virology blog

About viruses and viral disease

Commentary

Should viral vaccines be made for profit?

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This past week the vaccine against influenza made world news when the British government suspendend the manufacturing license of a Liverpool factory that produces the vaccine. The factory is owned by Chiron, which had hoped to sell influenza vaccine produced there in the U.S. As a consequence, the U.S. will fall about 48 million doses short of the 100 million doses of vaccine that should have been available this winter. Another producer of influenza vaccine, Aventis, will supply 54 million doses to the U.S. A very different influenza vaccine is produced by MedImmune – a live virus preparation sprayed into the nose – but only 1-2 million doses of that vaccine will be available.

As Dr. Robert Webster of St. Jude’s has said, “This is unacceptable in the United States. It is a bloody scandal”. Why is the U.S. caught in this position? Because vaccine manufacturing is a for-profit industry. Although this approach has been successful in the past, it is no longer viable.

Thirty years ago, there were numerous manufacturers of influenza vaccine – as many as 25. Today there are just three. There are no manufacturers of the poliovaccine in the U.S. – our supply of inactivated poliovirus vaccine is provided by Aventis. The lack of plentiful virus vaccine manufacturers can be readily explained: vaccine manufacturing is a risky business with low profit margins. Vaccines are expensive to develop and produce, and litigation over side effects further increases the cost.

The solution to this problem, to which I have subscribed for many years, is to transfer viral vaccine development and manufacturing from the private sector to the U.S. government. Vaccine institutes could be established throughout the U.S. where the manufacture of influenza, poliovirus, and other vaccines could be carried out. These vaccines would be sold by the government at low cost, not only to the U.S. but to other countries who require them. What better way to propagate global goodwill than to sustain life, rather than terminating it?

The U.S. has already taken a small step towards this plan by establishing the Vaccine Research Center. However, I envision a much broader initiative where such centers not only develop new vaccines, but manufacture and distribute existing products such as the influenza virus vaccine.

My colleagues have criticized this plan because it prevents scientific innovation. I do not believe a government run vaccine facility need be devoid of scientific creativity. The National Institutes of Health is an example of a government research facility that conducts outstanding scientific research. The key is to attract the best scientists, and provide them with a flexible, stimulating, and scholarly atmosphere in which to exercise their talents.

Science Fiction or Fact?

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In “The River: A Journey to the Source of HIV and AIDS”, Edward Hooper claims that HIV-1 was introduced into humans in Kisangani, Democratic Republic of the Congo in the 1950s. He suggests that the stocks of oral poliovirus vaccine (OPV) that were being used in clinical trials were produced in cultures of kidney cells from chimpanzees that were infected with simian immunodeficiency virus, SIV, the predecessor of HIV.

Hooper’s hypothesis has been convincingly shown to be incorrect by a number of independent investigations. For example, analysis of the OPV used for the Congo trials revealed that it was not produced in chimpanzee cell culture (Nature. 2001 Apr 26;410(6832):1035-6). In addition, the strains of SIV that circulate in chimpanzees in the Congo are distinct from all strains of HIV-1 (Nature. 2004 Apr 22;428(6985):820).

A recent article by Paul Osterrieth (Oral polio vaccine: Fact versus fiction) provides the final death knell for Hooper’s hypothesis. According to Hooper, Dr. Osterrieth was responsible for preparing kidney cell culture from chimpanzees and using these cultures to prepare the stocks of OPV used in the Congo trials.

Osterrieth categorically denies that he ever sacrificed chimpanzees to produce kidney cell cultures, and states that he never prepared any poliovirus in cell culture. The article is well worth reading because it highlights the non-scientific means used by Hooper to support his now defunct hypothesis. As Osterrieth writes, “Mr. Hooper’s method is to take any word slip or hesitation and to convert it into a mysterious allusion to hidden crimes. This is the way of a prosecutor, not an investigator, and it has more to do with science fiction than fact.”

HIV, AIDS, and Condoms

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In October 2003, the Vatican published a paper claiming that the HIV virus can pass through latex condoms and cause infection. I have not seen the original paper, but have read about some of its points in various online newsreports, such as this one from BBC News World Edition. In this report, Cardinal Alfonso Lopez Trujillo, president of the Vatican’s Pontifical Council for the Family, claims that causative agent of AIDS, HIV-1, can pass through small pores in the condom. I would like to see the ‘scientific evidence’ supposedly in this report, but I have no doubt that it is entirely wrong. HIV-1 virions are very small, but latex is not sufficiently porous to allow the virions to pass through. It is quite clear that the proper use of condoms is highly effective at preventing spread of this virus.

In fact, as long ago as 1992, the question of whether or not HIV-1 virions could pass through latex was discussed in the Washington Times. A good synopsis of these issues can be found in The Straight Dope.

The Vatican report has been roundly criticised by a wide range of individuals, from scientists to religious leaders. Yet, the Vatican refuses to reverse their position. Clearly this is an example of how the Vatican’s position on birth control – all forms being unacceptable except ‘rythmn’ – is clouding their view on the health and safety of millions of people. Many will believe the Vatican, and stop using condoms, which will only increase transmission of the disease.

The Vatican does not want people to use condoms, but it is highly irresponsible for them to use HIV-1 and AIDS as a means of discouraging their use. Especially when the excuse for not using condoms – that they pass the virus – is categorically wrong. In the end, more people will contract AIDS as a consequence of the Vatican’s pronouncement. Shouldn’t the Vatican be trying to save lives?

The Bioterror Boondoggle

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Scientists who conduct research on viruses depend heavily on outside sources of funding to staff and supply their laboratories. One of the major sources of funding for independent research is the National Institutes of Health. Funds for research are allocated through a grant mechanism in which investigators submit detailed proposals for the work they wish to carry out. The proposals are reviewed by a panel of experts and graded, and the best proposals are funded.

This type of NIH-funded investigator-initiated basic research has proven enormously successful since the 1950s. The best innovation comes when scientists decide what they wish to work on. From the most obscure beginnings have emerged discoveries that have revolutionized medicine. For example, research on bacteria and viruses that infect bacteria lead to the development of recombinant DNA technology. This technology forms the basis for many of today’s blockbuster drugs and diagnostic tests.

As a consequence of the release of Bacillus anthracis (a bacterium) in the U.S. in 2001, the NIH has shifted some of its resources towards work on viruses, fungi, and bacteria that could be used for bioterrorism. In addition, the NIH has adopted what it calls a ‘roadmap‘, in which it identified the most important areas of medical research that investigators should focus on.

I have problems with both of these issues, e.g. diverting NIH funds to bioterrorism research, and establishing a ‘roadmap’. A few months ago, Alan Dove, a freelance science writer, asked my opinion on the recent shift in focus at NIH, and snippets of my responses have appeared in this week’s Nature Medicine.

My thoughts on bioterrorism research will need a separate post. Meanwhile, here is my complete response to Alan Dove’s question:

“The first problem is that NIH has never been good at deciding what to work on. Drugs and vaccines are fine; but as far as basic research goes, who is to say what should be done? The best work comes from letting scientists follow their own paths. Find a good scientist, give ’em money, and you’ll get good science. That’s where recombinant DNA came from, if I recall. In today’s climate, the NIH is not likely to put a high priority on, say, phage research; but one could argue that it might still have unseen surprises that are widely applicable. I don’t think anyone is smart enough to predict what to work on, the current NIH leadership included.

“On the other hand, I think it’s great if the NIH wants to fund development of drugs and vaccines that are third-world problems and not likely to get the attention of US pharma. In fact, I think all drug and vaccine development should be out of the private sector, but I understand that is heretical and not a capitalistic view. Drug and vaccine development should not be driven by profit, but by need. The only way to deal with this is to have the government do the work – at the NIH, or extramurally.

“I’m not worried about diverting a good part of the NIH budget for these purposes. The effect will certainly be to divert money away from investigator-initiated research, e.g. RO1 grants. For the next five years, it will be hard to get grants; but everything cycles and I expect that at some point it will become less difficult.

“I do think it is important to be smart about what the NIH decides to direct its money towards. I’m not sure that scientific logic prevails; probably politics are playing too great a role. Politicians need to tell their constituents how they spend their tax dollars; it’s easy to point out a shiny new jet fighter, but not so easy to point out what the NIH does. Hence, ‘directed research’. Here everyone, we are making an AIDS vaccine, or a TB drug. But pouring money into ‘biodefense’ research is just a load of crap. We really have to focus only on anthrax and smallpox – nothing else is likely to work very well and I defy anyone to engineer a virus or bacterium to be more lethal than it already is. Biodefense research is just another political ploy and a waste of NIH dollars.”