Members of Congress Put Costly Drugs in Their Crosshairs

  • by Shannon Firth

WASHINGTON — Prescription drug prices are getting more attention on Capitol Hill, with two senators from opposite sides of the aisle announcing plans to investigate while House Democrats declared they were forming a task force on the issue as well.

Sen. Claire McCaskill (D-Mo.) and Sen. Susan Collins (R-Maine) this week announced a bipartisan probe into drug costs, according to a press release from McCaskill’s office. The senators are requesting drug pricing information from four companies whose products’ prices have recently spiked: Valeant Pharmaceuticals, Turing Pharmaceuticals, Retrophin, and Rodelis Therapeutics.

“We need to get to the bottom of why we’re seeing huge spikes in drug prices that seemingly have no relationship to research and development costs,” McCaskill said, in the statement.

According to the release, the investigation will look into:

  • “Substantial price increases on recently acquired off-patent drugs”
  • “Mergers and acquisitions within the pharmaceutical industry that have led to dramatic increases in off-patent drug prices”
  • “The FDA’s role in the drug approval process for generic drugs, the agency’s distribution protocols, and, if necessary, its off-label regulatory regime”

The Senate Special Committee on Aging has scheduled an initial hearing on this issue for Dec. 9.

At a press briefing on Wednesday, Rep. Lloyd Doggett (D-Texas) announced the formation of the “Affordable Drug Pricing Task Force.”

House representatives said they hope to advance legislation that would enable Health and Human Services Secretary Sylvia Burwell to negotiate Medicare prices and to force drug companies to be transparent about the cost of making their products.

Doggett cited the now infamous example of Turing Pharmaceutical’s Daraprim (pyrimethamine), a drug for treating infections common in patients with cancer and AIDS. After the company acquired the drug 3 months ago, the price went from $13.50 to $750 per tablet. On Tuesday, the company said it would lower the price by the end of the year, but did not say by how much.

“But exorbitant drug prices are not about one wrongdoing, or one drug, or one class of drugs; they are a systemic problem that involve a wide range of manufacturers,” said Doggett while standing at a podium flanked by posters of Turing’s CEO Martin Shkrelivilified by the media for his tone-deaf comment that his actions would benefit society — and Michael Pearson, CEO of Valeant Pharmaceuticals.

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Understanding the role of pharmacists

Pharmacist Amy Schiveley talks with a customer at Lakeview Pharmacy

If your recent flu vaccine was administered at a pharmacy, you have already sampled the expanded role that pharmacists play in our health care today.

A flu shot, though, is just one of many patient-care services pharmacies across the country offer beyond filling prescriptions. From blood pressure tracking to Medication Therapy Management counseling, today’s pharmacists can be a resource for a wide range of information and advice.

In a Medication Therapy Management session, pharmacists can sit down with a customer and go through all of their medications, find out what is working and what’s not, review the purpose of each medication, explain how they work and more, according to Amy Schiveley, managing pharmacist at Lakeview Pharmacy, 516 Monument Square.

Pharmacists already provide some consultation when a customer picks up a prescription, Schiveley said, but MTM sessions take a more in-depth look at the entire medicine profile — including over-the-counter products and supplements — and help the patient better understand what they are taking, why they are taking it and how to take it.

“We go through all of it with a fine-toothed comb,” Shiveley said.

Pharmacists can also help patients understand the risks versus benefits of each medication; explore ways to reduce costs; and work with physicians and insurance companies to figure out what medication options are best for each person, she said.

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Congressman and Medical Doctor Phil Roe Presents An Outstanding Obamacare Alternative

Family Research Council discussion of the Republican Study Committee’s alternative to the Affordable Care Act, known as “Obamacare.”

Dr. Phil Roe, the Congressman representing Tennessee’s First Congressional District, will present an overview and answer questions about the RSC’s patient-centered and free market alternative, the American Health Care Reform Act. More information about RSC’s bill can be found here. Because of the federal government’s expansive role in structuring health care’s cost and coverage, this important discussion is relevant to all Americans. Dr. Roe has a valuable perspective as a medical doctor who understands the challenges facing America’s health system today.

Congressman Phil Roe represents the First Congressional District of Tennessee. A native of Tennessee, Phil was born on July 21, 1945 in Clarksville. He earned a degree in Biology with a minor in Chemistry from Austin Peay State University in 1967 and went on and to earn his Medical Degree from the University of Tennessee in 1970. Upon graduation, he served two years in the United States Army Medical Corps. Congressman Roe serves on two Committees, Education and the Workforce, and Veterans’ Affairs, that allow him to address and influence the many issues that are important to the First District students, teachers, veterans and workers.

Click here to watch this presentation on YouTube >>> Congressman Phil Roe: An Obamacare Alternative

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Psoriasis and Look-alikes—A Photo Essay

Click on this picture for a slide show of photos and descriptions of psoriasis and look-alikes

Understanding Melanoma In Situ (Stage 0)

Symptoms, treatment, and prognosis for melanoma in situ, the earliest stage of melanoma.

.By Diana Rodriguez

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With regular and thorough examinations of your skin, you can increase your changes of catching any abnormalities very early — which is good news in terms of treatment and prognosis if that abnormality turns out to be a malignant melanoma. In fact, experts now recommend that men and women of all ages check their skin frequently to increase their odds of spotting potential malignant mole at the earliest possible point: stage 0, or melanoma in situ.

What Is Melanoma In Situ?
Melanoma in situ comes from the Latin phrase “in situ,” which means “in place.” Melanoma in situ is cancer in the very early stages, when it affects only the top layer of the skin. At this point, the cancer has not spread deeper into the body. Cancer diagnosed at this early stage also means that it is less likely to recur or spread to other parts of the body than melanomas that are diagnosed at a later stage.

The very first symptoms of melanoma are any abnormalities in one or more moles on the skin. Abnormalities include moles with anyAsymmetry, uneven Borders, different Colors, large Diameter, orEvolution (any change). That’s why learning the ABCDEs of melanoma and checking yourself regularly are so important. If you see anything different about any of your moles, it could be a sign of melanoma in situ. The best course is to report any changes that you see to your doctor and schedule an exam to rule out melanoma, or to catch and treat it early.

How Is Melanoma In Situ Treated?
The treatment for melanoma in situ is usually fairly simple. In a doctor’s office, an outpatient procedure can be performed in which the melanoma is cut out of the skin, a process that medical personnel call resecting or excising.

“The treatment option for early stage melanoma is a wide excision procedure,” says Bruce A. Brod, MD, a clinical associate professor of dermatology at the University of Pennsylvania School of Medicine. “The key prognostic feature in melanoma is the thickness [in millimeters] of the melanoma, which is based on the initial biopsy of the lesion.”

How much skin needs to be cut out depends, then, on the biopsy results. “The consensus for treatment of melanoma in situ is to remove a half-centimeter diameter around the lesion or the initial biopsy site,” Dr. Brod says. “The consensus for treating melanomas less than 2 millimeters in thickness is to remove a 1-centimeter diameter, if possible, around the lesion.”

If the melanoma is larger in size, more skin may need to be removed, and a biopsy performed. “In melanomas greater than 2 millimeters [in thickness], the consensus is to excise a 2-centimeter diameter area around the lesion,” he says. “Since melanoma can spread to the lymph nodes in close proximity to the initial melanoma, a biopsy of lymph nodes is sometimes performed for melanoma close to or greater than 1 millimeter in thickness at the time of the wide excision procedure.”

Following Up on Melanoma in Situ
The good news? People who are diagnosed with melanoma in situ and receive early treatment have a great survival rate — 100 percent at 5 and 10 years. And everyone with melanoma in situ, including those diagnosed at an early stage, should check in with their doctors frequently to be certain that the cancer has not returned. Patients should have a complete physical and skin exam every six months for a year or two after their initial diagnosis, and typically once each year for several years after that.

“When melanoma is found early, it is easily cured with simple outpatient surgery,” says Catherine Poole, president and co-founder of the Melanoma International Foundation. “When found in later stages, it may become life-threatening, and there are few effective therapies to treat metastasized melanoma.”

Some good advice for healthy, cancer-free skin: Protect your skin at all times. “The most effective sun protection is to wear protective clothing, a broad-rimmed hat, seek shade, avoid being in the sun during the prime-time solar hours of 10 to 4, and use sunscreen as an adjunct to these behaviors,” says Poole.

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Note *

A couple of weeks ago an ugly mole was removed from my stomach. After the biopsy results came back Doctor Rowe said that it was confirmed to be ‘Melanoma In Situ.’
Got it early enough that it shouldn’t be serious. I Praise God and thank the Veterans Administration!

Going back for one more minor surgery as a precautionary move. — Bob Diamond

Odds of quitting smoking are affected by genetics

NIH-funded research shows genetics can predict success of smoking cessation and need for medications

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Genetics can help determine whether a person is likely to quit smoking on his or her own or need medication to improve the chances of success, according to research published in today’s American Journal of Psychiatry. Researchers say the study moves health care providers a step closer to one day providing more individualized treatment plans to help patients quit smoking.

The study was supported by multiple components of the National Institutes of Health, including the National Institute on Drug Abuse (NIDA), the National Human Genome Research Institute, the National Cancer Institute, and the Clinical and Translational Science Awards program, administered by the National Center for Advancing Translational Sciences.

“This study builds on our knowledge of genetic vulnerability to nicotine dependence, and will help us tailor smoking cessation strategies accordingly,” said NIDA Director Nora D. Volkow, M.D. “It also highlights the potential value of genetic screening in helping to identify individuals early on and reduce their risk for tobacco addiction and its related negative health consequences.”

Researchers focused on specific variations in a cluster of nicotinic receptor genes, CHRNA5-CHRNA3-CHRNB4, which prior studies have shown contribute to nicotine dependence and heavy smoking. Using data obtained from a previous study supported by the National Heart Lung and Blood Institute, researchers showed that individuals carrying the high-risk form of this gene cluster reported a 2-year delay in the median quit age compared to those with the low-risk genes.  This delay was attributable to a pattern of heavier smoking among those with the high risk gene cluster. The researchers then conducted a clinical trial, which confirmed that persons with the high-risk genes were more likely to fail in their quit attempts compared to those with the low-risk genes when treated with placebo. However, medications approved for nicotine cessation (such as nicotine replacement therapies or bupropion) increased the likelihood of abstinence in the high risk groups. Those with the highest risk had a three-fold increase in their odds of being abstinent at the end of active treatment compared to placebo, indicating that these medications may be particularly beneficial for this population.

“We found that the effects of smoking cessation medications depend on a person’s genes,” said first author Li-Shiun Chen, M.D., of the Washington University School of Medicine, St. Louis. “If smokers have the risk genes, they don’t quit easily on their own and will benefit greatly from the medications. If smokers don’t have the risk genes, they are likely to quit successfully without the help of medications such as nicotine replacement or bupropion.”

According to the Centers for Disease Control and Prevention, tobacco use is the single most preventable cause of disease, disability, and death in the United States. Smoking or exposure to secondhand smoke results in more than 440,000 preventable deaths each year — about 1 in 5 U.S. deaths overall. Another 8.6 million live with a serious illness caused by smoking. Despite these well-documented health costs, over 46 million U.S. adults continue to smoke cigarettes.

The study can be found at: http://ajp.psychiatryonline.org/article.aspx?articleID=1169679. For information on tobacco addiction, go to: www.drugabuse.gov/drugs-abuse/tobacco-addiction-nicotine. For more information on tools and resources to help quit smoking, go to: www.smokefree.gov/.

All ‘Boomers’ should be tested for Hepatitis C infection

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ATLANTA — With “baby boomers” believed to account for 75% of the hepatitis C infected population in the U.S. — the CDC is recommending that everyone ages 47 to 67 be tested for infection.

The CDC estimates that some two million Americans born from 1945 to 1965 are infected with HCV — that’s about 3% of the boomer generation. But because many years usually elapse before noticeable symptoms develop, most don’t know they are infected.

The CDC said one-time HCV testing of all “baby boomers” “could identify more than 800,000 additional people with hepatitis C, prevent the costly consequences of liver cancer and other chronic liver diseases, and save more than 120,000 lives.”

“CDC believes this approach will address the largely preventable consequences of this disease, especially in light of newly available therapies that can cure up to 75% of infections,” the agency said in a statement issued Friday.

Most boomers do not have the risk factors that, until now, the CDC had used as the basis for testing recommendations. Those risk factors include use of illegal injected drugs, receiving blood products or organ transplants before HCV testing became routine, known exposures to HCV, presence of hepatitis symptoms, and all patients with HIV.

Vietnam era veterans — all baby boomers — are a well-know risk group due to blood exposure in military field hospitals as well as drug use.

Infection with HCV often leads to liver cancer. However, the recent introduction of HCV protease inhibitors, including telaprevir (Incivek) and boceprevir (Victrelis), has made the disease more manageable, possibly even curable.

The recommendation will be open for public comment from May 22 to June 8, after which the CDC will release a final version.

The CDC also set Saturday, May 19, as “National Hepatitis Testing Day,” and announced that it would make a total of $6.5 million in grants to make testing available to specific populations including Asian-American Pacific Islander communities (which have high rates of hepatitis B infection) and injection drug users, as well as members of the “boomer” generation.


John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University.

Drug companies profit as ‘Chronic Pain’ fuels boom in opium-based pain medicines

By John Fauber, Reporter, Milwaukee Journal Sentinel

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Prescriptions for narcotic painkillers soared so much over the last decade that by 2010 enough were being dispensed to medicate every adult in the U.S. around-the-clock for a month.

Fueling that surge was a network of pain organizations, doctors and researchers that pushed for expanded use of the drugs while taking in millions of dollars from the very companies that made them, a Journal Sentinel/MedPage Today investigation found.

Last year, the Journal Sentinel/MedPage Today found that a University of Wisconsin-Madison based organization had been a national force in helping liberalize the way opioids are prescribed and viewed. During a decade-long campaign that promoted expanded use of opioids — an agenda that critics say was not supported by rigorous science — the UW Pain & Policy Studies Group received $2.5 million from makers of opioid analgesics.

After that article was published last April, the UW Pain group said it had decided to stop taking money from the drug industry.

But the UW Pain group is just one link in a network of national organizations and researchers with financial connections to the makers of narcotic painkillers.

Beginning 15 years ago, that network helped create a body of “information” that today is found in prescribing guidelines, patient literature, position statements, books and doctor education courses, all which favored drugs known as opioid analgesics.

Without rigorous scientific evidence to prove that their benefits out weigh potential harm, drugs like OxyContin and Vicodin increasingly have been used to treat a wide array of chronic pain syndromes including low back pain and fibromyalgia.

Current practices reflect a gradual shift from the use of these drugs to treat short-term acute pain such as post-surgical pain, as well as severe pain associated with metastatic cancer or end-of-life pain — uses that were based on solid evidence that such use was safe and effective.

But the benefit seen for those conditions was extended to treatment of chronic pain syndromes, an extrapolation that had no evidence to back it up.

Caught in the middle are millions of Americans with real pain that can last for years and thousands of doctors who want to help them.

It’s a situation that was ripe for the influence of the pharmaceutical industry, said Mark Sullivan, MD, a professor of psychiatry and behavioral sciences at the University of Washington.

By 2010, those firms were selling four times as many prescription painkillers to pharmacies, doctors’ offices and hospitals as in 1999.

Led by OxyContin, sales of prescriptions of opioid drugs totaled $8.4 billion in 2011, up from $5.8 billion in 2006, according to data supplied by IMS Health, a drug market research firm.

“We’ve never really exposed so many people to so much drug for so long,” Sullivan said. “We don’t really know what the long-term results are.”

Click here to read the entire article > Chronic Pain Fuels Boom in Opioids

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Worried about those pills you found in your teenager’s room? What are they?

What kind of pills are these?

Worried about those capsules you found in your teenager’s room? Not sure about some of those leftover pills still in the bathroom cabinet? There’s a good chance that our Pill Identification Wizard (Pill Finder) can help you match size, shape, colour… then lead you to find the detailed description in our drugs database.

NOTE: As a general rule, we should all periodically check our medicine cabinets for any expired, re-bottled, or unidentified pills. The safest bet is to keep all medications in their original bottles or packets, with pertinent labeling and instructions attached, to avoid confusion and mistakes.

Most pills can usually be identified by color, size, shape and a combination of letters and numbers.

Click here for a Pill Identification Wizard

Contrary to Popular Belief Breast Cancer Rates Unaffected by Family History

By Kristina Fiore, Staff Writer, MedPage Today

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

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CHICAGO — Women ages 40 to 49 with no family history of breast cancer have similar rates of invasive disease as those with familial risk, radiologists reported here, firing yet another salvo at government mammography guidelines.

Among a group of more than 1,000 breast cancer patients, 64% of those with no family history of breast cancer had invasive disease, as did 63.2% of those with family history, a non-significant difference, according to Stamatia Destounis, MD, of Elizabeth Wende Breast Care in Rochester, N.Y., and colleagues.

“We were intrigued and surprised by the data,” Destounis said during a press briefing at the Radiological Society of North America meeting, noting that general wisdom suggests women with a family history are at greater risk of developing the disease than other women.

“Since there’s no difference in the rate of invasive breast cancer for women in their 40s whether they have a history of breast cancer or not, the recommendation should be that women in their 40s have screening mammography yearly,” Destounis said.
In 2009, the U.S. Preventive Services Task Force recommended against routine screening for women ages 40 to 49, leaving patients and clinicians to make individual decisions based on their risk. Mammograms should start at age 50, the committee said, and be performed every two years.
Yet the American Cancer Society (ACS), the American College of Obstetricians and Gynecologists, and other groups have called for continued screening in this age group, which Destounis said has led to confusion among patients and their doctors.
Still, the debate has shown few signs of letting up, as studies have continued to flood in — some showing that screening women 40 to 49 offers a robust mortality benefit while others have found only a trivial benefit.
Destounis and colleagues reviewed data on all breast cancer patients seen at their clinic between 2000 and 2010, with a total of 1,071 patients ages 40 to 49 treated for 1,116 cancers.
A total of 373 of those had been diagnosed via screening at their clinic; 61% of those patients had no family history of the disease, while 39% did. There were no significant differences in terms of the percentage of patients in either group who had a personal history of the disease.
The investigators also found that similar percentages of patients with and without familial risk had disease that metastasized to the lymph nodes (29.4% of those without versus 31.3% of those with).
“We agree with the ACS, which recommends screening for every woman in her 40s,” Destounis said.
Gary Whitman, MD, of MD Anderson Cancer Center in Houston, who was not involved in the study, told MedPage Today there are “very few mammographers who feel differently about the need to screen all women at 40 years of age.”
Edith Perez, MD, of the Mayo Clinic in Jacksonville, Fla., who also was not involved in the study, noted that it may show that family history isn’t necessarily useful for deciding whether a younger woman may be at greater risk of breast cancer, though this hypothesis would need further testing.