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The Bush FDA: Profits Before People


Lucky
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Where was the FDA when the data became available showing the danger of the arthritis drug Vioxx? Concerns have arisen over whether the federal agency has become too beholden to pharmaceutical companies that donate big bucks and provide them a revolving door.

http://story.news.yahoo.com/news?tmpl=story&cid=533&e=2&u=/ap/20041002/ap_on_he_me/fda_drug_safety

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Much as I'd love to pin this on Bush, I think Vioxx was approved towards the end of the Clinton administration.

 

This is a tough one. The FDA has been under terrific pressure to speed up its drug-approval processes, yet hasn't received any significant increases in funding or staff to do that. And some side-effects don't show up for many years after a drug has been used, so even a drug that has had lengthy testing may still turn out to have serious adverse effects decades later.

 

Some of this comes from the greed of pharmaceutical companies, but some comes from the desperation of the public for new therapies for difficult diseases.

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The information that Vioxx has an increased risk of heart attack and stroke has only come out since Bush became president. The refusal to act on that information is clearly attributable to the current administration.

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Guest Merlin

The President does not appoint all the members of the FDA, some are holdovers from Clinton. And of course, he does not have a voice in the operation of the FDA. This whole subject is too complicated to jump to conclusions. Part of the high and increasing cost of drug is the enormous cost of getting drugs approved by the FDA. So the suggestion that longer and bigger clinical trials should be conducted means that prices would be much higher. And the long term effects may still not be discovered. When a new drug is discovered which has a desirable effect, there is pressure to get it available. The very people now complaining would be the same ones demanding that the new drug be put on the market and that relief not be denied because of beaurocratic hold up.

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>The President does not appoint all the members of the FDA,

>some are holdovers from Clinton.

 

There is only one Commissioner of the Food and Drug Administration. He/she reports to just one Secretary of Health and Human Services, who is appointed by the President.

 

Which brings up the results of a recent poll:

 

Harris Interactive conducted a poll last week that showed George Bush with a two point lead over John Kerry. Within the poll, Harris found that Bush's supporters are less educated than those voters who support John Kerry. Here are the new numbers:

 

 

High School or Less:

Kerry: 42%

Bush: 51%

 

 

Some College:

Kerry: 44%

Bush: 50%

 

College Graduate:

Kerry: 50%

Bush: 45%

 

College Post-Graduate:

Kerry: 58%

Bush: 37%

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A Drug Free America

 

There are a number of problems here:

 

At the same time that the government (Democrat and Republican alike) is engaging in a costly and expensive war against drugs which has, on the one hand, made criminals of a huge percentage of the population and incarcerated more U.S. citizens than at any time in this nation's history, and on the other hand, is also devastating the country side of, for example, Columbia, simply because the citizens of this country, in spite of the war on drugs, continue to buy and trade in cocaine.

 

Additionally, the government (again, from both parties) accepts large contributions from the drug companies and passes legislation such as the medicare prescription drug benefits which both disallows importation of drugs, including those manufactured by the same plants which make the drugs sold in the U.S., but also explicit prohibits the U.S. government from using its buying power to bargain and negotiate for better pricing.

 

On top of this is the canard regarding the cost to bring a drug to the market. Yes, research is expensive, however many of the drugs being brought to the market are "me-too" drugs. Even in areas where research money is being spent, such as HIV retrovirals or pain relief, the drugs being brought to trials and for FDA approval are variations or improvements of existing drugs. In addition to which, the profits made over the life of a patent far outweigh, in huge variance, the funds expended. Drugs companies are among the most profitable sectors of the economy at this time and have been for many years.

 

Finally, the public at large is to blame. $75 million was spent to market this drug last year. Comparable amounts are spend to market drugs for allergies, depression and, of course, impotence. This advertising all states: tell your doctor or ask your doctor about XYZ medication. When you are asking or telling your doctor about a specific drug, he is no more than a dealer.

 

While I firmly back people becoming more informed in their health care and treatment, specifically asking a doctor to give you a medication is not good medicine. Asking him or her if there are drugs with minimal side effects, or a comparable, equally effective generic equivilent is one thing - asking them to prescribe something the doctor would not otherwise have given you without your request, that is something totally different.

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>>The President does not appoint all the members of the FDA,

>>some are holdovers from Clinton.

>

>There is only one Commissioner of the Food and Drug

>Administration. He/she reports to just one Secretary of

>Health and Human Services, who is appointed by the

>President.

 

Both the Secretary of HHS and the Commissioner of the FDA are political positions, and are appointed by the President. So there is a political element involved in many of the decisions they make.

 

In the case of Vioxx, I don't know that the Bush adminstration (which I otherwise despise) "failed" to do anything about the drug. I don't know when the reports of adverse side-effects began appearing, and I don't know when it was concluded that Vioxx definitely or most probably was the cause of those problems. If there was a long delay after it was concluded that Vioxx was causing dangerous side-effects, that would be something to blame FDA and the administration for. If they acted promptly, they did the job they're supposed to do. I believe Merck withdrew Vioxx voluntarily, but that doesn't mean the FDA hadn't advised Merck that it was about to ban Vioxx if Merck didn't act on its own. Of course, Merck has an incentive to act on its own to avoid seeming more culpable when it's sued for any damage users have suffered.

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RE: FDA a "Bystander" about Vioxx Risk

 

Here's a story from The New York Times for you, tri:

 

OP-ED CONTRIBUTOR

Good Riddance to a Bad Drug

By ERIC J. TOPOL

 

Published: October 2, 2004

 

 

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.

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Guest Merlin

RE: FDA a "Bystander" about Vioxx Risk

 

Congress has been wisely reluctant to control the prices of drugs because it will inevitable chill the research and development needed to bring new drugs to market. Allowing drugs to be purchased out of the US and brought into the US is a form of price controls because the lower price results from the fact that other countries control durg prices and threaten to dishonor our patents if we do not honor their prices determinations. If price controls is a good thing, we should do it ourselves. If is harmful to research, we should not allow controls indirectly through imports. For the same reason, Congress refused to allow Medicare to negotiate prices. Medicare payments are such a large part of the market, that its negotiations would amount to price controls on drugs neede by the elderly. The government buys and distributes most vaccines and negotiates the price. The result is that most companies have left the field, and vaccines are often in short supply. Canada controls the price of drugs and has not itself developed a new drug since 1947. If we control prices, who will develope new drugs?

Remember that while high profits may seem like an evil thing, most of the "profits" are retained in the company and used to finance research and development of new drugs, and yes the extensive testing and clinical trials necessary come out of "profits". If we restrict profits to a "reasonable" amount, drug companies can obtain the same profits with other investments with lower risk.

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RE: FDA a "Bystander" about Vioxx Risk

 

>Congress has been wisely reluctant to control the prices of

>drugs because it will inevitable chill the research and

>development needed to bring new drugs to market.

 

This is one of the biggest loads of horse hockey this side of Crawford,Texas. Drug companies never cut R&D budgets, because it would be against their best interests to do so......after all, new drugs are what keep their companies afloat. The highest profits come from the new drugs, because they are proprietary for a number of years and the drug companies charge as much as possible for these non-generic drugs. It is clearly disingenuous to suggest that controls on pricing would somehow have a chilling effect on R&D, because the new drugs are their bread and butter. Of course, the pharmaceutical companies want you to buy into this ludicrous argument, so they can frighten away any attempt to regulate prices.

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Guest Merlin

RE: FDA a "Bystander" about Vioxx Risk

 

Your statement is internally inconsistent, bucky. Yes drug companies NOW pay for research and development because if a new drug is produced, they can during the patent period, charge, in the US, what they decide to charge. BUT, all that will change if the government controls the prices of the new drugs, which is the subject under discussion. If price controls are imposed, the companies will not be able to charge as much as the wish, even during the patent period. Then they will have to worry whether they can charge enough to make a enough profit to justify the risk. The experience from other countries tells us that with price controls, R&D will dry up. And remember that in other countries, such research as is done is in large part done in the expectation that if a product is developed, it can be sold in the huge US market without price controls. Price controls here will inhibit research world wide. The US consumer is being forced to bear the worlds cost of R&D. But price controls are not the solution.

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RE: FDA a "Bystander" about Vioxx Risk

 

>Your statement is internally inconsistent, bucky. Yes drug

>companies NOW pay for research and development because if a

>new drug is produced, they can during the patent period,

>charge, in the US, what they decide to charge. BUT, all that

>will change if the government controls the prices of the new

>drugs, which is the subject under discussion.

 

Uh, no, it's not. The bottom line, which you fail to acknowledge, is that the drug companies make so much money that there is absolutely no way they will diminish what they spend on R&D, regardless of drug pricing, because it would be counterproductive to their interests. Your argument against price controls is just more of the typical Republican "sky is falling" nonsense. You, like all free marketers, have an unwavering faith in letting these corporations charge whatever they want for anything they want. I'll be you would have no problem if credit card banks charge 90% interest......after all, there's nothing stopping them from doing it. At the present time, there are now banks planning to charge 48% APR.

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Guest Merlin

RE: FDA a "Bystander" about Vioxx Risk

 

But the money they make depends on drug pricing. You seem to believe that the money they make has no relation to pricing. You are mistken. The amount they make depends directly on the price. If the government sets the price, they cannot be assured of making enough money to justify the risk.

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