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Month: September 2005

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

• 3

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.

CONSUMERS: Trade up players, but maybe not enough of them

• 12

Once again there’s something very important in a WSJ/Harris poll which concentrates on the people that, when I was at Harris, were called the "Trade up players". These are the people with enough discretionary income to buy themselves a better class of service from their providers.  As I know many of you don’t have WSJ access, I’ve quoted most all of the results.

"Do you have health insurance? It could be from an employer, that you purchase yourself or from a government program like Medicare or Medicaid?"

Base: All Adults

Yes, have health insurance 87%
No, do not have health insurance 13

* * *

"Which one of these statements best describes you?"

Base: Adults with health insurance

Total
I only go to doctors that accept my health insurance 85%
I sometimes go to doctors who don’t accept my health insurance 15

* * *

"Whether or not you have done so in the past, how willing would you be to go to a doctor who doesn’t take your health insurance if he or she was highly recommended by a source that you trust?"

Chart1

"How willing would you be to pay the full cost of a doctor’s visit – rather than use your health insurance – if you . . .?"

Chart2

The important issue is that pretty uniformly, those with incomes over 50K, which is a little over average household income and around US median income, are willing to spend more money to get a better class of service. Obviously this means a couple of things

a) If you are marketing a health care service to wealthier Americans there is a willingness to pay for it. Of course that’s a well known fact to chiropractors, orthodontists, and cosmetic surgeons. But it might mean that other physicians and providers might start to think about providing better access and customer service, for a small fee (and I don’t mean insisting on $20,000 for concierge service). This is the Nordstroms approach, and one that health care providers should be thinking about emulating (and one that some are).

b) This willingness to pay is a minority effect — it’s a big minority and may be a majority in the case of referrals from someone the patient trusts.  But for most of these services more people are unwilling to pay extra, and of course large majorities of those with lower incomes, even those with health insurance, do not want to pay extra.

This tells me that continued bifurcation is likely to be the case when people seek health services that they have to pay out of pocket for, with roughly double the number who want to "trade up" skimping on "extras". Why does this matter?  Because in our brave new consumer world, cash may be an increasingly important way that patients pay for health care, especially for "minor" care out of their HSAs. So this correlates with much other data about user fees at the point of care–they tend to prevent lower income people from getting care (including often needed care).

Like it or not, we are slowly heading towards this future.  Unless, that is, you live in Rochester New York.

Meanwhile, (and this is a bit of a throwaway for Ron) the Kaiser Network Health Policy Report notes that the CBO is out with a study showing that "Uninsured workers are unlikely to purchase individual health insurance, regardless of whether they receive tax credits or other subsidies to help cover the cost of premiums, according to a report released on Friday by the Congressional Budget Office". Proving to my mind once again that high deductible health plans are not going to solve the uninsurance problem and that voluntary universal health care is a myth.
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