FDA Tyranny
(posts about the FDA, latest posts on top, see www.fdareview.org for more)
Posted 6/1/08 ( by Travis)
Grassley's War on Cancer Patients
5/31/08 WSJ
Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee, requested that the Government Accountability Office launch an inquiry into whether the FDA behaved appropriately in granting the "accelerated approval" of Avastin, a drug for treating women with metastatic breast cancer. Mr. Grassley's action will have a catastrophic effect on America's ability to develop new drugs.
Posted 12/9/07 (By Travis)
Right to Medical Self-Defense, The
12/9/07 NYT
If laws banning the use of force are relaxed when an intruder crawls in your window and you’re home, shouldn’t stringent F.D.A. regulations bend when you’re backed into a dark corner by a terminal illness? That was the gist of an argument made by the U.C.L.A. law professor Eugene Volokh in the May issue of The Harvard Law Review. Citing the concept of “medical self-defense,” Volokh contended that a dying American should have the right to buy any drug that has passed the F.D.A.’s preliminary safety tests. Currently, the F.D.A. insists that most terminally ill patients await, like everyone else, full proof of a drug’s safety and efficacy.
Posted 10/1/07 (By Travis)
SOMA Resolution on FDA approval
This past weekend,
SOMA (Student Osteopathic Medical Organization), representing over 14,000* Medical Students, 15%* of
the total medical students in the United States, passed the following resolution (only the final
'RESOLVED' statement was officially passed, the 'WHEREAS' parts are included here only for
completeness):
Subject: SOMA Resolution on FDA approval
1) WHEREAS, New pharmacological advances have resulted in major healthcare
2)
3) advances and enabled physicians to enhance patient care (4),
4)
5) WHEREAS, This year the FDA has so far approved only 7 NCE (new
6)
7) chemical entities), down 31% from last year (1),
8)
9) WHEREAS, It takes an average of 12-10 years and $400-800 billion to
10)
11) bring a new drug from lab to marketplace, in large part due to legal and
12)
13) current regulatory compliance (2), (3),
14)
15) WHEREAS, Generic drugs take over 20 months for approval,
16)
17) increasing cost and decreasing access (6), (7), (8),
18)
19) WHEREAS, Terminally ill patients are routinely denied opportunity to
20)
21) try new or experimental drugs and therapies (5), (9), (10), (11),
22)
23) therefore be it;
24)
25) RESOLVED, SOMA recommend agencies investigate ways to: 1)
24)
25) Review, reform, and hasten the current regulatory processes regarding
26)
27) the current FDA approval process for NCE (new chemical entities). 2)
28)
29) Review, reform, and hasten the current FDA approval process for
30)
31) generic brands. 3) Review, reform, and ease the FDA rules and
32)
33) regulations for entry of properly consenting terminally ill patients into
34)
35) clinical trials. Specifically, the FDA should not be allowed to prevent a
36)
34) terminally ill, properly consenting, educated, and fully lucid adult, from
35)
36) undergoing experimental treatment(s).
1) http://www.physorg.com/news106639362.html
2) http://www.allp.com/drug_dev.htm
3) http://www.fdareview.org/harm.shtml
4) http://www.telegraph.co.uk/news/main.jhtml
6) http://www.washingtonpost.com/wp-dyn/content/article/2006/02/03/AR2006020302598.html
7) http://www.medscape.com/viewarticle/421495_3
8) http://www.fda.gov/fdac/features/2003/503_drug.html
9)http://www.washingtonpost.com/wp-dyn/content/article/2007/07/05/AR2007070502149.html
10) http://reason.com/news/printer/120763.html
11) http://www.abigail-alliance.org/
This resolution will be passed onto the pertinent committee(s) at the AOA (American Osteopathic Association), which represents 52,000 DOs, 5% of the country's physicians, for their review.
Posted 8/10/07 (By Travis)
Court Rejects the Right to Use Drugs Being Tested
8/8/07 New York Times
The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe and effective before they are made available.
The decision preserves the current regulatory system. If it had gone the other way “it would have undermined the entire drug approval process,” said William B. Schultz, a former deputy commissioner of the Food and Drug Administration, who wrote an amicus brief arguing against the early access to drugs.
If only we could be so lucky...
In a dissent, Judge Judith W. Rogers wrote that it was “startling” that the “right to try to save one’s life is left out in the cold,” not protected by the due process clause of the Constitution, “despite its textual anchor in the right to life.”
Remember that even in the 'land of the free' you are not allowed to try to save your own life, even when terminally ill. It's simply too dangerous.
Posted 7/26/07 (By Travis)
Aug/Sep Reason
A great and thorough article makes the case against the FDA.
"The prerogative asserted by the FDA...impinges upon an individual liberty deeply rooted in our Nation's history and tradition of self-preservation."
Posted 7/12/07 (By Travis)
China executes ex-food safety chief
7/10/07 Ft.com
The execution of Zheng Xiaoyu (China's equivalent as head of the FDA), 62, was confirmed by state media after the Supreme People’s Court approved the death sentence on charges that he took Rmb6.5m ($855,094) in bribes from eight pharmaceuticals companies. <.>
Mr Zheng was accused of approving the sale of six medicines that turned out to be fakes during his seven-year tenure as head of the State Food and Drugs Administration. In one case, a gallbladder medicine containing the wrong ingredients is believed to have led to the deaths of at least five people.
It is unclear if the eight companies that gave bribes are related to the six companies that were selling 'fake' medicines. In fact, a lot of what actually occurred is rather obscured. Where are the statistics over how many people have died in this regulatory environment 'run amok'?
The state-run news media said the government accused Mr. Cao of approving 277 medicines, six of which were bogus, in exchange for bribes.
What about the other 271? How many people died because they were not able to receive these medications in a timely manner due to the apparent necessity to pay off the criminal (pun intended) government.
Additionally, articles on this subject make no distinction between outright fraud (drugs which contain different ingredients then they claim) and the approval of medications with, as of yet, unproven benefit. The few cases of actual deaths reported appear to be due to fraudulent drugs, an important point because such actions are crimes, with or without an FDA. In the United States similar 'legal bribes' take place; FDA officials leave to take jobs in pharmaceutical companies and advisory committees are infiltrated with corruption.
Interestingly, the lessoned and sporadic regulation in China has lead to an explosion of growth, research, and entrepreneurial activity:
Many experts say the drug regulators were overwhelmed by a fast-growing industry where entrepreneurs were eager to make blockbuster profits — quickly. And so new drugs were popping up every day.
For instance, Mr. Wang said that when Mr. Cao served as head of the registration division, it approved 14,000 drugs in three months, even though the department had only a dozen staff members.
Where is all the death? Where is all the carnage? Such growth and innovation may not be around for long:
In 2005, for instance, the state-run news media reported that the authorities banned 114,000 unlicensed drug manufacturers and demolished 461 illegal factories.
While news reports list only a scattered deaths, for arguments sake let us multiply these by a few orders of magnitude, and assume all of them are due to lack of regulation rather than fraud. Contrast this deliberate exaggeration with just one story:
A jab to halt Alzheimer's could be available within a few years
7/23/07 The Daily Mail
When the jab was given to mice suffering from a disease similar to Alzheimer's, 80 per cent of the patches of amyloid protein were broken up.
The vaccine is now being tried out on 60 elderly Swedish patients in the early and middle stages of Alzheimer's. Half of the men and women are being given the vaccine while half are being given dummy jabs. <.>
The jab, which is now being tested on patients, could be in widespread use in as little as six years. The most common cause of dementia, Alzheimer's affects around 500,000 Britons, with about 500 new cases diagnosed every day as people live longer.
Surely there are many people suffering from Alzheimer's who would dearly love to try such an experimental drug. These terminally ill people are prevented from doing so for their own 'safety', by their own government. Who is the criminal? The company trying to bribe their way through the government in order to release what might be lifesaving medication, or those fully utilizing the heavy hand of government to prevent that reality?
Admittedly, this cited Alzheimer's story is probably somewhat sensationalist. But the particular validity is besides the point. There are many miracle medicines out there, in the pipeline, in the que, stopped up in the clogs of FDA bureaucracy.
Yet the coverage of these happenings is strangely paradoxical, heroes are labeled criminals, the villains cloaked as saviors, and the big picture obscured in status quo group think journalism.
Surely we should be the ones looking to China for answers; not the other way around.
Posted 3/31/07 (By Travis)
Judge:
Government must allow meatpackers' tests for mad cow (Required
Reading)
3/29/07 Mohave Daily News
Creekstone Farms Premium Beef, a meatpacker based in Arkansas City, Kan., wants to test all of its cows for the disease, which can be fatal to humans who eat tainted beef. <.>
The Agriculture Department currently regulates the test and administers it to less than 1 percent of slaughtered cows. The department threatened Creekstone with prosecution if it tested all its animals. <.>
Larger meat companies feared that move because if Creekstone tested its meat and advertised it as safe, they could be forced to do the expensive test, too. <.> The Agriculture Department argued that widespread testing could lead to a false positive that would harm the meat industry.
This story is not satire, and has been added to 'Required Reading' for obvious reasons. Despite their ostensible purpose, regulatory agencies do not protect consumers. They do not even help industries, as the meat industry as a whole would be better off without them. The only beneficiaries from these unconstitutional meddlings and regulatings by these agencies and the politicians propagating their power are the few largest meat companies. The oft described 'creative destruction', turnover of industry and liquidation of inefficient companies, a hallmark of freedom and capitalism, is limited.
This pattern can be found to some extent or another in nearly all government agencies. It continues because of a mix of public ignorance, misplaced public advocacy by self appointed 'do gooders', unscrupulous lobbyists and businessperson, and criminal politicians.
U.S. District Judge James Robertson ruled that the government does not have the authority to regulate the test.
The biggest threat to consumer health is expansive and expanded government.
Posted 3/31/07 (By Travis)
Parkinson's Drug pulled From the Market
3/20/07 Seattle Post-Intelligencer
The Food and Drug Administration said Thursday that pergolide, sold under the name Permax and also in generic versions, is being withdrawn at the agency's request. <.>
Temple said withdrawal was requested after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage - up to 20 percent - in patients taking the drug.
While these side effects are certainly cause for concern, we must also consider Parkinson's can be an incredibly debilitating and even lethal disease. One of the great follies of regulatory government agencies, and even perceptions in the common culture and medical establishment is this idea that people represent an idiosyncratic 'mass', and just because a majority of people respond in a certain way or a minority have certain adverse effects, the application is universal. It may be a stretch, but can we view this through a political lens, as a sort of 'medical collectivism' or 'medical socialism'? We are all unique individuals with distinct biophysiological makeups. Our innate capacity to weigh variables and passion to strive for life certainly allow us to make more positive choices than a regulatory political agency ever could.
"Our conclusion is that pergolide has no demonstrated advantage over other therapies," Temple said. "We believe almost all patients can be converted to another drug." <.>
Temple said a few people may not be able to change to another drug and the agency is making arrangements to have pergolide available for them.
Above we see tacit admission of the described theory; certain people, albeit a minority, have found pergolide to match well with their underlying biochemistry. These folks are lucky the FDA has generously 'allowed' them to continue to purchase this medication. Future Parkinson's patients will not have this option.
Posted 3/23/07 (By Travis)
FDA issues new guidance on whole grains
2/15/07 Seattle Post-Intelligencer
"It's very important that consumers are able to have a consistent and uniform terminology of what constitutes a whole grain," said Barbara Schneeman, director of the FDA's office of nutritional products, labeling and dietary supplements. <.>
While the FDA is trying to make things clearer for consumers, the agency seems to be causing confusion in the food industry.
Posted 2/25/07 (By Travis)
Fish in Mother's Diet Benefits Child, Study Finds
2/16/07 Washington Post
A large study has found that children of women who ate little fish during pregnancy had lower IQs and more behavioral and social problems than youngsters whose mothers ate plenty of seafood, a finding that challenges the U.S. government's standard advice to limit seafood while pregnant.
If one wants to live healthy, a good rule of thumb is to do the opposite everything the government advises. :) I'm only half joking. Regardless of correctness in this particular issue, it is advisable to get government out of science and stop issuing these sorts of recommendations. They are a waste of taxpayer money, not to mention more often than not harmful to its citizenry.
The study found that children born to women who ate about three servings of fish per week or less -- near the maximum advised by the Food and Drug Administration and the Environmental Protection Agency -- had lower verbal IQs, more problems with fine motor skills, and higher rates of behavioral and social difficulties, compared to youngsters whose mothers consumed more seafood during pregnancy.
There appears to be a bit of jurisdictional overlap...
Posted 2/19/07 (By Travis)
Bionic eye restores sight to the blind
2/17/07 The Times
Well, the FDA is continuing it's war against the blind.
A bionic eye that can restore sight to the blind should be available commercially within two years, scientists behind the revolutionary technology announced yesterday.
An early version of the prosthetic retina has already
been fitted to six patients with retinitis pigmentosa, a degenerative and incurable eye condition
that affects 1 in 3,500 people. All have recovered the ability to detect light and motion, and even
to make out large letters and to distinguish between objects such as a cup, a knife and a plate.
The second-generation device that is now starting trials should provide even better vision, as it
contains 60 light-sensitive electrodes, compared with 16 in the previous model.
More improvements are expected within five to seven years with a 1000-electrode implant that will enable previously blind people to recognise faces, Professor Humayun said.
Imagine if you were blind. Perhaps I should stop there, because it is impossible for our imagination to do us true justice. It is easy enough to take these sorts of things for granted, forgetting what a precious gift sight really is. But, try to imagine you are blind and you hear this news and, despite the risks, you and/or your family are willing to pay tens of thousands, or even hundreds of thousands to try this experimental procedure. Imagine you are an entrepreneurial doctor, flush with money from venture capitalists, attempting to do good and tap this market (synonymous goals), and you research and discover this amazing new procedure. So, our two imaginary friends come together, money is exchanged, the procedure is completed and....
the doctor is thrown in jail.
Because his actions are illegal as they have not been sanctioned by the bureaucrats at the FDA:
The artificial retina has been cleared by US regulators to begin trials on between 50 and 75 people suffering from two of the most common causes of blindness, opening the way for millions more to benefit from similar implants in the future.
If you're not one of those 50-75 people, you're just plain out of luck.
Thousands of people have already volunteered.
And if you're young? Forgedaboutit:
The trials will be conducted at five centres in the US, on patients over 50. The US Food and Drug Administration has insisted on older subjects as they have less to lose if the experiments go wrong.
Who are they to judge what someone has to gain or loose?
Reminds me of the many stories of how the FDA was falling over itself denying treatments to critically ill patients in order to ostensibly 'protect' them.
In conclusion, it is likely safe, affordable, and even further advanced bionic optical procedures would be available at present if it were not for the FDA and Co.
Posted 1/23/07 (By Travis)
Curing Cancer: A Patent Impossibility
1/22/07 LewRockwell.com
I can't vouch for the efficacy of DCA, whether it might actually 'cure' some forms of cancer or help in treatments, but the basic premise of this article is true and deserves further exploring and analysis.
Posted 10/5/06 (By Travis)
Nanotechnology
Risks Unknown
9/26/06 Washington Post
The United States is the world leader in nanotechnology -- the newly blossoming science of making incredibly small materials and devices -- but is not paying enough attention to the environmental, health and safety risks posed by nanoscale products, says a report released yesterday by the independent National Research Council. <.>
Norris Alderson, associate commissioner for science at the Food and Drug Administration and chairman of the working group that created the administration's summary research plan presented to Congress last week, said the document -- which was supposed to be delivered six months ago -- was meant as "a first step."
Is this the beginning of the end of the nanotech industry?
Posted 10/4/06 (By Travis)
10/1/06 Washington Post
The FDA requires milk to be pasteurized (heated) and homogenization (filtered). Why? If it is not treated as such, it is claimed we could get sick from bacteria. Thus, to protect us from ourselves, the FDA and other big government types will throw us in jail if we sell this sort of milk or dairy products. Sure, there are cases of raw milk being harmful, but there are also cases of pasteurized and homogenized milk being harmful.
In any case, this is a thorough, well written article; the author has a good sense of humor. :)
Case in point, here is a good contrast:
The FDA'S 2006 science forum was held in April in a cavernous, blue-carpeted hall at the Washington Convention Center. There were row after row of poster presentations with titles such as "Characterizing Perfluorochemical Migration From Food Contact Paper" and "Evaluation of Nanomaterials' Immunotoxicity: Examples of Polystyrene Nanoparticles."
Versus:
His wife also grew up drinking raw milk on a dairy farm. They feed their kids raw milk. He says he has never become ill from drinking it. Neither has his wife or his kids. In fact, he's never known anyone who has gotten sick from drinking raw milk. When I tell him that the FDA has called raw milk "inherently dangerous," he rolls his eyes. "Yeah, that's what they say," he says. The young farmer is not a man of lengthy explanations.
Reminds me of this quote:
State a moral case to a plowman and a professor. The former will decide it as well, and often better than the latter, because he has not been led astray by artificial rules.
- Thomas Jefferson
Posted 9/7/06 (By Travis)
Since we're on the subject of the FDA, I thought I'd take the opportunity to show off my new license
plate :) :
Posted 9/7/06 (By Travis)
Gene Therapy Found Effective Against Terminal Cancer
8/31/06 Los Angeles Times
Scientists
for the first time have genetically modified tumor-fighting immune cells, allowing patients to rid
themselves of an aggressive form of cancer, according to a study released Thursday.
The technique, used to cure two patients with advanced melanoma, paves the way
for a new approach to fighting cancer by harnessing — and boosting — the body's own immune
system instead of relying on toxic chemotherapy and radiation treatments to kill out-of-control
tumors.
They
added that there is still more failure than success with the technique. Fifteen other melanoma
patients enrolled in the study failed to show sustained improvement from the modified immune cells.
Twelve of those patients have passed away, and the other three are near death, Rosenberg said.
But the success with two patients, who are cancer-free more than a year and a
half after their treatment, was enough to demonstrate the possibility of a new front in the long,
intractable war against cancer.
Now, as we know, any doctors that try this approach on
terminally ill patients with cancer will get thrown in jail by the FDA. We can assume this
particular trial was only allowed to go forward with the utmost bureaucratic involvement and
haggling and we've already documented
that the FDA has severely limited gene therapy trials.
Melanoma
accounts for only 4% of skin cancer cases, but it is the most lethal type. More than 62,000 patients
will be diagnosed with melanoma this year, and 7,910 people will die from it, according to estimates
from the American Cancer Society.
If we assume the success rate for this type of therapy is 2/15, 13%, and that all of the 7,910 people who are about to die want to try the therapy, then it follows that 1054 of these people would be alive today. That is, if the FDA did not exist.
Of course, one might argue that not all of these folks would try the therapy and that we don't even know for sure what the actual percent of success is, given the small sample size and the propensity of docs to 'creatively' design trials and interpret data. Maybe so. But I'd counter with the fact that the FDA has surely set back gene therapy (and other therapies!) years and years with its asinine regulations and prohibitions on trials etc... (Readers may recall the article posted about the exodus of patients and clinicians to china.)
If history is any guide, and the FDA has delayed gene therapy 12 years, which is, on average, how long it takes for a new drug to get approval, then it is not unreasonable to estimate that over 12,000 persons are now dead due to the FDAs attempts to protect us, and, apparently, the deceased. In fact, the number is likely higher, because with more trials and competition, the therapies would have improved faster and started earlier.
Again, let us be clear, the efficacy of gene therapy is besides the point, the substitution of 'any medical advancement' for gene therapy, will illustrate the pattern in question.
Posted 9/7/06 (By Travis)
Implantable Heart Device Receives F.D.A. Approval
9/5/06 New York Times
As you can see, expert opinion here at Neoperspectives.com has already been expressed on this subject. :) However, I'd like to leave one further quote, and another example of the FDA, and its outside 'expert' docs playing God:
In June 2005, a panel of heart experts appointed to advise the F.D.A. voted, 7 to 6, against approving the Abiomed device, in part because of concern that the risks from complications like bleeding, strokes and infection outweighed the benefits. Some panel members expressed concern about whether patients would live long enough with an improved quality of life to justify the risks.
Who better to weight the risks and benefits than the terminally ill patients themselves? What about their concerns? Who owns their lives? Who are these meddling middlemen?
Posted 9/6/06 (By Dobber)
FDA approves of saving lives of 4,000 people per year
ABC News
The Food and Drug Administration gave preliminary approval today to Abiomed Inc. to sell its AbioCor device, the first fully implantable mechanical heart, just over a year after an FDA panel of outside experts voted against giving the Massachusetts company permission to sell the device.
How is it that we the people, define expert? Would your definition of expert be the same as mine? Maybe or maybe not. The FDA hired experts to determine whether or not a private company could sell a potentially life-saving device to willing private citizens. The experts voted no. A year later, apparently against the advice of the experts, the FDA changed its mind.
Continue to think about that. The FDA hired experts to make a decision for them. The FDA apparently could not make the decision itself, so rather than wallow in its own stupidity, or non-expertise, it hired experts to make the decision. The FDA took the advice of the experts....for one year.
Somehow, the FDA has decided that the experts it hired are no longer experts. They did not hire more experts to examine the previous experts expertise, they simply decided, in a very non-expertise way (they aren't experts, if they were, they wouldn't have hired experts), to discontinue the advice the experts put forth, after one year.
The company, who ingenuously conceived of, researched, developed, built, and tested the device? Not experts.
Enough of that...read on.
The company received "humanitarian exemption" for the device, meaning it is approved for terminally ill heart failure patients who are believed to be in the last month of life and thus not eligible for a normal heart transplant.
Aha! Humanitarian Exemption! The company, who had possibly developed a life saving device for countless Americans, and people all over the world, was not considered humanitarian, until now. Today. They weren't humanitarian last week, or last month. But today, they are.
But remember, this device can only be used for patients who are believed to be in the last month of life. What if the doc thinks you have six months to live? What if his expert opinion puts you at 37 days?
An FDA spokesman expects that the company will sell between 25 and 50 devices a year
First of all how could we trust the voice of an FDA spokesman? He is certainly not an expert! If he were, he would have been an outside expert.
I certainly don't trust the number of 25 - 30 which the non-expert FDA generated. But why should we care about how many of the life-saving devices the non-expert FDA has projected for sales?
...although the FDA has given it approval to sell as many as 4,000.
It gets worse and worse! Pray for the 4001 person that orders one of these life-saving devices from the recently humanitarian but non-expert company!
"This represents a culmination of 30 years of transplant research," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
Excuse me, non-expert (experts don't work for the FDA, they hire them to approve or disapprove of inventions made by private citizens) Dr. Daniel Schultz, in your non-expert opinion, how do you feel about the four thousand first applicant who will be denied a life-saving device by your organization?
I wonder how many people, who in their last month of life, over the past year, sat thinking about possibly buying this mechanical heart. Remember, the experts disapproved of the now humanitarian heart.
The initial approval was granted after studying 14 human patients who'd received the mechanical heart. The patients lived for an average of five months after receiving the implant, which costs about $250,000.
Would you pay 250K for an extra few months? Uhh, yeah! But more importantly, this is the first ever device of its kind. How good did the first car do, compared with a 2006 Honda Civic? How would the first airplane compare to today's jumbo jet?
"The results of AbioCor have not been good. … I am surprised that the FDA gave their approval," said Dr. Frank Sellke, chief of cardiothoracic surgical research at Beth Israel Deaconess Hospital in Boston.
Hmm. I wonder if he's an expert? Franky thinks the government ought not give you, in your dying days, the freedom to put a device in your body that will probably prolong your life. Is it worth it, for even a day? Ask those people in their dying days whose eighteen year old daughter will graduate high school in three months. Ask those people whose son comes back from a tour in Iraq in six weeks.
Sellke was involved in one of the original trials of the AbioCor, but his team never actually implanted the device into a patient because "it was a hard moral decision to make. We didn't know it it worked."
What!??!!? The patient is laying on a hospital bed, ASKING you to please perform the surgery. If you don't do it, move out of the way for the thousands of doctors who would love to!
Creators of the artificial heart do agree that much research and development is still required . Follow-up studies to look at the device are planned in up to 10 facilities.
How else will they make improvements in order to make a profit? A friend of mine, the future Dr. Trista, gave her opinion, that the FDA should only be allowed to approve of hearts made of Swiss cheese. Obviously, she has a future with the FDA since no sane human being would call her an expert. Lucky for Vanderbilt University, they have a possible expert
Some surgeons do not like the idea of an artificial heart. Sticking an artificial heart into a terminally ill patient is "like swatting a mosquito with a bazooka," said Dr. John Byrne, chairman of the department of cardiac surgery at Vanderbilt University Medical Center.
... a mosquito....with a bazooka... expert
Posted 8/9/06 (By Travis)
Drug Helps Restore Sight: Relief for wet macular degeneration
8/6/06 MonteryHerald.com
After years of having to tell patients losing their eyesight to wet AMD that nothing could be done, doctors now can offer hope. On June 30, the U.S. Food and Drug Administration approved Lucentis to treat wet AMD, which strikes an estimated 155,000 people a year. The approval came seven years after the drug's maker, Genentech Inc., began the first test in humans, said Dawn Kalmar, a spokesperson for the company based in San Francisco.
About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease.
Let's see, 7 x 155,000 = 1,085,000 people who could have had their vision restored, but were prevented from doing so by the Federal Government of the United States and the unconstitutional FDA. But don't you folks worry, the FDA was busy 'protecting' you from yourselves.
(Added to 'FDA Tyranny')
Posted 7/22/06 (By Travis)
Prescription Errors Kill, Injure Americans, Report Says
7/20/06 Washington Post At least 1.5 million Americans are sickened, injured and killed each year by avoidable errors in prescribing, dispensing and taking medications, the influential Institute of Medicine concludes in a major report released today. <.>
Inlander said that the IOM panel sought information about how many people may have died as a result of drug errors, but said the estimates were so different -- ranging from 7,000 to 50,000 a year -- that they were not included in the report. <.>
But the panel members did make clear that they believe the pharmaceutical industry and the FDA have not done enough to make information about individual drugs clear and easy for consumers to understand and caregivers to dispense.
So there you have it. A rather silly report IMO. Not silly in that I'm doubting the accuracy of it, but silly in the focus and perspective of both the authors and the journalist. Why should these sorts of things even be studied, no doubt with taxpayer money? Of what use is this information? A much more pertinent and relevant question is: How many people are injured or killed each year because of the existence of the FDA? I'll bet the number is greater than those injured or killed by 'drug errors' and any 'nonaction' by the FDA and pharm companies.
The report also addresses the issue of errors of "omission" -- medications that patients should be getting but do not. Panel co-chair J. Lyle Bootman, of the College of Pharmacy of the University of Arizona, Tucson, said yesterday that the panel believed those errors to be as widespread as other errors, but that researchers have not yet quantified the problem. Bootman said that the question of errors of omission is one of many that has to be aggressively researched so that corrective steps can be taken.
This 'errors of omission' path is another dangerous one and could lead to happenings like we saw in the post (7/21) below on Katie Weirnke.
FDA 100 Years of Misguided Missions
7/7/06 OC Register
Economist Sam Peltzman has shown that the number of new drugs approved declined precipitously after
imposition 44 years ago of the effectiveness requirement. He also showed that the proportion of
inefficacious drugs didn't change in wake of the added requirement, writing that the "penalties
imposed by the marketplace on sellers of ineffective drugs … left little room for improvement by a
regulatory agency." His conclusion has been confirmed by other researchers.
NCEs stand for New Chemical Entities, new drugs. This Peltzman chart is from fdareview.org.
Noble intentions aside, any reasonable concept of safety is at best relative. The safe use of a drug
is dependant on innumerable particulars, unique to the individual. By attempting to create a safety
standard for something as variable as physiology, the FDA imposes onto the marketplace a rule that
is at once clumsy and constricting.
Consumers are protected by a dynamic mixture of expert consultation, individual experimentation, independent and industry certification and the tort system. The FDA should be mindful of this existing system, because no one lobbies for the patients who die, or delay treatment, while waiting for a promising therapy to be approved.
I'd love to see this sort of article in the Washington Post. Don't hold your breath. :)
Posted 5/25/06
3 Wall-Street Journal Articles (FDA)
2005 WSJ Found this group of articles from the Abigail Alliance. Contained therein is the usual: terminally ill patients refused access to medications they desire, bureaucratic FDA incompetence and foot dragging, and on and all. However, of especial interest is this blurb:
While it came too late to save Mrs. Karnes, our reporting of her plight certainly generated a lot of attention. Bayer and Pfizer -- developers of two investigational drugs showing much promise for this particularly deadly cancer -- both contacted her doctor almost immediately to discuss the appropriateness of providing the compounds. Mrs. Karnes's family was also contacted by the FDA and told that the agency stood ready to approve such treatment on an emergency basis. All encouraging steps. But isn't it a national scandal that cancer sufferers should have to be written about in The Wall Street Journal to be offered legal access to emerging therapies once they've run out of other options?
This is further evidence of what I have always maintained: the FDA is a political institution, under political control, and, as with all government agencies, is more concerned with not 'shaking the boat', generating positive media coverage, and attaining more funding, and expanding its own power, than it is with accomplishing its ostensible goal of 'protecting patients'. If the FDA was the omnipotent, benevolent, scientific, objective type of agency that its proponents make it out to be, then its decisions would not be influenced by public opinion.
When people are killed by the FDA, as in when a beneficial new drug that would have saved many lives is delayed many years, there are no headlines because the victims are nameless, faceless, and unseen. However, when one, let me repeat, ONE, person dies in gene therapy trials, there is a person and therefore a name and face and thus media coverage and hence:
The National Institutes of Health and the Food and Drug Administration opened hearings to explore the safety of gene therapy treatment after a teen died while receiving the experimental care. (As an aside, more people have died in Gene therapy trials, although I'd guess nearly all probably would have died anyway, but this particular case, for whatever reason, seemed to galvanize the political health establishment.)
This lack of context and imagination is how asinine policies develop, such as the creation of an agency like the FDA . Politicians, government officials, and agency bureaucrats are moved to actions by names and faces, causing the exponentially greater number of nameless and faceless to perish or suffer from their actions. However, in their defense, the actions of these folks merely reflect the contextless media coverage and the misguided reactions of equally emotional constituents.
This pattern is not unique to healthcare, although, since 'lives are at stake', the emotional appeal of such cases are strongest in this field and represent a primary reason for the prevalent hurtful socialism of healthcare in the United States and other countries. But, this trend can also be seen in other policy arenas, such as free trade vs protectionism and often poses barriers to the lifting of other government imposed economic burdens. For example, sad sob stories can be created about steel workers loosing their jobs if tariffs are removed, but who can gin up an equally emotional story about the prosperity (and added jobs) gained by all Americans via lower prices of a vital commodity? Similarly, when public industries (schools, roads etc..) are privatized, or when deregulation of various industries are undertaken, new businesses/companies are guaranteed to spring up and prosper in the given industry, yet these are faceless and nameless as they exist only in the future. In contrast, Teachers Unions, Unions in general, parasitic private companies using government for their protection, and a host of other 'special interests', all exist in the present, have employees with families, names, faces, and, perhaps most importantly to politicians, posses political power and contributions that will likely outweigh those of the apathetic populace.
One of the biggest obstacles to school reform, aka, school choice, is the fact that the private schools, charter or otherwise, that would replace our horrid public schools do not yet exist to have a voice.
In the end, liberty can only be assured when the populace itself is louder in their advocation of the faceless and nameless, than the special interests are with their agenda of perpetuating stagnation; or, in the case of the FDA and the Abigail Alliance, when names and faces are given to the nameless and faceless by activist citizens.
Posted 5/10/06
Scientist Seeks Quicker Tamiflu
5/5/06 BBC
However, a new process would require extra investment in chemical equipment; and any drug produced in the Corey fashion would have to be separately licensed by the medical authorities.
Which, in the US, takes an average of 12 years. Imagine if you discovered a new cure, something that would save millions of lives. How many would die before the FDA, even if they 'fasttracked it', allowed consumers the choice of using it?
Posted 5/5/06
Court Backs Experimental Drugs for Dying Patients
5/3/06 Washington Post
Saying that dying patients have a basic "right of self-preservation," the court held that drugs that have passed the first phase of FDA review -- which determines whether a product is safe -- should be made available if they might save someone's life.
Why does it have to pass the 'first phase'? How much time, money, and bureaucracy stand in the way of a drug passing this 'first phase'? And why is this limited only to terminally ill patients?
However, the best is yet to come:
In its opposition to the challenge, the FDA had said that the agency already has programs that make potentially lifesaving drugs available before final approval. In addition, it said that allowing large numbers of patients to take unapproved drugs could put many at unacceptable risk, even if they are terminally ill.
Glad to see, yet again, the FDA is doing its best to protect those irresponsible incompetent terminally ill patients... from themselves.
If you can believe it, the Washington Post came out with a doozy of an editorial that actually argued against this court decision:
But since when did access to experimental therapies become a "fundamental right" -- defined in Supreme Court case law as a right deeply embedded in the fabric of American tradition and without which ordered liberty would not be meaningfully free?
Heh heh... where do the editors at the Washington Post get this 'ordered liberty' from? The Constitution mentions liberty at every turn, but never 'ordered liberty'. From the Declaration of Independence we get a more eloquent depiction:
We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.
The WP editorial continues:
If this right is real, it potentially calls into question the whole fabric of drug regulation.
Well, I agree, as it should! The whole fabric of drug regulation does not square with the Constitution. But then again, why should one respect the Constitution and such a concept as 'liberty'?
The FDA's balancing of the competing interests of patients, public health and science may not be perfect. But the cure does not reside in the Constitution.
(Added to 'FDA Tyranny')
Posted 3/1/06
3/1/06 Business Weekly
Suffering from late-stage cancer of the esophagus, he has come to Beijing for a Chinese gene-therapy drug called Gendicine that's supposed to kill tumor cells.
Patel tried just about everything before coming to China. He did three months of traditional
chemotherapy, flew to the Bahamas for treatment at an alternative healing center, and tried to find
clinical trials of experimental drugs. Nothing panned out. By late 2005, his doctors said that
additional surgery or chemo could bring him only a few more months.
That
wasn't good enough. "I'm not interested in buying time," says Patel, sitting on a
couch at Haidian and holding his wife's hand.
And why should he be? The human spirit will not be shut down so easily. Even by the heavy foot of the Federal Government of the United States. Why did Patel have to travel all the way to China for this therapy?
In the West, this experimental branch of biomedicine suffered major setbacks following the death of one patient in a clinical trial in 1999. Other patients later came down with cancer as a result of their added genes, and the U.S. Food & Drug Administration halted a number of trials.
I can't help but contrast this with Desperate Measures, an excellent short piece, originally in the New Yorker, by Atul Gawande. In it, Gawande describes the initial near total failures in the history of organ transplants. The fatality rate was 100% for many of these early procedures, yet patients without any other options still chose to attempt them. Eventually, through growing experience and just plain luck, doctors were able to develop many procedures that have since saved millions of lives.
"A good doctor employs any effective means available. And if there is no effective means available? Then you must come up with one. Death must never be seen as acceptable". Confronted with a dying patient, he [Francis Moore] did not hesitate to consider the most outrageous proposals.
Today, the FDA and the various bureaucrats in government would throw any doctor who dared boldly act on such a philosophy in prison. And in doing so they have condemned untold numbers of patients to death.... for their own safety.
However, Patel is not one to roll over and die as the FDA has instructed him to (for his own safety). Luckily, he can go to China and take his chances.
Without the same regulatory obstacles, they were able to take ideas that originated in the U.S. but stagnated there. SiBiono's Gendicine, for instance, is similar to a gene therapy treatment that was pioneered by Introgen Therapeutics Inc. in Austin, Tex., but has yet to win approval from the FDA. As safety concerns forced the U.S. and Europe to apply the brakes, "China speeded up," Li says.
As a result, China has attracted not just American patients but also American researchers. James S. Norris, chair of microbiology and immunology at the Medical University of South Carolina, is president of the International Society for Cell & Gene Therapy of Cancer, which last December had a conference in Shenzhen, China. "If I were making a long-term investment in biotech, and particularly in gene therapy, I would be making it in China, not here," Norris says. "They have figured out how to get [gene therapy] approved." Norris is now trying to get funding to test his own promising gene therapy approach in China.
<.>
Clinical trials are inexpensive, at about one-tenth the cost in the U.S. And the
regulatory climate is favorable. "The Chinese government is more open to innovation and new
ideas, compared to the foreign counterparts such as the FDA in America," says Peng.
<.>
Some people wonder if Chinese regulators should have required longer trials before approving Gendicine. "Maybe they went into this prematurely," says Dr. Bauer E. Sumpio, chief of vascular surgery at Yale University School of Medicine. "It is hard to believe this would pass muster through our own FDA." Adds Takeo Ohnishi, a professor at Japan's Nara Medical University: "After the [problems] linked to gene therapy in the U.S, nobody wants to have anything to do with such treatments here."
Nobody, except perhaps the people who actually have terminal cancer. But why should they, of all people, have a say?
(Added to 'FDA Tyranny')
Posted 2/12/06
2/9/06 East Valley Tribune Editorial (reprinted in full, (emphasis mine))
An advisory panel to the U.S. Food and Drug Administration has recommended that an over-the-counter asthma inhaler sold as Primatene Mist be taken off the market.
The stated reason is not that the product has harmed any asthma patients, but that the inhalers are propelled by chlorofluorocarbons (CFCs), the compounds that allegedly destroy the Earth’s ozone layer and have been banned for most other uses.
The notion that the chlorofluorocarbons in asthma inhalers are a threat to the ozone layer is
absurd. Before the ban, about a million metric tons a year of CFCs were produced. The inhalers
produce about 4,000 tons a year.
Even if the science on CFCs and the ozone layer is valid — and it’s less
conclusive than most people believe — the chlorofluorocarbons used in asthma inhalers are not
enough to be a factor.
It’s more likely, as one doctor suggested, that the panel’s recommendation has more to do with the fact that the active ingredient in Primatene Mist is epinephrine, which comes from a plant and cannot be patented. Since it can’t be patented, it has no hefty constituency to influence the FDA’s decisions, which (given that it is a government body) are more political than scientific.
According to Wyeth, the largest manufacturer of epinephrine inhalers, about 3 million Americans use
Primatene, with two-thirds of them also using prescription inhalers but keeping Primatene as a
backup. Another 700,000 people use them because they don’t have a prescription or lack health
insurance.
Wyeth has asked that it be given a couple of years to develop an inhaler that
doesn’t use chlorofluorocarbons. It would be far better if Big Nanny FDA backed off this cruel
idea and rejected the proposal to deprive asthma sufferers of a valuable, relatively inexpensive and
convenient tool to deal with their condition.
I'm not going to speculate on whether the article is correct about the political forces at work, or if it is simply an unfortunate mix of incompetence and extremist environmentalism. It is easiest to lump both possibilities into the ideology of liberalism and tout it as yet another example of big government hurting the poorest and most vulnerable portion of the populace. The very people its proponents claims to help.
Posted 2/11/06
First Inhaled Insulin Approved
1/27/06 Forbes.com Exubera, the first inhaled insulin, has finally passed muster with the U.S. Food and Drug Administration after years of delays for Pfizer.
From another story:
But in June of last year, CNN/ Money reported that analysts were predicting that the FDA would spend two more years evaluating Exubera because of the lack of long-term tests establishing whether it would cause respiratory problems for smokers, as well as its effects on children.
This is another example of the pattern alluded to in previous posts. The FDA finds some small marginal group it has 'concerns' about and then destroys the beneficial opportunities for everybody. What about healthy adults? What about the 14 million Americans, most of whom are nonsmoking adults, with type I or type II diabetes? What about those who get sicker and sicker because they don't like sticking themselves with needles every day? Don't you folks worry. The years and years of delay was worth it because the FDA needed to 'protect' you.
FDA Approves Inhalable Insulin
1/28/06 Washington Post
Millions of Americans need treatment with insulin but don't get it because it
involves frequent, painful needle sticks and injections. About 5 million take the hormone, but a
high proportion inject themselves too few times during the day because it's so inconvenient. Doctors
hope inhaled insulin will overcome some of that resistance, helping diabetics ward off a slew of
medical problems that afflict those who don't control their disease.
Studies show that the new product, to be sold by Pfizer Inc. under the brand name
Exubera, works and appears to be safe with short-term use. Patients who have used inhalers told
researchers they prefer them to needles by a wide margin, according to studies sponsored by Pfizer.
"I'm just flabbergasted at the number of people who really do seem to want this, and want it
substantially," said Jay Skyler, a University of Miami doctor and one of the nation's leading
diabetes experts.
But, of course, who are mere patients to know what is best for them.
He has been on the product continuously for seven years without a problem, he said. "The flexibility that I have is incredible," he said.
What if others wanted to join in this trial too? Could Pfizer have sold this product to customers who wanted it, who were willing to take the risks, who couldn't or wouldn't deal with the tightly regimented diabetic needle regime? Of course not. Pfizer executives would be thrown in jail and the company fined; all for the 'crime' of providing a service to a willing customer.
Pills help some people, but many others need supplemental insulin, which cannot be given as a pill. They have to prick their fingers to test blood-sugar levels and inject themselves repeatedly throughout the day with insulin, or wear pager-size insulin pumps that deliver the hormone through tiny needles.
The sheer tedium of the task gets diabetics down, and overall, they do poorly at it. A third of Americans with diabetes don't even know they have the disease, the government estimates, and many others fail to achieve adequate control of their blood sugar. The long-term result is a litany of severe medical problems: blindness, impotence, limb amputation, kidney failure, heart attack. The government pegs costs at more than $100 billion a year.
Mohamed Shakir, head of endocrinology at Howard University Hospital, said the
new product could be particularly important in a city like Washington. There's a big racial
disparity in diabetes, with blacks, Hispanics and native Americans more likely to contract the
disease and less likely to receive adequate care. And Shakir said people lower on the income scale
aren't as willing to read up on the disease and take control of their illness.
Again, the consequences of expansive government fall heaviest on the most
vulnerable sections of the populace.
He said he hopes Pfizer will price Exubera fairly, and he looks forward to offering it to newly diagnosed diabetics.
The price of Exubera is none of Dr. Shakir's business. The 'fair' price is, by definition, whatever Pfizer chooses it to be. If they price it 'too' high, it is likely many people will not be able to afford it and Pfizer will not sell as many and therefore attain a poor profit. If they price it 'too' low, Pfizer will not recoup sufficient profit to justify their research expenditures. My guess is that they will probably price it just about 'right'. If they do not, they will probably find it difficult to remain competitive within the pharmaceutical industry.
Also, notice that Exubera will be available only by prescription. This will raise the price of this medicine for many patients and limit access. There is also a safety factor, people who have unexpected swings in sugar levels or forget their inhaler at home cannot stop in at the closest gas station. But, government tells us that mandating these prescriptions are necessary in order to protect the patients from themselves. Surely none of them is competent enough to manage their illness themselves.
So, the final questions are: how many preventable deaths occurred in the at least 7 years that the FDA wasted 'studying' the efficacy of Exubera? What has the cost been to society? How many of these were minorities and/or those in poverty?
When will people rise up and throw off the yolk of Big Government?
Posted 2/4/06
Generic Drugs Hit Backlog At FDA / No Plans to Expand Review Capabilities
2/4/06 Washington Post
At a time when low-cost generic drugs are being embraced as among the few ways to slow skyrocketing health care costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market -- an all-time high.
As a result, experts say, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide.
"We have a kind of crazy situation now where the FDA's generic reviews -- which are supposed to be quicker because they're less complicated -- on average take longer than the new drug reviews," said Kathleen Jaeger, president of the Generic Pharmaceutical Association.
Who is hurt most by the delays in getting these new drugs on the market? You guessed it, the poor, the minorities, the women, the ch
