Court Ordered Drug Rehab

 

St. Petersburg Times

BAD MEDICINE

A Times Editorial

Tuesday, September 22, 2009

 

It’s now clear that the pharmaceutical industry that claims its goal is to improve lives is just as likely as any other industry to manipulate the truth to make a buck. Even more disturbing: Drug companies have found a stable of doctors willing to help them in exchange for cash or prestige. Doctors should know better, particularly those affiliated with medical schools, and the medical schools should adopt stricter rules.
Recent disclosures, forced by court cases or federal regulators, have laid bare the complicity of doctors, including some in Tampa Bay, in helping drug companies sell their products. Experts estimate for each $1 spent on such marketing, companies reap $12 in increased prescription sales. When doctors receive thousands of dollars from drugmakers to help deliver their message, it creates an inherent conflict of interest with their primary job: Caring for their patients. Medical schools should be attacking this ethical problem directly, particular in an era when costs are leaving many uninsured.
Some schools, such as Harvard and Stanford, have banned the lucrative relationships. Short of that, medical schools should at least require strict reporting and public disclosure, with serious consequences for lapses. That hasn’t been the case in the past at the University of South Florida College of Medicine.
The St. Petersburg Times’ Kris Hundley reported on Sunday how drugmaker Wyeth for years paid for and influenced the ghostwriting of medical journal articles and continuing education conferences in an effort to boost sales of its hormone treatments for menopause. The campaign continued even after a federal study indicated the drugs might make it harder to detect breast cancer in patients. Dr. James Fiorica, then a professor at USF and head of the gynecologic oncology program at H. Lee Moffitt Cancer Center, was among those who participated. He chaired a Wyeth-backed conference and signed his name to two ghostwritten articles. He, like other doctors earning money from pharmaceutical companies, said he never signed his name to a position he couldn’t scientifically defend.
And last month, Hundley wrote about Eli Lilly & Co.’s program that paid physicians tens of millions of dollars in the first quarter of this year to talk about its drugs. One of Lilly’s highest paid physicians and its top earner in the Tampa Bay area is Dr. Maria-Carmen Wilson, a neurologist and USF professor who is director of Tampa General Hospital’s Headache & Pain Center. She was paid $54,400 in the first quarter of the year for speaking with fellow doctors about Lilly’s Cymbalta drug on 27 occasions. Wilson reached Lilly’s annual cap of $75,000 in May.
Nonetheless, Wilson failed to follow USF policy to get prior approval before making presentations on behalf of a drugmaker. Wilson also failed to inform USF when she took free trips to Scotland and Spain for drugmaker Astra-Zeneca. Last month, USF approved Wilson’s Lilly activities retroactively.
Another USF-affiliated physician, Dr. Brian Keefe, also failed to disclose earning $15,000 from Lilly in the first quarter.
In April, USF medical school announced new reporting guidelines for interactions between faculty and drug- and medical device makers. But it seems the message has not gotten through, and faculty who ignore the rules are retroactively given a pass.
USF’s answer is that more clarity is coming. Dr. Stephen K. Klasko, CEO for USF Health and dean of the College of Medicine, says he has convened a group to look at all faculty relationships with pharmaceutical companies in order to make new rules and reporting requirements “as simple and as consistently enforceable and as clear as possible.”
“We’re going to have a zero tolerance policy,” Klasko says.

That can’t happen soon enough. Patients rely on doctors to give them the best treatment possible, not just the treatment they’re paid to support.

 

Information (Informed Consent)
 A patient has the right to be given by his or her health care provider information concerning diagnosis, planned course of treatment, alternatives, risks, and prognosis, unless it is medically inadvisable or impossible to give this information to the patient, in which case the information must be given to the patient’s guardian or a person designated as the patient’s representative. A patient has the right to refuse this information.
 
 A patient has the right to refuse any treatment based on information required by this paragraph, except as otherwise provided by law. The responsible provider shall document any such refusal.

 

A patient has the right to express grievances to a health care provider, a health care facility, or the appropriate state licensing agency regarding alleged violations of patients’ rights. A patient has the right to know the health care provider’s or health care facility’s procedures for expressing a grievance.

The money tells the tale

 In a recent study conducted by the American Chemical Society (ACS), it was discovered that between 85 and 90 percent of the paper money in the United States showed traces of cocaine. Seem amazing? Well it should. But while this does indicate that the majority of the citizens in the U.S. are technically carrying cocaine in their wallet, purse etc, the real scary fact here is the indication of how huge a problem cocaine truly is throughout the United States and in fact the world.

We here about cocaine being a widespread problem in many forms. We hear about large scale cocaine busts in nearby areas and cocaine overdose issues in our local hospital, but how big does the problem have to be if nearly 90 % of the paper money in the United States has been in contact with cocaine leaving traces of the drug behind?

Roughly 19 billion notes ranging from a $100 denomination to a $2 dollar denomination are in circulation at this time. This means that over 17 billion individual pieces of paper currency have come into direct contact with cocaine during its circulatory lifetime. Again, the magnitude of the cocaine addiction problem currently facing our nation must be even more massive and far reaching than is usually thought for this amount of our money to be “touching” cocaine during its relatively short lifespan of circulation.

Cocaine addiction experts say this contact with cocaine stems primarily from a variety of methods including the use of paper currency to “snort” the drug or inhale it in its powder form,  the presence of large quantities of money in and around major drug scenes where tons of cocaine is either being processed or packaged, residue from the fingers and hands of those addicted to cocaine leaving their residuals behind during a cocaine purchase where both parties the seller and purchaser have the substance on their hands, and storage of the bills in direct contact with cocaine either for shipment over sees or in police lock ups.

Clearly this nation is underestimating the magnitude of the cocaine problems we still face and more needs to be done to fully address the size of cocaine addiction problems we have. With 3 percent or less of those who have become addicted to drugs like cocaine actually receiving the treatment needed to stop the demand for their drugs of choice, there will likely continue to be an overwhelming rise in the number of innocent bystanders who become prey for cocaine dealers and drug dealer in general.  The time is now to step up and truly confront the cocaine addiction issues that plague our nation.

~ excerpted from article by Megan Thorpe

Pfizer to pay record $2.3B penalty for drug promos

Repeat offender Pfizer paying record $2.3B settlement for illegal drug promotions

• By Devlin Barrett, Associated Press Writer
• On Wednesday September 2, 2009, 6:43 pm EDT

WASHINGTON (AP) — Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drugmaker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Authorities called Pfizer a repeat offender, noting it is the company’s fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.

As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.

“They were entertained with golf, massages, and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

To prevent backsliding this time, Pfizer’s conduct will be specially monitored by the Health and Human Service Department inspector general for five years.

In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.

Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can help the American public at a time when budgets are tight and health care costs are rising.”

Perrelli announced the settlement terms at a news conference with federal prosecutors and FBI, and Health and Human Services Department officials.

The settlement ends an investigation that also resulted in guilty pleas from two former Pfizer sales managers.

Officials said the U.S. industry has paid out more than $11 billion in such settlements over the past decade, but one consumer advocate voiced hope that Wednesday’s penalty was so big it would curb the abuses.

“There’s so much money in selling pills, that there’s a tremendous temptation to cheat,” said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.

“There’s a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship.”

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.

The $1 billion in civil penalties was related to Bextra and a number of other medicines.

A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.

Pfizer’s top lawyer, Amy Schulman, said the settlements “bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines.”

In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures.”

In financial filings in January, the company had indicated that it would pay $2.3 billion over the allegations.

The civil settlement announced Wednesday covered Pfizer’s promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.

The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.

The allegations came to light thanks largely to five Pfizer employees and one Pennsylvania doctor, who will now share $102 million of the settlement money.

FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to “speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”

To rein in the abuses, the government’s five-year monitoring will force Pfizer to notify doctors about Wednesday’s agreement, encourage them to report any similar behavior, and publicly post any payments or perks it gives to doctors.

Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state’s attorney general, Andrew Cuomo.

When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer’s position as the world’s top drugmaker by revenue, is expected to close before year’s end.

Shares of Pfizer dropped 14 cents to $16.24 in midday trading.

AP Business Writer Linda A. Johnson in Trenton, N.J., contributed to this report.