The American Spectator : FDA Decision Dooms Cancer Patients

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The Public Policy

FDA Decision Dooms Cancer Patients

By Robert M. Goldberg on 7.1.11 @ 6:08AM

Two senior Public Citizen operatives now set policy for the FDA.

Opponents of medical progress are celebrating the decision of a Food and Drug Administration panel to revoke approval of the use of Avastin in treating advance breast cancer.

Not so fast.

As Scott Hensley, a health care reporter for NPR, wrote:

The day after a panel of experts advised the Food and Drug Administration to go ahead with plans to revoke approval of Avastin to treat breast cancer, European authorities moved in the opposite direction.

The European Medicines Agency (EMA) gave the OK to an expansion of Avastin’s approval to include using the drug in combination with Xeloda, a chemotherapy drug, to treat metastatic breast cancer, Genentech parent company Roche said Thursday.

The Europeans considered the same information that hasn’t proved persuasive to U.S. regulators. Among other things, a study called RIBBON 1 found Avastin plus Xeloda increased progression-free survival or PFS — (living longer without tumor growth) of women by 2.9 months over women getting Xeloda alone.

This improvement seems small but is actually quite significant. Gains in PFS among patients with cancers that spread through the body are hard to achieve because when the disease spreads it is considered incurable. And over time, the small victories over incurable cancers extend and improve life.

The EMA believes 2.9 months is a great beginning. The FDA sees nothing less than 6 months to be worth it and worked hard to make sure Avastin would never hit that mark.

The FDA’s Richard Pazdur, who heads up FDA’s Office of Cancer Drugs, had approved Avastin’s use in breast cancer on the condition that future studies confirmed the improvement in PFS. Genentech conducted three studies that hit that mark. But then Pazdur claimed that PFS was not enough. He wanted evidence that median overall survival increased.

While an increase in overall survival has been considered the gold standard for cancer drugs, progression-free survival has been used as a benchmark for longer and better quality of life.

That’s because a standard like overall survival only tells you what the median survival is for all patients — it doesn’t take into account individual differences in response based on genetic, clinical and other factors.

Yet when results of additional studies this summer concluded that Avastin doesn’t extend life on average, an FDA advisory committee suddenly decided that Avastin should be measured by overall median survival — not progression-free survival.

Before this measurement switch, the FDA admitted that the new studies showed a statistically significant improvement in PFS with Avastin. But then it said, “the magnitude of treatment effect, as commonly assessed by clinicians based on differences in median PFS, was marginal.”

Pazdur seems to want to toughen standards based on a one-size-fits-all measure that requires longer and more expensive clinical trials. In doing so he has been supported by such left-leaning and anti-innovation entities as the Center for Science in the Public Interest’s Merrill Goozner and Public Citizen, a Naderite group that has warned against most new medicines for cancer and diabetes since the 1970s. These and other Avastin opponents — who have long regarded the drug as a symbol of corporate greed — have lobbied for median survival as the key standard. They know that applying that standard would harm the perception of Avastin’s effectiveness.

Goozner — who has no medical background — was appointed to an FDA advisory committee on pharmaceutical science. Two senior Public Citizen operatives, Peter Lurie and Larry Sasich, now set policy for the FDA. Fran Visco, the head of the National Breast Cancer Coalition, applauded the FDA decision after lobbying for it over the past year. Visco, a Democrat, is also on Experts Advisory Panel for the Universal Health Insurance Program at the New America Foundation, a left-wing think tank supporting Obamacare. The NBBC also supported the administration’s decision not to cover mammograms for women under 50 though many breast cancers grow faster and earlier in African-American women.

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About the Author

Robert M. Goldberg is vice president of the Center for Medicine in the Public Interest and founder of Hands Off My H ealth, a grass roots health care empowerment network. His is new book, Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit, was published last month by Kaplan.

Letter to the Editor View all comments (44) | Leave a comment Leave a comment

Bill Hussein O'Stalin| 7.1.11 @ 6:33AM

Many in the Obama administration love death chambers whether they are virtual or actual.

They need to rid the earth of the human species and return it to a pristine state in which only the animals killed and ate each other.

Things of man such as houses and buildings and cars can not be tolerated.

The best way to rid the earth of people is to control health care and deny coverage for the elderly.

They've lived their lives so who cares. If you can also get rid of millions of women who are the egg poppers by denying them medicine, well all the better.

lydia | 7.1.11 @ 8:35AM

I am a 28 years old doctor, mature and beautiful.and now I am seeking a good man who can give me real love , so i got a username Andromeda2002 on--s'e'ek'c'ou'ga'r.c óm--.it is the first and best club for y'ounger women and old'er men, or older women and y'ounger men,to int'eract with each other. Maybe you wanna ch'eck 'it out or tell your friends!
It is bad enough that women with incurable metastatic breast cancer have to deal with this disease. Having to take on the added burdens of fighting the FDA and now the CMS just to stay alive is a cruel and unusual punishment unbecoming of a civilized society.

Humbert Humbert| 7.1.11 @ 10:51AM

Lydia: Didn't your Mommy tell you it was wrong
to sell sex for money?

USSAlabama| 7.1.11 @ 9:12AM

Anybody thinking of that 'daddy' commercial?

POST American| 7.1.11 @ 7:05AM

STILL another FDA decision has DOOMED millions more here and worldwide --that's the decision to say and do nothing about the
saturation of our food supply by the 'EUGENIC
enhanced' GMO's.

Monsanto, and the other 4 mega-agra corps
should surely be held for VAST capital crimes
prosecution.

Likewise Canadian PM Harper for signing secretly
for the stealth introduction of this toxic swill
across Canada ----all done in secret.

Sterility, organ failure and cancer are skyrocketing.

And then there's the intergenerational sterility feature
wherein your children, or granchildren are
set to be neutered ---even before birth.
In other words, when it begins to dawn on
Joe six pack --his posterity is smoke, the
perpetrators will be gone too. Truly a
perfect crime.

AS we're dealing with the 5th person on our
street dying of bizarre meurological disorders
or cancers ---something unheard of prior to
the 90's---we felt we should say something.

Mike Hawk| 7.1.11 @ 7:09AM

Beamed down from the mothership again, I see.

Stephanie| 7.1.11 @ 8:25AM

I agree with you Post Am. Totally. Monsanto is a monster and if the left was truely into controlling monster corporations, they would tackle this one. Doesn't anyone else here wonder about the explosion of cancers? I know so many folks with this dreaded disease and can't help but worry why.

PJ| 7.1.11 @ 9:41AM

There are credible studies showing that abortions & oral contraceptives increase the rate of breast cancer in women. Maybe if women stopped ingesting obvious chemicals found in pills to regulate the hormones involved in their menstrual cycle or refuse unnecessary elective abortive surgery that screws up their hormonal system, then we might actually see a major decrease in breast cancer.

Karibou Kidd| 7.1.11 @ 3:52PM

100 years ago most people died before their 50th birthday. Cancer is generally a disease of older age. Now that people live longer there are more who develop cancer. Duh!

Drunken Sailor| 7.1.11 @ 12:36PM

Seems our old friend DeeSee goes by many names.

Mike Hawk| 7.1.11 @ 7:10AM

Obamacare is always Shovel Ready.

WRTolkas| 7.1.11 @ 8:19AM

Dear Mr. Hawk,

An excellent comment to be added to my list.

Everyone have a safe and enjoyable 4th of July weekend.

Timothy L. Pennell| 7.1.11 @ 7:17AM

As you can clearly see, the DEATH PANELS are already in place. And, in true Marxist/Liberal/Progressive fashion, there won't be ONE Death Panel, it will be LAYERS of Bureaucracy, set up as a MAZE, to keep the prying eyes away.
"Harte Arbeit Wird Euch Frei Machen"
They are coming.
Actually, THEY ARE ALREADY HERE.

Terry Kalley | 7.1.11 @ 7:28AM

We in the Avastin patient community have no choice but to keep battling Big Brother in order to keep our loved ones alive. I established Freedom of Access to Medicines so that the Avastin women had at least one organization dedicated to their cause.

We will keep pressuring the FDA, an organization in need of major reform.

We will also pressure the Centers for Medicare and Medicaid Services, which yesterday first told Reuters that it would keep coverage for Avastin place only to add later in the day that it would review coverage for Avastin sometime within the next year.

It is bad enough that women with incurable metastatic breast cancer have to deal with this disease. Having to take on the added burdens of fighting the FDA and now the CMS just to stay alive is a cruel and unusual punishment unbecoming of a civilized society.

To support the Avastin women in this horrific fight, please sign the petition at www.fameds.org

Melvin| 7.1.11 @ 7:31AM

I guess there is only one solution to this problem.....Get them before they get us. For we are in a fight for the very air that we breath.
No ones going to miss a few less socialists.

USSAlabama| 7.1.11 @ 9:09AM

But how to do it? Watch Food Inc. and see how deeply the corruption has penetrated. Like a cancer.

Puprle Lips| 7.1.11 @ 8:26AM

The rush that senior bureaucrats must fell when they know they hold the keys to life and death must quite a thrill. And for a few weeks they have national reporters from the Post, Times, CBS, NPR, and ABC calling to do lunch. Then there are the calls from the White House, Big Pharm, and Congress. The high profile committee meetings, not to mention invites to Fox News, Hardball, and To Meet the Press make life worth living. As senior bureaucrast they hold more power than any President, House Speaker, or Supreme Cout Justice. They're beyond recourse to the law; they are the law. And for hundreds of thousands the stroke of thier pen can mean life or death.

Yes, life is good at the top.

And then the calls from Cuba... a certain lifetime President from South America has cancer. Can the bureaucrats be of assistance? Chavez, after all, is a fellow traveller. Yes, life is good.

youfamissim | 7.1.11 @ 8:29AM

I watched my wife die from breast cancer - unable to access drugs and other therapies - that are the sole therapies efficacious to breast cancer patients whose genetics predicate that fate. Avastin is not the only drug the FDA or other federal agency declare Strang Verbotten when ideology, or Fact Cat donors (who wish to retain market share by limiting competition) work with regulators to Help sick people. The most deadly form of breast cancer - genetic - has a low survival rate. You'd never know that from the American Cancer Societies , ACS, web site - where they twist data to claim a + 90% survival rate. Check the data for survival past the 5 year mark and you'll be disappointed. Other drugs removed include:

Artemisinan - a wormwood product that had worked well outside the USA. Cheap and effective - it had to be banned.
Hydrazine Sulfate is another product that helps cancer patients avoid cachexia - the wasting that occurs. Safe and cheap - that too was removed from shelves. (see Dr. Burton Goldberg's testimony before Congress for a didactic on the FDA's methods)
Insulin Potentiation is another effective method of using small doses of Cheomtherapy with higher cancer cell "Kill Rates" and none of the side effects - hair loss, sickness, fatique. This was mocked and ridiculed by the FDA - they limit its practitioners and availability. IP kept my wife alive for over a year when her oncologist said she had less than 90 days to live.
DMSA - (meso-2,-3-dimercaptosuccinic acid. DMSA was sold for years for metal chelation and as a dietary supplement and alternative for Ritalin. The EPA is working furiously to make Lead Paint the next asbestos liability product. The EPA recently removed DMSA. When Lead can be controlled and removed from the body cheaply, effectively, trial lawyers lose access to billions.

Lastly, clinical trials test only use patients whose disease is far advanced. This clever practice assures a new drug's failure rate is guaranteed, thereby permitting regulators broad latitude in determining which drugs get to market. To bring a new drug to market cost 1 Billion dollars. Many small and innovative firms cannot afford that ante. Drugs that have little curative value remain in place while newer ones that work cannot pass muster at the FDA.

Did you know the ACS spends most of the money it receives in Real Estate investment - not helping Cancer patients? Their portfolio is impressive... and they produce cheerful, PC pamphlets. I learned their claims of working to cure cancer were a secondary interest after I turned to them for them.

PJ| 7.1.11 @ 10:09AM

Youfamissim,
You have my condolences & prayers.

I use to work in the pharmaceutical industry. I concur that there is so much politics involved when dealing with the FDA & marketing.

I would like to make 1 comment about clinical trials using patients with advanced cancer. Most patients & their doctors want to first use those therapies that have been tested & verified to show a major success rate. They are not interested in questionable therapies but want to be cured. Why take chemicals that sometimes have horrible side effects & an iffy success rate? This results in clinical trials taking on those patients whose cancers have not responded to all FDA-recognized therapies. In other words clinical trials for experimental cancer drugs are usually the last hope for many of these patients.

Also the FDA imposes strict controls on these trials which includes the type of patient that is allowed to participate in.

Like your post implied, there is enough blame to go around.

D Carter| 7.3.11 @ 12:09AM

I hope you keep educating people and try getting Congress's attention. You make a wonderful advocate for Women's health. If Democrats would spend as much time helping with this kind of serious women health issues vs protecting Planned Parenthood ability to perform abortions imagine how much better off women's heath would be!

Big Java| 7.1.11 @ 8:39AM

Thank you, Ralph Nader! Another fine example of you and yours not knowing s***!

MikeBee| 7.1.11 @ 8:57AM

Terry's comments (above) are on the mark. Today, panel members of the FDA are often ex-employees of one of the drug giants. In this cushy position (which they may have gotten because of promotion/lobbying by their drug company), they have often been responsible for pushing drugs through approval which their old drug company manufactured, often placing the public at risk (Vioxx, anyone?). It very well may be that some members on the panel are not approving Avastin simply because the drug giant that got them their panel position is close to making their own version of Avastin. Let's hold up the other guy's product, while we develop our own. As Terry mentions, the FDA is in need of major reform, starting with how panel members are placed.

Also, am I the only one who's not surprised that a Democrat leader of a group was lobbying for something that would be harmful to BLACK women? (See bottom of page one of the article.) Yet another sign of Democrat racism, trying to hold down the numbers in the Black population (can't have one of THOSE living in our neighborhood, you know?).

Melvin| 7.1.11 @ 10:15AM

Well lookee, lookee, Big Pharma is now in control with the government, to cull the herd to maintain market share.
The big winners in Obama Care weren't the masses it was the monopoly that was created by the government to Big Pharma.
Now the government and Big Pharma will sit like Gods much like Julius Caesar, where the cancer patient will stand alone in the arena, and the IPAB panels will stand up with all their Roman finery and extend their arms, with a thumbs up, you live, and thumps down you die.
I wonder how many Democrat donors who contribute enough will be able to play God to Conservatives.

Claypoole| 7.3.11 @ 5:16PM

Over three years ago, Big Pharma--specifically Genentech--saved my life. They provided at no cost through their Access to Care Foundation a drug my oncologist prescribed and that I took for one year. Without Genentech's intervention, the drug would have cost about $36,000 for that year. I have been cancer-free since that time. I certainly would not claim that all of Big Pharma are angels, but after my experience, I did want to put in a
good word for some of what they do.

Wayne | 7.1.11 @ 12:14PM

FDA decisions have resulted in the deaths of untold thousands of people, maybe millions since its inception. It has limited options, favoring the a segment of the medical establishment. Its rules are capricious and arbitrary and leads to monopolies by a few drug companies and suppliers. It is totally unnecessary.

It is time to cut the strings and let people decide for themselves what kind of treatments to pursue, what drugs to take, what doctors to hire. We do not need a nanny state to force us to pursue prescriptions. We should not be forced to only buy drugs in the US. We have tolerated the tyranny of the FDA far too long.

Jack London| 7.1.11 @ 12:37PM

I guess I'll be alone in saying I'd prefer to see drugs on the market that actually work. Avastin does have some benefit in other types of cancer but not breast cancer. The Europeans have kept it approved only for one combination that doesn't show any survival benefit and could well reverse that decision soon.

By the way, those who advocate abandoning the FDA - are you confident your insurer would cover you for any drug you wanted to take?

Occam's Tool| 7.1.11 @ 8:59PM

Jack---Insurers very COMMONLY do not cover FDA approved medications for their indications. For example, in my specialty, psychiatry---Latuda is frequently not covered, despite being the cheapest drug in its class of newer antipsychotics. Abilify, Zyprexa, Risperdal consta, Invega Sustenna, I could go on and on.

For example, despite being on the market for years now, it is difficult to get Lexapro covered, although it is the best tolerated antidepressant there is (and by the way, although I was a speaker for many drug companies in the past, I no longer am, and the only drug company I own directly (I have mutual funds through work) is the generic company TEVA, as I do my best to invest in Israeli stocks whenever possible)

FDA approval allows for the drug to be available in the US. The FDA has nada and squat to do with the insurance companies covering any medications once approved.

In addition, the worst coverage for medications tends to be Medicaid, not private insurers.

Thanks for playing, Jack. Sit down and be quiet and learn something. The grownups are talking.

Jack London| 7.2.11 @ 6:35AM

This is nonsensical. The point I was making was if there was no authority approving drugs, what would happen? Would you and your insurer take on trust that a drug was safe and effective?

And what about Avastin for breast cancer, which is the main topic here. It sadly does not work so why aren't we putting pressure on the industry to create effective drugs and not waste billions giving useless and harmful products to people?

David C| 7.2.11 @ 9:35AM

What is actually nonsensical, Jack, is your response.

Insurance is irrelevant. The dependence on medical insurance is one of the factors wrecking health care in this country -- but that's another topic for another day. I have no insurance and don't want any.

As for taking something on trust, we needn't do that just because a big-government bureacracy isn't the final arbiter of what medicines we are and aren't allowed to use. Drug produces can still be required to test and keep effectiveness data on their products -- and then make them always available to prospective patients. People and their doctors could then decide for themselves.

It's all a matter of who you choose to trust more -- yourself and other individuals, or government bureacrats.

As for Avastin, Mr. Goldberg clearly disputes your assertion that it just "does not work." It seems that the "EMA and every major group of cancer providers" disagrees with you as well.

The simple question is shouldn't a patient who thinks that Avastin is (or can) work for her -- even if that makes her a 1 in 10,000 -- be able to tell Jack London and the FDA to f*ck off?

Jack London| 7.2.11 @ 3:44PM

Well you must be rich. With no insurance if you get cancer and want Avastin you'll have to pay $88,000 a year.

And I note the passive: 'Drug producers can still be required to test and keep effectiveness data on their products' - who will require them to do this?

I don't think you understand that many drugs are available off label - and this will also apply to Avastin in breast cancer. As you think insurance is irrelevant, then there are no concerns surely.

As for whether Avastin works, you should be aware that Goldberg's outfit is a pharma mouthpiece. The trials show that it doesn't have any survival benefits. When we start ignoring what the science tells us we are not on strong ground.

Occam's Tool| 7.2.11 @ 1:40PM

My point is that the insurers don't cover drugs that are safe and effective now, even drugs that have been demonstareted as safe and effective for 10 years or so.

Jack, the research on Avastin is still out. The usage would be for treatment resistant breast CAs. In addition, the drug companies DO spend billions doing their best to make sure the drugs are safe and effective. I can do things now that would have been impossible in 1993 with my patients, WHEN I am allowed to prescribe according tolatest data. I have found that insurance companies, PARTICULARLY government run insurance such as Medicaid, do all in their power to retard the latest developments.

With all due respect, Jack, you are not where the rubber meets the road. When you are a board certified physician with almost 2 decades of experience and a history of having treated tens of thousands of patients, may be I'll listen to you.

Jack London| 7.2.11 @ 4:04PM

Pharma spends a lot on safety/effectiveness because regulators require them to do so.

Avastin in metastatic breast cancer is not a safe and effective treatment, as the trials show. Will more trials change this? Very unlikely I'm afraid.

I have a good knowledge of oncology and molecular biology as part of my work and I suspect I know a lot more about this than you do.

Wayne | 7.2.11 @ 2:05PM

My insurer doesn't cover my Naturopath, but I assure you it doesn't stop me from seeing him.

JFGalt| 7.1.11 @ 12:53PM

What govt agency is left in this country that is not corrupt and infilatrated by corporate or ideological parasites? What bothers me more than anything about all this is the fact that it is so easy to find people to go along with what they must know to be wrong. For years people wondered how the Nazis managed to subvert the people of Germany into their insanity. Well, the answer is all around you. Look at cops that shoot peaceful protestors. TSA agents patting down children at airports. Congressmen passing laws they know to be bad. Monsanto destroying our food production in order to ensure their profits or corporations that have offshored their entire production and gutted America. The enemy is within. And it is us.

Richard| 7.1.11 @ 2:18PM

And why do we have such a death deciding organizaiton like FDA. Originally the FDA was created by the original Food and Drug Act which outlawed, for example, opium disguised as tonic. Why are they allowed to make such decisions as this? This appears to be another area of too much government.

Nite| 7.2.11 @ 12:10AM

The left leaning loons are getting ready for Obamacare, where care is rationed, and meds that cost too much are banned, regardless of how effective they are. Avastin is the only hope of some women with advanced breast cancer. I am aware of numerous cases, where it was highly effective. Study results can be twisted according to the purpose of the FDA. Some of these so called experts are a joke and wouldn't know anything about study results if it bit them on the butt. This is nothing more than another over-reach by the minions of His Lordship Obama.

Tenn Slim| 7.2.11 @ 8:03AM

Cancer treatments, meds, etal, tend to get minimal MSM coverage, unless the pundit has the disease.
Fed manipulation of stats to implement a desired end result is just the tip of the Regulatory iceberg.
The same process, methods, and means are prevalent in the farm industry, auto industry, gas and oil, energy industries. We occasionly get to read the Obama derailment issues, but never the final answer.
The Left will not go quietly into the night come 2012.

Bruce Patton| 7.3.11 @ 1:35AM

Have any of you seen the documentary on Dr. Burzynsky? Cancer treatment is a big money business but cancer cure is not profitable. Burzynski has used a paradigm shift in treating the worst tumors by using genome data to find the missing peptides needed by the body to stop the cancer. FDA and PhRMA has fought him for forty years. I hope lots of people view this documentary, it reveals the corruption of the FDA.

Surgeon| 7.3.11 @ 11:01PM

I had considered Medical oncology, but I am so glad I didn't go into the field. They talk about disease free progression where you still die at the exact same time, suffer side effects of the medicine, but your tumor doesn't grow on CT or MRI scan. Who cares? The other sham is "partial response" where the tumor shrinks by 50%. You still die at the same time, suffer the side effects of the chemo, but die with a smaller tumor.

I have no problems with researchers carrying on studies in research protocols, but we don't need to be paying gazillions to pharmaceutical companies to actually make people finals months worse in terms of quality of life and die at the same time albeit with unchanged or smaller tumors.

POST American| 7.4.11 @ 9:09AM

There's been a relentless and long standing
Rockefeller medical mafia disinfo op on the
matter of skyrocketing cancer underway for
decades.

FACT IS cancer is nearly entirely man made
--caused by enviornmental pollution (air/water)
or foods, meds and things ingested.

For ages, even to the 70's. there were even substantial forces officially
disavowing the conneciton between cancer and smoking!

The skyrocketing of childhood cancer is
beyond dispute or denial.

Likewise the legacy of the high-profile EUGENIST
Jonas Salk's polio vaccine ---which contains the
a live simian cancer virus which sleeps in the
subject's system until hormones change ---around
retirement age.

DO try and get your background straight, and from people
NOT on the Rockefeller Foundation payroll.

It makes ALLLL the difference.

REALLY

Cappicola| 7.4.11 @ 12:46PM

Dread fear of litigation is fast becoming the single most destructive force within our society. We are defaulting to "safe" and playing everything close to the vest as a result. Political correctness, as just one example, is fueled mainly by this fear. For a person who has been diagnosed with cancer, perhaps an aggressive form, he or she should not be denied access to any drug that may help cure the disease or, at the very least, mollify its grip by providing a better quality of life for the duration. Now, it could simply come down to the signing and filing of a waiver by the patient, absolving the drug maker of any culpability in the event the condition worsens or the individual dies.

We need to begin K-I-S-S-ing more so that good people are not condemned to agony by legal wrangling. Our society needs to set up legislative bulwarks to protect those who may be legitimately be offering practical and readily available help from the clutches of the legal profession, an entity that I believe is the biggest threat to our society's very existence.

A person of means can easily travel to Europe and afford both the stay and the treatment and the availability of various new and/or experimental drugs. The person of average or lesser means cannot do likewise and may therefore be doomed.

weddingdress | 7.5.11 @ 4:14AM

FACT IS cancer is nearly entirely man made
--caused by enviornmental pollution (air/water)
or foods, meds and things ingested.

For ages, even to the 70's. there were even substantial forces officially
disavowing the conneciton between cancer and smoking!

Rich Rostrom| 7.5.11 @ 1:15PM

Mr. Goldberg asserts that this is a politically driven decision.

The FDA voted unanimously to rescind Avastin's conditional approval. They did so against the fervent advocacy of its maker Genentech (a subsidiary of the $50B company Roche Holdings) and emotional pleas from individual patients. That doesn't look like a politically convenient act.

Mr. Goldberg further asserts that the FDA rejected clear scientific evidence to gratify the agenda of some obscure Obama appointees. Is this really plausible?

Derek Lowe is a medicinal chemist with decades of experience in drug development, who blogs at "In the Pipeline" (http://pipeline.corante.com). He rarely discusses political issues, but he has been critical of Obamacare and skeptical of "climate change".

Mr. Lowe has commented on Avastin several times:

"Avastin: Taking It Back", "Avastin At the FDA Today: Passion Should Lose" (http://snipurl.com/27x9o8), "Avastin and Medicare".

As he notes, Avastin's benefits (if any) are marginal at best, and like nearly all cancer chemotherapies, it has severe, dangerous, damaging side effects.

He has looked at the studies (which Mr. Goldberg claims justify Avastin use), and concluded that
"... for metastatic breast cancer... Avastin doesn't seem like a good idea even if it were free."

The American Spectator