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Tag: Pharma

PHARMA/POLICY/POLITICS/PHYSICIANS: Tierney with some optimism on the DEA’s war on doctors

Writing (unfortunately behind the fire-wall) in the NYT, John Tierney attacks the Republicans as being the Party of Pain. With their attempts to stop the Oregon assisted suicide law, and the relentless attack of the DEA on pain doctors, the Republican conservative Christian establishment that captured the DOJ in 2001 continues to defy rationality. Tierney is hopeful, however, following the Supreme Court’s ruling in Oregon’s favor.

Of course we never needed to engage in this ridiculous vendetta against pain doctors anyway. In his harrowing long and excellent issue brief on the subject Ron Libby at Cato points out that Oxy wasn’t that big a deal anyway

A final problem with the DEA’s claims of an OxyContin epidemic is the agency’s inflated estimate of risk of death. In 2000 physicians wrote 7.1 million prescriptions for oxycodone products without aspirin or Tylenol, 5.8 million of them for OxyContin.55 According to the DEA’s own autopsy data, there were 146 "OxyContin-verified deaths" that year, and 318 "OxyContin-likely deaths," for a total of 464 "OxyContin-related deaths."56 That amounts to a risk of just 0.00008 percent, or eight deaths per 100,000 OxyContin prescriptions 2.5 "verified," and 5.5 "likely-related." Even those figures are calculated only after taking the DEA’s troubling conclusions about causation at face value.

So this is just a classic case of the DEA acting like the drunk looking for his keys under the lamp-post because that’s where the light is. And who suffers? Obviously the doctors in jail or ruined. And it’s not a issue for just a few pain doctors. Libby points out that between one in five and one in three pain doctors has been investigated by the DEA or local authorities. Would you keep doing your job if there was a one in three chance that you’d be investigated, maybe have your assets seized, and possibly be sent to jail for very long time just for doing it?

And why is it being done? Well the DOJ and local police departments get to keep all the money from asset forfeiture. In other words this is essentially theft with patients, doctors and the taxpayer picking up the tab

Tierney hopes that there’ll be a resolution to this:

The Supreme Court’s decision is a victory for patients and their doctors – including, I hope, some of the ones in prison for violating the federal legal theory that has now been rejected by the court. The doctors should go free, and Republicans in the White House and Congress should restrain the drug warriors who locked them up. When this year’s budget is drawn up, it’s the D.E.A.’s turn to feel pain.

These loonatics need to be stopped and whatever my political differences with Tierney and the Cato crowd I applaud them for getting this in the public eye. Unfortunately I think he’s being far too hopeful that any good will come of this given the number of theocratic fascists social conservatives  still in the Administration and heading to the Supreme Court, and the current DOJ attempt to promote laws already overthrown by a (slightly) more liberal Superme Court.

POLITICS/POLICY/PHARMA: Compare and contrast GWB and LBJ on Medicare

2_24_112205_teacher_sex2_smallJonathan Cohn takes a good look at the Medicare implementation now and then, in What Bush could learn from LBJ on Medicare. Not too surprisingly the current screw-up wasn’t evident in 1965, even though the Johnson Administration had only 11 months to implement an entire new program, as opposed to the Bush Administration’s 25 months to add a new one on.

It does have to be said that McClellan’s golden boy image is starting to look a little like his brother’s — he of the “I know nothing” attitude (If you don’t know what I’m talking about look under N here)

PHARMA: The gift that keeps giving, or PhRMA being dumb and dumber

Somehow I’ve ended up on Peter Rost’s mailing list. Now he’s a guy who knows a thing or two about the wacky behavior of big pharma. Peter sent me a press release about that novel that PhRMA funded until the grown-ups figured out in horror what they’d done. Unfortunately, their ham-fisted attempt to cover up the fact that they’d funded a novel about terrorists poisoning the drug supply from Canadian pharmacies apparently won’t die. Much more on the background at Health Care Renewal.

But you’d think that PhRMA would shut up about this and hope everyone forgets. After all it was fun while it lasted but there are other pharma-related issues on the front page now! Think again.

The latest round is that the consultant that PhRMA used as an intermediary is now apparently trying to stop the sale of the book — that’s already been published — and make the authors take done the email trail that is pasted on their website. Given that it’s pretty clear that PhRMA paid for the initial payment to the authors (although the consultant has been accused of taking a cut on the way), it sounds a little unlikely that PhRMA isn’t also behind trying to get this email trail taken down, and the book off the shelves. Of course the author Spivak, while claiming to be in high dudgeon, is loving the publicity, and is hawking the film rights claiming Nicole Kidman wants to star in it!

PhRMA apparently only offered them $100K to shut up early in the process. Presumably with the publicity they were already getting the authors thought they’d make more by keeping going. Perhaps a bigger number might have given them pause. I guess like many of big Pharma’s other products they’re discovering that doing the recall costs more and more, the longer you’ve been covering up the bad results.

Remember guys, there is a high road, and in the long run you’re better off taking it!

POLICY/POLITICS/TECH: Jon Cohn plays Gotcha on Part D

John Cohn finds the December GAO report that says that CMS wasn’t ready for Part D’s launch, and also McClelland’s response that the GAO was underestimating CMS. Make that “mis-underestimating”, I think. 

Here’s what the GAO Report says would be some likely problems with Part D’s introduction for the dual eligibles:

For dual-eligible beneficiaries who do not have Medicare drug coverage because they were either not identified and enrolled on January 1, 2006 or are newly qualified dual-eligible beneficiaries, CMS has developed a point-of-sale enrollment mechanism designed to enable pharmacies to assist these beneficiaries in obtaining immediate Part D coverage. The agency signed a contract with a designated PDP on November 22, 2005 to implement this mechanism. Because these arrangements were completed less than 6 weeks before the transition is to occur, limited time remains to educate all pharmacies about its availability and details of its operation.

For beneficiaries who were enrolled in a PDP but do not have their PDP information, CMS has facilitated a new information-technology process, known as the Eligibility Transaction, that will allow pharmacies to identify a beneficiary’s PDP and provide the beneficiary with the PDP’s contact information. As with the point-of-sale enrollment mechanism, it is unclear to what extent pharmacies are informed about the Eligibility Transaction and will use it. Despite CMS efforts to publicize this tool to industry organizations, a pharmacy industry association representative stated that it is unclear how many independent drug stores, which dispense the majority of the nation’s retail prescription drugs, plan to use the Eligibility Transaction.

Translation: a) Pharmacies are supposed to be able to immediately register dual-eligibles if they’re not already in a PDP but that was only developed in November and wouldn’t be ready. b) GAO was unsure how many pharmacies would use the eligibility transaction system.

GAO didn’t seem to predict what apparently is the major problem — the data on eligibility from the PDP’s that the transaction database is hitting against is wrong or it’s just not working.

We will find out more, but they had two years to get this right! And it seems to be getting worse!

POLICY/POLITICS/QUALITY: Supreme Court upholds Oregon physicians and patients rights

Some slightly good news in the DEA and DOJ’s continued campaign to get into the practice of medicine in the guise of preventing “drug trafficking”, or more accurately imposing the extreme morals of the religious right on the rest of us.

The Supreme Court upheld Oregon’s one-of-a-kind physician-assisted suicide law Tuesday upheld Oregon’s one-of-a-kind physician-assisted suicide law Tuesday, rejecting a Bush administration attempt to punish doctors who help terminally ill patients die. Justices, on a 6-3 vote, said that federal authority to regulate doctors does not override the 1997 Oregon law used to end the lives of more than 200 seriously ill people. New Chief Justice John Roberts backed the Bush administration, dissenting for the first time.

Of course the dissenters were Scalia and Thomas, both unreconstituted theocratic & social fascists conservatives. They were predictably joined by new Chief Justice Roberts. It’s no secret that Alito would have voted with them had he been confirmed. And this is for something the voters of Oregon have passed twice by large majorities. In other words the will of the voters is irrelevant in cases where social conservatives want to restrict freedom, including the freedom of physicians to practice in the way they like. And after Alito is confirmed, this will happen more and more…watch out Roe vs Wade.

PHARMA: Whistleblowing and more ways to make a buck in big Pharma, by The Industry Veteran

The Industry Veteran some time ago decided that the only decent career path left in pharma was that of whistleblower. He has more evidence to back his case. Here’s the Veteran’s restrained take on the matter.

Here’s another piece of evidence to support my argument that whistleblowing represents the most promising career path for a young person starting out in the biomedical industry. Biotechs such as Genentech, Amgen and the other large ones are an especially fertile venue. The avaricious ambitions of senior executives and their accompanying desire to mimic the Big Pharma operations tend to alienate both the scientists and the commercial people who were originally attracted to the biotech side of the drug discovery business. These increasingly disgruntled coworkers can provide excellent leads into illegal practices that the enterprising whistleblower can use to his/her advantage.

 

The current Genentech whistleblower held the job of medical science liaison or MSL. The medical science liaison position (also called health science associate, clinical liaison and other terms by various companies) remains especially advantageous for launching a whistleblowing career. The MSLs and their otherwise designated counterparts are hybrids who combine a sales function with that of clinical trials missionaries. Their putative function consists of discussing clinical trials with curious and knowledgeable practitioners. This gives them considerably more leeway in their interaction with physicians than that given to sales reps who are restricted to discussing information appearing on the current labels of existing products. In an effort to foster the appearance that MSLs serve a scientific and educational function, their departments report up to the medical affairs operations of the respective companies, rather than to sales. As part of the same illusory effort MSLs are relieved of responsibilities for delivering samples. Nor are they evaluated by measurements used to calculate bonuses for sales reps, such as market shares or sales volumes within their assigned territories. As a result the MSL people are held in high contempt by the great majority of their sales rep colleagues.

 

An acquaintance at Abbott Laboratories recently told me about some of his work as an MSL. He plies his trade on behalf of the company’s rheumatoid arthritis product, Humira. In this capacity he recruits influential and high prescribing rheumatologists to conduct redundant clinical trials (see  the article from 2 January Washington Post on “superfluous medical studies”). His effort serves several purposes. In the first place, the trials provide an acceptable cover for paying high volume prescribers to use the Abbott product. Marketers call this practice “buying market share,” the rest of us term it bribery. Secondly, by using influential and high prescribing practitioners to run these humdrum trials, the payoffs also exert a trickle down effect. Smaller fry, garden variety physicians develop their product preferences partly by following the usage patterns of acclaimed authorities in their geographic areas. Information about influential colleagues in the neighborhood who are conducting trials for a particular product, typically spread by the sponsor’s sales reps, sends a clear message to the vast number of follower physicians. Both the payoff and the trickle down functions are then enhanced when the sponsoring company hires the investigator-physician to speak to the small fry at dinner meetings and symposia.

 

Approximately a year and a half ago, my acquaintance was attending a rah-rah session at Abbott headquarters with his associates. The director of MSLs started out by voicing an obstreperous defense of the operation under his leadership and its contribution to Humira sales. “Don’t let anyone tell you,” the director exhorted his underlings, “that we don’t contribute to the top line.” As he advanced to the next PowerPoint slide, he emphasized the fact that MSLs had accounted for $78 million of added Humira sales during the recently ended quarter. Before anyone in the audience could inquire about the particular ass from which the director pulled that number, the company’s CEO, Miles White, jumped to the center of the presentation dais and used his body to block out the slide. In an enraged tone White pointed his finger at the startled MSLs and told them to forget they had ever seen such a slide or heard their director’s last comment. It seems White was immediately aware that his director’s effort to justify the continuing existence of an MSL department tore down the fictive Chinese wall by which the Pharma companies seek to separate their educational and scientific communications from crass selling.

 

In such an environment, I plaintively ask, is not whistleblowing the most noble calling?

PHARMA: What will it really take for big Pharma to go Hollywood? by The Industry Veteran

The Industry Veteran, who’s opening the year on quite the tear, has been pondering the latest “trend” in the pharma marketing chatter — the idea that Pharma needs to follow the Hollywood model. Here are his thoughts:

Here’s an interesting article from John Mack’s Pharma Marketing Blog that appeared last summer. In drawing an analogy between Big Pharma and  Hollywood, Mack claimed the drug industry should learn from the Hollywood studios and substantially alter their distribution strategy. According to Mack and a few other industry strategists, the studios understood that their largest revenue segment doesn’t come from movie theaters, but instead from DVDs.  In response they started pushing movies onto DVDs within a matter of weeks after the open in theaters. More important than the revenue from theater distribution, movie appearance in those outlets, and the supporting TV ads, function to build word-of-mouth for DVD sales.

 

Mack and others in the industry develop some useful insights, although John is actually a bit outdated in his description of movie industry dynamics. The share growth of home sales/DVDs has slowed in favor of view-on-demand.  Both Comcast and the dish-satellite companies have tried to sign deals with the studios to show movies in their view-on-demand services within a few weeks after theater openings. The studios want to make these deals but they have hesitated for fear of antagonizing Wal-Mart. Nevertheless, Mack argues that just as Hollywood creates greater revenue through an alternative distribution strategy, Big Pharma could do the same by pushing its drugs to move more quickly into generic and OTC status while the Pharmas acquire ownership of the generic and OTC companies.

 

This altered distribution scheme is another approach to a demand sensitivity argument by which higher volume and lower prices will net out at a larger total revenue for the industry. The idea of enhanced compliance is the New Year’s buzz in Big Pharma. Brad Sheares, the president of Merck’s US Human Health division, told his reps that he would ask them to support DTC promotions stressing the importance of filling prescriptions and finishing the entire package. In the current era of fewer new molecular entities, Pharma finds that too many written scripts fail to generate revenue because uninsured and underinsured patients can’t afford the high cost. In this scheme of things, Big Pharma’s push for generics won’t compete with the high-priced, branded products that will make their generous returns on investment within their first several years after launch. Instead the older, unconscionably priced brandeds that scream for price controls will give way to affordable generic versions.

 

Mack’s use of the Hollywood model for distribution dovetails neatly with Larry Ellison’s notion of a Hollywood analogy for product development. Ellison is the CEO of Oracle and he claims that Hollywood provided a precedent for Big Pharma decades ago when it decimated the big studio approach to producing movies that it used from the 1920s through the 50s. The studios since that time have become the financing, marketing and distribution infrastructures for independent producers. Ellison suggests that Big Pharma should learn from its elders. 

 

I suppose the Big Pharma company that has most definitively gone Hollywood in both product development and distribution is Novartis, which is now the largest generic company in the world. Of course all the Big Pharmas have signed scores of drug development deals in the past few years with the counterparts of independent movie producers: biotechs and startups. It’s probably no accident that Novartis, a Swiss company, has adopted a banker’s/financier’s model for Pharma. Its crosstown rival in Basel, Hoffmann-LaRoche, has even truncated the marketing portion of this financing-marketing-distribution model by decimating the marketing function. Unwilling to sustain the fixed SG&A expenses of other Big Pharmas that employ tens of thousand of reps, Roche partners out the marketing-selling activity for any primary care product that falls its way.

 

If Big Pharma does go Hollywood and contracts out most of its present functions, a new type of personality would have to prevail in the industry. The sort of imperious, arrogant ignoramus who now runs the Big Pharmas (McKinnell at Pfizer, Hassan at Schering-Plough, Miles White at Abbott, J.P. Garnier at GlaxoSmithKline) would have to be replaced by far more anonymous, benign bean counters, much the way that Hollywood’s Louis B. Mayers and Harry Cohens yielded in favor of their forgettable successors. The mid-level managers in Big Pharma are currently small, politics-playing, risk reducing, follow-the-leader types who can barely do their jobs and seek to avoid any original thoughts for the duration of their careers. That would have to change and they would need to be replaced by fast-moving sharks along the lines of the Ari Gold character on HBO’s Entourage.

 

Yes, I can see it now, on the bottles of blood pressure medication…Eli Lilly and The Ligand Company, in Association with Amgen and American Pharmaceutical Partners, bring you an Anadys discovery of a Cleveland Clinic renin inhibitor: Epericel…”and the vasculature was renewed.”

 

Coming soon to a drugstore near you, or call your MCO’s mail order house.

POLICY/PHARMA/PBMs: Health spending collapses–all the PBMs doing! (No, not really).

So the numbers on national health expenditure are out, and health spending plummeted by 50% in 2004!! Oops, what I meant to say was that health spending only went up by 7.9% — barely enough to trouble the scorers (as they say in cricket). But wait — you all think that health spending went down in the 1990s and up by 15% in the early 2000s.  That’s not true. That’s what happened to private sector insurance premiums.  The overall news (as can be seen in the NY Times chart) is that spending growth in the whole health care sector never went up much over 9% even in the worst years of 2001–2 but it hasn’t slowed down to the mid 1990s when it came down to 5%, which was near the same growth as the rest of the (nominal) economy.

Health.184Of course where there has been slowing in costs in the last year has been in pharmaceuticals.  Some of you might think that’s because lots of drugs went off patent and relieved consumers switched to generics, but you’d apparently be wrong.

“Mark Merritt, president of the Pharmaceutical Care Management Association, said the new data vindicated the techniques used by members of his organization to manage drug spending”

In other words, it’s another great triumph of the PBMs. Funny, I don’t remember Mr Merritt being quoted in this type of article in the late 1990s when drug costs were going up much faster than the rest of health care spending. Were there no PBMs back then? Oh well, he might as well claim credit as apparently the rest of the health care system is now out to undermine his brave members in their feverish attempts to lower drug costs.

But, Mr. Merritt said, at the federal and state levels, "lobbyists for brand-name drug makers, chain drugstores, trial lawyers and others are working to undermine many of the tools we have used to reduce the rate of growth in drug spending." For example, he said, brand-name drug companies have resisted state laws that encourage the substitution of generic drugs.

It takes a slightly cooler head to respond to what’s really going on. Paul Ginsburg from HSC noted that:

"The rate of growth in health spending slowed in 2004, but it’s still substantially higher than trends in earnings, which are the key to being able to afford health care," Mr. Ginsburg said. "Health insurance is becoming less affordable to more people." As usual, health spending grew faster than the economy or consumer prices. The Consumer Price Index, a widely used measure of inflation, increased 3.3 percent in 2004.

For those of you keeping score at home the count is now $1.9 trillion spent on health care in the US — an average of $6,280 a person, and 16 percent of GDP. Another area in which America proudly leads the world!

POLICY/PHARMA/PHYSICIANS/POLITICS: Some more publicity about the awful state of pain medication

Finally there is some word getting out about the reign of terror the DEA has been running against pain doctors and its awful impact. This article, called Let’s Get Serious About Relieving Chronic Pain picks up from the NEJM article I wrote about last week. We have known at least since the HHS report in the early 1990s that pain medication is massively under-prescribed. In this article, Jane Brody notes that :

"Pain is a common symptom in patients nearing the end of life," with up to "77 percent of patients suffering unrelieved, pronounced pain during the last year of life," Dr. Timothy J. Moynihan wrote in The Mayo Clinic Proceedings in 2003.

But the news is that the DEA, on its messianic quest to prevent us all going to hell or whatever the theocratic fascists think they’re doing, is not only wasting our time and money, and condemning innocent doctors and patients to prison.  They are also helping most people to suffer in their last year of life. Well I’m sure the DEA think it’s a deal worth taking, but I can’t believe any rational person does. If there’s one government agency that ought to be abolished and have all its employees sent to fill in prairie dog-holes in Nebraska (or wherever), it’s surely the DEA.

POLICY/POLITICS/PHARMA: Is Part D the begining of the end for Big Pharma? by The Industry Veteran

THCB’s favorite vituperative contributor, The Industry Veteran, is back with some New Year thoughts. He got what I was up to on NY Eve a little wrong, but may have a closer idea about what the long term effects of the New Year will bring to Big Pharma. The Veteran writes:

A healthy and prosperous New Year to you!! For some reason I have a picture in my mind’s eye of you sitting in a pub, raising many pints to toast in the New Year. At 2:00 a.m. I see you wearing a thick turtleneck sweater beneath a Harris Tweed sport-coat as the proprietor gives his inevitable call, “glasses, gentlemen.”

 

The following article from Tuesday’s Financial Times says some interesting things about plausible effects of Medicare Part D. The author maintains it will push the US closer to the rest of the world in terms of a national payer system, greater transparency in drug pricing and cost constraints. To advance that last objective, he sees the feds pushing IT and more rational provider management patterns, a sort of revenge-of-the-nerds that should delight you and a segment of your readership. I suppose since neither a Republican or a Democratic administration is likely to enact the sort of changes I would prefer (e.g., tumbrels, guillotines and iron maidens for the Hank McKinnells of the world), the sort of temporized-neuterized change from the back office is better than nothing.

 

The thing that strikes me as amusingly ironic about Medicare Part D is that it shows the folly of leaving economic planning to the monopolistic corporations.  The US throughout its history has disdained strategic economic planning by government because of the secular faith in the market among the country’s business leaders. So here we have the Medicare Modernization Act as developed by Big Pharma’s Pfizers, Mercks and their PhRMA lobby. They fashioned the MMA, with its confusing, competing PDPs, specifically to prevent Medicare from acting as a single payer that could make volume discount purchases. After all, if they could elect George by manipulating an electoral system to create the illusion that 3,000 elderly Jews in Florida voted for Pat Buchanan, a Rube Goldberg MMA could certainly boost their earnings at taxpayers’ expense. Now here we have consultants, journalists and equity analysts forecasting that by decade’s end, the MMA will do precisely what the CEO malefactors wanted to avoid. I dread to think what would happen if Big Pharma’s CEOs were half as bright as their sycophants in Pharmaceutical Executive and the other vanity rags claim.

 

Although as the Veteran has pointed out before, the crew running big Pharma in 2003 will be long gone counting their millions by the time those chickens come home to their successors’ roosts.

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