Climbing the Peak of CDER Sinai

03/11/2008 06:04 PM |

After a national search for a new CDER director -- the best and the brightest was chosen.

Dr.Janet Woodcock is returning as full-time center director.

An overdue homerun for the FDA.  Read More & Comment...

But Let's Prevent Them From Working With Industry Anyways

03/11/2008 10:56 AM |

Leave it to the conflict of interest police to dig an even deeper hole for academic researchers and destroy American competitiveness: NIH funding is declining, restrictions on NIH researchers and NIH supported researchers are tighter than ever and now the conflict Kapos want to prohibit researchers from any sort of collaboration with drug companies or biotech firms.

A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Scientists from UCLA, Harvard, Vanderbilt and four other research institutions say that the stagnant NIH budget is persuading young researchers to go into other careers or move to other countries which have proved more generous to biomedical research. To drive that point home, the report--"A Broken Pipeline"--profiles 12 young researchers engaged in groundbreaking work on stem cells, cancer and kidney disease and their difficulty finding new grants.

"This is a real problem, discussed at almost every meeting one attends on campus, that can't be simply dismissed," said Drew Faust, Ph.D., president of Harvard University. "This is about the investment that America is--or is not--making in the health of its citizens and its economy. Right now, the nation's brightest young researchers, upon whom the future of American medicine rests, are getting the message that biomedical research may be a dead end and they should explore other career options--and in too many cases, they're taking that message to heart. The president's latest budget proposal that calls for another year without an increase will only make the problem worse."

fiercebioresearcher.com

They live in a la-la- land where the government will just double NIH funding by raising taxes and -- according to the Soros-funded Institute for Medicine as Profession -- also add billions more to carry out drug development.

Why doesn't the media ever look at the implications of these ideas. I have always said, people like the folks at Healthcare Renewal, Sid Wolfe, Marcia Angell, Merrill Goozner, etc are willing to harm the public health en route to killing the private sector's role in drug development. If their conflict of inflict agenda is adopted -- which also opens doctors to the increased threat of lawsuits from trial attorneys -- they will have taken a strong stride towards that misanthropic goal....  Read More & Comment...

Disconnect on Drug Patents

03/10/2008 12:48 PM |

Two articles in the Wall Street Journal regarding the use, misuse and theft of drug patents...Of course all the drugs made by Thai-government run companies will be used for the poor and be of top quality....And none of them will ever make it onto the black market because there are SO many limits placed on selling inferior or bogus drugs to unsuspecting people in poor countries...



http://online.wsj.com/article/SB120515886199824251.html?mod=djempersonal

http://online.wsj.com/article/BT-CO-20080310-706680.html?mod=djempersonal  Read More & Comment...

Smokin Aces

03/10/2008 07:27 AM |

The House Energy and Commerce Committee's health subcommittee is scheduled to pick up Tuesday where it left off Thursday, discussing and possibly amending the tobacco-control legislation before certain passage. The full committee would then take up the bill, and passage there appears certain as well.

Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.

Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.

One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.

Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.

Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.

So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.

So for now, thank you for not regulating.

FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry.  Read More & Comment...

Something in the Water....

03/09/2008 03:52 PM |

Leave it to the mainstream media to pump out the ultimate scare: Big Pharma pollutes the water supply!!!!

AP probe finds drugs in drinking water

By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers

"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."

What no Viagra? What about OTC products? Is this some off-label use conspiracy?

"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."

Trillion? How about gazillion?


"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."

Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.

"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."

Yes, truly alarming, especially when you claim we don't know the risks.

"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."

Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.

The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:

"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."

Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?

The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:

"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."

Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...

Read Article Here

  Read More & Comment...

Getting into DDMAC's PJs

03/07/2008 03:51 PM |

What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?

For a complete answer, see here:

http://www.fda.gov/cder/ddmac/submissions.htm

And for an insight into regulatory creep, consider this little codicil:

"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."

This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.

After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.

Verifiable? How about verifiably inane.  Read More & Comment...

No empirical basis for measuring comparative effectiveness

03/07/2008 11:33 AM |

Here's Sir Michael Rawlins, the director of NICE, exposing comparative effectiveness as a back of the envelope calculation that has hardened into a tool for rationing:

" It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive."

Who do you trust, your doctor or the collective judgment of health economists and their ex cathedra statements..... Policymakers who support comparative effectiveness as evidence-based are engaging in Orwellian Newspeak.

Read more of the sloppy methodology deployed by cost containers....
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm  Read More & Comment...

Just do it

03/07/2008 08:28 AM |

Straight shooting from the Washington Post editorial page. And we concur.

Some snippets:

"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."

We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.

"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."

It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.

"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."

Yup.

Here's a link to the complete editorial:

http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html

It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.

Now.  Read More & Comment...

Junk Science and Austim: The Precautionary Principle Jackpot

03/06/2008 09:15 PM |

The National Vaccine Injury Compensation Program (NVIP) board voted to award a family monetary compensation in a case where the reviewers determined that the family was able to show -- not prove, not demonstrate on the basis of scientific evidence -- that it was not impossible to rule out that vaccines aggravated a rare mitochonrial disease (MD). MD is associated with systemic toxicity and nutrient starvation issues at the cellular level that can lead to developmental delays, brain damage and behaviors consistent with those found on the autism disorder spectrum.

Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.

Now the facts, ignored by the media and, it appears, the special masters reviewing the case:

1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.

2. Autistic features are associated with MD. So are developmental delays.

3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)

4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)

5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.

But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?

So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health.  Read More & Comment...

Ignorance, Bliss, and Gene Testing

03/06/2008 01:46 PM |

Can ignorance be bliss when it comes to information about your health? Is knowledge always power -- and can that power be abused? And what about the need for more robust FDA oversight of 21st centuty diagnostics?

Have a look at this article from today's edition of USA Today:

Companies cash in on checking your DNA for disease

By Rita Rubin, USA TODAY

Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.

Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.

Q&A: What to know about testing your genes

The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.


TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?

The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?

In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.

Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.

Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.

"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate."  Read More & Comment...

The End(point) is Nigh

03/05/2008 03:39 PM |

Since death is a surrogate for advancing to the next stage of Man's destiny, Senator Grassley should ask the GAO to investigate whether Pharma, in conspiracy with the FDA, is thwarting God's plan.  Read More & Comment...

Unintelligent Design

03/05/2008 02:32 PM |

So now Senator Grassley wants the GAO to determine whether or not using surrogate markers is sound science?

This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.

And the patient shall inherit the wind.  Read More & Comment...

Mass. Seeks To Ban Academic Freedom and Freedom of Speech

03/04/2008 05:54 PM |

MA Senate President Therese Murray wants to ban all gifts, grants and honoraria to physicians. You can go to jail and be fined $5000 for giving a talk sponsored by the biotech or drug company. Take a pen and go to the pen. Two years max.

All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.

I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...

And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..

" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.

Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html


No potential for conflict there.... I wonder who contributed to her campaign?

But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/

The conflict of interest movement is morphing into a lynch mob..  Read More & Comment...

Confusion, Conflict and Conflicts of Interests Grandfathered Into New Comparative Effectiveness Proposal

03/04/2008 04:56 PM |

Senators Baucus and Conrad have introduced the “The Comparative Effectiveness Research Act of 2008”. It has all of the conflicts and biases towards cost containment that other similar entities have.

1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.

But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.

2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?

3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "

Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...

Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."

Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.

4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.

Is there any evidence that these two assumptions are true?

How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...

And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?

How about a study about that?

All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.  Read More & Comment...

McCain and Autism

03/04/2008 09:24 AM |

On the heels of my article discussing McCain's market-driven views on health comes his statement to the effect that credible scientists believe that vaccines cause autism.

I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.

If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:

"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."

My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.

And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.  Read More & Comment...

"New Realism" Redefined

03/04/2008 07:41 AM |

We strongly support the free and fair sharing of legitimate scientific information. That's why we're in favor of both the use of reprints as an important way to share cutting-edge medical information with physicians and the FDA's draft rule on the appropriate ways to do so.

That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.

Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:

"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."

Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?

Some verbatim verbiage from the JAMA sales aid:

"Designed to be turn-key for rep delivery, mail, and distribution at conventions"

"Stimulates physician"

"Serves as an innovative, new offering for sales representatives and as a meeting premium"

The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:

"I use them as a sales tool and patient education material."

"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."

JAMA also quotes research showing the efficacy of such reprints:

"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."

There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.

Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.

Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."

Yeah, New Realism. It must be Dr. DeAngelis' favorite.

There's a lot of that going around these days.  Read More & Comment...

She was against it before she was for it

03/03/2008 01:33 PM |

According to an article in the Connecticut Post:

"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."

Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.  Read More & Comment...

Bangkok hears a WHO

03/03/2008 12:30 PM |

Previously we commented on the WHO sending a team to Bangkok to discuss compulsory licensing in the broader context of TRIPS flexibiltiies ("WHO to WIPO: Having wonderful time. Glad you're not here").

Here's a link to those comments:

http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html

Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:

Download file

To give you a hint as to the direction of the study, here are the final 14 words of the report:

"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."

And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."

However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:

"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."

But it's only a brief shining moment. Here's the end of that paragraph:

"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."

This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.

What would John Calvin say?  Read More & Comment...

More Thai Shtick

03/03/2008 12:13 PM |

According to a report in the International Herald Tribune (via the Associated Press), the recently appointed head of Thailand's Food and Drug Administration resigned Monday "amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs."

Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.

Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.

Here's a link to the complete article:

http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php

Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft.  Read More & Comment...

Saving costs, saving lives

03/03/2008 11:26 AM |

Although HTAs seem not to have hit my home country yet, because of socialized medicine this appears generally without giving its name.

Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."

Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.

This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »

The defence rests.  Read More & Comment...