Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe a New Drug for 1st 7 Years After FDA Approval

Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe a New Drug for 1st 7 Years After FDA Approval | Pharmaguy's Insights Into Drug Industry News |

At a 2013 Selling Sickness conference in Washington, DC. Sydney Wolfe, MD (Public Citizen), gave a rousing keynote presentation and declared war on the medical-pharma-industrial complex.

One of the main "weapons" Wolfe proposed to help win the war against what he sees as the dangers of FDA-approved drugs is his "Seven-year Rule for Safer Prescribing - No prescribing or imbibing any new drug, except true breakthrough drugs, for the first 7 years after approval." Here's the rule described in Australian Prescriber:

"You should wait at least seven years from the date of release to take any new drug unless it is one of those rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labelling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release."

Listen to this auto snippet of Wolfe's presentation that includes the 7-year Rule and other "solutions.

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Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI

Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI | Pharmaguy's Insights Into Drug Industry News |

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.

It would not be surprising that after enough women have been seriously harmed by the “irreversible, or life threatening injuries” about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits.

The FDA’s analysis showed that women using the drug had an average of only half to one more “satisfying sexual encounter” every month compared to those using a placebo.

Meanwhile, the FDA’s list of serious risks includes abnormally low blood pressure and fainting. The agency noted that these could be experienced when flibanserin is taken alone or with alcohol, and that these side effects “can result in serious, irreversible, or life threatening injuries.”

The agency also noted that a study showed taking the drug with alcohol consumed over 10 minutes led to drowsiness, low blood pressure when standing up, and fainting. Although the study subjects were predominantly male (23 of 25 subjects), the FDA stated that “[t]he effect of the combination of flibanserin and ethanol may be more pronounced in females.”

The FDA noted the difficulty of preventing alcohol use in women using the drug, saying that limits on such prevention would exist even with the implementation of a type of risk management plan intended to ensure that the benefits of prescription drugs outweigh their risks.

Unfortunately, we haven’t heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.

Pharma Guys insight:

Wolfe et al have a good track record predicting which drugs will eventually be pulled from the market due stop safety issues. read, for example, "Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval"; 

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