Feds Seek to Change Drugmakers' Practices With Pfizer Settlement

Greg Webb — Sun, 13 Sep 2009 14:41:06 GMT

A record $2.3 billion settlement with Pfizer has reinforced the Obama administration’s stance on health-care fraud. Recently, “Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.”

The investigation of Pfizer began four years ago when corporate insiders began to question the marketing practices that were being employed by the company in order to turn a profit. The methods used by Pfizer meant that employees were expected to “increase profits at all costs, even when sales meant endangering lives,” said John Kopchinksi, a Pfizer salesman from Florida. It was a group of employees, including Kopchinski, who called attention to the company’s illegal activity, which included bribing doctors into prescribing Bextra for conditions that it was not designed for, “[creating] sham requests for medical information as an excuse to send unsolicited advertising materials to physicians,” as well as writing articles to promote their product without disclosing the fact that they had a hand in preparing the promotional materials.

Pharmacia and Upjohn will pay $1.3 billion in fines and forfeiture and an additional $1 billion to state and federal authorities to “resolve civil allegations of improper marketing over Bextra and three more drugs,” with the former payment being the largest criminal penalty ever imposed in the U.S., according to prosecutors. The other drugs in question were: “Geodon, an antipsychotic medicine; Zyvox, an antibiotic; and Lyrica, an epilepsy medicine.”

The Pfizer settlement is one step in a long-term goal, with federal agencies more focused than ever on targeting and taking action against wrongdoing drugmakers in the health-care industry. In addition to the Pfizer settlement, the “task force” deployed by the Justice and Health and Human Services departments have been issuing indictments on smaller companies over the past several months for “[bilking] Medicare and Medicaid out of hundreds of millions of dollars through schemes involving wheelchairs, medical equipment and costly HIV/AIDS treatments.” With the Pfizer settlement, “the Justice Department’s civil division…has pledged to devote more attention to whistleblowers at drug companies and insurance firms who flag improper payments and marketing schemes.”

According to the acting U.S. attorney in Massachusetts, Mike Loucks, Pfizer, the world’s largest drugmaker, “has entered into four settlements with the Justice Department over the last decade.” With Bextra being voluntarily removed from the market in 2005 over its role in “strokes, heart attacks and blood clots in the lungs,” Health and Human services Secretary Kathleen Sebelius said scrutiny on the company will be heightened.

Despite the settlement, concerns grow that it will not be enough to sway drug companies from their “bad behavior.” With the pharmaceutical industry being one of the most profitable in the country (raking in close to $50 billion last year), Sidney Wolfe, director of Public Citizen’s Health Research Group notes: “The ever-escalating fines are unlikely to stop drug companies from continuing to bribe doctors because they represent just a fraction of drug company profits and no one has gone to jail.”

Originally posted at InjuryBoard by Greg Webb

FDA Panel Decides Acetaminophen Doses Should Be Changed

Greg Webb — Tue, 30 Jun 2009 22:07:43 GMT

On Tuesday, June 30, 2009, thirty-nine government safety experts, who were assembled by the Food and Drug Administration (FDA), recommended ways to reduce deadly overdoses of acetaminophen, which is the leading cause of liver failure in the United States. This liver failure sends about 56,000 people into the emergency room causing about 200 deaths each year. Due to these staggering numbers, the panel called for sweeping safety restrictions on the most widely used painkillers, including decreasing the maximum dose of Extra Strength Tylenol from eight pills of medication to a not yet determined amount and endorsed limiting the maximum single dose from 1,000 mg, or two tablets, to 650 mg; the 1,000 mg dosage should only be available by prescription.

The panel also narrowly voted to eliminate prescription drugs that combine painkilling ingredients with acetaminophen, such as Percocet and Vicodin, citing sixty percent of acetaminophen-related deaths are related to the prescription products. Some panel members, however, disagreed with this decision because so many Americans deal with chronic pain and depend on the medications. If these drugs stay on the market, members of the panel ask that the drugs’ label carry a black box warning, which is the most serious safety label available.

Drug companies avoided the most damaging potential outcome after the panel decided that over-the-counter cold medications, such as Nyquil and Theraflu, which combine other drugs with acetaminophen, could stay on the market. Though these drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, the FDA claims they only cause about ten percent of the acetaminophen-related deaths.

Although the FDA is not required to follow the advice of its panels, it usually does. Many doctors believe this is the opportunity to save a lot of people from inadvertent overdoses. For example, college sophomore Madalyn Byrne died after taking eight Tylenol a day for a week due to a toothache. Madalyn’s mother believes that had the bottle said to take four tablets a day instead of eight, her daughter would still be alive.

Originally posted at InjuryBoard by Greg Webb

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Feds Seek to Change Drugmakers' Practices With Pfizer Settlement

FDA Panel Decides Acetaminophen Doses Should Be Changed