Judge Orders Drug Maker to Provide Experimental Treatment to Terminally Ill Teenager

New York Times ^ | Aug 20, 2008 | MICHAEL M. GRYNBAUM

[decimon]

A 16-year-old patient, terminally ill with a rare form of muscular dystrophy, should be allowed to use an experimental drug treatment despite objections from the drug’s developer, a federal judge in Newark ruled on Wednesday.

The case, which touches on major ethical issues, is being closely watched by the pharmaceutical industry.

Under the ruling, Jacob Gunvalson, of Gonvick, Minn., would be able to start taking a drug intended to treat Duchenne muscular dystrophy, a rare and fatal disease that strikes boys and young men. The developer, PTC Therapeutics of South Plainfield, N.J., contends that Jacob does not meet the criteria to be a part of the drug’s clinical trial, and is planning to appeal. Federal regulators must also approve his application to use the drug.

[yankeedame]

The case, which touches on major ethical issues, is being closely watched by the pharmaceutical industry....

And hyena-like tort lawyers everywhere.

[decimon]

And hyena-like tort lawyers everywhere.

Yeah, the pharms are in a double-bind here. Demonized if they withhold a drug and demonized if they don't and there are complications.

[upier]

I see no problem with a terminal patient being given an experimental drug. Just have them sign a release that they are accepting all risks. What does the patient have to lose? Also shoot any lawyer that gets within 50 feet of the hospital.

[decimon]

I see no problem with a terminal patient being given an experimental drug. Just have them sign a release that they are accepting all risks. What does the patient have to lose?

I agree. If I'm a goner anyway then give me my one shot in a thousand while I serve as guinea pig.

Also shoot any lawyer that gets within 50 feet of the hospital.

There's the problem. The relatives of the deceased get to sue regardless of circumstances.

[3AngelaD]

Should judges be making these decisions? If those who are developing this drug believe the poor young man is not suitable for whatever reason to participate in their clinical trial, would his participation not skew the results?

[decimon]

Should judges be making these decisions?

That's the question. Like it or not, right or wrong, there are established procedures for these things. Established by insiders and not some Judge Martini, shaken not stirred.

[socialismisinsidious]

Socialized Medicine aka Universal Health Care PING LIST

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[bert]

.....Should judges be making these decisions?.....

The judge should be sued in federal court. His order should not be followed until upheld by the Supreme Court.

The decision is a responsibility of the Executive Branch, not the Judicial Branch. The young man is caught in the middle, but that is life.

[FormerACLUmember]

The pharmaceutical industry is one of the last remaining Crown Jewels of U.S. Industry not destroyed by the democrat party.

The crooked lawyer John Edwards wing of the democrat party is hard at work to anihilate this American gift to human civilization.

[GovernmentShrinker]

The judge is not ordering that he be included in the clinical trial, just that he be given access to the drug. The massive regulatory bureaucracy surrounding drug approval is something that no freedom-loving American should tolerate. It is serving government and large pharmaceutical companies, at the expense of sick people or small entrepreneurial drug developers. A drug is just a molecule with a specific structure. No entity should be granted government patent protection for having developed such a molecule for a specific medical purpose, and then be allowed to refuse to sell it to anyone who wants it. The patent holder can set the price, but the same price should apply to all would-be buyers.