Commons Sense

02/03/2007 09:19 AM |

Those who think there's health care nirvana Over There, should consider this article from today's edition of the Financial Times:

NICE faces inquiry by Commons group
By Nicholas Timmins

The Commons health committee yesterday announced terms of reference for a broad inquiry into the work of NICE, the National Institute for Health and Clinical Excellence.

The committee said it wanted to examine "why NICE's decisions are increasingly being challenged" after recent controversial recommendations that the NHS should not use certain costly cancer drugs and should restrict the use of drugs to treat Alzheimer's to those with moderate forms of the disease.

The committee said it wanted to know "whether public confidence in the institute is waning, and if so why", and said it would be looking at both NICE's evaluation process and the appeal system.

At the same time it will compare the work of NICE with that of the body that is roughly its Scottish equivalent. In some cases the latter has approved treatments that NICE has rejected.

The pharmaceutical industry's concerns that the NHS fails fully to implement NICE's recommendations when it does back new treatments and procedures will also be addressed.

The committee said it wanted to look at "which guidance is acted on, which is not and the reasons for this".

NICE is currently facing a judicial review backed by pharmaceutical companies and the Alzheimer's Society over its decision on Alzheimer's products.

The society said yesterday that the inquiry "should put a long-overdue spotlight on NICE's methods" and the "glaring absence" of an independent appeals process.  Read More & Comment...

Does Kenzi Punt on PDUFA?

02/02/2007 04:32 PM |

I have had the chance to read both Kenzi 2.0 and the FDA's response to the scientifically illiterate IOM report. It reads like a Nobel Prize winner grading a high school essay....

http://www.fda.gov/oc/reports/iom013007.pdf

Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.

It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."

And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?


As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.

The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.

It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.

The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.

Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.

Finally, I still don't believe that we have a big crisis in drug safety.

We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people.  Read More & Comment...

WHO to Coup: Don't Do!

02/02/2007 04:11 PM |

The World Health Organization has cautioned Thailand over its move to adopt compulsory licensing for producing generic versions of heart disease and anti-Aids drugs.

''I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity,'' said WHO director-general Margaret Chan.

Brava!

Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.

She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue.  Read More & Comment...

Legislative Biomarkers

02/02/2007 08:43 AM |

Here it is, Kenzi 2.0:

Download file

It's better. But is it reform?

The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.

Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.

The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.

Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.

But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.

The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.

The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.

What do we think about Kenzi 2.0? We can do better. We must do better.

And time is running out.  Read More & Comment...

Drugwonks: Not the Aquateam Hungerforce

02/01/2007 06:33 PM |

I have Peter's back when it comes to his post on Kenzi. I wrote a piece in the Washington Times supporting the beta version of the bill and I got nothing but flack by everyone for it. I supported the bill in it's nascent form because it understood that safety and efficacy were linked and that Critical Path was, well, critical to making medicines safer as opposed to requiring mindless chain of custody and post market data dredging for every drug.

The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.

Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.

Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.

Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.

And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.

As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly.  Read More & Comment...

Berenson Makes the News...

02/01/2007 06:13 PM |

Alex Berenson, who took a leave of absence from writing fiction at the New York Times to write fiction has himself become a central character in story that I bet Alex himself wish he had written:

Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer

A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.

The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."

In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.

Bad enough Jayson Blair made up facts.....  Read More & Comment...

Legislative Endpoints

02/01/2007 04:20 PM |

As we await the new version of the Kennedy/Enzi (nee, Enzi/Kennedy) bill and the debate over its half-brother PDUFA IV, it’s important to reflect on what “victory” looks like.

Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.” Drugwonks says “yes.” Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.

Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.” Drugwonks says “yikes.” If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.

Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenzi”) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst” alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.

Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?

Calling Dr. von Eschenbach ...  Read More & Comment...

AHRQ Comparative Effectiveness Studies: Depressing

02/01/2007 10:10 AM |

I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.

Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.

Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:

"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."

Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:

"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."

And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."


The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.

Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.

Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.

Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.



Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.

Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.

We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.  Read More & Comment...

Follow On Biologics....Weird Science and Fuzzy Math

01/31/2007 04:39 PM |

Follow-on biologics is a matter of when not if. But if it's introduction and explanation is left to the political hacks representing the managed care plans and the generic drug industry, Ben Affleck will have a hit movie many times over before a follow on biotech product is approved.

That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.

But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.

As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?





Download file  Read More & Comment...

Henry Waxman's Dangerous Political Science

01/30/2007 09:45 PM |

In his opening statement today on hearings about political interference with the work of government scientists (climate change) Henry Waxman said: I don't want politically correct science. I want the best science possible.

Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:

“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,” said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.”

It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....

In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.

Here's one effect of the Waxman peer review process...

Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.

The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.  Read More & Comment...

Drugwonks Welcomes a New Pharma Blog

01/30/2007 05:53 PM |

It's called Pharmalot (no relation to Spamalot) but the guy producing it does live about five minutes away from me. He's Ed Silverman, who has covered the drug and biotech industry for the Star-Ledger of New Jersey for over a decade. Ed's reporting has been hard hitting and informative (full disclosure, we have bought each other a cup of Dunkin Donuts cover twice in the past eight years).

Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.

Best of luck, Ed!  Read More & Comment...

Annal-yze This!

01/30/2007 03:28 PM |

Advertising is really a fancy word for calling attention to yourself, which is what the "authors" of a study -- more of a review of TV commercials -- in that prestigious medical journal the Annals of Family Medicine really is.

The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.

Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":

All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."

Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.

Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."

Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.

That's the difference between PSA's (pun intended) and advertising.  Read More & Comment...

Kamp, Counselor

01/30/2007 07:11 AM |

Our good friend John Kamp, Executive Director of the Coalition for Healthcare Communication, begs to differ with the recent report in the Annals of Family Medicine on the future of DTC communications. And he takes particular umbrage at a sidebar editorial by Dr. David Kessler.

As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.

We are proud to do so.

Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007

The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.

Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.

The full text of the statement can be found by clicking on this link:

Download file

Remember -- it's the First Amendment for a reason.  Read More & Comment...

The Love that keeps on giving

01/29/2007 07:15 AM |

Jamie -- you still haven't explained why a country with no primary health care system, with a growth rate of 6 percent per quarter and a medical tourism industry has to rip off patents (and your interpetation of the Blackberry case is novel to say the least..but then you have way of leaving out the context of situations to assert that something was compulsory licensing -- more research for me--) For every case you cite there is another view or another ruling. And you -- as you often do -- mix up arguments.

My point about Gleevec was the availabiliy of competent oncologists. And in any event, once you start confiscating patents you kill innovation so there's no Gleevec like drugs...Your prize idea is nice if you want to reward an idea but you vastly underestimate the risk and unpredictabiity of drug development, the cost of PM surveillance, the investment of follow on research, the need for industry and VC support of pre-clinical work, investment in new genomic based tools....

A proliferation of AIDS drugs manufactured by Asian pharmaceutical companies and the lack of controls for quality or delivery could create drug-resistant strains of HIV, warns a Treat Asia report made available to the New York Times. Treat Asia is a network of clinics, hospitals and research institutions sponsored by the American Foundation for AIDS Research (AmfAR). Only three companies out of at least 27 Asian firms that are producing HIV drugs meet World Health Organization quality standards, though these drugs are increasingly available in Asia and abroad, said Treat Asia. The drugs made by the 24 other companies have either not been reviewed or have not met WHO standards.

In addition, there are too few qualified doctors trained to prescribe and monitor the use of the drugs, Treat Asia said. China has fewer than 200 doctors to treat its 840,000 people with HIV. In Thailand, 100 doctors are trained to treat AIDS - one for every 6,700 patients. Thailand has exported $3 million in HIV drugs, yet it has 84,000 HIV-positive citizens who are not receiving treatment.

When China offered free treatment to 5,000 HIV patients recently, 20-40 percent stopped taking the drugs due to a lack of counseling and combinations that caused side effects, said the group. Elsewhere, many patients are left with "little or no instruction on the safe and proper use of antiretroviral drugs," the report said.

"Our point is if there is proliferation of the generic drugs, as many are calling for, where is the
infrastructure to deliver them?" said Kevin Robert Frost, report co-author and a public health worker in Bangkok for Treat Asia.

Treat Asia - which called for the creation of a regional database to help determine which drugs are available where - will make the report available beginning Sunday on its Web site: www.treatasia.org.

I also provide the link to the US Pharmacopeia report on the poor quality of generic version of drugs in Thailand...produced at the request of the President's AIDS program, the one you and I support...

http://www.uspdqi.org/pubs/other/ANEReview.pdf

You are living in the 1980s... and you have cast your lot with the parasites as opposed to the producers of better health.  Read More & Comment...

James Love Response to My Blog

01/28/2007 03:10 PM |

Robert, several points on this blog.

1. Countries can issue compulsory licenses for all sorts of reasons, not even limited to health, such as, for example, the recent US compulsory licenses for the Blackberry device, Microsoft DRM patents (held by Z4), Toyota, DirectTV and Johnson and Johnson.

2. Thailand has one of the best medical infrastructures in the world, which is one reason why it is becoming a common destination for European or US citizens, as a place for surgery. But this is besides the point. Since when do you need "infusion centers and trained technicians" to take Gleevec or Plavix?

3. Your claim that "The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains" is supported by what evidence? The WHO and the US FDA are both approving the quality of generic medicines for HIV. Is the Bush administration too "pro-generics" for you?

4. Your are free to have your own view of the Leavitt exchange. True, Leavitt did not issue a compulsory license to allow generic supplies. However, Leavitt has told Roche they must manufacture Tamiflu locally (a local working requirement on the patent), to protect US access and so the US can seize supplies in the case of an emergency. If Roche had refused this request? If they had refused, Leavitt was in the position to issue the compulsory license. The testimony has read by many as a unilateral demand by the US for local production, made at the very time the US Congress was asking for the compulsory license. As you noted, Leavett told the Congress, that if Roche did not expand production, "its important for Americans to know that the federal government will do everything necessary to protect people in this country." What exactly does that mean to you? Canceling Christmas cards for Roche?  Read More & Comment...

Jamie Love: Not a Bad Dancer

01/25/2007 10:48 PM |

In his blog in today's Huffington Post, Jamie Love implies it's ok to seize patents for all sorts of reasons. The fact is, there is only one reason, one measurable objective -- two actually -- that any nation can undertake to seize a patent before it expires and license to another manufacturer. First, it must demonstrate that their is an observable public health benefit that will be derived by that action as opposed to purely political gain. It's one thing to have a cheaper drug on a market. Another thing to have the infrastructure to deliver high-tech products. For instance, it would be nice to have Avastin available at discount prices in developing countries but you need infusion centers and trained technicians. Ditto Gleevec or Plavix.

Similarly, the whole HIV compulsory license thing has been a big fat joke on the developing world. The only people who have really benefit -- apart from those who are involved in the President's Global HIV plan and Gates activities -- are the profiteers in and out of the governments and the counterfeiters, those who mark up products fake or otherwise. The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains.

Now to top it all off, in his latest round of blogging...he misrepresents the truth. What a shock. He claims that Secretary Mike Leavitt testified he supported compulsory licensing. Here's the actual exchange between Congressman Tom Allen from Maine and Leavitt who just finished telling the House Commerce subcomm on Health that the prez wants to spend $7 billion to boost production of avian flu vaccine and anti-viral production

This video clip begins with Leavitt saying that Roche has promised not to let intellectual property be a barrier to generic production - Roche is willing to work with other companies that are able and prepared to produce the drug. He stresses that the drug is very difficult to produce, involving complicated steps, sometime dangerous - explosions are required in some of them. The Secretary concludes "It is not likely… that we will see any other manufacturers of Tamiflu certainly in a year and more likely two years. And that would be true in this country or any other country."

Allen responds that today the U.S. has insufficient manufacturing capacity for antiflu drugs, and Leavitt agrees. Allen tells Leavitt that on August 30, 2003 the WTO agreed on a set of rules under which countries with insufficient manufacturing capacity could import needed pharmaceuticals produced under compulsory license, but we opted out and persuaded other countries to opt out as well. The question from Allen: was this a wise decision? Leavitt answered that in times of a pandemic each country will only have access to what it can produce domestically, because each country will want to keep and use whatever it has inside its borders.

"Finally, Allen asks Leavitt if he would be prepared to issue a compulsory license if Roche failed to adequately expand production? Leavitt said that he did not think this would be needed, but he thinks its important for Americans to know that the federal government will do everything necessary to protect people in this country."

From this Jamie deduces that Leavitt is for compulsory licensing. What some people will do for America....  Read More & Comment...

Bill Clinton to Dems: We Were Right on Drug Price Controls

01/25/2007 10:22 PM |

Telling 100 Democrat strategists to expect aggressive health care proposals from his wife (would we expect shy ones) ex-President Bill Clinton -- who has not stopped spinning and legacy seaching (among other things) since he left office -- proclaimed that the recent Democrat retreat from imposing the VA formulary on seniors was a....(ready for this) vindication of HIS administration's effort to impose price controls on prescription drugs (including the Biotechnology Price Inquisition which caused biotech stocks to tank 40 percent and venture capital investment to hit the lowest point in the industry's history).

Yeah and the slaughter in Rwanda that happened under his watch and the hasty retreat from Somalia (also a Clinton production) was a roadmap for how to win in Iraq and send the right messages to Islamic fanatics.

Why does Newt Gingrich keep calling him the smartest man in American politics? Is that supposed to be a good thing?  Read More & Comment...

It ain't Shakespeare, but ...

01/25/2007 07:06 AM |

What? You haven't already read CBO's just released "The Budget and Economic Outlook: Fiscal Years 2008 to 2017!

Great prose? Certainly not. Great news? Absolutely (if you know where to look).

Consider this snippet which appears on pages 58-59 ...

"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."

"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."

Amazing as that news is, I do not predict a movie deal for the book.  Read More & Comment...

When is a Drug Risk not a Drug Risk?

01/24/2007 11:38 AM |

When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.

A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.

The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org

Not rocket science. Social science  Read More & Comment...

A Chronic Achievement

01/24/2007 08:08 AM |

President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.

It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).

Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).

And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.  Read More & Comment...