Monthly Archives: June 2007

Threats about the non-approval of a drug. Nobody’s bothered with me but as noted previously Provenge has at best marginal activity.

Bill Clinton’s legacy will ultimately rest on his work on HIV, not what he did during his presidency but afterward. His mobilization of generic drug manufacturers to provide inexpensive medications for AIDS treatment programs is remarkable because it works closely with the UN AIDS programs around the world and the individual countries with AIDS problems.

President Bush’s finest hour may also be recognized sometime in the future as his provision of funding to AIDS programs. His AIDS legacy however will have to overcome the program’s built-in subsidy to the patent pharmaceutical industry–the program will only allow use of drugs that are U.S. FDA approved–and it’s questionable limited educational message that emphasizes abstinence and having one partner.

Uganda has been the poster child for the Bush program, claiming a success for an abstinence based educational program. But there are questions about what happened there

“Pro-abstinence-only organizations are increasingly using Uganda as an example to indicate the success of their methods. But this is inappropriate, since the multiplicity of prevention methods used in Uganda mean that the decline in HIV prevalence was certainly not due to abstinence-only messages. Uganda’s success was based not only on encouraging abstinence until marriage but also on encouraging fidelity thereafter and condom use. It involved pragmatic discussion of risky sexual behaviors, strong governmental leadership, and condom distribution. The open and frank discussion of the sexual means of HIV transmission that took place is certainly not a feature of the pro-abstinence-only agenda.”

“Those in charge of America’s PEPFAR initiative accept that the ABC approach in Uganda involved more than only abstinence, but a large cut of the money is still being channeled through Christian organisations. The plans drawn up by some of these faith-based groups tend to be ideological rather than evidence-based and can neglect the other important aspects of HIV prevention. Promoting sexual abstinence until marriage without looking at these other issues is a recipe for failure, and Uganda’s example cannot be allowed to be misused in this way.”

“Unfortunately, there is no easy solution to an HIV epidemic. Uganda may have decreased its HIV prevalence but there have been many deaths in the country, and will be many more yet. There is no simple way to reducing the number of new infections – a number of different interventions are required. Foremost among these are a balanced ABC approach, committed political leadership, a willingness to discuss openly the ways in which HIV transmission can be prevented, and a vigorous response from communities across the country.”

Uganda’s decreased HIV prevalence however, may not represent a success of prevention. The decrease in disease that was reported over the past 15 years appears to have been due more to mortality and out migration than a great success of the ABC prevention method. In 2006 and increase in prevalence in Uganda was noted.

Faith based groups have control over the U.S. program’s message and their bias is affecting the objectivity of analysis and the educational message. It is not a little ironic that these same groups in the 80’s and 90’s essentially abandoned those with HIV and did not become involved with treatment or prevention until recently. Letting their bias against condom use subvert the educational message of the U.S. program is yet another AIDS tragedy–as Uganda may be finding today.

In addition to a more enlightened educational message, one would hope that the Bush program would become more efficient and make use of the least expensive generics for HIV so as to maximize the number of people treated. WHO has a means of certifying the medications which should be more than adequate for this purpose. The use of our FDA approval is simply a sop and subsidy to the patent pharmaceutical industry and blocks utilization of effective inexpensive medications from elsewhere.

Meanwhile, the U.S. hasn’t solved the problem of delivering appropriate treatment to patients here at home.

The annual oncology meetings (American Society of Clinical Oncology–ASCO) are on and we are destined, the next few days, to be bombarded with reports extolling the virtue of various interventions. There is real progress being made, new approaches based on blocking cell receptors, anti-angiogenic strategies and new combinations of various cyto-toxic agents.

The issue in not whether there is progress but how much progress and at what financial cost. The pharmaceutical patent monopoly allows companies to charge whatever they wish for new agents, no matter how marginal the results. The cost is based not on the cost of research or production or even the amount spent on promotion (which exceeds the costs of research by a wide margin).

Rather the pharmaceutical companies realize patients with cancer are not rational consumers who have the luxury of comparing products (approaches) and choosing the best value. Rather they are desperate for anything that might help their situation. I’ve been in the position of informing patients they have incurable disease and that the best we can do is offer medications that offer a chance of amelioration for a time–often as little as 10% response rate and as little as a month or two median improvement in survival. Patients more often than not choose to be treated, even though the costs are extreme.

There are numerous examples but take today’s news about a survival benefit in liver cancer with the use of a drug Nexavar . Nexavar is a multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases. These are found in both the tumor cells and blood vessels so the action sites are multiple.

Reuters reported from the ASCO meeting:

An experimental pill for advanced liver cancer helped patients live about three months, or 44 percent, longer than those on a placebo, according to a study released on Monday.

The trial found the drug Nexavar, by German drug maker Bayer AG (BAYG.DE: Quote, Profile, Research and its U.S. partner Onyx Pharmaceuticals (ONXX.O: Quote, Profile, Research, extended survival to 10.7 months, compared with 7.9 months for those on a placebo.

The drug was previously reported to be active against kidney cancer. In that tumor progress was delayed (“growth slowed”) for 4 months.

Last year Forbes noted:

“Onyx’s announcement that Nexavar will be priced at $4,333 a month, above the firm’s estimate of $3,200 and a Street consensus of $3,000, the financial analyst said in a report issued Wednesday.”

Also from the Forbes article this analysis: “We believe the drug should have limited exposure to price sensitivity, since Medicare Part D insulates Medicare patients from the cost of highly expensive drugs,” said the research analyst. “Private insurers are likely to look favorably on this drug as well, especially when compared to potentially toxic competitors with high treatment-associated costs,”

It’s wonderful that there is progress, but can we as a society afford the price? We need to revisit patents, the issue of responsible pricing and the non-negotiation policy of Medicare Part D–most of these patients are over 65 years of age.

The Daily Kos has this interesting post.

It’s similar to what’s happened in the media where the corporate owner’s interests affect the flow of information.