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...

Commons Sense

02/03/2007 09:19 AM |

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

NICE faces inquiry by Commons group
By Nicholas Timmins

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

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

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

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

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

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

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

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

Does Kenzi Punt on PDUFA?

02/02/2007 04:32 PM |

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

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

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

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

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


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

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

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

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

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

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

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

WHO to Coup: Don't Do!

02/02/2007 04:11 PM |

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

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

Brava!

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

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

Legislative Biomarkers

02/02/2007 08:43 AM |

Here it is, Kenzi 2.0:

Download file

It's better. But is it reform?

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

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

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

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

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

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

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

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

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

Drugwonks: Not the Aquateam Hungerforce

02/01/2007 06:33 PM |

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

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

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

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

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

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

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

Berenson Makes the News...

02/01/2007 06:13 PM |

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

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

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

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

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

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

Legislative Endpoints

02/01/2007 04:20 PM |

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

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

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

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

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

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