Latest Drugwonks' Blog
http://content.nejm.org/cgi/content/full/NEJMe1002322
The finding that valsartan failed to have an effect on either of the cardiovascular-disease outcomes but had a positive effect on the incidence of diabetes is surprising. Previous studies of ACE inhibitors and ARBs have suggested that these drugs have a beneficial effect on cardiovascular disease in patients with diabetes, and the lower blood pressure achieved would be expected to result in a reduction in cardiovascular disease. In the NAVIGATOR study, the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.
The results from the NAVIGATOR study do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect. Although the authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia, valsartan was relatively weak in preventing diabetes, and it did not lower the rates of cardiovascular disease. The prevention of diabetes remains a critical public health priority, but for now we should steer away from these two drugs and use effective lifestyle interventions and, in selected persons, metformin to combat the epidemic.PhRMA is supporting a new advertising campaign supporting health care reform legislation.
The new television ad, "Finish," along with two previously-released ads, "Covered" and "You Choose," began airing March 17 in targeted districts across the country where House Democrats undecided on how to vote might need a push to vote in favor of the reform package.
"It's been a long road, but now we've never been closer to common sense health reform," a voice in the "Finish" ad says. "Reform that leaves health care decisions to patients and their doctors, covers pre-existing conditions, and lowers out of pocket costs. A new path that lowers the deficit. Congress, keep fighting for health reform - all the way to the finish."
The 15-second clips in support of health care reform were produced by Americans for Stable Quality Care, a non-profit coalition of a number of organizations - including PhRMA, the Biotechnology Industry Organization, Families USA and the American Medical Association.
Health reform is a rough ride, so here’s a germane quote from America’s favorite rough rider -- Teddy Roosevelt:
“When you are in a hole – stop digging.”
Germane, because of some new poll numbers on health care reform.
According to a new national poll from GfK Roper (sponsored by CMPI-Advance), 70% of Americans oppose using budget reconciliation to pass health care reform and 60% believe it is unfair for House leadership to have the option to introduce a procedural rule that would “deem” the Senate health care reform bill as being passed without actually voting on the legislation itself.
Americans do not support for increasing Medicare payroll taxes for the high wage earners (46% support, 47% oppose) or reducing what doctors and hospitals are paid for their services (45% support, 48% oppose). The survey shows that Americans are evenly split in their belief that the Congressional health care proposal will increase taxes and premiums for the 73 million Americans with health insurance (as estimated by the Joint Committee on Taxation).
Other findings include:
· 81% of those polled strongly oppose health care reforms that would increase insurance premiums for healthy people to offset premiums of people who wait until they are diagnosed with an illness to purchase insurance.
· 80% oppose allowing the government to decide what kind of health care coverage Americans are able to purchase.
· 87% oppose having a government panel recommend or decide what medical procedures or medical advances your doctor can use or your health plan can pay for.
· 84% support reforms that would allow people to buy health insurance across state lines.
· 3 out of 4 Americans oppose healthcare reforms that would raise taxes and cut Medicare benefits to pay for health care subsidies for expanded coverage for the uninsured.
· 84% support healthcare reforms that would let people get lower premiums for getting or staying healthy.
Complete survey results can be found here.
Madame Speaker – stop digging.
Survey Methodology
GfK Roper completed 1,000 interviews, made up of male and female adults (in approximately equal number), all 18 years of age and over. The interviews were conducted between March 12 and March 14, 2010. The margin of error for this study is ± 3 percentage points.
Sampling for this study was conducted using a national probability sample of all exchanges and area codes across the continental United States. All interviews were conducted using a computer-assisted telephone interviewing system. Statistical weights were designed from United States Census Bureau statistics.
Physician Survey: Health Reforms Potential Impact on Physician Supply and Quality of Medical Care
Mar. – Apr. 2010
| Key Findings | |
Physician Support of Health Reform in General | |
| • | 62.7% of physicians feel that health reform is needed but should be implemented in a more targeted, gradual way, as opposed to the sweeping overhaul that is in legislation. |
| • | 28.7% of physicians are in favor of a public option. |
| • | 3.6% of physicians prefer the “status quo” and feel that the U.S. health care system is best “as is. |
Health Reform and Primary Care Physicians | |
| • | 46.3% of primary care physicians (family medicine and internal medicine) feel that the passing of health reform will either force them out of medicine or make them want to leave medicine. |
Health Reform, Public Option, and Practice Revenue/Physician Income | |
| • | 41% of physicians feel that income and practice revenue will “decline or worsen dramatically” with a public option. |
| • | 30% feel income will “decline or worsen somewhat” with a public option. |
| • | 9% feel income will “improve somewhat” with a public option, and 0.8% feel income will “improve dramatically” with a public option. |
Health Reform, Public Option, and Physician Supply | |
| • | 72% of physicians feel that a public option would have a negative impact on physician supply, with 45% feeling it will “decline or worsen dramatically” and 27% predicting it will “decline or worsen somewhat. |
| • | 24% of physicians think they will try to retire early if a public option is implemented. |
| • | 21% of physicians would try to leave medicine if a public option is implemented, even if not near retirement age at the time. |
Health Reform and Recommending Medicine to Others as a Career | |
| • | 36% of physicians would not recommend medicine as a career, regardless of health reform. |
| • | 27% would recommend medicine as a career but not if health reform passes. |
| • | 25% of physicians would recommend medicine as a career regardless of health reform. |
| • | 12% would not recommend medicine as a career now but feel that they would recommend it as a career if health reform passes |
Source:“Physician Survey: Health Reform’s Impact on Physician Supply and Quality of Medical Care,”
The Medicus Firm, www.TheMedicusFirm.com
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.
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.
