The prices of brand-name medications have continued to increase despite calls from all three major presidential candidates for pharmaceutical companies to make their products more affordable, the Wall Street Journal reports. Wholesale prices for the 50 brand-name medications with the most sales increased by an average of 7.82% in 2007, compared with increases of 6.73% and 6.22% in the previous two years, according to Delta Marketing Dynamics. The overall U.S. economy had an inflation rate of 4.1% in 2007.

In some cases, pharmaceutical companies have increased the prices of brand-name medications scheduled to lose patent protection to prompt patients to switch to similar, newer products that will have patent protection for a number of years. William Little, president of Delta, said, “Companies are under great pressure to deliver revenue, and it’s becoming increasingly difficult to do so as generics displace profitable brands.”

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Researchers from York University, collecting data directly from industry and from doctors, found that in 2004 pharma spent $235.4 billion: 24.4% on promotion; 13.4% for research and development. They also found the number of promotional meetings jumped dramatically from 120,000 in 1998 to 371,000 in 2004. Further evidence the U.S. pharmaceutical industry is increasingly market driven—not driven by life-saving research. The authors also note the money spent on marketing is likely an underestimate.

for full story, copy and paste this link:
http://www.motherjones.com/blue_marble_blog/archives/2008/01/6791_pharma_spends_t.html

An article in this week’s New England Journal of Medicine, entitled “A Pivotal Medical-Device Case” raises an important issue about the fairness of our civil justice system. Here is the link to the article.
http://content.nejm.org/cgi/content/full/358/1/76?query=TOC.

The issue raised by the article is not a new one, but the Defendant is asking the the United States Supreme Court to give broad and sweeping new protection to companies who manufacture defective and dangerous medical devices, even if those devices kill or seriously injure patients. The case discussed in the article is Riegel v. Medtronic, in which the patient was seriously injured because the balloon utilized in a coronary angioplasty surgery ruptured. The Plaintiff in the lawsuit claims that the balloon device was defective. The legal issue is now whether the injured patient is deprived of a legal remedy simply because the Food and Drug Administration had approved the device for use.

The history of medical device liability in this country is not generally known to the public. Some remember the Dalkon shield cases of the 1970’s, in which thousands of women either died or were seriously injured as a result of defective IUD devices. Following those cases, Congress gave the FDA authority to regulate the design and approval of medical devices. Yet, an injured patient has still retained the right to access to the justice system if injured by a defective product, even though the FDA has approved the product. The question before the Supreme Court in Riegel is whether the intent of Congress in granting such authority to the FDA, was to completely remove from the justice system the ability to adjudicate cases claiming that a medical device is defective. So, ask yourself if you would like for the FDA, with all of its political ramifications and lobbying influence, to determine whether an injured patient can have access to the justice system.

Recent news has pointed out the influence of pharmaceutical and medical companies, and their lobbyists, on the FDA approval process and on doctors’ decisions regarding drugs and medical devices. http://www.americastunnelvision.com/editable/medication_error.html. The Supreme Court is now considering whether that influence, with all of its attendant dangers, will deprive patients injured by medical devices of their day in court. Although this case has not received the coverage it deserves in the press, it is vitally important for the rights of injured patients.

Michael Townes Watson, author of America’s Tunnel Vision—How Insurance Companies’ Propaganda Is Corrupting Medicine and Law. www.StopMedicalError.com.

 Having been commissioned by the Food and Drug Administration (FDA) to evaluate the U.S. drug-safety system, the Institute of Medicine (IOM) published a report, The Future of Drug Safety, in September 2006 identifying weaknesses in the laws, regulations, resources, and practice of ensuring drug safety.¹ Some of the IOM’s recommendations were directed toward Congress, which it believed should increase FDA funding and regulatory authority. Some outlined ways in which other federal agencies could work in partnership with the FDA for the public good. But most of the report outlined deficiencies that the FDA itself — or the Department of Health and Human Services (DHHS), to which it belongs — should correct.

In general, the IOM implored the agency to “embrace a culture of safety” by increasing the priority accorded to the safety of patients. Such an emphasis could have ramifications for medical care that would be as broad and positive as those that the 1999 IOM report on medical error, To Err Is Human,² has had for the health care system. Sadly, the FDA’s official response falls far short of what the American public expects and deserves.³ Indeed, it highlights the very reason that the agency — with which I have had some firsthand experience — is in need of monumental change: its philosophy is no longer aligned with its regulatory mandate.

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This year, Congress had to consider reauthorization of the Prescription Drug User Fee Act (PDUFA), which it must do every 5 years. Under PDUFA, the major funding for the review of new drugs by the Food and Drug Administration (FDA) comes from user fees paid by pharmaceutical companies. This mechanism has been controversial because, although it was designed to accelerate the drug-approval process and can make new drugs available to patients without delay, it has directed no money to the postmarketing assessment of drug safety. In addition, some believe that user fees pose a conflict of interest for the FDA. Nonetheless, to ensure that the FDA has adequate financial resources, both the House and the Senate versions of the bill not only maintain these user fees but increase them (with some of the money now directed to safety assessment).

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House vote for a major prescription drug safety and FDA reform bill is good news for Americans who have been kept in the dark about dangerous drug side effects, and Consumers Union is urging conference committee members to not weaken consumer protections in the bill before sending it to the President.
“The House has taken a major step forward in protecting consumers and putting the pharmaceutical companies on notice by passing the first major drug safety reforms in 45 years,” said Jim Guest, president of Consumers Union, publisher of Consumer Reports. “Now it’s up to a small group of House and Senate members to reconcile the two drug safety reform bills, and it is vital they keep the strongest safety provisions in the bill sent to the President.
“As we approach the third anniversary of the news that Vioxx may have caused thousands of Americans to have heart attacks or strokes, it is well past time for Congress to deliver to the President a bill that will help prevent such future drug safety disasters,” Guest added.

Robert N. Butler M.D., a New York physician and nationally known expert in gerontology at Mount Sinai Medical Center, has added his name to the long list of leading doctors and health consumer groups who are endorsing passage of Rx gift disclosure legislation, S.2971 (Maziarz)/A.7468(Gottfried). In the meantime, drug companies are trying to halt the legislation, claiming it is not necessary.
“AARP welcomes the support of this critical issue from a national leader here in our state,” said Lois Aronstein, AARP New York State Director. “With just one week left in the New York State Legislative session, we have an important and timely opportunity to adopt a statewide policy to require disclosure of certain marketing activities. Unfortunately, drug companies and their army of lobbyists have come to Albany to kill this bill when so many New Yorkers could benefit from its passage,” she said.
The bill requires drug companies to annually report to the New York State Department of Health for disclosure to the public, all gifts (excluding free samples) to health care practitioners who prescribe drugs when such gifts have a value of $75 or more.
Dr. Robert N. Butler, President and CEO of the International Longevity Center and Professor of Geriatrics and Adult Development at the Brookdale Department of Geriatrics and Adult Development at Mount Sinai Medical Center, wrote a letter to members of the New York Legislature calling on them to support “legislation that will, in my view, take a major step towards strengthening patient confidence and limiting industry influence on the medical profession.”

Every 5 or 10 years, Congress enacts major legislation addressing pressing issues at the Food and Drug Administration (FDA). This year, the biggest reforms since at least 1997 are expected. A decade ago, reform was motivated by the perception that the agency wasn’t getting new medicines to patients as efficiently as possible. Today, a leading concern is that it isn’t protecting the public from drugs’ risks as effectively as it might. A key incident in raising such concern was the 2004 withdrawal by Merck of rofecoxib (Vioxx) because of an apparent increased risk of serious cardiovascular events. The withdrawal came amid questions about the FDA’s handling of a possible association between selective serotonin-reuptake inhibitors and suicidal ideation in adolescents. Further concerns were raised about the agency’s handling of staff disagreements about these and other drugs. In this context, the FDA sought a review from the Institute of Medicine (IOM).

The IOM’s September 2006 report included a broad range of recommendations.¹ Legislators have introduced various proposals reflecting these and other ideas, and the FDA has issued an action plan.² Major legislation on drug safety is almost certain to be enacted before fall, as Congress reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides fees from drug manufacturers to cover part of the cost of regulation. This legislation will influence the way safety issues are evaluated and addressed, with important implications for the available information about drugs’ risks and benefits and for physician prescribing.

It represents an opportunity to implement a more systematic approach to improving drug safety and effective use, if some challenges can be overcome. Steps intended to enhance safety could also increase costs and reduce access to beneficial drugs. Moreover, the tools available for learning about drugs and ensuring their effective use have changed enormously since the last time drug-safety legislation was seriously considered. Electronic data on prescription use and patient outcomes are now widely available, and prescribing is influenced by sophisticated drug-utilization–management programs, newer forms of drug coverage including tiered benefits, and extensive Internet resources for consumers.

^{for full article in  New England Journal of Medicine, click here}

Democratic lawmakers used their majority status to pass the measure. They said government negotiations in some cases could lower the cost of prescription drugs for Medicare beneficiaries. People in Medicare drug plans now rely on their insurers to conduct those negotiations.

When you’re negotiating on behalf of 43 million people, that’s leverage,” said Sen. Kent Conrad, D-N.D.

The legislation approved Thursday simply strikes a clause that prohibits the secretary of Health and Human Services from interfering in the negotiations between drug makers, insurers and pharmacies. The committee approved the bill 13-8, with two Republicans, Sens. Olympia Snowe of Maine and Gordon Smith of Oregon, voting with the Democrats on the committee.

Sen. Max Baucus, D-Mont., the bill’s author, said the prohibition on government negotiations went too far. “We eliminated the government’s role in getting fair drug prices for seniors,” he said.

Republicans noted that the Congressional Budget Office, in reviewing the measure, found it would have a “negligible effect” on federal spending. Sen. Charles Grassley, R-Iowa, said the bill made for a good sound bite, but not effective policy. He said the program is already costing less than expected and that Medicare beneficiaries say they’re happy with the drug benefit.
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Researchers at the nonpartisan Center for Public Integrity said that the drug industry spent nearly $111 million on lobbying in 2005, a record for the sector in any one year. The record pace appeared to be sustained in the first half of 2006, the report said.

Pharmaceutical industry officials said the report distorted the industry’s role in Washington, which they say is primarily educational and scientific. They said industry spending was designed to ensure that new drugs for intractable illnesses get government approval to be marketed.

“The Center for Public Integrity’s report, not surprisingly, misses the mark when it comes to efforts by America’s pharmaceutical research companies to educate policymakers,” said Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America. “Our priority has always been to help advance patient health and … we have supported policies and programs that bolster patient access to safe and effective medicines.”

Lobbying is only one facet of the industry’s influence. Drug company sources also accounted for more than $19 million in political contributions to candidates in last year’s congressional election, mainly Republicans. And user fees paid by drug makers make up more than half the budget of the Food and Drug Administration centers that evaluate new drugs.

The industry’s budget enabled drug makers to field about 1,100 agents to lobby congressional committees and administration offices in each of the last two years, the study said.

The industry achieved several of its major objectives, the report added, including upholding the government’s ban on imports of lower-cost medications from abroad.

“Essentially what they did is they blocked any legislation,” said M. Asif Ismail, director of the center’s project to monitor the drug industry. “There have been several attempts to revisit this issue, and importation is still illegal.”

With strong support from the Bush administration, the industry also appears to be in a position to make sure the prohibition against Medicare negotiating drug prices for seniors in its prescription program remains intact.

These battles are expected to be fought more fiercely this year because Democrats now control Congress. In the past, senior Republican leaders were able to keep import legislation from getting a floor vote.