According to a communication posted recently in aids-india, an e-forum for communication and information on AIDS related issues in India, Ranbaxy was forced to withdraw the drug due to the US government's intimidating stand. It said the company has been strong-armed into seeking approval from the FDA where they were planning to submitting data very soon and if the company thought these drugs were neither safe nor effective, they certainly wouldn't be going to the FDA. The communication alleges that the company's decision was due to 'intimidation' by the US Government and as part of the USFDA's attempt to establish itself as the global arbiter of drug quality, particularly for the developing world.
The author Gregg Gonsalves of GMHC, New York, says the reporters and editors have not dug too deep into the issue and are taking the propaganda from the Bush administration and its surrogates at face value. 'While there are indeed problems with some of the bioequivalence data from Ranbaxy and Cipla, there is other data to suggest that these drugs are indeed safe and effective', felt the author of the communication, forwarded to an Aids-India member from Healthgap list serve.
He said there was a coordinated campaign in US to line up the US government and the FDA as the global arbiter of drug quality, particularly for the developing world.
'The fact that some Bush administration officials and their surrogates, like the Hudson Institute, Public Health Watch and Frontiers for Freedom are exaggerating the problems with generic ARVs, means that this entire debate is not happening in good faith-sadly the Hudson Institute, Public Health Watch, Frontiers for Freedom have never had any interest in HIV/AIDS, what they do have an interest in is supporting right-wing social and economic policies and acting as the shock troops of the extreme right wing of the Republican Party" felt the writer.
An AIDS setback
The editorial appeared in San Francisco Chronicle on November 15, 2004 opines as follows:
In fighting Aids, one of the few success stories is generic drugs that smother symptoms and extend life. It's not an overstatement to say these pills -- cheap copies of costlier originals -- hold the power to sustain countries where up to 1 in 5 people is infected.
This crucial role may be in question, however. Ranbaxy, India's biggest drugmaker and a leader in generics, has withdrawn seven AIDS-fighting drugs. The reason? It could not prove to United Nations regulators that the knockoff medicine was as effective as a first-line drug.
The drugs may be retested and put back in circulation soon, but it adds a chilly note to the AIDS fight: a once-considered dependable tool doesn't always measure up.
The negative results may also feed arguments that the United States' $15 billion AIDS funding should only be used to buy brand-name drugs, which can cost five to 10 times more than foreign-made generics. This position undercuts a generally worthy White House program to contain AIDS, which has infected 40 million worldwide.
Generics are indispensable in this fight, especially in Africa where the toll is heaviest. Patients infected with the AIDS virus lose weight, suffer skin rashes and lose energy. With twice-a-day pills, the sick can show the "Lazarus effect" -- they are able to gain strength, weight and stamina enough to return to work and normal life.
Take these pills away, and small countries such as Uganda, South Africa or Malawi with high AIDS rates will be plunged into deeper trouble.
What is needed is a quicker test of international drug safety. The United Nations must inspect and certify the mainstay generics before they reach wide use. The United States should back a single international testing standard and drop its own rule-making, which serves major drugmakers better than AIDS patients.
Generic drugs are a mainstay in treating AIDS. They must be made more safe and reliable.
James K. Glassman, a resident fellow at the American Enterprise Institute, writes in Scripps Howard News Service on November 15, 2004:
The strategy of fighting AIDS in Africa with questionable generic drugs made in developing countries now lies in shambles, as an Indian company withdrew its medicines last week because it can't guarantee they are potent enough.
It's time now for the United Nations and its number-one financial angel, the United States, to reverse a policy that not only has failed to slow the AIDS epidemic but is almost certainly making people sicker.
The use of unverified generics--which are copies of drugs developed and patented by research pharmaceutical companies in the United States and Europe--has been aggressively promoted by UN agencies like the World Health Organization and by nongovernmental organizations like Doctors Without Borders, based in Paris, and the Clinton Foundation, established by the former president.
The WHO and NGOs have been claiming that generic companies in India, South Africa, Thailand and elsewhere can make sophisticated multi-dose combinations of AIDS drugs by cobbling together patented medicines. Instead, the generic makers are turning out to be the gang that can't copy straight.
The ostensible reason for the WHO strategy is cost, but the research firms sell drugs in Africa at big discounts or give them away. A study by the Hudson Institute found that, on average, patented drugs cost less than generics in poor countries.
The real reason for the strategy is vicious political animosity toward the United States and the research pharmaceutical companies. Such antagonism can kill.
At the root of the current debacle is a simple question: Do people sick with AIDS in Kampala and Kinshasa deserve the same medicines as patients in Copenhagen and Chicago? Of course they do. But UN agencies and their NGO pals don't act that way. The WHO maintains a list of about 90 drugs that it "pre-qualifies" for relief agencies. But the list is maintained by a tiny staff with no facilities for testing, and the WHO does not warrant safety or effectiveness. Drugs on the list are now floating all over Africa.
By contrast, American authorities have insisted on spending the $15 billion from President Bush's global AIDS program, the world's largest, only on drugs--generic or patented--that meet the standards of the US Food and Drug Administration.
The FDA even set up a fast-track process to speed approval of AIDS drugs made in developing countries. But, so far, there have been no takers--a fact that arouses suspicions about the generics.
On Nov. 9, the Indian firm Ranbaxy, considered the best of the generic makers, withdrew all its AIDS drugs from the WHO list. That action followed WHO de-listings in spring and summer of five drugs made by Ranbaxy and another Indian company, Cipla.
The moves vindicated U.S. policy, but the cost to sick Africans--and to the reputation of the WHO--is devastating. In addition, legal sources say NGOs that have been distributing the generics could face lawsuits from affected patients.
No one knows how many people have been taking deficient medicines. There is no effective system to alert these patients or to get them on other therapies--the procedure in the U.S. and Europe.
The WHO has taken a cavalier attitude toward recent blunders, stating that, while "in principle," patients should get off the de-listed drugs, they don't have to. And, incredibly, Daniel Berman of Doctors Without Borders told the Washington Post, "We are not worried about the safety of our patients. . . . We can't make an equation that if a drug is removed from the list, it's not a good drug."
The danger extends beyond Africa. A poorly made copy of a patented drug may deliver a dose of medicine so weak that the virus could adapt to it through mutation and become resistant. These new viruses would require far more expensive drugs--or drugs that don't even exist today. Such strains could migrate to countries like the United States, where AIDS deaths have declined significantly, thanks to medicines developed in the late 1990s.
Last summer, the respected American Foundation for AIDS Research sternly warned that a flood of untested generics, made by more than two dozen companies in developing nations, "could lead to widespread misuses and eventually to drug resistance, eradicating years of progress." That worry is fast becoming reality. At the very least, Congress should investigate the UN strategy and reconsider American funding. Stubborn advocates of the current policy must stop playing deadly political games with the world's health.