U.S. asks CVS about its prescription discount plan

(Reuters) - CVS Caremark Corp said it received requests for information about a prescription drug discount program it runs for uninsured or under-insured individuals from both the U.S. government and the Texas Attorney General.

In January, CVS received a subpoena from the U.S. Office of Inspector General requesting information about the company's Health Savings Pass program, CVS said in its 10k filing on Friday.

The company, which runs the CVS pharmacy chain and the CVS Caremark pharmacy benefits management service, said the request was connected to an investigation of possible false or otherwise improper claims for payment involving Health & Human Services programs.

In February, CVS received a civil investigative demand from Texas' Office of the Attorney General. That office requested a copy of information from the OIG subpoena and other information related to prescription drug claims submitted by CVS pharmacies to Texas Medicaid for reimbursement, the company said.

CVS said it would respond to the requests for information and cooperate with both investigations.

CVS markets its Health Savings Pass, which has a $15 annual fee, to people who do not have prescription drug coverage and to those who have limited coverage.

The Health Savings Pass lets patients fill 90-day prescriptions for 400 generic drugs for $11.99. Participants also get discounts such as 10 percent off visits at the CVS in-store health clinic, MinuteClinic and 10 percent off an annual flu shot.

The announcement comes about a month after CVS agreed to pay $5 million to settle charges of inaccurate pricing of some drugs for the elderly and disabled, ending a wide-ranging, multi-year probe into its business practices.

Shares of CVS closed down 28 cents at $44.27, after reaching a new high of $45 earlier in the day.

(Reporting by Jessica Wohl in Chicago; Editing by Richard Chang)

View the original article here

FDA Warns Health Officials About Counterfeit Cancer Drug

The FDA announced on Tuesday that a counterfeit version of the drug Avastin has made its way into the U.S. market. Doctors, hospitals, and pharmacists are being urged to check their supply of the drug to make sure it was manufactured by Roche Group partner Genentech, the maker of the real Avastin.

What is Avastin?

Avastin is a "designer drug" created to treat cancer by isolating a protein known as vascular endothelial growth factor, or VEGF, according to Genentech. VEGF helps the body create new blood vessels, which in a person with cancer, can help feed the cancerous cells. By blocking VEGF, Avastin theoretically can "starve" cancer cells and kill them off, according to NPR.

Avastin has only been approved to help treat certain kinds of cancers, including colorectal, brain, kidney, and lung cancer. It was initially approved late last year for treating breast cancer as well, but the FDA withdrew the approval while it is re-evaluating the drug's effectiveness in treating advanced cases of the disease.

How did the FDA find out about the counterfeit?

CNN reports that the FDA tracked purchases made from Quality Specialty Products, which in the U.S. appears to also go under the moniker Montana Health Care Solutions. The company is alleged to have been sourcing counterfeit drugs from overseas distributors and then selling them to U.S. practitioners.

Genentech themselves tested the suspected counterfeit version of the drug and found it to be not merely repackaged but fraudulent. Some 19 different potential buyers have been identified. The FDA warned all of them individually about the counterfeit drug before releasing a more general press statement on Tuesday.

Is the counterfeit version dangerous?

Yes, in that it is missing the active ingredient bevacizumab, the key component in the real Avastin medication. Therefore, anyone who has been treated with the counterfeit would not have been getting needed cancer therapy. Roche and Genentech released a statement on Tuesday giving details on how to identify fake medications, as well as warning practitioners that the counterfeit should not be considered either safe or effective.

Does the FDA know if anyone has actually been given the counterfeit?

Not at this time. The path of the counterfeit drug once it hit American shores is still being investigated, according to MSNBC. Because the agency is still unsure just how much of the counterfeit was purchased and distributed, the FDA hasn't been able to determine whether anyone was actually administered the faux treatment.

Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.

View the original article here

Marc Garnick Answers Six Key Questions About Prostate Cancer

The latest findings about the ineffectiveness of PSA testing to screen for prostate cancer has confused many men--and their loved ones. On the one hand is the seeming chance to catch cancer early. On the other hand is the growing realization that many prostate tumors grow so slowly that they will never cause a problem in an individual's lifetime.

After closely examining all the latest data, investigators from the U.S. Preventive Services Task Force concluded in 2011 that the PSA test holds little or no value as a screening test for most healthy men.

Dr. Marc Garnick explored the pros and cons of PSA screening in a feature article in the February 2012 issue of Scientific American entitled "The Great Prostate Debate: Does Screening Save Lives?" [preview]. After writing the article, Garnick, who is a prostate cancer expert and medical oncologist at  of Harvard Medical school and Beth Israel Medical Center in Boston, agreed to speak at greater length with senior editor Christine Gorman about the following questions in the prostate cancer field.

Q: Why are medical experts questioning the value of the PSA test to screen for prostate cancer?

In 2009, two very important studies—one from Europe and one from the United States—were published that looked at whether PSA screening saved lives. "The striking thing of these studies, which included tens of thousands of individuals, was that there was no difference in the overall survival of those men who were tested, biopsied, diagnosed with cancer and then treated compared to the control population who were not offered the testing whatsoever," Garnick says.

Listen to more of Dr. Garnick's answer about why the PSA test has come under fire for prostate cancer screening:

Click arrows for audioMP3 file

Q: So if you could summarize, you're saying that you don't live any longer if you get screened with the PSA test and you're subjecting yourself to really bad side effects from treatments for prostate cancer?

"That's the public health policy perspective," Garnick says. "It's obviously more difficult when you have the individual patient sitting in your office--especially a patient with a strong family history of the disease in whom perhaps their brother had the disease, their father may have had the disease and passed away from it."

Listen to Dr. Garnick explain what individuals with a family history of prostate cancer should know about the PSA test:

Click arrows for audioMP3 file

Q: What is the difference between a PSA test for screening and one used after a prostate cancer diagnosis?

"The PSA test for screening says, 'Yes, your value may be elevated but we don't know yet, short of doing a biopsy, whether or not you do or do not have prostate cancer.' In a patient who has an established diagnosis of prostate cancer, the PSA is very useful," Garnick explains. "So, for example, if a patient has prostate cancer and they're treated for their cancer and the patient, for example, is treated with a radical prostatectomy in which the cancer is thought to be confined to the prostate gland, surgical removal of the prostate gland should actually result in an undetectable PSA value . . . If it's not undetectable either not all the cancer was removed or there may actually be metastatic cancer that has already spread that is causing the PSA not to come down back to an undetectable level."

Listen to more of Dr. Garnick's explanation of how a PSA test can be helpful after the diagnosis of cancer.

Click arrows for audioMP3 file

Q: What is the latest thinking about what to do with a Gleason score in the middle zones?

Garnick says, "the majority of cancers that we see today are Gleason 3+3s. The other cancers are Gleason 7s (3+4 or 4+3). And then we have a group of very high-risk cancers that we call Gleeson 8 to 10 cancers, which are in general are Gleason 4+4 or 4+5 or 5+4. Those are very aggressive, what we call high-grade cancers.

"The problem is trying to distinguish what the biological behavior of a Gleason 6 cancer and a Gleason 7 cancer is going to be. A Gleeson 3+4 or a 3+3 are the real enigmas because those cancers can bifurcate into being cancers that will never cause problems in the patient's lifetime to cancers, which are going to problems months to years after being diagnosed.

"We don't really have right now a good set of molecular markers or other biomarkers that help us predict which type of behavior an individual patient's cancer is likely to experience."

Listen to Dr. Garnick discuss the Gleason score in greater depth.

Click arrows for audioMP3 file

Q: What are the options if you want to get screened with a PSA test for prostate cancer but are still concerned about the potential side effects of treatment?

"The criticism has been that we're over-diagnosing prostate cancer," Garnick says. "I actually think we're not necessarily over-diagnosing prostate cancer, we're actually over-treating prostate cancer . . .

"The recent National Institutes [of Health] consensus conference took a look at these low-grade or low-risk prostate cancers and actually recommended that we more strongly consider active surveillance in a lot of these men who otherwise would have been treated and suffer the potential consequences of therapy."

Listen to Dr. Garnick explain in greater detail what active surveillance is all about.

Click arrows for audioMP3 file

Q: What does the future look like for men with advanced cases of prostate cancer?

"This is actually one of the most exciting areas in prostate cancer biology," Garnick says. Over the past 30 years, "We've come from orchietctomy, which is surgical removal of the testicles, to estrogen therapy to the use of LHRH analogues—such as lupron and the anti-androgens—to first- and second-line chemotherapy to second-line hormonal therapy to immune therapy to agents that help bone health."

Listen to Dr. Garnick talk about results using recently approved drugs such as docetaxel, cabizitaxel and abiraterone, as well as some of the latest research on experimental medications like MET inhibitors and immune therapy for advanced prostate cancer. 

Click arrows for audioMP3 file

Follow Scientific American on Twitter @SciAm and @SciamBlogs. Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

View the original article here

Marc Garnick Answers 6 Key Questions about Prostate Cancer

The latest findings about the ineffectiveness of PSA testing to screen for prostate cancer has confused many men--and their loved ones. On the one hand is the seeming chance to catch cancer early. On the other hand is the growing realization that many prostate tumors grow so slowly that they will never cause a problem in an individual's lifetime.

After closely examining all the latest data, investigators from the U.S. Preventive Services Task Force concluded in 2011 that the PSA test holds little or no value as a screening test for most healthy men.

Dr. Marc Garnick explored the pros and cons of PSA screening in a feature article in the February 2012 issue of Scientific American entitled "The Great Prostate Debate: Does Screening Save Lives?" [preview]. After writing the article, Garnick, who is a prostate cancer expert and medical oncologist at  of Harvard Medical school and Beth Israel Medical Center in Boston, agreed to speak at greater length with senior editor Christine Gorman about the following questions in the prostate cancer field.

Q: Why are medical experts questioning the value of the PSA test to screen for prostate cancer?

In 2009, two very important studies—one from Europe and one from the United States—were published that looked at whether PSA screening saved lives. "The striking thing of these studies, which included tens of thousands of individuals, was that there was no difference in the overall survival of those men who were tested, biopsied, diagnosed with cancer and then treated compared to the control population who were not offered the testing whatsoever," Garnick says.

Listen to more of Dr. Garnick's answer about why the PSA test has come under fire for prostate cancer screening:

Click arrows for audioMP3 file

Q: So if you could summarize, you're saying that you don't live any longer if you get screened with the PSA test and you're subjecting yourself to really bad side effects from treatments for prostate cancer?

"That's the public health policy perspective," Garnick says. "It's obviously more difficult when you have the individual patient sitting in your office--especially a patient with a strong family history of the disease in whom perhaps their brother had the disease, their father may have had the disease and passed away from it."

Listen to Dr. Garnick explain what individuals with a family history of prostate cancer should know about the PSA test:

Click arrows for audioMP3 file

Q: What is the difference between a PSA test for screening and one used after a prostate cancer diagnosis?

"The PSA test for screening says, 'Yes, your value may be elevated but we don't know yet, short of doing a biopsy, whether or not you do or do not have prostate cancer.' In a patient who has an established diagnosis of prostate cancer, the PSA is very useful," Garnick explains. "So, for example, if a patient has prostate cancer and they're treated for their cancer and the patient, for example, is treated with a radical prostatectomy in which the cancer is thought to be confined to the prostate gland, surgical removal of the prostate gland should actually result in an undetectable PSA value . . . If it's not undetectable either not all the cancer was removed or there may actually be metastatic cancer that has already spread that is causing the PSA not to come down back to an undetectable level."

Listen to more of Dr. Garnick's explanation of how a PSA test can be helpful after the diagnosis of cancer.

Click arrows for audioMP3 file

Q: What is the latest thinking about what to do with a Gleason score in the middle zones?

Garnick says, "the majority of cancers that we see today are Gleason 3+3s. The other cancers are Gleason 7s (3+4 or 4+3). And then we have a group of very high-risk cancers that we call Gleeson 8 to 10 cancers, which are in general are Gleason 4+4 or 4+5 or 5+4. Those are very aggressive, what we call high-grade cancers.

"The problem is trying to distinguish what the biological behavior of a Gleason 6 cancer and a Gleason 7 cancer is going to be. A Gleeson 3+4 or a 3+3 are the real enigmas because those cancers can bifurcate into being cancers that will never cause problems in the patient's lifetime to cancers, which are going to problems months to years after being diagnosed.

"We don't really have right now a good set of molecular markers or other biomarkers that help us predict which type of behavior an individual patient's cancer is likely to experience."

Listen to Dr. Garnick discuss the Gleason score in greater depth.

Click arrows for audioMP3 file

Q: What are the options if you want to get screened with a PSA test for prostate cancer but are still concerned about the potential side effects of treatment?

"The criticism has been that we're over-diagnosing prostate cancer," Garnick says. "I actually think we're not necessarily over-diagnosing prostate cancer, we're actually over-treating prostate cancer . . .

"The recent National Institutes [of Health] consensus conference took a look at these low-grade or low-risk prostate cancers and actually recommended that we more strongly consider active surveillance in a lot of these men who otherwise would have been treated and suffer the potential consequences of therapy."

Listen to Dr. Garnick explain in greater detail what active surveillance is all about.

Click arrows for audioMP3 file

Q: What does the future look like for men with advanced cases of prostate cancer?

"This is actually one of the most exciting areas in prostate cancer biology," Garnick says. Over the past 30 years, "We've come from orchietctomy, which is surgical removal of the testicles, to estrogen therapy to the use of LHRH analogues—such as lupron and the anti-androgens—to first- and second-line chemotherapy to second-line hormonal therapy to immune therapy to agents that help bone health."

Listen to Dr. Garnick talk about results using recently approved drugs such as docetaxel, cabizitaxel and abiraterone, as well as some of the latest research on experimental medications like MET inhibitors and immune therapy for advanced prostate cancer. 

Click arrows for audioMP3 file

Follow Scientific American on Twitter @SciAm and @SciamBlogs. Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

View the original article here

FDA staff unsure about new use for Amgen's Xgeva

WASHINGTON (Reuters) - Reviewers from the U.S. Food and Drug Administration said on Monday that they were not sure whether Amgen Inc's Xgeva bone drug should be approved for a wider use of delaying the spread of cancer to the bone.

The injectable drug is already approved to prevent fractures caused by cancer that has spread to the bone, and it is seen as one of the most important growth drivers for the world's largest biotechnology company.

Xgeva delayed the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

Amgen said the drug would be targeted at about 50,000 men in the United States at that stage of the disease.

The FDA staff said it was unclear whether that length of time without cancer spreading was "an adequate measure of clinical benefit," especially as the drug did not help men live longer or delay the growth of prostate cancer.

Reviewers were also concerned that about one in 20 men treated with the drug developed osteonecrosis of the jaw, or death of jawbone tissue, and said it was uncertain whether the rate could be even higher if patients take the drug for a longer time.

An advisory committee will vote Wednesday on whether to recommend approval of the drug for the wider use. The FDA will make a final decision later.

Shares of the company were down 2.6 percent at $67.50 in morning Nasdaq trading.

ISI Group analyst Mark Schoenebaum said the critical review of Xgeva was expected, since the FDA had previously questioned whether a delay in cancer spreading to the bone was a meaningful benefit to patients.

"Even if the panel votes in favor of approval, commercial demand could be modest," he added in a note, and said sales could reach about $300 million a year.

In the fourth quarter, sales of Xgeva rose to $134 million from $100 million in the prior quarter.

Amgen is hoping a broader use will significantly accelerate sales of the drug. Xgeva, along with related osteoporosis drug Prolia, are expected to offset declining sales of the anemia drugs that had been the company's backbone.

The company said it would tell the advisory committee that Xgeva provided a meaningful benefit to prostate cancer patients by preventing the spread of their disease to the bones, which often happens.

"Bone metastases ... are irreversible and progressive, and contribute major morbidity to these patients," the company said in a statement. Amgen said that if Xgeva is approved, it would be the first drug to delay the spread of cancer to the bone for men with prostate cancer.

Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer and multiple myeloma, or cancer of a type of white blood cell.

(Reporting by Anna Yukhananov; Editing by John Wallace and Lisa Von Ahn)

View the original article here

FDA staff unsure about new use for Amgen's Xgeva

WASHINGTON (Reuters) - Reviewers from the U.S. Food and Drug Administration said on Monday that they were not sure whether Amgen Inc's Xgeva bone drug should be approved for a wider use of delaying the spread of cancer to the bone.

The injectable drug is already approved to prevent fractures caused by cancer that has spread to the bone, and it is seen as one of the most important growth drivers for the world's largest biotechnology company.

Xgeva delayed the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

Amgen said the drug would be targeted at about 50,000 men in the United States at that stage of the disease.

The FDA staff said it was unclear whether that length of time without cancer spreading was "an adequate measure of clinical benefit," especially as the drug did not help men live longer or delay the growth of prostate cancer.

Reviewers were also concerned that about one in 20 men treated with the drug developed osteonecrosis of the jaw, or death of jawbone tissue, and said it was uncertain whether the rate could be even higher if patients take the drug for a longer time.

An advisory committee will vote Wednesday on whether to recommend approval of the drug for the wider use. The FDA will make a final decision later.

Shares of the company were down 2.6 percent at $67.50 in morning Nasdaq trading.

ISI Group analyst Mark Schoenebaum said the critical review of Xgeva was expected, since the FDA had previously questioned whether a delay in cancer spreading to the bone was a meaningful benefit to patients.

"Even if the panel votes in favor of approval, commercial demand could be modest," he added in a note, and said sales could reach about $300 million a year.

In the fourth quarter, sales of Xgeva rose to $134 million from $100 million in the prior quarter.

Amgen is hoping a broader use will significantly accelerate sales of the drug. Xgeva, along with related osteoporosis drug Prolia, are expected to offset declining sales of the anemia drugs that had been the company's backbone.

The company said it would tell the advisory committee that Xgeva provided a meaningful benefit to prostate cancer patients by preventing the spread of their disease to the bones, which often happens.

"Bone metastases ... are irreversible and progressive, and contribute major morbidity to these patients," the company said in a statement. Amgen said that if Xgeva is approved, it would be the first drug to delay the spread of cancer to the bone for men with prostate cancer.

Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer and multiple myeloma, or cancer of a type of white blood cell.

(Reporting by Anna Yukhananov; Editing by John Wallace and Lisa Von Ahn)

View the original article here