Madoff Whistleblower Points The Finger At The FDA Also

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During Harry Markopolos' testimony this week, Congressman Alan Grayson, from the 8th District in Florida, uncovered a damning accusation made by Harry against the Food & Drug Administration. This was really no surprise to those at CareToLive, who have been fighting the FDA for the past two years, trying to get a safe and effective prostate cancer immunotherapy made available to the men who are in desperate need of it.

Congressman Alan Grayson: "You really have to start with the assumption that most of us in this industry really have our clients’ interests coming first." Do you know who made that statement?

Harry Markopolos: No.

Congressman Alan Grayson: Mr. Madoff made that statement. Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It's basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman Alan Grayson: And have you seen that in action?

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

(Source: http://www.cnbc.com/id/15840232?video=1021435842 - starts at 14:14)

This is another good reason to believe that the Food & Drug Administration (FDA) has interfered with the lack of progress in cancer treatments. It appears that the FDA, which is supposed to be looking out for we the people, has instead conspired to let the American people down in the worst, most inhumane way.

People have been fighting cancer for my entire 50+ years on this planet, with little progress made, except in a few types of cancer. Many of us thought there would be a cure for all cancers by now, yet according to the American Cancer Society, approximately 1,437,180 new cases of cancer were diagnosed in 2008 alone.

Harry Markopolos testified before Congress this week, about the Bernie Madoff Ponzi scheme. He said that he had spent 10 years sending information to the SEC, trying to get them to stop the Madoff scam. It took Harry less than 10 minutes to figure out if was a scam, and the SEC refused to investigate, costing many innocent victims their entire life savings.

Harry let Congress know, in no uncertain terms, that the SEC should have acted, and if they had, the $50 billion dollar ponzi scheme would never have grown bigger than $10 billion. Many lives would have been saved from ruination.

The FDA, like the SEC, has dropped the ball and refused to investigate or answer to the people in serious matters of treatment options. The FDA instead took care of certain business relationships, leaving people to die unnecessarily. The FDA ignored its own mission statement:

“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

Notice the word public is used three times in that statement and not the word client!

Nowhere is the corruption and incompetence clearer, than in the case of the FDA delay of Provenge®, a safe and effective, non toxic, non invasive immunotherapy for late stage prostate cancer. The FDA has kept this therapy from the public for almost 2 years, due to their conflicts and inconsistencies.

Approval of Provenge, would have opened the way for cancer to be treated safely and effectively without all the toxic side effects of radiation and chemotherapy, which destroys the healthy cells in the immune system that fight disease, as well as the cancerous cell. Hospitalization is unnecessary as this Immunotherapy treatment is similar to a blood transfusion, and can be administered in a doctor’s office.

Undoubtedly, the current entrenched treatments would suffer financially, perhaps even one day being rendered obsolete. Needless to say, Provenge has many enemies. Fortunately, it also has a staunch group of supporters, who are bound and determined to usher in the age of Immunotherapy.

The Markopolis testimony simply tells us that the FDA is captured and the real reason Provenge is not approved is because the FDA has forgotten it is the public it serves and it should not be a hostage to inter agency politics and concern for those that might influence their decisions. They have forgotten that they serve the public and instead think they serve special interest of big pharma and Wall Street and a few individuals that are able to exert control both from
inside and outside the FDA. They have become a beholden agency.

Instead, the FDA sold us out to their conflicted business relationships.

Provenge filed for approval in 2007 and was brought before an FDA Advisory Committee because it showed survival, the gold standard when looking at cancer treatments. That Committee voted Provenge safe, 17-0, and that it showed substantial evidence of efficacy, 13-4. Yet the FDA stopped it from reaching the men, and requested more data, despite the fact that they had over 10 years worth of data.

And we now have information from an Independent Data Monitoring Committee that reported Provenge shows a safe profile and a 20% survival advantage over placebo. FDA, NCI and the Prostate Cancer Foundation will tell you close to 30,000 men die every year in America from this lethal disease. 20% of 30,000 is 6,000 men! 6,000 lives!

The Provenge story proves how the FDA kowtowed to its friends and business relationships, conflicts which Harry Markopolos alluded to.

At the center of it is the Prostate Cancer Foundation, and its founder, junk bond king and convicted felon Michael Milken, along with his employee, consortium chairman, Dr. Howard Scher, who vociferously lobbied against approval.

In addition, ex-FDA Commissioner, Andrew Von Eschenbach, was also sleeping with the enemy.

See the connections here:

Von E pushed for Milken pardon//my response to the Times

http://www.investorvillage.com/smbd.asp?mb=971&mn=242559&pt=msg&mid=6606247

and here:

Bernard Madoff, the Mafia, and the Friends of Michael Milken

http://www.deepcapture.com/bernard-madoff-the-mafia-and-the-friends-of-michael-milken/

Congress mandated several years ago that the FDA has a duty to get safe and effective treatments to people with unmet medical needs. The FDA chooses to ignore this mandate.

When the FDA stopped Provenge, it hurt the advancement of the company behind it, namely, Dendreon, which is also working on a breast cancer treatment called, Neuvenge, causing it to be delayed due to lack of funds available due to the Provenge delay. They also have plans for immunotherapies for other cancers, brain, lung, colon etc, which have also been delayed due to lack of funding. This is another way the FDA interferes with progress.

"These data, together with the data we have published on the use of Provenge in prostate cancer, further substantiate the promise of active cellular immunotherapies as new treatments for different types of cancer," Dendreon”. Vice President of clinical affairs, Mark Frohlich, said.

"We are encouraged by the significant immune responses generated to NEUVENGE in these trials, which included patients with advanced breast, ovarian and colon cancer," said John W. Park, M.D., associate clinical professor of medicine and neurosurgery.

Even if you don't have prostate cancer or know someone who has breast cancer, ovarian cancer,  colon cancer, etc, you have a right to complain that the FDA has not fulfilled its mandate. You have a right to petition the government for a redress of grievances on behalf of your loved ones. The people who accepted jobs with these agencies and who took taxpayer money to do these jobs, must be held accountable. Some people go so far as to believe that the FDA is guilty of murder.

Of course they will likely ignore you. CareToLive filed a Citizen's Petition at the FDA in July of 2007, the only recourse a citizen has, and the FDA still has not answered it, despite a law that says they are supposed to respond within 180 days.

If anyone has any relatives or friends in the 8th District of Florida, we are asking them to contact Congressman Grayson and to request him to follow-up on this grave situation. We ask all of you to write to the President and your elected officials to pursue this very sad situation. We invite Harry Markopolos to shed more light on his comment.

To reiterate:

Harry Markopolos: Yes. It's basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman Alan Grayson: And have you seen that in action?

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

http://CareToLive.com/