Archive for the ‘General Cancer Research’ Category

Shock study: Chemotherapy can backfire, make cancer worse by triggering tumor growth

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Posted 08 Aug 2012 — by James Street
Category Chemotherapy, localized chemotherapy, side effects of chemotherapy
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Scientists found that healthy cells damaged by chemotherapy secreted more of a protein called WNT16B, which boosts cancer cell survival. ‘The increase in WNT16B was completely unexpected,” said Peter Nelson, of the Fred Hutchinson Cancer Research Center.

AFP RELAX NEWS

Monday, August 6, 2012, 12:59 PM

Long considered the most effective cancer-fighting treatment, chemotherapy may actually make cancer worse, according to a shocking new study.

The extremely aggressive therapy, which kills both cancerous and healthy cells indiscriminately, can cause healthy cells to secrete a protein that sustains tumor growth and resistance to further treatment.

Researchers in the United States made the “completely unexpected” finding while seeking to explain why cancer cells are so resilient inside the human body when they are easy to kill in the lab.

They tested the effects of a type of chemotherapy on tissue collected from men with prostate cancer, and found “evidence of DNA damage” in healthy cells after treatment, the scientists wrote in Nature Medicine.

Chemotherapy works by inhibiting reproduction of fast-dividing cells such as those found in tumors.

The scientists found that healthy cells damaged by chemotherapy secreted more of a protein called WNT16B which boosts cancer cell survival.

“The increase in WNT16B was completely unexpected,” study co-author Peter Nelson of the Fred Hutchinson Cancer Research Center in Seattle told AFP.

The protein was taken up by tumor cells neighboring the damaged cells.

“WNT16B, when secreted, would interact with nearby tumor cells and cause them to grow, invade, and importantly, resist subsequent therapy,” said Nelson.

In cancer treatment, tumors often respond well initially, followed by rapid re-growth and then resistance to further chemotherapy.

Rates of tumor cell reproduction have been shown to accelerate between treatments.

“Our results indicate that damage responses in benign cells… may directly contribute to enhanced tumor growth kinetics,” wrote the team.

The researchers said they confirmed their findings with breast and ovarian cancer tumors.

CANCER TREATMENT OVERVIEW

The result paves the way for research into new, improved treatment, said Nelson.

“For example, an antibody to WNT16B, given with chemotherapy, may improve responses (kill more tumor cells),” he said in an email exchange.

“Alternatively, it may be possible to use smaller, less toxic doses of therapy.”

Identified: a critical tumor suppressor for cancer

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Posted 05 Aug 2012 — by James Street
Category Lymphoma, MYC
Posted On: August 4, 2012 – 1:31pm

R, FL – August 2, 2012 – Scientists from the Florida campus of The Scripps Research Institute have identified a protein that impairs the development and maintenance of lymphoma (cancer of the lymph nodes), but is repressed during the initial stages of the disease, allowing for rapid tumor growth.

While the study, published in the August 3, 2012 edition of the journal Cell, largely focuses on the role of this new tumor suppressor in lymphoma induced by Myc oncoproteins (the cancer-promoting products of Myc oncogenes), the authors show this circuit is apparently operational in all human tumors with MYC involvement, which is more than half of all human tumor types.

“This opens a new therapeutic avenue to exploit for cancers with Myc involvement—including relapsed metastatic tumors and refractory tumors, those that have not responded to treatment,” said John Cleveland, a Scripps Research professor and chair of the Department of Cancer Biology, who led the study.

The Myc family of oncoproteins (c-Myc, N-Myc, and L-Myc) regulate critical pathways that contribute to tumors; c-Myc expression, which is activated in human Burkitt lymphoma, is sufficient to induce the growth of several tumor types in animal models.

John Cleveland, Ph.D., a Scripps Research professor and chair of the department of cancer biology, led the study.

(Photo Credit: Photo courtesy of The Scripps Research Institute.)

In the new study, the scientists focused on precancerous and malignant Myc-expressing B cells, part of the immune system affected in human lymphoma. Using transgenic animal models, Cleveland and his team, led by the efforts of senior postdoctoral fellow Robert Rounbehler, showed that Myc-directed repression of a protein called tristetraprolin (TTP/ZFP36) was important for both the development and maintenance of cancer. The suppression of TTP is a hallmark of human cancers with MYC involvement, Cleveland noted.

The scientists’ results showed that overriding this pathway by forced expression of TTP more than doubled the lifespan of Myc transgenic mice. Strikingly, Rounbehler discovered that re-introduction of TTP into Myc-driven lymphoma totally disabled these tumors, indicating an important therapeutic target.

The authors showed that Myc regulates hundreds of genes that contain adenylate-uridylate-rich elements (AU-rich elements), which play an important role in RNA stability and are found in many messenger RNAs (mRNAs) that code for oncogenes, nuclear transcription factors, and cytokines. AU-rich elements direct the mRNA for degradation; they are thought to be vital for controlling expression during cell growth.

“Myc regulates the expression of select AU-binding proteins to control the destruction of certain mRNAs,” Cleveland said. “Also, our study strongly suggests that other AU-binding proteins may also, in fact, function as tumor suppressors in other cancers.”

Collusion Between Pharmaceutical Industry and Government Deepens

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Posted 02 Aug 2012 — by James Street
Category Finance and Politics of cancer research and treatment

By Dr. Mercola

There’s no shortage of stories detailing conflicts of interest—so many in fact that you may be getting sick and tired of hearing of them. However, this is a truly important issue that must be tackled, and one of the ways of doing that is by exposing it to the harsh light of day. As long as people remain unaware, or turn a blind eye, it will continue unabated.

The price we pay for not paying attention is the loss of health, as the information disseminated by grossly compromised health agencies is skewed in favor of various industries, with Big Pharma leading the pack as one of the most powerful political and governmental influences.

Here, I will review two important revolving-door cases, and while neither is recent news, many of you may still be unaware of them.

Former CDC Director Now President of Merck’s Vaccine Unit

In the summer of 2011, Merck president Julie Gerberding said in a news interview1 that she’s “very bullish on vaccines,” as she recounted the various ways she helps Merck sell its products. What she didn’t divulge was her motivation for leaving her job as director of the Centers for Disease Control and Prevention (CDC)—an agency charged with overseeing vaccines and drug companies—and join Merck in the first place, back in January 2010.

If you don’t see the enormity of the influence her former high-level ties to the CDC can have, just consider the fact that Merck makes 14 of the 17 pediatric vaccines recommended by the CDC, and 9 of the 10 recommended for adults, and while vaccine safety advocates are trying to rein in the number of vaccines given to babies, safety concerns keep falling on deaf ears. The vaccine industry is booming, and it’s become quite clear that profit potential is the driving factor behind it.

One of the reasons for this is because vaccine patents do not expire like drugs do, so each vaccine adopted for widespread use has the potential to make enormous, continuous profits for decades to come. Vaccine makers also enjoy a high degree of immunity against lawsuits—and in the case of pandemic vaccines, absolute immunity—so the financial liability when something goes wrong is very low, compared to drugs.

Gerberding has a Long History of Disregard for Vaccine Safety

Joining a parade of other high-ranking government officials who pass through the revolving doors between government and Big Pharma, Gerberding left a trail of controversy behind her when she left the CDC. While a 2009 article by the Institute for Southern Studies lists a number of them2, I believe they left out the most important ones, namely her misinformation campaign about the pandemic swine flu vaccine, as well as her naive stance on vaccine safety issues in general.

The CDC disseminated extremely exaggerated data on the 2009 H1N1 “pandemic” and urged almost everyone in the U.S. to take the new, untested vaccines. When questions arose, they blocked CBS’s requests for samples of the swine flu cases and added obstacles to getting information. Despite the many dangers that have since been linked to the hastily developed vaccine—including the confirmed link to narcolepsy—the H1N1 vaccine is now part and parcel of the “regular” seasonal flu vaccine, although most people are completely unaware of this fact. And the CDC is now, for the first time ever, urging the seasonal flu vaccine on everyone in the country, from six months’ of age until death.

Even more disturbing, the CDC withheld data on miscarriages from the H1N1 vaccines under Gerberding’s lead, while insisting that pregnant women be put first in line to receive it. This was a dramatic reversal of its own recommendations. More than 3,500 post-vaccination miscarriages may have simply been ignored by the CDC.

One of Merck’s potentially most dangerous vaccines right now is Gardasil; a vaccine that so far has been linked to thousands of adverse events and at least 49 unexplained deaths. It’s a situation that the FDA and CDC have repeatedly denied, even as the adverse reports mount.

Gerberding’s 2004 report to Congress, ‘Prevention of Genital Human Papillomavirus Infection3 likely played a significant role in getting the controversial vaccine approved in the first place. Needless to say, the approval of this questionable vaccine guaranteed her future employer billions of dollars-worth of profits. Gerberding has also been a staunch defender of thimerosal, the mercury-based preservative used in many vaccines, and has consistently denied any links between vaccines and autism.

All in all, Gerberding has repeatedly demonstrated that safety is nowhere on her list of priorities or concerns when it comes to vaccines. It’s easy to see why Merck would want her to head up their vaccine unit. For the rest of us, however, her blatant disregard for proven vaccine safety is bad news indeed.

Former NIH Director Now Heads Sanofi Research Labs

Another former government official who’s switched sides is Elias Zerhouni, former director of the National Institutes of Health (NIH)—one of the world’s foremost medical research centers, and an agency of the US Department of Health and Human Services. Zerhouni is now head of Sanofi-Aventis’ research labs4. He also is a professor at Johns Hopkins School of Medicine; a member of the Board of Trustees at the Mayo Clinic; and is a senior fellow for the Bill & Melinda Gates Foundation’s Global Health Program5.

As pointed out in a recent article by Forbes Magazine6, Zerhouni is no stranger to controversies over conflicts-of-interest.

In the fall of 2003, the NIH with Zerhouni at its head faced grave accusations when it came to light that hundreds of its scientists had financial ties to the medical and pharmaceutical industries. According to a 2004 article in the NIH Record7, over 100 scientists did not get approval for their industry activities, even though the rules were so loose virtually all requests to conduct outside work were approved by the agency, without any limits on compensation or hours worked for outside entities.

In one case, an academic scientist was found to have a financial interest in a therapy that ended up killing a patient. The case served as a potent warning of how dangerous such conflicts of interest can be. While Zerhouni managed to emerge from the 2003 debacle looking like a good crisis manager, the following paragraphs from the NIH Record8 are quite telling. Essentially, Zerhouni dissuaded Congress from doing the right thing, which is ban all outside activities of those working for the NIH, limiting the restrictions for conflicts of interest to upper level management only:

“[Zerhouni] disclosed that “initially, Congress truly wanted to ban [all outside activities], and the members of the committee have been very public about that…I was fortunate to be able to make contact with legislators and to help them understand what happened, how it happened, and why [a draconian response] might not be the right thing to do.”

Zerhouni said that over the course of long discussion, a good consensus emerged that formed the basis of NIH’s approach to the issue: stewards of public funds should never be vulnerable even to the perception that their activities could result in private gain. The top concern, he said, is, “How do you keep a true firewall and separation between the public trust — the money the public has given us in trust — and the activities of those who manage that resource?”

He doesn’t think it was well appreciated outside of NIH that the agency “has a dual nature — number one, we are a granting agency, but number two, we are also one of the most advanced, most capable biomedical research institutions in the world.

So we’re both sort of an academic, scientific research place, and yet next to that we’re also a government agency with its own rules and regulations…I said, look, we need to build a firewall around those who have fiduciary responsibility relative to the government, and those who do not. And that’s where we came up with these much more stringent rules for directors, deputy directors, and people who have those authorities, versus those who do not.”

Conflicts of Interest Affect Your Life and Well-Being…

When it comes to medicine, mere disclosure of conflict of interest is not nearly enough. Patients need unbiased advice when it comes to making decisions that can impact their very life, and physicians and scientists with financial ties to the drug industry should not be allowed to participate in broad policy and public-health recommendations in the first place. Likewise, while it’s perfectly legal to engage the revolving door and switch jobs from government agencies to private industry and vice-versa, this practice has become so widespread it has undermined the entire system of checks and balances.

Conflict of interest is rampant not only within the field of medicine, but the revolving doors between government and industry has effectively led to a situation where it’s now extremely difficult, if not impossible, to trust conventional health advice from the federal government—which is supposed to be independent due to this massive collusion between government and industry. Here are a few more examples of the many revolving doors between the pharmaceutical industry and the US government:

  • The American Cancer Society has close financial ties to both makers of mammography equipment and cancer drugs. Other conflicts of interest include ties to, and financial support from, the pesticide, petrochemical, biotech, cosmetics, and junk food industries—the very industries whose products are the primary contributors to cancer
  • Drug companies pay seven-figure amounts into FDA coffers to gain approval of their drugs. FDA staff knows that the cash means higher salaries and more perks in the agency budget. (Incidentally, the FDA’s commissioner Margaret Hamburg came straight from the boardroom of America’s largest seller of dental amalgam, Henry Schein, Inc.)
  • Conflicts of interest are also rampant in a mass vaccination infrastructure that has the same people who are regulating and promoting vaccines also evaluating vaccine safety.
  • The vaccine industry gives millions for conferences, grants, and medical education classes sponsored by the American Academy of Pediatrics (AAP). The vaccine industry even helped build AAP’s headquarters.
  • President Obama’s nominee at the Department of Homeland Security overseeing bioterrorism defense, Dr. Tara O’Toole, served as a key advisor for a lobbying group funded by a pharmaceutical company that asked the government to spend more money for anthrax vaccines and biodefense research9

There are countless others—so many, in fact, I’m sure you could fill an entire book with examples. These types of blatant conflicts should simply not be tolerated, but they most certainly are. For now the majority still does not understand the pharmaceutical industry’s power and influence over government, and the field of conventional medicine itself, but the tide is beginning to turn, and will continue to do so as more and more people get informed.

What Can You do to Take Control of Your Health?

The good news is that increasing numbers of people are now waking up to these harsh realities, and you, being among those who are informed, can help share this knowledge with others. Remember that the definition of fascism is a government system that has complete power in regimenting all industry and forcibly suppressing opposition and criticism. What we have here is a hybrid—a sort of corporate fascism, where industry has powerful control over government, and forcefully suppresses anything that threatens their monopoly on profits.

Unfortunately, this can be extremely dangerous as it pertains to your health.

Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the United States your chance of achieving optimal health through the medical system is only getting worse. While the U.S. spends more than twice the amount on health care as other developed nations, we rank 49th in life expectancy worldwide—far lower than most other developed nations! The time is ripe for you to take control of your health, and this site is full of free comprehensive recommendations that can serve as an excellent, truly independent starting point.

When it comes to your health, you simply cannot accept claims at their face value … you’ve got to dig below the surface and use all the resources available to you, including your own commonsense and reason, true independent experts’ advice and other’s experiences, to determine what medical treatment or advice will be best for you in any given situation. Ultimately, you must come to the realization that YOU are responsible for your, and your family’s health — not me, not your physician, and certainly not any researchers or government health agencies on a drug or vaccine manufacturer’s payroll.

You’ve got to become an active participant in your care and make sure you are making decisions that correspond with your own best judgment, knowledge and experiences.

Stem Cells Could Fuel Cancer Growth

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Posted 02 Aug 2012 — by James Street
Category Stem Cell Research, Stem Cell Research

By MALCOLM RITTER AP Science Writer
NEW YORK August 1, 2012 (AP)

 

How can a cancer come back after it’s apparently been eradicated? Three new studies are bolstering a long-debated idea: that tumors contain their own pool of stem cells that can multiply and keep fueling the cancer, seeding regrowth.

If that’s true, scientists will need to find a way to kill those cells, apart from how they attack the rest of the tumor.

Stem cells in healthy tissues are known for their ability to produce any kind of cell. The new research deals with a different kind, cancer stem cells. Some researchers, but not all, believe they lurk as a persisting feature in tumors.

Over the past decade, studies have found evidence for them in tumors like breast and colon cancers. But this research has largely depended on transplanting human cancer cells into mice that don’t have immune systems, an artificial environment that raises questions about the relevance of the results.

Now, three studies reported online Wednesday in the journals Nature and Science present evidence for cancer stem cells within the original tumors. Again, the research relies on mice. That and other factors mean the new findings still won’t convince everyone that cancer stem cells are key to finding more powerful treatments.

But researcher Luis Parada, of the University of Texas Southwestern Medical Center in Dallas, believes his team is onto something. He says that for the type of brain tumor his team studied, “we’ve identified the true enemy.”

If his finding applies to other cancers, he said, then even if chemotherapy drastically shrinks a tumor but doesn’t affect its supply of cancer stem cells, “very little progress has actually been made.”

The three studies used labeling techniques to trace the ancestry of cells within mouse tumors.

Collectively, they give “very strong support” to the cancer stem cell theory, said Jeffrey M. Rosen, a professor of molecular and cellular biology at Baylor College of Medicine in Houston. He did not participate in the work but supports the theory, which he said is widely accepted.

Another scientist who’s skeptical about the theory, and said he has plenty of company, said the new papers did not change his mind.

Parada’s team worked with mice genetically primed to develop a certain type of brain tumor. The scientists genetically labeled particular cells in the tumor and then attacked the cancer with the same drug given to human patients. It kills growing tumor cells and temporarily stops the cancer’s growth.

After treatment, when the tumor started growing again in the mice, the researchers showed that the vast majority, if not all, of its new cells had descended from the labeled cells. Apparently these were the tumor’s cancer stem cells, they concluded.

Parada said his team is now trying to isolate cancer stem cells from mouse brain cancers to study them and perhaps get some leads for developing therapies to eradicate them.

He also said that preliminary study of human brain tumors is producing results consistent with what his team found in the mice.

Parada’s study appears in Nature. In a second Nature report, British and Belgian researchers found evidence for cancer stem cells in early stage skin tumors in mice. And in the journal Science, a Dutch group found such evidence in mouse intestinal polyps, which are precursors to colon cancer.

Scott Kern of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore is skeptical about whether tumors contain cancer stem cells. He said that since the new studies didn’t involve human tumors, it’s not clear how relevant they are to people.

The two European studies focused largely on lesions that can lead to tumors, he said. And as for Parada’s brain cancer study, he said he believed the results could be explained without relying on the cancer stem cell theory.

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

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Posted 30 Jul 2012 — by James Street
Category Big Pharma, Ethics of Science, FDA, Finance and Politics of cancer research and treatment

Sunday, 29 July 2012 08:37 By Martha Rosenberg, Truthout | Interview

 

The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of “actors” and collaborators.

The paranoid and retaliatory email monitoring program, which sought to suppress the safety opinions of those hired to give their safety opinions, has provoked swift action from Capitol Hill. “I am writing to express my disappointment and disbelief with the way the Food and Drug Administration (FDA) has retaliated against whistleblowers who expressed concern to Members of Congress and the Office of Special Counsel (OSC) regarding safety concerns about medical products,” wrote Sen. Charles E. Grassley (R-Iowa), ranking member on the Judiciary Committee, to FDA Commissioner Margaret A. Hamburg, the day after the breadth of the surveillance was reported in The New York Times.

Government agencies cannot discourage whistleblowing and reporting of wrongdoing by monitoring employees, echoed a White House memo sent to all government agencies about the FDA spy program.

“Devicegate” dates back at least to January 2009 when scientists in the FDA’s Center for Devices and Radiological Health wrote President Obama that top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along.” Review procedures at the agency (which approves stents, breast implants, MRIs, and other devices and machinery) were so faulty that unsafe devices – including those that emit excessive radiation – were approved, charged the scientists, provoking an OSC investigation.

For reporting the safety risks, the scientists became targets of the now-disclosed spy program and some lost their jobs. “It has been brought to our attention that FDA management may have just recently ordered the FDA Office of Criminal Investigations (OCI) to investigate us, rather than the managers who have engaged in wrongdoing!” wrote the FDA scientists in a follow-up letter a few weeks later to President Obama. “It is an outrage that our own Agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

During the same time period, Ronald Kavanagh B.S.Pharm., Pharm.D, Ph.D., an FDA drug reviewer in the Center for Drug Evaluation and Research, encountered similar intimidation and suppression of safety research. Truthout met with Dr. Kavanagh on several occasions to learn about his FDA whistleblowing experiences.

Martha Rosenberg for Truthout: You were an FDA drug reviewer from 1998 to 2008, working on well-known drugs like Cymbalta, Zyprexa, Concerta, Invega, Provigil and Saphris, and encountered the same kind of coercive working environment as the device reviewers.

Ronald Kavanagh: That’s correct. In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.

MR: What are some of the ways in which safety risks were minimized in drug evaluation and review?

RK: Well, first of all I think most people would be shocked at how malleable safety data is. Human studies are usually too short and the number of subjects in them too small to adequately characterize the most dangerous risks. That’s why even a single case has to be taken seriously. A safety signal from any study – and not just safety data from short term efficacy and safety studies (used for labeling) – needs to be evaluated. This means data from long term safety studies needs to be evaluated as well as the data from even longer, ongoing safety studies and from clinical pharmacology studies. Some of this information also needs to be examined during development of a drug. Yet I have seen new drug reviews where none of this was done by the medical safety reviewer.

MR: Would you give an example?

RK: For example, human clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the efficiency and cost effectiveness of the drug’s development. New labeling policies can also mask risks as they exclude the labeling of adverse events if they are under a certain percentage and/or not double the rate found with a placebo. By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all. On top of that, I frequently found companies submitting certain data to one place and other data to another place and safety information elsewhere so it could not all be pulled together and then coming in for a meeting to obtain an agreement and proposing that the safety issue is negligible and does not need further evaluation.

MR: Like they are trying to pull the wool over the FDA’s eyes?

RK: During development, if reviewers say things that companies don’t like, they will complain about the reviewer or they will call upper management and have the reviewer removed or overruled. On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had “paid for an approval.”

MR: That is shocking. Wouldn’t the FDA managers want safety risks investigated?

RK: Just the opposite. Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission, but invariably that’s where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed. In addition, management would overload us with huge amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document.

MR: You have recounted that this is what happened to you with the nerve gas drug pyridostigmine.

RK: Yes, pyridostigmine is intended to be given preventatively in case of a nerve gas attack with the nerve agent Soman and it was used experimentally on Gulf War troops. After the first Gulf War, there were concerns it was linked to Gulf War Illness. Then, prior to Operation Iraqi Freedom, the Defense Department (DoD) tried to have President Bush waive informed consent for pyridostigmine, even though it was still an investigational drug.

MR: Why?

RK: Possibly because there is less hassle medicating troops if no informed consent is required. When President Bush refused to waive informed consent, the FDA approved pyridostigmine using the “Animal Rule” which allows the approval of drugs for human use based on animal data. It was employed because it was unethical to dose humans with the nerve agent Soman to see if pyridostigmine would actually prevent death. However, the way the drugs were used in the animal studies didn’t reflect how they would be used in humans and resulted in misleading conclusions.

MR: Another FDA reviewer turned down pyridostigmine before you?

RK: Yes. I was assigned to re-review his conclusions regarding pyridostigmine and even before I began my review I was pressured to approve it and this pressure continued through nearly two dozen meetings with FDA management. After it became clear that I would not be pressured into an approval and it became apparent that it would be approved according to the animal rule in spite of the science, I raised an even stronger objection: not only did it not work against nerve agents other than Soman, but pyridostigmine actually increased lethality in the presence of other nerve agents and we knew that Saddam Hussein was not using Soman and was instead using these other nerve agents.

MR: So, you were just stating what should have been obvious?

RK: This information was not secret – both FDA and DoD public documents acknowledge increased lethality with other nerve agents such as Sarin, and DoD and other government documents that are public also document that Saddam Hussein was not using Soman and was instead using these other nerve agents exclusively. Yet because I raised this as an objection, I was immediately replaced as the primary reviewer so that I could not document my concerns and so that pyridostigmine could be approved. It’s since been proposed that if we ever face the prospect of nerve agents in the future, that this approval will be used as a justification to convince the President at that time to waive informed consent without presenting a full picture. Even though using pyridostigmine would likely only invite the use of nerve agents.

MR: Why would the FDA and DoD allow troops to be put in this kind of harm’s way?

RK: I don’t know and don’t want to speculate. However senior managers made statements indicating knowledge that the approval was illegal. In any case, it was clear and known that use of pyridostigmine would interfere with the operation of our troops.

MR: Your training as a pediatric clinical pharmacologist has made you especially sensitive to drug risks for children. What are some of the unique drug risks children face?

RK: Pediatric approvals are based on the assumption that children will respond similarly to similar exposures. Yet dosages that are used for studies in children are often based on approved adult dosages rather than a scientific determination of whether children achieve the same or higher exposures than adults. This is because companies don’t want to develop lower dosages for children if they don’t have to. Thus exposure studies in children are done after the efficacy studies have been begun instead of before when it’s needed. The exposure studies then may also use overweight children as well as too few children. Since no allowance is made for race, age, puberty, or actual weight and since there are differences in children’s clearance of drugs, there are often higher exposures to active and toxic metabolites in children compared to adults. Thus there are often unnecessary risks with the doses that are approved.

MR: Are there other risks with one-size-fits-all doses?

RK: There are racial differences in drug metabolism that are not taken into consideration. For example, one anticancer drug breaks down faster in African Americans, so patients don’t get sufficient exposure to the drug to kill tumors. Yet African Americans were not included in the safety and efficacy studies. When drugs break down faster by one particular pathway, the patients will also sustain greater toxicity and even death from the toxic metabolite that is formed. This is especially true when the company subsequently recommends higher doses to overcome the lower exposure due to faster metabolism. In one case, this occurred with a drug used in pregnant women, where hormonal changes during pregnancy cause a greater breakdown to a metabolite that is suspected to cause mental retardation in children exposed during the pregnancy. Not only does the labeling suggest possible use during pregnancy, the labeling recommends a higher dose during pregnancy. All the while, it appears that the company was aware of the formation of a metabolite that likely affects brain development from well before the drug was ever submitted to the FDA.

MR: Are the risks just ignored?

RK: FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling. In fact, when patients exhibit drug toxicity, it is usually attributed to an underlying condition which we know is likely to make the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to the drug in any way. Consequently, toxicities are only attributed to the drug when the evidence is irrefutable. Thus the majority of cases where there is a contributing factor are simply dismissed. When you do raise potential safety issues, the refrain that I heard repeatedly from upper management was‚”where are the dead bodies in the street?” Which I took to mean that we only do something if the press is making an issue of it.

MR: You have also spoken about the dangers of certain ADHD drugs and presented some damning data about Cephalon’s stimulant Provigil.

RK: In 2006, a medical reviewer found several cases of what he thought might be Stevens Johnson Syndrome (SJS) in children who took Provigil or modafinil. SJS and the related conditions erythema multiforme and toxic epidermal necrolysis (TEN) are life-threatening skin conditions where huge swathes of skin covering large sections of the body die and slough off and the mucus membranes are also affected. The diseases are incredibly painful and kill 10 and 40 percent respectively of the people who develop them. The reviewer believed he was going to be overruled and asked me for help. We were able to get an advisory committee meeting in which I was allowed to present slides of the data that supported a diagnosis of SJS in a child in the study. I also showed that a metabolite of modafinil was 16 times higher in children than in adults and similar to the worst drug that exists for causing SJS, Blephamide. The drug company doctors were unprepared for my presentation and claimed they had no information on the child, including no photos and that they had lost contact.

MR: One of the pharma doctors actually tried to downplay SJS with modafinil, saying a child was hospitalized, but was not in the “burn unit,” according to the transcript.

RK: Yes. Largely because of my presentation, the advisory committee voted 12-1 against approval, but Cephalon claimed in the press that the rash was viral and was not from the drug. The next year, armodafinil, a related drug, was approved with a contraindication for children with a contraindication following three months later for modafinil. Contemporaneously, Cephalon agreed to pay $425 million for off-label marketing of modafinil. That means that for 18 months, the FDA kept quiet about the issue of SJS in children, while Cephalon continued off-label marketing at full steam. Later, I found that the FDA had internal documents that had the same conclusion as my analysis but they had been withheld from the advisory committee.

All drugs have dangers including death, and psychiatric drugs tend to be particularly dangerous, but as long as we make reasonable attempts to minimize risks, and provide adequate information for prescribers and patients, I am not opposed to them. On multiple occasions I have stood up for smaller drug companies against FDA management.

MR: The recent revelations of reprisals against FDA device reviewers must not have surprised you at all.

RK: No they didn’t. After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with. I saw strange cursor movements on my computer when I was just sitting at my desk reading that I suspected was evidence of spying. After I gave Representative Waxman’s (D-CA) office a USB drive with evidence, FDA staff was admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with outsiders to Senator Grassley’s office and the House Committee on Oversight and Government Reform, I was threatened with prison if I should release trade secret information to Congress.

MR: That is similar to the FDA’s claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as “trade secrets”?

RK: Because much of the information we receive are trade secrets and companies explicitly label everything they provide the FDA as such and explicitly prohibit their dissemination. In spite of this, the Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley’s staff to destroy the evidence I provided them. The threats, however, can be much worse than prison. One manager threatened my children – who had just turned 4 and 7 years old – and in one large staff meeting, I was referred to as a “saboteur.” Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.

MR: Still, the FDA transparency meeting transcripts indicate you not only went to members of Congress, you appealed to the Health and Human Services inspector general.

RK: Congress did put me in contact with the Justice Department, however, I don’t believe my complaints were taken seriously by the FBI or investigated. I believe that actual felonies may well have occurred. For example, I found evidence of insider trading of drug company stocks reflecting knowledge that likely only FDA management would have known. I believe I also have documentation of falsification of documents, fraud, perjury, and widespread racketeering, including witnesses tampering and witness retaliation.

MR: And in addition to this alleged wrongdoing, the public is at risk from unsafe drugs that were approved?

RK: Yes. In fact, thanks in part to the Prescription Drug User Fee Act, [in which drug companies pay for expedited reviews] thalidomide could not be stopped today.

New drug candidate shows promise against cancer

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Posted 25 Jul 2012 — by James Street
Category Cisplatin
Platinum compound may offer an alternative to cisplatin, a widely used chemotherapy agent.
Anne Trafton, MIT News Office

July 11, 2012

Drugs containing platinum are among the most powerful and widely used cancer drugs. However, such drugs have toxic side effects, and cancer cells can eventually become resistant to them.

MIT chemistry professor Stephen J. Lippard, who has spent much of his career studying platinum drugs, has now identified a compound that kills cancer cells better than cisplatin, the most commonly used platinum anticancer drug. The new compound may be able to evade cancer-cell resistance to conventional platinum compounds.

“I’ve long believed that there’s something special about platinum and its ability to treat cancer,” Lippard says. Using new variants, “we might have a chance of applying platinum to a broader range of cancer types, more successfully,” he says.

Mildred Dresselhaus, Ann Graybiel and Jane Luu
From left to right: Postdoc Ying Song, MIT chemistry professor Stephen J. Lippard and postdoc Ga Young Park.
Photo: M. Scott Brauer

Lippard is senior author of a paper describing the new drug candidate, known as phenanthriplatin, in the Proceedings of the National Academy of Sciences (PNAS). Lead author is postdoc Ga Young Park; other authors are graduate student Justin Wilson and postdoc Ying Song.

Cisplatin, first approved to treat cancer in 1978, is particularly effective against testicular cancer, and is also used to treat ovarian and some lung tumors, as well as lymphoma and other cancers. At its center is a platinum atom bound to two ammonia molecules and two chloride ions. When the compound enters a cancerous cell, it becomes positively charged because water molecules replace its chloride ions. The resulting positive ion can attack negatively charged DNA, forming cross-links with the DNA strands and making it difficult, if not impossible, for the cell to read that section of DNA. Too much of this damage, if not repaired, kills the cell.

For many years, Lippard has studied the mechanism of cisplatin’s action and has pursued similar drugs that could be more powerful, work against more types of cancer, have fewer side effects and evade cancer-cell resistance.

One way to do that is to vary the structure of the platinum compound, altering its activity. In this case, the researchers studied compounds that are similar to cisplatin, but have only one replaceable chlorine atom. Such a compound can bind to DNA at only one site instead of two.

From early research on platinum compounds done in the 1970s, researchers thought that platinum compounds needed two DNA binding sites to have an effect on cancer cells. However, in the 1980s, it was discovered that certain positively charged platinum compounds that can only bind to DNA at one site have anti-cancer activity, rekindling interest in them.

In 2008, Lippard’s group investigated a compound called pyriplatin, in which one of the chlorine atoms of cisplatin is replaced by a six-membered pyridine ring that includes five carbon atoms and one nitrogen atom. This compound had some anti-cancer activity, but was not as powerful as cisplatin or oxaliplatin, another FDA-approved platinum-based cancer drug.

Lippard then set out to create similar compounds with larger rings, which he theorized might be more effective at blocking DNA transcription. One of those was phenanthriplatin, the compound described in the new PNAS paper.

Phenanthriplatin was tested against 60 types of cancer cells as part of the National Cancer Institute’s cancer-drug screening program, and it was found to be four to 40 times more potent than cisplatin, depending on the cancer type. It also showed a different pattern of activity than that of cisplatin, suggesting that it could be used to treat types of cancer against which cisplatin is ineffective.

One reason for the efficacy of phenanthriplatin is that it can get into cancer cells more easily than cisplatin, Lippard says. Previous studies have shown that platinum compounds containing carbon can pass through specific channels, found in abundance on cancer cells, that allow positively charged organic compounds to enter. Another reason is the ability of phenanthriplatin to inhibit transcription, the process by which cells convert DNA to RNA in the first step of gene expression.

Another advantage of phenanthriplatin is that it seems to be able to evade some of cancer cells’ defenses against cisplatin. Sulfur-containing compounds found in cells, such as glutathione, can attack platinum and destroy it before it can reach and bind to DNA. However, phenanthriplatin contains a bulky three-ring attachment that appears to prevent sulfur from inactivating the platinum compounds as effectively.

Luigi Marzilli, a professor of chemistry at Louisiana State University, says the new compound appears to be very promising. “It expands the utility of platinum drugs and avoids some of the problems that existing drugs have,” says Marzilli, who was not part of the research team.

The researchers are now conducting animal tests to determine how the drug is distributed throughout the body, and how well it kills tumors. Depending on the results, they may be able to modify the compound to improve those properties, Lippard says.

Yale researchers find way to boost effectiveness of cancer drugs

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Posted 25 Jul 2012 — by James Street
Category NanoTechnology, Physics and Engineering
Posted:   07/24/2012 10:16:04 AM MDT
Updated:   07/24/2012 10:19:58 AM MDT

By Jim Shelton
Register Staff
— Yale University researchers say they’ve found a way to boost both the effectiveness of cancer drugs and the body’s own defense mechanisms through the use of tiny particles called nanogels.

“There is a promising path forward here for cancer therapy in general,” said Yale bioengineer Tarek M. Fahmy, lead researcher and author of a new paper in the journal Nature Materials.

“So much of the challenge with cancer therapy is delivery,” Fahmy explained. “How do you get the drug to a specific place, rather than dispersing it throughout the body? We’ve learned the nanogel is much more effective as a delivery package.”

Essentially, a nanogel is a particle that can be designed to carry a drug or a combination of drugs and proteins to a tumor within the human body. Because it’s constituted as a gel, it holds together longer and hangs onto more of its therapeutic cargo as it makes its way to the tumor. Once there, it slows down and deposits the drugs in a more concentrated dose than traditional methods.

In this case, the nanogel contained a drug that inhibits tumors, plus a protein – called a cytokine – that heightens the body’s immune system response. Yale researchers tested the nanogels on live mice with metastatic melanomas, which are particularly aggressive skin cancers.

Richard A. Flavell of Yale and the Howard Hughes Medical Institute collaborated with Fahmy on the project.

The researchers introduced nanogels two ways: intravenously injection and direct application to the tumor. In both instances, the nanogels delayed tumor growth and improved survival rates.

Human tests are still two or three years away, but Fahmy said the response he’s received from oncologists about the nanogel technology has been overwhelmingly positive.

He likened the nanogels to custom-made buses that fit specific passengers. Those passengers the cancer drugs can be the same drugs already in use. They’re simply made more effective, with less potential for side-effects.

“The chemistry is old, but the rules for assembly are new,” Fahmy said.

As the research progresses, he said, Yale scientists will be looking into both a pill and topical patch form of delivering the nanogels. Beyond that, there may be applications for nanogels to carry medicine to treat other forms of cancer, such as lung or pancreatic tumors.

“What we have now are a set of tools that are extremely encouraging,” Fahmy said.

Penn researchers enlist dogs in battle against human cancers

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Posted 14 Jul 2012 — by James Street
Category Dog Osteosarcoma, listeria bacteria, vaccine
Posted: Sat, Jul. 14, 2012, 3:01 AM

By Faye Flam

Inquirer Staff Writer

Penn veterinarian Nicola Mason, left, with Sasha and the dog

TOM GRALISH / Staff Photographer
Penn veterinarian Nicola Mason, left, with Sasha and the dog’s owners, Carlos and Liliana Ruano. Sasha lost a foreleg to bone cancer and is now receiving experimental treatment.
HEALTH
 

 Sasha is still spunky at 12 – a white dog with a smattering of black, floppy ears and a sweet face. Even after she lost her right foreleg to bone cancer, her owners said, she could jump and catch a Frisbee. Unfortunately, in nearly all cases like Sasha’s, the surgery offers just a short respite before the cancer comes roaring back. Her only hope now lies with an experimental treatment being developed at the University of Pennsylvania.

Tuesday, doctors at Penn’s School of Veterinary Medicine pumped a modified listeria bacteria into her bloodstream, hoping to push her immune system to kill remaining cancer cells. If the treatment works, it is likely to be tested next on humans with this type of bone cancer, called osteosarcoma.

Veterinary scientists say such cross-species research is on the rise. While animal research has long played an important role in human medicine, an increasing number of clinical trials for dogs are being designed to help both species.

Right now, the vast majority of cancer treatments that work in mice fail in people, said immunologist Carl June, director of translational research at Penn’s Abramson Cancer Center. By testing the treatments in dogs, he said, veterinarians are helping sort out the potential winners.

Osteosarcoma is also easier to study in dogs because it’s relatively common, especially in larger breeds. In humans, it’s an orphan disease, but it takes a vicious toll. It strikes young people, most of them between the ages of 13 and 25. Often their only hope for survival is a radical amputation.

Liliana Ruano said she and her husband, Carlos, wanted a dog that could accompany the North Carolina couple on hiking and camping adventures, and Sasha turned out to be just perfect. They often visit Carlos’ family in Pennsylvania and hike with Sasha in French Creek State Park.

The first sign of trouble came earlier this year, when Sasha started limping. The local veterinarian thought it was an injury; it seemed to get better for awhile, but then it got much worse.

An X-ray revealed bone cancer, and the doctor offered grim choices. They could do nothing and their faithful hiking buddy would die in agony, or they could amputate the leg, which would give her a few months of pain-free life before the cancer returned, usually as a fatal chest tumor. Mild chemotherapy would extend her life slightly.

They opted for the surgery and chemotherapy, and Sasha came through very well. She’s running around and playing Frisbee – for now, anyway.

Concerned that Sasha’s cancer would come back, Liliana found information about the Penn trial on a Facebook page about dogs and cancer. She called to find out more and connected with Nicola Mason, who explained the treatment, its risks and benefits. Mason told them the tumor would have to be of a certain type for Sasha to qualify – expressing a marker called her2/neu. Sasha’s tumor tested positive.

Mason, who has both a veterinary degree and a doctorate in immunology, said osteosarcoma tumors that strike dogs are very similar to those that strike humans. Dog and human lymphomas are also similar, and she is also involved in a trial to treat dog lymphoma.

Treatment with listeria bacteria might sound scary because it’s associated with food poisoning, but it is disabled, Mason said. “It’s modified so it does not cause disease and is rapidly cleared.” But it should still prompt an immune response in Sasha.

Modified listeria has been tested in mice and used in some trials connected with human cervical cancer, she said. For this treatment, the listeria was also genetically modified – a gene was added to allow the bacteria to make a protein called her2/neu – the same one they tested for and was expressed in Sasha’s tumor.

The idea is to train the patient’s immune system with the her2/neu protein the way you might train a bloodhound with a piece of someone’s clothing. The immune cells are geared to attack listeria, but they will also be trained to recognize and attack cancer cells that express the her2/neu. This protein is one of the few marks that distinguishes the cancer cells from healthy ones, so the immune system should go after the cancer.

Though Sasha looks healthy now, amputations almost always leave behind a few malignant cells, which is why dogs often bounce back after an amputation but almost always get a fatal recurrence.

“They are sitting on time bombs,” Mason said. In virtually all cases, stray malignant cells eventually spread to the lungs and kill the dog. “What we’re doing with the immunotherapy is mopping up the cancer cells we can’t see,” she said. So far, they’ve signed up six dogs, and they aim to recruit 9 to 18.

Why can’t the immune system kill the cancer cells without all this help?

Our immune systems do best when fighting foreign cells, said the University of Minnesota’s Jaime Modiano, who is, like Mason, a veterinarian with a doctorate in immunology. Cancer cells are so similar to our own cells that it can be hard for the immune system to recognize them as invaders.

In a given patient, canine or human, cancer cells undergo their own version of natural selection. The ones that evade the immune system survive and proliferate, he said. Cancer cells can evolve a host of evasive maneuvers. The challenge with immunotherapy is getting around all those tricks.

Modiano says clinical trials elsewhere are testing new therapies for brain cancer and other malignancies that strike both canines and humans. Working with dogs gives them information they couldn’t get studying mice or people, he said. There is no shortage of dogs with spontaneous cases, he said, since cancer strikes about one in three dogs.

Studying dogs also allows researchers to learn at an accelerated pace – literally in dog years. If a treatment keeps a terminally ill dog alive for two years, that’s like keeping a human alive for 10 or 15 years.

Penn’s Carl June sees clinical trials with dogs as a way to take advantage of an explosion of untested but promising new approaches to fighting cancer and to accelerate the process of sorting the winners from the losers.

Immune therapies are a good case in point, he said. “This is exactly the sort of thing that should be done on a dog,” he said.

No other large animals routinely get cancer the way dogs and humans do. Monkeys rarely get cancer spontaneously, and many people have ethical concerns about giving cancer to fellow primates. Scientists see some striking similarities in the genetics and biology of dog and human cancers. Cats, too, are starting to be entered in clinical trials, but Mason said dog research is further ahead.

Sasha had her first treatment at Penn on Tuesday. She will stay several days for observation before her owners take her back to North Carolina.

Liliana Ruano says she understands the risks and potential benefits. “Dr. Mason spent a lot of time with us to make sure we were comfortable,” she said. Ultimately, she decided to go ahead because of the chance to extend Sasha’s life. “I’m not ready to let her go yet.”

 

Understanding Rechallenge and Resistance in the Tyrosine Kinase Inhibitor Era: Imatinib (Gleevec) in Gastrointestinal Stromal Tumor

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Posted 09 Jul 2012 — by James Street
Category GIST, Gleevec
Agulnik, Mark MD; Giel, Jennifer L. PhD

Abstract

Disease progression after treatment with a particular therapy, in the traditional view of cancer chemotherapy, indicates resistance to that treatment. However, targeted therapies such as tyrosine kinase inhibitors (TKIs) do not follow these same principles. The purpose of this review is to educate about TKI resistance and rechallenge in oncology, using the TKI imatinib in the treatment of gastrointestinal stromal tumor (GIST). True imatinib resistance does occur; however, in contrast to expectations with traditional chemotherapy, a number of instances of apparent imatinib resistance may not actually be true treatment resistance. For example, clinical evidence indicates that patients with metastatic or unresectable GIST that progressed after cessation of initial imatinib therapy who were rechallenged with imatinib achieved response or stable disease. Also, progression during imatinib treatment may be indicative of noncompliance or a need for dose increase rather than true resistance. The ability to rechallenge with a previously used therapy after progression on or after TKI therapy is relevant to both the adjuvant and the metastatic/advanced settings. Ongoing clinical trials, which are further examining imatinib rechallenge in combination with other agents in patients with GIST who have developed resistance to imatinib and/or another TKI, may impact the treatment paradigm for GIST.

(C) 2012 Lippincott Williams & Wilkins, Inc.

New Research Reveals Some Natural Supplements Effective Against Prostate Cancer

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Posted 03 Jul 2012 — by James Street
Category Herbs, Prostate Cancer

press release

June 21, 2012, 1:00 p.m. EDT

BOSTON, June 21, 2012 /PRNewswire via COMTEX/ — Several university studies conducted by medical researchers have had some surprising results, revealing evidence proving several common, naturally-occurring ingredients are effective in reducing or eliminating prostate cancer cells in both lab cultures and live mice studies. As a result, nutraceuticals containing extracts of these ingredients may be indicated in supporting men’s prostate health.

African Plum Tree Bark Extract – The extract of the bark of the African plum tree (pygeum africanum) is currently used in the US and Europe in the treatment of enlarged prostate (also known as benign prostatic hyperplasia, or BPH). In a recent study conducted by researchers at the University of Missouri-Columbia, pygeum africanum was shown to induce tumor cell apoptosis (tumor cell death), And laboratory mice who were fed a preparation of the pygeum extract exhibited a reduced incidence of prostate cancer compared with control mice that were fed a standard diet.

White Button Mushroom Extract – The extract of this edible mushroom (agaricus bisporus) has been indicated as successfully inhibiting the growth of prostate cancer cells. In a study carried out at the Beckman research institute, tumor cells exposed in vitro and in vivo to the extract of the white button mushroom showed a significant decrease in tumor size and reduced rates of cancer cell growth.

Sang Huang Mushroom Extract (phellinus linteus) – According to researchers at the Harvard Medical School, a preparation of phellinus linteus was injected into laboratory mice who were affected by prostate cancer. The results showed that the Sang Huang extract played a role in reducing the rate of cancer cell growth, as well as causing a significant reduction in overall tumor size.

To read abstracts of these university studies and find information on how to obtain extracts of these supplements visit the website: www.prostateph.com

Preventing Prostate CancerPreventing prostate problems and other men’s health issues depends in part on making the right lifestyle choices. Practicing good dietary habits, getting plenty of physical exercise, avoiding the use of tobacco products, and keeping alcohol consumption to a moderate level can lead to overall good health and maximize the body’s ability to fight off diseases ranging from the common cold to cancer. Nutraceuticals can play a major role in protecting a person’s health.

For additional information on men’s prostate health, visit: http://www.prostateph.com/ . John Dugan writes about Men’s health and is a contributing editor to numerous online publications.

Media Contact: John Dugan, 508-620-2862, joc@bankcardconcepts.com

SOURCE ProstatePh