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Tag: Pharma

PHARMA: Rost loses, or wins?

There’s an amazing place in the world called the Chinese War Memorial. It’s in Taiwan, and it recounts the tale of the Chinese Civil war from the nationalists side, ending with the glorious retreat to the Republic of China, while that little revolutionary difficulty is still going on in those other small Chinese provinces over there on the mainland. It may well be the only place where the losers wrote the history books!

I’m not sure whether Peter Rost’s suit against Pfizer/Pharmacia is in quite the same league, but thanks to the power of the blogosphere we have the official version “Suit dismissed, Pfizer wins” in Brandweek and then we have Rost’s version—we lost on a technicality that will be overturned by the same judge and so we won really. (This is from an email he sent out to his list)

We have a GREAT Qui Tam Court decision, which will help us move the Genotropin qui tam case forward. For me personally, it is a complete vindication of the false accusations Pfizer repeatedly made against me in the press. As you may remember, Pfizer had filed a motion to dismiss my complaint and had made four arguments, three of which the Court eloquently rebuked and the fourth is a technicality which will be relatively simple to handle based on additional information.

Apparently the key question is whether there is a patient database somewhere in the bowels of Pfizer that has patient identifiers that identify the specific program. Or not—as I assume Pfizer thinks. And I guess in the next round we’ll find out who’s telling porkies and who’s not.

Meanwhile Rost has a party coming up on his blog this Sunday. I won’t spoil his surprise, but you might get somewhere in guessing what it is if you look at the title this Spot-on column I wrote a while back.

 

PHYSICIANS/PHARMA/TECH: A take on the news, sort of

Things we already knew:

Doctors are poor at judging their own abilities. It’s a bit like everyone says they’re a good driver, but that 75% of drivers are terrible.

Merck earnestly believes that it was as pure as the driven snow over Vioxx and never knew that it was dangerous until it took it off the market(who knew about Dodgeball, eh — let alone what Kaiser knew several months earlier).

Little girls don’t really cry tears of stone

Things that I don’t think we did know

Online PHR use is up to 7% by July. Which is about 6% higher than they said it was 2 years ago.

According to the survey, commissioned by UnitedHealth Group and conducted by Harris Interactive ® , only 7 percent of U.S. adults use online personal health records and 35 percent of people surveyed were not even aware this resource technology exists.

PHARMA: Probably another false start from the DEA

The black stone that resides in the chest of DEA administrator Karen Tandy in the place where the rest of us have a heart must have some gravel chipping off today. The DEA allegedly has revised its rules on prescribing pain-killers:

Yesterday, DEA Administrator Karen Tandy said the agency had been wrong in limiting the multiple prescriptions and had made the tough decision to reverse course. She said the DEA received more than 600 comments from doctors, patients and others about its policies on narcotic pain killers, many of them strongly opposed to the agency’s position on limiting refills.

But basically this is a tiny move—allowing multiple prescription refills for those in chronic pain, but only by doctors who the DEA considers not to be in violation of their unwritten laws. After all, 2 years ago—right in the middle of William Hurwitz’s trial when his defense was about to introduce them—they introduced some similar guidelines they’d worked on with pain specialists for two years. So what happened then?  Well given the choice of allowing rational behavior, even according to guidelines they developed and allegedly agreed with, and putting a doctor treating the chronically ill in jail. Guess which one they took?

The agency briefly posted the guidelines on its Web site in 2004 but then pulled them down and disavowed them.

Siobhan Reynolds from PRN is rightly, rightly suspicious

But Siobhan Reynolds, who created the Pain Relief Network several years ago to help defend pain doctors who she said were being unfairly arrested and prosecuted, disagreed and said the new DEA policy has changed little. "Ms. Tandy states here, as she has on many occasions, that doctors need not fear criminal prosecution as long as they practice medicine in conformity with what these drug cops think is ‘appropriate,’ " Reynolds said. "If that isn’t a threat, it will certainly pass for one within the thoroughly intimidated medical community.”

The story is that chronic pain is massively under-treated in this country, and opiates are the most effective way of dealing with that pain. Yet as I pointed out over at Spot-on the mad Calvinists who run our criminal justice system care not a whit. 

PHARMA: Jim Edwards is very smart

Brandweek’s Jim Edwards is very smart and sees through the industry BS very well—almost at a Venessa Furhman level. He probably should be plying his trade on a bigger stage given the rubbish that the science/business reporters of certain national dailies have been writing about health care lately.

His latest is one called, Drug Companies Won’t Sell Sales Reps Short. Jim notices that despite all the pundits (me included) thinking that pharmacos will have to rationalize their sales forces, they haven’t actually done so yet, and don’t appear very keen to do so.

PHARMA/POLICY: New trial for Hurwitz

Excellent news as there’ll be a new trial for William Hurwitz. I’m trying to find out if they’ve released him from jail already. I and my crusty old dad have both contributed to his defense fund, and it looks like it’s paying off. (More on the story here)

Of course in any just society, Hurwitz would be practicing medicine, with the forces of organized medicine at his side protecting him and his patients instead of just turning their backs, and the scumbag DAs and DEA arseholes who put him in jail would be rotting there in his place—and being denied the pain medication that they need.

How about a new trial for Richard Paey now?

PHARMA/POLITICS: Just when you thought it was safe to go back in the FDA toilet

Anti-Abortion Groups are opposing the FDA Nominee over the compromise on the OTC switch for for adults only for Plan B. Robert Steeves, who’s desperately trying to stay dry on what’s a fast receding sand bank for rational Republicans, writes to me to pick out one phrase from the story:

"Amid the political accusations, the FDA is contacting both the anti-abortion groups and their main opponent, Planned Parenthood, to hear their last-minute arguments over the fate of the drug, called Plan B. " 

Robert’s comment: This plebiscite is a first in the annals of NDA consideration and neither medical nor scientific, eh?

Well from this mob of faith-based crooks, what did he expect?  But even by my cynical standards this is going some.

But perhaps we’ve been looking at this the wrong way and instead there’s a new theme here. Forget those expensive clinical trials, let’s do all NDAs American Idol style!

PHARMA/POLITICS: Closing the loop on Plan B

PlanbSo finally we got some resolution to the ridiculous Plan B situation which has helped drag the FDA even further into the mud —F.D.A. Gains Accord on Wider Sales of Next-Day Pill . It will go OTC but only for people over 18.

The drug agency has asked that the new Barr application restrict over-the-counter sales to women older than 18. Girls younger than 18 would have access to the pills only with prescriptions. Over-the-counter pills would be sold just in pharmacies and licensed clinics, the chairman of Barr, Bruce Downey, said.Mr. Downey said the acting Food and Drug Commissioner, Andrew C. von Eschenbach, had assured him in a call that the agency was committed to resolving the Plan B impasse. Barr had hoped to sell Plan B to women and girls of all ages, Mr. Downey said, “but I don’t have the ability to get all that I want.”

Of course this is bloody stupid, as women under-18 are those just as likely to be having unprotected sex and the consequences of them having unwanted pregnancies are much greater for them, and for the taxpayer and society, than for older women. And they are far less likely to want to have to deal with the shame and expense of going to a doctor to get a prescription. Plus the solution is unenforceable, because those under-18 will just get their friends to buy it, and they won’t even have the minor benefit of the pharmacist’s counseling.

But don’t worry about them, or the rest of us dealing with teenage pregnancies, Jesus (or at least his "representatives" on the loony right) will be happy. And they’re the ones who make scientific decisions these days.

POLICY/HEALTH PLANS/PHARMA: Part D–a tale of two headlines

Most Beneficiaries Enrolled in Medicare Rx Benefit Satisfied With Drug Plan, Nearly Two in 10 Experienced Major Problem, Study Finds

or if you prefer

Poll shows 80% of those enrolled in Medicare drug plan satisfied

So go ahead and guess which headline came from a non-profit foundation’s news service and which one was from the inhouse newsletter for the trade group for health plans, which of course run the biggest Medicare PDP (Part D plans).

So when is a series of problems not a problem? Apparently if you don’t care much about consumer problems.

34%, of seniors who have used their drug plans have experienced what they perceived as problems, including 18% who described them as "major" problems and 16% who described them as "minor" problems. The experiences cited as problems included having unexpected costs, not being able to fill a prescription at the pharmacy, not receiving an enrollment card and having to change medications because a prescription is not covered. Ninety percent of seniors who experienced minor problems and 55% who experienced major problems feel the issues were resolved satisfactorily. (my emphasis)

So by my math 9% of Part D recipients have had major unresolved problems. Most consumer companies would freak out if they had that level of unsatisfied customers.

But don’t worry, for the $600 billion over 9 years (or whatever mythical number we’re now being quoted is the cost of Part D) that the taxpayer is spending, we’re sure saving all those recipients lots of cash right? Well not quite all—in fact not even most!

Of seniors who have used their Medicare drug plans, 46% say they are saving money on prescription drug costs, while 34% say they are paying about the same as before the drug benefit and 17% say they are paying more.

Oh well, at least the people who the bill was designed to help are benefiting. On Tuesday the NY Times told us that:

The summer revival in the pharmaceutical industry continued as Merck and Schering-Plough, two major American drug makers, reported second-quarter profits yesterday that were well ahead of analysts’ expectations. Medicare Part D, which offers prescription coverage for people over 65, is fueling the profits, as drug makers benefit from new prescriptions and somewhat higher prices for medicines, Wall Street analysts say. The number of prescriptions has risen 3 percent this year, and growth accelerated in June to more than 5 percent, according to a report from Merrill Lynch. Eventually, Part D could fuel a political reaction if prices continue to rise, but analysts expect the industry’s influence in Washington will delay any changes for years.

And the taxpayer isn’t getting screwed any more than they were going to be already in Part D are they? Well there’s this little nugget too

Overall prescriptions are also increasing, according to data from Citigroup and Merrill Lynch. For the year, total prescriptions in the United States are up about 3 percent, but they accelerated in June, rising 5.4 percent over the previous June. Drug makers have also increased prices for many popular drugs and are paying rebates to the private insurers who run the Medicare Part D program that are lower than the 15 percent rebates they paid to Medicaid.

Well at least the market is working—of course Adam Smith might not notice this as being the kind of free market he was thinking about.

PHARMA/POLICY: Medicaid gets screwed over on best price, Ignagni fibbing again.

A little while ago I sat through a webcast starring my favorite factually challenged health plan lobbyist. Karen Ignagni said this about the costs of pharmaceuticals for Medicaid that are now bought instead by the private plans working under Part D:

"I’m hearing shock from (state) Medicaid directors that we’re getting better prices than they are"

At the time I postulated this

Ignagni is either lying here
(or massively overstating the truth from a few anecdotes), or going to
find a few men in sharp suits from the rich part of K street funded by
big Pharma coming down to see her carrying baseball bats.

You see, Medicaid plans get from pharma manufacturers
what’s known as “best price”. In other words if they give a better
price to another customer, they also have to give that price to
Medicaid. Medicaid is still of course buying its drugs for its
non-Medicare dual eligible population. The drug companies know this, so
I doubt that what she’s saying is true. But if it is true that
Ignagni’s health plan members are getting a better price than the
states are, then the states can go back to the pharma manufacturers to
get a better rebate — oh, and also prosecute Pharma companies for fraud
over not giving them best price, as has happened many times.

And today writing in the New York Times Milt Freudenheim has picked on the issue, which he calls  a Windfall From Shifts to Medicare. So was Ignagni telling the truth? Were the prices that Medicaid is now paying for its drugs via Part D lower than they were paying under the best price regime? Well take a wild guess.

Under that program, as it turns out, the prices paid by insurers, and eventually the taxpayer, for the medications given to those transferred are likely to be higher than what was paid under the federal-state Medicaid programs for the poor.

McLellan is also quoting the line that Part D is getting better prices, but the article has a raft of evidence suggesting that the drug companies think they’re doing better, and the states are being asked to return more under the "clawbacks"–the amount they are being billed as they no longer have to provide drugs for the dual eligibles–than if they’d maintained their own programs. Several states are suing the Feds about that.

Meanwhile, I still think that they ought to be able to go to the drug companies and get "best price" for the rest of their Medicaid drugs (unless someone can tell me they have an exemption under the law). Which I guess in the end may make this a wash, if the drug companies have to provide even cheaper Medicaid drugs.

But for now it’s just more evidence that Part D is a windfall for drug companies and health plans, and that AHIP’s President has been caught being extremely economical with the truth. Not exactly news, I know.

QUALITY/PHARMA: Someone’s going to get fired at the DEA for sure

The WSJ writes about a serious scientific study of the hallucinogen in magic mushrooms.  As you might expect virtually all of the participants thought that the sessions had a very powerful effect and 60% of the clinical trial participants said that effect was very positive indeed. But 30% of the cases felt incredibly bad effects, largely increasing paranoia. That’s not much of a surprise—people react differently to different drugs. The researchers are interested in seeing if these drugs (and presumably others like MDMA/Ecstasy) have value in treating psychiatric cases.

What’s amazing is that someone in the DEA signed off and allowed this research. After all, this is a substances banned for hysterical political reasons and, like LSD its synthetic equivalent, no one is pretending that they’re not very powerful. Of course the government does allow equally powerful psychotropic drugs to be widely used and dispensed with a false pretense that somehow their use is morally different.

The main differentiator is of course what the government will allow to go through clinical trials. Now that an approved trial of one class of banned drugs that may have a positive effect has been allowed, how can the DEA justify the continued delays in granting permissions for real trials of another banned drug that we all know has significant medicinal qualities? They can’t justify it morally or rationally or even legally, but they certainly continue to raid medical marijuana dispensaries to justify their existence, their power and their budgets. So when word gets out that someone inside the DEA made a rational decision on allowing a study that counters the drug warriors’ propaganda—well, I’m sure their career is on the outs.

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