Just watching the sands of the hourglass.
Did you read KB's thesis? There is much there to contemplate.
There is also a plethora of theories and ideas for the treatment of PD in the literature; that's what a PD researcher does first before they think hard and propose a "program" to search for other ideas that may get closer to a chemical hit, either small molecule, small molecule interaction with macromolecule or surgical intervention, as a better alternative to what we have. All of the things that KB has had to say, may fuel the next "program" in some pharmaceutical or biochemistry or neurosurgical program.
The reason that we are still not yet there are still; why are some people completely resistant to PD while others suffer terribly at an early age. I think that this is a question as yet unanswered, and indeed, the "holy grail" of our understanding of PD and steps to it's elimination from our genome.

Dear CS,

I won't call you ol, you may have a few years on me, but you have a young outlook on life. My concern is the contracts the research companies have patients' desire to help others end up being used in research designed to prove one company's drug is better for other company's drug, therfore improving the Marketing of the company doing research.

Researchers' primary goal should be sure not to protect the research subjects. However, research is used not for developing new drugs, but to find ways to better market old ones.

FDA is in a tough position. They do not want to be in an adversarial position with the pharmaceutical industry, because this would slow down research and the constituants would complain that the FDA takes to long to approve drugs. The FDA has chosen an easier path, but now the pendulum has swung the other way and the pharmaceutical industry has taken advantage of the FDA, not for the good of humanity, but for high profits.

Pharmaceutical Industrys' claim all their profit goes for research. But the research is not patient oriented but marketing oriented, to prove their drug is the best for what ails the consumer, to fight the encroaching generic competition, for patents which repackage their existing drugs as a patch, chewable tablet, combination of two drugs, etc.

The Industry also claim to educate the physicians with post education about new drugs and the FDA gives the physicians' credit for this type of post medical training at the hands of a biased pharmaceutical company. The FDA is between a rock and a hard place. Citizens call for lower taxes meaning less money for educational research at public universities allowing truely scientific research. The FDA also allows universities to sell their research to the highest price offered by pharmaceutical companies so they can patent the research. What a mess! The question is how do you advocate for reform?

Vicky

here's one active bill :


from UPI:
http://www.upi.com/Health_Business/Analysis/2007/05/09/analysis_senate_backs_fda_reform_bill/4840/
Analysis: Senate backs FDA reform bill
By TODD ZWILLICH

WASHINGTON, May 9 (UPI) -- The Senate backed a bill reforming the Food and Drug Administration Wednesday, increasing fines for industry wrongdoing, but avoiding several efforts to strengthen the agency's authority.

The reforms are part of a larger package reauthorizing a $370 million user fee program. Under the program drug makers pay money directly into FDA coffers in exchange for a guarantee of faster drug approvals.

Lawmakers voted to give the agency new power to compel drug companies to conduct studies of the safety of drugs already on the market. It also gave it new authority to change drug warning labels without first negotiating with firms.

FDA reforms have been on the congressional agenda since 2004, when Merck pulled the pain drug Vioxx from pharmacy shelves after evidence emerged that it raised heart attack and stroke risk when used by patients long term.

"The FDA should be the gold standard for safety but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," said Sen. Edward Kennedy, D-Mass., the bill's main sponsor.

The bill passed 93-1 after a week of debate on the Senate floor that at times involved intense behind-the-scenes negotiations. Sen. Bernie Sanders, I-Vt., voted against the measure.

"This bill will meet the challenges of protecting American consumers and patients and usher in a new era of drug safety," said Sen. Mike Enzi, R-Wyo., the bill's chief GOP sponsor.

Some lawmakers who supported the bill in the end said it was significantly weaker than they had wanted.

"It was alright," Sen. Byron Dorgan, D-N.D., said of the bill. He got broad support for a measure allowing U.S. consumers to import lower-cost drugs from Canada and other industrialized countries. The Senate then blocked the program because of a threatened White House veto.
Lawmakers also narrowly rejected an attempt to crack down on the conflicts of interest on FDA expert advisory panels. One amendment would have restricted panels to just one member with financial ties to industry, but that was rejected after a tied 47-47 vote.

Watchdogs have criticized the panels, and the FDA recently adopted stricter conflict-of-interest standards.

Kennedy's original bill gave the FDA the power to block direct-to-consumer drug advertisements for the first two years of a medication's marketing life. But the provision was removed before a final vote.
The Senate also rejected an amendment creating an independent FDA office to monitor the safety of the U.S. drug supply. Such monitoring is now under the authority of the division that approves new drugs, an arrangement some lawmakers called a conflict of interest.

Pharmaceutical companies lobbied Congress heavily on the bill. The industry opposed drug importation and broad new regulatory authority for the FDA.

"Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous safety and efficacy standards in the world today, said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America.

Tauzin, a former Republican congressman from Louisiana, chaired the House committee that oversees the FDA.

Consumer groups gave the bill a mixed reaction. David Sloane, chief lobbyist for AARP, called the bill "a good start" to lowering drug prices for seniors but said "much remains to be done."

But Sidney Wolfe, director of Public Citizen's Health Research Group, said the bill would do little to improve patient safety.

Wolfe said the bill did not address concerns that the FDA routinely ignored the advice of some of its scientists over drug-safety issues. He also criticized the approval of the 15-year-old user fee program.

"If anyone thinks (user fees) do not alter FDA's vigilance over the industry, they're just delusional," Wolfe said in an interview. "Anyone who thinks this is going to slow or halt the seemingly endless series of drug disasters is really wrong."

Lawmakers approved one amendment boosting fines the FDA can impose on drug makers from $10,000 to $250,000.

"These penalties need to be more than just an insignificant cost of doing business in order to affect behavior," said Sen. Charles Grassley, R-Iowa, who sponsored the measure.
The bill must now go to the House of Representatives, which is considering a slightly different set of reforms.

Rick,

Yes, you started a good discussion. Just as RLSmi stated I can also be of help with pubmed stuff. And may some experiments with mice!
As you know, I am going thru Ayurvedic therapy and I feel a lot better already. I am hoping to be a part of a research group here that is investigating ayurvedic and other therapies for PD patients. So there may be room for curcumin and other things there.

Thanks
Girija

[I]"It was alright," Sen. Byron Dorgan, D-N.D., said of the bill. He got broad support for a measure allowing U.S. consumers to import lower-cost drugs from Canada and other industrialized countries. The Senate then blocked the program because of a threatened White House veto.
Lawmakers also narrowly rejected an attempt to crack down on the conflicts of interest on FDA expert advisory panels. One amendment would have restricted panels to just one member with financial ties to industry, but that was rejected after a tied 47-47 vote.

Watchdogs have criticized the panels, and the FDA recently adopted stricter conflict-of-interest standards.

Kennedy's original bill gave the FDA the power to block direct-to-consumer drug advertisements for the first two years of a medication's marketing life. But the provision was removed before a final vote.
The Senate also rejected an amendment creating an independent FDA office to monitor the safety of the U.S. drug supply. Such monitoring is now under the authority of the division that approves new drugs, an arrangement some lawmakers called a conflict of interest.

Pharmaceutical companies lobbied Congress heavily on the bill. The industry opposed drug importation and broad new regulatory authority for the FDA.[/I

]


I agree with senator Kennedy's remarks. The lobbying by the pharmaceutical industry (PI)took all the teeth out of the bill by stopping drug importation and not making the PI not having to compete with the lower prices of imports. The imports are more than likely safer because they are government regulated. The PI are allowed to operate in a closed market rather than a free market. This is not the way America business operates. It would be like the Auto industry getting a bill passed to not allow imported cars. They made alot of money before other countries began developing smaller cars and technology to significantly increase the milage for a tank of gas. The consumer voted for Toyota over GM by buying Toyota's products. This will force American car producers to improve technology to have their products get better gas miliage. It can only be a winning situation for the consumer, free market competition.

As long as American PI does not have to compete in a free market enterprise system prices of drugs will remain high and American consumers will not have the opportunity to vote for lower prices by buying lower priced imported drugs. Advocacy needs to be done to overpower the US drug cartel lobbying of the political system.

Sorry Paula, I look at your post and see no improvement. It is just keeping the status quo. The bill changes nothing.

Vicky

P.S. I can't believe I am supporting the Democratic party. But when they are right, they are right.

another two quality posts. Things sure have been shakin' around here lately, did the Imp of lassitude go under the bridge for a wee-wee? I can hardly read all the good stuff posted recently by the gals and guys of this blogg. Imagine what we could do collectively if we weren't so complacent (i know,I know, speak for myself ). Have you ever written what you thought was a great post or a great answer to a post and then just deleted it because you were too tired to finish it? I sure have
Now Vicky, about clinical test to show better compliance or efficacy in a patient population, have you ever gotten into one of these study reports and seen the stats, so many died over the study period, so many dropped out, X many got side effects A,B,C and D..... Sometimes a 10 million dollar study will clearly point to bugs in the drugs of the sponsoring company, and superioriity of their competitors compound (this of course is often hush hush; they don't go tell it on the mountain, over the hills and everywhere )
And Paula, having the FDA in your pocket is still a possibility, but ALL drug companies whine constantly that the FDA takes too long, eating into patent profits, which they try to compensate for by bringing dates of submiission closer in line to what the companies want (or some other "slights of hand"). I mean even six months extention to a patent could mean a great year or a poor one (low raises, bonuses for the peons, only 10 million bonus for the poor little CEO)
And you are right to see that what they say about "plowing profits bach into the field" is so much horseyhoohoo. Research is peanuts compared to development, and it doesn't have to be this way. Development is where all the "froth" is "skimmed off". Well, time for some more dopa, the keyboard is slow today! cs

No offense taken here...I just posted the bill because you asked about change. Ted Kennedy was supposed to speak at Bio right before MJF but was tied up and sent a tape.

As Mary Richards from PAN says, "a bill is fair when both sides are equally frustrated".

paula

Why are you assuming I am trying to offend you? My argument is against the bill, not you personaly. I cannot agree with Mary Sullivan of PAN. Increasing a one time fine to the pharmaceutical industry to $250,000 is a slap on the hand when the industry is earning a million a day in profit.

Public Citizen's assessment of the ten drug firms among the Fortune 500 companies in the United States showed that they were substantially more profitable than any other industry in 2002. There are three methods to calculate profits: as a percentage of revenue, of assets, and of equity. Using these three methods, drug company profits are (respectively) 5.5. 6.1 and 2.7 times higher than the average for all Fortune 500 firms.

There was no "fair" negotiation on this bill. The PI spent a great deal for lobbying because they had the money to do it and were very sure of being successful. Now what I would like to know is how much campaign funding President Bush received was from PI.

CS, yes I have read study results, particularly, of every drug I have had prescribed for me. I am also aware of ghostwriters, rather than scientists, used to promote spins on research results.

Vicky

It appears that my message was misstated. I only said no offense taken because you said sorry paula i look at your post and see no improvement. it wasn't a disagreement. Anyway i came in to post this link which i think is an excellent source for all these things we are talking about. scroll down some too.

http://www.gooznews.com/

here's a bit more:

5/11 Water Cooler Talk on FDA Reforms
Proposal to Give FDA More Muscle Gets Mixed Reviews ... "[The provision for a post-market drug surveillance system], if adequately funded and implemented, should help restore confidence in the agency and, more importantly, allow the benefits and risks of a drug to be updated over years of use — as opposed to our current system that gets its safety information almost exclusively from research studies that are neither performed in real-world settings nor in real-world patients" — A. Mark Fendrick, Univ. of Michigan ... [ HealthDay ]
See also: Passage of Drug Safety Bill Was Common Goal for Two Very Different Senators [ NY Times ]
See also: Senators who weakened drug bill received millions from industry [ USA Today ]



paula