Wednesday, January 12, 2005

US Biodefense Crossing the Line?

A recent report published on TheScientist.com pertains to developments in the biodefense program in the United States of America.  Apparently, we are planning to spend about $1.7 billion dollars to expand the amount of Biosafety Level Four labs in the country.  They add:
[...] Critics immediately condemned the plans, charging they would violate international bioweapons treaties and may set off a global biological arms race. For example, the new lab will genetically alter bioweapon diseases and package them so they can be dispersed as weapons.

While a DHS spokeswoman later characterized this research as necessary to learn how to counter such weapons, three veteran US biological arms control experts strongly disagreed. The DHS plans "may constitute [prohibited weapon] development in the guise of threat assessment, and they certainly will be interpreted that way" by other countries, wrote James Leonard, Milton Leitenberg, and Richard Spertzel in the journal Politics and the Life Sciences in May. [...]

It was not obvious, immediately, what the criticism was about.  Turning to the article cited, Biodefense Crossing the Line, we get some more specific information:
[...] Task areas for biothreat-agent (BTA) analysis and technical-threat assessment were summarized as "Acquire, Grow, Modify, Store, Stabilize, Package, Disperse."   Classical, emerging, and genetically engineered pathogens are to be characterized for their BTA potential. Aerobiology, aerosol physics, and environmental stability will be studied in wet-laboratory and computer-laboratory settings.   Computational modeling of feasibility, methods, and scale of production will be undertaken, and   Red Team   operational scenarios and capabilities will be assessed. BTA use and countermeasure effectiveness will be studied across the spectrum of potential attack scenarios through [h]igh-fidelity modeling and simulation.   And so forth.

The rapidity of elaboration of American biodefense programs, their ambition and administrative aggressiveness, and the degree to which they push against the prohibitions of the Biological Weapons Convention (BWC), are startling. [...]

In recent remarks elsewhere, Dr. Korch noted that one NBACC objective, creation of genetically engineered agents, might raise BWC compliance questions. Yet other NBACC objectives could prove even more problematic. [...]

Work on bioregulators and immunomodulators in the former Soviet offensive BW program during the 1980s is in retrospect realized to have been among the most dangerous and reprehensible of its numerous nefarious activities, despite having never approached weaponization, staying safely at research-and-development stages. Other than context  -- a preposterously huge offensive BW program -- was work on bioregulators and immunomodulators qualitatively different from the work now to be carried out in the United States?
So, we are planning to work with genetically modified pathogens.  This work is to involve studies of aerobiology and aerosol physics.  The authors point out that it is very difficult to establish a clear distinction between defensive work, and that which would constitute weapons development. 

I happen to be somewhat knowledgeable about things such as bacteria, viruses, and disease, although I am not an expert on biological warfare.  It is not clear that there is any legitimate rationale for working with genetically modified pathogens.  It would seem that the defense against such organisms would not be substantially different than the defense against naturally-occurring organisms.  The threat assessments would vary, of course, but I cannot think of how one could quantify that without actually using the agents to infect people.  Even being as cynically as I am, I doubt that human experimentation is being contemplated.  So if the use of genetically-modified pathogens cannot be justified on the basis of need for the development of defense, and if risk assessment cannot be done ethically, what is the purpose of experimentation with such organisms? 

Is there are reason that an outside observer might think that the US work is not defensive?
Recently declassified documents demonstrate that the US intelligence community possesses evidence demonstrating that interested terrorist groups --  al Qaeda among them -- still have no capability to work with classical BW agents and certainly cannot engineer agents genetically.
The United States of American already has cast aside any right to a presumption of innocent motives. A country that endorses the use of torture, alienates the UN and the World Court, and  endorses a policy of preemptive military action, cannot be assumed to have innocent motives. 

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Tuesday, January 11, 2005

More Bad Apples

The prisoner abuse scandal keeps getting worse.  Alberto "Torture Al" Gonzales probably will be the next Attorney General of the United States of America.  Low-level grunts are getting punished, but there appears to be no interest in the Administration for fingering higher level authorities.  This appears to be the case, despite the following:
Rumsfeld: 'I Take Full Responsibility'
NewsMax.com Wires
Friday, May 7, 2004

WASHINGTON – Defense Secretary Donald Rumsfeld on Friday extended his "deepest apologies" to Iraqi prisoners abused by U.S. military personnel, told Congress he accepted full responsibility and favored compensating prisoners for their suffering.

"These events occurred on my watch. As Secretary of Defense, I am accountable for them. I take full responsibility," Rumsfeld told the Senate Armed Services Committee.
Obviously, that is a damn lie.  He does not take full responsibility.  If he did, he would not stand for low-ranking service personnel being punished, while he himself gets reappointed.  What Rumsfeld said, "I take full responsibility," is ridiculous.

Through some bizarre, contorted logic, the Administration feels that the Commander-in-Chief has the authority to abrogate international treaties, condone torture, yet not take responsibility.  The media seem content to let them get away with this.  Even the medical profession has colluded with this, although some are speaking out...

The latest NEJM has an article (Volume 352:3-6, January 6, 2005), When Doctors Go to War, by M. Gregg Bloche, M.D., J.D., and Jonathan H. Marks, M.A., B.C.L.  Irritatingly, they do not provide open access to the article, but I have cited it liberally here. 
When military forces go into combat, they are typically accompanied by medical personnel (physicians, physician assistants, nurses, and medics) who serve in noncombat roles. These professionals are bound by international law to treat wounded combatants from all sides and to care for injured civilians. They are also required to care for enemy prisoners and to report any evidence of abuse of detainees. In exchange, the Geneva Conventions protect them from direct attack, so long as they themselves do not become combatants.

Recently, there have been accounts of failure by U.S. medical personnel to report evidence of detainee abuse, even murder, in Iraq and Afghanistan.1 There have also been claims, less well supported, that medics and others neglected the clinical needs of some detainees. The Department of Defense says it is investigating these allegations, though no charges have been brought against caregivers.

But Pentagon officials deny another set of allegations: that physicians and other medical professionals breached their professional ethics and the laws of war by participating in abusive interrogation practices. The International Committee of the Red Cross (ICRC) has concluded that medical personnel at Guantanamo Bay shared health information, including patient records, with army units that planned interrogations.2 The ICRC called this "a flagrant violation of medical ethics" and said some of the interrogation methods used were "tantamount to torture."2 The Pentagon answered that its detention operations are "safe, humane, and professional" and that "the allegation that detainee medical files were used to harm detainees is false."2

Our own inquiry into medical involvement in military intelligence gathering in Iraq and Guantanamo Bay has revealed a more troublesome picture. Recently released documents and interviews with military sources point to a pattern of such involvement, including participation in interrogation procedures that violate the laws of war. Not only did caregivers pass health information to military intelligence personnel; physicians assisted in the design of interrogation strategies, including sleep deprivation and other coercive methods tailored to detainees' medical conditions. Medical personnel also coached interrogators on questioning technique. [...]
The authors go on to cite the arguments that the Pentagon uses to try to justify the actions of its medical personnel. 
In helping to plan and execute interrogation strategies, did doctors breach medical ethics? Military physicians and Pentagon officials make a case to the contrary. Doctors, they argue, act as combatants, not physicians, when they put their knowledge to use for military ends. A medical degree, Tornberg said, is not a "sacramental vow" — it is a certification of skill. When a doctor participates in interrogation, "he's not functioning as a physician," and the Hippocratic ethic of commitment to patient welfare does not apply. According to this view, as long as the military maintains a separation of roles between clinical caregivers and physicians with intelligence-gathering responsibilities, assisting interrogators is legitimate. [...]
What this would imply, of course, is that such medical personnel are note entitled to any protection as noncombatants.  Is that really a good idea?  I think not.  That point, however, is not argued in the article.

More contorted logic is evident here:
In testimony taken in February 2004, as part of an inquiry into abuses at Abu Ghraib (and recently made public under the Freedom of Information Act and posted on the Web site of the American Civil Liberties Union [ACLU] at www.aclu.org), Colonel Thomas M. Pappas, chief of military intelligence at the prison, described physicians' systematic role in developing and executing interrogation strategies. Military intelligence teams, Pappas said, prepared individualized "interrogation plans" for detainees that included a "sleep plan" and medical standards. "A physician and a psychiatrist," he added, "are on hand to monitor what we are doing."
If they are actings as combatants, are they really "monitoring" what is being done?  Colonel Pappas seems to imply that the fact that the interrogation is medically monitored means that the interrogation methods are OK: since they are medically monitored, they do not endanger the prisoners.  But if the medical personnel take that role, then they are acting in the interest of the prisoner, which implies a noncombatant status.  If the noncombatant status is rejected, then the fact that the interrogations are medically monitored is meaningless. 

Furthermore, what does it mean that the medical personnel were monitoring what was going on?
Most people we interviewed who had served or spent time in detention facilities in Iraq or Guantanamo Bay reported being told not to talk about their experiences and impressions. Dr. David Auch, commander of the medical unit that staffed Abu Ghraib during the time of the abuses made notorious by soldiers' photographs, said military intelligence personnel told his medics and physician assistants not to discuss deaths that occurred in detention. Physicians who cared for so-called high-value detainees were especially hesitant to share their observations.
So they were there to monitor what was going on, but were told not to talk about it? 

The article concludes with some commentary that is not flattering to the Administration:
The conclusion that doctors participated in torture is premature, but there is probable cause for suspecting it. Follow-up investigation is essential to determine whether they helped to craft and carry out the counter-resistance strategies — e.g., prolonged isolation and exposure to temperature extremes — that rise to the level of torture.

But, clearly, the medical personnel who helped to develop and execute aggressive counter-resistance plans thereby breached the laws of war. The Third Geneva Convention states that "[n]o physical or mental torture, nor any other form of coercion, may be inflicted on prisoners of war to secure from them information of any kind whatever." It adds that "prisoners of war who refuse to answer [questions] may not be threatened, insulted, or exposed to any unpleasant or disadvantageous treatment of any kind." The tactics used at Abu Ghraib and Guantanamo were transparently coercive, threatening, unpleasant, and disadvantageous. Although the Bush administration took the position (rejected by the ICRC) that none of the Guantanamo detainees were "prisoners of war," entitled to the full protections of the Third Geneva Convention, it has acknowledged that combatants detained in Iraq are indeed prisoners of war, fully protected under this Convention.

The Surgeon General of the U.S. Army has begun a confidential effort to develop rules for health care professionals who work with detainees. Such an initiative is much needed, but it ought not to happen behind a veil of secrecy. Ethicists, legal scholars, and civilian professional leaders should participate, and the process should address role conflict in medicine more generally. An Institute of Medicine study committee, broadly representative of competing concerns (including the military's), would be a more suitable venue. To their credit, some military physicians in leadership roles have tried to involve outside ethicists in discussion of duties toward detainees. The Pentagon's civilian leadership has blocked these efforts.

Military physicians, nurses, and other health care professionals have served with courage in Iraq and other theatres of war since September 11, 2001. Some have received serious wounds, and some have died in the line of duty. By most accounts, they have delivered superb care to U.S. soldiers, enemy combatants, and wounded civilians alike. We owe them our gratitude and respect. We would affirm their honor, not besmirch it, by acknowledging the tensions between their Hippocratic and national service commitments and by working with them to map a course between the two.
If Rumsfeld really took full responsibility for all of this, he would not allow the Pentagon to block the involvement of nonmilitary experts in the development of rules for medical personnel who work with detainees. 

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Sunday, January 09, 2005

The Two Crises Facing Health Care

The two crises are these: managing medical information, and manging costs.  Of course, the two are related.  Management of information will cost money, although properly done, it can save a lot more than it costs to implement.  We cannot expect information management to solve the cost problem, though.  Although the potential savings are considerable, they could not possibly offset the cost increases that are projected currently.

Although estimates vary, it probably is reasonable to believe that the total cost of health care in the United States will rise to 30% of GDP within 50 years.  Dr. Kenneth Rogoff writes in the latest issue of Foreign Policy:
As rich countries grow richer, and as healthcare technology continues to improve, people will spend ever growing shares of their income on living longer and healthier lives.

U.S. healthcare costs have already reached 15 percent of annual national income and could exceed 30 percent by the middle of this century—and other industrialized nations are not far behind.
The need for better information management is increasing at least as fast as the costs of healthcare.  The are many reasons for this.  For one, the number of medications is increasing every month.  Two, the amount of information needed to prescribe these medications properly is increasing.  As we learn more about how the drugs work, we understand better how they interact with each other.  It is not feasible for physicians to remember all the potential interactions; computers are required for this.  Also, as genomic medicine flourishes, we come to understand more about how individual patients vary in their response to medications.  Managing that kind of information also is beyond the capability of the human brain.  A good illustration of this is found in a recent issue of the New England Journal of Medicine:
Life-threatening opioid intoxication developed in a patient after he was given small doses of codeine for the treatment of a cough associated with bilateral pneumonia. Codeine is bioactivated by CYP2D6 into morphine, which then undergoes further glucuronidation. CYP2D6 genotyping showed that the patient had three or more functional alleles, a finding consistent with ultrarapid metabolism of codeine. We attribute the toxicity to this genotype, in combination with inhibition of CYP3A4 activity by other medications and a transient reduction in renal function.
Another factor complicating the information management problem is the issue of drug formularies.  Different patients have different insurance plans, and each plan has different coverage for different medications.  These formularies change at least once per year.  As a result, a prescription that is appropriate for one patient may not be appropriate for the next, virtually identical, patient.  Again, it is not possible for a physician to remember all these details. 

As if the information management challenge is not already great enough, there is another complication that is emerging, as the practice of medicine becomes more sophisticated.  Certain drugs can be prescribed safely only by certain physicians, those with special qualifications in the management of particular disease states.  Clozapine is a good example.  It is the most effective drug we have for treatment of schizophrenia.  However, it causes neutropenia in about 2.5% of patients.  Neutropenia can be fatal. 

In order to prescribe clozapine, a physician must register with a national database.  Each patient must register as well, along with the patient's pharmacy.  The patient has to get a blood count done, and the results must be transmitted to the laboratory, before each prescription can be filled.  This system enables us to treat persons with treatment-resistant schizophrenia safely. 

Clozapine was discovered a long time ago, I think in the 1960's, but it was not approved by the FDA until the 1990's.  What enabled the FDA to approve it was the development of technology for the storing of all the pertinent information (computers), as well as the timely transmission of this information (fax machines). 

Clozapine is not the only example.  Alosetron is a medication for the management of irritable bowel syndrome.  After it was released on the market in the US, there were a few fatalities caused by bowel obstruction.  It was pulled from the market, not because it is more dangerous that clozapine, but because the condition for which it is used, IBS, did not seem to warrant the risk.  Patient advocacy groups complained, and it was reintroduced.  When it was reintroduced, however, it was marketed in the context of a special prescribing program (1  2). 

As more medications are marketed with such restrictions, and more information is needed about each medication and each patient, and as insurance issues become more prevalent, the complexity of the information management problem increased exponentially. 

As mentioned previously, there will be cost savings.  I haven't seen a cost analysis, but there is little doubt that these programs save money.  Those interested in the topic may want to see Mark A. R. Kleiman's post about the concept of special rules for the prescribing of various medications.  He focuses on the problems with drug safety that could be managed by such systems, but certainly any safety improvements would be accompanied by cost savings.  Doug, posting on Lines in the Sand, has some additional thoughts on the subject.  He points out the role of pharmacists in overseeing patient safety issues. 

Back to the issue of health costs: the costs are going to keep going up.  In fact, it seems likely that the total cost of providing health care in the country will rise so long as money is available to pay for it.  I don't see any reason to think that the costs will reach a plateau, ever.  What this means, is that when the economy is doing well, costs will go up.  When it is doing poorly, the costs still will be there, but the means with which to pay them will not.  Therefore, we can predict that periodic crises will occur with each iteration of the economic cycle. 

Admittedly, I don't have any bright ideas about how to prevent these crises; in fact, if I am right, there isn't any way to prevent them.  All we can do is manage them.  This has several implications. 

Implication #1: People are going to have to accept health care rationing.  This actually is not news; health care rationing exists now, and always has.  The health care system never has been large enough to deliver all the services that people need.  It probably never will be.  It's just that, so far, most people have managed to convince themselves that problems with access to health care are isolated problems with the system. 

Implication #2:  Health Care rationing will become more widespread, and will be a major issue of political contention.  Today's NYT has an article about contemplated changes in Medicaid financing.  this gives us a small taste of the enormity of the issue:
The cost of New York's Medicaid program has risen $14 billion, or about 46 percent, in the last five years, making it the most expensive in the country, state officials say.

But Medicaid cuts have long proved unpopular with state legislators - and not just with Democrats. Medicaid dollars are a major part of the operating budgets for hospitals, nursing homes and home care providers that serve middle-class communities, many of them in Republican districts.
Implication #3: Innovation in health care will be stifled.  As stated in the FP article:
But if all countries squeezed profits in the health sector the way Europe and Canada do, there would be much less global innovation in medical technology. Today, the whole world benefits freely from advances in health technology that are driven largely by the allure of the profitable U.S. market. If the United States joins other nations in having more socialized medicine, the current pace of technology improvements might well grind to a halt.
Implication #4: Health care priorities are going to be harder to figure out.  There will be a shortage of persons qualified to hold policymaking positions, as the issues become more complex.  For example, when the HIV/AIDS crisis began, we were able to meet it with substantial funding increases.  Some may argue that the increases are/were not large enough, but the fact is, we were able to get a major research program up and running fairly quickly.  Such choices are going to be much more difficult in the future, as we face increasingly difficult choices between paying for the health care needs we have now, preparing for the needs of the future, and meeting new challenges.  As if that is not bad enough, as climate change progresses, new challenges are likely to come up more frequently.  Currently, how many people do we have who are knowledgeable about economics, public health, epidemiology, pharmacology, and climatology? 

Implication #5: The general public will have to become more sophisticated about policy matters.  Ok, that one is a long shot.  But as policy questions become increasingly complex, it will be difficult for voters to understand the decisions that are being made about their lives.  Bloggers will have an increasingly difficult time informing their readers about the issues.  Indeed, the Internet will help to some the problem of educating the public, and informing discourse, but people are going to need more and more education just to understand the debates.  Increasingly, we will see issues that are not merely either-or decisions, based upon one set of opposing principles.  Rather, the issues placed before voters will be multifaceted issues that have wide implications in a variety of areas. 

Dr. Rogoff concluded his article in FP by casting the health care cost issue as a manifestation of the struggle between capitalism and socialism:
Ultimately, the case for some government intervention and regulation in health care is compelling on the grounds of efficiency (because costs are out of control) and moral justice (because our societies rightly take a more egalitarian view of health than of material possessions). The issue is precisely how much redistribution of income and government intervention is warranted. With the health sector on track to make up almost a third of economic activity later this century, the next great battle between capitalism and socialism is already underway.
I'm not sure that I would put it that way.  I would prefer to cast it as a struggle between reality-based and faith-based factions.  The reason is this: the issues regarding health care financing are just too complex for simple political maxims to be useful.  With simple issues, it might suffice to rely on a saying such as "smaller government is better."  But the challenge of financing health care in the next half-century are much too complex for that approach. 

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A World Without Israel?

This evening, I went into Border's on Liberty St., after dining at the Madras Masala.  I had parked in the parking structure, but had no money in my wallet, for some reason. (I had given it to my teenage son, for a wild night on the town.)  I needed to get the parking stub validated.  Otherwise I would be embarrassed at the ticket booth.

On the magazine rack, there was a copy of Foreign Policy.  FP, by the way, is one of the most influential publications in the world.  The cover was rather startling:

Now, Foreign Policy is not something I profess to understand.  But I had though it was a field populated by serious scholars, not science fiction writers.  In the SF genre, one often encounters "future histories," basically "what if..." stories: projections about what the world would be like, if such and such either happened, or did not happen.  So the title story is something one would expect in SF, but not FP.

I did not buy the magazine.  Instead, I came home and read the online version.  What I found was that the author, Josef Joffe, has adapted the SF subgenre of "future history" to perform a thought experiment; basically, he explores the current status of the impact of the existence of Israel using a fictional device. 

His conclusion is that much Mideast strife would exist even without the State of Israel:
Let us start the what-if procession in 1948, when Israel was born in war. Would stillbirth have nipped the Palestinian problem in the bud? Not quite. Egypt, Transjordan (now Jordan), Syria, Iraq, and Lebanon marched on Haifa and Tel Aviv not to liberate Palestine, but to grab it. The invasion was a textbook competitive power play by neighboring states intent on acquiring territory for themselves. If they had been victorious, a Palestinian state would not have emerged, and there still would have been plenty of refugees. (Recall that half the population of Kuwait fled Iraqi dictator Saddam Hussein’s “liberation” of that country in 1990.) Indeed, assuming that Palestinian nationalism had awakened when it did in the late 1960s and 1970s, the Palestinians might now be dispatching suicide bombers to Egypt, Syria, and elsewhere.

Let us imagine Israel had disappeared in 1967, instead of occupying the West Bank and the Gaza Strip, which were held, respectively, by Jordan’s King Hussein and Egypt’s President Gamal Abdel Nasser. Would they have relinquished their possessions to Palestinian leader Yasir Arafat and thrown in Haifa and Tel Aviv for good measure? Not likely. The two potentates, enemies in all but name, were united only by their common hatred and fear of Arafat, the founder of Fatah (the Palestine National Liberation Movement) and rightly suspected of plotting against Arab regimes. In short, the “root cause” of Palestinian statelessness would have persisted, even in Israel’s absence.
Dr. Joffe goes on to illustrate the rationale for his conclusion ("Israel’s elimination from the regional balance would hardly bolster intra-Arab amity."), using a series of "what if" scenarios.  It appears, to this relatively naive reader, that his main point is this: there is no pan-Muslim unity; there are numerous factions that would be at each other's throats regardless of the existence of an Israeli state.  For example:
Ideologies vs. Ideologies: Zionism is not the only “ism” in the region, which is rife with competing ideologies. Even though the Baathist parties in Syria and Iraq sprang from the same fascist European roots, both have vied for precedence in the Middle East. Nasser wielded pan-Arabism-cum-socialism against the Arab nation-state. And both Baathists and Nasserites have opposed the monarchies, such as in Jordan. Khomeinist Iran and Wahhabite Saudi Arabia remain mortal enemies. What is the connection to the Arab-Israeli conflict? Nil, with the exception of Hamas, a terror army of the faithful once supported by Israel as a rival to the Palestine Liberation Organization and now responsible for many suicide bombings in Israel. But will Hamas disband once Israel is gone? Hardly. Hamas has bigger ambitions than eliminating the “Zionist entity.” The organization seeks nothing less than a unified Arab state under a regime of God.
Of course, all of this raises the questions: Why should someone in Midwestern United States care?  Does this have any significance for the US?  Although Dr. Joffe does not pose this question directly, he does provide an answer:
Finally, the most popular what-if issue of them all: Would the Islamic world hate the United States less if Israel vanished? Like all what-if queries, this one, too, admits only suggestive evidence. To begin, the notion that 5 million Jews are solely responsible for the rage of 1 billion or so Muslims cannot carry the weight assigned to it. Second, Arab-Islamic hatreds of the United States preceded the conquest of the West Bank and Gaza. Recall the loathing left behind by the U.S.-managed coup that restored the shah’s rule in Tehran in 1953, or the U.S. intervention in Lebanon in 1958. As soon as Britain and France left the Middle East, the United States became the dominant power and the No. 1 target.[...]

Take the Cairo Declaration against “U.S. hegemony,” endorsed by 400 delegates from across the Middle East and the West in December 2002. The lengthy indictment mentions Palestine only peripherally. The central condemnation, uttered in profuse variation, targets the United States for monopolizing power “within the framework of capitalist globalization,” for reinstating “colonialism,” and for blocking the “emergence of forces that would shift the balance of power toward multi-polarity.” In short, Global America is responsible for all the afflictions of the Arab world, with Israel coming in a distant second.
What this implies, is that resolution of the Israeli-Palestinian conflict will do little to ease the tension between the other Mideastern countries and the United States.  All it would do would be to remove one excuse for the tension. 

I do not mean to argue that the USA should not invest substantial time and money to finding a resolution.  The peoples of Israel and Palestine have suffered plenty, and anything we can do to help is worthwhile.  But we should help with an understanding that the goal is an humanitarian one.  If Dr. Joffe is correct, resolution of the Israeli-Palestinian conflict will do little to enhance our own security. 

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