have been unmitigated disasters around the world.
Let’s take Canada for instance, our neighbor to the north.
Why are so many Canadians coming to a country with an uncivilized medical system every year? Especially when the Canadians are light years ahead of us as a civilized wealthy nation?
Mr. Miller bemoans medical bankruptcies, all the while pretending as if people in those other civilized wealthy nations of which he speaks do not take out loans and declare bankruptcy on account of medical bills.
Newsflash: People do take out private loans, mortgage their homes, declare bankruptcy, and even pull their own teeth because government denies them medical treatment in these countries.
Senate Majority Leader Harry Reid recently cited questionable medical bankruptcy numbers on the Senate floor. But as Keith Hennessey notes, even if the numbers are accurate that’s no reason to justify a massive transformation of the existing health care system.
Ontario’s Hamilton Spectator ran a series of pieces last month detailing the problems with the health system up north.
Case in point: They tell the story of a teenager named Brandon Taylor who had to contend with the pain of a herniated disc.
The Spectator reports:
The now 22-year-old Hamilton student and his father, Stuart, were told open-back surgery at Brandon's age could be dangerous.
The wait to see a specialist who could help decide treatment was up to a year, they were told. The best the Ontario health system could offer was prescription painkillers.
In August 2007, Stuart Taylor packed up his son and agreed to pay $28,000 in Florida for minimally invasive laser microsurgery. The treatment worked for Brandon, now a fourth-year engineering student at McMaster University.
Brandon’s father remortgaged his house to pay for the $28,000 surgery.
Get this, though – the use of lasers is considered “experimental” in Ontario.
We’re talking about procedures that are relatively routine here in the United States, but out of reach for so many Canadians.
So after the drama of this whole episode, what is the Taylor family doing now?
They are trying to secure reimbursement for the out-of-pocket expenses.
As this article explains, not only do these Canadians have to spend money out pocket to come to the United States for quality medical care, but they have to jump through bureaucratic hoops in a mostly vain attempt to get expenses reimbursed. Some people can afford an attorney to represent them, but many cannot.
Brandon’s father believes the process is an uphill battle that is draining his family emotionally and physically and will end only in loss of their case. He said, "Mentally, I'd love to abandon it because it's dragging me down ... but I can't imagine (doing that) now after all this work."
This is the sort of civilized health care system you can look forward to in Matt Miller’s brave new world.
Though, of particular note is Daniels position on the health care reform package underway in the US Senate, specifically with regard to the expansion of Medicaid.
Here is an excerpt from Bob’s piece:
Taking the lead on health care is something Daniels is doing more frequently these days. His off-the-cuff critique of the House health care bill at last week's Republican Governors Association meeting was withering: " ['Deficit neutral'] is a fraudulent description of the cost of the bill. It counts ten years of taxes and only 5-6 years of spending. On this Medicaid mandate [for the states] . . . we all know a sucker play when we see one. The states' share will be relatively small initially. This is what people told subprime borrowers about their adjustable rate mortgages. We know the balloon payment will come outside the scoring window. The taxes on our states will be much, much higher. . . . The worst effect will be the depressing effect on economic growth."
Bob recently interviewed Governor Daniels on the Medicaid issue and other reform ideas at his Indiana office.
To watch this video interview, click here:
Governor Mitch Daniels of Indiana on Health Care Reform from CMPI on Vimeo.
Good article in this month’s Nature Biotechnology on some of FDA Commissioner Peggy Hamburg’s recent appointments.
I am quoted as follows:
Lurie has earned the reputation of being an industry antagonist. When you’re at the FDA, you need to look at each individual circumstance agnostically. If you go into the job as an advocate, you are doing the agency and public health a disservice.
Not meant as a dis to Peter (a nice guy). More of a warning shot across the bow that people are watching.
Nature Biotechnology, comments on the broader range of appointments (many of them stellar – specifically that of John Taylor):
The number of outside critics brought into the agency is a signal that Hamburg is not so much cleaning house as building a team with the most interested and motivated people she can find. According to Frank Torti, formerFDA chief scientist and principal deputy commissioner, who served as acting commissioner after Andrew von Eschenbach stepped down, “I think it’s important and wise to actually engage people from a variety of viewpoints in thinking about the FDA, so that reaching out to advocacy groups is a smart and necessary piece of reflecting different viewpoints. It makes some sense to me.”
Me too. Mostly.
The complete Nature Biotechnology article can be found here:
http://www.nature.com/nbt/journal/v27/n12/pdf/nbt1209-1067.pdf
It begins with a symbol:
“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”
And ends with a reality check:
“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”
And, in between, much useful information and conversation.
The complete article can be found here:
http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html
And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."
And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."
Senator, don’t go home mad. Just go home.
http://theweeklystandard.com/Content/Public/Articles/000/000/017/277bjeer.asp?pg=2
Senator Bill Nelson (D, FL) is threatening to vote “nay” unless the Senate busts President Obama’s $80 billion Big Pharma “deal.” Senator Nelson wants deeper Medicare/Medicaid discounts and the complete annihilation of the infamous doughnut hole.
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.
