PhRMA Shows Its Committment to Transparency With Revised Principles on Conduct of Clinical Trials

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors announced yesterday their unanimous endorsement of revised principles to increase transparency in medical research through their newly revised PhRMA Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results.  The revised principles are part of an effort to encourage behavior that benefits the healthcare community and the public through objectivity in research and strengthened transparency in medical studies.

PhRMA states that the Principles of Conduct, which are to take effect on October 1, 2009, will:

Fortify our commitment to patients and healthcare professionals by increasing transparency in clinical trials, enhancing standards for medical research authorship and improving disclosure to manage potential conflicts of interest in medical research.

The pharmaceutical and biotech industries have been under recent pressure to become more transparent, specifically concerning the disclosure and publication of clinical trial results, the disclosure of physician payments/reimbursement for conducting clinical trials, and authorship standards.

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The FDA to Evaluate 25 Medical Devices Marketed Before 1976 Without Premarket Approval

The FDA announced last week that they are requiring the makers of 25 medical devices marketed before 1976 to submit safety and effectiveness information regarding their devices.   These devices were allowed onto the market without undergoing the current FDA testing and classification because they were first manufactured before the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, and include many of the riskiest devices — defibrillators, pacemakers accessories, and heart valves.

The FDA classifies medical devices into three categories, with class III being the riskiest devices– as such, they require premarket approval.  Currently, the 25 pre-amendment devices in question are class III, but based on the 1976 law these devices were not required to undergo premarket approval at the time.

The FDA will use the submitted safety and effectiveness data to review the devices and classify them into what they deem to be the appropriate risk category.  According to the FDA, if a device is found to be a class III device, the manufacturer will need to submit a premarket approval application.  If the device is moved to class I or II, it will not require premarket approval.

The FDA’s announcement comes after the Government Accountability Office reported in January that the FDA was not doing enough to thoroughly evaluate the safety and effectiveness of many medical devices marketed before 1976.  They urged the FDA to review the devices and said that “it is imperative that FDA take immediate steps” to fix this review and approval process for devices.

Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said regarding the FDA’s new requirement:

We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency.  New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.

This decision to evaluate these devices and further public safety comes after recent criticism of the agency, such as the opinion expressed publicly by a number of  FDA scientists that the “FDA is fundamentally broken.”  We have blogged about the much maligned agency on numerous occasions, with specific emphasis upon the Center for Devices and Radiological Health and a decline in medical device lab inspections.

House Subcommittee Hearing Scheduled Today: The End of “Pay to Go Away” Deals Between Drugmakers?

A House Energy and Commerce subcommittee hearing was scheduled for today regarding the practice of brand-name pharmaceutical companies paying generic drugmakers to delay the launch of their drugs.  These agreements, sometimes known as “pay to go away” arrangements, allow the brand-name pharmaceutical companies to benefit by keeping the cheaper generic drugs off the market for a period of time,  and essentially holding a monopoly on the drug for longer.  The generic drug company also benefits, as they are paid to simply delay their drug’s entrance into the market.

The Wall Street Journal reported that the FTC has fought these payments for years, Democrats have discussed passing legislation to forbid such deals, and President Obama has promised to stop the arrangements in his budget.  Senator Herb Kohl (D-Wis.) introduced a bill in February to abolish these deals and Rep. Bobby Rush (D-Ill.) introduced a comparable bill in the House last week.

The WSJ states that generic drugs can cost as little as a quarter of the brand-name drug, which can ultimately save billions of dollars in drug costs.  Eliminating the deals that keep the generic drugs off the market would therefore create significant savings to the country’s health care system.  Scott Hemphill, associate Professor at Columbia Law School, told the WSJ that ten brand-name drugs with about $17 billion in annual sales are now protected by the agreements, including Pfizer’s Lipitor.  Pfizer said that this was not the case.

Since 2001, the FTC has filed six suits to stop these deals, with little success.  However, in February, FTC Commissioner Jon Leibowitz said that he believed Obama’s administration was going take action to stop the “pay to go away” deals.  According to Medical News Today:

Leibowitz said “The new administration does seem to recognize that this is a real problem.”  He added that “fixing it … would actually help pay for health care reform.” Leibowitz said FTC will take a two-pronged approach to stopping “pay-for-delay” settlements. First, the agency will challenge the most anti-competitive settlements in court, and secondly, it will support legislation against such deals. Leibowitz said he expects the Obama Department of Justice to be “much more supportive” of legal challenges to the settlements than the Bush administration. He added that it also is possible “the-pay-for delay settlement issue or problem will get resolved in health care reform, and … if that happens, then it will presumably get resolved more expeditiously.”

U.S. District Court Says FDA Decision on Plan B Was Influenced by Political Pressure

A U.S. District Court ordered yesterday that the Food and Drug Administration (FDA) allow for the sale of the Plan B morning-after pill to females 17 years old and older without a prescription.  Since 2006, based on a FDA decision during the Bush administration, Plan B has been available over the counter only to women over the age of 18.  The FDA must comply with the order within 30 days.  Plan B is a back-up birth control pill that can reduce the chance of pregnancy when taken within 72 hours of unprotected sex or contraceptive failure.  It is manufactured by Duramed, a subsidiary of Barr Pharmaceuticals.

Judge Edward Korman of the Eastern District of New York wrote in his decision that the FDA was influenced by political pressure and their conclusion was not based on the scientific evidence available concerning the drug.  Judge Korman wrote that:

These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making.  Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.

Judge Korman’s statements echo similar sentiments expressed as of late that the “FDA is fundamentally broken.” We have blogged about the subject, and the alleged political influences on FDA, in a number of posts most recently.

The WSJ Health Blog wrote today that the ruling specifically blasts past and current FDA officials such as acting Surgeon General and acting Secretary for Health and Human Services, Dr. Steven Galson, and then-FDA Commissioner Lester Crawford.

The FDA is reviewing the decision and the WSJ reports that “If the Obama White House doesn’t appeal the ruling, it would mark the fourth significant departure from Bush administration positions on controversial health-care issues since President Barack Obama took office.”

Susan Woods was a top FDA official who resigned in 2005 due to the delays surrounding a FDA decision on the pill.  The Associated Press quoted her as saying:

What happened with Plan B demonstrated that the agency was off track, and was not being allowed to do its job properly.  This is telling the FDA to move forward with a focus on good science.

The President and CEO of the Reproductive Health Technologies Project, Kristen Moore, said “This ruling validates what we have known all along - politicians trumped the scientists when it came to the FDA’s handling of Plan B.”

Naturally, many conservative groups are angered over the ruling.

Unpublished 1997 Study Linked Drug to Weight Gain and Diabetes, Now Thousands Sue Claiming They Were Not Warned of Side Effects

The Washington Post reported today on the “silenced drug study” of AstraZeneca’s antipsychotic drug, Seroquel.   The study, known as Study 15, was conducted in 1997 and showed an increase in weight gain and diabetes among Seroquel users.  The results were never published and the information was not released to the public or physicians.  The study was, however, provided to the FDA but they did not have the authority to publish the results.  Seroquel was approved by the FDA in 1997 after they received the study’s findings.

AstraZeneca contends that they did disclose the drug’s health risks on the label, as required by the FDA.  Spokesperson Tony Jewell wrote in an email to The Washington Post that the results of Study 15 “did not identify any safety concerns.”  Study 15 compared Seroquel to another similar drug, Haldol.  Jewell also wrote that “A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret.”

Over 9,000 lawsuits have been filed against the drug by patients who experienced weight gain, hyperglycemia and diabetes.  It is through these lawsuits that internal documents and details regarding the buried study have emerged.  Internal documents show that AstraZeneca was well aware of the results indicating significant weight gain and worked to spin the results favorably.  The company presented information that Seroquel caused patients to lose weight at two meetings in 1999. This data was based on a much smaller company-sponsored study even though AstraZeneca had concerns with the study and the doctor who conducted it.

The Washington Post says:

The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.

An obvious concern with unpublished or silenced studies is that they may lead physicians to make medical decisions without all the information that should be available to them.  As the Center for Health and Pharmaceutical Law & Policy recommends in its recently-released whitepaper:

All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature.  Transparency in the relationship of industry and physicians would be critical tool in this effort.

Biopharmaceutical Companies Continue to Advance and Invest In Rough Economic Times

A recent press release from the Pharmaceutical Research and Manufacturers of America (PhRMA) reports that pharmaceutical and biotech companies continue to invest substantial amounts of money into research & development, despite the dismal current economic situation.  Research from PhRMA and Burrill & Company shows that “pharmaceutical research and biotechnology companies invested a record $65.2 billion last year in the research and development of new life-changing medicines and vaccines — an increase of roughly $2 billion from 2007.”  There are almost 30,000 medicines in development in the country right now.

In a time when most other industries are struggling and the unemployment rate is the highest it has been in 25 years, it is encouraging to see that the biopharmaceutical industry, one whose existence and success directly impacts the health of our nation, is continuing to invest and advance.  For example, this week we saw Merck make a serious investment through its $41.1 billion merger with Schering-Plough.    In addition, as we posted in December, Merck announced its plan to enter the biosimilars market, which will cost an estimated $1.5 billion.

Biopharmaceutical companies are continuing to spend on R & D, and the great majority of their investments are within the US.  According to “The Biopharmaceutical Sector’s Impact on the U.S. Economy: Analysis at the National, State, and Local Levels”, a study out this month by Archstone Consulting and Dr. Lawton R. Burns, this industry creates millions of US jobs and contributed three times as much to the GDP than the average of other industries and sectors in 2006.

Besides the struggling economy, drug companies face other challenges.  As we recently reported, President Obama’s health reform plan may negatively impact pharmaceutical companies through an increased discount to Medicaid (from 15.1% to 22.1% of avg. manufacturer’s price).   Despite the economic crisis and health care reform changes, it is hopeful to hear the industry’s continued commitment to progress. Said PhRMA President and CEO, Billy Tauzin:

America’s pharmaceutical research and biotechnology companies are not immune to the challenges presented by our current economic crisis.  However, the important work that we do every day in the battle with disease cannot stop. The U.S. is the world’s hotbed of medical innovation, and throughout the country, we remain committed today to finding tomorrow’s cures, despite the incredible challenges that are posed by the current economy.

Supreme Court Rules that Preemption Does Not Exist in Drug Labeling Case

The Supreme Court held today, in a 6-3 decision, that FDA federal approval of drug warning labels does not preempt state regulations and therefore does not prohibit claims of insufficient drug warnings brought under state law.  The ruling in Wyeth v. Levine upheld a $6.7 million award to Diane Levine, whose arm was amputated after a flawed injection of Wyeth’s anti-nausea drug, Phenergan.

The case centered on the drug’s labeling, as Ms. Levine argued that the label did not warn of the risks associated with administering the drug through “IV push” and that it must contain these warnings in accordance with Vermont law.   The NY Times reported that Wyeth wrote in their brief that they “could not change Phenergan’s labeling to comply with Vermont law without violating federal law.”   They argued that because the drug label was approved by the FDA, a federal agency, Levine’s state law claims were preempted by federal regulations.  The Supreme Court disagreed with this argument, holding that Wyeth could have complied with both state and federal regulations, and reaffirmed the ruling of the Vermont Supreme Court.

Senate Judiciary Committee Chairman Senator Patrick Leahy (D-Vt.) filed an amicus brief for this case in August, 2008.  Today he issued the following statement regarding the Court’s decision:

This decision to uphold the Vermont Supreme Court’s ruling in Wyeth v. Levine has far-reaching effects on the ability of countless Americans to seek justice in their courts. Diana Levine’s life and career have suffered irreparable - yet preventable - damage. The Court’s decision soundly rejects the anti-consumer position of the Bush administration, and reaffirms Congress’ primacy concerning the extraordinary power to preempt state law. Most of all, the decision reclaims for all American citizens the ability to seek justice in their courts of law.

In the 110th Congress, the Senate Judiciary Committee held several hearings to examine the way in which federal agencies have overstepped their authority in the area of preemption, and, given what I viewed as an untenable position by the drug maker and the former administration, I filed an amicus brief with the United States Supreme Court in Ms. Levine’s case. I am gratified that the Court has spoken so clearly on this issue. While recent Supreme Court decisions have shielded big business from accountability and have undermined stronger state consumer protections, this ruling alters that earlier course and affirms that Congress never intended to preempt state laws in the way claimed by Wyeth and the Bush-Cheney administration, claimed. This is a clear victory for Ms. Levine, and for all American consumers. It is also a clear vindication for our own laws and courts in Vermont.

Wyeth’s comments on the decision can be found here.

Medical Imaging: Why Are We Spending So Much?

It is not only the sheer number of medical imaging tests (necessary and unnecessary), such as MRIs, CT scans, and PET scans, that is contributing to the overall cost of medical imaging.  Other factors adding to the fact that insurers’ expenditures on medical imaging are growing at 18-20% annually are the use of older imaging machines, the growing trend of physicians who have ownership interests in imaging machines, and radiologists’ high compensation.

Currently, imaging centers are not required to, but may choose to, become accredited by The American College of Radiology.   Therefore, the age of an imaging machine is not regulated and older machines may produce blurry or poor scans.  This leads to repeat tests and misdiagnoses, which can result in an illness remaining undetected or even unnecessary surgery, as is depicted in the NY Times article.

In the current system, compensation is not based on the quality of the scan and therefore there is no incentive for the facility or physician to purchase a new and very costly imaging machine.  As the Wall St. Journal Health Blog points out radiologists read the scans and the insurer who pays for the scan never sees it to determine its quality. Read more