Latest Drugwonks' Blog
From the pages of Politico ...
Pharma tries to protect its deal
As Democrats scramble to finish drafting health reform legislation, drug lobbyists are working overtime to ensure that the final bill doesn’t bust the $90 billion deal they have with the White House and Senate Democratic leaders.
For the past few days, drug industry lobbyists have huddled with Democratic staffers to work out how to structure the fees drug makers will pay under reform while still making good on Democrats’ promise to close the gap in seniors’ drug coverage. Last winter, the industry pledged $10 billion to help close the coverage gap in addition to the $80 billion deal it had struck earlier in the year.
Drug makers were asked to sign off on multiple solutions, giving Democrats backup options should any of the fixes run into problems passing muster with the Senate parliamentarian, who, because of procedural rules, essentially has the final say over what’s included in the legislative package.
With billions of dollars hanging in the balance, there was “real heartburn with the bill over the weekend and over the last week,” an industry source said.
The industry also decided to drop its push to be carved out from an independent Medicare payment advisory board – vowing instead to fight it if it becomes law, sources said. The board would essentially force cost cutting measures on lawmakers, limiting the influence of outside groups like PhRMA to lobby the outcome.
With all the drama of reform coming down to the wire, the players’ nerves are rubbed raw, said one insider. Still, the industry expects its deal to hold.
Democratic are racing to finish a reconciliation bill that could pass the House this week and win Senate approval before Congress breaks for the Easter recess at the end of the month. Democrats are crafting the bill so it only needs 51 votes to pass, bypassing the Republicans’ filibuster threat.
But Republicans pounced on the wheeling and dealing as another symptom of what’s wrong with reform.
“All we hear about is the arm-twisting and the horse-trading that’s going on over there behind the scenes – the mad dash ahead of the big vote. And once again, Americans can’t believe what they’re hearing,” Senate Republican Leader Mitch McConnell said Monday on the chamber floor. “The drug lobbyists were here in the Capitol over the weekend huddling with Democrat staffers to make sure their interests would be protected in the final bill. This is precisely the kind of thing Americans rebelled against after the last vote on this bill.”
Also Monday, senior pharmaceutical industry sources denied a New York Times report that the industry has invested $12 million in new, pro-reform advertising. PhRMA has not signed off on a new ad campaign, no ad copy has been approved, nothing has been done, said the sources, who are intimately familiar with the situation.
"I cannot say this more emphatically, it's not true," said one source, who is not authorized to speak publicly.
In fact, the White House has been leaning on the industry to buy positive ads to provide air cover to wavering House members, whose districts have been inundated with opposition advertising. But the drug makers are holding out until they see, and sign off on, the final reconciliation bill, industry sources said.
As a key White House ally, the drug industry has been the money behind much of the pro-reform advertising this past year. Drug makers' decision to hold out could mean there will be little in the way of pre-vote cover. But, if the industry supports the final bill, it's almost guaranteed a post-vote blitz of thank you ads praising lawmakers who voted yes will air and they will likely see support through Election Day.
It's looking likely that the Pharmaceutical Research and Manufacturers of America wasted up to $100 million in advertising to promote a health-care-reform bill that will ultimately offer the industry no protection.
Some pharmaceutical-industry observers and blogs are suggesting that the backroom deal made last year by the drug makers' top lobbying group and the White House -- a controversial handshake agreement that limited Big Pharma's share of footing the health-care bill at $80 billion over 10 years -- has fallen apart now that President Barack Obama has introduced a revised form of the bill last in the wake of shifting public opinion. And the deal's architect, PhRMA President Billy Tauzin, a former Congressman from Louisiana, announced his resignation last month. That resignation is effective June 30.
The problem for PhRMA is that it's already honored its end of the deal and can do nothing to stop the terms from changing. The new health-care proposal includes, among other things, a clause that allows the government to negotiate directly for Medicare drug prices. That language was not in the initial health-care bill as part of PhRMA's deal with the White House. And as of now, that $80 billion cap is likely to increase to $90 billion, if not more. Indeed, with no firm deal in place, there's nothing protecting PhRMA at all.
"The deal PhRMA negotiated could still be on the table, but you need to have the other side actively engaged," said longtime pharmaceutical expert Peter Pitts, a former associate commissioner at the FDA and now president of the Center for Medicine in the Public Interest. "The White House is not necessarily in coordination with the Senate and the House, so it's confusing and now it's a bit of a crapshoot."
AARP, also an active player in the advertising business last year in support of health-care overhaul, said this week it would scale back its media spending this time around. "Are we just going to sit on the sidelines? No," David Sloane, senior VP-government relations for AARP, told Roll Call, the newspaper that covers Capitol Hill. "[But] I don't think advertising is the way to secure votes."
Meanwhile, several entities -- all against the health-care legislation -- have launched or are about to launch ad campaigns, the biggest of which is an effort from the U.S. Chamber of Commerce and a coalition of 248 lobbying groups that will spend up to $10 million in measured media over a 10-day period.
The rest of the story can be found HERE
Such delays are routine, even though Israel's health plans regularly discourage patients from using specialists and procedures. Gatekeeping merely postpones use and could often increase it by making illnesses more severe. The claim that there are "too many" procedures is made all the time. The problem is, no one knows with any degree of certainty we feel comfortable with, which are necessary in their place and time and which are not. All we know is what we are not certain of. Sooner is better than later especially if it can lead to healthier behavior...
The first is a nice omnibus article from the current edition of Nature Biotechnology, "One year in -- Obama's biotech scorecard."
The next piece is from the Belgian medical publication Le Generaliste. It's focus is on American healthcare reform. It's in French and is headlined, "USA: les soins de sante a la croisee des chemins" (US healthcare at a crossroads).
And finally a new piece in Commentary by our good pal Tevi Troy, "Health Care: A Two-Decade Blunder."
Enjoy.
As seen on the op-ed page of the Orange County Register
Cheaper medicines not always better
By PETER PITTS
President, Center for Medicine in the Public Interest, former associate FDA commissioner
Savings on drugs often result in higher costs in other areas.
The health care reform debate has been focused almost entirely on just two broad issues: the large uninsured population and the rising cost of care. But there's another problem that plagues our health system, and it's just as serious. Doctors are losing their ability to treat patients without being obstructed by outside parties.
Any discussion about improving our health system must recognize that rules which empower bureaucrats to get in the way of the doctor-patient relationship are a serious threat to the quality of medical care.
A strong, trusting relationship between doctors and patients is crucial to a well-functioning health care system. Without such a bond, serious conditions might go misdiagnosed or improperly treated, patients might give inaccurate medical histories, or doctors' orders might be ignored.
This is no small problem. Failing to follow a prescribed treatment regimen – a practice known as "nonadherence" -- costs the U.S. health system over $100 billion a year in avoidable medical costs. And, according to a study published last year in the Annals of Internal Medicine, patients who don't have a close relationship with a single doctor are less likely to receive the proper tests for preventing chronic illnesses.
Yet some policies that are gaining popularity are weakening the doctor-patient relationship by putting treatment decisions in the hands of third parties.
Chief among these schemes is "step therapy." Also called "fail first," this is a policy that is sometimes adopted by insurers and government health programs to save money on pharmaceuticals. It forces patients to try cheaper alternatives to a prescribed drug before they are permitted to get the medicine that their physicians ordered.
So even though a doctor might recommend drug A to treat a patient's hypertension, an insurance company or government program would require the patient first try cheaper drugs B and C, and only after the cheaper drugs are shown to be ineffective can the patient receive the medicine his doctor recommended.
There are several reasons such a policy hurts our health system. For one, it is an assault on the relationship between physicians and patients. When a doctor decides on a treatment, he is employing years of medical experience and weighing countless factors, like the patient's age, diet, and lifestyle. Patients, meanwhile, trust that the doctor knows best.
When it's possible for a health care bureaucrat to override the decision of a trained medical professional, this valuable association between a patient and his doctor breaks down. A patient is no longer under the care of single medical expert, but is now being treated by faceless organization looking to cut corners.
This breeds distrust among patients, but it also results in worse medical outcomes and higher overall costs.
One study of schizophrenia drugs used in Georgia's Medicaid program showed that, while step therapy saved the state close to $20 a month on drugs for every patient, the savings were more than offset by increased costs in other services. Indeed, the program saw a monthly increase of nearly $32 per patient in outpatient care.
Similar studies have shown that private plans utilizing step therapy saw hospital and emergency-room visits increase, resulting in higher overall costs.
What's troubling is that step therapy is becoming more widely adopted. In 2000, 20 percent of private insurance carriers used step therapy. By 2008, it was half.
Reformers need to recognize that policies giving health care administrators control over treatment regimes are hazardous to patient health, and actually inflate overall costs.
The deterioration of the doctor-patient relationship is a serious threat to our health system. Ending step-therapy programs is one way to fortify this relationship.
Via the Pink Sheet:
FDA could use more authority to bring negotiations over a drug's Risk Evaluation and Mitigation Strategy to a close, Principal Deputy Commissioner Joshua Sharfstein indicated during a House Energy and Commerce Health Subcommittee hearing on March 10.
The agency can require a REMS, but not specify its contents, he explained, noting the drug sponsor proposes a REMS and negotiates the final strategy with FDA.
"It's very important for us to work with companies to come up with something that works," Sharfstein said. "There's no question there's a lot we learn from the interchange with companies," but it sometimes can take a long time to come to agreement, and a level of consistency between REMS may be desirable if one approach makes sense.
The agency is open to discussions about how it can more effectively move to closure on these strategies designed to protect public health, he said.
Rep. John Shimkus, R-Ill., newly designed as the subcommittee's acting ranking member, suggested a limit on the time allowed for negotiations. Sharfstein noted that if an application is pending, companies have an incentive to finalize a plan; the problem arises particularly with drugs already on the market.
Another area that needs to be addressed, Sharfstein suggested, is the different treatment of brand and generic drugs when it comes to imposing a REMS with a communication plan for alerting health care professionals and patients about a drug's risk. Brand sponsors must implement such a plan, whereas FDA must pay for and operate a communication plan for generic drugs, he noted.
Via AP -- and something to watch:
Stricter government oversight of dietary supplements is moving closer thanks to an agreement among senators to include guidelines in a food safety bill.
Four key areas of “common ground” are outlined in a letter sent by Sens. John McCain, an Arizona Republican, and Byron Dorgan, a North Dakota Democrat, to Sen. Tom Harkin, the Iowa Democrat who chairs the Senate Health, Education, Labor and Pensions Committee.
McCain and Dorgan were co-sponsors of legislation introduced last month, the Dietary Supplement Safety Act, aimed at regulating the industry. This week’s letter to Harkin—also sent to the committee’s top Republican, Sen. Mike Enzi of Wyoming, and Sen. Orrin Hatch, a Utah Republican—talks about incorporating the “areas of agreement” into the FDA Food Safety Modernization Bill
Those provisions include:
— requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services;
— giving the Food and Drug Administration authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded or “the use
of such supplement could cause serious adverse health consequences such as death;”
— requiring the FDA commissioner to publish guidelines on new dietary ingredients “as soon as possible;”
— mandating that the FDA notify the Drug Enforcement Administration when a new product contains a synthetic anabolic steroid.
Athletes from various sports have blamed positive drug tests on substances that turn up in dietary supplements even though they aren’t listed as ingredients on the label.
McCain has said his bill would protect professional and Olympic athletes— along with casual sports participants who use supplements.
Pro sports leagues and the U.S. Anti-Doping Agency have been supporting McCain’s efforts on supplements, and USADA chief executive officer Travis Tygart said Wednesday the letter indicates areas in which the new legislative effort “fills holes.”
“These are obviously needed improvements, and the agreement provides additional consumer protections which are certainly important to all athletes and why the pro sports and the Olympic sports came together to push for better regulation,” Tygart said in a telephone interview with The Associated Press. “It also continues to allow all consumers to have access to legitimate supplements. It’s a fair balance, and this step in the process has resulted in a quick and beneficial agreement.”
Agriculture Appropriations Subcommittee Chairman Herb Kohl, (D, WI), suggested there are "powerful interests" blocking legalization to foreign drug importation.
And he’s right – the powerful interests of the public health.
Do doctors need more and better information on how to get the right dose of the right drug to the right patient at the right time. Yes! But denying FDA approval to one drug because, in a large randomized controlled clinical trial, it may not be "as effective" as another is not only meaningless -- it's counterproductive. How can care be improved if physicians are denied access to new drugs that work? Hm.
What we DO need are more and better molecular diagnostics and more adaptive clinical trials to show what drugs work best in specific subpopulations. That's not comparative effectiveness, it's clinical effectiveness. And it's crucial to the advancement of 21st century medicine.
Here's the NPR story on the NEJM articles:
http://www.npr.org/templates/story/story.php?storyId=124516838
Watch for the issue of an FDA "third leg" to come up during the upcoming debate over PDUFA reauthorization. Watch "comparative" effectiveness morph into "cost" effectiveness. And remember -- what we need to discuss is "clinical" effectiveness.
http://www.whitehouse.gov/health-care-meeting/proposal/titleiii
Fast forward to the present. The RAND Corporation reviewed the ability of Britain's National Health Service -- the ultimate public option with centralized control over health spending, treatment practices, reimbursement levels and performance standards -- to keep people healthier and make sure qualiity of care drives all decisions. RAND looked at the NHS ability to deliver high quality care after increasing spending on health care during that time at a rate faster than spending in the US.
Here's what the study found:
A damaging rift between doctors and managers: “The GP and consultant contracts are de-professionalising, and have had the peculiar effect of simultaneously demoralising and enriching doctors. We’ve lost the volitional work of the doctors and far too many of us are now just working to rule.”
Pointless new structures. “Stop the restructurings. The only thing they generate is redundancy payments.” One body responsible for improving standards reported to five different ministers and had three different names in the space of 30 months.
A culture of fear and slavish compliance. “The risk of consequences to managers is much greater for not meeting expectations from above than for not meeting expectations of patients and families.”
http://www.timesonline.co.uk/tol/news/uk/health/article7052606.ece
RAND notes that the NHS has implemented all manner of quality commissions, practice guidelines, performance standards, value-based reimbursement contracts with doctors, etc. Sounds a lot like the Senate and House bills right? The RAND study noted that comparative effectiveness studies came in for particular criticism by everyone within the NHS:
"NICE is too focused on fiscal issues: This concern likely arises because NICE is simultaneously considering clinical effectiveness and cost effectiveness. Implementation of NICE technology appraisals is mandatory which underscores the focus on fiscal issues. Concerns were also raised about whether the thresholds are adequate (£30,000 per quality adjusted life year) and about the limited and somewhat weaker economic evidence relative to clinical evidence. This led some observers to suggest that the UK needed guidelines development that would not account for resource issues."
This concern about NICE -- the "group of doctors and health experts" President Obama refers to -- is related directly to the feeling among NHS managers and and GPs that they are simply instruments for carrying out the fiscal goals of the NHS at the expense of the needs and health of patients. And meanwhile, none of the new structures, measurements or studies have improved care. Instead, as the RAND study notes:
"Concerns have been raised about perverse incentives for treating multimorbidity patients imbedded in the financial incentives."
Or as the President said: "And to make sure that the quality of care for seniors drives all of our decisions, a group of doctors and health care experts, not Members of Congress, will be tasked with coming up with their best ideas to improve quality and reduce costs for Medicare beneficiaries."
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.
