A Cross-Roads On Cheap AIDS Drugs

by Dennis Onyango

Now that the battle over cheap Aids drugs has shifted to Kenya, "pundits" and "experts" are all-over with all the reasons why Kenya is not ready for the generics. Most of the reasons are things we already know, that there is no cure yet and emphasis should be on prevention.

There is also the already known idea that Aids drugs are highly toxic and the longer patients keep off them the better. Then there is the view that Kenya has no infrastructure to monitor the highly complex administration of Aids drugs.

Another explanation has emerged lately ; that Kenya has no capacity to test the efficacy and soundness of cheap generic drugs. All these come on top of the traditional objection raised by the drug manufacturers ; that allowing generics will kill research.

On the surface, it would appear like the pharmaceutical companies are being good, trying to save Kenyans from taking drugs that may only end up killing them.

What the "pundits" and "experts" are not telling us, however, is that pharmaceutical companies have a history of being at war with people. When the companies are caged as they are now, they do not deal with their opponents directly. They do it through third parties whom they sponsor. The war is not about how to treat people better. It about how to keep profits high.

The pharmaceutical industry makes life-saving products. But it has never been warmly embraced by patients who take those products.

A recent case in the US illustrated how Abbot Laboratories struggled and managed to keep a generic version of its $500 million-dollar a year high blood pressure drug out of the market. Abbot was worried about what generics would do to its profits.

In a report entitled How Companies Stall Generics and Keep Themselves Healthy, The New York Times reported last year that Abbot agreed to pay Zenith Goldline Pharmaceuticals as much as $2 million per month up to a maximum of $4.5 million if Zenith agreed not to produce the generic.

Abbot also agreed to pay another rival, Geneva Pharmaceuticals up to $4.5 million a month, up to a maximum $101 million over the life of the contract, as long Geneva never produced the generic.

Geneva Pharmaceuticals is an affiliate of the larger Norvatis AG, the Swiss health and agricultural conglomerate. The generic version of Hytrin, the contested drug, stayed out of the market until 1999 when the US began antitrust investigations against Abbot.

Last week, The New York Times reported that a coalition of 17 consumer groups have filed several lawsuits against two companies, Barr Laboratories and AstraZeneca, charging that the companies colluded to keep a generic version of an important breast cancer drug off the market.

According to the suit, Zeneca paid Barr $21 million and Barr agreed to sell Zeneca’s drug rather than produce its own generic version.

Prescription Access Litigation Project, the consumer group that has sued, promises "to stop these abusive drug company practices by going after them drug by drug."

Given the secretive nature of the world’s most lucrative industry, no one knows how many such deals exist. But the deals are known to have kept antibiotics, cancer and heart generic drugs out of the market.

It is war over profits, not infrastructure or some danger that lies ahead for users of generic drugs.

The Kenya Coalition on Access to Essential Medicines fear that the multinationals may try to do here what they do in the West. They could put pressure on the Kenyan government "to drop or amend these vital, legal and internationally recognized safeguards, which could ensure the right of access to affordable medicines for millions of people suffering from AIDS and other diseases," Dr Christopher Ouma says on behalf of the coalition.

"Kenya cannot afford to rely on the charity of profit making companies for its future," Ouma says.

Revelations of conspiracy in the industry have only tarnished the industry’s image, and the drug makers know it.

It is for this reason that the industry spends millions every year in trying to make its image good. When it comes to spending money on lobbying and public relations, pharmaceutical industry is only gun, tobacco and insurance industries rival the pharmaceuticals. The industry stands alone as the organisation with links to all sorts of groups. It maintains a broad and usually unseen reach where its critics are.

In the US, the industry sponsors all sorts of political organisations. Because it is lucrative and powerful, it usually hires well-placed former government officials as lobbyists. The industry finances studies that advance its views, then run heavy advertising campaigns that cleanse their image.

In 1999, according to the Journal of American Medical Association, top 15 pharmaceutical companies in the US spent about $60 million, up from $45million in 1998. The money was spent on lobbying, sponsoring studies that advanced the industry’s views and on advertising to save its image, not on research.

In the US, where there are several patient advocacy groups, the industry stems criticism by financing those groups. It also contributes to public policy groups. Such lobbying ensures the industry of patent extensions and tax breaks. In Africa where there are no such groups, the industry has had a field day.

Pharmaceutical companies are known to sponsor studies then heavily advertise the results, without disclosing that it is them who sponsored the study.

In places like the US where the industry is caged, it creates seemingly independent groups who promote the industry’s agenda. Last year, as the US campaigns focused more on the industry, a "consumer organisation," Citizens for Better Medicare emerged. It waged a $50 million campaign against plans for a government-controlled drug industry just as another, Alliance for Better Medicare came up to do the same thing.

What the companies did not say was that they sponsored all these "consumer organisations" to protest against the government. The idea was to make it look like it is the people who don’t want the government to control the industry.

It would not matter if these activities were only applicable abroad. But the industry has branches all-over the world and what they resolve in Washington and London apply in Africa too.

The permanent secretary in the ministry of health, prof. Julius Meme, says what exists in Kenya are just branches of multinationals in the US and Europe.

"The decision on whether to allow generics will be made out there, not here."

To save its image, the pharmaceutical industry has toyed with all sorts of names, changing them to suit the times.

In the 1900s when the drug makers had no enemies, they came together under the name of Ethical Pharmaceutical Companies. That was to distinguish them from sellers of herbs, snake oil and all other sorts of cures that competed with the industry.

The name served them well until around 1984 when the word generic drugs began to enter the public vocabulary. That year, the US Congress, pushed into action by mounting complaints about the cost of brand-name drugs, passed the Drug Price Competition and Patent Restoration Act. The intention of the Act was to push prices down by speeding up the emergence of generic drugs.

So fed up was Congress that it eased the regulatory burden on generics. Generic manufacturers were not required to run costly clinical trials to prove the effectiveness of their products.

All that was required was for them to prove bioequivalence---that the generics contain the same key ingredients as the brand, and that they work the same way. Congress went a step further. It offered a six-month competition-free period for the first generic drug maker to seek approval for a particular medicine. Seven months after the law took effect, 800 generics had lined up, seeking approval.

In exchange, brand name manufacturers were given five-year patent extensions.

The pharmaceutical industry began to see red. That is when they came up with the scare they have stuck to : Research. They reasoned that the world risked getting sicker if generics were allowed into the market as they would kill research. No new drugs would be invented.

Research remained a low-key idea until 1994 when the Clinton administration proposed sweeping changes that favoured cheap, generic drugs. The administration was toying with allowing the government to shop around the world and get cheap drugs for its citizens.

The industry changed its name from Pharmaceutical Manufacturers Association to a more appealing and intimidating one ; Pharmaceutical Research and Manufacturers of America, PhRMA. Research had entered the industry’s central vocabulary to scare and entice the public at the same time.

Some companies became so scared of losing profits that they patent the colour of their pills. Some even patent the shape of the bottle the drug comes in.