Sunday, September 27, 2009

Now breast milk is bad for you -- but only in Denmark

Since Denmark and Finland are both highly "correct" countries that are also very similar in most other ways, this is probably best seen as an artifact of poor sampling. The Finnish sample may have been more rural, for instance. And it certainly "explains" nothing. Correlation is not causation

A study in Denmark suggests hormone-disrupting environmental chemicals may explain why so many men in the country develop the disease. Danish men are up to four times more likely to have testicular cancer as men in neighbouring Finland. Denmark also suffers high rates of other male reproductive disorders, including poor semen quality and genital abnormalities. Some experts believe man-made pollutants that alter the effect of hormones in the developing foetus may be to blame.

Researchers measured levels of 121 chemicals in 68 samples of breast milk from women in Denmark and Finland. They found a dramatic difference between the two countries. Danish breast milk had significantly higher levels of some chemicals, including dioxins, polychlorinated biphenyls (PCBs) and pesticides, than Finnish breast milk. Chemicals in breast milk acted as a marker of exposure to the pollutants in the womb, said the scientists, whose findings are reported in the International Journal of Andrology. Previous research in animals and humans has suggested a connection between hormone-disrupting chemicals and testicular cancer.

Why women in Denmark should have more of the chemicals in their breast milk than their Finnish neighbours remains unclear. Study leader Professor Niels Skakkebaek, from the University Department of Growth and Reproduction in Copenhagen, said: "We were very surprised to find that some EDC (endocrine disrupting chemicals) levels, including some dioxins, PCBs and some pesticides, were significantly higher in Denmark than in Finland. "Our findings reinforce the view that environmental exposure to EDCs may explain some of the temporal and between-country differences in incidence of male reproductive disorders."

However he urged women to continue breast feeding which had "many beneficial effects for the child".

Rates of testicular cancer vary greatly around the world. In the UK, almost 2,000 men are diagnosed with the disease each year, while in the US the number is more than 8,000.


The FDA Rejects Another Good Cancer Drug

No wonder people are worried about bureaucrats controlling health care. They can do what they like -- and do. In this case the usual Leftist enmity to drug companies seems to have been at work. Margaret Hamburg, Obama's appointee as boss of the FDA, is of course a known Leftist. See here for one example of politics being behind bad FDA decisions.

But how would it be if your health insurer were equally arbitrary? What if a black official didn't like the fact that you are white, for instance? It's very hard to get official decisions overturned and you could well die in the meantime

As the debate about health-care reform has heated up, there's been a lot of talk about creating expert panels that give bureaucrats control over what treatments we can receive. Truth be told, these panels already exist. Earlier this month, the Food and Drug Administration (FDA) bureaucracy made a decision that will deny women a viable option for fighting ovarian cancer.

Ovarian cancer is a rare disease and is therefore not usually targeted by drug companies. The pharmaceutical industry tends to focus on cancers that strike a large number of people. Finding treatments for such cancers gives drug companies their best chance to earn enough profit to pay for the enormous cost of developing a new drug.

Thus it was remarkable that the Centocor Company even developed its chemotherapy agent Yondelis. The culmination of the company's efforts was an appearance July 15 before the FDA Oncology Drug Advisory Committee (ODAC), a panel of cancer experts that assists the FDA. But on the day of the meeting the FDA turned its back on 25 years of regulatory precedent and rejected a new cancer drug that by all known standards had passed muster for approval.

Centocor had all of its ducks in a row. For example, in 2006 approval standards for ovarian cancer drugs changed. So Centocor modified its process to meet the new standards. The FDA told the company that Yondelis would have to show a six-week improvement over the most effective therapy now being used to slow the progress of ovarian cancer. When its efficacy results came back, Yondelis showed a six-week improvement.

Instead of approving the drug, however, the FDA had second thoughts and decided the drug did not show enough efficacy to outweigh its toxicity levels. But those levels were not out of line with what other chemotherapies cause. Centocor recommended countering these toxicities by monitoring those who received the drug. Women who received the drug in the clinical trials reported feeling no worse on Yondelis than those who were on the less-effective control drug.

More importantly, these known lab toxicities were well characterized at a meeting in 2006 that the company had with the FDA. If the toxic effects were so important, why didn't the FDA tell Centocor it needed to show 12, 20 or whatever number of weeks that would pass muster? If the standards the FDA set up for this drug weren't enough to pass it, was it ethical to allow women to take this drug during its trials? The FDA needs to be held accountable if it failed to guide the company toward what it needed to do to gain approval.

One member of ODAC briefly challenged the FDA's role in choosing the parameters for this drug's success. But it's too much to expect the panel to be a counterweight to the FDA. The FDA's cancer director, Richard Pazdur, heavily influences the choice of ODAC members each year. This is a little like allowing a prosecutor to pick his friends for a jury. When the ODAC acts in lockstep with the FDA, it's reasonable to question the fairness of the system.

Those of us in the rare-cancer community were sickened by the fate of Yondelis. Women's gynecological cancer has always been an afterthought to drug developers. The more drugs we have to fight these diseases the better.

This episode shows that a healthy dose of reform is needed in two areas at the FDA Office of Oncology Products. The first reform is that the FDA should tell the sponsor exactly what is needed for approval. A concrete measure of efficacy should be added if doubts exist about toxicity.

The other area is reform of the manner by which the cancer panel is chosen by the FDA cancer director in the first place. Given the life and death importance of the issues, there should be a more independent process to assure that the "jury" has been selected fairly, so that, when needed, truth can be spoken to power. A truly independent and impartial ODAC, critiquing both the regulated and the regulators, is the best way to show that the FDA is secure in its science. That will help restore public trust in this important institution.


1 comment:

Isis said...

Natural breast milk can't be bad for anyone.Yes, But i do agree toxic environment chemicals can disrupt milk producing hormones which could be toxic.