Category Archives: news-you-can-use

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the full article here.

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery.

Four studies indicate that lumpectomy patients live longer.

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan  reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[1] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[2] They were also less likely to have died of breast cancer or of other causes.  This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[3] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[4The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[5] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[6] Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk.

The Bottom Line: these enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer should undergo surgery to remove only the DCIS lesion or cancer, not the entire breast.   The women who undergo lumpectomy with radiation usually live longer than those who undergo mastectomy or bilateral mastectomy.  In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing mastectomies or bilateral mastectomies that threaten their lives.  Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References 

  1. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
  2. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
  3. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer 2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
  4. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association 2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
  5. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
  6. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1

Prophylactic or optional mastectomies

Diana Zuckerman, PhD, and Brandel France de Bravo, MPH

Every year, thousands of women choose to undergo a mastectomy (surgery to remove the breast tissue) when lumpectomy (removal of only a small part of the breast) would be an equally effective option for them. Some women choose a bilateral mastectomy (removal of both breasts, also called a double mastectomy) when there is cancer in only one breast. Even women who do not have breast cancer may undergo mastectomies as a preventive measure because of their high risk of breast cancer, as was the situation with Angelina Jolie. If either one or two breasts without cancer are removed, the surgery is called a “prophylactic mastectomy.”

Helping patients make an informed decision about whether to have a mastectomy is an important aspect of the physician-patient relationship. Unfortunately, many patients are not able to get the information they need from their physicians. A patient who is seriously considering a mastectomy or bilateral mastectomy that is not medically necessary may be basing her decision more on fear than on information. They may benefit from unbiased information, counseling, or from a second opinion before making a final decision.

The purpose of this article is to provide information that patients and family members can use to help them discuss their options with their physicians.

Should I remove one breast or both?

 Women in the U.S. who are diagnosed with early-stage breast cancer sometimes remove both breasts even if only one has cancer.  However, new research indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.  Even though removing a healthy breast lowers the risk of getting cancer in that breast in the future, the risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.1 Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk. In a study of more than 4,000 women, removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. Dr. Fahima Osman of the University of Toronto presented these findings at the 2013 meeting of the American Society of Breast Surgeons.2

What if I have a breast cancer gene (BRCA1 and BRCA2)?

Women with known mutations in the BRCA1 and BRCA2 genes have a lifetime risk of breast cancer ranging from 40% to 65% on average, compared to 12% for women in the general population. Women with BRCA1 or BRCA2 mutations often develop breast cancer before age 50 and have a high risk of bilateral breast cancer and ovarian cancer.3 Removing breasts with no sign of cancer is called a prophylactic (preventive) mastectomy. Prophylactic mastectomy and prophylactic oophorectomy (removal of the ovaries) have both been shown to greatly reduce – but not eliminate – the risk of breast cancer in BRCA mutation carriers.3  Among women with strong family histories of breast cancer, individuals of Ashkenazi Jewish descent have an 8 times greater frequency of carrying these mutations in BRCA1 or BRCA2 compared with other women.4

Lumpectomy with radiation therapy is just as effective for preventing same-breast tumor recurrence in breast cancer patients with BRCA mutations as it is for other women. Questions remain, however, about how other adjuvant treatments (such as chemotherapy) affect survival of women with these gene mutations.4

For women with the BRCA1 or BRCA2 genes, it is important to remember that the risk of breast cancer in the next 5 or 10 years is much lower than the lifetime risk of breast cancer. For example, the risk of breast cancer in her 20s is very low, even with BRCA1 (less than 3%) or BRCA2 (approximately 1%). For a 30-year old woman, the risk by age 39 is higher (10% for women with BRCA1 and 8% for BRCA2). For a 40-year-old woman, the risk by age 49 is 16% for women with BRCA1 and 13% for women with BRCA2.4 Although these 10-year risk levels are much higher than for most women, they are much lower than the life-time risk that is so frightening. It is also important to remember that cancer treatments and prevention strategies are improving, so the risks of cancer may decrease and the survival rates are improving.

Is there something I can do other than Prophylactic Mastectomies?

Prophylactic mastectomies can prevent breast cancer, but many women who undergo prophylactic mastectomies would never have developed breast cancer, even without the surgery.  To make an informed decision about whether to undergo a prophylactic mastectomy, women need a clear understanding of the risks and benefits as well as other strategies that also reduce risk.

Tamoxifen and raloxifene have both been shown to reduce the risk of breast cancer for women who have not had cancer but are at greater risk. These drugs can also reduce the risk of breast cancer for women with BRCA1 or BRCA2 mutations.

For women at high risk of breast cancer for any reason, routine screening starting at a young age can be an alternative to prophylactic mastectomy. Options include clinical breast exams, mammograms, ultrasounds, and MRIs. MRIs are much more accurate than mammograms for young women and women with dense breast tissue, and avoid the additional risks associated with radiation — risks that should be avoided by women who already are susceptible to breast cancer. A 2012 study of women with BRCA1/2 mutations who were under 30 years old showed that the increased radiation they were exposed to from early, frequent mammograms increased their risk of breast cancer. Women with the most radiation exposure had the highest risk of breast cancer, compared to other women with the same gene mutations.5 Those risks can be avoided by replacing early mammograms with MRIs instead. However, it is important to note that MRIs used for screening tend to result in overtreatment, including unnecessary biopsies and mastectomies.6

Research indicates that a low-fat diet, weight control, and exercise may reduce the risk of breast cancer for all women, including women at high risk and women who previously were treated for breast cancer.78

What do stakeholders think of FDA’s latest effort to get patients timelier access to devices?

By Michael Williamson, Bloomberg BNA

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.

Medicare panel voices doubts about genetic cancer tests

By Virgil Dickson, Modern Healthcare

The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) has expressed little confidence in genetic tests that supposedly predict common cancers. The decision raises doubts about whether the CMS will authorize Medicare coverage for such tests.

“This is such a promising and exciting field, but the excitement is far ahead of the data,” said Diana Zuckerman, a panel member and president of the National Center for Health Research, an advocacy organization. These tests “could be so helpful if only we knew more.”

Specifically, there was a concern among committee members who met Tuesday about the lack of data regarding clinical utility, which indicates if a test result was actually helpful to a consumer.

“The evidence got very thin, very quickly,” said Dr. Beverly Guadagnolo, a panelist and associate professor in the radiation oncology department at the University of Texas.

Industry stakeholders present at the meeting disagreed. “Two hundred-plus labs around the country wouldn’t be doing these tests if they didn’t have clinical utility,” Dr. Jan Nowak, medical director of molecular diagnostics and cytogenetics at NorthShore University HealthSystem, Evanston, Ill., said during public comments.

Another leading concern was to ensure people did not undergo unnecessary chemotherapy. “We need to be on the side of the angels and minimize access to drugs that don’t necessarily need to be given,” said Dr. Josef Fischer, a panelist and professor in the surgery department at Harvard Medical School and Beth Israel Deaconess Medical Center.

The eight-member panel was asked to vote on a scale of 1 to 5 on how confident members were that the tests they were reviewing would actually benefit Medicare beneficiaries by bettering quality of life, helping them avoid inappropriate anti-cancer treatments or death. The tests that were up for consideration claim they help predict the chances of colon, rectum, breast and lung cancers.

Panel member votes were collected and averaged. Most of the tests received an average score under 3, though a test related to breast cancer rated higher at 3.8. Another test meant to find cancerous lung cancer genes scored the lowest at 1.375.

The panelists also were asked to discuss if they would feel more comfortable with a test being used by beneficiaries if it were a laboratory-developed test from a facility certified under the Clinical Laboratory Improvement Amendments or a test that received Food and Drug Administration approval or clearance. Members seemed more comfortable with an FDA-approved test.

It’s unclear what direction the CMS will take moving forward. MEDCAC is generally considered influential, but the agency recently decided to not concur with a committee vote to not recommend Medicare coverage of annual CT scans to detect lung cancer in heavy smokers.

During the meeting, CMS liaison Dr. James Rollins indicated that any future coverage given to these type of tests would need to prove clinical utility. Today, most entities developing these tests focus on proving analytical validity, how accurately a test detects a specific genetic variant, or clinical validity, how well the genetic variant is being analyzed.

See original article here.

Breast implants in France to carry cancer warning: researchers find a ‘clearly established link’

By Dana Dovey, Medical Daily
March 18, 2015

Following France’s National Cancer Institute finding a “clearly established link” between breast implants and a specific type of cancer, the country will now order all breast implants to come with a cancer warning. This announcement came after 18 cases of anaplastic large cell lymphoma were directly linked to women with silicone breast implants since 2011.

Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin’s lymphoma that affects the blood. The link between breast implants and this form of cancer is extremely rare, so French officials have urged women who already have the implants not to remove them, the Daily Mail reported. Given the severity of the cancer in the few women who do develop it, French officials felt it necessary to inform women of all the possible risks associated with the surgery.

ALCL is extremely rare, affecting around one to six in every three million women who undergo breast augmentation, Medical News Today reported. However, a study conducted by researchers from Cambridge University in the UK found that nearly all cases of ALCL in breasts occurred in patients who had undergone breast augmentation, suggesting a link between the two. Although it’s not clear why silicone breast implants can sometimes cause cancer, the Cambridge investigation did shed some light on the mystery.

“It’s becoming clear that implant-related ALCL is a distinct clinical entity in itself,” Dr. Suzanne Turner, lead researcher of the Cambridge study, told Medical News Today. “There are still unanswered questions and only by getting to the bottom of this very rare disease will we be able to find alternative ways to treat it.”

Breast implants are a very popular surgery, with Dr. Diana Zukerman, president of the National Center for Health Research, explaining that in 2013 alone 300,000 American women opted for the operation. Of these women, around 80 percent undergo breast enhancement for cosmetic reasons while a further 20 percent have breast implants following breast cancer.

This is far from the first time that breast implants have been implicated in causing a health hazard. In 2011, French firm PIP caused global hysteria when plastic surgeons reported an abnormal amount of the implants rupture, the Daily Mail reported. It was later found that the firm had been manufacturing these breast implants using industrial grade silicone intended for use in mattresses.

The implants were subsequently found faulty and banned from use. Women who had already received the implants were advised to have them removed, although European health officials found no medical or toxicological evidence to back this advice.

See original article here.

Candidate to lead FDA has close ties to big pharma

By Massimo Calabresi, Time

Duke’s Dr. Robert Califf sees closer collaboration between government and industry

Dr. Robert CaliffLast May, Duke University’s Vice Chancellor for clinical research, Dr. Robert Califf, told an audience of executives that the American system for developing drugs and medical devices was in crisis. Using slides [pdf] developed by Duke’s business school, he said the system was too slow and too expensive, and required disruption and transformation. Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.

Such views are not uncommon in industry, academic research and on Capitol Hill, but they are noteworthy coming from Califf because he could soon be America’s top regulator overseeing the safety and efficacy of the country’s drugs and medical devices. Califf is already set to become deputy commissioner at the Food and Drug Administration (FDA) next month. Now sources familiar with the process tell TIME he is on President Barack Obama’s short list to run the agency following this month’s announcement that its long-serving commissioner, Margaret Hamburg, will step down in March.

The White House declined to comment on pending personnel decisions, but word that Califf is in contention for the top spot at the FDA comes at a key moment. The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. He says he is divesting his holdings in two privately-held pharmaceutical companies he helped get off the ground.

Califf says such collaboration, not just between industry and academia, but with government, too, is the way of the future. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says. He says there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” He says it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studiessuggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

The tension over Califf’s collaboration with industry gets to the heart of the future of the FDA at a pivotal moment. While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future. Califf heads a successful and powerful clinical research program, the Duke Translational Medicine Institute, which brings together industry drug researchers, academic scientists and federal regulators to speed drug development and approval. Califf estimates 50-60% of its $320 million in annual research funding comes from industry.

Capitol Hill is considering codifying parts of that collaborative model for the FDA. The powerful Energy and Commerce Committee in the U.S. House of Representatives recently introduced a draft bill called 21stCentury Cures, which would loosen the drug approval and post-market oversight process. Califf says because the bill is still in draft it is too early to pass an overall judgment on it but he says, “I support a lot of the concepts in the bill.”

In the Senate, the Health, Education, Labor and Pensions (HELP) committee has begun work on its own bill, with committee chairman Lamar Alexander declaring, “It takes too long and costs too much to develop medical products.” In a report paving the way for his legislation, Alexander concluded the FDA has grown too large, has fallen behind scientific innovation and threatens American leadership in biomedical innovation. Reform efforts in the Senate may be aided by the support of liberals like Elizabeth Warren who back looser regulations on the medical device industry.

The FDA uses a model for drug testing and oversight largely developed in the early 1960s, with phased trials before drugs and devices are approved for sale to ensure they are safe and effective, and “post-market” studies afterwards to monitor them. Over time, the agency has come to rely on the medical product industry for more than 60% of its budget for post-market monitoring.Accused of regulatory capture by those who see undue industry influence, the FDA has faced attacks from both sides.

That means the FDA has few defenders and will rely heavily on its next commissioner to stand up for it in public and on Capitol Hill. “This is a very dangerous time for the agency,” says Zuckerman of the National Center for Health Research, “It’s under fire in a way that is unprecedented in the last 20 years.”

Califf’s supporters point out that he is among the ten most cited medical authors in America, and that he has spent his career as a clinician helping patients. Regarding the danger of regulators being “captured” by their interactions with industry, Califf says, “The difference between capture and collaboration towards improving human health is a pretty big difference.”

The White House has set no time frame for its decision on Hamburg’s replacement. It has announced the acting commissioner will be Dr. Stephen Ostroff, a scientist and long-time official at the Health and Human Services department, when she steps down in March.

Link to original article here.

Letter to the Editor: "Keep the Medical Device Tax"

THE NEW YORK TIMES, FEBRUARY 13, 2015

Our research strongly supports your Jan. 30 editorial “No Case for Killing the Medical Device Tax”: Repealing the tax is indeed “a terrible idea” that solves a nonexistent problem. It could result in cutting health care programs that patients rely on.

Thanks to the Affordable Care Act, millions more Americans can now afford medical care that relies on devices like CT scans, cardiac implants or joint replacements. Our nonpartisan research center just released a report indicating that the device industry is thriving in the two years since the tax went into effect.

Stock prices increased an average of 66 percent for the largest United States-based device companies and even more for the smaller ones, much higher than the pharmaceutical companies, Nasdaq or the New York Stock Exchange.

Device companies’ sales and research and development also increased, and profit margins remained very strong. These data are consistent with the Congressional Research Service report that said the benefits of the health care law would help make up for the minimally negative effect of the tax.

Congress intended for industries that would benefit from the health law to help pay for it. The $29 billion raised from the device industry is far less than the amounts raised from other industries that benefit from the law, like drug makers and insurance companies. Why should those industries pay if the device tax is repealed?

Paul Brown, Washington

The writer is government relations manager at the National Center for Health Research.

See original letter here.

Congress is up to something and only you can stop them

January 23 Update

After this blog was written, Sen. Orrin Hatch (R-UT) introduced S. 160, which would repeal the tax described below. No need to look at the facts – just bow to special interests while trying to kill Obamacare! To see which 5 Democrats and 23 other Republicans who support a bill that would help destroy Obamacare, scroll below this blog. And make sure they hear from you!

Congress is Up to Something | The Huffington Post

by guest blogger Diana Zuckerman, PhD, National Center for Health Research

If you think health insurance should be affordable and you didn’t get a 65 percent raise over the last two years, keep reading!

Congress is up to something, and only you can prevent it from happening. Even though the upcoming Supreme Court decision about the Affordable Care Act could drastically curtail it, that may not be the greatest threat to the millions of Americans who don’t want to lose their health insurance.

A greater threat comes from certain U.S. companies and from hundreds of members of Congress, and the culprits might surprise you.
The senators and representatives you need to worry about include some of the most conservative Republicans, but also some Democrats that are usually strong supporters of patients and consumers–including Elizabeth Warren, Chuck Schumer, and Barbara Mikulski.

And they’re bowing to pressure from companies that advertise on NPR, your favorite TV shows, and other media, touting how they save lives every day. In truth, these companies do save lives. But they also make billions of dollars and don’t feel like giving any of it to help pay for the Affordable Care Act, as the legislation requires. And that could be fatal to countless Americans.

This is what happened: The three industries that would benefit from millions more insured Americans were asked to make small financial compromises to help pay the cost of subsidies that would make health insurance affordable to millions more Americans. The compromises included lowering certain prices, limiting profits, or paying a small excise tax on products sold.

Two of the industries kept their agreements, but the third immediately tried to repeal the part of the law that affected it.

No, it’s not Big Pharma that is the problem. Those companies understand how the Affordable Care Act helps their bottom line and their patients.

It’s not the insurance companies, either. They fought the Affordable Care Act but eventually agreed to the terms that have helped keep prices under control. They haven’t reneged, and they even lined up in greater numbers to sell policies at lower costs through the state exchanges this year.

The problem includes companies that make lifesaving heart valves and stents, hip and knee replacements, PT scanners and mammography machines, and the contact lenses that millions of us rely on.

The medical device companies selling these and other products spent more than $150 million to try to repeal a 2.3 percent tax on the devices they sell in the U.S. These include implants that cost $20 to make but that sell for $500, as well as devices that sell for half a million dollars but are as obsolete as your iPhone 2 after a few years.

They’re complaining to Congress that the tax is killing jobs and cutting funds for the research and development needed to create the innovative products that patients deserve. If they get their way and the tax is repealed, there will be $29 billion less to pay for health insurance over the next decade, and we can expect Pharma and the insurance companies to try to get out of their contributions, as well.

I’m a scientist, so I decided to examine the evidence for the “job killing” and other claims made by the device companies.

First we looked at stock prices–all publicly available online. Not all device companies have publicly traded stock, but the ones complaining the loudest about the device tax do. We looked at the 12 largest U.S.-based companies that sell nothing but devices (not ones that also sell pharmaceuticals or appliances). In the two years since the tax started, their stock went up a whopping 65 percent on average–much more than the NY Stock Exchange (25 percent) or the largest U.S.-based pharmaceutical companies (54 percent).

Then we looked at sales. Sales steadily increased over the last decade, including after the device tax was implemented. So, there would seem to be no reason to cut jobs and every reason to hire more workers.

What about R & D costs to develop new products and possibly hire new workers? Again, a steady increase over the decade, and after the tax went into effect.
What about profit margins? These were stable over the decade for most companies, despite the 2008 economic meltdown and despite the device tax. Again, no reason to cut jobs or raise a ruckus about the tax.

And yet, the House of Representatives has passed several bills that include repealing the tax, and the Senate passed a bipartisan resolution declaring its opposition to the tax. Fortunately, the resolution specified support for repeal only if another source is designated to make up for the $29 billion in revenues that the tax would provide.

Finding another $29 billion seems unlikely, yet congressional leaders keep saying there is overwhelming support to repeal the tax, and journalists repeatedly report that “widespread bipartisan opposition” to the tax will inevitably result in a repeal.

If that happens, the dominoes start to fall and the Affordable Care Act would become unaffordable.

Don’t let that happen. Here’s more information and the Senate voting record on repealing the tax. Let your voice be heard.

Diana Zuckerman is the president of the National Center for Health Research. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, newspapers, and websites.

Around the same time this blog went online, 29 Senators co-sponsored a new bill to repeal the medical device excise tax: 5 Democrats and 23 Republicans. Contact the senators who haven’t co-sponsored S. 149, to urge them to reject this bill.
And if any of your senators have signed on, let them know how you feel:
S.149: Medical Device Access and Innovation Protection Act
Sponsor: Sen Hatch, Orrin G. [UT] (introduced 1/13/2015) Cosponsors (28)
Related Bills: H.R.160
Latest Major Action: 1/13/2015 Referred to Senate committee. Status: Read twice and referred to the Committee on Finance.
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COSPONSORS(28), ALPHABETICAL:
Sen Alexander, Lamar [TN] – 1/13/2015
Sen Ayotte, Kelly [NH] – 1/13/2015
Sen Barrasso, John [WY] – 1/20/2015
Sen Blunt, Roy [MO] – 1/21/2015
Sen Burr, Richard [NC] – 1/13/2015
Sen Capito, Shelley Moore [WV] – 1/21/2015
Sen Casey, Robert P., Jr. [PA] – 1/13/2015
Sen Cassidy, Bill [LA] – 1/13/2015
Sen Coats, Daniel [IN] – 1/13/2015
Sen Collins, Susan M. [ME] – 1/20/2015
Sen Crapo, Mike [ID] – 1/20/2015
Sen Donnelly, Joe [IN] – 1/13/2015
Sen Flake, Jeff [AZ] – 1/22/2015
Sen Franken, Al [MN] – 1/13/2015
Sen Gardner, Cory [CO] – 1/20/2015
Sen Inhofe, James M. [OK] – 1/20/2015
Sen Isakson, Johnny [GA] – 1/13/2015
Sen Kirk, Mark Steven [IL] – 1/20/2015
Sen Klobuchar, Amy [MN] – 1/13/2015
Sen Lankford, James [OK] – 1/21/2015
Sen Moran, Jerry [KS] – 1/20/2015
Sen Murkowski, Lisa [AK] – 1/13/2015
Sen Portman, Rob [OH] – 1/13/2015
Sen Roberts, Pat [KS] – 1/20/2015
Sen Scott, Tim [SC] – 1/13/2015
Sen Shaheen, Jeanne [NH] – 1/13/2015
Sen Toomey, Pat [PA] – 1/13/2015
Sen Wicker, Roger F. [MS] – 1/13/2015