The Truth About Drug Spending

01/29/2008 12:06 PM |

Article published Jan 29, 2008 The Washington Times
Health care spending


January 29, 2008

By Robert Goldberg - What do Hillary Clinton and the recent government data on prescription drug spending have in common? In both cases, the mainstream media got it wrong. Just days ago every reporter and pundit were predicting that Mrs. Clinton was on the verge of a major blowout in New Hampshire and that Barack Obama's nomination was virtually assured. We know what happened. Now of course, the media is furiously spinning in the other direction, calling her victory "historic" and the election a "horserace." Until the next primary.

With prescription drug spending, the media of course reported that it increased in 2006 by about 8.5 percent, more than last year because of increased Medicare drug spending. Health care spending went up overall too, by about 6.7 percent about the same as last year. So all the headlines and stories claimed that "drug spending fueled rising health care costs" "Drug benefit fuels Medicare spending" and so on.

But the press got that wrong too. And unlike electoral politics, the pundits didn't have to rely solely on exit polls and recycled "experts" for the intelligence estimates. They were all working from the same study, which was published in Health Affairs.

Drug spending for Medicare did increase. But that's not news because when you give 39 million people a new drug benefit that's going to happen. Apart from the fact that the Medicare Part D program is running at 20 percent under budget estimates, it is not fueling Medicare spending overall. Quite the opposite.

Even as drug spending has increased by nearly 9 percent as a percentage of total health care spending its share remains about the same. If it's fueling the rise in spending it is very efficient fuel. Indeed, the increase in drug spending corresponds nationally with a decline in the rate of increase in spending in hospitals, nursing homes and visits to the doctor.

Could it be that more drug spending is driving down the rate of increase in other health care spending, particularly in Medicare? Public money (mostly Medicare and Medicaid) pays for about half of those other expenses. The surge in drug spending, which includes a shift of the Medicaid drug population to Medicare coincides with this decline in spending in other areas.

What's more, the goal of the Medicare Part D program was to reduce the cost of prescription drugs for people with limited incomes and chronic illnesses. It has accomplished that. Studies have shown, most recently another study in health affairs, that by eliminating the co-payments for prescription drugs, people use more medicines. When that happens their chronic illnesses such as diabetes, blood pressure and depression improve. They use other, more expensive health care services, less often. They are happier and healthier. Which is the real value of medicine in the first place.

Does this relationship apply for seniors in general? It would be great to see more research done using current Medicare beneficiary data. According to earlier work by my colleague Frank Lichtenberg, Courtney Brown Professor of Economics at Columbia University's School of Business, it does. Access to newer drugs costs more money but is offset by a reduction in hospital, home health care and physician costs according to Dr. Lichtenberg's research.

In other words, the value of the Part D program is not just that it makes drugs affordable but that it makes new medicines rapidly available as well. Efforts to restrict access to new drugs through co-pays and formularies would not only discriminate against the poor and chronically ill, it would actually drive up spending across the board. (Dr. Lichtenberg has also found that Medicare Part D has increase drug usage by less than 5 percent nationally. So much for claims that it created a huge windfall for drug firms. ) What's news is that the media, which was so quick to bill the Medicare prescription drug program as a failure two weeks into it's existence, once again rendered a snap judgment so far from reality that it should have used Narnia as its dateline.

James Q. Wilson has observed that journalism, like so much scholarship, now dwells in a postmodern age in which truth is hard to find and statements merely serve someone's interests. Health care will be an important issue in the coming campaign. Accuracy is always a casualty of electioneering. Too bad journalists are increasingly part of the problem whether it's coverage of candidates or the concerns that shape our vote in the first place.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest.  Read More & Comment...

The Cost of Ad Hominem Attacks

01/28/2008 01:20 PM |

Attacking the "conflicts" and "coverups" of companies and affiliated researchers in an attempt to discredit the commercialization of medical research comes at a price: undermining confidence in the science and the use of products themselves. As with all Ad Hominem attacks, particularly circumstancial, the fact that a researcher may stand to benefit from the acceptance of their research does not affect the validity of the research itself, since scientifically established evidence can stand or fall on its own merits. The failure to challenge such research in this fashion is of course, intellectually dishonest and manipulative. The consequence and object of such manipulation is to "frame" the choice or perspective of research as a risk to be avoid and as not relying on the research and its results as a place of certainty..

Which lead us to the spike in whooping cough cases triggered by the decline in the number of kids being immunized:

"Before the development of a vaccine, whooping cough was a major public health threat, particularly from the 1920s to the '40s, when it infected as many as 265,000 Americans a year and killed as many as 9,000 a year, said Dr. Mary Healy, director of the Texas Children's cocoon-strategy program.

Since the vaccine, she said, its annual incidence dropped to around 30,000 in the 1950s and as low as about 1,000 in 1976. It began creeping up in the 1980s and 1990s."

Click Here for More Info

Parents are convinced vaccines are unsafe not because of any evidence they are dangerous but because critics claim that the people pushing vaccines like Paul Offit are "conflicted" and therefore should not be trusted. ....Ditto the decline in SSRI and rising suicide rates because of "conflicts" and "coverups". This is now the new standard for determining whether or not research or a scientist is acceptable. Truth is now function of political correctness and adherence to the view that the commercialization of medical research is inherently corrupting. Can someone say Lysenko?

Pseudoscience leads to pseudocertainty which leads to a decline in the public health.
Those who claim that it "seems that negative studies are suppressed" are substituting emotion and bias for the scientific method. So too are those who change the subject from the outcomes to the studies to the character of those who sponsored them. Or as Saul Bellow once said: "A great deal of intelligence can be invested in ignorance when the need for illusion is deep."  Read More & Comment...

Governor Spitzer's Pajama Game

01/28/2008 10:56 AM |

Fresh from his victory in the drivers’ licenses for illegal aliens campaign, Governor Spitzer is turning his attention to reforming health care in the Empire State.

Here's the lay of the land, status quo ante:

Prior to any actions, New York will spend approximately $1.9 billion in State funds on prescription drugs in 2008-09 through the Medicaid and EPIC programs. The 2008-09 Executive Budget recommends actions that would control these costs and generate $172 million in State savings.

But these "savings" come at a cost -- the cost of quality health care for low income New Yorkers. And, considering that prescription medicines represent but 4 percent of the New York State health care spend (4 cents on the NY health care dollar), it's a penny wise/pound foolish proposition. "Seven and a half cents," the famous "Pajama Game" song tells us, "doesn't mean a hell of a lot." But when it comes to prevention, life saving interventions, and chronic care, four cents does.

The sampling of ideas below all save money for Albany in the short term -- and will result in a lower quality of care for New York's Neediest and a higher taxpayer burden for expensive hospital stays and other high cost health care interventions. Governor Spitzer's plan is a perfect examples of a cost-based, "government first" paradigm --when what we really need is more cost-efficient and humane patient-centric, "people first," health care policy.

* High Cost Drugs. A Specialty Pharmacy Program will be created within Medicaid to lower the price of high cost drugs, which have increased dramatically in number and cost. Specialty drugs typically require specific handling and have a limited distribution.

Translation: Rationing.

* Clinical Drug Review Program. The Executive Budget reflects the addition of new drugs to the Clinical Drug Review Program (CDRP) to generate additional savings while continuing to ensure proper usage of certain high-risk drugs.

Translation: Rationing through questionable evidence-based medicine schemes.

* Physician Education. A program will be started to provide prescribes with unbiased clinical information about medications and to balance marketing efforts by manufacturers. This will improve patient outcomes and reduce unnecessary expenditures by providing objective information to prescribers.
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* Translation: Rationing. Anyone care to wager what these "unbiased" studies will recommend? Echoes of CATIE and ALLHAT. It's the battle between 20th century practice variation and 21st century patient variation/personalized medicine.

* Pharmacy Reimbursements. Pharmacy reimbursement will be reduced from Average Wholesale Price (AWP) less 14 percent to AWP less 17 percent for brand name drugs to more closely reflect the actual wholesale price to pharmacies. This reduction will be offset by a one dollar increase in the dispensing fee for generics and brand name drugs in the PDP. In addition, co-payments for brand name drugs in the Medicaid PDP will be reduced from $3.00 to $1.00. These changes will encourage the use of lower cost and preferred products.

Translation: Bribe pharmacists to switch their customers to generic drugs -- even if that switch is from an on-patent medicine recommended by a patient's physician to an entirely different molecule. Savings first. Patients last.

What’s most peculiar is that Governor Spitzer offers only a few small initiatives to deal with the most important health care issue in New York State (and, for that matter, every state) – chronic disease. This is, perhaps, the most explicit example of sins of omission and the Gov’s focus on short term vs. long term savings. It’s an ignorant and dangerous omission. Sins of omission, the saying goes, are seldom fun. And, while this particular omission may be politically expedient – it’s also dangerous and short-sighted.

Here's a link to the full health care section of the Governor’s executive budget:

http://publications/budget.state.ny.us/eBudget0809/fy0809littlebook/HealthCareMedicaid.html

In "The Pajama Game," the union boss "Prez" sings, "With a pencil and a pen I figured it out." Governor Spitzer (who some say would like to play Prez himself some day) needs to return to the drawing board and figure out a way to put patients first -- before he prepares for his own second act.  Read More & Comment...

Trial Lawyers Inc. Enters the Vytorin Fray

01/25/2008 05:44 PM |

Just a matter of time before the juggernaut switched gears from Vioxx to Vytorin. (How cool that they go in alphabetical order, it will make life easier for the paralegals at least.)

Now we at drugwonks get to play our version of connect the dots as the purists line up on the side of the bottom feeders offering their services as consultants, their opinions in the media, white papers, policy support through web sites and groups like the Soros funded Prescription Project and the Institute on Medicine as Profession. We already have two"dots": Susan Wood, recipient of silicone breast implant settlement cash (where no evidence of wrongdoing or harm existed)
Read More



"Schering says there were problems with the way the data from the study were collected and analyzed, and that it needed all this time to fix those problems. Susan Wood, a professor at George Washington University and former Food & Drug Administration official, doesn't buy that. "You can't just say, 'Wait, we'll fix it,'" she says. "You have to get it out and let people decide."

The other dot is Steve Nissen who of course has been conducting (for pay) his own set of studies to determine whether increase HDL (regardless of genetic variation) can lead to plaque reversal and can correlate with a reduction in death using his own imaging studies. According to Matt Herper he is gunning for Zetia. (Here's a link to an article where Nissen gushes over the plaque reversing power of a drug he was working on but has never, ever made it into human trials.)
Read Full Article Here

The lesson here: Don't you dare do a plaque reversal study with imaging as your surrogate endpoint without using Steve Nissen. Oh, another lesson: Steve Nissen does no work on genetic sensitivity to statins or personalized medicine, the real future. The ENHANCE study in its backhanded way essential demonstrated that Vytorin is the drug which can lower cholesterol for a small genetic subset but not reduce plaque.

In any event, what people think about this matter -- and what to do about it -- will be shaped by their views of capitalism and medicine, not by the science. Will every large clinical trial of a drug on the market now become an opportunity to attack, expose, sue and investigate.

I think so. The "dots" profit from it in terms of publicity, consulting fees, foundation grants, their cut from class action suits and consolidation of control over the conduct of clinical trials, prescribing patterns, etc.
  Read More & Comment...

The Conflict of Interest Pile On: A Cultural and Psychological Explanation

01/25/2008 10:28 AM |

The New York Times "breaks" the story that the American Heart Association receives support from Schering and Merck. The implication is that the AHA came out with a statement as a result of that connection. Let's assume for argument's sake that this is correct. And let's forgive the AHA for putting Donny Osmond on their website.

Here is the gist of the AHA statement:

Because Vytorin does not appear to be unsafe, lipid-lowering therapy with simvastatin is of proven benefit, and some patients have been prescribed Vytorin because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,” said Dr. Jones. “However, patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol.”

Does anyone have a problem with that statement. If I were a Schering or Merck handler I would not think I got my money worth.

Or maybe the critics are not thinking conspiratorially enough. AHA also gets money from Novartis, GSK, Pfizer and other companies. Maybe they used their financial clout to water down what was going to be a hearty endorsement of the drug. Or maybe the money went to the millions AHA gives out in research grants to academic medical centers for CME and other reasons. Which is it? We don't know. And of course the rest of the pontificators have rushed to judgment based on the NY Times without regard to the essence of the AHA ENHANCE statement.

The next point of course is that if the AHA is simply a paid for mouthpiece for Big Phama, it goals, views, tactics, etc by virtue of receipt of financial support, then that cause and effect relationship must apply equally to organizations and individuals who receive support from organizations. So therefore, physicians, researchers, etc who receive money from foundations such as Commonwealth, the Open Society Institute, Pew, Josiah Macy, etc to share its biases and ideology. Similarly, people from HMOs, insurance companies, CMS, Medicaid who share a cost cutting view will reflect that bias and particular view of technology.

Finally, there is the so what question? As Ezekiel Emanuel as stated regarding for-profit IRBs: "What we should really focus on then is not the ideology of profit status but these substantive outcome data."

No one has proven that the purist approach will produce better health, better drugs, safer medicines. The movement against so-called conflict of interest is all based on a revulsion towards the profit motive in health. It is more like the Taliban trying to purify the planet than a systematic effort to make medicine more patient centered based on an mechanistic undestanding of how to predict and prevent illness. The purists skip right past personalized medicine because it is not part of the grand scheme to rid medicine of the corruption.

Quite the opposite, the evidence that expelling "commercial interests" from CME (I guess that would mean Danny Carlat and Howard Brody since they make money off books and lectures), academic detailing, state formularies based on so-called evidence based medicine, conflict free FDA advisory committees, the application of the precautionary principle to the development and use of medicine (don't use any new medicine for 7 years according to Public Citizen), turn over all drug development to government and shorten patents and of course a single payer system would improve health.

Academic detailing according to CATIE and ALLHAT? One size fits all medicine? Paying doctors to prescribe generic when will have genetic tests and algorithms that indicate otherwise? The attempt to discredit researchers who have worked or have received funding from pharma is an intellectually dishonest and weak way to simply not engage in discussion or consider important, mechanistically valid research. It is the new Lysenkoism.

You wouldn't know from all the rapid pharma hating that mortality and morbidity has been declining worldwide in direct proportion to the rate of introduction of new drugs, devices and surgical techniques. Medical technology has done more to advance and enhance humanity than anything else we could have come up with. Check that, the commercialization of medical technology.

Rather, the piling on is just an expression of a hatred of capitalism. To paraphrase Aaron Wildavsky, my critics see medical technology as part of the apparatus by which corporate capitalism maintains inequalities that harm society and the public health.

The piling on is a product of a particular view of how the world works. These are angry, fearful people who have a utopian plan to take medicine back to a pristine time that never existed. The disturbance is, in fact, in their psyche and souls. Their success in enacting their plan comes at the expense of the reputation of good scientists everywhere, trust in science generally and medical progress. To make themselves right, they would destroy others and rule over the rest.  Read More & Comment...

Not so magic markers

01/25/2008 08:53 AM |

Here’s how the Wall Street Journal story, “FDA Procedures Draw Scrutiny” begins, “Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar.”

This is just the latest iteration of politicians and media jumping on the “FDA as tool of industry” bandwagon. And it’s neither true nor accurate. It seems odd that one day the media is writing, pundits and pronouncing and politicians are orating about a parched pipeline and over-zealous regulators while in the next breath about the need for the agency to "raise the bar." Consistency? We don't need no stinking consistency.

And then there’s the bit about proxy markers.

Here’s what the Journal story has to say about that:

“ … proxy markers can be misleading. Sometimes a drug works on a proxy but doesn't deliver the promised benefit for the primary health problem. Or a drug can have side effects that don't surface during initial proxy-marker studies but end up outweighing its benefit.”

What? You mean using markers doesn’t guarantee 100% accuracy! Shocking, just shocking. Here’s the bad news folks – there is no perfect predictor of either risk or benefit. And if we allow ourselves to poo-poo the significant advances that biomarkers deliver than we are heading down the slippery slope of the Precautionary Principle that warns us to “do nothing until we know everything.” Markers aren't magic, nor are they a "perfect" solution. Risk/benefit analysis is an inexact science and safety is a relative concept.

Here’s a link to the complete WSJ story:

http://online.wsj.com/article/SB120122452254515507.html

The best way to help the FDA to “raise the bar” is to accelerate 21st century regulatory science. And that means funding the Reagan/Udall Center. Everything else is just rhetoric.  Read More & Comment...

Importation : not so safe. Really.

01/24/2008 10:41 AM |

When I first published my paper on parallel trade of medicines in 2003 (http://www.cne.org/publications2.htm) there were no reported links between this phenomenon and counterfeit drugs in Europe. Today, it seems that this connection is increasingly established, unfortunately.

As pointed out here (http://www.pharmatimes.com/WorldNews/article.aspx?id=12674) the other day, the European Commission is gearing up to legislate on this after the summer. Commissioner Verheugen said before Parliament that packaging and labelling, and indeed product recalls pose a "considerable risk" to patient safety.

How’s that ? Parallel traders, admittedly a legal and legitimate business in the EU, have the right and are often obliged to interfere with the original manufacturer’s packaging (except for the blister packs) by re-boxing and re-labelling the goods, before re-exporting them. Patient leaflets need to be replaced when sending products intended for the Greek market to the UK, for instance. Parallel importers are in principle legally obliged to submit the modified packaging to the original supplier ; in practice, this is hard to enforce and therefore rarely occurs. And here’s the rub : as the supply chain is broken and packages are modified, there is opportunity to introduce both counterfeit, substandard or useless products.

Ultimately, parallel distribution hinges on the paradox by which EU member states set prices but goods are simultaneously free to circulate within the Union : Verheugen announced that solutions will be presented, but until further notice, pricing is not part of the EU’s remit. And free pricing will not be part of the member states' political agenda in the short or medium term; and only this would in effect resolve the issue, but it entails wholesale health care reform to get the government out of the sector.  Read More & Comment...

Aubrey Blumsohn, Tenacious but Wrong

01/24/2008 12:00 AM |

Aubrey Blumsohn who runs the scientific misconduct blog attacked us recently and I am trying to figure out why.

http://scientific-misconduct.blogspot.com/

Dr. Blumsohn is a researcher who, according to a report by NPR (a known front for Big Pharma), did not like the statistical analysis of the study he did for Proctor and Gamble. Blumsohn found out that 40 percent of the data was tossed out and was not happy, so he went public with the process.

The fact is, many researcher don't do their own analysis and rely on others to do the statistical analysis and select the statistical analysis and study design. This is changing and in many cases investigators do have control of the whole megillah. Indeed in many cases the drug or biotech companies themselves will rely on academics to take the lead. Blumsohn has presented the entire data set by the way though it has not been published as of yet.

I give Dr. Blumsohn credit for sticking to his guns with respect to the integrity of the data as he saw it. His university apparently wanted to give him cash to drop the whole matter and he told them no. You have to admire that sort of tenacity. We need more truth seeking everywhere. And everyone should post their clinical trials. Period.

But to suggest that because more of the clinical trials are funded by the private sector means more misconduct or a dearth of null studies is empirically wrong. The same goes for suggesting that receives pharma funding is corrupt and that only pharma funding is a source of conflict or that it always taints research outcomes. As a JAMA article on the subject noted: "Contrary to the often-voiced concern that major journals do not report null studies, we found that a substantial proportion of the cardiovascular trials published in JAMA, The Lancet, and the New England Journal of Medicine between 2000 and 2005 reported either no significant difference between therapies (34.6%) or a significant difference favoring SOC over newer treatments (6.8%). Furthermore, among trials funded solely by not-for-profit organizations, the proportion of trials not favoring innovation was 51.0% suggesting that, at least for these trials, evidence of publication bias is minimal."

But bias on the part of the scientific misconduct blogosphere does exist. It has constructed a conspiracy theory based on speculation, anecdotes and hubris.

The link to the NPR report, which Dr. Blumsohn seems not to have posted, is here:

http://www.npr.org/templates/story/story.php?
storyId=5234621

It is a balanced account of what happened.

The bias of the blogosphere is showing.   Read More & Comment...

Uncle Sam, MD

01/23/2008 09:53 AM |

What's the difference between "universal" health care and "government" health care? Just who are these 47 million uninsured Americans that everyone's talking about?

Here's a new op-ed (from both the San Francisco Examiner and the Washington Examiner) that addresses both issues.

Commentary

Peter Pitts: Uncle Sam, M.D.?

On both sides of the political aisle, presidential candidates have labeled universal health coverage as the moral challenge of the decade. But is a government-run health care system the best means to bring this about?

Well, that depends on whether you want your health insurance and medical services to be provided by the same folks who run the Department of Motor Vehicles and Federal Emergency Management Agency.

Look abroad and you’ll see the disastrous effects of a government takeover of the health care industry.

In Canada, patients languish on surgical waiting lists for months. In the province of British Columbia, for example, more than 75,000 citizens were waiting for surgery at the end of September 2007. Even for serious procedures such as cardiac surgery, the average wait time is more than nine weeks.

In the single-payer health systems dotting Europe, price controls on prescription drugs have reduced the supply of treatments available to patients. Good news for the bean counters, but bad news for the sick.

What’s more, price controls have caused an atrophy of the European pharmaceutical industry. Fifteen years ago, European firms were responsible for 80 percent of drugs invented worldwide; today, they account for less than 20 percent of new drugs.

So not only have European patients taken a hit, thanks to reduced availability of medicines, so has the European economy.

Such dirty secrets are why most advocates of universal health care harp exclusively on access to insurance, which everyone agrees is important. In doing so, they obscure these insidious aspects of a government-run system.

But the fact is, access to health insurance is not a problem for most Americans.

Among those who work full- time, for instance, the vast majority receive access to either a health maintenance organization or a preferred provider organization through their employer. Older Americans have Medicare, while Medicaid serves the poor. Active and former military personnel are in the insurance system run by the Department of Veterans Affairs. Self-employed people may acquire individual policies or exploit the benefits of high-deductible insurance policies and health savings accounts.

Even for the indigent, care is widely available — at either a heavily subsidized level or often for free. And it’s illegal to turn a patient away from a hospital emergency room for lack of an insurance card.

Vaccinations are often free for children and the elderly, and free or low-cost walk-in clinics have grown in popularity throughout the country.

When it comes to prescription drugs, both manufacturers and retailers have set up programs to provide needed medicines to low-income patients at reduced cost.

So in a very real sense, “universal health care” already exists.

What about the oft-cited 47 million Americans who “lack insurance?” Such a number sounds catastrophic, but an examination of the details reveals that such figures are not always what they seem.

First, included in that number are scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it. They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.

That figure also includes 10 million illegal aliens. None of the politicians currently touting his or her plan for universal coverage has addressed this significant portion of the uninsured pool. And if the government can’t identify who’s here illegally anyway, how can it possibly ensure that they’ve purchased health insurance too?

Finally, the 47-million statistic isn’t static. Most of those who are without insurance are only without it temporarily — as when switching jobs.

When we get down to brass tacks, it turns out that many politicians and media types have created a phony verbal distinction between “universal health coverage” and “government-run health care.” Universal coverage is not possible without government coercion — and all the disastrous side effects that come along with it.

Our current system may be problematic. But the “free lunch” promised by advocates of government-run health care is anything but. Its costs are clear: price controls that stifle medical innovation, and a rationing of medical services that leaves many patients out in the cold.

Peter Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.

While it's nice having a doctor in the family -- it shouldn't be your Uncle Sam.  Read More & Comment...

It Depends On What Your Meaning of Debate Is

01/23/2008 08:00 AM |

Jan 22, 2008 20:58 | Updated Jan 23, 2008 9:48
Oxford Union stages 'farcical' debate
By JONNY PAUL, LONDON

From the Jerusalem Post

Oxford University's debating society is being accused of childishness and sensationalism by Jewish groups after inviting participants with alleged anti-Israel backgrounds to support a motion questioning Israel's right to exist in a debate on Thursday....

Proposing the motion are Norman Finkelstein, formally of De Paul University in Chicago, and Ted Honderich, professor of philosophy at University College London.

Finkelstein's books include The Holocaust Industry: Reflections on the Exploitation of Jewish Suffering and Image and Reality of the Israel-Palestine Conflict. On his Web site, he hosts Brazilian cartoonist Latuff, whose work won second prize in Iran President Mahmoud Ahmadinejad's Holocaust denial art competition in December 2006....

Opposing the motion in the Oxford debate is Palestinian scholar and activist Ghada Karmi, who believes that Jews do not constitute a nation and they lack "biological, racial or national characteristics."

Joining Karmi is Israeli academic Ilan Pappe, currently at Exeter University in the UK.

Last February, Pappe declared his warm friendship with Hamas leader Ismail Haniyeh and suggested that Hizbullah leader Hassan Nasrallah "should be put on the committee to decide the future of Israel."

Emily Partington, president of Oxford University Union told The Jerusalem Post: "The motion was decided upon as it is a current topic of discussion, and people who might not have extensive knowledge about the State of Israel may well question the existence of a state which appears to differ so greatly from others. Much of the interest in the motion derives from the debate about what constitutes Israel, and what Israel does. All of the participants in the debate will be arguing from their own independent perspectives, rather than representing anything or anyone else."

Translation: we excluded people who support Israel from the debate who are "paid" to represent Israel and who therefore are obviously biased in their view of a what a state is and should be is so different (and by our standards, racist.) So our debate is really the fair and balanced one because our participants independently concluded Israel should be wiped off the map.

Excluding scholars because they associate with Israel or disqualifying them because they represent Israel is just plain wrong. The same goes from barring them from engaging in important research, holding faculty positions, sitting on panels, etc? Where does the the game of connect the dots turn into outright persecution?

Isn't it wrong in other areas of intellectual and political life as well?
Read More


  Read More & Comment...

Why the Media and Pharma Blogosphere Fails to Get Personal

01/22/2008 10:01 AM |

Consider Alex Berenson's coverage of the cholesterol-heart disease risk connection and his mangling of Eric Topol's insights to fit a certain ideology:

“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.

Makes it sound like he is trashing statins like Vytorin right?

Here's Eric on two different ocassions: First, from his provocative blog on the ENHANCE study which I summarize:

Not all LDLs are the same. There are different ways to lower different LDLs based on the ways they are oxidized. Topol is emphatic in pointing for instance that women do not benefit as much from statins in LDL as men do. Are we not doing enough or have we overcooked the aggregate LDL-heart attack link?

http://blogs.theheart.org/

Previously to that, Topol noted in the wake of the discovery of genes that cause differential response to different statins: "Researchers have known for years that cholesterol, a fatty protein that can cling to the walls of blood vessels and raise heart risk, is linked to the action of enzymes that can be blocked with medicines such as Pfizer Inc.'s Lipitor. The genes open up the possibility of new drugs that can help more patients avoid heart disease"

``Obviously, we only knew part of the story,'' Topol said Jan. 11 in a telephone interview. ``Now we can study whole new pathways and understand how they become deranged in people with blood vessel disease.''

On top of all this come this hasty fix of yet another Berenson boo-boo

"Correction: January 18, 2008

A headline in Business Day on Thursday with an article about research involving two widely used cholesterol-lowering drugs misstated the issue raised by the results. It is whether using drugs to lower cholesterol at all costs is always medically effective, or even safe; there is no question that cholesterol itself can pose dangers."

Rush to judgment or poor reporting or both? And who said the conclusion of ENHANCE was to lower cholesterol at all costs? Roy Poses? That sounds like a pretty ill-informed or biased reading of ENHANCE since the question once again whether or not Vytorin reduced the risk of heart attack caused by atherosclerosis in familial hypercholesterolemia. Nothing more. It did lower LDL more than generic Zocor alone but missed the athero endpoint as measured by the murky imaging marker. As Nissen knows, lots of trials designed to reduce plaque by reducing LDL or even increasing HDL tend to miss their mark. We don't know why, but I put my money with Topol instead of Nissen to come up with new drugs based on new insights and for someone else other than Healthcare Renewal to explain the clinical value in an unbiased matter that would benefit me as a patient.

It would have been nice to have given Topol's insights on personalized medicine more play. But that would have undermine the effort to paint Big Pharma as a bunch of thieves. So here's the point: the failure of the I hate pharma crowd in the media and blogosphere to address the personalized medicine story is not an oversight. It is Lysenkoism and Healthcare Renewal is leading the way.

http://www.newsinferno.com/archives/2418  Read More & Comment...

And speaking of statins ...

01/22/2008 09:05 AM |

According to today’s Wall Street Journal, “Researchers said they identified a genetic variant that is linked to both an increased risk of a heart attack and a person's chances of preventing such an attack by taking a cholesterol-lowering pill called a statin.”

“Discovery of the KIF6 variant was announced by Celera Group-Applera Corp., an Alameda, Calif., diagnostics company known for having mapped the human genome in 2000 in a high-profile race with a government-funded project.”

Details are reported in three studies being published Jan. 29 by the Journal of the American College of Cardiology and now available on the publication's Web site:

http://content.onlinejacc.org/in_press.dtl

“The interaction of KIF6 with statin therapy "is a very interesting and unexpected finding," said Marc Sabatine, a cardiologist at Brigham and Women's Hospital, Boston, and a co-author of one of the papers. While it would be "premature" to base treatment decisions on a patient's KIF6 status, he said, the results "take us one step closer to personalized medicine" in which doctors use genetic data to tailor therapy for patients.”

Celera plans to launch "in the coming months" a genetic test for about $200 for the KIF6 variant.

"It's quite provocative," said Eric Topol, a cardiologist and director of Scripps Genomic Medicine and a cardiologist at the Scripps Clinic, La Jolla, Calif. "It could be a marker but there are a lot of question marks surrounding it."

Researchers said further study of KIF6 could help identify mechanisms for how heart disease develops and possibly new targets for drugs to treat it.

Here is the link to the story (subscription required):

http://online.wsj.com/article/SB120096559471905225.html?mod=dist_smartbrief&apl=y&r=204309

And personalized medicine marches forward.  Read More & Comment...

Everyone has a right to their own opinion as long as they agree with me

01/21/2008 02:29 PM |

Let me respond to the latest tut-tut from Roy Poses who insist he isn’t calling physicians who work for drug companies or consult for them prostitutes but just wants transparency about their funding sources. I see a backtracking big time, much hypocrisy and huge bias. There is no doubt Poses is part of the “I hate Pharma” crowd along with many in the blogosphere. And he presumes that the only source of bias that affects the public health adversely – mostly without empirical evidence – is financial inducements from drug companies. He even uses the pejorative term “collaboration” as in drug companies are “now are the largest collective source of medical research money, they are thus under great pressure to collaborate with these companies. An academic trying to raise research money from one such company might find it hard to resist offers of consulting fees, speaker’s honoraria, advisory board positions, etc from that company. But once the academic thus starts to work part time for the company, who knows where his or her interests lie?”

So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog).

He gives two examples

“For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.”

Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality.

Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural” cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach?

Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.”

Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False:

“Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable].

But let us focus on other forms of bias.

For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.”

The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates” with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers.

Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep.

In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power.

The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted:

“Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.”  Read More & Comment...

DTC² and Vytorin

01/21/2008 08:36 AM |

Should Vytorin continue to advertise? What impact, if any, will this question have on the larger issue of DTC regulation? These and other questions are discussed in a worthwhile article in this week’s edition of Advertising Age.

Here’s a link to the article:

http://adage.com/article?article_id==123228

And a few paragraphs to whet your appetite:

"Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.

Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold, Mr. Pitts said. DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it.

But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. The industry should absolutely explain to the general population where drugs come from and how they're made," he said. “It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."

That being said, it’s good news that, in yesterday’s edition of the New York Times (and elsewhere) there was a Vytorin ad that tried to put the current study into perspective.

Nice start – but more needs to be done. Vioxx was a missed opportunity to talk (soberly and sensibly) about safety (risk/benefit). Let’s not let Vytorin be a missed opportunity to talk about what clinical trials can tell us – and what they cannot.

This is an important teaching moment -- and can show the potency of DTC advertising and, more broadly, DTC² (direct to consumer communications) as a way to educate the public (yes -- politicians too) about the urgency of personalized medicine and 21st century clinical trial design.

Tough and complicated topics? You bet. But (as Tom Hanks said in A League of Their Own) "If it was easy, anyone could do it."  Read More & Comment...

Sunday Best

01/20/2008 10:12 AM |

Have a look at today’s New York Times editorial,“The Real Price of Fakes.”

Here’s a link:

http://www.nytimes.com/2008/01/20/opinion/20sun3.html?_r=1&ref=opinion&oref=slogin

And here’s the concluding paragraph:

“Some people in Congress want to tighten penalties on counterfeiters, a good but modest move. More to the point, the Consumer Product Safety Commission and the Food and Drug Administration need more money. And businesses that often avoid acknowledging the fake trade, for fear of damaging their brand, should be more open with consumers about how to tell the difference between real and unreal. Until then, buyer beware.”

A few points. First is that, absolutely, penalties must be significantly enhanced. Today the risks are too low and the rewards too high – and that will only lead to exponential growth in the counterfeiting of prescription medicines. According to the WHO, “The US based Centre for Medicine in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.”

Willy Sutton, the depression-era criminal, when asked why he robbed, replied “because that’s where the money is.” If Willy Sutton were alive today, he’s be in the counterfeit drugs business – because that’s where the money is.

Second – and speaking of money – glad to see that the Times is calling on Congress to give the FDA more money to combat prescription medicine counterfeiting. And while they’re at it, the Times editorialists should also call out those members of Congress who want to actually tie FDA’s hands in dealing with this menace.

In 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.
Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.

Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market.  Read More & Comment...

The Anti-Pharma Crowd Is Anti-Growth

01/18/2008 03:02 PM |

I have a lot of respect for John McCain but I wonder about what Leon Wieseltier of the New Republic praised and referred to as his "contempt for drug companies."

His contempt is getting in the way of clear thinking and good policy. And at time when we will need all the high paying, green jobs we can get, McCain's stance on pharmaceutical innovation -- where most of those jobs will be created worldwide -- is downright regressive and is at odds with his claim to be a pro growth Republican. If there has been a Republican, nay a member of Congress, with more pronounced and persistent antipathy to the pharmaceutical or biotech industry than John McCain, I can't think of one with the exception of New York’s two senator’s Charles Schumer or Hillary Clinton.

If he took the same position on the auto or housing industry he has on pharmaceuticals and biotech, he would shove the nation into an instant depression.

His contempt has been on display throughout the campaign, most notably in the New Hampshire debate when he call them "the bad guys". Why? From the straight talk express we never seem to get a straight answer. Seems to be related to his belief that drug companies inflate drug costs at government expense and artificial monopolies.

If drug costs reflects value, fine," "But if there are ways to bring greater competition to our drug markets by safe re-importation of drugs, by faster introduction of generic drugs, or by any other means we should do so. If I'm elected President, we will."

McCain has said: Problems with costs are created when market forces are replaced by government regulated prices.."

Yet he has aggressively pushed importation of drugs from foreign countries where "market forces are replaced by government regulated prices." And his legislation would force drug companies to sell as much of their price controlled product that is made to foreign spec -- not US spec -- as distributors would order and then would force the FDA to approve it instantly as safe and effective for the US market. Imagine forcing car, timber, building product, and steel companies to do the same! Meanwhile, Canada is the transhipment point for drugs from Iran, Pakistan, China, Venezuela..all our friends. The ultimate destination. America. McCain has no problem with letting Canada's lax importation policy stand as a surrogate for our drug and homeland security.

What are the “other means?” McCain voted for price controls and government run drug formularies for Medicare, especially when an HMO wanted to save money and pass it on to the government. This approach is used at the VA to restrict access to newer drugs and has actually shortened the lives of veterans. If imposed on Medicare and Medicaid it would mean seniors and the poor would be the last to the get what newer medicines are developed, if any are left.

Meanwhile according to a study by the Milken Institute, the biotechnology industry generated more than 2.7 million jobs and $172 billion in real output in 2003. The average income of each “green: job? $60000 plus benefits. But leave it to McCain to be the sponsor of a bill this coming session of Congress that would give overseas generic drug firms an incentive to sue new biotech firms for their patents before they expire in order to create “competition.”  Read More & Comment...

Don't Ask, Don't Tell? Or All the News that's Fit to Print?

01/18/2008 01:55 PM |

Yesterday we commented on the New York Times neglecting to mention -- in a story about clinical trial transparency and Prozac (along with other drugs) that Eli Lilly & Co. posts its clinical trials on a public website.

Well, sins of omission are seldom fun.

Here's Lilly's response:

INDIANAPOLIS, Jan 18, 2008

"Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.

The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.

Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.

In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.

In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.

The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.

We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked."

Has the New York Times changed its motto from "All the news that's fit to print" to "Don't ask, don't tell?"  Read More & Comment...

Consumerism vs. Populism

01/18/2008 08:02 AM |

The “authorized generics” debate has made it to the other side of the pond. The Financial Times reports that the EU Commission is concerned that the price of medicines is rising -- while innovation declines—and will investigate whether the pharmaceutical industry abuses patent rights to delay the introduction of low-cost generic alternatives.

The Financial Times writes, “The answer may be that collusion between companies keeps prices high. But the pricing of medicines in much of Europe is more government-controlled than in the US. Companies may profit from national pricing. In the UK, where there is a freer approach, competition is more intense and discounting heavy. Not enough deregulation may be the bigger problem.”

Here is the complete Financial Times editorial:

http://www.ft.com/cms/s/0/75dbce42-c52c-11dc-811a-0000779fd2ac.html?nclick_check=1

For more discussion of the authorized generics issue, along with an economic analysis of the same, please see:

http://drugwonks.com/2007/05/rockys_racoon.html

The conclusion of the Financial Times editorial is spot on – and something we should take to heart on our side of the Atlantic as well – that we must be careful that “a consumer-first approach does not become a populist one.”

And -- when you consider some of the health care rhetoric being bandied about by the Presidential candidates -- that’s a notion worthy of serious consideration.  Read More & Comment...

The Ultimate "Halo" Effect

01/18/2008 07:37 AM |

A US study by the Banner Good Samaritan Medical Center in Phoenix, Arizona has found surgical residents performed better during simulated surgery after playing on the Wii for an hour beforehand.

"The whole point about surgery is to execute small, finely controlled movements with your hands, and that is exactly what you get playing Wii," Kanav Kahol, who conducted the study with colleague Marshall Smith, told New Scientist magazine.

Professor John Quin, executive director of surgical affairs at the Royal Australasian College of Surgeons, said the study was interesting and showed promise, but it was still not clear whether better performance in simulated surgery translated into better performance in surgery on a live patient.

"What it shows at the moment is only that if you repeatedly play video games you get better at playing video games," he said, adding the RACS was conducting a Federal Government-aided study to determine the effectiveness of simulated surgery.

Professor Quin said he hoped high-tech tools like the Wii and simulated surgery proved useful because "it's getting more and more difficult to train the full experience of the surgical operation".

The study found only those games requiring precise movements, like Marble Mania in which a player guides a marble through a 3D obstacle course using the Wii's motion-sensitive remote, are effective.

"You don't gain a lot from swinging an imaginary tennis racket," Kahol said.

Past research by other academics has similarly found video games requiring fine control can help build the skills surgeons need for operations like keyhole surgery.

Kahol and Smith are now reportedly designing Wii software to accurately simulate surgical procedures. For developing countries unable to provide expensive professional training systems, the Wii could be used as a cheap and effective training tool.

In conducting their study, the pair called on eight trainee doctors to play the Wii for an hour before performing virtual surgery using a tool called ProMIS. The training tool provides a 3D simulation of a patient's body and tracks the surgeon's movements while they are "operating".

Movement data was then processed using an algorithm and the surgeons were given scores. Those who played the Wii scored 48 per cent higher on tool control and performance than those who didn't.  Read More & Comment...

The $300 medical prognostication

01/17/2008 12:53 PM |

A combination of common and minor variations in five regions of DNA can help predict a man’s risk of getting prostate cancer, researchers reported Wednesday.

According to today's New York Times:

"A company formed by researchers at Wake Forest University School of Medicine is expected to make the test available in a few months, said Karen Richardson, a Wake Forest spokeswoman. It should cost less than $300.

This is, some medical experts say, a first taste of what is expected to be a revolution in medical prognostication. The results, they agree, are clear. But the question is what happens next."

Here’s a link to the complete story:

http://www.nytimes.com/2008/01/17/health/17cancer.html?scp=1&sq=medical+test  Read More & Comment...