All posts by CPTFeditor

Pharmaceutical industry, under scrutiny for prices, has history of big political wins

In the News, News Stories & Editorials
Brianna Gurciullo, OpenSecrets Blog at Center For Responsive Politics
October 2, 2015

Soaring drug prices already had customers unhappy. The pharmaceutical industry hardly needed a new poster boy to add volume and passion to the complaints.

But that’s just what it got last week when Martin Shkreli, the CEO of Turing Pharmaceuticals, made a name for himself after he hiked the price of a drug for AIDS and cancer patients by more than 4,000 percent. Now, some lawmakers are scrutinizing another company, Valeant Pharmaceuticals, for increasing the price of two heart drugs this year.

[…]

There’s work to be done, for sure, but the industry has never lacked for resources to amplify its voice in politics and policy making. Since 1999, pharmaceuticals/health products has poured more money annually into lobbying than any other industry, including $229 million last year alone. PhRMA led the group, plowing $16.6 millioninto helping advance drugmakers’ priorities in Washington.

Pharmaceutical company employees and PACs have also given big to politicians. During the last presidential cycle, federal candidates, political parties and outside spending groups received $51 million – the largest-ever total from the industry. In last year’s midterms, it provided $32.1 million.

What’s been the return on this substantial investment? For one thing, dodging a number of bullets bearing PhRMA’s name. One of the industry’s greatest victories has been preventing Medicare from being able to negotiate drug prices with pharmaceutical companies. That was ensured when Congress passed and President George W. Bush signed the Medicare Modernization Act of 2003, which expanded Medicare to cover outpatient prescription drugs. The law also prohibited drug re-importation from Canada and Europe, where prices are often lower.

[…]

Recently, pharmaceutical companies have set their sights on the 21st Century Cures Act, a bill to accelerate new drug approval by the Food and Drug Administration. Castellani has said that the legislation would help “ensure biomedical advances continue and are available to the patients who need them to live longer, healthier lives.”

Critics like Diana Zuckerman, the president of the National Center for Health Research, argue that speeding up the process means smaller studies that fail to show whether a drug correlates with not only short-term changes – like, for example, a tumor shrinking over a few months – but also living longer, spending less time in the hospital and experiencing a better quality of life.

Agent Orange and Serious Diseases including Multiple Myeloma

Environmental Exposures, Other Cancers
Nicholas J. Jury, PhD and Diana Zuckerman, PhD
2015

It has taken many years to determine how Agent Orange exposure during the Vietnam War has harmed the health of those who were exposed. One of the reasons is that it can take decades for cancer to develop after a dangerous exposure.  Agent Orange was used extensively by the United States military during the Vietnam War to clear vegetation to make it easier to see enemy soldiers. Agent Orange was contaminated with dioxin, making it more dangerous to humans. Nearly 1.5 million veterans were exposed to Agent Orange during the war 1  when approximately, 20 million gallons of Agent Orange were sprayed over Vietnam during Operation Ranch Hand. 2,3

Although more research is still needed to learn more about the risks of Agent Orange, by 2012, the Institute of Medicine had concluded that individuals exposed to Agent Orange are more likely to develop these types of cancers and serious diseases 4:

Cancers:

  • Chronic B-cell leukemia
  • Chronic lymphocytic leukemia
  • Hodgkin disease
  • Non-Hodgkin lymphoma
  • Prostate cancer
  • Respiratory cancers (bronchus, larynx, lung, and trachea)
  • Soft tissue sarcoma

Serious diseases:

  • Early-onset peripheral neuropathy
  • High blood pressure
  • Ischemic heart disease
  • Parkinson disease
  • Stroke
  • Type 2 diabetes

The report also stated that some of the children being born to those exposed had spinal cord birth defects. 5

New research indicates Agent Orange also increases the chances of developing a type of cancer of the bone marrow called multiple myeloma.

Veterans who have been exposed to Agent Orange or other herbicides during military service are eligible to receive Veterans Administration health care benefits and compensation for respiratory cancers without having to prove the connection between their disease and exposure.  6

Does Agent Orange cause Multiple Myeloma?

Bone marrow is crucial for making new blood cells. Multiple myeloma causes blood cells to accumulate in the bone marrow and interfere with the process of making new blood cells. 7  Patients who develop multiple myeloma are usually diagnosed first with a condition called monoclonal gammopathy of undetermined significance (MGUS). 8, 9  Patients who have MGUS tend to develop multiple myeloma, and this risk increases over time. 10  More than 26,000 people are expected to be diagnosed with multiple myeloma this year, and less than half are predicted to survive. 11

In its 2012 report, the Institute of Medicine stated that there was insufficient evidence to conclude that exposure to Agent Orange can cause multiple myeloma. 12  However, a study published in a cancer journal in 2015 reported that veterans who were exposed to Agent Orange were 2.4 times more likely to develop MGUS than the veterans who were not exposed to it. 13  The study was based on 958 veterans who served in the United States Air Force during Operation Ranch Hand. This study provides compelling evidence that Agent Orange exposure can increase the risk of multiple myeloma.

Tanning beds: safe alternative to sun?

Diet, Habits, & Other Behaviors, Environmental Exposures, Prevention, Skin Cancer
By Heidi Mallis, B.A and Diana Zuckerman, PhD
Updated 2015

For many years, tanning beds were advertised as a safe alternative to a natural suntan, but in fact, there was no evidence that was true.  No U.S. government agency evaluated sun lamps, tanning beds, or tanning booths to make sure they were safe.  As a result, nearly 30 million people in the U.S. were using tanning beds each year14, 2.3 million of whom were adolescents.15

Research evidence was growing about the risks of tanning beds.  According to the American Academy of Dermatology and the World Health Organization, indoor tanning increases a person’s chances of developing melanoma by 59 percent, and the risk goes up with each use.16

Finally, in 2014 the U.S. Food and Drug Administration (FDA) announced that all sun lamps and UV lamps intended for use in sun lamp products must come with warnings include the following:

  • This product is contraindicated for persons under the age of 18 years;
  • This product must not be used if skin lesions or open wounds are present;
  • This product should not be used on people who have had skin cancer or a family history of skin cancer
  • People repeatedly exposed to UV radiation should be regularly evaluated for skin cancer3

As evidence grew of the link between tanning beds and skin cancer, especially for men and women in their 20s, more than 60% of states passed some kind of legislation restricting the use of tanning salons by children under 18 and two states, California and Vermont, have passed complete bans of indoor tanning for minors.17

What does this mean for you?

Tanning beds expose the user to a lot of artificial UV radiation in a short period of time. Just one 8-20 minute session exposes a person to more UV radiation than an entire afternoon spent in natural sunlight. In fact, doses of UV radiation emitted by high pressure sunlamp products may be up to 10 to 15 times higher than that of the midday sun, which is more intense than UV radiation found in nature.

A study conducted by Dr. S. Elizabeth Whitmore and Dr. Warwick Morison of Johns Hopkins University School of Medicine found that ten tanning sessions in two weeks produced evidence of a suppressed immune system among participants. This means that the body is less capable of fighting off infectious agents.18 Tanning bed use is also associated with faster skin aging because the UV radiation destroys skin fibers and damages elasticity. Characteristics of skin aging include wrinkles, dark spots, and a leathery texture.19

The International Agency for Research on Cancer lists tanning beds in its highest cancer risk category, “carcinogenic to humans.” This means that there is enough evidence to conclude that tanning beds can cause cancer in humans. Prior to 2009, the agency, which is part of the World Health Organization (WHO), previously classified tanning beds as “probably carcinogenic.” The change came after an analysis of more than 20 epidemiological studies indicating that people who begin using tanning devices before age 30 are 75% more likely to develop cutaneous melanoma, the most serious type of skin cancer20

Skin cancer is the most common form of cancer, with more than one million cases diagnosed each year in the U.S. There are three types of skin cancer: squamous cell, basal cell, and melanoma. Squamous cell carcinomas typically occur on surfaces exposed to the most sunlight, such as the ears or face. This type of skin cancer can spread quickly to other organs in the body. Basal cell carcinomas account for 8 out of 10 skin cancers. They grow very slowly and rarely spread to other parts of the body (as a result, they are highly treatable). Melanomas are the third and most dangerous type of skin cancer. They are less common than basal and squamous cell carcinomas but much more serious.21 Melanomas usually present as a change to an existing mole or an entirely new mole that is black or has a blue-black area. Their diameter is typically larger than that of a pencil eraser. If caught early, melanomas are often completely curable. However, they are much more likely to spread to other parts of the body if not found early.22

Risk factors for all three types of skin cancer include:

  • Lifetime exposure to UV radiation (from natural or artificial sources)
  • Family history of skin cancer
  • Geographic location (people who live close to the equator as well as in the mountains are exposed to higher levels of UV radiation)
  • Fair skin that freckles or burns easily
  • Severe sunburns as a child
  • Radiation therapy

Here are a few ways to lower your risk and avoid wrinkles and other skin damage:

  • Avoid direct sun exposure during midday hours (from 10 am-4 pm),
  • Use sunscreen with a sun protection factor (SPF) of at least 15
  • Regularly check your skin for any new moles, sores, or scaly patches (and visit a dermatologist if you notice the lesion changing form or color), and
  • Avoid using a tanning bed or booth (especially if you are a child, teenager, or young adult).23

Keeping track of moles and other changes to your skin are an easy way to improve your skin health. However, the U.S. Preventive Services Task Force suggests that if you are not at an increased risk of developing skin cancer, there is no need for yearly skin checks by a dermatologist.24

Continue to monitor any existing or new moles and contact your doctor if you detect any significant changes in size, shape, or color.

 

Psst! Industry has taken over FDA

In the News, News Stories & Editorials
By Jim Dickinson, Medical Device and Diagnostic Industry
September 17, 2015

Just six years ago, the industry-at-arm’s-length tradition held sway—as it had throughout FDA’s history—when Califf was passed over in Obama’s hunt for a commissioner.

The reason? The Duke University researcher of numerous drug industry clinical trials was then viewed as being too close to the pharmaceutical industry—the same reason that had for decades kept other similarly situated candidates from being chosen to lead the world’s premier health regulatory agency. New York health commissioner Margaret Hamburg was chosen instead.

[…]

No matter how sincere a commissioner might be—and Hamburg was—in divesting him or herself from all potential appearances of possible conflicts of interest before taking on the job, suspicions will linger in the minds of people and groups ready to provoke investigations that cost taxpayer dollars.

That is exactly what seems to be developing in the case of Califf’s nomination.

In a press release, Public Citizen said the Senate should reject it because of Califf’s close ties with industry over the years. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” the group said. “Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.”

Echoing similar concerns, National Center for Health Research president Diana Zuckerman said Califf could have a bias toward industry after working in tandem with companies that funded clinical research at Duke.

When Califf joined the agency last February as deputy commissioner for medical products and tobacco—a step widely seen as grooming him to become commissioner—Zuckerman told Time that his “interdependent relationships” may bring into question his “objectivity and distance.” In the Time article, she pointed out that research has shown that scientists may unknowingly be swayed by their industry relationships.

Read the full article here.

Califf nomination for FDA chief gets mostly high marks

In the News, News Stories & Editorials
By Joyce Frieden, Medpage Today
September 16, 2015

WASHINGTON — The nomination of Robert Califf, MD, as FDA commissioner is getting good reviews from most health policy and cardiology experts.

“He has a very good understanding of industry and academia, and think that will serve him well,” Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today in a phone interview. “He built and grew the Duke Clinical Research Institute into a behemoth, so he has deep experience in drug development. On the medical products side, he has a deep and comprehensive understanding … from manufacturers and academia, so I think he’ll be very well suited there.”

[…]

Califf was nominated on Tuesday by President Obama; he is currently serving as FDA’s deputy commissioner for medical products and tobacco. Prior to that appointment, Califf was vice-chancellor for clinical and translational research at Duke University in Durham, N.C., where he also co-chaired the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials.

[…]

One area that might cause controversy with Califf’s nomination is his ties to the pharmaceutical industry. “His very close ties to industry [are] his greatest weakness from a public health point of view,” Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank here that researches the safety of medical products for consumers, said in an email. “That’s why Republicans have supported his nomination and many Democrats have opposed it. Those ties have also been a source of great concern to public health experts across the country.”

“If he is confirmed, he will need to show his independence from industry in order to protect the safety of patients and the integrity of the FDA as a public health agency,” she said. “This will be especially important because the 21st Century Cures Act, which passed the House overwhelmingly and is being revamped in the Senate, has the strong support of pharmaceutical and device companies, as well as academic researchers who depend on industry funding, as Dr. Califf did when he was at Duke.”

Read the full article here.

Michael Milken, from junk bonds to legislative advocate

In the News, News Stories & Editorials
By Sheila Kaplan, Boston Globe via STAT
September 14, 2015
WASHINGTON — Nearly 1,200 lobbyists roamed the halls of Congress this year, trying to shape legislation to speed up the federal approval of new drugs and expand medical research. But the advocate who arguably has had the biggest impact on the process isn’t a registered lobbyist at all. It’s onetime junk bond king Michael Milken.

[…]

He has pushed his agenda with a muted public presence, one that stresses quiet messaging over press releases and networking over campaign contributions. His goal is passage of the 21st Century Cures Act, a bill that would accelerate regulators’ review of new medical treatments and boost funding for the National Institutes of Health by nearly $9 billion over five years.

[…]

Not everyone is pleased with Milken’s behind-the-scenes advocacy. While supporters say the Cures Act, a version of which was passed by the House in July, would make it cheaper and faster to get cutting-edge drugs and medical devices to patients, critics warn that it would create dangerous regulatory shortcuts. They fear that Milken is doing the bidding of the Pharmaceutical Research and Manufacturers of America, the drug industry’s main trade group.

“This is a bill that has many provisions that are exactly what PhRMA wants and what the device companies want,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank in Washington.

Please see full article here.

DCIS: Mostly good news

Breast Cancer, Breast Cancer
By Diana Zuckerman, Ph.D.

Thanks to widespread use of and technical improvements to screening mammography, there has been a dramatic increase in women diagnosed with ductal carcinoma in situ (DCIS), which is also called Stage 0 breast cancer.  DCIS accounts for 20-25% of new breast cancer cases diagnosed each year.25 The National Cancer Institute no longer refers to DCIS as breast cancer.

It’s important for doctors to do a better job of explaining DCIS to patients, because the number of cases of DCIS has increased by 750% over the last two decades.  This has resulted in thousands of women being upset by a DCIS diagnosis that in many cases frightened them as much as a diagnosis of invasive breast cancer would have.

This epidemic is good news and bad news

The epidemic seems like good news because it means that a lesion that can cause breast cancer is being diagnosed very early, before it is life-threatening and before the radical treatments that women most dread (mastectomy and chemotherapy) are necessary. It is bad news because many women are not fully informed or do not clearly understand the difference between DCIS and invasive cancer, and as a result of their fear of cancer, many undergo mastectomies that are not medically necessary.

Standard treatment for DCIS is mastectomy or lumpectomy with radiation.  Sometimes patients also have hormonal treatment. In most cases, lumpectomy with radiation is as safe and effective as mastectomy or bilateral mastectomy.  And the latest research suggests that for most women, being treated for DCIS instead of waiting to be treated for breast cancer is not saving lives.26

A diagnosis of DCIS means that cancerous cells were found in the lining of the breast duct, and will not spread.  The fact that DCIS can’t spread means that it is not harmful to patients.  However, DCIS can change to Stage 1 breast cancer, which can spread and can be fatal. DCIS is much less dangerous than other breast cancers, but patients are frightened by a diagnosis of cancer, often resulting in over-treatment.

Is it necessary to have any kind of treatment for most types of DCIS?  Some women choose not to get any treatment.  That used to be considered risky because it was difficult to predict if DCIS would ever change to breast cancer or not.  However, as experts have learned to diagnose the most risky types of DCIS, experts in the field are now encouraging some women to consider not undergoing treatment, or considering hormonal treatment instead of surgery.

Although early detection of breast cancer can save lives, DCIS is not life-threatening the way  invasive breast cancer can be, and so the benefits of detecting it is controversial.

Unfortunately, many women diagnosed with DCIS undergo unnecessarily radical surgery and treatment. Over-treatment is expensive and can be harmful and debilitating to patients and their loved ones. And, when women diagnosed with DCIS undergo mastectomies just like women with later-stage breast cancer, it may discourage other women from having regular mammograms, since there seems to be no noticeable benefit to early diagnosis.

At a DCIS conference at the National Institutes of Health (NIH) in 2009, experts concluded that breast-conserving surgery is as safe and effective as mastectomy, although mastectomy is more likely to be recommended if the DCIS is in more than one location in the breast. Combining radiation therapy with lumpectomy helps prevent recurrence and the development of invasive breast cancer, and other hormonal treatment is sometimes used in combination with one of these surgical treatments. According to the NIH, the long-term disease-free survival of women treated for DCIS is between 96% and 98%. Despite the high survival rate, the NIH concluded that the “current diagnosis and treatment of DCIS have considerable emotional and physical impact for women diagnosed” making it important “for the medical community to consider eliminating the inclusion of the term ‘carcinoma’ in this disease, as DCIS is by definition not invasive—a classic hallmark of cancer.”

Research published in 2015 reported that the death rate for women with DCIS is very low – about 3% over the next 20 years after diagnosis, compared to about 1.5% for the general population of women.27 However, the risks are higher for black women with DCIS than for white women.

Low-income women with DCIS have been more likely to undergo mastectomy instead of breast-conserving surgery with radiation, compared to higher income women with the same diagnosis. One possible explanation for this is that mastectomy is less expensive than lumpectomy with radiation in the short-term. Treatment choices are often more influenced by the information a woman has about DCIS and her understanding or confusion regarding that information, rather than her actual diagnosis.28 Physicians’ recommendations are the most influential factor in a woman’s treatment choice.29

Tackling the DCIS Epidemic

The Cancer Prevention and Treatment Fund of the National Center for Health Research has worked on the forefront of patient education on this issue.  We have also educated health professionals through a popular continuing medical education course. Several years before the NIH Consensus Conference, we received federal grants to convene two conferences at NIH for experts to discuss the most effective treatment options for early-stage breast cancer and DCIS, as well as how to improve patients’ understanding of their treatment options. The result of these meetings was a patient booklet for women with several different types of early-stage breast cancer, developed by our Center in partnership with the National Cancer Institute and NIH, and the NIH Consensus Conference on DCIS.

With support from the Jacob and Hilda Blaustein Foundation, we developed a free patient booklet for women with DCIS.

Statement of Dr Diana Zuckerman: regarding the introduction of The Prescription Drug Affordability Act of 2015

Legislation, Policy
Dr. Diana Zuckerman, PhD
September 10, 2015

We applaud Sen. Sanders and Sen. Cummings’ bill, which is tackling an issue of great importance to all Americans.  The cost of medications should reflect the value they provide, not “whatever the market will bear.”  We call on Congress to support these efforts and find a way to stop the epidemic of unaffordable medications.

To learn more about the bill, click here. For an example of unfair pricing of medical products, see this article in the New York Times.

Free patient booklet on ductal carcinoma in situ (DCIS)

In the News

To view, download, or print a free copy of our patient booklet, here is a PDF of

DCIS: What You Need to Know.

DCIS Booklet

The Cancer Prevention and Treatment Fund has developed a free, easy-to-read 32-page color booklet for women diagnosed with ductal carcinoma in situ (DCIS). DCIS is also known as Stage zero breast cancer. It explains DCIS and commonly used medical terms in plain language and helps women make informed decisions about their treatment.

Experts estimate that at least half of all women diagnosed with DCIS would never develop breast cancer even if they never received any treatment for their DCIS. Since no one knows for sure which women with DCIS will develop breast cancer and which won’t, most women with DCIS choose to get some form of surgery, usually lumpectomy. This booklet focuses on helping women decide what kind of surgery to get and what other kinds of treatment they might want or need.  Patients should keep in mind that if their physician tells them that they have a particularly low-risk type of DCIS, they may want to consider active surveillance or tamoxifen only, rather than surgery in addition to other treatments.

The current booklet was approved and funded by a grant from the D.C. Cancer Consortium through the Department of Health, Government of the District of Columbia, and a grant from the Jacob and Hilda Blaustein Foundation.  To request copies of the free patient booklet, write  info@stopcancerfund.org .

We are currently updating the booklet to include information about active surveillance.