PharmaReform is no substitute for Reading Pharmaplasia™

As a reader of are you wondering why you should read Pharmaplasia™?

If you have found PharmaReform  helpful and informative you may want to consider reading Pharmaplasia™.    It  is a perfect compliment to the discussions we have at PharmReform.

Unlike most books about the pharmaceutical industry that take a sensationalized, exposé approach,  in Pharmaplasia™ I try to arm you with the background and information necessary to help you facilitate a change for a better future.  You will not find this insider’s perspective, analysis,  or assimilation of  recommendations anywhere else on the web or in any other books written about the industry.   Pharmaplasia™ provides  specific practical solutions to  many of the the major issues the industry is now facing,  from the implications of healthcare reform to marketing and sales challenges, diminished R & D productivity, and the loss of public trust.

The philosophical perspectives behind Pharmaplasia™ and are consistent but the book provides much more depth and important details about the root causes of the industry’s dysfunction (like me,  you may think you know what these are, but I didn’t), explains why it happened, and answers tough questions many people (especially executives) in the industry are afraid to address openly.  Without the background and context provided by the book,  even the recommendations for changes discussed at PharmaReform can seem random and perhaps even idealistic.

For those who still have questions, I invite you to check out the revised Pharmaplasia™ page or shoot me an e-mail. I’d love to hear from you.

Enjoy the read.

Time to Take Pharmaceutical Manufacturing Serious

It is alarming to see prominent pharmaceutical industry names in the headlines these days regarding manufacturing issues serious enough to require recalls and plant closings, and for the DOJ to be compelled to seek prosecution.  Is it just a matter of the FDA increasing their surveillance scrutiny and compliance enforcement or is there really something more fundamental going on with pharmaceutical manufacturing?

Even with all the automation, IT support, instrumentation, purpose built facilities, and technical expertise, pharmaceutical manufacturing is difficult.  Those who do or have done pharmaceutical manufacturing know how challenging it is to maintain consistency and the high quality of products, batch after batch for tens of millions of tablets, capsules, or doses, year in and year out.

Pharmaceutical manufacturing is tightly regulated for quality with highly developed quality systems supported by rigorously defined product specifications, detailed SOPs (standard operating procedures), training requirements, job qualification expectations, and mandatory supervisory and quality assurance (QA) checks and balances.  One of the biggest question I  had when these issues started to more frequently hit the press was, “where was  Quality Assurance management?”

I believe with all the regulatory safeguards supposedly built into pharmaceutical manufacturing,  industry executives who have never worked in manufacturing have  very simplistic views of manufacturing, have developed a false sense of security about compliance requirements, and many are probably taking quality of manufacturing for granted.

Here are a few issues, attitudes, and situations that may be at the root of some of these pharmaceutical manufacturing issues.  Many if not all of them have to do with management’s perspective or the perspectives and expectations they project to their manufacturing teams.

  • Management thinking that manufacturing is all about efficiency, so “let’s have manufacturing find another 5% reduction in cost of production.”  If you make this request year after year, at what point do you compromise quality?
  • With the jobs so well defined in our SOPs, “we can train anybody to do these jobs.  How hard can it be?”
  • Once the process is defined, it’s just a matter of production execution and efficiency
  • Repetitive, routine operational steps by otherwise competent operators can lead to complacency, including at the checking and double checking steps of the supervisory role
  • we don’t need QA people who are going to be difficult to work with (interpretation…we don’t need people who aren’t flexible in their process reviews and sign-offs)
  • “we are not making any product when we are cleaning.”  “what is the longest stretch of time between cleanings that we can justify?”   Facility, manufacturing room, and equipment cleaning time, when viewed as non-production time (reduces productivity), puts pressure on performance metrics.
  • Similarly, “when people are training they are not making product”
  • “We are not going to let a meticulous operator get in the way of making our numbers.  Find a new operator.”
  • “I am so busy with paperwork…nobody is going to know if I just sign off on this, even though I haven’t really checked it”
  • “Nobody in management needs to know, we’ll just write that batch off as waste”
  • “Let’s just do another sampling. I’m sure the batch will pass”
  • “let’s just get a management authorized override for that deviation”
  • We can’t afford the shutdown time to make the necessary upgrades to the process, even though it makes sense.
  • FDA will require a new set of trials if we make these changes to our outdated process
  • “We’ll never get caught up with these CAPAs” (Corrective Action and Preventive Action).  Sometimes the hardest but most important never get addressed in a timely fashion despite SOP defined prioritizations and timelines that are supposed to safeguard against delaying the fixes.

OK.  I think I have made my point.  Time for pharmaceutical manufacturing to get some respect and more importantly, some much needed investment.  I’m not talking just about buildings and machines although that may be in order for some.  I’m talking about putting quality standards of production ahead of production output metrics (no game playing, not just lip service).   I believe well managed manufacturing teams of  competent, conscientious operators, supervisors, and QA/QC staff with expertise and integrity will take pride in delivering high quality products as efficiently as they feel is possible.  It is the “well managed” part that I believe may be missing in some manufacturing operations.

It is also time for pharmaceutical company executives to appreciate the contribution manufacturing makes to the revenue line and not just look at the expense line impact.  Some executives, unfortunately, now know the negative impact manufacturing can have on revenues, especially if you take it for granted and don’t pay attention to it.

The Single Biggest Reason we need Big Pharma Drug Discovery

“I’m sorry we have done everything we can do…there is nothing left to try.”

Nobody wants to hear these words, especially as it relates to our health or the health of a mother, father, son, daughter, close relative, or friend.  Most of us have had people in our lives who have heard these words.  From what should be simple to treat infectious diseases to the complexities of cancers and physically debilitating, if not lethal diseases like Alzheimer’s, there remains a huge medical need for effective and safe new treatments.  Too many people hear these helpless words today and even more may hear them in the future as the population ages with increasing life expectancy.

We have seen how financial rewards can drive  decision making and  behavior in the pharmaceutical industry but really… not wanting to hear these words should be the single biggest reason pharmaceutical companies continue to invest heavily in drug discovery research.

It starts with a mindset to discover truly innovative new drugs that are better than what we have available and that can treat diseases we can’t treat today.  It is frightening that the industry has spent so much in the last decade to deliver so little in terms of innovation.  Think about the billions of dollars spent on clinical trials just to get  “me-too” drugs to the market.  It is equally frightening to think of the cash being spent on mega-mergers and acquisitions to source near-term products to fill the depleted late stage pipelines.  Neither of these contributes to bringing innovative new products to the market that wouldn’t otherwise have come to market.  I’m also not sure how long biotech can support the drug discovery needs of Big Pharma before that well runs dry.

I believe the current “product driven mentality” of many Big Pharma company executives today (and Wall Street analysts) is blinding these companies to the long-term solutions to finding truly innovative new products.  I have said it before.  Drug discovery is hard work and getting harder. It is going to take a much deeper, multidisciplinary understanding of human biology, molecular biology, biochemistry, and pathophysiology of diseases that most companies only think about once they have a potential therapeutic target or drug candidate in hand (most likely acquired from outside the company in most recent history).

I believe this comprehensive approach to drug discovery is where Big Pharma should be making significant investments.  Choose a therapeutic area of interest.  Find, recruit, and collaborate with world class scientific and medical expertise in that therapeutic area.  Invest in an exhaustive understanding of the disease,  explore beyond the known,  and challenge common principles of disease management.  Don’t just look for a compound, look for a comprehensive approach to treating and possibly curing the disease.

Big Pharma is one of the few place with sufficient resources to fund, coordinate, and execute this comprehensive approach over a long period of time.  I am not suggesting universities and biotech companies won’t continue to be a great source of novel, innovative new drug candidates.  In fact, much of the necessary drug discovery expertise now resides in academia.   At the same time however, I am concerned with Big Pharma moving away from drug discovery and relying on universities and biotech as their primary sources of innovative new products.  Why?

Because… I don’t want to hear… “I’m sorry we have done everything we can do…there is nothing left to try.”

5 Ways to Eliminate the Financial Influence of Big Pharma

The recent disclosures of payments to physicians for speaking engagements, consulting fees, and even royalty payments have come under the scrutiny of industry critics.   Some are probably even embarrassing  to those in the industry.  The publicity clearly has further raised visibility and concerns about the financial influence of the pharmaceutical industry.   Here are 5 ways to eliminate the potential for Pharma Company financial influence:

  • To eliminate the financial inducements of speaker fees associated with pharmaceutical industry promotional education programs, medical schools should provide free CME programs to rural or non-medical center community healthcare providers.  To ensure a sufficient number of programs, there should be a national requirement that each medical school affiliated clinician (good speaker, expert, or not) be required to do six medical school sponsored CME programs per year outside their institution  and preferably be given in rural areas.
  • Medical School and university affiliated clinicians, in the spirit of independent research, should financially support drug company related trials without pay or compensation from drug companies (no university or institution overhead charges, no pay for staff, no lab fees, etc).  Nominal ancillary pass-through expenses could be reimbursed.  Clinicians should be required to publish in reputable journals  and present the data at major medical meetings without drug company compensation.
  • All Pharma requests of Medical School or university clinicians, researchers, or scientists for consulting expertise should be done free of charge (university subsidized) and should be fulfilled by priority of request and existing industry workload of the consultant at the time.  No researcher could consult with the same company more than a cumulative 6 months in a given 5 year period of time. All related travel expenses, including meals provided, would be paid by the university and anything that resembled an exotic meeting location would avert attendance by the consultant.
  • Medical School affiliated clinicians and university researchers or scientists could not benefit from any royalties or payments related to their inventions.  All such payments would go to the Medical School or university general research fund to support ongoing research.
  • If Medical School or university affiliated clinicians or executives, feel compelled to sit on Pharma Company Boards of Directors or Advisory Boards they should do so without compensation (this includes no stock or stock options).  They should also pay their own expenses to attend meetings, including paying for meals provided.

You are probably saying, “These make no sense.”

Yet, industry critics sensationalizing the highly paid speakers and consultants or Medical Schools and universities going after sales representative pens, sticky pads, and free lunches are, in a very self serving way, distracting the public from the real financial influence of the pharmaceutical industry.

If they were serious about eliminating industry financial influence it would mean giving up hundreds of millions, if not billions of dollars of industry support and compensation subsidies for Medical School and university affiliated faculty, staff, and their research programs.   Because they have no other financial sources to replace the magnitude of this funding, Medical Schools and universities (and industry critics) have to ignore the fact that these financial subsidies from the Pharmaceutical Industry can have a far greater influence than a sticky pad, a free lunch, or a couple thousand dollars in speaker or consulting fees.

How Accountable Care Organizations (ACOs) will affect Pharmaceutical Sales Representatives

There is still considerable debate and experimentation as to how the proposed Accountable Care Organizations will be structured and function.   It is also hard to understand how widespread it will be once implemented. What is known is that as healthcare reform begins to take shape, the push (with financial incentives) for accountability in delivering higher quality care at lower cost will drive a more coordinated approach to comprehensive healthcare for patients.  As a result, hospitals and physicians are beginning to explore the best ways to work together to ensure that the quality of care they deliver will be accurately reflected in whatever measurements the government (CMS) decides to use for evaluation.  ACOs will in theory be rewarded by sharing the cost savings resulting from keeping their enrolled populations healthy and treating their patients efficiently and effectively.

The comprehensive care expectations for Accountable Care Organizations are beyond the capabilities of most solo physician practices or even small groups.  Also, hospitals will need to expand their roles to include better coordinated post hospitalization care to ensure patients continue their recovery without relapse and re-hospitalization.   This integration of care approach is causing some private practice physicians to consider joining larger group practices and encouraging hospitals to reach out to employ and align with the best physicians in their geographic coverage areas.

So how will this affect pharmaceutical sales?

The first implication of Accountable Care Organizations is most likely going to be a further reduction in sales representative access to primary care physicians as they join larger, busier group practices or hospitals.  Representative access to these physicians is  likely to be governed by even more selective product recommendations and administrative policies developed by the Accountable Care Organization.  The impact on physician time with patients and the potential for sales reps to influence expensive branded product use will also affect access decisions.  If representatives can demonstrate value by favorably impacting quality of care or cost reductions, they will find physician access less challenging.

Adoption of best practices and formalizing treatment guidelines will mean physicians will  be less autonomous in their prescribing practices. They will also have a financial vested interest in prescribing cost effective treatments, complying with formularies, and following recommended treatment guidelines established by the Accountable Care Organization. This will make it more difficult for pharmaceutical representatives to directly influence prescribing of products not supported by ACOs.

Electronic health records (a prerequisite for Accountable Care Organizations) will make the real world impact of drugs on provider quality of care and costs more readily available for evaluation.  Electronic medical records and e-prescribing will also allow for managing and monitoring compliance with treatment guidelines. These assessments and compliance monitoring will leave less opportunity for random use of expensive branded products with marginal clinical benefit.  Deviations from treatment guidelines will require justification and could result in reprimand or potentially expose physicians to financial penalties if repeated non-compliance results in increased costs without clinical benefit.

Companies with products that can demonstrate improvements in clinical outcomes (better than alternative treatment options) or reductions in overall healthcare costs will find a much more receptive institutional audience than they might have in the past.  Companies armed with compelling data will be able to influence the inclusion of their products on formularies and in treatment guidelines.  This is especially true for value-priced preventive medicines, vaccines, and companion diagnostics.

Sales representatives with new products or products that are not favorably received by the ACOs in their territories will be faced with the challenge of gaining acceptance.  Unlike having to convince (selling) individual physicians to prescribe your product, formulary and treatment guideline recommendations will be determined by healthcare provider teams with therapeutic and cost benefit expertise.  More importantly, electronic health records will provide these teams with easy to analyze comparative clinical outcomes and cost data from their own organizations, making it even more difficult for companies (and representatives) without comparable data to make their case.  Collective expertise, real world data, and financial incentives for delivering good clinical outcomes at low cost will make for a hostile environment for companies and representatives who are not equally armed with expertise and real world therapeutic and cost benefit data.

On the other hand, if the Accountable Care Organizations feel a product can help them achieve their quality of care and cost savings goals, representatives may be enlisted to assist the ACO achieve its goals.  Representatives could be encouraged to help educate physicians and other healthcare providers about the appropriate use of their product (within treatment guidelines).  They might even be called on to assist with implementing adherence and compliance programs to make sure patients take their medications as directed.  It might even get to a point where products are placed in treatment guidelines contingent on delivering the expected clinical outcomes and cost benefits.  This would require representatives to understand the metrics for assessing their product performance and staying current with how their products are performing (clinical outcomes and cost savings) within that ACO.

Regardless of how the ACOs are structured or how they decide to operate, it will mean a completely different work environment for pharmaceutical sales representatives.

Was Antibiotic Development a Casualty of Comparative Effectiveness Expectations?

As early as the mid- to late- 1980s the market started to become increasingly managed (think formularies) and the availability of many inexpensive generic antibiotics even then made it easy to set superiority expectations for new market entries.

About the same time, the widespread use of antibiotics rightfully started to raise concerns with the Infectious Disease community about the development of resistance.  Armed with microbiology data and clinical studies, formularies and treatment guidelines were developed to encourage appropriate antibiotic use.  Selectively targeted narrow spectrum treatments were preferred to the mindless routine use of broad spectrum agents.  To preserve their antimicrobial activity, the use of some uniquely effective agents was further restricted to prior approval by Infectious Disease specialists.

While these were responsible and commendable actions taken, they presented the pharmaceutical industry with a new set of expectations for developing antibiotics. The message was clear.  If you want your new antibiotic to be used and you want to be paid a premium price for it, you better have the data (comparative effectiveness) to support that it is better than what we already have (including generic alternatives) and be able to prove it is worth the money (comparative value) you want to charge.  And, even if it is that good and costs that much, we are going to make sure it is used selectively in only those patients who absolutely need it.

This wasn’t and still isn’t a very attractive investment opportunity for the industry given the ease of tweaking molecules and the lack of market resistance in other therapeutic categories. Even for companies that decided to have a go at antibiotic drug development, it hasn’t been a very easy road to market.  The few products that have gotten approved and done well were able to demonstrate or at least imply a clinical advantage over other drugs.

Now the industry and the FDA are faced with trying to figure out how to design trials that would allow for fair comparisons of different antibiotics.  Not satisfied with clinical “non-inferiority” the FDA and the industry seem deadlocked in trial design limbo.  More importantly for the industry, the market expectation is for superiority anyway. The company will need near impossible – to – obtain “substantial evidence” in their clinical data to obtain an FDA approved superiority claim needed to promote the antibiotic as superior.

Could other therapeutic categories become similarly unattractive for drug development?  When market expectations and regulatory hurdles become impractical and seemingly financially infeasible pharmaceutical companies will make one of two choices.  They will take on the task in hopes of beating the challenging circumstances so they can charge a super premium price when they bring that superior product to market.   Or, more likely, they will gravitate to therapeutic categories with lower market expectations and fewer regulatory hurdles.

Many pharmaceutical companies will fail making the first choice and many diseases will never have optimal treatments given the second choice.

Collateral Damage of Downsizing in the Pharmaceutical Industry

Many pharmaceutical companies have been divesting assets and downsizing operations as they try to accommodate the impending patent cliff, disappointing research productivity, diminishing impact of traditional commercial tactics, and the slowing revenue growth.   Given the state of the industry and in light of the market changes taking place,   I also recommend in Pharmaplasia™  that pharmaceutical companies downsize their operations.   Despite being painful to employees (and their families)  and as disruptive as it might be for the company, it in many cases is the absolute right thing to do,  but how you go about doing it matters.

Criteria used to assess what gets divested or downsized include things like poor or mediocre past performance, lack of perceived need, and the magnitude of the potential expense savings.  In the spirit of fairness (especially when it comes to employee relations issues) and to satisfy the quantitative justification needs of management, numbers often drive the decision making process.  As strategic as companies might try to be,  a numbers-based decision making process will lead to collateral damage with unintended consequences including:

  • Loss of  expertise
  • Loss of management experience
  • Disruption of business relationships

Unfortunately, these are the very business assets pharmaceutical companies need and can least afford to jeopardize as they prepare for the evolving new healthcare market.

But you might be thinking that companies and management are smart enough to avoid these pitfalls by being analytical about their choices, right?  Well, let’s take a look at a few examples of where the process may not yield the results expected and could be detrimental to the company.

  • Early retirement packages often accommodate employees with years of experience, including seasoned managers, scientists with expertise, and employees (including sales) with valuable long standing business relationships.  How many of your best people can’t resist the offer and walk out the door?  Remember, your best people are not afraid of being unemployed for too long if they take your offer.
  • How about when the numbers  suggest eliminating sales representatives and territories with lagging sales and diminishing physician access.    Are less effective and even poorer performers being protected by having better sales numbers because their territories are in a less managed market…today?  Are your sales numbers a real reflection of the experience, expertise, and effectiveness of your sales representatives and managers?
  • What about a manufacturing operation with a perfect track record for production that has comparatively higher costs driven mostly by the expenses associated with a larger, more experienced quality staff and more operational training.  Is this staffing and training perceived to be quantitatively excessive and unnecessary in the context of downsizing expectations?  Have you factored the complexity of their manufacturing and the impact (and expense) of a recall compared to the other production facilities? If so, do you eliminate the management experience, the staff (operational expertise), or the training?  What numbers do you use for that decision?

The point is that divestitures and downsizing while necessary in the current business environment for most large pharmaceutical companies will have collateral damage that goes well beyond the personal impact such decisions have on employees and their families.  Also,  a company’s assets may not be accurately reflected in the numbers used for the analysis of what to keep and what to let go.  Companies that are aware of potentially losing these hidden assets may ultimately make the same decisions but they also might look to find ways to avoid the loss or at least mitigate the impact rather than just accepting collateral damage as a part of the process.

Protecting your Career and Financial Security from Healthcare Market Changes

I don’t know about you but it really bothers me that there are now tens of thousands of ex-pharmaceutical industry employees out of a job.  What really bothers me is that the current state of pharmaceutical industry dysfunction should have never happened and didn’t have to happen in the first place.

Warning: This post is intended to be a genuine offer of help to people who work in or for the pharmaceutical industry through an invitation to purchase Pharmaplasia™.

Are you wondering about the future of the pharmaceutical industry and whether your company is making the right strategic choices to succeed in the evolving new healthcare market?  Do you have the insight and “know-how” to exploit the changing environment to your advantage? Or, are you wondering if the pharmaceutical industry is still the place for you to advance your career, fulfill your professional aspirations, make a living, and support your family?  Are you wondering how long this will last… for you?

As in any dramatically changing market environment (think typewriter manufacturers and sales people in light of the personal computer) you want to stay ahead of the changes so you don’t find yourself with outdated thinking, products with no market, or obsolete skills.

Pharmaplasia™ can help you understand and plan for the changes taking place.  It will help you broaden your perspective, challenge your biases, and give you a context to frame your own conclusions.  And even if you don’t agree with all the findings, Pharmaplasia™ will force you to think through your current situation and its viability in the evolving new healthcare market.

If you work in or for the pharmaceutical industry, understanding the impact of the changing healthcare market and the implications for you personally are critical to your career success and financial security.  Pharmaplasia™ describes the impact of healthcare reform at the functional level of a company with specific recommendations for change in leadership, sales and marketing, research, and operations.

Pharmaplasia™ will help you evaluate your personal situation so you can determine what you should be doing to prepare for the changes so you not only have a job but have a professionally satisfying career with financial security in the evolving new healthcare market. You’ll be able to assess your company initiatives against the strategic scenarios and specific recommendations for change to determine for yourself whether or not your company and its leadership understand what lies ahead and are taking the necessary steps to align with the new market expectations.   Using what you learn from Pharmaplasia™, you can also evaluate other companies to see who in the industry seems to be getting it right.  Who has the pipeline products you think will make it in the new marketplace?

No need to leave your career and personal financial security to chance.  Stay in the industry, stay with your current company, or change?  Stay in your current area of expertise and functional responsibility or prepare for a career change? Change to what?

I invite you to order your copy of Pharmaplasia™ so you have the information you need and a context to evaluate and help make informed, rational decisions about the changing healthcare market and the implications for the pharmaceutical industry and more importantly ….. the implications for you.

Pharmaceutical Research Thinking that Needs Rethinking

NIH (not invented here) is probably dead or at least dying at most Big Pharma today as is the thinking that companion diagnostics are not commercially interesting because they imply smaller market opportunities.  But, are there other research maxims that need to be reevaluated in the context of the evolving new healthcare market?  Here are 5 to consider changing if your company still thinking this way:

  • “kill early, kill fast”

This has been intended to encourage researchers to cut losses by quickly identifying drug candidates that have a high probability of failing in later trials because of safety concerns or lack of efficacy.   Poor Phase 1 or Phase 2 results may raise concerns about mass market use of the product but may not necessarily reflect how the drug candidate might perform in a more targeted population.  Think personalized medicine with companion diagnostics.  A more comprehensive understanding of the disease, product pharmacokinetics, and pharmacogenomics may be needed to avoid killing promising compounds for smaller, targeted patient groups with significant unmet medical needs.

  • “what’s the fastest, commercially viable indication that will get us to market”

The thinking behind this was that “we can use the scientific literature and medical education to expand the market.”  This will become increasingly difficult as the FDA, CMS, and the managed market become more demanding for label indications and data to support claims for use and reimbursement.  Relying on traditional sales and marketing tactics to fill the label claim or data voids to expand market opportunities will be less likely and less tolerated in the evolving new healthcare market.

  • “if we do that study or analyze that data, we might find something we don’t want to know”

Product liability cases continue to make headlines and the ability for pharmaceutical companies to “bury” findings, mislead the market, cover-up or ignore potential safety issues or inferior efficacy results is becoming increasingly difficult.  Research organizations might as well assume that if they know or suspect an issue, they will need to explore it, get the science behind it, and be forthcoming about the findings.

  • “our research is built around (you name the biological target) program”

As many “target-based” biotechnology companies and Big Pharma research programs have found, this is a very high risk strategy of  “either it works or it doesn’t work” (betting black or red at the roulette table).  In the evolving new healthcare market where proven innovation and differentiation are going to be essential for commercial success,  I believe companies that take a more comprehensive approach to understanding the pathophysiology of the disease will have more opportunities to discover and develop ways to intervene in the disease process, will better understand how different targets interact with each other, and will reduce the risk of betting on a single target.

  • “we can do it cheaper and better in house”

Market expectations for innovative and differentiated product profiles will make research pipelines more variable than they have been in the past.  The days of merely bringing any safe and effective product through the regulatory development process and onto the market are gone.  Disciplined research portfolio management will eliminate those products that will not meet market expectations, creating more dramatic time gaps, and making pipeline flow less consistent than in the past.  This will require research flexibility of facilities, equipment, and staffing.  While a core team of research expertise is essential to retain in-house, most laboratory, preclinical, and clinical work can now be outsourced to well staffed, competent CROs that often have as much if not more expertise, capabilities, and capacity than the research teams at Big Pharma.  Even at higher per project costs, these incremental expenses will be far lower than the inevitable up-sizing and downsizing of staff or the carrying costs of intermittently idle facilities, equipment, and staffing.