Category Archives: We’re In the News

Breast Implants Linked to Rare Cancer

News Stories & Editorials
Diana Zuckerman, PhD, National Center for Health Research, on behalf of Cancer Prevention & Treatment Fund, in Our Bodies Ourselves:  March 24, 2017

breast implants

 

Last week the media discovered that breast implants can cause cancer. Rather than causing breast cancer, experts now say that breast implants can cause a type of lymphoma (cancer of the immune system) called anaplastic large cell lymphoma (ALCL).

You’ll be excused for thinking this is news. The truth is that experts have known that breast implants cause ALCL since at least 2013, and some of the foremost plastic surgeons in the country were discussing it behind closed doors since at least 2010.

The U.S. Food and Drug Administration (FDA), which is responsible for making public information about the risks of medical devices, including breast implants, first published a report on its website about ALCL and breast implants in 2011. At that time, they said there was evidence that implants might possibly cause ALCL. The FDA’s report came months after anarticle published in Allure magazine stated that plastic surgeons and their medical societies were studying the possible link between breast implants and ALCL.

Articles subsequently published in medical journals concluded that breast implants cause ALCL. But despite the growing evidence, the FDA didn’t update its website to officially report that breast implants really can cause ALCL until last week. That’s when the media realized it was a real story.

If you think women should have been told this sooner, here’s what you need to know:

In May 2016, the World Health Organization published a report that included the term breast implant associated ALCL (BIA-ALCL). A few months later, the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease. The guidelines (you need to sign up for a free account to see them) include a guided algorithm for surgeons and oncologists to test for and diagnose the disease. The authors conclude that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants are  implanted must be evaluated.

They also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years to make sure the ALCL is eliminated.

Why didn’t plastic surgeons or the FDA make that information more widely available? I’m sure there are women and their doctors who would have benefited from that information in the last few months.

In 2015, plastic surgeons who had denied any link between breast implants and cancer for more than two decades published an article in a plastic surgery journal about 173 women with ALCL that was caused by their breast implants.

However, plastic surgeons across the country focused on reassuring women that BIA-ALCL is “very rare” and the FDA echoed that mantra.  But, although rare, it seems that BIA-ALCL is not “very rare.”  In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., the Australian Department of Health estimates that BIA-ALCL affects as many as one in 1,000 women with breast implants.

The estimates of plastic surgeons and the FDA are much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. than in Australia. Given the dramatic increase in BIA-ALCL diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

For women with ALCL, it doesn’t matter how rare it is. The sooner it is diagnosed, the more likely it can be cured easily by removing the implants and scar capsule surrounding it. At later stages, women will need chemotherapy and are less likely to survive, according to research conducted at the MD Anderson Cancer Center that was published in 2013.

The study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis. You can read more about the study here.

ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.

A published response in the same medical journal urged physicians to respond quickly and to check patients who have swelling near their implants for ALCL. This would require cytology testing rather than testing for bacteria.

This news is especially important to women who undergo mastectomies to prevent cancer or for DCIS or very early breast cancer, either of which is equally likely to be cured with a lumpectomy instead. Women trying to beat cancer by undergoing a radical surgery they don’t need are unlikely to do so if breast implants will put them at risk of developing a different type of cancer.

The news is equally frightening to cosmetic surgery patients. Many health insurance companies refuse to cover the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. We now know this can result in undetected ALCL, which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.

Women deserve to know the facts.  And they deserved to know them years ago.

Read the full article here. 

Right to Try National Law Would Exploit False Hope

In the News, News Stories & Editorials
Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund
Published in 19 newspapers including, Chicago (IL) Tribune, Sacramento (CA) Bee, McAllen (TX) Valley Voice, Bellingham (WA) Herald, Cambridge (OH) Sunday Jeffersonian, Lawton (OK) Constitution, Mason City (IA) Sunday Globe Gazette, Willimantic (CT) Sunday Chronicle, New Bedford (MA) Standard Times, Frederick (MD) News Post, and others from March 16-20, 2017

right-to-tryIf you or a loved one were dying of a terminal illness and your doctor told you there were no proven treatments, would you take the risk of trying an experimental, unproven drug?

Many patients would say yes. But as with most medical decisions, the more you know, the more you realize the answer is not so simple.

As has been clearly shown, Congress is not very good at making complicated and nuanced decisions about medical care.

That’s reason enough to question the new federal Right to Try Act dozens of senators and representatives are pushing this spring.

The most important thing to know is that all terminally ill patients already have a right to try experimental drugs in this country.

The proposed new law, however, is much more dangerous to all patients, and not just those facing fatal illness.

Here’s why:

The current national expanded access program enables doctors to request experimental drugs for their patients. If the company that makes the treatment agrees, the patient will get the treatment for free or at cost; companies are not allowed to sell experimental drugs for a profit.

Many patients get access to experimental drugs through this existing program, and improvements are underway to further streamline the process.

In contrast, under the proposed new law, a drug company could charge desperate patients as much as they want to get access to an experimental drug.

Since insurance companies do not pay for experimental treatments, many patients would wind up with the right, but not the money, to try such regimens. Out of desperation, some would surely go into debilitating debt to try a drug that might harm rather than help them.

The current national program makes sure patients understand the risks of taking an experimental treatment and requires that the drug has been studied enough to know that the patient might possibly benefit from it.

Under the proposed new law, drugs that were only studied at a low dose on a small number of healthy volunteers could be sold to patients, and unethical doctors could receive kickbacks for persuading patients to try treatments that will not help them.

It’s easy to understand why every patient wants to have hope of a cure, and that’s the power of right-to-try laws.

So far, hype and false hope have convinced 33 states to pass right-to-try laws that provide no real advantage over the current national program. But rather than learning from the mistakes at the state level, patient activists and others are pushing Congress to pass a much more dangerous federal law.

In addition to encouraging the sale of unproven treatments at sky-high prices to desperate patients, the 2017 federal Right to Try Act would do the following:

  • Allow the sale of almost all experimental drugs, even those never tested on patients before.
  • Prevent patients and family members from suing the company if the treatment harms or even kills them.
  • Prohibit doctors and scientists from evaluating the benefit or harm of the experimental drugs.

Desperate patients are lobbying for the bill, but do they realize what they are lobbying for?

Instead of getting access to free experimental drugs that have some evidence of benefit and are being tested to help all patients, this law would allow naive and desperate patients to be exploited by greedy companies and unethical doctors.

The right-to-try movement opposes the FDA for what’s described as “interfering” with the doctor-patient relationship. They do not understand that unbiased scientific evidence is needed to help physicians and patients make informed decisions – whether to save a life or make a patient’s last months as enjoyable as possible.

Patients already have a right to try through the FDA’s humanitarian expanded access program, which gives them hope while protecting them from greedy exploitation. The proposed federal Right to Try Act would not.

Read original article here.

On the other side of the debate, Naomi Lopez Bauman of the anti-FDA Goldwater Institute wrote a misleading article about why they support a national Right to Try law. 

Let’s set the record straight on at least a few of her misstatements::

  • She claims that companies are prohibited by law from charging more for the investigational treatments than their “actual cost.”  That is true of current law.  However, the national Right to Try Acts that are being considered in Congress specifically allow companies to determine what they will charge for their experimental drugs.
  • She states that in 2015, FDA only allowed 1,300 patients to have access to experimental drugs through their Expanded Access program.  That is true but very misleading, because the FDA is approving 99% of the applications to participate in the program.  The reason the number is low is that when doctors request access for their patients, the companies that are being asked to make their drugs available are not always willing or able to do so.  In some cases, they don’t have enough of the experimental drug available.  In other cases, they believe that the specific patient requesting the drug could be harmed and would not be helped by taking the drug.
  • She states and implies that the national law would not change FDA safeguards and would do no more than make the current state laws national.  That is not true.  On the contrary, the national law would eliminate the role of the FDA from these decisions and the protections that current law provide to prevent patients from being exploited by greedy companies or doctors.
  • She states that “promising new treatments” take more than a decade to be approved by FDA.  We don’t know where that inaccurate statistic comes from, but we do know that the average drug is approved about a year after it is submitted to the FDA, and an article in Cancer World concluded that the FDA approves drugs an average of 6 months faster than the European medical agency
  • She expresses concern that “FDA would retaliate” against those utilizing Right To Try laws.  There is zero evidence to back up that statement.  That is just anti-FDA rhetoric.
  • She states that “most” of the 78 patients treated by an “oncologist” under the Texas Right to Try law “are doing very well,” according to his testimony before a U.S. Senate committee.  If you watch the video of his statement online, you can see the doctor who testified (Ebrahim Delpassand, who is a radiologist, not an oncologist) never said “most are doing very well.” He said that the treatment “has helped many” of the patients, but he doesn’t say how many or to what extent the treatment helped, nor does he say how many were hurt by the treatment.
  • She says something is wrong because “fewer than one-tenth of 1 percent of terminal patients can take advantage of the FDA’s compassionate use exception.”  But the truth is that experimental drugs are just that: experimental and not proven to work or be safe.  Patients can die sooner and in agony from experimental drugs, especially those that have only gone through tiny, preliminary studies of a few healthy volunteers or patients (as the proposed national law would allow).  She neglects to mention that only about 15% of the drugs that complete those preliminary trials are eventually proven to be safe or effective.  The other 85% are either not safe, not effective, or both. That is a very important reason why most patients (and their doctors) do not seek experimental treatments even when they know they can.

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

In the News, News Stories & Editorials, news-you-can-use
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.

Statement of Dr. Diana Zuckerman, President, National Center for Health Research, Regarding the American Health Care Act

News Stories & Editorials
Diana Zuckerman, PhD, National Center for Health Research, on behalf of Cancer Prevention & Treatment Fund:  March 9, 2017

The goal of the American Health Care Act is to replace the Affordable Care Act (ACA) with something better, but instead it represents a giant step backward for health care for all Americans. This proposed plan will cover far fewer Americans than the Affordable Care Act (ACA), and insurance will pay for less and cost more. The proposed tax credits and Health Savings Accounts (HSAs) will not begin to provide adequate health insurance for Americans covered under the ACA, particularly low-income patients.

A substantial number of people who had health insurance for the first time under ACA will lose it. The proposed 30% surcharge for those who let their insurance lapse is an insufficient incentive for healthy people to purchase insurance. Since the surcharge is the same for patients whose insurance lapses for 2 months or 20 years, it actually discourages healthy patients from buying health insurance until they have substantial medical expenses. The lack of healthy patients in the insurance pool means higher premiums and deductibles for all of us. And, as more uninsured patients end up in hospitals needing expensive medical care for cancer, heart disease, or other serious illnesses, that uncompensated care means higher hospital costs for all of us.

The very obvious shortcomings of the proposed TrumpCare bill are the reasons why hospital organizations, the American Medical Association (AMA), AARP, and many insurers are all against this legislation. It would disrupt the marketplace, create confusion and uncertainty, and reduce or strip health care coverage from millions of Americans.

Meanwhile, the bill would provide tax breaks for the wealthy at the expense of those losing health coverage. The legislation also would serve to severely reduce Medicaid benefits over time, by eventually turning the Medicaid coverage now provided into block grants to states, many of which might spend the funds on issues other than health care.

Amid Flurry of New Cancer Drugs, How Many Offer Real Benefits?

In the News, News Stories & Editorials
Liz Szabo, Kaiser Health News: February 9, 2017

Marlene McCarthy’s breast cancer has grown relentlessly over the past seven years, spreading painfully through her bones and making it impossible to walk without a cane.

Although the 73-year-old knows there’s no cure for her disease, she wants researchers to do better. It’s been years, she said, since she has found a drug that has actually helped. McCarthy said she’s frustrated that the Food and Drug Administration is approving cancer drugs without proof that they cure patients or help them live longer. […]

Pushed by patient advocates who want earlier access to medications, the Food and Drug Administration has approved a flurry of oncology drugs in recent years, giving some people with cancer a renewed sense of hope and an array of expensive new options. A few of these drugs have been clear home runs, allowing patients with limited life expectancies to live for years.

Many more drugs, however, have offered patients only marginal benefits, with no evidence that they improve survival or quality of life, said Dr. Vinay Prasad, assistant professor of medicine at the Oregon Health and Sciences University, who has written extensively about the FDA’s approval process for cancer drugs.

Overall cancer survival has barely changed over the past decade. The 72 cancer therapies approved from 2002 to 2014 gave patients only 2.1 more months of life than older drugs, according to a study in JAMA Otolaryngology-Head & Neck Surgery.

And those are the successes.

Two-thirds of cancer drugs approved in the past two years have no evidence showing that they extend survival at all, Prasad said.

The result: For every cancer patient who wins the lottery, there are many others who get little to no benefit from the latest drugs. […]

In a November study published in JAMA Internal Medicine, researcher Diana Zuckerman looked at 18 approved cancer drugs that didn’t help patients live longer. Only one had clear data showing that it improved patients’ lives, such as by relieving pain or fatigue.

Two drugs harmed quality of life. For example, thyroid cancer patients taking the most expensive drug, cabozantinib, scored worse on a scale measuring five symptoms: diarrhea, fatigue, sleep disturbance, distress, and difficult remembering, Zuckerman said. […]

“We cannot have a system where drugs that may not even work are being sold for these amazingly crazy amounts of money,” said Zuckerman, president of the National Center for Health Research, a nonprofit in Washington that aims to explain research to consumers.

Recognizing the slow pace of progress, the American Society of Clinical Oncology has set goals for new cancer drugs of extending life or controlling tumors for at least 2.5 months. The bar was set relatively low because “it’s not very often that we come across a transformative treatment,” said Dr. Sham Mailankody, an assistant attending physician and myeloma specialist at Memorial Sloan Kettering.

Yet in a study published in September in JAMA Oncology, Mailankody found that only one in five cancer drugs approved from 2014 to 2016 met those standards. […]

The FDA wants to give patients the chance to benefit as soon as possible, rather than waiting for definitive proof of improved survival, Pazdur said. In some cases, the FDA requires pharmaceutical companies to perform long-term studies after drugs are approved, to measure whether drugs live up to their early promise.

But many of these studies never provide an answer, Zuckerman said. Once a drug is approved and is available to anyone, patients have no incentive to participate in a clinical trial. So studies can end with no clear conclusion. […]

Unless the FDA requires companies to provide survival data before approving a drug, “we may never have answers,” Zuckerman said. “We will have all of these expensive drugs on the market and we will never have the information we need about how well they work or even how safe they are.”

President Donald Trump has vowed to cut regulations at the FDA and recently told pharmaceutical industry leaders that he wants to further speed up the drug approval process. […]

Read the entire article here.

Trump Calls for Lower Drug Prices, Fewer Regulations in Meeting with Pharmaceutical Executives

In the News, News Stories & Editorials
Carolyn L. Johnson, The Washington Post: January 31, 2017

President Trump met with leaders of some of the world’s biggest pharmaceutical companies Tuesday and emphasized the need to lower “astronomical” drug prices, decrease regulations and bring more drug manufacturing into the United States.

Trump offered no specific policies, but mentioned increasing competition and “bidding wars” as a way to bring down prices. In the past, he has lashed out at the pharmaceutical industry for “getting away with murder” and threatened to use the government’s bargaining power to force down drug prices for programs like Medicare.

Most of Tuesday’s meeting was held behind closed doors, but Trump spoke to the media beforehand while surrounded by executives from a half-dozen large drug companies. He struck a less combative tone and didn’t mention government intervention directly.

“We have to get prices down for a lot of reasons. We have no choice,” Trump said, flanked by chief executives Kenneth Frazier of Merck and Robert Hugin of Celgene. “For Medicare, for Medicaid, we have to get the prices way down.”

In the past, pharma companies have railed against government intervention in pricing, saying those prices fund development of future, lifesaving drugs. […]

There are many empty positions at the FDA, said Diana Zuckerman, president of the National Center for Health Research. The recently enacted 21st Century Cures law provided for additional hiring authority.

“But with the hiring freeze, will they be able to hire anyone?” she asked. […]

Read the complete article here.

Actress Elisabeth Rohm Urges You to Give Back and Join the Fight Against Cancer!

In the News, Press Releases

We are are proud to share our new public service announcement (PSA) featuring a devoted mother and talented actress, Elisabeth Rohm.

Click here to watch!


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You’ve seen Elisabeth in Law & Order, The Last Ship, and with Jennifer Lawrence in Joy and American Hustle. And she has just joined the cast of CW’s Jane the Virgin.  We hope you will join Elisabeth Rohm by supporting The Cancer Prevention and Treatment Fund with a donation today.

We need your support now more than ever because of the very real threats from Congress. They want to reverse the ban on cancer-causing chemicals in our air, water, and our homes and neighborhoods.  And they are trying to lower safety standards on cancer medications.

Your donation makes a difference, because 98 cents of every dollar goes directly to programs and services, making us one of America’s Best Charities. The Cancer Prevention and Treatment Fund thanks you for your support on Giving Tuesday, and will continue to work tirelessly in the fight against cancer.

Thank you in advance for considering us worthy of your support!

Congress Just Quietly Handed Drug Companies a Dangerous Victory

In the News, News Stories & Editorials
By Adam Gaffney, New Republic: 

The 21st Century Cures Act has been lauded as a bipartisan success. It’s actually the result of a long war on drug regulation.

Christmas came early for the pharmaceutical industry this year. Last week, the Senate followed the House in passing the 21st Century Cures Act. Though this bill has been lauded by liberals for providing much-needed funds for medical research, its real impact will be elsewhere. Whereas drug approval traditionally required the demonstration of real clinical benefit in a randomized clinical trial, under the Act drug firms will increasingly be able to rely on flimsier forms of evidence for approval of their therapies (incremental steps in this direction, it is worth noting, have already occurred). The Act, by reconfiguring the drug regulatory process, lowers the standards for drug approval—a blessing for drug makers, but an ill omen for public health.

In the Senate, a grand total of five senators—including Bernie Sanders and Elizabeth Warren—voted against it. The media, meanwhile, has for the most part done a poor job dissecting its actual contents. As a result, few now realize how detrimental the act is likely to be for drug safety, or appreciate the mix of conservative ideology and pharmaceutical industry greed underlying the longstanding campaign that brought it to fruition.

The thinking behind the 21st Century Cures Act—and likeminded proposals—goes something like this: In the twenty-first century, the pharmaceutical industry—driven by the profit-motive—continues to do a fine job innovating new therapies. Far too often, however, they are being held back by risk-adverse, slow-moving FDA bureaucrats with outdated standards for approval. “Modernize” the FDA—release the cures! Yet if the law did nothing other than weaken FDA standards, it may not have passed: Liberals understandably embraced the act’s new NIH funding, its mental health provisions, and its support for state anti-opioid programs. For Democrats, it also represented the sort of bipartisan “victory” that shows that all is not gridlock in Washington, after all.                

Yet this thinking is flawed on multiple levels: “We need to remember,” as former editor-in-chief of the New England Journal of Medicine Marcia Angell wrote in her 2004 pharmaceutical exposé, The Truth About the Drug Companies, “that much of what we think we know about the pharmaceutical industry is mythology spun by the industry’s immense public relations apparatus.” First among these myths is the notion that the status quo of private sector drug research and development is the best of all worlds. On the contrary, as Angell put it, “me-too” drugs—lucrative, duplicative agents that do not improve on existing therapies—are in fact the “main business of the pharmaceutical industry.” We can’t rely on the profit motive to bring forth new cures, when it’s just as easy for companies to make big profits by redesigning or tweaking drugs that already exist.

Second, the notion of a slow-moving, risk-adverse FDA is wrong: If anything, the agency’s drugs review process is sometimes too hasty, while its standards of evidence for approval are frequently too lax. Consider, for instance, two recent studies of new cancer drugs. The first—published a year ago in JAMA Internal Medicine by Chul Kim and Vinay Prasad—looked at cancer drugs approved by the FDA on the basis of “surrogate endpoints” between 2008 and 2012. “Endpoints” is a term for outcomes: Hard clinical endpoints refer to outcomes such as survival, where the benefit to the patient is unambiguous. Surrogate endpoints, however, refer to metrics like the change in the size of a tumor on a CT scan. Though a shrinking tumor logically sounds like a good outcome, it is only meaningful if it actually translates into an improvement that an individual actually experiences, like a longer life or a better life. Often, however, that’s not the case: New therapies can change numbers without improving our actual health. This is what Kim and Prasad found: Of the 36 drugs approved on the basis of surrogate endpoints, at least half had no demonstrated benefit.

Perhaps they had other benefits? Or perhaps not. In late November, Tracy Rupp and Diana Zuckerman in the same journal examined these 18 drugs, and found that not only did they not improve survival, but only one had evidence that it improved quality of life (the others lacked data or had no effect, negative effects, or mixed effects). Despite this lack of benefit for either the quantity or quality of life, they note, the FDA withdrew approval for only one drug. Those drugs that either didn’t improve or actually worsened quality of life continue to be sold at an average price of $87,922 per year. Not a bad return for a basically useless drug.

How has this state of affairs come about? At least in part because, as scholar Aaron Kesselheim and colleagues describe in a 2015 study in the British Medical Journal, a total of five new “designations” and one new pathway (“accelerated approval”) have been created since 1983 to lubricate the drug approval process. As they find in their study, as of 2014 some two thirds of drugs are now being reviewed through one or more of these expedited programs, which sometimes allow them be approved more quickly, in some instances with skimpier evidence.

The 21st Century Cures Act will only take us further down this road. Indeed, as Trudy Lieberman has written at Health News Review, the bill is best seen as the “culmination of a 20-year drive by conservative think tanks and the drug industry that began during the Clinton Administration to ‘modernize’ the FDA.” PhRMA—the industry’s primary lobbying group—alone spent $24.7 million on Cures Act-related lobbying, according to data assembled by the Center for Responsive Politics and reported by Kaiser Health News. No less important, however, are the industry’s generous campaign contributions, which have helped construct a compliant and conducive political climate in Washington over the years.

The act reverses many of the protections that stemmed from the 1962 Kefauver–Harris Amendments, signed by John F. Kennedy, which bolstered the Food and Drug Administration’s (FDA) regulatory powers: These reforms meant the FDA could require proof not just that a drug was safe, but that it actually worked, prior to approval.


Read full article here.

Trump’s Rumored FDA Candidate Strikes Nerve

News Stories & Editorials
By Peter Sullivan, the Hill: December 8, 2016

The possibility that President-elect Donald Trump could nominate Jim O’Neill, a Silicon Valley investor with no medical background and controversial views, as head of the Food and Drug Administration (FDA) is setting off alarm bells among some healthcare experts.
[…]
The most attention has fallen on O’Neill’s comments in a 2014 speech, where he called for changing the FDA’s mission so that it no longer considers whether drugs are effective when deciding whether to approve them. Instead, O’Neill said the agency should only consider whether drugs are safe.
[…]
Diana Zuckerman, president of the National Center for Health Research, said that O’Neill’s idea of having the FDA no longer consider whether a drug is effective would cause chaos because insurance companies would no longer be able to use FDA approval to decide which drugs they would cover, and possibly could have to start making those determinations on their own.

“It would throw the entire U.S. healthcare system into turmoil,” she said.

To read the full story, click here

Congress Passes Bill with Billions for Cancer Research

News Stories & Editorials
By Teresa Carr, Consumer Reports: December 7, 2016

Congress has passed the most expensive and far-reaching health reform bill since the Affordable Care Act in 2010.

The 21st Century Cures Act, which garnered widespread, bipartisan support in both the House and Senate, is expected to be signed into law by President Obama soon.

The bill signifies an investment of billions of dollars over the next decade to fight cancer, prevent and treat brain disorders, and harness enormous amounts of data to develop individualized treatments based on a person’s environment, genes, and lifestyle.

But the bill also lowers the bar for the kind of scientific evidence that companies must provide to gain the Food and Drug Administration’s (FDA) approval for their products. It would mean, for instance, that in some circumstances the FDA could rely in part on individual patient experiences with a drug or device, instead of evidence from large-scale, randomized controlled clinical trials.

[…]

Faster Drug Approvals, But Lower Standards

The Cures Act loosens requirements for how drugs are studied and approved that have been in place since 1962.

Here’s how it usually works: A company submits evidence from studies done under controlled conditions, comparing patients who received the treatment with those who didn’t. The studies typically have to show that people who were given the new drug lived longer or felt better than those who didn’t get it.

This kind of research can be expensive and time-consuming for drug companies to collect, says Diana Zuckerman, Ph.D., president of the National Center for Health Research, a nonprofit think tank focused on health research. Cancer drugs, for example, can take several years to show that a drug improves survival.

The Cures Act calls on the FDA to approve some drugs more quickly, based on less thorough testing. The problem with this, says Zuckerman, is that “getting drugs to market faster doesn’t help consumers at all if they turn out not to work or causes them harm.”

To read the full article click here…