By Erin Sherbert
By Howard Cole
By Erin Sherbert
By Erin Sherbert
By Leif Haven
By Erin Sherbert
By Chris Roberts
By Kate Conger
Jeff Stark's article about GHB ("Drug Story," Nov. 29) seriously misled readers about two issues and did them a minor disservice on a third.
First item: Despite what FDA and drug industry spokespersons would like everybody to believe, GHB cannot be patented. Period. Ask a patent lawyer. They will tell you that naturally occurring chemical structures that are found in the human body (like GHB) are not eligible for chemical patents. Chemical patents can only be obtained for "novel" chemical entities that are created by the patent seeker.
The FDA's attempts to mislead the public by intimating that use patents are somehow equivalent to chemical patents is disingenuous. Quite the contrary, use patents are ineffective for recouping the levels of investment required to obtain FDA approval for anything. Use patents do not protect against competition from other uses of a substance, of which there are usually many. Since a company cannot have the market exclusivity that would come from a chemical patent, they cannot charge the hundredfold markups that would be required to earn the millions of dollars it costs for FDA approval. Michael Swit was quoted as saying, "The people who tell you that it cannot be patented and that that prevents the FDA from approving are giving you an argument that is not 100 percent viable." Big deal, so it's only 99.44 percent viable. To a lawyer, the tiny profit that use patents engender may be technically real enough to mislead the public, but to a venture capitalist it is merely a belly laugh.
Use patents do not drive the pharmaceutical market. The rare exception is when technical production methods are either supremely difficult (as in the Taxol example offered), or directly patentable themselves (as in the Taxol example offered), or the substance can only be used under controlled conditions (i.e., intravenous administration by doctors). Gee, Taxol, again. None of these circumstances apply to GHB.
Second item: GHB is no longer legally considered a drug in the United States. Since the passage of the Dietary Supplement Health & Education Act in November of 1994, GHB falls under the new definition of "dietary supplement" and is therefore a food. This new law prevents the FDA from removing GHB from the food category without a rule-making hearing sponsored by the Department of Health and Human Services. Despite this legal change, the FDA and Justice Department continue to prosecute people for having sold GHB as a dietary supplement in the past. Not only is this policy a huge waste of taxpayer money, it is futile. The fundamental weakness of the government's case and prosecutorial misconduct are causing their cases to unravel faster than they can spin new falsehoods about GHB.
Third item: The article left readers with no means of obtaining GHB other than the street. This is risky. Alternatively, CERI maintains a listing of mail-order sources that can supply high-purity pharmaceutical-grade GHB. U.S. sources require a prescription; overseas sources do not.
Jeff Stark replies: My story did not imply that a chemical patent for GHB was possible. However, a use patent, if approved by the FDA, can give a company a short-term monopoly for a specific application, allowing it to recoup dollars spent on the approval process.
He'll Be Watching
In "C.R.U.S.H." (Nov. 22) George Cothran writes, "But sometimes, in the legitimate pursuit of killers, they [police officers] appeared to cross the line." Breaking the law to pursue people breaking the law, especially violating people's civil rights, is not legitimate pursuit. If the SFPD is violating people's civil rights while reporters are doing stories, one can imagine how often the police break the law when reporters are not around.
As someone who documents police misconduct with video cameras, I can tell you that the way the police act on camera is regularly very different from when they are off camera. In fact, I would say that some officers violate people's rights so much that they forget what those rights are in the first place -- and can't remember when a video camera (or reporter) happens to be there. For instance, it appears in the article that the officers forgot that holding a boombox and wearing red bandannas and red sweaters is not probable cause for detaining people and performing warrant checks on them. Then one of the officers has the gall to say, "If someone goes off on you, we could be there for you," while he and his fellow officers are the people "going off" on two citizens on a street corner.
The SFPD is out of control, and the SFPD doesn't realize it's out of control. This is a dangerous problem. I wish I could have been there with my video camera to try to stop those police officers from "going off" on those two bystanders.
Timothy Craig Maschok
Staking a Claim
Paul Reidinger takes a stab (literally) at La Paloma ("California Sweet," Eat, Nov. 22), a restaurant that deserves better. Reidinger ought to stick to films, and you should hire someone who knows how to review a restaurant -- not try to put a stake through its heart.