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The illusions of “right to try” laws

[Ed. Note: For additional commentary on why “right-to-try” laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.

The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation

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Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of EAV are explained in an article on Quackwatch.

I’ve written about electrodermal testing before. I’ve explained how it amounts to fooling patients with a computerized Magic 8 Ball and I’ve discussed the legal and regulatory issues.

Now Stephen Barrett (founder of Quackwatch and Vice-President of the Institute for Science in Medicine) has written an article in FACT (Focus on Alternative and Complementary Therapies) entitled “Bogus electrodermal testing devices: where are the regulators?” He points out that existing regulations are sufficient to ban these devices, but that regulators have failed to take appropriate action.

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Posted in: Acupuncture, Energy Medicine, Medical devices, Politics and Regulation

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Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

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Posted in: Diagnostic tests & procedures, Energy Medicine, Legal

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