Re: NYTimes.com Article: F.D.A. Panel Considers Warning Label for a Heart Medicine

[Guest guest]

I don't take it however a quick story related to the drug companies.

I am in the security business and I do work for a great many wealthy people.

Several years ago I was hired to design a system and supervise its

installation in the home of the CEO of one of America's largest

pharmaceutical companies. I will not say which one because I do not want to

compromise him or his family. I will say that the house was in one of the

most exclusive and expensive neighborhoods in the San Francisco Bay area.

When all was said and done the system cost was well over $100,000 and of

course it was paid for by the company. Just another perk for a man earning

in excess of $20,000,000. as the head of a drug company. This man also took

a helicopter to work every day, yes his home had a helipad.

My point is this, the drug companies make billions of dollars in profits

every year on people just like us. Granted, many drugs make our lives better

and more comfortable but the drug companies use us as guinea pigs. Why

don't most physicians inform their patients about alternative therapies and

continue to prescribe drugs? Because physicians are subsidized by the drug

companies.

Ask your doctors about alternative therapies and medications, also ask about

generic brands. Ask questions, knowledge is power.

OK, I am stepping off my soapbox now.

Regards,

BC

----- Original Message -----

From: <rmax@...>

< >

Sent: Thursday, May 24, 2001 1:17 PM

Subject: [] NYTimes.com Article: F.D.A. Panel Considers Warning Label

for a Heart Medicine

> This article from NYTimes.com

> has been sent to you by rmax@....

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> Anyone taking this drug for Blood Pressure?

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> F.D.A. Panel Considers Warning Label for a Heart Medicine

>

>

> By MELODY PETERSEN

>

>

>

> n advisory panel at the Food and Drug Administration will hear

> arguments today on whether to add a warning to the label of

> Cardura, a popular blood pressure medication, telling doctors and

> patients that it may be less effective than a much cheaper generic

> drug.

>

> Pfizer, the maker of Cardura, has done little to tell doctors and

> patients about the results of a government study of the drug's

> effectiveness, according to a lawsuit that was filed last year on

> behalf of patients.

>

> For years, it has not been clear whether newer medicines like

> Cardura are actually better than older generic treatments for high

> blood pressure.

>

> In Cardura's case, a large study by the National Institutes of

> Health found last year that patients with high blood pressure who

> took Cardura were two times as likely to be hospitalized for

> congestive heart failure than if they took an older generic

> diuretic. The study did not find that patients taking Cardura were

> any more likely to die than patients taking the diuretic.

>

> Startled by the finding, researchers immediately halted the part

> of the study involving Cardura and offered an alternative medicine

> to the 9,000 patients taking the drug in the trial.

>

> But government regulators have never asked Pfizer to change how it

> markets the drug. And according to Pfizer documents included in the

> suit, the company has continued to sell the medicine aggressively,

> schooling its sales representatives in what to say to doctors who

> had doubts about the drug.

>

> Pfizer spent $66 million to market Cardura last year, and the

> drug's sales reached $365 million in America, according to IMS

> Health.

>

> After Milberg Weiss Bershad Hynes & Lerach, the firm representing

> the patients, filed the lawsuit, asking that Pfizer be forced to

> notify patients of the study's findings, a federal district judge

> in Manhattan told the lawyers that they would have to take the

> matter up with the food and drug agency.

>

> Pfizer said yesterday that it had acted appropriately in

> continuing to market the drug. It also said that it believed that

> Cardura was safe.

>

> nn Caprino, a Pfizer spokeswoman, said that the company had

> reviewed the 316 clinical trials it had sponsored to study Cardura

> and had been unable to find any link between Cardura and congestive

> heart failure. The company also reviewed studies by other

> researchers and said it found no link.

>

> Pfizer believes, Ms. Caprino said, that the government's findings

> may have been caused by the way the trial was designed.

>

> " We don't believe a change in the label is warranted, " she said.

>

>

> When scientific data have shown that a drug may be unsafe, the food

> and drug agency has issued such warnings in the past.

>

> Pfizer said that the government had never given it the data from

> its study, making it hard to notify patients and doctors.

>

> " Pfizer alerted regulatory authorities around the world " after the

> government stopped the trial last year, Ms. Caprino said. " Not one

> of these agencies has asked Pfizer to take any action of any kind. "

>

> But some doctors say they are worried that some patients still

> taking Cardura could be harmed.

>

> " Pfizer's delay in providing such notification may every year

> cause thousands of unnecessary cases of heart failure among the

> large number of hypertensive patients who currently use Cardura, "

> said Dr. Curt D. Furberg, chairman of the steering committee of the

> government study, in an affidavit that is part of the suit.

>

> Lawrence R. Krakoff, professor of medicine at Mount Sinai School

> of Medicine, said in another affidavit, " Pfizer's delay or refusal

> to provide such notification to date may have already caused

> hospitalizations. "

>

> Dr. Krakoff is expected to speak at today's hearing in Bethesda,

> Md.

>

> The government study, the Antihypertensive and Lipid Lowering

> Treatment to Prevent Heart Attack Trial, is also exploring whether

> two other relatively new drugs are more effective than generics.

> The study will conclude in 2002.

>

> According to internal company documents made public as part of the

> suit, as the government was preparing to halt the part of the trial

> looking at Cardura, Pfizer began to take steps to remedy what it

> saw as a " potential threat " to its business.

>

> Company executives discussed seeking the support of the American

> College of Cardiology, the nation's largest group of cardiologists,

> according to the documents. Pfizer also wrote responses to be used

> when a doctor that the company considered to be a high prescriber

> of Cardura raised questions about the trial.

>

> " It is extremely important that everyone selling Cardura gives a

> consistent, unambiguous and powerful response to a physician's

> questions, " said an internal Pfizer e-mail message included in

> court filings.

>

> Ms. Caprino agreed that the company had continued to market the

> drug. " The regulatory agencies did not put any restrictions on our

> ability to market the drug, " she said.

>

>

http://www.nytimes.com/2001/05/24/business/24DRUG.html?ex=991735479 & ei=1 & en=

38e2a7e1a2fab196

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