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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.
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!

Annal-yze This!

  • 01.30.2007
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.

Kamp, Counselor

  • 01.30.2007
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.
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.
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?
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....
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?
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.
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
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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