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.

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.

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.

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....

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.

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.

The left has been complaining for years about how the tax system is unfair to the poor and working class. So when the president comes along with a plan level the playing field where it really counts -- a tax cut that makes health care affordable no matter where you are or whether you are working -- their reaction is predictable: spend money (either directly or in the form of tax credits) to shove people into Medicaid.

Here's Ron Pollack's predictable response to the tax cut:

“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.”

Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?

Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.

But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.

Ask the 10,000 people at Pfizer who are losing their jobs.

Story Landis, director of the NIH's National Institute of Neurological Disorders and Stroke testified before a Senate committee today that need for federal funding for embyronic stem cell research was compelling:

"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"

That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --

Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:

* A drug is a single source drug, which means there is only one brand name of the drug available;

* A drug was created with substantial taxpayer funding for its research and development;

* A private insurance plan requests help; and

* For any fallback plan for which the Secretary must provide.

A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"

Now that the Democrats control the purse strings, left wing organizations will try to force their ideology on to science-based federal agencies. It will happen with the FDA and it has just happened with NIH where the crazies have decided that because researchers consult for industry they are a notch below or above being criminals. It's not enough that talented NIH scientists are leaving the agency in droves. Now anyone who lectures on subjects they know about can't participate in guideline development. That leaves people who, of course, are loyal to the left wing agenda of groups like the Center for the Science in the Public Interest.

As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.

Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.

Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."

All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.

NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong

The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.

The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.

The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.

In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.

The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.

The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.

The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."

As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.

The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.

According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.

Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.

The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.