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November 23, 2004

Vioxx Shows: FDA Unable To Protect Public From Deadly Medical Drugs

According to recent congressional testimony, "the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenceless," said David Graham, associate director of the agency's Office of Drug Safety. The quote is from an article published in South Africa, titled Doctor: FDA is too cosy with drug firms.

The FDA is the national food and medicines regulatory agency of the US but it has been held in high esteem in countries world wide, where drug safety is the issue. So much so, that many drugs are approved around the world as if by an invisible domino effect. Once the FDA gives it the green light, there are rarely questions about approving the same drug in the majority of other countries.

Might those national health agencies have been wrong in taking the FDA's word on drug safety? How many drugs have been approved all over the world that are essentially worthless and damaging to boot? No one knows, but it is time to find out.

Why we can't trust the FDA's judgement on drug safety is really a question of how the agency is organized. The office of approval of new drugs is a pharmaceutical company playground - it's closely aligned with the (commercial) interests of the pharmaceutical producers. That could be expected in a profit based economy, but unfortunately the FDA's office of drug safety is located in the same department, but in a junior position to the new drugs office. Needless to say, conflict of interest abounds. Unsafe drugs are both approved and kept on the market against all accumulating evidence of harm.

Only in the rarest of cases however are we afforded a view of these mechanisms. The current investigation into the withdrawal of the Merck pain drug Vioxx and the ensuing investigation opens such a window into the real world of drug regulation. In an insightful comment, Joseph Kay has put together some of the information that is emerging about the FDA's organization and the drug firm's undue influence on the approval and general on the drug regulatory process...

.

The Vioxx scandal: damning Senate testimony reveals drug company, government complicity

By Joseph Kay
22 November 2004

(see the original here)

Several scientists testifying before the Senate Finance Committee on November 17 provided substantial evidence that the drug company Merck and the US Food and Drug Administration (FDA) knew of safety problems years before the drug Vioxx was withdrawn from the market.

Vioxx, which was used to treat arthritis and severe pain, was withdrawn by Merck on September 30 after conclusive evidence emerged that it greatly increased the risk of heart attacks and strokes. Some 80 million prescriptions of the drug have been filled around the world, most of them in the US, since it was approved in May 1999.

The principal testimony was given by Dr. David Graham, the associate director for science and medicine at the FDA’s own Office of Drug Safety. The ODS, responsible for monitoring the safety of drugs already on the market, is part of the Center for Drug Evaluation and Research (CDER), which also includes the Office of New Drugs (OND), responsible for approving new drugs for the market. Graham explained how he came into repeated conflict with the OND as he sought to raise concerns about the safety of Vioxx.

The OND is one of the branches of the FDA that is most closely tied to the giant drug companies it is nominally responsible for regulating. Since passage of the 1992 Prescription Drug User Fee Act, the office gets much of its funding directly from drug companies, in the form of new drug application fees of more than $500,000 per application. Most of this money goes toward speeding up the approval of new drugs.

Graham explained that the OND, which has a higher position in the FDA hierarchy than his ODS, is generally very reluctant to issue new regulations for drugs already on the market or order mandatory withdrawals of unsafe drugs that the office has approved. In the case of Vioxx, the drug was pulled from the market only after its producer, Merck, decided that the evidence of harmful consequences was overwhelming. It was not withdrawn as a result of any regulatory action by the FDA.

A study led by Graham that was concluded in the summer of 2004 found that Vioxx was responsible for an estimated 38,000 excess heart attacks and sudden cardiac deaths. In his testimony, Graham stated that this was a conservative estimate. He said that “a more realistic and likely range of estimates for the number of excess cases in the US” was between 88,000 and 139,000. “Of these,” he added, “30-40 percent probably died. For the survivors, their lives were changed forever.”

To dramatize the number of people affected, Graham noted that “this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past five years.”

Graham testified that as his team concluded its study and prepared to present its results, it was attacked by the Office of New Drugs and other sections of the FDA. “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present” the paper reporting his study’s conclusions. “An email from the director for the entire Office of New Drugs was revealing. He suggested that since FDA was ‘not contemplating’ a warning against the use of high-dose Vioxx, my conclusions should be changed.”

Up to a week before the drug was pulled from the market by Merck, FDA management, according to Graham, was attempting to undermine Graham’s conclusions.

Graham said, “[W]e are virtually defenseless” against another catastrophe on the scale of Vioxx. “The organization structure within CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is ‘safe and effective.’ When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat.... At the same time, the Office of Drug Safety has no regulatory power and must first convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done.”

The prevailing sentiment at the FDA, said Graham, is one that views “the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the dugs it approves, and seriously under-values, disregards and disrespects drug safety.” When it comes to drug safety, he said, the operating principle is that the drug is safe unless it is proven to be unsafe beyond a shadow of a doubt. New drugs, including Vioxx, are pushed through the approval phase in a matter of months, before sufficient tests are done to ensure their safety. Independent clinical testing is rarely carried out by the FDA, and indications of safety problems are ignored or deliberately undermined.

Later, Graham pointed to five drugs currently on the market that he felt were potentially dangerous: Acutane, which is used to treat acne; Bextra, a painkiller; Crestor, used to lower cholesterol; Meridia, used to treat weight loss; and Serevent, used to treat asthma. All of these can cause dangerous side effects and have not been adequately tested for their safety, Graham asserted.

Others providing testimony included Gurkirpal Singh, from the Stanford University School of Medicine, and Bruce Psaty, co-director of the Cardiovascular Health Research Unit at the University of Washington. The two scientists reviewed some of the history of the testing of Vioxx and concluded that, even with the limited data available, the drug should have been pulled from the market well before it was eventually withdrawn.

Singh noted that there was evidence of serious heart problems associated with Vioxx before it was approved in 1999. “In 1998, Dr. Doug Watson, a Merck scientist, presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs. This analysis concluded that men taking Vioxx had a 28 percent greater risk (not statistically significant), but in women, the risk was more than double (216 percent, statistically significant) compared to people not taking any drug in other Merck studies. To the best of my knowledge, these data were never made public.”

Merck has continually asserted that at the time of Vioxx’s approval, no evidence existed indicating that the drug caused additional heart attacks. The main study carried out by Merck, known as VIGOR, showed a fivefold increase in serious heart conditions relative to another drug, naproxen (the generic form of Aleve). Merck explained these results as a consequence of naproxen’s beneficial effects, rather than Vioxx’s harmful ones. However, in 1999 a scientist at the FDA remarked that “thromboembolic events [such as heart attack and stroke] are more frequent in patients receiving Vioxx than placebo.” Singh noted, “This meant that not only did Vioxx not [have the benefits of naproxen], but for some reason, it was likely to promote heart attacks directly.”

The evidence was still limited, Singh said. “There were not adequate data to make a firm conclusion one way or another. In fact, the FDA reviewer went on to point out that ‘[w]ith the available data, it is impossible to answer with complete certainty whether the risk of cardiovascular and thromboembolic events is increased in patients on rofecoxib [Vioxx]. A large database will be needed to answer this and other safety comparison questions.’ ”

Instead of carrying out a larger study, the FDA quickly approved the drug for use. This was in spite of the fact that the drug served no pressing necessity. There were already drugs on the market that performed the same function as Vioxx: to relieve inflammation without causing stomach problems. The FDA did not even require a caution on the drug’s label about the increased risk of hear attacks until April 2002.

Nor did Merck attempt a larger study. The New York Times reported on November 14 that such a study was contemplated in May 2000, but management rejected the idea. According to the Times, a slide prepared for an executives’ meeting stated, “At present, there is no compelling marketing need for such a study.... The implied message is not favorable.”

In their defense, Sandra Kweder, the deputy director of the Office of New Drugs, and Raymond Gilmartin, chairman and CEO of Merck, simply repeated the claim that everything was done to determine the safety of Vioxx as quickly as possible, and that the drug was immediately withdrawn as soon as safety problems became evident. The overwhelming evidence indicates the opposite: that tens of thousands of deaths likely caused by use of Vioxx were entirely preventable.

Here is a report from the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.ahrp.org

The Chicago Tribune reports (below) about an eggregious example of the abuse of power by FDA officials who are retaliating against an independent scientist whose unique research project for detecting rare adverse drug reactions has uncovered potentially fatal side effects of 17 currently marketed drugs.

Dr. Charles Bennett, a Northwestern University researcher, has developed a proactive method for detecting adverse drug effects by examinning adverse drug reports submitted to FDA's database and reports from reports by phamaceutical companies and independent groups of researchers thoughout the US and Canada. The project is called the Research on Adverse Drug Events and Reports (RADAR).

For example, Dr. Bennett discovered that the widely used anti-clotting drug, Plavix, can cause "a catastrophic collapse of the blood system." He urged the FDA to issue Black Box warnings, but the FDA refused, but did add a less prominent warning.

Dr. Bennett published a paper in the journal Stroke (February) in which he compared the effectiveness of various systems for detecting adverse drug effects. The FDA system ranked at the very bottom:

"The study assessed how the FDA, Plavix's manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent."

The Tribune reports that The FDA retaliated against Dr. Bennett for publishing the results by cutting off his access to FDA's post marketing surveillance databaseóas if the agency were a private contractor. FDA's Christine M. Bechtel wrote:

"While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your groups special status."

FDA officials forget that they are public servants who have an appalling record on drug safety issues. Their failure to develop a viable tracking system for adverse drug effects has resulted in a health crisis due, largely to the agency's failure to put safety as the top priority.

Dr. Bennett notes: "Half of the drugs prescribed today are being used in situations where we don't have a good handle on whether they're either safe or effective, and that's a big problem," Bennett said.

Whether it is because of a culture of arrogance, or incompetence, or bad faith, FDA policies keep physicians and the public in the dark about adverseóeven lethalódrug effects.

Ref: In the Dark About Drugs, Los Angeles Times editorial, February 19, 2005


Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org


CHICAGO TRIBUNE

FDA cut off critic's access to drug database


By Ronald Kotulak
February 20, 2005

Over the last five years, a Northwestern University researcher has used information from the U.S. Food and Drug Administration--along with adverse drug reports from pharmaceutical companies and independent groups--to uncover potentially fatal side effects for 17 drugs.

One of those drugs is Plavix, an anti-clotting agent that has been given to more than 41 million patients worldwide since 1998. A group led by Dr. Charles Bennett reported in 2000 that in rare circumstances the drug can cause a catastrophic collapse of the blood system, leading the FDA to require the manufacturer to add a warning label.

Early last year, however, Bennett wrote another article giving the FDA a failing grade on post-marketing drug safety. Nine months later, the agency cut off his special access to its adverse drug reaction database.

Critics call the FDA's action another misstep that reveals the agency's shortcomings in monitoring drugs after they have been approved, thereby putting many patients at risk for adverse drug reactions.

One such patient was Marion Rao, an energetic 78-year-old from Manhattan who loved to travel. Last May she had a routine stent put in to open a blocked coronary artery. She also was prescribed Plavix.

What happened to her next was not routine. Rao went downhill. Bruises began appearing on her skin, a sign of internal bleeding.

"It was very difficult to see the doctor," said Rao's daughter, Joanne Perrotta. "They kept putting us off. When I did go see them, they made her see the nurse practitioner who looked at the blotches on her leg and said, `Oh it's nothing.'"

When Rao was finally admitted to the hospital, her daughter recalled, the doctor on call said: "Plavix. It's TTP." That stands for thrombotic thrombocytopenic purpura, the scientific name for the meltdown of her blood system. Other doctors disagreed. Three weeks after receiving Plavix, Rao died.

All drugs have potential risks, but some risks only become apparent when thousands, even millions of patients, have used a drug. The problem is that the FDA does not have an effective system for monitoring complications from drugs after they've been approved, according to many authorities.

Reporting adverse reactions is voluntary, and most doctors don't bother to document problems, often because the process is time-consuming, and they are wary that the records could be used in malpractice suits.

The FDA can ask pharmaceutical companies to conduct trials to determine the safety of a drug when questions arise, but there is little enforcement. And half of such trials sought by the agency have not even been started.

The result is a gross underreporting of adverse drug reactions. The FDA receives about 350,000 to 400,000 adverse drug reports each year, but this represents only 3 to 10 percent of the actual number, experts estimate. An estimated 100,000 people die annually from drug reactions.

The drug surveillance program operated by Bennett, of Northwestern's Feinberg School of Medicine and the Jesse Brown VA Medical Center, is an effort to prevent some of the potentially deadly reactions. His program and several other independent ones are funded by the National Institutes of Health.

Called the Research on Adverse Drug Events and Reports (RADAR), Bennett's project is a collaboration of researchers from around the U.S. and Canada who actively look for the most serious drug reactions, ones that cause organ failure or death.

Plavix's side effects, for example, were uncovered after Bennett organized 20 blood banks nationwide to be on the watch for blood disorders that might be linked to drugs. The drug has proved beneficial to many patients, but it should contain a stronger warning of possible adverse reactions, Bennett contends.

Bennett originally asked the FDA to require a black box warning on the label, the agency's strongest. The FDA, however, declined, saying that a regular cautionary note was sufficient since the life-threatening side effect was too rare to warrant a black box.

Though FDA officials have praised Bennett's efforts to discover drug problems, he apparently raised the agency's ire in a paper published in February in the journal Stroke. The study assessed how the FDA, Plavix's manufacturer and RADAR pursued adverse drug reports, documented the side effects and assessed patient outcomes over a four-year period. Basically it was a report card, and RADAR scored 92 to 100 percent; drug companies, 8 to 58 percent; and the FDA, 0 to 23 percent.

The FDA "did terrible. They flunked, and the drug companies didn't do much better," Bennett said. "The system is broken in many ways, and safety is on the bottom of their lists."

Bruce Lambert of the University of Illinois at Chicago's College of Pharmacy said restricting access to the FDA's post-marketing surveillance reports is "a bad idea."

"These reports should be wide open, especially to people like Dr. Bennett who are devoted to trying to understand adverse events," he said.

In notifying Bennett of the cutoff, the FDA's Christine M. Bechtel wrote: "While we have valued our relationship with you in the past, the thousands of requests we receive annually make it impractical and unfair to afford you and your groups special status."

Reacting to mounting criticism, the FDA on Tuesday said it will establish a new independent Drug Safety Oversight Board to monitor medicines once they're on the market and alert doctors and patients to any risks. Critics quickly pointed out that the board would be advisory and would not have the power to withdraw a drug.

Another major problem facing the FDA is the lack of a system for tracking adverse drug events for the 50 percent of medications that are used off label. Once a drug is approved, physicians can prescribe it for conditions for which it was not originally approved, but the drugs are usually not tested for safety in such off-label uses.

"Half of the drugs prescribed today are being used in situations where we don't have a good handle on whether they're either safe or effective, and that's a big problem," Bennett said.
Copyright © 2005, Chicago Tribune

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

See also related:


Scientist raises estimate of Vioxx ill-effects

Boston Globe: Calls are mounting for revamp of FDA

Forbes Magazine: Face Of The Year: David Graham

Scientist says FDA system 'broken' - Doubts agency ability to stop another Vioxx

JAMA Proposes Independent Drug Safety Board

November 23, 2004 - Report: Bayer Held Back on Drug Dangers
Another pharmaceutical company may have concealed safety information about a dangerous drug - this time Bayer and its once-popular cholesterol medication Baycol - according to a report in a prominent medical journal. Baycol was pulled from the market in 2001, but an analysis released Monday by the Journal of the American Medical Assn. argued there were strong indications of its dangers three months after its introduction in 1998.

Bad medicine
There ought to be a special place in hell for companies like drug giant Merck, whose painkiller Vioxx may have killed 55,000 people.
By Arianna Huffington. You will have to watch an ad before you get to the article, but I recommend. It's a good read - if only to confirm that health is becoming a mainstream political concern...
A quote:
If Democrats want to appeal to voters who believe in promoting what the president calls "a culture of life," they should make it a priority to put an end to the kind of corporate behavior that promotes a culture of death.

Consumers Union - Prescription for Change - Campaign to stop Drug Companies from Hiding Study Results!
The removal of arthritis drug Vioxx from the market is the latest example of the need to overhaul our drug safety system -- and the role the powerful pharmaceutical industry plays in the process.
Reports show that drug maker Merck may have known about the heart attack risk of Vioxx as early as 2000 from a clinical trial. The Food and Drug Administration often has access to drug safety risks, but does not make them public -- keeping researchers, doctors and patients in the dark. Recent testimony by an FDA staffer raised potential safety concerns with several other widely-prescribed drugs.
It's time to stop the blame game and protect consumers. Clinical trials should be made public so important safety information is available to everyone and drug advertisements are clear about potential harmful side effects. We also should study the cost-effectiveness of new drugs.
Act Now! Send a message to your representatives to support a mandatory clinical trial registry.

FDA Chooses Drug Industry Health Over Public Health
by Ritt Goldstein - Commondreams.org
The U.S. Food and Drug Administration (FDA) is supposed to ensure the safety and quality of drugs reaching the public, acting on the taxpayers' behalf. As of Friday (February 18), an extraordinary three-day FDA Advisory Committee meeting is finishing, but investigation suggests business interests have superseded public health at the agency.

Boston Globe: What ails the FDA? Payola
By Marcia Angell - March 10, 2005
LET'S FACE it. The FDA is doing a poor job of ensuring that prescription drugs are safe and effective. It approves drugs that offer only minimal benefit, and then sometimes leaves them on the market long after they've been shown to be dangerous.

New York Times: April 24, 2005
Evidence in Vioxx Suits Shows Intervention by Merck Officials

In 2000, amid rising concerns that its painkiller Vioxx posed heart risks, Merck overruled one of its own scientists after he suggested that a patient in a clinical trial had probably died of a heart attack.

In an e-mail exchange about Vioxx, the company's most important new drug at the time, a senior Merck scientist repeatedly urged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the Food and Drug Administration and in a paper published in 2003, Merck listed the cause of death as "unknown" for the patient, a 73-year-old woman.

The discussion of the death is contained in several previously undisclosed Merck records, including e-mail messages from Dr. Edward M. Scolnick, Merck's top scientist from 1985 until 2002, and from Dr. Alise S. Reicin, a vice president for clinical research, that indicate Merck's concerns about data contradicting its view that Vioxx was safe.

In one e-mail message, Dr. Scolnick said the drug trial that included the woman's death had "put us in a terrible situation." In others, he fiercely criticized the F.D.A. and said he would personally pressure senior officials at the agency if it took action unfavorable to Vioxx. As lawsuits against Merck over Vioxx move toward trial, the documents could help plaintiffs paint a picture of the company that is at odds with Merck's public statements that it had no evidence of Vioxx's cardiac risks until last fall.

Doctors Sue Merck Over Vioxx Animal Tests
WASHINGTON, 14 July 2005 ó In a lawsuit to be filed this week, the Physicians Committee for Responsible Medicine (PCRM) and plaintiff Nancy Tufford allege that Merck wrongfully relied on animal tests that showed Vioxx to be safe while setting aside mounting evidence that Vioxx increases risk of cardiac events in human patients. PCRM has obtained previously undisclosed Merck data that form one of the cornerstones of the legal challenge.

The FDA, Vioxx, and crimes against humanity

No Cardiovascular Studies Done on Vioxx Before Launching It

August 2005: First Vioxx Verdict A Big Defeat For Merck

Merck faces huge bill after widow wins $250m Vioxx claim

Investigation: Victims of drug that took a hidden toll

The Boston Globe: Lessons from Vioxx
December 19, 2005
MERCK PHARMACEUTICAL company took the pain reliever Vioxx off the market more than a year ago, after a clinical study found that it caused heart attacks. And now instead of helping people with chronic pain, it is the subject of thousands of lawsuits contending that it helped to kill them. The drug might be doing some good in limited use today, if only the Food and Drug Administration had slowed the approval process enough for the data about danger to catch up with the marketing hype...

Merck loses key US Vioxx lawsuit
The jury awarded $18m to Frederick Humeston, who suffered a heart attack after taking Vioxx for knee pain, and a further $2m to his wife. This was the second case brought by Mr Humeston after an earlier suit failed. Fresh evidence on the dangers of Vioxx prompted the new trial. The jury in the second case found that Merck had failed to provide adequate warnings about the health risks associated with Vioxx.

Vioxx Caused Heart Attacks In Two Weeks!
This is one study many people have been waiting three years to see - except Merck people. Known as Victor, the study suggests that increased heart risks associated with Vioxx began immediately after people took the painkiller. That contradicts Merck's assertion, since it withdrew Vioxx in September 2004, that the drug caused serious heart risks only after 18 months of use.

 


posted by Sepp Hasslberger on Tuesday November 23 2004
updated on Friday December 10 2010

URL of this article:
http://www.newmediaexplorer.org/sepp/2004/11/23/vioxx_shows_fda_unable_to_protect_public_from_deadly_medical_drugs.htm

 


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October 07, 2004 - Sepp Hasslberger

Furberg Says Bextra Similar to Vioxx - Fired From FDA Panel
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FDA Waffles Over Antidepressants Causing Suicides
According to an article in the New York Times, officials of the FDA are now acknowledging that antidepressants do cause children and teenagers to become suicidal, but the FDA is not taking the steps it should - ban the drugs for use in children, as the UK has already done. The major preoccupation seems to be that if antidepressants are removed or carry strong warnings, there is nothing left to... [read more]
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FDA - Monsanto: dangerous relations
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Most Pain Killers Deplete The Body Of The B Vitamin Folic Acid
With all negative news concerning Non Steroidal Anti Inflammatory Drugs (NSAID's) and the Cox 2 inhibitors Vioxx, Celebrex and Naproxin, it is notable that all the experts - doctors and pharmacists - have failed to mention one salient fact. All of these drugs, including the oldest pain killer Asprin, deplete the body of the B vitamin Folic acid. Folic acid is one of the most common vitamin deficiencies and... [read more]
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$1.2 billion to buy the FDA? What you say never - well read the following. This is yet again proof that the governments work for the industry under the pretense of looking after our interests. Most new drugs are produced with expediency at the expense of safety and efficacy. Frequently they are not as effective as the older one's that they may be replacing... Secrecy & Conflict of Interest Why... [read more]
August 26, 2004 - Chris Gupta

 

 

 


Readers' Comments


I would add Zelnorm to the list of potentially-dangerous pharmaceuticals, because in some women it has caused Ebola-like symptoms. It is really scary how "mainstream medicine" has become so dysfunctional under bureaucratic and corporate influences. You see so many drug ads, often times simultaneously with ads from lawyers representing those damaged by comparable drugs! We should make some real core reforms to put consumers and doctors back in charge of health care, moving to a more integrative model that melds all the best healing methods into a harmonic whole.

Posted by: Visionaerie on November 25, 2004 02:04 AM

 


A comment received by email which I would like to share with readers as the article that came with it is very well written...


I thought you might be interested in this article I received as a newsletter from financial site 'Hemscott', which gives a another perspective on the pharma industry and their dubious relationship with the FDA.

Best wishes - D



Big pharma has taken a big hit following the extraordinary allegations in recent days of serious shortcomings at the US Food and Drug Administration, including that its relationship with drug companies is far too cosy.

An FDA insider, David Graham, lit the touchpaper by claiming the body failed to act quickly enough on concerns about suicide risk among children taking certain antidepressants. The body was also slow to move on worries about the safety of Merck's arthritis medication Vioxx, he says, adding that his research led him to estimate that Vioxx hurt 88,000 to 139,000 Americans, with 30-40% of them dying. Vioxx was pulled from the market in September.

Graham went on allege that five other prescribed drugs, including GlaxoSmithKline's asthma treatment Serevent and AstraZeneca's cholestrol-lowering drug Crestor also posed serious health risks.

Graham cannot be easily dismissed. He has been at the FDA for 20 years and is an associate director of its Office of Drug Safety. The FDA has sought to distance itself from his comments but that appears only to have riled Graham even more. We have a system that is biased towards approving drugs almost regardless of the safety, he said in an ABC Nightline interview on Tuesday, adding that any reason will be looked for to approve a drug, unless there is an overwhelming safety reason not to approve a drug.

Before the FDA and drug industry had the time to reel, never mind recover from Graham's attack, a series of articles and commentary, also highly critical of the FDA and drug companies, appeared in the influential Journal of the American Medical Association (JAMA). The articles raise a number of concerns about drug approval and monitoring and some of the statistics flung at the two parties look quite damning.

JAMA says for instance that the FDA has decreased drug approval times from 27 months in 1993 to 14 months in 2001. Meanwhile the drug recall rate has leapt from 1.56% for the period 1993 to 1996 to 5.35% for 1997 through to 2001.

Other major concerns highlighted by JAMA include the danger of a conflict of interest from the FDA being responsible for both pre- and post-marketing surveillance systems for prescribed drugs. These, it says, need separating with the creation of an independent unit for post-marketing surveillance.

No drug is completely safe and all have some toxic effect. One cannot therefore overestimate the crucial role the FDA plays, or is supposed to play, as the world's premier drug assessor and regulator, in balancing risks against benefits of treatments on behalf of the public. That reputation has been dented this week. The accusations flung at the FDA are all the more shocking considering the venerable history of the FDA, which in its modern form will be 100 years old in 2006.

It would be surprising, despite its distancing from Graham's criticism, if the FDA did not act at all on some of the concerns, especially those relating to conflicts of interest. An intense period in which it will be under heavy scrutiny lies before it.

Big pharma's woes also look set to continue as the sector looks to reassure an increasingly worried public. That task will not be made any easier by GlaxoSmithKline being currently at the centre of a probe by the UK Medical and Healthcare Products Regulatory Authority (MHRA) for allegedly failing to reveal trial data showing its antidepressant Seroxat did not work in children.

In an echo of the charges levelled at the FDA, the MHRA has been accused of having ignored vital safety data on Seroxat for many years. There are concerns that it also has been too close to the industry, resulting in conflicts of interest. The MHRA report on GSK may be published before the end of the year although a Department of Health spokeswoman said earlier this week that no date has been set yet and the investigation was ongoing.

With such a saga going on then it is not perhaps surprising Hollywood is looking to muscle in on the act with controversial film-maker Michael Moore, whose documentary work includes Bowling for Columbine and Fahrenheit 9/11, said to be working on a critical film about the health industry, apparently titled Sicko. Moore, whatever your views about his work, is rather adept at generating publicity and his 'Sicko' project promises to further ensure the drug industry's shortcomings remain high profile. Lets hope the industry and regulators do not provide him with the ammunition to make a sequel.


Posted by: Sepp on November 27, 2004 06:00 PM

 


A comment from Betty Martini of Mission Possible, regarding Vioxx and similar drugs and their interaction with the poisonous sweetener Aspartame. The comment was to my sending a copy of the excellent piece about Vioxx written by Arianna Huffington, which appeared on Salon.com (I added some links to Betty's email):


Date: Sun, 28 Nov 2004
From: "Dr. Betty Martini"
Subject: Vioxx, Merck and Arianna - and aspartame


Remember that Merck are the people who in their home edition of the Merck Manual says to take aspartame in pregnancy when they know it can kill the baby or cause birth defects. I sent them twice the articles, Aspartame Murders Infants, Genocide by James Bowen, M.D., Dr. H. J. Roberts position paper on aspartame and pregnancy and Dr. Louis Elsas testimony before Congress on how aspartame causes birth defects and mental retardation. (www.mpwhi.com/main.htm) Headache is #1 on the FDA list of 92 symptoms and yet Merck makes a product for headache and puts aspartame in the product. Why do you have to sweeten a pill? If someone wanted to make a case that Merck was working to reduce population the evidence would show they have no defense.

Dr. James Bowen recently wrote an article on the interaction of Vioxx and aspartame which 70% of the population is using and 40% of the children. He says when something damages the mitochondria or life of the cell like aspartame it probably would interact with all drugs. It was criminally approved as an additive when in fact they knew it was a neurotoxic drug. The law states that an additive must be inert or non-reactive and aspartame is about as inert as nitroglycerin. Dr. H. J. Roberts medical text (Aspartame Disease: An Ignored Epidemic, www.sunsentpress.com or 1 800 827 7991 ) has a large chapter on aspartame and the drugs we know it interacts with such as insulin, all antidepressants, all cardiac medication, hormones, L-dopa, anti-seizure medication such as Dilantin, Lidocaine, etc. We know this because these drugs have been used to treat some of the problems aspartame triggers such as Parkinson's, diabetes, seizures, behavioral and psychiatric problems, for starters. Other reactions are listed in Dr. Russell Blaylock's books (www.russellblaylockmd.com) .

Attorney Keith Silverstein (ksilverstein@shslawpro.com) is taking the Vioxx cases as well as Celebrex and Bextra. The most horrendous reactions that we have received have involved Celebrex in those using aspartame.

To make matters worse aspartame is a chemical hypersensitization agent that triggers polychemical sensitivity syndrome and interacts with other unsafe sweeteners such as Sucralose or Splenda which is a chlorinated hydrocarbon, acesulfame potassium, and even vaccines and genetically engineered foods. Four support groups on line currently handle the sick and disabled on aspartame. Lawsuits continue to be filed.

Wake up FDA! Eventually people are going to start calling the FDA the Food and Death Association. If you can't do your job and prevent approval of poisons, and continue to lie to the public and refuse to recall them, close your doors forever.

The Center for Disease Control did one of the most damning investigations on aspartame ever done and then put on their web site a summary that contradicts the investigation. The actual 146 page investigation is on http://www.dorway.com/cdctext.txt. This is discussed in the new movie, Sweet Misery: A Poisoned World (contact cori@soundandfuryproductions.com) Attorney James Turner is also in the movie and tells the incredible political clout that caused the approval of aspartame when the FDA said it wasn't safe and to revoke the petition for approval. Consider that the FDA is constantly approving poisons and even Richard Horton, Editor of the Lancet said they endanger the lives of the people and take money from industry. Yet aspartame is so poisonous that even the FDA said no and tried without success to have the original manufacturer indicted for fraud. Unfortunately, the pharmaceutical industry is so powerful with bottomless checkbooks because of gouging the public for drugs, they bought the U.S. Prosecutors. Both of them, Sam Skinner and William Conlon hired on with the defense team and the statute of limitations expired. Now the FDA without blinking has approved Neotame and the manufacturer has applied for an extended patent. Because of a little known case, the fact that the FDA rebirthed the toxin aspartame, the statute of limitations can now be eliminated on aspartame with an informant. And US Attorneys can be called in. The whistle blower can remain anonymous and receive quite an amount, while doing a great service to the people of this nation and the world.

The point of all this is NO DRUG IS SAFE AS LONG AS ASPARTAME IS ON THE MARKET!

All my best,
Betty
www.mpwhi.com/main.htm and www.wnho.net

Dr. Betty Martini, Founder, Mission Possible Intl, 9270 River Club Parkway, Duluth, Georgia 30097 770 242-2599 www.mpwhi.com/main.htm and www.wnho.net
Date: Sun, 28 Nov 2004 19:56:48 +0100


Posted by: Sepp on December 1, 2004 06:46 PM

 















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