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Tax Forms Current Finance Reports. Somewhere along the line, we learned to doubt our perception, discount our feelings, and overlook our needs. We looked to others to tell us what to think, feel, and behave. Other people supplied us with information about who we were and should be. We find the Promises coming true, one day at a time. When you find your first meeting, and walk in the door, you will find a safe place, where all are welcome. There is only one requirement to join; a desire for healthy and loving relationships. These are the foundation of our program, and you will come to find great comfort in them, one day at a time as you walk the path of recovery from codependence. For online and telephone meetings, we would like to display meeting results in your time zone. We have detected your time zone using your browser. Search Search for:. Learn More. Recording of the Board public meeting October 5th, CoDAteen A safe place for teenagers to share experience, strength and hope. Submit your Meditation. What is codependence? What to Expect When you find your first meeting, and walk in the door, you will find a safe place, where all are welcome. Find A Meeting:. Fair Use Privacy. Recent Comments. Show results within km mi of. Click To Filter. Mexico D. George St. George, UT St. John St. Joseph St. Louis St. Paul St. Petersburg St. Petersburg, Saint Petersburg St. Petersburg, Saint Petersburg, St. Your Time Zone For online and telephone meetings, we would like to display meeting results in your time zone. Please confirm your timezone or select a different time zone. Current timezone Confirm.

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My name is James Love. I work for the Center for Study of Responsive Law, where I am Director of Economic Studies and also the Director of the Taxpayer Assets Project TAP , a group created by Ralph Nader to monitor the management and sale of government property, including intellectual property rights from government funded research. I have presented testimony or comments on this subject to the U. Congress on several occasions, and I have written articles for public policy, trade and general interest publications. One presumes, based upon the published notice and Draft Mandate, that this second forum is designed to provide additional balance to the comments provided by the industry at the July 21 forum. Because of the short timetable, consumers and public interest organizations have not been given an adequate opportunity to prepare for this meeting. We ask that NIH give the public an additional 60 days to prepare comments on this important topic. Only the third panel focuses entirely on the reasonable pricing clause, and then only with a highly selective set of questions which focus on the potential conflicts between reasonable pricing and product development — a trade-off which does not exist at all for some government funded drugs. NIH could have organized the forum much differently, and indeed, if NIH had bothered to work closer with its critics, it would have avoided the appearance of yet another one-sided assault on the reasonable pricing clause. For example, the three panels could have been asked to consider such questions as:. If NIH framed the reasonable pricing issue with questions such as these, the discussions would likely focus on constructive changes in the administration of the reasonable pricing clause, rather than a debate over whether or not to eliminate the clause. Why then is the NIH reasonably pricing clause so important? The answer is two fold. First, the one fifth of the NIH research budget which is spent on intramural research is a substantial amount of money that is highly productive in terms of new drug development. The new drugs which are developed with direct NIH involvement are important in terms of their efficacy, innovation and the severity of the illnesses which they treat. Since a single new drug can generate billions of dollars in revenue, even if it has a tiny population of users, companies want to preserve as much pricing flexibility as possible. Secondly, the existence of any reasonable pricing mechanisms creates a model which may someday be applied in broader applications. Before such actions are likely, the government will have to confront the thorny issue of a reasonable pricing methodology. This is an important question, which deserves thoughtful analysis. But, this simplistic scenario is not appropriate for several reasons. If that was not true, we would instantly increase the NIH budget by large multiples and cease all efforts to reduce drug prices through the use of generics, formularies, or other mechanisms. Attempts to control expenditures on pharmaceuticals are necessary, not because of moral outrage over drug company profits, but because as taxpayers and consumers we have limited resources. In a wide range of important cases, changes in drug prices will not delay or discourage development. For example, in the cases of ddI and Taxol, the government funded the preclinical research, sponsored the clinical trials, and controlled the intellectual property rights. The NIH reasonable pricing clause is only one of several mechanisms that the government can use to control health care costs. Among the range of options are broader review of drug prices patented under the Bayh-Dole Act, loss of exclusive marketing rights under the Orphan Drug Act, deeper Medicaid and Medicare discounts, use of generic drugs and formularies or a general program of compulsory licensing or price controls for pharmaceutical drugs which do not face effective price competition. However, there are clearly other measures which can more than compensate for any negative impacts. For example. While the government would set a minimum level of reinvestment, the companies would be free to follow market forces in choosing particular investment projects, as they are today. Similar proposals are being considered elsewhere. Taxpayers have some interest in higher government royalties, particularly insofar as exports of the technology are concerned, but the overwhelming issue remains the prices the public faces as consumers. Any serious effort to get the government to recoup its investments through royalties will fail on several counts. Among the more important considerations:. From the standpoint of economic efficiency, the marginal cost of making a new pharmaceutical technology is often extremely low, and policies which artificially raise prices above marginal costs will reduce social welfare. NIH have a concern that there be a reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public. Accordingly, exclusive commercialization licenses granted for NIH intellectual property rights may require that this relationship be supported by reasonable evidence. This model language is often modified through negotiations. NCI has a concern that there be a reasonable relationship between the pricing of Taxol, the public investment in Taxol research and development, and the health and safety needs of the public. Bristol-Myers Squibb acknowledges that concern, and agrees that these factors will be taken into account in establishing a fair market price for Taxol. Both changes significantly weakened the provision. She described the NIH reasonable pricing clause as though it had religious significance. The difficulty with the reasonable pricing clause is it was a spiritual statement. It was a statement of trust, of understanding that we thought that the companies should recognize the public investment, but in fact, if you look at the contractual agreement, there are no teeth. There is no mechanism at NIH for enforcing it. There is no contractual responsibility on the part of any of the partners to divulge information that would lead to a mechanism to achieve a price. There is not articulation of what pricing strategy might even be. Rather than repeat criticisms that we have provided elsewhere, I will focus on the particular factors which are important for rehabilitating the usefulness of the reasonable pricing clause. From the point of view of the contract language, it is fair to say that the model language is quite vague with respect to pricing methodology. Of course, NIH did itself no favors by weakening the clause in the ddI and Taxol contracts, particularly since the government was in a very strong bargaining position in both cases. Indeed, even with the modified contract terms that were used for ddI and Taxol, NIH still retained a good deal of power to insist on a much lower price. It is fair to say that many NIH officials are so hostile to the reasonable pricing clause that we expect them to actively sabotage the provision. One wonders how much matters would change if even a small fraction of the money to pay for the NIH developed therapies was paid for from the salaries of the NIH officials who are responsible for the reasonable pricing clause. We have concluded that many of the high paid NIH officials, all of whom enjoy excellent health care benefits, have little appreciation for the burdens faced by citizens who earn lower salaries and pay for medications out of pocket. The Secretary of Health and Human Services should consider a reorganization which places the responsibility for the reasonable pricing negotiations in the hands of an agency outside of NIH that has a clearer mandate to protect consumer interests. The industry has rightly pointed out that the extremely vague language in the present model reasonable pricing clause presents uncertainty. Of course, the industry is unlikely to welcome reductions in that uncertainty, if a new more detailed methodology results in lower drug prices. In order to move forward, beyond this increasingly tiresome debate over whether or not to control prices, it is a good idea to establish some basic concepts. The government cannot do a good job of evaluating the reasonableness of a drug price without better data. The federal government has historically funded one fourth to one fifth of all clinical trials. These data alone would make a very useful database, but it would be even more useful if the government had the power to compel reporting by the private sector as well. There is also a great need for data on prices and sales revenues and production costs. Of course, NIH can obtain information of this type through contractual provisions, but the broader reporting under a statutory authority to compel disclosures would be preferred. The relevant market for pharmaceutical drugs is international. The relevant drug revenues are from international sales, not domestic sales. The government should routinely collect and study drug prices from other countries, including countries that use compulsory licensing to lower drug prices. The U. In Taxol and ddI the government made a fundamental error. It evaluated prices based upon the costs of other drugs, rather than the value added contributions of the license holder or CRADA partner. Investments in the riskier stages of development are more valuable than investments in more mature development stages. Out of pocket investments should be adjusted for risk. These rules apply to both the government and company investments. Industry consultants make generous adjustments to out of pocket investments, to reflect risks and the time value of money. Government officials report taxpayer investments in nominal terms, without any adjustments at all. This gives a distorted view of the relative contributions by the government and the industry. The largest area of undervaluing concerns pre- clinical research. The industry estimates that more than two thirds of the cost of a new drug is due to the cost of pre- clinical research, once the investments are adjusted for risk and the time value of money. In a number of cases, NIH should be able to rely upon market forces to determine reasonable prices. If NIH can articulate a sound pricing rule or method, it should be possible to allow firms to competitively bid to obtain a CRADA or license agreement, on the basis of a bid variable that is related to the eventual consumer price. That bid variable could be the price itself, or a related item such as the gross or net revenue from sales, or even the years of marketing exclusivity. NIH should retain the flexibility that it already has to waive or modify the reasonable pricing clause, but it should do so only after a finding that the wavier or modification was in the public interest, and after public comment. This is important stuff, and it deserves more than the symbolic attention that it has received in the past. The government has the opportunity to save taxpayers and consumers billions of dollars, and the industry stands to lose billions of dollars in windfalls on government funded research. Put together a team that is equal to the task. Of course, NIH already has the authority to do this, and has often modified the model reasonable pricing agreement, even when there was no apparent rationale for the changes. Argentina and Brazil do not currently recognize patents on pharmaceutical drugs. Both countries are facing pressure from the United States to enact new patent laws. The United States negotiators are asking both countries to adopt provisions which are more strict than are required by the new GATT, and in respects, more strict than now exist for members of the European common market or in the United States. The written statement from the May 12, meeting is available upon request. Box , Washington, DC I. Introduction My name is James Love. For example, the three panels could have been asked to consider such questions as: If a firm obtains rights to an invention developed principally with public funds, should the company be free to charge consumers what ever the market will bear, without limit? What can be done to prevent the public from paying twice for drug development, first as taxpayers, and then as consumers? Should the government routinely collect information on the economics of drug development and marketing, for those drugs developed with significant public support? For example, should the government obtain information on the annual sales revenue, manufacturing costs and marketing costs for ddI or Taxol? For those drugs which are developed with significant public support, how much of the sales revenue is obtained from patients who are insured by the government, through medicaid, medicare, the military or other programs? Under this methodology, a drug such as levamisole could be increased in price by more than 1, percent and still be considered reasonably priced. Should NIH use the median prices of drugs used for similar therapeutic purposes as a benchmark for a reasonable price? Higher royalties are not a substitute for a reasonable pricing clause. Among the more important considerations: Efficient royalty schemes would be complex, and in many important ways, even more complex to administer than a reasonable pricing clause. Should the government be party to a policy that denies poor segments of society access to a therapy in order to increase government royalties? Patients who have already paid for research as taxpayers will object to being asked to pay a second time as consumers. Reasonable Pricing Methodology. The one distributed at the July CRADA forum read as follows: NIH have a concern that there be a reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public. In response, Senator Cohen and Dr. Bernadine had the following exchange: Senator Cohen: When you say it is a spiritual thing, or a spiritual provision, it is really a meaningless provision, is it not? Senator Cohen: Let me not engage in any kind of teleological argument with you about the value of spirit in our lives. We have no way to monitor what a reasonable price is and no mechanism to enforce it. We are doing a greater disservice than by not having a clause in any event, because we are giving the appearance that we are doing something in fact, when we are doing nothing. Information is important. Think globally. Reward companies for value added contributions to research. Reward risk taking. When possible, rely upon market forces. Take the job seriously. Endnotes 1. These included a patent for ddI and exclusive rights to patient records for Taxol.

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