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Cancer and the Presidential Candidates

 
Posted on Tuesday, February 26, 2008
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Obama, Clinton and McCain Compared

Cancer is now the leading cause of death in adults under the age of 85.  It is also the leading cause of death by disease in children.  Every day more than 1,500 men, women and children die of cancer in the U.S.  That is more than 1 person every minute.  What do the current presidential candidates, Obama, Clinton, and McCain know about cancer?  What do they plan to do to help put a halt to this outrageous death toll?


Cancer Awareness – The Personal Connection

All three candidates have a personal connection to cancer. Obama’s mother died of ovarian cancer in 1995 when she was 53.  Since 1993, McCain has had at least three bouts with melanoma.  (McCain’s aides say that he has been cancer-free for more than five years although, like all cancer survivors, he faces a risk of recurrence.)  Hillary Clinton lost her mother-in-law to breast cancer in 1994.  And in January 2001, Bill Clinton was diagnosed with the highly curable basal cell carcinoma.  Clearly, all three candidates are acutely aware of cancer.

Treatment and Prevention – Records, Not Rhetoric

Putting their rhetoric aside, let’s look at their records when it comes to leadership in cancer treatment and prevention. A search of cancer related bills sponsored in the Senate by each candidate revealed one for McCain, and several proposals from both Obama and Clinton.

Obama has sponsored or cosponsored bills to accelerate genomics research (S 976), enable states to develop or expand activities to monitor exposure to environmental toxins and pollutants (S 1068), and improve biomarkers for the early detection and screening of ovarian cancer (S 2569).

Senator Clinton has sponsored or cosponsored bills to provide education on the health consequences of exposure to secondhand smoke (S 2005), support Pancreatic Cancer Awareness Month (S Res 222), ask the President to declare lung cancer a public health priority (S Res 87), require health plans to provide coverage for a minimum hospital stay for mastectomies, lumpectomies, and lymph node dissection for the treatment of breast cancer (S 459), and amend the Safe Drinking Water Act to protect the health of susceptible populations from trichloroethylene a probable carcinogen (S.1911).

In addition, both Obama and Clinton were among the cosponsors of S.471 a bill to provide for human embryonic stem cell research.  And all three candidates cosponsored a bill to issue a postal stamp to raise funds for breast cancer research (S.597) and a bill that would provide grants to better understand the environmental factors related to breast cancer (S.579).

Presidential Cancer Forum

The Lance Armstrong Foundation held a Presidential Cancer Forum on August 27, 2007 and invited all the presidential candidates to attend.  Clinton attended.  Obama and McCain did not.

At the forum, Clinton said, “What really bothers me is that we are on the brink of so many medical breakthroughs right now. And instead of pushing forward with the resources and the focus that is needed, the current administration has literally called a halt to the War Against Cancer.”  Clinton introduced her nine-point plan for tackling cancer (available on her website).  One item on the list was doubling of funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI) over 10 years.

During this Forum, Senator Edwards pointed out that Clinton has accepted campaign contributions from the health care industry.  He challenged how much change is possible when Clinton’s position was to give drug companies, insurance companies and their lobbyists “a seat at the table.” 

And, although not in attendance at the Presidential Cancer Forum, Obama had previously signed the American Cancer Society’s “Congressional Cancer Promise” which emphasized increased cancer screening and increased funding for the National Cancer Institute.  In addition, Obama is quoted as saying, “As President, I will make ending cancer the top priority it needs to be by increasing funding for the NIH, NCI, and other medical research grants. The fight against cancer is a critically important issue in the lives of millions of Americans. It needs to be a top priority for our government."

Is More Money the Solution to the Cancer Problem?

The rhetoric from the democratic candidates indicates that they are prepared to throw more money at the cancer problem.  Is that the answer?

The NCI has spent over forty billion dollars in research in just the last ten years alone.  Drugs companies also spend tens of billions of dollars on cancer research.  Yet with all this money, there have been no significant breakthroughs in the treatment of advanced or metastatic solid cancers since the “war on cancer” was launched on January 22, 1971, during President Nixon’s State of the Union Address.  The median survival rates for solid advanced or metastatic cancers are measured in weeks or months and are largely unchanged.  Thirty seven years later, people continue to run for the cure, march, bike, and shave their heads to raise more money.  How much money is needed?  We have already spent well over one hundred billion dollars since the “war” was launched.  Should we spend another hundred billion?  Or do we need to spend a trillion?  What is the price tag to cure cancer?

More money may not be the solution.   If money is not the answer, what is?  In a word – “freedom.”  Freedom to use other treatment modalities outside the current narrow range officially sanctioned by our health authorities.

Lack of Freedom of Choice and the FDA

The FDA does not allow all potential cancer treatments to reach the market, only those that they approve after a drug company invests an estimated $500 million to take the treatment through clinical trials.  Drug companies, however, will only invest this much money in treatments they can patent.  A patent allows the pharmaceutical company to control the product, set the price, and make a profit.  The problem, of course, is that patentable cancer drugs are by definition synthetic; they are made in a lab.  This shuts out virtually every naturally occurring compound that already exists in nature and explains why no mushroom, vitamin, herb, or other naturally occurring whole entity has ever been FDA approved for the treatment cancer.  This also explains why “terminal” cancer patients have so few viable options with conventional medicine.

Today, a patient and their licensed medical doctor can not use whatever cancer therapy they choose.  They must abide by what the FDA approves.  If, however, licensed medical doctors could select whatever cancer modality they (and their patients) decide is appropriate then the universe of options would expand immensely. 

Freedom of Choice is Dangerous – Really?

The FDA contends that allowing this freedom of choice is dangerous because it would bypass the requirement for clinical testing for carcinogenicity, toxicity or efficacy. 

No one wants to take a drug that can or may cause cancer. However, requiring carcinogenicity testing in the context of cancer is disingenuous for at least three reasons.

First, there is no logic in stopping cancer patients from accessing a therapy because they could get cancer from it in five, ten or twenty years. A small theoretical risk of developing cancer in the future carries little significance compared to the reality that the individual is dying of cancer now. 

Second, the requirement for carcinogenicity testing suggests that all the products that are approved by the FDA are tested for carcinogenicity. This is not true. For example, none of the thirty or more vaccines that millions of children are administered before they are eighteen months old have been tested for carcinogenicity.  In fact, these vaccines contain known or suspected carcinogens such as mercury and formaldehyde.  Despite cancer being the leading cause of death by disease in children, the FDA permits healthy children to be injected with untested products that contain potential carcinogens, yet prohibits cancer victims with little time left to take a similar risk.

Third, the FDA admits that many conventional drugs ‘routinely used’ to treat cancer patients can have serious or life-threatening effects.  In fact, many chemotherapy drugs are listed as known or suspected human carcinogens with the National Toxicology Program, whose participating agencies include the FDA, NIH, and the Centers for Disease Control (CDC). 

The FDA’s position, therefore, is that a cancer patient may be poisoned with a known carcinogen (i.e. chemotherapy), but it would be too dangerous for the patient to take a natural agent that is only theoretically carcinogenic.

Besides carcinogenicity, the FDA argues that because people can be injured or killed from the toxicity of unapproved drugs, physicians and patients should not have the freedom to use these drugs.  Apparently the FDA believes that the same risk-benefit equation applies to every drug and disease. Such logic is unsupportable.  For example, the FDA cites the thalidomide disaster as a reason to clinically test every single drug.  Thalidomide was a sedative that was prescribed to pregnant women to combat many of the symptoms associated with morning sickness.  This drug killed or produced catastrophic birth defects in many children.  However, thalidomide was a sleeping pill and no one dies from insomnia. It is therefore legitimate and appropriate for the FDA to require thorough and meticulous clinical testing of a sleeping pill because any risk may outweigh the benefit.

However, cancer is not insomnia. In the context of a cancer patient who has been sent home to die or for whom orthodox therapies are ineffective, the potential benefits of an unapproved treatment is not dying or not dying in tremendous pain. The hypothetical risks that many cancer patients are willing to endure for such benefits are enormous. Nonetheless, the FDA insists that treatments for insomnia and cancer must be subject to similar procedures for clinical testing and approval.

In addition, clinical testing under the auspices of FDA approval does not guarantee a drug’s safety. For example, according to the New England Journal of Medicine, “the results of clinical trials submitted with an application to the FDA to market a drug, cannot provide comprehensive information on possible adverse events.”

Ironically, while most chemotherapy drugs are FDA-approved for something, many are not approved for the specific cancers for which they are used.  Over time, and often with the urging of drug companies, these “off-label” uses become part of the standard of care.

In addition to treating cancer like insomnia, the FDA treats laboratory drugs the same as natural agents. The FDA states that “[I]t does not matter to FDA (sic) whether a product is characterized as ‘mainstream’ or ‘alternative’; it does not matter whether the product was synthesized in a state-of-the-art laboratory or was found in the Brazilian rain forest.”  Even herbs, the FDA points out, can “pose serious risks.”  This argument ignores at least one critical point. There is a tremendous history and wealth of information regarding the application of certain herbs and other naturally occurring agents to human disease.  While many naturally occurring substances can be dangerous or deadly, it is pure arrogance to insist that the existing, extensive folk and medical knowledge regarding the safety and efficacy of certain natural agents in the treatment of cancer should be ignored.

The FDA also maintains that without clinical testing, physicians and patients cannot make informed choices regarding a treatment’s benefits (i.e. efficacy).  In the cancer context, this is a hypocritical argument. Under the rubric of standard clinical testing, thousands of cancer patients are administered drugs whose biological effects are not yet known.  In other words, it is acceptable for patients to use their bodies as a living laboratory to test a synthetic drug from a major pharmaceutical company, but it is not acceptable for those same patients to try a naturally occurring agent prescribed by their physician. In both scenarios, data can be collected on patient outcomes and compared to the figures of patients who use other treatments. In this way, the results of using non-approved therapies can be calculated and compared to standard treatments.

Furthermore, the FDA ignores the fact that a licensed medical doctor who has used a particular treatment is the expert on its application and use. While the treatment may be new, and thus not routinely used, a small minority of physicians will always be ahead of the rest. Such is the nature of medicine. Nonetheless, for the FDA, this physician’s experience, knowledge and expertise is trumped by uninformed FDA bureaucrats sitting in an office or cubicle.

And finally, beneath its public relations veneer as our protector, the FDA is an agency that reportedly lets drug company representatives make decisions for the country, approves dangerous drugs, and does not perform necessary follow-up on approved drugs.

Dramatic Reformation of FDA Needed

Addressing the inherent problem of FDA centralized control over what is or is not accessible to cancer patients would require a dramatic reformation of the FDA which is something that the next president could theoretically accomplish.  This agency is part of the United States Department of Health and Human Services (DHHS).  And the DHHS is a department of the federal executive branch which, of course, reports to the president.  

Unfortunately, neither Obama, Clinton, or McCain seem poised to actually reform the FDA.  In fact, the only candidate still in the running who has indicated a willingness to fundamentally change the FDA is Republican candidate Ron Paul.  Paul, a physician, sponsored H.R.2117 (The “Health Freedom Protection Act”).  This bill is designed to shift the burden of proof to the FDA to prove that health claims for supplements are not scientifically warranted.  Currently, health claims for supplements are forbidden as advertising unless they relate directly to either the body’s structure or function.  For example, it is permissible to say that Vitamin C “boosts your immune system.”  But, one cannot advertise that Vitamin C can help with the common cold, scurvy, or cancer.  If H.R. 2117 was passed, claims would be permitted unless and until the FDA proved the claim was false.  While HR 2117 would not permit cancer patients to have access to any cancer therapy they wanted, it would at least allow factual treatment claims to be made for supplements, a position which is currently illegal.

Some Unsolicited Advice for the Next President

Currently, we have a system in place that centralizes decision making power among a small number of bureaucrats; a system that enriches drug companies and drives Wall Street speculation; a system that requires that any approved treatment for cancer be an expensive synthesized drug; a system that insures that a whole universe of potential cancer treatments is unobtainable.  So here is an unsolicited suggestion for the next president:

Dear Mr. (or Ms.) President:

If you are genuinely interested in addressing this nation’s cancer problem don’t make the same false and disastrous assumptions that others have made that have propelled cancer to become the number one cause of death in this country.  Don’t assume that opening a checkbook is the answer.  Don’t assume that our current system of centralized control of treatments through one bureaucracy strife with failures and conflicts of interest is in the best interest of the country.  Don’t be afraid to take on the drug companies who have profited in the billions from the current status quo while patients continue to die. Don’t be afraid to give medical doctors and their cancer patients the freedom to select their treatment of choice without outside interference.  After all, our country was founded on the belief that individual freedom was something to be embraced and protected.  Finally, if you do not change the course we are currently on, you can expect over two million American men, women and children to die of cancer during your 4-year term.

References

For cancer statistics see the National Cancer Institute statistical information.

For FDA’s position on why cancer drugs have to be clinically tested and quoted FDA statements above see: Patient Access to Alternative Treatments: Beyond the FDA Before the Government Reform Committee of the House of Representatives, 105th Cong. (Apr. 22, 1998) (statement of Michael A. Friedman, M.D. Lead Deputy Commissioner Food and Drug Administration).

For information on the lack of testing of pediatric vaccines for carcinogenicity see: PHYSICIANS’ DESK REFERENCE 1510, 1520, 1528, 1819, 1737, 1740, 1833, 1843, 1908, 2316, 2320, 2333, 3048 (53rd ed. 1999).  For a list of  pediatric vaccines, see Center’s for Disease Control Recommended Childhood Immunization Schedule United States.

For information on cancer being the leading cause of death by disease in children see:
American Cancer Society,—Childhood Cancer, Introduction

For citation to New England Journal of Medicine see: G. A. Faich, Adverse-Drug-Reaction Monitoring, 314 NEW ENG. J. MED. 1589-92 (1986).

For conflicts of interest at the FDA see: Lurie P, et al., Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings. JAMA. 2006 Apr 26;295(16):1921-8.  Available here. 

For FDA’s approval of dangerous drugs see: PBS Frontline interview with Sidney Wolfe, MD.  Available here
   
For FDA’s lack of follow-up on approved drugs see: FDA says firms still lagging on follow-up drug studies by Andrew Bridges, Associated Press, March 4, 2006. 
Available here.  

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