Thursday, June 07, 2007
Meeting of the minds on cancer
Although I have so far been spared the diagnosis of cancer, I did watch my mother die from lung cancer. That was less than eight years ago. But so much has happened in cancer research and treatment in that short time. Had she received her diagnosis today, I'm confident she would have lived longer than the three months she had between diagnosis and death. Because of medical advances in treatment and therapy, we now have more cancer survivors in the United States than ever - 10 million - and experts believe that number can double in the next decade.

Earlier this week, more than 32,000 cancer specialists met in Chicago, Illinois, to present and learn about the latest successes (and a few failures) in cancer research and treatments. Over 4,000 new studies were presented at the annual American Society of Clinical Oncology meeting. There were no blockbuster breakthroughs or discoveries, but a lot of studies were presented, showing - as Dr. Archie Bleyer, a Bend, Oregon, oncologist, put it, "Investment in cancer research is paying off."

For the first time, researchers have found a way to treat advanced liver cancer and extend survival (Nexavar - Full Story). Doctors also reported on better, more tolerable treatments for some of the other, more difficult cancers - like ovary, thyroid and kidney. Until recently, there were no good treatments available for these cancer patients. But according to many cancer specialists, this progress is in danger of seriously slowing down. That's because the funding of cancer research is dwindling.

Dr. Allen Lichter, ASCO's vice president & CEO and former dean of the University of Michigan's Medical School, told reporters at the beginning of the conference, "We are now in the midst of the longest sustained period of flat funding in research in decades." He says in real dollars, the funding of the National Cancer Institutes has actually declined 12 percent over the past four years.

Many doctors I spoke with at this conference are concerned about the lack of research funding. Some are finding alternative resources such as the Lance Armstrong Foundation. But these alternatives cannot replace what the federal government can offer. Armstrong, a cancer survivor himself, told you earlier this year how he's running out of patience on this funding issue and wants congressional leaders to act. (Full Story)

Slowing down the pace of cancer research and breakthroughs can be devastating to those suffering from the disease. "1,500 people will die from cancer today," Lichter told reporters. But there are only so many tax dollars to go around.

Next June, more than 32,000 cancer specialists will gather in Chicago again. Will cancer research funding be an even bigger issue then? What should be done? Should more tax dollars go to cancer research? Should, as Lance Armstrong suggests, cancer research be a more prominent topic discussed among our elected and potentially future elected officials? .
I think the supply of funds for many types of research, cancer included, is severely lacking. In that respect, I wonder why some things that are really odd DO get funding- like "does cow flatulence really affect the ozone layer" or the "survey of rhinotillexomania" (compulsive nose picking), or "do bees talk to each other". That makes NO sense. I think tax dollars should be POURED into cancer research, as well as Alzheimer's, Celiac Disease, Mental Disorders, and pretty much anything that is making us unhealthy (or killing us).

My personal fear is not physical decline and becoming decrepit, but losing grasp of my mental capacity.
You say there were no blockbuster reports - I disagree. There have been several stories in the news about the study that shows that cheomotherapy for breast cancer is almost entirely useless (only helps 8% of women), and extremely dangerous - including permanent heart damage that used to be passed off as "temporary", and a shocking rise in leukemiam. Why are women still being sold this disastrous brew as "a life saver", when it is no such thing?

I also disagree that there has been so much progress on cancer. Yeah, maybe there are more people managing to live a few more years, but what about the quality of that life? After almost 30 years of our "War on Cancer", we're having about as much success as our "War on Terrorism".

Sorry, I'm not a cheerleader for the cancer industry. I've seen too many people hurt and not helped by them.
Prostate cancer kills over 27,500 men per year, yet the FDA recently refused to approve a treatment, Provenge, that extends life without the side effects of taxotere chemotherapy. The FDA's own advisory comittee recommended the treatment as safe (17-0) and having "substantial evidence of efficacy." Nonetheless, the FDA, for reasons unexplained, asked Provenge's developer, Dendreon, for more data that delays for 2 to 4 years this new approach that attacks cancer cells by priming the patient's immune system. In the meantime 27,000 plus men with advanced prostate die annually because the FDA denied life extending therapy. This is a scandal! And CNN hasn't covered this story. Sanjay, Help.
Hi Miriam,
Cancer affects all of us in one way or another. It is a horrificly cruel disease. By the time my Father was diagnosed with pancreatic cancer last year, it had spread to his liver and beyond. He had less than three months to live. I have seen several people die of cancer. It breaks your heart beyond repair and it is NOT the way I want to go.
This week~end I will be attending the funeral of a 19 year old girl who died of cervical cancer. A simple vaccine could have saved her life.
We must put more funding into cancer reasearch and it should be a more prominent topic discussed by elected officials and potentially future elected officials. We should stop the suffering from this dreaded disease. Also, I believe that medicinal marijuana should be available for every cancer patient. In the meanwhile, preventative measures should be taken by everyone. A diet with lots of veggies and less red meat! More exercise!
Have a great healthy and happy week~end all!
Dr. Gupta,

I am sorry to hear that you lost your mother to Cancer. As we both know it is a horrible disease which effects almost every American in one way or another.

It is very true that funding is lacking for research by our government.
However, there is a vast pool of private investment funds. More then enough to fuel all the research you could ever imagine.

Ironically it is the government which is restricting these funds to be utilized for research.

The private investor has become very weary of the way the FDA and Big Pharm have controlled the "drug scene".

I could write a book citing instances of this travesty.
However, one very profound instance of this is occurring as I type this comment.

Prostate Cancer is the second largest Cancer which affects American men (after skin cancer).

Nearly 30,000 men die of Prostate Cancer per year in the US alone.
As it stands now there is only 1 drug which PC patients can take. This is the Chemotherapy Taxotere.
By using this drug it not only kills cancerous cells but also any good ones and it has some horrifying side effects. As it is more than half the PC patients would rather die gracefully then be ravaged by this toxic chemical of a drug.

So there are no other alternatives for these dying men. What if there was a drug that has proven to be virtually 100% safe and has shown to extend life by years in patients that had only months? Would you want it?

There is one; Provenge by Dendreon a very small biotech out of Seattle Washington. On March 29th a panel of FDA appointed Doctors recommended to that the FDA approve this drug therapy. And then on May 9th the FDA said they wanted more studies done!

More studies is great if it were for a drug that was not safe and if the drug was not one which was for patients which had no other options.

These men are dying. They have no options. They are willing to take it. There Oncologists want to have it in the quiver to offer!??

Now evidence has come out that two of the Doctors sitting on the Advisory Panel have some serious Conflicts Of Interest.

What is happening inside the FDA???? There is clearly corruption.

If they were simply fair and non-corrupt then there would be no funding problems. The investors which drive these small biotech firms have less of an incentive knowing that it is not a fair playing field. And that the Big Pharmaceutical companies and the huge Hedge Funds of Wall Street are the ones who really dictate the happenings of the FDA.

More importantly, drugs such as Provenge which are proven safe and life saving would be saving lives right now if it were not for the corruption which exists within our FDA. It is really that simple.

So you see funding is not the problem it is the corruption which exists within the system.

The last thing we need to do is throw more of the tax payers money at the issue when it will only be utilized for anyone but the American citizens best interest.

If we as Americans can clean up the FDA and make it fair then we can get the investment community to do just that , invest.
And then you can start talking about more government funding!

We really can find cures and quickly but not with the staus quo.

Good luck to all Cancer patients.
I made the mistake of addressing my post to Dr Gupta.

I hope that you would change this to Dear Miriam,

And more importantly, I hope that you post my comment.

Thanks you
Cliffhucker
If politician would ask citizens in general how far they would be willing to go to fund cancer research, they would probably be astounded. Cancer is a plague on our society and we treat the heck out of it but appear to grossly underfund preventative research.
While the good doctors were at ASCO with their big Pharma buddies, some of us were in DC trying to raise awareness of the great travesty done by the FDA to not put Provenge on the market for prostate cancer patients. Over 50,000 men will needlessly die in the next two years because FDA requires "statistical purity" using research study guidelines from the last century and has Dr's give judgement that have severe financial conflicts of interest.

It is a sad time. Contact your congressman and see www.provengenow.org

Bruce E. Holmes, PE
Dear Miriam,

Time and money spend on Primary Health Care Education and Prevention in Cancer is as much important and in my opinion even to a higher extent than curing.
So far, research proven the possible oncological paths of the development of cancer, which is resourceful in primary prevention, indicating early detection and health promotion. We can go on and on looking for much better and better cures for cancer, but primarily we can also prevent the onset of cancer. Money funding is considered in either directions.

It is true that prevention and research funding is more focused on women's breast cancer and less on men's prostate cancer. THe main culprit is that we have less advocates fighting for and paying attention to men's health.
Lance Armstrong is the one of the few men, fighting for men's health rights. My advice to Lance Armstrong: team up with those women who are already experienced with women's health advocacy, rights and funding. It should not be just a sex/gender oriented thing, but focused on all health in general.
I watched helplessly when my father died from lung cancer – or in reality, he died from the chemotherapy treatment. He would have lived longer, but the chemo made him too weak – instead of months, he died within weeks. If I were to be diagnosed today, I would not even consider chemotherapy.

There are drugs that exist today (in perpetual clinical trials or waiting endlessly for FDA approval) that have can help the terminally ill; however, they are killed as much by bureaucracy and politics as by the disease. It is inhumane to tell a terminally ill person that they do not have access to a drug that might save or prolong there lives.

A perfect example is the recent delay to approve the prostate cancer drug Provenge. In the time that it takes the FDA to get their statistics in order, tens of thousands of men will die. WHY?
I'm also familiar with the Provenge story. Here is a drug that everyone acknowledges is safe. But because some have problems with the efficacy data, it's been held up for years, while men in the US die of prostate cancer at the rate of 27K/yr.

Considering that Immunotherapies act slower than chemotherapies, because their MOA is to train the body itself to fight the cancer, the Provenge trials clearly (in retrospect) were not well designed. But although surrogate markers such as tumor shrinkage can be delayed, overall survival, at which Provenge excelled, cannot be faked.

The FDA ignored its own panel's vote of 17-0 on safety and 13-4 on efficacy to send Provenge back to trial. There's also a very interesting story here of deep conflicts of interest (despite some clear public denials) and unorthodox behavior by two panelists who were dead set against Provenge.

Recently the NCI went to capitol hill to moan about a shortage of cancer funding. Yet FDA's unexpected blow to Provenge's maker, which almost sunk the company financially as investors went running, passed without comment. If NCI wants to see more dollars flow into the biotech research sector, they might petition the FDA to act more reasonably and consistently concerning drugs that have been proven safe and efficacious, and place more importance on the critical needs of dying men with no other options than on statistical trivial pursuits.

This story is a scandal in the making, begging to be told. Hopefully Congress will soon call the FDA on the carpet to explain why they value the lives of so many men so cheaply.
I just returned from the American Cancer Society's Relay for Life event held in my community. My mother died with breast cancer last year, not from the cancer but from a reaction to the chemotherapy. Eventually every family in America will be touched by this terrible disease. Yes there may be over 10 million survivors, but all too often the cure is as brutal as the disease. I was dismayed to read the comment about the immunotherapy drug Provenge being denied approval to end-stage prostrate cancer patients. If this is true, and the treatment is universally agreed to be safe, the FDA should be ashamed of itself. Poison (chemo) alone is not going to be the answer, even us laypeople know that.

Someday there is going to be a Radical Change that completely changes the landscape of cancer treatment. Guess what? It ISN'T going to come from BIG PHARMA! This is an industry totally focused on, and rewarded by, selling Nexium at $5/pill over Prilosec when the latter (97% as effective) is approved for OTC and generic distribution.
There were no blockbuster breakthroughs or discoveries reported because one potentially breakthrough, Provenge was silenced by the FDA. Provenge is an immunotherapy treatment which was turned down by the FDA for approval on May 9, 2007; even though, the FDA’s own advisory panel of 17 experts overwhelmingly recommended Provenge for approval on March 29, 2007.

There are so many unanswered questions and a great deal of controversy surrounding Provenge, I don't know what to think any more. Advanced prostate cancer patients should have an opportunity to utilize the treatment, if they so desire. They and their doctors should be given any and all treatment options to fight this war on cancer. I am baffled as to why this is so difficult to accomplish. Currently, the only available treatment for advanced prostate cancer is chemotherapy, which most men refuse, due to the dreadful side effects and decreased quality of life.

According to the CDC, “African-American men have higher rates of getting and dying from prostate cancer than men of other racial or ethnic groups. During the lifetime of an African American male, one out of five will be diagnosed with prostate cancer and one out of 20 will die from prostate cancer”. Most African American men and men in general with prostate cancer have never heard of Provenge and if the FDA has its way, they never will. I believe if prostate cancer was affecting Caucasian men as it affects African American men, we would be shouting this injustice from every roof top. This story is begging to be told and the actions of the FDA should be investigated, now. Prostate cancer survivors don’t have the luxury of time. By 2008, the death rate from prostate cancer will reach 54,000. The FDA has set access to Provenge back at least until 2008 and at most until year 2010, not to mention the grave disservice to advanced prostate cancer survivors and mankind, especially African American men.
As a physician, I am appalled at the actions of the FDA of late. They have disregarded their own expert committee in delaying the medicine Provenge, the first cancer vaccine ever, for advanced prostate cancer. I am equally appalled at the few oncologists who displayed a visceral opposition to this medicine, moving the FDA to overturn the overwhelming recommendation by the panel of experts. What effect do you suppose this will have on cancer research?

This medicine was recommended as incredibly safe and effective. Yet the FDA wants years more data. 60,000 American men will die from prostate cancer in the next few years, more than the combined death count of both the Iraq and Viet Nam wars. Yet the FDA wants more data. Most of these men refuse chemotherapy at this stage because of the horrific side effects. Yet the FDA wants more data. And most telling, the few docs exerting so much pressure against Provenge all had conflicts of interest that are shameful. I would like to think their approach to this groundbreaking medicine is simply a case of “the earth is flat” mentality. Unfortunately, I believe it is more nefarious than that. And many, many thousands of Americans, as well as cancer research will pay dearly.
In my opinion investment has become a waste of money because every new treatment that the biotechnology firms develop get killed by the FDA's Bridge to the afterlife. Look at: PHARMACYCLICS INC, IDM PHARMA INC, DOR BIOPHARMA INC, & DENDREON CORP... all recently had promising drugs that the FDA killed even though they showed that they extended life. Dendreon's Provenge which already had passed the Advisory Council's look with overwhelming praise got murdered by the FDA and along with many prostate cancer victims. Why?!??! that is the question! Why?!!!

Sadly, The people of the United States will have to look to China for cures in the coming years and beyond.
Our FDA has failed us.

CE
On the bright side, some good news about progress made on cancer preventive nutrition: Researchers at UC Berkeley recently announced that Diindolylmethane (a phytochemical found in Broccoli) is a direct modulator of Interferon-Gamma sensitivity and production and as such it has potent anti-viral, anti-bacterial and anti-cancer properties.

More information about this ground breaking discovery is available at:

http://www.diindolylmethane.org/

http://www.activamune.com/

Regards,

Michael
Having the FDA approve some of these promising biotech drugs like Provenge would be a start! Denial and delays only strangle cash flow and hinders these safe and effective treatments from ever reaching the terminally ill people that are desparately in need.
Hello Dr. Gupta,

I am usually not one to write letters to opinion makers.
I know that many people requested that the FDA explain to the people and their medical doctors why it chose not to approve Provenge, even though it was advised by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
Among the NOs, Dr. Sher and Dr. Hussain.

Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon to be insufficient, why did it even submit the data to a panel of experts for their opinions?

Some of those doctors that voted "NO" as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) "leaked" to the media. They were Dr. Sher and Dr. Hussain. I let everybody out there judge on the ethics of this behaviour.

If nobody has the gift of foresight, we can use hindsight.
On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker's prostate cancer treatment, causing Novacea shares to double.
Both Dr. Sher and Dr. Hussain are Novacea consultants.
Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

I close with a few more questions.
When Mr. Von Eschenbach, the FDA Commissioner, says the FDA is going to be "a bridge and not a barrier", what does he mean?
When one sees FDA's consultants try to influence FDA's decisions, one wonders who is in charge at the FDA?

I'm a white male. I run a statistically significant risk to have PC. I'd want to have Provenge available, just in case.

I wish you all the best,

phil
Chemotherapy is extremely toxic. They are derivative of the Mustard Gas used in World War I. In many cases, people die just from the chemo. Chemo is shown to be barely effective - for some lucky people it beats the cancer. But not without horrible side effects. Sadly for most, the effects of chemo not only destroy the patients' quality of life, but the quality of life of the people they love... and all for naught. For the survivors, it sometimes means permanent memory loss and other side effects.

Recently the FDA rejected a novel therapy for late stage prostate cancer called Provenge. Patients diagnosed with late stage PC often don't live 20 months. 9% of patients survive 3 years. Those who take chemo, only 11% live 3 years. But of the patients on Provenge, 33% of the patients lived 36 months or longer. This is truly remarkable, and confirmed by 2 phase 3 clinical trials.

The FDA rejection of this drug was cold and heartless. It simply appears that the FDA is either incompetent or corrupted or both. They appear to be in the grip of the Chemo lobby. The corruption and incompetence in Washington is not limited to congress and the white house. It has spread like a cancer into nearly every agency including the FDA. FDA advisors railed against Provenge, despite the fact that it has low toxicity and quite remarkable survival advantage.

Provenge is a new class of drugs called immunotherapy. It teaches the immune system to attack cancer cells through the use of targeted proteins. Unlike chemo it only kills Cancer cells.

The FDA's own panel of experts voted unanimously that it was safe, and 13-4 that it was effective - yet in an almost unprecedented move the FDA still refused to grant the drug approval.

What can I say? This decision is an abomination. Here is a drug that has undergone 10 years of testing and shows a dramatic improvement in life expectancy with very minimal side effects, and the FDA refuses to let dying patients have it!?! The FDA is sick. 80,000 or more men may die prematurely as a result of this decision, and the research behind immunotherapy may be set back many years. The company that developed this drug is also working on drugs for Breast, Renal, Lung and other cancers, but because of the FDA decision all these studies have to be shelved, setting scientific advancement back and causing even more premature deaths.

I am sick of this FDA. They show so little compassion for their fellow human beings. It is time for a complete overhaul of this agency from top to bottom. They need to get their priorities in order - and the top priority should be getting novel cancer therapeutics into the market for patients with late stage cancers. Instead of helping, they are simply standing in the way. It is an absolute outrage.
The FDA recently reviewed a drug called PROVENGE that offers a radically different approach to treating Prostrate cancer. If approved, this would have been the first immunotherapy for Prostrate cancer treatment (i.e. teaching the immune system to fight the cancer).The drug is both safe and effective as evidenced by the voting pattern of prominent specialists convened by the FDA to review the data package. The Advisory Committee met on March 29 and in a 17 to 0 vote declared the drug (Provenge) to be safe. And in a 13 to 4 vote that it demonstrated substantial efficacy. Curiously, two weeks later the FDA denied approval, going AGAINST the recommendation of their advisory committee.

Three of the dissenting votes were from AC members who had significant conflicts of interest and who have a lot to lose if the drug is approved. The other “no” vote was from an FDA statistician who stated that the chance that the data was a fluke was one in 40. Two of the no voters then wrote letters to the FDA in which they criticized the AC results. These letters were leaked to the press.

The FDA then refused to approve the drug, saying that “More data is required” Such data will take two to four years to develop. In effect, the FDA is sending a message to terminally ill patients that it’s either chemotherapy or nothing while we spend another year or two to ponder over the statistical purity of the current studies.

While the existing therapies (radiation, hormones, etc.) are viable alternatives as front-line therapy, the patient population would be so much better served if this drug (PROVENGE) was added as an alternative.
Is the FDA in bed with Big CHEMO Pharma? It sure looks like it to me! On March 29th the FDA's panel voted 17-0 that Provenge was safe and 13-4 that there was "substantial evidence of efficacy! So, lets see 30,000 men will die earlier than they should each year so the FDA can make sure 100% that it works is a bunch of crap! Patients treated with Provenge stand a 34% chance of being alive after 3 YEARS vs 11% forthe untreated group! Provenge only side effect is a mild flu-like symtom lasting 2-3 days after each infusion vs chemo's many horid side effects! Something sure stinks at the FDA and the news media and Congress need to look into it! IMHO there is a lot of wrong doing that needs to be brought to light! Let the chemo side of the FDA and big chemo pharma take the "CHEMO" I'll take the vaccine! Immunotherapies like Provenge are the FUTURE! Chemo is the past!
As one of four "maturing" brothers between the ages of 64 and 51 in my family who had both Grandfather's as victim's of prostate cancer, we all are active in having the necessary, regular medical exams and tests to be sure any such cancer, if it develops, is caught by early detection in us.

None of us have been able to comprehend the FDA's action in delaying for 2 to 4 years or more the release of PROVENGE to the market so prostate cancer patients and their physicians have only a second available treatments for this horrible, deadly disease (taxotore chemo is the only other alternative currently).

As others pointed out, according to the American Cancer Society, prostate cancer will kill some 27,000 men this year... that's a body count of prostate cancer victims equaling 74 men per day -- EVERY DAY for the next year!

If the news media splashed such a death toll count nightly on the national news, this nation--men and women--would be up in arms immediately.

The unfortunate additional bad news for both genders is that this brand new type of cancer therapy--an imunotherapy which rejuvenates the body's own immune system to start fighting the cancer--is that this small company's other clinical and pre-clinical trials for promising treatments for breast, cervical, ovarian, lung, colon and kidney cancer have been placed on hold in order to devote their limited resources to getting the "Additional Data Required" by the FDA. ... stunning and unbelieveable!!

Additionally, it appears the existing completed clinical trials show good SAFETY data as shown by the March FDA's own Advisory meeting voting 17-0 that it's safe and 13 to 4 that it shows substantial effect in fighting prostate cancer. At any time, the FDA still has the ability to stop sales if previously unknown unsafe factors appears--as the FDA has done with several high-profile drugs recently.

Releasing this safe drug--even CONDITIONALLY while awaiting further data taking years to gather--is a no-brainer!

Physicians (many of whom want to be able to use this treatment for their patients who have only 1 or even no other option) and patients
should be given the opportunity to make an informed CHOICE!!!

Thankfully, some media attention has been shown on this situation; more--much, much more--is needed to activate the American public--men and women--to let their voices be heard to help convince their Congress person and the FDA to release this treatment to terminal prostate cancer patients..... the original Cancer Victims this treatment is currently aimed to help... the key word is TERMINAL!!!

.... NOW ! ! ! ! !

Let's help the head of the FDA, who has publicly stated the FDA is going to be a BRIDGE and not a BARRIER, to get new treatments to patients who need them and who have no or few alternatives--exactly what Provenge is.

Finally, this new field of fighting cancer called immuno-therapy--activating the body's own immune system to recognize and to fight cancer cells on it's own offers another weapon in the arsenal to help the FDA achieve it's Commissioner's, Dr. Andy von Eschenbach, stated goal of getting rid of cancer by 2015.

Please look into this treament and offer your opinion to those who can free up the BARRIER for terminally ill men.

td... Virginia Beach, VA
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