COMPARATIVE EFFICACY DOWN THE TOILET

Science Dies Again

The U.S. House has put so many stipulations around the potential uses of comparative efficacy data, that it is--in the words of another blog--entirely "neutered."

So insurance will continue to be the ones who _do_ deny and ration care based on their own versions of comparative efficacy. So will formularies based on the usual "arrangements," some legal, some not. And science will be flushed down the toilet.

http://www.reuters.com/article/rbssHealthcareNews/idUSN3043148420090730

Physician owned hospitals - what a mess!

Interesting article with one theory about how health care in this country has been derailed.

Follow the link to the article by clicking on the title of this post.

Here are some excerpts:

"On May 15, a 25-year-old woman named Hilary Carpenter had an operation at the Colorado Orthopaedic and Surgical Hospital in Denver to replace a shunt valve in her brain. After the surgery, Carpenter experienced a severe headache and nausea. After consulting with a physician on duty, a registered nurse at the hospital administered Demerol, but the dosage was wrong, and Carpenter's heart stopped. In a scene that state investigators later described as "chaotic," hospital staff was unable to locate quickly the equipment needed to revive Carpenter. According to the investigators, there were only a few people on hand that day to deal with the crisis, and those present lacked training to handle such emergencies. Eventually the staff did something you wouldn't normally expect a hospital to do: They called 911. A paramedic team took Carpenter to a different hospital, where she died."

- Seems the hospital she was being treated in was a private, physician owned hospital and they did not have the staff nor the services required to treat such a serious situation. In fact, they are not required to as they typically try to avoid these types of cases....

More from the article:

"Doctor-owned hospitals are the most conspicuous manifestation of a culture of entrepreneurship that's gone a long way toward creating today's health care crisis. Although traditional economic theory holds that competition drives prices down, in medicine competition had tended to drive prices up as doctors explored new avenues for profit, most typically through fee-for-service overuse of expensive technologies and procedures. It's easy to shrug at such things and say, "That's capitalism." But, in fact, market-driven medicine didn't exist a generation ago, because the American Medical Association didn't allow it. "I saw it happen before my own eyes," says Dr. Arnold Relman, 86, emeritus professor at Harvard Medical School and former editor of the New England Journal of Medicine."

But, doesn't this completely go against the code of ethics of the AMA? One would think! There seems to be a serious conflict here.

What say you?

MYLAN, THE FDA, AND THE GENERIC MBA

Mylan and FDA Continue to Contradict Each Other

While Mylan pharma continues to insist that FDA's investigation (see below) is complete, and FDA already denied that is true, Mylan's CEO reasserted today that the investigation is complete while FDA again said that it is ongoing.

Do we have a problem in communicatin'? Or is it something else?

Here is a summary of the story to this point:

http://www.bizjournals.com/pittsburgh/stories/2009/07/27/daily48.html

Addendum: In another report, Heather Bresch, who had been COO, has been promoted to President of Mylan. Ms. Bresch is the daughter of the Governor of West Virginia, where Mylan's main manufacturing facility is located.

Readers of Pharmalot will recall that Ms. Bresch is also the person whose MBA from West Virginia University was questioned and eventually revoked byWVU.

http://www.post-gazette.com/pg/09210/987120-100.stm

Orders For Wyeth (Or better yet, “No more orders for Wyeth”)

As reported by the Chicago Tribune, U.S. District Judge Bill Wilson has ordered that thousands of pages of Wyeth documents be unsealed. At issue is Wyeth’s marketing practices and the safety of their hormone replacement therapy drugs, Prempro and Premarin. The release request was made by The New York Times and the biomedical journal Public Library of Science (PLoS).

The data is relevant in a case involving 8,000 combined lawsuits which will be heard by Judge Wilson. Of interest is whether Wyeth properly reported the risks of breast cancer from hormone therapy.

As described in a Decwember 12, 2008, New York Times article, Wyeth had relinquished the documents to Sen. Grassley for use in a Congressional investigation regarding the pharmaceutical industry’s influence on doctors.

“Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.” See: Wyeth’s Use of Medical Ghostwriters Questioned - NYTimes.com

Although shown to a jury, the documents have been under a confidential seal and not made available to the public. However, on June 17, 2009, the Times joined PLoS in their attempt to have the documents released.

“‘These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions,’ said Little Rock attorney Gerry Schulze, who represented the Times.’”

Questions: If Wyeth is found to have hid and embellished medical data, who is the most guilty?

A. Wyeth?
B. The doctors who signed or allowed their names to be used in published articles?
C. Our legal system for allowing such information to be kept from the public?
D. All of the above

What should be done to protect the public?

To read all about it, see: Judge orders Wyeth papers unsealed -- chicagotribune.com, Associated Press, July 25, 2009

"CATASTROPHICALLY SERIOUS"?

Will Mylan Be the Next Big One?

Almost lost in the news was a report yesterday (Sunday, 7/26) that has the potential to be Act I of a major drug disaster. The article appareared in the Pittsburgh Post-Gazette (hat tip to FDLI blog) and can be accessed at:

http://www.post-gazette.com/pg/09207/986516-28.stm

To excerpt briefly from the article:

"MORGANTOWN, W.Va. -- Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.
Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.
But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

The violations of standard operating procedure at the world's third largest generic drug company, uncovered May 11, were "very serious," the report stated, involving "falsifying information" and "altering product."

The report said the practice was "pervasive," occurring on all three shifts at the plant, which makes roughly 19 billion doses of medication annually. The drugs are used to treat diabetes, high blood pressure, depression, cancer, epilepsy and other conditions.

The report did not say how long the unauthorized practice had been going on at the plant, which employs about 2,000. One worker interviewed by company investigators indicated it had been happening for at least two years.

Former Food and Drug Administration inspectors and industry consultants say the widespread breach of protocol raises troubling questions about the integrity and oversight of the plant's quality control operations."I've never before seen anything like this, that has reached this level of cheating," said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. "



To say the obvious: 19 billion doses annually is a lot of doses. And even a small percentage of "altered product" from the third largest generic drug manufacturer could impact enormous numbers of people.

The article further notes that Martha Bennett, a former senior compliance officer at FDA, noted the internal report "descriibed multiple serious FDA violations, including the falsification of batch production records." By law, such records are required to be maintained. That is the only way to track which batches might be misbranded, or worse.

Bennet continued, re: the "serious FDA violations": "I can't determine from this report whether it's catastrophically serious." That is, whether and how much of the relevant meds got onto the market. But the article suggests that the problem had been going on for a couple of years, and there has been no recall to this point.

The article notes that Mylan has refused public comment. Read the article and make your own call about what we know about the company's response at this point. It suggests that FDA was never notifiied. And it ends with this:

"Employees who provided information to the newspaper did so on the condition that they remain anonymous. They said the feared losing their jobs at Mylan, one of the Morgantown region's largest and best-paying employees.

Some of them are bracing for more fallout.

'There's an overwhelming feeling this is not over," said a source close to the situation. "It's like a slow boil. Everyone is waiting to see what happens next.'"


***********************

Addendum: It is reported today that FDA will initiate an investigation of this situation. Mylan has explicitly denied that any misbranded drugs have been distributed.

MORE NUANCED DISCUSSION OF BIOLOGICS AND EXCLUSIVITY

In todays's New York Times....

http://www.nytimes.com/2009/07/22/business/22biogenerics.html?emc=tnt&tntemail1=y

Adverse Event Reporting - Problem, What Problem?

As reported by the Wall Street Journal on 7/20/2009 - GAO: FDA Can't Determine Its Funding Needs "The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."

(click on the title to access the full article)

Which is the worse problem? Can't track adverse-event reports or Don't know how much my budget should be to do my job adequately. Either way it sounds like a train wreck in the making.

THE CHAMBER OF COMMERCE WANTS TO GET INTO YOUR PANTS

COC Readies Attack Ads on Healthcare Reform

The U.S. Chamber of Commerce, the most powerful lobbying organization in the country, is about the launch attack ads against the healthcare reform bill sponsored by the Democrats. The COC has also led the way in the attempt to institutionalize full FDA preemption. Here is a relevant excerpt from yesterday's WSJ:

Ad Campaigns Aim at Health Overhaul

By JANET ADAMY
WASHINGTON – Major business groups are launching a series of new advertising campaigns aimed at shaping Congress' health overhaul.

The U.S. Chamber of Commerce, which represents three million employers, plans to introduce a sharply worded multimedia advertising campaign in the next several days pushing back against the key planks of Democrats' health overhaul proposals. The group plans to run television and print advertisements in the Washington area and about a half dozen states with lawmakers who hold key votes in the debate, including Maine, Arkansas, Louisiana and Nebraska.

The ads will take aim at Democrats' proposals to create a public health insurance plan and raise taxes on the wealthy. The campaign also will emphasize the significance of existing employer-provided health insurance plans, which currently cover about 170 million Americans.
"The government already gets the shirt off your back," reads one print that features a bare-legged man covering himself with a briefcase. "If Congress passes new tax reforms, then hold on to your pants!"

"We don't think Congress should be racing" to pass the health legislation, said Bruce Josten, executive vice president of the U.S. Chamber of Commerce. "I think you're seeing a growing unease.... in Congress itself." Mr. Josten said the group will spend "a couple million" dollars initially on the campaign, though he declined to specify the precise amount.

WAXMAN ON BIOLOGIC EXCLUSIVITY

Hat tip to Uncle Ed. The op ed below related to recent threads on biologics and generics. What I didn't know, and no one commented here, is that biologics have had eternal exclusivity because they emerged post Hatch-Waxman.

Interesting split between "liberals" like Ted Kennedy and Waxman on this.

***********************

Biotech drugs: Limit pharmaceutical monopolies to make drugs affordable
By Henry A. Waxman
2:00 a.m. July 17, 2009
Twenty-five years ago, Ronald Reagan signed the landmark Waxman-Hatch law, delivering generic drug competition to the American marketplace. Since that time, generic drugs have provided millions of American consumers with access to low-cost, yet safe and effective drugs. In the last decade alone, generics have saved consumers, businesses and state and federal governments $734 billion. Making sure that Americans have access to, and can afford, life-saving medicines has been one of my chief goals as a member of Congress, and I am proud of the success of generic competition in helping achieve that goal.
Unfortunately, Americans now face even higher drug prices on a category of drugs that have no generic competition – biotech drugs. These drugs didn't exist 25 years ago and were not covered by Waxman-Hatch. As a result, they have the equivalent of permanent monopolies. And they are now the fastest growing – and most expensive – class of drugs on the market. Many of these drugs cost patients between $10,000 and $100,000 per year. Some cost even more. And the drug industry is raising biotech drug prices at almost three times the rate of inflation. AARP has reported that the average prices for biotech drugs jumped by more than 40 percent from 2003 to 2007, while general inflations was 14 percent over that time.
Even patients with insurance can be crippled by co-pays on biotech drugs. Uninsured patients may be denied them entirely. And private and government purchasers of these drugs, like the California Public Employees' Retirement System, are warning that without generic competition for biotech drugs, they will soon lose the ability to offer affordable coverage for these life-saving/enhancing medications. They will have to substantially increase co-pays or premiums or even stop reimbursing for these drugs. Life-saving drugs do no good if no one can afford them.
In the coming days, we have an opportunity to bring generic competition to the biotech marketplace. With Democratic and Republican colleagues in the House and Senate, I have introduced a bill, the Promoting Innovation and Access to Life-Saving Medicine Act, to do just that. It allows the Food and Drug Administration to approve safe and effective copies of biotech drugs. Our bill has broad support from national organizations representing patients, businesses, seniors, workers, and pharmacists, including AARP, Consumers Union, AFL-CIO, Kaiser Permanente, and the National Community Pharmacists Association. And we are extremely proud to have the support of President Barack Obama.
Congress has moved toward a consensus on how to ensure that generic biotech drugs are safe and effective. But we remain divided on what incentives are needed to ensure continued innovation.
As we did in Waxman-Hatch, we must maintain a balance between increasing competition and providing incentives for innovation. Some monopoly protection is appropriate to encourage investment in research and development, but too much subverts competition and denies Americans the cost-savings they desperately need. We don't need to give drug companies open-ended monopolies and unlimited profits at the expense of patients.
The drug industry, however, is engaged in a massive lobbying campaign to persuade members of Congress that there will be no more life-saving drugs if they don't get 12-or 14-year monopolies – more than double the monopoly protection available to all other drugs. Yet, even their own experts say that biotech drugs cost no more to develop and take no longer to bring to market than the drugs covered by Waxman-Hatch. And their sky-high prices more than cover their higher production costs.
In establishing an appropriate monopoly period, we would do well to remember that Waxman-Hatch has delivered low cost drugs and innovation for 25 years. Traditional drugs receive three or five years of monopoly protection, in addition to their patents. Remarkably, even as generic competition has saved this country billions of dollars a year, investment in research and development of innovative drugs has soared, increasing every year at a rate higher than inflation. This is not a surprise to the independent Federal Trade Commission, whose recent study concluded that early competition in the biotech marketplace will spur innovation, and, indeed, that 12-to 14-year monopoly periods will harm patients by discouraging new breakthroughs.
A bill granting such lengthy monopolies is not just a windfall for the drug industry; it will effectively eliminate competition. According to news reports, generic drug industry executives have told Wall Street that monopolies of that length will extinguish market incentives to compete in the generic biotech market. So the overreaching of the drug industry will deprive consumers of affordable biotech drugs for the foreseeable future. This is not a result any of us can afford. It's also the wrong prescription for America. On the 25th anniversary of Waxman-Hatch, my wish for Americans is that Congress will stand up to the drug industry and create real competition for biotech drugs.

Waxman, a Democrat, is chairman of the House Committee on Energy and Commerce. He represents the 30th Congressional District, which includes Beverly Hills, Malibu, Santa Monica, Westlake Village, Calabasas and parts of Los Angeles.

New Drug Development and Access

While the government debates extending the patent term for biologics, let's get the discussion rolling here on what sort of changes might make drug discovery, development, approval and access more economical for patients, while preserving economic returns and incentives for innovative therapies.

The ability to bring innovative cost effective drugs to market is paramount. Consider these facts from the website NCHC - Facts about Health care Costs in the US:

National Health Care Spending

• In 2008, health care spending in the United States reached $2.4 trillion, and was projected to reach $3.1 trillion in 2012.1 Health care spending is projected to reach $4.3 trillion by 2016.¹
• Health care spending is 4.3 times the amount spent on national defense.³
• In 2008, the United States will spend 17 percent of its gross domestic product (GDP) on health care. It is projected that the percentage will reach 20 percent by 2017.¹
• Although nearly 46 million Americans are uninsured, the United States spends more on health care than other industrialized nations, and those countries provide health insurance to all their citizens.³
• Health care spending accounted for 10.9 percent of the GDP in Switzerland, 10.7 percent in Germany, 9.7 percent in Canada and 9.5 percent in France, according to the Organization for Economic Cooperation and Development.⁴

Employer and Employee Health Insurance Costs

• Premiums for employer-based health insurance rose by 5.0 percent in 2008. In 2007, small employers saw their premiums, on average, increase 5.5 percent. Firms with less than 24 workers, experienced an increase of 6.8 percent.²
• The annual premium that a health insurer charges an employer for a health plan covering a family of four averaged $12,700 in 2008. Workers contributed nearly $3,400, or 12 percent more than they did in 2007.² The annual premiums for family coverage significantly eclipsed the gross earnings for a full-time, minimum-wage worker ($10,712).
• Workers are now paying $1,600 more in premiums annually for family coverage than they did in 1999.²
• Since 1999, employment-based health insurance premiums have increased 120 percent, compared to cumulative inflation of 44 percent and cumulative wage growth of 29 percent during the same period.²
• Health insurance expenses are the fastest growing cost component for employers. Unless something changes dramatically, health insurance costs will overtake profits by the end of 2008.⁵
• According to the Kaiser Family Foundation and the Health Research and Educational Trust, premiums for employer-sponsored health insurance in the United States have been rising four times faster on average than workers’ earnings since 1999.²
• The average employee contribution to company-provided health insurance has increased more than 120 percent since 2000. Average out-of-pocket costs for deductibles, co-payments for medications, and co-insurance for physician and hospital visits rose 115 percent during the same period.⁶
• The percentage of Americans under age 65 whose family-level, out-of-pocket spending for health care, including health insurance, that exceeds $2,000 a year, rose from 37.3 percent in 1996 to 43.1 percent in 2003 – a 16 percent increase.^{7
  ______________________________________________________________________}

<sup>Consider that many Americans have lost their jobs in the past year and are struggling with "Cobra" and other temporary measures while they try to find employment.

In 2006 12.6% of health care spending was shelled out for pharmaceuticals. This rose from 9.3% in 1996, but there are many more countries that were ahead of the US in spending on Pharmaceuticals.

There is no "money tree" in the Pharmaceutical industry. Drugs and treatments are paid for by employer/employee contributions and taxes. We have got to spend it wisely.

A couple of things I am thinking about:

We have discussed this before - but the drug approval process at the government level has to be examined.

With this in mind:
1.) companies drug development, clinical trial practices, medical/regulatory departments are completely audited by a fully accredited governmental agency. This would also include complete employee screening. Once you have been reviewed, this and other factors might help in speeding up the NDA process for your company.
2.) All new NDA being filed are scrutinized by an independent team of reviewers, much like a jury being assembled for a court trial. Meaning you go out in the field and independently and randomly pick health care professionals to co-review the NDA. This would also include review of the data and issues by a biomedical ethicist and a pharmacoeconomics expert. There is some nominal fee paid, and there are time limitations.
3.) Cap the amount of investor capital that can be raised to fund new drug development projects
4.) Government sponsored Phase II clinical trials
5.) Global Pharmaceutical industry regulation, this would be meant to facilitate access to important innovative drugs to all citizens of the world

Just some thoughts....</sup>

IT DEFINITELY AIN'T OVER......

See Last Two Threads.....

To clarify, the bill to extent biologic exclusivity only passed in the Senate's HELP Committee. It has not yet been endorsed by the full Senate nor the House. See below...This puppy definitely is not yet a dog.....

I predict some sort of eventual compromise. Eight years? Whoever guesses correctly wins a free subscription to Phamalittle....

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US Senate panel backs 12-year biotech drug shelter
Mon Jul 13, 2009 11:57pm EDT

* Decision seen as victory for biotech drugmakers* White House, AARP back seven-year limit* Generic drugmakers decry decision as blow to consumers (Adds biotech industry group comment, paragraphs 10-11)By Lisa RichwineWASHINGTON, July 13 (Reuters) -

Biotechnology medicines would be protected from cheaper rivals for 12 years under a plan that cleared a U.S. Senate committee on Monday.The 16-7 vote in the Senate health committee was a victory for major biotech drugmakers such as Amgen Inc (AMGN.O) and Roche Holding AG (ROG.VX). Manufacturers of brand-name biotech drugs have been pushing for a period of 12 to 14 years before generic copies of their medicines can win approval.

Generic drugmakers have backed proposals limiting the exclusivity period to five or seven years.The Senate plan could change when the healthcare bill goes to the floor for a vote. Senators also will need to work out an agreement with the House, where the issue is still being debated.A key lawmaker, House Energy and Commerce Committee Chairman Henry Waxman, backs up to five years of protection.Biotech medicines, or biologics, are made from living things and are more complicated to produce than traditional, chemical-based drugs. They can cost tens of thousands of dollars per year.The drugs treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Roche's Herceptin and Avastin cancer treatments, and Amgen's Epogen and Aranesp anemia therapies.Lawmakers working on an overhaul of the U.S. healthcare system are crafting plans to create a legal path for approval of cheaper copies of biotech medicines. The exclusivity period for the brand-name versions has been a key sticking point.Brand-name companies say they need an adequate period without competition to encourage companies to develop new medicines."A minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition," said Jim Greenwood, president of the Biotechnology Industry Organization, which represents brand-name biotech drugmakers.The Senate panel's vote "marks a significant defeat for those who would shortchange future breakthroughs and the hope for cures for some of the most devastating diseases by providing an abbreviated period of data exclusivity," Greenwood said.The committee rejected a shorter period of seven years, the time the White House says strikes an appropriate balance between promoting innovation and providing competition. Seniors lobbying group AARP also backed seven years."This unprecedented action strikes a huge blow to consumers at a time when many Americans are struggling to pay for the medicines they need," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said of the Senate panel's action.Companies aiming to sell copies of biologics include generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O). (Editing by Eric Walsh)

Twelve years it is!

The senators have voted to extend biologics for twelve years of protection before generics can be made.

The president was defeated, wonder what will happen with health care reform.

BATTLE OVER BIOTECH EXCLUSIVITY

On Sausage and Substance


The article below, excerpted from today's WSJ, links recent threads about extending patent exclusivity for biologics and the impact of constituencies on Congresspeople. It is not surprising, nor delinquent, that Sen. Kennedy is championing Amgen's et. al.'s cause. Senators and Reps always seek to advance the interests of their states, and industries within their states, for a range of reasons, and--in our system as it exists--it is expected that they do so. Thus what looks like "pork" from the perspective of Arizona may be tofu salad in New Jersey.

Still, given the system as it is, the question remains how much this strains the possibility of attaining rational national policy. It is, in a way, the reverse of the preemption issue philosophically--the extent to which balancing various interests and local constituencies can yield good policy or, in essence, a mush so compromised by compromise that there is, in effect, not much substance left.

That was my own initial assessment of the FDAAA. The effort to "keep everyone on board" led to throwing too much over the side. I would qualify some of my initial disapppointment, but my overall assessment is pretty much the same.

National healthcare policy is enormously more complicated. I understand that legislation is like "making sausage." On the other hand, every now and then there's some really great sausage.

******************************
JULY 13, 2009
Blood Boils Over Bill To Protect Biotech Drugs

By ALICIA MUNDY
WASHINGTON -- The biotech industry is moving closer to a victory in Congress that would protect lucrative drugs from generic-drug competition for a lengthy period, though the issue continues to rile up lawmakers and consumer advocates.

The Senate Health, Education, Labor and Pensions Committee will be looking at a bill this week that would grant so-called biologic drugs -- those engineered from living cells -- made by companies like Amgen Inc. a total of 13½ years of intellectual-property protection, which is about twice the length of time proposed by the White House.

The proposal, introduced by the committee's chairman, Sen. Edward Kennedy (D.,Mass.), would be part of an ambitious health-care overhaul sought by President Barack Obama. It may prevail because it would help keep the pharmaceutical industry on board with the overhaul, said industry lobbyists and Senate staffers.

But the question of how long to protect brand-name biologics' intellectual property -- referred to as their 'exclusivity' -- has caused a rift in the health committee, which oversees the Food and Drug Administration, and in the overall Senate, industry representatives and Senate staff said.
It has also sparked an advertising battle between consumer groups, which want a shorter period of exclusivity for biologics, and the industry, which has said such an approach would hamper innovation........

[sound familiar?]

How many more have been faked?

Yet another reason why it is so important to strike down preemption in ANY form....

Follow the link in the title of this post to read the full article.

Two researchers conducting animal studies on immunosuppression lied about experimental methodologies and falsified data in 16 papers and several grants produced over the past 8 years, according to the Office of Research Integrity (ORI).

The scientists, Judith Thomas and Juan Contreras, formerly at the University of Alabama at Birmingham (UAB), falsely reported that they performed double kidney removals on several rhesus macaques in experiments designed to test the effectiveness of two immune suppressing drugs -- Immunotoxin FN18-CRM9 and 15-deoxyspergualin (15-DSG) -- in preventing rejection of the a single transplanted kidney.

KENNEDY PROPOSES DOUBLING PATENT EXCLUSIVITY FOR BIOTECH DRUGS

Twelve More Years

In a story that is perhaps related to the nexus between certain companies and certain Congressfolk, Ted Kennedy has proposed doubling patent exclusivity for at least some biotech drugs. Here is the story:

http://www.bloomberg.com/apps/news?pid=20601087&sid=aTBO6eZ4B_Js

It is perhaps interesting to speculate whether this is part of wider negotiations, which seems likely, or something else. Personally, I have favored extending exclusivity for drugs that require an unusually arduous approval process and/as a kind of "reward" for superlative regulatory compliance, particularly in the arenas responsible completion of phase IV studies and responsible promotion.

Kennedy's proposal is so out of synch with what the administration has proposed that it will be "interesting" to see where the middle turns out to be.

Bought and Paid For

Although many healthcare groups have promised their help in reform, major players are hiring former congressional staff members and retired members of Congress as lobbyists in a campaign to block reform.

In a $1.4 million a day plan, the “The nation's largest insurers, hospitals and medical groups have hired more than 350 former government staff members and retired members of Congress in hopes of influencing their old bosses and colleagues.”

Of note, former House Majority Leader Richard Armey and Richard A. Gephardt are now lobbying for a New Jersey pharmaceutical firm.

Many insiders formerly worked with lawmakers, such as Senators Max Baucus and Charles Grassley, on committees concerning whether or not a public insurance plan should be implemented--a policy opposed by the healthcare industry.

“The push has reunited many who worked together in government on health-care reform, but are now employed as advocates for pharmaceutical and insurance companies.”

Two former chiefs of staff to Senator Baucus, who chairs the Senate Finance Committee, are David Castagnetti and Jeffrey A. Forbes. Both men, now lobbyists, collectively represent such clients as: PhRMA, Merck, Genetech, Amgen, and America’s Insurance Plans.

Castagnetti and Forbes were amongst those who attended a June 10 closed-door committee meeting between aides to the Senator and other healthcare lobbyists. Another attendee was Richard Tarplin, who previously worked with the Department of Health and Human Services and Senator Dodd, a leader in reform.

Currently, Mr. Tarplin heads Tarplin Strategies, a lobbying firm that represents the American Medical Association. Mr. Tarplin sees his role as a lobbyist as being important, because, as he states:

"For people like me who are on the outside and used to be on the inside, this is great, because there is a level of trust in these relationships, and I know the policy rationale that is required."

Refuting that, however, are those who work to protect the pubic interest. They are concerned that the revolving door between government and K Street has altered the healthcare debate.

“ ‘The revolving door offers a short cut to a member of Congress to the highest bidder,’" said Sheila Krumholz, executive director of the Center for Responsive Politics.”

A well-known example of the revolving door is Rep. Billy Tauzin, who, after being successful in moving the Medicare prescription bill through Congress, became the head of PhRMA--where he received a starting salary of $2.5 million a year. That appointment led Congress to pass a bill barring former members from such activities as, “bringing clients onto the House and Senate floors and from lobbying their friends in members-only gyms.” It also “forbade direct lobbying contacts with former colleagues for a year in the House and two years in the Senate.”

Mr. Tauzin argues, however, that it’s not unusual that experienced individuals get the job. As he puts it:

"Is it a distortion of baseball to hire coaches who have played baseball? Is it a distortion of universities to hire from academia?"

"The bottom line is that people work in the fields in which they have experience. Somehow there are people who think that's unusual for politics, but I think it's pretty normal."

I guess so. But we are not playing baseball or looking for the best teachers. We are not looking for more conflicts of interest. We are looking for and need to trust in someone who will watch over us.

What is your opinion of former employees of Congress working as lobbyists for the healthcare industry?

If you find that policy unhealthy, what should we do about it?

For the full article, please see: Former Lawmakers and Congressional Staffers Hired to Lobby on Health Care - washingtonpost.com by Dan Eggen and Kimberly Kindy , July 6, 2009

Are Clinical Trials Rigged?

A news article by Ivanoe Medical news, accessible by the link in the title of this post, brings together some of the critical background information on results being skewed and summarizes some of the findings in a JAMA article.

The articles say's: “Many medical journals are becoming marketing instruments for the drug companies," Sidney Wolfe, M.D., Director of Public Citizen's Health Research Group, said.

A new study finds 2 percent of scientists admit they have fabricated, falsified or altered data to improve the outcome at least once. About 35 percent admit to questionable research practices. A JAMA study reveals that 30 percent of the original research studied was either false or exaggerated. Problems include small study size, design flaws, publication bias and failure to publish negative results.

"A smart drug company -- maybe not an ethical one, but a smart one -- might decide to publish only those studies that put its drug or device in the best light," Dr. Lurie said."

But what can be done to protect patients/consumers? Some momentum is being gained to establish a data base were the results of all clinical trials, negative and positive results, can be queried.

We have posted many articles on this subject, which makes a strong case against preemption.

Knowing what we now know, can we afford to not do anything? I think not.

Any plan to overhaul our health care system has got to include a critical assessment of the FDA, medical associations and their guidelines including the guidelines for publishing clinical trial results.

We need to restore credibility and trust in our health care system.

Adverse Event Reports Go Unreported While Consumers Loose Eye Sight.

In a report by the Associate Press (June 20, 2009) the company – Advanced Medical Optics - chose to not report at least 9 Adverse Events cause by it’s product Complete MoisturePlus that showed a connection between its product and a serious eye infection caused by Acanthamoeba.

“Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP,three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage. By June 2007, the CDC had confirmed nearly 160 cases of the infection in patients across the U.S.

Currently there are 257 Adverse Events listed in the Medical Device database (MAUDE).

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.”

Apparently AMO chooses to not understand the requirements or purpose of Adverse Event Reporting. Suggesting that they are not required to report a problem that their label does not specifically address seems to indicate that the company feels that they are not obligated to be at all concerned about the consumer after they have taken payment for their product.

It is a given that AMO will play the FDA Preemption card in their liability defense. It is also likely that the case will be thrown out of court on those grounds.

OFF-LABEL PROMO BY SALES DOCS

Have I Got a Pill for You!!!!


According to an article in today's WSJ, companies are relying on "Medical Science Liaisons," often docs, to do their off-label promotion.

http://online.wsj.com/article/SB124597622797657621.html

But this is old news, isn't it? Wasn't the initial Neurontin bust exactly over this, and brought by Dr. Franklin who was fulfilling that role?

Or did I miss something???!

DAN TROY'S LAST PUFF

THE FALL OF THE HOUSE THAT TROY BUILT


As many here know, former FDA Chief Counsel Dan Troy earned his stripes in his successful efforts on the part of Brown & Williamson to block FDA regulation of tobacco during the Clinton years. That effort, and other deregulatory struggles against FDA especially regarding off-label promotion, made him the perfect candidate for FDA's top lawyer--and close to de facto Commissioner--during the first four years of Bush II. He is now Chief Counsel and #2 of Glaxo.

Given the FDA's successful bid to regulate tobacco, much to the house that Troy built has now been successfully dismantled. His arguments in favor of preemption were dismissed as essentially irrelevant by both sides in Wyeth v. Levine. With the regulation of tobacco, another piece of the Troy legacy goes into the dustbin.

Of course, one should never underestimate the persistence of those who fight for the agenda that Troy championed, and almost certainly still champions, from inside the walls of Glaxo. The Washington Legal Foundation and other hard-right "think tanks" have not given up their aims. They are only a bit more quiet about it at the moment.

The take-over that the hard-right engineered that culminated in the Bush years was a long time in the making. They are patient people. And they continue to sit on more money, as Philip Morris once put it, "than God."

GAO Has an Opinion of the FDA - Not Good

Add one more in the long line of respected authorities to raise the flag of danger about the FDA's capability to protect the American public.

The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.

"...these shortcomings in both premarket and postmarket activities raise serious
concerns about FDA's regulation of medical devices."

The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.

Gung Ho

From 1998 to 2007, drug and device companies, as well as other medical groups, have gifted Department of Defense medical personnel with over $10 million in free trips.

A study conducted by the Center for Public Integrity and Northwestern University's Medill School of Journalism revealed, “ … the medical industry was by far the biggest sponsor of free travel, accounting for about 40 percent of all trips. The sponsors included not only drug and device makers but also health foundations and trade groups often funded by those companies.”

These trips are permitted under federal regulations; however, critics complain that the system is broken.

“Allowing the drug industry to send military pharmacists to Las Vegas or letting a Saudi prince pay a top official’s way to Riyadh, they warn, can create serious conflicts of interest.”

Medtronic spent $13,000 on trips for a surgeon who, it was discovered, “overstated the benefits of Infuse, a Medtronic drug it uses to treat combat-related bone injuries.” The company also sponsored nearly a hundred trips to conferences and seminars for specialists and other medical personnel.

How do you feel about these industries influencing military medical personnel?

To read the entire article, please click the link below.

Pentagon Travel - A Center for Public Integrity Investigation

CONGRESS DOING DRUGS

According to the WSJ and WaPo, a number of key Congressfolk have very significant investments in medical industry stocks, including pharma. Note that these are personal/family investments or employment, not campaign contributions. Here is some of the list:

Harry Reid, Senate majority leader: At least $50,000 invested in a major health-care index.

Sen. Judd Gregg (R-N.H.): Between $254,000 and $560,000 of stock holdings in major health companies, including Bristol-Myers Squibb and Merck.

Rep. Jane Harman (D-Calif.): Her family held at least $3.2 million in more than 20 health-care companies at the end of last year.

Sen. Johnny Isakson (R-Ga.): At least $165,000 in drug and medical stocks.

Sen. Kay Hagan (D-N.C.): At least $180,000 in investments in more than 20 health-care companies.

Sen. Christopher J. Dodd (D-Conn.): His wife serves on the boards of four health companies, receiving more than $200,000 in salary and stock for 2008. (WaPo cited the Associated Press on that fact.)

Sen. John Kerry (D-Mass.): Along with his wife, he holds at least $5.2 million in companies including Merck and Eli Lilly.

Sen. Michael Crapo (R-Idaho): $16,879 worth of stock in companies including St. Jude Medical.


What say you? If Chief Justice Roberts recused himself for owning $10K of Pfizer, should, for example, should the Kerry's either sell the stock or should Kerry recuse himself for owning "at least $5.2 mil" of Merck and Lilly? What about COIs on FDA Advisory Committees?

Or do we assume that pols, exactly because they are pols, inherently have "conflicts of interests" (their own and those of constituents) which means that "objectivity" has a far lower threshold, if it has any at all?

BIG PHARMA'S FRIVOLOUS LAWSUITS

In an effort to curb brand companies' lawsuits designed to delay generic competitors, bills have been proposed in Europe based on a partial "loser pays" model.

As described in the story below, from London's Finanacial Times, the great majority of such suits (60-80%) are lost. Like paying off potential generic competitors (see our recent story on this), the primary purpose of the suits is to add 2-3 years of protection beyond patent expiration while the suits are being sorted out.

Many have described this as a perversion of Hatch-Waxman. This is an interesting proposal to do something about it.


Drug groups seek cure for 'spurious' patent lawsuits

By Andrew Jack in London
Published: June 12 2009 03:00 Last updated: June 12 2009 03:00

Generic drug companies are demanding that pharmaceutical companies post a financial "bond" that they would forfeit if they lose litigation designed to prevent the loss of patents on their medicines.

In submissions to the European Commission, the European Generic Medicines Association calls for a mechanism to ringfence up to 20 per cent of the sales from any medicine on which a drug company seeks to maintain its exclusivity through legal action once the patents expire.
The aim is to discourage what the low-cost generic manufacturers claim is a growing number of spurious lawsuits designed to delay competition and maintain high prices on drugs beyond their original patent life.

The request is one of a number sought by the association in recent submissions to policymakers, including a formal response to the pharmaceutical sector inquiry launched by the EU's competition directorate.

Its action comes ahead of publication of a final report from Neelie Kroes, the EU competition commissioner, who last autumn issued a scathing preliminary analysis of the practices of the pharmaceutical sector designed to stall generic competition, including settlements between generic and innovator companies to delay generic launches.

Gerard van Odijk, European president and chief executive of Teva, the world's largest generic business, and an advocate of the proposal said of the bond: "This would rebalance the model. Pharmaceutical boards would be more cautious in defending their patents. My bet is it would halve the number of cases they bring."

He estimated that pharmaceutical companies lost 60-80 per cent of the legal actions designed to stall the launch of generic versions of their medicines, but continued to launch a growing number of cases in the courts.
Copyright The Financial Times Limited 2009

WYETH LOBBYING FOR PREEMPTION

According to a recent Forbes article Wyeth spent a significant amount of moolah lobbying in favor of preemption in anticipation of the Levine decison.

Find the article here:

http://www.forbes.com/feeds/ap/2009/06/12/ap6539686.html

One might wonder how much of the nearly million dollars in lobbying (not only on preemption)might have gone into new drug development, scientific innovation, making life-saving drugs more accessible, and all the other good things preemptors never cease to repeat they're committed to.

"You're Guilty - Now Go write a book!"

Former Bristol Myers Squibb executive is found guilty of providing misleading statement to the FDA regarding the patent issue with Plavix.

His sentence? Two years probation $1,000 fine and write a book, a cautionary tale to other executives....

I wonder how much the book will sell for?

Hmmm, this judge might be on to something...

Bravo - Vermont Bans Pharma Gifts to Doc's

"MONTPELIER – Gov. James Douglas signed into law Monday what is believed to the strongest ban in the country on pharmaceutical company marketing to doctors and other medical professionals.

The new law, which takes effect July 1, restricts nearly all forms of financial contributions and gifts between the companies that make prescription drugs and the medical professionals in Vermont who prescribe them."

Click on the link to read the full article.

1.) What are the chances of this becoming law in other States?
2.) Anticipated response from Pharma?

PREEMPTION TIES THE HANDS OF JUSTICE

In an article solidly behind preemption we see this from the Southeastern Texas Record -

Citing federal preemption, MDL judge dismisses hundreds of Medtronic suits

"Stating the plaintiffs' claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, Judge Kyle wrote that the court recognized that at 'least some plaintiffs have suffered injuries' but that the 'plaintiffs assert claims for which the Court simply cannot provide a remedy.'

The article goes on to support the decision but what becomes obvious is the simple fact that no matter how much harm might come to unsuspecting medical device patients and no matter what a judge might want to do to remedy that, preemption does not allow any other course of action, even including discussion, fact finding or investigation into management practices, fraud or outright criminal conduct.

With FDA Preemption we live in a town without a sheriff. Be very careful that you don’t come into the company of a bad crowd.

NOT YOUR FATHER'S FDA

Sweeping Changes in Store

It happens in small steps, but every day we learn another bit about the changes the Hamburg/Sharfstein team are bringing to an FDA saddled in dysfunction, corruption, and incapacity. Most recently, they have announced a program that would bring much more transparency to decisons on NDAs and applications for new indications that could unearth material on drugs and devices that are normally not surfaced except in litigation. Read about it in the New York Times:

http://www.nytimes.com/2009/06/02/health/policy/02fda.html?emc=tnt&tntemail1=y

After years of having to put up with an FDA leadership that wanted mostly to hide under rocks or their jockey shorts of their benefactors, it is almost difficult to believe we are seeing this much change. I still wonder how many dead-enders there are who will offer pockets of resistance--and maybe more--as reform goes on. Old and corrupt regimes die hard, as the last eight years have taught us, even at their most grotesque.

One interesting tidbit I didn't know. After the scam around the CLASS study was uncovered, and JAMA learned that it had been given the only part of the data set, the journal explicitly disowned the article. Neverthless, detailers continued to use it to sell Celebrex. I never get tired of quoting what Bob Temple said at the time: That the hype from the JAMA article will always have greater impact than our labeling does.

Ethics in Vogue

In response to student concerns regarding corporations and how they impact individuals and communities, top business schools are offering courses and activities relating to ethics.

Harvard MBA grads are taking an oath of ethics. So far, almost 20% have signed a student-led pledge that promises, “[they] will act responsibly, ethically and refrain from advancing their ‘own narrow ambitions’ at the expense of others.”

Columbia Business School has an honor code which states, “As a lifelong member of the Columbia Business School community, I adhere to the principles of truth, integrity, and respect. I will not lie, cheat, steal, or tolerate those who do.”

“I don’t see this as something that will fade away…It’s coming from the students. I don’t know that we’ve seen such a surge in this activism since the 1960s.” - Diana C. Robertson, professor of business ethics, Wharton University.

It is nice to know tomorrow’s leaders are striving to make the future better. Hopefully, it is not a fad and won’t change with necktie styles.

For the full story, click: A Promise to Be Ethical in an Era of Immorality - NYTimes.com, http://www.nytimes.com/2009/05/30/business/30oath.html?

Hat tip, LESLIE WAYNE, New York Times, Published: May 29, 2009

FDA TO ISSUE NEW ADVERTISING GUIDELINES

The End of Liver Failure, the Musical?

The FDA has sent out a first pass at new guidelines for advertising--both DTCA and to HCPs. Below are excerpts from a WSJ article today. Besides what is included below, there is further comment on ways _not_ to minimize risk information, which include even the level of "general impression."

That's bound to create controversy in a marketing environment.

What do you think? Can DTCA, intended to market and not simply inform, ever be "fair and balanced"? Would absolute risk numbers, as known, needed to be cited, as well as absolute effectiveness numbers related to placebo? Should they be?

***************************************************************

The Food and Drug Administration issued proposed advertising guidelines for drug and medical-device makers, with suggestions on ways to present risk information to consumers and health-care professionals.

The draft guidelines, posted Tuesday on the agency's Web site, aren't binding, but they offer several ways that the industry can avoid running afoul of its rules. The FDA said the omission or minimization of risk information is the most frequent violation cited in dozens of enforcement or warning letters each year.

...As an example, the FDA pointed to music over the details about a drug's side effects. An advertisement for a cholesterol drug, for instance, could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed....
.
The 24-page document goes into detail about how fonts, the type of contrast and even white space in print materials can best present risk information.
The agency said it will accept comments for 90 days before issuing guidelines.

Merck say's investors had enough indications of alleged fraud for Vioxx....

Well, Well, Well......

Seems that The Supreme Court is going to listen to an appeal by Merck in their bid to throw out the investor fraud lawsuit over the Vioxx debacle...

You can read the full article over at Bloomberg.com by clicking on the title of this post which links to it.

But here's an interesting paragraph:
"In its appeal, Merck said the investors had enough indications of alleged fraud by 2001 that they should have begun investigating. The company argued that the 3rd Circuit’s approach would prevent the two-year window from opening until “evidence supporting specific elements of fraud claim falls into an investor’s lap.”

So, a spokesperson for Merck is actually saying, that investors had enough indications of alleged fraud by 2001 and should have launched their lawsuit then rather than wait until 2003. Interestingly the shareholders, say that they actually believed what the company told them about the reasons why Vioxx was 5 times more likely than Naproxen to cause heart attacks....Anyway, I sure hope the folks down under in Australia present this article as evidence in their class action lawsuit......

So, the investors believed them, the doctors believed them, the patients believed them and now the company is "laughing" at everybody for believing them!!!

This has cost billions of dollars to Merck: "Merck agreed in 2007 to pay $4.85 billion to settle more than 26,000 patient lawsuits. The company, which is buying rival Schering-Plough Corp., is based in Whitehouse Station, New Jersey. " Who were the marketing "Wizards" that came up with the idea to play hide-n-seek with the cardiotoxicity data? I wonder what the total tally for Vioxx is with regards to drug discovery, clinical trials, bonuses, honorariums, marketing campaigns, and of course law suits. Has this become one of the most expensive failures? Hmmm, we should start a list....

Seroquel - Emails shows marketing blocked company scientists from expressing concern about safety

Last Tuesday, emails were released to the public that show the Marketing department at Astra Zeneca interfered with company medical and scientific personnel on bringing attention to safety concerns regarding weight gain and other issues.

Click on the title of this article for the link to the full article.

This is no surprise as we have been raising the issue of interference from Marketing in many of the issues facing big Pharma these days....

If it were not for these law suits we would not be able to access this information. No wonder Pharma was so very "Pro" Preemption...

Click on this link to peak at the actual emails that were released last week - PharmaGossip

OBAMA ON PREEMPTION

Memo on Overall Policy

In what I believe is the first general policy statement on federal agency preemption, the Obama administration directly rejects what had been the pattern of the past eight years. In particular, note is made of agency preambles which insert preemption language (or presumption) without basis in statutory law. The Troy-era FDA "preemption preamble" will be the most obvious example to people here.

The UPI story on the policy memo is here:

http://www.upi.com/Top_News/2009/05/20/Obama-issues-memo-on-pre-emption-regs/UPI-19211242855063/

In some respects, the Troy-era position was already dissolved. In Wyeth v. Levine, even the dissent paid essentially no attention to it. The majority blew it aside as irrelevant.

Editorial opinion: ding, dong the witch is dead.

DDMAC BUSTS J&J FOR ULTRAM MARKETING

Stop Doing it; Show Remedial Plan

In a detailed warning letter, DDMAC has demanded that J&J stop marketing Ultram through materials that minimize the drug's risks and overstate its efficacy. The warning letter can be found here:

http://www.fda.gov/cder/warn/2009/Ultram_ER_Warning_Letter.pdf

Some of what is interesting about it is that the letter calls for evidence of a remedial plan as well as ceasing to use the materials. The relevant section reads:

"Because the violations described above are serious, we request, further,
that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in this letter to the
audience(s) that received the violative promotional materials."

It is a single example, but it is one of others in which companies are being required to send out materials to _correct_ problems with earlier marketing. It is also of a few that suggest that the days of deregulating DDMAC, which reached a peak during the Bush administration in which the number of such letters dropped by roughly 600%, has come to a close.

In connection with earlier threads, it also suggests the different kind of FDA which is under construction.

TRYING TO PEG, PEG

What Kind of FDA Commissioner Will Margaret Hamburg Be?

As everyone here knows, the long history of FDA Commissioners has been an oscillation between those who have taken an essentially collaborative approach minimizing confrontation with industry, and those who have been, let's say, more skeptical from the start. ("Skeptical" is not the same as "adversarial," although there have been a few--very few--of those as well.)

Over the last few administrations, conciliation and collaboration have certainly won the day. The mostly "acting" Commissioners during the Bush 2 administration, and even the acting ones, were about as far from adversarial as it is possible to be. But the history goes back longer. Jane Henney, Commissioner during the end of the Clinton administration, also took a generally light-handed approach, and it was her mission to do so. Clinton-Gore believed that only through such a policy would companies do the kind of self-regulation upon which we ultimately depend. The rash of withdrawals from the "class of '97"--and especially the Rezulin saga--raised questions about that thinking. But it certainly did not change.

Hamburg and Sharfstein seem to be ready for some bold steps, but their style is not to make much noise about it. That's probably a good thing. The fact that they (especially Hamburg) have such bipartisan support, and the support of industry as well, could be interpreted in a variety of ways. At the least, it seems likely that virtually everybody now knows what every study has said: FDA as it has been functioning at least since the mid-90s (and, some would say, for much longer) is barely afloat. The former deregulators (Gingrich, et. al.) who are now the preemptors seem certainly to have accepted that sinking FDA entirely--close as they came--is not the future. And "deregulation" is not a winning philosophy in the midst of recent economic history.

So it is an unusual collection of mariners who have gotten on board whatever in FDA is above waterline. Whether they will be able to get it to sail, and work as anything resembling a crew, remain to be seen.

MY PEN IS BIGGER THAN YOUR NOTHING

Size Doesn't Matter!

In a study that has already been done a zillion times, research shows that even small trinkets influence attitudes toward drugs and, presumably, prescribing behavior. Read about it in the NYT:

http://www.nytimes.com/2009/05/19/health/research/19beha.html?emc=tnt&tntemail1=y

The two-part study, "All Gifts, Large and Small," showed the same thing a few years ago. And it has been replicated and replicated elsewhere. Is this because lawsuits are crushing innovation in social psychology? If so, we are all in trouble. Our access to the next life-saving social psychology study could be in jeopardy.

The more interesting studies in this area suggest that the reason "size doesn't matter" is the norm of reciprocity. You scratch my back--even a bit--and it kind of sets me up to scratch yours. Whether an hour of reiki in Hawaii would make you even more inclined to rub my back seeems likely, but perhaps we knew that already.

Of course, we also knew this already.

Whatever.

PFIZER DRUGS FOR UNEMPLOYED

Who says we never say good things about pharma? Actually, the whole point of posts that are critical, at least here, is to support the industry through policy choices that, in the long view, most of us view to be in its interests. Which also means ours.

Many of you will have heard about the Pfizer program extending drug benefits to the unemployed. The details (thanks to our Inspirational Leader) can be found here:

http://media.pfizer.com/files/pfizer_maintain_release_051409.pdf

What may be most impressive, but not surprising, is that the idea of the program--as well as half the funding--appears to have come from Pfizer employees. Needless to say, they know what it is to live in uncertainty re: job loss as well as any group. It is an impressive move.

According to the release, the other half comes from the Pfizer Foundation. Yes, this certainly means it will amount to a substantial tax write-off for charitable donation. But that's why we have such incentives. And, yes, it will reinforce "brand loyalty" and is great PR. But loyalty is a virtue when it is deserved.

So it is a good move all around, as far as I am concerned. Let's see more such, and--ideally--more such from the top down as well. That would be terrific.

Medical Devices

Bad Back Investments

The New York Times has reported New Jersey’s Attorney General, Anne Milgram, announced a settlement with medical device maker, Synthes.

The consumer fraud case alleged that the device maker paid researchers, in company stock, to recommend their ProDisc artificial spinal disk. Although Synthes agreed to the settlement, “in the interest of a speedy resolution to the inquiry,” they did not admit to any wrongdoing.

The settlement stipulates that Synthes is to “disclose any future payments or investments held by doctors involved in researching its products.”

In a statement, Ms. Milgram said:

“It is outrageous that doctors who are testing, and in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make these devices…”

Upon further investigation, it was learned many doctors had investments in the company and that Synthes and doctors had failed to disclose such conflicts to the FDA. In a letter to the FDA and members of Congress, Ms Milgram, criticized the agency for their lack of regulating financial conflicts of interest.

In 2008, The New York Times wrote an article about the ProdDisc and a clinical study that involved almost 240 patients. The research took place at 17 centers; “doctors at about half of the 17 research centers involved in the study… stood to profit financially if the Prodisc succeeded…” Their report to the FDA did not include an “unusually large number of patients,” some of whom had unfavorable outcomes. See: Financial Ties Are Cited as Issue in Spine Study - New York Times

Stay tuned. The Attorney General’s office will be looking into other conflicts of interest within the medical device industry; they have already issued subpoenas to several major device makers.

For the full story see: Medical Device Maker Settles With New Jersey - NYTimes.com

Question: After reading this, how confident would you be about back surgery? Or any surgery? How do you feel about the passage of the Medical Device Safety Act? What else can we do to protect our health and wellbeing?

Hat tip: REED ABELSON, NYT, Published: May 6, 2009

Scare Tactics and Presumptions Continue as Congress Debates Medical Device Safety

As time approaches for Congress to protect our civil rights we see another misguided article intended to scare Congressional decision makers into believing that ending the 2 year old policy of FDA Preemption will destroy the inventiveness of the Pharmaceutical industry.
Shame on them for presuming (or at least presenting the position) that our Pharmaceutical Industry is not capable of making both effective and safe products.

Here again is the article in full to be examined for its falsity. Please also note the source -

Patients Call for Continued FDA Preemption Authority

FDA Best Positioned to Review Medical Technology
WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.
"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"
"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."
Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."
The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Patients came to Washington from across the country to explain the importance of medical devices in saving and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:
Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.
The patients emphasized how critical it was for them to have access to devices when they needed them most.
"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."
"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replacement surgery.
"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."
Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.
"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.
"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."
The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.
SOURCE AdvaMed

STUDY ON MEDICAL DEVICE PREEMPTION - Your Thoughts?

Title Revision 2

I will go ahead and copy the report on this study word for word as I think it is important to see.

Your thoughts on this are appreciated.


Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access

BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment.
The paper, "The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs," comes as Congress considers legislation that would remove Federal preemption of state rules and litigation that exists for a small percentage of medical devices that undergoes the most rigorous FDA review. The report highlights the damaging economic, health and societal impacts the legislation would have on patients, medical device industry innovation and employees, and the public health.
"As economic and health care researchers, we felt it was important to examine how this regulatory change could harm innovation, and ultimately impact the patients who rely on these treatments and the people who are employed by the device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor in Applied Economics, MIT Sloan School of Management. "Congress should carefully weigh any policies that could increase health care costs and reduce high-paying jobs, particularly during an economic downturn."
The authors' research highlights the consequences to multiple stakeholders - patients and the public health, medical device inventors and manufacturers, their employees and the government - if medical device preemption were eliminated. For example,
Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.
Physicians will increasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.
"The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."
"Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.
The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.
SOURCE Berndt Associates

Frankenstein, Dracula, U.S. Chamber of Commerce Coming to a Theater Near You!

The U.S. Chamber of Commerce wants you to know,

“…the biggest problem facing the country today isn’t the financial meltdown, record unemployment, two wars, swine flu, toxic peanut butter… It’s lawsuits … by average working families, especially the ones against corporate executives who defraud and poison people.”

The ads will be run at Regal theaters in Washington, D.C., and may soon be at a theater near you.

To read more, please see: ThePopTort: U.S. Chamber of Commerce Finally Makes it Fun To Go To The Movies!

Hat tip: thepoptort.com

Controlling Conflict of Interest

The prestigious NEJM have published an article in the current on-line edition "Controlling Conflict of Interest - Proposals from the Institute of Medicine", By Sr. Robert Steinbrook.

The article starts by defining what is conflict of interest :"a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The primary interests of concern include "promoting and protecting the integrity of research, the welfare of patients, and the quality of medical education." Secondary interests "may include not only financial gain but also the desire for professional advancement, recognition for personal achievement and favors to friends and family or to students and colleagues."

The article covers the recommendations of the IOM and of particular interest to me is the following from the article: Academic medical centers, teaching hospitals, faculty members, students, residents, and fellows should "reform relationships with industry in medical education"; these institutions and professional societies "should provide education on conflict of interest."....

To read the entire article, please follow this link: http://content.nejm.org/cgi/content/full/NEJMp0810200?query=TOC

MY TIME TO GAG

Chantix Kicking Butt in Wisconsin

With multiple hat tips and bows to our inspirational leader, we learn that Pfizer has sponsored a continuing education online course through the University of Wisconsin which promotes Chantix. The "course" ignores both other first-line treatments and the variety of problems associated with the drug. More than two-thirds of those who have taken the "course" are MDs.

In the Milwaukee article cited, the following is noted about a recent JAMA report: "In the first quarter of 2008, Chantix accounted for more serious injuries (1001) than the top ten best-selling drugs combined (837).

Here is a link to the relevant article:

http://www.jsonline.com/news/43837682.html

You've come a long way, baby.

Medical Device Safety Act Petition

There is an online petition supporting the passage of the Medical Device Safety Act of 2009.

To add your name, please see:
http://www.PetitionOnline.com/tftwj23/petition.html
or
Medical Device Safety Act Petition

Thank you

MERCK TRIES PAY FOR PERFORMANCE DRUG COST

As reported by the New York Times today -
Drug Deals Tie Prices to How Well Patients Do

According to New York Times -

"In a deal expected to be announced Thursday, Merck
has agreed to peg what the insurer Cigna
pays for the diabetes
drugs Januvia and Janumet to how well Type
2 diabetes patients are able to control their blood sugar. "

An interesting concept that has been tried in other countries. Is this the way to go? Could this initiate the effective top down directive that permeates the corporate culture or just another gimmick to bolster sales?

If this practice became common place what might it mean to the pharmaceutical landscape?

FDA MEETING ON DIVISIVE DEVICES

ALL HANDS ON DECK, NONE BEHIND BACK

After months of reports of relative "horror stories" emerging from FDA's device approval and review departments, the FDA will today hold a meeting to discuss these issues. The NYT report is at:

http://www.nytimes.com/2009/04/22/health/policy/22fda.html?_r=1&hpw

This should be the first test of whether the Obama FDA's leaders will respond differently to dissenting reviewers than more recent versions of the agency. It will certainly be interesting and important to follow.

UNITED AGAINST FDA PREEMPTION

Two Groups Join Forces Against Device Preemption and Michigan's Shield Law

(yes, an issue dear to some of our hearts....)

Two Anti-preemption Groups Unite
For release, April 20. 2009

Americans for Drug and Device Accountability (ADDA) and Justice in Michigan (JIM) have announced their consolidation into a single organization dedicated to fighting FDA preemption in the drug and device arenas, and on both the state and national levels. Their updated website is http://pharmaccountability.org/.

ADDA was formed one year ago and consists of business people, patient advocates, healthcare professionals, and concerned citizens. Members represent the full political spectrum—from conservative Republicans to liberal Democrats. They also include current and former employees of the pharmaceutical industry who agree that FDA preemption is bad policy—a disaster for patient rights, public health, and industry accountability. A petition initiated last year quickly gathered nearly 1,000 signatures and comments, including those of Dr. David Graham of FDA, Dr. Joel Lexchin, Dr. Doug Bremner, Dr. Howard Brody, Vera Sharav, Tom Lamb, and many more.

JIM was formed four years ago, primarily by social scientists, policy analysts, and bioethicists in Michigan. Along with issues of healthcare and social justice generally, the organization’s focus has been on Michigan’s unique drug industry shield law, passed in 1996, that fully bars Michigan citizens from bringing suit over drugs approved by the FDA. Michigan’s law is the most draconian in the nation. Courts have ruled that even the most egregious negligence or fraud would not open the courthouse to Michigan citizens. That is thirteen years of justice denied.

Both ADDA and JIM believe that it will take legislative action to restore justice. On the national level, this means the Medical Device Safety Act which would restore the right of citizens to bring suit in the medical device arena. In Michigan, it means rescinding drug industry immunity. The Michigan House has already voted twice to do so. But the bills have been killed by a small number of immunity supporters in the Michigan Senate.

The national and state levels of these issues reinforce each other. Across both parties, and across this land, citizens are recognizing that the days of special interest legislation—along with the era of government arrogance and irresponsibility—are drawing to a close. Before long, we will look back at this time as a nightmare from which we will be thankful to have awakened. In the meantime, Americans for Drug and Device Accountability and Justice in Michigan fight toward that dawn.

Join us.

http://pharmaccountability.org/

Shock Corridor!!

Did you know that in America, the land of human rights, you can legally be given repeated electric shock treatments, for no reason, for years and years, and no one can help prevent that from happening?

Ray Sandford, 54, lives in a group home in Minneapolis. He has not been charged with any crime, and his mental problems subsided long ago. However, against his will, Ray has received over 40 court ordered shock treatments.

Here are some of the sad facts:

● “Electroshock machines have never been tested for safety or efficacy.

● They were "grandfathered" into the system when the FDA assumed jurisdiction over medical devices in 1976.

● In 1990, Congress ordered the FDA to have shock machines tested.

● Both ECT manufacturers and the closely knit shock advocates--most of who have significant financial interests in ECT--vehemently opposed safety tests.

● The agency went along with the vested stakeholders and failed to comply with the congressional order.

● Electroshock--unlike other medical devices--is most often forced on
non-consenting patients” - Vera Sharav (AHRP)

Beyond the fact that human rights are being trampled, the safety of these devices is not even certain. The Medical Device Safety Act of 2009 is being considered by Congress. If you believe Americans are in need of better protection, please contact your U.S. Representatives and Senators to let them know how you feel. Thank you.

-Hat tip to Vera Sharav of ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

See: Alliance for Human Research Protection - "Doctors of Deception" Electroshock machines to Undergo safety & efficacy tests

See also: In Their Own Words: ECT Survivor, Advocates Speak Out Against Continued Forced Electroshocks Twin Cities Indymedia Movement Media for Minneapolis-St. Paul

WE WON!

David Vladeck to FTC

When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.

Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.

Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.

So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.

So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,

http://www.democraticmedia.org/jcblog/?p=791

open a brewsky, and say--with relevant satisfaction--"We won."

And they didn't.