THCB

Categories

Tag: Pharma

PHARMA/POLICY: Steeves responds to McGarvey

Ayelish McGarvey is back with a follow up to her piece in The Nation on Plan B, which was the subject of a previous piece here in THCB.  The new piece called Plan B for Plan B explains the weird double application for joint "behind the counter" and prescription status, and suggests that it cannot be signed off on by FDA lawyers. She continues her thesis that this is mostly Galson’s fault. Robert Steeves is not so sure. He writes

There is nothing in the Ayelish McGarvey piece that went unconsidered in my piece.  I think she is wrong on the Galson "acting alone" and apart from Crawford. A new guy just appointed in a ‘acting’  capacity just would  not step out on his own and create this national storm certain to reach the White House.  Give me a break.  This casts Galson as a "suicide bomber" ready to sacrifice self for the cause (a certifiable disqualification to lead CDER if there ever was one). 

For sure, most FDA lawyers would not "sign off" on the distribution scheme, but who says they must. They are not barriers to a decision(unless the decision-maker wants a place to hide) but advisors. This is illustrated by the line authority for the lawyers at FDA coming from the HHS General Counsel, not the Commissioner. Usually, a legal warning that "if you go there, you are on your own legally" is enough to scare any one into a "revise" this policy mode, but it need not be.  Somebody at FDA must have a reasonable rationale for legal support for the policy which neither Barr nor FDA has revealed. However, this overlooks the possibility that the Bushites do not intend Plan B OTC to be approved in any event under any theory. 

As we will see with the State Law workarounds for Plan B, the first "religious right" lawsuit is likely to overturn any state law giving Plan B OTC status under the Federal Supremacy Clause of the U.S. Constitution.  And the same legal challenge is sure to come to any "unconventional" Federal OTC approval scheme like the bifurcated OTC/Rx status pending.  FDA has raised the issue of the under 16 women as a safety problem, so it seems unlikely that it can now go back and "admit error" to permit a legally correct approval.

If State Plan B workarounds were doable, we’d have marijuana, laetrile, and lots of other substances legalized in many states. No one can establish that Plan B is not in "interstate commerce", no matter where it is distributed today. The States work under the police power(denied the Feds??) to protect their citizens. In the past, this has meant a State can more rigorously regulate a drug product, but cannot relax that status. Perhaps the argument will be that a State "must act to provide Plan B to better protect its women and citizens because the Fed’s have failed to do so and . . . . .(this is the tough part).

Barr CEO Bruce Downey says Barr may turn to the States to get Plan B on the market but he is a lawyer and should know all the above. Importantly, I have never heard or seen him expound on his "legal rationale" for this position.  Nor can I understand Barr’s strategy in raising this faux solution unless, like Galson, he has some secret ally that we have not yet heard  about.

As for Hager, thanks to Ayelish McGarvey’s earlier article, we now know he’s a hypocrite or worse.  But I think she fails to understand the basic principle involved in both cases — do not put much weight in what is being said, watch what they actually do.  And FDA has not, and will not, approve Plan B.  The Congress might have a case to legislate the approval if it is to be done at all.

In any event, the interests of science and women’s health are not at the forefront of this FDA decision.

PHARMA/POLICY: More on Plan B and its relationship to the overall chaos at the FDA

A little more about my FDA article from Monday….

Prospect/Nation journalist Ayelish McGarvey, who wrote the article about David Hager, and knows way more about Plan B than I’d ever want to, says that I (and by implication Robert Steeves who’s earlier article on Plan B I lifted for THCB) don’t actually understand what’s really going on with Plan B’s non-approval. She tells the real story in a long comment to my piece over at Ezra’s blog.

Essentially Barr’s first application to make Plan B available OTC was turned down. The delay in approval, over which the three Dem senators are holding up Crawford’s nomination is for a second application in which Barr Labs asked to put Plan B behind the counter for women over 16 years old and by prescription only for those under 16. FDA hasn’t approved drugs in that manner before, and its lawyers won’t sign off. To know more we need to wait till McGarvey’s article comes out (next week), but it’s clear that in her view, Steven Galson, the director of the Center for Drug Evaluation and the surprise signatory to the original non-approval (the one that turned over the 23-4 scientific vote in favor of approval) acted more or less independently from Crawford. It’s certain that he went against the staff scientists advice. This is what it says on the FDA page about Plan B:

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

And the differences between the political leadership of the bureaucracy and the staff are huge. Meanwhile there is a pretty good article which I missed at the time in the NEJM on what happened, and another blog, The CarpetBagger Report, picks up the story from what Jon Cohn wrote in TNR.

On the other hand, I really only wanted to make two points about the FDA.

First, there are fundamentalist loons with an agenda inside FDA (i.e. whoever it was inside FDA who asked Hager to provide a dissenting opinion), or at least those who want to air the fundamentalist loon’s opinions. I can never tell if its the fundamentalist loons using the cynical rightwingers or the other way around, but their views are clearly being heard and acted upon.

Secondly, forgetting Plan B — which in the grand scheme of things is just another story of how screwed up sex education and reproductive health in this country have become — the issue of whether FDA can be trusted on pharma safety overall is still a complete mess. That cannot change unless we get a total change in the current regime at FDA including Crawford, Galson and anyone else favoring either fundamentalist loons or the short term interests of big pharma over full disclosure about drug safety. I know that Ted Kennedy (and by Ayelish’s implication Sens Clinton and Murray too) have given up on trying to fix that, but someone needs to be reminding the American public about it!

And, for the nth time, full disclosure about drug safety may lead to people taking drugs that could be considered dangerous.  Some people might want to take a Cox-2 and trade off pain relief for a higher chance of heart disease.  But the key is that they need to be sure that the FDA is making all the information available — and that’s where it’s fallen down on the job and lost the public’s trust. And in the end it’s better for big pharma to be in a market where the public trusts what the government says about their products.

On another topic, talking of what pharma says about its products, the Washington Legal Foundation, which got DTC ads on TV in the first place, is causing a little more fuss in that arena.

PHARMA/POLICY/POLITICS: The FDA remains in tatters

• 23

It’s time to dip into the murky waters of the FDA once more. This is a classic tale of politics intruding into an agency that should have science as its prime motivator. Here’s the story summarized so far.

The FDA has barely had a full time official commissioner since the start of the Bush Administration. Mark McClellan was officially head for a brief while in 2003, but he barely had time to look embarrassed on 60 Minutes when asked why Canadian drugs weren’t safe enough for Americans before he nipped off to the rather more rarefied atmosphere of CMS — where he’s much better suited.

Meanwhile before, after (and basically during) McClellan’s time at FDA, the acting commissioner has been Lester Crawford. Some cynics have noticed that there are a few clouds over Crawford. He was involved in some pretty close to the wind activities when he was in charge of Food Safety (ironically this weekend, there’s more suspicion about the Administration covering up a second case of Mad Cow).  But more recently there’s been much fuss over both his personal affairs (i.e. was he or wasn’t he abusing his power to forward the career of a female colleague with whom he was having a close relationship) and, much more importantly, about his being behind the non-approval of Barr Labs’ Plan B emergency contraceptive.

Robert Steeves has written convincingly on Why Plan B went down.  Essentially Crawford overruled a scientific committee which voted overwhelmingly that Plan B (an emergency morning-after contraceptive) was safe and effective.  So it won’t go on the market. Of course, any time you hear anything to do with "safety" in reproductive health care in this country, your ears should prick up. There are allegations that information was withheld from the Senate Panel investigating this. Whether that’s true or not, David Hager the physician who apparently has Crawford’s ear and was a one of the few dissenters on the panel, appears to be a certifiable loon. Yup, he attributes all his research skills and influence to God and is not shy about telling the world about it.  However, his ex-wife is not shy about telling the rest of the world about Hager’s at the least inhumane and at most criminal treatment of her — including paying her (at first) and then forcing her into types of sex that many on the Christian right probably think of as against God’s law and should be banned (although they all probably indulge in private…OK that’s my last direct slam on the Fundamentalists in this piece).

At any rate, it’s good to know that the future of contraception in this country is in such stable and rational hands. And overall of course the whole thing is a payback from Crawford to the Christian right for supporting his appointment. 

As a result, three Democrats on the panel are going to hold up Senate confirmation of his nomination even though it got out of committee — even with Ted Kennedy supporting him. (Kennedy says that FDA needs a leader of some kind to remove uncertainty). The real joke is that one of those delaying his vote is an even more extreme member of the Christian right, Sen. Tom Coburn of Oklahoma (ironically like Hager another ObGYN obsessed with sex, although in his case it’s rampant schoolgirl lesbianism) who thinks that the FDA should be printing warning labels on condoms because they aren’t effective enough preventing disease (and of course Coburn probably thinks that people shouldn’t be having sex anyway).

This might all be fun and games in an inside baseball kind of way if the issues at hand weren’t so damn important. Since the Vioxx scandal there is no trust of anything the FDA says about drug safety, and it’s fairly clear that the FDA leadership at least has basically been in PhRMA’s pocket. We’re now even getting whiff of a bigger scandal about the contentious link between mercury and autism. I won’t even pretend to look at the science behind that, but it’s safe to say that the Robert Kennedy article that has reignited this fuss wouldn’t have had nearly so much press if the FDA commanded more respect, and if the allegations that it covered up studies on behalf of the pharma industry — as essentially it did in the cases of Vioxx and Celebrex — weren’t so believable.

The final piece of the puzzle rest with now famed FDA whistleblower David Graham. With maverick Republican Sen. Chuck Grassley in his corner, he is taking aim at the newly appointed FDA safety panel. Essentially, instead of creating an external review board with the power to pull drugs from the market, the FDA has created an internal panel to which insiders like Crawford control all the appointments. FDA needs to be seen to be scientific and neutral, but that’s not happening. For example, the advisory panel that voted to continue sales of Celebrex and narrowly voted to allow Vioxx to return to market was shown to be filled with scientists with drug company ties, and that when they were excluded the tallied votes would have been very different. This may be what big pharma thinks it wants, but it’s not what is good for the country or for that matter for the future of big pharma. We need an FDA that is beyond reproach or politics.

Instead we have a series of government agencies, with the FDA being a prime example, where whistleblowers are needed to maintain standards of honesty and dignity; something our Dear Leader said he was going to bring back to the White House (ha, ha). And the whistleblowers are being treated pretty badly, even if they do have the protection of an influential Senator.  (If you want more look at this article and editorial from PLoS about the treatment of whistleblowers)

Given that there are other Presidential appointments in deep trouble, and that a Supreme Court fight is about to start that will get nasty very quickly, one cynic has suggested to me that Crawford will be confirmed without a vote as a recess appointment. In any event, the politicization of every government agency has now produced a situation where the politicians, the bureaucrats and the industry are conspiring against the public. This is bad for business, bad for health care, and bad for America.

PHARMA: A start-up data success? IMS Health buys PharMetrics

• 2

This one may be a little too inside baseball for some of you, so don’t be afraid to skip it.  However, if you care about pharma marketing, read on.

Yesterday IMS Health said it was buying PharMetrics. PharMetrics is a company that succeeded where my old company i-Beacon, and several others backed rather better, failed in creating a business for longitudinal patient data. What that means is that it linked medical claims and Rx claims data about the same people over time.

Theoretically that tells a drug company whether their drug is getting its "share" within its disease category and also whether its drug is working in reducing medical claims. (You remember that theory about drugs improving care quality and lowering cost?) It’s also supposed to tell a health plan whether its disease management efforts are working, or what disease management plans are working elsewhere, although local rival IHCIS concentrates more on that market. (i-Beacon BTW matched PharMetrics-type Rx and claims data with other consumer data in a very clever and legal way to help score DTC marketing–not that we ever really got the product to market).

PharMetrics gets its data as a by-product of a weird agreement with a tools company called Symmetry Health, and receives data on roughly 50 million people via lots of health plans. From my recall (which is some years old now) they don’t know who the people are (other than having a unique plan identifier so that they know it’s the same person). Therefore they a) don’t have a way of tracking the people once they leave their plan, which presumably makes the data somewhat less robust over time as most people change plans every couple of years, and b) can’t fulfill the pharma marketing wet dream of telling the detail reps which patient at which doctor ought to be on their drug but isn’t. Of course getting to that stage would be unethical, not to mention illegal! But the basic problem with these longitudinal patient data sets is just that. They can tell you what might work in general but cant point your sales people to specific things to do in particular cases because that would mean identifying individuals. Of course eventually if we all get electronic medical records, some organizations which have  legitimate right to do so will be doing that.  In fact Active Health Management, bought by Aetna last month, does just that–but they are then by definition confined to disease management and can’t sell that data to the pharma companies–who are the best market.

IMS Health of course has the "specific" data base on doctors and their prescribing habits, and it’s not only wrapped into telling the pharma sales forces what to do, but is also a direct component of how the sales forces’ compensation is scored. That’s why IMS is the best (and most profitable) franchise in all of information services and why big and small companies (like Arclight, PharMetrics and i-Beacon) continually take a run at them–often with the intention of getting bought.

PharMetrics seems to have achieved that goal. I don’t know specifically how well it was doing but with 75 people and probably $10-20m in revenue, it probably went for around $50m. Of course that’s pure speculation and we won’t know the real numbers till IMS next 10Q comes out, but the main thing is that the VCs who put in $30m over time got out alive.  And who knows, maybe they all did much better, which will of course only encourage others to get into the ring.  And that’s much of the driver behind the grimy little sector of pharma data analysis.

PHARMA: Is Pfizer’s Black Knight on the way out?

• 3

So the slow burn of Peter Rost’s time at Pfizer appears to be picking up. The NY Times reports that he’s essentially been comparing him with the Black Knight (in Monty Python and the Holy Grail) in not noticing how bad his situation really is. But in the NY Times article a couple of interesting things are revealed. It’s already known that Rost sued and beat his previous employer Wyeth in a whistleblower-type scenario when Wyeth was underpaying taxes.  Rost may also be involved in some kind of a whistle-blower suit currently, as according to the Times "Pfizer disclosed that the Justice Department had opened an
investigation into its marketing of genotropin, the growth hormone Dr.
Rost was responsible for selling at Pharmacia". Presumably if Rost was a bad guy in that scenario Pfizer would happily fire him, so it must be assumed that he’s probably a whistleblower or at least neutral.

The whole thing about reimportation is of course ridiculous. In Europe the courts have just ruled that "parallel trading" is legal, and you don’t see the drug industry give up selling its products in Europe because of that. If Canadian imports were legal here, there wouldn’t be that much difference to the current market.  But that’s an old discussion and we know the positions there are not going to change much.

The interesting point is that Rost gets $600,000 a year to do whatever he’s doing at Pfizer, and of course he can’t leave that and get anything like as much anywhere else. Those of you who consider that you’re selling your souls to big pharma/corporate American might wonder whether you are getting your fair share!

Pharma: At last we talk about the issues! By Jib

• 3

For those of us who thought the government would never take health care seriously, there’s finally evidence that people in Washington are starting to get serious.  The latest thought-provoking issue is … Medicaid viagra for sex offenders! 

Apparently up to a hundred sex offenders in New York have been getting government sponsored Viagra through the state’s Medicaid program.  New York Governor George Pataki scored political points at a press conference this morning, blaming the problem on a Clinton-era loophole in the law.  The reference did not go unnoticed.

A story nobody even knew existed 36-hours ago now leads Google News with 617 stories, putting it ahead of Crestor (503), the bird flu (295) and the stem cell debate (137 stories).   

PHARMA: More smoking guns around Plan B’s no approval, by Blunter

If any further proof of the politicalization of the Plan B marketing is needed
(which there is none), this recent FDA Release on the oral hygiene product
should show what should have happened to Plan B, absent any conservative
religious agenda, if the FDA had any substantial concerns about women  under 16
years getting direct access to the product.  And it should underscore that FDA
need not create any new or novel marketing system for Plan B to approve its OTC
use.  Karl Rove makes a very poor  FDA Commissioner, de facto or de jure and
Crawford and Galson should have followed the existing law rather than cede their
responsbilities to a political  campaign.

 

The Food and Drug Administration (FDA) today approved a new prescription
treatment for gingivitis, a common gum disease that affects most adults at some
point in their lives. The Decapinol Oral Rinse treats gingivitis by
reducing the number of bacteria that attach to tooth surfaces and cause dental
plaque. Decapinol is approved for use in persons 12 years of age or
older when routine oral hygiene is not adequate to prevent gingivitis. Decapinol
is not recommended for use by pregnant women.

PHARMA: DTC advertising works; not exactly a revelation!

• 12

So I spent far too much of my life trying to figure out the exact impact that DTC drug ads would have on the exact consumer sub-demographic so that marketing could be refined, and consumer segments sliced and diced.  Turns out that was totally unnecessary.  All you have to do is to get the patient to say the name of the drug in front of the doctor and think that they might have an associated symptom and the doc is only to happy to get them out of the office with said script. 

And it’s good for a five-fold increase in prescriptions compared to patients who don’t ask for it by name. The hidden persuaders don’t need to be that hidden!

PHARMA/PHYSICIANS: Smoking Gun on the Chemotherapy Drug Concession? by Greg Pawelski

• 7

Neil Love, M.D. reports from a survey of breast cancer oncologists based in
academic medical centers and community based, private practice oncologists. The
academic center-based oncologists do not derive personal profit from the
administration of infusion chemotherapy, while the community-based oncologists do
derive personal profit from infusion chemotherapy, while deriving no profit from
prescribing oral-dosed chemotherapy.

The results of the survey show that for first line chemotherapy of metastatic
breast cancer, 84-88% of the academic center-based oncologists prescribed an
oral dose drug (capecitabine), while only 13% prescribed infusion drugs, and
none of them prescribed the expensive, highly remunerative drug docetaxel.

In contrast, among the community-based oncologists, only 18% prescribed the
oral dose drug (capecitabine), while 75% prescribed infusion drugs, and 29%
prescribed the expensive, highly remunerative drug docetaxel. The existence of
this profit motive in drug selection has been one of the major factors working
against the individualization of cancer chemotherapy based on testing the cancer
biology.

This is not to imply that the academic center-based oncologists are without
their fair share of collective guilt. They were misguided in not recognizing
that they were trying to mate notoriously heterogeneous diseases into
one-size-fits-all treatments. They devoted 100% of their clinical trials
resources into trying to identify the best treatment for the average patient, in
the face of evidence that this approach was non-productive. However, such
unsuccessful experiments will never be viewed as such by the thousands of people
whose careers are supported by these experiments.

Henderson, et al, entered 3,100 breast cancer patients in a prospective,
randomized study to compare cyclophosphamide/doxorubicin alone versus
cyclophosphamide/doxorubicin plus Taxol (in the adjuvant, pre-metastatic
setting). The results were microscopically positive, at best, and cannot begin
to justify the enormous financial and human resources expended (while making no
effort at all to test and improve methods to individualize treatment).

But these results changed the face of the adjuvant chemotherapy of breast
cancer.

Cyclophosphamide+Doxorubicin+Taxol became standard of care. Taxol recently
went off patent. Now the thrust is to identify on-patent therapy which is
microscopically better in clinical trials of one-size-fits-all treatment.
Already, the community-based oncologists are migrating to
Cyclophosphamide+Doxorubicin+Docetaxel (expensive/remunerative) so what was the
purpose of doing that 3,100 patient prospective, randomized Henderson study?

 

PHARMA: Overstepping the line. Who could have known?

It’s a tough life these days in the pharma business. Profits are down, sales force lay-offs are coming up, and the industry is restricted from using its favorite techniques to get doctors to write more scripts, while its reputation is in the gutter. Some people must be looking for a return to the halcyon days of the mid-late 1990s, when new blockbusters were rolling out of the pipeline (rather than off the patent), the public loved the industry, and anything went on the sales side. 

But wait. Apparently not absolutely anything went, or at least not according to the pesky US Attorney’s office in Boston.  They’ve apparently decided that offering a few important doctors an all expenses-paid trip to the south of France (where they’d supposedly have to show up at a conference, mind you) in return for writing a few scripts of a failing anti-AIDS drug, is apparently an indictable offence!

Hang on a minute.  The "offence" was in 1996.  The indictment took 10 years. Isn’t this the same US Attorney’s office in Boston that couldn’t get a conviction in the TAP pharmaceuticals case, when basically everyone knew and the company all but admitted paying direct bribes to doctors to get them to prescribe Lupron? Do they really think that at the same time when Enron, Worldcom, Healthsouth and scamsters in dotcoms and Wall Street were putting together their schemes to defraud the world that a few regional sales directors, desperate to keep their jobs, should face hard time for offering out a few trips for a doc and his long-suffering wife or mistress to hit the beach? And how different is that from taking the doctor out to a dine and dash every week? How’s a poor pharma rep to know where the line is?

Coda: One of the docs that apparently wouldn’t take the bait was a Dr RL of Florida.  Over on DB’s MedRants one of the most fun commenters is a retired doc called RGL, otherwise known as Roaring Remy. Could Roaring Remy and the Dr. RL in the indictment be per chance related?  And if so, didn’t Remy want to go to the south of France?  Would he have preffered somewhere cooler?

assetto corsa mods