Healthcare Reform: United We Stand
Edwards, Clinton and Obama have unveiled drafts of their healthcare plans. I say “drafts” because, for each, the plan is a work in progress. All three have indicated they have more to say on the subject.
Reforming healthcare is a complicated business, but I’m optimistic that we are heading in the right direction because the three candidates agree on some of the most important points.
If only their supporters could see that. Instead, when Barack Obama released his health reform plan, he came under fire by Democrats who saw the plan, not as one of three proposals that might advance the discussion about heath care reform--- but as a litmus tests as to whether Obama deserves to be president. The verdict: Obama may be too cautious.
The problem, as Dr. Atul Gawande suggested today in The New York Times, is that “presidential candidates’ proposals . . . are treated, by campaigns and media alike, as some kind of political G.P.S. device — gadgets primarily for political positioning. . . . So this was how Mr. Obama’s plan was reported.”
“And if what you care about is which candidate can one-up the others” Gawande continued, you might well find Obama’s plan “rather disappointing. But if what you care about is whether, after the 2008 election, we’ll be in a position to finally stop the health systems’ downward spiral, the similarity of the emerging proposals is exactly what’s interesting. I don’t think you can call it a consensus, but there is nonetheless a road forward being paved . . . “
Let me be clear: I am not advocating Obama’s plan. Nor do I have a clear view as to which of the three would be the best presidential candidate. But I do think these are separate questions.
Most importantly, I believe that Democrats need to stand united on healthcare reform. Granted, Democrats love to argue with each other. But rather than dividing our ranks by attacking what we find wanting in a candidate’s plan, we should applaud the strongest proposals in each plan—encouraging the candidates to take a page from the best in each other’s proposals. We don’t want Democratic candidates to compete on healthcare. We want them to collaborate.
What is impressive is that, already, they are taking on the powerful corporate interests that help make U.S. healthcare unaffordable for millions. Under all three plans, insurers will no longer be able to “cherry-pick” healthy patients, deny coverage to patients with pre-existing conditions, or charge them exorbitant premiums.
Clinton’s plan also insists that insurers cover essential preventive care-- without co-pays-- while Obama requires insurers to "justify any premium increases" to a regulatory agency that would limit insurers’ profits.
Finally, both Edwards’ and Obama’s plans create national health insurance that competes with private insurers. (Clinton has not yet released details on this point.)
Under Obama’s plan, the uninsured, the underinsured, and anyone who works for an employer who wants to get out of the health insurance business altogether (and instead, pay a tax into the national system) can enroll in the national plan. Think Detroit.
The three plans also challenge Big Pharma by letting Medicare negotiate for discounts on drugs. And all three establish an independent public agency that would compare the effectiveness of new drugs, devices and treatments to existing products. Researchers would have no financial stake in the outcome. (Today, the FDA lets manufacturers oversee trials comparing their new products to placebos—not to the older, products that they are trying to replace.)
Despite the similarities, Obama’s liberal critics have pounced on the fact that while his plan mandates that children and young adults under 25 must be covered, he does not require Americans over 25 to purchase insurance. His ultimate goal, he says, is universal coverage. But first he wants to put a plan in place and make sure that it is affordable-- before mandating that everyone must buy into it
.
What’s ironic is that in the past, as, Mark Schmitt pointed out to me today, liberals have opposed mandates that forced everyone to buy insurance: “The rapidness with which the individual mandate has moved from a controversial centrist idea to a liberal must-have is astonishing.”
For example, he notes, liberals “denounced” the mandate in Schwarzenegger's plan as “criminalizing” being uninsured. “The limited mandates in the Bradley plan in 2000 were denounced by Gore from the left, as harming poor people.
“And some of the criticism was correct,” Schmitt adds. “An individual mandate with inadequate subsidies . . . would be a trap.”
The mess in Massachusetts shows what can happen. Originally, then-Governor Mitt Romney predicted that low-cost plans would be offered for roughly $200 a month.
But in January, when the Commonwealth reviewed insurers’ proposals, they found the cheapest plans average $340 to $380 per month. Insurers were told to sharpen their pencils and come up with less expensive plans.
Dr. Steffie Woolhandler, co-founder of Physicians for a National Health Program, warned that insurers would begin peddling bare-bones plans: "people will be forced to pay thousands of dollars for a policy that is . . . full of gaps . . .. They'll be facing the worst of both worlds: [being] forced to hand over thousands of dollars to private health insurance companies, and finding that they're not actually covered when they get sick."
By contrast, Obama’s plan forces private insurers to provide coverage that is at least as comprehensive as the insurance offered by his national plan (which is similar to Medicare, and modeled on the coverage available to federal employees)
But before mandating insurance, Obama wants to roll out the plan and see who signs up: “If working families don’t sign up, we’ll know the subsidies aren’t high enough, and we’ll raise them,” pledges David Cutler, Obama’s health expert. What if more affluent adults don’t sign up? “Then we would have to revisit the idea of a mandate.”
Is this the best way to go? Not necessarily. (I’d like to see a mandate that applies, from the outset,to anyone earning over, say, $50,000.)
But it’s early innings. I’m interested in hearing what the candidates say as they clarify and expand on their plans.
They ARE gadgets for political positioning. Who believes any of them. I sure don't.
Give me a candidate who wants to mandate CARE not insurance. Give me a candidate who wants to DELIVER health care not reform it.
It's doable. Really. Heck, they just flew the President of Iraq all the way to Rochester, MN so he could get health care.
If we can care for the President of Iraq, we can care for the American people.
Come back to me with a candidate who will commit to universal delivery of health care. Until then, I believe these candidates just as much as I believe them on Iraq (not).
May 31, 2007 6:01 PM | Reply | Permalink
MM has a way of taking a step back and taking a deep breath from these things, and I appreciate it. I, too, think the proposal isn't necessarily thewway to go but don't think that's the right way to judge Obama. As she says, as long as for now they're working on making reform a priority, even at the expense of interest groups, it's impressive. We'll definitely have to position ourselves, though, since any failures owing to the lack of sweeping change in the Massachusetts plan are going to be held against reform soon. Anyhow, I agree in applauding Obama for giving it a go.
But also, remember that Gawande has an agenda, too, and it isn't so nice. He's less concerned with equality or covering all Americans so much as what might bring cost down, in his eyes by certain limits on treatment that he sees at odds with letting people have health care, period. In the process, he's even willing to pose the two goals in opposition, which the European example keeps telling us isn't so. I don't mean to criticize MM, just to broaden the focus.
John
http://www.haberarts.com/
May 31, 2007 6:27 PM | Reply | Permalink
A breath of fresh air -- that's how I feel about this post. I'm relieved there are liberals on a well-respected blog calling out the "not good enough" crowd for what it is.
I don't get the outrage about Obama not making insurance "mandatory." For the purists, shouldn't the outrage be that it's insurance at all? I mean, how does "mandatory" help the cause? But if the not-good-enough crowd had to rail against all the candidates advocating "insurance" over "single payer", it'd get pretty loud. No, instead, they pick a nit, and go after that.
What about "mandatory insurance" is any more Universal than affordable, accessible insurance? Nothing.
I know too many people who do not have health care who maybe, just maybe, will get insurance if they feel they can afford it and it will really cover them. Let's face it -- people buy cable and it's not "mandatory." If a service is of value and affordable, they'll get it.
May 31, 2007 6:58 PM | Reply | Permalink
First, thanks you for the comments.
I have just one question: Jhaber, I'm curious why you feel that Gawande's agenda "isn't that nice." I've read his first book (Complications) which I like very much and most of his pieces in The New Yorker--but I haven't read his newest book.
Could you expand on your reservations about his agenda?
Maggie
May 31, 2007 7:11 PM | Reply | Permalink
When I first read about Obama's plan I was among those who were extremely disappointed. I was even wondering if I was backing the right candidate. But, then I read more about what he was offering, and why he was offering it. Barack Obama is a man who very strongy believes in working with all people to solve common problems. He recognizes that doing so involves compromises, but believes that taking steps forward is far preferable to just sitting still and waiting for the perfect solution to be accepted by everyone.
So, now I agree with his plan. We saw what happened with Hillary's committee's plan back in 1993, and it was not universal single payer health care at all. It was a complex mix of compromises aimed at trying to satisfy all segments of the opposition. It was attacked with fury by everyone.
There is no chance at all of a single payer health care system, a universal Medicare system, to ever pass Congress in the next 10 years. Far too many Congressmen of both parties are beholden to campaign contributions from the insurance industry and the health care industry for that to be allowed to happen.
But, Obama's plan is little more than small, but critical steps in the right direction, something that can be sold even to many Republicans. And, it does not put the health insurance business in bankruptcy. It should be possible to get that plan thru Congress.
Expanding that "new" health care system in future years can then be possible, and eventually a good system should result. But, if we hold out now for the system of our dreams, in ten years we will still be holding out.
I oppose any law that forces me to buy a product from a private company. In my opinion that is not constitutional unless that company is very well regulated, just as utility companies have been in the past. I believe Obama is proposing the bare bones of just such a regulatory agency. So, I judge that proposal to be a very good one.
Hoppy in Sacramento
May 31, 2007 7:21 PM | Reply | Permalink
I disagree with your analysis about the 1994 Clinton plan. Full disclosure - I am not an Obama supporter (or a Clinton or Edwards supporter for that matter). Rather than conclude that the Clinton experience calls for more cautions incrementalism, I would argue that it shows why cautious incrementalism is the wrong approach. No matter how many bones health care reformers try to throw to those who are doing well by the current system their proposals will still be savagely attacked as "socialism", "big government", etc. by the corporatists and the right-wingers.
It's going to take a monumental effort to reform the health insurance situation and we're likely to be stuck with whatever we end up with for a lot longer than the 10 years you estimate it would take to pass a universal, single-payer program. Why waste the fight on baby steps? Saying that only incremental improvements can pass is not only wrong (if that were the case then Clinton's plan would have passed) it's misguided.
The expectation that
is naive.
If we haven't be able to produce needed reforms so far what makes you think that we'll be able to do so after a bare-knuckle brawl to gain even the smallest concessions from the protectors of the current system?
May 31, 2007 7:47 PM | Reply | Permalink
Hallelujah! One truthteller appears.
Even before I retired from my professional career, I had spent maybe a decade as an itinerant antique dealer.
The true professionals who sometimes worked at nothing else scrabbled for a living in a way that no one who has not been there could fully appreciate.
Most were here and gone overnight. They were as different as the Vietnam combat veteran who had never really come home and gathered most of his artifacts from the rebel-held areas of Myanmar and had stories to tell that even few combat veterans could match to Mary, an aging primitive dealer, who once was dropped off with tables and merchandise in an open field at the huge show in Brimfield, MA, for a week by her husband and slept under the tables in all manner of weather. Mary's husband had long passed away, her eyes were going bad and Mary could only drive during the day. She sighed to me she didn't know how she could continue but had no money to retire on.
Only a few of these people had any health insurance. Some couples dared not marry because one had insurance from employment and the other didn't. Of those that could and did buy insurance, it was generally far from adequate and payments would somehow have lapsed at precisely the time they needed it most desperately. One aging couple living nearby worked for another decade from their 70's into their 80's paying hospital and doctor bills because a change in insurance had not taken effect when the wife was hospitalized. Then the husband fell ill and the game was over.
What will any of the health care plans do for these people? Hey, what will they do for the vast paperwork expense and to prevent the profiteering that puts the burden of supplying R&D for new medicine and devices for the rest of the world mainly on the backs of sick Americans? How will they truly end the most expensive and one of the worst systems of any advanced country and many not so advanced?
I guess you could ask who needs greedy little merchants who can't make a decent living in the first place and sell what no one needs.
I can't answer that. Don't like to think about it.
Best, Terry
May 31, 2007 8:24 PM | Reply | Permalink
The changes Obama is proposing are hardly the "smallest concessions". What he is proposing is almost revolutionary, stopping just short of a single payer system. He would introduce a requirement that health care insurance be equivalent to the health care program Congress enjoys. He would allow people to opt out of buying private insurance and buy a federal insurance instead. He would set up a requirement that insurance companies justify their rates. He would require that preventative health care be covered by all insurance plans, along with pre-existing health problems. Those are not small concessions at all, they are major corrections. Once this program is enacted it will be like the Social Security program, something it would be political suicide to tamper with.
Hoppy in Sacramento
May 31, 2007 10:23 PM | Reply | Permalink
Paceliner and Terry--
I agree completely with both of you.
We don't need cautious incrementalism.
But there is nothing cautious about the Democratic candidates' plans. Read them.
They are far more radical than the plan that the Clintons proposed in the early nineties.
Believe me, I am not in favor of incremental reform. I want a single payer system. But there is no way to pass legislation that decrees that an entire industry (for-profit insurers) must simply disappear. (For one, there are too many jobs involved.) The only way to get there is to force for-profit insurers to compete with a governnmet plan -- as both Edwards and Obama do. (And my guess is that, when we see the rest of Clinton's plan, she will too.)
If for-profit insurers have to compete with
a national plan like Medicare--and if they can no longer "cherry-pick" healthy patients while charging sick patients more, much of the for-profit industry will simply wither away. It just won't be profitable enough for them to stay in the game.
In the meantime, all three plans are dealing with the fact that we are now wasting as much as one out of three of our healthcare dollars on
overpriced, often unproven bleeding-edge drugs, devices and treatments that are no better than the older, less expensive--and often safer--products that they are replacing.
All three candidates are insisting on setting up independent reserach institutes where researchers who have no financial stake in the outcome will test these new treatments against existing treatments. This will be a huge change--not only will it save wasted healthhcare dollars, it will protect patients from the hazardous waste of being exposed to treatments that have not been fully tested by researchers who have no financial stake in the outcome.
Finally, the Democratic plans offer government subsidies to make insurance affordable--not just Medicaid for the very poor, but subsidies for
working-class and middle-class Americans. In other words, these plans acknowledge that
all Americans have a right to affordable, high quality health care.
May 31, 2007 11:26 PM | Reply | Permalink
Yeah, I live in the real world too though it is nice to dream of a better one.
Would you consider a cure - not a treatment that keeps some alive a bit longer but a cure - for all cancers worth a bit of change? Mice have been cured of lung cancer, septicemia and glaucoma by the same "drug." (Explaining an experimental gene treatment that has not yet and may never be formulated into a drug is far beyond the scope of this thread.)
This is not some dreamscape though mice are mice and men are men.
Unfortunate for sure that Big Pharma spends most of its research dollars trying to eat each other's lunch with experimental drugs mostly of the same class as that of the other guys while some really great research is strangled by lack of funding and wild attacks by the hedgies Hillary thinks are such a fine bunch.
Guess who gets hurt most by most proposals?
Best, Terry
June 1, 2007 6:20 AM | Reply | Permalink
From your original post:
Now you're saying:
Well, which is it?
June 1, 2007 6:33 AM | Reply | Permalink
This appears to be a critical weakness. Should my daughter be denied the most effective drug for her just because some independent (effectively unaccountable) board desides that some other drug is better and cheaper for most users. No thanks.
The FDA already requires safety and effectiveness, after that leave the choice of what to prescribe to individual doctors and patients.
The sons of the prophet are noble and bold,
and quite unaccustomed to fear.
But the bravest by far in the ranks of the Shah
was Abdul Abulbul Amir
June 1, 2007 7:21 AM | Reply | Permalink
In the early stages of a primary where many of us even here at TPMCafe are undecided, it's not time for Democratic unity.
This is when we hash stuff out.
I'm considering Clinton, Edwards, Obama and Richardson in no particular order at the moment.
So while we can all agree that some healthcare reform is necessary (and I think we all do) now is the time that we're supposed to be tearing every individual proposal to shreds. We have decisions to make, after all.
I think that some of what you saw in the coverage of Obama is just evidence that his media honeymoon has ended. I've gotten that sense here too as criticisms and comments about Obama have become more pointed. Just last week 2 separate threads (One by Andrew Golis and another by Jim Sleeper) dealt with the merits of Obama and they garnered about 250 comments over the course of 2 days.
We're in "sorting things out" mode. Now's the time for some fighting and some back and forth. Call for unity after we choose a candidate.
thosethingswesay.blogspot.com
June 1, 2007 7:34 AM | Reply | Permalink
Lapis: "What about mandatory insurance is any more Universal than affordable, accessible insurance?" I believe the idea is that it's hard to afford to make coverage available to all if people can opt out. Either they'll opt out because they're least at risk, meaning the system has to insure mostly hig-risk cases that impose more costs of care on the insurer, or else because they're so poor that every dollar counts, in which case they wait until it's emergency care, again raising costs. Of course, one could argue that the restrictions Obama favors on what insurance plans must offer will help both in reducing costs directly and in encouraging people to buy in.
John
http://www.haberarts.com/
June 1, 2007 7:57 AM | Reply | Permalink
Maggie: "Could you expand on your reservations about his agenda?" With apologies, I'm probably too uninformed, as I haven't read his book. I may be overgeneralizing from his contributions to The Times. However, they did leave me with the impression that he thinks (a) insurance is the wrong issue, when (b) we should be focusing on wasteful spending. Both (a) and (b) would appear to be reasons to discourage patient care and the insurance that makes it possible.
John
http://www.haberarts.com/
June 1, 2007 8:00 AM | Reply | Permalink
I agree that this is the time to sort out the differences among the group of very good Democratic candidates. While doing that, let's not sink to the level of smearing the candidates that don't quite meet our expectations. The Republicans will do that quite well without our help.
Another thing to keep in mind: any new health care proposal is just a proposal. The final product will be a result of negotiations and compromises in the Congress, and is highly unlikely to include all of the details as proposed by any of the candidates. It would be futile to expect one of the candidates to propose something that cannot possibly survive that Congressional process - we can leave that type of proposal to Kucinich. (This isn't snark. It is very helpful to have one candidate out on the fringes, pushing the others towards the ideal programs.)
Hoppy in Sacramento
June 1, 2007 8:25 AM | Reply | Permalink
It is both. The important thing is that the small steps are the critical ones, the ones that lead to a universal health care system that is affordable. It takes considerable skill to pick out those small steps and propose them in a form that will achieve that desired result. Obama's plan is not a list of concessions, let alone "smallest concessions". It is a carefully designed list of small changes, all of which should be palatable to even the Republicans, but which, together, move our health care system into the 21st century alongside the other developed nations in the world.
The best part of Obama's plan is that it is achievable in today's political climate. A single payer system isn't.
Hoppy in Sacramento
June 1, 2007 8:31 AM | Reply | Permalink
Abdul Abulbul Amir--
Unfortunately, the FDA does not approve drugs based on safety and effectivness. It approves drugs based on political pressure from
manufacturers.
You should read transcripts of FDA panel hearings where they decide whether or not approve a drug (available at www.fda.gov.)
It's an eye-opener.
The FDA frequently approves drugs that are of minor benefit (in one case a cancer drug that might allow patient to live 1/3 of a month longer--that's right about 10 days--with very little information about risk. Often these drugs have been tested on relatively small groups of people for short periods of time.
An independent commission would do what the Mayo Clnic now does for its patients--test drugs against existing rivals (not placebos) looking at effectiveness and risk. Of course reserachers recognize that some drugs are effective for certain people; other drugs effective for others.
For example, the Mayo Clinic recognized that Vioxx was no more effective than older, cheaper, safer pain-killers for Most People. But there are some people who can't use the older pain-killers because they suffer from gastrointestial bleeding. So the Mayo Clinic continued to give it to those patients--but not to most patients.
(This was two years before Merck, which had been
marketing Vioxx as the best painkiller for everyone, was forced to take it off the market because of the danger of strokes. The FDA had "fast-tracked" it without full information about long-term risks.)
June 1, 2007 8:52 AM | Reply | Permalink
Destor 23 & Jhaber
I agree that this is the time to "hash out" the details of reform in different proposals, but I don't think that means "tearing them to shreds."
That's what those who oppose reform are supposed to do are they argue that no plan is workable, that they are all fatally flawed, unrealistic, etc.
It seems to me that we need to "sort out" the details by idetifying what we most like in each proposal, debating those points with each other (insofar as we like differet solutions), offering good evidence for our preferences, and in some cases persuading each other. In the meantime, we'll letting the candidates know which planks we like best in each proposal, and hopefully, as they expand and refine their plans, they will adopt the best of each other's ideas. Obama already has incorporated ideas that originally came from
Kerry and Hillary in his plan--and is happy to
give them credit. I hope the others will do the same. This is too important to let egos get in the way.
jahber- Actually I agree with Gawande that wasteful spending is a huge problem because it's
not just a waste of money, it's hazardous waste--
waste that is hazardous to your health.
About one in three of our healthcare dollars is spent on unncessary sometimes unproven treatments, redundant tests and over-priced bleeding- edge drugs and devices that are no better than (and sometimes riskier than) the older products that they are trying to replace.
Every treatment, no matter how minor, carries some risk. And if it's not necessary, then the patient is exposed to risk with no benefit.
The bottom line is that we have two big problems in this country: the uninsured and underisured get too little medical care while the well-insured (and people on Medicare) often are
over-treated.
I've written about this in the latest issue of Dartmouth Medicine here (http://dartmed.dartmouth.edu/spring07/html/atlas.php) you might find it of interest.
June 1, 2007 9:21 AM | Reply | Permalink
Second, even if, and it's a big if, your assessment is correct, and that the generally effective, more economical treatment is not the correct one in a specific case, and it is for whatever reason not available in your case, a supposition that is not supported by the citation, which is more general in its nature, you could always pay for it yourself.
June 1, 2007 11:41 AM | Reply | Permalink
It never ceases to amaze me the amount of energy that can go into a project just to avoid doing the right thing. The best, simplest, least costly, most effective thing we could do is expand what has been working so well for years, Medicare. You get sick, you get care, and the caregiver gets paid. What could be simpler?
Medicare is clearly not perfect, but it is way ahead of whatever is in second place. If we could just get our politicians off the insurance industry dole they'd fix it overnight. We don't need an insurance industry, we need a care-givers industry.
Jack Lohman
www.BusinessCoalition.net
Business Coalition for Single Payer Healthcare
June 1, 2007 12:24 PM | Reply | Permalink
I like the alphabetical order you've used. :)
I agree that we are in a sorting stage, but I don't think that requires "tearing every proposal to shreds." I want critique rather than criticism. What about a careful look at the pros and cons of each proposal? That still gives us the information we need for sorting things out -- but without the long-term baggage.
June 1, 2007 12:34 PM | Reply | Permalink
Maggie says: "...But there is no way to pass legislation that decrees that an entire industry (for-profit insurers) must simply disappear. (For one, there are too many jobs involved.)"
Who says the industry has to "simply disappear?" Why do you think it's all or nothing? Have any of you looked at the Conyers-Kucinich bill HR 676? It is a single payer plan with a 15-year roll out and it includes funding for re-training of those insurance industry people -- currently the insatiable parasites on the "system" -- who'd lose those jobs. They have 15 year notice to find other work; it's more than they give us when our premiums are late!
Of course the CEO of BlueCross here in little old Vermont probably won't need retraining unless he has had really poor investment advice for the last few years: his compensation in 2005 totalled more than $845,000!! How many Vermonters (and there are only 650,000 of us in the whole state) could have accessed every bit of health services they needed for his salary alone?!
There is no health economic model that sees the current financing system as sustainable. And there is no moral model that sees it as just. As long as any proposed reform to health care financing includes continued subsidies to insurance companies, it is doomed to fail. Why propose a reform that at its birth is known to be doomed? That isn't what I call thoughtful leadership.
Compromising by having both private and public plans results in adverse selection: the healthy wealthy purcahse the private coverage and the un-healthy un-wealthy get the public plans which therefore will bankrupt. Then the insurance industry throws their hands up in the air and says "See, we told you socialized medicine doesn't work!" thereby ignoring all evidence to the contrary in every other developed nation.
Anyway, look at HR 676
www.citizensforhr676.org
www.healthcare-now.org
June 1, 2007 12:37 PM | Reply | Permalink
Thanks for a link to a great article. Now, I'm not one here who's been knocking the candidates for their "incremental" proposals. However, can I ask if you think the article makes a strong case for single payer? It outlines a very difficult problem, and it suggests changes in what gets paid through, say, Medicare, which presumably is more readily controllable than HMOs.
John
http://www.haberarts.com/
June 1, 2007 1:06 PM | Reply | Permalink
Exdem-
Actually, I like the Conyers/K bill very much. I've been talking about it for more than a year. And Conyers has been fighting this fight for a very long time.
But I have had a hard time getting anyone else interested.
The general feeling seem to be that if you tell Americans that eventually they all will have to sign on to a goverment health care bill--that there is no other choice-- they will freak, and there will be a huge movement to defeat the bill.
If, on the other hand, you tell them that they can EITHER sign up for Medicare (or a very similar from of nationall health insurance with comparable benefits)
OR they can stick with private insurers, the people who are terrified of "government heatlhcare . . socialism etc." won't have much reason to complain. If they prefer private insurance, they can have it.
Americans don't like being told what to do. (Did you read the story in the papers today about New Hampshire repealing the seat belt law?! It seems to me crazy, but this is the way some people are, and we just have to work around it.)
And I do think there is merit to the argument that if people don't feel FORCED into a govt' plan,
many will voluntarily sign up for the national health insurance (Medicare by another name) as long as the plan is at least as good as Medicare.
The key is that the competition between the national health plan and private insurers must take place on a level playing field : private insurers cannot be allowed to
cherry-pick health patients and turn down the sick ones; private insurers must be required to offer plans that are at least as comprehensive as the public sector plan (otherwise, private insurers wil offer cheap, high-deductible plans to healthy 20-somethings and 30-somethings---siphoning off those people, and leaving the national plan with the sickest patients.)
All three Democratic plans would, I think, create a level playing field.
If they do that, then private insurers would have a very hard time offering the upper-middle class a better package for less money than Medicare because private insurers have a lot of expenses that a public plan wouldn't have: private insurers need to advertise, pay lobbyisets, pay huge salaries to executives and profits to shareholders.
Admittedly, private insurers might offer the very wealthy a luxury health care plan that guarantees private rooms in hospitals, some payment toward botox and other cosmetic surgery, a doctor who calls you back at home at night--perks that are nice, but not medically necessary. Such plans would be very expensive, but could siphon off a slice of the upper-class market.
But as long as the national plan is very good (say as good as Medicare, plus discounted presciprtion drugs), very few people would be willing or able to pay the premium for those luxury extras.
June 1, 2007 1:21 PM | Reply | Permalink
"Did you read the story in the papers today about New Hampshire repealing the seat belt law?!" Gives new meaning to "live free or die."
John
http://www.haberarts.com/
June 1, 2007 1:29 PM | Reply | Permalink
jhaer-
I see the Medicare reform that I talk about in that article as something we can begin to
do now --paving the road for national health insurance.
If Medicare cuts its waste and improves its quality, it becomes easier to ultimately offer Medicare (or a similar publicly funded plan) to all.
If we cut the hazardous waste, we can afford universal coverage --no question. And if we're going to offer universal access we want to be
offering universal access to high quality care.
Otherwise, national health insurance will become "a poor plan for the poor"--with wealthier Americans opting out.
In that article I didn't see a reason to explain that Medicare reform paves the way for health care reform. Not everyone agrees with me about health care reform, so why upset them? I'd
like to just get them on board with Medicare reform now (while we wait for Bush to fade away)
and then let them see that when given the choice between Medicare and private insurance, the majority of Americans will pick a really good
public sector program. (see my post below)
June 1, 2007 1:33 PM | Reply | Permalink
repeats preceding post
June 1, 2007 1:35 PM | Reply | Permalink
But I think HR 676 can be rolled out carefully, thoughtfully, and slowly enough that people will eventually realize that they've been brainwashed about the whole "socialized medicine means bad medicine or no choices." It just needs a champion with the charisma (there must be a better word than that, but I need to get out and feed the horses!) to sell it. Maybe I'm hopelessly naive, but I'm also unreformably (another bad word) vengeful toward the insurance comapnies! I want so badly for them all to die their richly deserved deaths! I'll hang on to hope about single payer...I'm voting Kucinich in the primary then God only knows what in the general.....
June 1, 2007 1:38 PM | Reply | Permalink
Thanks Viviane-that's exactly what I was trying to get at. mm
June 1, 2007 1:50 PM | Reply | Permalink
repeats previous comment (sorry!)
June 1, 2007 1:55 PM | Reply | Permalink
Because such a board will serve no purpose other than to block payment for drugs that would be most effective but to a small (therefore politically weak) number of people. Further, we know that not all persons react the same to drugs. For the same malady, some will benifit most from drug A, some from drug B, some from drug C, and some will not respond to any existing drug. We all have different DNA. Such a board is not putting patients first.
The concept of a "generally effective" drug only means thats the one to start treatment with, not the one to restrict patients to.
The sons of the prophet are noble and bold,
and quite unaccustomed to fear.
But the bravest by far in the ranks of the Shah
was Abdul Abulbul Amir
June 1, 2007 2:01 PM | Reply | Permalink
Re: It is a single payer plan with a 15-year roll out and it includes funding for re-training of those insurance industry people -- currently the insatiable parasites on the "system" -- who'd lose those jobs.
I've made this point many times, but I'll make it again: Other than merketing folks and a lot of upper level executives few health insurance workers would lose their jobs. Any conceivable hwealth plan is going to need all those people to do more or less what they are doing right now, because that work is an inherent part of any health plan. Indeed, with universal coverage and 45 million mofe peopel in the system, we'll probably need more people to process their claims, answer their phoene calls, determine authorized treatments, maintain IT systems, staff mailrooms, and oversee the financials of the system. Healthcare reform will not be a major job killer.
June 1, 2007 2:46 PM | Reply | Permalink
I have ever increasing respect for Mahar's blend of high minded goals and incremental pragamtism.
Mahar is absolutely correct in maintaining a clear vision of long term goals and measuring short term progress against them, while also encouraging unity and positive momentum in the short term to get things rolling.
My take on Obama's plan is that it shares Mahar's long term goals, but feels the political stickion is the most significant challenge. Therefore, incremental legislation is the best way to get things moving, with ever increasing acceleration, and his campaign has stated that further legislation will be forthcoming.
So far, so good. If the political climate changes to be more favorable to rapid change, I would be happy as would Mahar, and I suspect Obama would as well. But we don't need another failed attempt at reform which maintains the status quo for another generation either.
June 1, 2007 3:18 PM | Reply | Permalink
To paraphrase a famous quote, "America will always do the right thing, but only after failing at everything else."
I agree that we must be pragmatic as we get closer to a vote. But if we start high we won't have to ultimately settle too low.
Jack Lohman
www.BusinessCoalition.net
Business Coalition for Single Payer Healthcare
June 1, 2007 3:28 PM | Reply | Permalink
A suggestion:
Why not enroll everyone in Medicare (or a Medicare-like equivalent) but give them the option to opt out?
June 1, 2007 3:38 PM | Reply | Permalink
I don't pretend to know the mix of policies that would produce the optimum healthcare system but I would not assume that small steps get you there.
Americans were once not afraid to think big and think outside the box. Why have we become such timid convention ridden souls that we begin every discussion of every issue by drawing the smallest box around the parameters of thought and debate.
Maybe we need big changes. Maybe only a really big issue will ever prompt another political realignment and get Americans in general to think outside the box of corporate conservatism.
June 1, 2007 3:39 PM | Reply | Permalink
Medical insurance today is, to a large extent, sold by independent contractors who syphon off a very large chunk of the premiums as their commission. There is the waste that is especially bad. I know two people who made $250,000 in 4 months just selling health insurance over the past year! And that is just in a small area of the state, let alone in the country.
There are many reforms needed in that industry.
Hoppy in Sacramento
June 1, 2007 4:00 PM | Reply | Permalink
Maggie...
The private health insurance industry doesn't need to disappear for single payer. It just needs to be made public.
There's this idea in the Constitution called eminent domain. It's used for making private property public. It can be used to make the entire private health insurance industry a public industry.
All current private premium payments would immediately become public revenue, which of course should be used to finance the system - and the system would thus immediately be single payer. Additional taxes would only be needed if costs increase; if they decrease as expected, premiums could decrease as well. And the uninsured could be insured immediately, via a tax on a means-adjusted basis - the poor should not have to pay anything. The difference is that there is a single pool, not one for the privately insured and another for the publicly insured, where the premiums for the public pool would have to be larger to make up for the pool's much smaller size.
I'm a socialist; I'm not afraid of eminent domain. But we should think about it; the largest public works project in the country's history (AFAIK), the Interstate Highway System, was built on eminent domain. The land which is now Interstate Highways and their frontage, which is largely occupied by businesses, was private land acquired by eminent domain, and much of it is again private. FDR's idea was to buy it cheap and sell it high to make the project self-funding, since it would become prime retail property after the highways were finished, though I don't know if that's entirely what happened or not.
Trying to regulate private industry is largely futile in most cases. It would be better to make them public first; owners can do things non-owners can't. And there's nothing that says that if there's good reason for it, companies thus made public can't continue to exist as separate institutions, or that they can't be sold off and thus privatized later, case by case.
In too many cases, capitalists make things too darned hard, when they aren't really that hard. Think like a socialist, whether you like the word or not, and some of this might be easier than you'd think...
By the way, with a Democratic president and a Democratic congress, it shouldn't matter at all what Republicans think of socialized medicine - it should only matter what Democrats think. But of course, that's the real problem, isn't it?
June 1, 2007 8:59 PM | Reply | Permalink
I agree, and this is part of why I suggest eminent domain buyout of the private health insurance industry.
The problem with private insurers is largely that their profits are private. Making those same companies public domain makes those profits public revenue that funds the system instead of taking away from it. Nothing else has to change immediately. Making them publicly owned instead of privately held also allows them to have legislated policies and accountability, instead of having to pass and try to impose and enforce regulations that are more likely to drive costs up than keep them down.
June 1, 2007 9:11 PM | Reply | Permalink
The problem with HR676 is that it outlaws private insurance. Easier, I think, to buy out private insurers with minimal initial disruption, than to try to outlaw them, either immediately or after some years. Once the bulk of the industry is public domain, there will be little economic incentive for large-pool private insurers anyway. But if a few luxury-class insurers do pop up and pose a problem for the larger pool - buy them out, too.
Eminent domain buyout solves many problems, it seems to me.
Why Americans are more comfortable with a few greedy individuals who own way too much and answer to no one, to having the entire public owning the same things with democratic control and accountability, is beyond me. Maybe it's because we don't really take seriously that stuff about "government of, by and for the people," "consent of the governed," and so forth. I, for one, take it very seriously indeed, and I'd like to see it a full reality in my own lifetime.
As they used to say in the intro to "the Six Million Dollar Man:" we can fix it - have the technology...
June 1, 2007 9:22 PM | Reply | Permalink
What makes you think medical researchers decide much of anything?
Besides political science, the misapplication of statistical theory tends to be the dominant decider of what even gets to market.
African sleeping sickness (trypanosomiasis) is a kind of brain rot that is invariably fatal. An Americas form is transmitted by the kissing bug. You definitely do not want this bug to fall on your lips or in your mouth. After the kissing bug sucks blood from the mouth or lips of his victims, defecates and departs; Trypanosoma cruzi may emerge from the feces to enter the open wound left. Trypanosoma then follows a path to the brain of the victim where it does its damage.
While Bill Gates was bragging at the U.N. that his millions had provided an oral, generally non-toxic cure for the terrible disease, Jim Cramer's Street.com was suggesting that the trials in The Congo were a hoax. The company that was benefiting from Gates' donations was arranging the clinical trials run by a French company that specializes in such an imposing task while under terrific assault by the hedgies. Cramer brags about having started fictitious rumors to damage the price of stocks he was shorting when he was a hedge fund manager. Apparently it is not easy to shake old habits.
Trypanosomiasis is of interest to norteamericanos because not only are there immigrants here from the tropical countries of Central and South America with the disease but it is thought to be a threat to the blood supply. A handful of Canadians were thought to have contracted Chagas' Disease from blood transfusions. There is one odd report that dogs in Oklahoma are sometimes victimized by Chagas' Disease.
Oh BTW there is no evidence that Bill Gates' drug will do anything for Chagas' Disease. The company sponsoring clinical trials is too busy for now with african sleeping sickness trials in The Sudan, Angola and The Congo. Be delighted if Cramer took a field trip to see if it is a hoax on Gates or not. In the meantime, those suffering brain rot in this country will just have to suffer the fate of becoming wingers.
Best, Terry
June 2, 2007 3:56 AM | Reply | Permalink
The American economy has a history of transformation. The makers of buggy whips had to (and did) find something else to do after the automobile was invented. America used to be a nation of farmers. Now, about one percent are. More recently, the manufacturing sector has moved off shore and American job growth has been in the service sector.
What is so sacrosanct about the insurance business?
The inefficiencies associated with the chaos that is the American Health Care System eat up 30% of our health care dollars.
Health care is too expensive to accomodate a make-work program for insurance companies. Workers in the insurance business will, like so many others throughout our history, need to find something else to do.
Fortunately, there are plenty of other things that need doing.
June 2, 2007 6:02 AM | Reply | Permalink
I am very appreciative of your main point but the statistics can be very misleading if not examined in detail.
For an extreme hypothetical consider there are actual cures of 49% by a drug but no effect on 51%. The drug would then show no benefit at all based on median survival.
Iressa is a prime example of what I am talking about. It failed two Phase III trials in non-small cell lung cancer (NSCLC) and then was approved based on response rate in a Phase II trial despite a "trail of death" in Japan. That was followed by another Phase III trial where it again failed to show extension of median survival. What was happening was the drug had an outsize benefit for a few but little or no effect on others. It seemed rather pointless to me to run the last pivotal trial considering the previous data.
The tyranny of the statisticians is not as complete as it once was, which I think is to the good. Of course, statistical analysis is absolutely essential but should be examined with great care.
Best, Terry
June 2, 2007 7:21 AM | Reply | Permalink
I understand what you're saying about statistics, but unfortunately there are very few cancer drugs that cure anyone (though sometimes people go into indefinite remission and we don't know why.)
And in this case while 10 days was the median for this particular drug, even when it was most successful the effect was minimal. . .
Finally, of course, we need large samples for the statistics to be meaningful and often
manufacturers attempt to get drugs appproved based on small samples (180 people, for
instance . .
June 2, 2007 8:07 AM | Reply | Permalink
repeats above
June 2, 2007 8:09 AM | Reply | Permalink
repeats above
June 2, 2007 8:09 AM | Reply | Permalink
John--
It's not that the insurance industry is so sacrosanct--the problem is that it is so rich, and owns so many Congreessmen (Democrats as well as Republicans.)
I would be delighted if we had a president who was so charismatic that he could come forward and persaude the American public that we need single-payer. But keep in mind that even FDR,who many found charistmatic, accomplished such radical change because things were so desperate--in the Great Depression people were starving and hospitals were in danger of going under because almost No one could pay their biills. And FDR
just barely managed to get the New Deal through.
He was hated by a huge number of Americans.
Short of another Great Depression, I just don't think the American people will react well if we say we want to take the insurance industry public. On the other hand, if we say "we want to give you the choice of enrolling in Medicare or keeping private insurance--and we're just asking private insurers to compete with Medicare in
a fair way . . ." that should seem reasonable to most people. Meanwhile, Congressmen who receive handsome contributions from the insurance industry will have a hard time explaining why they are against that.
June 2, 2007 8:57 AM | Reply | Permalink
Consider how you frame FDR, the only president elected 4 times, as "hated by huge numbers of Americans". Well, sure, a huge number of Americans can still be a minority. Consider the 45+ million without health care access. That's a "huge number of Americans" too.
Hillary was in town yesterday and she got terrific local TV coverage of her visit concerning giant healthcare systems and their giant IT programs to automate medical records. Very cool. Very high tech. Very cost saving for giant healthcare systems who provide care to those who are well employed and well insured and no one else.
Hillary made very, very clear that she is NOT for "big government". Oh, no not Hillary. We did NOT see Hillary being filmed at the nearby county hospital, one heck of a great hospital by the way, and struggling as are we local property tax payers with how to continue to be one heck of a great hospital and still serve the needs of those unable to afford health care and those footing the bill for the taxes to pay for both quality and care.
No, Hillary did not get near the poor or the public and she did not get near my property tax problem and she did not tell me one thing about health CARE.
But I know she's made a friend with a huge private healthcare company in my state and then want on to a private country club where tickets costs $1000 and up. The local paper covered the private healthcare visit on the front page of the local section but any reference to universal care was buried on page B7 and tossed off by the Senator as a secondary issue that seemed to have no connection whatever with the focus of her visit.
So no, I'm not "unified" on anything because whatever problem most of the candidates are trying to solve, it appears to be almost entirely concerned with their campaign contributions and framing themselves to the right of center.
June 2, 2007 9:12 AM | Reply | Permalink
Obama Campaign Elaborates
After Sen. Barack Obama released his health care plan on Tuesday, there was a flurry of blog reaction, led by The American Prospect’s Ezra Klein and The New Republic’s Jonathan Cohn – both of whom argue that Obama’s plan falls a step short of achieving universal coverage.
But the Obama campaign is further elaborating on the plan, and stating otherwise. Over at the Campaign for America’s Future blog, Obama ’08 health care adviser and Harvard economics professor David Cutler posts that, "All Americans will be covered automatically under this plan. And the resources are set aside in the plan to do whatever is necessary to guarantee affordable coverage for every American."
Roger Hickey, Campaign for America's Future www.ourfuture.org
June 2, 2007 9:44 AM | Reply | Permalink
Mercedes:
Thanks for the reply - and the candor. It's pretty clear that any health care proposal with a chance of passing must accomodate the bribery and extortion currently asserted by insurance corporations.
I understand the rationale behind your "realpolitik" position.
But doesn't it make you mad?
June 2, 2007 10:17 AM | Reply | Permalink
Maggie, not Mercedes. My apologies.
June 2, 2007 10:20 AM | Reply | Permalink
For sure. Cancer is very bad.
But I can remember a room of doom in a hospital I passed by for a couple weeks when I was in college where parents brought their children with juvenile leukemia. At that time the diagnosis was a death sentence but there were those hoping for a miracle. The miracle happened.
I have always hoped the miracle might have occurred for some of those children and their parents, who were treated very badly those days. Some would wait all day and then be told that maybe tomorrow a doctor might be able to see them.
That happens without treatment as well.
Not so.
Large samples are required when a treatment has a minimal benefit or is simply non-inferior.
But a large benefit can easily be statistically significant with a small sample.
There is no doubt that the FDA loves large samples with standard treatment - and that is the problem. I loved Obama's bill directed towards tailored treatment. The FDA hates novel treatments.
Best, Terry
June 2, 2007 12:12 PM | Reply | Permalink
In an ideal drug testing world, Phase I trials, which, again in ideal terms, give usually a single dose to healthy volunteers, to determine immediate side effects and the concentration achieved in the body by a dose of a given size. For certain diseases where some patients have run out of established therapeutic options, diseased patients may receive a Phase I drug. Generally, Phase I trials are on tens or low hundreds. They are intended to do a preliminary safety assessment and also give data on pharmacokinetics and pharmacodynamics, but not therapeutic efficiency.
Phase II trials, again in an ideal world, would typically be in one center, with perhaps several hundred patients. This stage does look for evidence of efficiency.
Phase III is multicenter, ideally with low thousands of patients. Not only does it look for safety and efficacy, but that different treatment teams can reproduce the results.
The challenges of small samples
These ideals, however, assume that an adequate number of volunteers are available, so the trials have statistical significance. If the disease in question is rare, and the treatment falls into the "orphan drug" category, it may be extremely difficult to get a significant sample.
What should be done in such cases? Not allow it on the market? Allow it with extreme warnings? I don't suggest that I have an answer. What's yours?
Risk-Benefit tradeoffs
Are there different standards for the risk-benefit of the drug? If so, how do we quantify this? For example, it would be reasonable to require more significance from a drug likely to be widely used for a minor condition, such as an antihistamine for allergic rhinitis. An antibiotic that works against vancomycin-resistant Staph. aureus, a drug that may slow progression of amyotrophic lateral sclerosis, or an anticancer drug for glioblastoma multiforme (generally consider the worst possible), logically has a different standard for approval.
Orphan drugs for diseases that may not be quickly lethal, but result in poor quality of life, are an intermediate category.
Phase IV: Post-approval surveillance
When a drug for a reasonably common disease is approved, it is likely to be used by millions of patients, obviously a more significant group than anything in trials. Phase IV, Postmarketing Surveillance, comes up here.
The case of Seldane (terfenadine), the original second-generation, nonsedating antihistamine, illustrates the strengths and weaknesses of Phase IV, to say nothing of the earlier phases. Seldane was thought to be so safe that the manufacturer was close to having it approved for over-the-counter sales.
Shortly before it went nonprescription, a cluster of cases of it causing a rare and fatal heart arrythmia, torsades de pointes, was documented. I don't think anyone anticipated this. Since it was for a minor disease, effective if sedating alternatives were available, and safer nonsedating drugs were in the pipeline, no one seriously argued against it being pulled completely from the market.
Informed consent vs. hype
COX-2 inhibitors such as Vioxx definitely are hazardous, but I believe it is appropriate to have one still on the market (Celebrex), while we work to understand why these cause a greater incidence of heart disease. COX-2 inhibitors, in certain patients with arthritis and other painful diseases, are the only drugs that give a reasonable quality of life. I believe patients in that category should have the right to take the risk, to get the benefit, with fully informed consent.
It does bother me that there is direct-to-consumer advertising of Celebrex, which has to be considered a last-resort drug. The ads don't give me a sense that it is in that category. Everything they say is literally true, but they lack context.
Another model for specialized drugs
Perhaps some of the more risky and specialized drugs might be handled as are a number of drugs for parasitic infections essentially absent from the US, but that a patient might contract while traveling. No drug manufacturer could make a business case for gaining US approval of these pharmaceuticals.
The Centers for Disease Control (CDC), however, maintains stockpiles of a number of such drugs, some imported from foreign manufacturers and some made under government contract. A physician needing them can call a 24-hour number and get a supply, and CDC epidemiologists get good data on normally non-US diseases. There are some diseases that could spread in the US, but just have never done so.
CDC also has contracted for manufacturing of other drugs that were long off patent, but for which there was a clinical requirement. Streptomycin and sulfadiazine can be effective in tuberculosis treatment, but had gone out of commercial production. CDC acted to fill the gap. Some old antibiotics, almost gone from the market, are useful for infections we are encountering in Iraq and Afghanistan -- luckily, colistin still was in limited commercial production.
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 2, 2007 3:07 PM | Reply | Permalink
These ideals, however, assume that an adequate number of volunteers are available, so the trials have statistical significance. If the disease in question is rare, and the treatment falls into the "orphan drug" category, it may be extremely difficult to get a significant sample.
Orphan drug designation is often available for very common diseases with connivance - er, cooperation of the FDA for treating a cut-out segment of the population as long as the number does not exceed 200,000 annually.
Truly rare diseases may indeed present a problem in recruitment but I think it is generally more a matter of profiling and public relations than an actual shortage of patients.
Again very small samples may have excellent results if the benefit from the drug is large. Admittedly the FDA is averse to accepting small samples but statistical theory adjusts for the sample size in attempting to eliminate chance.
What do you think of approval of a drug recently without any testing for efficacy for treatment of a disease that doesn't exist?
The disease, of course, is the feared pandemic bird flu but much the same is true of, say, ebola which does exist. I would be glad to volunteer Cheney but he is probably as unwilling to volunteer to be infected with ebola as he was to be drafted for Vietnam.
Best, Terry
June 2, 2007 4:10 PM | Reply | Permalink
Are you referring to an indication for oseltamivir ?
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 2, 2007 5:31 PM | Reply | Permalink
Best, Terry, I really don't understand your point, and I confess I have never heard of Trypanosomiasis, although it sounds horrific. Are you saying that Bill Gates is a fake, and really doesn't care? Did he say the drug treated Chagas Disease?
What does this have to do with universal health care here in our country? I know you tied it to the question about how drugs are approved for dispensation, but I disagree with your point.
It will always be a problem to decide who gets what therapy, and there are ways of dealing with that issue that work globally, but when it is "your daughter" they become painful and heart-rending.
Decisions about complicated, expensive therapies must be based on providing them to those who can actually benefit from them, and that should be the final arbiter if we have limited resources and there are ways to evaluate this with very high accuracy (I have written about this extensively before, for example, APACHE) I agree with Maggie wholeheartedly that many new therapies are compared to placebo rather than existing therapies to give a false impression that the newest, most expensive (and least known) MUST be better.
That said, my impression of Bill Gates is that he is a man of enormous wealth, trying to make the world a better place; not someone who is trying to get wealthier by backing fake drug trials. Do you have another take on him?
Jan
June 2, 2007 5:42 PM | Reply | Permalink
Pretty much the precise opposite.
The Bill and Melinda Gates Foundation had donated over a billion dollars into fighting tropical diseases and a few months ago added more with the pair dedicating the remainder of their lives to the cause. That inspired Warren Buffett to dedicate most of his considerable fortune to the cause.
It would take a rather pathetic bunch, to say the least, to denigrate that sort of action don't you think?
One of the diseases that the Gates Foundation might truly have funded a cure for is african sleeping sickness, which is one form of trypanosomiasis.
Jim Cramer and his Street.com were late to the party in attempting to profit from a wild bear raid on a commercial enterprise that was receiving funds from the Gates Foundation but made the most spectacular and false charge of all under the authorship of Adam Feuerstein; to wit, that the brag of Bill Gates to the UN may have been the result of a hoax. Even Cramer's fine crew was not up to attacking Gates personally.
I asked the CEO of the company if there was any truth to the odd claim by a flack hired by the company that its drug was not effective against Chagas' Disease, an Americas form of trypanosomiasis. He told me that there had been no research of any kind in that regard that he was aware of and had no idea where the claim came from. There simply were not funds available for any research. It obviously is of no little consequence for the victims.
So why the hell would the FDA, or possibly the EMEA in Europe, be asked to approve a drug for treating a disease resulting from the bite of the tsetse fly in tropical countries of Africa?
Because those coutries affected generally have no approving authority. The Gates Foundation would not only pay for the trials but then was expected to pay for distribution of the drug, though it is possible other charitable groups, private and/or governmental, might pick up the tab.
Only tangentially.
It has to do with research and development of drugs in this country.
What is it you disagree with?
????
The rule is that a control for a clinical trial must have at least the standard of care provided. It is only possible to have placebo-controlled trials when the standard of care is observation only.
Pentamadine is the standard of care for african sleeping sickness. It is an injectable with terrible side effects that themselves can even be lethal. The Gates drug is an oral version that is so mild that it is being tested as a prophylactic against malaria for visitors to malaria endemic regions.
I suppose a trial of, say, an acne medication could include a placebo control. Some stages of cancer can include a placebo arm though it is quite rare.
I suspect I would be more likely than Maggie to think some drugs should be approved for marketing.
Provenge, the vaccine for treating prostate cancer, failed every endpoint in its pivotal clinical trial, most notably time to progression. But later follow-up and certain analysis showed it increased survival. The FDA, rather predictably, refused to approve a generally non-toxic drug despite the vote of a panel of experts. The general result of this is protection of Big Pharma's monopoly on older, more toxic treatments and enormous additional costs for small innovative biotechs, not to mention greater pain and earlier deaths for patients.
Naderites, along with the political scientists at the FDA, are the best friends Big Pharma has in my view.
(BTW I don't pretend I have gone into the arguments for and against approval of Provenge in any depth. This is not the place for it. I accept that there are valid scientific arguments against approval.)
Best, Terry
June 3, 2007 12:10 AM | Reply | Permalink
John,
Yes, it does make me mad, but I've been mad about the control lobbyists have over our
health care system for a long time.
Now,I want to get even--and I think we have a good chance.
June 3, 2007 8:35 AM | Reply | Permalink
Howard-
In my ideal world, studies of "orphan drugs" (that work for a small group of patients, usually suffering from a rare disease) would be done by NIH or another government agency that has no particular interest in how large the market is).
Finding enough patients for good clinical trial is especially difficult if it seems that the FDA is about to approve the drug--or has already approved it. People don't want to go into a trial and take the "risk" of getting the placebo because they assume (wrongly) that the new drug must be better--because it is newer.
For this reason I think it is a good idea to keep these drugs in clinical trials until we are quite certain that the benefit outweighs the risk, long term. That way, the small number of people who need the drug can enroll in the trials, with a chance of getting the new drug--and just as importantly, having the chance to help advance research on their disease. Hopefully their doctors can explain to them that We Just Don't Know whether they will be better off if they get the new drug or the placebo. (The majority of drugs that make it to phase IV clinical trials utlimately fail.But people assume that if it made it to phase IV, we must be 95% certain that it works. A lot of this is Wall Street hype--stocks double when it is announced that a drug is in phase IV . . .)
Keeping the drug in clinical trials is also the best way to make it clear to patients that they are taking an experimental drug.
The only reason to rush a drug out of clinical trials and into the marketplace is because the manufacturer (and Wall Street) wants to begin reaping the profits of selling it to as many people as possible (even those who don't need it).
I agre with you about Cox-2 inhibitors. They are very useful for a small group of people who cannot tolerate the older painkillers. But they should not be advertised direct to consumers because those ads inevitably try to make viwers feel that this is the best pain-killer for everyone. It's a scandal that Celebrex is still advertised that way.
Another way to get large samples of patiets for clnical trials--not just of orphan drugs, but of all drugs--is to go outside the U.S. We've begun doing this and it makes clinical trials much more affordable. The cost of running a trial in Singapore, or India is much less. But we do have to be careful that we're not rushing to large-scale trials of dangerous drugs--and using people in other countries as guinea pigs. We should test on patients outside the U.S. only if we would be willinig to test the drug on Americans.
Finally,you're right, the CDC does invaluable work in these situations. Another example of how, when it comes to healthcare, certain things are better done agencies and institutions that are not thinking about profits.
June 3, 2007 8:59 AM | Reply | Permalink
Terry--
The majority of FDA trials of new drugs are against placebo. As Merrill Goozner pointed out on GoozeNews in December 2005:
"When industry has exclusive control over studies of its new drugs and medical devices, the most important questions usually do not get asked.
"Most trials aimed at gaining Food and Drug Administration approval for a new product compare it to a placebo. Instead of asking whether it is better than what is already out there, they ask if it is better than nothing. As often as not, it is. In some cases the clinical trial protocol designed by industry-funded researchers compares the new drug to a rival drug but at doses designed to put it in the best light. That was the case with Vioxx, whose original trial compared it to high doses of naproxen to show that it caused less stomach distress."
As for Provenge, I'm afraid it simply isn't true that "later follow-up and certain analysis
showed it increased survival."
I realize that you noted that you don't know much about the research --but then how can you say analysis "showed it increased surival? Read the transcript of the panel hearing. There was no evidence that some improved survival was due to anything more than "chance."
Finally, see Merrill Goozner's post today with an excellent suggestion for reforming drug trials (http://www.gooznews.com/archives/000717.html.)
June 3, 2007 9:20 AM | Reply | Permalink
Maggie,
Aside from having worked on 21CFR11 tools and some bioethics issues, I've been a patient, for over 10 years, in a long-term cardiac followup program at NIH Clinical Center. This hasn't involved drug trials except some contrast agents for ultrasound -- a large part of what they use me for is seeing "normal" heart disease with new imaging techniques. Weird things always happen when I am admitted for inpatient studies; I'll avoid the at least R-rated stress echocardiogram, and merely mention that one occasion had half the team baffled and the other half in hysterics. They were evaluating the new Biosense technology for evaluating stunned versus infarcted myocardium. The fellow performing the procedure is English, and, somehow, our comments drifted until we were describing his mucking about inside my heart in terms of the Monty Python Blue Parrot skit. (I always try to stay awake and alert during procedures).
There are a couple of variants here. One is the "compassionate use" protocol, where non-study patients' physicians can apply for use of a still-experimental drug when they make the professional judgment that it may be the only chance for the patient. This is probably most common in AIDS therapy, where the patients tend to be exceptionally well-informed
In fact, there is a mechanism in place for handling what would reasonably be considered orphan drugs: the antimicrobial, mostly antiparasitic against tropical diseases, drugs that physicians can request from CDC.
Maggie, don't get me started on direct-to-consumer advertising, even for nonprescription drugs. As you mention, the typical ad tries to convince people that the advertised drug is the best drug.
On my medicine shelf are aspirin, acetaminophen, and naproxen (sometimes ibuprofen) tablets, along with capsaicin cream. Icepacks and heatpacks are on hand. I don't say this would work for everyone, but I have enough knowledge not only to say there is no single best over-the-counter painkiller, but that all the approved ones have preferred indications.
It's even more true that there may be several significant choices among prescription drugs. Before prescribing COX-2 inhibitors, it's reasonable to have tried aspirin and perhaps other salicylates, acetaminophen, nonspecific COX inhibitors (NSAIDs) including at least three classes, and tramadol. If one gets away from opioid phobia (yes, tramadol is technically an opioid but is not abusable or controlled substance), I would consider at least codeine and some NSAID less risky than a COX-2 inhibitor.
I hope I am consistently doing what I do and what I say. I'm taking about 15 drugs at present, and may well add two more, and change one. The indications for every one of those drugs were specific, discussed at length, and for a specific indication. In some cases, at my suggestion, I went back to an "old" drug from the "newest and greatest", in a successful attempt to avoid certain side effects.
Incidentally, I will pass along something that most practicing physicians will greatly appreciate: everyone should keep a list of the drugs they take, including over-the-counter agents, herbals, supplements, and other alternative medicines.
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 3, 2007 9:29 AM | Reply | Permalink
I didn't say that at all, Maggie.
I said this wasn't the place to discuss the competing analyses of the data. Recall that the expert panel overwhelmintly recommended approval of Provenge.
Essentially the objection to the analysis offered is an estoeric one; i.e., that the protocol did not include survival as an endpoint and did not specify the type of statistical analysis to be utilized.
You have the bizarre case of Provenge failing to gain approval because it failed to meet a primary endpoint of a marker for survival while it clearly increased survival.
BTW there is no substantial safety threat from cancer vaccines as there is from most other treatments and they offer the chance for outpatient treatment.
Canada approved Melacine, a melanoma vaccine, that never had a chance of approval by the FDA. It was essentially based on quality of life issues. The actual results of the first pivotal trial actually had lower survival of patients from the rather crude vaccine as compared to the very toxic Dartmouth Protocol though the difference wasn't statistically significant.
I accept your claim that most clinical trials match a drug against a placebo but restate the rule that patients in trial with a life-threatening or other serious diseases must be given standard of care. With cancer that means that a placebo-controlled trial would only be possible if standard of care is observation only. I presume a new headache powder would have no such difficulty.
Best, Terry
June 3, 2007 9:48 AM | Reply | Permalink
From your Goozner link:
For sure. Morals doesn't seem of great importance with these folk.
Would be nice though for reformers to address the incredible costs and inefficiency of clinical trials that are ruled by political scientists given the status of divinity.
Clinical trials by their very nature are beastly affairs that some wonderful day may become obsolete through the advance of science and - ahem - math.
A math professor - and diabetic - asked the CEO of a company developing a continuous glucose monitor why the company was testing its device as if the monitor was a periodic pin prick when the possible benefits were so much greater. "Because that is what the FDA demands," was the response. "That is what they know and are comfortable with."
Such is the problem of dealing with hidebound idiots, who write their own rules and are mostly secure in their empire.
Best, Terry
June 3, 2007 10:18 AM | Reply | Permalink
From argument by FDA biostatistician Bo-Guang Zhen, Ph.D:
http://www.psa-rising.com/med/immun/provenge--fda-zhen.html
Not chance at all, Dr. Zhen. :-)
Please note that Zhen did not say that analysis precluded a survival benefit but rather that results and statistical analyses can be fudged to prove a benefit when benefit is only due to chance.
In other words, instead of addressing the data, the FDA attacked the lack of adherence to the scientific method.
The issuance of an approvable letter shows the FDA was not denying a survival benefit but rather was not convinced.
Best, Terry
June 3, 2007 10:41 AM | Reply | Permalink
I'm not sure the glucose monitor company is acting correctly. Medical device certifications are handled differently than drug certification. Under FDA 510(k) rules, devices are categorized as to risk. A cardiac pacemaker would be a Class I device, while a passively recording information system capturing data otherwise available might be Class III. There are also classes considered not requiring premarket approval.
I'm involved with some clinical information systems that are sufficiently complex that we may be in Class II.
If that continuous glucose sensor was directly controlling an insulin pump, it probably would be Class I. My educated guess is that if it's purely used as a more convenient (and therapeutically superior) replacement for fingerstick monitors, it's probably Class II.
While I haven't been involved in a 510(k) certification of a Class I device, for the lower classes, the requirement for approval tends not to be a classic, 21CFR11 clinical trial, but rather some formal functional equivalence testing verified by the FDA.
I'd note that the 510(k) FDA people with whom I've worked are diligent, but also are extremely professional. I never had an adversarial feeling from them, but a more collegial one about protecting the public being our common goal.
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 3, 2007 10:44 AM | Reply | Permalink
Once again, we have gone from a broad call for unity (though not one that would have us even unite on a philosophy) into an arcane discussion, in this case esoteric debates on how to conduct clinical trials.
CBS did the rare thing last night, OK it was Saturday a good place to bury the issue -- they broadcast a report on rural women who have no access to health care of any kind, the skyrocketing (Russian level) infant mortality rates, and the recent 20% cut in Medicaid roles. These women have no clinics, no access to transportation, and insufficient literacy to navigate the bureaucracy and forms that might qualify them to receive services, if there was a clinic to deliver the services. Hence, their children die.
Meanwhile, Hillary is off framing herself as a healthcare wonk discussing the attributes of electronic medical records.
Could we put the horse before the cart and rally around the idea that every American should have the right to have a medical record, i.e., access to primary care - and I don't mean after they've filled out enough forms and passed enough entry barriers to qualify them for Yale.
June 3, 2007 10:58 AM | Reply | Permalink
My apologies, Terry- I mis-interpreted "don't pretend I have gone into the arguments for and against approval of Provenge in any depth." to mean that you hadn't read about the pros and cons in depth --when in fact you meant you hadn't written about them in depth in this post.
Still, I have to diagree with your reading of how the panel's "experts" voted. There were just two people on the panel who specialize in prostate cancer--they both voted against the drug. Most of the others on the panel were not even oncologists.
The two experts pointed out that it was only in an "ad hoc analysis," after the two trials failed to shows benefits in slowing the dieases , that the manufacturer went back and and said "hey, look more people survived in the group that took provenge."
This could have been for any number of reasons. First, people in the control group suffered more soft tissue and bone disease--which could be why they died sooner. (Because the study was not designed to compare survival, the manufacturer didn't worry about making sure the two groups were equally sick.) Also, the placebo was not inert--so it might have contained something that caused more deaths in the control group. Finally it was a very small sample, so the fact that a few more people survived may well have been "chance."
In addition, the people in the group who took Provenge were 3 times more likely to suffer strokes. Does this mean provenge causes strokes?
We don't know. Because the sample was so small,this too could have been simply chance.
Finally, a few of the people who took provenge lived a few months longer--but what about their quality of life? The company said "we didn't look at that" Of course they didn't. Quality of life for late-stage prostate cancer patients during last few months before death is often pretty horrible. The pain becomes extreme as the cancer moves into the surrounding bones.
June 3, 2007 11:19 AM | Reply | Permalink
repeats above (sorry! lead thumb)
June 3, 2007 11:20 AM | Reply | Permalink
canceled repeats above
June 3, 2007 11:22 AM | Reply | Permalink
Thanks, Bluebell, for pulling things back to the right track. (I hope it works!)
Jan
June 3, 2007 11:48 AM | Reply | Permalink
Thank you very much. I am as guilty of transgression as anyone.
Indeed the lack of adherence to the scientific method was exploited to the fullest by opponents. I have no disagreement with an obvious fact.
And the pain itself can kill.
As best a fading memory can recall from years ago pain reduction was a secondary endpoint that failed statistical significance. Quality of life is a selling point for cancer vaccines but of little consequence to the FDA. Theoretically quality of life alone could gain approval but I am told it would be most foolhardy to attempt it with any cancer drug. Such succeeded with a very primitive cancer vaccine in Canada.
A doctor/mathematics Ph.D. reported that 70% of men 70 years old have prostate cancer. Kind of chilling for us 70-year-olds. He is trying to sell, among other things, biomarkers that would distinguish between aggressive and slow-growing cancers as well as benign growths without surgery. I am not terribly anxious to start wearing a diaper again to avoid the possibility of another kind of pain.
A math lesson that some might find amusing and possibly even informative:
http://www1.investorvillage.com/smbd.asp?mb=4856&mn=74&pt=msg&mid=2217372
Best, Terry
June 3, 2007 12:13 PM | Reply | Permalink
With the disclosure up front that I build things in this area, might I also suggest that every American healthcare provider has a right to the tools that will allow them to create electronic healthcare records without adding to their workload? Might I also suggest, as has the Institute of Medicine, that such devices also provide error-checking, so a clinician has immediate warning of a drug interaction, or, if they so choose, get drug recommendations and the evidence supporting the recommendation?
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 3, 2007 12:30 PM | Reply | Permalink
Howard,
Don't the 510(K) rules only apply to modifications of existing devices?
As best I understood the process, approval would require a modification of drug approval without the same stress on safety.
The monitor was initially targeted at intensive care where patients, not just diabetics, would have automated monitoring of glucose levels. At some future time, a monitor was to be worn by diabetics.
Whatever the case, the ultrasound device ran into a slew of problems after its prep for painless pediatric vaccinations did not sell. One wag suggested junkies as a far more lucrative market that would not require FDA approval.
Best, Terry
June 3, 2007 12:34 PM | Reply | Permalink
No. 510(k) applies to new devices, although the FDA staff can specify, especially for Type I devices, that clinical trials, not just equivalency tests, are required. Even for a Class I, such as my pacemaker, the clinical trial requirement is more to establish functional equivalence with other pacemakers, if it's not brand-new technology.
I can speak from direct experience only from the perspective of information systems that accept the data from devices connected to the patient, and do analysis, sound alarms, etc. The FDA asked us to come up with a set of functional test cases, and we would need to demonstrate compliance. For example, we might need to show that a pulse oximeter caused an alarm to trigger after the trigger point was set to less than 90 percent saturation. We had to show that a graph of saturation versus time matched one based on visual observation of the display at the patient bedside. We had to show we would generate an alarm on other devices if we stopped receiving signal, and to distinguish between a loss of signal and a significantkly low level.
Apropos of junkies, when Michael Halberstam, David's brother, was my physician, he told me that junkies were the best people in the world to find veins. He generally drew blood himself, and was quite good at it. When I commented on it, he referred to the fairly recent middle-class heroin epidemic in DC, and said when he looked, in shock, at the veins of a junkie patient, when the junkie asked for the syrings, Michael would hand it to him, and then admire the technique in drawing blood from a vein he couldn't even find.
I cannot help but share another story. As you know, there's more and more use of skin patches for continuous administration of a drug. Fentanyl patches are the standard of care for chronic pain that requires opioid therapy.
Other drugs, of course, are administered with patches. I read a case report of an ER patient who had attempted suicide with nicotine patches. The doctor described him as a patchwork quilt that was explosively vomiting. No real danger to life, but embarrassment as well as unpleasant symptoms.
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 3, 2007 12:50 PM | Reply | Permalink
FOREIGNID: 253495
FOREIGNPARENTID: 0
FOREIGNCOMMENTERID: 16231
AUTHOR: Maggie Mahar
DATE: 06/03/2007 06:38:39 PM
June 3, 2007 6:38 PM | Reply | Permalink
Bluebell,
I agree that the discussion of drug approval got a little arcane--and I hope people who weren't interested just scrolled down to pick
up the thread when it became interesting again.
At the same time, one of the things I like about tpmcafe is that it attracts different types of people with a variety of interests and areas of expertise.
And if I have something useful to say, I try to respond to these different points of view.
Finally, corruption in the drug approval process is important to universal health care because if we don't wring out the waste (millions spent on ineffective over-priced drugs), we won't be able to afford universal care.
But I understand completely why everyone isn't equally interested in the details about Provenge.
June 4, 2007 2:34 PM | Reply | Permalink
Maggie,
The FDA did put out warnings about sleepwalking and other automatic behaviors for Ambien and other sleeping pills. Did they forget to mention sleep-posting? :-)
--
Howard
*equal opportunity offense to both extremes*
"Those who cannot remember the past are condemned to repeat it" [George Santayana]
June 4, 2007 3:21 PM | Reply | Permalink
repeat
June 4, 2007 4:34 PM | Reply | Permalink
repeat
June 4, 2007 4:35 PM | Reply | Permalink