Tag: FDA

The pharmaceutical marketplace is dysfunctional
The controversy over the steep price of EpiPen—an injectable device used to treat severe and potentially life-threatening allergic reactions—is among the strongest signals to date that the pharmaceutical marketplace is dysfunctional, and that Congress needs to step in.

EpiPen’s list price jumped nearly four-fold in five years, from $165 to $608. The generic drug in EpiPen costs pennies to make and the device has been on the market for over a decade.

Of course, prescription drugs like EpiPen deliver enormous benefits, improving health and extending lives. They can also save money relative to other forms of treatment. But, over the last few decades, the pharmaceutical industry has become the poster child for poor business ethics and, more recently, out-and-out price gouging.

Since 1990, for example, the federal government has fined drug companies $15 billion for “off-label” promotion of their drugs—marketing them for uses that the FDA has not approved. Drug companies have also tested their drugs on people in developing countries in unethical and sometimes illegal ways. And, they have been caught hiding study results that show their drugs may not be as safe or as effective as they claim.

The only justification for raising the price of the EpiPen so substantially was greater profits. Sales of the device jumped 10-fold from $170 million in 2007 to $1.7 billion in 2015. That’s primarily because the drug’s manufacturer, Mylan, has a near monopoly in this medical niche, allowing the company to raise the price of EpiPen as high as the market would bear. And, since insurers and the government do most of the buying, Mylan knows that most consumers were shielded from the direct impact.

But, we all pay the bill in the end, indirectly, through higher insurance premiums, deductibles and copays and in taxes that support public insurance programs such as Medicare and Medicaid.

Despite this, Mylan’s response to public pressure to simply lower the price of EpiPen has been to act primarily (and predictably) in its own interest and in the interest of its shareholders and the other companies that take the drug from manufacturer to market, including wholesalers and pharmacies. All take a bite out of the price of every drug.

First, Mylan agreed to increase the co-pay assistance to people who need but can’t afford the drug. That’s helpful, but it requires consumers to jump through hoops to qualify and is limited. When that didn’t quell the outrage, Mylan announced on August 29 that it would sell its own generic version of EpiPen for half the price of the brand-name product—around $300 instead of $600.

That move keeps the money flowing into Mylan’s coffers and does not anger the supply-chain companies. It also may stall other generic companies—one is known to be waiting in the wings—from bringing an EpiPen competitor to market.

What Mylan’s move will not do is make this essential medicine—which, again, probably cost less than $30 to $50 to make—affordable for all who need it and fairly priced for the system as a whole.

For example, some middle-income families who don’t qualify for the assistance but who have high-deductible health plans or steep co-pays would still be stuck with a sizable out-of-pocket expense for generic EpiPen at $300.

For the rest of us, EpiPen’s still-too-high price gets built into the cost of insurance, both public and private—along with the rising tab for all prescription drugs.

As such, EpiPen’s unjustified price hike is the latest reminder that drug pricing needs major reform. We allow drug companies to take advantage of their monopoly power to gouge consumers and undermine people’s health and financial security. And the FDA does not help matters when it is slow to allow competition, preserving drug company monopoly power.

Here’s more from Just Care:
August 31, 2016
Biosimilars, almost identical to brand-name drugs at discounted cost
In this 21st century digital world, it seems like every day a new word or expression surfaces and goes viral. Badass, lit, basic, I can’t keep up. But, when it comes to health care, I try my best! So, I’ve learned that biosimilars are intended to be almost identical to brand-name drugs, essentially generic versions, offering the same outcomes at 20-30 percent less cost.

Even though biosimilars are made of living cells, a new study published in the Annals of Internal Medicine that looked at one class of biosimilars, indicates that they are safe and effective. Dr. Caleb Alexander, a study author, told Stat news, that after looking at 19 studies, researchers found that the biosimilar drugs for rheumatoid arthritis, inflammatory bowel disease, and psoriasis are essentially “comparable” to the brand-name biologics.

But, to date, according to Stat news, the FDA has only approved two biosimilars. The alleged concern is that because biosimilars are made of living cells they are slightly different from the brand-name drugs, and those differences could affect their safety. Of course, the drug industry is concerned about the competition that would drive down profits and is investing heavily in keeping biosimilars from being approved.

Amgen recently won a federal appeals court challenge against a biosimilar manufacturer aimed at slowing down approval of biosimilars. In short, the court prevented the biosimilar manufacturer from marketing its biosimilar drug; it affirmed the lower court opinion that the Biologics Price Competition and Innovations Act keeps manufacturers of biosimilars who receive FDA approval for their drugs from marketing their drugs until 180-days after they give notice of their marketing license, which they only get once the drug is approved.

This 180-day post-FDA-approval and marketing license period gives brand-name drug manufacturers additional time to sell their brand-name drugs without competition and come up with patent and other challenges to biosimilars.

More research needs to be done around the safety of biosimilars. And, policies need to evolve to speed up their post-approval entry into the market. Biosimilars open the door to billions of dollars of savings on some critically important and very expensive drugs, like Remicade and Humira, among others.

Here’s more from Just Care:
August 24, 2016
New FDA rules let companies decide what food is safe
The FDA just issued a new rule on foods “generally recognized as safe” or GRAS. And, according to the Center for Science in the Public Interest, the rule does not deliver on protecting people from unsafe chemicals. It permits companies to decide which chemicals are safe in foods without being accountable for their decisions.

The Center for Science in the Public Interest argues that decisions about what chemicals are safe in foods “should be transparent and unbiased.” But, the new rule allows companies to market foods they deem safe without even letting the FDA know; the companies do not even need to list the chemical additives in processed foods as ingredients. The FDA also allows companies to hire their own scientists who are beholden to the companies to determine which foods are safe.

So, the question remains, how safe is the processed food you eat? Read more from Just Care on food safety here.

Here’s more from Just Care:
August 24, 2016
How safe are the drugs you’re taking?
You might think that the FDA ensures that the drugs you’re taking are safe. And, generally, drug companies must complete several costly drug testing phases before the FDA approves a drug to go to market. But, did you know that doctors in the U.S. prescribed unsafe drugs more than one hundred million times before they were recalled? How safe are the drugs you’re taking?

We explained in an earlier Just Care post that once popular drugs may be pulled from the market. Sometimes, it’s because the clinical trials that appeared to show a drug was safe and effective were too small to accurately reflect the drug’s safety. Sometimes, it’s because healthy younger people test the drug and older and/or less healthy people react differently to it, or people use the drug differently in the real world than as tested in the trial, where the environment is controlled. Or, sometimes, it’s because drugs are prescribed off-label and have unforeseen effects.

The FDA also sometimes streamlines its drug approval process, much like its medical device approval process, to help drugs get to market faster. But, in the process, it may approve drugs that are unsafe or ineffective. Indeed, a recent article in JAMA found that the majority of cancer drugs the FDA has recently approved don’t work.

It can be several years before FDA-approved drugs are pulled from the market. According to a June 2016 article in the International Journal of Health Services by Steffie Woolhandler, David Himmelstein, David Bor and Danny McCormick, 17 drugs that the FDA had approved were subsequently withdrawn over a period of 18 years. While they were on the market, doctors prescribed them 112 million times.

Given the risks to patient safety of the current approval process, Congress should be requiring the FDA to raise the bar for approving drugs. Instead, the House has already voted on legislation, the 21st Century Cures Act, that would speed up the FDA approval of drugs, relaxing the process so that it is less stringent. And, the Senate is now considering companion legislation.

Recently, six former FDA commissioners argued that the FDA should become an independent agency, like the SEC, Securities and Exchange Commission. It has oversight of products that represent about 25 percent of the U.S. economy. A federal budget process that is unpredictable makes it difficult for the FDA to function effectively; the FDA is currently too often a tool of the politicians, many of whom are beholden to the pharmaceutical and medical device companies. To ensure patient safety, the FDA should be an independent agency, not an arm of the Department of Health and Human Services.

Here’s more from Just Care:
July 20, 2016
More data needed to drive down health care costs, improve patient safety
A new Health Affairs blog post speaks to the need for Medicare to collect and report data on the hundreds of thousands of hip and knee replacements it pays for each year. Medicare should report this data, as should every commercial health insurer. Indeed, we should have access to a wide range of health care data from both commercial insurers, like UnitedHealth, Blue Cross and Aetna, and Medicare. More data is needed to drive down costs and improve patient safety.

Medicare should be able to identify and address defect and safety problems with medical devices and products. It should also have a way to steer people to high-quality devices and products. But right now it can’t. Commercial insurers should collect and report these problems as well, and should be holding companies that sell defective products accountable on behalf of their policyholders. But, it’s not clear they can. How often do they do so?

When it comes to traditional Medicare, to a significant extent, Congress is to blame. It compels Medicare to cover every FDA-approved product and device that’s medically reasonable and necessary. Commercial insurers should have nothing stopping them from identifying and steering their members to quality products and devices. But, who knows whether they do or even what data they collect? While they are called for stricter rules for FDA approval and tracking of medical devices, they do not share their data, to the extent they have it, to help improve overall patient safety. Their business interests appear to outweigh the public benefit.

The Health Affairs post suggests Medicare can remedy the problem of not knowing which medical devices are defective or unsafe by collecting data on which devices are implanted on its claim form. It should. Why leave this responsibility exclusively to Medicare though? The Brookings Institute reports more than 3,000 potential deaths each year from defective medical devices and more than 50,000 serious adverse events.

Why not have a public registry that records all devices implanted, and which are found to be unsafe or defective, so that we can track and report how well they perform and notify everyone with an implanted device easily if it fails or is found to be unsafe?

The authors claim that registries are costly to implement and maintain. In this digital world, and with electronic medical records, one would think that the cost of setting up registries pales in comparison to the benefits, including easy notice of product failures to all patients, not simply Medicare patients, and better information to all insurers about the products they are paying for. Doctors should have this information available as well. The medical device industry makes a practice of giving them money and gifts as a way to market their products, and we need a strong check on that.

There is no perfect health insurance in the United States. All insurers impose large out-of-pocket costs. And, many make it hard to access care and impossible to be assured continuity of care. We should keep in mind that, while it could do better, only traditional Medicare ensures both relatively easy access to care and continuity of care and makes much of its data public.

One of the most compelling arguments for expanding Medicare, as Hillary Clinton proposes, is that it offers our only wide lens into what’s working and not working in our health care system and the power to drive system-wide change and improve quality of care for everyone. Commercial insurers should either step up to do their part for the public health or step away and support giving everyone the choice of Medicare.

Here’s more from Just Care:
July 20, 2016
Medical device to remove fibroids causes cancer to spread
About half of all women have uterine fibroids. Some need them removed. A story in Boston Magazine explains how a medical device to quickly remove fibroids causes hidden cancer to spread, harming patients unnecessarily. Would you think to ask your doctor about the potential risks of using this or any other surgical device? It’s clear we should. (Here’s a set of questions you should always ask your doctor before surgery.)

Instead of taking out a fibroid mass in one piece, doctors may use a power morcellator when they perform laparoscopic surgery. It is an easy and inexpensive tool. It minces and suctions up the fibroid. But, in the process, it can also chop up a cancer that may be growing hidden in the uterine wall and scatter it throughout the abdomen. That’s what happened to Amy Reed, at Brigham and Women’s Hospital in Massachusetts.

As a result, after her operation, Reed’s doctor let her know she had an aggressive cancer, and her doctor told her she needed another operation to remove her ovaries. Amy ended up needing four more operations to remove new tumors that were seeded in her abdominal cavity, along with chemotherapy.

Amy’s husband has made sure that everyone knows the danger of power morcellation, to prevent its use for the removal of fibroids. He has managed to get some health insurers to stop paying for procedures that remove fibroids using morcellators. And, he has enlisted two members of Congress to review the current FDA process for reviewing new medical devices, as well as requirements for manufacturers to report adverse events. The FDA did not require pre-market testing of morcellators in women with fibroids.

Johnson and Johnson no longer sells its morcellator. The FDA has now issued an opinion discouraging the use of morcellators to remove fibroids and put a black-box warning on their use for fibroid removal.

The FDA recently stated that the odds are abut one in 350 that someone needing surgery to remove a fibroid will have a cancer as well. If a fibroid is removed in one piece, there is a 50 percent survival rate for people with cancer. With morcellation, the survival rate drops to 20 percent or less.

Here’s more from Just Care:
- Five steps to get your affairs in order in case of emergency
- Medical error the third leading cause of death
- How to prepare for a doctor’s visit
- Plan ahead for a hospital visit: Talk to your doctor about these seven important items
- Pay attention when someone you love leaves the hospital
July 7, 2016
Drug industry spending tens of millions to keep states from lowering drug prices
The drug industry is on the defensive. The federal government may be doing precious little to bring down prices, but some states are on the offensive. And, according to Stat News, the drug industry is spending tens of millions to keep states from lowering drug prices.

However, just last month, Vermont passed a law that requires drug companies to justify price increases. In California, the Senate has passed a similar requirement and there’s an upcoming ballot measure that would limit the price of some drugs. Ohio has a similar upcoming ballot measure.

Pharmaceutical companies are responding by giving tens of millions to opponents of the ballot measures, which were initiated by the AIDS Healthcare Foundation. Merck and Pfizer, among others, have given some $68 million to fight the California ballot measure alone.

At the same time, they continue to raise drug prices ever higher. Why not so long as they can? The average price of brand name drugs rose 14 percent last year, according to the market research firm Truveris. We are now paying three times more than people in the United Kingdom for the top 20-selling drugs in the world.

Pfizer has raised its drug prices almost 9 percent recently. And, six months ago it had raised its drug prices 10 percent. Johnson & Johnson upped its price for rheumatoid arthritis drugs 30 percent in the last 18 months. Amgen did the same. Biogen’s multiple sclerosis drug now costs 18 percent more.

The pharmaceutical companies are continuing to blame insurers for high drug prices. But, so long as they charge a lot for unique brand-name drugs, insurers have no choice but to raise premiums, deductibles and/or copays.

Brand name prices will remain high until there are generic substitutes. And, unfortunately, there is a long list of generic drugs waiting for approval by the FDA.

Here’s more from Just Care:
June 23, 2016
FDA requires companies to show amount of added sugars in processed foods

For the first time since nutrition labels appeared on processed foods back in 1994, these labels will have a new look and improved nutrition information. Among other things, the Food and Drug Administration is requiring companies to show on the nutrition label the amount of added sugars in processed foods. In addition, the serving size listed on the package will be more in sync with the average amount people eat and the calorie information will be easier to see.

Until now, the FDA has allowed companies simply to list the total amount of sugar in a product, without distinguishing between natural sugars and added sugars. It also had not required companies to list the recommended daily percent of sugar intake.

The FDA’s new policy requires companies to list the “percent daily value” for sugars, so that people know the amount of sugar in a product in relation to how much they should be consuming. The FDA recommends no more than 10 percent of daily calorie intake come from added sugars, which is about 200 calories or 50 grams. Research shows increased risk of heart disease when added sugar represents more than 15 percent of your caloric intake.

Companies must also state the percent daily value of vitamin D, calcium, iron and potassium as well as the actual amount. You can learn more from John Oliver on the risks of eating too much sugar here.

Most companies must comply with the new requirements no later than July 2018.

Here’s the old label on the left and the new one on the right

May 25, 2016
How safe is the food you eat?
How safe is the food you eat? It’s hard to say. The U.S. Food and Drug Administration is leaving it to industry to ensure the safety of the chemical additives in our food. So, processed foods and beverages may contain chemical additives that the FDA has not tested. It’s another reason to follow a Mediterranean diet, if you can and to stay away from processed foods to the extent possible.

How is it that the FDA is not required to test the chemicals in our food? The Federal Food, Drug and Cosmetic Act requires the FDA to create a system of pre-market review of chemicals added to foods and to reassess their safety periodically as new evidence emerges. But, the FDA can and has allowed the food and beverage industries to conduct their own review of the safety of chemicals in food. And, the FDA lets the industries’ experts determine whether the chemicals are generally recognized as safe, “GRAS.”

Senator Edward Markey of Massachusetts is on a campaign to get the FDA to assess the safety of all chemicals in foods and beverages rather than delegate this role to the food and beverage industries. Right now, there are an estimated 1000 chemicals in our food supply that the FDA has not tested for safety, according to the Pew Charitable Trusts. The FDA does not even know which chemicals are being used, which foods contain them, and the amount of these chemicals in a particular product, because there are no disclosure requirements on industry.

The food and beverage industry should not be able to self-determine their safety. And, they should have to disclose these chemical ingredients in their products. Allowing industry to hire the “experts” who decide whether particular ingredients in their foods are safe poses a real conflict of interest.

But, there appears to be a question about the scope of the FDA’s authority to assess the safety of these chemical ingredients, which is concerning. It’s not clear that the FDA has the authority to ensure the safety of GRAS ingredients, let alone the budget. It’s also not clear whether the FDA could require special labeling of foods with GRAS ingredients.

Even when the FDA knows about ingredients with safety concerns, the industry can still include these ingredients in their foods. For example, the FDA found sweet lupin caused allergic reactions in people with peanut allergies. But, the company that notified the FDA about its use of sweet lupin pulled its notice to the FDA. An investigation into the use of sweet lupin found 20 foods containing it; their manufacturers were still allowed to deem the ingredient GRAS.

At the very least, shouldn’t there be a label on all foods with GRAS ingredients letting the public know that the FDA has not approved these ingredients as safe?

Here’s more from Just Care on good nutrition and food safety:
May 4, 2016
Bitter pills: Once popular drugs pulled from the market

Nearly 5 billion dollars.

That’s how much pharmaceutical company Merck paid to people and families who claimed the painkiller Vioxx harmed them or their loved ones. In one of the largest civil lawsuit settlements in recent history, the Vioxx manufacturer in 2007 agreed to pay $4.85 billion to people involved in the 27,000 outstanding Vioxx lawsuits against Merck. Those cases claimed that Vioxx was linked to stroke, heart attack or premature death. But while the company agreed to settle, it never admitted the drug was at fault.

Many drugs that come on the market with promise are advertised to the hilt and taken by thousands or millions of people around the world — and then either quietly (or with a big splash, as with Vioxx) disappear. Why? Here are four reasons:

1. Clinical trials aren’t as big as you think, explains drug safety expert Glen Schumock, PharmD, the head of the department of pharmacy systems, outcomes and policy at the College of Pharmacy at the University of Illinois, Chicago. Some may enroll as few as 1,000 people, and while all side effects are noted, some are uncommon. “Say there’s an adverse effect in 10 out of 100,000 people, but if you only have 6,000 people in your trial, you might not see that side effect because the frequency is so rare,” says Schumock. Consider, though, when that drug is given to 1,000,000 people — that means 10,000 people will have that “rare” side effect. (See our blog, “Do Rare Side Effects Happen?”)

2.”Real world” use of a drug differs, sometimes dramatically, from what goes on in a clinical trial. People selected to take part in a trial “typically have to meet some kind of criteria that is designed to give the drug the best chance to work,” says Schumock. Trial subjects may not be as sick as the average patient, are not taking other medications, and don’t have other diseases. Such participants are also highly monitored, typically seeing a medical professional every couple of weeks. Clinical trials are controlled environments. The real world, well, isn’t.

3. Time plays a role. Once a medication is approved by the FDA, patients and physicians may discover negative food or other drug interactions that didn’t occur during the trial’s timeline.

4. Off-label prescribing may bring up unexpected issues. A drug may be approved for one condition or population, but physicians are free to prescribe it for other uses or people, including children or the elderly, says Schumock. This can be problematic: children can be more sensitive to a drug’s side effects; the elderly, who may be more likely to have kidney function problems, might be exposed to more toxicity because the drug leaves the body at a slower rate.

All this helps explain why some drugs might get pulled from the market — either thanks to legal or regulatory pressure, or voluntarily on the part of the manufacturer — but you may not always hear that a drug is no more.

This post is excerpted from Medshadow. To read more about drugs that have been pulled from the market, click here.

April 7, 2016