Vioxx is indicative of a larger problem at the FDA.  It takes years for a drug therapy to be approved and costs billions of dollars.  Charges are now made that the FDA is more interested in doing the CYOA thing than taking a chance on a therapy that might save thousands of lives.  The entire process is so painstakingly slow it is almost anal.  Here are the steps necessary for a new drug to make it through the process.

"...It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved..."

The proven CURE for melanoma has been in the pipeline for at least fifteen years.  I have personally met a man who was diagnosed as a late stage three fifteen years ago.  He was dying, unable to respond to any of the known chemo treatments.  A friend was working in the lab of a major university.  He mentioned the testing of a possible cure.  This man said he wanted the drug and not the plecibo.  If he died quickly it was better than a slow melanoma death.  (Many people do not realize most late stage brain cancers occure from an undiagnosed melanoma primary.  The final stage of death for melanoma is brain cancer.)  So, he and thirteen others were given the 'cure'.  Another group was given the placibo.  EVERY single person in his group is still alive - all were late stage threes.  He suspects there were a few stage fours, also.  All must take a yearly booster. 

The cure is not chemo.  There are no side effects.  All it does is CURE MELANOMA.  This man told me within three months he was back at work, completely melanoma free. 

The lab where the cure is being develooped has yet to seek FDA approval -which means we are in for another ten years of waiting.  They want to tinker with the cure until boosters are no longer needed. 

Who cares?

I don't.  I had melanoma.  I go, religiously, every six months for a complete check-up.  This is the rest of my life.  It is the only way I can be assured that I can live melanoma free - unless I have access to that medication.  Odds are, and so far I have beaten them, that I will have another diagnosed primary.  If it is undiagnosed I will die because there is no cure on the market, even though it is available.  This is how Maureen Reagan died.  The cure was there, but she had no access to it because of the lab and the FDA.  She and thousands of other people have died, needlessly.

As far as I am concerned, this is murder.

Another friend has a very rare genetic problem.  Her husband wrote, "It's called The Alpha 1 disorder. She's missing the Alpha 1 enzyme that helps people fight off breathing disorders. In most cases it's a hereditary thing. Her brother was never tested as he was a heavy smoker, and he had the same thing Carrla has. Her sister does have the enzyme though. Her father probably was without the enzyme, as he also suffered breathng disorders." 

There  is a cure for Carrla's disorder.  There was a cure (treatment) years ago, but it is so expensive very few physicians know about it.  If her physician had known, she could have recieved the proper medication for it.  Now, because her physicians did not know, and the fact that it is still considered 'experimental' - and somewhere around $100,000 a pop, no insurance company will pay for it.  Fortunateley she could afford to do so on her own.  But, because of the extreme cost, it was not made available to her.  She is now waiting to find out if she qualifies for a lung transplant. 

Her husband is on an errand of mercy.  Every physician he encounters, he tells about the condition and the medication.  There is a very simple, but incredibly expensive genetic test that some physicians want given to 'screened' newborns.  If the test comes out positive, literally an 'antidote' can be administered so early that the child will never suffer from the problem.  Problem is cost.  The test is expensive, 'experimental' and uncovered by any insurance plan.  The powers that be are so short-sighted they do not recognize the fact that the costs of treating a child immediately would be far less than a life-time of non-treatment that leads to eventual organ transplants. 

A few months ago I was listening to Michael Reagan rant and rail about the whole system.  This is the article he was referring to...and it is eye-opening to say the least.  The bottom line is our dearly beloved Dems have put so many regulations in play that good drugs are not allowed to come to market the way they should, thus ensuring the deaths thousands.  Reason?  CYOA - the FDA pencil pushers don't want to do the ever present Congressional inquirery perp walk in front of national cameras when something goes wrong.  Thus - innocent people die, not from bad drugs, but from having cures with-held from them.

"...Senator Charles E. Grassley (R-Iowa), the chairman of the Senate Finance Committee, which held hearings in November, chided the agency, "The health and safety of the public must be the FDA's first and only concern." He is right, but particularly when governmental pre-marketing approval of a product is required, greater safety is not synonymous with more stringent regulation. In fact, net benefit to patients often suffers because of an obscure regulatory anomaly: the asymmetry of outcomes from the two types of mistakes that regulators can make. A regulator can commit an error by permitting something bad to happen (approving a harmful product, a Type I error in risk-analysis parlance), or by preventing something good from becoming available (not approving a beneficial product, a Type II error). Both outcomes are bad for the public, but the consequences for the regulator are very different...."

Type one errors are when dangerous medications reach the public and people die.  Pencil-pushing government employees don't like becoming the target of press incited witch hunts, so they become over-cauticious - and thousands die because of their caution.  Because no one ever knows the names of those who die, no crime, no foul, no problem!

"...Type II errors, in the form of excessive governmental requirements and unreasonable decisions, can delay commercialization of a new product, lessen competition to produce it, and inflate its ultimate price. The detrimental effects of FDA delays in approving certain new drugs already approved in other industrialized countries are well documented. These include the greater than three-year delay in the approval of misoprostol, a drug for the treatment of gastric bleeding, which is estimated to have cost between eight and fifteen thousand lives per year; and the lag in the approval of streptokinase for the treatment of occluded coronary arteries, which may have caused the loss of more than ten thousand lives per year.

 Although they can profoundly compromise public health, Type II errors caused by a regulator's bad judgment, timidity, or anxiety seldom gain public attention. Often, only the employees of the company that makes the product and a few stock market analysts and investors are likely to be aware of them..".

 

So people like my friend Carrla must suffer.  Maureen Reagan died.  I could die...

"...This proposal differs in critical ways from those of critics of the FDA who have called for the creation of a new regulatory agency wholly separate from the FDA that would focus on the safety of already-approved drugs. (They seem to have lost sight of the fact that patients are just as dead if they're killed by the delay of a life-saving drug—misoprostol, streptokinase, and Heptavax come to mind -- as by an adverse event from an approved one.) The existence of an agency with such a narrow focus would make it easier for drugs to be withdrawn from the market, even if they were highly cost-effective for a certain narrow population (e.g., Accutane). It could also lead to more frequent use of absurdly restrictive and expensive distribution mechanisms, such as that for Thalomid (formerly, Thalidomide), which is controlled as though it were highly enriched uranium that could be made into nuclear weapons. We should have learned from bitter experience the outcome of regulation that focuses narrowly on "safety," to the exclusion of benefit: for example, the EPA's over-zealous, anti-consumer, anti-innovation oversight of pesticides and other chemicals.

 

In contrast to the creation of a new entity narrowly concerned with the safety of marketed drugs, the ombudsman panel described above would redress errors of both over- and under-regulation, a more balanced and effective approach that would make regulators more accountable for their actions. (Such a mechanism could also be of value for improving the performance of non-regulatory agencies, such as the CDC, which admitted in November that it erred significantly in making a widely publicized calculation of how many people died from obesity in the last decade.)

 

Americans are, literally, dying for regulatory reform. And once Congress gets around to it, it would behoove them to remember that where regulation is concerned, sometimes less is more."

Treatments and drugs are approved much quicker in the UK than here.  There is a many year lag which seems strange.  When you read this, you will begin to understand there is more of an emphasis in numbers and the legalities of a situation and the way a medication is used than consideration of human suffering and the possibilities that lives could be saved.

"...Wardell's argument eventually won at least partial acceptance among top FDA staff and was well publicized at the first Congressional hearing to criticize the FDA for being too strict rather than too lax.11 Still, although several studies12 have updated the counts of drug approvals in Britain and the U.S., no one has attempted a new, comprehensive assessment of the clinical significance of gains and risks.

One reason may be that such comprehensive studies are difficult to carry out. Another is that, at least with respect to Britain, the lag has disappeared. There is still a U.S. lag when we consider all drugs approved since 1962, but, for the most recent period for which we have full data (1983-87), the U.S. introduced considerably more drugs and introduced mutually available drugs sooner than Britain.13 To the extent that standards of proof contributed to this shift, most observers attribute it to toughened British standards rather than to looser U.S. standards.14 Whatever the reasons, the apparent disappearance of a lag reduces incentives to explore the clinical and normative significance of the differences. It also eliminates the alternative drug regulation regime needed to compare different standards of proof. Its disappearance leaves us in more of a quandary about how to assess U.S. performance.

We can, however, ask whether the FDA has acted in accord with an important implication of the error cost minimization principle: The standard of proof should vary with the size of the error costs.15 When potential drug benefits are large relative to risks, the expected cost of withholding it is large. Therefore, the standard of proof should be lower. The FDA should not have one standard of proof, but many. As discussed above, it has moved to adopt a lower standard for AIDS drugs and perhaps others, but we still do not have much insight into what the different standards ought to be...."

Then you have the 'liberal' version where groups like the AARP want ever part of life regulated.  I think this is where the problem is.  If the individuals on the approal panals could go into a situation where they could be anonymous and not be held libel by the press or litigators perhaps things might be different.

Take this article from the NY Sun about The Price of Too Much Caution

"...Consumers are angry that these problems were not unearthed earlier. But the higher risk of heart attacks caused by Vioxx, for example, was on the order of about six or seven heart attacks for every 1,000 patients who took the drug. In an older-patient population that al ready suffered more heart attacks, such a risk could have been easily missed, even with a clinical trial that included 10,000 patients or more. With this additional testing, the benefits of an off chance of discovering a rare side effect before a new drug is approved is eventually outweighed by the cost of keeping promising drugs from patients.

Even delaying seemingly ordinary drugs can have dramatic consequence on the public health. The first non-sedating anti-allergy medicine, Claritin, took almost seven years to get approved, while sleepy drivers with sniffles continued to cause car accidents. Each of the popular anti-cholesterol drugs known as statins that today prevent 15% to 30% of heart attacks took several years to get approved. How many people died waiting? The math is straightforward.

Or consider this math: It's estimated more than 20,000 people died between 1985 and 1987 waiting for streptokinase, the first drug that could be intravenously administered to reopen the blocked coronary arteries of heart attack victims. Between 1988 and 1992, about 3,500 kidney cancer patients died waiting for Interleukin-2, which was available in several European countries. In 1988 alone, it is estimated between 7,500 and 15,000 people died from gastric ulcers caused by aspirin and other non-steroidal anti-inflammatory drugs, waiting for the FDA to approve misoprostol, which was already available in 43 countries.

This is the price of too much caution, when drugs are held hostage to safety testing with lethal consequences. The poisonous compromise is becoming the prevailing orthodoxy inside the FDA right now, as the agency understandably withdraws under the withering attacks from a sound-bite-obsessed Congress and headline-hungry press.

The effects of this deadly atmosphere can already be seen in the FDA's decision two weeks ago to delay approval of a promising cancer drug, Marqibo, for the treatment of aggressive non-Hodgkin's lymphoma. This go-slow approach was also apparent in the lopsided vote to withhold approval of the testosterone patch for women, being touted as the "Viagra for women." That decision was driven by theoretical fears of certain risks rather than problems already manifest..."

And then there are the costs, clones, ads, etc.

The dirty little truth about the whole process is that most research is being done in universities, such as the melanoma CURE, but big companies buy it up and then charge huge prices.

"...Our utopia of miracle pills is now beginning to look a bit like a nightmare. Drug companies use our tax money to pay for their research, turn around and sell the results to us at high prices, spend the resulting profits on massive campaigns to mislead us about their effects, which then encourage doctors to prescribe an expensive pill which may not help much and might even make things worse. Year after year, drug companies are by far the most successful industry. They use their stunning profits to buy off politicians and propagandize the public into maintaining this state of affairs. Only by learning the true state of affairs can we begin to fight back...."

Then there is Mort Zukerman's view from Jewish World Review, definately a must read article.

"...The drug companies face tough times for two reasons. First is the cost of clinical trials required by the Food and Drug Administration. Today, roughly 40 percent of the $30 billion the 20 top drug companies spend on research and development goes to clinical trials. Second, the profits to meet such costs are being eroded because their patents are expiring. Patents for mechanical instruments extend for generally 18 to 20 years; for drugs, patents have a life span of just 12 to 14 years. That's because patent licenses begin when a new drug is registered, before it can win FDA approval and start earning back its investment.

And approval is hardly a given. Eight of the top 15 drug companies did not get the go-ahead for a single drug last year. In 1980, drug companies spent some $2 billion on R&D, and 34 new drugs were approved. Last year, the drug companies spent close to $30 billion, but only 24 drugs were approved. It is costing lots more, in other words, to get much less. And even those drugs given the all clear by the FDA don't pay their way. Seven of 10 of the drugs approved by the FDA never make enough money to even justify their development costs...."

And even worse is the following - which is only going to get worse.

"...Democrats in the Senate are unwilling to approve anybody for the FDA's top job who has any experience with the drug industry. This is just shortsighted. There are plenty of people in the drug industry who understand the process and have the ethics to be fair-minded and objective. In fact, it is an understanding of this process that makes a background in the drug industry such a big plus. That kind of knowledge would allow a new FDA chief to accelerate the reviewers' work without diminishing the quality of their reviews. Ted Kennedy, the chairman of the Senate committee now objecting to an industry designee, might recall that his father, Joe Kennedy, was appointed the first head of the Securities and Exchange Commission precisely because he understood how the financial markets worked...."

Sometimes the FDA just won't approve a drug, such as the one that is the perfect sunscreen, available world wide - but not here.

"...But is there no common sense here? All drugs have risks as well as benefits. Mexoryl has been in use in other countries for 13 years. It's passed many safety tests. Why won't our FDA even talk about it? Although buying or selling sunscreens with Mexoryl is illegal in the United States, that doesn't mean sunscreens with Mexoryl aren't bought and sold here. We found it at some pharmacies. It was expensive — $30 to $50. "People really want this stuff. People go to pharmacies and they keep it under the counter, like it's a secret ingredient, like prohibition or something and people will still buy it," Rigel said. I don't fault the pharmacies, they're serving their customers. Everyone is always telling us, protect yourself from the sun, but then the government won't give us permission to have the best sunscreen? ..."

And there are other medcations held up in the process.

Then there is the problem of non-popular diseases.  There are 'glamerous diseases' like AIDS where literally billions are pumped in for treatments.  Until they become 'popular' there is not enough money to properly do research into treatments.  They are called Rare Diseases.  Included in this list is Lupus, which effects my dear friend Alicia.

The bottom line is I don't know what the bottom line is.  All I know is people are dying, needlessly.  There are cures out there that your family doctor doesn't even know about.  There are cures your insurance company won't cover.  And, there are cures the FDA will not approve.  Then, there are cures out there that aren't 'scientific' but work.  The big problem is now when a person or family has a problem, they must educate themselves to a point where in just a few short days they need to know almost as much, and sometimes even more than your physician.