Healthcare reform isn’t just about the public option and paying for doctor’s visits — it’s also about equal, affordable access to life-saving medications for all Americans. That’s why many Big Pharma watchdogs are so disappointed with a recent amendment slipped into healthcare legislation that proposes extending patent protection on biologic drugs, delaying for years the public’s access to affordable follow-on versions.

What are “biologics”? They’re the next big wave in medicine — drugs made not from simple chemical formulations, but from biological components. They’re very expensive, and poised for enormous success:

By 2014, the biggest-selling meds will be biologics, according to an analysis from Evaluate Pharma. Taking the place of Pfizer’s gargantuan drug Lipitor will be Roche’s Avastin, a cancer med expected to account for $9.23 billion in 2014 sales. (Even when you factor in the recent trial disappointments.) The next five top sellers, in order, are expected to be Humira (Abbott Labs), Rituxan (Roche), Enbrel (Wyeth/Amgen), Lantus (Sanofi-Aventis), and Herceptin (also Roche).

Evaluate also predicts that half of the top 100 drugs in 2014 will be biotech meds — a huge change from last year’s level of 28 percent and 11 percent in 2000.

Because biologics are so complex, the system we all know — where patented brand names enjoy a period of exclusivity, then eventually make way to cheaper generics — doesn’t translate perfectly. Biologic “generics” are called “biosimilars,” and they are not seen as generic equivalents. They must be submitted for approvals as new drugs and do their own clinical trials, etc. 

The Eshoo-Barton amendment, named for sponsoring Representatives Anna Eshoo (D – Calif.) and Joe Barton (R – Texas), would give brand-name biologic drugmakers 12 years of market exclusivity. By comparison, President Obama favors seven years, and Rep. Henry Waxman (D –Calif.) feels that the public should have access to “generic” biologics after just five years. By contrast, says Medical News Today, “The Biotechnology Industry Organization maintains that there should be a minimum 14 years of exclusivity to account for a development process that on average takes 10 years and $1.2 billion for a product to reach market.”

5, 7, 12, or 14 years? As you can see, there is a real difference of opinion on this subject. One person who has written extensively on this is author James Love on the Huffington Post. Here he explains why this amendment is harmful:

The Eshoo/Barton amendment, which has the support of many newly pro-PhRMA democrats, will extend the period of monopolies for biologic medicines, when compared to the original Waxman text. The only question is how long. Part of the harm will be the longer period prohibiting generic suppliers from relying upon evidence that medicines are safe and provide therapeutic benefits. Much of the other harm will come from a number of technical changes in the bill that make it much easier for incumbent firms to block entry through technical issues, extended litigation, and ever-greening of protection from small medically unimportant changes in protected medicines.

This is essentially a case of innovation versus access. Drug companies want protection from the risks and costs borne in the creation and testing of new drugs; patient advocates say that Big Pharma (or Big Biotech, if you like) already make large profits and that the public deserves access to affordable biosimilars in a more timely fashion. “Entities that support longer periods of exclusivity — such as universities, biotech companies and venture capitalists — are ‘fighting to protect inventors’ rights and ensure more thorough clinical trials.’ On the other side, consumer groups, labor unions, insurers and generic drug manufacturers ‘see shorter exclusivity as the way to deliver safe, affordable and quality drugs to patients and open the marketplace to increased competition,’” explains Medical News Today.

The latest high-emotion development is blogger Jane Hamsher’s “Are You Or Someone You Know Paying $50,000 A Year For Drugs?” It paints an ugly picture of what happens to people who cannot affording life-saving biologics. A few days later, Rep. Eshoo responded to this and other online attention with a blog post on The Hill’s Congress Blog titled “Setting the record straight on our health care legislation.” If you check in with these two articles, you’ll have the latest from both side of the “biologic generics” debate.

Our mission, as always, at EDrugSearch.com is to improve the American public’s access to safe, quality medications at an affordable cost.

For more information:

• Should We Be OK With The PhRMA Deal With White House?
• US House Panel Backs Exclusivity for Biologic Drugs
• Pay or die: Deadly Pharma amendment in HCR going right under radar

Despite celebrity endorsements courtesy of Photoshop (above), and a real endorsement by eDrugSearch.com and others, Pfizer whistleblower Dr. Peter Rost came up short in his bid to become the next FDA commissioner. President Obama on Saturday announced the selection of Dr. Margaret Hamburg for the top food and drug post.

We knew Peter was a longshot for the post, but what the heck — it was worth a shot.

The good news is that Dr. Hamburg will bring a passion for and history of reform to an agency that needs it desperately.

For Americans under 30, it might surprise you to know that the FDA has not always been a public laughingstock. In fact, in the 1970s, it earned a public confidence rating of 80 percent — among the highest of all government entities. That rating has now dropped to less than 40 percent, making it one of our least trusted federal agencies.

It’s not difficult to track this decline.

During the Reagan presidency, the FDA’s staff was slashed by 30 percent. It was cut even more in the ’90s, when Newt Gingrich led a pogrom against the agency, effectively arguing that private businesses could police themselves. This “starve the beast” mentality continued under George W. Bush. From 1994 to 2007, the agency staff was chopped from 9,167 to 7,856.

Ironically, the whole anti-FDA movement started with President Reagan’s claims that the agency was effectively “murdering” Americans by spending too long approving needed drugs.

Of course, cutting agency personnel by 30 percent doesn’t necessarily speed things along; it just spreads agency resources more thinly, so that more mistakes are made, the agency gets blamed, and more resources are cut to punish the agency as a result.

And so finally, the FDA reached a breaking point — and we’ve seen an across-the-board meltdown over the past few years, both with food safety and drug safety.

President Obama clearly wants to turn the ship around, back in the right direction. Here’s a brief video in which he outlines his plans for the FDA:

We announced today that the Healthcare 100 now includes more than 1,000 health and medical blogs submitted by bloggers worldwide.

For those of you not familiar with the Healthcare 100, it is a directory, search engine and ranking system designed to assist individuals who are seeking health information from blogs.

Since we started the Healthcare 100 in June 2007 with just over 100 blogs, hundreds of health and medical bloggers have submitted their blogs to our directory, turning it into one of the Web’s go-to resources for health-related content. Surpassing 1,000 member blogs is a milestone not just for us, but for the community of health bloggers.

One reason I created the Healthcare 100 was to help consumers gain confidence in the value and reliability of health and medical blogs. As old-timers like me may recall, health blogs were once viewed as questionable sources of information by many people. Health professionals and the media were skeptical, and consumers weren’t sure whether they could believe the health news and information they found.

By developing ‘power rankings’ that show the relative influence of a wide range of health blogs using data from Google, Yahoo, Technorati, Alexa and other sources, we created a tool that has helped consumers identify worthwhile content they can trust.

While attending the January health blogger summit at Consumer Reports, it really struck me just how far the health and medical blogosphere has come in less than two years.

The mainstream media has now fully embraced the health blogosphere, a fact that is evident in reviewing the Healthcare 100 today. The New York Times and Wall Street Journal currently manage two of the top blogs in our rankings. When we started the Healthcare 100, few traditional journalists could be found anywhere on the list.

What’s great about this, as demonstrated at the Consumer Reports summit, is that journalists and bloggers, including doctors, patient advocates and others, are now coming together at the same table to discuss the issues and challenges facing our healthcare system. That’s good for all of us.

Earlier this year, I was privileged to participate in a health blogger summit convened by Consumer Reports at its New York headquarters. One of the topics discussed at the event — in fact, the one that generated the most controversy — was online health ratings systems.

Many in attendance — including doctors and consumer advocates — were supportive of online ratings, particularly in helping patients find a doctor. But others, most notably Avery Comarow, editor of “America’s Best Hospitals” for U.S. News & World Report, dismissed Web ratings as dangerous popularity contests. Avery made the point that online physician ratings were biased toward negative reviews and had little objective medical basis.

I agree with Avery that doctor ratings sites are far from perfect. But frankly, to dismiss them out of hand is just silly — or at least unrealistic. People use them because, increasingly, people need them.

Years ago, most people found a physician by asking their neighbors and friends for recommendations – and they often stayed with their physician for many years. Today, because of health insurance plans, social mobility, and other factors, patients are seeking new methods for finding and vetting their doctors.

In addition to offering subjective reviews, physician-rating Web sites can help patients research whether a doctor is board-certified, their educational history, office hours, accepted insurance providers, and other information.

If you haven’t used a doctor ratings site before, here are a few that are worth checking out:

• AMA DoctorFinder
• RateMDs.com
• MDNationWide Physician Ratings
• Book Of Doctors
• HealthGrades.com
• Angie’s List > Health

Avery is right that patients who have had a bad experience are more likely to write about it on these sites than those who haven’t.

You should certainly keep this in mind, but I’m a firm believer in giving consumers as much information — and as many choices — as possible in making their healthcare decisions.

As part of our visit to Consumer Reports headquarters last month to participate in the health blogger summit, we had an opportunity to tour the famous Consumer Reports labs — where they seemingly test every product under the sun, from cameras to stereos, home-gym equipment to washers and dryers. They even have food testers who have to sit behind metal doors waiting for food to taste — so the aroma from the test kitchen doesn’t cloud their judgment!

Here are a few of my photos from the tour (you can view the full set on Flickr):

This is where they test the audio equipment. It’s very quiet — and totally soundproof. Sometimes, when groups of schoolchildren or Boy Scouts tour the facilities, the editors will invite them to come in here and scream at the top of their lungs (with the adults on the other side of the door, of course.)

This is where they test the washers and dryers. To test the washers’ performance on various stains, they use test strips featuring a sample of every kind of stain you can think of, which they import from Europe at a cost of $30 each. They go through 1,000 of these strips during comparative testing, so you can see that doing this right isn’t cheap.

A Consumer Reports editor stands in the test kitchen — in front of those metal doors I was telling you about (under the coffeemakers).

We tried our hand at food testing, comparing two brands of chocolate chip cookies. We decided that the brand pictured wasn’t chocolatey enough.

The photography testing lab.

They use this simulator (as well as actual humans) to test the aerobic equipment.

I’ve been a reader of Consumer Reports for most of my life, so it was a thrill to see where all those ratings I’ve relied on came from. I plan to write some more posts about the conference, but I was determined to get these lab pics up this week!

Have a great weekend.

We were fortunate to be invited to a health blogger summit coordinated last Thursday by Consumer Reports. The event — held at CR’s headquarters in Yonkers, New York — was an opportunity to meet with the publication’s editors as well as other health bloggers, and to discuss the future of social media and social networks as they relate to the public health.

The event’s 31 attendees were also treated to an intimate Q&A with Craigslist founder Craig Newmark, who is on the board of Consumers Union, which owns CR.

Here are some of my pics from the event, with captions beneath each image. Click the pics to enlarge.

Julie Deardorff of the Chicago Tribune moderates a panel on health ratings systems, featuring (left to right) Dr. John Santa of CR; Avery Comarow, who edits “America’s Best Hospitals” for U.S. News & World Report; and Kathy Ciccone of the Healthcare Association of New York State.

Craigslist founder Craig Newmark is interviewed by CR Health Online Editor Trisha Brandon.

Craig talks with Organized Wisdom founders Steven Krein and Unity Stoakes and Wall Street Journal editor Scott Hensley.

Craig and Cary!

I have some thoughts on the substance of the conference which I’ll save for later posts. Needless to say, it was a great experience and it hatched a number of ideas that I plan to apply to our blog and our business.

• Loss of function and prognosis in older patients (Pallimed: A Hospice & Palliative Medicine Blog)
• Medicare Part D: Comparing Prescription Drug Use in Special Needs Plans and Other Medicare Advantage Plans (Piper Report)
• Racial disparities in hospice use (Health Disparities Blog)
• Southwest Recipe Nutrition Breakdown (The Family Fork)

Subscribe to the eDrugSearch Blog with Bloglines:

• An Unfortunate Victory for EU Repackagers (Drug Channels)
• Valeant buys Dow in $285M deal (Fierce Biotech)
• New PhRMA DTC Guidelines Ignore Elephant in Room: Moratorium (Pharma Marketing Blog)
• Pharma Trade Group Has New DTC Guidelines (Pharmalot)

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The Day of New London, Conn., has a nice article on Dr. Peter Rost’s bid for FDA commissioner. Here’s an excerpt referencing our interview with Peter:

If Pfizer Inc. were to describe its worst nightmare, it might very well be seeing former company whistleblower Peter Rost become commissioner of the U.S. Food and Drug Administration.

So guess who is actively seeking the FDA’s top post?…

Rost said he is looking for a shakeup of the FDA, including a reorienting of the agency’s priorities from serving the drug industry to helping American citizens.

”That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling (is) revised in a more timely manner,” Rost said in an interview this week with eDrugSearch. com, which endorsed his candidacy.

Some of Rost’s most controversial stances include his views on reimportation of drugs from Canada, which he approves, and his opposition to direct-to-consumer advertising.

”DTC advertising is not part of a ‘free market’ – it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for,” Rost said.

It should come as no surprise to readers of this blog that we are delighted about the prospect of a new FDA commissioner in 2009 — one who we hope will put the interests of the people above those of large pharmaceutical companies.

We have also been pleasantly surprised to see the groundswell of public support for Pfizer whistleblower Dr. Peter Rost for the FDA’s top job. A clear industry outsider like Dr. Rost might seem a longshot to ultimately win the job — but then again, Obama was a longshot to win the presidency. And there are these three hopeful signs:

1. Dr. Rost is blowing away the competition in the voting at John Mack’s influential Pharma Marketing Blog. (Vote here.)

2. President-elect Obama’s chief of staff is a big fan of Dr. Rost.

3. Dr. Rost himself has jumped on the bandwagon, renaming his blog “Peter Rost for FDA Commissioner”!

Today, eDrugSearch.com officially endorses Peter Rost for FDA commissioner. We think he would bring the changes the agency so desperately needs.

On the occasion of our endorsement, Dr. Rost agreed to answer a few questions about how he would handle the commissioner’s job. He has some insightful comments on topics ranging from Canadian drugs to DTC advertising. Enjoy —

eDrugSearch.com: In the 1970s, the FDA had one of the highest public approval ratings among government agencies. Today, the agency’s reputation is a mess. What went wrong?

Dr. Rost: Same reason Wall Street’s reputation used to be great and is now a mess; they screwed up. The FDA is there to protect the public health, both by approving life-saving drugs and taking dangerous drugs off the market. They got too focused on approval and lost out on protecting the public against dangerous drugs (i.e. Vioxx); as a result we’ve had a number of scandals when the FDA has been perceived as being way behind the eightball.

eDrugSearch.com: What are the first three actions you would take as FDA commissioner, and why?

Dr. Rost: It is really impossible to answer without first having had a chance to evaluate the agency from the inside. In general terms, however, I’d like to reorient the FDA to focus on its primary customers . . . American citizens, instead of primarily serving the drug industry. That means the agency would focus not only on the fastest and most efficient processing of new drug applications, but would also ensure that unsafe drugs are taken off the market or labeling revised in a more timely manner. Both these objectives should be equally important.

I would also want to ensure that hundreds of unapproved drugs that are sold illegally as prescription drugs would be taken off the market, and that reimportation of drugs would become legal and regulated and appropriate safety measures taken to protect the public.

Finally, I’d want to bring the kind of internal and external accountability that normally exist within private corporations to a government agency and work for limitation of direct-to-consumer advertising, which is counter productive to efficient healthcare.

eDrugSearch.com: Are there concrete steps the FDA commissioner can take — directly or indirectly — to help reduce the cost of prescription drugs for American consumers? If so, what are these steps and how would they impact drug prices?

Dr. Rost: Support legalized and regulated reimportation of drugs, which would increase price pressure.

eDrugSearch.com: What is your view of the Wyeth v. Levine case? How do you believe the Supreme Court should rule and why?

Dr. Rost: My view is that no government agency, including the FDA, should be considered the equivalent of “God.” An FDA decision or lack of decision shouldn’t preempt a legal challenge and an FDA decision or lack of decision shouldn’t be used as a legal shield. The FDA doesn’t know everything, doesn’t have all information, only what it receives from drug companies and doctors . . . quite frankly, a decision in favor of preemption would be a disaster for American consumers.

eDrugSearch.com: What should the FDA do about direct-to-consumer drug advertising? Is there a role for consumer advertising of prescription medications — and if so, what should that role be?

Dr. Rost: I used to be in favor of DTC and a “free market” but a free market requires informed consumers. Most of them don’t have medical degrees; hence, most of them are not qualified to judge and make decisions based on DTC advertising and, hence, DTC advertising is not part of a “free market” — it is part of manipulation of consumers who don’t know better and doctors who give the patient whatever they ask for. DTC advertising is not in the best interest of evidence-based healthcare or the American consumer.

eDrugSearch.com: Are there ways the FDA can leverage Health 2.0 and other technologies to do its job better?

Dr. Rost: Yes. We are still in the Stone Age when it comes to optimizing use of eHealth, sharing information and medical collaboration and education. Too big a topic to get into detail.

eDrugSearch.com: What would you do as FDA commissioner regarding Canadian drug reimportation?

Dr. Rost: I’m in favor of regulated and legalized reimportation with access to these drugs through regular brick and mortar pharmacies. Today we have a very dangerous system, the Wild West. We need to protect consumers from illegal and misbranded drugs sold by Internet pharmacies. The only way to do it is to legalize and regulate this trade.

eDrugSearch.com: President-elect Obama has been a vocal advocate of Canadian drug reimportation. Apparently in response, Big Pharma and its proxies have been waging a renewed battle against reimportation in the media. Specifically, opponents of reimportation make the case that the FDA lacks the necessary staff and other resources to effectively regulate drugs coming in from Canada. What do you think of this argument?

Dr. Rost: That’s BS, like most of what Big Pharma has been saying in respect to reimportation. In Europe this has been done for 20 years with no major staffing issues.

eDrugSearch.com: Opponents of drug reimportation also claim that drugs coming into the United States from Canada do not meet the same standards as the drugs dispensed to Canadian residents. What do you think of this argument? Can we trust the Canadian government’s licensing procedures to protect the safety of U.S. consumers? What should be the FDA’s role in this issue?

Dr. Rost: Untrue. We can trust both Canada and Europe, since they use drugs from the same manufacturers and have stringent approval procedures. In fact, drugs from these countries may be safer than U.S. drugs, since we have a completely fragmented, state-based system regulating drug trade and wholesalers with lots of entry points for counterfeit drugs. The FDA’s role should be the same as for any other drug, ensuring safety of the drug supply.

eDrugSearch.com: eDrugSearch.com is delighted to endorse you for FDA commissioner! Any final thoughts for our readers?

Dr. Rost: Well, if Obama really is looking for CHANGE what better way to do this than to appoint a candidate who has already shaken up the drug industry?

In the end, we need an FDA accountable to the public, ensuring not only availability of life-saving drugs but also better protecting us against dangerous drugs.

We’ve had enough of tainted advisory boards and people who scratch each others backs, I think I could bring in some fresh air and sunlight.

The FDA is never going to be perfect, but we can all agree that this is one government agency which could do a lot better. The American public deserves better and so do all the great FDA staffers. I don’t think FDA employees are the problem, I think the issue we’ve had is a lack of leadership at the top and we need to bring in someone who has the guts to do what it takes and the vision to know that nothing is ever impossible.