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Tag: Policy/Politics

PHARMA/POLICY/POLITICS: FDA Official Quits Over Delay on Plan B, with UPDATE

The FDA official in charge of women’s health quits over the delay on Plan B‘s approval. Well it’s good to see that some of the staffers left at FDA have some spine, because it’s clear that, whatever the lies being told by the Administration, this is all about cow-towing to the loonies on the Christian right rather than the science of the situation.

There are a couple of telling shots in the story. Crawford swore up and down that this was his decision and that it was a science-based one.  Not so. 

Susan F. Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, said she was leaving her position after five years because Commissioner Lester M. Crawford’s announcement Friday amounted to unwarranted interference in agency decision-making. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.

Of course there were strenuous denials from all concerned, but what was she told?

Wood also said other FDA officials who are typically involved in important matters were kept in the dark about the contraceptive, called Plan B, until Crawford announced his decision, which she believed was made at higher levels in the administration. Wood said that when she asked a colleague in the commissioner’s office when the decision would be made, the answer was, "We’re still awaiting a decision from above; it hasn’t come down yet."

So you could argue that this was not Crawford doing what he thought the loonies wanted him to do, but instead he was actually taking instructions from Leavitt or Rove or whomever.  On this issue  they can send a sop to their "social conservative" friends. After all it’s only a small pharma company they’re pissing off here, not a big one, Just as well Lipitor doesn’t impact birth control, eh?

Meanwhile, there’s just a delicious piece of doublespeak from Leavitt that really outdoes some of the stuff we’ve had to put with from Rumsfeld over the years:

Many supporters of the Plan B application — including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) — accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford’s ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.

Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn’t always yes and no. Sometimes it requires additional thought.

So now when you’re asked by your wife, boss, teacher, whomever why you haven’t done something you were supposed to have done (you know, "taken action") you can tell them that you were thinking about it and that is exactly the same thing! Not only that — it’s now official policy in what passes for the circus we call a government.

UPDATE: Bob Steeves points me to this quote from the spokesman for Mike Enzi (a Senator with an "R" after his name), showing that he didn’t get the Talking Points on this one and looks a little pissed:

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, is considering whether to hold hearings on the FDA’s handling of Plan B, said spokesman Craig Orfield. Enzi had expected "a firm decision" from the FDA, not further delays, Orfield said.

INTERNATIONAL/PHYSICIANS: Canadian doctors going home means the US sucks, n’est-ce pas?

This one I find hilarious and gives me great deal of personal satisfaction. The pro-American health care system, "it’s the finest on earth crowd" goes on and on about how terrible the Canadian system is and how all the doctors are leaving. In fact it was that sentiment especially from the wonderful, but confused, Sydney Smith over at Medpundit that inspired my "Oh Canada" tome.  (Actually I re-read "Oh Canada" the other day and it’s a pretty damn good piece of analysis if I say so myself).

Syd was basically saying that all the doctors were leaving cos they hated the clinical restrictions of the single payer system and wanted to move to the glorious homeland of free-choice medical practice and CABGs for 97 year olds. I showed pretty conclusively using actual real life data that a) very few doctors were leaving Canada for the US, and that b) if they were leaving it wasn’t that surprising as they get paid about twice as much by sneaking below the 49th parallel.

Well now we have more actual statistics and real data that shows that more Canadian doctors are heading back to Canada than are leaving — and this was in 2004 when hockey was on strike so there was no real reason to go to Canada! The numbers are:

Canada has seen more doctors returning than leaving for the first time in 30 years, a report by the Canadian Institute for Health Information (CIHI) shows. The report, released Wednesday, says that between 2000 and 2004,the number of physicians leaving Canada declined by 38 percent. In 2004, 317 physicians returned to Canada and 262 left. That was a drop from 2000, when 420 doctors left the country and a significant decrease from the peak of 771 physicians who moved abroad in 1994.

I’m looking forward to the barrage of articles from the know-it all alleged "free-market" crowd who get spoon-fed rubbish by Frasier, PRI, Manhattan et al offering their apologies to the Canadians and admitting that their system is better than the one down here.  After all the alleged rush of Canadian doctors to the US was absolute proof in their mind that the reverse was true.

I’m waiting, I’m waiting….

POLICY/PHYSICIANS: Is the Medicare reimbursement issue more serious this time?

This week things are starting to get a little serious regarding physicians’ Medicare reimbursement. The AMA is gearing up for a fight, trying to avoid a scheduled 4.3% cut in Medicare reimbursement. Meanwhile a survey of California doctors suggested that they would stop taking new patients at the lowered rates. Much of this is just bargaining rhetoric, but CMS is determined to start Medicare down the pay-for-performance road, and has already begun to initiate this process by paying hospitals for reporting quality measures (even though it’s less than 0.5% of their Medicare revenue).

Meanwhile Republican house rep Nancy Johnson is pushing a pay-for-performance bill which would change how physicians get paid. Anytime you put doctors, money, and quality and performance requirements in a sentence together, be prepared for at the least a vigorous debate. Medicare is still the big Kahuna, and where it goes other payers will follow — if they’re not moving there already.

POLICY: HSAs for Medicaid–cost-shifting to the poor by Theora Jones

Policy analyst Theora Jones has been a little quiet at THCB lately, but the news that South Carolina is going to be giving all its Medicaid recipients HSAs got her a little riled up.

THCB recently pointed out that if the government could risk-adjust perfectly, we’d have no need for insurance companies, (Well I didn’t quite say that but close enough, MH) which is why this recent story from SC is so confusing–call me crazy, but I don’t think they’re out to replace the insurance industry.

So golly gee, what’s behind this? Does SC they think the private sector can control costs better? There’s no evidence of that. Do they think that people on Medicaid will get better care? Well, they’re not proposing any case management or disease management or quality measures, so…no. Wait, I think I’ve found the nut graph:

"South Carolina would cap how much it will spend on a recipient, and if health care costs more than the account will pay for, then the low-income people would have to make up the difference themselves or go without."

Ah, rationing. That’s neither new nor radical.

Please note that in order to qualify for Medicaid (2003 numbers), a mom in a family of three has to earn less than $7,510 a year. Disabled and blind folks have to earn less than $12,120 ($9k if they’re single). The old folks can pull down a cool $16,362, and kids can be covered even if their family of 3 is rolling in cash–up to $22,890! With disposable income like this, I’m SURE they’ll be able to make up the difference on that triple heart bypass. Or the asthma medication.

Legislation like this confirms my greatest fears–that HSAs are going to have a worse impact on the health care system than managed care ever did. Their effect on the health care system will be more pernicious and long-lasting–they will exacerbate the fragmentation and the injustices in the current system, and they will stymie the effects of reformers who are trying to achieve clinically focused quality improvements, greater access, and efficient financing.

PHARMA/POLICY/POLITICS: Clinical trials corrupted by Wall Street

FrontpageThis is a doozy, and as it’s in the second first newspaper of a minor major west coast city metropolis and world class cultural center (Sorry, Ichiro & Frasier fans! See the comments, but I stand corrected!) it hasn’t quite had the attention that the front page of the NYT would give it.  Basically the Seattle Times has found a bunch of cases where hedge funds and other Wall Street brokerages found out who was running clinical trials for supposedly "double-blind" studies, and bribed the doctors (sorry, paid them consulting fees) to spill the beans ahead of the official announcement. Here’s their whole special, go punt around.

Now, insider trading happens all the time in Wall Street.  I myself have seen countless stock charts where an hour or two before an announcement the stock has gone doolally. Nothing ever seems to get done about it.  But this is a little different as it may impact the integrity of the clinical trial and the FDA’s role (not to mention the SEC).  And that tends to mean that Chuck Grassley wants in.  And he does.

For a long time people have been complaining about the fuzzy line between academic medicine and making money off it.  Apparently in several cases that line has been obliterated in a way that was not only unethical for medicine, but illegal even for Wall Street. This might, just might, be one of those trigger events that really changes how things get done in clinical trials and even biotech research. Well worth watching and kudos to the Seattle Times for coming up with it.

POLITICS: Debunking the Drug War

John Tierney has written an excellent article essentially agreeing with what I said on THCB yesterday — only he gets to do it on the editorial pages of the New York Times. This one is about how addicted law enforcement is to drugs, particularly the meth "epidemic" and it’s called Debunking the Drug War. It’s Tierney’s 3rd article on the stupidity of the drug war in less than a month.  About time someone with some national stature started raising this lunacy as a political issue — and it is a political issue, as we’ve traded in our human rights and our good sense so that law enforcement and the prison-industrial complex can take more of our money.

POLITICS: Denny speaks, sort of

Who’s Denny Hastert? He’s my favorite politician. I regularly ask this question at parties, among college educated yuppies in San Francisco.  Frequently NO ONE knows — and I am not joking. Incidentally by my recollection of the constitution, he’s number 3 in line to the nuclear codes. Funnily enough he even has some limited power and influence running around after Tom Delay, and he thinks about health care, believe it or not.

What does he think about about health care? Funnily enough he too believes that the main problem in the country is that of the uninsured.  And we’re going to solve that by reducing malpractice costs, or at least I think that’s what he said…maybe it was AHPs and getting the state out of insurance regulation…yes that’s it, that’ll work! After all all those AHPs and cross-state individual plans are going to really help contain costs, and get sick people into easily affordable insurance plans — especially after we’ve driven out the 0.5% of the cost of the system that malpractice causes.

More perhaps on this later, or perhaps we’ll leave that discussion to Jon Cohn. About time I got him back, and I know he’s thinking about it

POLICY: Employees want health insurance, not pay rise

This week two studies confirmed that employment based health insurance, or the lack of it, is becoming a political issues. Harris Interactive’s poll of employees shows that American workers continue to view health insurance as a crucial employee benefit. In addition while they perceive other aspects of compensation such as pay to be getting slightly better, they think their health benefits are getting worse. And they’re right. California health insurance commissioner John Garamendi produced a report highlighting the problems with the high cost of health insurance and how it’s forcing employers and individuals out of the market. Garamendi criticized the now popular low cost/high deductible plans as a false solution, and many employees seem to agree.

We have a slowly dying employer-based insurance system, and no apparent ideas on how to replace it. This will have eventual political consequences.

POLICY/POLITCS: Clintoncare — a quick review

Following my piece on Hlillarycare and why it failed, Martin Goldsmith wrote to me with a slightly more comprehensive review of everything that happened. This is from a article submitted for the forthcoming 11th Presidential Conference — William Jefferson Clinton @ Hofstra University. Martin is a Philadelphia hospital system veteran who was President of National Association of Urban Hospitals during the time in question.

——-

The climate never looked more ripe for reform than it did in 1993.

Relatively unknown Democratic candidate Harris Wofford beat popular former Governor Dick Thornburgh in the 1990 Senate race in Republican-leaning Pennsylvania on healthcare reform platform – not a lot of specifics but  “everyone deserves a doctor” got the job done .The recession of the late 80’s/very early 1990’s caused middle class suburbanites to fear the loss of health care coverage. This anxiety soon was evident throughout much of the country.

With the election of Clinton, in part, on a health reform platform, there was an air of inevitability. In, fact, it was near impossible for any group to oppose broad-based health reform and few did.

For the first time, The American Medical Association, U.S. Chamber of Commerce, Republican Senate leadership – i.e. Bob Dole, supported universal coverage and employer mandates.

While my paper focused on the Clinton healthcare legacy, it was impossible to explore that legacy without substantial exposure to the views of assorted scholars, pundit/journalists and former administration insiders as to the reasons the Clinton Administration failed:

The content is borrowed – the categories are mine

  • There really was a right wing conspiracy – immediately after the Wofford victory, Newt Gingrich began organizing to stop the Democrats (this predated Clinton’s nomination) from successfully sponsoring health reform. He feared if they owned it, the political boost would rival the decades long benefit they enjoyed from the New Deal
  • The Task Force was a huge bust
    • The anti- feminist reaction to Hilary’s appointment to lead the Task Force
    • Ira Magaziner was a kook, there was too much secrecy, the endeavor was too academic and theoretical and it took far too long
    • The Reform Task Force excluded and demonized key stakeholders – Republicans, drug companies and others almost insuring their opposition
  • In the end there was insufficient popular support
    • The economy improved – the middle-class’s fear dissipated
    • The middle class, with the help of the Clinton’s opponents, feared increased taxes to pay for the health care of the uninsured.
    • The fear of government involvement – the old socialized medical argument – the risk of the loss of privacy
    • The scandals – Whitewater, Troopergate, …caused the President to lose influence with Congress and the public
  • What did you expect, health reform was the 3rd most important domestic priority for the American people?
  • The packaging of health care as an inalienable right didn’t resonate with the public

  • The Practical Realities
    • The health care system may simply be too large & complex to really achieve a complete overall. For sure, the solution was too complex.
    • The passage of the deficit reducing/tax increasing first Clinton budget consumed too much political capital
    • The whole thing took too long. There were too many obstacles…from the illness and subsequent death of Hilary’s father to Somalia, Haiti, NAFTA…..
    • The power of the special interest groups on the Hill was too great.

  • Political Missteps
    • The Administration didn’t work with Congress soon enough. A little party unity would have gone a long way.
    • The timing was terrible; welfare reform should have gone first
    • The opponents ran a better campaign – Harry and Louise resonated with the American people. The Administration’s proposal had supporters but no real champions

“Medicare” expansion — the simpler, most obvious approach — was largely ignored!

POLICY/POLTICS: Why Hillarycare failed…and what we need to learn from that failure

This is the continuation of an article I’ve threatened THCB readers with for some time about what in my view really happened the last time we got serious about health care reform.  And in it there are lessons for what we should do when the opportunity next comes up. (It’s also really long, so for the first time over here I’ve continued it "below the fold")

There are lots of versions about what killed the 1993-4 health care reform effort.  Hillary Clinton has now decided that the problem was the lack of incrementalism in her plan.  Last week the New York Times said that since becoming a Senator:

She has deliberately avoided the major mistake she made as first lady, namely trying to sell an ambitious plan to a public with no appetite for radical change. <SNIP>. She summed up her approach in the first floor speech she delivered in the Senate about four years ago, when she unveiled a series of relatively modest health care initiatives. "I learned some valuable lessons about the legislative process, the importance of bipartisan cooperation and the wisdom of taking small steps to get a big job done," she said, referring to the 1994 defeat of her health care plan.

On the other hand, some people are still claiming victory for the plan’s defeat even if they were at most modest bit players.  Here’s what one fawning bio says about former New York Lt Governor Betsy McCaughey

A 35-year-old senior fellow named Elizabeth McCaughey…wrote an article for The New Republic on what she discovered in a close reading of the 1,431-page document containing the Clinton Health Care Plan: Namely, that it would put every citizen in a single government-operated HMO. That one article shot down the entire blimp, and Betsy McCaughey became a 35-year-old Cinderella. One of the richest men in America chose her as his wife, and George Pataki made her lieutenant governor of New York.

Ignoring the fact that McCaughey spent her time thereafter putting poor New Yorkers into those HMOs she so despised, and then went off the deep end en route to divorce from Pataki, the rich guy, and reality (not necessarily in that order), it’s not really true that one article in The New Republic can be quite that influential. (Sorry Jon!).  Even if the overly geeky Clintonistas in the White House did feel that they had to come out with a point by point rebuttal. And anyway, the article only came out in January 1994 by which time the die was more or less cast the other way. Again we have to look elsewhere for the explanation.

If you want to go back and spend a few minutes wallowing in the era of trial balloons and secret task forces, there’s a very interesting time line of the whole process on the NPR website, as well as a briefer information over at the Clinton Health Plan Wikipedia site. It seems like there was a moment when it could have succeeded, and indeed there may well have been. What has been missing from the whole discussion over multiple blogs over the last couple of months has been the understanding that there’s a real world outside Washington and that sometimes (but not too often) what’s going on there has an impact inside the beltway.

Continue reading…

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