Vioxx & Celebrex

[Admin]

I had not paid a great deal of attention to the Vioxx withdrawal until the last few days as my email in-box was filling up with spam emails seeking participants in class action law suits .... trust lawyers to stoop to such tactics :mad:

Then a headline in this morning's papar caught my eye claiming that deaths from Vioxx could be in the 1000's :( - I fully understand that there is nothing like the truth to get in the way of a good story, so did some looking and found these very recent stories:

Vioxx recall sparks health safety concern, doctors say (http://www.alertnet.org/thenews/newsdesk/N19572511.htm)
Vioxx Pain Could Spread to Medco (http://www.thestreet.com/_googlen/stocks/melissadavid/10195259.html?cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA)
US drug agency accused on Vioxx (http://www.rte.ie/business/2004/1119/merck.html)
After Vioxx, Other Drugs May Also Get Pulled (http://www.wesh.com/health/3934487/detail.html)
Beyond Vioxx: 5 other drugs under FDA review (http://www.khou.com/news/local/stories/khou041119_jt_aftervioxx.729bf789.html)
Official Insists FDA Acted Appropriately With Vioxx (http://www.theiowachannel.com/health/3932752/detail.html)
FDA defends action on Vioxx and other drugs (http://rdu.news14.com/content/headlines/?ArID=59260&SecID=2)
Drug alarm grows (http://www.heraldsun.news.com.au/common/story_page/0,5478,11439689%255E662,00.html)
A drug company in for a little pain (http://www.journaltimes.com/articles/2004/11/17/local/iq_3219171.txt)
Another study on Vioxx emerges (http://www.iht.com/articles/2004/11/18/business/vioxx.html)
The Murky History of Merck's Vioxx (http://www.thestreet.com/_googlen/stocks/biotech/10195104.html?cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA)
NYT: Merck had earlier Vioxx info (http://edition.cnn.com/money/2004/11/18/news/fortune500/merck_vioxx.reut/)

All these stories were free access at the time of posting. Some news organizations require paid access to archives after a period of time.

[Admin]

VIOXX .... WOW!!! - in a matter of minutes of posting the above message, all the Vioxx adverts appeared at the top of the page via Google!!!! - this Vioxx issue certainly must be a money spinner for the lawyers!!! :eek: .... don't figure :confused:

[Admin]

Here is an eg of the spam flooding the in-box:
Over 85 million people who have taken this drug may be at
risk. Are you one of them? If so, YOU might be entitled to
monetary damages. Merck has withdrawn Vioxx(R) from the market
due to its use being linked to heart attacks, strokes, and
even death in some cases.
Fill out this form today to see if you are eligible for a
settlement. Takes only 45 seconds to fill out..... The FDA announced that Vioxx(R) hurt people
Merck knows that Vioxx(R) contributed to many health problems
including heart attacks and strokes. They still pushed the
drug. Are you one of those people who took Vioxx(R)? If so,
you may be entitled to a settlement: from getting money back
from your prescriptions to hundreds of thousands of dollars
in settlement. Fill out this form that takes only 45 seconds
for your free, no obligation evaluation.

[Admin]

News from British Medical Journal:
FDA is incapable of protecting US "against another Vioxx" (http://bmj.bmjjournals.com/cgi/content/full/329/7477/1253?etoc)
The approval of rofecoxib (Vioxx) by the US Food and Drug Administration has led to the "single greatest drug safety catastrophe in the history of this country or the history of the world," charged one of the agency's own experts, Dr David Graham, in US Senate hearings last Thursday Senator Charles Grassley, chairman of the Senate's finance committee, opened the hearings on the FDA and rofecoxib and its manufacturer, Merck, saying he hoped Congressional investigation would help shed "disinfecting sunlight" on the approval of rofecoxib by the FDA and its subsequent withdrawal by Merck on 30 September, when the company acknowledged that the drug carried "serious cardiovascular risks".
Senator Grassley charged that the FDA "has lost its way when it comes to making sure drugs are safe" and that its relationship with drug companies was "too cosy."Full story (http://bmj.bmjjournals.com/cgi/content/full/329/7477/1253?etoc)

[Admin]

Some new news stories on Vioxx:
Merck Resisted Tests on Vioxx-Aspirin Mix (http://www.rednova.com/news/display/?id=106105)
Loss of Vioxx Pains Erie, Pa.-Area Arthritis Patients (http://www.rednova.com/news/display/?id=105664)
Merck's Vioxx withdrawal illustrates power of regulation by trial lawyers (http://www.madisonrecord.com/arguments/argumentsview.asp?c=132747) :mad:
Vioxx scare an issue (http://www.times-journal.com/report.lasso?WCD=3070)

[Admin]

US drug regulator too close to pharmas: critics (http://story.news.yahoo.com/news?tmpl=story&cid=1507&ncid=1507&e=2&u=/afp/20041128/hl_afp/us_pharma_health_agency_041128203948)Doctors, lawmakers and even an official at the US agency that vets drugs before they are sold to the public say the Food and Drug Administration is too cozy with the companies it regulates and needs reform...Full story from Yahoo! News (http://story.news.yahoo.com/news?tmpl=story&cid=1507&ncid=1507&e=2&u=/afp/20041128/hl_afp/us_pharma_health_agency_041128203948)

[Admin]

Vioxx Critic Defends Self

From Forbes.com (http://www.forbes.com/2004/12/01/cx_mh_1201topol.html):

Eric Topol, chairman of cardiology at the Cleveland Clinic, was one of the leading voices challenging the safety of the arthritis drug Vioxx, which was eventually pulled from the market. That is why the news that he was acting as a consultant to a hedge fund that sold Merck short--essentially betting shares would fall--came as a shock.

Today, Topol explained his involvement with the investment fund via a prepared statement and an email.

Topol's first published criticisms of Vioxx occurred in the Journal of the American Medical Association in August 2001. He says he became an advisor for the investment fund, Great Point Partners, two years later in August 2003. The news was first reported by Fortune magazine.

In today's statement, Topol says that he was retained by Great Point Partners for a fee of $12,000 per year. However, he says, he never discussed Merck nor Vioxx with the fund, and had no knowledge that it was shorting Merck. Nor did he invest in the fund. Moreover, he says he has not seen marketing material referenced by Fortune that implied that he had helped the fund "get the jump" on its investing strategies--perhaps including Vioxx, and that he quit as soon as he heard about the potential conflict, on Oct. 28.Full story (http://www.forbes.com/2004/12/01/cx_mh_1201topol.html)

[Admin]

Merck Sued by New York Fund Over Vioxx (http://http://story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=10&u=/ap/20041201/ap_on_bi_ge/merck_lawsuit)
NEW YORK - The New York state comptroller sued Merck & Co., claiming the drug maker hid certain risks associated with the painkiller Vioxx.

Merck pulled its Vioxx pain medication from shelves Sept. 30 after a clinical trial showed patients taking the drug showed an increased risk for heart attacks and strokes after 18 months. The move came after several physicians and other studies raised concerns about the drug's potential health risks.

The company has been the subject of several investor lawsuits since it pulled Vioxx off the market, mostly because its stock has lost well over a third of its value since the recall. One of the losers has been New York state's pension fund, which has recorded $171 million in paper losses related to Merck, according to state Comptroller Alan G. Hevesi.
Full story from Yahoo! News (http://story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=10&u=/ap/20041201/ap_on_bi_ge/merck_lawsuit)

[Admin]

Celebrex Benefits From Vioxx Withdrawal (http://story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=20&u=/ap/20041130/ap_on_he_me/painkiller_sales)
WASHINGTON - Pfizer's Celebrex gained a majority of sales for new-generation painkillers in the month after Merck & Co. yanked Vioxx due to safety concerns, according to IMS Health, a pharmaceutical information company.

Pfizer's other cox-2 inhibitor, Bextra, gained fewer prescriptions in October, and in November confronted heightened scrutiny of its safety.

Merck faces a flood of lawsuits after Vioxx was linked to increased risk of heart attack and stroke and the company withdrew it from the market Sept. 30. Analysts estimate the company's legal liabilities could reach $18 billion.

In October, the first full month of data after the Vioxx withdrawal, sales of Celebrex topped $260 million, or 63.5 percent of the market for cox-2 inhibitors, according to IMS Health data. In September, Celebrex had accounted for 48.7 percent of the market for the new-generation painkillers.
Full story from Yahoo! News (http://story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=20&u=/ap/20041130/ap_on_he_me/painkiller_sales)

[Admin]

Celebrex Linked to Heart Attacks
Celebrex more than doubled heart attacks in people enrolled in a cancer-prevention study, Celebrex maker Pfizer said today.

Celebrex is in the same family of drugs as Vioxx. Vioxx recently was pulled from the market after a colon-cancer prevention trial found it increased the risk of heart attacks.

Pfizer also makes Bextra, another drug in this Cox-2 family of drugs that may have heart risks. Full story (http://my.webmd.com/content/article/98/104848.htm)

[pgcarter]

Only Celebrex at high doses, I believe.

[Admin]

Clinical trial links Celebrex to heart risk (http://www.freep.com/news/health/pfizer18e_20041218.htm)
Pfizer says there's not enough proof to pull drug off market (http://www.freep.com/news/health/pfizer18e_20041218.htm)
December 18, 2004


In an announcement that many doctors were waiting for, Pfizer Inc. said its top-selling painkiller Celebrex -- which is similar to Vioxx -- caused an increased risk of heart attacks when used in high doses during a clinical trial.

But Pfizer said it has no plans to take Celebrex off the market. The U.S. Food and Drug Administration has not made a decision about the drug but expects to do so in the next few days.
The news worries Jane Ramsden, 52, of Troy, who calls Celebrex a "wonder drug."



"It broke my heart because it's been the greatest drug," she said.



Ramdsen's podiatrist prescribed Celebrex for a constant sharp pain in her heel a year and a half ago. The pain went away almost immediately after taking the drug, she said. Full story (http://www.freep.com/news/health/pfizer18e_20041218.htm)

[Admin]

The lastest Journal of the American Medical Association has this:
Arthritis Medicines and Cardiovascular Events—"House of Coxibs" (http://jama.ama-assn.org/cgi/content/full/293.3.366v1?etoc)

[Admin]

From the latest British Medical Journal:
Warnings issued over COX 2 inhibitors in US and UK (http://bmj.bmjjournals.com/cgi/content/full/330/7481/9-c?etoc)

[Admin]

Reuters are reporting:
New prescriptions for Pfizer Inc.'s COX-2 inhibitor Celebrex (celecoxib) fell 56% last week after the company released data showing the drug may increase the risk of heart attacks and strokes, according to Verispan, a market research company.
New prescriptions for naproxen fell 33% in the week ending Dec. 24 after the National Institutes of Health linked it too to possible heart risks.Full story from Medscape (http://www.medscape.com/viewarticle/496756)

[Admin]

A letter to the editor in the latest MJA argues that:
All COX-2-selective drugs should be removed from the market until they have been properly evaluated.
Full letter (http://www.mja.com.au/public/issues/182_04_210205/matters_arising_210205_fm-1.html)

[Admin]

Medscape have this discussion:

What Are the Options Available for Anti-inflammatory Drugs in the Aftermath of Rofecoxib's Withdrawal? (http://www.medscape.com/viewarticle/500056)

Registration (free) is required to access it.

[pgcarter]

Glucosamine sulphate.....or Diclofenac sodium (Cox 1 and Cox 2 pathway) if it has to be trad NSAID...as long as it is tolerated. Constant use is a problem of course. When used to take the top off a spike of activity over shorter periods this is probably less of an issue.
Regards Phill

[Admin]

From latest Canada Medical Journal:

New restrictions on celecoxib (Celebrex) use and the withdrawal of valdecoxib (Bextra) (http://www.cmaj.ca/cgi/content/full/172/10/1299)

[Admin]

I will bump this old thread with this story for the Canadian Medical Journal

Vioxx award good news for Canadian lawsuits (http://www.cmaj.ca/cgi/content/full/173/7/744)

A Texas jury's decision to award US$253 million to a widow who sued pharmaceutical giant Merck & Co.

[Craig Payne]

OK ... I going to stick my neck out here and get on my soapbox... :D

I think juries in the US that award damages are thick (as we would say back in NZ "thick as pig****" --- for those that do not know, pig**** can be thick).

Some basic epidemiology....
Say, for eg, the risk for developing a fatal heart attack at age X is 1:50 000
If you take Viozz that risk is increased to, say for example, to 3:50 000

THATS NOT CAUSATION, THATS AN INCREASE IN RISK. :eek:

Why are the juries so thick that they not grasp this basic epidemiology!!!!

Look how wrong they got it with the silicone breat implants and connective tissue disease. A company went bankrupt over this, jobs were lost, bottom dwelling lawyers got rich .... but now we know (as the good science has been done) that there is NO increased risk for connective tissue disease from the use of silicon breast implants ---- those bottom dwelling lawyers that litigated these cases should be force to pay all the money back. :p