February 10, 2008

Learning from Vytorin and Zetia

Not only should we all be angry at the drug manufacturers Merck and Schering-Plough for not disclosing that Vytorin and Zetia had serious flaws, we must look at the process that allowed that to happen and try to correct it.

Current findings indicate that for two years these companies knew that while their drugs reduced cholesterol, they also increased plaque, the major cause of heart attack and strokes and thus potentially catastrophic.

They did not find this out accidentally. Medical and clinical pharmacology investigators who conducted this study established these findings. Why then did these healthcare professionals not speak out when the manufacturers did not? I would hazard a guess that they were either directly employed by Merck and Schering-Plough or had been compelled to sign a non-disclosure agreement. In either case they cast aside the basic principle of “do no harm”.

In the past studies regarding drug efficacy and safety were far more independently conducted using strict FDA protocols and results were communicated both to the manufacturer as well as to the FDA. Clearly this is no longer the case. Why? We must consider that the staggering amount of political contributions from the pharmaceutical industry to both major parties has made oversight of their activities a sham.

If the FDA had been a party to the study as it should have been, at the very least Merck and Schering-Plough would have been obliged to advise doctors what the study had determined. Conceivably the FDA could have compelled the removal of these products pending further investigation. To hide such results from government agencies and practitioners while continuing to market these products with flashy TV spots to the lay public is reprehensible and without a doubt grossly indifferent to the safety of the public.

We can only guess how many other unfavorable studies are hidden away by pharmaceutical companies far more interested in bottom line profits than in the safety and well being of the American public.

Sadly, it appears the FDA has become as political as many other parts of government whereas its mission was and should be to safeguard the public. Recently we saw a similar situation with the CDC. Surely agencies such as these should be above the petty frays of political interference.

We could of course hope that one or more of the current candidates would pledge to change these policies. Doubtful.

February 9, 2008

Contemplating Calamity

This was written in July 2005 in Tanzania


So far all of my work has been in the City and not in the rural provinces and for that I’m relieved in one way because the time pressures to complete the writing are great.

On the other hand, a part of me misses seeing basic primary healthcare provided in a rural dispensary without electricity or running water. It misses the wonderment of glimpsing women trudging miles to fetch water and maybe a few twigs to make a fire and knowing that they do that every day and always will. What I don’t miss is hearing there is no water or if there is that an “entrepreneur” has decided that he will collect a few shillings for the privilege of letting you take water from the stream - or if you have no money – well, you can imagine what the barter system means then. I don’t miss the look of hopelessness on the faces of these women, as they know they will probably become one more statistic to the “skinny disease”.

I miss seeing real humanitarians – not people like me who come and go – but people who came and stayed, stayed because this was the life they chose.

I miss traveling to the villages and visiting with old women with young children gathered around - what I don’t miss is knowing that the children are orphaned from AIDS; that most of them are positive and that she is one of the few adults left alive.

One of the aspects of Public Health that takes some getting used to is that the needs of the many are what drive your efforts and sometimes the needs of the few or the one cannot be answered.

I met a young woman last time I was here; an Irish Doctor, a Nun, who has been here 35 years, introduced her to me. She was HIV positive – not AIDS yet – but nevertheless…She had been a grad student in Greece when she was screened for HIV and found to be positive. The Greek government gave her a 6-month supply of ARV drugs and sent her back home to Tanzania. She told me she had sold the drugs here in Dar! I was speechless. This was an educated, well-spoken woman who knew full well what she was doing and yet that allowed her make that decision. She explained that her family could never have afforded the drugs after the six-month supply was finished, assuming that the type of pharmaceutical was even available in Dar. On the other hand, she could (and did) sell the drugs to a wealthy family and use the money to make her family a little better off.

I knew that her raison d'ĂȘtre was logical; this is East Africa, and accordingly I had to accept her judgment. That still did not make it any easier as we sat there and quietly drank coffee together. She has passed away.

She was the “one” - the “few” - and as for the needs of the many? - I know that someone (not me of course) but someone can and will find a way to stop this scourge. If I did not believe that I would certainly go mad.

Bill Clinton is coming here today; he was in Lesotho yesterday. Lesotho is a small country, completely surrounded by South Africa to whom it “exports” water when there is a drought. There has not been one in a few years now. Clinton told the people there that unless they took drastic measures to curb the rate of HIV infection that their country would cease to exist – reflect on that! A country wiped out, not by war or nuclear winters but by a pestilence that is biblical in proportion. He is right.

Governments must be honest with the scale and intensity of this epidemic.
Tanzania reports HIV solely from voluntary testing and blood donors. Consider the futility of that process in a country with a per-capita income less than the cost of tickets for a Broadway play. Do they really believe that they can accurately estimate the incursion by these simplistic methods? They know better of course but this is an election year and so we hear figures like 4% and 6% - when the reality is probably five times that. The cause of death statistics shows almost no HIV occurrences, partly because of the lack of clinical algorithms to diagnose but also the embarrassment to the families. Yet everyone knows the truth; it is just not spoken.

The very fabric of society is disintegrating as we watch - in a way like we watched the genocide in Rwanda or the horrifying policies of Mugabe in Zimbabwe. Civil servants leave rural postings out of fear; farmers die before they can teach the next generation; teachers die and cannot be replaced; mothers and fathers die; and young girls die because men are…I don’t even know the word.

Is there a future for Lesotho and Malawi and Botswana and Tanzania and so many other places? I don’t know. Perhaps the people and these political entities will quietly disappear into history, the weeping of the “few” being the only sounds to linger.

It has happened before on this terribly beautiful continent.; Conrad’s Africa had a heart but now it is bleeding.

Dar-es-Salaam, Tanzania
July 2005

Safe Or Not Safe: Drugs from China or Canada?

The New York Times reported recently that a subsidiary of Shanghai Pharmaceutical Group, one of the largest drug makers in China was accused of covering up contamination of some of its products resulting in serious injuries to untold number of Chinese patients. The same company is the sole supplier to the United States of the morning-after pill known as RU-486.

The FDA has not commented on the situation except to say that RU-486 was made in a separate plant that had passed FDA inspection.

Just a year or two ago the Bush Administration said that it was taking steps to forbid Americans from purchasing Canadian drugs saying that they could not guarantee their safety. Yet they allow their appointed regulators at the FDA to license the importation of drugs made in China. Is this not the height of hypocrisy?

The FDA Commissioner has stated his agency had found "thousands of examples of unapproved and potentially unsafe medicines" coming into the United States from "many countries, including from Canada" and in a subsequent news conference went further, saying there were "lots of examples of unsafe drugs coming into the United States from Canada." Yet both the FDA's director of pharmacy affairs and the Congressional Research Service support the safety of drugs from Canada, reporting that medications manufactured and distributed in Canada meet or surpass quality control guidelines set by the FDA. Comparing this, last year China executed its top drug safety official after he was shown to have accepted bribes. An example perhaps of extreme actions calling for extreme measures but then again it is China.

All the evidence and rhetoric aside, someone in the FDA came to the conclusion that drugs from China were safe while drugs from Canada were not. Does this make any sense to anyone?

The dependence by the FDA on the US Pharmaceutical industry is well documented. Many FDA senior staff leave their posts to take jobs in the same industry they were regulating. In addition, the political contributions from US Pharmaceutical companies are legendary leading to the obvious question: Who is really safeguarding the American people from contaminated drugs?

St Petersburg, Florida

Thoughts and Impressions from Tanzania

Social and economic underpinnings and their effect on the provision of healthcare

Tanzania is many things.

For those drawn to the vision of Hemingway-esque safaris, of wide savannas and dense forests all under a snow capped mountain, Tanzania is Nirvana. In the Hemingway short story "The Snows of Kilimanjaro", Harry Street, a lazy, indifferent and cynical writer, reflects on his life, his successes and failures. Today’s Harry judges his success and failure by catching a glimpse of the majestic “Big Five” animals. With energy and passion that Harry lacked, his inheritor’s goals and dreams are met in places with names like Ngorogoro and Serengeti and Selous. Twenty thousand other heirs to Harry’s legacy follow each year, each seeking to see elephant and rhino and leopard and buffalo and lion. Paradoxically, Tanzania’s truly indigenous occupiers remain its largest source of foreign income.

That picture aside, Tanzania is poor, one of the poorest countries in the world. Larger than twice the size of California, 36% of its nearly 40 million people live below the poverty line as reported by the Government of Tanzania. More than half its citizens live on less than 70 cents a day. The GDP per capita ranks 188 out of 194 countries: a mere $800; Gross National Income is $350. As a comparison, in Europe it is $34,000; Latin America and Caribbean $4,800 and even neighboring sub Saharan countries average $850. Tanzania has an external debt of $8 billion and servicing this debt accounts for 40% of total government expenditures. Every World Bank or African Development Bank loan exacerbates this problem even if the project meets its goals. Many do not. It is valid to ask if the purpose of all these study projects is to further learning and understanding or to keep local bureaucrats in their jobs.

In developing nations there is hope; in the underdeveloped there is little but despair. Tanzania is not a developing country; rather it is in that group termed under-developed, characterized by highly dependent economies chiefly producing primary products for the developed world while importing back finished goods; traditional, rural social structures; high population growth; and widespread poverty. Coffee beans are grown and harvested by small landowners, sold for little profit and sent raw to Switzerland to be returned by Nescafe as coffee to be purchased by Tanzanians at high prices. The scenario is the same for cotton returned as clothing and wood as furniture.

The median age of the population is less than eighteen; the birth rate per woman is more than five; infant mortality is among the highest in the world; Malaria and HIV are a scourge; Typhoid, Plague and Leprosy common. The current AIDS crisis, even at its admittedly understated level, nevertheless will decrease the gross domestic product by 15–20% by 2010. If the real incidence is higher as international public health authorities believe, that effect could be catastrophic. Few will live long enough to become contributing productive adults who can pass on skills to the rapidly increasing younger generation. Civil and social order could literally cease functioning within a decade of that happening.

Notwithstanding this the population increases by almost 4% annually. Logic would indicate that feeding this burgeoning populace would seem within the means of an agrarian country. It is not. Though agriculture is the foundation of the Tanzanian economy, less than 5% of its vast land resources are arable. Amazingly, these bleak resources account for half of the national income, three quarters of exports and provide employment opportunities for 80 percent of Tanzanians. Still, hunger is an every day issue for most of the population.

Whereas in Western Europe and the Americas, agriculture was patently enhanced by the use of draft animals, in most of sub Saharan Africa this growth did not happen as oxen and horses were victims of the tsetse fly. Post feudal Europe population centers saw transport systems such as roads escalate as the necessary means to get bigger agricultural production to market. In Africa this never happened. Here, agriculture is transparently local.

Agriculture in Tanzania is dominated by small peasant farmers cultivating between two and seven acres. Without tractors or draft animals, 70 % of Tanzania’s almost exclusively domestic food crops are cultivated by hand. For these difficult tasks, women constitute the main part of the agricultural labour force. Productivity is poor due to substandard skill levels and technology and on unreliable and irregular weather conditions. Simply put, the vast majority of agriculture is grown in individual gardens not farms. Subsistence growing such as this allows a family to produce for its own needs and maybe a little extra with which to barter with a neighbor. Tradition plus the quality of the soil and the lack of irrigation do not permit consolidation of these efforts.

The growth of population coupled with low agricultural outputs has brought the country to the point of being unable to provide sufficient foodstuffs for its own people. The numbers are staggering: 80% of the Tanzanian workforce cannot feed 100% of the people. In developed nations, 5% do so. The textbook short-term remedy is to import food and to pay for it with exports of industrial goods. In Tanzania that is problematical. Accounting for only about 10% of Gross Domestic Product, Tanzania's industrial sector is one of the smallest in Africa.

The industrial sector is also dominated by foreign corporate ownership together with a growing white South African sphere. Thus, even if manufacturing growth were to be seen, the earnings from these efforts would most probably not be retained in country. This is evident now in areas such as gold mining in which the most difficult jobs are performed by local unskilled labour while earnings from these activities are sent overseas after a relatively small payment to the Tanzanian Government.

There exists a small middle class, almost exclusively in Dar-es-Salaam, and is composed principally of multi-generation Tanzanians of Asian decent who account for 1% of the population. Retail shops, information technology providers, import-export companies and cross-licensing operations are most commonly conducted by this faction.

The indigenous peoples, 99% African, representing more than 130 tribes are ranked lowest on most economic indicators. Education should be part of the solution but the numbers of native Tanzanian children completing school are decreasing. In part this is the result of mandatory payments for secondary education which though small, nonetheless in traditional large families means that one or two of the older sons may be sent to school and the remainder, particularly young girls, not. Coupled with this is the growth of fundamental Islam on the mainland and the corresponding drop off of young women attending mixed-gender schools. Finally, the dire economic circumstances of the country as a whole compels parents to have their children work in a desperate attempt to survive. If that was not enough, the effects of HIV-AIDS have impacted the numbers of teachers especially in rural areas.

And what of the health of the people?

UN Statistics and WHO comparisons do not tell the story. They are but numbers on a page; numbers that tell us what health experts in Geneva say about “average” families in Tanzania. Try doing that for America or just Texas. Are the demographics for healthcare the same in Galveston as in El Paso? Not according to the American Psychiatric Association.

Traveling across the wide distances of this or most any other sub Saharan country tells you much more. It tells us that even in major (regional) hospitals, those in larger population centres, seventy percent of the beds are occupied by HIV-AIDS patients. Occupied is the operative word because the healthcare system cannot begin to treat these patients even assuming such treatments were available. Recent US programs may move some of these victims to home based programs assuming that efforts to educate rural communities that they need to take care of these people are successful. Till then, other patients who perhaps could be successfully treated cannot be with often tragic results.

The AIDS crisis has also decreased the number of people entering healthcare occupations in never seen before numbers. Currently district health authorities are reporting 60-70% vacancies in approved positions. Most critical are highly skilled professions such as physicians and nurses. Many who complete their training move on to better paying posts in other countries in Africa or to Western Europe. Correcting these problems is a long term issue.

The Tanzanian government is far from self-directed in forming health policy. International organizations from IMF to UNESCO and AfDB all dictate their requirements before monies are made available. Even within the government, the Ministries of Health and Finance as well as the Prime Ministers Office for Regional and Local Government all vie for control. Decentralization, mandated by the World Bank, has placed decision making into the hands of locally elected officials who too often have little knowledge of the complexities of health issues to say nothing of the financial resources to solve them.

Past government policies ultimately failed because they were inadequately implemented and financed. The same is happening today. The health sector is pitifully under-resourced. The current level of finance provided by the government meets only a third of the requirements of the public health system. Donors fund nearly 50% of minimally targeted total health care spending. The remainder remains unfunded, leading to further degradation of the system.

Tanzania is in an economic crisis and healthcare is no exception. Government health care expenditures are falling, reserves of foreign exchange (needed to import vital drugs and equipment) are reduced by currency fluctuations, and structural adjustment programmes have cut back on allocations to the social sectors. The health of the population has declined; mortality rates have begun to increase, and morbidity rates are rising. Healthcare is in crisis.

Worldwide but especially in third world countries, women are the key factor in health seeking activities. The too often repeated scenario of a mother being discriminated against by male health care staff has a direct negative effect on the wellbeing of children and their mothers. In the majority of rural villages, healthcare is provided by native healers and they are trusted far more than the dispensaries or health centers that are either closed or lacking both equipment and drugs.

Accurate data on burden of disease is questionable. Tanzania is a rural country and an individual’s entry into the healthcare system begins at a local dispensary, a government administered echelon with minimum staff and equipment but responsible for up to ten thousand people. The diagnoses agreed here flow up the information trail and are rarely changed. Consequently, the least trained of the medical cadre are those who determine the initial diagnoses and in turn the statistics that are determined from them. Among the top one hundred illnesses, there is no mention of breast cancer or cardiac disease or leukemia. Fevers in children equal malaria; coughs in adults equal pneumonia or TB. Lack of diagnostic equipment and trained staff dictates this and true or not the numbers are published.

At each level in the healthcare hierarchy, dispensary, health center and hospital, equipment is either non existent or is non-functioning, to an estimated eighty percent nation wide. So deep are the shortages of skilled personnel that even if equipment such as an x-ray machine is available, usually from a donor, there is often no technician to use it; no mechanism to process the film (assuming films were available); no radiologist to interpret the film and most importantly, no maintenance system to keep the machine in safe working order.

Adding to the problem is a lack of transport and communication and many rural locations are completely isolated during the rainy season resulting in no transfer of patients up the line from dispensary to health centres and then hospitals, district and regional. Pharmaceuticals and supplies are distributed from a central purchasing source in the capital city and losses of products over and above well known distribution problems are an every day occurrence.

Resulting from years of bureaucratic mismanagement, government hospitals are understaffed, poorly equipped, under funded and often lack electricity, clean water and basic sanitation. The absence of qualified medical and nursing staff anywhere but in the capital makes even simple medical care challenging. Finally, the little qualified staff that exists is often enticed to the private sector by larger salaries or to other countries where they can have both better incomes and a better life style.

Bureaucracy was certainly not invented by Tanzania but its bureaucrats have learned well how to use their status for personal profit. A multitude of studies, investigations, reports and analyses have been conducted in every region and district, many in healthcare. The results are most often known in advance; the effort merely confirms them and of course keeps more staff employed to write and edit the findings. They also serve to increase the debt as many of these programs are not grants but loans and part of the loan pays the bureaucrats.

To affect a paradigm shift in the provision of effective and consequential healthcare will require much more than the good intentions of the Tanzanian government and donor nations and multi-national organizations. The social and economic underpinnings of Tanzania as a whole must change. The non metaphorical question is: are those changes possible within the context of the political dynamics of not only Tanzania but of much of sub Saharan Africa.

It takes a developing nation to even consider beginning to keep its sick alive so that when well they can return as productive citizens. It is easy to let them die but what is then lost cannot be recovered. Tanzania may never be “developed” but it can become a place of hope, a hope that comes from its own people and then is supported by the humanity of others.

It is far too undemanding to say that Africa must help itself and stop there. Rather, should the collective “we” of Europe and North America accept a degree perhaps not of blame but of responsibility.

That answer is far from easy.

A Catastrophe of Leadership

A year ago, frustrated with the failure of the newly empowered Democratic leadership of Nancy Pelosi and Harry Reid to do anything meaningful, I changed my party designation to independent. To be true, I have always voted my conscience and that included votes for Nixon, Ford, Reagan, Bush 41 and even once for the current occupant. Nevertheless, for an Irish Catholic brought up in traditional Democratic Party politics in New York, it was a big step to admit that I was now an independent.

Admittedly, this year’s cycle of presidential primaries made me question if being neither fish nor fowl was a good idea. Initially there were candidates galore. The Democrats seemed to have found a new inner force with aspirants from previously unrepresented social groups: African-American, Women and Latino in the persons of Obama, Clinton and Richardson. Their deliberations with Edwards and the counter-balancing main stream candidacies of Dodd and Biden, were exciting. There were for a time even others including the rather droll Mike Gravel, whose debating approach was characterized by Tim Russert as a family dinner when your eccentric uncle comes down from the attic. It was fun; it was politics; it was American.

In accordance with tradition we culturally went through the peculiarity of pot-luck supper caucuses in Iowa; the polling non-accord of New Hampshire; the bickering in South Carolina and for perhaps its first time, Nevada whose very name pronunciation was national news. Then the supposed non events in Florida and Michigan and finally the long awaited Super Tuesday. Even after all that, we appear to have a statistical tie: Obama and Clinton!

Having witnessed these interminable prefaces and the ensuing commentary from the leadership of the Democratic Party I am more convinced than ever that I was right to quit. Here’s why.

We welcomed proportional voting in the primary but clearly the party leadership did not trust the judgment of the masses. We now realize that there are non elected delegates, not chosen by the people but appointed by the party privileged largely because of Howard Dean’s insistence. Apparently in the Democratic Party, all men might well be created equal but some are more equal. They are the Super Delegates. The end result is that these people, largely elected officials, major contributors, back-room power brokers and, to use a word from my youth, ward healers, could actually be the ones to pick the final democratic candidate for president. So much for democracy or one man one vote and all that other stuff we learned in civics class.

There are voices calling for change. Donna Brazille, a respected member of the Democratic Party, a fellow at Harvard University's Institute of Politics, and an Adjunct Professor of Government at Georgetown stated yesterday that if the party allows the so-called super delegates to be the deciders in the nomination process, she will resign from the party. This is very meaningful not the least because she herself is a super delegate. Let us hope there are more with her convictions.

Chairman Dean pompously pronounced after the Super Tuesday results that irrespective of his previous declarations, the question of seating the delegates from Florida and Michigan would be decided by the Party’s Credentials Committee. In reality this is an assemblage selected proportionately by the leading candidates and augmented by twenty five members selected by the Party Chairman, Dean. So, after vilifying the state party leadership and forcing all candidates to sign a pledge that they would not campaign in these states, it appears that Chairman’s prerogative trumps fairness.

For some reason, the erstwhile physician, governor and devotee of Edvard Munch had elected to hold the quadrennial gathering of party faithful in September, a mere eight weeks before the national election. Would the possible become the probable? Woud there conceivably be a brokered convention? Could it be that the rights of the people to select candidates would actually be upheld? Alas, no.

Dean stated that he would not tolerate an open convention and if there was no winner, consensus or otherwise by the late spring he would meet with the leading candidates and knock some heads together to pick the ticket. This sounds more like a Mugabe or Putin form of democracy and makes you wonder why we even need a convention. Tradition I expect. But tradition of the party chairmen brings back memories of Jim Farley but only because he spent much of his time at Yankee Stadium. The names of most of the other chairman are about as well remembered as our ambassadors to Luxembourg.

The party of Jefferson and Madison; of Wilson and Roosevelt and Truman; of Kennedy and Johnson should be very discomfited in the realization that the actions of the current party leadership may well cause whoever is its candidate to fail to win back the presidency.

St Petersburg Florida
February 2008