Mr. President, Senator Hatch, Senator Brownback and I are pleased to introduce today the Project BioShield II Act of 2005. This is the fourth bill I have introduced on this subject, and the third…
Mr. President, Senator Hatch, Senator Brownback and I are pleased to introduce today the Project BioShield II Act of 2005.
This is the fourth bill I have introduced on this subject, and the third with Senator Hatch as my lead cosponsor. We are delighted today to be joined by Senator Brownback, a leading advocate for research to cure deadly tropical diseases.
None of us on the Hill--especially those of us with offices in the Hart Building--will forget October 15, the date of the anthrax attack on Senator Daschle's office. This date is the bioterrorism equivalent of September 11. We also need to remember October 5, the third anniversary of the 2001 anthrax death of Bob Stevens, a photo editor at American Media in Boca Raton, Florida, and November 17, the third anniversary of the discovery of a similar anthrax laced letter mailed to Senator Leahy. Similar anthrax attacks during these weeks were directed at NBC, ABC, CBS and other news organizations. All told five people died and thousands who might have been exposed were put on Cipro, including many of us and many of our staff.
This attack on civilians with weapons grade anthrax was unprovoked. And unlike the case with the 9/11 attacks, we still don't know who mailed the anthrax letters. As with the 9/11 attacks, we were totally unprepared for the anthrax-laced letters. We are responding forcefully to the 9/11 attacks--the commission that Senator McCain and I proposed has issued a superb report and the Government Affairs Committee, where I serve as the Ranking Democrat, is hard at work translating its recommendations into legislation. Unfortunately our response to the 10/ 15 anthrax attack has not been as forceful.
Unlike our response to 9/11, we have not seemed to consider the 10/15 attack to be the equivalent of a declaration of war. While we have taken a few constructive steps to strengthen our Bioterror defenses, we remain painfully vulnerable to another Bioterror attack, or a chemical or radiological attack.
Many of us believe that enactment of BioShield I, last July, is a step in the right direction, but we don't believe that BioShield is sufficient. If we listen carefully, we will hear that the biopharma industry--which is hiding on this issue--is saying that BioShield is not enough. So we already have strong warning signs that more needs to be done.
There is no terror threat greater than that of Bioterror. With an attack with a plane, a chemical attack or a radiological dispersion device, dirty bomb, the loss of life can be catastrophic, but the perimeter of the attack is fixed. With an infectious disease, the perimeter of an attack might grow exponentially as the infection spreads. It is possible to kill thousands with a bomb, chemical or radiation, but it is possible to kill millions with a bioterror pathogen.
In the 2001 anthrax attack, the terrorist wrote a note in the letter to Senator Daschle that said, ``09-11-01. You can not stop us. We have this anthrax. You die now. Are you afraid? Death to America. Death to Israel. Allah is great.'' If this note had not been included in the letter, and if the intern who opened the letter hadn't been suspicious, it is possible that some Senators and many Capitol Hill staff from our offices--perhaps hundreds--might have died. We would only have discovered the attack in hospital emergency rooms, where Cipro might have proven to be ineffective. Cipro works as a prophylaxis only when it catches anthrax early, before the toxins are released into the bloodstream, which can happen within 24 hours of an infection. Our current anthrax vaccine is administered in six shots over 18 montns.
The 9/11 Commission report states that al-Qaida ``was making advances in its ability to produce anthrax prior to Sept. 11'' and cited former CIA Director George Tenet as warning that an anthrax attack is ``one of the most immediate threats the U.S. is likely to face.'' Russia developed dozens of strains of anthrax and the security at these former bioweapons laboratories is suspect. It is estimated that a mason jar of anthrax spores sprayed over an urban area could infect 400,000 residents, and if undetected until they started showing up in emergency rooms, kill half of them. It is also estimated that one hundred anthrax laced letters could cross contaminate thirty million letters and infect 10,000 people with anthrax. Imagine what would happen if our mail system--which processed over 200 billion pieces of mail last year--were closed for a few months. What we need, and don't yet have, is a therapeutic that disarms the anthrax toxins at a late stage of the disease--which is the aim of a pending RFP at the Department of Health and Human Services.
We saw the potential for morbidity and mortality, and massive economic disruption, with SARS. When SARS was rampant, Beijing, Hong Kong and Shanghai closed down. Quarantines were imposed and China authorized the death penalty on anyone who willfully spread the disease. During the epidemic, there were reports that the SARS virus was mutating to become more virulent. In China's countryside, fear of SARS has led to some villages setting up roadblocks to keep away people from Beijing and at least four riots against quarantine centers have been reported in recent days. Thousands were quarantined in China. In the end SARS spread to thirty countries on five continents, sickening nearly 9,000 and killing 850. SARS is a zoonotic disease that apparently can jump back and forth between animals and man, which makes it much more difficult to eradicate it. We may not have seen the last of it.
We can also remember the devastating impact of the 1918 Spanish flu pandemic that killed more than died in the first World War, about 30-40 million people equivalent to 100 million today. In the month of October, 1918, 200,000 Americans died of the disease, 43,000 soldiers died, and 28 percent of our population was infected. The flu's lethality rate was only 2.5 percent the lethality rate of the most common form of smallpox, variola major, is 30 percent and for hemorrhagic smallpox it approaches 100 percent. The lethality rate for SARS was about 15 percent. If the 1918 flu pandemic killed the equivalent of 100 million people, think of how many smallpox or SARS-- both of which could be weaponized by terrorists--could kill.
Public health authorities are concerned about the incidence of avian influenza in humans. There is now concrete evidence that this virus can be transmitted human-to-human. When humans contract the pathogen from birds, the death rates are very high; a majority die. Since January 2004, a total of 23 confirmed human cases of avian influenza virus infections have been reported in Vietnam with 19 deaths and 12 cases in Thailand with 9 deaths. These cases were associated with widespread H5Nl poultry outbreaks that occurred at commercial and small backyard poultry farms. Since December 2003, nine countries have reported H5Nl outbreaks among poultry. More than 100 million chickens have been culled in an effort to stop the outbreak. The virus now appears to be able to infect mammalian hosts, including pigs and cats, an unusual prowess for an avian virus. This raises concern as pigs are also hosts of human flu viruses and this could yield
a hybrid avian flu strain that can be passed human-to-human. The avian flu virus apparently is now carried by migratory birds so it may be very difficult to eradicate the virus. We have no vaccine for the disease and the one therapeutic Tamiflu--is only effective if given very early after the onset of symptoms. It is feared that the virus might evolve resistance to Tamiflu. Public health officials believe that in theory the avian flu could cause a ``pandemic killing millions of people worldwide, and possibly hundreds of millions.'' Whether H5N1 could be used as a Bioterror weapon against agriculture or humans is not known.
In 1947 there was an outbreak of smallpox in New York City. Eventually two of the twelve who were infected died. But the smallpox vaccination campaign was massive 500,000 New Yorkers received smallpox vaccinations the first day and eventually 6.35 million were vaccinated in less than a month, 85 percent of the city's population. President Truman was vaccinated prior to a trip to New York City.
If we suffered another smallpox outbreak, it is not likely that a vaccination campaign would go so smoothly. It is now estimated that if the current smallpox vaccine were deployed in the United States 350 to 500 individuals might die from complications. The current vaccine is not recommended for patients who have eczema or are immunosuppressed, HIV-positive or are pregnant. Even worse, based on a 1971 accidental release of smallpox from a Soviet bioweapons laboratory, some speculate that the Soviets successfully weaponized a rare and especially lethal form of smallpox, hemorrhagic smallpox, with near 100 percent lethality.
Mother Nature's pathogens are dangerous--smallpox, anthrax, plague, tularemia, glanders, typhus, Q fever, Venezuelan equine encephalitis, brucellosis, botulinum toxin, dengue fever, Lassa fever, Russian spring-summer encephalitis, Marburg, Ebola, Bolivian hemorrhagic fever, Argentinean hemorrhagic fever and fifty other pathogens could kill thousands or even millions. But on the horizon are more exotic and deadly pathogens.
We have reports that the Soviet Union developed genetically modified pathogens such as a hybrid plague producing diphtheria toxin. This manipulation increased virulence and made the plague microbe more resistant to vaccine. Other possibilities include a Venezuelan equine encephalomyelitis-plague hybrid is a combination of the virus and bacteria; we have no idea what symptoms such a pathogen would manifest or how we might diagnose or treat it. Other hybrid pathogens might be developed, including a Venezuelan equine encephalomyelitis-Ebola hybrid.
We have reports that the Soviet Union developed a powdered Marburg, a hemorrhagic fever where every cell and organ of the victim bleeds. Symptom of Marburg include kidney failure, recurrent hepatitis, inflammation of the spinal cord, bone marrow, eyes, testes, and parotid gland, hemorrhaging into the skin, mucous membranes, internal organs, stomach, and intestines, swelling of the spleen, lymph nodes, kidneys, pancreas, and brain, convulsions, coma and amnesia.
Genetically modified pathogens are another possibility. In 2001 the Journal of Virology reported that Australian scientists seeking to create a contraceptive for mice used recombinant DNA technology to introduce Interleukin 4 into mousepox and found that it created an especially virulent virus. In the words of the scientists, ``These data therefore suggest that virus-encoded IL-4 not only suppresses primary antiviral cell-mediated immune responses but also can inhibit the expression of immune memory responses.'' This public research suggests that introducing IL-4 can create an Andromeda stain of a virus, information of potential use to terrorist sociopaths. In addition, published studies describe how to create a recombinant vaccina virus to induce allergic encephalomyelitis in rabbits, and potentially--highly lethal smallpox virus capable of causing paralyses in humans and how to synthesize the polio virus in a biochemical laboratory .
Other possible pathogens--some of which the Soviet worked on--include antibiotic resistant pathogens. The Soviets apparently developed a strain of plague resistant to ten different antibiotics, and a strain of anthrax resistant to seven different antibiotics. Some claim the Soviets developed a strain of anthrax resistant to the current U.S. anthrax vaccine. A part of this research in a hamster model was published in ``Vaccine'' so this information is available to terrorists.
Other exotic pathogens might include autoimmune peptides, antibiotic induced toxins, and bioregulators and biomodulators. An autoimmune peptide might stimulate an autoimmune attack against the myelin that sheaths the target's nerve cells. Antibiotic induced toxins are hybrid bacteria-viruses where antibiotics administered to treat the bacterial infection stimulate the virus to release a deadly toxin; the greater the doses of antibiotics, the more toxins are released. Bioregulators and biomodulators are synthetic chemical that bond to and disrupt receptors that govern critical functions of the target, including nerve, retinal, liver, kidney, heart, or muscle cells to cause paralysis, blindness, schizophrenia, coma, or memory loss.
Some of these might be available now from the 60 bioterror research laboratories maintained by the Soviet Union. Eventually, terrorists might be able to set up full-blown biotechnology laboratories. Rogue states could do so and they might then transfer bioweapons to terrorists or lose control of them. Over the long term, as the power of modern biotechnology grows, the bioterror threat will grow and increasingly virulent and exotic weapons might become threats.
In November 2003 the CIA's Office of Transnational Issues published ``Our Darker Bioweapons Future,'' which stated that the effect of bioengineered weapons ``could be worse than any disease known to man.'' The rapid evolution of biotechnology makes monitoring development ofbioweapons extremely difficult. Some ofthese weapons might enable the development of ``a class of new, more virulent biological agents engineered to attack distinct biochemical pathways and elicit specific effects, claimed panel members. The same science that may cure some of our worst diseases could be used to create the world's most frightening weapons.'' It specifically mentioned the possibility of ``binary BW agents that only become effective when two components are combined (a particularly insidious example would be a mild pathogen that when combined with its antidote becomes virulent)''; ``designer'' BW agents created to be antibiotic resistant or to evade an immune response; weaponized gene therapy vectors that effect permanent change in the victim's genetic makeup; or a ``stealth'' virus, which could lie dormant inside the victim for an extended period before being triggered.
Illustrating the speed with which biotechnology is advancing to create new bioterrorism threats is a recent announcement by Craig Venter and his Institute for Biological Energy Alternatives that in fourteen days they had synthetically created working copies of the known existing bacteriophage virus Phi X174. Other researchers had previously synthesised the poliovirus, which is slightly bigger, employing enzymes usually found in cells. But this effort took years to achieve and produced viruses with defects in their code. So the timescale has shifted from years to weeks to make a virus. There are other bigger viruses that would require more time to assemble. Venter asserts that his team could make a bacteria with about 60 times larger genome from scratch within about a year of starting. Does this mean that the debate about whether to destroy smallpox virus stocks is pointless because any virus or bacteria whose DNA sequence is published is eventually going to be easily creatable by labs all around the world?
These pathogens might be deployed by terrorists, sociopaths or rogue states that have no compunctions about killing massive numbers of ``infidels'' or enemies in the west. They would experience great joy in sowing widespread panic, injury and death in America. Osama Bin Laden's spokesman, Sulaiman Abu Ghaith, bragged that al Qaeda has ``the right to kill 4 million Americans'' in response to deaths he claims the west has inflicted on Muslims. We are facing sociopaths with no compunction about using
whatever weapons of mass destruction they can develop or secure. They would see the potential to unleash a weapon in North America and trust that our borders would be closed so that it would only rage here and not spread to the Muslim world.
The Brookings Institution estimated that a bioterror attack would cause one million casualties and inflict $750 billion in economic damage. An earlier Office of Technology Assessment found that there might be three million casualties. If there are this many casualties, what can we expect in the way of public panic and flight? A 2004 poll finds that ``most Americans would not cooperate as officials would expect them to during a terrorism incident.'' Only 2/5 said that they'd ``follow instructions to go to a public vaccination site in a smallpox outbreak'' and only 3/5 would ``stay in a building other than their own home . . .'' A vivid vision of what an attack might look like is found in Albert Camus' The Plague, with its incinerators and quarantine camps. We can review the history of the Black Death, which killed up to one half of Europe's population between 1348 and 1349.
Imagine what would happen if the attack involves a pathogen for which we have no diagnostic, vaccine or therapeutic. If we resorted to quarantines, what would the rules of engagement be for the police and military forces we deploy to enforce it? Would it be possible to establish an effective quarantine if there is mass panic and flight? Would our hospitals be overwhelmed by the ``worried well'' ? Would public health workers continue to serve or also flee? If our hospitals are contaminated, where would Americans receive medical care for non- terror related emergencies?
What would happen if a bioterror, chemical or radiological attack closed Atlanta's Hartsfield International Airport--which handled nearly eighty million passengers last year? Or what would happen if we put a hold on the one hundred and twenty million international airline arrivals and departures we see each year? What would happen if we were forced to close our borders with Mexico and Canada--with 500 million crossings last year? What would happen if we restrained the 2.79 trillion automobile passenger miles driven in the U.S., one billion of which exceeded 100 miles?
What would happen if a terror attack rendered certain types of business activity uninsurable? What will happen if large swaths of residential real estate--none of which is currently insured for acts of terror--were contaminated and rendered worthless with anthrax spores?
We are vulnerable to a bioterror attack in many ways, but one of the most troubling is that we have essentially none of the diagnostics, therapeutics and vaccines we need to treat those who might be exposed or infected. If we don't have these medicines, we are likely to see quarantines and panic, which will amplify the damage and disruption. My office is on the 7th floor of the Hart Building, immediately above Senator Daschle's office. We were told if we immediately started a course of treatment with Cipro we would not die, so there was no panic. Think what would have happened if the government had said, ``We don't know what this is, it's deadly, we have no way to tell who has been exposed, and we have no medicines to give you.''
In the summer of 2000 the Defense Science Board found that we had only one of the fifty-seven diagnostics, drugs and vaccines we most need to respond to a bioterror attack, we had a therapeutic for chlamydia psittaci, a bacteria. It projected that we'd have twenty of the fifty-seven within 5 years and thirty-four within 20 years. But today we have only two of the fifty-seven countermeasures, we now have a diagnostic for anthrax.
At this rate of developing these medical countermeasures, we won't have twenty of them available until 2076 and we won't have thirty-four until 2132. This list does not include antibiotic resistant pathogens, hybrid pathogens, genetically modified pathogens, and a host of other exotic bioterror pathogens.
The Congress administration have not responded to the anthrax attack with an appropriate sense of urgency, especially with regard to the development of medicines. We have not responded with a crash industrial development program as we did when we developed radar during the Second World War or as we are now undoubtedly undertaking to detect roadside bombs. Reluctantly, I would characterize our national response as lackadaisical.
December 4 is the third anniversary of my introduction of legislation to provide incentives for the development of medical countermeasures-- including diagnostics, therapeutics and vaccines--for bioterror pathogens, S. 1764. Chairman Hatch, October 17 is the second anniversary of our introducing our first bill together on this subject, S. 3l4, and we introduced our current bill on March 19 of last year (S. 666). Twenty months ago President Bush proposed Project BioShield, a bill based on one of the twelve titles in our bills, and it was finally enacted into law on July 21. If we enact one of the titles of our bill every two years, it'll take 22 more years to complete our legislative work.
The critical issue for this hearing is whether Project BioShield, Public Law 108-276, is sufficient or whether we need to supplement it with BioShield II, a bill that you and I intend to introduce this Fall. BioShield is only one title of our proposal--the title that provides that the government will define the size and terms of the market for a Bioterror countermeasure in advance before a biopharma company puts its own capital at risk. This is a necessary first step; companies won't risk their capital to develop a product unless they can assess the possible rate of return, product sale on their investment.
Enacting BioShield is a step in the right direction. If we were to enact only one idea first, this is the right first step. We will now see how the Department of Health and Human Services implements this law. We will see what R&D priorities it sets, whether it projects a market for these products sufficiently large to engage the better biopharma companies in this research, and whether it sets contract terms that company Chief Financial Officers find acceptable.
Unfortunately, we all heard a deafening silence from biopharma industry--the target of this legislation--as BioShield was being considered. The industry did essentially nothing to fix the Administration's draft--which the industry privately stated was laced with dysfunctional provisions. The industry did essentially nothing to pass BioShield. And the industry has said essentially nothing since BioShield was enacted.
It is clear to me that BioShield is not sufficient to secure development of the medical countermeasures we need, indeed, I believe it is woefully insufficient.
The industry is skeptical that the government will be a reliable partner during the development bioterror countermeasures. The basis of its skepticism runs deep.
The industry points to the Cipro procurement as a case in point. In 1999, before the anthrax attack, Bayer, the developer of Cipro, was asked by FDA and CDC to secure a label indication for Cipro for anthrax. The government wanted to have one antibiotic available that was explicitly labeled for anthrax--it understands that patients might be reluctant to take a medicine for anthrax where it is not labeled for this indication. Bayer incurred the expenses to do this with no expectation of ever utilizing the product in this manner, and when the attack occurred, Cipro was the only therapeutic with a label indication for anthrax. Bayer handled this emergency with honor. It immediately donated huge stocks of Cipro, 2 million tablets to the Postal Service and 2 million tablets to the Federal government to be used to protect those who might have been exposed or infected. The government then sought to procure additional stocks of Cipro and demanded that Bayer sell it as one-fourth the market price. Threats were made by Members of Congress that if Bayer would not agree to this price the government might step in to challenge the patent for Cipro. Bayer readily agreed to the deep discount. We can assume that every other purchaser of Cipro then demanded this same price and that this cut Bayer's market return for Cipro. To add insult to injury, Bayer has had to defend itself from lawsuits by those who took Cipro in response to the attack even though it did what was asked, provided more than enough free product to treat
all patients and greatly reduced it's stockpile pricing. Bayer also was deeply concerned with employee and plant security risks when it was publicly identified as the sole source of this counter-bioterrorism agent.
The industry view this incident as proving that with regard to bioterrorism research, no good deed will go unpunished. If a large pharmaceutical company can be manhandled this way, what would happen to a small biotechnology company? The industry expects that if there is an attack, and the company has the indispensable medicine we need to respond to it, the government is likely to steal the product. The industry is deeply skeptical of the government already. It has very complex and often contentious relationships with other HHS agencies, including the Center for Medicare Services, the Food and Drug Administration, and the National Institute of Health. It has constant battles with state Medicaid agencies. This is not an industry that trusts government.
Some in Congress have proposed legislation that feed industry fears. In 1994 and 1995 legislation was introduced in the House, H.R. 4370, introduced on May 10, 1994, and H.R. 761, introduced on January 31, 1995, that provided the government with eminent domain power with regard to AIDS to confiscate ``all potential curatives and all data . . . regarding their development,'' including the patents for such compounds. Similarly, in 1999 and 2001 legislation was introduced in the House, H.R. 2927, introduced on September 23, 1999, and H.R. 1708, introduced on May 3, 2001, that provided for the compulsory licensing of ``any subject invention related to health'' where the government finds it ``necessary to alleviate health or safety needs'' or the patented material is ``priced higher than may be reasonably expected based on criteria developed by the Secretary of Commerce.'' Legislation has been introduced that would deny the benefits of the R&D tax credit for research by pharmaceutical companies where the products that arise from that research are sold at higher prices abroad than in the United States. See H.R. 3665 introduced on February 15, 2000.
The industry response to these threats to its patents must be seen in light of the events of March 14, 2000. On that day a White House spokesman apparently indicated that the government might move to challenge some biopharma industry patents for genes. The industry lost $40 billion in market capitalization in the panic that ensued on Wall Street. That was not only the beginning of a deep drought in biotech company financing, it was the beginning of the collapse of the entire NASDAQ market. A similar collapse and drought had occurred in 1993-1994 the Clinton Administration proposed that the prices of ``breakthrough drugs would be reviewed by a special government panel.''
The issue of price controls and patents was recently considered and rejected by NIH in response to a petition for the government to march- in on the patent of Abbott Laboratories for ritonavir, sold under the name of Norvir, an AIDS therapeutic. The petitioner, Essential Inventions, asked that the government cancel the license of this patent to Abbott, which it alleged was charging too much for Norvir. The petitioner had also been involved in the 1994-1995 NIH proceeding, where NIH reviewed the impact of its 1989 protocol to review whether ``reasonable'' prices were being charged by companies that had licenses with NIH. NIH found that this price review process was destroying the NIH technology transfer program--companies simply would not enter into agreements with NIH. As a result, NIH repealed the price review process. The new march-in petition raised essentially the same issues and if the petition had been granted, we could have expected that the NIH tech transfer process will be crippled--again, as it was from 1989- 1995. In rejecting the petition, NIH did not state, however, that is has no right to march-in based on the price of a product, implying that it could or might assert such power in the future. This can only have a chilling impact on companies considering entering into biodefense procurement and research agreements.
Aside from fears about government actions, we could not have picked a worse time to ask the industry to undertake a whole new portfolio of research. The biotech NASDAQ index stood at 1380 and it now stands at about 725. The Amex biotech index peaked at 801 and it now stands at about 525. The Dow Jones pharmaceutical index peaked at 420 and it now stands at about 275. The biotech industry raised $32 billion in capital in 2000 and only $16 billion last year. In June of this year, 36 percent of the public biotech companies had stock trading at less than $5 per share. There were 67 biotech IPOs in 2000 and only 7 last year. The industry losses each year continue run to $4 billion. The National Venture Capital Association reports that only 2 percent venture money went into biodefense following the October anthrax attack.
Of the 506 drugs publicly disclosed to be under development by the 22 largest pharmaceutical companies, only 32 are for infectious disease and half of these are aimed at HIV/AIDS. In 1967 we had 67 vaccine companies and in 2002 we had 12. World wide sales vaccines is about $6 billion, but the world wide sales of Lipitor are $10 billion.
In addition, it is not clear whether the government is able or willing to provide the industry with the operating margins--profits--it sees for its other products. The operating margin for successful biopharma companies is 2.76 to 3.74 times as great as the operating margins for major defense contractors. This means that the defense contractor model will not work to engage biopharma companies in developing medical countermeasures for bioterror agents. Whether the successful bipharma companies are ``too profitable'' is a separate issue. The issue addressed here is the operating margin that successful biopharma companies seek and expect as they assess lines of research to undertake. If the operating margin for biodefense research is less, or substantially less than the operating margin for non-biodefense research, it is not likely that these companies will choose to undertake biodefense research. This research is a voluntary undertaking putting their capital at risk; there is no requirement that they do this when the prospects for profits are not competitive with that from other lines of research.
Mostly we are seeing the industry hiding, not commenting on the pending legislation, not participating in the legislative process, and making every effort not to seem to be unpatriotic or greedy. Companies do not say in public that they are disinterested. They will not say what package of incentives would be sufficient to persuade them to take up biodefense work. They fear a debate on patents. They feel besieged by the current drug import debate, pressure from CMS over drug prices, and the debate over generic biologics. While I understand these fears, we simply have to know what it would take in the way of incentives to establish a biodefense industry. If the incentives in BioShield or BioShield II are not sufficient, we need to know what incentives are sufficient. We need to know what reassurances would persuade the industry that what happened to Bayer will never happen again. And only the industry can give us a clear answer to these questions. We cannot have a dialogue on these urgent national questions without the government listening and the industry speaking.
The goal of BioShield II is to shift the risk of countermeasure research and development to the industry. Given the skepticism of the industry about the reliability of the government as a partner, shifting the risk to the industry--with it risking its own capital to fund the R&D--will be difficult. But engaging the industry as entrepreneurs, rather than as defense contractors, is likely to be less expensive for the government and it's much more likely to secure the development of the medicines that we need.
If the Government funds the research, the industry can expect to receive the operating margins that are typically paid to defense contractors--8.5-9 percent. If the industry risks its own capital and funds the failures and cost overruns, the industry believes it would be justified demanding the operating margins that are typically paid in the commercial sector--28-32 percent.
If the Government funds the research, the industry expects that the government will control or own the patents associated with the medicines. If the industry funds the research, it
believes it has claims on all the patents.
The only companies that are likely to accept a defense contractor model are companies with no approved products, no revenue from product sales, and no other source of capital to keep the lights on. For them Government funding is ``non-dilution'' capital, meaning it's a form of capital that does not dilute the ownership shares of its current shareholders. Many biotech companies have stock trading in the low single digits, so they cannot issue another round of stock that would enrage the current shareholders. For them this Government funding might validate the scientific platform of the company, generate some revenue, and hype the stock.
Biotech industry executives state in private that if their capital markets strengthen they will be even less likely to consider bioterror countermeasure research. One CEO whose company has received an NIH grant for bioterror countermeasure research stated in private that his company would never have considered this entanglement with the Government if it had any other options to fund its research.
Our goal with BioShield IT should be to engage the successful biopharma companies in this research--companies that have brought products to the market--and persuade them that the Government will be a reliable partner. Then the risk of failure and cost overruns is shifted to the industry and we've engaged the companies with a track record of bringing products to the market. The Government will need to provide substantial rewards if--and only if--the companies do succeed in developing the medicines we need, but then the Government is only paying for results. When the Government funds the research, it funds a process with no guarantees of any success. Providing the industry with substantial rewards for success is a model that engages the industry as entrepreneurs, drawing on the greatest strength our Nation has in the war on terror.
Our bill addresses a critical question: who is in charge for Government if there's a mass casualty event and how do they lead the multifaceted response. The legislation sets up an interagency board to map out and develop the response to such an event and places a new Assistant Secretary Chief Medical Officer at the Department of Homeland Security as its chair. In addition, the new Assistant Secretary would lead the DHS assets and resources as part of this effort. While this proposal is the result of discussions with some of the experts in this area, we recognize there may be different points of view about the optimal structure for the medical response capabilities within DHS and the proposed structure in this bill is open to further discussion. I look forward to working with the chairman of the Senate Homeland Security and Government Affairs Committee, Senator Collins, and others in exploring these complex issues. On these issues, this bill is a discussion draft.
We should not need a 9/11 Commission report to galvanize the administration and the Congress to respond to the unprovoked and deadly bioterror attacks of 3 years ago. The threat could not be more obvious and what we need to do is also obvious. If we don't develop the diagnostics, therapeutics, and vaccines to protect those who might be exposed or infected, we risk public panic and quarantines. We have the world's preeminent biopharma industry and we need to put it to work in the national defense.
BioShield I is a step in the right direction, but it is a small step that does not take us where we need to go. We need to follow the implementation of BioShield very carefully and set clear metrics for determining its effectiveness. We should not wait to begin to review the policy options available to supplement BioShield. Senator Hatch and I will be proposing BioShield II and we will press for its consideration. We should press the biopharma industry to present its views on what it will take to engage it in this research and what it will take to establish a biodefense, research tool, and an infectious disease industry.
The American philosopher, George Santana said, ``Those who cannot remember the past are condemned to repeat it.'' It's only been 3 years since the anthrax attack but I fear our memory of it already has faded. Let this hearing stand as a clear statement that some of us in the Congress remember what happened and are determined not to permit it to happen again. War has been declared on us and we need to act as if we noticed.