Big Bucks Big Pharma Essay Definition

Pharmaceutical companies have contributed to people’s improved health and prolonged life, generally speaking. Research and development of drugs that are brought to market can be costly and there are strict regulations and requirements that companies must follow in most countries. But the details reveal further concerns.

For example, marketing practices and priorities of the pharmaceutical industry have come under scrutiny for many years. It seems that there is increasing emphasis on drugs that fit scare-mongering and over-medicalized problems.

Testing and thorough clinical trials are fundamental to good medical drugs, but there are numerous accusations of shortcuts, including pressuring for favorable results, testing on people without their proper approval, using drugs for unapproved uses and much more.

Ideologically, many drug companies support the position of less government involvement, yet in the developing world in particular, diseases and illnesses affect the poorest the most who cannot afford expensive (or even sometimes cheap) treatments. In the past decade or so, pharmaceutical companies have therefore also been criticized for ignoring this because they can’t pay.

Public announcements of drug donations to poor countries are often welcome, but sometimes the details reveal murkier intentions; some of the drugs are close to, or even past, their expiry date (and are expensive to dispose, adding more costs to recipient countries) for example.

Poorer countries encourage their drug companies to make cheaper generic alternatives to expensive branded ones or use other tools available at their disposal to help bring the price of medicines down to more affordable levels. But they face immense pressure from international institutions and multinational pharmaceutical corporations, even when generics and other options pursued are legitimate under international rules. For these multinationals, they’ve poured billions into some of these drugs and therefore want a patent system that will protect their investments for as long as possible.

For the developing and poorer countries, as remote as these issues may seem, patents and intellectual property rights issues can mean life or death. (For example, at the end of the 1990s, the pharmaceutical industry lobbied the US government to threaten sanctions on South Africa for trying to produce generic drugs to fight its growing AIDS problem. It took huge public outcry to get the case dropped some 2 years later.)

These and many other issues are discussed further below.

Priorities of the Pharmaceutical Industry

Historically, the desire to protect colonial interests and needs, such as the health of settlers and soldiers, typically drove medical research of tropical diseases.

Modern science has been able to research and develop cures for most illnesses and diseases, yet, politics and corporate greed affect who can benefit from this, resulting in what a French newspaper, Le Monde, describes as an apartheid of pharmacology.

In addition, as observed by the British newspaper, the Guardian, more emphasis is placed on profitable research and cures for problems such as impotence and , while many tropical diseases are given far less attention:

Additionally, corporate priorities of profits can imply that the most appropriate treatments won’t always apply (especially when they are cheap).

J.W. Smith’s concerns do not seem too far-fetched given just a few examples:

In May 2001 the Guardian newspaper reported that a pharmaceutical company, Aventis, used to produce the only safe medicine for the late, fatal, stage of sleeping sickness. However, they stopped making it in 1995 because they couldn’t make any profit from it.

In 2000, Bristol Myers Squibb, used the drug for profitable purposes in the West—as an ingredient in hair-removing cream, under license from Aventis. That, together with the public outcries about the shortage of medicines in Africa at that time, and over the court case brought by 39 pharmaceutical companies against the South African government over access to cheap drugs, Aventis agreed to donate the drug to the World Health Organization and help fund research and treatment programs.

While that was definitely welcome, it was criticized that it had to come after public outcries, given that sleeping sickness

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But why should the Pharmaceutical Industry care about the problems of Developing Countries?

Some may argue that criticizing pharmaceutical companies for not spending as much on diseases of the poor is unfair, and that instead it should be up to those nations affected by such problems to invest in appropriate research, that the private corporations cannot be expected to solve all of the world’s problems and that they would also go broke from such activities. Furthermore, they provide jobs which helps create wealth. However, a number of issues, rarely discussed in the mainstream, makes this picture more complicated:

The western nations that the pharmaceutical corporations are typically based in have, through colonialism and post-war global economics, fostered an environment that has led to further poverty and dependency of the poorer nations on the first world countries. Post-War policies from the IMF and World Bank have forced most developing countries to cut back on such social expenditure as health and education, in the first place. Many countries have faced downward spirals due to such policies.

Furthermore, pharmaceutical companies often tout their strengths of having vast capital resources to do research, bringing benefits to humanity the world over. Unfortunately though, the quest for ever more profits are a hindering factor to what they will research. Tropical disease cures are not profitable for them because most people with such diseases are too poor to afford cures.

Of course, as well as addressing unfair practices by large pharmaceutical companies, poverty should be addressed too. Poverty is often a root cause, so tackling poverty (which may also be a major preventative measure, requiring less drugs in the first place) is ideal. But these are not necessarily separate; they are intertwined in a complex web. For example, poverty is also related to the way international trade rules and institutions are influenced by power politics:

Pharmaceutical companies also make enormous profits that would probably not affect the ability to do some research and production of other more urgent medical problems.

And when nations and companies actually do try to develop cures and possibilities, these same pharmaceutical companies will often complain about unfair trade practices! This can be seen in sharp detail in the AIDS crisis, where such companies lobbied the US government to threaten sanctions on South Africa just for trying to do something that the pharmaceutical companies would not do—help its people.

Pharmaceutical companies often claim they need intellectual property enforcement to help recoup their investments. Many have argued that pharmaceutical companies owe a lot to the public education sector for providing the scientific basis. Pharmaceutical companies do note that their taxes on profits are ploughed back into the government, and contributes to the GDP so that it is a reinforcing circle. Noam Chomsky adds that there is a LOT of base science that such companies have benefited from:

Furthermore:

And commenting on the U.S. for example:

And for the developing world:

It could be argued that those corporations don’t need to spend much money on these things as before, because they have already spent that in the past, sufficiently, and have produced the medicines needed. Instead, it is a failure by governments to ensure that those in need get access to existing medicines.

There may be some truth to this. As discussed in this site’s section on health care around the world, poor countries lack resources and sufficient health infrastructure. Even if some medicines are available, they may not be able to get it to the needy.

However, there are also cases where even in poor countries, much-needed vaccines have been widely distributed, suggesting that mobilization of resources is possible.

The other problem is that this is not enough of an excuse to reduce R&D in this area; new medicines are also needed — for example, to overcome bacterial resistance to existing drugs. This is a significant and growing problem for Malaria and TB, in particular.

In addition, new drugs are needed to help make it easier for poorer people to complete a course. It is harder for poorer people to finish a course that takes a long time — people either do not understand that they need to complete the course even when symptoms begin to improve, or they may horde part of the course for future use or for other family members’ use, because the costs may be prohibitive, or it is difficult to turn up for supervised treatment frequently over a long period, etc (which increases the risk of bacterial resistance to some drugs).

Furthermore, it is not just a government failure to get existing medicines to those who need it, but a more global failure that pharmaceutical companies are a key part of: an intellectual property rights regime that actually makes it harder for poor countries to use cheaper (and affordable) generic versions, or that makes the cost of those existing drugs higher than it could otherwise be in an Intellectual Property Rights (IPR) regime that was more forgiving. Many pharmaceutical companies, for example, are at the forefront of opposing governments attempt to make medicines cheaper, widely available, or generic.

In addition, first world diseases are increasingly a problem in the developing world. It can therefore be argued that R&D in this areas is also more important for the developing world than R&D in infectious diseases.

The problem is that for developing countries, research into these first world problems may seem beneficial, but the benefit can only be reaped by the developing world if it is in the context of good IPR programs that make the medication available and affordable to those who need it.

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Hiding behind patents to prevent legitimate — and cheaper — generic use

Patents are supposed to encourage innovation by providing incentives for private companies to further investment and research. But for areas such as health, patents can also restrict access to medicines for those who cannot afford them.

In addition, large corporations from developed countries are patenting so many resources from developing countries that it makes it difficult for those nations to be able to produce medicines for themselves.

The World Trade Organization’s TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights) makes it difficult for other countries to produce medicines if the product is already patented.

However, there are some provisions in the TRIPS agreement to allow generics, but that is only when there is an emergency and the products are not used for commercial use (and even this clause is under attack from the US and pharmaceutical companies.)

Furthermore, as detailed further in this site’s global health overview section, poorer countries that do have industrial capacity to produce generic alternatives are facing pressure not to sell them to other poor countries who do not have such capacity.

As Noam Chomsky points out,

It is also an example of inequality being structured into law, also summarized here:

There is room, thanks to efforts by developing countries and others, in the WTO rules for some ability for governments to incorporate provisions in national patent laws to ensure and increase access to essential drugs, using mechanisms such as compulsory licensing and parallel imports.

WTO patent rules allow 20 years of exclusive rights to make the drugs. Hence, the price is set by the company, leaving governments and patients little room to negotiate, unless a government threatens to overturn the patent with a

Such a mechanism authorizes a producer other than the patent holder to produce a generic version of the product though the patent-holder does get some royalty to recognize their contribution.

Parallel importing allows a nation to effectively shop around for the best price of the same drug which may be sold in many countries at different prices.

These are potentially very effective tools to get the price down. But there has been constant threat by the large pharmaceutical industries in the U.S. and Europe for example, that feel threatened by these mechanisms. They have pressured developing nations and international agreements in various ways to minimize the impact these would have on them.

Pharmaceutical groups have lobbied the U.S. government, to exert pressure on other countries about this — such as to threaten sanctions on South Africa for trying to develop cheaper and generic drugs, as mentioned earlier. (See for example, an article about the relationship between globalization and equitable access to essential drugs, from the Third World Network for more on this).

(Some governments also levy various import taxes on such products, and the cost of transporting them etc may add to the cost of that medicine, but the point is that the price is high to start with.)

Some of the larger developing countries, such as Thailand, India, Brazil, Egypt and others, have tried to do something about the dual problems of high pricing and corporate/Western pressure:

  • Some, like Brazil, have tried to develop cheaper, more generic drugs
  • Others, such as South Africa, who may have tried this before, have also tried to purchase cheaper generic drugs or import them from where it is sold the cheapest. This works out well between developing countries.

These attempts are important because they recognize the need to reduce dependency upon large multinational corporations which charge high prices. It also shows a sign that these governments are attempting to meet their obligations to their own people.

In a radio interview, Brazilian Ambassador to the WTO, Celso Amorim, points out that the United States provides vast amounts of aid and subsidies to its pharmaceutical corporations to research drugs and so forth, and yet when other developing countries try this, the US complains via the WTO about it.

In fact, the pharmaceutical corporations and the United States challenged Brazil, South Africa and other’s attempts by claiming that they were breaching the above-mentioned TRIPS. The fear has been that if a few developing countries succeed in this sort of independent path, then other developing countries will follow suit, and this will threaten markets.

India’s successful pharmaceutical industry, built on its patent laws that allow the development of very cheap generic drugs has been under threat from WTO property rights rules on patent protection, and pressure from the large pharmaceutical companies.

The additional fear is also based on how if companies from developing countries are able to make inroads on profits on products that are not actually sold much by the large multinational pharmaceuticals, then for other products that generate more sales and profits, companies from developing countries could pose a real threat to their bottom line.

Furthermore, if other companies are able to offer similar drugs for much lower prices, it indicates potentially how much the public of the industrialized world are being over-charged.

A huge public outcry forced 39 pharmaceuticals to drop their case in April 2001 against South Africa. The publicity that had been generated by this had potentially wider implications to the whole TRIPS regime:

Additionally, in June 2001 the United States dropped its WTO complaint against Brazil for the production of generic AIDS medications. However, it was at a potentially enormous cost to Brazil and other developing countries; While following even some rules in the WTO TRIPS agreement, the U.S. agreed to drop its case as long as Brazil tells U.S. State Department 10 days in advance of any generic drugs being developed, allowing the U.S. in effect to monitor Brazil’s public health policies in these areas. Also, other countries might think twice about doing what Brazil and some others have tried—legally—to do here, as the fear of U.S. pressure might be persuasive enough.

Just a couple of months later, Brazil made a bold, but important move to produce AIDS drugs themselves, but at the same time, breaking the patent rights of Swiss pharmaceutical company, Roche. The Brazilian currency, the real, had become weaker with its devaluation, therefore making the costs of imports even more expensive.

Furthermore, a subsequent global AIDS fund set up by the U.N. also led to warnings of concern at things like patents, pricing and so on, which is captured well by Philippe Riviére, who is worth quoting at length:

And, as the following quote suggests, large Pharmaceutical companies’ claims on dents to profits and so on, seem hollow:

In the same article as quoted just above, the point is also made that while profits aren’t important to CIPLA, However, if compulsory licenses are not allowed, then it won’t be possible. Pharmaceutical companies are against these licenses, because large profits are important to them.

The Doha WTO round in November 2001, while controversial in some aspects, included some provisions to make access to affordable medicines easier. However, just over a year after that, even this might be reversed:

  • All the other 140 countries of the WTO unsuccessfully opposed United States desire to block access for poor countries.
  • This was due to pressure from the pharmaceutical industry. The Guardian newspaper reports, for example, (December 21, 2002) that
  • Since the Doha Agreement, rather than all developing countries, as originally agreed. (The U.S. was part of that agreement process as well.)
  • The repeated concern has been that copy-cat drugs will under price and override patents, and research will dry up.
    • Yet, as the article continues,
    • In addition,
    • In other words, dents on profits wouldn’t be as big as feared.

The above adds further consideration on the actions of pharmaceutical companies in response to growing criticism of the way they are pricing drugs, the way they are researching and so on;

  • That is, in response to the criticism while it is good they have reduced prices, the dependency on them that still exists is still a problem.
  • When fluctuations in currencies can be sharp, especially for poor countries, the effects can be enormous, as mentioned above with Brazil’s currency devaluation. This has a dramatic impact on the affordability of external medicines from the expensive multinational pharmaceuticals.
  • Currently, it seems as though pharmaceutical companies are hiding behind their patents, power and influence to accumulate profit and maintain their position, claiming they are the only ones that can help, with their approach. Real technology transfer and sharing with others around the world does not appear part of the debate. Only when it is profitable or not harmful to them too much, will they it seems.
  • After all, the public their wealth in the form of huge government funds, public research and subsidies etc. to help pharmaceutical companies. It is only fair they back!

Further denting the credibility of the U.S. in this area has been that President Bush has picked a former top executive of a major U.S. pharmaceutical company to head the U.S.’s global AIDS initiative, leading to further accusations of a commercial agenda, and lack of real experience in the issues that matter. (As well as the previous link, see for example, similar criticisms from Health GAP and Global Treatment Access Campaign, two organizations campaigning for global access to affordable medicines.)

Despite the apparent success at Doha, the US has sought to undermine the agreement made there. Oxfam, a prominent NGO, has been highly critical of the practices of big pharmaceutical companies, arguing that, Oxfam also believes the US is In addition,

The Third World Network reported on a global AIDS conference in Bangkok, July, 2004 and also commented on the negative impacts of the growing number of bilateral agreements signed with the US that Oxfam alluded to as well. These To add to the sour French-US political relations,

It is not so much that these developing countries are necessarily adamantly against the WTO or even the large pharmaceuticals, but it is the unfair deal they are being given by the imposition of the current system that is causing the problems; while international legal frameworks for trade is welcome, it is an example where institutions like the WTO have been used by the more powerful countries and their corporations to further their own interests without much regards to others; Western leaders go on about how rules-based systems are essential, but they don’t discuss the pros and cons of the actual rules themselves. This is how inequality can become structured into law.

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Power and influence in drug testing

On April 27, 2003, Britain’s Channel 4 aired a documentary titled Dying for Drugs, raising many of the hard issues discussed here, that drugs bring billions to those companies, and hopes to people. Yet, how far would drugs companies go to get their drugs approved and the prices they want? As the documentary said in their introduction, the implications are alarming and if their

In Africa the documentary showed how one of the world’s biggest drug companies experimented on children without their parents’ knowledge or consent. In Canada it revealed how a drug company attempted to silence a leading academic who had doubts about their drug. In South Korea it followed the attempts of desperately ill patients to make a leading drug company sell them the drugs they need to save their lives at an affordable price. And in Honduras they showed the brutal consequences of drug companies’ pricing policies. This documentary therefore covered four basic areas:

  1. Testing on humans without permission
  2. Voluntary human trials but where doctors are pressured not to reveal problems
  3. Successful human trials, but drugs priced beyond the reach of many patients
  4. Prices that kill, and resorting to breaking the law to save lives by smuggling medicines from other countries.

Testing on humans without permission

Increasingly, the documentary highlighted, human trials without permission are taking place in the developing world, far away from scrutiny of European or American authorities.

The documentary focused in on a case in 1996 in a northern Nigerian town of Kano, already suffering from severe cholera and measles outbreaks. At that time, a third problem occurred: meningitis, where some 150,000 people were affected, and some 15,000 dies, many of which were children.

While this was mostly unreported in the West, it was noticed by the world’s biggest and richest drug company, Pfizer. They moved fast and flew to Nigeria with a new drug, a , Trovan.

Trovan had never been tested on children before, and Médicins Sans Frontiéres (Doctors Without Borders, or MSF) had been at the hospital that Pfizer came to, and had for a number of weeks been offering free life-saving treatments, successfully treating thousands of people.

Yet it turned out that Pfizer were doing human testing or experiments without the voluntary consent of patients, a violation of basic human rights:

  • From standards set at Nuremberg trials after WWII, there are strict rules on the conduct of experiments on humans.
  • The first rule (and sentence of the Nuremberg Code) is that voluntary consent of the human subject is absolutely essential.
  • This basic right was ignored, the documentary pointed out.
  • Consent and risk explanation is normally recorded.
  • Yet Pfizer had Pfizer claimed this was because parents were illiterate, so was explained verbally.
  • But interviews with some 100 sets of parents highlight that they too were not asked for consent, and that many could read and write.
  • A lawyer trying to sue Pfizer on behalf of some of the parents says that if they were told that this was experiment and there was option for actual alternative treatment (which groups like MSF were offering) then they would have gone with them.

But there was also apparent outright lying as well. Not telling your test subjects what you are doing is a fundamental breach of medical ethics, but that was not the only charge.

  • Trials like this must be approved in advance by an ethics committee.
  • Pfizer claimed an ethics committee approved Pfizer’s actions.
  • Their ethics committee approval letter was shown to be a backdated later, because when dated, the committee didn’t exist at the time.
  • A Pfizer doctor later admitted to doing this.

Unfortunately, as the documentary also noted, this is

One explanation given by James Love (also mentioned above on this page), Health Economist with the Consumer Project on Technology was due to lack of accountability. he said,

The United States had refused to license Trovan for use on children because of known side effects it caused.

  • Some children in Nigeria died when on this treatment.
  • It is not known if they could have been saved had they been on the other more standard treatment that organizations like MSF were already helping with, but it is standard practice to change treatment if a patient is not responding to one treatment when their life is on the line. Pfizer doctors did not do this.
  • A doctor in the Nigerian hospital said that , referring to a baby that died when under such treatment and had not been switched to an alternative.
  • One of the most damning pieces of evidence was a letter sent to the Pfizer chairman, by the company’s own childhood disease specialist, Dr Walterspiel, protesting in the strongest possible terms about the trial.
    • The letter detailed 8 major objections, including that the drug was not tested against this particular form of meningitis.
    • The letter also referred to the lack of consent forms.
    • As a result of this letter, the company sacked him.

As well as the issue of human experimenting without permission, the actions of Pfizer highlighted the various ways power could be exercised to deal with the controversy. For example:

  • Sacking the doctor who sent a message about the challenges to research scientists.
  • Lawyers in New York took this case, but Pfizer succeeded in getting the NY courts to agree that this trial should be held in Nigeria, which as the documentary pointed out, was rated the second most corrupt nation according to Transparency International, implying that Pfizer would be able to take advantage of that.

But even where trials were going well but doctors had concerns about side-effects, pharmaceutical companies have used their power to try and stifle concerns and criticisms.

Voluntary human trials where doctors are pressured not to reveal problems

The documentary moved on to talk about a situation in part of the wealthy world, Toronto, Canada, where even where trials were voluntary, doctors may have been pressured not to reveal concerns to their patients.

This was a case at a hospital where children were suffering from a blood disease, thalacemia, (where the body doesn’t make red blood cells), requiring blood transfusion, regularly, to prevent certain side-effects, requiring lots of injections, which can be painful for children. Dr. Nancy Olivieri, one of world’s leading experts on thalacemia had been searching for alternatives to painful nightly infusions for many years and the inconvenience of the process that could affect compliance in patients to adhere to the things they needed to do.

She came across a pill, L1, by a drug company called Apotex offered this alternative. They agreed to fund international trials, which went very well. Dr. Olivieri was chair of these worldwide trials. But she began to detect worrying effects.

  • She wanted to simply inform patients to help in decision-making
  • Therefore she wanted to adapt the trial to help work out why these problems were occurring
  • The reaction from Apotex was shocking because, as the documentary said, she was questioning Apotex’s potential multimillion dollar drug.
  • She was basically reminded of confidentiality clauses in the trials and threatened to keep quiet. In addition Apotex immediately ended the trials and indicated that the product was going to market. This threat came from Mike Spino, Apotex Vice President.
  • She was fired as chair of worldwide trials and gagged from telling her patients or anyone else about her concerns about the drugs.

Professor, Sir David Weatherall, of the Weatherall Institute for Molecular Medicine at Oxford University, raised the issue of threats to with this situation.

Also commenting on Dr. Olivieri’s situation, Dr. Drummond Rennie of the Journal of the American Medical Association added that, Apotex

As well as patients suffering, Dr. Olivieri was showing signs of strain and this was an example of the threat to doctors as well as impact on patients.

As Dr. Rennie also added,

All the while, concern about the effects of L1 were increasing. A panel of experts agreed with Dr. Olivieri’s concerns and findings, so despite legal threats, she advised patients to go back to the needles instead of using this drug, which she felt was unsafe.

After a year of silence, she confided with a senior colleague who, with other colleagues lobbied the university for support in the battle against Apotex. What they didn’t know was that the then president was negotiating a multi-million dollar donation from Apotext to fund a new building (some $20 million).

, asked Dr. Rennie,

One of the first colleagues Dr Olivieri had confided in had received letters, with various threats.

  • But they managed to find out who sent those letters from DNA tests.
  • It was a colleague, the man who first involved Apotext in the trials and who was still receiving substantial research funding from the company, associate director of research, Dr. Gidian Corran.
  • He strenuously denied the allegation, initially. But after months of denial, with DNA proof, he finally admitted to sending the hate mail.
  • As the doctor receiving the threat commented,

Under apparent pressure, the hospital fired Dr. Olivieri. But, intervention by a few key people led to her being reinstated. Apotex decided to move elsewhere. In 1999 Europe became the first territory to license L1 under the brand name Ferriprox.

The issue raised was not if doctor was right or wrong, but really the premature licensing of a drug without proven safety. The safety of this L1 drug had not been fully determined, and so this would not have been the time to release the drug. Apotex alleged that the trials Dr. Olivieri conducted were flawed, but this was proven wrong by independent verification. This whole process also took months away from Dr. Olivieri’s important work by having to defending these claims. The documentary highlighted that many other doctors had suffered similar problems in many situations, and their professional lives had been destroyed.

As Dr. Rennie also added, Dr. Olivieri Dr. Weatherall described her as a foremost person in this field that would be hard to replace. But as he also concluded,

But there are also other situations, where even if all these trial processes were going well, the issue of pricing beyond the ability of many patients had also been causing concern.

Successful human trials, but drugs priced beyond the reach of many patients

In the next example, the documentary highlighted how after successful trials, high pricing of drugs meant they were sometimes beyond the means of the very same patients in the trials who depended on those drugs. The case in question involved an innovative drug for a form of Lukemia, developed by Novartis, trialled successfully in South Korea, but the issue highlighted deeper political and economic problems.

Even though the trials were very successful (the drug was approved in record time, for example), the eventual price of the drug was out of the reach for many, who ended up protesting on the streets.

This drug was going to be priced by Novartis at around $55K a year, 19 dollars a tablet, 8 a day. Yet, even with the Korean government helping with costs, many patients said they could not afford the drug.

As Jamie Love commented,

Commenting on why this was more than merely economic issues, Dr Drummond Rennie pointed out,

But high pricing for drugs are often controversial. As the documentary noted,

Commenting on this Nathan Ford, of Médicins Sans Frontiéres said,

As noted earlier on this page, this is related to how markets for pharmaceutical companies are not just about finding people to target, but people with money. Dr. Jonathan Quick of the World Health Organization (WHO) added that the majority of the market for some of the tropical diseases is in developing countries but,

The drug’s price from Novartis was justified due to the research and development costs, yet, as Jamie Love pointed out, the price was still too high:

  • A lot of important development was paid for by U.S. government.
  • The speed to approval and get to market was quick.
  • Short, small trials and short development period implies a relatively inexpensive product to bring to market.

All this touched deeper issues of intellectual property rights and international institutions such as the World Trade Organization (WTO).

  • WTO patent rules allow 20 years of exclusive rights to make the drugs.
  • Hence, the price is set by the company, leaving governments and patients little room to negotiate, unless a government threatens to overturn the patent with a
  • Such mechanism authorizes a producer other than the patent holder to produce the product though the patent-holder does get some royalty to recognize their contribution.
  • This is a very effective tool to get the price down. For example, the drug in question here had been offered in Brazil at 8 dollars per pill by Novartis themselves because of the threat of generic versions that would threaten competition.

In June, 2001, in Korea, leukemia patients turned to a lawyer who delivered a compulsory license application to the Korean authorities.

  • As the documentary detailed, the Korean government got a swift response
  • But it was from the U.S. Secretary of Commerce, warning Korea’s Minister of Health and Welfare not to meddle with the price of drugs. the Secretary said in a letter to the minister,
  • Despite these threats, the Korean minister went on to campaign for lower drug prices.
    • He was sacked.
    • He went on to speak out about what he believed was behind the sacking—the power and influence of the pharmaceutical industry.
  • Also commenting on this, Jamie Love touched upon the pervasive concentrated power,
  • In another example of how this power was used, in 1990, the Thai government was making a number of generic drugs. They also wanted to make a generic AIDS drug. But the U.S. Trade Representative threatened them with export tariffs on wood and jewelry exports, which made up some 30% of Thailand’s total exports. The Thai trade representative was very frightened and they stopped making the generic drugs.
  • Yet, these were not isolated cases. As also mentioned above on this page, and mentioned in the documentary, hard fought changes to WTO rules that would have allowed poorer nations easier access to generic drugs was agreed to by virtually every country in the world, but was resisted by the U.S. Their veto killed the agreement.

A major source of cheaper generic drugs in Asia is India, which has a strong, established generics sector. Under Indian patent law, big pharmaceuticals have only been able to patent the production process, not the final product. That is, only the way the product is made. This allows other companies to produce generic versions of the same product, using different processes. One such company is CIPLA, also mentioned above. CIPLA has been famous for offering AID drugs for a dollar a day, when the bigger ones were offering nearer to 30 dollars per day. Because CIPLA has been competing with other generic manufacturing companies this has also contributed to keeping prices down.

At the request of some Korean patients, CIPLA said they were able to make generic version of Novartis’ drug, at some 80 cents to 1 dollar per capsule they said. This was less than one twentieth the Novartis price. But the compulsory license on which the deal depended to have these generic drugs available in Korea, was thrown out by the Korean authorities. Novartis still insisting on that 19 dollar price.

Big pharmaceutical companies consider the generics companies as pirates, because of the threat to profits, and because they create the same end product without the amount of research and development effort that the big pharmaceuticals supposedly invest. Yet, as detailed above, often, a lot of initial research and development has come from the public sector, and so some have considered the big pharmaceuticals to also be guilty of the accusations that they levy against generics companies.

Under pressure from the large pharmaceutical companies, the WTO has decided that from end of next year, India must bring in full patent protection. India is one of the world’s main sources of cheap drugs, and this is now under threat. By destroying such competition, big pharmaceuticals, Dr. Rennie adds, will be able to charge anything. After 30 years of having drug prices undercut by India, they will once again have total control of supply. Just a handful of manufacturers will have a lot of control.

The documentary then moved on to show how these prices directly caused the death of a child in Honduras, suffering from AIDS, while activists resorted to breaking the law and attempted to smuggle cheaper drugs from across the border, where generic ones were being sold.

Killer prices and breaking the law to save lives

Even before rule changes, mentioned above, the power of big pharmaceuticals is already pervasive. The documentary followed a woman in Honduras forced to break the law by smuggling cheaper generic drugs across the Guatemalan border, in order to try and save lives. This just highlights how inequality and injustice is structured into law itself, to have to break it.

In Honduras, there is some degree of free health care. However, there are some 14,000 AIDS orphans and 60,000 people with HIV infection. A poor country, it desperately needs cheap AIDS drugs, like those made by CIPLA.

The documentary followed an activist trying to help a child dying of AIDS because the price of drugs was beyond the reach of the family. The child, a 12 year old by, was called Jairo. The pictures were quite disturbing, showing the child near the end of his life. The situation was so urgent that the documentary crew offered to pay for some of the medicine that was needed and got a local specialist doctor in quickly.

The doctor pointed out that the child was suffering from various illnesses that could be addressed using readily available (though expensive) drugs. The few drugs that the family could afford was having distressing side-effects.

National MS Society Decision Makers Take Big Bucks from Big Pharma

As I detailed in two recent Wheelchair Kamikaze essays, the American National Multiple Sclerosis Society has repeatedly rejected grant proposals to help fund the only FDA approved human MS stem cell trial currently being conducted in the US, which is now underway at the Tisch Multiple Sclerosis Research Center of New York (click here and here). These two previous posts resulted in a flood of email and phone calls to the powers that be at the NMSS (thank you, dear readers), who responded by saying that the Society makes decisions regarding which research projects to fund based on the recommendations of committees populated by a wide range of internationally renowned experts. This got me thinking, just who are these experts and what elements might go into their decision-making process? Inspired by a comment left by WK reader Jennifer Ziegler, I decided to do some digging.

One of the provisions of the ever controversial Affordable Care Act (otherwise known as Obamacare) is the creation of a website that allows the general public to search a database of pharmaceutical company payments to physicians, called the Open Payments Data website (click here). For those who may be blissfully unaware – and as outrageous as it may seem to those who are aware – it’s common practice in this country for pharmaceutical companies to line the pockets of the physicians who prescribe their products by way of cash payments given out largely as consulting and speaking fees. Mind you, for the most part these payments are perfectly legal, but it does make one wonder just how objective even the most well-meaning physician can be when making decisions that involve choosing between the products of the drug manufacturers whose money they accept versus those of their benefactor's competitors. This ethical quagmire is often described quite politely as a potential “conflict of interest”.

The NMSS helpfully provides lists of the “Scientific Peer Reviewers” who advise the Society on decisions regarding which research projects are worthy of support (click here). Plugging the names of these peer reviewers into the Open Payments Data website reveals what I think is some enlightening information. First, though, please let me illustrate just how much money the pharmaceutical companies that sell MS drugs pay to physicians in efforts to promote their wares. On a drug by drug basis, the following list details the amount of money that made its way from pharmaceutical company coffers into the pockets of MS doctors in the five months spanning August-December 2013. Naturally, the list excludes drugs that have been approved since 2013. I gleaned this info from the Pro Publica website (click here), which provides detailed numbers derived from the database compiled by Open Payments Data:

· Aubagio $3.4M

· Avonex $775.8K

· Betaseron $510.8K

· Copaxone $4M

· Gilenya $682.2K

· Rebif $856.6K

· Tecfidera $2.2M

· Tysabri $1.4M

· TOTAL $13,825,400

Your eyes are not deceiving you, the pharmaceutical companies paid MS doctors who prescribe their drugs $13,825,400 during the last five months of 2013 alone. Again, this is all publicly disclosed data, and such payments are perfectly legal. Call me crazy, but I can think of only one non-expletive that can adequately describe that number: Yikes!

Now, moving on to the NMSS and its peer reviewers; the National Multiple Sclerosis Society utilizes nine standing committees to review research grant proposals for MS research. As previously noted these committees are comprised not only of physicians, but also PhD researchers as well as lay experts in various related fields. It should be noted that the Open Payments Data website contains only information on pharmaceutical payments to licensed physicians, so while the PhD researchers who sit on these committees might occasionally benefit from pharmaceutical company largesse, such payments wouldn’t show up in the database. It should also be emphasized that the physicians on the following list are not evil people; far from it, they are simply professionals legally taking part in an insanely dysfunctional medical system. I'm sure that those who actively treat patients care deeply about those patients. I’ve even had the occasion to meet one or two of these doctors, who I would without hesitation describe as quite brilliant. Still, the pernicious influence of pharmaceutical company money can’t be discounted, even if it works only on a subconscious level.

The two committees I chose to investigate are those that include licensed MDs and which seemed most likely to play a role in making decisions on human stem cell trials. Here then, a list of MD peer reviewers who sit on NMSS advisory committees who accepted pharmaceutical payments from August through December 2013, and the amount of money they received. These totals exclude any funds paid for medical research efforts:

MDs On The NMSS "Research Programs Advisory Committee" Who Received Pharma Money

· Dr. Bruce Cohen, Northwestern University Medical School – $224.87

· Dr. Anne Cross, Washington University – $4311.28

· Dr. Stephen Hauser, UCSF – $4184.86

· Dr. Mary Hughes, Neuroscience Associates – $13.62

· Dr. Aaron Miller, Mount Sinai School of Medicine – $26,855.11

· Dr. Michael Racke, Ohio State University Medical Center – $5733.86

MDs on the NMSS "Clinical and Translational Research Committee" Who Received Pharma Money

· Dr. Laura Balcer, University of Pennsylvania – $2281.36

· Dr. Bruce Cree, UCSF – $74,965.41

· Dr. Philip Dejager, Brigham and Woman's Hospital – $15,294.97

· Dr. Edward Fox, MS Clinic of Central Texas – $76,760.44

· Dr. Omar Khan, Wayne State University – $112,964.52

· Dr. Andrew Pachner, UMDNH-New Jersey Medical School – $29,995.44

Yes, in the mere five months covered by the records of the Open Payments database one of the NMSS research committee physicians received over $112,000 from pharmaceutical companies, two received over $74,000 each, and two more received over $25,000 each. When considering these numbers, ask yourself whether you would trust the recommendations of a film critic who was found to be receiving generous payments from some of the movie studios which produced the films he was reviewing? Would you allow that critic to decide which scripts should be greenlighted and made into movies if you knew that some of those scripts might in some way damage the profit-making abilities of the studios from which he was receiving payments? Me neither.

I’ve often railed that the NMSS should immediately stop accepting funding in any form from the pharmaceutical companies, if only to avoid even the slightest hint that those funds might influence the Society’s actions. I’m confident the goodwill generated by the Society taking such a public stand would far outweigh any financial hit they might incur, and in fact would be priceless. After looking into the pharmaceutical monies received by physicians who serve with the NMSS in research decision-making capacities, I find myself aghast at my discoveries. Even if the doctors involved are nothing but well-intentioned, as I’m sure they are, I would think it impossible that the tens or even hundreds of thousands of dollars they receive from pharmaceutical companies would have no influence on their decision-making process, perhaps even only on a subconscious level. If these payments didn’t result in tangible benefits for the pharmaceutical companies making them, they wouldn’t be made. Large corporations are not in the habit of handing out millions of dollars a year for no good reason. This may be good business, but it makes for bad medicine.

I urge the NMSS to immediately institute a policy forbidding physicians who sit on any of their decision-making committees from accepting pharmaceutical monies for any reason. The confluence of the interests of for-profit corporations with the clinical practice of medicine and medical research cannot be anything but corrosive. These practices will only stop when we as patients and those who love us rise up and demand action. It’s horrendous enough to be stricken with a dreadfully heinous disease intent on robbing those it attacks of their very humanity; to find oneself simultaneously caught in the misguided, tangled mess that is the modern medical industrial complex can crush the soul. It’s time for those of us stricken with MS to make our voices heard, to make a stand and demand that the largest MS advocacy organization in the world take the initially painful but ultimately crucial steps towards living up to their mandate; to not preserve the status quo but instead eradicate once and for all the fetid scourge of multiple sclerosis, a mission I fear impossible when done in concert with corporate entities whose own legal mandate is to turn illness into industry.

The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here). I would ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, making pains to avoid personal attacks. The goal is not to antagonize, but to foment change that would benefit both the National Multiple Sclerosis Society and the patients it is meant to serve.

I leave you with the following brilliant piece of video from the HBO TV program Last Week Tonight, featuring John Oliver. This incisive and hilarious segment illustrates better than I ever could just how insane is the current state of Big Pharma/physician relationships. Please, please watch, learn, and enjoy…


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