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Good Riddance to a Bad Drug


Good Riddance to a Bad Drug -- Posted by Roman Bystrianyk on 10-04-04 17:27


http://www.healthsentinel.com/news.php?event=news_print_list_item&id=300

Eric J. Topol, "Good Riddance to a Bad Drug", New York Times, October
2, 2004,
Link: http://www.nytimes.com/2004/10/02/opinion/02topol.html?oref=login

Cleveland — After three years of denying that the arthritis drug Vioxx
could induce heart attacks and strokes, this week Merck bowed to
reality: it withdrew Vioxx from the market.

The impact of this decision is far-reaching, and not only because tens
of millions of people have tried Vioxx. It also highlights the absence
of Food and Drug Administration oversight of the pharmaceutical
industry as well as the lack of comprehensive long-term studies of not
only Vioxx but its entire class of arthritis drugs.

In 2001, I was part of a team from the Cleveland Clinic that published
a paper demonstrating the significant heart attack risk of Vioxx. Our
research, published in The Journal of the American Medical
Association, found that compared to naproxen, a commonly used
over-the-counter anti-inflammatory drug with similar benefits, Vioxx
has a five times greater heart attack risk. In response, Merck claimed
that early conclusions about the risk were flawed, and attributed the
comparatively high heart attack rates to an unproven protective effect
of naproxen. Our study was followed by several others demonstrating
Vioxx's dangers. Each time Merck had a similar reply: the study was
"flawed."

Merck finally had to acknowledge the truth, but only by accident. The
company undertook a large, randomized trial of 2,600 patients with
colon polyps in hopes of proving that Vioxx could help their
condition. In the process, though, Merck discovered that 3.5 percent
of patients taking Vioxx suffered heart attacks or strokes as against
1.9 percent taking a placebo. Merck at last did the right thing by
voluntarily and abruptly taking Vioxx off the market.

There are two important issues to consider here. First, the risk of
heart attack or stroke found in the Merck study, at 15 cases per 1,000
patients, may be greatly underestimated. Merck's trial did not include
anyone with known heart disease - patients who might be expected to
have the highest risk.

And the problem may extend beyond Vioxx and its users. While it's true
that when compared to the other Cox-2 inhibitors, Vioxx has repeatedly
carried a far greater risk of heart attack and stroke, none of the
manufacturers of Vioxx's class of drugs, called Cox-2 inhibitor
agents, have studied patients who already have heart disease. The
number of patients who may have sustained heart attack or stroke as a
result of using these drugs could be tens of thousands. It would be
premature to conclude that the other drugs still on the market, like
Celebrex and Bextra, do or do not carry some risk of heart attack
until sufficient testing is done.

While we remain in this zone of uncertainty, people with arthritis
should remember that conventional over-the-counter agents like
naproxen (as in Aleve) or ibuprofen (as in Advil) work extremely well,
are much cheaper than the Cox-2 agents, and are not known to have any
risk of heart attacks. In addition, one of the most-cited benefits of
the Cox-2 agents - that they are less likely to cause stomach ulcers
than over-the-counter drugs - may ben grossly exaggerated.

Second, and what may be more alarming, is that despite studies showing
the magnitude of the public health problem, for several years Merck
did nothing to investigate. This surely represents a conflict between
the interests of the public and the interests of a company with a
blockbuster drug that had sales of $2.5 billion in 2003.

Instead of doing the requisite research in patients with heart disease
- who frequently have arthritis as well and are thus prime users of
anti-inflammatory medicines - the company undertook studies that
avoided them. At the same time, Merck spent at least $100 million a
year for direct-to-consumer Vioxx advertising, while the company's
employees and their consultants published several papers in medical
journals rebutting studies reporting Vioxx's heart attack risk. The
Food and Drug Administration could have forced Merck to do the
appropriate research studies, but instead it was a bystander.

As the Vioxx debacle shows, we have a long way to go in this country
to get on track with prescription medications. Most important, we need
a stronger regulatory agency to compel pharmaceutical companies to do
the proper studies and force these companies to stop
direct-to-consumer advertising unless a drug has major benefits for
patients and negligible increased risk of heart attacks and strokes.

Our two most common deadly diseases should not be caused by a drug.

Eric J. Topol is chairman of the department of cardiovascular medicine
at the Cleveland Clinic.


Re: Good Riddance to a Bad Drug -- Posted by Katherine Wolfe on 10-10-04 10:39



"Roman Bystrianyk" wrote in message
news:4f28e591.0410041627.52c1ebc2@posting.google.com...
> http://www.healthsentinel.com/news.php?event=news_print_list_item&id=300
>
> Eric J. Topol, "Good Riddance to a Bad Drug", New York Times, October

> 2, 2004,
> Link: http://www.nytimes.com/2004/10/02/opinion/02topol.html?oref=login
>
> As the Vioxx debacle shows, we have a long way to go in this country

> to get on track with prescription medications. Most important, we need
> a stronger regulatory agency to compel pharmaceutical companies to do
> the proper studies and force these companies to stop
> direct-to-consumer advertising unless a drug has major benefits for
> patients and negligible increased risk of heart attacks and strokes.

Oh boy, good luck getting *that* out of the Bush administration....

Katherine



Re: Good Riddance to a Bad Drug OTP -- Posted by Harvey R. Stone on 10-10-04 14:19



"Katherine Wolfe" wrote in message
news:ckbrrj0n1q@enews1.newsguy.com...
>
> "Roman Bystrianyk" wrote in message

> news:4f28e591.0410041627.52c1ebc2@posting.google.com...
>> http://www.healthsentinel.com/news.php?event=news_print_list_item&id=300
>>
>> Eric J. Topol, "Good Riddance to a Bad Drug", New York Times, October
>> 2, 2004,
>> Link: http://www.nytimes.com/2004/10/02/opinion/02topol.html?oref=login
>>
>> As the Vioxx debacle shows, we have a long way to go in this country
>> to get on track with prescription medications. Most important, we need
>> a stronger regulatory agency to compel pharmaceutical companies to do
>> the proper studies and force these companies to stop
>> direct-to-consumer advertising unless a drug has major benefits for
>> patients and negligible increased risk of heart attacks and strokes.
>
> Oh boy, good luck getting *that* out of the Bush administration....

>
> Katherine


Shallow ideas as a response to a gov. agency that has bogged down with
protecting itself. Its not about administration. It is about what
happens to a gov. agency with time and layer upon layer of bureaucrats.
The same thing has taken place with NASA. The same thing has taken place
with the court system and judges that are not about existing laws but try to
make their own laws with their court.
Vioxx had high hopes for people who could not use a sulfa based drug
but needed a NSAID that did not eat holes in their stomach. It did that
but it also had its own side effects and had to be stopped. Blame the
present administration???? Too easy a reply and not one that will improve
the FDA.

Harv



Re: Good Riddance to a Bad Drug OTP -- Posted by Katherine Wolfe on 10-10-04 16:08



"Harvey R. Stone" wrote in message
news:THhad.3995$q%7.1952@newssvr11.news.prodigy.com...
>
> "Katherine Wolfe" wrote in message

> news:ckbrrj0n1q@enews1.newsguy.com...
> >
> > "Roman Bystrianyk" wrote in message
> > news:4f28e591.0410041627.52c1ebc2@posting.google.com...
> >>
http://www.healthsentinel.com/news.php?event=news_print_list_item&id=300
> >>
> >> Eric J. Topol, "Good Riddance to a Bad Drug", New York Times, October
> >> 2, 2004,
> >> Link: http://www.nytimes.com/2004/10/02/opinion/02topol.html?oref=login
> >>
> >> As the Vioxx debacle shows, we have a long way to go in this country
> >> to get on track with prescription medications. Most important, we need
> >> a stronger regulatory agency to compel pharmaceutical companies to do
> >> the proper studies and force these companies to stop
> >> direct-to-consumer advertising unless a drug has major benefits for
> >> patients and negligible increased risk of heart attacks and strokes.
> >
> > Oh boy, good luck getting *that* out of the Bush administration....
> >
> > Katherine
>
> Shallow ideas as a response to a gov. agency that has bogged down with

> protecting itself. Its not about administration. It is about what
> happens to a gov. agency with time and layer upon layer of bureaucrats.
> The same thing has taken place with NASA. The same thing has taken place
> with the court system and judges that are not about existing laws but try
to
> make their own laws with their court.
> Vioxx had high hopes for people who could not use a sulfa based drug
> but needed a NSAID that did not eat holes in their stomach. It did that
> but it also had its own side effects and had to be stopped. Blame the
> present administration???? Too easy a reply and not one that will
improve
> the FDA.

Well, Republicans generally and the Bush administration in particular
doesn't have much of a history of strengthening regulatory agencies. For ex
ample, the USDA had geared up to require stricter Listeria testing at meat
packing plants, but the executive order that required it was put on hold by
the Bush administration. OHSA was completing regulations requiring testing
of people who were regularly in contact with TB patients for TB, but the
Bush administration cancelled them. The EPA was investigating dozens of
coal-fired power plants for pollution that was illegal under regulations at
the time, but the Bush administration eased the regulation, and cancelled
the investigation.

These actions are a reflection of the philosophy of the administration
toward federal regulation in general. John D. Graham, who oversees federal
regulation for the Bush White House, said regulations are "a form of
unfunded mandate that the federal government imposes on the private sector
or on state or local governments."

It seems to me to be unlikely that any appreciable action will be taken to
stiffen regulations at the FDA by an administration that holds a philosophy
that is fundamentally inimical to regulatory interest, and that holds a
history of reducing regulations on industry in every agency. I'm not
blaming the Bush administration for the Vioxx debacle, however, I am saying
that we shouldn't expect to see much action to improve the FDA, if that
means they're going to actually increase regulation of drug companies.

Katherine




Re: Good Riddance to a Bad Drug OTP -- Posted by Harvey R. Stone on 10-10-04 17:24




I'm not
> blaming the Bush administration for the Vioxx debacle, however, I am
> saying
> that we shouldn't expect to see much action to improve the FDA, if that
> means they're going to actually increase regulation of drug companies.
>
> Katherine

>

Well said but changes nothing in what I said. I do not expect change from
either party until major changes are made in how things are done. I
really think that finding blame in this situation solves nothing. You say
it is not Bushes fault about Vioxx but you just did that.
Nothing is proven,,, nothing is changed,,,, no more to say.
Harv



Re: Good Riddance to a Bad Drug OTP -- Posted by Katherine Wolfe on 10-10-04 22:40



"Harvey R. Stone" wrote in message
news:npkad.2719$Lk3.2015@newssvr12.news.prodigy.com...
>
> Well said but changes nothing in what I said. I do not expect change from

> either party until major changes are made in how things are done.

What kind of changes do you think would help things? The article suggested
more regulation on consumer ads on prescription drugs, my understanding is
the AMA wants that too, but I'd be interested in hearing your ideas on the
subject.

> I really think that finding blame in this situation solves nothing. You
say
> it is not Bushes fault about Vioxx but you just did that.

Well, no, I really don't think it's Bush's fault - how do you know that
insufficient testing has been done until sufficient testing has been done?
I was saying that, if more regulation is the answer, don't hold your breath,
because that really isn't something that the Bush administration believes
in. My comment wasn't isn't so much about what has happened as it was about
how to prevent similar things from happening in the future.

Katherine


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