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Behind the hype of an Alzheimer's ‘cure’

/ Source: NBC News

It is the type of call that every beat reporter dreads.

Monday of last week I was driving through southern Arizona, returning from covering a story about health care along the border. The almost simultaneous phone and e-mail messages from several of my editors all were shouting essentially the same thing: “There is a cure for Alzheimer’s disease!”  Immediately I thought, “How could I have missed this?”

A few quick phone calls revealed there were no claims of a cure in the wire-service stories that prompted the messages. But it was hardly surprising that someone could mistake what the articles called a breakthrough. A press release from Myriad Genetics, a biotechnology company in Salt Lake City, said its drug Flurizan “may be capable, not only of slowing the decline of Alzheimer's disease, but of halting the disease in its tracks.”

Immediately, I pulled over to the side of the highway to make some phone calls. The first, as always in such situations, goes to Judy Silverman, my research colleague of more than a decade, who among her many duties covers the phones when I’m on the road. Working together, Judy and I quickly discovered that neither the Alzheimer’s Association, nor several top Alzheimer’s researchers we routinely talk with, had any idea what this was about.

So, right away, the question became: Is this dramatic, unexpected new research or yet another case of biotechnology hype?

The first scenario is unlikely. Seldom does something entirely unexpected happen in science. The second is, sadly, common.

In a recent article in The New York Times, Andrew Pollack described several biotechnology companies that have survived decades without making a profit while burning through millions of dollars of investor money. The article quoted Arthur Levinson, CEO of Genentech, as saying that since his (highly successful) company’s founding in 1976, the biotechnology industry as a whole has lost almost $100 billion. The article noted that only 54 of 342 publicly traded American biotech companies earned a profit in 2006.

In such an environment, even rumors that a company might have a successful drug can boost the stock price just enough to allow another few months or years of survival. Indeed, hype about allegedly promising drugs has become almost synonymous with biotechnology.

To be sure, Myriad Genetics is not one of the unprofitable biotechs, nor, in my experience, a purveyor of hype.

In the early 1990s the company won a highly publicized race to determine the structure of the gene called BRCA-1 that increases risk for breast and ovarian cancer. It now markets tests to measure genetic risk for breast, ovarian, colon and other hereditary cancers. Last year, it recorded profits of $73 million — not bad — but peanuts compared to the billions to be made from a truly effective drug for Alzheimer’s.

Which brings us back to Flurizan. 

Hardly sensational
Flurizan is one of the first of a new class of drugs that many experts believe could provide a significant treatment by eliminating a protein in the brain called a-beta 42 that plays a key role in causing Alzheimer’s. In July of last year Myriad completed a phase II trial of the drug with some 200 Alzheimer's patients and announced mildly interesting, but hardly sensational, results. 

So what was new? The latest press release — which offered no data — was based on what the company calls a “responder analysis.” The company took the people who seem to have done best in the original trial and followed them for another year. 

According to Dr. Robert Green of Boston University, who is running the much larger phase III trial of the drug, the total number of patients studied for the claims made in the press release was 43. Green says 42 percent of those on the highest dose of Flurizan did not get any worse during the year compared to between 14 percent and 17 percent on either placebo or a lower dose. Green says he finds the results interesting, but says the group is too small to prove anything.

In an e-mail, a spokesman for Myriad Genetics noted the data had been presented at a gathering the weekend before at the meeting of the American Association for Geriatric Psychiatry. “We are also required by the SEC [Securities and Exchange Commission] to promptly announce anything of a material nature of which investors should be informed,” the spokesman wrote.

Disclosure is certainly required, but the language can be highly variable. 

I hope that the phase III trial, with results due in July 2008, proves Flurizan to be so effective a drug that it makes everyone who owns Myriad Genetics stock wealthy. Meanwhile, there is no reason yet to think Alzheimer’s can be stopped in its tracks.