A Clinical Trial Should Not Be a Death Sentence

02/13/2007 10:15 AM |

Great commentary piece on expanding access to experimental therapies by CMPI board member Mark Thornton MD.

Drugwonks understands the need for well designed studies to prove safety and efficacy. But given the extent to which political pressure shapes what tools are used, we are skeptical when demands for longer, slower studies of the randomized type are constantly invoked. And when such studies turn away patients willing to enroll and ignore molecular /genetic diversity that can lead to better treatment, quality of life and knowledge, we are downright cynical...

We have to turn the tide against those who want to spend more gathering data on drugs we already know how to use safely -- starting with the imperious IOM report written by it's conflicted panel ( I will get to this issue, I promise!) --- and increase spending on tools that allow more people to become an "army of one" in the war to defeat cancer and other illnesses.

http://online.wsj.com/article/SB117124379156005353-search.html?KEYWORDS=disease&COLLECTION=wsjie/6month  Read More & Comment...

Denying the Holocaust -- and IP Protection

02/13/2007 09:11 AM |

Thailand confiscates patents before talking to drug companies -- 20 patents under consideration and counting. No doubt the principal beneficiary will be the corrupt and poorly run government drug monopoly. Meanwhile, the military junta is eagerly reaching out to boost it's economic ties to one of the great democracies on the planet...Iran.

TEHRAN (Fars News Agency)- Thailand's Commerce Minister Kroekrai Chiraphaet stressed his country's strong support for Iran's membership in the World Trade Organization (WTO).

Speaking in a meeting with Iranian Ambassador to Bangkok Mohsen Pak Ayeen, the Thai official noted Iran's economic potentials and underlined, "Not only Thailand, but also all other Asian states view Iran's membership in the World Trade Organization positively."

He further voiced pleasure for the increasing volume of the two countries' trade exchanges, and welcomed endorsement of cooperation agreements by Iran and Thailand, particularly in the area of trade.

Chiraphaet reiterated that endorsement of trade contracts by Iran and his country can play a significant role in the boosting of the two sides' trade exchanges.

Highlighting the role of the private sector in the growth of the two sides' trade exchanges, he called for the reinvigoration of trade cooperation and frequent mutual visits by the two countries' private sectors.

For his part, Iran's Ambassador to Bangkok Mohsen Pak Ayeen wished success for the new government of Thailand, and expressed the hope that the two sides' growing trend of relations and cooperation would continue.

He stressed the need for the development of Iran-Thailand trade ties, and viewed holding of the 8th joint economic commission meeting in Bangkok as a crucial step for the strengthening of the two countries' trade cooperation.

Pak Ayeen further underscored that consolidation of relations with Asian countries, particularly with ASEAN member states, sets a priority for Iran's foreign policy.


http://www.irandefence.net/showthread.php?t=5773


Meanwhile, Israel's Natan Sharansky is calling for a world-wide mobilization against Iran and it's economy similar to that brought against South Africa and the USSR for its policies of repression. In Iran's case, it is leading a global effort to wipe out Israel.

http://www.jpost.com/servlet/Satellite?apage=2&cid=1170359835461&pagename=JPost%2FJPArticle%2FShowFull
Where do the NGO's stand on this important issue?  Read More & Comment...

Witch Doctors

02/12/2007 11:43 AM |

Wounded in battle, Alexander the Great's last words were, "I am dying at the hands of too many doctors." I know how he feels.

Marcia Angell weighs in on the Medicare prescription drug benefit, predictably calling it a giveaway to drug companies, claiming that the VA drug lists -- as well as drug formularies throughout the world -- only ditch drugs that are not cost-effective. Like Herceptin, Lipitor, Avastin, Gleevec... Angell is the only person in the world who doesn't know that Medicare Part D is ruthlessly shifting patients to generic medicines by the way, which is why she continues to flog me too drugs..

And she continues to talk about drugs that were first discovered 25 years ago instead of what companies are investing in now. Talking about the future means talking about genomics, targeted therapies, personalized medicine, translational research...all the activities companies are spending dough on. And she continues to perpetuate the lie that companies spend more on things other than R&D by lumping in the total cost (administration) of running a corporation to the cost of marketing.

My question is: what new drug has Dr. Angell invested in, worked on, discovered or developed in her lifetime? How would she make drug discovery and development more effective and efficient? Does she have special pre-knowledge about which medicines will work that other scientists do not? If so, I wish she would stop recycling the same old crappy op-ed and share the recipe for developing breakthrough drugs without have to develop all those me-too medicines...

High cost for me-too drugs

And speaking of recycling crap...Steve Nissen is once again claiming that he courageously warned America about the cardiovascular dangers of taking drugs for ADHD, drugs he still claims -- as someone who knows nothing about ADHD -- are way too overused. This time he is claiming this in front of Bart Stupak's Health subcommittee Feb 13th, joining other luminaries such as David Graham to trash the FDA.

I post a response from Dr. Joseph Biederman from Mass General Hospital, one of the nation's expert on treatment of ADHD and use of stimulants for treating the disease to Nissen's nonsense. I have sent it to members of the Health subcomm so they have an idea of what the facts about the risks and benefits of ADHD meds really are.

http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf  Read More & Comment...

The VA's Pack of Lies

02/08/2007 10:27 AM |

The VA is in full retreat about it's penny-wise pound foolish formulary approach. It presented a power point presentation at an AEI summit on price controls in Medicare and then exported the propaganda to a meeting on drug formularies in Helsinki which is ironically the namesake of protocols designed to protect patients from getting screwed without their knowledge.

http://www.aei.org/events/eventID.1447,filter.all/event_detail.asp

Here's a breakdown of the myth's and fact's that the VA is now pushing:

1. VA offers more individual drugs that Part D

Fact: The VA offers more different varieties of the SAME drug but (formulations, doses, etc). Part D offers more unique new molecular entitites.

2. The VA formulary is not restrictive

Fact: The VA quotes a report written in 1998 (published in 2000) before it began an effort to push prescribers to adhere more tightly to closed formularies.

3. VA system participants live longer lives

Fact: The VA outright lies and uses a chart that is an outright mischaracterization of Frank Lichtenberg's study Older Drugs, Shorter Lives? An Examination of the Health Effects of the Veterans Health Administration Formulary (which I commissioned when at the Manhattan Institute).

http://www.manhattan-institute.org/html/mpr_02_f4.htm

Frank's chart is above. As you can see, he never claims that people in the VA don't live longer than people not in the VA. And he explains why in a footnote to the paper.

While there are some reasons to expect the mean value of Et to be lower than the mean value of the life expectancy of all U.S. males at birth-serving in the military may impair one's future health-there are other reasons to expect it to be greater. Et is based on a population of individuals who have been veterans, i.e., who lived long enough to serve in the armed forces (e.g., did not die in infancy) and who survived serving in the armed forces. It would be more appropriate to compare Et with the life expectancy of all U.S. males at age twenty, for example. Such data are available for some years (it was 73.25 for 1989-1991 and 75.6 in 2002) but are not available annually (Arias, 2004, Table 11).

What Lichtenberg shows is that after the VA formulary was introduced, the increase in life expectancy at any given period declined. He did not compared differences in LE.

But that's not good enough for the VA. It had to fudge the chart itself. So it introduced a chart that compared periodic life expectancy of vets to life expectancy of all Americans at birth in a way that erases the decline in life expectancy.

4. The VA claims it provides better pharmaceutical care.

Fact. There are many health care services that the VA does extremely well. However to the extent that the VA itself seeks to reduce hospitalizations and prevent disease the use of the best pharmaceuticals is critical to maximizing these goals. The failure of the VA to devote its considerable health IT resources to determine what the best drug for the right patient is reflects an insular and outdated view of medicine. It is very good at achieving better results on process measures relative to some commercial health plans and some evidence that the care it provides is a good as private hospitals. But the VA refuses to allow outside researchers examine the impact of formulary restrictiveness on patient outcomes and total health care costs.

5. The VA doesn't use mail order pharmacy.

Fact: According to GAO and the VA itself, the VA fills 83 percent of its prescriptions through mail order.

6. The VA claims newer is not always better

Fact: Does that mean the VA has more older drugs than Medicare Part D. Does that mean older is always better? In fact, most new drugs are associated with an increase in well-being and clinical improvement with some subpopulation. And in the case of the VA it has not added drugs even the FDA regarded as priority medicines, drugs that have a significant therapeutic value, to its formulary.

7. The VA does not have have a three year wait on all new drugs.

Fact: The VA is right on this count. Sort of. It generally waits a year. Or longer. It was only recently, under pressure from Part D, that it began adding new medicines in a timely fashion. It still hasn't added many new cancer drugs.

8. There have not been 1 million Part D defections

Fact: No defections. But 2 million have signed up for Part D in addition to the VA benefits they receive. Why can't the VA just be honest. There are plenty of people who double dip...

9. Drugs not on the VA formulary are in fact available.

No one said they are unavailable. That's a VA strawman. Drugs not on the formulary are just hard to get. It takes anywhere from 3 days to a week to get an answer. Often you have to try a drug for a while before you can ask for a change, which means traveling to see a doctor. As a result, even the VA's own numbers show that less than 5-10 percent of its patients get medicines like Lipitor, Ambien or Protonix.

10. Doctors are satisfied with the restrictive formularies.

Fact. Fully a third of all doctors who took the time to respond to a VA run survey complained it took too long to get requests answered. (Provider perceptions of pharmacy management: lessons from the military health system.
Med Care. 2004 Apr;42(4):361-6. )

Another survey (also self-selected respondents) found that 35 percent of doctors believed the national formulary restricted access to important drugs. Glassman PA, Good CB, Kelley ME, Bradley M, Valentino M, Ogden J, Kizer KW. Related Articles, Links
Free Full Text Physician perceptions of a national formulary.
Am J Manag Care. 2001 Mar;7(3):241-51.  Read More & Comment...

Not So Exclusive After All

02/08/2007 10:22 AM |

Here's something I would like the opponents of authorized generics to explain: Why is it ok for generic drug companies to divy up the profits during the exclusivity period after a Para 4 challenge but not for an innovator company to introduce it's own generic version that does the same thing?

To wit from Beth McClean's article about Apopletic's Bernie Sherman in Fortune:

"Because they (meaning the generic firms) had all filed on the same day, they would have had to share the 180-day period - meaning profits would have been slim even during the period of supposed exclusivity."

The high price of drug patents  Read More & Comment...

Lapp Dance

02/08/2007 09:43 AM |

I've been in Helsinki for the past few days attending a conference entitled, "Financing Sustainable Healthcare in Europe." My fear was that it would devolve into a conference on Sustainable Healthcare Financing in Europe. It didn't.

It didn't, even though there was a presentation by the US Veterans Administration on, among other things, their wonderful formulary.

It didn't, even though there were more than a few presentations on both evidence-based medicine and healthcare technology assessment.

It didn't, even though the issue of information-to-patients and the "empowered consumer" were discussed.

And this was in Europe! A good sign that sanity may yet prevail in the land that brought us such wonderful acronyms as NICE and IQWIG.

It might be overly optimistic to say this was the beginning of a continental debate on ways to save the future of health care in Europe in ways other than just saving money.

It might be overly optimistic -- but it's worth hoping for the best. And the best and the brightest were in attendance in Helsinki.

The event was sponsored by SITRA, the Finnish Innovation Fund, Luxembourg's Ministry of Health, and Pfizer. Attendees came from across Europe and included health ministers and senior government advisors (the health ministers of Finland and Poland and a former prime minister of Finland attended and participated) along with leading academics, decision-makers and thought leaders from both "New" and "Old" Europe, and other points on the map (Finland, Sweden, Demmark, Norway, Estonia, the Czech Republic, Greece, Italy, Malta, the Netherlands, Poland, Cyprus, France, the United Kingdom, Slovenia, Bulgaria, Albania, Luxembourg, the Slovak Republic, Latvia, Lithuania, Romania, Portugal, Hungary, Ireland, Germany).

There was also a minyan or more of senior officials from the European Commission and the European Parliament. In fact, the conference was chaired (and expertly so) by Pat Cox, the former President of the European Parliament.

The bonus of having so many high-profile government types in one room at the same time is that they tell memorable stories. The best came from Aho Esko (the former Finnish PM) who recalled the time when the Premier of Iceland said to the Prime Minister of Israel that their two nations were very different -- Israel being the nation chosen by God. Iceland the one frozen by God.

The presentations from the event should be shortly available at http://www.sustainhealthcare.org

The most important take-away was that many of the presentations focused on the theme that "health is wealth" -- and that, as such, health care is a worthwhile investment.

Wither such positive momentum? Time will tell.  Read More & Comment...

Deja Vu on HIV

02/08/2007 09:11 AM |

How is it that every time the debate on treating AIDS pops up (in this case triggered by a military junta in Thailand seeking to deflect criticism of its regime) it is always a re-run of the drug price issue?

Drugs are the smallest part of the cost of treating people with HIV and countries that do not improve their public health systems or increase spending on training, facilities and infrastructure will not get pills to patients. Similarly, countries that rush pills into production will promote drug resistance...

Here's a great article by Hudson Institute's Jerry Norris that makes the case against deja vu on HIV:

http://www.chinapost.com.tw/editorial/detail.asp?onNews=&GRP=i&id=96521  Read More & Comment...

Cognitive Remapping

02/08/2007 08:48 AM |

You mean working at a pharmaceutical company isn't all about the money?

The Role of Scientific Reseachers in Pharmaceutical R&D

Source: Clinical Discovery Magazine By Jim Loftus and Dr. Mark Edwards; January/February 2007

Introduction

The road to a more effective, new medicine for use by patients is necessarily long, complex and fraught with pitfalls. For every 40 potential new drugs that show promise in vitro, only 1 or 2 ultimately become “approved” medicines 10-15 years later. It is therefore not surprising that pharmaceutical companies demand the highest calibre scientists to work in their R&D groups. In this article, we describe the roles and the potential career development opportunities within pharmaceutical R&D for two types of researcher; the Research Biologist and the R&D Clinician.

The Research Biologist

Preclinical drug discovery and development offer numerous opportunities for well trained life scientists. For any drug it is important to establish that it works, is safe for patients to take, and what happens to it once it’s administered. This is broadly the remit of Discovery Biology, Drug Safety R&D (DSRD) and Pharmacokinetics, Dynamics and Metabolism (PDM).* Entry to careers in these departments is possible at a number of levels, from school leaver to graduate to PhD, and at more senior levels. Although these departments will recruit biologists from a range of backgrounds (including Pharmacology, Physiology, Biochemistry and Molecular Biology), roles for Biomedical Scientists can be found in all departments working as part of multidisciplinary teams. Examples include histologists working in discovery programmes looking at tissue changes in disease models and the ability of experimental drugs to prevent these. In drug safety they look for drug related histopathology. Scientists with a clinical chemistry background have skills relevant to bioanalytical roles analysing pre-clinical and clinical samples for drug levels and therefore enabling pharmacokinetic profiles to be analysed. Their skills and knowledge are also useful in identifying and analysing potential efficacy and safety biomarkers, which is an area of great importance in modern drug discovery and development. Toxicology labs also have a requirement for trained pathologists to diagnose histological changes in preclinical toxicology.

For graduate entry level positions a usual requirement is a 2:1 honours degree with some practical experience. Occasionally vacancies will arise for experienced graduates with transferable skills and a flexible attitude. Factors affecting availability of these positions will be the structure of the individual company and where and how it does its research. It’s worth investigating websites of pharmaceutical companies and CROs (contract research organisations) to see what potential opportunities there are. If a lack of research or industrial experience hinders your job search, and you don’t have the opportunity to pursue this in your current environment, one solution might be to find contract work through an agency, although there is no guarantee of permanent employment at the end of a contract.

Once employed by a pharmaceutical company your career path can take various directions. Flexibility is a key word – my career took me from being a histologist (I trained in a hospital pathology laboratory) to carrying out in vitro biochemistry experiments looking at cellular metabolites, to research looking at whole animal disease models, and eventually out of the lab altogether into a training and recruitment role. Other people build their careers moving up the research ladder into roles of increasing scientific impact and responsibility. Others use their scientific training to move into any of a multitude of roles available in the pharmaceutical industry, including some of those described in the next section on clinical research.

*The names of departments with similar functions will vary from company to company. A search of individual websites is a useful way of orientating yourself to their structures and terminology.

The R&D Clinician

Clinicians working in pharmaceutical R&D usually have a medical degree with a postgraduate qualification (e.g. MRCP, MD, PhD) or a biomedical PhD with experience in clinical research. Clinical experience may be broad or highly specialised within a specific disease area.

Within the Clinical R&D department of a large company conducting research into many therapeutic areas, a clinician will gain a broad range of professional and research experience. Working within large multidisciplinary drug development teams, the central role of these “clinical research” doctors is to bring their clinical perspective to all research and development activities.

Before human clinical studies commence, the clinician must work with other research colleagues (e.g. Discovery Biology) to ensure that an appropriate level of prospective scientific thinking goes into understanding the clinical development strategy for an investigational drug. For example, is the unmet medical need fully understood i.e. which patients will potentially benefit from this new medicine? what does preclinical data suggest about the potential efficacy, tolerability and safety profiles in humans?; how will biomarkers be developed and validated?; how will theoretical, potential or actual risks be assessed and appropriately communicated? In essence, their role is to develop the clinical aspects of a “product profile” to ensure all feasible clinical uses for the new drug have been considered. This maximises the potential benefit of the medicine to patients and society.

The clinical trial is the fundamental tool of clinical research and in collaboration with colleagues in other specialties the R&D clinician is responsible for their design. Clinical trials must be designed with the highest scientific rigour as they generate the data that underpin both internal decision-making as well as approval of a new medicine by regulatory agencies. The clinician is also responsible for understanding and communicating the emerging benefit-risk of a new medicine as it progresses through the stages of clinical development.

Hopefully this gives some flavour as to how varied the role of a research clinician may be. There are various career paths for an R&D clinician that will usually depend on an individual’s area of interest. For example, someone with a good balance of technical and people-management skills could pursue either clinical team leadership or therapy area management opportunities. However, those whose interests remain more firmly centred in science and technology would probably have opportunities as senior “scientific advisers”. Alternatively their scientific expertise and background in “clinical application” may be usefully transferred to other departments (e.g. Discovery).

The Medical Marketing group is often the beneficiary of clinicians with R&D experience, especially if that person has taken the drug through its development to regulatory approval. In this instance the R&D clinician often brings years of medical therapy area and drug knowledge that can readily be applied to the development of marketing strategies. They can understand the totality of the research results for a medicine and ensure that product strategy and marketing is supported by a good quality evidence base. Here, the clinician would also be responsible for product positioning via the review and approval of promotional materials, interactions with key opinion leaders, sales force training and the design, medical execution and interpretation of phase 4 clinical trial programmes.

Pharmacovigilance (drug safety) is another area where clinicians with R&D experience may find career development opportunities. The ongoing review of safety data throughout a clinical programme is fundamental to the identification, assessment and management of emerging safety signals, as is the timely and comprehensive regulatory reporting of serious adverse events. These data form a pivotal component of the clinical safety summaries that are submitted to regulators as part of their review and approval process for a new medicine.

Finally, possessing a clinical background can also provide complementary skills sets to departments that are not primarily clinically or medically focussed. As well as Discovery, other departments within pharmaceutical R&D where clinicians may find rewarding development opportunities include Regulatory Affairs, Clinical/Development Operations and Science Policy and Public Affairs. A career in this industry is varied and rarely dull. Clinicians work at the cutting edge of science - interpreting this and translating it into medicines that bring benefit to patients and society. Biology is unpredictable; the attrition in our industry is high. No two days are the same and problems are often those that have never been faced before. The intellectual challenge is great. The reward when a successful medicine reaches the patient is fantastic.

Summary

The research and development of new medicines in the pharmaceutical industry is a challenging and highly rewarding career option for research scientists. Pharmaceutical R&D requires scientists of the highest calibre and while specific skills sets are needed for some individual tasks, a successful outcome i.e. the delivery of a new therapy for patients, will only happen as a consequence of integrated working within a multidisciplinary development team over a lengthy period of time. Opportunities for career development are extremely varied and reflect the multiple skills needs that a successful R&D company must have. For an individual scientist, no career path should ever be thought to be impassable or closed.

Authors

Jim Loftus GIBiol, Discovery Recruitment Manager, Pfizer Global Research and Development, Sandwich Laboratories

Dr Mark Edwards BSc MB BS FRCA, Senior Director Science Policy, Pfizer Global Research and Development, Sandwich Laboratories  Read More & Comment...

Pfizer's Effort to Extend Viagra's Name in China Cut Short by Court

02/07/2007 11:16 PM |

I had to get that headline in there...

Pfizer sells Viagra in China as "Wan Ai Ke," but argued that it also is known as "Wei Ge," or "Mighty Brother," and other companies should be barred from using that name. A court in China stiffed Pfizer's challenge to have that a ruling against them overturned.

I think I will stop now.

Pfizer loses battle over Chinese name for Viagra  Read More & Comment...

Not All Patents Created Equal?

02/07/2007 09:44 PM |

UPitt Law Prof. Janice Mueller writes in the NEJM in mild favor of India's attempt to seize the Novartis patent for Gleevec. She notes that India has a world class generic drug industry and that Indian generics companies, for instance, supply 84% of the AIDS drugs that Doctors without Borders uses to treat 60,000 patients in more than 30 countries.
http://content.nejm.org/cgi/content/full/356/6/541?query=TOC

Wow. That's almost .005 percent of all HIV positive patients in all countries.

She goes on to note that under TRIPS WTO members have the flexibility to fine-tune what they define as inventive-step criteria to reflect national socioeconomic conditions. Which means that if NGOs and their fellow travelers want to argue that Gleevec is not really that much of a breakthrough for purposes of compulsory licensing that's ok. Which is pretty funny when you realize that the purpose of TRIPs according to NGOs is to make breakthrough drugs available to the poor.

But does it? Where is the evidence that compulsory licensing has really made a difference in improving health or making medicines available. The fact is, partnerships in improving infrastructure and in the development and production of new medicines are more productive than confiscation. And the fact is, patents are essential to bringing new products online every step of the way in most countries.


And what about the consequences of undermining innovation. What will happen to patented drugs in the future when they come from Indian, Singapore, China or partnerships formed by universities and the Gates Foundation?

The debate about IP and global health -- whatever that means -- has been polarized. I place most of the blame on the NGO class that is more interested in killing IP than in saving the lives of people on this planet. Drug companies have their own problems but the fact it is, the future of global health now rests in the hands of partnerships and new generation so global health entrepreneurs who most be the focus of our attention.

To this end, the following observation from www.ipgh.com is highly relevant.

We believe, under certain circumstances, that patents (as one form of IP), used solely to help achieve global health objectives, can and will speed delivery of affordable and accessible global health solutions. We also believe, under different circumstances, that patents will not help achieve these objectives and/or will hinder their attainment. Our responsibility, as IP managers and in consultation with cross-functional teams working to bring these solutions to fruition, is to determine which scenario (or ones in between) apply. When we get it "right", we save lives.

What's needed is not more interchange as to whether IP rights are "good" or "bad"; they are neither. Instead, we need to turn our attentions to how they can be used and answering highly project- and situation-specific questions like:

* Based on our experience and what we know now, can we use IP to help attain our global health objectives for this specific endeavor? If so, how?
* Might third party IP prevent us from achieving our objectives and if so, what can we do about it and when?
* What can we learn from the IP record about competitors and potential partners?
* How might we use IP management to make data and information sharing easier and hence accelerate development?  Read More & Comment...

Free Janet!

02/06/2007 01:39 PM |

Perhaps the most important announcement emanating from the FDA is the past month has been the appointment of Dr. Janet Woodcock as the agency's chief medical officer.

Janet can now focus her laser-beam attention and prodigious talents towards, among other things, making the Critical Path program a major cornerstone of a 21st Century FDA.

And she will.  Read More & Comment...

More Evidence That Scaremongering Takes Lives

02/06/2007 09:17 AM |

A couple of months ago was attacked by a group called Breast Cancer Action for their scaremongering about the risks of mammograms for women under 50. Now it seems like that organization's efforts are also paying off:

Fewer Mammograms Means More Breast Cancer Deaths

It is a small statistic in a straightforward report. But its impact and implications are potentially huge.

From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4 percent to 74.6 percent — a 1.8 percent drop.

Because in real terms, this means that thousands of women may have undetected breast cancer and could potentially miss the opportunity to save their own lives.

This wasn't really unexpected by those of us who try to keep up with current mammography practices.

My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography-screening compliance. We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer."

I would like to attribute the decline to complacency (mammograms are paid for) or a fear of finding out but studies suggest otherwise. Instead, the small fall off reflects an offshoot of a growing trend of people getting medical advice from scam artists and enemies of medical progress who themselves have a financial or ideological agenda....

Now, who would you trust? Organizations that ultimately have a goal in making people healthy who make money in the process or people who make their money and get their publicity by scaring people away from seeking out and obtaining care that can save their lives? (Scientologists, Breast Cancer Action, Joseph Mercola, Kevin Trudeau, Public Citizen)  Read More & Comment...

Link Between SSRI's and Suicide Risk

02/06/2007 08:43 AM |

I guess Gardiner Harris, the Scientologists, Eliot Spitzer, Shankar Vendantam, The New York Times editorial page, the British Medical Journal, David Graham, and everyone else who hyperventilated about the link between SSRI's and suicide were right, finally. It was hard work but it all paid off.

According to Drug Benefit Trends.."data from Medco Health Solutions showed that at the end of the first quarter of 2004, the number of persons younger than 18 receiving antidepressants declined by 18% compared with the fourth quarter of 2003; the number dropped another 5% in the second quarter of 2004.[1] This decline contrasts sharply with what had been a 77% increase in the number of filled prescriptions for antidepressants and other psychotropic medications for children and adolescents from 2000 to 2003."
http://www.medscape.com/viewarticle/504164

The result?

Kids' Suicides Rise, CDC Report Finds

By LINDSEY TANNER Tuesday, February 06, 2007

CHICAGO - New government figures show a surprising increase in youth suicides after a decade of decline, and some mental health experts think a drop in use of antidepressant drugs may be to blame.

The suicide rate climbed 18 percent from 2003 to 2004 for Americans under age 20, from 1,737 deaths to 1,985. Most suicides occurred in older teens, according to the data _ the most current to date from the federal Centers for Disease Control and Prevention.

By contrast, the suicide rate among 15- to 19-year-olds fell in previous years, from about 11 per 100,000 in 1990 to 7.3 per 100,000 in 2003.

Suicides were the only cause of death that increased for children through age 19 from 2003-04, according to a CDC report released Monday. (It should be noted that many in the media confused suicidality with suicide and never explained the difference thereafter in fanning the flames of fear.)

Here's the link to the AP article:

http://www.casperstartribune.net/articles/2007/02/06/ap/health/d8n3tp7o0.txt  Read More & Comment...

Useful Fools, Patents and Thailand's Military Dictatorship?

02/06/2007 08:30 AM |

Here's a story about the regime that is seizing drug patents in Thailand. It's clear to me that the junta is taking a page from Hugo Chavez and trying to win support internationally from NGO's and liberal Dems event as popular support at home plummets. As soon as the junta, which has suppressed political freedoms and individual liberties, announced it was taking drug patents NGOs led by Jamie Love and Dems lead by Henry Waxman applauded, ignoring the lack of democracy and bolstering the junta in the process.

http://www.worldpoliticswatch.com/article.aspx?id=468  Read More & Comment...

NGOs and Congressional Dems Defend Thailand's Military Dictatorship

02/05/2007 10:32 PM |

The real story about Thailand's seizure of drug patents is that support for the military junta that took power and imposed martial law in 2006 is collapsing under is misrule, corruption and oppression. The compulsory licensing moves are an effort to win support for the regime from human rights groups, NGOs and the international press who see any attempt to nationalize industries or seize IP, particularly pharmaceutical IP, as a strike against globallization and capitalism.

The NGOs, led by Jamie Love, have taken the bait. They are giving aid and comfort to an increasingly repressive and unpopular regime, one that is succeeding in making all foreign investors nervous. (Leave it to Big Pharma to behave like is doing something wrong and nearly apologizing. When will it ever learn?) They are joined, incredibly by six Democratic members of Congress who are urging the administration to let the junta proceed with its seizure of the patent of Abbott's HIV drug Kaletra which has had it's own policy travails in the US.

Sadly, the NGOs are quite willing to allly themselves with any government willing to break patents. That is all they care about, human rights and democracy be damned. Sad to say, the same goes for certain members of Congress.

http://www.worldpoliticswatch.com/article.aspx?id=468  Read More & Comment...

And some spending money too...

02/05/2007 10:19 PM |

The FDA fares fairly well in the President's 2008 budget. Critical path gets $6.8 mill and there is an increase for other initiatives tied to modernizing drug review. And from my perspective the user fee money is tied to Critical Path type projects. So as long as it user fees are not squandered on useless book-keeping activities proposed in Kenzi and devoted to activities that truly improve the risk-benefit profile of medicines the FDA should be in decent shape. Now it's time for industry to ramp up participation in programs that make adoption of CP tools possible at the reviewer level.

By comparison the proposals put forth to turn the FDA into a parcel inspection service and fencing operation for foreign drug wholesalers, or creating a whole new drug safety agency or creating what amounts to a Smithsonian Institution for data mining of HMO data for David Graham and other risk averse zealots (proposed by IOM )will never make it past congressional budgeteers.  Read More & Comment...

Choking off Competition

02/05/2007 10:51 AM |

Four members of Congress have introduced bills to bar drug companies from introducing generic versions of their own drugs during the time another generic firm are marketing their own version of that drug during the so-called 180 day market exclusivity period. I call it so-called because two generic companies can already share that exclusivity and it is clear that the exclusivity only applies to a generic company's monopoly relative to other firms that seek to challenge an innovator patent. Authorized generics promotes competition which is what the original Hatch-Waxman bill sought to do. Are these elected representatives now doing the bidding of "Big Generics?"  Read More & Comment...

Patient No More

02/05/2007 10:36 AM |

I was struck by the petulance of the response of Kurt Strange, the Annals of Family Medicine's editor in response to John Kamp's letter criticizing a "content analysis" of DTC ads (one person's opinion of TV ads in plain English):

DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.

These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.

Two insights can be gleaned from this temper tantrum:

Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!

The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy...  Read More & Comment...

When is a lot a little?

02/05/2007 09:13 AM |

Today's New York Times editorial, "Moving Toward Greater Drug Safety," makes some good points and some bad ones.

On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.

On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."

Note to New York Times editorial board: The FDA already has all those powers.

But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:

"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."

Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.

But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."

Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.

But, hey, it's the editorial page right?  Read More & Comment...

WHO Says Whoa to Thailand and Patent Robbers

02/03/2007 02:00 PM |

Here's why...

1.Treaties are based on trust. Thailand has violated the principle of the Doha agreement with this patent grab and in light of previous good faith efforts to negotiate partnerships with companies to promote comprehensive programs to speed access to medicines in the past, the outright seizure is akin to kicking private firms right in the ....intellectual property.

2. The patent seizure is based on a novel economic theory pursued by the not so smart Nobel Prize winner Joe Stieglitz, namely that generic companies that make drugs for profit are okay but innovator companies that do so are like Ebenezer Scrooge. That is generic companies are entitled to make a profit on drugs because they charge a "just price" for drugs but not innovator companies. Indeed, Jamie Love and others have argued that compulsory licensing should be invoked by any country, for any product, for any public use as long as a royalty is paid (just compensation).

WHO's president knows -- as does the Gates Foundation -- that the spread of this approach would leave only Jamie Love, Doctors Without Brains and a handful of generic companies in India in the business of developing new drugs for the developing world. Which means no new drugs at all.

3. The screw the drug company approach ignores the fact that most of these countries still underinvest in their public health systems and require NGO involvement above and beyond the rhetorical contributions of leftist and anti-globalist groups that have the ear of reporters at Le Figaro and The Guardian. The WHO President's rebuke of Thailand's health ministry reflects an effort the need for greater international and corporate investment and incentives to support such investment. Outright patent seizures are not an incentive the last time I checked.  Read More & Comment...