Looking Behind the WARF Stem Cell Patent Challenge

The California scientist behind the challenge to the WARF stem cell patents says scientists have an obligation to be sure that research "can benefit the society that supports it."

Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, made the remark in a recent piece on "Nature Reports: Stem Cells."

Loring wrote about the history behind the challenge to the patents and her motivation. The piece also carries remarks from WARF.

Here are a couple of excerpts:

"We were surprised when WARF responded (to the challenge) with a press release saying, correctly, that I and the other scientists also have patents. This isn't relevant to the validity of the WARF patents, and seems to be an attempt to undermine our credibility. Our patents, like (Jamie) Thomson's, are assigned to companies or to our universities, and we have little control over how they are enforced. We are not challenging Thomson; we're challenging the patent owner, WARF."

Loring continued:

"I do not get paid for our work on this challenge. I did not set out to become an expert in patent law, and it is still very much outside my comfort zone. I'd rather be spending my time learning more about the molecular interactions that make human ES cells pluripotent. But the spirit of scientific inquiry often requires us to venture beyond our areas of expertise, and I think that scientists have an obligation not only to perform research but to make sure that our research can benefit the society that supports it."

Scientific Criticism and Libel Update

The next proceeding in the Flamm-Cha libel lawsuit will be Nov. 20 in Los Angeles Superior Court. The case involves Bruce Flamm, a Riverside, Ca., physician and stem cell researcher Kwang Yul Cha.

Earlier this month, Cha failed to override an anti-SLAPP motion by Flamm. For more on this, see our item here.

Celebrity Leeza Gibbons Named as CIRM Director

The latest addition to the board of directors of the $3 billion California stem cell agency is former television talk show hostess, Leeza Gibbons.

California Gov. Arnold Schwarzenegger Wednesday announced the appointment of Gibbons(shown in photo). She fills the post formerly held by scientist Leon Thal, who died in a plane crash last February. Gibbons fills a slot designated for a patient advocate for Alzheimers as the result of her nonprofit group, Leeza's Place, which is aimed at caregivers for persons with memory disorders.

Gibbons' celebrity status attracted more news coverage than the usual appointments to the CIRM Oversight Committee, which are almost invisible in the media. She co-hosted "Entertainment Tonight" from 1994 to 2000. This year, she appeared on the "Dancing with Stars" TV show, part of the so-called reality genre. She appeared in at least one movie, "Last Action Hero(1993)," with Schwarzenegger.

Gibbons may be the only member of the Oversight Committee with a personal web page and public blog, which can be found on her web site. However, she is not the only Hollywood figure to serve on the 29-member panel. Sherry Lansing, a former top film executive, has a seat on the board. Jonathan Shestack, a Hollywood producer, also is a member.

Gibbons' efforts with memory disorders grew out of her own family's experience with her mother, according to her web page.

The Leeza's Place site says,

"Developed in response to the challenges Leeza and her family encountered while seeking specific and needed support, Leeza's Place is a potent source of information, strength and purpose. Nestled within your own community, Leeza's Place is a multifaceted reprieve, for both caregivers and the recently diagnosed, that integrates educational programs, connective social activities, emotional support, and intergenerational programming designed to help you navigate through your community's continuum of care."

The site also sells books and information on dementia, such as "Brain Longevity" by Dharma Singh Khalsa and "scrapbooking" software, which is aimed at preserving memories. Also offered are a "memories forever" bracelet and a "comfort and care" candle.

The governor, whose motto is "action, action, action," left Thal's position vacant for nine months despite a provision in state law that requires Oversight Committee vacancies to be filled within 30 days. However, it is not uncommon in state government for such provisions to be ignored.

One vacancy now exists on the Oversight Committee: the slot occupied by Brian Henderson, dean of the USC School of Medicine. Henderson has retired from USC, which makes him ineligible to serve. Filling that vacancy is also the responsibility of the governor. Look for Henderson's replacement in nine months.

Excessive Haste on $300,000 Stem Cell PR Contract

The California stem cell agency's plan to hire a public relations firm for $300,000 is a case of misplaced priorities.

It is quite clear that CIRM needs to move swiftly on its communications needs, particularly in light of the emphasis placed on public education by both its interim and incoming presidents.

But first CIRM needs to find a permanent chief communications officer. Otherwise, the agency will be signing a major contract without consulting the person who will have responsibility for overseeing it. Premature selection of a PR firm, in fact, could hinder the hiring of a top-notch person, who might look askance at the choice or at the management that chooses to take such precipitous action.

CIRM will be issuing the contract without what amounts to very necessary "peer review." And that is the kind of scrutiny that a skilled communications professional would give any prospective PR firm.

Some also question the need for a PR firm, period. One is John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who argues for a minimalist approach.

Simpson, who is a practitioner of the fine art of PR, among other things, told the California Stem Cell Report in part (his full comments are carried in the item below),

"People who hire PR firms are more interested in image than in substance. The way you get good media relations is simple: Do good work in an open way and answer all questions candidly.

"CIRM needs a committed and knowledgeable communications officer and an assistant completely familiar with all CIRM and ICOC activities. With the current downsizing in the news business many such talented people are available."

However, we do not believe that CIRM can fulfill its major communications responsibilities with two persons. CIRM is limited by law to no more than 50 employees; it now has about 26. Given the limit, a good communications firm would be necessary to execute the agency's ambitious public education plans outlined in the strategic plan. Without outside help, it would require a personnel commitment that probably is beyond CIRM.

And the outside help should be picked under the direction of CIRM's own communications expert, which is what that person is hired to do..

CIRM has gone through two PR firms and two staff PR persons in its short history. The largest contract $378,000) went to Edelman PR and generated some dissatisfaction at CIRM, which is at least partial evidence that the agency needs expert help in picking a new firm.

Regardless, any contract will generate negative attention. Reporters and editors in the mainstream media have a jaundiced view of highly paid PR firms. Too often they fail to serve either their masters or the media well.

(Here is a link to the request for bids on the contract, which are due Nov. 30. The request says that the contract could be awarded prior to end of the year.)

FTCR on $300,000 PR Plan

Here is what John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, had to say about the CIRM's $300,000 plan to hire a public relations firm, perhaps before the beginning of the year.

"People who hire PR firms are more interested in image than in substance. The way you get good media relations is simple: Do good work in an open way and answer all questions candidly.

"CIRM needs a committed and knowledgeable communications officer and an assistant completely familiar with all CIRM and ICOC activities. With the current downsizing in the news business many such talented people are available.

"In a rare case, perhaps for a specific large task, under the close direction and supervision of the CIRM communications officer, there might be a benefit from an outside consultant.

"It's absolutely essential that the communications officer play the key role in hiring any communications consultants. Consider it peer review – the scientists should understand that concept.

"CIRM should put a top priority on hiring a communications officer."

"Instead, what the RFP calls for won't facilitate communication with the media. It will hinder it and irritate the working press.

"CIRM will end up wasting $300,000 of taxpayer money and the ICOC will be wondering why they are unhappy with the news coverage they get."

Fresh Comment

Mark Braly has posted a comment on the item below.

CIRM: An Evaluation at Age Three

The Sacramento Bee this morning carried an evaluation of the performance of the California stem cell agency, which is three years old this month.

Produced by this writer, the opinion piece said, among other things,

"By many measures, the institute is a huge success. Its impact stretches well beyond state boundaries and has stimulated the growth of similar research efforts in six other states and excitement in even more. The agency has established what are widely regarded as the toughest research and ethical standards for embryonic stem cell research in the nation. It has pioneered development of revenue sharing requirements that will come into play if successful medical therapies are created.

"But by other standards, including its own strategic plan, the institute doesn't measure up. The money is not flowing as fast as called for. Rosy campaign promises of cures and an economic boom still await fulfillment. Built-in conflicts of interests pervade the institute's activities. A penchant for closed-door grant reviews and secrecy screens much of the institute's most important decisions from public view. And, more than once, calls have arisen for the resignation of its chairman, Robert Klein, a man who triggers both admiration and animosity."

Given the space constraints of print media, condensation required the omission of much more that could be said, both pro and con. To provide a more comprehensive picture, we are carrying below a statement by California stem cell chairman Robert Klein and comments from CIRM's chief communications officer, Dale Carlson, prior to his departure from the agency.

Also useful are the following items: CIRM's strategic plan, the California state auditor's report on CIRM, a report by the Foundation for Taxpayer and Consumer Rights, a report and update by the Center for Genetics and Society and remarks by interim CIRM president Richard Murphy from the transcript (pages 16-25) of the October Oversight Committee meeting

Your comments are invited as well. You can post them directly by clicking on the word "comments" at the end of this item. We prefer that you use your name when commenting, but remarks can be posted anonymously, protected from disclosure to even this writer by the provider (Google) of this web site. Or you can send your comments directly to me: djensen@californiastemcellreport.com.

Text of Statement from Robert Klein

As part of the reporting for the Nov. 11 article in The Bee, we asked Robert Klein, chairman of the California Institute for Regenerative Medicine, for a statement on the accomplishments and challenges facing the agency. Here is the text of what he provided.

"For families suffering from chronic disease or injury, Proposition 71 has brought hope; for medical scientists who have dedicated their lives to reducing human suffering, it has been an inspiration; and for patient organizations, it has created a model for a paradigm change in the structure, scope and term of medical research funding in America. To date, approximately $210 million in grants have been approved by the governing board after a competitive, scientific peer review process, and another $300 million is in process. All elements of the court system in California, including the Supreme Court, have exhaustively reviewed this grant making system, the medical and ethical standards, the conflicts policies and the constitutional authority of the governing board and the agency and the Supreme Court has found all of the initiative’s aspects to be constitutional and operated through the agency and the board in a manner completely consistent with the statutory intent and all state laws.

"California has become the largest funding agency in the world for embryonic stem cell research, creating history in funding medical research, as the intellectual health care capital of the society, with long-term state bonds. The great universities, research hospitals, and research institutions of California have recruited world class scientists and clinicians to lead and inspire the medical research programs of California. At the funding agency itself, Dr. Richard Murphy, the former President of the Salk Institute, is building an extraordinary scientific organization and Dr. Alan Trounson, a global leader in stem cell research, will assume the Presidency by the end of this year.

"Globally, California’s performance under Proposition 71 has earned the state agency a world class leadership position, with California serving as a member of the International Stem Cell Forum on an equal membership standing with 19 member nations. Within the United States, California’s grant approvals in 2007 alone are approximately seven times the funding by the National Institutes of Health for embryonic stem cell research. California’s medical and ethical research standards, drawn up in collaboration with the National Academy of Sciences, have become an international model and the new “gold standard” for our nation, with the state of Illinois adopting them in their entirety just four months ago.


"Challenges

"Proposition 71, its governing board, and the funding agency created by Prop 71 face a number of immediate challenges as the momentum of stem cell medical research funding increases.

"First, its preliminary strategic plan must be examined and strengthened as the new President of the agency, Dr. Alan Trounson, brings global scientific credentials and insights to broaden the strategic path while closing research gaps in the plan like immunology, which is so critical to implementing stem cell replacement therapies for Parkinson’s, HIV/AIDS, diabetes and heart disease. As another example, strategic initiatives in immunology might broaden the feasible applications of existing adult stem cell therapies, by utilizing embryonic stem cells as a source of immune tolerance cell transplants. Adult stem cell therapies have raised survival rates for patients with leukemia or multiple myeloma (a bone cancer) from six percent to the 70% plus range; but, these therapies currently only reach the 40% of patient candidates for whom a sufficient immune system match can be found. By strategically focusing on immunology challenges to expand the reach of adult stem cell therapies, more lives may be saved when scientific breakthroughs in immunology are combined with the immune tolerance of embryonic stem cells and/or the possibility of immune system matches through SCNT (immune matched stem cells) breakthroughs.

"Second, stretching the resources approved by the voters - to fund more grants (over time) – by creating a revolving loan fund (to compliment the grant program) could have a dramatic impact on the range of therapeutic advances the agency can fund. The board has just begun phase two of the financial plan by studying how to implement the loan provisions of the initiative. A basic model of revolving seven year loans, as a substitute for some grants when dealing with the private sector, will be investigated over the next year. Potentially, a loan program could recycle over $1.5 billion – in the first 15-17 years of the agency’s life – bringing the total effective resources to fund medical research up to $4.5 billion.

"Third, the board and the agency need to launch a major public information program, including a specific focus on the upcoming human embryonic stem cell clinical trials. These clinical trials, over time, bring the possibility of remarkable medical advancement, but they also bring the potential for initial tragedies, despite the best safety procedures. Even with the benefit of extensive animal, pre-clinical trials, setbacks may occur – particularly given the broad spectrum of therapies and chronic disease challenges. The patients will have independent medical doctors advising them, along with family and friends; but, pre-clinical animal trials are not completely predictive of human outcomes. We must respect each patient’s decision to take “managed and reasonable” risks that may redeem their futures or save their lives. Medical therapies for the patients in the trials and all future generations are dependent upon the courage of individual patients, if medicine is to advance. With a deep reverence for life, we must inform the California public and every patient about these risks and build the patience and understanding that will be critical elements of medical research risk tolerance, if we are to secure the path to therapeutic success, which will involve many attempts and many 'trials.'"

Text of CIRM Statement

Earlier this year, we asked Dale Carlson, then CIRM's chief communications officer, for a perspective on the performance of the California stem cell agency. Here is the text of what he provided.

"The early history of CIRM is remarkable on a number of points, particularly given constraints on our budget and staff imposed by the delay in issuing bonds.

"The project is innovative from its inception: no one has ever funded scientific research with debt financing. Governments float bonds for public capital projects routinely – for roads, schools, prisons, libraries, water storage and transport, and other physical infrastructure needs – but never before for the development of intellectual capital until California voters approved Proposition 71. Similar bond programs are now proposed in New York, Texas, Massachusetts, and New Jersey, and have been considered by states in Australia. I don’t offer that as an example of something CIRM has ‘done right,’ but to establish as background the fact that everything we’ve done since is new, untried, and uncharted.

"The CIRM Scientific Strategic Plan specifies clear objectives and funding initiatives for 10 years. The fact that we have a 10-year plan is remarkable. I know of no other government agency (or public company for that matter) that’s ever developed such a far-sighted blueprint for its activities. It sets specific goals and benchmarks so the public can measure our progress. It lays out a detailed course of action for the six months and three years following its adoption. It does not dwell on generalities, as is common in strategic plans for public agencies. We were lauded for being realistic in our goals and for the open, public process used to draft that document, including the scientific meeting held in 2005 to assess the state of stem cell research globally.

"Our medical and ethical standards for research go beyond any in place or recommended by other scientific funding organizations. In at least one case, they’ve been adopted wholesale by another state.

"Our intellectual property policy for non-profits and the for-profit policy currently in development go beyond those of other private and public funding agencies. Again, some believe our requirements go too far, some not far enough. And again, this is another instance where we’re largely working without benefit of a successful model in place at the federal or state level.

"We’ve issued four RFAs, reviewed more than 350 applications, and brought recommendations to our governing board. In each instance, the time from RFA concept approval to grant approval has been far shorter than researchers have seen from other agencies. (Have I mentioned that we have limited staff for this work?) To date, 136 grants totaling more than $208 million have been awarded or approved at 23 institutions.

"We commissioned the Institute of Medicine to hold a conference on the risks to women who donate oocytes, the first meeting ever held on this subject.

"The Institute’s global leadership is well-recognized, even before awarding significant research funds. We forged strong relations with foreign countries and international organizations of stem cell researchers. We were the only state invited to join these organizations. The International Stem Cell Forum will hold its annual meeting next year in California, after considering offers to host the session from Israel and China.

"Few have any experience organizing a new government agency from scratch, let alone one devoted to such a novel concept. We’ve struggled at times with the challenges and requirements that presents, and we’ve not always made the right decisions when first faced with a decision or dilemma. Where we’ve erred or fallen short, we’ve quickly changed course in favor of a better approach. The Bureau of State Audits report is a good example of that pattern. If the BSA found a problem in our policies or practices, we made no attempt to defend or justify our conduct. We simply said, “You’re right. We’ll fix it.” And we have, in most instances.

"Some do not believe the Institute operates with sufficient regard for public participation or scrutiny, particularly where the review of grant applications is involved. Without revisiting the extensive discussions we’ve had with our critics on these points, it’s clear the CIRM is more open, solicitous, and responsive to the public than any other agency – private or public – engaged in research funding. The conflict of interest policy we follow for grant reviewers exceeds the requirements in place at NIH and elsewhere."

Proposed Lab Grant Review Procedures Posted

The California stem cell agency has posted more information on its proposed procedures for the facilities group review of applications for $227 million in grants for construction of stem cell research labs.

You can see the 18-page Power Point presentation here. The San Francisco meeting to consider them is Nov. 15.

CIRM Rules for Grants to Businesses

The California stem cell agency is going to take a whack Nov. 16 at how it proposes to run its program for research grants to busineses, ranging from ethics to allowable expenses to sharing of biomedical materials.

Biotech businesses have plenty to chew on in the 47 pages of proposed policies that have been released in a nicely timely fashion. No excuses if they don't weigh in now.

The actual occasion is an "interested parties" meeting at sites in San Francisco and San Diego that will be linked telephonically. Here is an Internet link to the meeting notice, which includes a separate link to the 47 pages.

The Big Oil-Stem Cell Interface

The peripatetic John M. Simpson is a man of many parts.

As stem cell project director for the Foundation of Taxpayer and Consumer Rights of Santa Monica, Ca., he has followed the affairs of the California stem cell agency, a task that has kept him busy for more than two years. But on other occasions, his work for the foundation calls him to different venues.

Recently he was in downtown Los Angeles at an appearance of the chief executive officer of Chevron Oil. Simpson's job? Bestow the Golden Nozzle award on the chairman. Here is a link to a video that tells all.

More Details Due Friday on Lab Grant Meeting

Regarding the $227 million lab grant item below, Richard Murphy, interim president of CIRM, just sent us the following:

"The slides with the specifics for the meeting are in the process of being edited and should be available on the Web Friday."

How to Wrestle with Requests for $227 Million: CIRM Agenda Vague

The California stem cell agency will deal once again next week with its plans for its largest round of grants ever, but exactly what is on the agenda is a virtual mystery.

No matter. If you are looking for some cash to build labs, you better be at the Facilities Working Group session Nov. 15. The details are what counts here, and missing one could mean the loss of tens of millions of dollars.

On the agenda is something listed only as "Consideration of Process and Procedures for Major Facilities Grants Review Meeting." We queried CIRM for more details. None were forthcoming. Perhaps they will be available in time for applicants and other interested parties to make plans to be in San Francisco.

The facilities group will be dealing with the applications for $227 million in lab construction grants next year, following the scientific review and the first cut in January by the Oversight Committee. The scientific review will be behind closed doors but the facilities group session is scheduled to be public.

The Shifting Sands of Stem Cell Support

New Jersey voters on Tuesday sent a message to sanguine supporters of stem cell research in California: Do not assume that the public is always behind you.

Analysis this morning of the election results is a bit preliminary but news reports are characterizing the rejection of the $450 million stem cell research measure as a surprise.

And it is not good news for those in California who find reassurance in the 59 percent voter approval of Proposition 71 in 2004, the measure that created the state's $3 billion stem cell program.

We have pointed out previously that stem cell research is not well understood by the public. Support for it is weak despite often rosy polls that seem to indicate it is a motherhood issue, at least in the eyes of some at CIRM. That is not the case, as shown in a poll by the Pew Forum for Religion and Public Life. According to that survey, support dropped from 57 percent nationally two years ago to 51 percent in August this year. It also showed that 55 percent of the public had heard little or nothing about stem cell research.

The New Jersey vote signals that it is imperative for CIRM to move forward thoughtfully and effectively on its public education/PR plans and promptly fill the vacant position of chief communications officer.

The New Jersey vote showed the vulnerability of stem cell research in the political marketplace. Voters can be fickle. To forestall erosion of support in California, CIRM must move to shore up its weaknesses. Those include its penchant for closed doors and secrecy – all of which breed suspicion and provide a recipe for scandal.

CIRM Offers $300,000 PR Contract

"Anonymous" posted a comment on our "communications void" item below that merits some attention. Here it is, and here is the link to the RFP that the comment mentions. Our thanks to "anonymous."

"FYI - There is an RFP out for PR firms. The below is from Odwyerpr.com

"CALIFORNIA ISSUES $300K RFP FOR STEM CELL PR


"California's state-backed entity set up to distribute funds for stem cell research has issued a six-figure RFP for state, national and global public information and communications work.

"The California Institute for Regenerative Medicine is backed by $3 billion in bonds and distributes funds via an independent citizens' oversight committee, which plans to dole out nearly $300M each year over the next decade.

"The Institute has issued an RFP for a firm to handle its public information needs for the next year with a budget capped at $300K. The work includes a full media relations program, strategic counsel, outreach to patient advocacy and health organizations, and internal communications.

"The CIRM wants a firm steeped in education and advocacy for scientific and medical research, public funding and related topics.

"Proposals are due Nov. 30."

Science, Libel and the Law: A California Case

A California physician, who also serves on the UC Irvine faculty, says a lawsuit against him by a Korean stem cell scientist is an attempt to "stamp out any critical scrutiny" of the researcher's credentials and techniques.

The matter, which will hit a Los Angeles court room on Wednesday, pits Bruce Flamm against Kwang Yul Cha.

Flamm works at Kaiser Permanente in Riverside, Ca. Cha, an internationally known scientist, heads a "a vast conglomerate of medical facilities in Korea and the United States," according to legal filings by Flamm.

Last March the California stem cell agency awarded a $2.6 million grant to a nonprofit, Los Angeles subsidiary of the Cha organization. Directors of the agency approved the application without knowing the identity of the applicant, following a recommendation from another CIRM panel arrived at behind closed doors. Both procedures are standard for the agency. A flap arose when the media reported the applicant had links to Cha and reported the controversy surrounding the scientist. In September, the subsidiary withdrew its grant application.

The Flamm-Cha story began with a 2001 article by Cha and two other persons that was published in the Journal of Reproductive Medicine. Flamm said it reported that "distant intercessory prayer can double the success rate" of IVF. The article generated international attention and comment, including some from Flamm.

In August of this year, Cha filed a libel lawsuit against Flamm, saying that Flamm defamed him in a March 15, 2007, article in the Ob/Gyn News. In October Flamm filed what is known as an anti-SLAPP lawsuit against Cha.

Flamm's suit is based on a California law aimed at preventing stifling of public discussion through the use of lawsuits. SLAPP is an abbreviation for "strategic lawsuit against public participation."

Flamm is contending that his comments concerned matters of "significant public interest," are not prima facie defamatory and are protected by California's anti-SLAPP statute.

Flamm told the California Stem Cell Report via email that "Kwang Cha's attorneys will attempt to over-ride our anti-SLAPP motion" in Los Angeles Superior Court at 8:30 a.m. Pacific Standard Time on Wednesday.

WARF Stem Cell Patents: The Latest Chapter

Two groups challenging WARF's stem cell patents, an effort supported by the incoming president of the California stem cell agency, Alan Trounson, are rejecting the Wisconsin organization's latest attempt to beat back the move.

The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation said WARF's latest filings do not merit overturning a preliminary ruling against the organization.

You can find the latest legal argument by the two groups here. You can find the press release here.

Fresh Comment

"Anonymous" has posted a comment on the "high priests" item below. It includes a link to more details on American Chemical Society and its activities regarding open access.

High Priests vs. Open Access to Research

The high priests of the newspaper business – otherwise known as editors and publishers -- have learned about the power of the Internet the hard way. Their business is turning remorselessly downward as advertisers shift their dollars to chase readers who have abandoned print.

Now comes the turn of the high priests of scientific journals. And the forces at work are something that the California stem cell agency will have to confront as it deals increasingly with public access to publicly funded research findings and how quickly that access becomes available.

Merrill Goozner, director of the Integrity in Science project for the Center for Science in the Public Interest, wrote recently that both houses of Congress have approved legislation that would provide free public access to all published articles from NIH-funded research. The measure was opposed by publishers who say that their ability to support independent peer review requires exclusive copyrights.

Goozner cites an article in The Scientist that points out that there may be a link to profits, which in turn are linked to salaries, for example, at the American Chemical Society, which generates $500 million a year from its 36 journals. Several top executives at the society earn more than $750,000 a year.

Any researcher working for a private company knows that he who pays the piper calls the tune. The fact is that taxpayers finance this research. At the heart, they own it just as much as a bank owns a mortgaged house or shareholders own a company.

The Internet is like a tidal force. Resisting its imperative may appear to be possible in the short term, but over the long term the high priests will be sweep out to sea. The alternative is come up with a better business plan and to find a way to ride the tide instead fighting it.