Part D: Enrollment Up, Costs Down

02/01/2008 08:25 AM |

The three-year-old Medicare Part D drug program is seeing the number of its enrollees climb, even as costs for the program fall.

"Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high," Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), told reporters.

According to Weems, the projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. "This means that over the 10-year period [from] 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion," he said.
At the same time, he reported, after the third open enrollment period that ended in December, the plan now has an additional 1.5 million people.

"Overall, there are about 25.4 million people enrolled in Part D," Weems said.

Most people surveyed today -- more than 85 percent -- are satisfied with the plan, Weems noted.

Can Part D be made even better -- absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda, but rather because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical intertventions -- which in turn reduces our overall national health care spending.  Read More & Comment...

Mental health care as if patients mattered: A second look at CATIE

02/01/2008 07:15 AM |

Much has been made about how great and definitive large head to head studies of drugs such as CATIE or ALLHAT are in guiding what drugs to us. We at CMPI have often bee criticized when we talk about diagnostics replacing one size fits all trials as saying such personalized medicine is not ready for prime time. But what if more research – such as larger observational studies or Bayesian analysis of social experiments -- allowed a closer and statistically meaningful look at patient differences and how drugs worked? Given all available drugs and subtracting the cost of additional research how valuable – measured in terms in years free of schizophrenia -- would research that allow doctors and patients to prescribe the right drug generate.

Using the CATIE results as a baseline, Anirban Basu, PhD, David Meltzer, MD, PhD and Herb Meltzer, MD of Vanderbilt University estimate that such personalized research would be worth $342 billion over the next 20 years assuming that each additionally additional year of life free of schizophrenia is worth $50000. The authors note that this estimate does not take into account the ability to assign patients to treatment using more highly predictive algorithms that could raise the value even more. The value to more precisely establishing the cost-effectiveness of typical/atypical antipsychotics by more precisely establishing differences in patients –even in the absence of genetically based diagnostics is enormous. Considering that CATIE cost $42 million and is justified largely in terms of saving money for government, the CATIE results should not be considered definitive.

The study was sponsored by Best Practice, Inc. with partial support from the Foundation for Education and Research on Mental Illness, Janssen Pharmaceuticals, and the Center for Medicine in the Public Interest.

For full study results go to

http://www.cmpi.org

And look under "Reports" for "Expected Value of Research on the Comparative Cost--effectiveness of Antipsychotics Drugs."

Important stuff.  Read More & Comment...

What Price Hope?

01/31/2008 08:21 AM |

Important story in today’s Wall Street Journal on the topic of patients who suffer adverse events during clinical trials and the broader issue of informed consent. The article focuses largely on the story of Suzanne Davenport, a 71-year-old retired kindergarten teacher, diagnosed with Parkinson's in 1989.

Here’s a link:

http://online.wsj.com/article/SB120173515260330205.html?mod=hpp_us_pageone

One of the major issues discussed is standardization of consent forms. According to the Journal:

“Consent forms and compensation plans vary by institution. There have been sporadic calls to standardize these programs, but none have been widely adopted. The Institute of Medicine, a nonprofit group that advises the government on health policy, recommended in 2002 the creation of a "no fault" compensation system for injured subjects. The goal was to help trial participants resolve their claims quickly, without having to resort to lawsuits.”

But a far more difficult question (not discussed in the WSJ article) is that of patient therapeutic misperception. Can a patient really make an informed decision about what risks he or she is willing to take in the face of serious disease?

To investigate what patients really understand about the trials in which they have enrolled, leading Parkinson’s Disease researchers, ethicists Kim and Kieburtz, have been awarded a 2007 Michael J. Foundation grant to study ongoing participants of PD clinical trials that involve sham surgery controls. They plan to assess, by structured interviews, the potential for the therapeutic misconception i.e., why and how PD patients make their decisions regarding participation in sham surgery controlled studies

Regardless of the outcome, the biggest question remains the concept of what desperate patients want to understand and what they will do for a glimmer of hope.  Read More & Comment...

IQWiG-ing Out

01/30/2008 08:36 AM |

On January 24th, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) released the first version of its draft methodology paper on cost-benefit analysis.

Here's a link:

http://www.iqwig.de/download/08-01-24_Methods_of_the_Relation_of_Benefits_to_Costs_Version_1_0.pdf

(It's in English. What does that tell you?)

IQWiG will host an open forum on February 26 to discuss this paper, and written comments will be accepted until March 31, 2008.  Read More & Comment...

Boss-Based Accounting

01/30/2008 08:25 AM |

According to the Wall Street Journal (and other media) "Congressional Democrats began a push for more Food and Drug Administration funding, saying the agency lacks the resources to deal with risks to consumers and pressing the agency's head to endorse more spending."

Now as far as Andy tin cupping -- that's not going to happen. Not that it isn't justified -- it's just not how the system works. That's the job of Andy's boss -- and his boss' boss.

But increased funding is required -- and it ain't gonna come from PDUFA fees.

Time to step up to the plate, Mr. President.  Read More & Comment...

Man Hours vs. Mandates

01/29/2008 02:03 PM |

Talk about a report that's dated before it gets printed. A just released GAO study reports that ... ready ... sitting down ... here it comes ... the FDA is under-staffed and under-funded. Gasp.

What? You thought FDA reform was a done deal. Er, no.

Consider this factoid, over the last 14 years, the FDA has lost 1311 employees and nearly $300 million in appropriations -- while Congress has lathered on additional mandates and responsibilities.

And they have the chuzpah to accuse FDA of not doing its job. Shameful but, unfortunately, not surprising.

And you know who you are.

Okay -- once more with feeling -- those four little words that mean real FDA reform ...

Show me the money!  Read More & Comment...

Speaking of Selling Out to Soros

01/29/2008 12:53 PM |

While we are on the subject of conflicts, I am still waiting for the Pharmaceutical Purity Priesthood to connect the dots between those who comment on pharmaceutical funding and their funding from George Soros. While doing so, here's a great piece by Michael Fumento in the Weekly Standard on how the Lancet continues to ignore and coverup the Soros funding of the now deeply discredited 2006 Lancet study of Iraqi war deaths. Not only did the Lancet hide the Soros funding and not ask the authors to disclose the funding, it timed the release of the highly inflated numbers to the weeks running up to the 2006 mid-term election where of course it received maximum coverage.

Fumento writes:

"Horton spoke at a rally in 2006 sponsored by Stop the War Coalition, a British group set up on September 21, 2001, which is to say its purpose was to oppose punishing and defeating the perpetrators of the 9/11 attack. At the rally, Horton shouted about the "mountain of violence and torture" in Iraq--and no, he wasn't talking about Saddam. "This axis of Anglo-American imperialism extends its influence through war and conflict, gathering power and wealth as it goes, so millions of people are left to die in poverty and disease," he angrily added. This is not your father's medical journal editor.

As National Journal revealed, Lancet's 2006 study was about half funded by antiwar billionaire George Soros, who in a November 2003 Washington Post interview said that removing President Bush from office was the "central focus of my life" and "a matter of life and death." This no doubt explains the release of the Lancet study four weeks before the 2006 midterm elections, just as Lancet's 2004 study was released days before the presidential election. Even the magazine's ardent defenders don't claim the timing was a coincidence.

The 2006 Lancet report states only, "Funding was provided by the Massachusetts Institute of Technology and the Center for Refugee and Disaster Response of the Johns Hopkins Bloomberg School of Public Health." Soros is known for concealing his massive political donations, and the Lancet was complicit on this occasion."

As I have noted before, there are many sources of bias and conflict in publications. Financial conflict is but one. I would say political and ideological bias looms larger and is more problematic. As I will argue in future posts, a new pseusdscience of pseudocertainty is forming around meta-analysis to feed into the desire of trial attorneys to usurp FDA control over drug labeling authority. My guess is that much of the leftist and purist blogosphere will fall into line around using meta-analysis to challenge the FDA's right of pre-emption on the subjective grounds that it is a "captive" of the industry it regulates. Again, this challenge ignores outcomes and risks and arrogates the framing of those risks to trial attorneys and "their" experts who are funded by....George Soros, trial attorney backed groups, etc.

Not coincidentally, though this is entirely speculation on my part, the Lancet was the source of the article that claimed the MMR vaccines caused autism.



http://www.fumento.com/military/lancet2008.html  Read More & Comment...

Is Infectious Disease Resistance Futile?

01/29/2008 12:39 PM |

Antibiotic research is drying up because of a politically inspired demand for larger clinical trials and a push for placebo controlled trials where they need not be required. Congress tosses money at the problem when reform is needed. So I agree with Sid Wolfe when he says: “I’m tired of all these lures to an industry making so much money today that they can’t even see straight,”

The lures are to biotech start ups mostly. But mostly they need regulatory help and money for Critical Path. Two weeks ago the FDA, academics and industry held a workshop on clinical trial design in cooperation with the Infectious Disease Society of America. The key issue was when to use adaptive trials and other approaches. This is like returning to "GO" in Monopoly. We should be much farther ahead in our approach to drug development in infectious diseases. Kudos to Helen Boucher, David Shlaes and FDAer Ed Cox who have been nurturing this working relationship. It needs -- via support for Reagan Udall -- support from unusual suspects such as hospital groups, private foundations, food companies, as well as FDA senior leadership, from HHS and Congress. Oh wait, this might lead to conflicts. So forget it, let a thousand bugs multiply. What's a thousands deaths and disease when the real disease we are trying to contain is the corruption of our medical research establishment at the hands of BIg Pharma?

http://blogs.wsj.com/health/2008/01/28/new-antibiotics-grow-scarce-as-bad-bugs-multiply/  Read More & Comment...

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.
.
* 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...