Tag: FDA

Has osteoporosis been mistreated?

Osteoporosis drugs strengthened the bones of millions of women. But their future may not be so bright. Here’s what we know about their long-term effects.

Since the mid-90s, when Fosamax (alendronate) was first approved, bisphosphonates have been commonly used to effectively treat osteoporosis in millions of patients.

But bisphosphonates (the class of drugs that work to rebuild and strengthen bone tissue), which are taken either orally or as injections, are not without side effects and recently, some of the potential long-term effects of these medications, while rare, have come under scrutiny. Conversations about what those effects might or might not be and who, in fact, should be taking these drugs have been taking place in the media and medical community alike.

One issue is that no one really knows yet the optimum length of time patients should be taking these drugs. A study by the FDA, published in the New England Journal of Medicine, caused a stir — taking on the question of whether or not continued use of bisphosphonates helps patients or might put them at increased risk for atypical fractures or other side effects.

‘In other therapies we are confident in saying the effects of the medicine are gone, once we stop giving them… Whereas with bone the exact opposite is true.’ — Kurt Kennel, MD

The study suggests that taking bisphosphonates beyond 5 years doesn’t necessarily continue to improve bone density or strength for all patients. One recommendation is that patients who were initially at low-risk for osteoporosis-related fractures would probably benefit from discontinuing the medication after 3 to 5 years, whereas those patients at a greater risk from the outset would benefit from continuing.

To read the rest of this article from the Medshadow Foundation, click here.

To learn about the latest findings on proton-pump inhibitors, click here. And, here are five ways to avoid heartburn without drugs.

If you have Medicare, here are six ways to save money on your drugs.

March 9, 2016
Do Prilosec and other PPIs increase people’s risk of dementia?

Millions of people take proton pump inhibitor drugs (PPIs) such as omeprazole (Prilosec), esomeprazole (Nexium), and lansoprazole (Prevacid) for heartburn or gastro-esophageal reflux disease (GERD). This week, news outlets reported a link between these drugs, which many people stay on for years or even decades, and the risk of dementia.

Researchers in Germany examined an insurance claims database that included over 73,000 people, 75 and older, and free of dementia at the study’s start. They found that over seven years those who took PPIs had a 44% increased probability of receiving a diagnosis of dementia.

Since this finding comes from an observational study, and not a clinical trial, the researchers can’t say whether the drugs actually cause dementia, although they discuss some plausible reasons why they may.

Nothing is known about long-term side effects of drugs when they are approved by the FDA. (See this Just Care post about FDA-approved cancer drugs that don’t work.) So, observational studies are an important way to gather this information.

This is the second study indicating that PPIs may contribute to dementia risk. More evidence needs to accumulate though, such as showing that those who take higher doses have a higher probability of dementia, before a more definitive causal link can be established.

For those interested in a more in-depth discussion of the findings, click here.

To learn about ways to avoid heartburn or GERD without drugs, see this Just Care post.

To understand the signs of dementia, see this Just Care post. To learn about safety at home for people with dementia, see this Just Care post. And, for some tips on the benefits of early diagnosis of dementia, click here.

February 25, 2016
FDA backlog keeps generics from coming to market

In October 2015, there were as many as 3,000 generic drugs waiting to be approved by the Food and Drug Administration. FDA underfunding may explain it in part. So might incomplete information on applications by their manufacturers as the FDA claims. But, whatever the reason, the result is that we end up paying high drug prices, (though some generic drug prices are sky high.)

Generics can cost as little as 20 percent of what brand-name drugs cost; they can also cost a lot more. Around 8 out of 10 prescriptions are for generic drugs but they account for less than 30 percent of our drug spending.

The 2012 Generic Drug User Fee Amendments now require drug makers to help offset the cost of FDA review. In exchange, the FDA is supposed to speed up approval of these applications. And, the FDA says it has. However, it also says that the application process is often slowed down because of faulty applications, which may fail to address negative side effects of inactive ingredients or other important information.

Here are four things you may not know about generic drugs and, if you’re interested, a short primer on how federal policy promotes high drug prices.

January 19, 2016
Should drug companies be allowed to advertise on TV?

On November 17, 2015, the American Medical Association voted to support a ban on drug and medical device company advertising on TV. The AMA sees a negative impact from these ads and also says these ads lead to an increase in drug and device prices. Moreover, they say these ads lead individuals to ask for drugs which they don’t need, are more expensive than other treatment options, and can be harmful to them.

In the last two years, there has been a 30 percent increase in the amount that drugs and device companies are spending on direct-to-consumer advertising, now at $4.5 billion annually. The AMA is particularly concerned with the cost of drugs, which rose almost five percent last year. They are often unaffordable to patients, even those with insurance, keeping them from getting needed care.

Drug and device companies could only conduct extremely limited direct-to-consumer advertising until 1997 when the FDA loosened restrictions. For almost 20 years they have been advertising heavily to consumers, Yet, most people do not have the scientific or technical knowledge to understand whether a particular drug or device is right for them based on an ad.

That notwithstanding, the ads do lead nearly three in ten people to talk to their doctor about a drug. And, two out of three of these people ask their doctors for the prescription.

A recent Kaiser Family Foundation poll shows that about half the population thinks the drug company advertising is generally good. But, almost 90 percent of the public, Democrats, Republicans and Independents alike, supports FDA review of the ads for accuracy and clarity before they are aired.

Given that prescription drug advertising drives up drug costs, the risk of harmful side effects from many drugs, along with FDA drug and device approvals that are sometimes not based on clinical evidence of safety and efficacy, do you think drug and device companies should be allowed to market directly to consumers? Please post your comment.

December 9, 2015
Majority of cancer drugs that FDA has recently approved don’t work

According to a new study in JAMA, there is no evidence that the majority of the U.S. Food and Drug Administration (FDA) approved cancer drugs over the last five years work. The FDA used substitute measures, laboratory measures rather than clinical evidence, to approve two out of three cancer drugs, without any indication that the drugs either improve health or prolong life. Indeed, in follow-up studies, 86 percent of drugs approved through substitute measures showed no clinical benefits.

In the case of bevacizumab, a breast cancer drug treatment, the FDA allowed the drug to go to market based on substitute measures that showed “progression-free survival” or PFS. But, a later study showed substantial toxicity and no improvement in life expectancy. And, the FDA ended up removing authorization to market it.

In 2009, the U.S. Government Accountability Office took the FDA to task for failing to do postmarketing studies on all drugs that are approved using substitute measures. The GAO reported that the FDA had plans to improve oversight, but it was not prepared to say whether those initiatives would be effective. According to the GAO, there are no specific conditions that require the FDA to speed up the withdrawal of a drug from the market if a drug company does not conduct a follow-up study in a timely manner or if a drug is shown not to be beneficial in a follow-up study.

The drug companies prefer getting drug approvals using substitute measures that do not focus on efficacy or health outcomes. Substitute measures allow drug companies to bring drugs to market faster and at less cost. When the drug companies use clinical measures that look at health outcomes, they must spend more time and money on their trials.

The problem is that substitute measures may show good performance when in fact health outcomes are not any better. Health complications may also not be evident through the substitute measures. So, drugs approved using substitute measures may actually hurt patients.

The price of a new cancer drug can easily be $10,000 a month, regardless of either the drug’s worth or its cost of development. The cost of cancer drugs can literally bankrupt a person with cancer. In 2014, the least expensive new cancer drug approved cost more than $120,000 a year.

Today, the drug industry helps cover the cost of the FDA’s work. And, we are left to wonder whether the FDA’s independence has been compromised at the expense of patient safety. At the same time, the public may wrongly assume that FDA approval means the drugs are safe.

Here’s a short post on how Congress leaves insured Americans at the mercy of the drug industry. Top 20-selling drugs in the U.S. are now three times more than the in the U.K. And, here are six tips for keeping your drug costs down, along with five programs that could lower your costs if you have Medicare. And, for other free and low-cost assistance programs, click here.

October 30, 2015
President’s nominee to head the FDA has strong ties to the drug industry

President Obama has nominated Dr. Robert Califf, a cardiologist, to head the Food and Drug Administration (FDA). He is currently Deputy Commissioner of the FDA. But, many policymakers and thought leaders believe Dr. Califf is the wrong person for the chief post because of his strong ties to the drug and medical device industries.

As a researcher at Duke University, Dr. Califf took millions of dollars from the big drug companies. The majority of the funding for his research center came from the drug industry. And, Dr. Califf also received substantial payments from drug companies to consult for them and to cover his salary. Of additional concern, Dr. Califf has removed his name as co-author of a number of papers critiquing the FDA for its oversight of clinical trials.

Dr. Califf’s nomination as head of the FDA is “bad news for patients and public health,” according to Dr. Michael Carome, Director of Public Citizen’s Health Research Group. He urges the Senate to reject Dr. Califf for the FDA post. Dr. Carome argues that the FDA has never been and should not now be headed by an individual with such close ties to the medical device and drug industries as Dr. Califf.

The head of the Food and Drug Administration is charged with overseeing the safety and efficacy of drugs and devices in the United States. We need an independent FDA chief to protect the public health.

Senator Bernie Sanders has stated that he will oppose Dr. Califf’s appointment as head of the FDA.

October 16, 2015
Three big problems with “21st Century Cures” bill

U.S. Representatives Fred Upton and Diana Degette have a plan for getting drugs to market more quickly, embodied in the “21st Century Cures” bill. Among other concerns it raises, it allows drug and medical device companies to go to market with new products evaluated using lower standards of safety and efficacy than required today. The bill’s expressed goal of fostering medical innovation may sound good, but it in fact puts all patients at serious risk while helping the health care industry see greater profits.

First, the bill does an end-run around the US Food and Drug Administration, essentially compromising its role to ensure drugs and devices are reasonably safe and effective. As it is, the FDA has several mechanisms for speeding up the development and approval proces[s for new drugs and devices. But, the bill allows drugs to go to market with less evidence about safety and even without evidence on effective clinical outcomes.

Second, the bill only opens the door further to price gouging by drug companies (read here about pay for delay and here about exorbitant prices for cancer drugs and here about the latitude drug companies have to control prices) and higher hospital costs. It rewards pharmaceutical companies unduly for developing new antibiotics, allowing them effectively to set prices. And, it encourages hospitals to use these new antibiotics, through higher payments, without regard to either their costs or the risk of increased antibiotic resistance through their overuse or unnecessary use.

Third, the bill provides a handout to the medical device industry, weakening the approval process for devices such as prosthetic hips and knees. In fact, that process needs strengthening.

In short, nothing in the bill encourages the drug and device companies to address unmet patient needs. Rather it implicitly condones escalating prices for less safe and less effective products. But, the medical industrial complex is a big supporter of members of Congress and a tremendous supporter of Congressman Upton. The bill passed the House of Representatives in July. It goes to the Senate some time this fall.

To read more about why the Senate should not pass 21st Century Cures from Breast Cancer Action, click here.

October 2, 2015