According to the Wall Street Journal, “Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa).”

“The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.”

Can anyone out there think of even one drug that the FDA wanted recalled that was not “voluntarily” recalled?

No – I didn’t think so.

(Also, isn't the FDA already an entirely independent government agency?)

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

What does “too cozy” mean? Really, what does it mean?

Senator Grassley believes the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials.”

And what does that mean? Any evidence to back up such blowhard accusations?

Too boot, here’s some really shoddy reporting by the Journal’s Alicia Mundy,

“Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs”

She is referring to www.thoreau-fda.com/index.php.

This site defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

That’s nice. But when you check out to whom the site is registered, it turns out to be Jim Dickinson of FDAWeb.com – long-time FDA antagonist -- and no former FDA employee.

Oops.

But who needs facts when you have red-hot rhetoric and a gullible reporter who's willing to take a leak anywhere?

Experimental cures are often the last hope for dying patients in the U. K. health system. Thanks to the British government, however, many sick Britons will soon have their last hopes dashed.

Why? Pharmaceutical companies from around the world have been scaling back clinical research in the United Kingdom, largely because of government parsimony. And British citizens have paid the price.

Read more about this distressing development here:

British system discourages availability of new drugs

With health care reform in America at the top of the agenda this election season, it’s more important than ever that we be aware of the dangers of government- run health care. America should avoid Britain’s mistakes and make sure we keep the interests — and hopes — of patients first in our pursuit of reform.

Per the Zyprexa show-trial, consider the remarks of US District Court Judge Jack Weinstein:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

How do you spell “r-e-c-u-s-a-l?”

As we mourn the passing of Victor McKusick, “the father of medical genetics,” his legacy lives on in today’s healthcare headlines.

Today, as if in honor of the great man's passing, the FDA will announce an advisory for physicians to use a genetic test to screen patients before prescribing abacavir, a widely used drug for H.I.V. infection and AIDS.

(Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen. It is also a component of two combination pills — Trizivir and Epzicom.)

According to Andrew Pollack in today’s New York Times, “The recommendation for the test is part of a movement toward so-called personalized medicine, in which genetic or other tests are used to determine which drugs are best for a patient and which should be avoided.”

Here is the complete New York Times story

Let’s honor Dr. McKusick by fully funding the Reagan/Udall Foundation and advancing the agenda of the FDA’s Critical Path Initiative.

If there’s, as some claim, a “media love fest" going on with Senator Obama, then the Man from Illinois’ healthcare rhetoric isn’t part of it.

Consider today’s story in The New York Times, “Health Plan from Obama Spurs Debate.”

Except that after you read the article, you realize that the headline should have more appropriately been, “Health Plan from Obama Spurs Derision.”

According to the Times:

“While there is consensus that the American health care system is bloated with waste, eliminating enough to save $2,500 per family would require simultaneous and synergistic solutions to a host of problems that have proved intractable for decades.”

And:

“Mr. Obama … is offering a precise “chicken in every pot” guarantee based on numbers that are largely unknowable. Furthermore, it is not completely clear what he is promising.”

And:

“But the health policy advisers who formulated the figure say it actually represents the average family’s share of savings not only in premiums paid by individuals, but also in premiums paid by employers and in tax-supported health programs like Medicare and Medicaid.

And, according to Harvard’s David Cutler (an unpaid advisor to the Obama campaign and a certified smart guy), “Our attempt to lay out one plausible scenario for the savings had created more problems than it had solved.”

And:

“But whether employers and governments respond that way cannot be guaranteed, particularly in a difficult economy. And a number of health policy experts have questioned whether the $2,500 projection is either fiscally or politically realistic. Reducing health care costs, they emphasized, means taking money from someone’s pocket and rationing care that Americans have come to expect, a recipe for stiff resistance.”

Here is a link to the complete NY Times story:

New York Times story

Well gosh, you mean that healthcare reform is going to be hard? Stop the presses. (Or, perhaps, start them.)

Another regularly bandied about “solution” is for the United States to adopt “free” healthcare, “like in Europe.”

Let’s address that shibboleth.

People in other healthcare systems often pay more than Americans do, sometimes in the form of taxes. And they may also incur high costs if they need a drug that is not covered by their health system or want to see a specialist.

In the US, a family of four with an employer-based PPO will have around $15,609 total this year in healthcare costs. Of this amount, the employer will pay $9,442 and the employee will contribute $3,492 in premiums and $2,675 on co-pays, etc. That’s about 6 percent of average family income.

In Canada, while the percentage of taxes used to provide healthcare varies, it is estimated that 22 percent of taxes collected went to the health system in 2004. Several provinces, including Quebec, Ontario, Alberta, and British Columbia, also charge additional premiums. Canadians also may spend money to receive private treatment for procedures or drugs that are not covered by the government system.

Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week. Though the co-pay for drugs is low, many drugs are not covered, often because they not considered cost efficient. And anyone who uses their own money to buy powerful but expensive drugs not paid for by the NHS finds him or herself shut out of the NHS for having gone outside the system.

In Germany, coverage from a public sickness fund currently can range significantly in cost, from around 12.2 to 16.7 percent of income, with the employee paying a bit under half. As of fall 2008, premiums are to be standardized from the federal level and healthcare experts anticipate that they will be set around 15.5 percent. Private patients can generally expect to pay more than they would in the public system.

In France, employees contribute only to 0.75 percent of their salaries towards medical care, but also pay a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the majority of costs for doctor visits and for a portion of the costs of medications. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, costing approximately 2.5 percent of salary.

For a more complete look at “myths vs. facts” of “free” European-style health care, have a look at this new article in the Journal of Life Sciences:

Journal of Life Sciences article


And if you’re ready for a barrage of reality about how patients fare under various European systems (Canada too), click here:

www.biggovhealth.org

And let the debate over real reform begin.

Nearly 40 years to the date they were conceived, managed care plans come together to come to the realization that to stay in business they should focus on patients not on cutting costs...

amednews.com

Insurers are the new worried well (America's Health Insurance Plans annual meeting)
In the wake of declining profits, health plan executives discuss what they need to do to remain viable. Their solution: focus on changing patient behavior.

By Emily Berry, AMNews staff. July 28, 2008.

Reports from conferences important to physicians

Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.

Paul Wallace, MD, a Kaiser Permanente medical director, stood before other health plan leaders during a packed session at the annual meeting of America's Health Insurance Plans in San Francisco in June and told them their job is no longer to pay bills, but to manage members' health.

They got the message. As Dr. Wallace concluded, he asked the audience: "Is anyone here not in the behavior-change business?"

No hands went up.

The admonition that health plans are meant to manage care might not sound new, given that back in the early 1970s HMOs were created to do just that. But health plans are now talking about managing care not only as essential for their members' health, but essential to their own.

That message echoed throughout the AHIP Institute, the name for the annual meeting of the trade group representing health plans.
http://www.ama-assn.org/amednews/2008/07/28/bisa0728.htm


But let's not get too enthusiastic....just a couple of months ago the HMOs said they would dump patients to protect profit margins...
BUSINESS
Health plans say they'll risk losing members to protect profit margins
Meanwhile, businesses and individuals are dropping coverage in the wake of higher insurance premiums.

By Emily Berry, AMNews staff. May 19, 2008.

The nation's largest publicly traded health plans say they don't plan to temper premium increases for the sake of keeping members on their rolls -- particularly not while they are under pressure from Wall Street over what it sees as their disappointing earnings.
Article here


And let's not forget how AHIP and CBO are working together to "bend the curve" on health care by setting up a comparative effectiveness institute run by government bureaucrats....