Tag: Pharmaceutical companies

Internists urge government to negotiate drug prices
The American College of Physicians, a trade association of doctors in internal medicine, joins the majority of the public, along with a growing chorus of doctors and other influentials in calling for the federal government to negotiate drug prices. In a paper published last month in the Annals of Internal Medicine, they say they are representing their patients struggling to afford needed drugs. And, they believe Congress should regulate the price of drugs just as every other developed country does.

Inexplicably, the American College of Physicians, the “ACP,” stops short of urging Congress to negotiate drug prices for everyone in the nation.Seven out of 10 Americans take at least one prescription drug. Every other member country of the 34-member Organization for Economic Co-operation and Development (OECD) reins in prices for everyone, not just older adults and people with disabilities.

The ACP does call for allowing Americans to reimport certain drugs from Canada and other countries that regulate drug prices, provided they are deemed safe. The ACP further recommends that policymakers should take heed of how pharmaceutical companies price their drugs. Pharmaceutical companies should be transparent about their costs, particularly for drugs developed with government funding through the National Institutes of Health and the Veterans Administration.

We should also understand the comparative value of different drugs. Policymakers should assess the cost, pricing and value of prescription drugs.

It’s not clear what it will take to get Congress to pass legislation to regulate drug prices or allow drug reimportation. Members and their staff routinely leave Congress to work for the drug industry. And, many have a financial stake in the drug companies. Republicans and some Democrats in Congress appear to have no problem using their power to allow drug companies to gouge consumers and prevent them from getting needed care.

Here’s more from Just Care on drug prices:
April 13, 2016
Members of Congress have a stake in drug and device companies they regulate

We all know about the large amount of money the drug and device companies contribute to members of Congress, with the hope that it will lead them to support legislation that maximizes their profits. (And, indeed, federal policy supports high drug prices.) But did you know that many members of Congress invest substantially in these companies? According to a STAT investigation, some 30 percent of Senators and 20 percent of House members have a stake in drug and device companies they regulate.

Three of the most common investments, according to STAT, are Johnson & Johnson, Pfizer and Merck. And, members of Congress are allowed to hold them even when they sit on the committees that regulate these companies, the House Judiciary Committtee, which oversees patent law, and the House Energy and Commerce Committee, which oversees the FDA and drug regulation.

U.S. Representative Christopher Collins has a $5-25 million stake in a company he co-founded that makes the parts for a machine that performs diagnostic tests. So, not surprisingly, when the FDA said it wanted to regulate those tests, he objected strongly. He also appears to object both to FDA monitoring of drugs for safety and efficacy after they go to market, calling for a loosening of this oversight activity, and to the medical device tax in the Affordable Care Act.

U.S. Representative Scott Peters objects to the Innovation Act bill, which would benefit consumers by permitting more challenges to pharmaceutical company patents. It would also impose a significant cost on the drug companies. His wife is a big investor in pharmaceutical companies. The list of members with conflicts between their personal desires and their responsibilities to the public goes on and on.

With their wealth in part contingent on high returns on investment for the drug and device companies, it’s no wonder Congress has yet to pass a law that would permit Americans to import drugs from abroad, let alone to allow the negotiation of drug prices.

Here are six tips for keeping your drug costs down if you have Medicare.

December 9, 2015
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
Obama’s chief economic advisor is minimizing impact of escalating drug prices

There appears to be little or no chance that the Obama administration will use its final year in office to rein in drug prices. Indeed, at a time when the drug industry is demonstrating a love of price controls—so long as the drug companies dictate the prices—Jason Furman, head of the Council of Economic Advisors, is minimizing the impact of escalating drug prices and seems opposed to measures that constrain them.

In a speech to the Hamilton Project, Furman warns against making too much of huge increases in drug spending because our annual drug spending, which was up 13 percent in 2014 to $374 billion, is only around 10% of overall health spending. (In Medicare, it’s 11 percent.) Rather than focus on the need for negotiated drug prices or the fact that many brand-name and generic drug-price increases have been out of control–we’re now paying three-times more than the Brits for top-selling drugs–Furman posits that “the main factor driving faster drug spending has been the arrival of costly, though often effective, new therapies.”

Furman even suggests that drug spending may not continue to grow as rapidly as it has been growing. However, based on recent price hikes, there’s good reason to believe that drug companies are likely to raise their prices even more. Moreover, with hundreds of new biologics in the pipeline, projections are that drug spending will grow monumentally over the next 15 years. And, though Furman mentions that “trends in this area have raised concerns,” Furman himself appears unconcerned about the increasing number of Americans with costly conditions who cannot afford needed medicines.

In Furman’s words: “While the implications of the recent acceleration in drug spending for the overall health care spending outlook should not be overstated since drug spending currently accounts for only about one-tenth of total health care spending and growth may not persist at its recent rapid pace, trends in this area have raised concerns about access and affordability in both the public and private sectors.”

Based on his comments, it’s pretty clear that Furman is not running for political office. Thankfully, both Hillary Clinton and Bernie Sanders are responding to the public outcry over prescription drug prices and calling for drug price negotiation in the Medicare program, if not for everyone.

Government drug price negotiation ranks as the top policy issue for Americans. But, with a strong Republican majority in the House of Representatives, it’s unlikely we will see Congress enact legislation to control prescription drug prices in the near future. Some states, including California and Ohio, are opting to address the issue themselves. This is another reason your vote is important in 2016.

October 22, 2015
Top drugs in U.S. now three times more expensive than in U.K.
You’re not imagining it. Drug prices in the United States continue to escalate at lightning speed. A new Reuters-commissioned analysis reveals that we are now paying three times more than people in the United Kingdom–that’s right, 3 times more–for the top 20-selling drugs in the world. Americans subsidize the cost of drugs for people around the world, paying 6 times more than Brazilians and 16 times more than people in India for the same drugs.

Unlike in every other country, drug companies control the price of drugs in the United States. Not surprisingly, drug companies have jacked up prices astronomically between 2008 and 2014, with prices increasing 127 percent. Shkreli is one of many drug company CEOs giving drugs extraordinary price hikes. Hedgeclippers reports on the 25 drugs with the largest price hikes in the last two years. Since the drug companies control the prices of these drugs, there is no apparent limit to how high they will go. Here are six of the 25:
1. After Shkreli became the CEO of Turing pharmaceuticals, he raised the price of one of its drugs, Daraprim, 5,000 percent, from $13.50 to $750 a pill. To enable the increase, he created a barrier to keep generic drug firms from producing a generic equivalent of Daraprim. Of note, Daraprim sells in the United Kingdom for 66 cents.
2. Valeant produces 12 of the 25 drugs that have increased most in price in the last two years, an average of 378 percent, and 27 of the 50 drugs that have had the largest price increases. These price increases came at the time it partnered with Pershing Square Capital to buy Allergan.
3. Horizon Pharma bought Vimovo a brand-name arthritis drug from AstraZeneca. Because there is no generic alternative, Horizon Pharma was then able to raise Vimovo’s price sky high, in this case 1200 percent in under two years.
4. Egalet Corporation increased the price of Sprix 500 percent after buying it from Luitpold Pharmaceuticals. Its investor materials reported that Sprix’ wholesale price went “from $185 to $942 for one box of five bottles.”
5. After selling a majority share of Alvogen to Pamplona Capital Management, Macrodantin, Alvogen’s treatment for urinary tract infections, climbed 48 percent.
6. The price of Dutoprol, a blood pressure drug, rose 1000 percent after a company owned by the private-equity firm, Cerberus, bought it from AstraZeneca.
October 21, 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
Unite with doctors to advocate for lower cancer drug prices

Last week, in an article for Mayo Clinic Proceedings, a group of 118 distinguished doctors united to question the pricing of cancer drugs, which is “unsustainable,” and to call for a new pricing method. As this 60 Minutes report reveals, the drug companies set the price of cancer drugs as high as they can. And because of their market power, cancer drug prices have risen an average of $8,500 a year for the last 15 years, a five to ten-fold increase in the price of new cancer drugs over that period.

One in three Americans will have some form of cancer. And, even with insurance, they typically will end up bearing 20 to 30 percent of the cost of their cancer drugs. The insurers have no ability to rein in prices so insurers simply shift more drug costs to their members. People who need a new cancer drug easily could end up with out-of-pocket annual costs of $30,000 just for their cancer medication. Worse still, they might have to forego needed treatment. In 2014, the least expensive new cancer drug approved cost more than $120,000 a year.

American households have an average gross income of $52,000. And half of people over 65 have incomes under $23,500. When out-of-pocket costs for cancer medications are anywhere near $20,000 a year, most people will need to sell assets or take out loans to pay for the drugs; $20,000 represents half of the take-home pay of a typical working family and slightly less than the average income of older adults.

Not surprisingly, as many as one in five cancer patients today are not taking their cancer treatments or taking less than the amount they need. They and their families are suffering and some are needlessly dying. The doctors argue that something has to change.

The doctors offer several possible solutions, including Medicare drug price negotiation, which is the top policy priority for Americans. They also suggest legislation that would prevent pharmaceutical companies from paying generic drug companies to delay putting generic drugs in the market at lower prices and/or that would allow Americans to import drugs from abroad at lower prices. Click here to read their other proposed solutions.

If you agree that we need federal action to stop these high cancer drug prices, email [email protected] or click here, and we will add your name to the campaign list. In the meantime, if you’d like some tips for keeping your drug costs down, click here.

July 28, 2015
Drug and device companies paid $6.5 billion to doctors and hospitals in 2014

The latest data from the Centers for Medicare and Medicaid services show that drug and device companies paid just shy of $6.5 billion to doctors and hospitals in 2014, the first full year for which data is available. This money includes payments for research, speaking fees, transportation and meals. It also helps ensure tight relationships between the drug and device manufacturers and health care providers.

Many Americans have deep concerns about these tight relationships among many doctors, hospitals and drug and device companies. They question the extent to which doctors and hospitals who take money from the drug and device companies are conflicted when they prescribe particular drugs or use specific medical devices. So, the Affordable Care Act requires the Centers for Medicare and Medicaid Services to collect and report the amount of money the drug and device companies pay providers, by provider name and type of payment.

You can check out whether your doctors are among the 607,000 who received payments from drug or device manufacturers in 2014 and how much they received. One goal of reporting this data is to keep drug and device companies from inappropriately influencing research, education and health care decision-making.

If your doctors are receiving money from the drug or device industry, talk to them about it. Find out what they are using the money for, and how it affects the drugs they prescribe and the devices they use.

July 2, 2015
576,000 Americans with annual drug bills over $50,000 in 2014

How much is too much to expect Americans to pay for prescription drugs? Unlike just about every other country, which negotiate drug prices, in the United States, Congress permits drug companies to set prices sky high. Not surprisingly, a new Kaiser Family Foundation poll shows that about three-quarters of Americans believe drug prices are not reasonable.

Since insurers must cover medically reasonable and necessary drugs, regardless of the price, drug companies focus on profits and seem not to concern themselves with whether needed drugs are affordable. For example, two new FDA-approved drugs to treat heart disease by lowering LDL cholesterol levels and protect against heart attacks are expected to cost between $7,000 and $12,000 a year. And, Sovaldi, a new drug to treat hepatitis C costs $84,000 for a 12-week treatment. Of note, insurers do not generally cover the full cost of these drugs; patients usually spend thousands of their own dollars in copays and coinsurance for them.

A recent report by Express Scripts details the problem of rising drug costs, reporting that “An estimated 576,000 Americans spent more than the median household income on prescription medications in 2014,” up 63 percent from 2013. And,140,000 people had drug costs of $100,000 or more, three times the number of people with these costs in 2013; slightly more than half of these people were baby boomers, between 51 and 70.

About ten percent of Americans, millions of people, report that they have trouble affording their drugs, according to the Kaiser poll. And, many of them say they are not filling prescriptions or cutting their pills in half to reduce their costs at the expense of their health. No wonder that government drug price negotiation is the top national policy priority for Americans today.

Here are six tips for keeping your drug costs down if you have Medicare.

June 19, 2015