How Many Melanoma Patients Did the FDA Kill?

By my estimate, more than 1,000 people have died prematurely because of foot-dragging by the FDA. Here’s why:

After an “expedited” analysis that lasted a year and a half, the FDA has finally approved Bristol-Myers Squibbs’ Yervoy (ipilimunab) for metastatic melanoma. The deadliest type of skin cancer, melanoma killed 8,700 Americans last year, according to the National Cancer Institute. BMS submitted its application to the FDA on August 18, 2010, with a target date for approval of December 25. On November 2, the FDA pushed out the target date. On March 25, the FDA approved the lifesaving medicine.

So, the question is: How many patients did the FDA kill by delaying the medicine?

Well, 46 percent of the subjects taking the drug were alive one year later, and 20 percent were alive two years later. In the control group, only 25 percent survived one year, and 14 percent two years. The difference between 46 percent and 25 percent is 21 percent. 21 percent of 8,700 is 1,827 lives. Similarly, the difference between 20 percent and 14 percent is 6 percent, or 522 of 1,827 lives.

Assuming that BMS was willing to supply the medicine as of August 18, 2010, the FDA’s initial period of review (to December 25) took 129 days. This implies that 645 melanoma patients died a year earlier than they would have without the legal requirement for FDA approval. However, because the FDA delayed a further 90 days (to March 25), 450 more patients died a year early. The point estimate for the total number of melanoma patients who died a year early is 1,095.

Of course, many of those would have died after another year. The delay only cost 313 patients two years of life. But I hardly think that’s a comfort to melanoma victims and their families.

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Smokers are risking more than they think

Bettina Arndt

Anti-smoking measures are in the news. Unit owners in an Ashfield block recently adopted a bylaw against smoking, South Australia has outlawed it in various public places and a Melbourne council has banned smoking in parks. Australia is a world leader in producing powerful advertising campaigns which very effectively spread the message about the health impacts of smoking. But there is one consequence that rarely makes it on to the radar: the impact below the belt for men.

Unlike many other countries, Australia has never conducted a major campaign focusing on the link between smoking and erectile dysfunction. Six years ago the British Health Department launched a campaign warning that smoking can ruin your sex life, including ads about physical attractiveness - "If you smoke, you stink" - and impotence - "Your penis thinks you should stop smoking". British surveys found one in two smokers said they would quit to improve their sex appeal and 88 per cent of smokers did not realise smoking is a major cause of impotence.

Similar campaigns have been run in Europe, Brazil, Venezuela and Mauritius, and Egypt has stepped up with a rather coy effort featuring a limp cigarette with the slogan: "Long-term smoking has an effect on marital relations."

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It sure does. One in two men in their 50s in Australia is struggling with erection problems; it's , 40 per cent of men in their 40s.

Men who smoke have twice the risk of developing erectile dysfunction. Smoking damages the penis in two ways. First, smoking has a direct "vasospastic" effect, causing spasm of the arteries in the penis reducing blood supply. That is amazing to see. I witnessed research where a man was wired to a penile plethysmograph, a gadget that measures blood flow in the penis. As soon as he started to smoke, you could see the arteries starting to constrict and the blood flow changing.

But there are also long-term effects such as endothelial dysfunction, which means a breakdown in the normal biochemical processes carried out by the cells lining the inner surface of the blood vessels. Plus smoking causes hardening of the arteries, and the delicate penile arteries are often some of the first to be affected. These physiological changes combine to narrow the penile arteries leading to constriction and blockages, resulting sometimes in permanent damage to the erection mechanism.

The link between smoking and erectile dysfunction is strongest in younger men, and the more they smoke the more likely their equipment will let them down. There is even evidence suggesting smoking affects testosterone levels, reduces the volume of ejaculate and lowers sperm counts causing both abnormal sperm shape and impaired sperm motility.

Health authorities in Australia have yet to be convinced that young men can be persuaded to quit to avoid future failure between the sheets. Young studs have not had the problem and do not see it as relevant.

Yet many tell me they are not aware of the sexual damage smoking can cause - the message simply isn't out there. Anti-smoking campaigns always have trouble reaching young men, who feel they are bullet-proof. Perhaps we would have a better chance of getting through by explaining why smoking means shooting themselves not in the foot, but in the crotch.

"Give it up to get it up!" That's a slogan that would have impact. How about targeting women to explain the stress erectile dysfunction can cause on future relationships? They need to know, for instance, that a penile prosthesis can cost more than a new kitchen. One of the illustrations used in the British campaign shows two inverted male fingers with drooping cigarette held in the crotch, almost totally ash and about to expire. It is a brilliant image, carrying a similar punch to the famous anti-speeding campaign where the young woman wriggles her pinkie at the speeding male driver. If we could persuade women to give male smokers a drooping pinkie sign, we might just get somewhere.

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